effectiveness and cost effectiveness of dose administration aids

EFFECTIVENESS AND COST EFFECTIVENESS

OF DOSE ADMINISTRATION AIDS (DAAS)

PHASE 3

FINAL REPORT

11 May 2006

Project conducted by

Quality Medication Care Pty Ltd in conjunction with the

Therapeutics Research Unit, University of Queensland,

Princess Alexandra Hospital

This project was funded by the Australian Government Department of Health and Ageing as part of the Third Community Pharmacy Agreement through the Third Community Pharmacy Agreement Research and Development Grants (CPA R&D Grants) Program managed by the Pharmacy Guild of Australia

Quality Medication Care Group, School of Medicine, University of Queensland

Project Chief Investigators: Professor Mike Roberts

Quality Medication Care Pty Ltd &

Director, Therapeutics Research Unit,

Southern Division of School of Medicine,

University of Queensland

Doctor Julie Stokes

Therapeutics Research Unit,

Southern Division of School of Medicine,

University of Queensland

Project Manager: Julie Stokes

Report prepared by: Julie Stokes, Clare Ientile and Michael Roberts

Contributors: Geoffrey Lewis

Chris Doran

Alison Haywood

Beverley Glass

Elizabeth McDowell

Martyn Symons

James Leslie

Quality Medication Care Group, School of Medicine, University of Queensland i

TABLE OF CONTENTS LIST OF ABBREVIATIONS.......................................................................................................VIII

PREFACE ....................................................................................................................................IX

EXECUTIVE SUMMARY ..............................................................................................................X

AIM ....................................................................................................................................... X

APPROACH .................................................................................................................................. X

FINDINGS ................................................................................................................................... XI

RECOMMENDATIONS ..................................................................................................................XIV

1. INTRODUCTION................................................................................................................. 1

1.1 AIMS AND OBJECTIVES ..................................................................................................... 3

2. STUDY PLAN ..................................................................................................................... 4

2.1 ETHICAL APPROVAL ......................................................................................................... 6

2.2 THIS REPORT ................................................................................................................... 6

PART A - BEST PRACTICE MODELS ........................................................................................ 7

3. DEVELOPING BEST PRACTICE MODELS - METHODS................................................. 7

3.1 CONSULTATION................................................................................................................ 7

3.1.1 DAA Expert Panel ..................................................................................................... 8

3.1.2 Focus groups ............................................................................................................ 8

3.1.2.1 Recruitment ....................................................................................................................9

3.1.2.2 Conduct ..........................................................................................................................9

3.1.2.3 Analysis of focus groups ..............................................................................................10

3.1.3 Pharmacy dispensary assistant/technician interviews............................................ 10

3.1.4 GP perspectives...................................................................................................... 11

3.1.5 Legal viewpoint on best practice............................................................................. 12

3.1.6 Stability of medications in DAAs ............................................................................. 12

3.1.7 Other consultation................................................................................................... 13

3.2 PRODUCTION OF DRAFT BEST PRACTICE MODELS............................................................. 14

4. DEVELOPING BEST PRACTICE MODELS - RESULTS................................................ 15

4.1 CONSULTATION.............................................................................................................. 15

4.1.1 DAA Expert Panel ................................................................................................... 15

4.1.2 Summary of focus groups....................................................................................... 17

4.1.2.1 Participants...................................................................................................................17

4.1.2.2 Community pharmacy views.........................................................................................19

4.1.2.3 Hospital pharmacists views ..........................................................................................21

4.1.2.4 RCF management and staff views ...............................................................................22

4.1.3 Pharmacy dispensary assistant/technician interviews............................................ 24

4.1.3.1 Roles and practices experienced by respondents ........................................................25

4.1.3.2 Problems associated with DAAs and their solutions experienced by dispensary

assistants/technicians ..................................................................................................29

4.1.3.3 Training and instruction on DAA preparation received by dispensary

assistants/technicians ..................................................................................................35

4.1.3.4 Legislative, standards and guideline framework related to DAAs.................................37

4.1.4 GP perspectives...................................................................................................... 38

4.1.5 Other consultation................................................................................................... 39

4.2 LEGAL PERSPECTIVE ON BEST PRACTICE ......................................................................... 42

Quality Medication Care Group, School of Medicine, University of Queensland ii

4.3 DRUG STABILITY IN DAAS AND GOOD PACKING PRACTICE................................................. 44

4.3.1 Introduction ............................................................................................................. 44

4.3.2 Physicochemical stability implications relating to solid dosage forms.................... 46

4.3.3 Current practices affecting drug stability in DAAs .................................................. 47

4.3.3.1 Packing procedures......................................................................................................47

4.3.3.2 In-use environment.......................................................................................................49

4.3.4 Currently available stability information .................................................................. 50

4.3.5 Risk assessment of drug product suitability for repackaging into a DAA ............... 51

4.3.5.1 Occupational health and safety issues .........................................................................52

4.3.5.2 Unsuitable solid dosage forms .....................................................................................52

4.3.5.3 Moisture-sensitive solid dosage forms .........................................................................52

4.3.5.4 Solid dosage forms sensitive to air (oxidation) .............................................................55

4.3.5.5 Light-sensitive solid dosage forms ...............................................................................55

4.3.5.6 Solid dosage forms sensitive to heat............................................................................56

4.3.5.7 United Kingdom manufacturers’ position on repackaging ............................................56

4.4 SYNTHESIS OF PROBLEMS AND POSSIBLE SOLUTIONS ...................................................... 61

4.5 BEST PRACTICE MODEL FOR THE PROVISION AND USE OF DOSE ADMINISTRATION AIDS I

N THE COMMUNITY ......................................................................................................... 66

4.5.1 Introduction ............................................................................................................. 66

4.5.2 Preamble................................................................................................................. 66

4.5.2.1 Purpose and scope of this best practice model ............................................................66

4.5.3 Recommendations.................................................................................................. 69

4.5.3.1 Assessing community patients’ need for DAA services................................................69

4.5.3.2 Tripartisan agreement specifying obligations and promoting mutual awareness..........70

4.5.3.3 Patient held medication template to empower patient and facilitate communication

about medication regimen and changes.......................................................................72

4.5.3.4 Communicating medication changes............................................................................73

4.5.3.5 Continuity of care between hospital and community for patient with DAAs ..................73

4.5.3.6 Quality control, quality assurance/ monitoring procedures for packing/ checking and

communications flows ..................................................................................................76

4.5.3.7 Efficiency in the pharmacies procedures......................................................................77

4.5.3.8 Negotiating a mutually acceptable payment for DAA services .....................................79

4.5.3.9 Ensuring adequate monitoring and care of DAA patients. ............................................79

4.6 BEST PRACTICE MODEL FOR THE PROVISION AND USE OF DOSE ADMINISTRATION AIDS IN

RESIDENTIAL CARE FACILITIES..................................................................................................... 80

4.6.1 Introduction ............................................................................................................. 80

4.6.2 Preamble................................................................................................................. 80

4.6.2.1 Purpose and scope of this best practice model ............................................................80

4.6.3 Recommendations.................................................................................................. 83

4.6.3.1 Residential care facilities tendering for pharmacy services ..........................................83

4.6.3.2 Contracts specifying obligations and promoting mutual awareness .............................84

4.6.3.3 Communicating medication changes............................................................................86

4.6.3.4 Continuity of care between hospital and RCFs for patient with DAAs ..........................87

4.6.3.5 Quality control, quality assurance/ monitoring procedures for packing/ checking and

communications flows ..................................................................................................89

4.6.3.6 Review of charting systems..........................................................................................91

4.6.3.7 Efficiency in the pharmacies procedures......................................................................91

4.6.3.8 Facility receipt of packed medication............................................................................92

5. EVALUATING PRELIMINARY BEST PRACTICE MODELS .......................................... 93

5.1 METHODS...................................................................................................................... 93

5.1.1 Selection of stakeholders to review models ........................................................... 93

5.2 RESULTS ....................................................................................................................... 96

Quality Medication Care Group, School of Medicine, University of Queensland iii

5.2.1 Responses received ............................................................................................... 96

5.2.2 Views on the best practice model in the community setting................................... 97

5.2.2.1 Assessment of need for DAA service .........................................................................100

5.2.2.2 Tripartisan agreement for DAA supply .......................................................................104

5.2.2.3 Patient held medication template ...............................................................................109

5.2.2.4 Communication of medication changes......................................................................116

5.2.2.5 Continuity of patient care between hospital and community.......................................118

5.2.2.6 Quality control (QC) and quality assurance (QA) for packing, checking and

communication ...........................................................................................................121

5.2.2.7 Efficiency in pharmacy procedures (prescription management, packing procedures

and staff roles)............................................................................................................123

5.2.2.8 Fair payment for DAA services...................................................................................125

5.2.2.9 Monitoring and care of DAA patients..........................................................................127

5.2.2.10 Role of GPs in community DAA best practice ............................................................129

5.2.3 Views on the best practice model in the residential care setting.......................... 130

5.2.3.1 Tendering for DAA services........................................................................................133

5.2.3.2 Written agreement for DAA supply .............................................................................136

5.2.3.3 Communication of medication changes......................................................................141

5.2.3.4 Continuity of patient care between hospital and RCF.................................................143

5.2.3.5 Quality Control (QC) and Quality Assurance (QA) – Monitoring procedures for

packing, checking and communication.......................................................................146

5.2.3.6 Review of charting systems........................................................................................147

5.2.3.7 Efficiency in pharmacy procedures.............................................................................147

5.2.3.8 Facility receipt of packed medication..........................................................................149

5.2.3.9 Role of GPs in RCF DAA best practice ......................................................................150

5.2.4 Implementation issues .......................................................................................... 151

5.2.4.1 Main barriers to the models ........................................................................................151

5.2.4.2 Supporting widespread adoption ................................................................................155

PART B - ECONOMICS OF PROVIDING DAAS TO COMMUNITY PATIENTS..................... 158

6. COMMUNITY PATIENT FOLLOW-UP........................................................................... 158

6.1 METHODS.................................................................................................................... 158

6.1.1 Interview/questionnaire development ................................................................... 158

6.1.2 Participant follow-up.............................................................................................. 158

6.2 RESULTS ..................................................................................................................... 159

6.2.1 Response rates and outcomes ............................................................................. 159

6.2.2 Changes in DAA use status.................................................................................. 160

6.2.3 Community patient medication use....................................................................... 160

6.2.4 Community patient health and quality of life......................................................... 163

6.2.5 Health service use ................................................................................................ 166

6.2.6 ADR and health consequences ............................................................................ 166

6.2.7 Willingness to pay................................................................................................. 168

6.2.8 Characteristics related to outcome status at 1 year follow-up.............................. 168

7. HIC DATA ANALYSIS.................................................................................................... 170

7.1 METHODS.................................................................................................................... 170

7.1.1 Data request ......................................................................................................... 170

7.1.2 Data receipt........................................................................................................... 171

7.1.3 Data preparation ................................................................................................... 171

7.1.4 Analysis................................................................................................................. 174

7.1.4.1 Adjusting for covariates ..............................................................................................174

7.2 RESULTS ..................................................................................................................... 176

Quality Medication Care Group, School of Medicine, University of Queensland iv

7.2.1 Unadjusted service use for the year prior to the home visit.................................. 176

7.2.2 Comparison between pharmacy DAAs and OP users before and after DAA

started ................................................................................................................... 177

7.2.3 Adjusting HIC service costs for covariates ........................................................... 183

8. CHARACTERISING COMMUNITY PATIENTS WHO USE A DAA............................... 187

8.1 METHODS.................................................................................................................... 188

8.1.1 Preparation of model variables ............................................................................. 188

8.1.2 Logistic regression models ................................................................................... 190

8.1.3 Non-linear machine learning models .................................................................... 191

8.2 RESULTS ..................................................................................................................... 192

8.2.1 Logistic regression model used to derive propensity scores for economic

analysis ................................................................................................................. 192

8.2.2 Logistic regression models including drug use variables ..................................... 194

8.2.3 Non-linear machine learning models .................................................................... 199

8.2.3.1 Interpreting output ......................................................................................................199

8.2.3.2 Decision trees.............................................................................................................200

8.2.3.3 Rule sets ....................................................................................................................204

8.2.3.4 Comparison of logistic and decision tree classification...............................................206

9. COMMUNITY SETTING ECONOMIC ANALYSIS ......................................................... 208

9.1 OVERVIEW................................................................................................................... 208

9.2 BACKGROUND ............................................................................................................. 208

9.3 COST OF SUPPLYING DAAS.......................................................................................... 208

9.3.1 Summary of cost results ....................................................................................... 208

9.3.2 Sensitivity analysis................................................................................................ 209

9.4 POTENTIAL COST SAVINGS FROM PREVENTING ADRS .................................................... 211

9.4.1 Methods ................................................................................................................ 211

9.4.2 Results .................................................................................................................. 212

9.4.2.1 Sensitivity analysis of healthcare cost savings ...........................................................213

9.4.3 Comparison with Phase 2 results ......................................................................... 214

9.4.4 Cost-effectiveness analysis of using DAAs to avoid ADRs and deaths ............... 215

9.4.5 Cost-benefit analysis of using DAAs to avoid an ADR ......................................... 215

9.4.5.1 Costs ..........................................................................................................................215

9.4.5.2 Benefits of DAA..........................................................................................................215

9.4.6 Cost-benefit analysis of using DAAs to avoid an ADR ......................................... 216

9.4.6.1 Sensitivity Analysis.....................................................................................................216

9.5 COST SAVINGS AND ECONOMIC EVALUATION ASSOCIATED WITH PATTERNS OF HEALTH

SERVICE UTILISATION ................................................................................................... 217

9.5.1 Methods ................................................................................................................ 217

9.5.1.1 HIC DATA...................................................................................................................218

9.5.1.2 Patient reported service use and outcomes ...............................................................220

9.5.1.3 Health service use consequences..............................................................................221

9.5.2 Results .................................................................................................................. 222

9.5.2.1 Sensitivity analysis .....................................................................................................222

9.5.2.2 Health service use consequences for patients still living in community setting ..........223

9.5.3 Cost benefit analysis of DAAs using health system data for all patients.............. 224

9.5.4 Cost benefit analysis of DAAs using health system data for patients living in

the community....................................................................................................... 224

9.6 DISCUSSION OF ECONOMIC ANALYSIS ........................................................................... 225

9.6.1 Overview of purpose............................................................................................. 225

Quality Medication Care Group, School of Medicine, University of Queensland v

9.6.2 Limitations............................................................................................................. 225

9.6.3 Main findings......................................................................................................... 229

10. DISCUSSION AND CONCLUSIONS ............................................................................. 230

10.1 DEVELOPING THE BEST PRACTICE MODELS .................................................................... 231

10.1.1 Development of the preliminary models ............................................................... 231

10.1.2 Evaluation of the preliminary best practice models .............................................. 233

10.1.2.1 Limitations of the evaluation of best practice models substudy ..................................235

10.1.3 Future development and implementation of best practice models ....................... 236

10.2 STRATEGIES TO IMPROVE THE STABILITY INFORMATION AVAILABLE TO PHARMACISTS

PROVIDING A DAA SERVICE .......................................................................................... 237

10.2.1 Improving drug stability in DAAs in the current situation ...................................... 238

10.2.2 Gathering more evidence of drug instability and drug stability............................. 238

10.2.2.1 Gather reports of suspected physicochemical instability observed in DAAs ..............238

10.2.2.2 Stability studies on the most commonly packed solid dosage forms ..........................240

10.2.2.3 Other sources of stability information .........................................................................245

10.2.3 Current good packing practices ............................................................................ 248

10.3 POLICY AND PRACTICE IMPLICATIONS FOR COMMUNITY-BASED RECIPIENTS OF PHARMACY

DAA SERVICES ............................................................................................................ 249

10.3.1 Current recipients.................................................................................................. 249

10.3.2 Policy and practice implications............................................................................ 251

10.4 FUTURE PROVISION OF DAAS TO COMMUNITY PATIENTS ................................................ 252

10.4.1 Targeting community patients for DAA services................................................... 253

10.4.1.1 Predicting DAA use ....................................................................................................253

10.4.2 Building future evaluation and research into the implementation of DAA

services for community patients ........................................................................... 258

10.5 CONCLUSIONS ............................................................................................................. 260

10.6 RECOMMENDATIONS .................................................................................................... 262

11. REFERENCES................................................................................................................ 265

APPENDIX A: ETHICAL APPROVALS ................................................................................... 269

APPENDIX B: DAA EXPERT PANEL MEETING .................................................................... 274

APPENDIX C: FOCUS GROUP AND INTERVIEW MATERIALS AND REPORTS................ 291

RCF FOCUS GROUPS .............................................................................................................. 291

RCF management focus group materials ......................................................................... 291

RCF Staff focus group materials ....................................................................................... 292

RCF management and staff focus group report................................................................ 293

Inefficiencies and unsafe practices resulting from DAA use ........................................................293

Solutions to inefficient and unsafe DAA practices........................................................................294

Model of medication supply .........................................................................................................295

Current and optimal levels of staff training for DAA use...............................................................296

Issues and barriers to DAA use resulting from existing standards and legislation .......................297

Impact of hypothetical changes ...................................................................................................297

PHARMACY MANAGEMENT FOCUS GROUPS ................................................................................ 298

Community pharmacist focus group materials .................................................................. 298

Community pharmacist focus group report ....................................................................... 300

Problems and issues related to DAA supply ................................................................................300

Solutions to problems and issues of DAA supply.........................................................................301

Review of the best practice model of DAA supply .......................................................................302

Events that may affect the safety and efficiency of DAA supply ..................................................302

Quality Medication Care Group, School of Medicine, University of Queensland vi

Issues and barriers to efficient DAA use related to current standards and legislation..................303

Reasons for pharmacies not complying to current guidelines......................................................304

Materials presently used to supply DAAs and improvements in materials that may facilitate

greater efficiency in supply ..........................................................................................................304

Impact of hypothetical changes to current DAA practices............................................................305

HOSPITAL PHARMACISTS FOCUS GROUPS.................................................................................. 307

Hospital pharmacist focus group materials ....................................................................... 307

Hospital pharmacist focus group report ............................................................................ 307

Problems and issues with discharge planning for patients returning to RCFs and solutions

implemented by hospital pharmacies...........................................................................................307

Proposed requirement for specific admission and discharge procedures for RCF patients .........308

Problems and issues in discharge planning for community patients and practices and

solutions to overcome these ........................................................................................................308

Problems and issues for compiling medication profiles for new patients and practices and

solutions used to overcome these ...............................................................................................309

Information, and adequacy of information, provided to hospital following patient admission

from RCF ...................................................................................................................................309

Information provided to RCFs and other sources upon patient discharge and potential

improvements to the communication process..............................................................................310

Recommendation/provision of DAAs as part of patient discharge and circumstances and

procedures involved in any such recommendation ......................................................................310

Hospital policy regarding patients own medication and own DAAs..............................................311

Judgment of adequate/sufficient medication supply upon discharge and relation to DAA use ....311

Methods for minimising medication wastage during patient admission to, and discharge from,

hospital ...................................................................................................................................312

Issues and barriers to DAA provision based on current standards and legislation ......................312

Reasons why pharmacies are not complying to current guidelines and ways compliance may

be improved .................................................................................................................................312

PHARMACY DISPENSARY ASSISTANTS/TECHNICIANS INTERVIEWS ................................................ 313

Dispensary technician interview materials ........................................................................ 313

APPENDIX D: LEGAL OPINION.............................................................................................. 315

HYPOTHETICAL DAA SITUATIONS FOR CONSIDERATION OF LIABILITY........................................... 315

REPORT FROM GUILD LEGAL LTD: DOSE ADMINISTRATION AIDS (DAAS) - SOME

LIABILITY CONSIDERATIONS............................................................................................. 317

APPENDIX E: THEORETICAL CONSIDERATIONS IN REPACKING DRUG PRODUCTS

INTO A DAA ................................................................................................................... 324

UNSUITABLE SOLID DOSAGE FORMS .......................................................................................... 324

MOISTURE-SENSITIVE SOLID DOSAGE FORMS ............................................................................ 324

SOLID DOSAGE FORMS SENSITIVE TO AIR (OXIDATION) ............................................................... 325

LIGHT-SENSITIVE SOLID DOSAGE FORMS ................................................................................... 325

SOLID DOSAGE FORMS SENSITIVE TO HEAT................................................................................ 326

PACKAGING AND/OR DRUG INTERACTIONS ................................................................................. 326

APPENDIX F: DRAFT TOOLS TO SUPPORT BEST PRACTICE MODELS.......................... 327

APPENDIX G: TOOLS USED TO GUIDE FEEDBACK ON THE BEST PRACTICE

MODELS......................................................................................................................... 332

COMMUNITY PATIENT FEEDBACK MATERIALS.............................................................................. 333

COMMUNITY PATIENT BEST PRACTICE ISSUES SUMMARY AND SURVEY......................................... 333

COMMUNITY PHARMACIST BEST PRACTICE FEEDBACK SURVEY ................................................... 339

HOSPITAL PHARMACISTS FEEDBACK QUESTIONS........................................................................ 343

EXPERT PANEL QUESTIONS ..................................................................................................... 345

Quality Medication Care Group, School of Medicine, University of Queensland vii

GENERAL PRACTITIONER FEEDBACK QUESTIONS ....................................................................... 348

RCF MANAGEMENT FEEDBACK QUESTIONS ............................................................................... 350

RCF RESIDENT INTERVIEW ....................................................................................................... 352

APPENDIX H: COMMUNITY PATIENT FOLLOW-UP SURVEY............................................. 355

APPENDIX I: HIC DATA DISTRIBUTIONS AND MODELS .................................................... 369

DISTRIBUTIONS OF AGGREGATED HIC SERVICE USE VARIABLES ................................................. 369

MULTIVARIATE MODELING OF COSTS ......................................................................................... 374

APPENDIX J: INTRODUCTION TO MACHINE LEARNING ................................................... 379

Quality Medication Care Group, School of Medicine, University of Queensland viii

LIST OF ABBREVIATIONS

AACP Australian Association of Consultant Pharmacy

ACAT Aged Care Assessment Team

ACPPM Australian College of Pharmacy Practice and Management

ADGP Australian Divisions of General Practice

ADR Adverse Drug Reaction

ADRAC Adverse Drug Reactions Advisory Committee

AIN Assistant in Nursing

AMDS Automated medication dispensing system (automated DAA)

ASMI Australian Self-Medication Industry

APAC Australian Pharmaceutical Advisory Committee

BSDGP Brisbane South Division of General Practice

CMI Consumer Medicines Information

CP Community patient

CQI Continuous Quality Improvement

DAA Dose Administration Aid

DDR Daily dose reminder (Dosett type DAA)

DON Director of Nursing

EN Enrolled Nurse

GP General practitioner

HIC Health Insurance Commission – now Medicare Australia

HMR Home Medicines Review

ICT Information Communication Technology

IT Information Technology

MBS Medical Benefits Scheme

MDS Monitored dosage system (blister pack DAAs)

OP Original pack

PBS Pharmaceutical benefits scheme

PCA Personal Care Assistant

PGA Pharmacy Guild of Australia

PRN As required

PSA Pharmaceutical Society of Australia

QA Quality Assurance

QC Quality Control

QCPP Quality Care Pharmacy Program

QDGP Queensland Divisions of General Practice

RACGP Royal Australian College of General Practitioners

RCF Residential Care Facility

RMMR Residential Medication Management Review

RN Registered Nurse

RUM Return Unused Medication

TGA Therapeutic Goods Administration

WTP Willingness to pay

Quality Medication Care Group, School of Medicine, University of Queensland ix

PREFACE

The work in this report continues the evaluation of the effectiveness and cost-

effectiveness of Dose Administration Aids (DAAs) services provided by community

pharmacies to residential care facilities (RCFs) and to community-based patients. This

Phase 3 follows on from our previous work in Phases 1 and 2 where we found that

while DAAs were felt to be effective by the users and to improve clinical outcomes for

those who would benefit from their use, there were areas that could be improved in the

provision of DAA services, including the health economics of providing DAAs to people

in the community. The Phase 3 work therefore set out to develop best practice models

to support safe, effective and efficient DAA service provision, and to further explore the

economics of DAA use by community patients.

Phase 3 of the project undertaken collected data throughout Australia and involved

patients, pharmacies, general practitioners, nurses, residential care facilities (RCFs)

and researchers. Two key outcomes emerged. Firstly, two preliminary best practice

models for the provision of DAA services to were developed and evaluated. Secondly,

a further understanding of the health economics of DAA service provision, and in

particular, a need to further evaluate the health economic impact of any future program

of DAA service provision for community patients.

Two people have been instrumental in making this project happen: Julie Stokes and

Clare Ientile. Together they have planned, executed, analysed and written up this work.

Their professional and committed work has enabled the successful conclusion of this

project.

Finally, I would like to recognise the assistance and support of all those who took part

in this Phase 3 work. Many have continued their involvement from Phase 2. On behalf

of my team, I reiterate our thanks to all those who helped make this work possible at all

levels from the Expert Panel members and consultants, the EAG committee, the

management and staff of participating pharmacies, residential aged care facilities (in

particular Bluecare), hospital pharmacists and other stakeholders who provided input to

the development of, and comment on best practice models. Key information was

provided by customers of community pharmacies and residents of RCFs who took part

in the study.

It is our hope that the strategies for best practice can be included in the implementation

of the recently funded subsidised DAA service program for community patients and that

this opportunity to collect more information and enable a better understanding of the

cost effectiveness of this service is taken up.

M.S. Roberts

Brisbane, May 2006

Quality Medication Care Group, School of Medicine, University of Queensland x

EXECUTIVE SUMMARY

This report describes Phase 3 of a body of work examining the effectiveness and cost

effectiveness of dose administration aids (DAA) services provided by community

pharmacies to people in Residential Care Facilities (RCFs) and to people living in the

community (Community patients (CPs)).

As a result of the preceding Phases 1 and 2, it was evident that best practice strategies

to deliver a safe, effective and efficient DAA service could optimise the effectiveness

and cost-effectiveness of this resource intensive and time consuming service. In

Phase 3, we set out to develop best practice models and to re-examine the cost-

effectiveness of the provision of DAAs to community patients.

AIM

The aims of this Phase 3 project, funded as part of the Third Community Pharmacy

Agreement between the Commonwealth and the Pharmacy Guild of Australia, were to

develop:

(1) Best practice models and tools to facilitate improvements in the way DAAs are

used in the RCF and community settings. These models would improve the

effectiveness and efficiency of the DAA service and the use of the devices.

(2) A more sophisticated methodology to re-examine the cost-effectiveness of DAAs in

the community setting by measuring and valuing the benefits to the health care

system utilising additional data on health service use.

APPROACH

The approach to best practice model development involved the following components:

Identification and review of existing materials including guidelines, standards and

protocols, policy, best practice manuals and current practice and standards of DAA

provision.

Expert advice on aspects of DAA service provision including the legal

consequences and the quality of DAA packing processes especially as this related

to medication stability in DAAs.

Integration of the results of this review with the views of stakeholders obtained

through focus groups and structured interviews.

Multivariate modelling of the characteristics of community patients who chose to

use a pharmacy-provided DAA rather than original packs (OPs).

Development of preliminary best practice models based on research findings in

Phases 1 and 2, a review of existing materials and consultations undertaken in

Phase 3.

Identification of possible tools including the development of some draft tools;

including patient held medication records to resolve problems arising from DAA

use, and to facilitate the implementation of the best practice models.

The use of stakeholder feedback on preliminary best practice models to identify

areas for improvement or change and to evaluate the feasibility and impact of the

best practice models by identifying the costs and quality implications of

implementing the models.

Quality Medication Care Group, School of Medicine, University of Queensland xi

In addition, the economic modelling of DAA services for community patients was

examined. The approach included:

Extraction and analysis of four years of community patient health care service use

recorded by the Health Insurance Commission (HIC, now Medicare Australia) and

similar data for Department of Veterans’ Affairs (DVA) clients.

Multivariate modelling of the characteristics of community patients who chose to

use a pharmacy-provided DAA rather than OPs, including analysis of patient data

using propensity scores to adjust for differences in DAA and non-DAA groups

resulting from non-random sampling.

Follow-up of the Phase 2 community patients and evaluation of the retrospective

patient/carer reported use of other health service data not recorded through HIC

(i.e. respite care, community nursing and residential care admission).

An economic evaluation of the costs and benefits of DAAs from a limited societal

perspective utilising actual service use data (stochastic rather than deterministic

analysis).

FINDINGS

The factors that contribute to unsafe practices, reduced effectiveness of DAA services

for patients with special needs, and inefficiencies in service provision were identified.

There were six underlying factors that contributed to the problems (4.4)

encountered in the provision of DAAs:

Poor communication and timely information sharing particularly about medication

changes and at hospital discharge.

Poor awareness of responsibilities and obligations of the various parties that

caused systems to fail. A lack of understanding or awareness by the various people

involved in the DAA service about each other’s roles and constraints (e.g.

profession-specific regulations) or practices contributed to these problems.

Lack of a systematic approach to patient assessment as to whether a DAA was

appropriate, monitoring of patients and the service quality itself and, accountability

for the service and its outcomes.

Patients using DAAs had high levels of dependency on others for help with

medication management and the risks of disempowerment, reduced medication

knowledge and other medication management problems were not routinely

addressed or monitored.

The situation where the costs incurred are borne largely by the community

pharmacies without adequate means of remuneration.

That the information available about medication stability in various DAAs is limited.

Two preliminary best practice models were developed for community (4.5) and

RCF (4.6) settings. These models included recommendations addressing:

Formal, structured and documented patient assessment of ability to use a DAA and

possible risks from DAA use prior to a community-based patient starting a DAA.

Written agreements between parties involved that specified the service to be

delivered and obligations, and promoted mutual awareness.

A template for medication packing (including packed and non-packed medications).

A copy of this template was to be carried by a community patient and used by the

General Practitioner (GP) to record medication changes.

The recording of communication about medication change in writing or by electronic

means. This would also act as an audit trail.

Quality Medication Care Group, School of Medicine, University of Queensland xii

Continuity of care to improve the timely flow of medication regimen information and

supplies of medications when community and RCF patients were admitted to

hospital. The recommendation covered both information to be provided to the

hospital and practices in hospital to facilitate patient discharge and transfer of care

to the community and RCFs.

Quality control, quality assurance and monitoring, patient education about drug

storage and issues related to the stability of medicines packed into a DAA.

Efficiency in the pharmacy including ensuring that prescriptions are available when

required, reminder systems for doctors and patients, and DAA packing practices

(including use and training of non-pharmacist staff).

Improved the cost-effectiveness of the service i.e. that pharmacists negotiate a

appropriate price for the service and target the service to only those community

patients who will benefit.

Monitoring of community patients’ ability to use a DAA initially, when they were

starting a DAA and on an ongoing basis. This monitoring should include at least

quarterly consultations with the GP, the provision of medication information by the

pharmacist and monitoring of compliance by returning DAAs. Bi-annual re-

assessment of medication management ability, medication knowledge and

concordance with medication regimen records (patient, GP and pharmacy) was

suggested.

A tendering process for DAA services in RCF that addressed service expectations

quality assurance and payment.

Regular checks of agreement or concordance between medication regimen records

kept by the RCF, GP and pharmacy.

Registered Nurse checks of packed medicines against the medication chart

(appropriate to the pack type) at the time of delivery for any packs where residents

are self-medicating or where enrolled nurses (ENs) or personal care assistants

(PCAs) assist residents to take their medications from the packs. These checks

were to be in addition to usual medication administration practices.

To evaluate the feasibility and benefits of these preliminary best practice models,

the impacts of the best practice models (e.g. on costs) and quality implications,

structured feedback was obtained from sixty-eight individual stakeholders (5.2.1). The

evaluation of these models found that they are likely to be beneficial in achieving

improvements in practice and generally feasible (5.2.2 and 5.2.3). Implementation

of some recommendations in the models would require only small changes to existing

systems but others would require substantial change, and particularly in the case of

continuity of care guidelines, time. The evaluation of the models also identified aspects

of the models and recommendations that could be improved but also highlighted areas

of disagreement among stakeholders about what direction changes should take, for

example, about standardisation versus flexibility and individualisation or RN checks of

packs at delivery. Agreement among stakeholders on such key principles needs to be

reached to provide direction for further revision of the preliminary best practice models.

While individual practitioners have and could implement aspects of the best practice

models, further development of the best practice models, supporting tools, resources

(such as improved access to information about drug stability in DAAs) and procedures

with the consultation and participation of stakeholders is required before wide

spread implementation (5.2.4). Revision of the model will also be required with the

Quality Medication Care Group, School of Medicine, University of Queensland xiii

advent of changes to the health care system such as changes to the Pharmaceutical

Benefits Scheme (PBS) and the introduction of e-health initiatives (10.1.3).

In developing the best practice models, a review of the evidence supporting the stability

of medication in DAAs undertaken showed that the stability information available to

pharmacists is extremely limited (4.3). A range of strategies to promote good

packing practices to improve the current situation (4.3.5 and 10.2.1) and to acquire

more evidence on which to make decisions about the likely stability of medications in

DAAs have been suggested (10.2.2).

The modelling of the provision of DAA services to community patients highlighted that

people receiving DAA services from community pharmacies are fundamentally sicker

and have greater care needs that patients using medications in original packs (OP)

(8.2). Analysis of HIC service use showed that users of pharmacy-provided DAAs had

the same service use costs (pharmaceutical and medical benefit scheme costs) despite

having greater care needs and illness burden than OP users (7.2). Follow-up of

community patients from Phase 2 at one year supported these findings (6.2). As

expected for a group with higher care needs, there was a higher rate of death and RCF

admission at one year for DAA users, but OP users who had died at one year had

better function and health in Phase 2 compared to DAA users. This suggests an

additional benefit of DAA use that using a pharmacy-provided DAA maintains people

with higher care needs in the community (10.3.1). This may reflect better control of

medication management and service use associated with the enhanced relationships

within the health care team needed to provide a DAA service.

The characteristics of community patients receiving DAAs largely agrees with current

recommendations and literature (10.3.1). Characteristics of community patients found

to predict perceived benefit as indicated by a choice to continue DAA use included:

Any hospitalisation in the preceding year as reported by the patient;

Age;

Admission of adherence problems by response to the question “Do you ever forget

to take your medications”;

Greater care needs as indicated by regular community health worker visits and

impaired instrumental activities of daily living (IADL) score.

Community pharmacies appear to be providing a needed service to a fairly specific

needs group. The economic modelling indicated that this was largely at a cost to

themselves (10.3.2).

In Phase 2, the use of DAAs in RCFs was shown to minimised overall costs. For

community patients outcomes such as better satisfaction and confidence in managing

medications and reduced carer burden were described in Phase 2, however, the cost

effectiveness for community patients was less favourable than for RCFs. Follow-up at

one year (6.2) and analysis of HIC service use data (7.2) suggests additional benefits

(10.3) but the additional economic modelling undertaken in this phase (Chapter 9) did

not alter the conclusions regarding the cost effectiveness of DAA services for

community patients derived in Phase 2. With the negotiation of funding for a subsided

DAA service for community patients, there is an opportunity to better understand the

cost-effectiveness of the service by developing an evaluation plan in parallel with

the implementation plan for this service and collecting data prospectively as the new

Quality Medication Care Group, School of Medicine, University of Queensland xiv

program is rolled out (10.4.2). The preliminary best practice model for the provision of

DAA services to community patients should be used to inform the implementation plan

for this new service.

RECOMMENDATIONS

The following recommendations relate to both services to community patients and to

RCFs. The recommendations are shown separately for convenience although a

number of recommendations are duplicated.

Recommendations for DAA service provision to community patients

1. Dose Administration Aids (DAAs) should be targeted to community patients with a

need for and likelihood of benefit from the service.

2. Criteria need to be defined to assess need and likelihood of benefit for community

patients. Modelling conducted in this and other studies should be used to inform the

criteria.

3. A structured patient assessment protocol for community patients should be

developed to determine need for a Dose Administration Aid. This assessment

should be repeated at intervals to monitor the effects of the service.

4. The Pharmaceutical Society of Australia (PSA) in conjunction with the Therapeutics

Good Administration (TGA) should develop a “current good packing practice”

document using the code of good manufacturing practice as a frame work. The

good DAA packing practice code should include staff training and competencies.

These could be developed by PSA and the Pharmacy Guild and included in the

Quality Care Pharmacy Program (QCPP) and in dispensary technician training

programs.

5. The strategies identified in this study to better define drug stability in Dose

Administration Aids should be implemented.

6. There needs to be an overarching emphasis on quality in the provision of Dose

Administration Aids services.

7. A Dose Administration Aid service should reflect best practice to optimise the

provision of a safe effective and efficient DAA service.

8. It needs to be recognised that such a model involves the effective collaboration of

the patient care team including the doctor, the pharmacist and community nurses,

patients and carers, and government.

9. The quality assurance measures included in the best practice model should be

seen as a priority for implementation.

10. The issues and strategies included in the preliminary best practice model should be

widely disseminated and the principles integrated into existing QUM and safety and

quality initiatives such as the APAC guidelines (continuity of care and community),

PSA guidelines, QCPP, Aged Care Assessments, Divisions of General Practice

Aged Care, Home and Community Care, Commonwealth Department of Health and

Ageing, Department of Veterans’ Affairs and state health programs.

11. Further consultation among stakeholder peak bodies is needed to reach agreement

on and to define that desired future direction of the best practice models. This

should include defining a continuing development plan for the models and an

implementation plan for DAA best practice initiatives.

Quality Medication Care Group, School of Medicine, University of Queensland xv

12. The preliminary best practice model and findings of its evaluation should be used to

inform the development of the implementation plan for a subsidised DAA service for

community patients.

13. The Pharmacy Guild of Australia should convene a working party including

appropriate stakeholder representation (see 5.2.4.2) and participation to develop an

implementation plan for a community DAA service that embraces best practice,

accountability and quality principles.

14. An evaluation plan should be developed in parallel to an implementation plan to

prospectively collect data to inform future program evaluation. Patient assessment

can provide data for both eligibility checking and future evaluation.

15. The implementation working party should seek input from, and convene technical

advisory panels of experts to advise on (1) further development of the knowledge

base about drug stability in DAAs, (2) the evaluation of the health economics of the

subsidised community DAA service, and (3) refinement of eligibility criteria.

16. Any business rules developed for subsidised DAA service to community patients

should embrace the principles of best practice described in the preliminary best

practice model developed in this study or any subsequent revision.

17. It is recommended that an online system be used to register and assess eligibility

for subsidised DAA provision to increase efficiency and to capture data for later

evaluation.

18. The development of documents and protocols to support best practice in the

implementation of a subsidised DAA service should include trialling and use

document/web design expertise.

19. It is recommended that the government support the use of Dose Administration

Aids services in the community where patients meet the appropriate access criteria

and the service provided reflects best practice.

Recommendations for DAA service provision to RCFs

1. Appropriate Dose Administration Aids services should be encouraged in RCFs and

the role of the service in minimising overall medication management costs in RCFs

should be recognised for appropriate funding to the suppliers of the service.







programs.







Quality Medication Care Group, School of Medicine, University of Queensland xvi


the patient care team including the doctor, the pharmacist, RCF staff, patients and

carers, and government.

7. Systems whereby a legal order on a medication chart can act as a prescription as

part of a supply claim mechanism should be established to improve the safety,

effectiveness and efficiency of DAA provision to RCFs. This may require changes

to state and commonwealth regulations, and current Medicare payment claim

procedures. Any new system should address accountability, safety and regular

medication review.





quality initiatives such as the APAC guidelines (residential care and continuity of

care), Aged Care Standards, PSA guidelines, QCPP, Divisions of General Practice

Aged Care, Commonwealth Department of Health and Ageing, Department of

Veterans’ Affairs and state health programs.





11. The Pharmacy Guild should convene a working party including appropriate

stakeholder representation (see 5.2.4.2) and participation to develop an

implementation plan for an RCF DAA service that embraces best practice,


12. The requirement for the operation for a best practice DAA service should be

included into existing programs for RCF accreditation, recognising that best

practice is not solely the responsibility of the pharmacy providing the DAA services.

Quality Medication Care Group, School of Medicine, University of Queensland1

1. INTRODUCTION

Many consumers are taking a number of medications at once (often between 8 and 24)

and frequently may need to take these medicines at different times during the day.

Dosage administration aids (DAAs) are designed to improve the adherence (or

compliance) of consumers by clearly setting out the medicine doses in separate

compartments, ensuring the correct medication is taken in the correct dose and at the

appropriate time.

In general, community pharmacies pack and supply DAAs for individual consumers

living in RCFs, and to consumers living in the community. DAAs are most commonly

given to consumers who have complex medication regimens and/or who have

problems adhering to their regime. To date, DAAs have been implemented to varying

degrees in a significant number of RCFs and community pharmacies, with almost all

low care facilities using DAAs to achieve accreditation.

This report describes Phase 3 of a body of work examining the effectiveness and cost

effectiveness of dose administration aids (DAA) services provided by community

pharmacies to people in Residential Care Facilities (RCFs) and to people living in the

community (Community patients (CPs)).

Phase 1 of this work was a review of the literature that expanded and updated a 1997

review (School of Pharmacy and Medical Sciences at University of South Australia &

Australian Association of Consultant Pharmacy 1997), taking into account national and

international literature published from 1997 to December 2002, included in

bibliographic records as at April 2003. The following issues were addressed:

Types of DAAs.

Advantages and barriers to DAA use.

The safety of DAAs and the health gain associated with their use.

Limitations of DAA use.

Characteristics of people and related disease states who would benefit most from

DAAs.

Direct and indirect monetary costs and benefits to the health system, healthcare

providers and consumers related to provisions and use of DAAs.

Technologies to assist with dispensing and packaging of DAAs and provision to

consumers.

Implementation practices, policies and funding models for DAAs.

Measuring efficiency of medication delivery through systems analysis.

Any available data on cost-effectiveness and outcomes.

The review also took into consideration the changes that had taken place an Australia

since the last literature review, and the impact of these on the context in which DAAs

were used. These changes largely concerned the advent of automated DAA systems

and the policy drivers of DAA use. The review was included in the Final report of

Phases 1 and 2 (Ientile et al. 2004) and can be found at http://beta.guild.org.au/

uploadedfiles/Research_and_Development_Grants_Program/Projects/2002-519_fr.pdf.

An update of the literature search for articles discussing DAA use (rather than articles

simply about non-adherence without DAA type interventions) found only two additional

reviews (MacLaughlin et al. 2005; Morrison et al. 2004), neither of which cited


references later than 2003, and a survey about DAA provision by hospitals in the

United Kingdom (Green et al. 2005).

In Phase 2, a systems approach was taken to identifying the current situation with

respect to DAA use in the community and RCF settings in Australia. The project aims

were to answer the following questions:

1. Are DAAs effective in the community setting?

2. Are DAAs cost effective in the community setting?

3. Are DAAs effective in the RCF setting?

4. Are DAAs cost effective in the RCF setting?

5. What are the requirements for best practice DAA provision?

As part of a cross-sectional study, purposive samples were drawn from populations of

pharmacies (N=83), RCFs (RCFs) (N=27), community patients (CPs) (N=353), general

practitioners (GPs) (N=34), community nurses (N=60) and DAA manufacturers (N=4).

RCFs were sourced through the Aged Care Standards and Accreditation Agency;

facilities nominated GPs that may have been interested in participating in the study.

Pharmacies were sourced from the Yellow Pages phone directory, and they identified

community patients for participation. Data collection for the evaluation of project aims

involved interviews (total of 544), questionnaires (615), observations (381) and self-

report logs (778). Each of the data collection tools were developed in consultation with

the members of the reference committee, and focused specifically on evaluating the

relevant aspects of the effectiveness and cost effectiveness of DAAs in each setting.

All data was collected on location around Australia from both rural and urban sites by

27 trained observers.

The results of Phases 1 and 2 indicated that DAAs were effective in helping community

patients and RCFs to manage medications, and that the stakeholders valued DAAs, as

evidenced by their high levels of satisfaction. While the economic evaluations indicated

that DAAs were a more cost efficient system for medication provision for RCFs

compared with original packs, the use of DAAs in the community setting was cost-

ineffective. The results of Phase 2 indicated that pharmacists need to deliver a high

quality DAA service to maximise benefits, DAA services need to be targeted to

customers who will benefit most (i.e. recently hospitalised customers) and efficiency in

packing and checking procedures is essential in minimising costs. Therefore, a

number of opportunities for further research were identified with respect to the

development of best practice models to maximise the efficiency and effectiveness of

DAA provision and in the economic evaluation methodology for DAA service provision

to community-based patients.

Phase 1 and 2 revealed that there were a number of issues in current practice that

could be improved upon. The quality of DAA services provided by pharmacies was

inconsistent and did not conform to all Pharmaceutical Society of Australia (PSA)

guidelines and PSA/Quality Care Pharmacy (QCP) standards. In addition, there were a

number of problems identified in the literature and through data collection that are not

adequately addressed by existing guidelines. The underlying issues with DAA

provision and use are essentially the same across the two settings (community and

RCF) but there are differences related to who the key stakeholders are and what the

priorities are. Issues common for both settings include:


DAA users are not adequately informed about what is involved or trained in how to

maximise the benefits of DAA use.

The frequency and quality of communication between stakeholders (pharmacy,

patients, RCF staff and General Practitioners (GPs)) regarding medication changes

and errors is inadequate.

DAA packing sessions did not optimally utilise the skills and experience of

pharmacists.

The processes involved in packing and checking were not clearly identified in the

pharmacy.

During packing sessions, pharmacists and pharmacy staff had limited resources to

which to refer regarding the effect of DAAs on the stability of medications.

Community pharmacy bears the burden of medication management and

professional responsibility without adequate remuneration.

Specific issues with respect to DAA use in RCFs included:

The observed rate of errors in DAAs.

The accuracy of medication administration and the professional de-skilling of

Registered Nurses (RNs).

The lack of standard operating procedures for effective handling of medication

administration when DAAs are used in RCFs.

Specific issues for DAA use in the community were:

Community patient loss of ownership with respect to medication management, as

evidenced by the lower levels of medication knowledge and high levels of

dependence on the pharmacy.

DAAs are highly relied upon in the RCF and community settings, and are effective

provided that the limitations of supplying and using DAAs are addressed. As a result of

the preceding phases 1 and 2, it was evident that best practice strategies to deliver a

safe, effective and efficient DAA service could optimise the effectiveness and cost-

effectiveness of this resource intensive and time consuming service. In Phase 3, we

set out to develop best practice models and to re-examine the cost-effectiveness of the

provision of DAAs to community patients.

1.1 AIMS AND OBJECTIVES

The aims of this Phase 3 project were to develop:

(1) Best practice models and tools to facilitate improvements in the way DAAs are

used in the RCF and community settings. These models would improve the

effectiveness and efficiency of the DAA service and the use of the devices.

(2) A more sophisticated methodology to re-examine the cost-effectiveness of DAAs in

the community setting by measuring and valuing the benefits to the health care

system utilising additional data on health service use.

1. Objectives in the development of best practice guidelines for DAA provision and

use include:

Conduct a review of existing materials including guidelines, standards and

protocols, policy, best practice manuals and current practice and standards of

DAA provision.


Integrating the results of this review with the views of stakeholders obtained

through focus groups and structured interviews.

Expand on the best practice models developed to date based on the review of

existing materials and consultations.

Develop tools; including DAA provision agreements and patient held medication

records to resolve problems arising from DAA use, and to facilitate the

implementation of the best practice models.

Evaluate the feasibility and impact of the best practice models by identifying the

costs and quality implications of implementing the models.

2. Objectives of the measurement and evaluation of the economic benefits of DAAs

include:

Extraction and analysis of four years of community patient health care service

use recorded by the Health Insurance Commission (HIC) and similar data for

DVA clients.

Follow-up of the Phase 2 community patients and evaluation of the

retrospective patient/carer reported use of other health service data not

recorded through HIC (i.e. respite care, community nursing and residential care

admission).

Analysis of patient data using propensity scores to adjust for differences in DAA

and non-DAA groups resulting from non-random sampling.

An economic evaluation of the costs and benefits of DAAs from a societal

perspective utilising actual service use data (stochastic rather than deterministic

analysis).

2. STUDY PLAN

The two aims of this Phase 3 project are related but distinct sub-studies, each with a

separate study plan.

To meet Aim 1, a best practice methodology was planned. Best practice is defined as

a technique or methodology that, through experience and research, has been proven to

reliably lead to a desired result. The development of best practice models, through a

synthesis of Phase 1 and 2 findings and the experience of key stakeholders, was used

to identify strategies and tools to maximise the safety, effectiveness and efficiency of

DAA.

In Phase 3, we proposed a variety of qualitative and quantitative techniques to develop

and evaluate best practice guidelines for the RCF and community settings with respect

to the areas identified above. We intended to further develop the preliminary best

practice model identified in the Phase 1 and 2 using the methodology presented in

Figure 2.1. Best practice requires collaboration between stakeholders, and the

synthesis of research and experience.

In the development of best practice models, we planned to use a range of qualitative

techniques including the Consensus Development Panel technique, as described by

Bowling (Bowling 1997), populating a series of panels with key stakeholders from our

target populations, and triangulation of responses as part of a rapid appraisal

methodology (Bowling 1997).

The following stakeholders were the proposed participants:


Doctors that prescribe medications for DAA patients in RCFs and the community.

Pharmacists (and their staff) that supply DAAs to RCFs and community patients.

Nursing staff from RCFs using DAAs.

DAA manufacturers and suppliers.

Community nurses with patients who use DAAs.

Community patients and carers who use DAAs.

Therapeutic Goods Administration (TGA).

It is well recognised that the TGA has a pre-eminent role in the approval of

manufacturer goods and packing and have had a long track record of improving

outcomes in terms of the quality use of medicines mission of the Australian

government. TGA input was to be sought to provide better information on the safety

and stability of medicines in the various DAAs.

RESEARCH EXPERIENCE+

Identification of issues with the supply and use of DAAs

Phases 1 & 2

Exploration of issues and identification of practice limitations

and possible solutions

Focus groups

Development of preliminary best practice guidelines

Synthesis of findings

Refining best practice guidelines

Consensus panel techniques with

stakeholders

Development of tools to facilitate the implementation of best

practice

i.e. packing templates, contracts

Evaluate the feasibility and impact of implementing best practice

guidelines

Survey stakeholders

Analyse and report on the outcomes and processes

Figure 2.1 Proposed methodology for the development of best practice

To assess the feasibility of implementing the best practice guidelines devised by the

expert panel, we planned to develop survey tools designed to evaluate the anticipated

impact of these guidelines on the following areas:

Impact of adhering to best practice guidelines with respect to changes in current

practice.

Changes in workloads and associated costs.

Perceived outcomes with respect to changes in the quality of DAA service

provision.

Surveys were to be circulated among samples of doctors, pharmacists, RCF staff,

community nurses, community patients and carers.


To undertake further economic modelling of the provision of DAAs to community

patients (Aim 2), we planned to be collect data through interviews with community

patients and by requesting four years of health service expenditure from the Health

Insurance Commission (HIC) and Department of Veterans’ Affairs (DVA) for those

patients who participated in Phase 2. Health services use (subsidised under the

Medical Benefits Scheme (MBS)) and medications dispensed (subsidised under the

Pharmaceutical Benefits Scheme (PBS) and Repatriation Pharmaceutical Benefits

Scheme (RPBS)) was requested. This data was to be aggregated to produce total

costs of service use and compared for community patients using DAAs and original

packs after adjusting for potential covariates of health service use (i.e. number of

medicines used, age and health status).

Data collected at interview was to include:

Additional service use including community nursing, respite and long term care.

Other specific data on costs and outcomes such as the cost of treating and adverse

drug event and willingness-to-pay, and health utility measures.

Cost-benefit analysis was to be conducted from a limited societal perspective to

evaluate the full range of costs associated with DAA use. The possibility of identifying

cohorts of community patients who benefit most from DAA (in terms of savings in

healthcare costs) was to be explored and sensitivity analysis and threshold analysis

conducted to assess the precision around the costs and effects of DAA use.

2.1 ETHICAL APPROVAL

Ethical approval for the protocol and the follow-up community patient

questionnaire/interview has been sought from and granted by the following properly

constituted ethics committees:

The Princess Alexandra Hospital Research Ethics Committee.

The University of Queensland Medical Research Ethics Committee.

The approval letters can be found in Appendix A.

Ethical approval was also sought from the Department of Veterans’ Affairs (DVA)

Ethics Committee.

2.2 THIS REPORT

This report follows on from the final report on Phases 1 and 2 (Ientile et al. 2004). It is

a stand alone document but makes reference to the findings of Phases 1 and 2.

The structure of the report reflects the two aims of the study:

Part A concerns the development of best practice models incorporating methods,

results and certain specific discussion.

Part B examines the economic implications of DAA provision to community

patients. The methods, results and certain specific discussion is included for data

collected to inform the economic analysis plus modelling of the characteristics of

Phase 2 participants that predicted use of a DAA or original packs. The modelling

of DAA user characteristics crossed over to the community best practice model.

The overall discussion and conclusions addresses both aims and possible future

implications for DAA service provision.


PART A - BEST PRACTICE MODELS

3. DEVELOPING BEST PRACTICE MODELS -

METHODS

The proposed best practice model, integrating research and experience was followed.

The step of refining models through stakeholder consensus techniques was integrated

with the development of the models as the models were iteratively improved with each

focus group, consultation and other input. It was also necessary to add three additional

steps to address the issues of drug stability, liability issues and the characteristics of

community-based patients who continued to use DAAs. The overall methodology for

the best practice component of this Phase 3 project is shown in Figure 3.1.

Identification of issues with the supply and use of DAAs per Phases 1 & 2

Define current ‘best’ systems of medication supply and use in RCF & community setting

Identify practice limitations & possible solutionsExpert panel provides technical and context

information to support model development

Wider practitioner input to explore issues & identify limitations & possible solutionsFocus groups, interviews, data mining,

other consultation

Identify problems & potential solutions:• for drug product stability in DAAs

Literature, expert consultation

• for legal perspective on best practice Expert consultation

Identify characteristics of community patient DAA users Multivariate models of Phase 2 survey

data & Phase 3 health service use + 1 yr

outcome (Activities also inform Aim 2)

Develop tools to facilitate best practice

Evaluate feasibility & impact of implementing best practice modelsSurvey/consult stakeholders (practitioners, patients, expert panel & others)

Analyse & report on outcomes & processes

Develop preliminary best practice modelsSynthesis of findings

Figure 3.1 Overall methodology for developing best practice models

3.1 CONSULTATION

Individuals and people representing organisations or specific stakeholder groups who

were consulted in the initial phases were identified using key informant and snowball

sampling methods. This consultation added to the input from stakeholders garnered in

Phase 2. Community patients and carers, community pharmacists, DONs and RNs

from RCFs, general practitioners, community nurses and DAA manufacturers

contributed to the understanding of DAA services in Phase 2. In Phase 3, input was

also sought from hospital pharmacists, dispensary technicians who were at the coal

face of DAA production and various stakeholder organisations.


3.1.1 DAA EXPERT PANEL

Since providing a DAA service involves technical activities, a DAA Expert Panel of

pharmacy stakeholders was set up to inform model development from a technical

perspective and to act as a sounding board for the research team as new information is

obtained from other stakeholders that contributed to model development. Many of the

DAA Expert Panel members participated on the Phase 2 Reference Committee. The

following people are involved with the expert panel:

Gary Lambrides and Simon James (APHS)

Klaus Petrulis (Persocare)

Gerard Stevens and Paul Hannan (Webstercare)

John Proper (and Chris Clarke) (MPS)

Emma Jordon (Mayo Healthcare – Nomad)

Dianne Grant (Douglas)

Karalyn Huxhagen (Community Pharmacist & PSA representative)

Andrew Petrie & Danielle Stowasser (Queensland Health)

Debbie Rigby (MMR facilitator & pharmacist)

Mark Hickey (Community pharmacist and Reference Panel member, Phase 2)

Bill Kelly (AACP)

Gilbert Yeates (Guild Queensland Branch Committee representative, community

pharmacist)

Kay Davison, Michael Watson, Brian King (Community Pharmacists, Phase 2 participants)

Ric Lord (community pharmacist, DAA researcher)

Lisa Nissen (SHPA)

Rollo Manning (Pharmacist, DAA researcher)

Lance Emerson (Guild Secretariat)

Kos Sclavos (Guild, Queensland Branch)

Corresponding members, Sue Scott (PSA representative in phase 2), Lyn Todd (PSA

Professional Services Pharmacist)

As a focus for discussion, materials summarising the best practice issues identified in

Phases 1 and 2, solutions suggested in the Phase 2 report and plans for Phase 3 were

prepared and sent to panel members. These materials and the agenda are included in

Appendix B.

The meeting of available members of the DAA Expert Panel was held at the Australian

Pharmacy Professional Conference at the Gold Coast. People who were unable to

attend the meeting were sent the meeting materials and minutes of the meeting. The

minutes of the meeting are included in Appendix B.

3.1.2 FOCUS GROUPS

The aim of the focus groups and other initial consultation was to understand the full

range of DAA service problems and issues and any potential solutions by exploring the

experiences of respondents. Information about use of currently available guidelines,

models, policies, regulations and other documents that provide a framework for DAA

service provision was also sought.

To promote discussion from a variety of stakeholder perspectives about DAA service

problems and issues and potential solutions, a number of stakeholder specific work

flow diagrams that identified the sequence of necessary steps in DAA provision and

use were produced, based on the system analyses of Phase 2. The diagrams had

expanded detail in steps specifically relevant to a given stakeholder group and were


sent to participants so that these could be viewed during the focus groups or

interviews. These diagrams were developed iteratively with successive rounds of

consultation. The separate diagrams were later combined to produce overall workflow

models for inclusion in the preliminary best practice model diagrams.

3.1.2.1 Recruitment

Health professionals participating in focus groups were recruited in several ways:

For the RCF management focus groups, the 28 facilities from Phase 2 were

contacted and invited to participate. Since Western Australia (WA) was not included

in Phase 2. a further 4 RCFs from WA were contacted at the suggestion of a

Western Australian pharmacist with interests in DAA in that state (a contact

recommended by an DAA Expert Panel member; see minutes of the meeting in

Appendix B). A further 3 RCFs in Queensland were invited to participate as these

facilities had connection to the community nurses who were in the Phase 2 focus

groups while an additional Queensland RCF was invited to participate to increase

the representation of RCFs who used automated DAA systems.

As the decision was made to conduct RCF staff focus groups face-to-face, RCF

staff were recruited by the managers of 4 Queensland RCFs (where the managers

has participated in the RCF management focus groups). The facilities chosen

allowed a ranged of issues to be explored: different DAA systems (types and pack

sizes (e.g. a 35 day pack was used in one site)), administration by non-RNs and

self-medicators, issues related to residents choosing not to use the pharmacy with

the supply contract.

Initially, the community pharmacist focus groups were planned as face-to-face

sessions so that 4 pharmacies close to Brisbane that had participated in Phase 2

and another known to provide DAAs on the Gold Coats were contacted. When

telephone focus groups were to be used, a pharmacist from WA recommended by

a DAA Expert Panel member was contacted. Eleven pharmacies who had

participated in Phase 2 were selected to represent the various states, rural/regional

and urban/metropolitan settings, different types of DAAs and size of DAA business.

One additional pharmacy from the Northern Territory (NT) was approached as a

provider to DAAs in the area. Ten pharmacists who contributed to Auspharmlist

discussions on DAAs were emailed and invited to participate.

Four hospital pharmacies in Queensland were initially identified through

consultation with the Society of Hospital Pharmacists of Australia (SHPA)

representative on the expert panel. The intent was to seek out hospital

pharmacists not just from tertiary metropolitan hospitals but also regional and rural

hospitals, and both public and private sector hospitals, and across the different

states. The informal network of hospitals and hospital pharmacists known to the

research team was used to target large hospitals in the various states. The initial

contact was asked to suggest colleagues with an interest and involvement with

DAAs and to suggest regional or rural hospital pharmacy colleagues who might

also have involvement with DAAs. A further 15 hospital pharmacies were

contacted.

3.1.2.2 Conduct

Data was generated through facilitated focus group discussion. For each focus group,

the facilitator had a list of prepared questions (see Appendix C for material), which

were read aloud to participants, one at a time, to encourage discussion. Once the


discussion of each question had drawn to its natural conclusion, or participants

indicated they were ready to move on, the facilitator read aloud the next question. It is

important to note that each of the focus groups was conducted via teleconferencing

with participants from various states of Australia, not face to face as per convention.

While this approach provided the distinct advantage of allowing access to a range of

participants across different environments, its limitation was that participants and

facilitators were unable to respond to non-verbal cues throughout the discussions.

Participants were remunerated for their time as follows:

RCF management $100

RCF staff $60

Pharmacists $140

3.1.2.3 Analysis of focus groups

Upon completion of the focus groups, the results were transcribed from digital

recordings and subjected to a modified conceptual analysis. In this approach,

participant statements are analysed for their primary concepts through selective

reduction, which essentially results in a ‘distillation’ of the participant’s statements.

Within this methodology, each concept is then treated as a separate statement and, as

such, allows for those instances in which participants address several topics (or several

aspects of a topic) within a given statement. The selective reduction process was

ceased upon reaching redundancy, that is, when further reduction fails to yield any

conceptually distinct data.

The frequency with which the themes derived from conceptual analysis were raised

among the focus group participants was recorded. It is important to note that not all

participants responded to each issue and on several occasions participants tendered

several responses to the same issue. Typically, the tabulated results will only include

concepts with a response frequency of greater than one. Those concepts with a

response frequency of one are generally included within the results, but should be

treated with caution, as they may be more representative of the responder’s personal

experience than of any problem inherently related to DAA provision.

3.1.3 PHARMACY DISPENSARY ASSISTANT/TECHNICIAN INTERVIEWS

Non-pharmacist staff who assisted in the dose administration aids service were

included in the consultation phase as a form of validation of pharmacist views and to

provide a perspective not influenced by formal pharmacy training. For the latter

reason, pre-registration trainee pharmacists who pack DAAs in many pharmacies were

excluded from the pharmacy staff interviews.

Semi-structured interviews were conducted with non-pharmacist assistants involved in

dose administration aids services. Because it was difficult to set a time when sufficient

assistants were able to take part in a group session (a face-to-face group sessions was

initially planned where participants in the Brisbane area would be recruited), individual

interviews rather than group sessions were conducted.

Three recruitment strategies were used to identify non-pharmacist staff willing to take

part in the interviews:

Initially, 10 pharmacies in the Brisbane area that had taken part in Phase 2 were

contacted to seek non-pharmacist input into the consultation. A staff member from


one of these pharmacies took part (two other pharmacies used pre-registration

trainee pharmacists to pack DAAs, two declined to participate, 2 could not be

contacted and in 3, the contact person for Phase 2 had left and the pharmacy did

not wish to be involved).

Pharmacists who took part in the community pharmacist focus groups were asked

whether they would agree to allow a member of their staff to be interviewed. A

further 4 participants were recruited in this way. Two of the six proprietor/manager

pharmacists who agreed did not later nominate or arrange an interview with staff.

A invitation was sent to the community pharmacy moderated discussion list

“Auspharmlist” seeking participants. Four pharmacists or dispensary technicians

responded and completed the interview. In one case, a pharmacist made enquiries

but decided not to involve staff further.

At the time of recruitment, a set time for each interview was agreed and the interview

questions and a flow diagram of DAA processes was sent to interviewees in advance.

The flow diagram was used to promote discussion about problems and issues and

solutions (See Appendix C). Participants (or their employers where agreed between

the participants and employer) were paid $60 for taking part in the interviews.

At the start of the interview, the participant was asked what type of DAA service did

they provide (community patients, RCFs or other) and what types of DAAs were

packed. The questions shown in Appendix C were then asked.

Responses were recorded in writing on an interview recording form with selective

reduction being applied to participant responses. In potentially ambiguous situations,

the recorded response was read back to the interviewee for confirmation. At times,

issues that informed the question of DAA practice were volunteered although the

comments were not directly related to the questions. This information was also noted.

Each interview was summarised and concepts were then analysed in terms of their

predominant themes and the frequency with which these themes were recorded.

3.1.4 GP PERSPECTIVES

To inform the GP perspective about DAA services, common themes were extracted

from open-ended question responses supplied by 34 GPs servicing RCF residents who

were interviewed in Phase 2. GPs responses to the following open-ended questions

were reviewed:

Do you have any particular likes or dislikes about any [DAA] system(s)? Does this

system affect what you do in the facility? (Prompts: Does this system affect: Charting

requirements, Drug wastage issues, Presentation, Paperwork)

What types of services, if any, are provided by the main pharmacy to help you

provide care for the patients in the specified residential care facility?

Please describe the nature of any interaction you have had with the main pharmacy

supplying the facility in the last 3 months?

Is there any additional assistance that the pharmacy could provide to help you with

servicing residential care facility patients?

The GP interview responses were appraised with the aim of identifying the GP

perspective on problems with the supply of DAAs by community pharmacy and the use

of DAAs by RCFs and community patients. In addition, any potential solutions to


problems were also identified. Both key themes (issues reported frequently) and

atypical opinions (issues reported infrequently) were extracted.

3.1.5 LEGAL VIEWPOINT ON BEST PRACTICE

Given the medico-legal ramifications of error, and risk reduction strategies associated

with the provision of a DAA service, an opinion as to the impact on liability associated

with various current practices and proposed best practice processes was sought from

Elizabeth McDowell, Principal Solicitor, Guild Legal Ltd. Ms McDowell was asked to

comment on the liability implications of a number of hypothetical scenarios (see

Appendix D) and if possible, to summarise the contributing factors of any litigation of

any pharmacy/pharmacist associated with the provision of DAA services.

3.1.6 STABILITY OF MEDICATIONS IN DAAS

The Phase 1 literature review identified that there was little published information on

the stability of drug products in DAAs. In the light of this lack of evidence, we

considered that a risk assessment/risk management approach to judging the suitability

of a particular product for packing in a particular kind of DAA was feasible.

Dr Larry Kelly (Acting Director, Therapeutic Goods Administration (TGA) Laboratories

Branch) was consulted as to the potential utility of drug product manufacturer’s

packaging type (e.g. bottle versus tropicalised foil pack), storage and shelf life

information as input into decisions pharmacist may make on the suitability of a product

for DAA packing. Further, the availability of original pack type, storage and shelf life

information in an electronic form was sought. We also requested a copy of any of this

electronically available data.

Further expertise was provided by Dr Alison Haywood (Pharmacy School, Griffith

University) and Professor Beverley Glass (School of Pharmacy, James Cook

University) who preparing an initial report that addressed the theoretical issues related

to product stability in DAAs, how this theoretical framework could help pharmacists in

practice and to make recommendations related to the repackaging of drug products

into DAAs. Associate Professor Andrew McLachlan reviewed the final version of this

report. To support this report, we carried out the following activities:

Sending materials provided by the various manufacturers of DAAs (about the

devices, how they are sealed, any in-house stability/instability data) to the experts.

Identifying DAA packing practices (good and bad) that may influence the stability of

drug products.

Further literature searching was conducted on drug stability in general (not limited

to stability in DAAs), and identification of any pharmacopoeial standards that

applied to drug packaging, storage and potentially repackaging. The Australian

Code of Good Manufacturing Practice was also retrieved. A range of bibliographic

and other databases (Medline, Embase, International Pharmaceutical Abstracts

and SciFinder Scholar current to October 2005) were searched for terms related to

drug stability, instability and storage of solid dose forms (including hydrolysis,

oxidation, moisture decomposition, degradation, dissolution, bioavailability,

packaging and containers). Given the limited data available, reference texts

(textbooks) related to the field, reference lists of articles and abstracts from

conference proceedings were also examined. The goal of the literature search for

phase 3 was to provide a background on physicochemical stability issues relating to

the repackaging of medicines in DAAs in the absence of specific evidence.


Follow-up with Professor Roger Nation on any ongoing work that may be relevant

to drugs in DAAs (Professor Nation has previously carried out work in this area).

International contacts (Professor Gordon Flynn) were also approached to ascertain

whether any other research (potentially unpublished) was known.

Contributed to the various revisions of the report and the development of

recommendations.

3.1.7 OTHER CONSULTATION

Input from several other stakeholder groups was sought prior to developing the best

practice models. Meetings were held with:

Dr Kay Sorimachi and Ms Lyn Todd of the Pharmaceutical Society of Australia

(PSA) to discuss best practice in DAAs and the current state of the review of the

PSA guidelines. PSA sets professional practice standards and is the author of

existing guidelines and standards for DAA services.

Ms Lorraine Humphreys, Director of the Quality Care Pharmacy Program (QCPP).

The professional practice standards developed by PSA were included in the QCP

program (an accreditation program for community pharmacies).

Preliminary input was also sought from Aged Care Assessors. Four individual

assessors in the south east Queensland (QLD), Northern Rivers District of NSW were

contacted by telephone.

Discussions with Dr Larry Kelly (Acting Director, Therapeutic Goods Administration

(TGA) Laboratories Branch) also addressed other aspects related to the preparation of

DAAs in pharmacies. At his suggestion an email requesting a search of the Adverse

Drug Reactions Advisory Committee (ADRAC) database was sent, seeking reports of

adverse events associated with the use of DAAs.

Key informants also identified via snowballing methods were:

The Aged Care HMR Coordinator of the South East New South Wales (NSW)

Division of General Practice. This division was identified by through following a link

provided by PSA. The Division had undertaken a project to improve links between

GPs, RCFs and pharmacists aimed at improving communications and systems.

The Queensland Health Safe Medication Practice Unit. This unit was identified a

developing systems to be used in Queensland Hospitals to improve medication

safety along the continuum of care.

Dr Ro Saxon (Director, HDG Consulting Group), who was involved in a project to

develop implementation tools to support the APAC RCF medication management

guidelines (Australian Pharmaceutical Advisory Council 2002), including those

associated with medication management. This link was identified by a community

pharmacist (and Guild National Councillor) who had taken part meetings associated

with the project.

PSA also identified that the Australian Pharmaceutical Advisory Committee were

developing a document, “Guiding Principles for medication management in the

community” that might potentially impact on DAA best practice. As at February 2006,

this document had not been approved for release. On contacting APAC, we learned

that we could not make further reference to this draft document as it had not been

approved.


3.2 PRODUCTION OF DRAFT BEST PRACTICE MODELS

The approach taken by APAC in the production of their “Integrated best practice model

for medication management in residential aged care facilities” (Australian

Pharmaceutical Advisory Council 2000) was taken as a model for the production of the

preliminary drafts of best practice documents that were later circulated for comment. In

the APAC document, recommendations for practices were made followed by a more

detailed discussion of the issues or potential practice problems and the solutions to

these problems suggested in the best practice model. In the DAA models, the goal of

best practice was to adopt strategies available to prevent or minimize disruptions to the

medication administration system and when the use of these strategies improves the

efficiency of the overall system. Issues/problems addressed in the models were the

factors that were identified as contributing to unsafe practices, reduced effectiveness of

DAA services for patients with special needs, and inefficiencies in service provision.

Solutions were the strategies that practitioners are using or propose to use to

overcome the barriers to safe and efficient DAA provision. Draft tools to help in the

implementation of the best practice models were produced to support some

recommendations.


4. DEVELOPING BEST PRACTICE MODELS -

RESULTS

4.1 CONSULTATION

4.1.1 DAA EXPERT PANEL

Since providing a DAA service involves technical activities, a DAA Expert Panel of

pharmacy stakeholders was set up to inform model development from a technical

perspective and to act as a sounding board for the research team as new information is

obtained from other stakeholders that contributes to model development. A meeting of

the panel was held at the Gold Coast in March 2005.

Several key issues for model development arose from the DAA expert panel meeting:

That “best practice” refers to the process of model development and does not imply

that the model cannot be improved further.

That the best practice model should be an implementation template model (a ‘how

to’ approach) with a system focus rather than yet another guideline.

The project also needed to address dissemination and adoption of the model. It

was suggested that collaboration with the PSA team working on new DAA

guidelines was desirable. PSA guidelines would then feed into QCPP guidelines as

a way of increasing awareness and as a roll-out methodology. This relationship with

PSA was formalised.

Ideally, that other stakeholders should be expanded to include hospital pharmacists

(practitioners as well as the peak body), pharmacy information technology providers

(dispensing software, Palm etc), other IT providers (e.g. Medical Director) and

others supporting medication administration e.g. providers of medication chart

systems in RCFs.

Part of the best practice project should be to raise awareness among RCFs of what

is entailed in the provision of a DAA service, including the costs of that service.

The dearth of information about the stability of medications in packs should be

included (note: This was included in the Phase 3 proposal).

The panel noted that pharmacies from Western Australia were omitted from Phase 2.

Contacts have now been made with pharmacist DAA providers and staff from RCFs in

Western Australia. Later consultation was be sought from all states and territories

based on the panel comments.

The draft community model was considered by the panel (Figure 4.1). The panel felt

that identifying suitable recipients for DAAs should be included in the model. For

community DAA users, some baseline assessment of medication knowledge and errors

with medication management should be included as a means of monitoring the impact

of the service on these aspects.

A very early model was developed for RCFs focusing on the information flows as poor

communication was identified as a cause of many problems with systems (Figure 4.2).

The RCF systems are more complicated than community patient systems. This model

was presented to the expert panel and input invited. There was concern expressed that

it was assumed the medication chart was correct and the pack was wrong. The panel


indicated that this was not always the case and the model needed to reflect this. The

possibility of HIC accepting a medication chart as a prescription should also be noted.

New patient to start DAA(need already assessed)

Is it 6 months since last

formalcheck?

Yes

No

Pa

tien

t-h

eld

te

mp

late

kep

t u

p-t

o-d

ate

by

pa

tien

t, c

are

r &

GP

Inclu

din

g m

edic

ations c

hanges n

ot needin

g p

rescription

DAA packed by staff using template

Pharmacist checks DAA using template

DAA sent to patient

Pharmacist check/update template before next packing

Patient-held template/ medication record

Tripartisan Agreement*• Patient/carer• GP (+/- specialists)• Pharmacy

Formalise service to be delivered, expectations & obligations

*see break-out box for content

Full review/ renewal of template

• Patient, GP & pharmacy

Template for medication packing• Shows medication regimen & preferred

time of day for each dose

Reflect• Patient habits/preferences• GP preferences• Current medication & optimal schedule• Type of pack & packing interval• Check medications suitable for packing• Other constraints e.g vision impaired

Pre

scriptions

dis

pensed

Template approved by all

Template copy to GPNew patient to start DAA(need already assessed)


formalcheck?


formalcheck?

Yes

No

Pa

tien

t-h

eld

te

mp

late

kep

t u

p-t

o-d

ate

by

pa

tien

t, c

are

r &

GP

Inclu

din

g m

edic

ations c

hanges n

ot needin

g p

rescription



DAA sent to patient











Pre

scriptions

dis

pensed


Template copy to GP

Break out box

Issues to address in agreement Obligations of parties - examples In simple language

Explanation of how service expected to work

Patient consent to service and necessary information

sharing between GP & pharmacy

Patient, GP and pharmacy agreement to service

obligations

Agreed cost of service including any GP costs as

negotiated

Billing/account aspects

Where prescriptions and original packs physically

stored

Is pack to be collected or delivered (address

timeliness & exception procedures)

How medication regimen changes to be handled

Duration of agreement & an understanding that the

situation to be reviewed every 6 months

Pharmacy to prepare packs at agreed interval

(frequency & period in advance of distribution)

Any additional support services e.g. education, Home

Medicines Review the pharmacy agrees to provide

GPs responsibilities for owing prescriptions &

prescription continuity (e.g. writing repeat

prescriptions without patient consultation) including

timeliness of prescription receipt

Pharmacy processes negotiated to fit in with GP

practice

Address GP expectations for payment & who will pay

if any cost

Patient & GP to give timely notification of pharmacy

of any medication changes including those that do

not generate a prescription e.g. ceasing a medication

Patient/carer & GP to maintain patient held template

Figure 4.1 Best practice model for operation of a DAA service for community patients

The panel raised other issues to be addressed in an RCF model:

Situations where 2 pharmacies are used, each providing DAAs or where one

pharmacy provides a DAA and another fills the occasional prescription and so that

item is not packed.

Patients getting medicines from either hospitals (e.g. outpatients for specialist

items) or mental health clinics – not from the pharmacy packing DAAs. The

pharmacy needs to maintain the profile but decisions on best practice of packing

these non-pharmacy sourced medications are needed.

What happens with non-packed medications (also an issue for RCFs)


GP

Pharmacy* supplying RCF

New resident

RCF

*assumes main supplying pharmacy but resident has choice to choose separate one

Current drug regimen

Order toadminister drug

Medication chart

Advise of medication

supply system,

obligations &

expectations

Order to supply

Medication chart

Authorising

payment for

supply

PBS prescription

Reminder on

continuity of

supply

RCF medication system

including DAArefill

schedule

System of supply – obligations & expectations

including responsibility for script management,

who notifies pharmacy of changes

Mutual obligations &

expectations

Figure 4.2 Best practice model for information flows necessary to operate a DAA

service for RCF residents

Subsequently, based on preliminary feedback, an RCF model showing the steps

involved in a DAA service in RCFs was devised to trigger discussion in focus groups

and structured interviews (Appendix C).

4.1.2 SUMMARY OF FOCUS GROUPS

Overall a total of 11 focus groups were conducted, with the following groups of health

care professionals: community pharmacists, hospital pharmacists, RCF nursing staff

and RCF management e.g. Directors of Nursing (DONs). Throughout the course of

these focus groups the challenges and rewards of DAA provision were examined, both

within the current context, and with regard to the development of a best practice model

for DAA supply. Through these focus groups it was possible to identify the limitations of

DAA supply, the benefits of DAA supply and the changes that can be made to ensure

that DAA provision results in optimal outcomes for all concerned. In this section, the

findings of the focus groups are summarised. The full focus group reports can be found

in Appendix C.

4.1.2.1 Participants

Of the 28 community pharmacists invited to participate, 19 (68%) were able to take part

in the telephone focus groups at the times specified. Reasons for non-participation

were: being too busy, being on holidays, not being available at the specified times and

not having very much involvement with DAAs.

Four focus groups were conducted there were 20 participants in total from 6 states,

including 2 technicians managing DAA services in two sites (one of whom was not

expected in the group but invited by her employer).

Of the 19 hospital pharmacies approached, staff from 11 (58%) were available and

participated at the specified time. Two focus groups were conducted with 11

participants in total. Participants represented 5 states, tertiary, regional and rural

hospitals, public, repatriation and other private hospitals.


Out of the 32 facilities contacted, 13 (41%) were able to participate in telephone focus

groups within the timeframe specified. Reasons for non-participation included:

Not being available at the dates and times chosen for the focus groups.

Being on leave.

Too busy (e.g. undergoing accreditation).

Staff shortages.

Staff changes so contact person no linger available.

In total five focus groups were conducted:

Three Directors of Nursing (DON) focus groups with a total of 14 participants from

13 facilities across 6 states representing metropolitan, regional and rural RCFs.

Two RCFs staff focus groups (Registered Nurses (RNs), Enrolled Nurses (ENs)

and Assistant Nurses), with a total of 16 participants from 2 facilities in one state.

The RCFs had high care and low care units, and some had self-medicating

residents.

Participation rates in preliminary model development are summarised in Table 4.1.

Table 4.1 Summary of participation in preliminary model development

Stakeholder group

No. invited to participate

No.participating

Participantsinvolved in Phase 2

Characteristics of respondents & comments

Expert panel 25 14 attended meeting; 11 sentmaterials only

10 had been members on Phase 2 Reference Committee

See Section 3.1.1. *3 community pharmacists on panel also participated in community pharmacist focus groups

RCFmanagement

32 13 RCFs of 8 participants involved with Phase 2

Represented 6 states, metro, regional and rural, profit & not-for-profit RCFs; 5 DAA types;

RCF staff 4 (3 homes at one site)

16 1 RCF (6 participants) in phase 2

SE QLD – 2 DAA types, medication administered by RN, non-RN & self-medicators

RCF residents - - - - Community pharmacists

28* 19 11 took part in Phase 2

Participants from 6 states, 5 DAA types, serving RCFs, CPs, intellectually handicapped units & indigenous communities; 8 regional/rural

Pharmacy dispensary technicians

Unknown; incl. AusPharmList recruitment, 10 SE QLD pharmac--ies, 6 community pharmacists in focus groups

9 Pharmacies of 4 technicians in Phase 2

From WA, NSW, NT, QLD, VIC ; 4 DAA types; serving RCFs, CPs, specialised units (intellectually handicapped & renal) and indigenous communities; 4 regional/rural

Hospital pharmacists

19 11 None Represented 5 states, tertiary, regional and rural, public, repatriation and private hospitals

GPs 34 34 All phase 2 interviews

Representing 6 states, metro, regional/rural

Community patients

- - - -


4.1.2.2 Community pharmacy views

From the community pharmacy perspective, a variety of issues emerged as being

critical in the safe and efficient supply of DAAs. The issues are summarised in Table

4.2. Among these were: the need for standardised procedures regarding medication

changes; the need for unambiguous and up-to-date medication charts; and the need

for changes to DAA supply legislation. Naturally, community pharmacists also identified

various other DAA supply issues, however, many, if not all, of those issues could be

attributed to poor communication and solved through improved communication. Indeed,

poor communication was a primary causal factor in problems such as difficulties with

medication changes, owing prescriptions, ambiguous patient medication charts,

medication errors and problems with continuity of care when patients were admitted or

discharged from hospital.

With respect to the proposed best practice model flow diagram (see Appendix C -

Community pharmacist focus group materials), pharmacists were typically positive in

their appraisal, with noteworthy suggestions being: an inclusion in the model denoting

where patient accounts must be sent (i.e. to the patient/family or the RCF) and a step

in the model evaluating the suitability of medications for packing in DAAs. The findings

of the community pharmacists’ focus groups were similar to the findings of the earlier

Phase 1 and 2 studies. In these studies, poor communication between parties and

uncertainty regarding the packing of medications in DAAs, were both identified as

issues of concern for pharmacists.

Community pharmacists were also largely in favour of allowing medication charts to act

as prescriptions, but identified the potential for chart errors to be translated to the

patient’s pack, where as currently, chart errors were likely be identified before this

could occur. On the issue of a tripartisan agreement for DAA supply, pharmacists were

again positive, with many believing it would help to formalise the responsibilities of

each party – again assisting in the communication process. There were reservations

about any legal responsibility arising from the agreements.

Summary: Poor communication is linked to owing prescriptions, medication changes

and DAA packing errors. All of these factors affect both the efficiency and safety of

medication supply. Changes to make current guidelines less ambiguous, and improved

communication throughout the whole DAA supply process, including education of

doctors and RCFs on the effects of medication changes on DAA work flow, would

greatly improve the situation for pharmacists and increase safety for patients.

Pharmacist also believe they should be remunerated more fairly for DAA supply.


Table 4.2 Summary of issues raised in the community pharmacy focus groups

Problems of, and solutions to, DAA supply

o Ambiguous/out of date medication charts: Developed modified chart system

o Poor integration of IT solutions: requires integrated DAA and dispensing software

o Owing prescriptions: improved communication

o Medication changes: improved communication

o Problems with continuity of care: improved communication

o Integration of DAA supply into pharmacy business: improved organisation and use of

staff time – still require better remuneration

Additional inclusions for model of DAA supply

o Assessment of the suitability of medications for packing in a DAA

o Inclusion of an allowance for medication changes in the supply process flow diagram

Safety and efficiency of DAA supply

o Safety affected by poor communication (especially regarding medication changes):

Solution, keeping detailed records of patient medication status and changes, increased

communication with relevant parties

o Misunderstanding by doctors about the effects of medication changes: Solution, educate

GPs about the effect of changes and implement procedures for changes

o Errors in DAA packing: Solution, specialised staff for packing and checking, proper

training of staff, separate the packing and checking roles, clear and accurate medication

charts, an appropriate environment to reduce risk of errors

Legislative barriers to DAA supply

o Owing prescriptions and PBS rules

o Transition of patients from hospital to community – ensuring patient profiles updated,

see hospital pharmacy focus groups.

o Pharmacists feel guidelines are unrealistic in their expectation of pharmacists –

especially as they are often not remunerated.

o Pharmacies feel they must bend the rules to keep supplies current – applied to all of the

above

o Guidelines and standards are ambiguous across different bodies and how interpreted by

different nurses or RCFs

o No standards of communication between parties involved in supply

Materials to facilitate more efficient DAA supply

o Pharmacists generally happy with manufacturers materials

o Integration of DAA and dispensing IT programs would increase efficiency

o IT solution to keep all charts/packs/signing sheets up to date would increase efficiency

o Portable IT solution for taking to RCFs to check charts and profiles and to aid

medication identification would help

Impact of changes to DAA practices – Medication chart as prescription

o Overall responses positive, would save time and money

o Caveats: a lot of medication errors made on charts, not currently legally satisfying

(including PBS rules)

Impact of changes to DAA practices – Integration of RMMR/HMR to DAA supply

o Would be too inefficient, not a sound idea

o Provided done within a reasonable timeframe for community patients (1 month) there is

no need

Impact of changes to DAA practices – Shared electronic medication profile

o Responses positive: good tool for communicating medication changes; would improve

timing and quality of supply

o Caveats: would need flag to alert all parties of medication changes; would need method

of protecting patient privacy

Impact of changes to DAA practices – Introduction of tripartisan agreement

o Positive idea: would formalise responsibilities of all parties

o Some would prefer not to be legally binding


4.1.2.3 Hospital pharmacists views

From the hospital pharmacists’ perspective, while many of the problems with DAA

provision were different in nature to those identified by the community pharmacists’,

there remained a remarkable similarity of experience (see Table 4.3 for a summary).

Among the issues that were most problematic for hospital pharmacists were:

procedures for patient admission and discharge; discharge planning for patients; and,

procedures for handling patients existing medications on admission and discharge.

Problems encountered when patients using a DAA were admitted to hospital related to

incomplete or inaccurate information about current drug regimens. This was a point of

concern among hospital pharmacists as it led to inefficient use of time spent following

up missing information – a difficult task if the usual community pharmacy was

unknown. Some hospital pharmacies have developed a medication reconciliation form

to formalise the confirmation of current drug regimen information. The effect of packing

a medication in a DAA raised two other concerns with (1) the integrity of the product

(e.g. stability and non-contamination) and (2) identification of medications packed in a

DAA given concerns with labeling and the use of multidose packs.

Upon discharge, according to the APAC guidelines (Australian Pharmaceutical

Advisory Council 1998), hospitals should facilitate continuity of information a patient’s

current drug regimen and continuity of medication supply. Hospital pharmacists

themselves were inconsistent in the information they provided to the patient’s RCF and

community pharmacy. Medications supplied on discharge varied and depended on

hospital policy and community pharmacy preferences. To make appropriate plans for

post-discharge DAA supply, the hospital pharmacist had to know that a patient usually

used a DAA. Hospital pharmacists generally did not recommend DAAs but would

sometimes recommend patients to pharmacies that supplied DAAs. Discharge

planning, where the activities to support information transfer and continuity of

medications could be carried out in a timely manner, varied. Determining what

medications to supply, what would later be packed and not knowing the name of the

patient’s community pharmacy to find out the pharmacy preference could cause

problems. Discharging patients to rural areas had additional logistic problems.

Many hospital pharmacists expressed the opinion that they would like the patient’s

community pharmacy to be informed of any changes to the patients medication

regimen while in hospital, but did not enact this themselves. This was partly due to

problems identifying the patient’s community pharmacy on admission, partly because

there were no procedure in place and partly because of lack of resources. There was

also disagreement among hospital pharmacists as to whether standard procedures for

admission and discharge should be implemented, with the focus group participants

evenly split on this issue. On one hand, was the acknowledgement that standardised

procedures would reduce the variance in information, that pharmacists found

problematic, on the other, some pharmacists argued that standardised guidelines are

unnecessary and that common sense should prevail.

Most hospital pharmacists were satisfied with the legislative and guideline framework

for DAAs but some felt that they were ambiguous and that pharmacists were not

adequately recompensed.


Table 4.3 Summary of issues raised in the hospital pharmacist focus groups

Patient admission to hospital

o Hospital pharmacy needs complete and accurate patient medication profile and name

of patient’s community pharmacy and GP

o Patients should bring DAAs with them to hospital

o May or may not use these medications packed in a DAA due to concerns about

integrity of dose form and identification of specific medications within packs

Discharge planning

o Supply discharge sheet to RCF/patient AND community pharmacy

o Most problems could be solved by more frequent and structured communication

o Standardised procedures are needed for admission and discharge

o Standardised definition of sufficient medication supply

Reducing medication wastage – possible solutions:

o Using patients’ DAAs if brought to hospital with them

o Community pharmacies using discharge medications

o Returning DAA/OPs with unused medications to patients on discharge

Legislation, guidelines and standards

o Clarification of who can pack DAAs

o Modification of guidelines to allow someone other than pharmacist to label and

dispense? – Probably not a good idea.

Pharmacies should be properly remunerated for supplying DAAs.

Summary: Most problems can be solved through improved communication between

the relevant parties, especially with respect to admission and discharge planning. This

also applies to use of DAAs as hospital pharmacists can inform the community

pharmacy of the patients medications including any changes, etc., following discharge,

and can arrange for the community pharmacy to pack a DAA for patients upon

discharge – helping to reduce medication wastage. Wastage could also be reduced if

hospital pharmacists were more confident in using medications packed in a DAA.

Universal standards for packing and labelling could increase this confidence.

4.1.2.4 RCF management and staff views

RCF management and staff focus groups provided insight into the problems and

benefits of DAA use within the RCF setting. Overall it emerged that from the RCF

management perspective, the big picture, DAA use was beneficial as a tool for

organising and administering resident medications. The nursing staff perspective of

DAA use related to actually administering medications to patients using the systems

put into place by each facility to ensure safe medication administration that complied

with standards and regulations. For nursing staff, the benefits of using DAAs were

offset by their drawbacks but this perception may have been influenced by the

complicated systems needed in one facility in particular to address limitations of the

DAA service provided by their contracted pharmacy.

A specific concern of RCF staff in both focus groups and DONs was their ability to

detect DAA packing errors and the systems in place to check packs. The focus group

discussions did not, however, suggest that errors in packing were common, but rather,

if errors were to occur, that the RCF staff would be able to detect them. Errors were

seen as a critical incident not the norm. RCF systems needed to support DAA use were

complicated by the use of temporary agency staff who did not always follow the proper

procedures. Throughout the course of the focus groups both DONs and nurses

presented a number of suggestions that could lead to improved efficiency and


effectiveness of DAA use, including: staff training, modifications to current labeling

requirements for DAAs and changes to legislative requirements regarding medication

orders. The issues raised in the RCF focus groups are summarised in Table 4.4.

Table 4.4 Summary of issues raised in the RCF focus groups

Inefficient and unsafe practices in DAA supply – and solutions to these

o Medication changes/supply of medications after hours: Contingency plans for after

hours supply, good communication with pharmacy can eradicate the need

o DAA packing errors: Solution, internal auditing system to detect errors, staff training

in medication administration procedures

o Time consuming checking DAAs: no solution, must be done

o Staff cutting corners: Solution, thorough training

Delivery of medication

o Few problems

Medication receipt and storage

o No real problems – occasionally two or more medications in the same blister will stick

to each other during transport in a hot car

Medication administration

o DONs prefer DAAs to OPs, nurses are not as keen on them but accept them

o Major problem is the labelling of DAAs, particularly labelling of “generic” brand

medications with no reference to originator brand

o If medications to be crushed, problems determining which medications not suitable

for crushing and to separate these before crushing other medications

o Medications can be lost, dropped or refused by the patient – in which case there is

often not a replacement medication available

Staff training for DAA use

o Levels of staff training varied considerably between none and 2.5 days.

o Some RCFs also had regular refresher training courses, monthly or annually, for staff

o Training was generally done in house, few RCFs had pharmacy input in the training

program

o One RCF distributed drug information sheets provided by the pharmacy and quizzed

them on these every month

o Nurses were frustrated with the professional standards of temporary agency staff and

felt they didn’t exercise the same high standards

o Only one DON felt that DAAs led to a deskilling of nursing staff

Barriers to DAA use from guidelines and standards

o Medication charts not able to work as a prescription

o Poisons Act is outdated

o Nursing staff are unable to make notations on charts e.g. mapping “generic” brand

name supplied to brand written on chart – leads to confusion and inefficiencies

o Staff are confused as to who can administer what (RN, EN, PCA) when using multi-

dose and unit dose DAAs

o Standards are different across states – confusing

Impact of changes to DAA practices – Medication chart as prescription

o Responses overwhelmingly positive, felt it would save time, increase efficiency and

reduce paperwork

Impact of changes to DAA practices – Integration of MMR to DAA supply

o Current standards regarding this are fine, it would not be feasible in practice

Impact of changes to DAA practices – Shared electronic medication profile

o Responses positive, feel it would increase communication and efficiency

o Caveats: Financing of system – RCFs can’t afford it and it would require upkeep and

maintenance; Computer literacy is often poor among Drs, RCF staff and pharmacists

– would need to be usable by all these groups; System would also need to be able to

keep patient records secure.


Summary: DAAs were good for use in RCFs provided their limitations could be

handled. Checking DAAs, often repeatedly, was inefficient for nursing staff as was

reading DAA labels and patient charts where “generic” brands have been packed as a

substitute for brand names ordered on the chart. Nurses felt restricted by

legislation/guidelines that prevented then making notations on charts to address this

type of issue (i.e. annotating on the chart the “generic” brand actually in the pack).

Once again, communication was an issue with respect to medication changes and RCF

staff needed contingency plans to allow for after hours changes. Current standards

were confusing as to who can administer certain medications, made more complicated

by standards and nursing body guidelines varying between states. DONs and nurses

were very much in favour of allowing the chart to act as a prescription and feel that an

electronic medication profile would be a big positive, they were, however, opposed to

the integration of initial DAA supply to new residents with a RMMR.

4.1.3 PHARMACY DISPENSARY ASSISTANT/TECHNICIAN INTERVIEWS

Nine interviews were conducted with non-pharmacist (and non-pharmacy student) staff

i.e. dispensary assistants/technicians (DAs) who were directly involved in the packing

and checking and other aspects of the operation of a DAA service. Five DAs worked in

pharmacies whose owner/manager had taken part in the pharmacist focus groups. The

interview questions were more specifically targeted to in-pharmacy procedures that

those asked of community pharmacists, and sought information on training and

knowledge of these key participants in DAA services.

The represented 5 states, metropolitan and regional centres, and provided services to

RCFs and/or community patients. Community patients included some intellectually

handicapped patients who lived in special accommodation, indigenous health services,

drug and alcohol rehabilitation patients and patients in a renal unit. Some respondents

prepared more than one pack type. The pack types provided were:

Webster multidose 7 day packs (6 respondents) including 1 ‘jumbo’ pack provider

Webster unit dose (systems), a service provided to RCFs (4 respondents)

Webster Flexipaks (1 respondent)

Douglas cold seal packs (1 respondent)

Douglas non-cold seal packs (1 respondent)

Medico packs linked to the FRED dispensing software (1 respondent)

Dosett boxes (2 respondents) – there were provided to some community patients at

patients’ request.

In reviewing the flow diagram sent to respondents in advance (see Figure 4.3), five felt

that steps were missing:

The return and correction of a pack if there were changes (a point raised by two

respondents). If the medication change did not involve a new drug (e.g. drug

ceased or a dose time change), then the steps of dispensing the prescription and

checking the dispensed medication would be skipped, i.e. the workflow would jump

from step 2 to step 6. Further, there may be a need to trigger Step 13, the return of

the old, now incorrect, packs to the pharmacy prior to effecting any changes in the

pack. Changes to packs was a “huge time factor” especially when GPs visited an

RCF during the week covered by the DAA (when there could be as many as 10

charts/day with changes). One DA indicated that some doctors annotated

prescriptions or orders “make changes when the next DAA is packed” – this was

felt to be helpful and reduced waste.


One respondent also felt that the diagram could indicate that non-packed and “prn”

medications could be prepared in a separate location and by separate staff to those

preparing DAA packs.

Explicit mention of inventory management processes (2 respondents) when

assembling medications to dispense and pack i.e. is there enough stock on hand to

fill packs at the next scheduled packing day? If not, the workflow would include

ordering and receiving this stock from wholesalers/distributors.

The explicit inclusion of a step that when dispensing the last repeat on a

prescription, a repeat reminder be printed and sent to the doctor (to reduce owing

prescriptions).

Steps to deal with telephone orders.

While some of these additional steps were felt to be specific cases of a more general

workflow, aspects such as stock control and notifying when a new prescription is due

were later added to the best practice models.

4.1.3.1 Roles and practices experienced by respondents

In examining the roles of the dispensary assistant/technicians (DAs) in providing a DAA

service, respondents were asked which steps in the work flow diagram (Figure 4.3) that

they were involved in.

1. Medication order• Prescription from GP• Medication chart from RCF

2. Develop or update pharmacymedication profile

0. GP orders & prescribes medication

2a. Support activities

• Prescription management*

• Accounts

3. Dispense prescription

7. Pack medication according to profile

8. Check packed medication

10. Deliver / collect medication

11. Medication receipt &/or storage

12. Administer medication

* If chart for administering and prescription for payment

Non-packed

medications

13. Medication returns to pharmacy

Different procedures needed for:• New resident• Medication change• Other situations eg. going to &

returning from hospital

External Internal to PharmacyKEY:

4. Check dispensed prescription

6. Prepare for packing (labels, assembling medications etc)

5. Store dispensed medications not yet packed

9. Store packed medication

Figure 4.3 Work flow diagram used as a prompt for dispensary assistant/technician

interviews

At various times, the respondents performed the steps internal to the pharmacy

excepting steps 4 and 8, checking activities to be done by a pharmacist, according to

PSA guidelines (Pharmaceutical Society of Australia 1999). Developing and reviewing

the medication profile might be expected to be a pharmacists professional

responsibility, however, two respondents mentioned that they were involved in entering

medications into the profile while another did this step in conjunction with the


pharmacist. One respondent explicitly mentioned that this activity was performed by the

pharmacist. The main focus of technicians/assistants was on the steps related to actual

packing of the DAA and the processes involved in prescription management (including

following up with doctors to get new prescriptions or warn that a new prescription would

soon be required). One technician noted that she liked the responsibility of looking after

the DAA service. This same technician visited new community-based DAA users in

their homes soon after DAA were started to check that the patient was managing the

new system.

In reviewing the work steps, most respondents described their processes. Some

practices deviated from those in the PSA guidelines (Pharmaceutical Society of

Australia 1999) or professional practice standards [Pharmaceutical Society of Australia,

2006 #321]. For example, in 3 cases, packs were prepared based on the printed

backing foils or header cards rather than any profile. The PSA guidelines require

reference to the original medication chart or prescription each time a DAA is filled while

the standards require reference to the current prescription or medication regimen (p18).

One reason for the practice was that the foils were the most up-to-date information and

the profile had to be updated to actually produce the foils.

In the interviews, practices related to several specific aspects of the service were also

explored:

How non-packed medications were handled

Procedures for medications returned in DAAs

Starting a new customer on a DAA

Templates, tools or materials used to facilitate DAA supply

4.1.3.1.1 Non-packed medications

The PSA standards [Pharmaceutical Society of Australia, 2006 #321](p18) include two

indicators related to non-packed medicines i.e. that the medication history lists those

medications not delivered in a DAA and that the patient or carer has a list on non-

packed medicines. Procedures to ensure that non-packed medications were supplied

sometimes depended on whether medications were supplied to an RCF or to

community patients:

Non-packed medications were recorded in the profile (4 responses) and were

added to the delivery list for community patients as required (patient notified

pharmacy). In once case, the pharmacy kept track of need based on expected use

and items were sent when “due”.

Non-packed medications were written on the header or top card of the DAA.

The community patient advised the pharmacy when supply was required (2

responses) but support was provided by the pharmacy e.g. if a patient was forgetful

or had not requested re-supply, the pharmacy would ring to check.

Supplies of non-packed medications were checked as part of an “active home visit”

approach to delivery

Non-packed medications were ordered by the facility as needed (3 responses)

(after routine, monthly supply of eye drops or RCF orders resulted in stockpiles in

the RCF in two cases). Stocks were monitored on an informal basis. One pharmacy

initiated a monthly order list for non-packed medications for some RCFs.

The DA checked non-packed medications e.g. eye drops, when in the RCF and

sent supplies as required.

4.1.3.1.2 Medicines returned in DAAs


Respondents were asked how returns were handled since all medications in a DAA

should have been taken by a patient so that the return of medications in a DAA can

potentially indicate a medication management problem. Further, the PSA guidelines

recommended that “unwanted medicines from the DAA should be returned to the

pharmacy for safe disposal and should not be reused. The pharmacist should request

information…. and note the reason(s) for any unused medicines” (Pharmaceutical

Society of Australia 1999) and follow up returns “known or suspected to be due to non-

compliance”. Actions to deal with the medications included:

Placing returned medicines into the Return Unused Medicines (RUM) bins (3

responses). In one case, this explicitly referred to medicines in original packs and in

another, to multidose pack contents.

Re-using drugs returned by a given patient for that same patient’s next pack

provided the integrity of the medication was felt to be maintained (2 responses).

The batch numbers recorded in one pharmacy were used to indicate older packs

whose integrity was more likely to be compromised. The reuse of certain

medications was used to minimise waste and cost to the patient.

Re-using if needed for the same patient if for on-going use otherwise disposal of

medications (2 responses).

Discarding all medications returned from indigenous communities.

Recording, monitoring and followed up varied, with the following procedures being

described by DAs:

Having follow-up procedures for medicines that are returned, where the situation

was recorded and reported up to the pharmacist (and possibly the doctor) for

further action (2 responses). In one pharmacy, incidents were reviewed weekly.

No formal recording of returns but informal monitoring and follow-up if further action

is required (4 responses).

Packs used were disposable so not usually returned but for some community

patients where there was a suspicion of problems, the delivery person was asked to

bring back packs to check whether the patient was coping. No records were kept of

returns but actions taken to address any concerns were formally documented.

For indigenous communities, a stock-take of packs in the health centre was done

each fortnight as compliance varied; there was no way of finding out reasons for the

unexpected non-use of packs. The pack type used was disposable so no returns.

Other pack types require the person to return a plastic frame, for example, and this

requirement did not match philosophy of the community.

4.1.3.1.3 Starting a new community DAA customer

The practices of pharmacies and roles of DAs in starting a new customer on a DAA

varied. Some (2 responses) had no involvement with new DAA users. Some DAs (4

responses) undertook much of the start-up activities including explaining the costs to

the patient or their family, what’s involved (including individualising delivery procedures

(some using a leaflet to explain)), what is needed by the pharmacy and any pharmacy

policies. Two technicians mentioned occasionally making an assessment of the

patient’s suitability for a specific type of DAA, even if informally. One technician was

also involved with liaison with or referral to the GP when new community patients

wished to start using a DAA. Another DA sometimes visited new DAA patients in their

homes to explain the system and collect medications for initial packing. The visit

include demonstration of a sample pack and how to use it (said to be “very helpful” by


the DA). Four pharmacies had information sheet to help explain the service (e.g. need

for regular visits to the doctor, the fees involved) to new DAA users.

4.1.3.1.4 Supporting templates, tools or materials

Awareness and use of tools to support DAA activities was limited. Only some DAs were

able to describe existing templates, tools or materials used to facilitate DAA supply,

and these 4 of these DAs described several each. In a number of cases, these were

tools provided by the manufacturer of the DAA type used. Tools used included:

Manufacturer’s forms (3 responses, e.g. entitlement, Medicare number checking.)

and sample packs (1 response).

Manufacturer’s procedures and IT systems (2 responses).

Other IT or dispensing systems that allowed the profile to be used as a batch sheet.

A checklist for new patients (to ensure all necessary actions had been taken).

A change notice form requesting old packs back so they could be changed.

An order form for non-packed medicines for use by a clinic and indigenous

communities.

A template in the computer to generate requests for scripts on the last repeat. The

pharmacy tried to align re-supply/re-order times so that several requests could be

sent at once.

An incident book in which medicines returned by DAA patients, errors in packing

and out-of-stock events were recorded. This book was reviewed weekly.

A DAA collection chart to record collection of DAAs by community patients.

A “request for medication chart” to send to a doctor for RCF residents and a

“medication change” form. This was also used to get information from hospitals.

A recorder sheet for the packer to note that the last prescription was used and a

new one would be required from the GP.

A form to advise the RCF of changes in individual packs e.g. a medicine ceased so

here is a new pack, send the old pack back, or, an additional medicine is in an extra

pack this week but will be in a pack with other medicines from next week.

Three DAs worked at sites with a quality improvement approach to practice, each

developing and using a number of tools. Two DAs mentioned using these tools to

monitor and solve problems. Two other DAs demonstrated little appreciation of quality

improvement, one saying there were no problems with existing tools and another

stressing the need to minimise paperwork. Some improvements to tools and materials

were suggested as being helpful such as:

Automated reordering of new prescriptions from doctors (writing up lists of doctors

and prescriptions required, faxing the list and following up was felt to be the most

time consuming activity).

Using the manufacturer’s software that integrated DAA profile and label production

with dispensing (the pharmacy prepared their own version of the packing form and

used free-form labels felt to be not very professional by the DA).

As checking logs and delivery logs were documentation tools included in the PSA

guidelines and in the QCPP resource kit, respectively, use of these tools was

investigated. Records of packing and checking varied:

Checking was recorded on a checking/packing sheet (4 responses)

The packer and checker each signed the foils.

No checking logs were kept but checked packs are put in a separate location (1)


Maintenance of a delivery audit trail (as required by the distance dispensing PSA

standard [Pharmaceutical Society of Australia, 2006 #321]) also varied.

No delivery receipt records were kept in one pharmacy.

Delivery and collection (from a patients home or RCF) logs were kept (2 responses)

while another site where patients collected DAAs from the pharmacy kept a

collection log.

One pharmacy supplying isolated indigenous communities used registered couriers

and logged every aspect of the delivery.

4.1.3.2 Problems associated with DAAs and their solutions experienced by

dispensary assistants/technicians

Problems experienced by DAs were generally in the areas of:

1. Obtaining and maintaining a current medication profile. Includes problems learning

of changes to medications and ensuring these changes are reflected in packs.

2. Obtaining valid and legal prescriptions in order to dispense medications in time for

the cycle of packing a DAA. This led to problems with “owing” prescriptions, with

continuing medications supplied before the GP sent a PBS prescription.

3. Patients, RCF staff and doctors having unrealistic service expectations or lack of

awareness of constraints faced by the pharmacy in providing a DAA service.

4. Continuity of medication information and supply issues when patients were

admitted or discharged from hospitals (a combination of problems determining the

current profile, getting prescriptions in a timely manner and unrealistic

expectations).

5. The risks of packing errors, including problems reading medication charts.

6. Control/supply of non-packed medications in RCFs and for community patients.

7. The risks of patient, carer or RCF misuse of the DAA.

8. Needing to record and type in the medication list in many places e.g. the

dispensing software, any profile and the DAA labelling software.

Details of problems or contributing factors and strategies used by pharmacies

employing the respondents are described in the following sections.

4.1.3.2.1 Current medication profiles

In order to pack a DAA that is correct at the time of use, the pharmacy needs to know

the full and current drug regimen, and this information must be reliable. For community

patients, some changes that involve changing a dose time or ceasing a drug would not

require the GP to write a new prescription. Relying on patients to advise of changes or

to provide a full drug regimen was felt to be inadequate. Obtaining a full and current

drug regimen from the GP at the time of starting a DAA was the preferred solution –

generally the regimen was to be in writing.

Of particular concern was detecting changes that do not result in a prescription being

written (e.g. to stop a drug). Pharmacies must have mechanisms in place to detect and

implement medication changes that result in a new prescription and those where no

prescription is written. Solutions and tools suggested were:

Only accept notification of changes in writing from the GP (3 responses). In one

pharmacy, with any change the GP had to provide a new, complete list of current

medications including non-packed medicines, not just writing the change.

The pharmacy reconfirms the profile with the GP every 3 months (in writing) when

the patient sees the doctor. This facilitates concordance and ensures that the

patient sees their doctor at least every 3 months.


Faxing the doctor a medication change or addition form to complete and fax back

as documentation of the change.

Have forms to fax to GP to confirm that the pharmacy profile is current.

Establish that the GP has the responsibility to notify the pharmacy of changes

especially if a drug is stopped.

In RCFs, problems related to an instruction for a medication change can be due to:

The RCF notifying the pharmacy of only some of the changes for a patient,

particularly where the change does not necessitate the supply of a drug (e.g.

stopping a drug or changing the dose time).

The doctor writing a change in the patient notes but not on the medication chart.

The doctor giving a verbal order (telephone order) to nurses so that the order is not

on the medication chart.

Where the prescription conflicts with the medication chart. The order can be written

in the medication chart but the doctor writes a slightly different order on a

prescription written on his or her return to the surgery.

The change not communicated in a timely manner to the pharmacy. Lack of

communication between GPS and the RCF was felt to be the main contributor.

The usual approach to this problem was to specify that the whole medication chart

must be faxed through to the pharmacy before a pack is change, not just the page with

the change.

One DA who was involved in providing DAAs to indigenous communities and hospital

clinics found that medication orders (the charts and prescriptions) from the doctors

were not always completed properly, with details about the drug regimen or details

required for PBS claims, etc, being omitted. Nurses and community health workers

were trained to check for these details at the time the order was written.

Lack of communication of medication regimen changes within the pharmacy was

another possible problem. Solutions were:

Stressing to all pharmacy staff the importance of communication of medication

change information as part of the supply of DAAs.

Having systems in place to record notification of medication changes.

4.1.3.2.2 Timely receipt of valid and legal prescriptions

Continuity of supply of ongoing medicines for DAA users requires continuity of legal

and valid prescriptions. In some situations, medications were supplied in advance of

the receipt of a prescription because of patient need and the time constraints of

packing a DAA. This can lead to the problem of “owing scripts”, a situation that had

been experienced by all respondents. The practice is contrary to regulations and, if a

prescription is not ultimately received, the pharmacy also bears the cost of the

medication. One DA said that “owing scripts” was more a problem for community

patients because the doctors wanted to see the patient before writing a new

prescription and it can be difficult for a patient to get an appointment in time.

A related problem was that of GPs giving the pharmacy a telephone prescription (which

was then dispensed in good faith) but failing to reduce that verbal order to a written

prescription in the timeframe required. In one area servicing a renal unit, phone orders

from the doctor were relayed by the nurses to the pharmacy, increasing chances for

translation/transfer errors. Procedures were put in place to address phone orders

including a requirement to fax the written order to the pharmacy. Another DA indicated


that if a doctor had given the RCF staff a phone order, the pharmacy had forms to fax

to the doctor (a medication change or addition form, also used for community patients)

to get documentation directly from the doctor.

The need to dispense prescriptions in advance of when the medications would be

taken by the patient and frequent medication changes (that increased the rate of

wastage) also generated problems when GPs complained that new prescriptions were

ordered “too early” (as flagged by prescribing software). This was particularly a

problem with PBS items requiring an authority. [Authority prescriptions are written for

certain, generally high cost, PBS items where the quality, re-supply dates and other

aspects of the prescription required prior approval from the PBS. If these conditions are

not met or details do not match when the pharmacy submits a claim for payment to the

PBS, the claim is rejected and the pharmacy bears the cost of the dispensed

medication.]

One DAA noted that any system to improve communication and prescription continuity

broke down if it was blocked by the doctor’s receptionist. This problem was

experienced especially in relation to Schedule 8 medication prescriptions.

How busy GPs were and their workloads were two explanations offered for the problem

of untimely prescriptions but a lack of appreciation/respect or understanding of

prescribing and dispensing regulations was felt to be a contributing factor (see

4.1.3.2.3). The efficiency of DAA packing was reduced if the prescribing and

dispensing of medications was not organised in advance of the day DAAs were

packed.

There were two main strategies used to overcome the “owing prescription” problem:

Pharmacies had a policy not to do “owing scripts”. Some had procedures to inform

the RCF, patient and GPs that no medications would be supplied without a current

prescription. Others advised the RCF or patient that a new prescription would be

needed and gave the RCF or patient the responsibility to organise a new

prescription with the GP (with some additional reminders from the pharmacy). The

latter strategy was not optimal because any delays reduce the efficiency of packing,

but one DA noted that “patients learn what to expect and are well trained” i.e. they

take ownership or responsibility for the continuity of prescriptions (patients were

charged for DAAs at $3.20 per week in this pharmacy). An alternative method was

to ask that the prescription be faxed to the pharmacy and the pharmacy would

collect the original at a later time.

Many pharmacies had reminder systems, some elaborate, to notify GPs when new

prescriptions would be required for a patient. If the last repeat was dispensed, a reminder was printed and sent to the doctor.

One DA felt that the dispensing system she used was inadequate in that it could not

generate a list of prescriptions due in the next two weeks. Unless this information was

recorded manually, GPs might be contacted on many occasions where a different

prescription for a different patient was requested each time.

One solution being developed in a region was to hold talks between the pharmacies to

work towards common strategies to be used by the pharmacies in interacting with the

GPs so, for example, if a doctor is asked to write a prescription, pharmacies use the

same request form and the same procedures (e.g. that the pharmacy will ask the

doctor for all items due in the next set period).


4.1.3.2.3 Unrealistic expectations

Many of the problems with communication of medication changes and appropriate and

timely prescriptions relate to a lack of understanding or appreciation by RCF staff and

doctors of the rules and regulations with which the pharmacy must comply to dispense

and supply medication – “staff at the RCF and doctors and patients aren’t aware of the

consequences to pharmacy of them not doing their jobs”. For example, RCF staff

expected the pharmacy to supply medications that were ordered by the doctor on the

medication chart. Staff did not understand that the chart was a legal order for

administration of the medicine but not a legal order to supply for the pharmacy, and

that a prescription was required. Another DA said that communication problems, not

following agreed procedures and problems with the rules and regulations were more

often a problem with new doctors visiting an RCF but also occurred with new RCF staff.

There was an attempt to implement an induction program about the pharmacy system

for the RCF in response to “more things starting to go wrong” but this failed since it was

up to the RCF to initiate the process.

In these situations, mutual awareness-raising about the situation from the perspectives

of all (RCFs, GPs and pharmacy) and education was suggested as solutions:

One pharmacy met with the Director of Nursing at the RCF they serviced once a

year to confirm the quality of the service (e.g. meeting expectations).

Tripartisan meetings to discuss issues such as owing prescriptions were held in a

small community. These were effective in raising awareness among fairly

supportive local doctors but problems still arose with locum doctors.

An induction for new doctors visiting an RCF (and new RCF staff) to cover the

RCF-Pharmacy systems and how to deal with the pharmacy supplying the RCF.

The “cracked record” approach, repeated explanations of regulations/procedures.

A written tool explaining the systems would be helpful.

4.1.3.2.4 Continuity of medication information and supply with hospital admission and

discharge

From the DA perspective, there were problems with admission and discharge to

hospitals. When a patient is admitted to hospital, unless the pharmacy is notified, new

DAAs may be packed that are not required. This medication is then wasted, particularly

where medications are different at discharge. Wastage also occurred when patients

did take their medications in the DAA to hospital. Some hospitals did not use these

medications and re-dispensed a new supply. One DA had the experience where the

medications of an RCF resident were sent in the ambulance with the resident except

for the patient’s dangerous drugs (Schedule 8 (S8) medications, that must be recorded

in a register) as the RCF would not send S8s with ambulance officers. The pharmacy

was then called to transfer the S8s to the hospital.

More issues were raised with discharge from hospital. In order to pack a DAA, a

pharmacy needs to have reliable information about a patient’s whole and current drug

regimen plus valid and legal prescriptions are required for any drug dispensed. This is

even more complicated when a patient is discharged back to an RCF where a valid

order from which an RN can administer a drug is required. Lists of drugs at discharge,

especially those prepared by non-medical staff, do not meet the requirements of the

various Poisons Regulations for an order to administer. The experience described by

one DA was not uncommon:


A patient arrived at the RCF with little warning, accompanied by a list of current medications

at discharge that had been prepared by the hospital pharmacy (a “MedProf”). The RCF

wanted medications on hand by the time the next medications were due and so expected

the community pharmacy to pack a DAA based on the MedProf. The pharmacy did not do

this as the MedProf was not a legal prescription or administration order. The doctor was

required to attend the RCF to write the medication chart and the prescription, which delayed

the supply of medications. If the doctor cannot see the patient on the day of discharge, the

doctor may call to give a verbal prescription to pack a DAA as per the discharge MedProfs.

The pharmacy is asked to pack the medications supplied by the hospital (so there is no

dispensing fee for the pharmacy to defray this cost) and then, when the doctor sees the

patient the next day, there are medication changes that generates rework in packing a DAA.

Patients discharged from hospital with PBS prescriptions (valid, legal prescriptions) still

generate significant work. For example, after receiving the prescriptions, the patient

profile is cross-checked and any differences clarified with the patient’s GP before the

DAA is packed. If there is not enough time to do check and confirm the complete drug

regimen, to avoid re-packaging if there are later changes, a small amount is supplied in

original packs until the profile is confirmed and a DAA can be prepared.

Failures to do with admission and discharge planning means that medication continuity

is not addressed. There needs to be a reliable and legal flow of medication regimen

information between settings. Some experiences or suggested strategies that address

some of these needs include:

Two pharmacies in a smaller community are advised when patients go to hospital. In one, packs are put on hold until discharge. The pharmacy packs from the discharge

note sent from the hospital (where there is always a doctor on duty). Problems

occurred, however, it a patient returned from the capital city where they had been

seeing a specialist or were in hospital.

In another, if a patient is admitted to the public hospital, the patient’s own medicines (in

DAA and original packs) are used. In the private hospital, DAA medicine are not used

but the remainder of previously dispensed medicines in the original pack is used when

the hospital “gets the pharmacy to send up all the medicines from the patient’ bucket [of

stored medicines in the pharmacy] with a copy of the pharmacy profile”. On discharge,

the pharmacy “collects medications from the hospital and the doctor’s medication chart

or discharge summary which is used to update the profile. [We] then pack up what’s left

of that week to get back in sync [packing cycle synchronisation]”.

A solution offered in another smaller community was for the GP to be more involved

in discharge at the hospital.

While not directly related to a hospital admission, some community pharmacies packed

unusual medicines supplied by hospitals (e.g. trial drugs or medicines supplied under

Section 100 or other provisions) into DAAs for community patients. In this case,

continuity of supply was an issue as the pharmacy had to rely on the patient to bring

medications from the hospital to the pharmacy to be repacked into a DAA. This was

often not timely with respect to the packing cycle especially for mental health patients.

4.1.3.2.5 Other problems

Errors in packing DAAs were explicitly mentioned as a problem by some DAs:

The need, in some systems, to re-key drug regimen firstly into the dispensing

program and then into the DAA program was felt to be a potential source of errors.

Double checking of the profile against the dispensing system was used.


Medication charts could be hard to read due to bad handwriting and so the wrong

drug dispensed, however, prescribing errors could occur with computerised charts,

so that confirmation with the prescriber was required. This stopped work flow.

Variable doses where the GP crossed out parts of the order and overwrote an order

with a new dose meant that it was not always clear what the prescriber intended.

Human error through decreased concentration and not checking properly could

lead to errors leaving the pharmacy. Noise and interruptions were felt to contribute

to errors and increased the checking time. Good packing and checking procedures

and the right environment (a dedicated area with enough space, quiet area away

from the dispensary or customers and without interruption) were needed (5

responses).

New staff unfamiliar with the medicines could make more errors. Efficient and

effective staff training was felt to minimise errors.

Few error logs were maintained. Two DAs mentioned recording errors. In one

pharmacy, these were reviewed weekly and in another, only errors that were detected

after a pack left the pharmacy were recorded but there was informal monitoring of

unrecorded errors detected and fixed before the DAA was delivered.

Users of the DAA also made errors. One factor contributing to these errors was a

different “generic” brand being packed in the DAA to that on the medication chart. In

one pharmacy, the DA made sure that the brand written on the chart was the brand

packed and so this required the GP to write the appropriate brand name (not always

the originator brand name) on the chart. This policy was developed by the pharmacy

over the years and was well known to the GPs.

Solutions to omission or oversupply of medications not packed in the DAA included:

Recording non-packed medications on the profile.

Auditing supplied on hand, either in the RCF or in the patient’s home.

Monitoring prescription or supply refill intervals.

Problems also occur when a community patient is unable to manage the DAA, for

example, because of confusion. Problems using the pack correctly were linked to poor

explanations to the patient about how to use the pack. One DA visited a new DAA

patient at home, soon after a DAA was started to check that the patient could manage

packed medications. Another DA explained that patients were trained/counselled to

leave a dose in the pack if they had forgotten to take it at the correct time.

One DA had observed problems due to a community nurse sometimes “popping” out

the wrong blister. She attributed this to the specific type of DAA saying they were “not

so straight forward for busy nurses or nurses not familiar with them”.

Poor integration of the various software programs involved contributed to inefficiency

(due to re-keying of medication details) and errors. In one instance, the drug regimen

was keyed three times (the profile form in a word processing document, the dispensing

program and then the packing program). One DA used a system where the dispensing

and DAA labelling functions were integrated.

One DA raised problems with the delivery of medications to community patients who

were not home at the time of the delivery. The pharmacy staff did not like to leave

medicines “on the front porch” as requested and did make some re-attempts to deliver,

but at times, medicines were left.


4.1.3.3 Training and instruction on DAA preparation received by dispensary

assistants/technicians

The training on DAA packing procedures technicians received was largely informal and

involved observing the processes then doing the processes, sometimes under

supervision and sometimes with the support of written procedures (Table 4.5). The

practical approach was felt to be good but in some instances, more structure or formal

training was felt to be an improvement.

Table 4.5 DAA training received by dispensary assistants/technicians

Type of training received Comments on quality and improvement needed

On the job supervision for several days when starting packing DAAs

Supervision was good so no need for improvement. Supervised practice was better than reading “essays” or lots of written procedures.

A short period of observing a peer then followed in-house written procedures. Also a brief mention of DAAs in the Guild Dispensary Assistant course completed later

In-house training was felt to be good because hands on learning was needed. The Guild course could have been improved – it emphas- -ised what a DA can or can’t do but not about the packs or procedures (the “how to do”).

On the job, practical training after being given a verbal overview of the whole system by pharmacist e.g. shown the profiles, described where stock came from and how to get all the necessary equipment

Overview was good but a chart (like the one provided to the interviewee) would be a good idea.

Trained by pharmacist. Given the documen- -tation, the packing chart was explained plus how to use it when packing. Packing then demonstrated then the DA started packing

No improvement felt to be needed.

Given detailed, step-by-step written procedures to read (but also had had prior experience) then intensive one-on-one supervision

No improvement needed. Training covered everything.

Limited initial training (8 years ago) – learned by observation. At current site, Webstercare manual followed and initial observation

Could be improved if manual supplemented by video/DVD on how to pack or an occasional short, face-to-face seminar to refresh ideas.

Followed the Webster manual and then applied common sense

Manual and update adequate but also take good ideas from other pharmacies

Observed packing then packed initially under supervision. Was given written procedures and booklet on FRED (dispensing/packing program)

Did Guild technician course. Happy with training but would have liked company training on FRED when new system was introduced.

Described as deep-end, hands on. Observed initially then supervised by an experienced DA (for about 3 weeks) as more details about packs, labelling, etc was slowly introduced

Hands on learning was felt to be good. Was told about the DAA steps but did not see the big picture i.e. awareness of doctor and RCF perspectives.

All respondents felt that they gained skills, knowledge and awareness as they

performed their DAA roles:

Problem recognition and development of strategies to prevent problems (4

responses). One respondent referred to the processes generally while another

mentioned problems related to prescribing rules and regulations (e.g. those for

dangerous drugs). Two respondents mentioned drug-related problems:


identifying possible problems while updating the patient profiles (e.g. an RCF drug chart

that had both Naproxen and Celebrex but no ceased stamp on the Celebrex that should

have been ceased). These were communicated to the pharmacist and so prevented a

drug interaction and possibly adverse outcome.

identifying possible areas to rationalise doses (e.g. 1x100mg instead of 2x50mg tablet).

Informal increase in drug knowledge (3 responses) – one technician also attended

pharmacy continuing education (Guild and PSA).

Organisation skills and time management (3 responses).

An appreciation or understanding of other parts of the health care system involved

in DAA provision (3 responses): The nursing home perspective e.g. how medication charts work, problems for nurses

when doctors order things but don’t write them on the medication chart or that the

Douglas packs were not so straightforward for busy nurses.

How the renal unit and indigenous health services work in relation to prescription

management and drug supply and the PBS.

How to deal with indigenous communities.

The importance of/need for constant contact between pharmacy and doctor, and

pharmacy and clients to make the system work.

Community patient needs and benefits from DAAs (2 responses) e.g. how DAAs

improved patients who are disorganised with their medication management, better

monitoring, see fewer different doctors and more holistic medication profile.

Improved attention to detail.

Communication skills (with doctors, nurses, pharmacist and other staff).

If the DAA packing area is near or in the main dispensary there are lots of mistakes.

It is important to be away from the dispensary to decreasing interruptions.

Procedures followed by most were detailed (8 responses) but were flexible and could

be changed to do things differently. Four respondents mentioned discussion and

changes as part of a continuous quality improvement (CQI) process. Examples of CQI

strategies given by two respondents were:

To decrease interruption (including a separate location to dispensing/front of shop).

Changing the person who packs from pharmacist to technician.

Streamlining checking.

Introducing a system to re-order prescriptions from doctors.

Developing procedures about how long to pack in advance in unusual situations

e.g. Christmas.

Two respondents commented on the importance of all people involved being aware of

and following the procedures “packing doesn’t work unless all people involved do the

same thing”. This team approach “ works better and has less stress”. Others overcome

this possible variation by having a single person doing the packing (3 responses) and

one had detailed procedures for pack changes and new packs needed outside the

usual packing cycle when the DA was not on duty. Others (3 responses) had flexibility

to a point (e.g. different procedures for deblistering) but a key sequence of steps or

guideline that had to be followed - “everyone does have a different way to pack but

there are core guidelines for the different pack types that are followed”. It was important

to “find a routine and stick to it”.

One respondent said that there were no written procedures when she first started in the

pharmacy. This caused hold ups as the DA was “forever chasing up my mentor” (an

experienced DA in the pharmacy). Written procedures have since been developed.


4.1.3.4 Legislative, standards and guideline framework related to DAAs

There was variation in the level of awareness DAs had of the legislative, standards and

guideline framework they had to work within – one DA did not recognise any

legal/guideline context except the PBS rules whereas others were aware of several but

not all of the other main legislation/guidelines (Table 4.6). Of the 5 main elements of

the legal/guideline framework, awareness of the PSA guidelines was lowest while

awareness of PBS rules was highest, perhaps because the PBS rules created the

greatest number of perceived barriers to an efficient service. From the DA perspective,

the barriers to efficient DAA provision were related to the PBS rules:

Waiting for prescriptions from the doctor (not timely response) to meet PBS rules is

an efficiency barrier (5 responses). Dealing with the rules led to the practice of

“owing” prescriptions as medication were required for packing before the

prescription was provided by the doctor. Owing prescriptions contributed to rework.

The 20 day rule (4 responses). One DA said that planning was needed to reduce

the effect of this rule on efficiency.

Processes related to authority prescriptions (2 responses). One DA encountered

problems requesting authority prescriptions but HIC said the prescription should not

be due (although the pharmacy needed the prescription ahead of time to pack a

DAA). There was no flexibility, the request was rejected and the pharmacy did not

get paid.

Doctors not reducing a verbal prescription into writing within three days.

Rules related to safety net entitlements.

Table 4.6 DA awareness of legislation/guideline framework for DAA provision

Number of respondents Regulation, standard or guideline Aware of

rules Aware with prompting Unaware or not explicitly

mentioned

PBS rules 5 4 aware but did not see PBS rules as “legislation”

Poisons regulations or similar 5 4

PSA DAA guidelines 2 1 6

QCPP standards 4 1 4

APAC aged care standards 1 1 – aware of document but not looked at

5

2= Not applicable

Regulations related to Schedule 8 or dangerous drugs were mentioned as an efficiency

barrier by one respondent. Three DAs did not mention barriers explicitly; they just

accepted working within the rules.

Respondents were asked to reflect on why pharmacies and RCFs may have trouble

complying with the legal/guideline framework and what might improve the situation.

The postulated reasons and possible solutions are summarised in Table 4.7.


Table 4.7 Reasons and possible solutions postulated for non-compliance with

legal/guideline framework

Reasons postulated for compliance problems Possible solutions A lack of understanding of the rules (PBS, Poisons etc) by others (doctors, nurses, carers and patients) (3 responses) so, for example, doctors don’t do their part and don’t recognise what the pharmacy needs to operate within the system - “Pharmacies sometimes overlook the guidelines to get medications for patients”.

Increasing doctor awareness of the PBS rules and what is required by the pharmacy (2 responses)

Holding a tripartisan meeting with RCF staff, doctors and pharmacy to discuss issues (1 response).

Problems getting repeat prescriptions from doctors leads to “owing” prescriptions (3 responses)

Institute a “no script, no pack” policy (2 responses). One pharmacy arranged a meeting with local doctors before instituting a “no script, no pack” policy; another attached notes to advise where the patient or RCF why the drug is missing so that patients and RCF pressure doctors

Time pressures (2 responses). To reduce the time taken and to increase efficiency, pharmacies may try and “cut down on legalities to make the process quicker”

That the PBS rules don’t match the practicalities of packing DAAs (2 responses).

Changes to PBS rules as they apply to medications in DAAs (2 responses). A different claim type for DAA-packed medications was suggested as a solution to make PBS rules more practical for DAA packing including exemptions to the 20 day rule and more flexible authority and owing prescription rules. A different type of PBS prescription for medications supplied in a DAA where a medication chart or full regimen written by a doctor is valid as a prescription that can be submitted as a valid PBS claim (1 response)

People not thinking about the situation and solutions (1 response).

Participative problem solving sessions with the people involved can lead to improved procedures as a result (1 response).

Not enough human resources (1 response), particularly in country areas where there are fewer GPs and pharmacists. It can be difficult for all involved to do all things because of the workload in servicing the community.

More human resources needed to follow all the rules and guidelines (1 response).

4.1.4 GP PERSPECTIVES

From the GP perspective the problems/issues arising from DAA provision and use

include:

Pharmacy request scripts too early (contrary to dispensing software alerts) or after

having just written another prescription (legalities) or requests are inaccurate i.e.

medication has been ceased, script is at RCF, patient is deceased.

Pharmacy nags doctors with multiple faxes about prescriptions.

Pharmacy packs too far in advance (5 weeks) consequently more than 1

prescription is required and the prescriptions need to be written on different days.

Doctors would prefer to generate scripts electronically to keep records so some

have a computer in the RCF linked to the GP surgery.

DAAs result in medication wastage.


Inability to monitor wastage or compliance based on script rates.

Lack of flexibility and responsiveness to changes (delays in starting and changing

medicines).

Alterations to patients medicines requires detailed communication.

Pharmacy need to check the charts more frequently.

Nurses/RCFs relinquished responsibility for medication management and use of

DAAs deskills nursing staff.

DAAs make more work for Doctors and RNs but makes life easier for pharmacist.

DAAs increase workloads for everyone due to documentation and bureaucracy.

GPs can’t charge a fee for writing prescriptions without a consultation with the

patient so are not reimbursed for their time.

Some of these solutions to issues from the GP perspective were incorporated into the

recommendations for an integrated best practice model for the RCF and community

settings.

4.1.5 OTHER CONSULTATION

As part of consultations with other key informants, problems associated with DAA

services were explored; methods and tools to facilitate best practice implementation

were also investigated.

Consultation with the staff at PSA led to the identification of key documents and key

informants. The approach to best practice was supported by PSA who indicated that

the work would inform the revision of the PSA DAA guidelines and professional

standards. At the suggestion of PSA:

More detailed questions exploring the dispensary assistant experience with training

and skill development were included into this phase of the data collection (see

4.1.3.3).

Additional questions about the existence of Australian standards for the

manufacture of DAAs and the possibility of a United Kingdom requirement for new

drug products to be stability tested in DAAs before registration were asked of TGA.

[At present, there was no Australian TGA standard specifically addressing the

design and manufacture of DAAs nor was TGA aware of any UK proposal for pre-

registration stability testing.]

Key informants and key documents were follow-up as described in 3.1.7.

A key strategy to the implementation of best practice models identified by the expert

panel was inclusion into the Quality Care Pharmacy Program (QCPP). At a meeting at

QCPP, plans for revision of the type and format of QCPP standard were discussed.

The new format was to be:

An expression of the standard.

A list of actions required to meet the standard.

Evidence required for assessment of the performance of actions and compliance

with the standard.

Resources to support the pharmacy in attaining the standard.

It was felt to be desirable that a best practice model for DAAs included information on

what a pharmacist and pharmacy had to do to implement the standard and, that

procedures and templates were included.


At the preliminary stage, the individual assessors approached did not offer advice on

problems associated with DAAs nor their solutions. It was felt that assessing elements

of a DAA service was beyond the scope of their assessment process. Further, one

respondent indicated that “provided a facility has a good pharmacy, they will have no

trouble meeting the medication management standards”. In the light of this response,

further input from the assessors’ organisation was deferred until responses on a draft

model would be sought.

Discussions about drug stability and the information held by the TGA were held with Dr

Kelly. He indicated that, in the absence of specific stability studies (not required by

TGA), a risk assessment approach based on the manufacturers’ pack type and storage

and shelf life information, as suggested by the researchers, would be feasible as a way

of minimising drug instability when products were repackaged into DAAs. TGA reviews

the stability of medications in original packs prior to registration but this information was

not released, nor was it all available in a searchable, electronic format, and was not

available for grandfathered drugs (those registered prior to 1989). Dr Kelly indicated

that TGA did not have standards for repackaging but drew attention to other

pharmacopoeial sources (British Pharmacopoeia (BP) and United States

Pharmacopoeia (USP)) of standards. On later review by the researchers, only the USP

had standards relevant to the issue of drug stability after repackaging into DAAs (see

4.3 ). Moisture transmission was identified as a key factor in drug stability so that,

where drugs were package in “tropicalised packs”, this would be a good indicator of

potential instability in a DAA. For example, amoxicillin and clavulanic acid products

were packed in tropicalised packs as the clavulanic acid was degraded quickly with

moisture. Dr Kelly suggested seeking information from the manufacturers of DAAs

about moisture and air transmissibility. As part of a risk minimisation approach to

packing DAAs, Dr Kelly also recommended the Code of Good Manufacturing Practice

(GMP) as model for standards and procedures.

At Dr Kelly’s suggestion, ADRAC was approached about adverse reactions associated

with drugs in a DAA. The Adverse Drug Reactions Unit responded that:

“We have no record of any reports where DAAs have led or contributed to an

adverse drug event.”

In Phase 2 and in the focus groups and surveys undertaken in Phase 3, poor

communication was commonly cited as a barrier to safe and efficient DAA services.

The Aged Care HMR Coordinator of the South East New South Wales (NSW) Division

of General Practice, Julia Clapin, was contacted about her experiences with a project

to communications and systems between GPs, RCFs and pharmacists. She described

a process of initial surveys to identify issues followed by successive meetings in the

various towns in the divisions where the focus was on systems – the difficulties and

how to address them. An external mediator was felt to be valuable at these meetings.

Medication charting and owing prescriptions were common problem areas to be

addressed through this co-operative process but Julia stressed that one solution did

not fit all situations; some needed basic systems to be put into place while others were

more advanced in their problem solving and co-operation. In one town, the pharmacy

had good systems in place that included:

Communication systems.

Colour coding of communications e.g. requests for prescriptions owning were on a

specific colour of paper.


Reminder systems, for example, for when new prescriptions would be required.

In another RCF where residents visited the GP in the GP’s rooms, the solution to poor

charting of medications was to send the RCF chart with the resident so that it was on

hand at the time of consultation.

A number of GP divisions were conducting aged care projects related to computerised

medication charts and dispensing from medication charts, rather than the present

systems where a GP had to write both a medication chart for administration and a PBS

prescription for dispensing. Strategies included:

GPs generating medication charts from their own prescribing software, for use in

RCFs, rather than hand writing charts provided by facilities.

To do this, GPs would keep the primary electronic record in the facility or, there

would be a remote link to the GPs surgery computer so that when the GP was in

the RCF, changes could be made to the medication chart and a new one printed in

the facility (or in the surgery and sent to the facility).

In all of these projects, there was considerable individualisation of any intervention or

strategy to that it suited the circumstances of a given RCF and its related practitioners.

Julia felt that the best practice solution proposed by the researchers of defining

obligations and expectations, and promoting mutual awareness, would be beneficial in

addressing some of the problems encountered in her Division. The approach of

defining issues but not prescribing solutions allowed flexibility in implementation.

The problems and solutions associated with continuity of care was the focus of

discussions with the Queensland Health Safe Medication Practice Unit. The issues

identified in the hospital pharmacy focus groups were reiterated in these discussions

(e.g. concerns over the integrity of medications in packs). The problems discussed

applied to any patients admitted to or discharged from hospital and occasionally

specifically address the added complications of medications packed into a DAA.

Variation in the practices of RCFs and pharmacies related to how the DAAs were used

and the nature of a given DAA service increased the complexity. Concordance

checking and the taking of drug histories on admission was complicated by

medications packed in DAAs including how the DAA was labelled, what was packed

and whether the pack was sent to the hospital on admission. These aspects were to be

addressed by a reconciliation process for all admissions. A discharge process was also

in development to ensure timely medication information transfer and “adequate”

medication supply. The issues raised by community pharmacists and dispensary

technicians that reflected the variations in practices e.g.:

what level of documentation/veracity of the discharge medication regimen was

acceptable to a given community pharmacy,

of fitting in to the DAA packing cycle,

just which medicines needed to be supplied for an individual patient, and,

what “generic” brands were provided,

had not been addressed to date.

The unit was taking an enterprise wide approach to developing solutions to problems

related to the continuity of medication information and supply through the development

of tools and protocols. Improving communications with RCFs, GPs and community

pharmacists was felt to be critical. One strategy identified was a set of templates that

allowed hospital pharmacies to generate communications lists. After reviewing an early


draft of the best practice models, the following ideas were offered to improve problems

associated with the hospital admission and discharge for people using DAAs:

The GP admission letter could be used to provide a minimum dataset to the

hospital when a patient was admitted.

Hospital pharmacies could ask local RCFs and their supplying pharmacies about

their preferences.

The staff of the Safe Medication Practice Unit felt that the flow diagrams for the whole

DAA service (including interactions with hospitals) and the approaches to improving

communication and mutual awareness raising would facilitate improved practice.

A director of the HDG Consulting Group was consulted over the issue of potential

overlap between the best practice models and associated tools with those developed

as part of a Victorian project to address implementation of APAC guidelines for

medication management in residential aged care facilities (Australian Pharmaceutical

Advisory Council 2002). As part of the project, facilities were surveyed about their

current practices and those areas of the guidelines where implementation was most

troublesome. DAAs were the subject of Recommendation 9. Problems related to what

type of DAA was used as this would affect who could administer medications and

administration procedures. Labelling of DAAs could also contribute to non-compliance

with the guidelines. The ordering and supply of all medications using the approved

generic name (rather than a “generic” or alternative brand) was suggested as a

solution. The draft resource kit developed in the project included:

Competency assessment tools for Personal Care Assistants (PCAs) assisting with

medications. This checklist included the basic level of skill and practical aspects

such as washing hands with soap before administering medications.

Resident self-medicating assessment tools.

Draft procedures for policies such as administration of medications when a resident

is out for the day. This had additional ramifications where medications, often

enough for one week, are in a DAA.

Sample letters to GPs about the Medication Advisory committee.

A handouts or information sheet for residents and family explaining the medication

management systems. This did not their role and responsibilities as suggested in

the best practice model in this study. This aspect was supported by Dr Saxon.

As the tool developed for DAAs was a yes-no checklist to say whether the aspects of

Recommendation 9 were addressed, there was felt to be little overlap with the best

practice models but that the two projects would be synergistic.

4.2 LEGAL PERSPECTIVE ON BEST PRACTICE

The report received on how best practice can impact on liability indicated that a number

of strategies proposed as part of the best practice models were important for error

prevention and that the documentation suggested in the model was important as

liability risk reduction. The full report is in Appendix D but the key points were as

follows:

The resource (cost and time) pressures placed on the pharmacist in providing a

DAA do not diminish in any way the professional obligations of the pharmacist in

relation to the dispensing of medication and that appropriate procedures and written

protocols for dispensing that meet professional standards must be observed.

That staff involved in packing DAAs are appropriately trained and supervised by the

pharmacist who is ultimately responsible for the service, and that there are policies,


procedures and records of staff DAA training and supervision and for other aspects

of dispensing medicines and packing and checking DAAs (e.g. how a pharmacist

would check a pack). The dissemination and regular communication of these

policies and procedures should also be recorded (e.g. at induction or through

minutes of staff meetings).

To ensure the integrity of packing, there must be appropriate systems and

procedures in place including the checking of medication charts, the reviewing of

original packaging of medications and the keeping of appropriate records that

shows these procedures were followed.

Providing medicines in a DAA does not remove the responsibility to provide

counselling to patients who live in the community and to residents within the

residential care facility and their carers to ensure that medication regimes are fully

understood so as to be safe and effective. Counselling of patients discharged from

an RCF (where medicines had been packed) to go to their home with medicines in

original packs was particularly emphasised.

Recording those medicines not packed in a DAA and a record of counselling

provided for those medicines was noted.

The role of a clear agreement between the RCF and pharmacy that set out

responsibilities and obligations was seen as a valuable way of minimising errors,

such as those arising out of poor communication of medication changes. A well set

out agreement would not to create additional burdens on parties but to reinforce

separate obligations of the RCF and pharmacy related to DAAs.

Pharmacists also have an obligation to RCF staff. An RCF has a separate

responsibility to ensure that there are appropriate systems in place to ensure

appropriate medication administration but pharmacists providing DAAs in this

setting have a separate obligation to ensure that there is effective communication

with appropriate RCF staff. This obligation includes facility access to accurate and

up-to-date information about medication. The recording of the provision of such

information was emphasised as was the retention of these records. Pharmacy

procedures related to, and the maintenance of records of all communications with

an RCF were seen as a useful risk management tool. Similar record keeping by

RCFs was also a risk management tool.

Errors arising from poor communication related to medication changes for

community dwelling DAA users could be addressed by an agreement between

involved parties (including, as needed, carers/close relatives) provided that the

agreement was clearly understood by the patient who did not feel pressured to

agree. It was felt to be important to include how medication changes were to be

communicated in any written DAA service agreement between a doctor and a

pharmacist.

Clear and unequivocal directions to the pharmacist about medication changes were

felt to minimise error but the pharmacist must still give careful regard to changes

and verify with the prescriber as needed. Pharmacy systems (procedures and

records) to deal with ceased or changed medication disposal or separate storage

were discussed. For community patients, pharmacy procedures related to, and the

maintenance of records of communication of medication changes (e.g. by

annotation of dispensing records) was seen as a risk management tool. A central

storage system of all data in relation to a patient was encouraged.

The re-use of previously dispensed medicines (dispensed for one patient then

subsequently re-dispensed for another) was rejected and discussed at length.


Documented pharmacy procedures for the disposal of returned medicines were

seen as critical.

A pharmacy system to regularly ensure the pharmacy-held profile is accurate would

minimise the possibility of errors related to medication changes.

A number of risk management strategies were discussed related to packing errors.

These include appropriately trained and supervised staff if DAAs were not packed

by a pharmacist, and documented policies and procedures that include checking

and supervision (including evidence that the practices were followed e.g. signed

record that a pack was checked by a pharmacist). This was added to policies,

procedures and records of checking and supervision in the dispensing step. The

packing of a medicine for daily administration that was intended for weekly

administration was seen as a not infrequent error that needed to be addressed by

pharmacy systems, as the consequence was potentially fatal. RCFs needed

appropriate systems in place to prevent any packing error being compounded by a

Registered Nurse.

Three less typical examples of legal issues arising from the supply of medications

packed in DAAs were described, in particular, one case concerning recycling of

returned medicines.

4.3 DRUG STABILITY IN DAAS AND GOOD PACKING

PRACTICE

This report was initially prepared by Dr Alison Haywood (School of Pharmacy, Griffith

University) based on conceptualisation and contributions from Dr Julie Stokes (School

of Medicine, University of Queensland). Professor Michael Roberts (School of

Medicine, University of Queensland) contributed to the initial conceptualisation of the

utilisation of available stability information. Professor Beverly Glass (School of

Pharmacy and Molecular Sciences, James Cook University) and Associate Professor

Andrew McLachlan (Faculty of Pharmacy, University of Sydney) provided advice and

reviewed the various drafts of the report. This section was revised by Julie Stokes to

add a practice slant to theory. Given the limited information about the stability of

medicines in DAAs, the approach taken was to examine the theoretical factors affecting

drugs stability and identify methods to apply the theoretical concepts to current DAA

practices. Avenues to obtain more evidence on drug stability in DAAs are also

addressed.

4.3.1 INTRODUCTION

Drug stability is a rather broad term that encompasses chemical1, physical2,

microbiological3, therapeutic4 and toxicological5 stability not only of the drug substance,

but when taking account of the excipients, also the drug product (Allen et al. 2005; USP

<1191> 2005). Stability has been defined as the extent to which a product retains,

1 Each active ingredient retains its chemical integrity and labelled potency, within specified

limits.2 The original physical properties, including appearance, palatability, uniformity, dissolution and

suspendability, are retained. 3 Sterility or resistance to microbial growth is retained according to the specified requirements.

Antimicrobial agents that are present retain effectiveness within the specified limits. 4 The therapeutic effect remains unchanged.

5 No significant increase in toxicity occurs.


within specified limits and throughout its period of storage and use (i.e. its shelf-life),

the same properties and characteristics that it possessed at the time of its manufacture

(USP <1191> 2005). A similar requirement applies to prescription medicines registered

with the Australian Therapeutic Goods Administration (Therapeutic Goods

Administration 2004) (see http://www.tga.gov.au/pmeds /argpmap14.pdf). Stability of

manufactured dosage forms is routinely confirmed by the manufacturer, where stability

studies on active substances and packaged dosage forms are conducted by means of

“real-time”, long-term tests and accelerated stability tests at specific temperatures and

relative humidity that represent storage conditions experienced in the distribution chain

of the climatic zone(s) of the country or region of the world concerned (Aulton 2002;

Therapeutic Goods Administration 2004; USP <1150> 2005). Stability testing is the

primary tool used to assess expiration dating and storage conditions for pharmaceutical

products.

Although stability of a dosage form is often seen to be the responsibility of the

manufacturer, this does not include removal from the original packaging and

repackaging, which is often discouraged by the manufacturer (Church et al. 2006;

Walker 1992). According to the terms of each product licence held by a manufacturing

company, transfer to any type of compliance device/Dose Administration Aid (DAA) can

not be recommended without an assessment of the stability of the product in the device

in question being carried out, and the product licence adjusted accordingly (Church &

Smith 2006; Walker 1992). In electing to repackage a drug product into a DAA,

pharmacists must therefore consider the implications of the transfer to a non-

manufacturer’s pack on drug stability.

Despite the widespread use of Dose Administration Aids (DAAs) (medication

compliance devices/unit-dose containers), there is little available data regarding the

stability of the drug products during packaging or storage in these devices or even

whether a stability problem does or does not exist (Walker 1992). Pharmacists have

limited references on the stability of drug products during repackaging or storage in

DAAs. Additionally, there is no information on the stability of medicinal products when

placed in close physical contact with other medications. Limited studies have been

performed to provide specific evidence on the stability of drug products in DAAs, and

these studies do not reflect the complexities relating to the interaction of active

ingredient(s), excipients, specific dosage form/ drug delivery technologies (including

techniques used in the manufacture, such as coating), packaging materials and pack

types, or the environmental conditions at the time of repackaging or on storage.

In short, there is no simple way of determining whether a drug product is suitable to

pack into a given DAA. Pharmacists, therefore, must make an informed judgement as

to the suitability of a given drug product for inclusion in a DAA for provision to a patient.

This report provides a framework for pharmacists to consider the stability implications

of repackaging drug products into DAAs by:

Identifying stability ‘risk management’ issues and providing recommendations for

gathering further evidence to improve the quality of decisions pharmacists make

about repackaging of drug products into DAAs.

Providing a ‘risk assessment’ approach for using the currently available stability

information for a specific drug substance /product.


4.3.2 PHYSICOCHEMICAL STABILITY IMPLICATIONS RELATING TO SOLID DOSAGE FORMS

Drugs degrade to different extents on separate exposure to heat, moisture, air

(including oxidation) and light. Combinations of these stresses can cause complex

behaviour (Florence et al. 1998; Glass et al. 2004). In solid state formulations, the

presence of excipients further complicates the matter because the excipients may

increase, have no effect on, or decrease the inherent stabilities of the drug. Any

degradation will usually adversely affect the therapeutic activity of the drug substance

(Glass et al. 2004).

Many drugs are susceptible to some form of chemical decomposition when formulated

in either liquid or solid dosage forms. Such degradation not only leads to a loss of

potency of the drug substance but may, in some cases, cause changes in physical

appearance of the dosage forms, such as discolouration following, for example, the

photochemical decomposition of the drug substance (Aulton 2002; Florence & Attwood

1998; USP <1191> 2005).

In addition to the potential chemical decomposition (by possible hydrolysis, oxidation,

isomerisation, polymerisation, photochemical degradation) of the drug(s) and/or

excipient(s), physical changes to the solid dosage form, for example, changes in tablet

hardness, friability, disintegration and/or the dissolution rate may lead to both altered

physical appearance and/or bioavailability of the drug substance.

Manufacturers’ packaging is designed to protect products from environmental factors

encountered during storage, including light, air (oxygen, carbon dioxide and other

gases), and moisture whilst ensuring limited interactions between the product and the

packaging material. The dosage form itself may have design features to enhance the

physicochemical stability of the product, for example, titanium dioxide may be added to

the coating of tablets or the gelatin shell of soft gels to protect light-sensitive active

ingredient(s) and/or excipient(s).

Finally, inappropriate storage, transport and in-use conditions (especially exposure of

the product to changes in temperature) may enhance physicochemical instabilities and

degradation rates of the active ingredient(s) and/or excipient(s) or result in an increase

of potentially toxic degradation products (Aulton 2002; Florence & Attwood 1998; USP

<1191> 2005).

Drug decomposition often does not follow simple reaction processes (kinetics)

(Florence & Attwood 1998). With certain drug substances, more than one type of

decomposition can be occurring simultaneously, increasing the complexity of the

situation. The kinetics of drug decomposition in solid dosage forms is often more

complex than in solution (Allen et al. 2005; Aulton 2002; Florence & Attwood 1998).

Additionally, any increase in temperature, often encountered in storage, transport or in-

use, usually increases the rate of degradation. This situation is further complicated by

the many possible combinations of drug products being packed in a single blister or

sachet of a DAA, providing increased potential for interaction.

Further information on the theoretical aspects of drug stability can be found in

Appendix E.


4.3.3 CURRENT PRACTICES AFFECTING DRUG STABILITY IN DAAS

There are a number of situations arising from the packing, storage and use of DAAs

that may impact on the stability of a medication when a product is transferred from its

original pack to a DAA (see below). Pharmacists have potential to modify packaging

practices that might increase the risks of drug instability i.e. risk management.

4.3.3.1 Packing procedures

Due to variation in the types of DAAs used, the patients’ medication regimen and even

the number of packs that the pharmacy handles, a variety of packing methods and

procedures are utilised by community pharmacies, for which the following should be

considered:

Type of DAA pack: The commercially available DAA packs have varying degrees of

protection against air, light and moisture. The traditional compartmentalised box

type DAA pack is made from a combination of styrene and acrylic polymers and is

not airtight or light resistant. Blister packs consist of plastic trays commonly made of

PVC (polyvinylchloride) which is permeable to moisture and oxygen. The PVC may

be of varying thickness, with a thicker film offering more resistance to moisture and

oxygen (note that there are USP standards for packaging materials). PVDC

(polyvinyldiene chloride) offers even more resistance, but is costly. Blister packs

may be multi-dose packs (i.e. containing multiple medications within one blister) or

unit-dose packs. The blisters usually have an aluminium foil backing. A newer

product, the Clamshell-pak ™ has an integrated locking lid and does not require

heat to close. This DAA is made from PVC and offers protection against air and

moisture that is greater than a compartmentalised box but less effective than a heat

sealed blister. Sachet systems are made from various materials which offer varying

degrees of protection against moisture and air. Some sachets are standard paper-

foil or thermal paper-foil, others, like the sachets produced by the Tosho tablet

packing machines, are polyethylene film (personal communication, Dirk Correl,

MPS Australia, Brisbane, 4/11/05). The JVMedi sachets are Class C FDA approved

medical cellophane, low density polyethylene (personal communication, Richard

Finster, (Meditec) 9/11/05). Most DAAs do not offer much resistance to light, with

the transparent blisters allowing for visual inspection of the contents (a desirable

property from the viewpoint of checking pack contents but not necessarily from a

stability perspective).

Packing in advance: When a seven day supply is requested, the DAA may be

packed and delivered up to two weeks in advance (observations in Phase 2). When

a 28 day supply is requested, the DAA may be packed and delivered up to one

week in advance, allowing a total of five to six weeks between packing and finishing

the supply of medications in the DAA. Based on a moisture permeation study in

1993, the Royal Pharmaceutical Society confirmed a guideline that “medicines

should not be left in solid monitored dosage systems for longer than 8

weeks”(Report of the moisture permeability testing of monitored dosage systems.

1994). This 8-week figure needs to be interpreted with caution as the evidence

cannot necessarily be extrapolated – the maximum number of days of treatment

was 34 days with some products being treated for 7 days.

DAA pack sealing: DAAs may be sealed via a heat sealing or a “cold” (chemical

pressure-sensitive adhesive) seal process. The heat sealing process may include


the following: application of pressure to the DAA for a short period (typically one to

three seconds) at a temperature of 120-130ºC (in the case of a proprietary heat

sealing device) or applying pressure with a household/hand iron set at the

cotton/linen/wool temperature (medium to high heat setting on a household iron),

taking care to run the centre of the iron right around the perimeter of the pack/DAA

(per the Implementation Protocols for Medicopak, Douglas Pharmaceuticals,

November 2003). The Webstercare heat seal film requires 85ºC for one second

(personal communication, Gerard Stevens (Webstercare) 4/11/05). This heat and

time level is optimally achieved by a purpose designed (and more expensive) heat

sealer. In practice, many packs are sealed with a household iron.. The heat-sealed

PersoPak guidelines target a temperature of below 120ºC for 3-5 seconds

(personal communication, Klaus Pertrulis (Persocare) 8/11/05). The temperatures

reached by household irons, however, can vary (personal communication Andrew

McLachlan (Faculty of Pharmacy, University of Sydney), 12/11/05) so that

temperature may exceed those recommended or to achieve an adequate seal, the

contact time may take longer than 1-3 seconds. Where possible, a proprietary heat-

sealing device is likely to be preferable to a household iron in producing a reliable

heat seal. The heat seal one of the brands of automated packing machines used in

Australia (JVMedi) operates at 72-73ºC for less than 1 second to seal a sachet

(personal communication, Richard Finster, (Meditec) 9/11/05).

The effect of these temporary temperature spikes on the stability of drug products

repackaged in DAAs is uncertain. The PSA Dose Administration Aids Guidelines

(Pharmaceutical Society of Australia 1999) recommends that consideration be

given to the effect of heat sealing on some dosage forms (e.g. soft gel capsules). In

some practices, provided an air space exists between the foil backing and the

capsule, problems with melted soft gel capsules are generally not observed with

heat-sealed blister packs (personal communication with Mr Gerard Stevens,

19/10/05. Mr Klaus Pertrulis (Persocare) concurred that problems were not

generally observed with soft gel capsules used with a heat seal (personal

communication 19/10/05)). Others have observed problems when blisters are so

full, that there is not protective airspace (personal communication, Andrew

McLachlan (Faculty of Pharmacy, University of Sydney) 12/11/05). Others have

experienced melting of liquid-filled capsules and pulvules when the initially heat-

sealed pack was opened to make a change and re-sealed (personal

communication with Karalyn Huxhagen, 28/10/05). That manufacturers often use

high temperature heat seal films with a dwell time of one second as part of original

packaging tempers the argument of instability risk with a heat seal.

While the application of heat to seal a pack may be associated with theoretical

stability risk, cold seals may result in a less effective barrier to air and moisture than

heat seals (Reamer et al. 1978). A 1994 study of moisture permeation (Report of

the moisture permeability testing of monitored dosage systems. 1994), packs with

adhesive seals generally had a higher moisture permeation rate. There is however,

disagreement about the comparative effectiveness of heat versus cold/pressure

seals as a air/moisture barrier (per personal communication (ibid) with Klaus

Pertrulis (Persocare) and Gerard Stevens (Webstercare)).

Packing environment and practices: It is assumed that packing occurs in a dedicated

packing space under controlled (temperature, humidity, light) environmental

conditions and that the staff exercise due care with regards to general hygiene (e.g.


wearing gloves, hand washing ) and avoiding exposure of medications to moisture,

air and light (e.g. ensuring that the bench and/or packing instruments such as tongs/

tweezers or trays are clean and dry and that the medications are removed from the

manufacturer’s pack immediately prior to being sealed in the DAA). These

precautions are included in the PSA guidelines (Pharmaceutical Society of Australia

1999), however, observations from Phase 2 suggest that non-compliance to both the

hygiene and exposure to the environment aspects of the guidelines occur. In Phase

2, the mean packing time for pharmacy-packed DAAs has been shown to range from

three to 18 minutes, and in some instances packs may be left unsealed for a

pharmacist to check at a later stage. The latest USP standards on beyond-use date

setting for repackagers of unit-dose packs recognises that solid drug products

opened to the atmosphere potentially have their stability compromised and requires

that the original bulk container has not previously been opened as a criterion for

setting a beyond-use date (USP <1178> 2005).

Splitting tablets further exposes the solid dosage form to environmental factors which

may lead to stability problems, especially if the remaining tablet halves are stored for

an extended period in unsealed blisters/ zip-lock bags/ plastic labelled bottles.

Automated systems can also involve practices that expose unpacked medicines to

the environment. For most automated tablet packing systems, medication is required

to be emptied into bulk canisters or cassettes before packing in sachets. The bulk

canisters/cassettes offer varying degrees of protection from air, moisture and light in

the intermediate step between removal from the manufacturers pack and sealing into

sachets. Medicines can be stored in the bulk canister/cassettes for varying lengths of

time.

Therefore, in making a judgement on whether to pack a medicine in a DAA, the

protective properties of the type of DAA used should be considered. Some products

may be suitable to pack into a blister-type pack and not into a daily dose reminder

compartmentalised box type. Other products may be suitable to pack into a cold-sealed

blister but not into a heat sealed blister, and visa versa. The pharmacist should review

packing practices (and consider any intermediate steps when automation is used) to

minimise exposure to the environment and other forms of heat, light and moisture

during packing, and review the time between initial packing and use of the last

medication in the pack by the patient as some packing cycles unnecessarily extend the

time that the medication is in the DAA.

4.3.3.2 In-use environment

It has been identified from customer and pharmacist reports in Phase 2 that patients

store DAAs in a variety of places, including, amongst others: on the kitchen bench next

to the kettle (to remind themselves to take the medicines), in the refrigerator, on top of

the television, next to the bed or in the bathroom. It has also been identified that remote

communities in the Northern Territory have concerns with humidity during the wet

season when temperatures ranges from 30-50 ºC and humidity is high (for example, in

Darwin relative humidity (RH) may range from 60% in June/July to 84% in February at

9am ([http://www.bom.gov.au/cgi-bin/climate/cgi_bin_scripts/idl_RH_graphs/

rh_script.cgi?14015]). A recent study highlighted complaints from patients in the

Kimberley area with respect to the use of DAAs including: “the DAA not fitting into a

handbag, insomnia from crinkling blister-packs under the pillow at night, and the


backing card disintegrating and disgorging soggy medicines after sitting in a bag with a

moist plug of ‘ngunju’ (chewing tobacco)” (Larkin et al. 2005). Note that heat sealed

packs that have an aluminium foil backing that would be resistant to the kind of external

moisture problem demonstrated by the third situation described above.

Any consideration of the ‘in-use’ environment should also include storage conditions in

the pharmacy, any RCF and during delivery or transport. One provider of DAAs

described an instance where sachets containing enteric coated sodium valproate

tablets “melted” when left in a delivery van for several days (personal communication,

Dawn Woodward, APHS, 7/11/05).

Patient education on the preferred storage and use of DAAs is therefore especially

important and patients should be encouraged to report any visual or other problems

which may be related to medication instability to their pharmacy. Patient education

about how to use a DAA could include examples of signs of drug instability that a

patient might observe i.e. what type of ‘problem’ to report.

4.3.4 CURRENTLY AVAILABLE STABILITY INFORMATION

The labelling of a packaged active substance or drug product will reflect the effects of

temperature, relative humidity, air, and light on its stability and storage requirements to

ensure the integrity of the drug product throughout its distribution and storage range

(USP <1150> 2005). Label temperature storage warnings will reflect both results of the

“real-time” storage tests and allow for expected seasonal excursions of temperature

(USP <1150> 2005). The storage requirements specified in the labelling for the drug

product must be observed throughout the distribution of the product (i.e. beyond the

time it leaves the manufacturer up to and including its handling by the dispenser or

seller of the product to the consumer) (USP <1150> 2005).

Information about drug storage and shelf-life is available in product information, to

varying levels of detail. Using the product information would require the pharmacist to

look up many products rather than searching a specific storage/shelf-life electronic

database. The TGA has only electronic records of some storage and shelf-life

information (see Table 4.8 for an example), but this is not available to the pharmacist

on the public Register of Therapeutic Goods (https://www.tgasime.health.gov.au/

SIME/ARTG/ARTGPublicWeb.nsf?OpenDatabase) and can be incomplete and

inconsistent. In the example, below, there is no consistency on basic storage

conditions even in original packs of products with the same active ingredient.

Information on the results of stability testing in original packs is provided to the TGA as

part of the registration process for prescription medicines but this information is not

available to community pharmacists (Therapeutic Goods Administration 2004) (see

http://www.tga.gov.au/pmeds/argpmap14.pdf, p 11). Note, however, product

information relates to the manufacturers original packaging and while it does provide

information to the pharmacist about the susceptibility of the drug substance/drug

product to heat, light, oxygen and moisture, there is still no specific information that

allows them to be completely confident about the effect of repackaging in DAAs.

Limited resources are available on the instability of specific drugs (Church & Smith

2006; Dean 2000) and many studies are concerned with drugs in solution as opposed

to solid dosage forms (Dean 2000; Florence & Attwood 1998). While using these

references on drug stability can be useful in identifying medications that are at

potentially higher risk of instability, this strategy may be unnecessarily constraining.


Many reactions leading to degradation are related to the surface area exposed to the

reaction (e.g. to moisture, heat or light). Drug molecules in solution have a higher

surface area compared to solid dosage forms and this will reduce the extent of any

degradation when a drug is in solid dosage forms.

Table 4.8 Frusemide example of the type of dosage form, storage and shelf-life data

available in the internal dataset of the Therapeutics Goods Register

Brand name, dosage Form,& original pack type

Shelf Life Conditions Shelf-life temp: Store below:

Shelf-life

FRUSEBETA 40mg uncoated tablet, bottle Protect from Light 25 °C 3 yearsFRUSEHEXAL 40mg uncoated tablet, bottle Protect from Light 25 °C 3 yearsFRUSID 40mg uncoated tablet, bottle Protect from light & moisture 30 °C 3 yearsGENRX 40mg, uncoated tablet, bottle Protect from light & moisture 30 °C 3 yearsCHEM MART 40mg uncoated tablet, bottle Protect from light & moisture 30 °C 3 yearsTERRY WHITE CHEMISTS FRUSEMIDE 40mg uncoated tablet, bottle

Protect from light & moisture 30 °C 3 years

4.3.5 RISK ASSESSMENT OF DRUG PRODUCT SUITABILITY FOR REPACKAGING INTO A DAA

In the absence of specific information on the stability of a medicine or combination of

medicines in a specific DAA to be used in specific conditions, the pharmacist needs to

take a risk assessment approach in making a decision to repack a medicine into a

DAA. The following section details the specific issues associated with the stability of

drug products when repackaged and stored in DAAs, highlighting the potential causes

of instability, such as heat, light, oxygen and moisture, and includes those dosage

forms which should generally not be packed due to practical, occupational health and

safety (OH&S) or other reasons. Pharmacists need to use their professional judgement

in determining the risks and benefits for a specific patient in choosing to pack a

medicine that would generally not be packed for the aforementioned reasons. In some

cases, it may be more important to pack a medicine to ensure that the medicine is

actually taken as the prescriber intended. For example, a weekly dose of a cytotoxic

agent may be omitted by a patient unless it is included in a DAA or in some cases,

packing a weekly cytotoxic may prevent inadvertent daily administration. In these

cases, strategies to minimise the risks of instability or patient/carer exposure to certain

medicines need to be used. Documentation of such decisions and risk

management strategies would be prudent.

The decision to pack or not pack a drug product is a professional judgement and the

decision-tree (detailed in Figure 4.4) is intended to provide structure to the decision

making based on stability information available to the pharmacist. The decision-tree

has been developed based on currently available information (e.g. package inserts;

Consumer Medicines Information (CMIs)) for repackaging medications into DAAs. The

decision-tree does not guarantee that a drug product will, on later testing, be found to

be suitable for repackaging into a DAA. Further, different DAA pack types and different

packing practices provide different levels of protection against the various causes of

drug product instability.

Unfortunately, the current situation requires pharmacists to make clinical and

operational decisions regarding the repackaging of medications in DAAs with

incomplete evidence. Further research into the physicochemical stability of solid

dosage forms packed in DAAs is urgently needed. However, pharmacists are able to


improve current practice (until such time that further evidence is made available) by

educating patients on the preferred storage and use of DAAs and improving their

packing methods procedures to allow for the various stability issues outlined in section

4.3.3 above.

4.3.5.1 Occupational health and safety issues

Certain drug products (such as oncologic agents, hormones, penicillin derivatives,

teratogens and other solid dose cytotoxic agents) require special handling

(occupational health and safety precautions) because they are considered very potent

or toxic, and because transfer of any portion of these products to another product could

have deleterious effects (Pharmaceutical Society of Australia 2004; USP <1146>

2005).

4.3.5.2 Unsuitable solid dosage forms

Certain dosage forms are highly sensitive to moisture and should not be dispensed in

DAAs. Examples include: effervescent tablets, dispersible tablets, buccal tablets,

sublingual tablets and wafers (Corlett 1996; Pharmaceutical Society of Australia 2004;

Walker 1992).

Certain medications are not suitable for dispensing in some DAAs for practical reasons.

Large solid dosage forms (e.g. Gaviscon® tablets), or multiple tablets to be taken at a

single time, may not fit into the individual compartments of the DAA. “As required/ when

necessary” (PRN) medication, if placed in a DAA with other medicines, may be taken

unnecessarily on a regular basis (Corlett 1996). Additionally, drug products that look

alike should not be dispensed in the same DAA (Corlett 1996).

Splitting tablets to obtain the required dose further exposes the solid dosage form to

environmental factors (particularly when the tablet has a protective coating), which may

lead to stability problems, especially if the remaining tablet halves are stored for an

extended period in unsealed blisters/ zip-lock bags/ plastic labelled bottles/ bulk

canisters or cassettes in automated systems.

4.3.5.3 Moisture-sensitive solid dosage forms

The stability of solid dosage forms may be affected by the moisture content of the

atmosphere in the container in which they are stored (Allen et al. 2005; Chen et al.

2003; Florence & Attwood 1998). Moisture is considered to be an important factor that

must be controlled in order to minimise decomposition during storage (Allen et al. 2005;

Aulton 2002; Badawy et al. 2001; Florence & Attwood 1998). In addition to the dosage

forms specifically designed to rapidly disintegrate when exposed to moisture, other

drug products can be adversely affected by moisture.

The original manufacturer’s package design is particularly critical for a moisture

sensitive product, since it must ensure that the product is adequately protected from

moisture during its shelf-life (Badawy et al. 2001). Desiccants (e.g. small packets of

silica gel) are frequently included in the packaging configuration of these products in

order to maintain low relative humidity inside the package and hence protect the

product from moisture (Allen et al. 2005; Badawy et al. 2001).

Drug products packed with a desiccant or packed in ‘tropicalised’ packs (double-sided

foil packs that keep light, air and moisture out) are a warning of potential instability due


to moisture. Careful consideration of DAA type, packing practices (including any

intermediate steps) and handling by the RCF or patient should be given in making a

decision to pack such products in a DAA. A recent example of moisture related

instability relates to Adalat Oros ® where the product information states “The drug

release mechanism of Adalat Oros is triggered by moisture. Contact of the tablets with

moisture may not be apparent but loss of contents may have already occurred. To

prevent this, the tablet must be kept in its original blister foil packaging until

immediately before use” (TGA approved product information amended 20 July 2004).

The extent to which the moisture within a DAA triggers nifedipine (active ingredient of

Adalat Oros ®) release (a light sensitive drug, see 4.3.5.5) is unclear (see 10.2.2.1 for

other examples). One strategy suggested to minimise this instability risk was packing

the medicine still in its individual foil wrapper into the DAA blister and “instructing the

carers to remove the foil before administration” (per Auspharmlist.net.au posted

17/10/2005 and a practice described by a different pharmacist on 28/10/2005). The

trade off is the increased complication of medication administration for the carer or

patient and the risk that the patient may swallow the medication still in the foil.

Swallowing a medicine still in its blister or foil can lead to intestinal perforation and has

been fatal (Blister-strip warning. 1996).

Temperature cycling can also lead to increased condensation in DAAs with suboptimal

seals/closures, resulting in increased physicochemical stability issues and also an

increased potential for microbial contamination. In use, DAAs may be subjected to a

reasonable degree of handling, during which accidental rupture or opening of nearby

compartments, blister seals or sachets may occur (Saville 2001), allowing further

exposure to humidity.

In addition to causing chemical degradation in susceptible active ingredients or

excipients, moisture can cause tablets to harden (or soften) with a subsequent effect

on disintegration and dissolution behaviour (Al-Zein et al. 1999).

It is essential that the packaging material and closure of the DAA offers sufficient

moisture protection for moisture-sensitive solid dosage forms. The pharmacist should,

at the very least, ensure the integrity of the DAA before it leaves the pharmacy and

counsel the patient not only on storage conditions, but also to be vigilant and monitor

that the integrity of the DAA is maintained throughout the dosage period. One option is

to reduce the interval between placing a moisture sensitive medicine in a DAA and the

time when the last dose is used in that DAA.


Package Insert/ CMI

OH&S issue?

Protect from light –

is DAA light-proof?

Protect from moisture –

is DAA moisture-

proof?

Transfer to DAA NOT

recommended

Problems not

expected

Unsuitabledosage

form?

* E.g. Cytotoxics

* E.g. Sublingual/

buccal/ dispersible/

effervescent tablets

YES

Are there known

interactions with

packaging/ other drugs?

YES

YES

YES

Protect from heat –

Heat sealing process?

Protect from air –

is DAA airtight?NO

NO

NO

NONONO

YESYES

NO

NONONO

NONONO

YESYES

YESYES

Figure 4.4 Decision-tree based on currently available information for repackaging medications in DAAs


4.3.5.4 Solid dosage forms sensitive to air (oxidation)

It is essential that medications required to be protected from air (especially oxygen) are

stored in an airtight container (Allen et al. 2005; Florence & Attwood 1998; USP

<1191> 2005) and that exposure to air during packing be minimised. A suboptimal

seal/closure on the formed container (DAA) will decrease the protective properties of

the container – insufficient temperature, time or pressure during a heat or cold seal

operation may enable the passage of moisture or oxygen through the seal area over

time (USP <1146> 2005) in addition to any air or moisture that permeates the

packaging materials.

Again, the pharmacist should, at the very least, ensure the integrity of the DAA prior to

leaving the pharmacy and also counsel the patient on both the timely removal of drug

products from the DAA and the importance of monitoring the integrity of the DAA.

4.3.5.5 Light-sensitive solid dosage forms

Although many drugs are found to decompose on exposure to light, the practical

consequences may not necessarily be the same for all these compounds (Tønnesen

2001). Some drugs will decompose by only a small percentage after several weeks of

exposure, while other substances, such as derivatives of the drug nifedipine, have a

photochemical half-life of only a few minutes (Tønnesen 2001).

Light-sensitive drugs can be affected either by sunlight (especially the UV component)

or artificial light sources (e.g. fluorescent light especially the UV component). This may

not only lead to photodegradation of the drug substance (with a subsequent loss of

potency or therapeutic activity), but also to a change in the physicochemical properties

of the product (e.g. discolouration/ changes in appearance, and dissolution rate)

(Tønnesen 2001).

The method most commonly used to protect photosensitive drugs is to place the

product in suitably protective packaging (e.g. amber or coloured non-transparent

containers). Some tablets have been photostabilised by the addition of light-absorbing

compounds (including scavengers and quenchers) and/or film coating with opaque

films (e.g. yellow iron oxide and titanium dioxide) (Glass et al. 2004; Tønnesen 2001).

As oxidation may be catalysed by exposure to light, some solid dosage forms with

susceptible ingredients may be stabilised (to a limited extent) by the addition of

antioxidants (i.e. agents that are more readily oxidised than the drug/excipient) (Aulton

2002).

It is essential that the packaging material and seal/closure of the DAA offer sufficient

light protection for light-sensitive solid dosage forms. The USP (USP <1146> 2005)

advises that if light protection is required for a drug product, the repackager (see

definitions in Appendix E) should follow the requirements for light transmission (USP

<661> 2005) and that this testing should be conducted on the formed container (i.e.

DAA), because the light protective properties of the film are compromised once the film

is thinned during the forming process (USP <1146> 2005). While this USP standard

does not apply to pharmacists repackaging medicines for individual patients, it gives an

indication as to the rigours required to optimise the stability of a drug product.

The pharmacist should ensure that DAAs containing light sensitive drug products are

prepared in a way to minimise the exposure to light and that they are stored in a dark


environment. This includes storage in the pharmacy, any RCF or the patient’s home.

An additional strategy is to consider an ‘amber’ DAA or if using a light-protective ‘cover’

or a ‘sleeve’, counsel the patient not only to avoid excessive exposure to light of the

DAA on storage, but also to maintain storage in this ‘cover’ or ‘sleeve’.

4.3.5.6 Solid dosage forms sensitive to heat

The stability parameters of a drug product are known to be influenced by environmental

conditions of storage including exposure to adverse temperatures (Allen et al. 2005;

Aulton 2002; USP <1150> 2005; USP <1191> 2005). In general, the rate of a chemical

reaction increases exponentially for each increase in temperature (Aulton 2002; USP

<1191> 2005). Exposure to increased temperatures may therefore enhance

physicochemical instabilities and degradation rates of the active ingredient(s) or

excipient(s), or result in an increase in potentially toxic degradation products (Aulton

2002; Florence & Attwood 1998; USP <1191> 2005). Thus the likely storage and

transport conditions of medicines in a DAA may be factors in deciding whether or not to

repackage a drug product into a DAA.

Heat is also a consideration where the DAA has a heat sealing process. Critical sealing

parameters include pressure and temperature control, since any undesirable variation

in these parameters may yield inadequate seals (USP <1146> 2005) thus contributing

to instability associated with moisture or air ingress into the DAA.

The pharmacist needs to take note of the above stability considerations regarding

exposure of medications to heat during DAA preparation, storage (in the pharmacy and

in RCFs) and during delivery. Patients should be advised on storage of DAAs in their

homes in order to avoid excessive exposure to high temperatures. An appropriate DAA

pack type/configuration (i.e. cold adhesive seal as opposed to heat seal) should be

selected for drug products sensitive to heat, in the absence of other stability

considerations.

4.3.5.7 United Kingdom manufacturers’ position on repackaging

In a UK survey conducted in two rounds (late 2002 and September 2004),

manufacturers were asked about the suitability of their products for repackaging into

DAAs (Church & Smith 2006). Fifty medical information departments responded about

392 products (note that there are very many more products available in the UK).

Responses were assigned to 6 stability codes. The majority of products were assigned

the code to indicate that there was no stability data so repackaging into a DAA could

not be recommended (see Table 4.9). This approach is cautious and may be

unnecessarily restrictive. No product was listed where the manufacturer held stability

data which indicate suitability for a DAA.

In using the list of products published by Church and Smith several issues need to be

considered by Australian pharmacists:

The likely storage conditions that manufacturers needed to consider were ambient

temperatures and humidity in the UK.

A number of products are not used in Australia. Even if the active ingredient and

the drug company are the same in the UK and Australia, the product name can be

different so that pharmacists can only assume stability code applies to the same

product formulation as available in Australia.


A number of products assigned to Stability Category 1 are those that would not be

packed for OH&S reasons or because the dose form is unsuitable (e.g. dispersible)

On review of products with codes other than 2, several were excluded from packing

because of occupational health and safety (OH&S) issues for the packers and some

because the dose form was unsuitable. A number of others were drugs or dose forms

that are currently not available in Australia or would not usually be packed into a DAA.

Thus additional stability information that might be of assistance to Australian

pharmacists was available for 84 items (Table 4.9). These items are listed in Table

4.10. For Code 3, a risk assessment approach could be taken by pharmacists in

choosing to pack these items.

Table 4.9 Frequency of stability codes in from a UK survey of manufacturers (Church

& Smith 2006)

Number of products Stability code

Overall Exclude unhelpful items*

1. Do not put into a DAA 62 26

2. Not recommended as no stability data is available. 27 -

3. Not recommended as no stability data available but

company indicated reasons for specific concerns.

3 11

4. No stability data but it is “probably” suitable to pack.66 36

5. Stability data available in a container other than

original packaging, but not necessarily in a DAA.

4 11

6. Stability data in a DAA shows product suitable for

repackaging. *Items excluded for the following reasons: OH&S, inappropriate dose forms, items definitely not available

in Australia, item an antiinfective or prn drugs (e.g. vardenifil for erectile dysfunction) and not likely to be in

a DAA.


Table 4.10 Products where UK survey produced stability information potentially useful to Australian pharmacists

Code Drug and Brand Manufacturer Explanation

4 Acarbose Glucobay Bayer Should be stable for 7 days

5 Alendronate 5mg Fosamax MSD Stable for 3 months at 40C and 75% relative humidity

4 Anastrazole Arimidex AstraZeneca Probably ok for short term storage in a compliance aid

1 Aripiprazole Abilify BSM Hygroscopic

3 Atorvastatin Lipitor Pfizer Disintegrates in bright sunshine

1 Baclofen Lioresal CephalonUK Protect from moisture

4 Bisoprolol - IVAX Probably stable for 7 days

4 Cabergoline Cabaser Pfizer Probably stable for 7 days

1 Cabergoline Dostinex Pfizer Should be stored with desiccant

1 Carbamazepine Tegretol CephalonUK Susceptible to moisture

1 Carbamazepine Tegretol Retard CephalonUK Susceptible to moisture

3 Carvedilol Eucardic Roche Protect from light

3 Chlorpromazine Largactil Hawgreen Can cause contact dermatitis when handled (wear gloves); must be protected from light

1 Ciclosporin Neoral Novartis Ethanol vaporises out of the capsule when out of the original packaging

4 Citalopram Cipramil Lundbeck Probably stable for 6 months

4 Clobazam Frisium SanofiAventis Probably stable for 4 weeks

3 Clonazepam Rivotril Roche Store in dark

4 Co-beneldopa Madopar Roche Probably stable for 14 days

1 Co-careldopa Sinemet BMS Powder is hygroscopic

1 Co-careldopa Sinemet CR BMS Powder is hygroscopic

1 Co-careldopa Sinemet 110/250 BMS Blue dye can fade on light exposure; moisture will cause levodopa to turn black on prolonged exposure

4 Desloratidine Neoclarityn ScheringPlough Unlikely to be hygroscopic

4 Dexamethasone - Organon Unlikely to be any issues

1 Diclofenac +misoprostol Arthrotec Pfizer Misoprostol is extremely moisture sensitive and may degrade

1 Didronel PMO - P&G See Calcium carbonate and etidronate

4 Digoxin Lanoxin GSK Probably stable for 14 days

5 Dipyridamole MR Persantin Retard BI Moisture sensitive; stable for 30 days out of the original container, eg, plastic dispensingbottle



5 Dipyridamole MR/ Asasantin Retard BI Stable for 30 days out of the original container, eg, plastic aspirin dispensing bottle

3 Dipyridamole Persantin BI Protect from light

4 Donepezil Aricept Pfizer Probably stable for 14 days

4 Dosulepin (dothiepin) tablets Generics(UK) Probably stable for 7 days

4 Dosulepin (dothiepin) capsules Generics(UK) Probably stable for 7 days

1 Enalapril Innovace MSD May hydrolyse at high temperature and in the presence of moisture; 10% loss of potency occurred when exposed to 40C and 75% humidity for 13 weeks

4 Escitalopram Cipralex Lundbeck Probably stable for 6 months

5 Esomeprazole Nexium AstraZeneca Stable for 6 months at 25C and relative humidity of 60%

4 Ferrous sulphate - Alpharma Probably stable for maximum of 14 days (could taint other tablets)

4 Fluoxetine Prozac Lilly Probably stable for up to 4 weeks

4 Gliclazide Diamicron Servier Probably stable for 8 days

4 Gliclazide Diamicron MR Servier Probably stable for 8 days

4 Haloperidol - IVAX Probably stable for 7 days

4 Indapamide Natrilix Servier Probably stable for 8 days

4 Indapamide Natrilix SR Servier Probably stable for 8 days

4 Isosorbide mononitrate - Alpharma Probably stable for up to 14 days

4 Isosorbide mononitrate - IVAX Probably stable for 7 days

5 Isosorbide mononitrate Imdur AstraZeneca Stable for one month

4 Isosorbide mononitrate Monomax SR Trinity Probably stable for 4 weeks

4 Isosorbide mononitrate Monomax XL Trinity Probably stable for 4 weeks

3 Ketoprofen Orudis Hawgreen Must be protected from light

3 Ketoprofen MR Oruvail Hawgreen Must be protected from light

4 Lansoprazole Zoton Wyeth Probably stable for up to 4 weeks in a compliance aid which offers a barrier against moisture*

1 Loperamide Imodium Janssen-Cilag Moisture sensitive and could change colour

1 Misoprostol Cytotec Pfizer Moisture sensitive and may degrade

5 Nicorandil Ikorel SanofiAventis Stable for at least 7 days in a dry environment

1 Nifedipine Adalat LA Bayer Very light sensitive and will significantly degrade very quickly; moisture can affect release mechanism



4 Nizatidine Axid Lilly Probably stable for up to 4 weeks

4 Olanzapine Zyprexa Lilly Probably stable for up to 4 weeks; sensitive to light; wear gloves if breaking or dividing the tablets due to potential contact dermatitis

1 Omeprazole capsules - Generics(UK) Hygroscopic

5 Omeprazole capsules Losec AstraZeneca Stable for 14 days at room temperature 25–30C) and relative humidity up to 75%

1 Oxybutynin XL Lyrinel XL Janssen-Cilag Hygroscopic; packaged in high density polyethylene bottles with a dessicant

4 Paracetamol - Alpharma Probably stable for up to 28 days

1 Pergolide Celance Lilly Unstable — light sensitive and extremely hygroscopic (notably the 50 g strength)

4 Perindopril Coversyl Servier Probably stable for 8 days

4 Perindopril/indapamide Coversyl Plus Servier Probably stable for 8 days

4 Potassium chloride Slow K Alliance May absorb water; probably stable in an airtight compliance aid for 14 days

1 Pyridostigmine Mestinon Valeant Store in a brown bottle with a desiccant

4 Quetiapine Seroquel AstraZeneca Probably stable for up to 7 days

4 Quinine sulphate - Alpharma Probably stable for up to 7 days

1 Rabeprazole Pariet Janssen-Cilag Hygroscopic

1 Ranitidine - Generics(UK) Hygroscopic and may turn brown

1 Ranitidine Zantac GSK Hygroscopic and degrades in the presence of water

5 Ropinirole Requip GSK Stable for up to 28 days below 25C and at 60% relative humidity

1 Selegiline HCl Zelapar ZeneusPharma Hygroscopic

3 Spironolactone - IVAX Protect from light

3 Tamoxifen Nolvadex AstraZeneca Known to be light labile

3 Tamoxifen - Generics(UK) Sensitive to light

1 Topiramate Topamax Janssen-Cilag Hygroscopic; hydroxylates and becomes unstable with water

1 Valproate sodium EC Epilim EC SS Hygroscopic

1 Venlafaxine Efexor Wyeth Moisture sensitive*

4 Venlafaxine XL Efexor XL Wyeth Probably stable for 7 days*

5 Zafirlukast Accolate AstraZeneca Stable for 30 days at 60-80% relative humidity

3 Zopiclone - IVAX Protect from light

4 Zuclopenthixol Clopixol Lundbeck 2mg stable for 14 days; other strengths stable for 4 weeks Manufacturer key: BI Boehringer Ingelheim; BSM Bristol Myers Squibb; GSK GlaxoSmithKline; MSD Merck Sharpe & Dohme; P&G Proctor & Gamble; SS Sanofi Synthelabo


4.4 SYNTHESIS OF PROBLEMS AND POSSIBLE SOLUTIONS

From the preliminary investigations, a number of problems and possible solutions

emerged, reflecting the perspectives of the various stakeholders. For some problems,

having only one perspective limited solutions arising from the various stakeholders, so

that other possible macro or “big picture” solutions were devised by the researchers to

address some problems. In this section, problems and possible solutions that formed

the basis of best practice models are summarized (see Table 4.11 to Table 4.15).

Table 4.11 Problems from the RCF (management and staff) perspective and possible

solutions (soln)

RCF (management and staff) perspective Issue Accuracy of packs (packing from previous version of chart due to packing in advance or

poor information flow, discrepancies in brand of drug on chart versus brand packed, omission of medications, use of multi-dose packs and tablets that a difficult to identify, prn medication directions, changes )

Soln Improve systems for information flow to pharmacy through standard templates including minimum data sets and IT solutions

Utilise information and communications technology solutions wherever possible, that are not reliant on significant personnel or maintenance to support

RCF/GP awareness of packing cycles Quality assurance/ monitoring procedures introduced in pharmacy RCF responsibility to check packs if administering done by ENs or PCAs and for self-

medicators Review of charting systems to eliminate ambiguous orders and ensure that charts are

up to date. Issue Doctors having to write-up prescriptions when they have already written the medication

order on the patient’s chart. Soln Developing a system and procedures where the medication chart acts as prescription

for pharmacist payment via HIC/Medicare Australia. i.e. modify the supply claim mechanism

Issue Labelling of DAAs Soln DAA should have patient’s photo on it

Packs labelled with both generic and prescribed name of medicine Information on suitability for crushing required on pack Patient or drug information should not be obscured in anyway

Issue Pharmacy responsiveness to change (what do RCF staff do when doctors orders do not match available pack )

Soln Disseminate between stakeholders information affecting the packing cycle e.g when is packing done, when staff are available in pharmacy and RCF to deal with changes, usual doctors rounds when more likely to make changes.

Procedures i.e. details of how to identify tablet to be removed and when to expect changes to occur

Issue Staff issues – use of ENs & PCAs and agency (problem recognition & legality actions) Soln RCF responsibility to check packs if administering done by ENs or PCAs and for self-

medicators. Additional checking step where RN checks pack to ensure accuracy before other staff administer from pack. Facilities need to take responsibility and record all pack errors to be fed back to pharmacy – awareness of problems should help overcome them

Agency guidelines/training (currently done but need details of what to do when things go wrong ie dropped tablets)

Standardise charts to reduce variation for new staff/agency staff Issue Hospitalisation of residents and transfer of information about medication changes and

administration instructions. Soln Model/guidelines for transition between RCF and hospitals


Table 4.11 continued RCF (management and staff) perspective Issue Need for written orders to administer medication (need to be accurate, timely and

responsive to changes) Soln Hospital discharge summary until new profile available – stop gap measures.

Procedures for dealing with changes to regimen after hours or when no RN available Promotion/ communication between RCF staff and doctors regarding staffing/legal &

other practical issues that may affect the facilities ability to deal with medication changes or particular doses

Issue Need/have existing good procedures/systems for monitoring and addressing problems and communication flows to keep staff informed

Soln Quality assurance/ monitoring procedures introduced in pharmacy Internal communication models – what needs to be communicated Procedures in the RCF e.g.:

how prn medicines handled, how practices need to differ if PCA or an RN administer medications, practices for packed versus non-packed medicines including ensuring non-packed

medicines are ordered & use monitored, how GPs order prn and non-packed orders and how administration recorded,

after hours medication changes & emergency supplies for ceasing supply of a particular packed medication or supply for a patient

Issue Integrity and reliability of medication charts (transcription errors to charts, how do you know it is current and complete).

Soln Standardisation? Electronic records? Use of pharmacy profile with regular validation?

Issue Patients using other pharmacies and doctors – variation in procedures and conflict between patient choice/rights and quality of care.

Soln Needs to be part of DAA contract with RCF and agreement with the patient i.e. explicit agreement about roles, obligations and responsibilities

Procedures for exceptions (available for agency staff) Issue Monitoring compliance for self-medicating patients Soln Agreement with residents

Table 4.12 Problems from the GP perspective and possible solutions

GP perspective Issue Pharmacy request scripts too early (contrary to dispensing software alerts) or after having

just written another prescription (legalities) or requests are inaccurate i.e. medication has been ceased or prescription is at RCF.

Soln Tripartisan agreement stipulating obligations and procedures Promotion and awareness raising of issues from perspectives of all stakeholders Template for reminders (what should it say) – Reminder should have patient’s name,

date of birth & Medicare number Keep resident/family, RCF and GP informed of what is needed when

Issue Doctors would prefer to generate prescriptions electronically to keep records in their medical software

Soln Provision of prescription computer in RCF or access to surgery computer from RCF, reminders prior to RCF visits

Issue Inability to monitor wastage or compliance based on prescription rates Soln Template for requests contain this information is fed back to GPs to allow monitoring Issue Lack of flexibility and responsiveness to changes Soln Raise awareness of RCF and pharmacy situations to modify GP perception or resolve

any real problems Issue Nurses/RCFs relinquished responsibility for medication management Soln Awareness raising to illustrate RCF procedures to GPs and address real problems Issue DAAs make more work for GP but easier for pharmacist Soln Raise GP awareness of all steps involved in safe, effective and efficient DAA service

(promotion to address perceptions and deal with any real problems) Raise pharmacy awareness of GP concerns and address any real prblems


Table 4.13 Problems from a community pharmacy perspective and possible solutions

Community Pharmacy perspective Issue Reliable and timely information on what to pack (includes charts-prescription mismatch) Soln Pharmacy require or accept written document/GP/doctor endorsed statement only

Review of medication charting procedures to eliminate ambiguous orders and ensure records are up-to-date

Whole new profile required from doctor including full drug regimen – view whole detailed drug chart – what has changed, what is the same

New packing template developed when changes occur RCFs use pharmacy-provided charts based on medication profiles & endorsed by GP For hospitals using PBS – doctors use medication chart as discharge prescription

(electronic document) signed by doctor faxed to pharmacy (new medications, changed or ceased medications – full regimen)

Issue Paperwork trail – owing prescriptions and PBS rules, and laws. Legalities of dispensing owing script if something happens to patient

Soln Raise awareness of other stakeholders of rules and laws pharmacy must operate within and any related pharmacy policy/procedure

Reminders (when done well) – template for managing prescriptions including means of monitoring wastage for GPs

Potential of medication chart to be accepted as the primary legal document for a residents prescribed medication to be accepted as PBS items.

Change the system of supply/payment system for patients on chronic medications packed into a DAA

Issue Unrealistic expectations from RCFs, doctors Issue No payment for high cost service Issue Resistance of other players to pharmacy attempts to improve situations Soln Address perceptions through promotion and mutual awareness raising

Promotional materials need to include what is required from all parties, what pharmacy has to do, why pharmacies need prescriptions in advance

Develop fee structures for DAA services e.g. an annual fee or provider-type fees paid for services such as prescription management, liaison with nursing staff, GPs and non-medical carers.

Also more explicit contracts and service agreements – verbally explain expectations and procedures and why do the pharmacy charges as it does!

Issue Pharmacy held responsible for issues such as charting and provision of sign-off sheets Soln Address service expectations in an agreement and payment for these services Issue Difficulty getting information on what products are suitable for packing or where to go for

this information. How to source information when nothing available. How to factor weather conditions especially in tropics i.e wet season in NT

Soln Use a risk assessment approach to existing information (decision tree) Collect and disseminate more information of drug instability Development of list of commonly packed products Document judgement calls made on suitability for packing

Issue DAA patients unique in their care needs and sometimes need to bend the rules to ensure continuity of supply

Soln Develop models of guidelines and legislative changes to facilitate caring fro DAA patients’ but ensure payment and monitoring of medication use by GP

Issue Errors in packing and checking DAAs Soln Appropriate packing procedures, environment (quiet, no interruption) and staff training

Pharmacy needs quality assurance/monitoring systems. If error occurs, determine how/why error occurred with goal of problem identification & resolution); packer & checker counselled in a non-accusatory way. Education/training offered if needed

Issue Need to rush packing and checking when patient discharged from hospital Soln Earliest possible notification from hospital pharmacy

Use of discharge template – full and accurate information Procedures to deal with hospital or clinic-supplied medications where there is an

expectation that a community pharmacy will repackage these into a DAA Issue Different points of view for hospital doctors and GPs; or GPs left out of the loop Soln Communication protocols for DAA patients entering & exiting hospital


Table 4.14 Problems from a hospital pharmacy perspective and possible solutions

Hospital pharmacy perspective Issue Lack of notification re: patient discharge Soln Need something to disseminate to medical staff to increase awareness that the

pharmacy needs a day or two to organize new DAA packs so need earlier than usual notification of discharge

Issue Difficult to identify which patients use DAAs, what type and who the community pharmacy who packs is

Soln Development of a patient, community pharmacy, RCF database about DAA use RCF charts/patient medication list/DAAs to be brought to hospital and have details of patient’s type of DAA and contact details for community pharmacy and GP.

Issue Difficulty communicating with community pharmacy & GPs Soln Electronic communication pathways for medication profiles between community and

hospital pharmacies Automated faxing or encrypted emailing of medication information sheet to GP on discharge

Issue Wastage – community pharmacy/ RCFs disposing of medication dispensed by hospital pharmacy rather than packing it

Soln Data base of RCFs and community pharmacies that contains details of their preferences with regard to using hospital medicines versus receiving discharge prescriptions only

Issue Privacy issues – need patient consent to share information with other Health PractitionersSoln Tripartisan agreement to initiate/continue DAA supply to include consent

Consent may be implied but explicit consent is preferred to prevent future problems

Table 4.15 Problems from a community patient perspective and possible solutions

Community patient perspective Issue Difficulties handling/using DAAs Soln Assessment of suitability of pack (including type) that involves an observation of a

patients ability to manipulate a pack Promotion of some negative aspects (problems) and potential solutions so that new DAA patients have a realistic expectation and strategies to deal with problems Ability to use a DAA and medication compliance may change with time so need monitoring systems in place e.g. repeat patient assessment (including knowledge and willingness to pay for pack) and formal review of returned medicines

Issue Complacency and the potential for error in packing Soln Responsibility of patient for hand-held template and facilitating information flow

Procedures to ensure patient medication knowledge is retained after starting DAA Issue Cost Soln Raising awareness of what is involved in a DAA service (promotion to address

perception) Be explicit about patient/carer obligations and responsibilities in a service agreement

Using a DAA complicated the continuity of care between the community or RCF and

hospital. The problems addressed by APAC guidelines on the continuum of quality use

of medicines between hospital and community (Australian Pharmaceutical Advisory

Council 1998) exist but there are specific DAA-linked problems including:

Hospital pharmacists concern about integrity and identification of drugs in DAAs

brought in on admission

Need for timely charting in RCFs and prescription for medications supplied under

the Pharmaceutical Benefits Scheme (PBS)

Preparing DAAs is resource intensive for community pharmacies. Requests for

DAAs outside scheduled packing times can be difficult to manage

Community pharmacy concern about packing medications dispensed by others


Needs of stakeholders to facilitate the smooth transition from hospital to the community

and RCFs for patients who use pharmacy-packed DAAs include:

Community pharmacies need to know when a DAA patient (community or RCF-

based) is admitted to hospital. Hospitals could advise community pharmacy of DAA

patient admission.

Hospital pharmacists need to know a patient uses a DAA and with whom to liaise

(GP, community pharmacy) as discharge approaches. When a DAA patient is

admitted, the hospital could trigger an alert/warning associated with patient ID

and/or address (for RCFs) on dispensing system to notify staff to activate DAA

organization protocol.

Failure to consider the policies and procedures of others involved in patient care

can lead to wastage and interruptions to the continuity of medication supply.

By compiling information on local community pharmacies who provide DAAs,

hospitals can address patient needs. The database would details such as who to

contact for a given patient and pharmacy details such as the type and cost of

packs, whether delivery available, requirements regarding prescriptions and stance

on using hospital dispensed medications. This information can be utilised when

advising patients about possibility of using DAAs if a new patient or organising

discharge supply for current DAA users.

Hospital staff, medical, nursing and pharmacy, need to recognise that discharging a

patient who uses a DAA requires more advanced notice as part of discharge

planning. At least a days notice is needed and staff need to be aware of potential

issues with continuity of care if discharge occurs outside business hours. Leading

up to discharge, both the GP and community pharmacy could be notified. The

hospital can confirm when the when new pack can be provided and whether

discharge medication is required.

When a patient returns to an RCF, staff need a legally valid and reliable order to

administer drugs. There can be delays in getting this order from the GP due to poor

information flow and the timing of discharge. Patients could return to an RCF with a

valid medication chart.

GPs need a timely discharge summary and need to know about changes for their

own records.

To pack the DAA, the community pharmacy needs timely, reliable and complete

information on the patient’s current drug regimen and a valid prescription for

payment. The hospital could fax or email (where security is addressed) a copy of

hospital prescriptions and discharge medication list to community pharmacy.

Community patients need to be understand what is required of them to facilitate the

transfer of medication regimen information and continuity of supply. Actions of

community patients also contribute to ‘continuity of information and supply’ failures.

A patient held template for community patients or a copy of the RCF medication

chart, contact details of a patient’s GP and pharmacy, and consent to share

information as part of a service agreement would aid medication information

transfer.

There are may variations in the systems of DAA service provision and in hospital

medication supply systems. Appropriate strategies that recognise these variations in

practice when care setting transitions occur reduce the chance of failures in continuity

of information and supply for DAA users.


4.5 BEST PRACTICE MODEL FOR THE PROVISION AND USE

OF DOSE ADMINISTRATION AIDS IN THE COMMUNITY

4.5.1 INTRODUCTION

Dose Administration Aids are widely used in Australia as a tool to assist with

medication management in a variety of settings. Approximately 80% of community

pharmacies in Australia pack and supply DAAs to meet the needs of consumers living

in the community. DAAs are used in the community by consumers who need and/or

would like additional support in managing their medications due to multiple solid

medication use, poor health, and disability.

The provision and use of DAAs is a complex process involving a number of steps and

the input and collaboration of different parties (the pharmacy, doctors, patients, carers

and sometimes community support services such as community nurses). Figure 4.5

shows the steps involved in DAA provision and use once the decision to commence

DAA use is made. From the pharmacy perspective, dispensing, packing and checking

medications for supply in DAAs, and likely support services such as managing the

patients’ prescriptions, account keeping, and delivery, take significantly more time than

providing the same medications in original packs.

Best practice is defined as a technique or methodology that, through experience and

research, has been proven to reliably lead to a desired result. The QMC group (funded

by the Australian Government via the 3rd Community Pharmacy Agreement Research &

Development Grants managed by the Pharmacy Guild of Australia) has conducted obs-

-ervational research and sought extensive feedback from a range of key stakeholders

from the medical, nursing and pharmacy professions, as well as industry, consumer

and government sectors to identify the factors that are contributing to unsafe practices,

reduced effectiveness and inefficiencies in the provision and use of DAAs. Key barriers

to safe, efficient and effective provision and use of DAAs in the community include:

Poor communication and the breakdown of information flows between parties.

Poor awareness of responsibilities and obligations which cause systems to fail

and require rework (i.e. follow-up communication, re-packing).

Community patient loss of ownership with respect to medication management,

as evidenced by lower levels of medication knowledge and high levels of

dependency on others for help with medication management.

Lack of monitoring and accountability for the quality of the DAA services.

The high cost of providing DAA services to community patients borne by

community pharmacy.

4.5.2 PREAMBLE

4.5.2.1 Purpose and scope of this best practice model

There are currently a range of standards and guidelines relating to the supply of medic-

-ines in the community and to the provision of dose administration aids by pharmacy.

These include: Professional Practice Standards (Pharmaceutical Society of Australia

2002), Dose Administration Guidelines (Pharmaceutical Society of Australia 1999),

Quality Care Pharmacy Program (QCPP) professional practice guidelines, DAA

specific manufacturers/suppliers guidelines (i.e. Webstercare, Douglas, Persocare,


AHPS and MPS). Various nursing guidelines and policies or procedures of nursing

organisations make reference to the roles of nurses. There is no existing resource,

however, that accounts for the multi-disciplinary involvement in the provision and use of

DAAs and that includes specific processes or procedures for optimising the provision

and use of dose administration aids for community patients.

1a. GP writes medication order• Records full current drug regimen for community patients

1b. GP writes prescription as order to dispense

3. Develop or update pharmacy-held medication profile• Review regimen, prepare dosing schedule (what to take when)• Develop packing plan (identify what is packed & not packed)

2. Transmit drug regimen information to pharmacy

3a. Support activities• Manage prescriptions

(e.g notify when new script due)

• Accounts, adequate stock on hand




10. Filled packs stored in pharmacy

12. Medication receipt • Counsel on medications; provide written information (CMI, MIC)

13. Patient stores medications (packed & non-packed)

14. Take medication (packed & non-packed)

15. Return unused medication to pharmacy• Pharmacy records & monitors missed doses, taking

action as needed; deals with returned medications

No

n-p

ac

ke

d m

ed

icati

on

s

Potential patient role:

• Monitor need for new

prescription;

• Obtain new prescription

as needed;

• Deliver new prescription

to pharmacy

Doctor Doctor & patient

Pharmacy support staff e.g. Dispensary technician

Pharmacist Patient

Patient & pharmacy

Key

Potential patient role:

• Monitor need for new

prescription;

• Obtain new prescription

as needed;

• Deliver new prescription

to pharmacy

Doctor Doctor & patient

Pharmacy support staff e.g. Dispensary technician

Pharmacist Patient

Patient & pharmacy

Key





Figure 4.5 Steps and input required in the provision and use of DAAs, once DAA

service initiated


While profession-specific guidelines are needed, there is also a need for an over-

arching integrated model. This proposed model takes into account existing professional

standards and relevant legislation, and makes recommendations to address the

limitations in the provision and use DAAs, to optimise the effectiveness of this

intervention and to facilitate interaction between health professionals and health

consumers. Despite this teamwork approach, many of these recommendations may

appear pharmacy centric. This is because much of the resource and cost burden

arising from the provision of DAAs is borne by community pharmacy. However, optimal

provision and use of DAAs cannot occur without multi-disciplinary involvement and the

recommendations reflect the roles and responsibilities of the different stakeholders

(see Figure 4.5, where they key indicates who generally performs the various steps).

The scope of these recommendations is restricted to issues relating specifically to DAA

use where it is different from medication management using original packs. The key

issues in providing medications in a DAA rather than original packs are:

(1) To supply the correct medicine, the pharmacist needs to know the patient’s

complete and current drug regimen (as all items must be packed) rather than

only a single new or changed medicine to be supplied in its original pack.

(2) The pharmacy, instead of the patient, tends to take responsibility for managing

prescriptions and ensuring the continuity of medication supply in an effort to

streamline processes.

(3) The extra steps involved in producing DAAs and the interdependence of the

stakeholders increases the potential for errors at any point in the process and

by anyone involved.

The purpose of this document is not to dictate or set standards in medication

management and the use of dose administration aids. Instead, the goal is to provide a

range of strategies and tools to overcome the barriers to safe, effective and efficient

DAA provision and use. Professional bodies may choose to incorporate these issues

into future guidelines or standards. The recommendations outlined in this document are

inter-related and together constitute a possible implementation model as outlined in

Figure 4.6.

This best practice model is based on the current situation whereby no subsidies are

available for the provision of DAAs. Were funding to become available in the future for

DAA provision, the elements of the model (specifically recommendation 1.3.1 and

recommendation 1.3.2) could be incorporated as part of the system of checks and

balances that would be necessary to ensure accountability with respect to the quality

and quantity of DAA services offered to community patients. An additional benefit is

that these documents could also be used to form part of a program evaluation of any

future DAA implementation. The model concentrates on the nature of information

transfers and processes rather than a specific mode (e.g. fax, encrypted email, etc).

Future IT developments (e.g. communication channels, software, encryption and public

key technologies, etc) may well be enablers to further increase safety and efficiency.


Potential new DAA user• Does patient meet DAA criteria? Have ability to use DAA?• Assess baseline medication management ability, knowledge• Communication between patient/carer, GP, pharmacy +/- community nurses involved

• Any other related services e.g. HMR?


formalcheck?


formalcheck?

Yes

No

Patie

nt-

held

tem

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te k

ept

up-t

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ate

by

pa

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are

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GP

Inclu

din

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edic

atio

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hang

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ot ne

edin

g p

rescription



DAA sent to patient



Tripartisan AgreementFormalise service to be delivered, expectations & obligations

Patient/carer GP (+/- specialists)

Pharmacy +/- community nurses

Full review/ renewal of template• Patient, GP & pharmacy

Template for medication packing• Shows medication regimen & preferred time of day

for each dose

Reflect• Patient habits/preferences; GP preferences• Current medication & optimal schedule• Type of pack & packing interval• Check medications suitable for packing• Other constraints e.g vision impaired

Pre

scrip

tio

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ispen

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Template copy to GP

Figure 4.6 Community patient implementation model

4.5.3 RECOMMENDATIONS

4.5.3.1 Assessing community patients’ need for DAA services

Prior to agreeing to initiate a DAA service, the needs and ability to manage a

DAA should be formally assessed including a structured assessment of pre-DAA

medication management ability and medication knowledge.

Users of DAAs generally have higher care needs and pharmacies appear to be well

able to identify people in need of a DAA. The existing approach to targeting DAA

services (Pharmaceutical Society of Australia 1999) emphasises individual assessment

while suggesting the following criteria:

Taking five or more medications

A history of poor compliance

On a complex medication regimen

Showing signs of cognitive or physical impairments

In Phase 2 ((Ientile et al. 2004), Table 4.33), the most frequently cited characteristics of

patients who benefited from using a DAA were similar to the PSA guidelines:

The elderly

Those with multiple medications

Those who were confused or with cognitive impairment

Those unable to coordinate their medications correctly

Those with physical barriers to medication taking

This assessment is apparently, informal and undocumented (4.1.2.2 and 4.1.3).


Analysis of HIC data (sections 7.2 and 5) supports the view that DAA users have

greater care needs as many of the covariates of higher health costs were proxies for

greater disability and/or poorer health. Since the people for whom DAA use might be

suggested generally already have impaired medication management abilities, formal

assessment of DAA needs and ability to use a DAA will help pharmacies provide an

appropriate service and to identify any potential risks for a given patient in using a DAA

by:

Appropriately defining specific needs (e.g. to deal with poor vision or reduced

mobility) that will need to be addressed by the DAA service provided.

Identifying potential risks from using a DAA (e.g. reduced medication knowledge)

so that risk reduction strategies can be put into place.

Ensuring that a specific DAA is optimal for an individual patient. Some patients

have more difficulty using certain devices than others.

Identifying other potential medication use problems (e.g. storing medicines in

inappropriate places).

Keeping a record of this assessment would provide a means of:

Accountability that DAAs are provided to people in need of them.

Quality assurance and patient risk management. Pre-DAA assessment of abilities

and knowledge will allow future monitoring of medication management ability and

knowledge when periodic re-assessments are performed and compared against

baseline (see recommendation in section 4.5.3.9).

As part of the assessment phase, health professionals involved in the medication-

related care of the patient need to be consulted in the decision to initiate a DAA

service, as each may be affected by the decision. Further, alternative medication

management strategies may be deemed to be more suitable for a specific patient or

additional services, such as a Home Medicines Review (HMR) may be requested.

4.5.3.2 Tripartisan agreement specifying obligations and promoting mutual

awareness

Community pharmacy should negotiate an agreement between themselves, the

community patient and/or carer and the patients’ doctor/s prior to beginning to

provide a DAA service.

The agreement should address:

That it is important for the pharmacy to know the correct, current medication

regimen so that a DAA containing the correct medications can be provided on time,

i.e. the importance of pharmacy profile maintenance.

How the service will work:

What type of pack will be provided (brand, period, how many packs needed,

how many weeks’ worth will be provided at once).

What medication will be packed (including whether some or all non-prescription

items such as complementary or vitamin supplements are to be packed) and

what is the optimal schedule (see 4.5.3.3).

How far in advance of distribution will the DAA be packed (and in some cases,

which day of the week) (i.e. what is the packing cycle?).

Where original pack medication and prescriptions will be stored.

Whether the pack will be delivered by the pharmacy or collected by the patient,

the delivery procedure and schedule.


What will happen if a medicine in a pack needs to be changed before the

current pack is finished.

What is the cost of the service, who is the payer and how the pharmacy will

charge for the service.

Procedures for start-up and preparing the first pack e.g. will medicines already

dispensed and in the person’s home be packed or will the person be asked to bring

all their medicines from home to rationalise?

Privacy: Patient consents to sharing of medication-related information between

doctor/s and pharmacy (and hospital and community nurse if required).

Medication changes:

Whose responsibility will it be to inform the pharmacy of medication changes

(patient/carer or doctor)?

What format is acceptable, (i.e. written instructions only- amended to full

regimen indicating ceased/changed and new drugs)?

What constitutes timely notification of changes so that rework is minimised.

The circumstances when a medication change can be delayed until the next

pack or when a change needs to be made more quickly.

Prescription management:

The understanding that a valid prescription is required before medicines can be

supplied in a pack, and that, depending on the packing cycle, the date a

prescription is needed may be earlier than if original packs were provided.

Will the pharmacy remind the patient to visit the doctor to obtain a new

prescription?

Will the pharmacy generate prescription reminder notices for the doctor/s?

GP practices related to prescriptions and repeat reminders e.g. under what

circumstances is the GP willing to write a prescription without seeing the

patient, any GP costs.

Who is responsible for following up that prescriptions are at the pharmacy in

time for packing (patient/carer or pharmacy).

What will happen if patient has no new prescription (i.e. medication not packed

in the DAA?).

Procedure for use of the DAA and what to do in exceptional situations e.g.:

When things go wrong (i.e. what to do if drop medication or open wrong blister).

What to do if have to have a prescription filled at another pharmacy (not the one

that provides DAAs) e.g. hospital pharmacy.

When patient away from home e.g. on holidays or in hospital, where there might

be a need for more packs than usual or where there is an interruption in the use

of packed medications (e.g. hospital admission or discharge).

How to ensure optimal use of the DAA:

How the pharmacy will provide counselling and medication information (e.g.

CMIs) to the patient (or their carer)

Patient agrees to return unused medication in the DAA to the pharmacy.

Pharmacist reviews returned DAAs to assess compliance or problems with use.

Pharmacist counsels patient/carer if problems occur.

Consent to re-assess how patients are managing with the DAA after a specified

time (such as 6-monthly) (see 4.5.3.1). This may involve a home visit.

The process of completing an agreement of this nature ensures that the patient and/or

carer receives adequate information about what is involved in receiving a DAA service

and training in how to use the DAA and what do if problems occur, and can address


patient preferences. In addition, this agreement allows the pharmacy, doctor and

patient to negotiate who will be responsible for undertaking the necessary activities to

ensure the accuracy of the DAA, the continuity of medication supply and the optimal

outcome for the patient. The agreement also allows the GP’s expectations and practice

patterns, policies and procedures to be recognised.

This agreement may also provide the pharmacy with some form of risk-reduction in

relation to potential future claims arising from situations where a patient/relative makes

a claim against the pharmacy.

4.5.3.3 Patient held medication template to empower patient and facilitate

communication about medication regimen and changes

The pharmacy, in collaboration with the patient and the patient’s doctor, should

establish a template for medication packing for each community patient

receiving a DAA service.

The patient should carry a current copy of this medication template with them as

an accurate record of their current medication regimen.

The patient’s doctor should record medication changes on the patient’s template

(in addition to other processes used by the pharmacy, patient and doctor to

maintain the currency of the profile, such as routine 6-monthly concordance

checks).

The patient medication template addresses a variety of issues. From the pharmacy

perspective it is essential that the pharmacy have a full and accurate record of the

patient’s current medication regimen from which to pack the DAA. This record should

reflect the patient’s current, optimal schedule and include detailed directions for

medication use including the dose, the frequency, the preferred time of day for each

dose (taking into account doctor and patient preferences) and which medications are

suitable for packing (see 4.5.3.6). The process of constructing the patient template

provides the pharmacist with the opportunity to review the patient’s medication regimen

to minimise the risk of medication misadventure, to ensure unsuitable medications are

not packed and to maximise the therapeutic benefits.

This template should be approved by the patient and the patient’s doctor (who, as the

primary medical care provider, has the ultimate responsibility for prescribing the

patient’s current drug regimen) and all parties should maintain a current copy. When a

change is made to the template, the pharmacy should provide a new copy of the

template to the patient and retain the out-dated template (to minimise latter confusion if

two different template are in circulation). This process ensures that the pharmacy has

an accurate record of the patients medication regimen and directions for use

(according to the intentions of the prescribing doctor) and that the doctor/s is aware of

what medications the patient is taking (both prescription and OTC), how the patient is

taking them and also provides the opportunity for the doctor to review the regimen if

necessary. This approach should be supported by a quality assurance activity, a

routine, 6-monthly check of concordance between the GPs records, current

medications as reported by the patient, and the pharmacy profile.


The strategy of having the patient/carer maintain a copy of the template has a three-

fold effect. First this strategy encourages the patient to take ownership of their

medication management by increasing their responsibility in that process and

improving their knowledge of their medication. Secondly, this medication template

facilitates communication about medication changes, especially those not requiring a

prescription (i.e. ceased medication or changes to medication dosages). In these

instances, the doctor can annotate the patient-held record and the patient and/or doctor

can provide written communication of medication changes to the pharmacy. Thirdly, the

medication template constitutes a legitimate/authorised, reliable, current and complete

record of the patient’s regimen which could be helpful if the patient consults with a new

health professional or is admitted to hospital.

4.5.3.4 Communicating medication changes

The pharmacy should maintain a written record of all communication regarding

medication changes for patients receiving DAA services.

The accuracy of the DAA pack is largely dependent on the currency of the pharmacy

profile. Maintaining a current medication profile requires full and detailed

communication about the medication regimen and any changes. In the community

setting, where the responsibility for informing the pharmacy of medication changes

generally falls to the patient, it is quite likely that the pharmacist may not be informed of

medication changes, particularly when the changes are not documented on a

prescription (i.e. if patients have a change in the dosage of their medications or cease

using a medication). The patient presenting the pharmacy with a new prescription does

not constitute adequate communication as the pharmacist may be uncertain of whether

this new medication is in addition to the current regimen or to replace another

medication.

The pharmacy should request that all medication changes be communicated in writing

(whether by fax, email, letter, etc). The communication should reflect changes in the

context of the patient’s full regimen and should be unambiguous and detailed enough

to allow the pharmacist to alter the medication profile and the DAA without further

consultation. The patient-held medication template should fulfil this requirement (see

4.5.3.3). An updated medication template should be provided to the doctor/s and

patient/carer to acknowledge the pharmacist’s receipt of the communication and to

ensure that all parties have a current record. Written records and documentation of

medication changes should be maintained by the pharmacy to ensure the accuracy

and accountability of DAA services. Note that if the pharmacy retained the out-dated,

changed copy of the patient-held template after annotating that the change had been

made to the profile, this should be sufficient documentation that a change was

communicated and enacted.

4.5.3.5 Continuity of care between hospital and community for patient with

DAAs

Each community pharmacy, hospital, doctor and patient should be aware of their

role and develop procedures to meet their responsibilities to ensure continuity of

care between hospital and the community, for patients using DAAs.


When a community patient uses a DAA, the issue of ensuring continuity of care on

discharge from the hospital to the community is more complicated and requires greater

collaboration between the hospital and community health care services (general

practitioners, community pharmacy, community nurses and carers). Stakeholders all

have roles and responsibilities in ensuring continuity of care for DAA users. To improve

practice, the needs and perspectives of all stakeholders should be considered. A failure

to consider the policies and preferences of others involved in patient care can lead to

wastage and interruptions to the continuity of medication supply.

Figure 4.7 shows the steps and inputs required to facilitate the supply of medicines

packed in a DAA after discharge from hospital. When a patient is admitted to hospital,

irrespective of whether they have their medicines in original packs or DAAs, the

hospital needs reliable information on the patient’s medication regimen, and so this

aspect is beyond the scope of this best practice model. Because the use of a DAA

complicates discharge, on admission, a hospital pharmacy (or the ward staff where

hospital pharmacists are not available) need to know firstly that a patient uses a DAA

and who to liaise with (which GP, community pharmacy and, if applicable, community

nursing service). In addition, the hospital pharmacy needs sufficient notice from the

hospital medical staff to allow for the necessary liaison. To pack the DAA, the

community pharmacy needs timely, reliable and complete information on the patient’s

current drug regimen (the discharge medication regimen) and a valid prescription for

payment and/or a sufficient supply of medication. To maximise safety and to minimise

wastage while ensuring essential medications are available, the hospital pharmacy

should liaise with the community pharmacy about what medications to supply on

discharge. For example:

The patient may be confused if the hospital supplies a different brand of an item

than is usually packed so that no discharge supply is a safer option.

The patient may be prescribed a drug that is not routinely available in the

community (e.g. a trial drug) so that discharge supply of this item is necessary for

continuity of supply.

The continuity of medication supply for DAA users is adversely affected by weekend or

after-hours discharge where it is unlikely that a hospital pharmacist will be available to

coordinate the information flow between hospital and community and the community

pharmacy is unlikely to be able to provide a new DAA in a short-time frame.

Where a hospital pharmacist is not available to perform this liaison task (e.g. if outside

hospital pharmacy hours or there is no hospital pharmacy), the hospital needs an

alternative procedure to ensure the continuity of information and supply for DAA users

who are to be discharged from hospital.

When a patient is admitted to hospital, DAAs may facilitate information flow to the

hospital from the community provided that they are prepared according to the

recommendations contained in this best practice document. Specifically, DAAs need to

be labelled or accompanied by a current document with the following information:

patient’s name and address, pharmacy name and contact details, doctor’s name and

contact details, date packed, list of all packed medications and their administration

schedule and list of non-packed medications also taken by patient.


Community patient

using DAA

Patient/relative brings DAA and medication profile to hospital

Hospital compile medication history/profile:

• Requires reliable & current information

• Sourced from patient/ carer, GP & community pharmacy

• Includes ADRs, allergies, DAA use

Patient receives treatment including changes to current medication regimen

Remind discharge doctor that sufficient notice of discharge is required to organise DAA

Contact community pharmacy to inform them that patient has been admitted, to withhold packs pro tem & new pack will be required. Ascertain pharmacy preferences for discharge procedures

If community pharmacy is a new contact add details to hospital pharmacy DAA database including preferences for discharge medications or prescriptions, packing schedule & fax number Medical staff inform

hospital pharmacy that patient will be discharged

If DAA pack not available on disch-arge, dispense enough of needed medications until DAA is ready

Community pharmacy to pack DAA from the hospital discharge list

General Practitioner contacts community pharmacy to give the OK to dispense from the hospital discharge medication listCommunity pharmacy

delivers DAA pack (or patient/carer collects)

Patient receives DAA in time for next doses OR uses hospital supply until DAA arrives

Adm

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urin

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ospita

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y 24hrs

†prio

r to d

ischarg

eD

ischarg

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ost d

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e

Counsel patient at discharge, explaining what has been arranged regarding DAA provision

Fax/email* a copy of hospital prescription and discharge summary to community pharmacy

Check pharmacy database. Contact pharmacy to confirm what pres-criptions &/or medicine is required & when pack will be available

Prepare discharge summary & discharge prescriptions

Fax/email* a copy of hospital prescription & discharge summary to GP

Review medication history, chart & medication changes

Hospital Medical staff

Hospital pharmacist

Community pharmacist

Patient/relative/carer

General Practitioner

Key

† earlier if weekend discharge* If security addressed

Figure 4.7 Steps and input required to facilitate continuity of medication supply for

patients using DAAs.

The following tools and documents could be utilised to facilitate information flows

between the community and hospital:


Patient held template (see recommendation 4.5.3.3 and Appendix F).

Hospital pharmacy database on community pharmacy and DAA patients (see

Appendix F for details of the type of information to collect/record).

Patient agreement to consent for information sharing (see recommendation

4.5.3.2).

4.5.3.6 Quality control, quality assurance/ monitoring procedures for packing/

checking and communications flows

Community pharmacies need to introduce procedures for quality control and

quality assurance and monitoring in DAA provision. These activities should be

recorded. Good packing procedures should more closely resemble those of

good manufacturing practice that incorporate quality processes. Support for the

development of a new Pharmacy standard or guideline “Current Good Packing

Practices” would significantly contribute to improving current practice.

Patients should be educated on the appropriate storage of medications in a DAA.

In the absence of better evidence on the stability of medications repackage into

DAAs, pharmacists should use existing guidelines on specific dose forms

considered as unsuitable for packing.

More evidence on the suitability of medications for repackaging into DAAs is

required. Strategies include:

Collecting empirical evidence by reporting observed changes in medications

in packs to a central body.

Perform short term, in use stability studies on the most commonly packed

solid dosage forms.

Using regulatory/manufacturer approaches to make more stability

information available to pharmacies.

Written procedures should include quality control measures (to prevent errors by

inspection) and quality assurance procedures (to reduce errors by having quality

systems and allowing for problem identification and resolution). Appropriate

documentation should be kept to support these procedures. Record keeping and

monitoring may be time consuming but it can help improve the safety and efficiency of

DAA provision and also constitutes a form of legal risk-reduction. Currently, RCFs have

procedures for reporting errors and dealing with administration problems such as chart

audits, and staff training. Community Pharmacy needs to implement similar procedures

i.e. packing and checking audits, communication audits, staff training and procedures

for dealing with packing errors – i.e. checker informs the staff member who packed of

error, the situation/system is reviewed and remedial action is taken e.g. the staff

member instructed/ trained/coached on ways to prevent making this mistake again.

Patient education on the preferred storage and use of DAAs is especially important and

patients should be encouraged to report any visual or other problems which may be

related to the medication’s stability to their pharmacy.

There is a need for more information about the stability of repackaged medications to

support pharmacists’ decision making. There are several approaches:

The current guidelines of drug dose forms unsuitable for DAA packing (effervescent

tablets, dispersible tablets, buccal tablets, sublingual tablets and wafers) are


appropriate because these medications are administered in a different way to the

majority of medications in multi-dose packs (taken at one time). Further, these dose

forms are more fragile and may be damaged if packed in a multi-dose DAA

The PSA (as a producer of professional guidelines and a body representing

pharmacy overall) should act as a central body to receive and collate reports of

physicochemical stability reported by health professionals. The reporting

mechanism could be in a form similar to the Adverse Drug Reaction Advisory

Committee (ADRAC) reports (See section 10.2.2.1 for sample).

Stability studies could be performed. To standardise the studies, an easily

accessible (widely disseminated) guideline outlining the methodology for

conducting these short term, in-use stability studies should be developed in

consultation with the various regulatory authorities, manufacturers of DAAs and

experts in the field. Drug targets for studies should be prioritised based on the most

commonly packed medications and those where there is a higher theoretical risk of

instability.

The Therapeutics Goods Administration (TGA) should support the collection of

short-term stability data derived under defined conditions and without the protection

of the original packaging for all medicinal products. Alternatively, manufacturers

should be required to indicate those products for which there is an absolute

contradiction to short term storage in the absence of original packaging. Such

information would permit the assessment of the true significance of stability

problems should a medicinal product need to be removed from its original pack

several days prior to administration.

4.5.3.7 Efficiency in the pharmacies procedures

The cost of providing DAAs to community patients can be reduced by increasing the

efficiency of supply. There is a great deal of variation in the efficiency of DAA supply to

community patients and between pharmacies supplying RCFs and pharmacies

supplying community patients only. Inefficiencies can arise when rework is required

due to poor systems to manage medication change (as well as wastage of dispensed

medications) (see 4.5.3.4), and in the internal practices in the pharmacy. There are a

number of strategies and procedures utilised by some community pharmacies that

minimise the time required to manage the supply of medications in DAA without

compromising the quality of the service. These strategies relate to prescription

management, packing procedures and appropriate use of human resources.

4.5.3.7.1 Prescription management

During the packing session, the pharmacy should record the quantity of

dispensed medication and the availability of repeat prescriptions to ensure

efficiency in managing the continuity of supply of medication for patients using

DAAs.

The pharmacy should have a system to provide written prescription requests

and reminders to doctors and/or patients to ensure that prescriptions are

available for all PBS medication to be packed in a DAA.

Prescription requests and reminders can improve the relationship between

stakeholders and increase the efficiency of communication between doctors and

community pharmacy, IF they are done well. Doctors have commented that reminders

need to be timely and accurate, that it should be easy to identify to which patient/s the


communication relates (i.e. include patients names, address and Medicare number).

This communication should also allow for doctors to monitor compliance/medication

use and presents an opportunity for information sharing and accuracy checking. A

template of the type of information that could be useful in a prescription reminder is

included in Appendix F.

Doctors and patients need to recognise that this is a service provided by pharmacy that

is labour intensive and costly. Pharmacist need to inform other stakeholders that a

current prescription is a legal requirement associated with the supply of prescription-

only medicines and to receive subsidised medicines under the PBS.

In devising their systems, pharmacies need to recognise doctors’ practice patterns e.g.:

Requests for new prescriptions for a patient should be sent in batches even if some

prescriptions are needed some time in the future rather than one at a time. This

saves the GP having to view the chart for each separate request.

Dispensing software may alert the GP that a prescription is “too early”, so that the

written prescription request should include a “date prescription needed by” to allow

the GP to check medication usage. The GP needs to be aware of the timing of the

packing cycle followed by the pharmacy as an explanation of why a request is

apparently “early” (see 4.5.3.2).

For pharmacy, there are opportunities to provide this service more efficiently by

optimising communication channels (i.e. fax or email) and utilising existing

dispensing/packing software reports.

4.5.3.7.2 Packing procedures


the number of packs that the pharmacy produces, a variety of packing methods and

procedures are utilised by community pharmacies. Some of the strategies that reduced

the amount of time spent packing a DAA included:

Packing then checking the DAA as separate procedures performed by different

staff members,

Having a dedicated packing space (where interruptions can be minimised) and

experienced staff, where possible.

Conducting staff training – so that all staff packing DAAs know what to do, what

order to do it in, and that this procedure is followed consistently by staff preparing

DAAs (an area to address in any quality assurance program, see 4.5.3.6).

4.5.3.7.3 Roles for pharmacists and non-pharmacist staff

Efficiency in DAA provision can be enhanced by good human resource management.

Specific tasks in the provision of DAA services should be performed by a pharmacist.

These tasks are those associated with the pharmacist’s professional responsibility i.e.

prepare packing profile, checking the dispensing of original packs, changing and

reviewing the packing profile, and checking the accuracy of the pack after packing.

Dispensary assistants and other non-pharmacist staff were found to be more efficient

at packing (take less time to pack and are a less expensive resource), possibly

because they can perform this task with fewer distractions. Provided that non-

pharmacist staff receive adequate training and supervision, the quality and accuracy of

DAA services is not compromised (Ientile et al. 2004).


4.5.3.8 Negotiating a mutually acceptable payment for DAA services

Community pharmacy needs to negotiate a mutually acceptable price for

providing DAA services and to provide this service only to patients who will

benefit from it.

The provision of DAAs is labour intensive and costly to pharmacy however the benefits

of this service have been recognised by doctors, patients, relatives and carers. The

majority of patients using DAAs have indicated that they are willing to pay for this

service and the amount that they are willing to pay is greater than the current amount

they pay. In addition, patients who paid for DAAs were more likely to appreciate this

service. However, some consideration should be given to the patients who are unable

to afford this service but depend on it for their medication management. Pharmacies

need to negotiate a realistic price for this service and to ensure that a patient has a real

need (see 4.5.3.1) to ensure that this service is worthwhile. Providing DAA services to

patients who are unwilling to pay or have no real need for this service constitutes a

waste of pharmacy staff time and efforts which could have a greater impact on

outcomes for the community and be better rewarded if re-directed to other services.

4.5.3.9 Ensuring adequate monitoring and care of DAA patients.

Community patients using DAAs should be monitored by their general

practitioner and community pharmacy to ensure that:

Any problems patients might have when starting to use a DAA are detected

and addressed.

Patients continue to manage their medications when some or all are in a

DAA.

Community patients who start using a DAA may have difficulty using the device

correctly. While educating patients about how to use the device (4.5.3.2) will minimise

this risk, close monitoring by the patient’s GP and community pharmacy in the initial

phase of DAA use should be carried out to identify and solve ‘teething’ problems.

As DAA use continues, systems are required to monitor that a patient continues to be

able to manage their medications. Evidence (Ientile et al. 2004) indicates that a small

proportion of DAA patients are not seeing their GPs regularly as the pharmacy is

managing their prescriptions and the GP is writing prescriptions without the patient

attending a consultation. While these patients may have more interaction with the

community pharmacy than other DAA users, this interaction is less likely to involve

communication about medication and counselling. DAA users in the community are a

high needs group that require monitoring to ensure they are coping with the medication

management. This monitoring should involve:

Seeing the GP for prescription renewal and consultation at least once per 3

months.

Seeing the pharmacist for medication information as needed (when medication

changes or problems are observed) or at least once per 3 months.

Returning DAA packs to prevent hoarding of unused medications and to allow for

compliance monitoring.

Regular re-assessment each six months to assess medication management ability,

medication knowledge and concordance in medication regimen records (see

4.5.3.1 and 4.5.3.2).


4.6 BEST PRACTICE MODEL FOR THE PROVISION AND USE

OF DOSE ADMINISTRATION AIDS IN RESIDENTIAL CARE

FACILITIES

4.6.1 INTRODUCTION

Dose Administration Aids are widely used in Australia as a tool to assist with

medication management in a variety of settings. Approximately 40% of community

pharmacies in Australia pack and supply DAAs to meet the needs of residential care

facilities (RCFs). DAAs are used in the majority of RCFs in Australia to assist facility

staff to provide safe and efficient administration of residents’ medication.

The provision and use of DAAs to RCFs is a complex process involving a number of

steps and the input and collaboration of different parties (the pharmacy, the RCF,

doctors, and the patients). Figure 4.8 shows the steps involved in DAA provision and

use. From the pharmacy perspective, dispensing, packing and checking medications

for supply in DAAs, and likely support services such as managing the patients’

prescriptions, account keeping, and delivery, take significantly more time than providing

the same medications in original packs.

Best practice is defined as a technique or methodology that, through experience and

research, has been proven to reliably lead to a desired result. The QMC group (funded

by the Australian Government via the 3rd Community Pharmacy Agreement Research

and Development Grants managed by the Pharmacy Guild of Australia) has conducted

observational research and sought extensive feedback from a range of key

stakeholders from the medical, nursing and pharmacy professions, as well as industry,

consumer and government sectors to identify the factors that are contributing to unsafe

practices, reduced effectiveness and inefficiencies in the provision and use of DAAs.

Key barriers to safe, efficient and effective provision and use of DAAs in RCFs include:

Poor communication and the breakdown of information flows between parties

A lack of monitoring and accountability for the quality of the DAA services,

A lack of mutual awareness among facilities, pharmacies and doctors about the,

existing profession-specific regulations, experiences and perceptions, practices

and costs involved in the provision and use of DAAs

A shift in the workload, cost and professional responsibility associated with

medication management from the facility to the community pharmacy.

4.6.2 PREAMBLE

4.6.2.1 Purpose and scope of this best practice model

There are currently a range of standards and guidelines relating to the supply of

medicines to residents in RCFs and to the provision of dose administration aids by

pharmacy. These include: Australian Pharmaceutical Advisory Council (APAC, 2002)

medication management guidelines), various Nursing Guidelines, Professional Practice

Standards (Pharmaceutical Society of Australia, 2002), Dose Administration Guidelines

(Pharmaceutical Society of Australia, 1999), Quality Care Pharmacy Program (QCPP)

professional practice guidelines and DAA specific manufacturers/ suppliers guidelines

(i.e. Webstercare, Douglas, Persocare, AHPS, MPS). However there is no existing

resource that accounts for the multi-disciplinary involvement in the provision and use of


DAAs and includes specific processes or procedures for optimising the provision and

use of dose administration aids for RCFs.

12. Medication receipt

13a. RCF stores medications (packed & non-packed)

13b. Self-medicator residents store medications

13c. Counsel self-medicators on medications (including CMI, MIC)

14. Administer medication (packed & non-packed) 15a. Self-medicators take medications (checked by RCF)

15. Record administered medications on RCF chart

16. Return unused medication to pharmacy• Pharmacy records & monitors missed doses,

taking action as needed; deals with medications

1a. GP writes medication order• On medication chart in RCF as order to administer















No

n-p

ac

ke

d m

ed

icati

on

s

Potential RCF role

Doctor Doctor & RCF Pharmacy support staff e.g. Dispensary technicianPharmacist RCF

RCF & pharmacyKey

Patient Potential RCF role

Doctor Doctor & RCF Pharmacy support staff e.g. Dispensary technicianPharmacist RCF

RCF & pharmacyKey

Patient

Figure 4.8 Steps and input required in the provision of DAAs by community pharmacy

to RCFs


While profession-specific guidelines are needed, there is also a need for an over-

arching integrated model. This proposed model takes into account existing professional

standards and relevant legislation, and makes recommendations to address the

limitations in the provision and use DAAs, to optimise the effectiveness of this

intervention and to facilitate interaction between health professionals. Despite this

teamwork approach, many of these recommendations may appear pharmacy centric.

This is because much of the resource and cost burden arising from the provision of

DAAs is borne by community pharmacy. However, optimal provision and use of DAAs

cannot occur without multi-disciplinary involvement and the recommendations

emphasise the roles and responsibilities of the different stakeholders. See Figure 4.8,

where the key indicates who generally performs the various steps.

The scope of these recommendations is restricted to issues relating specifically to DAA

use where it is different from medication management using original packs. The key

issues in providing medications in a DAA rather than original packs are:

(1) The pharmacist needs to know the resident’s complete and current drug regimen

rather than providing only a single new or changed medicine.

(2) The pharmacy instead of the facility takes responsibility for managing prescriptions

and ensuring the continuity of medication supply.

(3) The extra steps involved in producing DAAs and the interdependence of the

stakeholders increases the potential for errors at any point in the process and by

anyone involved.

The purpose of this document is not to dictate or set standards in medication

management and the use of dose administration aids. Instead, the goal is to provide a

range of strategies and tools to overcome the barriers to safe, effective and efficient

DAA provision. The following recommendations are interrelated and reflect the need for

further emphasis to be given to the process of tendering and contracting DAA services

as well as monitoring the quality of DAA services. Figure 4.9, shows the issues for

RCFs and pharmacies to consider in tendering/implementing for a DAA service and a

potential means of introducing quality assurance through existing accreditation

programs.

This best practice model is based on the current situation whereby no subsidies are

available for the provision of DAAs to RCFs. Were public funding to become available

in the future for DAA provision to RCFs, the elements of the model (specifically 1.3.2

and recommendation 1.3.5) could be incorporated as part of a system of checks and

balances that would be necessary to ensure accountability with respect to the quality

and quantity of DAA services offered to RCF residents. The model concentrates on the

nature of information transfers and processes rather than a specific mode (e.g. fax,

encrypted email, etc). Future IT developments (e.g. communication channels, software,

encryption and public key technologies) may well be enablers to further increase safety

and efficiency.


RCF• Assess pharmacy as provider of a

safe, effective & efficient DAA service*

• Address other relationships (e.g. GPs) to support DAA service

• What internal RCF processes are needed to integrate with process

• Any special needs• Have realistic expectation of fee for

service

Community Pharmacy• Consider how resources, & costs

of providing service affect ability to provide DAA service

• Define core DAA service components

• What RCF responsibilities & internal RCF processes needed

• Negotiate extras including support services, interactions with other (e.g.GPs, residents)

RCF-Pharmacy DAA Service Agreement should include:• Responsibilities for maintaining current pharmacy profile• How the service will work including: pack type, packing cycle,

responsiveness, exception procedures• Procedures for medication changes & prescription management• Other services the pharmacy will provide• Costs and account issues• Agree on key performance indicators (KPI) for pharmacy & RCF,

& their measurement

Tendering process

Contracting

Monitoring, QA of ongoing operation

External assessment via Aged Care Assessors check of key processes for links with pharmacy

RCF audit program of:• Internal processes associated

with DAAs• DAA Service KPI• Feedback to pharmacy

Pharmacy QC & QA program:• Internal processes associated

with DAAs• DAA Service KPI• Feedback to RCF

External assessment via QCPP assessor check of key processes for links with RCF

External check of service quality

*What to look for in a DAA service:

• Has pharmacy has been assessed externally for quality (i.e. QCPP)?

• Have own internal QC & QA programs?

• Are RCF needs (i.e.pack type, hours of service, problem resolution) met?

• Does service integrate RCF processes & internal procedures or special needs (e.g.use of non-RNs in medication rounds or support with chart production etc)

Figure 4.9 Implementation model for the provision of a DAA service to an RCF by a

community pharmacy

4.6.3 RECOMMENDATIONS

4.6.3.1 Residential care facilities tendering for pharmacy services

Residential care facilities need to evaluate a DAA supplier in terms of ability to

deliver a safe, effective and efficient DAA service.

Community pharmacy needs to negotiate a mutually acceptable price for

providing DAA services to RCFs.

Facilities and residents/carers and families need to address the issue of who

should pay for DAA services.

The provision of DAAs to RCFs is cost-effective in that there is a reduction in total

costs to facilities when DAAs are used compared to original packs (Ientile et al. 2004).


The proportion of cost borne by the pharmacy, however, is much greater as the

provision of DAAs is labour intensive and costly to pharmacy. Community pharmacy

services and DAAs are highly relied upon in RCFs, facilitating in the minimisation of

medication administration costs, staff costs and meeting accreditation standards.

However, the provision of DAA services is undervalued by facilities with just over half of

the pharmacies providing this service to RCFs being paid. The low rate of payment is in

spite of the fact that RCFs tend to report a high level of satisfaction with DAA services

and community pharmacy in general. This problem is compounded by pharmacies

discounting their services in order to win and/or retain RCF contracts. Providing DAA

services to facilities that are unwilling to pay for this service constitutes a waste of

pharmacy staff time and efforts which could have a greater impact on outcomes for the

community and be better rewarded if re-directed to other services.

The quality of DAA services impacts on savings to facility in terms of increased

efficiency in medication management, and the satisfaction of staff and doctors. Not all

DAA services are the same. Facilities need to consider whether the pharmacy is able

to provide a quality service. This involves considering whether the pharmacy has been

assessed externally for quality (i.e. QCPP), whether the pharmacy has their own

internal QC & QA programs, whether the pharmacy can offer a service that will meet

the needs of the RCF (i.e. type of pack, hours of service, problem resolution) and be

able to integrate with RCF processes and internal procedures (i.e. consider any special

needs such as use of staff other than RNs for administration, and additional support

required with charting etc). RCFs also need to have a realistic expectation of fees for

services provided.

Community Pharmacy need to consider what resources are required to provide this

service, what it will cost to provide this service and the impact it will have on business

profitability. For example, providing DAA services to 120 residents at two facilities

required approximately 22 hours of staff time per week (Ientile et al. 2004).

Facilities and residents/carers and families need to address the issue of who should

pay for DAA services. Residents have a right to choose which pharmacy to use

however facilities tend to discourage this practice by stipulating that the resident must

have medication packed into a certain type of DAA pack. Given this stipulation and that

the use of DAAs in an RCF is primarily to reduce administration costs for the facility

rather than to benefit the resident (i.e. administration from original packs by a RN would

not negatively impact on a resident) it would be reasonable to expect facilities to fund

this service. Potentially some of this cost could be off-set through resident contribution

and/or government funding.

4.6.3.2 Contracts specifying obligations and promoting mutual awareness

Community pharmacy should negotiate a written agreement between

themselves, the residential care facility and/or the resident and the residents’

doctor/s prior to beginning to provide a DAA service.

The provision of DAAs constitutes the primary interaction between community

pharmacy and the facility in terms of resources (pharmacy time and cost), however the

available templates for contracts between pharmacy and RCFs tends to be limited to

only the cost of the DAA service and additional pharmacy obligations, and not the

obligations of other parties. A detailed agreement between the pharmacy and facility


and the facility and the residents’ doctor/s provides a means of specifying obligations

and promoting mutual awareness.

The agreement should address:

That it is important for the pharmacy to know the correct, current medication

regimen so that a DAA containing the correct medications can be provided on time,

i.e. the importance of pharmacy profile maintenance.

How the service will work:

What type of pack will be provided (brand, period, how many packs needed,

how many weeks’ worth will be provided at once).

What medication will be packed (including whether some or all non-prescription

items such as complementary or vitamin supplements are to be packed) and

what is the optimal schedule (see 1.3.3),

How far in advance of distribution will the DAA be packed (and in some cases,

which day of the week) (i.e. what is the packing cycle?)

Where will original pack medication and prescriptions be stored?

What will the delivery procedures and schedule be?


charge for the service?

What will happen if a medicine in a pack needs to be changed before the

current pack is finished.


charge for the service.

Procedures for start-up and preparing the first pack e.g. will medicines already

dispensed and brought in by the resident be packed?

Privacy: Resident consents to information sharing between the facility staff, doctor/s

and pharmacy (and hospital if required)

Medication changes:

Whose responsibility will it be to inform the pharmacy of medication changes

(facility or doctor)?

What format will be acceptable, (i.e. written instructions only- amended to full

regimen indicating ceased/changed and new drugs, copy of full chart)?

How long will ceased medication (already dispensed to resident) be stored at

the pharmacy?

What constitutes timely notification of changes so that rework is minimised.

The circumstances when a medication change can be delayed until the next

pack or when a change needs to be made more quickly.

Prescription management:

The understanding that a valid prescription is required before medicines can be

supplied in a pack, and that, depending on the packing cycle, the date a

prescription is needed may be earlier than anticipated with original packs.

Will the pharmacy remind the facility to request the doctor visit the resident to

obtain a new prescription?

Will the pharmacy generate prescription reminder notices for the doctor/s?

GP practices related to prescriptions and repeat reminders e.g. under what

circumstances is the GP willing to write a prescription without seeing a resident.

Who is responsible for following up that the prescriptions are at the pharmacy in

time for packing (facility or pharmacy or doctor or other).

What will happen if resident has no new prescription? (e.g. medication not

packed in the DAA).


Procedure for use and what to do in exceptional situations e.g:

When things go wrong (i.e. what to do if facility staff/residents drop medication

or open the wrong blister).

What to do if a resident has a prescription filled at another pharmacy (not the

one that provides DAAs) e.g. hospital pharmacy

When a patient is away from the facility e.g. on holidays with family or in

hospital, where there might be a need for more packs than usual or where there

is an interruption in the use of packed medications (e.g. hospital admission or

discharge).

How to ensure optimal use of the DAA:

How the pharmacy will provide counselling and medication information (e.g.

CMIs) to the residents and facility staff.

Facility agrees to return unused medication in the DAA to the pharmacy.

Pharmacist reviews returned DAAs to assess compliance and problems with

use.

Pharmacist counsels staff/resident if problems occur.

Other services the pharmacy will provide (i.e. participation on medication

management committees, assistance with accreditation, medication reviews).

The process of completing an agreement of this nature ensures that the facility and/or

resident receives adequate information about what is involved in receiving a DAA

service and training in how to use the DAA and what do if problems occur. In addition,

this agreement allows the pharmacy, doctor and facility to negotiate who will be

responsible for undertaking the necessary activities to ensure the accuracy of the DAA,

the continuity of medication supply and the optimal outcome for the resident. The

agreement also allows the GP’s expectations and practice patterns, policies and

procedures to be recognised.

This agreement may also provide the pharmacy with some form of risk-reduction in

relation to potential future claims arising from situations where a patient/relative makes

a claim against the pharmacy.

4.6.3.3 Communicating medication changes

The pharmacy and the facility should maintain a written record of all

communication regarding medication changes for residents receiving DAA

services.

The accuracy of the DAA pack is largely dependent on the currency of the pharmacy

profile. Maintaining a current medication profile requires full and detailed

communication about the medication regimen and any changes. In the RCF setting, the

responsibility for informing the pharmacy of medication changes generally falls to the

RCF staff. The facility or the doctor presenting the pharmacy with a new prescription

does not constitute adequate communication as the pharmacist may be uncertain of

whether this new medication is in addition to the current regimen or to replace another

medication.

The pharmacy should request that all medication changes be communicated in writing

(whether by fax, email, letter etc). The communication should reflect changes in the

context of the patients’ full regimen and should be unambiguous and detailed enough

to allow the pharmacist to alter the medication profile and the DAA profile without


further consultation. An updated copy of the residents chart should fulfil this

requirement. Written records and documentation of medication changes should be

maintained by the pharmacy and the facility to ensure the accuracy and accountability

of DAA services.

4.6.3.4 Continuity of care between hospital and RCFs for patient with DAAs

Each community pharmacy, RCF, hospital and doctor treating RCF residents

should be aware of their role and develop procedures to meet their

responsibilities to ensure continuity of care between hospital and RCFs.

When a resident of and RCF uses a DAA, the issue of ensuring continuity of care on

discharge from the hospital back to the RCF is more complicated and requires greater

collaboration between the hospital and community health care services (RCF, general

practitioners and community pharmacy). Stakeholders all have roles and

responsibilities in ensuring continuity of care for DAA users (see Figure 4.10). To

improve practice, the needs and perspectives of all stakeholders should be considered.

A failure to consider the policies and preferences of others involved in patient care can

lead to wastage and interruptions to the continuity of medication supply.

Figure 4.10 shows the steps and inputs required to facilitate the supply of medicines

packed in a DAA after discharge from hospital. When a patient is admitted to hospital

from a RCF, irrespective of whether they have their medicines in original packs or

DAAs, the hospital needs reliable information on the patient’s medication regimen, and

this is achieved through the RCF faxing a complete (including prn medication) and

current copy of the residents chart. Because the use of a DAA complicates discharge,

on admission, a hospital pharmacy (or the ward staff where hospital pharmacists are

not available) need to know firstly that a patient is a resident of a facility that uses

DAAs and who to liaise with (which facility, GP and community pharmacy). In addition,

the hospital pharmacy needs sufficient notice from the hospital medical staff to allow for

the necessary liaison. To pack the DAA, the community pharmacy needs timely,

reliable and complete information on the patient’s current drug regimen (the discharge

medication regimen) and a valid prescription for payment and/or a sufficient supply of

medication. To maximise safety and to minimise wastage while ensuring essential

medications are available, the hospital pharmacy should liaise with the community

pharmacy about what medications to supply on discharge. For example:

The facility staff/resident may be confused if the hospital supplies a different brand

of an item than is usually packed so that no discharge supply may be safer option.

The patient may be prescribed a drug that is not routinely available in the

community (e.g. a trial drug) so that discharge supply of this item is necessary for

continuity of supply.

On discharge the RCF staff need a legally valid and reliable order to administer new

medications. There can be delays in getting this order because of the timing of

discharge and poor information flow to GPs.


RCFpatientusing DAA

RCF to fax patient chart & send DAA +other medication to hospital

Hospital compile medication history/profile:

• Requires reliable & current information

• Sourced from RCF, GP & community pharmacy

• Includes ADRs, allergies, DAA use

Patient receives treatment including changes to current medication regimen

Remind discharge doctor that sufficient notice of discharge is required to organise DAA

Contact community pharmacy to inform them that patient has been admitted, to withhold packs pro tem & new pack will be required. Ascertain pharmacy preferences for discharge procedures

If community pharmacy is a new contact add details to hospital pharmacy DAA database including preferences for discharge medications or prescriptions, packing schedule & fax number Medical staff inform

hospital pharmacy that patient will be discharged

Community pharmacy to pack DAA from the hospital discharge list

Community pharmacy delivers DAA pack

RCF receives DAA in time for next doses OR uses hospital supply until DAA arrives

Adm

ission

Durin

g h

osp

ital s

tay 2

4hrs†

prio

r to d

ischarg

eD

ischarg

eP

ost d

ischarg

e

Fax/email* a copy of hospital prescription and discharge summary to community pharmacy

Check pharmacy database. Contact pharmacy to confirm what pres-criptions &/or medicine is required & when pack will be available

Prepare discharge summary & discharge prescriptions

Fax/email* a copy of hospital prescription & discharge summary to GP

Review medication history, chart & medication changes

Hospital Medical staff

Hospital pharmacist

Community pharmacist

Patient

General Practitioner

Key

† earlier if weekend discharge* If security addressed

Send discharge summary with patient to RCF + non-packed medication if patient’s own used/ provided

RCF

RCF staff administer from discharge summary approved by GP if delays in altering patient chart

If DAA pack not available on discharge, dispense enough of needed medications until DAA ready

GP visits RCF to write medications on chart OR completes telephone order confirmation form

Counsel patient at discharge, as appropriate, explain DAA provision arrangements

General Practitioner contacts community pharmacy to give the OK to dispense from the hospital discharge medication list

Figure 4.10 Roles and responsibilities in managing continuity of supply for patients

using DAAs admitted to hospital from an RCF.

The continuity of medication supply for DAA users is adversely affected by weekend or

after-hours discharge where it is unlikely that a hospital pharmacist will be available to


coordinate the information flow between hospital and community and the community

pharmacy is unlikely to be able to provide a new DAA in a short-time frame.

Where a hospital pharmacist is not available to perform this liaison task (e.g. if outside

hospital pharmacy hours or there is no hospital pharmacy), the hospital needs an

alternative procedure to ensure the continuity of information and supply for DAA users

who are to be discharged from hospital.

When a patient is admitted to hospital from an RCF, the collection of medication history

is facilitated by the RCF faxing the patients’ medication chart in full to the hospital.

Specific information that is useful to the hospital and may be contained on a covering

letter and includes: Name of the facility and contact person, type of DAA used,

pharmacy name and contact details, doctors’ name and contact details, date packed,

list of all packed medications and schedule and list of non-packed medications

(including as needed or pro re nata drugs “PRNs”) also taken by patient.

The following tools and documents could be utilised to facilitate information flows

between the community pharmacy, RCF and hospital:

Residents chart

Hospital pharmacy database on community pharmacy supplying RCFs and

DAA patient (see Appendix F for type of information to collect/record)

Patient agreement to consent for information sharing (see 4.6.3.2)

4.6.3.5 Quality control, quality assurance/ monitoring procedures for packing/

checking and communications flows

Community pharmacies need to introduce procedures for quality control and

quality assurance and monitoring in DAA provision. These activities should be

recorded. Good packing procedures should more closely resemble those of

good manufacturing practice that incorporate quality processes. Support for the

development of a new Pharmacy standard or guideline “Current Good Packing

Practices” would significantly contribute to improving current practice.

In the absence of better evidence on the stability of medications repackage into

DAAs, pharmacists should use existing guidelines on specific dose forms

considered as unsuitable for packing.

More evidence on the suitability of medications for repackaging into DAAs is

required. Strategies include:

Collecting empirical evidence by reporting observed changes in medications

in packs to a central body.

Perform short term, in use stability studies on the most commonly packed

solid dosage forms.

Using regulatory/manufacturer approaches to make more stability

information available to pharmacies.

Written procedures should include quality control measures (to prevent errors by

inspection) and quality assurance procedures (to reduce errors by having quality

systems and allowing for problem identification and resolution). Appropriate

documentation should be kept to support these procedures. Record keeping and

monitoring may be time consuming but it can help improve the safety and efficiency of


DAA provision and also constitutes a form of legal risk-reduction. Currently, RCFs have

procedures for reporting errors and dealing with administration problems such as chart

audits, and staff training. Community Pharmacy needs to implement similar procedures

i.e. packing and checking audits, communication audits, staff training and procedures

for dealing with packing errors – i.e. checker informs the staff member who packed of

error, the situation/system is reviewed and remedial action is taken e.g. the staff

member instructed/ trained/coached on ways to prevent making this mistake again.

The pharmacy need to implement procedures and document the following activities:

Dispensing medicines for residents

Packing medicines in DAAs for residents

Checking packed medicines

Provision of medication information and counselling to residents and staff

Receipt of communication about medication changes, and

Disposal of dispensed medication

RCF staff education on the preferred storage and use of DAAs is especially important

and facility staff should be encouraged to report any visual or other problems which

may be related to the medication’s stability to their pharmacy.

There is a need for more information about the stability of repackaged medications to

support pharmacists’ decision making. There are several approaches:

The current guidelines of drug dose forms unsuitable for DAA packing (effervescent

tablets, dispersible tablets, buccal tablets, sublingual tablets and wafers) are

appropriate because these medications are administered in a different way to the

majority of medications in multi-dose packs (taken at one time). Further, these dose

forms are more fragile and may be damaged if packed in a multi-dose DAA

The PSA (as a producer of professional guidelines and a body representing

pharmacy overall) should act as a central body to receive and collate reports of

physicochemical stability reported by health professionals. The reporting

mechanism could be in a form similar to the Adverse Drug Reaction Advisory

Committee (ADRAC) reports (See 10.2.2.1 for sample).

Stability studies could be performed. To standardise the studies, an easily

accessible (widely disseminated) guideline outlining the methodology for

conducting these short term, in-use stability studies should be developed in

consultation with the various regulatory authorities, manufacturers of DAAs and

experts in the field. Drug targets for studies should be prioritised based on the most

commonly packed medications and those where there is a higher theoretical risk of

instability.

The Therapeutics Goods Administration (TGA) should support the collection of

short-term stability data derived under defined conditions and without the protection

of the original packaging for all medicinal products. Alternatively, manufacturers

should be required to indicate those products for which there is an absolute

contradiction to short term storage in the absence of original packaging. Such

information would permit the assessment of the true significance of stability

problems should a medicinal product need to be removed from its original pack



4.6.3.6 Review of charting systems

Regular (6-monthly) checks of concordance between the GPs records, the

residents’ charts and the pharmacy packing profile should be conducted.

Regular reviews of the residents’ medication charts against GP records and the

pharmacy profile will allow the pharmacy to confirm the accuracy and currency of the

profile and also eliminate any ambiguous orders. This quality assurance activity is key

to ensuring resident safety and will allow the pharmacy and facility to measure and

improve on the quality of information flow between parties. In addition, this activity may

offer the pharmacy a means of legal risk-reduction in the event of a claim against the

pharmacy.

4.6.3.7 Efficiency in the pharmacies procedures

The cost of providing DAAs to residents can be reduced by increasing the efficiency of

supply. There is a great deal of variation in the efficiency of DAA supply to RCFs and

there are a number of strategies and procedures utilised by some community

pharmacies that minimise the time required to manage the supply of medications to

RCFs in DAA without compromising the quality of the service. These strategies relate

to prescription management, packing procedures and appropriate use of human

resources.

4.6.3.7.1 Prescription management

During the packing session, the pharmacy should record the quantity of

dispensed medication and the availability of repeat prescriptions to ensure

efficiency in managing the continuity of supply of medication for residents using

DAAs.

The pharmacy should provide written prescription requests and reminders to

doctors and/or facility to ensure that prescriptions are available for all PBS

medication to be packed in a DAA.

Prescription requests and reminders can improve the relationship between

stakeholders and increase the efficiency of communication between doctors and

community pharmacy, IF they are done well. Doctors have commented that reminders

need to be timely and accurate, that it should be easy to identify which patient/s the

communication relates to (i.e. include patients names, address and Medicare number).

This communication should also allow for doctors to monitor compliance/ use and

presents an opportunity for information sharing and accuracy checking. A template of

the type of information that could be useful in a prescription reminder is included in

Appendix F.

Doctors and facilities need to recognise that this is a service provided by pharmacy that

is labour intensive and costly. Pharmacist need to inform stakeholders that a current

prescription is a legal requirement associated with the supply of PBS medicines.

In devising their systems, pharmacies need to recognise doctors’ practice patterns e.g.:

Requests for new prescriptions for a patient should be sent in batches even if some

prescriptions are needed some time in the future rather than one at a time. This

saves the GP having to view the chart for each separate request.


Dispensing software may alert the GP that a prescription is “too early”, so that the

written prescription request should include a “date prescription needed by” to allow

the GP to check medication usage. The GP needs to be aware of the timing of the

packing cycle followed by the pharmacy as an explanation of why a request is

apparently “early” (see 4.6.3.2).

For pharmacy, there are opportunities to provide this service more efficiently by

optimising communication channels (i.e. fax or email) and utilising existing

dispensing/packing software reports.

4.6.3.7.2 Packing procedures


the number of packs that the pharmacy produces, a variety of packing methods and

procedures are utilised by community pharmacy. Some of the strategies that reduced

the amount of time spent packing a DAA included:

Packing then checking the DAA as separate procedures preformed by different

staff members.

Having a dedicated packing space and experienced staff where possible, and

Staff training – knowing what to do, what order to do it in, and using procedures

consistent with other staff.

4.6.3.7.3 Roles for pharmacists and non-pharmacist staff

Efficiency in DAA provision can be enhanced by good human resource management.

Specific tasks in the provision of DAA services should be performed by a pharmacist.

These tasks include: prepare packing profile and making changes to the profile and

checking the accuracy of the pack after packing. Dispensary assistants and other non-

pharmacist staff were found to be more efficient at packing (take less time to pack and

are a less expensive resource), possibly because they can perform this task with fewer

distractions. Provided that non-pharmacist pharmacy staff receive adequate training

and supervision, the quality and accuracy of DAA services is not compromised (Ientile

et al. 2004).

4.6.3.8 Facility receipt of packed medication

Where medicine is self-administered by a resident or administered to a resident

by EN or PCA, an RN at the facility should perform a check of the DAA.

While the pharmacy must at all times endeavour to provide error free DAAs, the

possibility of human error is unavoidable. If a packing error was to occur and the DAA

is administered by a RN who checks the pack against the chart it is likely that the error

will be detected prior to transferring medication to the patient. This additional check is

not available when medication is administered by an EN or PCA/carer (who is not

qualified in medication administration) or even by a self-medicating resident. As an

extra step to ensure the accuracy of medication administered to residents an RN at the

facility should check DAAs against charts on receipt of the DAAs, prior to

administration by EN/PCA or self-medicating residents. This extra check allows the

facility to monitor the quality of DAA services provided by the pharmacy and the results

of this monitoring should be fed back to the pharmacy to allow for continuous

improvement.


5. EVALUATING PRELIMINARY BEST PRACTICE

MODELS

This section describes the evaluation of the preliminary best practice models.

5.1 METHODS

Evaluation of the newly developed best practice guidelines was conducted through use

of questionnaires sent to stakeholders in the DAA provision process. These

questionnaires guided responses and provided some structure to the review. For all but

the community patients, the best practice documents and any relevant tools were sent

by mail or by email, together with a covering letter and a questionnaire tailored to the

respondent to guide the feedback sought (see Appendix G for feedback questions).

The questions were tailored to direct the attention of the respondent to sections of the

model most relevant to them. To maximise GP response, GPs were asked to comment

on only one of the models, that which was most relevant to their work experience, and

this model and feedback questionnaire was sent to the GP. The members of the expert

panel were asked to comment on all sections.

Community patients were provided with a summary of the community model that

outlined the details of the sections directly affecting community patients (e.g. service

agreement, patient held template and initial and ongoing assessment). A questionnaire

was also sent to guide feedback (see Appendix G). Residents of RCFs were

interviewed face-to-face. In the interview, residents were asked about their experiences

moving into residential care, whether they would be willing to sign an agreement

formalizing the provision of DAA services and their attitudes/experiences with

Consumer Medicines Information (CMIs), areas of the draft best practice model that

would have more direct impact on residents and their families (see Appendix G).

Permission to tape the interview was sought at the beginning of the interview. Three

tools were used as prompts in the interview: (1) Pictures of various types of DAAs; (2)

A large print summary of the details of what would be specified in an agreement

discussed at the time a person moves into an aged care facility; and (3) A sample copy

of a CMI.

Where possible, responses were entered into an Excel spreadsheet. Open-ended

questions were coded according to their predominant themes using a modified

conceptual analysis approach. Frequency analysis of categorical responses and the

concepts coded from open-ended responses was done. Given that the number of

missing responses varied from question to question, the denominator of actual

respondents is presented rather than a percentage. Responses to the expert panel

questionnaire (including those from whom additional input was sought) were

aggregated and/or expressed in a way that preserved the anonymity of respondents.

5.1.1 SELECTION OF STAKEHOLDERS TO REVIEW MODELS

The selection of stakeholders to review the models was in line with the consultation in

the earlier phase and used key informant and snowball sampling methods. Participants

in the community pharmacist, hospital pharmacist and RCF management focus groups

were contacted and asked whether they would be willing to provide feedback on the

models. Members of the expert panel were also approached. Nominal remuneration


was offered to respondents for completion of the survey:

Expert panel members and GPs $50.

RCF DONS, Hospital and Community Pharmacists $35.

Community patients, a $20 Coles Myer gift card.

Residents were also interviewed from the two south east Queensland RCFs who had

also taken part in staff focus groups. No remuneration was offered for this input.

Additional input was sought from:

Queensland Divisions of General Practice (QDGP).

The Brisbane South Division of General Practice (BSDGP) Aged Care Program.

The Royal Australian College of General Practitioners (RACGP), Qld branch.

Carers Queensland.

The Aged Care Standards and Accreditation Agency (Queensland office).

Department of Health and Ageing.

The Quality Care Pharmacy Program (QCPP).

Queensland Health Safe Medication Practice Unit.

Additional researcher in field and community pharmacist.

Feedback by general practitioners was sought from those doctors had who previously

participated during Phase 2 of the project. GPs were contacted by telephone, the task

was explained and the GP was asked whether they would be willing to participate and

which of the two models was most relevant to their practice. Attempts were made to

contact all 33 Phase 2 GPs; of these:

5 were unavailable (due to retirement, leave or a practice change) and 13 GP’s could

not be reached by phone after 2 or more attempts;1 declined to participate initially.

14 practitioners indicated they would be prepared to provide feedback, however, a

further 2 later declined to comment after receiving relevant documents.

The majority of GPs decided to make their response choice when they had reviewed

the models so that 12 GPs were provided with the model for community best practice

while 11 were provided with the residential best practice model. Response rates and

comments made during recruiting indicate that most interest from GPs surrounded the

RCF model.

As with the GPs, all RCFs involved in Phase 2 of the study were approached to

contribute. In addition, 3 facilities solely involved in focus groups were also invited to

comment. Potential respondent interest was gauged by an initial phone call, during

which time DONs or facility representatives were queried as to whether DAA use was

the same as during Phase 2 of the study. While facilities that had changed

management were not included, new DONs who had taken over positions from

participants of Phase 2 were encouraged to participate if interested. Among 31 facilities

involved in Phase 2 and focus groups, 21 expressed interest in providing feedback.

Feedback from the hospital pharmacist perspective was gained from the group

involved with earlier focus groups. All 11 focus group pharmacists were provided with

best practice documents. Telephone contact prior to supplying documents yielded 4,

respondents interested in participating. The remaining 7 were provided with best

practice models “cold” as efforts to reach them first via phone had proved

unsuccessful. The hospital pharmacy feedback questionnaire was also sent to the

SHPA representative on the Expert Panel (rather than the full set of documents) and

the Queensland Health Safe Medication Practice Unit


A total of 19 community pharmacists who had participated or indicated a willingness to

participate in focus groups in Phase 3 were contacted to provide feedback on the best

practice models. This included three community pharmacists who had been involved

with the expert panel and participated in community pharmacy focus groups. The

majority of community pharmacists had previous involvement in Phase 2 of the study.

Seventeen community pharmacists were sent evaluation questionnaires and materials.

Members of the expert panel were asked to comment on both models and to discuss

issues of implementation. Guided feedback questionnaires were sent to 20 panel

members (those in 3.1.1 excluding 3 community pharmacists and the SHPA

representative). The ‘expert panel’ guided feedback questionnaire (or a version

modified to specific needs) was also sent to a pharmacist researcher working in the

area of DAA service, the QCPP director, QDGP, BSDGP Aged Care Program,

RACGP, the Aged Care Standards and Accreditation Agency, a representative of the

Department of Health and Ageing, and a representative of Carers Queensland.

Community patients were contacted with a view to canvassing a broad range of

experiences of those using DAAs in the community. The community patients involved

in the best practice evaluation were selected from a possible pool of 51, who had

consented to be contacted again following the completion of the Phase 3 Patient follow

up interview. With a goal of 15 completed responses, a purposive sample was drawn.

Selection was based on the criteria of geography (rural and urban areas, and all major

study sites), DAA type (where possible a variety of DAAs, although choice was limited

by the dominant market share of Webster Pak) and gender. In addition, to minimise

loss of recall, those who had more recently started using DAAs were selected.

Patients were contacted by telephone. This also allowed informal assessment of ability

to complete the questionnaire to be assessed (e.g. cognitive ability). Contact was

attempted with 25 patients; 19 patients were contacted however 2 were excluded on

the grounds of perceived cognitive difficulties. Of the 17 interested in participating:

There were 11 females and 5 lived in rural/regional areas.

DAA used: 13 Webster Multidose, 2 MPS sachets, 1 Medico Douglas, 1 Mediplanner.

Patients subsequently received a follow up phone call to ensure the survey had be

received and to assist with any difficulties in completing it that may have arisen. Two

additional attempts at follow-up were made for non-responders.

Input from residents of RCFs was sought through a face-to-face interview in the RCF.

The DONs of two RCFs were asked to assist in recruiting between 7 and 9 residents

and/or their family members who might be able to give insights into medication issues

they had to deal with early on in their admission to an RCF. The two facilities had quite

different policies and procedures, and used different types of DAAs. The following

criteria were suggested to each DON as a means of selecting possible interviewees:

(1) Willing to take part in the interview.

(2) Willing to have their comments recorded (where responses were to be aggregated

and no individual would be identified; the recoding was later wiped).

(3) Able to respond from a cognitive and physical perspective.

(4) Been admitted fairly recently and still be able to recall the experience.

To address variation in resident experiences with medication administration and

supply, DONs were also asked to approach, if possible, some self-medicating residents

and participants who used a DAA service/pharmacy different from the usual DAA

service provider for the facility.


5.2 RESULTS

The majority of respondents were asked to provide feedback as to the feasibility and

impacts of the various components of the best practice models. For patients,

respondents were asked about their experiences to date and whether they supported

the particular aspects of the best practice models that directly involved them (e.g.

tripartisan agreements and patient held templates).

5.2.1 RESPONSES RECEIVED

Feedback on the best practice documents was received from the majority of

stakeholder groups contacted:

GP response about the RCF model was received from 6 of 11 GPs sent the model

GP community model response was received from one GP of 12 sent the model.

Of the 21 RCF DONs sent the models, 9 responded.

Of the 17 community pharmacists sent the models, 9 responded (2 responded only

to RCF survey; 6 only to community survey).

Of the 11 hospital pharmacists sent the models, 5 responded. In addition, specific

hospital pharmacist feedback surveys were completed by the SHPA representative

and staff of the Queensland Health Safe Medication Practice.

Of the 20 expert panel members provided with the expert panel feedback survey, 14

responded. Of these, 2 did not respond using the questionnaire and one response

indicated general agreement with the models without giving specific feedback.

Additional comments were received from an additional researcher in field and

community pharmacist, the Aged Care Program of BSDGP, Carers Queensland and

a staff member of the Department of Health and Ageing.

Of the 17 community patients asked for feedback, 12 responded.

Interviews were conducted with 7 RCF residents (target was 7 to 9 interviews).

The RCF residents had been living at their respective facilities from 2-3 months to 6

years but five had moved into residential care within the past 18 months. There was

some variation in the extent of facility involvement in a resident’s medication

management; six had their medication supplied by the RCF’s nominated pharmacy and

handled by RCF staff. One resident looked after her medication supply, independent of

RCF assistance, and used a pharmacy not contracted to the RCF.

No specific feedback was received from other GP organisations approached (QDGP

and RACGP) after telephone calls and emails to various staff members. QDGP offered

to circulate surveys to GPs as well as give organisational level comments; the former

was declined as the payment requested was higher than budgeted and input from

individual GPs had already been sought. A face to face meeting of over one hour was

held at RACGP (QLD) offices to discuss the issue of best practice. In this discussion,

the problems faced by GPs in attending residents and ordering medications in RCFs

were discussed. The barriers to safe, effective and efficient DAA use included

medication charting burden in RCFs, requests for repeat prescriptions, ‘owing’

prescriptions and communication barriers. These issues were the same as those

emerging from other focus groups, surveys and discussions. Input from the Council of

Carers was suggested as part of the review. While support was given for the

collaborative approach to DAA provision and to further development of the best

practice models (with a mention of CQI systems in RCFs) and the possibility of using

Meals-on-Wheels volunteers as a mechanism for in-home checks of medication

competency, specific feedback on elements of the models was not received at the


meeting. Since RACGP is the body responsible for setting GP practice standards, the

organisation welcomed the opportunity for input and a response to the draft models

was promised.

No feedback was received from either of the “quality” organisations approached. After

initially agreeing to review the RCF model, staff at the Aged Care Standards and

Accreditation Agency, Queensland office referred the request to head office. No

response was subsequently received, nor was there a response from QCPP.

Participation in preliminary best practice models review is summarised in Table 5.1.

Table 5.1 Respondents to the review of the best practice models

Stakeholder group

No. invited to review model

No. expressing interest

No.responding

Comments

Expert panel 20 panelists 8 others

- 14 4 others

Others also sent this survey

RCFmanagement

31 21 9* Only 2 DONs in focus groups; RCFs from NSW, QLD, SA, TAS; 2 regional/rural.

RCF staff - - - - RCF residents 4 RCFs*

7-9 residents target

4 RCFs Unknown No. residents interested, recruited by RCF

7 * same RCFs as RCF staff focus groups

Community pharmacists

19** 17 2 to RCF 6 to CP

**Included 3 expert panel members; 2 regional/rural

Pharmacy DA - - - Hospital pharmacists

11 + 2 others 4 5 + 2 others 1 expert panel member & 1 other sent this survey; from ACT, QLD, SA, VIC, public, repat & private; 1 regional/rural

GPs 33 invited 11 for RCF 12 for CP

6 for RCF 1 for CP

All indirectly part of model development; from NSW, QLD, VIC; 3 regional/rural

Community patients

19 17 12 4 DAA types used, 5 in regional/rural areas

5.2.2 VIEWS ON THE BEST PRACTICE MODEL IN THE COMMUNITY SETTING

Overall, responses to the best practice guidelines were positive, although several areas

where revision would be required were identified. In comparing current practice and

best practice DAA provision in the community setting, in certain areas (e.g. assessment

of suitability for DAA use), the proposed best practice recommendations are largely

being followed. In others, only minimal changes would be required for best practice,

while in some areas, such as the implementation of a tripartisan agreement and

continuity of care between the community and hospitals, significant practice changes

would be required. The use of information and communication technologies was a

strategy commonly felt to improve sharing of accurate medication regimen information,

one of the intents behind the tripartisan agreement and patient-held templates.

As an indication of the extent of practice change in terms of the activities undertaken in

providing DAAs, Table 5.2 summaries community pharmacists’ reports on who

currently undertakes the various activities and beliefs about who should be doing the


activity. Note that at the time of the survey, there was no prospect of different funding

arrangements for a DAA service, so that attitudes reflect what was happening at the

time of the feedback. For three activities directly affecting patients, the views of

community patients are also included. Patients did not necessarily attend pharmacies

of the community pharmacists providing feedback.

Table 5.2 Comparison of views on who does and should perform various tasks

associated with DAA use by community patients

Community Pharmacist (n=7) DAA Tasks for community patients Currently done by: Should be done by:

Recommend that a patient use a DAA Carer+GP: 43% Anyone/various: 29% GP+Pharm: 14%

Anyone/various: 57%

GP+carer+Pharm: 14% GP: 14%

Assess a patient’s ability to use a DAA Nr+Pharm: 29% Unknown: 29% GP+carer+Pharm: 14% Pharm: 14%

Nr+Pharm: 14%

GP+carer+Pharm: 14% Pharm: 14% GP: 29% Pharm+Nr+GP: 14%

Ensure that the pharmacy has a current and complete record of a patient’s medicines

Pharm+GP: 14% Pharm+pt: 29% Pharm: 43% Carer+GP: 14%

Pharm+GP: 14%

Pharm: 14%

GP: 57% All: 14%

Decide what should be packed in the DAA

Pharm: 29% Pharm+pt: 14% GP+Pharm: 14% GP: 14% GP+carer: 14% Pharm+carer+pt+GP: 14%

Pharm: 29% Pharm+pt: 14% GP+Pharm: 14% GP: 29%

Pharm+carer+pt+GP: 14%

Decide what is the optimal schedule for the patient (times of day for each medicine)

GP: 29% Pharm: 14% GP+pt: 14% GP+pt+Pharm: 14% GP+Pharm+pt+carer: 14% Carer: 14%

GP: 14% Pharm: 29% GP+pt: 14%

GP+Pharm+pt+carer: 14%

GP+Pharm: 29% Pharm: 100% Pharm: 100% Community patients (n=12)

Store the patient’s repeat prescriptions

Pharm: 100% Community Pharmacist (n=7) Provide the patient with a current and

complete written record of their medicines

GP: 43% Pharm+GP: 43% Pharm: 14%

GP: 57% Pharm+GP: 43%

GP+pt: 43% GP: 14% GP+Pharm: 14% Pt: 14% Carer: 14%

GP+pt: 14% GP: 71% GP+Pharm: 14%

Community patients (n=12) (n=9)

Tell the pharmacy about any changes to a patient’s medicines

GP: 60% Pt: 25% GP+pt: 25%

GP: 67%

GP+pt: 33% Community Pharmacist (n=7) Making sure prescriptions are available

to ensure continuity of supply of packed medicines

Pharm: 71% Pharm+pt: 14% Pharm+GP: 14%

Pharm: 43%

Pharm+GP: 14% Pt: 29% Carer: 14%


Table 5.2 continued Community Pharmacist (n=7) DAA Tasks for community patients Currently done by: Should be done by:

Pharm: 71% Pharm+pt: 29%

Pharm: 71% Pharm+pt: 14% Carer: 14%

Community patients (n=12) (n=9)

Inform the doctor when a repeat prescription is required

Ask the doctor for a new prescription when you have no more repeats

Pharm: 58% Pharm via pt or phone: 8% Pt: 8% Pt after asking pharmacy: 8% Pt after pharmacy reminder: 8%Pt+carer: 8%

Pharm: 56% Pharm via pt or phone: 11% Pt: 11%

Pt+carer: 11% Pharm+pt: 11%

Community Pharmacist (n=7)

Assess how patients are managing with the DAA

Pharm: 29% Pharm+GP+Nr: 14% Pharm+GP+carer: 14% Pharm+family+Nr: 14% Carer: 14% Unknown: 14%

Pharm: 14% Pharm+GP+Nr: 14% Pharm+GP+carer: 14%

Carer: 14% Unknown: 14% Pharm+GP: 14% Nr+family: 14%

Key: Pharm=pharmacy; pt=patient; Nr= nurse or community nurse

Recommendations that a patient use a DAA were currently made with GP involvement

in over half of the community pharmacy practices providing feedback on the models,

however, it is evident that community pharmacists would prefer to move away from any

‘gate-keeping’ role for GPs as 57% indicated anyone should be able to recommend

DAA use. In terms of assessing a patient’s ability to use a DAA:

Pharmacists were not aware who currently made assessments in some cases, and;

Pharmacists thought that GPs should have a greater role in assessing ability to use

a DAA (14% currently to 57% for who should do this activity).

Pharmacists also felt that the GP should have a greater responsibility in ensuring the

pharmacy had a current and complete medication regimen record, but that patients

should be less involved. The latter may reflect reservations expressed about patient

reliability in maintaining the patient held template (see 5.2.2.3). Pharmacists also

wanted the GP to have a greater role and the patient to have a smaller role in advising

the pharmacy about medication changes. Patients also wanted less responsibility to

advise of medication changes, although some like this responsibility. The aspects

where a greater GP role was preferred are those same aspects where problems were

identified in the initial focus groups (4.1.2.2) and in Phase 2.

Both pharmacists and community patients believed that storing prescription repeats

was a pharmacy responsibility but this was not seen as incompatible with non-

pharmacists making sure prescriptions were available or asking/informing the GP that a

repeat prescription was required. Indeed, pharmacists would prefer to reduce their

roles in these activities. Interestingly, neither pharmacists nor patients indicated

significant responsibility for a GP to keep track of when repeat prescriptions or making

sure prescriptions were available to ensure continuity of supply. In terms of assessing

ongoing ability to manage a DAA, there was a slight preference for pharmacists not to

have this responsibility alone, and for greater assessment by others without pharmacy

involvement.

Feedback on the specific recommendations in the preliminary community patient DAA

best practice model is summarised in the following sections.


5.2.2.1 Assessment of need for DAA service

The preliminary best practice model includes a recommendation for formal, structured

and documented patient assessment of ability to use a DAA and possible risks

associated with DAA use prior to a community-based patient starting a DAA. The

recommendation also covered appropriate targeting of DAA recipients, interdisciplinary

consultation (note this was not approval seeking) and the possibility that other

medication management strategies could be more suitable for an individual.

Of the community patients who commented on the model, 7 of 10 patients reported

being assessed for ability to use a DAA. Common assessment types included: the

pharmacist/pharmacy staff showing the DAA to the patient and demonstrating how to

use it and, discussing the use of the DAA with the patient.

Five of the 7 community pharmacists felt that the patient assessment recommendations

were feasible. One indicated that the recommendation just formalized existing policy

while another indicated that such assessments were being carried out by Aged Care

Assessment teams (ACATs) locally. Two pharmacists expressed reservations; one felt

that the recommendation was feasible but unnecessary as if a patient could not use a

DAA (or who did not have someone to help them who could), then the patient should

be in care. This pharmacist felt all people on regular medications should be eligible for

a DAA. A second pharmacist had concerns that the recommendation was not feasible

as the pharmacist did not always meet the patient (e.g. when a family member

arranged the DAA), and that some aspects, such as checking storage conditions would

require the pharmacist to go to a patient’s house.

Majority (5 of 7) of pharmacists consult the patient’s GP when making a decision to

initiate DAA services. Perceived advantages of initial consultation were:

GPs could provide an up-to-date drug list/confirm a medication profile (4 responses).

To garner GP cooperation in relation to prescriptions (2 responses).

Make the GP aware that a patient was using a DAA (2 responses) (e.g. knowing a

patient was new to a DAA, a GP could check compliance and patient acceptability.

Better communication with the GP.

To obtain feedback from the GP about GP views of patient needs e.g. how often a

patient needs to visit the GP (as visits just for a new prescription would be reduced).

The only disadvantages mentioned were:

That getting in touch with the GP was time-consuming.

The time delay between the patient agreeing to start a DAA and the GP making a

decision about whether to support a DAA.

The single GP who commented on the community patient model indicated that she was

not consulted in decisions to initiate a DAA but suggested that prior consultation would

give the GP the opportunity to offer reasons why a DAA may not suit a particular

patient and to discuss with the patient the risks and benefits independently, not making

an assumption that a DAA is in the patient’s best interests. The GP felt that DAAs

increased costs and did not have proven benefits to justify the costs.

In order to implement formal patient assessment recommendations, two community

pharmacists reported they would have to increase their interaction with GPs and may

need more staff time to do so. Another indicated that they would actually need to do a

pre-assessment and keep a record of it, while another felt that only a change of their


current template would be required. Only one change to the recommendation was

suggested; to remove reference to assessment of patient medication knowledge as,

while this was desirable, it was not achievable in practice.

Since recommendations that a DAA is needed also arise at patient discharge from

hospital, hospital pharmacists were asked about the feasibility of hospital pharmacists

undertaking structured patient assessment. Of the 8 respondents, six indicated it was

feasible for a hospital pharmacist to undertake structured patient assessment when a

recommendation to start a DAA was made, but most had conditions or reservations:

A pharmacist from a smaller regional hospital indicated that in-hospital structured

patient assessment by a pharmacist was feasible but not practical because of the

resource issues, for example, when poor discharge planning means that assessment

is required at 4.30pm on a Friday. A similar issue of timeliness was noted by another

hospital pharmacist from a metropolitan hospital who indicated that DAAs were not

initiated from hospital and that the patient was sent to the local pharmacy, a decision

usually made “5 minutes before they leave the hospital”.

Assessment would need to be incorporated into current work practices.

Some hospital pharmacists do structured assessments when interviewing patients

on admission (taking a medication history and assessing medication management

risks) (2 responses). One pharmacist indicated that assessment was not formal and

usually happened as part of patient care.

Assessment could be feasible if the timeframe allowed and it did not take much time,

and assessment would “probably prevent initiation in some cases”. The question of

to whom to send the assessment needed to be addressed.

A pharmacist from a private hospital indicated that in one sense, in-hospital

assessment was feasible as there was a multidisciplinary team to review ability to

manage medications but it was not feasible because of the time constraints on

discharge. Information was also duplicated in hospital and community pharmacies.

Hospital pharmacists may not have sufficient time to chase all the information that

they would need to make a full assessment, however, a preliminary assessment

could be made, such as the suitability of DAA types for an individual patient.

At the present time, no hospital pharmacist respondent indicated that a GP was

consulted when a decision to initiate a DAA for a community patient was made,

however, six indicated that a patient’s usual community pharmacist was consulted.

The impact of changes to DAA initiation processes to adopt best practice generally

concerned time (finding the time to do an additional activity) (3 responses). Given the

staff shortages in hospital pharmacy, increasing staff was not always an option. The

time needed to make assessments, find fax numbers, send faxes, etc, would probably

prevent initiation in some cases. One pharmacist from a smaller regional hospital did

not envisage initiating DAAs. One pharmacy would need to develop a database while

another respondent indicated that community pharmacy DAA fields would need to be

added into an existing system. One pharmacist said that since hospitals were already

investing in continuity of care, the additional information needed for an assessment and

follow-up/communication of information should not have a significant impact on

workload; “all that would be needed is an addition of this to the list of things to do”. For

hospitals with no pharmacist on site, an alternative model or resources would need to

be developed. In a private hospital, a significant change to the model would be required

as the discharge process (involving DAAs) was nurse initiated, based on pharmacy

supplied criteria, and to adopt this model, the process would need to be pharmacy-


initiated. This would be much more time-consuming for the pharmacist and difficult to

capture all the ‘at risk’ patients.

From the hospital pharmacist perspective, the recommendation for structured

assessment could be improved by:

Recommending a standard procedure and a standard series of questions (e.g. an

extra QCPP standard).

Allowing verbal communication between hospital, community pharmacy and the GP.

Where a DAA is to be initiated after discharge, reconciling medications (comparing

admission medication history, medication chart and discharge prescriptions) should

be done in hospital, before dispensing and DAA packing.

Hospital doctors being able to initiate a HMR for suitable patients.

If hospitals are to make an assessment, identify in the model to whom the

assessment should be sent.

Twelve of the 13 respondents to the expert panel review questionnaire were generally

supportive of recommendations for structured patient assessment with one explicitly

supporting on-going or re-assessment. Five respondents said that this assessment

should be simple, streamlined or a “tick box” (4 responses). APAC guidelines on self-

administration assessment or similar were suggested as resources to facilitate

development of a structured assessment framework. One respondent said that

“complicated pre-initiation procedures that involve that patient could deter people who

have been identified as likely to benefit”. Another indicated that patients and carers

often underwent assessment processes and so any additional assessment should be

as streamlined as possible, and “not ultimately impact on the cost to the patient/carer”.

Basing the assessment on more objective evidence rather than self-report was felt to

be important. Another respondent indicated that “structured assessments need to be

validated and easy to administer without extensive training e.g. check list”. The same

respondent went on to make a somewhat confounding comment that criteria for

determining a need for a DAA should be flexible.

Eight respondents to the expert panel questionnaire commented on the assessment

criteria for targeting the recipient of a DAA service as areas for improvement:

Several commented on the need for flexibility and not strict criteria such as ‘5 or

more medications “patients with evidence of non-compliance on one medication will

potentially benefit from a DAA”.

Two respondents suggested that the criteria were too restrictive and may exclude

people later experience might show would benefit (e.g. patients taking drugs with a

low therapeutic index, drugs for cognitive impairment and drugs for treatment of

asymptomatic conditions such hypertension and hyperlipidaemia).

Two respondents felt that criteria should include need as determined by the

professional judgement of the pharmacist, GP or nurse or, poor compliance

identified by the carer.

There was a need for guidelines or a better definition of non-compliance (e.g.

define what a history of non-compliance is or what level of dose omission is ‘poor’

compliance.

One respondent indicated that the criteria cited in the community model should be

presented as risk criteria not absolute criteria.

Were DAAs to be subsidised, tighter criteria would be required to manage access

so that those most needy patients were identified and their DAA requirements

addressed.


A statement recommending that criteria for suitability/eligibility for a DAA need to be

developed and that these criteria should include a system for on-going review and

revision as necessary.

A criteria addressing patient geographical proximity to the DAA service provider

may be considered in any funding model to minimise the potentially negative effects

of distance on communication, quality and QUM outcomes.

Another respondent supported iterative refinement of the criteria for targeting a DAA

service recipient “Get it started and the model can be modified”. On-going monitoring of

the utility/appropriateness of the criteria for DAA receipt was recommended (2

responses).

Four respondents felt that the assessment recommendation should be explicit about

including all relevant parties in the assessment process:

“Assessments could be improved by including and involving carers in the

assessment process. Carers have particular knowledge that may not be available

to health professionals from a short consultation/meeting. For instance, the carer

may have particular knowledge regarding the memory, eye-sight, swallowing ability,

etc of the patient that it would be useful to know”.

“I do not feel that the pharmacist in isolation can assess the patient’s ability to use

the DAA effectively”.

Where applicable, input from community nurses should be included.

One respondent noted that the role of community nurses was not explicitly addressed

in the framework (all relevant aspects not only patient assessment) and needed to be

inserted as soon as possible as nurses “do have a potentially vital role in the process

supporting the functions of doctors”.

Several respondents suggested the integration of the structured assessment with other

processes. It could be done in conjunction with:

The tripartisan agreement and associated explanations. One respondent suggested

that the preliminary interview should be charged for and included in the cost of the

first pack, while another suggested incorporation into an establishment fee.

An ACAT assessment or assessments done by other health professionals.

The HMR program or care planning (under the Enhanced Primary Care Medical

Benefits Scheme (MBS) items).

There were felt to be benefits in integrating the assessment with an HMR as:

The criteria and patient needs were similar.

In home patient visits were already included in the HMR program.

The administrative processes and inter-professional communication processes

were already in place so that the need for a separate bureaucratic structure would

be minimized while providing accountability.

There were existing funding arrangements for ACAT assessments, HMR and care

plans that could cover the cost of the structured assessment.

Access to any subsidized DAA service could be managed such that those most in

need and likely to benefit received the service.

The control of access to a DAA by a requirement for an HMR was also seen as a

negative as the time constraints of arranging for an accredited pharmacist to conduct

an HMR might mean delays in providing a DAA. Also, the timing of an HMR in relation

to the initiation of a DAA needed to be defined.


The best practice recommendation also included assessment of potential risks and

specific needs that affected how a DAA service was to be delivered. This was

supported by one respondent to the expert panel questionnaire who felt that where a

carer was involved in medication management for a patient that the needs and

preferences of the carer should also be considered in assessments.

“For example, the carer may be expected to assist with administering medication

but may have poor eyesight themselves. Similarly, if they are expected to assist

with medication administration their availability and preferences need to be

considered – a carer may be at work during the day and not be available to assist

with administering medication during 9am-5pm”.

The use of technology to facilitate information sharing, people possibly needing a DAA

(e.g. flagging late or missed repeat dispensings) and reminders for re-assessment

were suggested as a way of improving the assessment processes.

A final area for further development was use of the DAA assessment process as an

avenue for accessing greater community care support when a DAA is felt not to help a

patient with their medication management because care needs are too great.

“at times there is a gap that even a DAA cannot fill for the confused/cognitive

impairment. We have a subset of patients especially those with dementia that even

the best DAA is unsuitable for. They need to have their medications given by a

carer/nurse. Unfortunately, as many of these dementia patients are community

based with community nursing assistance, this is a real problem. Community

nurses are unable to provide four times a day administration of medications and it

would be wonderful if the model was able to recommend funding for the patients

who are at high risk even with DAAs that was able to provide more home nursing

visits for medication administration”.

5.2.2.2 Tripartisan agreement for DAA supply

The community best practice model included a recommendation that the community

pharmacy should negotiate an agreement between themselves, the patient/carer and

the patient’s doctor/s that specified obligations and promoted mutual awareness before

beginning to provide a service. The recommendation included an extensive outline of

aspects to be addressed prior to taking up a DAA service.

Of the 8 community patients who commented on the tripartisan agreement concept, 3

patients currently had a written agreement with their pharmacy for DAA supply

(however, these were not tripartisan agreements involving the patient’s GP). Five

community patients reported that their pharmacists had discussed all aspects covered

by the best practice model while two more indicated that some of the aspects had been

discussed. Seven of 10 responding patients said it would be ‘extremely helpful’ if their

pharmacist had discussed the features covered by the tripartisan agreement with them

prior to commencing their DAA. As further support, 6 or 8 respondents indicated that

they would be willing to sign the tripartisan service agreement for DAA supply.

Five of 6 responding community were willing to have a written tripartisan agreement

(covering the service aspects mentioned). One pharmacist felt that it was a lot of work

with little benefit while the pharmacist who did not indicate yes or no asked “is it

necessary?”. Service aspects to be addressed/decided upon prior to starting the

service that were considered to be important or useful were:


The importance of the pharmacy having current medication lists (2 responses).

Whether a pack was to be collected or delivered, and delivery procedure/schedule.

What the cost of the service is, who is the payer and how charges will be made.

Prescription management (3 responses) including whose responsibility it is to obtain

prescriptions needed for continuity of supply.

How medication changes are to be addressed (2 responses) including who is

responsible for notifying pharmacy of changes.

The timeframes for packing and delivery, so that the doctor and patient are aware.

Two pharmacists felt that all aspects were important although one felt that some parts

of the agreement would need to be standardized for all patients and that a tick box

agreement would be good.

No pharmacists recommended changing or leaving out parts of the agreement,

however one pharmacist felt the agreement itself was “overkill” because the “patient

pays – they drive most of it”. This pharmacist did agree that communication with the

GP “is usually necessary”. ’

Five of 6 responding pharmacists indicated that the recommendation was feasible. The

impact on costs and staffing were felt to be minimal:

“Only the initial set-up would be costly in terms of time. The document is just

formalizing what we already do”.

“Time spent at the beginning will produce good results and save time later on” (3

responses like this)

Only one pharmacist was opposed to the agreement approach, saying it was “too

complicated when dealing with the people who really need a DAA”.

The GP providing comment on the community patient model indicated that she would

be willing to be involved in a tripartisan agreement provided it was discussion and not a

“fait accompli management exercise”. The GP saw the useful aspects of the agreement

as ensuring:

“The patient is fully informed of cons and benefits before making a choice”

“Costs to GPs in extra paperwork are remunerated and possibly a patient component

of this”.

The GP’s responses also indicated that prescription management issues needed to be

addressed in any agreement. This included GP practices about writing prescriptions as

this varies between GPs “it is our practice policy to negotiate scripts with patients… not

with pharmacies and we charge the patient a fee”. And the use of reminder notices also

varied. This GP indicated that in their practice, the patient was held responsible for

requesting prescriptions and that the pharmacy should notify the patient (not the GP).

Hospital pharmacists generally supported the tripartisan agreement. Aspects

considered important or useful were:

All aspects (3 responses). One hospital pharmacist said that the agreement reflected

that true medication management was a team process that was patient focused, and

provided a foundation to effectively and safely provide DAAs.

How the DAA service will work as detailed (3 responses) including type of DAA,

packing cycle, delivery, storage of unpacked medications.

Patient’s consent for transfer of information (community into hospital and vice versa)

(2 responses).

Prescription management (to prevent/minimise owing scripts) (2 responses).

Cost of service.


The importance of correct, up-to-date medication regimen information.

Prompt information flow about medication changes from the GP to the pharmacy.

Procedure for exceptional circumstances as detailed. This could be expanded to

address the potentially prolonged turn around times for adjusting/changing a DAA

when a patient’s medications have been changed while in hospital. In some regional

areas, this can be up to 3 days.

Ensuring optimal use of DAA.

There were some reservations:

The costs of sorting out the legal issues in an agreement; “if you had to discuss the

agreement with a solicitor, how much would that person charge for their time to

cover all the clauses?”

Arranging for an agreement to be signed off may take time, and result in a delay of

service following hospital discharge.

Suggested changes to the agreement were:

“An agreed communication strategy to ensure community pharmacist and GP is

informed of the patient’s discharge medication (including any changes and reasons

why) in a timely manner”.

“As we are all partners in this patient’s healthcare, consider sending an updated

copy (when the 6th monthly concordance check is done) of the patient’s current

medication profile to the hospital for their records.”

To explicitly address practices related to narcotics/opioids or other schedule 8 or

recordable drugs.

Details about how far in advance DAAs are prepared and the day of the week and

where packs are stored was felt to be a little too involved.

Who had responsibility for keeping all the ‘paperwork’ was not defined in the model.

One hospital pharmacist said that “leaving out items in the agreement leaves the

parties open to disagreement/dispute”. Another hospital pharmacist indicated that the

issue of medications dispensed by other pharmacies not being repacked into a DAA

(and so potentially wasting the medicine, money and time) needed to be addressed,

but rather than including this into the tripartisan agreement, the pharmacist felt a

definitive statement by Medicare Australia and state health departments, etc, was

needed.

The respondents to the expert panel questionnaire were generally supportive of the

intention behind the tripartisan agreement recommendation i.e. ensuring all parties are

aware of what is involved in and preferences related to a DAA service before beginning

the service. When asked which aspects of the agreement were considered

important/useful, nine of the 15 respondents felt that all aspects were useful. Aspects

specifically mentioned were:

That it formalized the process and increased GP awareness/understanding about

how the service generally worked (4 responses); “By increasing the involvement of

the GP’s in a formal process, pharmacy is forcing them to accept responsibility and

educate them on the processes involved”. Increased understanding by the

patient/carer and expected goals/outcomes would also be addressed by such an

agreement (3 responses) and so prevents any misunderstanding.

“The most frequent source of error is poor communication and setting up the

correct structure from the start is essential. This understanding would set out in

advance the responsibilities of all parties based on a common sense approach”


How the service will work (6 responses) including what the packing cycle was (2

responses), what medications are to be packed (plus whether non-prescription

medicines will be packed) and costs.

Prescription management procedures (6 responses) including: GP preferences for

writing repeats or writing owing prescriptions (3 responses, including when a patient

needs to see the doctor); pharmacy policies/procedures on ‘script owing’ issues

(e.g. what happens when there is no current prescription at the time of packing).

Procedures for medication changes (2 responses).

How optimal use of the DAA was to be ensured including information/counseling to

be provided (2 responses).

Importance of pharmacy knowledge of a patient’s current drug regimen (2

responses).

Policies of pharmacy and GP related to S8 and authority prescriptions.

Start-up procedures.

Procedures for what to do in exceptional circumstances (felt to be especially useful

for carers).

Consent of patient.

Several respondents seemed to interpret the agreement as a more generic document

that might include with ‘tick boxes’ rather than a service agreement for a specific

patient. For example, when asked what elements of the agreement should be left out,

one respondent (a pharmacist) indicated that delivery details could be left out as “these

may alter from patient to patient”. Three respondents suggested standard templates or

tick box forms as means of operationalising the agreement. Having different documents

for the different 2-way interactions was suggested by two respondents:

“While it is important for patient/carers to understand what is involved in the

agreement – the sort of understanding required is at a broad level and some of the

more specific intricacies related to service provision (e.g. issues between

pharmacist and doctor such as circumstances under which GP is willing to write a

repeat prescription without seeing the patient) would only serve to confuse them

and would be better left out. Mostly, they need to know in plan English what they

have agreed to do”

Other changes to the elements of the agreement suggested were:

Procedures for exceptional circumstances do not need to be written (2 responses)

but advise patient to contact the pharmacy if something goes wrong.

Include the role/responsibility of parties in relation to the patient held template.

Consider how agreements would work when patients change doctors.

Change the phrase “consent to re-assess” to “consent to formal review”. This could

be done via a practice standard that requires direct discussion with patient.

Strengthen the statement about referring for an HMR “these are the patients at risk

of medication misadventure and therefore most likely to benefit from an HMR”.

“Throughout the model ‘education’ needs to be better described and articulated. I

can imagine that not all pharmacists would necessarily have a good understanding

of how to do this well and consistently and this does not provide them with the

means to do so”.

Include community nurse where relevant as a party to the mutual understanding.

Recognising the limitations under which a carer operates e.g.:

“Privacy issues related to the carer accessing information about the patient that

might need to be sorted through so that the carer is not ham-strung in this

process where they have responsibilities but few rights”


“Making carers responsible for informing the pharmacy of medication changes

would assume that carers themselves are informed and I can assure you that

this is not always the case. You can’t necessarily expect a carer to perform a

role that they may not, through no fault of their own, be able to deliver on”.

The articulation of responsibility for continuity of prescription and prescription

management also raised comment because pharmacists often undertook these types

of tasks in an attempt to improve efficiency and ensure that legal requirements are met

when the responsibility and ultimately, prescription writing was outside their control.

The agreement was felt to highlight this responsibility to doctors but alternatives were

suggested:

“Responsibility for notifying GP for new prescriptions is OK but the pharmacist

cannot be responsible if the doctor is not forthcoming. This can have serious impact

on health care and is beyond the pharmacist’s ability to control. This has to be made

clear so the pharmacist is not held to blame. Therefore a simplified means of

ensuring continuity of treatment e.g. the medication profile signed by the doctor

could serve as the primary documentation for a prescription and payment for supply

or emailed PDF prescription”.

There were four main areas of contention or concern: (1) the extent to which a GP

needs to be involved with the agreement; (2) the extent to which GPs would participate

in such an agreement; (3) the use of the word “agreement” and any legal/contractual

implications associated with the term; and (4) costs.

Two respondents interpreted the agreement as one that required GPs to act as a

gatekeeper for service access. This was not felt to be feasible and would unnecessarily

complicate the process. A gatekeeper role for GPs was not the intention for the

agreement, rather the intention was to open communication, increase awareness and

to be explicit about roles and responsibilities of stakeholders in the service. Other

respondents were concerned about the willingness of GPs to be party to an agreement,

particularly without a funding model for this activity.

“While a multidisciplinary approach is optimal, it cannot be contingent on all parties

agreeing. As long as one health professional determines the need (whether

pharmacist/carer/domiciliary nurse), and that need is documented, it should proceed

with the patient’s permission. Many GPs will not be bothered filling in another form”.

One respondent predicted that the only way such agreements would exist “in black and

white and not just verbally is for it to be tied together by reward and punishment”.

Use of the term “agreement” was felt to have contractual implications. One respondent

wrote that doctors “worry about the medico legal aspects of being bound by third

parties”. An alternative title without the legal implications was suggested as a “Tripartite

Communication/Obligation Framework”, and the phrase “The agreement should

address” would be “Areas/issues to promote awareness/understanding and

communication”.

Funding was felt to be a critical element for success or adoption. Costs were

associated with GP involvement and at the pharmacy level; “It takes time to establish

these agreement criteria so some funding should be allocated to cover the time and

expertise required to arrive at agreement”. One respondent estimated that each

agreement would 20 minutes if initiated at pharmacy level, therefore there was a need


to introduce an establishment fee. Other pharmacy costs would be related to staff

training on initiating discussion, completing form and faxing to GPs, etc.

5.2.2.3 Patient held medication template

A recommendation for the establishment of a template for medication packing

(including packed and non-packed medications) was included in the best practice

model. This template was to be carried by the patient and used by the GP to record

medication changes. Processes to ensure that the template was current were also

included. A draft template was prepared to support this recommendation.

Of the 11 community patients providing comments, 10 said that their pharmacy

currently provided them with a full list of their medications. In addition to drug regimen

information (drug name, directions and a reminder of when to take the medicine +/- the

indication), often included in products like “MedProfs”, the draft best practice template

included details about the pack type, the packing schedule, contact details for the

pharmacy and GP plus adverse events and recent medication changes. It also acted

as a communication tool between the GP and the pharmacy, and the community and

hospital. Eight of the community patients said that they would find the best practice

medication template helpful with respect to improving their memory and keeping family

members/carers informed of their medication status. Nine patients were willing to take

the medication template with them to their doctor, pharmacy and hospital.

All 7 community pharmacists felt the patient held medication template would be useful

to them in their practice while 6 felt the medication template would also be useful to the

patient (1 did not answer saying that the template would only be useful to some

patients but that much of the information is already on the pack so many use this

information). For pharmacists, the template would be useful:

To improve continuity of care.

For better communication (2 responses) (removes guess work or problems with

faulty communication; accurate communication done in a simple manner).

As the pharmacy had an accurate record of what is supposed to be in the pack.

As it would help reinforce to GPs that it was their responsibility to inform pharmacy of

changes to the template to ensure it is current.

Only if the pharmacy also held a copy.

For patients, the template would be useful to improve continuity of care (3 responses)

(the copy could be used at hospital, checking with any GP or an after-hours service; a

link between all health care professionals) and so the patient has an accurate record of

what is supposed to be in the pack.

Pharmacists were asked about advantages and disadvantages of the doctor approving

the template (or pharmacy packing profile) prior to the pharmacy packing the DAA

(Table 5.3). The advantages in clarity of communication were balanced against

problems with workflow were the GP to not approve the template in a timely manner.

Some minimal changes would be required to implement this recommendation (in the

situation where the pharmacy would produce a template) in some of the respondent’s

pharmacies:

No change in one pharmacy.

Impact would be small. Two pharmacies already had a template. The change would

be to provide a copy to the patient and doctor.


Organise a template for the patient to keep with them and 6-monthly updates. Cost

would be minimal.

Others would need to make more changes:

One pharmacy felt there would be limited impact unless the pharmacy had to provide

the template.

One pharmacy did not have templates and felt that templates would be more

paperwork and take time “chasing up GPs to provide templates”.

Table 5.3 Advantages and disadvantages of GP approval of a packing template prior

to packing

Advantages Disadvantages

Accuracy and ease of packing Delays if doctor is away Should be mandatory, we already require this The medications should be correct and puts legal responsibility on to the doctor

Time for the doctor to do the template may hold up process

Medications that have been ceased by the doctor but not by the patient would be obvious Save time in the communication between parties involved Confirmation of drug regimen Problems if doctors did not update the template

Three community pharmacists felt that implementing the best practice medication

template would be feasible. One of these pharmacists cited patient reluctance to have

the extra paperwork or responsibility as a barrier; another felt that the staff time was a

barrier but one which could be overcome with government remuneration while the third

wondered whether doctors would participate. Three other pharmacists felt that the

recommendation was feasible on condition that the GP co-operated. Another

pharmacist felt that a recommendation that involved GPs being prepared to do extra

work was not very feasible; “I see pharmacists trying to chase templates as well as

scripts”.

Five pharmacists explicitly mentioned benefits from this recommendation in terms of

the safety of the DAA system and Quality Use of Medicines (QUM). The pharmacist

who felt the recommendation was not very feasible indicated that it would beneficial if it

worked. The only improvement to the recommendation suggested was to combine the

doctor’s agreement to use the template with any agreement to write prescriptions for

pack patients (as per the tripartisan agreement).

The GP providing comments on the community model felt that a template would be

useful to the patient only if it was shared between all carers (including pharmacy and

GP) with the patient’s knowledge and consent. From the GP’s own perspective, the

template would be a useful aid in patient education. The GP felt there were advantages

in being able to review medications before packing and to coordinate this with a patient

visit to review medications and educate the patient. The GP liked the draft template

indicating that “it could be stored … and easily populated by the computer extracting

data from the script list. It could be sent with all script requests from the pharmacy to

the GP and the GP would then have a reliable update for the patient’s file and could set

up reminders for authority script due dates”. Disadvantages of the template from the

GP perspective also related to the GP not always being available, but there was also a

possible cost to the GP of patient non-attendance and the paperwork involved.


All but two of the hospital pharmacists commenting on the community best practice

model felt that a patient held template would be useful to the hospital pharmacist to

communicate medication changes to the community pharmacy. One pharmacist

indicated that it filled the information void between the hospital and community in the

absence of a system of electronic information transfer, but warned that the likelihood of

the template being completed was an inverse relationship with the amount of

paperwork required. Several pharmacists indicated that the template would be useful

when patients were admitted (6 responses), provided the template was sent with the

patient and the information was current. It saved ringing the GP or pharmacy to

establish current medications, or at least was a useful start. However, one pharmacist

felt that the medication history reviews performed in hospital were easier and

potentially more accurate/current. Another pharmacist wondered how the process

would be managed if the patient had more than one healthcare provider (e.g. GP and

specialist).

One hospital pharmacist indicated the templates were not feasible because there was

always a problem with them being up-to-date. Another pharmacist from a smaller

regional hospital felt the template not to be feasible and that communication of “full and

detailed” medication regimen information was a “luxury” at discharge as discharges

were often done on an ad hoc basis, for example, when the emergency ward was full,

so “who can we discharge”, often patients with complex regimens.

Suggested changes to the recommendation to make it more useful to hospital

pharmacists were:

Supplying a copy of the medication chart for each DAA refill.

Asking the community pharmacist to also send an updated copy to the hospital (with

patient consent).

Despite the potential usefulness of the template, there were reservations about its

feasibility from a hospital pharmacist perspective:

Engagement, integration and participation of stakeholders was needed for

successful uptake (2 responses). It would only be feasible if all stakeholders (patient,

healthcare practitioners (hospital, community and specialists)) participated in the

work practices changes and collaborated. Political drivers would be needed to

incorporate an idea like the template as a communication tool into hospital practice.

The requirement for the patient to have a responsibility to remember to take the

template to hospital was a possible barrier (2 responses). Community pharmacy-held

and provided records were more feasible as there was patient-to-patient variability in

medication knowledge and motivation to provide records.

There were fundamental barriers in current practice like the doctor or community

pharmacist not updating the template or the patient losing it.

One pharmacist from a smaller regional hospital indicated the best practice model

recommendation was not feasible because of lack of staffing and a “medical culture

that is overworked and plays down the significance of explaining changes to

medication”.

The new software needed and additional costs were barriers.

As with other stakeholders, there were mixed views about the patient held template

among the 14 respondents to the expert panel questionnaire. A patient held medicine

template was felt to be useful or helpful to:

Community DAA users by 10 respondents; 3 respondents agreed conditionally.


Pharmacies providing DAAs by 11 respondents; 2 respondents agreed conditionally.

GPs caring for patients who use DAA by 10 respondents; 2 respondents agreed

conditionally and one disagreed.

There was support for the concept of the patient held template, with 7 respondents

providing strong support. Reservations about the feasibility of a patient held template

related to the ability of the patient to carry out their role in ensuring the template was an

effective communication tool and the willingness/co-operation of the GP to complete or

use the template.

To make medication regimen communication patient dependent “is to invite

disaster. Communication of medication changes must be between health

professionals”.

“Patients are notorious for losing records and whilst for some this may this would be

very effective, the reality is that one of the types of patient who usually benefit from

a DAA are the cognitively impaired and you could not rely on them to carry this

information with them.”

There is a risk that GPs would not be willing to do the paperwork “Just look at

HMRs and the way doctors boycott the process because they are not willing to do

the paperwork required”.

In relation to the community patient implementation model (Figure 4.6) “the

willingness of GPs to check a DAA template in sufficient detail to be useful [to the

pharmacy], would be limited especially as they are not being paid for this activity”.

Two other concerns were that:

“With this written template, doctors/pharmacists may be LESS inclined to TALK to

people about the medication list. Patients/carers need to be able to actively engage

and clarify their understanding, discuss their concerns/issues”.

Difficulties might arise “when the DAAs are provided from a source external to the

patient’s community pharmacy e.g. on a contract arrangement” and the community

pharmacy is required to provide the patient held template.

One respondent said that the concept of the patient held template would be beneficial

particularly were a standard approach be used and would only be feasible if there were

mechanisms to ensure that this standard approach was carried out (e.g. QCPP

assessment).

Opinions on the advantages and disadvantages of doctors approving a patient’s

medication template/pharmacy packing profile prior to the pharmacy packing the

patients medicines into a DAA are shown in Table 5.4. Prior GP approval of the

template was not included in the preliminary best practice model but opinions as to

whether this should have been included were sought. Two respondents completely

disagreed with this suggestion e.g. “process cannot be contingent of GPs” and others

identified significant barriers to initiating a DAA. The main advantage of GP prior

approval of a profile before a DAA is packed was that the drug regimen was likely to be

more accurate and reliable (so avoiding re-work associated with incorrect medication

regimen information).


Table 5.4 Expert panel views on the advantages and disadvantages of GP approval of

a packing template prior to packing


Would not happen without software/technology enabling linking GP and pharmacy medication records

Assumes doctor has accurate records (many don’t find time to get own records in order) Getting GP to do this unpaid task in a timely manner

Requires commitment from GP (2 responses). “they are unlikely to uniformly comply regardless of patient benefit. Will only be perceived as impost by pharmacy, especially if pharmacists are funded for DAA packing and they are not”

Includes GP in DAA decision-making process Alerts GP to the number of OTC preparations taken by the patient Educate GP on process of preparing DAAsImprove GP-pharmacy communication Accuracy of profile Opportunity for pharmacy to secure prescriptions needed to pack

Time taken; the process must be quick and simple

Need GP input for accurate profile Useful for direct communication between GP and pharmacy

Repeated contact with GP for confirmation would interrupt GP practice Risk if no source data to ensure accurate profile

Legal protection for pharmacy Up-to-data medication regimen information

Reduces errors from assumptions and out-of-date information

Additional task for already busy doctors Doctors would want to be paid for this task

GP awareness that patient has a DAA improves appropriate communication with the pharmacy when medication is changed

GP difficulties in finding time to complete paperwork

Have a common reference point for a persons medication regimen

Time taken and delays in getting access to the GP – “What are the risks to the patient with the need having been established but waiting to be actioned” Good document handling would be required

Three respondents indicated that there were likely to be additional costs involved in

using patient held templates (including staff time contacting doctors for confirmation,

faxing of templates to doctors, tracking paperwork and entering data, and costs for GPs

and other parties involved).

“It takes time of course to keep an update profile, however as this is possibly the

only complete profile it is worth the effort as it is also likely to identify non-

prescription medication being taken as well”.

The development and use of information and communication technologies were seen

as a way of minimising the time and costs.


Respondents to the expert panel questionnaire suggested many improvements to the

overall recommendation or ways of overcoming barriers to the adoption of the patient

template:

Change the phrase “this template should be approved by the patient and the

patient’s doctor” in the recommendation text to “endorsed by the patient and the

patient’s doctor” so that it is clear that it is not prescriptive that the GP approves a

template before packing can commence. This would also involved a change of

wording (e.g. to “template endorsed by all”) in Figure 4.6.

One respondent suggested that the recommendation needed to include strategies

that can be used when a patient cannot participate in the information transfer.

Others preferred making the process not dependent on reliable information transfer

by the patient or carer but provide the template to the patient e.g. “If doctors were to

fax/email dose and medication changes directly to the pharmacy then the pharmacy

could fax back the completed document for the doctors records”. A direct link

between the doctor and the pharmacy would be better as:

“Anyone can forget to bring their template with them when coming to the

pharmacy so some additional method would help such as email/post/deliver

copy to pharmacy. Cannot be relied upon as the only method of communication

and source of information. Failure to bring it to the pharmacy could mean a lot

of time spent by pharmacy seeking correct information. “.

Use information communication technology to facilitate effective and efficient

information transfer. “Hard copies would work in the interim with the pharmacist

maintaining the records [but] may be more cost effective if communicated

electronically”. However, there was a need to overcome barriers associated with

the “lack of technology that ‘talks to each other’”. One respondent suggested that a

future “Smartcard, if introduced, would offer the opportunity for the doctor to update,

patient to carry and pharmacist to check and record changes”.

One respondent overcame difficulties in getting GP time to complete the initial

template by providing “a kit to the patient/carer and they make a long appointment

for the Dr to complete the med profile plus all other information e.g. allergies etc.

the Dr is then involved in providing updates for their patient by whatever means

they find easiest”.

Processes need to recognise carers and other health professionals involved. The

community nurse and indeed, practice nurse, have a potential liaison role between

the patient, doctor and pharmacist that could “save pharmacists and doctors much

time and help them focus on their particular areas of expertise”. Carers need to be

kept informed of medication changes that might take place at a trip to the doctor or

pharmacy when the carer is not present. Also, if carer administering medications,

their preferences also need to be considered in determining the administration

schedule.

The model could include strategies for the GP’s practice to streamline information

sharing using the patient held template e.g.:

The GP practice could assign a liaison staff member “to reliably handle this

information”. “Often the [doctor] will provide the regimen but not specify dosage

times”.

“Finding ways of getting that info back into the patients record at the surgery”.

Need to add a process to check concordance between the GP records and the

template as HMR evidence is that GP records do not always match what the

patient does. [Note: the model includes a 6-monthly concordance check].


Three respondents made comments specifically related to improving the draft template

itself. The template may not be the optimal layout and could benefit from professional

design and a style guide on how to record information e.g.:

Half a tablet should be written as “half” not “1/2” as the latter could be mistaken as

one to two tablets. “These simple things can minimise confusion and prevent

medication misadventure.

Using plain English explanations for reasons for use (as the respondent anticipated

that this may not be as well done as the examples on the draft template). The

respondent also had concerns about the use of the phrase “urticarial rash” to

describe an adverse drug reaction (ADR). From a health professional perspective,

this term has specific meaning that would be more informative than “a lumpy, itchy

rash” to a prescriber considering prescribing a penicillin-related medication in the

future. Further developments of the template will need to consider the rationale for

including ADR information and the target audience for such information in any style

guide.

The recording of recent medication changes was of concern to two respondents e.g.

“We would have to be careful of how we have worded the ongoing documentation of

pack changes that appears underneath the current chart “. Completion of this section

by the doctor was suggested.

Additions to the template suggested were:

A column for brand name prescribed (to facilitate concordance checking with GP

records) and to change the column name “Brand Name(s)” to “Brand name packed

or dispensed”.

Add a “Notes to pharmacist – Dr only” column for the doctor to indicate changes to

the regimen such as “increased” or “changed dose” for continuing medications.

There would also need to be blank lines for new medications to be added and these

could be identified by the doctor using the “note to pharmacist column”. The

“Recent Medication Changes” section should be reserved for notification of ceased

medications i.e. called “Recently ceased medications”. This annotated form would

then go to the pharmacist who would amend the profile and provide a new template

to the patients.

Medicare number.

Specific space for carer’s contacts “so that this would act as an additional cue for

doctors/pharmacists to involve carers”.

One respondent also suggested including information about the storage of the drugs at

home, things that should be avoided (e.g. alcohol), possible side effects and to clearly

specify a person to contact, for example: in the event of missing a dose, side effects,

etc. Much of this information, however, would duplicate that of patient information

sources such as CMIs and unnecessarily complicate form whose purpose is to

communicate information to allow information on a patient’s current drug regimen.

Apart from models for funding that included GPs, and technology to assist the

communication, suggestions to facilitate implementation were:

Include the provision and use of the profiles as a standard under the Quality Care

Pharmacy Program (QCPP).

Communicate to “all parties the benefits of maintaining such a template in the

interests of safety, legal protection and value in an emergency situation”.


Incorporation of the production of the patient template into the dispensing process

so that the pharmacist could generate this quickly when processing prescriptions. A

“tick box to generate & notification of the last date it was generated to avoid printing

every time a script is filled” could be included. Another respondent suggested that

an “industry standard for inclusion in DAA software” was needed.

The establishment of a working party to improve the template and associated

communication.

5.2.2.4 Communication of medication changes

Poor communication of medication changes was a problem in phase 2 and was

identified in focus groups, particularly where the responsibility to communicate changes

fell to the patient. A recommendation to record communication about medication

change in writing was included in the best practice model. This would also act as an

audit trail.

The majority of patients (8 of 11 respondents) had their GP communicate medication

changes to their pharmacy. Only 3 of 10 respondents indicated that their GP

communicated ceased medications to them in writing. All patients were satisfied with

their current arrangement for communicating medication changes.

All of the 6 responding community pharmacists felt that this recommendation would be

feasible, two on the condition that an electronic record or the medication chart

produced by the computer were sufficient. Another felt it depended on the doctors

doing their part. Three pharmacists felt recording medication change information would

be beneficial for a safe, effective and efficient DAA service and 4 felt that medication

change records would reduce legal risk although one indicated that this would only be

the case if the communication was in writing and faxed/posted (i.e. hardcopy).

Pharmacists indicated that for most, few changes would be required:

Nil (2 responses); “we already do this and it works well”.

Minimal cost if the medication chart is printed when change occur.

Setting up systems for fax/email would help as all changes are done in consultation

with the doctor but sometimes just verbally.

Make sure all communication from doctors is in writing.

One pharmacist (who preferred electronic records) indicated that implementation was

likely to be difficult if it involved duplicating systems already in place. Another said that

government funding and education would assist with the implementation of this

recommendation. Overall, to meet this best practice recommendation, pharmacists

generally needed only to introduce the medication template and insist that medication

changes are communicated in writing. Only one improvement to the recommendation

was suggested: to make it mandatory for doctors to write and fax or post changes.

The GP who reviewed the community model indicated that she did not communicate

medication changes in writing. This would only be done if the pharmacy had consulted

the GP beforehand and the patient consented and an agreement had been worked out

beforehand.

The views of hospital pharmacists about communicating medication changes have

been incorporated into section 5.2.2.3.


Nine of the respondents to the expert panel questionnaire supported the

recommendation for communication of medication changes in writing as feasible,

promoting safe, effective and efficient DAA services and acting as a legal risk

reduction. In particular, the written communication of changes was felt to assist carers

who would not always be present at a doctor’s visit and yet still be expected to act as a

go between for doctors and pharmacists;

“Carers are often responsible for administering medication at home but are

excluded from the process around decisions related to medications (often on the

basis of ‘Privacy’). A real concern is when medications are cancelled or doses

changed and this is not communicated to the carer”.

Four respondents had some reservations about the recommendation:

“What is being suggested certainly is more complex but some form of a formal

process is certainly required to ensure medication safety and protect all parties”.

As long as there was co-operation from the doctor (2 responses) “Fine if the doctor

accepts that role of providing this information direct to the pharmacist in addition to

a copy going to the patient”.

There were concerns over making the patient responsible to report changes (2

responses) “I would feel very concerned if I relied totally on the patient to inform me

of any changes”.

Several respondents indicated that these practices were already in place with one

writing - “I cannot imagine a pharmacist changing a pack on the direction of the patient

alone so they would already be doing what is required in communication with the GP to

ensure accuracy and to keep risk exposure to a minimum”.

The impacts of this recommendation were felt to be small by 3 respondents who

indicated that these actions were already being done. Others suggested the following

impacts:

Costs associated with the operation of the system and record keeping (4

responses). One respondent indicated that these could be minimised by having a

standard reporting template for use by all pharmacies and another felt that an IT

solution would make the process more effective and efficient.

The pharmacy would need to have good communication with doctors.

Systems would be needed to maintain a good record of changes; “It is important

that whatever system is use can be followed in a chronological order”.

The improvement to the recommendation suggested was to allow an electronic record

or electronic communication. The wording could be changed from “written record” to

“non-verbal record”. Suggestions to assist implementation were to:

Have a standard template.

Include the process in an industry standard for DAA software and procedure

manuals.

Integrating dispensing software with profile maintenance so that a comment

(recording the date, the prescribing doctor and the medication details) is added to

the profile when a new medication is dispensed.

Add this process to the Quality Assurance (QA) cycle.

Include these packing support tasks in the service costing in any payment model.


5.2.2.5 Continuity of patient care between hospital and community

Recommendations in the best practice model also included strategies to improve the

timely flow of medication regimen information and supplies of medications when

community patients were admitted to hospital. The recommendation covered both

information to be provided to the hospital and practices in hospital to facilitate patient

discharge and transfer of care to the community.

As mentioned earlier, the majority of patients were willing to carry a medication

template to hospital with them to assist in the transfer of medication regimen

information.

Communication of discharge information for community patients to the community

pharmacies occurred infrequently; 3 pharmacists reported ‘sometimes’ receiving a

patient discharge summary from hospitals and another 2 had never received discharge

information; only 1 pharmacist reported ‘always’ receiving a discharge summary. In

terms of information flow to hospital, one pharmacist commented “we are always

available to help but often hospital staff don’t contact us”.

All 6 responding pharmacists felt the recommendations were feasible (although one

with a reservation about who would fund it) and three indicated it would be beneficial to

a safe, effective and efficient DAA service. Of the 4 responding pharmacists, 3

indicated that little or no change would be required for their pharmacy to implement this

recommendation. The other pharmacists indicated that the only change would be to

make sure that the medication template used by the pharmacy had enough information

on it for the hospital staff.

The model recommendations were felt to address community pharmacist reservations

about packing a DAA based on discharge information (provided it worked). The only

improvement suggested for the recommendation was that the community pharmacy

receive the information immediately at discharge (if not before). Pharmacy opening

hours were identified as a possible delay or complication for the discharge process

For community patients, the GP commenting on the community model indicated that

she sometimes received a discharge summary but that this was not always timely. The

GP did not communicate new medicines to the pharmacy packing a DAA for a

community patient because the information was received from the hospital too late

(improvements in this area were suggested). The GP did not believe the step of GP-

Community pharmacy communication was necessary as the patient and carer were

responsible for dispensed medicines.

Hospital pharmacists indicated that a discharge summary was always or mostly sent

when a community patient using a DAA was discharged from hospital (in one case,

provided the hospital staff send the patient’s medication to the hospital pharmacy for

finalising). The format of the summary varied:

It was part of the nursing discharge form but often poorly legible.

A discharge prescription that included all current medications (not a discharge

summary).

Discharge summaries were sent to the GP but not to the pharmacist.

Other hospital pharmacist views on patient assessment and the patient-held template

as a communication tool are summarised in sections 5.2.2.1 and 5.2.2.3.


Generally, hospital pharmacists were supportive of the model in Figure 4.7, related to

the continuity of care for DAA users, and felt it would be beneficial in promoting safe,

effective and efficient DAA services. There were concerns or issues about the

recommendations for community patients and residents of RCFs (both included in this

sections as comments from hospital pharmacists refer to both the community and the

RCF best practice models):

Step requiring the GP to contact the community pharmacy to confirm that it was OK

to pack from the discharge list may not be feasible (2 responses).

A lot of the processes for hospital pharmacists were extensions of the normal

process expected in discharging a patient from hospital, however the model was

complex and would need to be refined to a simple stepwise process for the hospital

pharmacist to follow.

The model may suffer from various hospitals’ polices e.g. the need to

unambiguously identify all drugs in a DAA brought to hospital.

There may be problems with staffing to carry out these activities.

One pharmacist questioned the need for the hospital pharmacy to notify the

community pharmacy that an RCF patient had been admitted (see Figure 4.10) as

this was not always feasible and the aged care facilities should have this

information and be able to inform the community pharmacy.

Another pharmacy followed the model on the whole expect that (a) the discharge

summary and medications were faxed by the ward to the GP, (b) the GP was not

asked to give the OK to fill a DAA from the discharge list and (c) if a DAA was in the

ward, the hospital pharmacy filled it and informed the community pharmacy (and

faxed a copy of the prescriptions).

Another pharmacist in a large tertiary hospital that the need to maintain a database

of community pharmacies was beyond their facilities and resources.

The model did not include patient consent to send the medication discharge

summary to the community pharmacy. [Note: consent for this information sharing

would have been included in the tripartisan agreement].

There was a concern as to whether RCF staff could administer medications from a

GP-approved discharge summary [Note: the previous step in the model allows the

GP to give a telephone order to administer medicines]. A global policy/standard

may be needed to address this issue.

Would an alternative model involving nursing and medical staff be needed for sites

without a hospital pharmacist? One pharmacist felt that the model would probably

not work with weekend discharges.

Implementing the draft best practice models would require some work practice changes

and impact on workflow:

The hospital pharmacy would have to send the discharge medication list to the GP

as soon a possible so the list could be approved by the GP before the patient

returned to an RCF.

The level of staffing might need to change.

The models require a change away from focusing on the items needed at discharge

and to improving the quality of care and so may impact on staff mix (need more

qualified staff not just support staff), and staff are not available.

The continuity of care model was also intended to address hospital pharmacists’

concerns about the reliability of medication information (from RCFs, the DAA pack or

the patient template) at patient admission. These concerns were addressed to some


extent (for example, by including the contact details for the GP and community

pharmacist on the template) but more was needed:

Medication regimen information and the patient template needed to be dated of

have another form of version control.

The DAAs themselves needed to be dated and include a description of all

medications (so that individual medications in a multidose pack can be identified). A

way of confirming that a patient had brought all current DAAs to the hospital (and

did not leave one at home, for example) was also needed.

An electronic record would address some of the problems about currency and

responsibility for record maintenance but the template was a good interim measure.

Other areas for improvement for the recommendations about continuity of care or

circumstances that might complicate/delay processes were:

Processes would need to be put into place to address discharges after-hours, on

weekend or public holidays, or in hospitals without a hospital pharmacist.

Processes to support the continued supply of non-PBS medications and packing

these into a DAA.

Remove the pressure for doctors to churn the patients out of hospital as quickly as

possible.

Waiting for the GP to give the “green light” to dispense from a discharge

prescription was not practical and “superfluous”.

A central database of pharmacies, possible Guild-operated that supplied DAAs

would help so that the hospital could arrange a DAA to ensure continuity of supply.

Ten respondents to the expert panel questionnaire indicated that this recommendation

about continuity of care and the model was feasible but most respondents had

reservations. Two respondents indicated that this was already being done, one saying:

“We have established this with our hospitals after a lot of time and consultation. It

works very well when there is goodwill between the pharmacies and the hospitals.

We are trying to suggest that we are involved in admission as well. It is coming

slowly”.

In general, all respondents felt that something needs to be done to communication with

hospitals but that this recommendation was felt to be too ambitious to implement at this

stage of best practice implementation and much more work, relationship building,

active support from hospitals, IT support and resources would be required. The

reservations generally related to:

The need for all parties to co-operate and participate (3 responses).

Only some hospitals consider this information transfer to be a priority when

allocating resources and establishing systems.

Need major changes in hospital systems (3 responses) including simple things like

notifying the pharmacy that a DAA patient has been admitted.

That it would be difficult to co-ordinate discharge days with packing days (2

responses).

The provision of a DAA by a hospital may be a different kind and confuse the

patient.

Requiring GPs to be intermediaries may delay the process and contribute to

errors/re-work.

Would need more staff resources in some hospitals.

The recommendation could become more feasible with the development of information

and communication technologies (ICT).


Because the existing structures and processes needed to support this recommendation

are in their infancy, the impacts of this recommendation on costs and staffing in

establishing the systems were felt to be considerable but future payoffs were

envisaged (4 responses). If recommendations are put in place, success is possible:

“It minimises staff time if done properly as the hospital communicates with us at a

reasonable time to allow discharge procedures to be enacted and we are able to

ensure the patient has the medication available once home. We have a system

that minimises our use of new medication as the hospital arranges discharge

medications to be used until the patient can see their GP. Previously we had

problems with starting new medications on discharge and then the GP did not

agree with the hospital’s recommendation and no one was writing prescriptions for

the medications given on discharge. Once again collaboration between pharmacy

and the hospitals has minimised the waste of medication and the costs to the

community pharmacy”.

Suggestions were made for the improvement of the recommendation:

Make this recommendation an “aspirational standard” rather than one to be met

now.

Make the GP the line of communication with the hospital.

Recommend a database of pharmacy DAA providers on the Guild QCP website.

Integrate or replace with an HMR on discharge from hospital. The timing of the

HMR would be critical.

In using GPs an as intermediary on discharge, change Figure 4.7 to allow s number

of ‘OR’ scenarios “i.e. do this ‘or’ if this cannot be done, do this….”.

To support implementation, the support of state health departments and others would

be required. Implementation of this DAA aspect with existing projects to support

continuity of care would be helpful (e.g. Queensland Health initiatives, the General

Practice Aged Care Quality Use of Medicines (GPAC QUM) project). Funding might

arise through co-ordination of care.

5.2.2.6 Quality control (QC) and quality assurance (QA) for packing, checking

and communication

Recommendations related to assuring quality in the processes related to packing and

checking were included in the community best practice model (and in the RCF model).

The recommendations included quality control and monitoring, patient education about

drug storage and issues related to the stability of medicines packed into a DAA.

All six responding pharmacists felt that record keeping and monitoring would promote

safe and efficient DAA services and act as legal risk reduction. Little change would be

required to implement the recommendation; one pharmacy already fulfilled the

requirements of the recommendation. Another documented errors but did not always

coach the staff member as errors were uncommon and “just silly mistakes”. One

pharmacists reported that implementing the QA and QC recommendation would

require “more paper work” and another felt that monitoring would not be possible in a

community pharmacy. In referring to recommendations about drug stability, this

pharmacist commented that “bodies outside the pharmacy [were needed] to set and

research this for us”.

No improvements were suggested to the proposed QA and QC recommendations in

the models but guidelines and more manufacturer information (2 responses) on short


term stability in DAAs (including co-operation between DAA and drug manufactures)

were felt to be helpful in implementing the recommendations.

All thirteen respondents to the expert panel questionnaire agreed that record keeping

and monitoring can be beneficial in promoting safe, effective and efficient DAA

services, and be a form of legal risk-reduction. Other benefits of record keeping and

monitoring recommendations were that:

They encouraged the QA cycle.

They provided a structured framework.

Records can help measure trends (2 responses);

“We have incident reporting and staff procedures in place to identify areas of risk.

In terms of QA we have identified problem drugs e.g. Epilim disintegration; work

issues e.g. ergonomics of bench height etc. We document these issues and

ensure all staff are aware of the procedures we undertake to minimise the

problems”.

The main impacts of this recommendation and the changes that would need to be

made to existing QC and QA processes were:

Costs (5 responses), particularly initial development, documentation and

implementation. On-going costs would be less.

The costs could be off-set (3 responses) by risk reduction and minimisation of

return of unusable medication or rework.

Having appropriate staffing (“preferably a DA who is task-oriented with good

attention to detail and a heart for aged care, properly trained and involved at least

one day per week in packing DAAs and updating records, uninterrupted by other

pharmacy duties”).

Suggestions for improvement in the recommendation and possible tools or process

guides that would be helpful were:

Make the reporting of suspected instability, the use of the ADRAC-type report the

responsibility of TGA not PSA (2 responses). This could be implemented on the

TGA website in a way similar to on-line ADRAC reporting.

Include standards and guidelines and QCPP standards (2 responses). There needs

to be a checklist with specific points stated to reduce the interpretation needed by

assessors (include ‘doing’ words in the standards).

Provide templates for audits (2 responses) “it would then be a matter of determining

what the quality indicators and benchmarks [should be measured and explain] how

to assess gaps and what processes we might suggest to remedy or close out any

identified deficiencies”.

Add another strategy to get stability information along the lines that specific data on

stability of a product in DAAs needs to be provided to TGA by the medication

sponsor and form part of the formal registration/marketing approval process.

Recommend that stability information in texts such as the Australian

Pharmaceutical Formulary (APF) and Australian Medicines Handbook (AMH), etc,

be continually updated.

Workshops including train-the-trainer (for in-house staff training) could be

developed to support this recommendation.

Guidelines or procedures related to ‘education’ of patients/carers that including

what should be provided and how.


Other comments in relation to implementation were:

Quality control, assurance and monitoring procedures “should be both pharmacists’

responsibility and DAA suppliers’ responsibility to develop and provide policies and

procedures respectively”.

The costs for QC, QA and monitoring could be averaged across the fee charged.

QCP standards are needed to reduce variation and ad hoc supply of DAAs; “If a

pharmacy is not interested in maintaining high standards of professionalism in

providing a DAA service then they should not be approved to supply DAAs”.

Future developments in both packing technology and information technology could

improve the efficiency of these processes by integrating automation with electronic

networks and would be in line with government policies.

Integration of some of the QC, QA and monitoring activities with existing programs

such as the dispensing software or adapting ePocathary (see

https://www.epothecary.com.au/?CurrentPersonID=0&CurrentPharmacyID=0&Curr

entUserID=0&MenuID=0&Digest=ge1Yqi2YDjXO4VW/1cHlYA) might increase

cost-effectiveness of these recommendations.

“Incorporation of the necessary monitoring and reporting feature into dispensing

systems may be more cost effective than trying to deal with all the packaging

system. The reason I suggest this is that these systems and providers

understand what is required and save for maybe a few things, it is possible in

most systems to put in the required information and be able to pull the necessary

fields to enable report production”.

5.2.2.7 Efficiency in pharmacy procedures (prescription management, packing

procedures and staff roles)

The community best practice model included recommendations aimed at increasing

efficiency in the pharmacy include ensuring that prescriptions are available when



Many pharmacies store patient repeats as part of processes to ensure prescriptions

are available when they are needed during the packing cycle as part of their

prescription management activities to support packing DAAs. All community patients

reported that their pharmacies manage their prescriptions for them and all had repeat

prescriptions stored at the pharmacy. The majority of patients (7) had their pharmacy

follow up repeat prescriptions with their GP.

All seven community pharmacists felt that the recommendations for pharmacy

procedures promoted safe and efficient DAA services. Two pharmacists indicated that

implementing this recommendation would not require any change while two others

indicated possible increased staffing time and costs, one saying that packing was not

possible under a pressured environment and that the packer must not be disturbed to

minimise mistakes. Another pharmacist indicated a positive impact, saying it was

“timely to record [the] amount of medication … and repeats available”. Only one

suggestion to improve the recommendations was given: to include the role of staff

rotation with packing to reduce occupational, health and safety issues.

Thirteen people responded to the question on the expert panel questionnaire about

whether the recommendations would promote safe, effective and efficient DAA


services; eleven agreed. An example of improved efficiency was offered by one

respondent:

“We have put a lot of energy into this area over the past six months as the doctors

have been so unhappy about the amount of prescription requests. We are using

our dispensing software reports more efficiently now to produce cumulative reports

for the doctors. There is an ability in Medical Director ™ for the doctors to be more

aware of what prescriptions a patient is about to need as well but very few doctors

are computer compliant enough to use this. I have many discussions with doctors

to explain that we are trying to minimise their time in writing scripts but that they

may need to override Medical Director’s prompts that say it is too soon for a drug

as we try to ask for all the meds that will be needed in the next fortnight”.

Two respondents had questioned parts of the statement:

One respondent wanted evidence for the statement that dispensary technicians

were more efficient [In Figure 4.11 and Table 9.5 in the Phase 2 report (Ientile et al.

2004)], dispensary technicians took less time per pack and cost less per hour than

pharmacists].

Another respondent did not believe that it should be assumed that prescription

management was the responsibility of the pharmacy. This happened by default as a

“result of there being no other way of getting prescriptions in a timely manner” and

pharmacists did this “to avoid the risk of owing prescriptions and not being paid by

the HIC”. A simpler method to ensure continuity of care could be developed where

a medication profile was acceptable for 3 months and then reviewed.

The main impacts of these recommendations were felt to be costs related to staff time

but these were again off-set by savings and reduction in errors, rework and stress:

“If you get it to work efficiently it actually reduces costs as you print a regular

request report rather than many individual requests. The pharmacist does not need

to be writing requests at the time of dispensing as the report identifies all the

scripts needed from the patient history. It speeds up dispensing, minimises

paperwork” and reduces the frequency the pharmacy interrupts GPs with

prescription requests.

One respondent felt that implementing these recommendations would be challenging

for pharmacies providing a DAA service without all the “bells and whistles”, while

another respondent felt that an IT approach would assist greatly.

Improvements to the recommendations suggested were:

Changing the phrase “The pharmacy should have ……to ensure that prescriptions

are available” to a phrase that does not assume continuity of prescriptions is a

pharmacy responsibility; it is that of the patient and prescriber as well.

Changing the flow chart in Figure 4.1 to allow flexibility in whether a pharmacist or a

technician would pack a DAA.

“I do not agree with implied statement and in flow chart that it is not the

pharmacist’s role to pack DAA – should allow flexibility for processes dependent

on individual pharmacies”.

The recommendation needs to state more of the specific tasks involved so that

these can be incorporated into checklists to aid implementation. Alternatively, the

detail could be provided by PSA guidelines.

Include some “suggestions as to what might constitute relevant quality indicators

and benchmarks”.


The development of training materials for packing was mentioned in 5.2.2.6 and

these would also apply here. [Note: the somewhat limited and varied training

reported by dispensary technicians in 3.1.3 would support more structured training].

Modifying the draft prescription request form to include a column number for the

repeat number last dispensed and to calculate the ‘number left till new prescription’

as including any tablets/capsules in the current original pack plus those on any

remaining repeats (but excluding those in the current DAA).

Using the full patient profile as the prescription request form by marking those items

on the profile for which a prescription is requested. This would streamline the

process for the GP by having the full profile at the time of writing each prescription

and also allow ongoing medication review by the GP.

As software that avoided re-keying of profile information is needed, the best

practice model could include a recommendation for the pharmacy profession to

establish standards and standard protocols that would enable software vendors to

produce software that facilitates compliance with any future DAA standards. [Note:

this recommendation could apply to more than one of the sections of the

preliminary best practice model].

One respondent suggested changes not specifically to the recommendation but to the

system of PBS prescriptions underpinning it:

“Change to a prescription/chart in one concept”.

“Simplify the prescription writing process by allowing a prescription say in PDF

format to be acceptable for payment. ….. Imagine emailing the doctor a new

prescription is needed and a few minutes later the prescription arrives via email, is

printed and filed in the pharmacy”.

5.2.2.8 Fair payment for DAA services

The draft best practice model included a recommendation to improve the cost-

effectiveness of the service i.e. that pharmacists negotiate a fair price for the service

and targeting the service to only those patients who will benefit rather than those using

the device as a convenience.

Community patients pay varying amounts for a DAA service, but the average price paid

in Phase 2 ($3.50/week) did not approach the cost of providing the service. In

commenting on the model, two community patients of 9 respondents said they would

consider ceasing their DAA service if the price increased. Patients reported that they

would be unable to continue to get their DAA service if the price was between $3 and

$30/week (average $9.06 and median $6.40, n=7). The most commonly reported price

at which patients reported they would cease using DAAs was $3 and if the price was

over $7.50/week, all but 2 would stop using DAAs. Thus, even at the upper limit of

patient perceptions of fair price, the pharmacy is unlikely to be compensated

commensurate to the actual cost of DAA provision.

All pharmacists felt that the best practice model for community patients should include

recommendations about fair payment for the DAA service. Pharmacists had mixed

reactions to the impact of charging a fair price for DAAs. One felt that the impact was

would be minimal if it was a ‘fair’ price while another already charged a realistic price

for packs and that this had posed no problems thus far. Two pharmacists indicated that

patients would not use DAAs (i.e. the ‘fair’ price would be too high if it approached the

true cost). One of these pharmacists indicated that the cost needed to be considered in


the context that providing DAAs was a community service and also increased

prescription trade. One pharmacists said that $4 was not a realistic price and that

DAAs should be paid for by the government or through a Medicare rebate. Another

pharmacist felt that fair pricing would result in greater uptake of DAAs.

Eleven of the 15 respondents to the expert panel questionnaire question about the

inclusion of ‘fair payment’ as a recommendation explicitly agreed that it should be

included, for instance:

“Fair payment = Fair service. An acceptable service needs acceptable levels of

staff, equipment and space. These cost money. The service will not be sustained

without a fair payment for services, that includes some profit”.

“Sustainability and equity of access is contingent on reasonable remuneration”.

Two respondents disagreed that fair payment was a best practice issue and another

two had concerns over the wording of the section:

Rather than the term “fair payment” which could be seen as combative or

contentious, the phrase “mutually agreed remuneration” recognises the spirit of

two-way negotiation.

The wording “patients need to recognise that this is a service provided by

pharmacy that is labour intensive and costly” should be handled more sensitively.

“The reverse is also true: pharmacists/GPs need to recognise that these

patients are vulnerable people that they have a professional responsibility to

assist them. Many patients/carers are under considerable financial strain due to

the cost of illness – this needs to acknowledged and doctors/pharmacists need

to be reminded of this fact. What may seem like only a few dollars is often of

huge consequence to people on limited means”.

A policy was needed so that a person was not denied access to the service if they

were unable to pay.

The impact of negotiating a realistic price for DAAs was felt to be:

Improved service quality through better resourcing by 5 respondents:

“A fair price would allow introduction of quality systems in all pharmacies who

pack DAAs. Some pharmacies currently charge little or nothing and resent any

extra time spent on the activity. This would ensure a better quality service to

patients with more safeguards”.

It would “enable service providers to properly staff and equip the service, and

provide a motivator to source suitable staff and train them”.

Increasing access (2 responses) by:

Encouraging “participation by pharmacists who otherwise cannot see the

economic value of providing such a service”.

Increasing the ability for a person’s preferred Pharmacy to meet a patient’s DAA

needs rather than having to use a different pharmacy that provided DAAs.

Fostering the development of specialist pharmacies involved in HMR, RMMR and

DAA services.

“It would reward the pharmacist who provides this service now”.

Three respondents answered this question assuming that the fair price referred to a

government subsidised price. One respondent felt that subsidising the service “under

PBS (including a small co-payment if necessary) or RPBS” may not result in a price “as

realistic as sought but would definitely be more acceptable by the majority”. The other


two respondents felt that government subsidy would promote equity of access, making

the service available to those in need who would otherwise not afford to pay for it.

“Why should people be unable to source the service because they cannot afford to

pay when the consequence of non-compliance could be hospitalisation? It makes

good common sense for this service to be properly funded”.

“Many of my community patients are mental health, dementia, homeless or in

rehab (drug and alcohol). They really have no money except their weekly pension

and are hopeless with managing finances…. Many of my seniors struggle with the

costs of their medication and our weekly fee but once again several of them are

poor money managers“.

Because of this issue on money management, this respondent felt that any funding for

a DAA “needs to go to either the pharmacy or to an appropriate manger for many of the

community patients I have”.

5.2.2.9 Monitoring and care of DAA patients

The community best practice model included a recommendation to monitor patients’

ability to use a DAA initially, when they were starting a DAA and on an ongoing basis.

This monitoring should include at least quarterly consultations with the GP, the

provision of medication information by the pharmacist and monitoring of compliance by

returning DAAs. Bi-annual re-assessment of medication management ability,

medication knowledge and concordance with medication regimen records (patient, GP

and pharmacy) was suggested.

All community patients commenting on the model reported that they saw their GP at

least once every 3 months. Nine of 11 patients were willing to return their used DAAs to

the pharmacy for monitoring. The patients unwilling to return their DAAs stated that

they felt it was unnecessary as they were capable of managing the DAA alone. [Note:

These responses suggest that the two patients did not have a medication management

ability deficit of sufficient level to warrant such a costly intervention]. Patients (9 of 11)

generally were also willing to allow their pharmacist/GP to conduct 6 monthly reviews

of their medication management ability, including home visits if necessary.

Three of the 7 responding community pharmacist felt that recommendations for

monitoring and care of DAA patients were feasible and two were already doing this

(e.g. visiting most of the DAA service patients at home and monitoring). One

pharmacist expressed a reservation that it could be difficult to get the GP involved.

Three pharmacists felt that the recommendations were not feasible, because:

Monitoring should be done by either the community nurse or the patient’s carer.

People did not return packs to the pharmacy (1 response) or that it was difficult to

detect the return of unused packs unless advised by a family member or carer (1

response).

Monitoring patients who needed to see a doctor was difficult and time consuming.

The GP commenting on the model indicated that she would only be willing to carry out

6-monthly concordance checks of drug regimen records if the patient consented and if

she had agreed to an appropriate fee.

Two community pharmacists would not have to make changes to implement these

recommendations. Other pharmacists reported that changes they would need to make

or the impacts of implementing the monitoring recommendations were:


Possibly needing to employ extra staff to perform the activity, or more staff time (2

responses).

Needing to visit patients in their homes.

The cost of replacing the pharmacist while the home visit was conducted.

Getting the GPs involved.

Arranging to receive all packs back from patients.

Creating a monitoring chart to check patients’ visits to GPs and to the pharmacy for

counselling.

Nine of the 12 respondents to the expert panel questionnaire felt that recommendations

for monitoring and care of DAA patients were feasible with two respondents indicating

that some of these recommendations were already in place. The main barrier foreseen

was one of cost (2 responses). Another felt that the impact would be minimal as

patients were visited each week:

“My staff who visit each week are trained to look for problems plus the GPs have a

system of recall for the patients when they feel they need to see them. Some GPs

send us a note that they will not write any more scripts till the patient see them. We

try to persuade GPs that it is their role to call the patient in”.

One respondent suggested that ongoing patient monitoring could be included in a more

regular HMR or other structured care plan monitoring and another agreed that an

”HMR (or a variation of it) might be the best way to ensure the check is performed”.

Six-monthly concordance checks were supported by 9 of the 13 respondents to the

expert panel questionnaire. Two conditionally agreed and two disagreed with the

following explanations:

Yes, if the patient agreed and if the privacy issues about information sharing in the

event of non-concordance were addressed (i.e. patient consented to information

sharing).

Yes, in an ideal world.

“this would be an onerous task for large organisations to undertake. I currently

pack [many hundreds of] packs a week and to conduct an audit every 6 months

of all of these packs would have a huge staff implication. If there was a way for

the software manufacturers to identify which patients have not had any

interventions for the past 6 months then that would be of use. Currently my

patient medication profiles all sit in a Microsoft word format and there would be

no report that I could run to identify the patients in need of audit”.

Was there evidence that a 6 month check was needed? Also, the terminology

“concordance” may not be appropriate as it implies patient acceptance.

Based on the experiences on one respondent “a review every three months would

be safer and this could simply mean a GP refreshing the profile and sending copies

to the pharmacy every three months as they do in aged care facilities when they re-

write the medication charts”.

Suggestions for improvement of the recommendation were:

To change the statement about the patient seeing the GP at least once every 3

months to “once every 3 months or as recommended by the GP”.

The regular re-assessment should be part of a formal review process with direct

discussion with the patient or carer. The pharmacist could retain the initial

structured assessment and repeat elements of this as a measure of service impact.

If these assessments were entered into a central database, this could provide


information on which to base any revisions to eligibility criteria or evaluating effects

of DAA provision.

A carer could assist with on-going monitoring. An easy reference guide on who to

call under what circumstances would be helpful to carers in performing this role.

One respondent suggested training and information provided through Divisions of

General Practice (possible the aged care panels) and other programs (e.g. the

Medication Management Review (MMR) Facilitator program) could facilitate

implementation.

5.2.2.10 Role of GPs in community DAA best practice

The community DAA best practice model involves the patient’s GP in a number of key

steps. Community pharmacists were asked to what extent those GPs the pharmacist

interacted with in relation to DAAs were already following the best practice processes

described in the preliminary model. One pharmacist said GPs rarely followed best

practice processes while another indicated that GPs mostly followed best practice; the

majority of pharmacists (5) indicated that GPs sometimes followed best practice, one

suggesting that there was a “need to educate the GP to be more diligent”.

Five community pharmacists said that the GP was central or vital to DAA best practice

or that it was imperative to maintain a good relationship with the GP. This pharmacist

suggested that the best practice model supported a good relationship as the

requirements and the “turf issues” had been addressed. One pharmacist indicated that

the GP role in the best practice model was feasible but payment would be needed for

GPs to be interested.

Four of the eight hospital pharmacists indicated that the GP was central or vital to DAA

best practice or that recommendations involving GPs seemed feasible; “the GPs are

important as they maintain treatment for the patient”. One respondent felt that the

model was as applicable to GPs as to pharmacists and that “They (GPs) are pivotal to

the successful application of this kind of best practice model….. the well used “Silo

system” of patient management is gone and now requires integration of care – anything

else is a waste of time. Luckily the current health environment is moving more and

more towards collaborative practice – a definite plus for this kind of model”.

Hospital pharmacists did identify conflicts with the premise that the GP was central to

the component of the model about continuity of care because of factors such as access

to GPs, the timeliness of response and other GP practices:

“it will be difficult for them to direct therapy when not visiting the RCFs”.

“with multi-practitioner surgeries, it can be hard to pin down the exact doctor

responsible”.

Usually the GP can’t react fast enough for the DAA to be produced in time. GPs

usually like to see the patient before confirming medication, and don’t like being used

as a ‘rubber stamp’.

A failure of hospital medical staff to inform a GP in a timely way that their patient is to

be discharged. This duty might fall then to hospital pharmacists or nurses but there

was concern that GPs might question the validity of medication regimen information

from a non-medical source.

Would a GP contact the community pharmacist as required by the model to confirm

the medication regimen to be packed?


One hospital pharmacist suggested that the central role was that of the community

pharmacy; the GP needed to be contactable.

The GP recommendations may become more feasible with electronic discharge

summaries.

From responses to the expert panel questionnaire, the role of the GP in a DAA service

for community patients was felt to be central but not pivotal to the service by 6

respondents:

“GPs can initiate the DAA and provide the information as to what the treatment is”.

“GPs are central. However, when not available nurses and pharmacist would need

to make decisions, based on an agreed set of guidelines”.

“Central role for GPs. Not pivotal, but would be optimal”

“The GPs role is the cornerstone or reference point for the flows of information,

prescriptions, etc”.

Two other respondents pointed to reduced access to DAA services and

delays/inefficiencies were the GP to have a gatekeeper role and experiences with the

HMR program show that sole access via the GP can make take up difficult, especially

given the time constraints GPs already faced. Two other respondents felt that

recommendations involving GPs were unlikely to occur without GP remuneration.

Conversely, another respondent cited GP support but that GP experienced frustration

about prescription writing demands.

Several strategies were suggested to improve the interaction between community

pharmacies providing DAAs and GPs providing care to community patients:

Remove any statements or inferences that GPs are gatekeeper (2 responses), but

“need to work with GP stakeholder groups to inform of benefits to patient of their

cooperation”.

Fund GP activities associated with DAAs.

“Co-operation in setting up the communication model is the most important aspect

of best practice”.

“Removing some of the frustrating inefficiencies associated with prescription

management … would help to both overcome barriers and to reduce costs”.

“I would like to have a better understanding of the medical prescribing software so

that I can help the GPs set up their software for these patients better”.

The model “has to be owned somehow by GPs practicing in this area. The

Divisions of General Practice in my opinion may be the best avenues to take this to

GPs”.

“Our mindset about DAAs needs to change. It is perceived as a bit of a hassle”.

“GPs will probably want options rather than be obligated to tasks or one particular

way”.

5.2.3 VIEWS ON THE BEST PRACTICE MODEL IN THE RESIDENTIAL CARE SETTING

As seen for the community model, responses to the RCF best practice model were

generally positive but some questions were raised as to feasibility and utility, and

several areas where revision would be required were identified. In comparing current

practice and best practice DAA provision in the community setting, changes were

required in most aspects covered by best practice guidelines. In particular, significant

changes would be required in relation to continuity of care between hospital and RCFs,

and communication of medication changes. The use of information and communication

technologies and changes to regulations allowing RCF medication charts to be used as


a prescription for PBS payment were strategies commonly felt to improve sharing of

accurate medication regimen information and the efficiency of DAA supply.

As an indication of the extent of practice change in terms of the activities undertaken in

providing DAAs, Table 5.5 summaries reports of DONs from RCFs, GPs and

community pharmacists about on who currently undertakes the various activities and

beliefs about who should be doing the activity. GPs, DONs and pharmacists did not

necessarily respond about the same RCF or DAA service provided by a community

pharmacy.

In comparing reports of which health care provider performs a DAA activity against

beliefs of who should perform each activity (Table 5.5), it is evident that greater GP

involvement was felt to be desirable by DONs, often by GPs and for some activities, by

community pharmacists:

DONs believed GPs should be more involved with assessing medication abilities of

self-medicating residents with a current rate of 22% indicating GP involvement

versus 75% of DONs indicating GPs should be involved. The latter rate was higher

that the rate of GP involvement GPs thought was desirable (57%).

Greater GP involvement in ensuring the pharmacy had a current medication record

for residents was sought be all groups of respondents and at about the same rate

(33-43%). DONs believed that RCFs were currently the main group performing this

activity and some DONs preferred no RCF involvement. Community pharmacists

believed they were the only current performer of this activity and that others should

also be involved.

In deciding what should be packed in the DAA, DONs wanted more RCF

involvement and GPs preferred more involvement in these decisions at times. All

community pharmacists indicated that they were currently and should be involved in

this activity.

Deciding on the optimal schedule for a medication regimen was the activity with the

greatest variety of responses. DONs felt that slightly less pharmacy involvement

and more involvement from others was desirable while GPs and pharmacists felt

that less RCF involvement was preferred; GPs also wanted more GP and

pharmacist input.

Again, nearly all respondents believed that storing repeat prescriptions was and

should be a pharmacy role but this was not seen as incompatible with other

prescription management activities (making sure prescriptions were available and

informing the doctor when repeats were required) being done by non-pharmacists.

Specific feedback from DONs, residents (where there was likely to be direct impact on

residents), community pharmacists, GPs, expert panel members and others on the

various sections of the RCF DAA service best practice model is summarized in the

following sections. Comments from hospital pharmacists related to both community and

RCF based patients and have been included in the previous sections about the

community model.


Table 5.5 Comparison of views on who does and who should do tasks associated with the use of DAAs in RCFs

DAA Tasks for an RCF DON Done now (n=9) Should do (n=8) GP Done now Should do (n=7) Pharmacist Done now Should do (n=3)

Assess a self-medicatingresident’s ability to use a DAA

RCF: 44% RCF+GP: 22% N/A: 22%

RCF+GP: 50% N/A:25%GP: 25%

RCF: 29% RCF+GP: 43% N/A: 14% GP: 14%

RCF: 29% RCF+GP: 43% N/A: 14%

GP+Pharm: 14%

RCF: 66%

GP: 33%

RCF: 33%

GP: 33%

Ensure that the pharmacy has a current and complete record of the residents medicines

RCF: 78% Pharm+RCF: 22%

RCF: 25% Pharm+RCF: 25% GP+RCF: 25% GP: 13% Pharm 13%

RCF: 29% Pharm+RCF: 14% GP+RCF: 29%

Pharm: 14% Patient or RCF: 14%

RCF: 43%

GP+RCF: 29% GP: 14% Pharm: 14% Pharm: 100%

Pharm+RCF: 33%

Pharm: 33%

Pharm+RCF+GP: 33% Decide what should be packed in the DAA

Pharm: 67% RCF: 11% Pharm+RCF+GP: 11%

Pharm: 50%

Pharm+RCF+GP: 13% Pharm+RCF: 25%

Pharm: 57%

GP: 14% Pharm+/-GP: 14%

Pharm: 43%

GP: 29% Pharm+/-GP: 14%

Pharm: 100% Pharm: 100%

Decide what is the optimal schedule for the resident (times of day for each medicine)

Pharm: 33% Pharm+RCF: 11% GP+Pharm: 11% Pharm+RCF+GP: 22% GP: 11% RCF+GP:11%

Pharm: 25% Pharm+RCF: 25%

Pharm+RCF+GP: 13% GP: 25% RCF+GP:13%

Pharm: 29%

Pharm+RCF+GP: 14% GP: 29% RCF+GP: 14% RCF: 14%

Pharm: 29%

GP+Pharm: 14% Pharm+RCF+GP: 14% GP: 29% RCF+GP: 14%

Pharm: 33%

GP+Pharm: 33%

RCF: 33%

Pharm: 66%**

GP+Pharm: 33%

(** consult with RCF/ patient (1 case))

Store the residents repeat prescriptions

Pharm: 100% Pharm: 100% Pharm: 100% Pharm: 86% RCF or Pharm: 14%


Tell the pharmacy about changes to residents’ medicines

RCF: 89% RCF+GP: 11%

RCF: 63% RCF+GP: 13% GP: 25%


RCF: 14% RCF+GP: 57% GP: 29%



Making sure prescriptions are available to ensure continuity of supply of packed medicines

Pharm: 78% Pharm+GP: 11% Pharm+GP+RCF: 11%

Pharm: 75% Pharm+GP: 25%


Pharm+RCF: 14%


RCF: 14%


GP? (unsure): 33% Inform the doctor when a repeat prescription is required


Pharm: 63% Pharm+RCF: 25% GP: 13%


Pharm: 86%

RCF: 14%



5.2.3.1 Tendering for DAA services

The first recommendation in the RCF best practice model for DAA services concerned

a tendering process that addressed issues to be considered including those of

payment.

The best practice model of tendering for DAA services was felt to be feasible by seven

of the eight respondents to the DON questionnaire; four indicated that something

similar was already in place. One DON said that systems would improve over time

while another indicated that the clear outline of expectations would “help ensure that

both the RCF and DAA service provider will be satisfied with the outcome”. One DON

questioned the feasibility saying that extra time and money would be needed to

implement the models. The quality assurance (QA) processes were felt to be feasible

by all 9 DONs; several already had systems in place (e.g. a weekly audit for errors,

monitoring pharmacy deliveries) and another felt it was desirable to add QA processes

directly related to the DAA service to the set of QA processes already externally

audited. One DON questioned whether the RCF would audit processes internally and

who would be the external assessors.

The DONs felt the impacts of implementing the model or changes that would need to

be made in their facility were:

Discussion of the model with current providers and if receptive, set up a service

agreement as well as setting up a QA monitoring and external checking service.

The understanding of relatives and carers who could not understand the billing

processes.

The implementation of audits targeting DAA activities potentially had extra costs for

staff to do audits, benchmarking and any education to correct problems identified.

Staff training would be required including training of the medication committee.

More time required to enter QA data (needs to be done daily).

Two DONs felt that there would be little local impact because tendering was done

centrally. Another DON said that the impact on the RCF would be minimal because the

pharmacist already did it “at his own expense”.

Suggested improvements to the best practice tendering model made by DONs

included:

RCF should pay for packing (2 responses). Where an RCF initiates use of DAAs,

the RCF should bear the cost. This stance may be supported by the Aged Care

legislation in relation to high care residents and should be checked.

A recognition that use of DAAs were not just a cost issue but also about quality

care. DAAs helped reduce errors and medication administration time for RNs and

made it easier to audit for mistakes, errors or underhand behaviour of staff.

Limiting resident payment or contribution for DAAs to self-medicating residents.

Funding by the government to ensure all RCFs comply.

That packaging is a pharmacy cost.

Adding a requirement for regular review of procedures and policies for DAA supply.

All community pharmacists indicated that the model and recommendations related to

tendering were feasible and as many pharmacies already tendered, there would be

little cost or staffing impacts for pharmacies. The main impact pharmacists identified

related to RCFs typically having little understanding of the true costs incurred by

pharmacies and a perception that RCFs were not prepared to pay. All community


pharmacists also felt that the aspect of the model relating to monitoring and quality

assurance (QA) were feasible with one indicating these activities were already

performed in his pharmacy. Another pharmacist indicated that some additional

resources (extra staff) would be required to perform these activities and that needed to

be streamlined so that they were not too cumbersome in paper. Suggested

improvements to the tendering recommendation and model were:

Government funding for DAA provision.

Some payment by the patient’s family for provision of the DAA service.

A need to focus on quality rather than just price in the tendering process.

From the GP perspective, 3 of the 7 responding GPs felt that participating in the

tendering process for DAA provision would provide no real benefits to them. One

doctor noted that while some overall medical involvement and some training of GPs

about the service would seem appropriate, for the facility to include each individual

doctor would be a ‘nightmare’. In addition, one respondent indicated they “don’t feel

(its) my place to interfere with business negotiations”. Three GPs listed benefits of

involvement namely: medical input/ knowledge of the type of DAA to be used and an

awareness/discussion of the obligations of the doctor. One GP suggested rather than

individualised contracts and service agreements (see also 5.2.3.2) between the

pharmacy and RCF where the GP was to be aware of the variations for each of the

RCFs attended, a standardised statement of service provision across all pharmacies

would be preferred by GPs. These views were similar to those expressed by GPs

associated with the aged care program in a division of general practice. Contracting

was felt to be a commercial decision not involving GPs, however, some input and

consultation with GPs (the most likely scenario would be through GP representation on

a Medication Advisory Committee) would be helpful:

“GPs see some benefit in being involved in discussions regarding the impact on

their work practices – one GP expressed extreme frustration at being asked to re-

write all patient charts when the RCF changed Pharmacy provider”.

“It is widely felt that the GPs should be informed of the Pharmacy service used”.

This information should include who is providing medication supply services and

who is providing Residential Medication Management Reviews (RMMRs)

(especially if different providers), appropriate contact person and contact

information and where to fax or mailing prescriptions and GP requirements with

regard to medication charts.

Six of the eight people who answered the question in the expert panel questionnaire

about the feasibility of the model and recommendations related to tendering felt that

these were feasible:

“It is good to make [the elements] transparent to all parties, so that they see the

true cost of the service”.

“They…provide an education tool that explains the complexities of the whole thing”.

“The model is feasible as long as adequate remuneration and/or a reduction in the

administrative overheads associated with management of prescriptions is

addressed”.

Tendering was already felt to be widespread but only some contracts with RCFs were

done via tender; “The requirement specifically in the Accreditation guidelines is that the

facility should pay for services at a price that reflects the market status. Some RCF’s

have interpreted this as a need to ‘tender’ but that is not a requirement”.


Two respondents to the expert panel questionnaire had concerns about the use of

tendering – “Like all ‘tenders’ the emphasis tends to be on price” with the final decision

on the preferred service provider being made by the financial controller (who is not

always aware of the “inadequacies of a substandard service and the potential health

and safety risks to the residents”) rather than someone who fully understands the

implications of service quality. One respondent wrote that RCFs assume all providers

will give a ‘professional’ service as part of their professional obligation so that only price

mattered and, “[RCFs] have an unrealistic view of pharmacists’ profit from prescriptions

and have historically kept the price below the costs of delivering a quality service”. This

“ultimately leads to poor quality service and failure to meet best practice standards and

a dilution of the potential benefits”. Tendering was also felt to have the potential to

create an environment where RCFs would not use local pharmacies, selecting more

distant providers who offered a cheaper service and could mean that only “big players”

in the provision of DAAs would survive.

An improvement suggested to this recommendation about tendering was an increased

emphasis that in any tender, the quality of the service should be the first basis of

assessment; “Ideally the service would be decided on the basis of the focus on patient

care, quality systems and sustainability of the service and not paid out of the RCF

funds”. Sample contracts were also needed.

Other changes suggested included:

Increasing the awareness of RCFs about what constitutes a quality service and that

it is necessary to pay a reasonable price to adequately resource such a service.

“The argument should be put to the facility that in cost-benefit terms this will save

them money”.

Using a term other than “fair price” which assumes the current fee to pharmacy is

not fair. A phrase like “mutually agreed remuneration” would be less presumptive.

Add geographical criteria i.e. that a DAA provider should be within a certain

distance of the RCF to the tendering criteria.

“Design of forms for pharmacist to enter their information, and not feel

overwhelmed when they have to develop and economic framework for working out

their costs”.

The aspect of the model relating to monitoring and quality assurance (QA) was seen as

feasible by five of the 10 people providing comments about this aspect of the

recommendation. Two respondents felt that this was feasible because systems were

already in place; in one instance, reports on these kinds of quality indicators were

made to a facility’s Medication Advisory Committee (MAC). However improvement in

these systems was needed “RCF’s are often in need of improving their quality systems

… Pharmacists need more encouragement and better training in how to keep records

of interventions”. One respondent had reservations about the feasibility of external

assessment based on experiences to date of aged care assessors and QCPP

assessors:

“In the majority they come with their own preconceived ideas and whimsical ways

…. Until we can make assessment and accreditation standards and people who

perform this work into uniform people delivering a role then I am a sceptic of this

process”.

The monitoring and QA aspects were felt to potentially impact on pharmacy costs

(through additional staff time) (2 responses) but this could be minimized by building


these activities into existing systems and facilitated by an IT approach. Three

improvements were suggested:

“Nursing Home accreditation should link into this process and should be based on

quality”.

“There needs to be some cross communication between the aged care and

pharmacy assessors with significant penalties applied if parties are non-compliant.

Currently aged care assessors can apply sanctions to RCFs. This may also need to

be considered if pharmacists are non-compliant with standards”.

“In the Community Pharmacy-RCF loop somewhere there should be mention made

of the feedback on the whole DAA/medication management process from the

reporting of the accredited pharmacist doing the RMMRs , especially if this person

is different from the community pharmacy”.

Sample templates were needed.

Other expert panel comments on the tendering recommendation related to the issues

of funding included in the text. Three respondents indicated that RCFs should not

control funding of the DAA service, in particular, based on experiences under Care

Aggregated Module (CAM) funding:

“Even though the money had to be acquitted and refunded if not spent, … there were still RCFs that out of principle refused to pay pharmacists for the services provided. … Inevitably the service suffers to the point of affordability judged by what the RACF thinks the pharmacy should be paid”.

Another respondent felt that patients should not have to contribute to DAA costs

“especially if they are not given any choice or control over the provision of the service”.

Two alternative funding or fee setting strategies were suggested:

That the RMMR payment model could be used as a framework for direct-to-

pharmacy payment from government for DAA provision.

“There needs to an independent arbitrator that sets a fee per bed” particularly

where DAA provider contract changes are seen to be due to price undercutting.

Other improvements to the model in Figure 4.8 and the recommendation overall were:

The model “seems to devolve much of the administration and responsibility to the

pharmacy; Improve by providing flexibility for RCF to do some activities“ (e.g.

prescription management that is already done by some facilities).

The model would be improved if the system of PBS prescriptions was changed so a

“doctor written medication order (on the medication chart) could act as a PBS

prescription for the life of the chart”.

“This document could be converted to a more meaningful working document where,

at the highest level of documentation, the big picture aspect of the proposed

working relationship is detailed and what that entailed”.

There may need to be anti-kickback legislation to support the process to “prevent

pharmacies and nursing home proprietors coming to financial arrangements”.

5.2.3.2 Written agreement for DAA supply

In a process similar to that of the tripartisan agreement for the community model, the

RCF best practice model also included a recommendation for an agreement that

specified obligations and expectations, and promoted mutual awareness about the

DAA service to be provided. As one GP group indicated “one of the basic problems

relates to a lack of understanding and opportunity to discuss the roles and needs of the


parties involved”. From the resident and family perspective, this agreement also

included how the service would work, payment and billing, procedures for start up to

streamline the transition after RCF admission, a recognition of privacy of information,

and how the pharmacy would provide counselling and medication information

(consumer medicines information or CMIs).

From the resident perspective, the move into residential care has potential to cause

considerable disruption in the medication management and supply of medication to

individual residents and there is a need for streamlined and explicit processes to

facilitate the transition. Of the residents interviewed for this work, all but one had been

living in their own home (one transferred from another RCF) and all had previously had

managed their own medication supply (several with some assistance from family

members). The move into an RCF required five residents to change their usual GP

and six to change their usual pharmacy. Only four residents recalled that RCF staff

had fully explained to them the medication supply-related processes involved in the

transition. Two other residents had been managing their own medication at the time

and another said the processes were not explained. No problems were recalled when

the responsibility for medication supply and prescription management was transferred

to the RCF; this was attributed to the organisational strengths of the RCF.

None of the residents interviewed had a formal agreement with their pharmacy

covering the details surrounding the provision of DAA services and six residents

indicated that they would be willing sign an agreement covering such points. No parts

of the agreement were felt to require change or omission. When asked to rate such an

agreement as either extremely helpful, somewhat helpful or not at all helpful for people

moving into aged care facilities, 2 residents considered it to be extremely helpful, four

somewhat helpful and one considered it to be not that helpful at all. While this resident

suggested that in her experience a formal agreement would not have been all that

useful, due to the fact that the RCF was so organised, she conceded from a general

perspective such an agreement would be beneficial, provided a resident’s cognitive

function was taken into account.

The provision of medication information for aged care residents forms a key feature of

the best practice model with the added aim of tailoring the information to a variety of

residents with differing involvement in their own medication management. Three

residents had been receiving written medication information from their pharmacy prior

to moving to an RCF and one indicated that although written information was available

they never personally requested it. Six residents indicated that it was still important to

receive medication information; one felt it wasn’t important because the RCF already

had taken care of all features concerning their medications for them. While no

participants had any real family/carer involvement with their medication management,

the potential need to provide medication information to families/carers was identified as

a relevant issue by one resident particularly where a resident had poor cognitive

function.

The provision of medication information to residents did occur. Five residents indicated

that they had received medication information since RCF admission; three were given

information verbally by either their doctor or nurses and two had received written

information. For both of these residents, written information was sourced from the

facility (one facility had a written sheet for every drug used by residents).


Since the RCF best practice model agreement included defining how written

medication information was to be provided, residents interviewed were asked about

their preferences for this type of information. Preferences varied based on a resident’s

level of participation in their own medication management. Since there are existing

guidelines for the provision of CMIs [see http://www.guild.org.au/public/currentissues/

mic/mic_when.pdf (last viewed 5/4/06)], residents were asked in which of the following

situations they would like to receive CMIs:

When first starting a new medicine: 5 residents.

When the drug information had been significantly changed: 4 residents.

When the dosage form had been changed: 2 residents.

When there was special information surrounding the use or precautions

surrounding a medication: 3 residents.

When they requested it: 5 residents.

Routine updates on long term treatments: 2 residents.

Verbal information was considered sufficient among several respondents when the

dosage form had been changed and with one respondent when there were special

reasons regarding the use/precautions surrounding a particular medication.

No resident indicated just one situation in which they wanted a CMI or similar, but two

residents said there were no circumstances in which they wanted to receive a CMI.

One resident said that they felt the doctors would tell them all the important information,

while the other indicated that they were happy to let the RCF staff handle all their

medication management issues. Given this variation in resident preferences for written

information, explicitly defining a resident’s expectations in an agreement should aid

appropriate service delivery and increase satisfaction.

From the RCF perspective, eight of the nine responding DONs were willing to enter into

a written agreement for DAA supply, as outlined in the best practice recommendations.

Five DONs considered that all aspects of the agreement were equally important, while

other DONs emphasized the importance of cost (3 of 8 respondents), how to keep

pharmacy resident profiles current and aspects of the pharmacy services such as time

of service availability, prescription management, the availability of medications and

other support services such as staff in service education and participation on the

Medication Advisory Committee (MAC). Clearly defining roles and responsibilities was

felt to fundamental by one DON. None of the DONs interviewed recommended leaving

out any part of the agreement. Suggestions for improvement or changes were:

No change; the guideline was good but needs to allow RCFs to adapt it to suit their

culture.

Adding specification of timeframes for the dispensing and delivery of drugs [Note:

this was included in the recommendation about how the service worked but was not

explicit in dealing with medication changes] and timeframes for doctors writing

prescriptions.

Leaving out visits to hospital (as hospitals have their own systems) and internal

pharmacy issues such as discussions with GPs or the length of time medications

are kept if ceased.

All community pharmacists were willing to have a written agreement as per the

recommendation with one pharmacist indicating that it was essential for parties to

understand their roles for the system to be effective. All pharmacists felt that every

aspect of the agreement was important although, one pharmacist did question the need

to address privacy as this was a “red herring” and another felt that it would be hard to


define how quickly a medication change should be done and that this section may

require careful wording. This same pharmacist foresaw possible difficulties where large

numbers of doctors visited an RCF. One area for improvement identified was the need

to explicitly include expectations for DAA service for residents admitted for respite care

(for a fixed, and usually brief period). The example given was: the patient arrives with

their own medication and “the facility would expect us to pack it up, for several weeks,

for nothing, and then, at discharge, justify exactly why certain amounts [of patient’s own

medications brought in on admission] were left over”.

Of the GPs commenting on the RCF model, four of seven indicated they would be

willing to participate in a formal agreement regarding DAA supply as per the best

practice recommendations. The aspects of the agreement felt to be useful or important

were:

Issues regarding medication changes (4 responses) including procedure, time

taken, and the responsibility for communication of changes to relevant parties (3

responses).

Prescription management (3 responses) including when a prescription would be re-

written without seeing a patient and communication about when new prescriptions

are required.

The formalization of how the service will work (2 responses).

Privacy issues.

What happens when RCF staff make an error.

What happens to wasted medications in a DAA.

How much responsibility the RCF and RNs involved are prepared to take.

One of the GPs who did was not willing to be involved in any agreement about a DAA

service stated “the difficulty with the agreement between the pharmacy and the doctor

is the we [the doctors] are employed by the resident; there is no business relationship

between the doctor and the pharmacy”.

On the whole, while written agreements for DAA provision were not embraced as

strongly by GPs in comparison to other stakeholders, many of the points addressed

within were positively received. Two GPs recommended changes to the agreement.

One suggested including a statement that the agreement was able to be read and

understood by the patient and one other family member but it was not clear what would

happen if patient agreement could not be obtained (e.g. if patient had dementia and no

family). The other GP suggested reducing the complexity and specificity of the

document. This GP said that “at present, where there is mutual respect, doctor and

pharmacist can come to agreement about the way medications are dispensed, etc”.

Another GP agreed that there was no need for a written agreement between the

pharmacist and the GP (although this should be a close working relationship); the

agreements should be between the RCF and pharmacy, and the RCF and the doctor.

The preference for a non-written arrangement or understanding also appeared to be

shared by another GP group who indicated that “where there has been an opportunity

for such discussions it seems that a mutually agreeable solution can be reached e.g.

one GP changed their RCF ‘visiting day’ to precede the pharmacy ‘packing day’ “.

Respondents to the expert panel questionnaire were also asked what aspects of the

suggested written service agreement with the RCF and/or patients or doctors were

important or useful. Of the 11 people responding to the questions, six indicated that all

aspects were important:


“It makes sense as it covers all aspects of the agreement and leaves nothing to chance”.

“Leave out None – RCFs often have an abysmal understanding of the logistics in

providing a DAA service (which they often expect for nothing) – this agreement

clearly articulates all the problems and conditions involved in the provision of the

service and provides some ammunition for a pharmacy wanting to charge for the

service and provides clear guidelines on who is responsible for what”.

One respondent did recognize that “these agreements will never be completely

inclusive as new issues come up all the time”.

Respondents to the expert panel questionnaire suggested the following changes to the

content of the agreement or the subjects to be negotiated:

Include the role/responsibilities of the accredited pharmacist doing RMMRs; “this

needs to be highlighted in any such document”.

The agreement needs to “recognise patient choice and rights and responsibilities”.

Change the implication that prescription management is the pharmacist’s

responsibility. “I can accept responsibility for notifying the doctor a new prescription

is due but I cannot take responsibility if the doctor fails to write it in a timely

fashion”.

“It should be acknowledged that it is not unusual for residents to be assisted by

their carers with their medication even within RCFs. Therefore there is a need to

involve and inform families/carers in this process just as much as within the

community. They too need medicines information and how this is to be provided to

carers should also be included in the negotiation discussion”.

There was some disagreement about whether the agreement should be a standard

template – two respondents felt a standard agreement was required (one indicating

that stakeholder input was required to develop this template) while two others felt that

the agreement was more a guideline that could be adapted:

Pharmacists and RCFs should be able to start with a broad agreement framework

and then trim it down to individualise it. “I think it is important to start with a

comprehensive agreement and then use the MAC and meetings with management

to tailor the agreement. I find differences between privately owned, corporate

RCFs, rehab centres, jails, etc, that I need to alter my basic agreement to a mutual

level”.

“Rather than provide a ‘sample’ agreement type approach, I feel it would be better

to establish headings which provide a framework. Mandatory and optional; that

way there is scope to clearly flag for all parties the ‘no compromise components’

and the ‘Flexible components’ ”.

Another respondent said that training sessions would be needed for implementation

while another suggested that the agreement should be presented in an acceptable

format; “It should be presented in a folder with clear headings and with explanations of

the importance of each section. It should explain the potential outcomes when certain

elements of that agreement are not adhered to”.

Some respondents felt that service delivery agreements were feasible and had a

positive impact:

“It is feasible and essential from a quality perspective. It is a requirement that all

aged care facilities have formal agreements with external service providers as part

of their accreditation requirements”.


“You need the mutual agreement document to ensure you minimise staff time and

costs. A facility with a poor understanding of the agreement and the contractual

procedures is the ones that give you the most grief in tying up staff time. It is always

hard to bring them back to a reasonable level of impost on your staff times if you do

not have a tight agreement at the beginning”.

“A good agreement up front solves may potential problems later on”.

“Once instituted, this would minimise pharmacy staff time as long as RACF staff

were all aware of their responsibilities”.

Another respondent anticipated additional costs to those involved:

“With the implementation of any procedure that guarantees quality there will be costs. The RCF needs to understand that what they are BUYING is REASSURANCE that what is delivered is RIGHT for the RIGHT patient at the RIGHT time”.

Two other respondents had reservations as to the feasibility of the recommendation:

That it would be prohibitive for smaller pharmacies.

That it was not feasible the way it is written, specifying what needs to be addressed

e.g. What happens if pack needs to be changes, rather than spelling out

(prescriptively) how a pack change should be done (e.g. that it is the RCF

responsibility to fax a copy of the changed medication chart to the pharmacy at

least 4 hours before the pharmacy close of business) leaves the pharmacy open to

unreasonable pressure from nursing homes to take on responsibility for all aspects

or to meet unreasonable expectations (e.g. A nursing home could force a

pharmacists to go out to home on the weekend). The document has little sense of

this commercial reality.

5.2.3.3 Communication of medication changes

Problems associated with the communication of medication changes was one of the

main barriers to a safe, effective and efficient DAA service identified in Phases 2 and 3.

While some issues associated with medication changes (e.g. responsibilities and

timeliness) have been included in the recommendation about a written agreement,

maintaining a written record of all communication about medication changes was a

further recommendation.

From the RCF perspective, all DONs indicated that the recommendations for the

communication of medication changes were feasible to implement and beneficial to

patients. All DONs also reported that these changes were likely to incur little or no

extra cost or use of staff time (as most were already using such systems). Some

changes to RCF practices (e.g. always keeping a record of communications to the

pharmacy) and some additional staff training (to ensure procedures are always

followed) may be required. Suggested improvements to the best practice model of

communication of medication changes included:

Increased role of GPs in communicating medication changes to pharmacies (2

responses).

Earlier notification by pharmacists of the need for new prescriptions e.g. by emailing

to RCF.

The use of medication charts ‘online’ to the pharmacy to efficiently communicate

changes “so that changes are immediately obvious to all”.

All three community pharmacists commenting on the RCF best practice model felt that

felt that the recommendations for communication of medication changes were feasible


or beneficial with one describing them as ‘vital’. Another pharmacist indicated that in

practice, it might be difficult to implement particularly for communication with specialists

and hospitals – hours could be wasted on the phone clarifying exact requirements. The

concept of a ‘written record’ was interpreted as a paper record by one pharmacist, who

stated a preference for an electronic record showing date of changes and gave details

of who communicated the change. The impact of this recommendation was felt to be

minimal except for more “paperwork”. One pharmacist did identify a change in current

RCF and GP practice where residents visited the GP in the GP’s surgery “patients

would need to take the medication chart to the doctors” so that the change could be

recorded immediately on the chart but there was also a risk that charts would not come

back to the RCF.

The only improvement to the proposed BP model for communication of medication

changes suggested by community pharmacists was the use of a traceable electronic

record or written records.

All seven GPs commenting on the RCF model indicated that they communicated

medication changes; two GP said they amended the medication chart but did not

specify how this information arrived at the pharmacy. Three other GPs wrote on the

medication chart and indicated that the chart was faxed to the pharmacy. It was not

clear for these 4 responses just whose role it was to communicate changes to the

pharmacy; in the other case, the facility faxed the amended chart to the pharmacy. One

GP used the prescribing program Medical Director® to print out a patient drug sheet to

send to the pharmacy. Another GP at times would write a hand-written note and only at

the request of nurses (who presumably communicate this to the pharmacy).

All 10 people responding to the question in the expert panel questionnaire about the

communication of medication changes in RCFs agreed that the recommendations were

feasible and beneficial, with several indicating they were vital or mandatory.

“Proper records enable us to pinpoint where problems arise especially when there

are so many agency nurses now in RCFs. It helps resolve disputes. It is hard to

ensure continuity of care unless these records are kept and proper communication is

mandated”.

Unlike the community setting, the pharmacy practice of asking for changes in writing

was often in place:

“We DEMAND a full medication chart is faxed with every change as that is our QC

[mechanism] to ‘discover’ all of the changes they forgot to send us. We are also not

very lenient on nurse initiated medications and we demand a medication chart

signed by the doctor or a telephone order/confirmation from the doctor”.

Some difficulties and costs were envisaged with implementation (“at the moment it

costs a lot for pharmacy to do this”) but an IT approach would help to minimize costs.

One of the improvements suggested for the recommendation was to explicitly allow

electronic records of communication in the recommendation (as also suggested for the

community model in 5.2.2.4). Other improvements suggested by the expert panel

questionnaire respondents were:

To ensure that the recommendation complied with all state and PBS regulations.

That a standard reporting/communication form be developed.

That the “nuts and bolts” of the process were detailed and agreed upon.


5.2.3.4 Continuity of patient care between hospital and RCF

As with the community best practice model, recommendations in the RCF best practice

model included strategies to improve the timely flow of medication regimen information

and supplies of medications when residents were admitted to hospital. The

recommendation covered both information to be provided to the hospital and practices

in hospital to facilitate patient discharge and transfer of care to the RCF.

Six of the nine DONs indicated that the recommendations for continuity of patient care

between hospital and RCFs were feasible. Some reservations were expressed:

The process was too complex (2 responses).

That hospitals would not be keen to be involved.

Use of a 4-week pack means that changes are often needed when a patient is

discharged and would residents pay for new medications?

It was also not clear who would take responsibility; a GP ultimately oversees the

situation on a resident’s return from hospital.

Can poor notification of discharge plans by the hospital be overcome?

Communication between the hospitals and the pharmacies not practical as the

combinations are too large in number and there is a risk of communication

breakdown with the RCF.

The impact of these recommendations was felt to be relatively minor:

No change or minimal changes required (4 responses) e.g. one RCF currently sent

a copy of the medication chart but did not send the DAA, because the model is

largely followed. There are, however, costs such as staff time, photocopying,

faxing, etc.

The hospital needs to communicate with the community pharmacy when patients

are discharged back to the RCF (2 responses). In one RCF, the facility receives the

discharge medication plan and communicates it to the pharmacy.

Staff time would be needed to liaise with the hospital pharmacy plus extra RCF-

pharmacy liaison so that the community pharmacy can liaise with the hospital.

Hospital staff require education about the need for appropriate timeframes so that

medications can be ordered and be on hand in the RCF.

Suggested improvements to the continuity of care recommendations or situations

where processes may be delayed were:

Situations where communication flow is under pressure e.g. emergency situations,

other time where not all parties communicate effectively, poor handwriting (2

responses about poor legibility of discharge orders).

May need explicit strategies to deal with admissions and discharges involving

Schedule 8 medications.

Medications for discharge may not be decided until very close to discharge.

Many medications at discharge may be short term (e.g. antibiotics) that may not

need to be packed or would not be packed in time.

Since routine medication administration times may differ between hospitals and

RCF, the transition may also need to address transition in medication

administration times.

The hospital may need to contact the RCF to find out what and how much medicine

to provide on discharge; the model currently relies on the community pharmacy to

provide this information.

Implementation of an electronic system like “Medical Director”.


Community pharmacist commenting on the RCF best practice model reported marked

variation in the receipt of discharge summaries, a step included in the continuity of care

recommendation; one pharmacist rarely received summaries, one sometimes received

summaries (although this was improving) and another always received summaries.

Two pharmacists felt that the model would be beneficial in promoting safe, effective

and efficient DAA services; one pharmacist explicitly indicated that the model was

feasible. All community pharmacists had reservations:

The timing of activities may be a problem; currently “all residents seem to be

discharged at 4.30pm with no medication and [with the RCF] making ridiculous

requests on the pharmacy for a DAA to be provided in 20 minutes (and delivered)”

[Note: a medication round at the evening meal (approximately 5pm) is common

practice in RCFs].

A lot of co-ordination would be needed.

The quality of discharge summaries varied.

There was a danger of a DAA being lost in the hospital if it was sent with a resident.

The medication chart should suffice.

The impact or changes community pharmacists would have to make were minimal, all

said no change would be required but with two qualifications:

No changes were required for patient admission to hospital.

No changes; “if the hospital notified the GP my workload would decrease”.

Two community pharmacists agreed that this recommendation addressed their

reservations about packing a DAA based on discharge information, one saying that

compliance from the hospital with aspects to increase the reliability of discharge

medication information can be a problem. The other pharmacist indicated that the

model was little different to what was already in place and did not address reservations.

Improvements to the recommendation for continuity of care were:

Specifying that the discharge medication list be printed or typed, not handwritten.

Specifying that residents of an RCF should not be discharged after 12 midday to

allow sufficient time for the supply of new packs to the RCF.

The circumstance identified that would complicate the discharge process was the

hospital not complying.

To provide information about the feasibility of this continuity of care model from the GP

perspective, GPs were asked about their current practices and experiences. GP

currently described variation in the extent of communication from hospitals when a

resident was discharged; one GP from a rural town indicated that he never received a

discharge summary, another sometimes received a summary while 4 indicated that

they mostly received discharge summaries for RCF residents (although this was not

always timely).

The best practice model for continuity of care between hospital and the RCF had a step

where the GP confirms with the pharmacy the medication a resident is to take on

arrival at the RCF, so that the pharmacy can pack appropriate medications into a DAA

minimising delays and the potential for rework. Three GPs indicated that, when a

resident was discharged from hospital with new medicines, they communicated with

the pharmacy who packed the DAA about what should be packed or changed. One GP

faxed a ‘changed DAA sheet’ to the pharmacy. One GP only communicated what

should be packed or changes if it was requested by the RCF or pharmacy. Three GPs


relied on the RCF to communicate with the pharmacy, one GP saying this was after the

RCF communicated with the GP, while another GP inferred that the RCF were notified

of discharge medications and communicated these changes directly to the pharmacy

without GP involvement (a situation described as “fortunate”).

GPs were asked whether the step of GP confirmation of a drug regimen after hospital

discharge was necessary. Two GPs felt this step was necessary, one saying “mostly

because the patient is seen in hospital in an acute setting, not the overall welfare of the

patient long term”. One GP felt it was unnecessary and that “when the GP is not

available, the pharmacy should be able to change DAA medications as listed on the

hospital discharge”.

To further probe the feasibility of the continuity of care model, GPs were asked to

describe their current procedures including the timeframe for updating a resident’s

medication chart when the resident has returned to the RCF from hospital with new

medication. The following practices were described:

Attempt to make changes within 24 hours (2 responses).

If substantial changes, attempt to charge the chart within the same working day. If

there are difficulties fitting in a visit to the RCF and the GP knows the resident and

staff well and there is only a minor change, the GP would alter the medication chart

in the surgery and fax the amended chart to the RCF.

Usually 24-48 hours.

Same day review of the patient BEFORE DAA change. The pharmacy is then

telephoned and a ‘changed DAA sheet’ is faxed to the pharmacy.

The hospital updates the RCF chart. The GP would normally see the patient within

1 week if the GP wanted to change any medication.

In an attempt to streamline the transition process, one GP practice in a rural town

tried to encourage visiting medical officers at the local hospital to send an amended

medication chart with the resident on discharge back to the RCF.

The new medication list is sent by the hospital to the RCF and the RCF send the

chart to the GP to amend [Note: this GP also worked at the local, rural hospital].

Circumstances that GPs felt complicated or delayed the transition of care process

included:

The GP being away or otherwise unavailable (e.g. family commitments) (4

responses).

Notification of discharge late in the day or weekend/public holiday discharges (3

responses).

When GP notification about resident admission or discharge is not timely e.g. “a

letter arrives on desk one week after discharge”.

Poor documentation from the hospital.

Pharmacy unwilling to make a DAA change on verbal order from the GP so that

faxing an instruction can cause a delay.

From the responses about continuity of care recommendations for RCF residents made

by the people completing the expert panel questionnaire, it is evident that opinions on

feasibility varied and many of the same problems with feasibility arose. For example:

“It seems fine in theory but very cumbersome and getting the

commitment/involvement of the GP ant the various stages will not be easy”.

“The model appears clear but may come into conflict with hospital policies which

differ from public to private hospital systems. Hospital pharmacists are not


specifically funded to coordinate with community pharmacists and may follow their

usual procedures and not worry about DAAs, leaving that for the community

pharmacist to worry about. This can either lead to double prescribing or repacking

by the community pharmacist (for which they are not funded!)”.

“Not feasible. It assumes all hospitals have the same resources”

“Doctors could make this process very difficult. It assumes a Doctor is there ready

to help the patient on discharge. I could see in some cases a DAA could take 5

days post discharge to be delivered”.

Another respondent indicated that the model in Figure 4.10 was “an ideal model”. Two

respondents indicated that the recommendations and model were largely being

followed and that there were benefits from the time invested in setting up these

processes:

“It comes down to following the process to completion and having a safety net

available so the resident does not miss doses”.

“We have established this in our community and it works well…. the time wasted in

packing for patients that have gone to hospital is minimised by effective

communication”.

Suggestions to assist implementation were:

Using an IT approach to facilitating continuity of care

“The roles and responsibilities might be “thrashed out and agreed upon at MAC or

GP panel meetings”.

5.2.3.5 Quality Control (QC) and Quality Assurance (QA) – Monitoring

procedures for packing, checking and communication

As with the community best practice model, the RCF model also included a

recommendation about quality control and quality assurance (where drug stability in a

DAA was included). All community pharmacists indicated that this recommendation

was feasible. The impacts of implementing this part of the model were minimal. One

pharmacist indicated that the pharmacy already had extensive QC and QA processes

while another felt that the costs would be higher and that help and guidelines would be

needed to assist implementation. The development of standards based on good

manufacturing practice was the only tool suggested as helpful to the adoption of the

recommendation.

The respondents to the part of expert panel questionnaire on the Quality Control,

Quality Assurance and monitoring had already commented on much of this

recommendation (5.2.2.6). For the RCF model, respondents were asked about the

differences between the recommendation in the RCF model and the similar one in the

community model, namely, educating RCF staff about medication storage and involving

them in capturing evidence of drug stability. Five of the 10 responses indicated that this

aspect of the recommendation was feasible. Such education could be part of normal

staff education and quality assurance. One respondent indicated that there was a

potential to integrate this activity with QUM responsibilities related to staff education in

the proposed changed model for RMMRs. Another respondent indicated that “I rely

heavily on the nursing staff alerting me to problems like this”.


Some of the difficulties foreseen were:

Capturing evidence of drug instability is not funded for any providers.

Unless instability is obvious (e.g. dose form visibly degraded or a pack has

malfunctioned), it can be difficult to identify.

It can be difficult to provide education in a situation where staff constantly change.

That calling for staff education about medication storage had the potential to create

huge expectations of pharmacy (as staff education was normally an RCF

responsibility) [Note: the recommendation does not indicate who should provide the

medication storage education].

5.2.3.6 Review of charting systems

As a record of a resident’s current medication is maintained in three places, regular

checks of agreement or concordance between these records was recommended in the

RCF best practice model. All community pharmacists were willing to check

concordance between the pharmacy packing profile, GP records and the RCF charts

every 6 months. Two indicated that this was already done (in one case, more

frequently) while another indicated that cost would be a problem.

All seven GPs were willing to conduct a 6-monthly concordance check between their

records, the resident’s chart and the pharmacy packing profile. One GP indicated that

this would be “an excellent idea” while two were already undertaking these

concordance checks (in one case, only checks between the GP records and the RCF

charts, but many of the charts were generated by the pharmacy).

Five respondents to the expert panel questionnaire supported 6-monthly concordance

checks. Three respondents indicated that these were already being done three-monthly

(“just part of the unremunerated extended service”);

“We find the check invaluable. It ensures our records are accurate and up to date

and it helps identify weaknesses in the communication between the RCF and the

pharmacy”.

There were concerns that there was no funding model for this 6-monthly check. One

respondent suggested that “the RMMR pharmacist could perform part of the activity

and provide information to the community pharmacist to collate and forward to the

doctor, however this would occur once a year only”. Two other respondents suggested

that the 6-monthly check could be incorporated into the proposed QUM model for

RMMRs. Other implementation strategies were suggested:

Using IT to facilitate the check.

That there needed to be accountability that the check happens (e.g. QCPP or Aged

Care assessors).

That the check could occur in conjunction with “the [APAC residential care

guidelines and Aged Care standards] recommendation for Doctors to do a six

monthly assessment of each resident. The RCFs push their doctors to do this as

they [the RCF] lose points at accreditation if this standard is not met”.

5.2.3.7 Efficiency in pharmacy procedures

The RCF best practice model also included recommendations aimed at increasing

efficiency in the pharmacy include ensuring that prescriptions are available when




All three community pharmacists responding to the RCF model felt that the

recommendations for pharmacy procedures promoted safe and efficient DAA services.

The impact of implementing these recommendations was unknown by two pharmacist,

one because this was already done and the cost was part of a “global costing”. The

other pharmacist indicated that implementation would be associated with higher cost.

All three identified that a change in the way prescriptions were written for RCF

residents would improve these recommendations i.e.:

“Allowing the pharmacist to dispense [and presumably get paid] directly from the

medication charts”.

Need to develop some way other than a prescription to supply RCFs – “getting

scripts from some doctors is nothing short of a miracle”.

“Repeat availability is difficult in the current situation”.

In Phases 2 and 3, ensuring that a valid and current prescription was available in time

for the DAA packing cycle generated problems for both GPs and pharmacists. The best

practice model included recommendations that involved the inclusion of explicit mutual

understanding of the procedure and practices associated prescription management in a

DAA service agreement (4.6.3.2) and in improving the efficiency of pharmacy

procedures (4.6.3.7.1). To inform the question of feasibility of these recommendations

from the GP perspective, GPs were asked about current prescription writing practices,

their preferences related to prescription reminders and how the recommendation about

prescription management (4.6.3.7.1) might be improved.

There was variation in GP views about prescription management. GPs were prepared

to write a prescription without seeing a resident in the following circumstances:

For continuing medications for one of the GP’s patients (6 responses).

Changes requested by the hospital or specialist.

Usually only order over the telephone, and only for temporary medications if the

staff on duty and the resident are well known to the GP.

For certain antibiotics, initiate on the advice of the nurse (patient seen later).

In Phases 2 and 3, pharmacists indicated that some GPs were not willing to write

prescriptions without having a consultation with the resident (and hence a consultation

fee). Some GPs charged the pharmacy for having to write new prescriptions for

ongoing medications if the resident had not been seen. Among the six respondents to

the RCF model however, none charged for prescription writing when a resident was not

seen, although one GP indicated that a fee of $2-3 would be fair.

Prescription reminders from the pharmacy to the GP were included in the best practice

model. This task was considered to be a pharmacy task in the model as discontinuity of

prescriptions has a big impact on the efficiency of pharmacy procedures related to DAA

packing and can disrupt the packing schedule. The prescription reminders, if well done,

were included to increase efficiency. GPs views on what should be included on a

prescription reminder to promote best practice were:

The medication, strength, form and dosage (4 responses).

Date last repeat issued/used (2 responses).

Date the prescription is needed by or next pack due date (2 responses).

Resident’s name.

Any recent changes of dose as if the change is made on the RCF chart, this is often

not transferred to the doctor’s computer in the surgery.


Pharmacies needed to track requests for repeats; one GP experienced repeated

requests for prescriptions for the same medication for a patient when they could not

have been needed. Another group of GPs also expressed similar frustrations with

prescription and medication chart requests and writing:

“GPs feel at times overwhelmed by the requests for chart and script re-writes and

are frustrated by the perceived need to do both”.

“GPs report frustration at and with repeated requests for scripts that have already

been written and perceived or real inefficiencies (both RCF and pharmacy) in the

recording and monitoring of script requests and the processing of scripts once

received by the pharmacy. Those GPs who have addressed these issues with the

relevant pharmacy services report improvements in the streamlining of these

processes and therefore a cessation of the need for ‘owed scripts’”.

“Timeliness of requests for scripts is also an issue and while the flowcharts appear

to address the multidisciplinary complexities, this area appears to cause much

frustration”.

Four GPs felt that the prescription management recommendation did not require any

addition or change. Suggested improvements to the model were:

Ensuring reminders were timely (from the GP’s perspective).

A discussion between relevant parties prior to commencement, determining the

best timing of reminders.

Another GP commented that there was also a need for the RCF to know what

prescriptions were due, so that when the GP visited the RCF, these could be requested

at that time, not the day or so later when the pharmacy generated the reminder. At the

present time, when prescriptions are stored outside the RCF, the GP has no record of

when the last prescription was ordered and cannot monitor prescription usage as there

is no record of prescription written unless these were done on the computer in the

doctor’s surgery. Electronic communication between the GP, the RCF and pharmacy

would improve the co-ordination and continuity of prescriptions.

Given variation in GP and pharmacy practices, it is likely that policies and procedures

related to medications in DAAs need to be explicit and to accommodate preferences

where possible, recognising that the goal is a safe, effective and efficient service (from

a whole of health system perspective).

The comments made by respondents to the expert panel questionnaire about efficiency

in pharmacy procedures are to be found in section 5.2.2.7 as these recommendations

are essentially the same in the two models.

5.2.3.8 Facility receipt of packed medication

The RCF best practice model includes a recommendation that an RN check packed

medicines against the medication chart at the time of delivery for any packs where

residents are self-medicating or where ENs or PCAs assist residents to take their

medications from the packs. This check reduces the risk of errors and is an opportunity

to monitor and improve service quality.

There were mixed views on this recommendation. Five felt that they already had

procedures in place that addressed the recommendation or did not have PCAs or self-

medicating residents. Four DONs indicated that the impact of this recommendation was

cost for staffing e.g. extra workload when an endorsed (to give medications) EN was on

duty or costs in the order of 8-12 hours/week @ $25. One RCF had an alternative audit


process in place where 10% of medication deliveries were checked against the

medication chart. Another RCF had said minimal changes would be needed as a

medication endorsed EN already checked self-medicating residents on a weekly basis

and should check the DAA at the same time, but a tighter policy might be required to

endure this was done. One DON felt that it was not necessary to do the second check

because:

It duplicated what the pharmacist did.

The RCF had procedures clearly stating that RNs, ENs and PCAs must check

packs against the drug order before administering drugs plus ENs had proven

competencies and PCAs (in low care) had been credentialed.

5.2.3.9 Role of GPs in RCF DAA best practice

The RCF DAA best practice model involves a resident’s GP in a number of key steps.

Community pharmacists were asked to what extent those GPs the pharmacist

interacted with in relation to DAAs were already following the best practice processes

described in the preliminary model. One pharmacist said GPs rarely followed best

practice processes because there were “too many different GPs wanting to do their

own thing”. Two pharmacists indicated that GPs sometimes followed best practice, one

saying that the main problem was a lack of awareness among GPs that a prescription

was needed to dispense medications not just an order in the RCF medication chart.

When asked about the feasibility of the recommendations involving GPs, one

community pharmacist said they were not feasible, although the GP role was crucial to

the delivery of a safe, effective and efficient DAA service. This pharmacist suggested

including regular meetings between the GPs, pharmacist and senior RCF staff as a

change to the best practice document to improve the interaction between pharmacists

providing DAAs to a RCF and the visiting GPs. Another pharmacist did not offer a

judgment on feasibility but that she would like to see the GP participate as per the

model (having previously noted the large number of GPs pharmacists must deal with

makes it exceptionally difficult to get all to comply). The other pharmacist felt that the

GP role was limited to writing medication charts and prescriptions, and the “most GPs

are lukewarm about DAAs”.

In the RCF best practice model, there is no requirement for a GP to approve a

resident’s pharmacy packing profile prior to the pharmacy packing the patient’s

medicines into a DAA. GPs were asked about the advantages and disadvantages of

GP approval prior to packing. The additional workload and possible delays were GP

approval to be required was balanced against the opportunity to double check a

medication regimen (Table 5.6).

Another group of GPs also commented on caveats on the GP role as the prescriber,

saying “while GPs may recommend a dosing regime for the patient/resident, this

remains dependant on the availability of nursing staff to administer the medication “.

The comments on this topic from respondents to the expert panel questionnaire can be

found in section 5.2.2.10. One respondent made a comment specific to a GP’s role in

RCFs:

“I feel that the GP panel idea for RCFs is a poor joke and should be reconstructed

to involve pharmacists as well and to extend to all managed care practices like

DAAs, chronic disease care programs, etc. It is under funded and poorly designed

and will fail in its present format”.


Table 5.6 GP views on the advantages and disadvantages of GP approval of a

pharmacy packing profile prior to packing for RCF residents


Another point of cross-checking to minimise errors

Finding time for the doctor to approve profile may hold up process

Interaction may facilitate learning for both GP and pharmacist Professional assurance that it is being done properly

Coordinating times would be difficult and may delay commencing medication

Ability to check times and frequency of dose Very time-consuming for doctors with more than 10 nursing home patients

Place responsibility on doctor More work Less errors and wastage Nil significant Time consuming and with adequate

communication at earlier stages, unnecessary

5.2.4 IMPLEMENTATION ISSUES

Community and hospital pharmacists, DONs, GPs and the expert panel were asked to

identify the main barriers and implications to implementing the recommendations in

their DAA service, plus any strategies or support that would assist widespread adoption

of the best practice model.

5.2.4.1 Main barriers to the models

Among community pharmacists, no major problems were envisaged (3 responses) for

the community best practice model, although one community pharmacist felt education

was needed to stress to all parties the importance of best practice and the need to

work better together. Possible barriers identified by 4 other pharmacists were:

Finding time to implement the model (2 responses).

Payment to GPs for input.

Patient willingness to pay and accept the service.

Increased paperwork taking up more time. A way to avoid duplication of information

was needed.

Gaining GP co-operation.

Trying to communicate with large numbers of GPs.

Gaining co-operation from hospitals.

Lack of real remuneration.

The lack of a fee structure to pay for GP and pharmacy time was a barrier also

identified by the GP who reviewed the community best practice model.

From a community pharmacist perspective, the main barriers to and implications for

implementing the RCF best practice recommendations were seen as:

Variable compliance by GPs (2 responses) “the biggest hurdle is likely to be getting

the doctors to agree”.

RCFs saying they could not afford staff time to undertake the activities in the model.

The time it would take.

The cost of extra pharmacist cover in the pharmacy while a pharmacist visits the

RCF.

In addition to those barriers already mentioned in sections 5.2.2.1-5.2.2.3 and 5.2.2.5,

the main barriers and implications to implementing the best practice recommendations

in the respondents’ hospital pharmacy practice were:


Resources: Time and staffing, therefore costs. Concerns over who pays, who will do

the work and cost shifting.

All parties have to be motivated; only as good as the weakest link.

That it was not feasible for the hospital pharmacy to contact the community

pharmacy of each patient admitted who used a DAA as it was not always possible to

know a patient used a DAA or which pharmacy packed it, for instance. [Note: the

tripartisan agreement and patient template were included in the best practice models

to overcome these problems].

The amount of potential paperwork. The formal patient DAA needs assessment was

another form to fill in while the tripartisan agreement was cumbersome; both seemed

time-consuming.

The need for a database of community pharmacies.

A formal process may delay the start of the services. An outreach pharmacist would

often set up a DAA or organize it with a community pharmacy at the time of an

outreach visit.

The need for a GP to agree to DAA filling after discharge.

Hospital pharmacists were asked whether the DAA best practice models integrated

with hospital continuity of care initiative. All five who responded indicated that DAA best

practice models did integrate, that they were an extension of the APAC continuity of

care model currently being implemented in hospitals and supported communication

between parties and advanced planning for discharge:

“Continuity of patient care depends heavily on transfer of accurate and

comprehensive medication related information in a timely manner. Having a

structured process that dovetails between healthcare settings is crucial.”

“As the use of electronic records progresses to some community providers, this

could be extended to community pharmacy”.

However, one pharmacist from a small regional hospital had practical reservations

“until staff issues improve, the models are a nice goal rather than complementing local

hospital practices”.

From an RCF perspective, the main barriers to and implication for implementing the

recommendations were seen as:

Time needed (2 responses).

Staff attitudes (2 responses) e.g. staff dislike of change in any process.

Unclear roles in the models.

Awareness of the legal implications.

Acceptance of the model by the contracted pharmacists. The pharmacist may

decide to increase the fee to the RCF to cover costs.

The model shifts the responsibility from the facility. Pharmacy is already stretched

and doesn’t know the resident.

That effective communication is required particularly with GPs and hospitals.

Poor facilities (e.g. lack of good fax with electronic memory) and practices (e.g.

poor recordkeeping about compliance).

The need for good working relationships with GPs and community pharmacy. In

some regional/remote areas, there is limited choice in pharmacists and GPs if

communication and relationship problems arise.

Need to have better ways of identifying tablets and capsules in packs e.g. detailed

and readable description of contents or MIMS on all computers [this text has photos

of, or shows the markings on the various products].


From the GP perspective, there were fundamental concerns about whether DAAs

should be used at all (irrespective of best practice or not) with some GPs citing lack of

proof that the benefits exceeded costs. Two GP were concerned about wastage of

previously packed medication when packs were changed and that a medication change

takes too long to implement if repacking is involved. One of these GPs also identified

problems when non-packed medications are forgotten (e.g. schedule 8 medications or

medications not suitable for packing). A different GP had experienced difficulties

because the pharmacy who was contracted to the facility and packed the DAAs were

located a considerable distance away and could not provide a timely service when

medication was available when needed. The pharmacy was seen as unwilling to deliver

medication the same day and the RCF did, at times, obtain medication from a local

pharmacy. Another GP felt that the cost to the community might be “better spent by

employing more RNs, not less i.e. give RNs the same duty of care they have in the

hospital setting”.

The main barriers to and implication for implementing the RCF best practice

recommendations were seen by GPs as:

Time constraints (2 responses).

The document itself was too much for a busy GP to read but

“the RCF should read it”.

There would be problems if each RCF had a different guideline. One document and

procedure for the whole state would be better.

Difficulty for pharmacy dealing with multiple doctors.

Computers in nursing homes would make it easier to keep track of medication

dosage changes.

Inability/unwillingness of the pharmacy staff to speak with the GP.

Lack of co-operation from some practitioners; “what will be done if practitioners

choose not to be involved?”.

Two GPs felt that there were no real barriers to implementation. One GP suggested

that a Medicare fee for participating in DAA best practice would seem appropriate.

Respondents to the expert panel questionnaire indicated several ‘main’ barriers to

implementation. Lack of or inadequate funding was cited as a main barrier by 4

respondents:

“Lack of commitment on the part of pharmacists for a poorly-remunerated service”.

“Funding issues are the main barriers to both community and RCFs. Only the most

essential service will be delivered (i.e. supply of the medications) if funding is not

available for the required expanded service with quality safeguards”.

“Payment for service is a major issue and may determine the quality of the service,

particularly in RCFs. Currently with a free market situation the supply of DAAs to

RCFs has resulted in a substandard service in many cases due to a low or no price

demanded by the RCFs. Many pharmacists who are prepared to supply a quality

service are unable to do so at the price demanded and therefore opt out of

servicing RCFs. …. Pharmacists who are supplying at no or low cost may be forced

to adopt poor standards and inadequate staffing to reduce their costs”.

“The fact some providers do not change is not an indication that the service should

not be paid for. We all have a right to fair remuneration for services provided”.

One respondent suggested that the costs to pharmacy of the additional activities

performed to ensure a quality service is delivered (i.e. safe, effective and timely, and

efficient) could be averaged across the fee when the fee structure was developed.


Four respondents to the expert panel questionnaire identified general lack of

awareness of what was involved in DAA service (i.e. what the pharmacist contributed

and what each professional’s obligations were):

That DAAs were essentially a risk reduction strategy, not just a supply service.

“There needs to be acceptance by all parties that the pharmacist is the key player

in medication management”.

“Professionals understanding the costs involved at each stage and patients and relatives understanding the work and costs involved in providing competent medication management”.

“RCFs understanding the legal requirements of the medical and pharmaceutical

professions”.

One of these respondents also identified the need for “tangible evidence that it was a

good thing to be doing for everybody” as a barrier.

The need for improved communication between health professionals was felt to be a

main barrier by two respondents to the expert panel questionnaire. “In the community

setting up and maintaining the tripartisan communication of the ‘living prescription’ is

vital and requires good communication between all parties”.

Two respondents felt that any suggestion that the GP should control access to DAA

services was likely to make the models unworkable (increasing delays and costs).

Two respondents felt that the comprehensive nature of the document and what was

required for best practice had the “potential to ‘scare’ local providers off service

delivery”, while the potential administrative costs to pharmacy of the model (and current

practices) were a barrier cited by two respondents to the expert panel questionnaire:

In the community “It may be [that] a threshold has to be reached to fully implement

otherwise the whole thing may be administratively heavy”.

In RCFs a major barrier is “the costs of administrative overheads in relation to

prescription management”.

One respondent commented that “establishing a good practice model also needs a

good business model attached as for many pharmacists it is something they feel they

should do for their patients but in reality it costs them money”. Two other respondents

suggested that a standardised approach with standard templates (including electronic

versions) with “appropriate training and resources” was needed to ensure smooth

implementation. Standard forms or frameworks suggested for the community model

included:

An initial assessment form (this could include similar assessment questions to

those used in the patient survey in the Phase 2 DAA study and include medication

knowledge at baseline) and could be recorded on-line or in some central system.

A letter for the pharmacist to advise the doctor that their patient was to commence

a DAA. This would include the initial template of the patient’s current medications

completed at assessment to allow the first concordance check with GP records.

A communication framework (Pharmacist-doctor/doctors and pharmacist-

patient/carer with feedback).

A re-assessment at 6 months form that would include similar key indicators from

the initial survey plus a check on the dispensing computer of repeat intervals. In this

assessment, concordance between pharmacy records and patient-reported

medication use would be performed.


A 6 month concordance check with doctor form where the findings of the pharmacy-

patient concordance check were reported.

The DAA patient profile maintained by the pharmacy.

The patient template. It was suggested, however, the combining the role of a

packing template and a communication/notification of changes function may

compromise both functions. A separate ‘communication of regimen change form (a

doctor note to pharmacist not via the patient) may be better so that the patient held

record is a different form.

A working party would be needed to develop and test these tools before widespread

implementation.

The need for a significant change in hospital practices especially at discharge was

identified as a barrier by one respondent;

“Hospital discharge requires major changes to hospital systems in relation to DAAs

as part of co-ordinated care of the patient. There needs to be far better

communication between GPs, community pharmacists and hospital staff and

management procedures set up across all the times when discharges and

admissions occur, not just Monday to Friday from 9 to 5. Patients may be assessed

in hospital and discharged on a DAA with a referral to pharmacists in the area able

to continue the service”.

Another potential barrier to implementation of the best practice model was the need to

implement accountability and quality safeguards. The lack of mechanisms, capacity or

a willingness to enforce quality standards were cited as potential problems. The

enforcement of quality standards was considered essential by one respondent.

“The inadequacies of a substandard service and the potential health and safety

risks to the residents may be picked up by aged care assessors [in RCFs], but

medication management is just one of 44 standards”.

Mechanisms or strategies suggested as supporting accountability and quality

safeguards were:

To incorporate the best practice approaches to nursing home accreditation

requirements and also as mandatory standard for community pharmacies via

QCPP as both involved external assessment.

To strengthen the emphasis on the quality assurance process (e.g. including the

QA cycle into Figure 4.5 and Figure 4.8) as the “QA process is integral to the

acceptance and sustainability as well as risk minimisation”.

“If remuneration is tied to accountability there may be less chance people will put in

unrealistic tenders [for RCF DAA provision]”.

The final implication for the best practice model raised was that the notion of ‘best

practice’ was not static and would change with time. One respondent to the expert

panel questionnaire identified a need to future proof each best practice document by

adding a recommendation that the models be continually reviewed in the light of any

streamlining and, technological and legislative changes.

5.2.4.2 Supporting widespread adoption

Strategies to support widespread dissemination of the community best practice model

suggested by community pharmacists were:

Hard work by the PSA, the National Prescribing Service (NPS) and the Guild.

Making best practice a QCPP requirement.


Making best practice a requirement for government reimbursement.

Pharmacy bodies to provide documentation to support the model practices.

Better software for community use.

Lobbying the government to provide a fee for the service.

To support implementation of the RCF model, two community pharmacists suggested a

need for government funding as a strategy necessary for widespread adoption. One of

these pharmacists indicated government funding would be needed “if the facility will not

pay”. Implementation would also be supported if the systems implemented were

streamlined including the automation of the doctor prescription request process.

From the hospital pharmacist perspective on the implementation of the continuity of

care part of the models, the two respondents from organizations representing hospital

pharmacists emphasized stakeholder involvement and extensive consultation.

Suggested parties include state health departments, a GP advisory council, Divisions

of GP, consumer groups, APAC, SHPA, PSA and the Pharmacy Guild. An integrated

and collaborative approach between the various pharmacy stakeholders (e.g. PSA,

SHPA, AACP and PGA) was also called for to minimise responses like “I’m not going to

be told what to do by…”. A top down approach was suggested to facilitate systematic

implementation that dovetailed with the current medication safety movement in health

care. Other hospital pharmacists suggested:

Incentives such as remuneration for DAA packing (2 responses).

Establishment of a community pharmacy database that summarized the key DAA

service aspects (e.g. that the service was provided, details of the pack type used

and usual packing schedule) and that is up-to-date and widely available to

hospitals.

Promotion to patients of the importance of a medication list.

Support strategies suggested by DONs for the RCF model were:

Education of those involved (3 responses) e.g. training workshops especially for

hospital staff, RCF, pharmacy and discharge RNs.

Peak bodies (2 responses) (e.g. Queensland Nurses Union, Aged Care

Queensland, unions) who were said to be very open to supporting best practice

models.

Introduction of the model in-house through the medication committee and joint

homes medical advisory meetings to encourage co-operation of GPs and

pharmacists.

One DON felt that the best practice model should not be a stand alone document

and must be supported by policies and procedures of the individual RCFs.

The facility could pay for the packing service. This DON indicated that their

pharmacist provided an extended and excellent service (including profile

maintenance, work on the medication committee, liaising with doctors) but did not

get paid for packing DAAs, his time or the service.

Respondents to the expert panel questionnaire suggestions of strategies that might

lead to widespread adoption of the best practice models included funding, integration

with existing program (e.g. aged care standards and assessment, QCPP) and systems

(e.g. dispensing software), wider stakeholder consultation and, involvement and

support of peak bodies.


Funding or adequate payment for the service was felt to be “the single most relevant

criteria that will define the extent and quality of the service provided is if the pharmacist

receives a payment from the RACF to offset the extra costs involved”. To support this,

one respondent indicated that the pharmacy peak bodies “need to ensure peak RCF

and doctor groups become aware of what is actually involved in providing a DAA

service”. Reform of other aspects of the payment system were also suggested

including how pharmacists seek payment for these services (i.e. charging practices)

and how the PBS funds the supply of medications in RCFs and indeed, in other chronic

care situations (i.e. use of a medication chart as a PBS claiming mechanism).

Integration with many programs or guidelines was suggested: PSA standards and

guidelines, APAC guidelines and QCPP, Aged Care Standards.

“QCP accreditation for DAA service is vital, and could provide govt with assurance

that capitation fee is justified and cost-effective”.

Updating the PSA protocols (guidelines and standards), the development of standards

with standard templates or tools and including a list of accredited DAA pharmacies on

Guild and PSA web sites were also suggested to support this integration as was

appropriate training and other resource development.

Integration with existing IT (e.g. dispensing, prescribing and DAA software) and future

ICT (information and communication technology) initiatives (e.g. HealthConnect and

SmartCard) would also support wider adoption of best practice models

“It needs a great deal of involvement from the software suppliers of dispensing

programs and packing software as I am sure that better integration of packing profiles

and medication profiles and a lot of the QC reporting could be performed more easily

than is current. For example in the packing process the batch number and expiry dates

should be able to be entered for the current bottles being used.”

Wider stakeholder consultation and involvement would be needed for more complete

buy-in including “meetings at the highest levels”. Stakeholders and peak bodies

suggested for inclusion were:

Divisions of General Practice.

The Standards Agency (for aged care).

Pharmacy organisations (including PSA, QCPP, the Australian Association of

Consultant Pharmacy (AACP) and the Australian College of Pharmacy Practice and

Management (ACPPM)).

TGA with the involvement of bodies like the Australian Self-Medication Industry

(ASMI) would be needed to address the true medication issues like stability in

DAAs.

Consumer bodies including those for carers.

The Australian Government Department of Health and Ageing.

The Department of Veterans’ Affairs.

State health departments and other hospital organisations.

Organisations concerned with healthcare-related safety, quality and QUM.

In all, the introduction of the best practice model represents a substantial change so

“change management strategies need to be considered and implemented”.


PART B - ECONOMICS OF PROVIDING DAAS TO

COMMUNITY PATIENTS

6. COMMUNITY PATIENT FOLLOW-UP

6.1 METHODS

6.1.1 INTERVIEW/QUESTIONNAIRE DEVELOPMENT

Telephone survey instruments were developed to measure quality of life, willingness to

pay, direct consequences of Adverse Drug Events (ADEs) and heath resource use.

Validated instruments used in the patient interview were the EQ-5D (Interview Part C)

and the EQ-VAS (Interview Part C). All other questions were adapted from literature

and our own previous work (Ientile et al. 2004).

Contingent valuation methods were used to assess willingness to pay in this phase.

We utilised an open-ended approach which involved directly asking participants their

maximum willingness to pay given three different attributes of DAAs. The same method

was used in Phase 2 but in that case only one attribute of DAA use was highlighted.

While this method suffers from a number of biases, it was preferable to other

approaches such as payment scales, dichotomous choice techniques and bidding

game formats (Bayoumi 2004; Ryan 2004; Shiell 2003; Whynes 2004). The direct

approach was also thought to be the simplest to explain to the participants, easier to

use over the telephone and translatable to a written survey format.

A mail-out version of this survey was produced to maximise response rates for

participants who did not wish to complete the interview over the phone. Both the

telephone interview and mail-out version have been included in Appendix H.

6.1.2 PARTICIPANT FOLLOW-UP

The participants were recruited in Phase 2 through their community pharmacy. For Phase 3, each Phase 2 participant was sent a letter which detailed the Phase 3 study and included a visual analogue scale to help complete the telephone interview (see Appendix H). This letter was then followed up with a phone call by project staff further explaining the Phase 3 study and obtaining verbal consent to conduct the telephone interview (see telephone interview script in Appendix H).

Where the participant was unwilling to complete the telephone interview they were asked whether they were willing to do a mail-out survey. Participants who received a mail-out survey were followed up with a phone call to increase response rates.

Where the participant did not complete the interview, an outcome or explanation was

recorded (see Figure 6.2). The results of the follow-up were entered into a purpose-

designed Microsoft Access database, which was prepared to capture all information

collected via the patient interviews and questionnaires. Checks of data validity have

been undertaken and some open-ended responses were recoded prior to analysis.

To examine the predictors of outcome at 1 year follow-up, the characteristics recorded

in Phase 2 were compared for the outcome groups at Phase 3 (still living in the

community, dead and RCF admission).


6.2 RESULTS

6.2.1 RESPONSE RATES AND OUTCOMES

Of the original 342 community patients in Phase 2 that could be matched to patient

consent forms and contact details, 196 (57.31%) completed the follow-up interview. Of

these patients, 149 (76.02%) completed the interview via telephone and 45 (22.96%)

completed or partially completed the written survey. A further 2 (1.02%) partially

completed the telephone interview (see Figure 6.1).

refused to participate

lost to follow-up

mail survey returned complete

mail survey returned partly completed

interview partly completed

interview completed

0 30 60 90 120 150

Frequency

refused to participate

lost to follow-up

mail survey returned complete

mail survey returned partly completed

interview partly completed

interview completed

0 30 60 90 120 150

Frequency

Figure 6.1 Results of the follow-up of 342 community patients from Phase 2

Differences in response rates were noted between patients using DAAs packed by the

pharmacy, patients using original packs and patients packing their own DAAs (see

Figure 6.2). Overall, pharmacy supplied DAA patients were more likely to be lost to

follow-up due to death, RCF admission and ill health.

Given the differences in rates of death and RCF admission at follow-up (approximately

1 year after the Phase 2 data collection), adjustment for heath status measures

collected in Phase 2 was be required.


Pharmacy supplied DAA group

Completed 80 (47.3%)

Refused 30 (17.8%)

Lost to follow-up 59 (34.9%)

• Deceased 16 (9.5%)

• RCF admissions 14 (8.3%)

• In hospital 4 (2.4%)

• Too sick 13 (7.7%)

• Unable to contact 12 (7.1%)

DAA not packed by pharmacy


Refused 4 (10.8%)



• RCF admissions 0 (0%)

• In hospital 0 (0%)

• Too sick 0 (0%)


Original Packs (no DAA)


Refused 26 (19.1%)



• RCF admissions 1 (0.7%)

• In hospital 1 (0.7%)

• Too sick 5 (3.7%)


Phase 3 follow-up of community patients N=196 completed interviews (57.3%)

Phase 2 community patients with consent formsN=342

Pharmacy supplied DAA n=169 (49.4%)

DAA not supplied by pharmacy n=37 (10.8%)

Original Packs (no DAA)n=136 (39.8%)

Figure 6.2 Patient outcomes for the Phase 3 community patient follow-up

6.2.2 CHANGES IN DAA USE STATUS

In the course of the year between the Phase 2 interview and the Phase 3 follow-up, 18

participants changed DAA use status. The majority of these changes were patients

who were using original packs who began to pack their own DAA (n=14, 77.8%). An

additional four participants who had been using original packs began having their

medicines packed in a DAA by the pharmacy (see Table 6.1). The main reasons for

starting to use a DAA included: not wanting to forget doses, making a complex

medication regimen simpler and in response to a serious health event such as

hospitalisation or on the recommendation of a doctor, hospital pharmacists or

community pharmacist.

Table 6.1 Comparison between DAA use in Phase 2 and at Phase 3 follow-up

Phase 2 DAA status Phase 3 DAA status DAA not packed

by pharmacy Original Packs Pharmacy packed

DAADAA not packed by pharmacist 28 14 0 Original Packs 0 70 0 Pharmacy packed DAAs 0 4 80

Shading indicates no change

6.2.3 COMMUNITY PATIENT MEDICATION USE

Patient reported medication use for the four weeks prior to the follow-up interview was

consistent with medication use data collected in Phase 2 home visits (see Table 6.2).

The number of regular medications used in the four weeks prior to follow-up was

significantly correlated (p<0.001) with the total number of current medicines and current

solid medicines found in patient homes at Phase 2 (Pearson’s correlation r=0.443 and

0.432 respectively).


Table 6.2 Community patient medication use in Phase 2 and Phase 3

Community Patient Medication Use N Mean Median Range

S.E.

Mean

Phase 3 Medication Use

No. diff regular PBS meds (4wks) 190 8.08 7 1-35 0.33

No. diff regular OTC meds (4wks) 188 1.04 0 0-32 0.19

No of regular medications (4wks) 184 8.74 8 2-35 0.34

Phase 2 Medication Use

Total number of current medicines in home 332 8.87 8 1-23 0.21

Total number of current solid meds 328 7.80 8 1-19 0.18

Comparisons between community patients using different medication management

systems as at Phase 2 (DAA not packed by pharmacy, original packs, or DAAs packed

by the pharmacy) indicated a significant difference in the number of regular prescription

medications reported in Phase 3 (see Table 6.4). Patients who had a DAA packed by

the pharmacy reported using significantly more regular prescription medicines

compared to patients who used original packs or a DAA not packed by the pharmacy.

This is also consistent with the findings from Phase 2.

Pharmacy packed DAA patients, despite reporting greater medication use, were

significantly less likely to report having a safety net medication card than patients using

original packs (Table 6.3). While the purpose of collecting this data was for inclusion in

a model to correct for variation in PBS medication use data, the results indicated that

pharmacists providing DAAs need to be diligent in ensuring that patients who are

eligible for assistance with medication costs and who rely on the pharmacy to help

manage these medications, receive this benefit or are made aware that safety net

information is kept by the pharmacy on the patient’s behalf and an entitlement card is

issued when the safety net is reached.

Table 6.3 Comparison between reported safety net medication card eligibility and

DAA status

Qualify for Safety Net Medication Card In last 4 yrs In 2001 In 2002 In 2003 In 2004

DAA status N % Yes N % Yes N % Yes N % Yes N % Yes

DAA not packed by pharmacy 28 16.47 24 18.60 24 17.52 26 17.33 25 16.13

Original Packs 81 47.65 62 48.06 68 49.64 74 49.33 79 50.97

Pharmacy packed DAA 61 35.88 43 33.33 45 32.85 50 33.33 51 32.90

Sig 3 group. * 0.001 0.005 0.003 0.001 <0.001

Sig Pharmacy DAA vs OP* 0.021 <0.001 <0.001 <0.001 <0.001* Chi-square test


Table 6.4 Comparison between medication management methods and medication use and cost for the 4 weeks prior to the follow-up interview

DAA not packed by pharmacy Original Packs Pharmacy packed DAA Medication

use & cost N Mean Median Range S.E

Mean

N Mean Median Range S.E

Mean

N Mean Median Range S.E

Mean

Sig. (P)

Number of different medications in past 4 weeks

Regular PBS 28 7.75 6.5 4-19 0.70 87 7.28 7 1-34 0.45 75 9.15 8 3-35 0.56 0.011*

0.003†

PRN PBS 28 1.11 1 0-6 0.27 85 0.61 0 0-8 0.12 74 0.73 0 0-10 0.17 0.185*

0.789†

Regular OTC 27 1.15 1 0-5 0.28 85 0.94 1 0-4 0.12 76 1.12 0 0-32 0.43 0.206*

0.126†

PRN OTC s 27 0.89 0 0-9 0.36 86 0.57 0 0-8 0.12 73 0.48 0 0-3 0.08 0.883*

0.947†

Cost to patient of medications in past 4 weeks

Regular PBS 26 44.41 34.9 10-156 6.73 74 35.76 30 0-200 3.88 56 48.73 40.7 0-285 6.01 0.040*

0.015†

PRN PBS 9 5.64 4.6 0-20 2.20 25 6.32 4.6 0-30 1.38 16 5.15 4.6 0-30 1.76 0.646*

0.330†

Regular OTC 10 14.18 8.1 1-70 6.44 33 16.04 8 0-100 3.93 19 10.26 5 0-60 3.34 0.573*

0.367†

PRN OTC 5 3.80 2 0-10 1.85 21 2.54 2 0-10 0.63 19 3.87 2 0-25 1.55 0.849*

0.816†

*3 Group test – Kruskall Wallis test, † 2 group test – Mann Whitney U test


6.2.4 COMMUNITY PATIENT HEALTH AND QUALITY OF LIFE

The majority of community patients felt that their health was about the same as when

interviewed the previous year (see Table 6.5), with no significant differences between

pharmacy packed DAA patients, original pack patients and own DAA patients.

Table 6.5 Patient ratings of level of health since February 2004 (one year prior)

N (%)

DAA status A lot worse Worse

About the same Better

A lot better ANOVA

Non-pharmacy DAA 1(3.6%) 8(28.6%) 13(46.4%) 4(14.3%) 2(7.1%) F=0.183

Original Packs 4(4.6%) 25(28.7%) 44(50.6%) 10(11.5%) 4(4.6%) P=0.825

Pharmacy packed DAA 8(10.5%) 16(21.1%) 34(44.76%) 11(14.5%) 7(9.2%)

There was also no difference between groups on the number or types of symptoms

experienced in either the four weeks or the 2 days prior to follow-up.

Table 6.6 Comparison between groups on symptoms experienced in the last 4 weeks

or 2 days

Non-pharmacy DAA

Original Packs Pharmacy packed DAA

Symptoms and conditions

N % N % N %

Chi-Square

Falls in past 4wks 1 3.57 12 13.95 14 18.18 0.087Falls in past 2 days 0 0.00 1 1.16 5 6.49 0.249Dizziness in past 4 wks 11 39.29 24 27.91 29 37.66 0.326Dizziness in past 2 days 6 21.43 14 16.28 19 24.68 0.644Headaches in past 4 wks 13 46.43 32 37.21 24 31.17 0.402Headaches in past 2 days 5 17.86 12 13.95 8 10.39 0.685Fever in past 4 wks 5 17.86 11 12.79 4 5.19 0.129Fever in past 2 days 4 14.29 3 3.49 2 2.60 0.384Depressed past 4 wks 9 32.14 37 43.02 36 46.75 0.335Depressed past 2 days 5 17.86 19 22.09 17 22.08 0.875Pain in past 4 wks 23 82.14 66 76.74 52 67.53 0.400Pain in past 2 days 16 57.14 54 62.79 46 59.74 0.153Fatigue in past 4 wks 17 60.71 50 58.14 47 61.04 0.845Fatigue in past 2 days 13 46.43 35 40.70 38 49.35 0.773Shortness of breath 4 wks 14 50.00 36 41.86 34 44.16 0.683Shortness of breath 2 days 8 28.57 25 29.07 22 28.57 0.348Nausea, constipation, diarrhoea 4 wks

12 42.86 32 37.21 29 37.66 0.868

Nausea, constipation, diarrhoea 2 days

5 17.86 16 18.60 13 16.88 0.770

Anxious past 4 wks 9 32.14 40 46.51 34 44.16 0.337Anxious past 2 days 8 28.57 29 33.72 24 31.17 0.631Vision problems past 4 wks 14 50.00 42 48.84 40 51.95 0.961Vision problems past 2 days 13 46.43 37 43.02 37 48.05 0.780Trouble sleeping past 4 wks 17 60.71 48 55.81 38 49.35 0.651Trouble sleeping past 2 days 14 50.00 32 37.21 29 37.66 0.706Memory trouble past 4 wks 16 57.14 29 33.72 34 44.16 0.071Memory trouble past 2 days 10 35.71 23 26.74 26 33.77 0.237Hearing problems past 4 wks 13 46.43 32 37.21 39 50.65 0.189Hearing problems past 2 days 13 46.43 29 33.72 33 42.86 0.154

On the quality of life measure EQ-VAS (possible range 0-100) there was no difference

between groups (see Table 6.7). There were also no significant differences based on

the method of data collection (i.e. whether participants completed this measure in

questionnaire form (indicating their response by marking the visual analogue scale),


over the phone with the EQ-VAS picture or over the phone without the EQ-VAS picture

(F=1.036, p=0.368)). Population comparisons for patients aged 70-79 (based on New

Zealand population statistics, as Australian data is not currently available) indicate

lower self-ratings of health in this sample. Devlin et al (Devlin et al. 2000) reported

mean EQ VAS scores of 76.8 (std dev 19.0) for respondents aged 70-79.

Table 6.7 Mean EQ-VAS scores for patients from the different DAA groups

N Mean Median Range S.E. Mean ANOVA

Non-pharmacy DAA 28 64.39 70 30-100 3.41

Original Packs 88 66.76 72.5 5-100 2.05 P=0.463

Pharmacy packed DAA 77 63.17 70 2-100 2.10

Pharmacy packed DAA patients were significantly more likely to have some problems

with mobility, personal care and conducting their usual activities compared with original

packs and self-packing DAA patients (Table 6.8).

Table 6.8 EQ-5D responses by DAA group

Non-pharmacy DAA

Original Packs

Pharmacy packed DAA

Chi-square*

Dimension Response

N % N % N % Sig.

no problems 16 57.14 45 50.56 19 24.68 0.001

some problems 12 42.86 44 49.44 55 71.43 0.001†

Mobility

more problems 0 0 0 0 3 3.90

no problems 22 78.57 79 89.77 47 61.04 <0.001

some problems 4 14.29 6 6.82 22 28.57 <0.001†

Self care

more problems 2 7.14 3 3.41 8 10.39

no problems 13 46.43 53 60.23 23 29.87 0.001

some problems 14 50.00 30 34.09 48 62.34 <0.001†

Usualactivities

more problems 1 3.57 5 5.68 6 7.79

no problems 9 32.14 34 38.64 25 32.05 0.627

some problems 18 64.29 44 50.00 41 52.56 0.345†

Pain

more problems 1 3.57 10 11.36 12 15.38

no problems 20 71.43 62 69.66 45 57.69 0.248

some problems 6 21.43 26 29.21 30 38.46 0.123†

Anxiety/Depress-ion more problems 2 7.14 1 1.12 3 3.85

* where dimension recoded as no problems or any problems † Pharmacy DAA vs OP

The results across the EQ-5D dimensions for original pack patients was consistent with

the percentage of reported problems for the New Zealand population of patients aged

70+ (Devlin et al. 2000) (Figure 6.3). However for the pharmacy packed DAA group,

the percentage of patient reporting problems was substantially higher. The finding that

pharmacy packed DAA patients have a poorer health status with respect to needing

greater assistance is consistent with the findings from Phase 2.


0

10

20

30

40

50

60

70

80

Mobility Self care Usual activities Pain Anx/Dep

EQ-5D Dimensions

% r

ep

ort

ing

pro

ble

ms

DAA not packed by pharmacy Original Packs

Pharmacy packed DAA Population comparison (70-79 years)

Figure 6.3 Sum of the proportion of level 2 and level 3 problems for each of the 5 EQ-

5D dimensions for the three DAA status groups and for a comparison

sample aged 70-79 (Devlin et al. 2000)

The scores on the five dimensions were transformed using the standard EuroQol

algorithm to produce a weighted health index score (range -0.2 to1). Based on this

measure, pharmacy packed DAA patients had a significantly poorer quality of life

(p<0.001) than original pack or non-pharmacy packed DAA patients (see Figure 6.4).

Interestingly, the Weighted Health Index scores were significantly correlated with the

OARS-IADL score collected in Phase 2 (Rho=-0.405, p<0.001, n=174).

0.6

0.62

0.64

0.66

0.68

0.7

0.72

0.74

0.76

0.78

0.8

0.82

Pharmacy DAA Non-pharmacy DAA Original pack

Weig

hte

d H

ealt

h In

dex

Figure 6.4 Comparison of Quality of Life measured by EuroQol between the DAA

groups


6.2.5 HEALTH SERVICE USE

Pharmacy packed DAA patients were more likely to have used support services in the

four weeks prior to follow-up, and were more likely to have been hospitalised and/or

used respite services in the 12 months prior to follow-up, than original pack and self-

packing DAA patients (see Table 6.9 and Table 6.11). The costs reported by patients

did not differ (Table 6.11).

Table 6.9 Percentage of DAA status groups reporting health service use

% or group using health service Used service in past 4 weeks

DAA not packed

by pharmacy

Original

Packs

Pharmacy

packed DAA

Chi-

square

GP services 75.0 80.9 79.7 0.802

Community Nursing 7.1 13.5 15.2 0.517

Other health professionals 32 29.2 30.4 0.955

Emergency Department treatment 0 6.7 7.6 0.144

Hospital clinic or outpatients

treatment

3.6 10.1 11.4 0.404

Other health care i.e. pathology 35.7 28.1 22.8 0.405

Support services (i.e. home help,

Meals-on-wheels, home nursing)

39.3 37.1 60.8 0.006

Used service in past 12 months

Public hospital 17.9 20.2 29.1 0.302

Private hospital 10.7 22.5 20.3 0.354

Any hospitalisation 25.0 37.1 49.4 0.051

Other care facilities 3.6 0.0 8.9 0.004

6.2.6 ADR AND HEALTH CONSEQUENCES

In Phase 3, overall lower rates of adverse drug reactions (ADRs) in the previous 12

months were reported compared to Phase 2 (27.5% vs. 39.3%). While in Phase 2,

significantly fewer pharmacy packed DAA patients reported ADRs compared with

original pack patients, in Phase 3 the difference in ADRs between DAA groups was not

significant (see Table 6.10). However, there was a significant correlation between

experiencing an ADR in 12 months prior to Phase 2 and Phase 3 (Spearman’s rho=

0.216, p=0.003). The number of patients needing hospitalisation, respite care or

community nursing as a result of ADRs was too low to allow for statistical testing but

the frequency of these consequences are reported in Table 6.10 below.

Table 6.10 Patient reported adverse drug events and consequences by DAA group

DAA not by

pharmacy

Original

Packs

Pharmacy

packed DAA

Total ADR and consequences

N % N % N % N %

Chi-

square

Experience ADR 8 28.6 28 31.8 17 22.1 53 27.5 0.367

0.161†

Not need treatment 2 25 12 44.4 3 17.6 17 32.7 0.068†

Need treatment 6 75 15 55.56 14 82.4 35 67.3

GP treatment 6 100 15 100 14 100 35 100 n/a

Medication changes 5 83.3 14 93.3 6 42.9 23 65.7 n/a

Hospital ED/admission 0 0 1 6.7 0 0 1 2.9 n/a

Respite 1 16.7 1 6.7 0 0 2 5.7 n/a

Community Nursing 0 0 0 0 1 7.4 1 2.9 n/a† 2 group test


Table 6.11 Health service use and cost to patient

DAA not packed by pharmacy Original Packs Pharmacy packed DAA

Number of times in last four weeks: N Mean Range

SE

Mean N Mean Range

SE

Mean N Mean Range

SE

Mean

ANOVA

Sig.

Seen doctor (GP or specialists) 27 1.11 0-3 0.15 89 1.87 0-10 0.22 78 1.85 0-17 0.26 0.224

Seen community nurse 26 0.08 0-1 0.05 85 1.01 0-30 0.50 76 0.91 0-14 0.34 0.505

Seen other health professionals 27 0.70 0-5 0.25 86 0.62 0-12 0.18 76 0.64 0-8 0.15 0.966

Treated in hospital emergency dept 27 0.00 0-0 0.00 84 0.07 0-1 0.03 77 0.10 0-2 0.04 0.304

Treated at hospital outpatient clinic 27 0.04 0-1 0.04 83 0.20 0-5 0.09 76 0.17 0-3 0.06 0.498

Used other health care i.e.pathology 27 0.41 0-2 0.11 84 0.46 0-4 0.09 75 0.35 0-4 0.08 0.636

Used support services 27 3.07 0-32 1.33 85 3.00 0-84 1.15 75 9.31 0-84 1.99 0.007

Other health services 27 0.15 0-4 0.15 85 0.12 0-8 0.10 70 0.07 0-3 0.05 0.872

In the last 12 months

No. times admitted to public hospital 27 0.19 0-1 0.08 83 0.37 0-5 0.10 76 0.74 0-18 0.26 0.192

No. of days spent in public hospital 25 0.32 0-3 0.15 79 2.37 0-50 0.86 73 5.64 0-120 2.29 0.158

No. times admitted private hospital 27 0.11 0-1 0.06 83 0.37 0-3 0.08 73 0.36 0-4 0.09 0.251

No. days spent in a private hospital 25 0.56 0-5 0.31 81 2.98 0-60 1.03 71 2.06 0-24 0.60 0.314

No. days spent in respite care 27 13.52 0-365 13.52 80 0.00 0-0 0.00 74 6.24 0-330 4.54 0.226

Total cost to patient in past 4 wks:

Doctors (GPs and specialists) 21 13.95 0-60 4.3586 63 16.4 0-350 6.44 52 19.5 0-750 14.5 0.952

Community nurses 2 0 0-0 0 11 18.2 0-200 18.2 11 12 0-50 5.04 0.846

Health professionals 9 14.33 0-50 6.7412 23 49.2 0-500 26.1 21 49.2 0-475 28.7 0.722

Hospital emergency department 1 0 0-0 . 6 0 0-0 0 3 0 0-0 0

Hospital outpatient clinic 2 0 0-0 0 7 30.7 0-205 29.1 6 0 0-0 0 0.567

Other health care 11 18.64 0-205 18.636 20 0.5 0-10 0.5 17 24.4 0-305 18.7 0.391

Support services i.e. Meals-on-

wheels 12 105.8 0-850 68.315 25 38 0-300 14.4 41 57.8 0-890 22 0.406

Other health services 1 0 0-0 . 2 12 0-24 12 2 0 0-0 0 0.625

Total cost to patient in past 12 mths

Private hospital 4 0 0-0 0 11 752 0-5600 497 12 30 0-200 20.4 0.236

Respite care/facility care 2 4250 0-8500 4250 0 . .. . 6 178 0-550 93.8 0.089


6.2.7 WILLINGNESS TO PAY

There was no difference between groups based on willingness to pay for DAAs, but

patients using original packs were more likely to be unable to put a value on this

service and were generally unwilling to respond to these questions, compared to DAA

patients (Table 6.12). There was also very little difference in the values nominated in

the three willingness to pay questions, with the majority of patients indicating the same

values for all three (Pearson’s R correlations between the three questions ranged

between 0.947 and 0.986 all significant at p<0.001).

Table 6.12 Comparison of willingness to pay across DAA status grouping and

question wording

How much are you willing to pay to

have medicines packed in a device…

DAA group N Mean Range 95% CI ANOVA

sig.

Non-pharm DAA 21 6.21 0-20 3.86-8.57 0.793

Original Packs 56 5.34 0-20 3.97-6.72

and delivered so that medication

taking was easy and convenient?

Pharmacy DAA 61 5.67 0-25 4.41-6.93

Non-pharm DAA 21 6.12 0-20 3.75-8.49 0.653

Original Packs 57 5.07 0-20 3.9-6.24

that would make remembering to

take your medications easier?

Pharmacy DAA 63 5.54 0-20 4.38-6.71

Non-pharm DAA 22 6.07 0-20 3.81-8.32 0.720

Original Packs 55 5.14 0-20 3.91-6.37

that would reduce your risk of

experiencing an adverse drug event?

Pharmacy DAA 61 5.58 0-20 4.36-6.79

In Phase 2, willingness to pay was assessed by asking patients “how much would you

be willing to pay to have medicines packed in a device that would make remembering

to take your medications easier?” Community patients using pharmacy supplied DAAs

were willing to pay a mean of $5.25 per DAA/per week (95%CI $4.62 to $5.87). While

this is consistent with the results of Phase 3 willingness to pay, there was no

correlation between Phase 2 and Phase 3 willingness to pay for any of the questions

(Pearson’s R ranged from 0.073 to 0.102, p>0.5 n.s.). It is likely that willingness to pay

is related to the cost actually paid. In Phase 2, price paid and willingness to pay were

significantly correlated (Pearson’s R=0.32, n=96, p<0.002). The correlation between

price paid in Phase 2 and Phase 3 willingness to pay approached significance

(Pearson’s R=0.238, n=47, p=0.108).

6.2.8 CHARACTERISTICS RELATED TO OUTCOME STATUS AT 1 YEAR FOLLOW-UP

For the 288 community patients who used either original packs (n=131) or pharmacy-

packed DAAs (157) whose outcome at 1 year follow-up could be determined, the

characteristics reported in Phase 2 were compared. For the OP users, at 1 year, 122

(93%) still lived in the community, 3 (2%) lived in an RCF and 6 (5%) were dead. For

the DAA users, at 1 year, 122 (78%) still lived in the community, 19 (12%) lived in an

RCF and 16 (10%) were dead.

Table 6.13 shows the relationships between patient characteristics and outcome after 1

year.


Table 6.13 Relationships between patient characteristics and outcome after 1 year

% with or value for characteristic within outcome group Characteristic In community In RCF Dead

Living alone DAA:55%* OP:41%

DAA:79%*OP:0%

DAA:63%OP:83%

Have regular carer DAA:57%* OP:33%

DAA:74%OP:67%

DAA:81%†OP:33%

Have regular community health visits

DAA:41%*OP:18%

DAA:58%OP:67%

DAA:48%OP:17%

Any hospital in last 12 months DAA:51% OP:41%

DAA:94%OP:100%

DAA:81%†OP:43%

Symptom frequency – most days DAA:49% OP:44%

DAA:44%OP:67%

DAA:44%OP:67%

Symptom severity – moderate or severe

DAA:58%†OP:46%

DAA:42%OP:68%

DAA:69%OP:50%

Any ADR DAA:36%† OP:48%

DAA:17%OP:68%

DAA:31%OP:50%

Impaired IADL (score<14) DAA:82%* OP:58%

DAA:100%OP:100%

DAA:87%OP:68%

Median OARS IADL score (higher is better)

DAA:11*OP:13

DAA:11OP:8

DAA:9OP:12

Any memory-related non-adherence

DAA:25%†OP:16%

DAA:26%OP:33%

DAA:13%OP:17%

Any deliberate non-adherence DAA:26% OP:32%

DAA:39%OP:33%

DAA:38%OP:33%

Any disorganised non-adherence DAA:52% OP:50%

DAA:53%OP:68%

DAA:44%OP:50%

Median number of GPs/doctors regularly visited

DAA:2*‡OP:2

DAA:2†OP:3

DAA:2OP:1

Median self-rated health status DAA: fair†‡ OP: fair

DAA: fair* OP: poor

DAA: fair OP: good

Mean number of times visited GP in past 2 months

DAA: 2.7 OP: 3.0

DAA: 2.7 OP: 2.3

DAA: 2.3 OP: 2.7

Mean number of different illnesses patient reports having

DAA: 3.2 OP: 3.3

DAA: 2.1* OP: 7.0

DAA: 3.9 OP: 3.0

Median age (years) DAA: 81* OP: 77

DAA: 82 OP: 79

DAA: 86* OP: 81

Median total number of current medicines in home

DAA: 8 OP: 8

DAA: 9† OP: 13

DAA: 10 OP: 7

Median number of current solid medicines

DAA: 8 OP: 7

DAA: 8† OP: 11

DAA: 9 OP: 6

Median number of current non-solid medicines

DAA: 0 OP: 1

DAA: 1 OP: 1

DAA: 1 OP: 0.5

Key: Comparison of DAA vs OP within outcome status groups: * p<0.05 † p<0.1

‡ DAA worse status or fewer doctors visited regularly


7. HIC DATA ANALYSIS

Data was obtained from the Health Insurance Commission (HIC) to inform the

economic model of DAA provision to community patients by pharmacies. The following

section describes service use for services claimed under the Medical Benefits Scheme

(MBS) and Pharmaceutical Benefits Scheme (PBS) in the year prior to the day of the

home visit conducted in Phase 2 for data collection purposes. A subgroup analysis of

service use before and after a DAA was started is also included. Since the comparison

groups in this analysis were not matched for a number of characteristics, multivariate

adjustment for covariates of cost and between group differences was also undertaken.

7.1 METHODS

7.1.1 DATA REQUEST

Approval to release data for consenting community patients from Phase 2 was sought

from the Health Insurance Commission (HIC) for 239 general benefit patients and 7

Department of Veterans’ Affairs (DVA) white card holders (for whom only some health

care is a DVA benefit) and from DVA for 81 veterans (including the 7 white card

holders). Data was therefore requested for 313 patients. Line item data for each

Medical Benefits Scheme (MBS) and Pharmaceutical Benefits Scheme (PBS) service

(and DVA equivalent data) provided in the period of interest to consenting study

participants was requested for each person that could be matched to their personal

identification number within the claims system (PIN). Community patients had

consented to the provision of personally identified information about their use of

medication and health services for services provided between 1 January 2000 and 30

June 2004

The following type of output was requested:

Preferred record content for each MBS service for each patient:

QMC patient ID - Identification number assigned by QMC (de-identification).

MatchFlag – Extracted match flag (tells how reliable the match between identifying details

provided by TCH and HIC PIN number was N=manual match, E=exact match, F=fuzzy date

of birth match.

Benefit – benefit paid for service (cost to Commonwealth – used in financial and cost

analyses) and Charge – Charge for service (benefit plus patient contribution).

DOP – date of processing of claim and DOS – date of service.

HospFlag – H=in-hospital service N=out of hospital service.

Item – Item number from MBS schedule.

Category – category of item number from MBS schedule.

Group– group of item number from MBS schedule.

Subgroup– subgroup of item number from MBS schedule.

BTOS – category of item number used in annual report.

Services – number of services.

DOR – date of referral and DOL – date of lodgement of claim.

Deidentified provider.

Preferred record content for each PBS service for each patient:

QMC patient ID - Identification number assigned by QMC (de-identification).

MatchFlag – as above for MBS services.

ItemCode – PBS or RPBS item code.


ATC – ATC code.

DOP – date of processing and DOS – date of supply.

GrossPrice – gross price of script (benefit + patient contribution).

Benefit - benefit paid for service (cost to Commonwealth – used in financial and cost

analyses).

Scripts – number of scripts and Repeats – number of repeats.

PatCat – patient status at the time of processing. A=general – ordinary; B=general –safety

net; C=general – free safety net; E=concession – ordinary; F=concession – free safety net;

H=Unknown – free safety net; I= other – DBOF; J= other – ostomy prep; K=non-PBS –

RPBS; L=non-PBS – SN RPBS; M=non-PBS – ostomy appliance; N= patient refund –

patient to refund pharmacist.

DOPres – date of prescribing.

Deidenfied Provider ID for prescriber if possible.

Deidentified dispensing pharmacy approval number.

7.1.2 DATA RECEIPT

MBS records for 237 patients and PBS records for 235 community patients were

retrieved by HIC. No matching data was found for 2 patients in the MBS data and 4

patients in the PBS data. An examination of the date ranges for services revealed that

the service data for a number of patients was incomplete (data was missing at the

beginning or at the end of the periods, or in some cases, in the middle).

As of 10 June 2005, data had not been received for the 71 DVA gold card holder nor

any service use by the 7 white card holders from DVA records (some data on these

patients was included in the HIC data). Despite frequent follow-up of this request by

the reachers, the data release request was misplaced and data release was not grated

in time to include veterans in this analysis.

7.1.3 DATA PREPARATION

The HIC data files were imported into a Microsoft Access database for cleaning and

aggregation and merging with Phase 2 data.

Patients with apparently incomplete MBS or PBS were excluded from the analyses

where data was missing. If either MBS or PBS data were missing, the patient was

excluded. Zero cost for MBS or PBS costs are likely to represent incomplete data

collection for these patients (since they were expected to have medicines and to see a

doctors in the time periods). These patients were also censored from analyses of

service use. Three other patients were excluded, one because HIC data was

requested for the wrong patient, another whose MBS service use (associated with

cancer treatment and including $26,517 of hospital MBS costs , 3 times the next

closest value) was an extreme outlier and another whose PBS service use was an

extreme outlier.

Variables of interest derived from the raw HIC data were:

Total number of items dispensed in year (for the cross-sectional comparison up to

and including day of home visit) Exclude ATC V04* (glucose testing strips etc),

Exclude stomal and wound dressing products (ATC V07AS and V07AY).

Sum of benefit received (cost to government).

Total number of different items dispensed.


Estimation of number of different regular medications – Total of number of different

items dispensed where more than 1 script per item was filled or if >1 script per item

filled, not an antiinfective agent.

Number of different prescribers.

Number of different pharmacies filling prescriptions.

Total number MBS items.

Total cost of MBS items (sum of benefit).

Total number MBS items provided in hospital (those to be included in each analysis

period that had no hospital items were coded as having zero items rather than

missing).

Total cost of MBS items (sum of benefit) provided in hospital (all those with no

costs were left null as mean costs were only to be calculated for those who were

actually incurred any costs).

Number of GP items not provided in hospital (those to be included in each analysis

period that had no GP items were coded as having zero items rather than missing)(item numbers 1-4, 20, 23-5, 33, 35-7, 44, 47, 50-54, 57, 59-60, 65, 83, 87, 89-91, 97-8, 160-162, 173,

193, 197, 601-2, 697-8, 700, 702, 720, 722, 724, 726, 730, 740, 759, 779, 900, 2517-18, 2521-22,

2546, but excluding bulk-billing payments).

Cost of GP items (sum of benefit) not provided in hospital (all those with no costs

were left null as mean costs were only to be calculated for those who were actually

incurred any costs).

Number of Emergency doctor attendance items (includes ED attendance but not

other service provided in hospital) (those to be included in each analysis period that

had no emergency items were coded as having zero items rather than missing)

(note that this includes GP emergency items) (items 1, 2, 97, 98, 511, 601, 602, 697, 698).

Cost of Emergency doctor attendance items (sum of benefit) as above (all those

with no costs were left null as mean costs were only to be calculated for those who

were actually incurred any costs).

Number of doctor attendance items (includes GPs and specialists) not provided in

hospital (those to be included in each analysis period that had no attendance items

were coded as having zero items rather than missing) (excludes anaesthetics and

pathology) (as per GP items plus item numbers 104, 105, 110, 116, 119, 122, 128, 160-162, 173,

193, 300, 302, 304, 306, 308, 445-47, 511, 809, 830).

Cost of doctor attendance items (includes GPs and specialists) (sum of benefit) as

above (all those with no costs were left null as mean costs were only to be

calculated for those who were actually incurred any costs).

Number of monitoring and pathology items potentially used to monitor medication

management (include taking sample) not provided in hospital (those to be included

in each analysis period that had no attendance items were coded as having zero

items rather than missing) (Items numbers: 65060, 65063, 65069, 65070, 65120, 65123, 65126,

65129, 66500, 66503, 66506, 66509, 66512, 66515, 66521, 66524, 66527, 66530, 66533, 66536,

66542, 66551, 66557, 66560, 66563, 66566, 66569, 66572, 66575, 66578, 66581, 66584, 66593,

66596, 66599, 66602, 66605, 66608, 66611, 66614, 66617, 66623, 66626, 66716, 66719, 66722,

66725, 66728, 66800, 66803, 66809, 66812, 66815, 73907, 73910, 73915).

Cost of monitoring and pathology items potentially used to monitor medication

management (include taking sample) not provided in hospital (sum of benefit) as

above (all those with no costs were left null as mean costs were only to be

calculated for those who were actually incurred any costs).

Number of Enhanced Primary Care items (those to be included in each analysis

period that had no attendance items were coded as having zero items rather than

missing) (item numbers 700, 702, 720, 724, 730, 779, 809 830 900).


Other MBS costs = Total MBS costs minus (GP costs + hospital costs +

monitoring/pathology costs).

The number of Enhanced Primary Care items in the period from 1 July 2001 to 30 June

2004 was also calculated (those to be included in each analysis period that had no

attendance items were coded as having zero items rather than missing).

The variables were aggregated for each of the 3 periods of interest:

For the Year prior to the home visit – for cross-sectional comparison.

1 July 2003 to 30 June 2004.

1 July 2001 to 30 June 2002.

Records in June2004 were considered incomplete if the pattern of dispensing over the

previous months suggested that additional supplies would have been needed before

July 2004.

Pre versus post DAA use analysis: Since the duration of DAA use was collected in

Phase 2, it was possible to create a subset who had started a DAA recently while still

having records of pre-DAA service use. OP users were compared to pharmacy DAA

users who had been using a DAA between 6 and approximately 18 months at the time

of the home visit. The duration of use was adjusted to reflect duration as at 30 June

2004. These DAA users were identified as follows:

Calculate amount of time in years between data of home visit and 30 June 2004.

Add this time to the time in years reported by the consumer as the duration of DAA

use at the home visit.

Select those consumers using a DAA with for longer than 0.5 years and less than 2

years of DAA use as at 30 June 2004 (85 of these but 2 packed their own DAAs).

Aggregate pre (1/7/01 to 30/6/02) and post (1/7/03 to 30/6/04) service use variables

for pharmacy packed DAA users and OP group with complete records for the

period.

For the cross-section variables, a number required transformation to more closely

approximate the normal distribution for use in parametric analyses or were recoded into

categorical variables:

Number of PBS items in the year prior to the home visit – square root

transformation.

Cost of PBS items (benefit) in the year prior to the home visit – natural logarithm

transformation.

Number of different PBS items in the year prior to the home visit – square root

transformation.

Number of different PBS items in the year prior to the home visit dispensed more

than once and excluding antiinfectives (ATC category J) – square root

transformation.

Number of different prescribers in the year prior to home visit- square root

transformation.

Number of different dispensers in the year prior to the home visit was recoded to

one or more than one.

The number of MBS items in hospital in the year prior to the home visit was

recoded as any hospital service (yes and no).

The cost of MBS items provided in hospital (for those with any items provided in

hospital) in the year prior to the home visit - natural logarithm transformation.


Number GP items (not provided in hospital) in year prior to home visit - square root

transformation.

Cost of GP items (not provided in hospital) in year prior to home visit - natural

logarithm transformation.

The number of monitoring/pathology MBS items (nonhospital) in the year prior to

the home visit - square root transformation.

The cost of monitoring/pathology MBS items (nonhospital) (for those with any of

these items provided) in the year prior to the home visit - natural logarithm

transformation.

The number of emergency doctor attendances in the year prior to the home visit

was recoded as any emergency attendance (yes and no).

The number of enhanced primary care items in the year prior to the home visit was

recoded as any EPC items (yes and no).

The number of other MBS items in the year prior to the home visit was recoded as

any other MBS items (yes and no).

The cost of other MBS items (not GP, hospital, monitoring/pathology) (for those

with any of these items provided) in the year prior to the home visit - natural

logarithm transformation.

The effects of these transformations on the distributions are shown in Appendix I.

7.1.4 ANALYSIS

The costs were compared only for those who incurred any of a specific cost type in the

previous year whereas the number of services received includes zero for those not

receiving the service. Both the aggregated and available transformed data were tested

for differences between pharmacy DAA, non-pharmacy DAA and OP groups and

between Pharmacy DAA and OP groups. Non-parametric tests such as Kruskall

Wallis, Mann Whitney U and chi-square tests were used for aggregated variables and

categorical data while parametric methods (t-test, ANOVA) were used for transformed

variables.

Service use by OP users and pharmacy DAA users were compared using

untransformed variables for the period before DAA users started using the device (pre

DAA) and for the year when they had been using the device for between 6 and 18

months (post-DAA), using the Mann Whitney U test.

7.1.4.1 Adjusting for covariates

An attempt was made to adjust various HIC service costs for differences in patient

characteristics between the groups that also covaried with the cost of services used

using multiple linear regression on the natural log transformation of the costs in the

SPSS version 12 General linear model procedure. The first step was to identify any

potential Phase 2 covariates that differed between the groups (potential covariates in

any multiple regression model were transformed to approximate a normal distribution

or recoded to be used as categorical variables). The second step was to identify

potential covariates for the dependent (transformed costs) variables.

For the people with HIC service use data, between group differences for the 3 group

comparison were found for the following Phase 2 characteristics or responses:

The number of doctors (GPs + specialists) visited regularly per patient report – OP

lowest, pharmacy DAA highest.


Age (the square root of 94-age) – non-pharmacy DAA users were the youngest and

pharmacy DAA users the oldest.

Living alone – more pharmacy DAA users lived alone than those in the other 2

groups.

Having a regular carer - more pharmacy DAA users had a regular carer than those

in the other 2 groups.

Having community health workers visit on a regular basis, again more likely in the

pharmacy DAA group.

Any hospital admission in the previous 12 months per patient report (highest in

pharmacy DAA group).

Any ADR - lowest in pharmacy DAA group.

Reporting any disorganised non-adherence (OPs lowest and non-pharmacy DAAs

highest).

The number of different prescribers of medicines per patient report (pharmacy DAA

lowest, OP users highest).

The number of different pharmacies dispensing medicines per patient report

(pharmacy DAA lowest, OP users highest).

OARS Instrumental Activities of Daily Living score (IADL) – pharmacy DAA users

had the lowest score (most impaired) with non-pharmacy DAA users having the

highest IADL score.

For the people with HIC service use data, between group differences for the pharmacy

DAA versus OP users comparison were found for the following Phase 2 characteristics

or responses:

The number of doctors (GPs + specialists) visited regularly per patient report –

pharmacy DAA highest.

Age (the square root of 94-age) – pharmacy DAA users were older.

Living alone – more pharmacy DAA users lived alone.

Having a regular carer - more pharmacy DAA users had a regular carer.

Having community health workers visit on a regular basis was more likely in the

pharmacy DAA group.

Any hospital admission in the previous 12 months per patient report (highest in

pharmacy DAA group).

Any ADR - lowest in pharmacy DAA group.

Gender (p=0.052) – more women in pharmacy DAA group.

The number of different prescribers of medicines per patient report (pharmacy DAA

lower).

The number of different pharmacies dispensing medicines per patient report

(pharmacy DAA lower).

OARS Instrumental Activities of Daily Living score (IADL) – pharmacy DAA users

had lower scores (more impaired).

For models of costs, all potential covariates of specific costs were added to the model

and a sequential regression was performed. At each step, the variable with the lowest

F value for the main effect was removed until variables that were independently

significant predictors of the dependent variable remained in the model. In some

models, some variables that were not independently significant were retained to

maximise the variance explained. The most parsimonious model that maximised the

amount of variance explained (maximised R2) was used for Step 3.


In step 3, the group variable (3 group or 2 group) was added to see whether group was

an independent predictor of the cost variable after adjusting for other predictors.

In step 4, any potential covariates that differed between the groups in Phase 2 were

added to the model. The effect of each of these variables on the overall model R2 was

examined, and only those variables that increased R2 were retained. Lastly, the effect

of any additional variables on group as an independent predictor of the cost variable

after adjusting for other predictors was re-examined. Estimated marginal means with

95% confidence intervals for the groups were calculated based on the model.

The same approach was used to model total MBS+PBS benefit costs (the natural

logarithm transformation) for the post-DAA period but including adjustment for the pre-

DAA period service costs (Ln transformed) into the model, for the sample of community

patients included in the pre-post DAA comparison.

7.2 RESULTS

7.2.1 UNADJUSTED SERVICE USE FOR THE YEAR PRIOR TO THE HOME VISIT

After extraction of data and data cleaning and aggregation, there was HIC service use

data for 106 pharmacy-supplied DAA users, 28 non-pharmacy DAA users and 90 users

of medicines in original packs (OP) for the year prior to the day of the home visit.

The service use patterns reflect the nature of the services, the frequency/extent of

services and the costs associated with the service (the government benefit cost)

compared between the groups (Table 7.1) :

The total number of PBS items dispensed (including repeat dispensings) tended to

be different for the three groups. People in the OP groups tended to have fewer

items dispensed compared to DAA users with non-pharmacy DAA users have the

highest number of items dispensed.

The cost of PBS items dispensed was significantly different between the 3 groups

with OP users having significantly lower PBS costs compared to non-pharmacy

DAA users (on post-hoc testing). PBS costs were not significantly different

between OP and pharmacy DAA users.

The number of different items supplied more than once and excluding antiinfectives

(ATC category J), a proxy for the number of regular medications, was not

significantly different between the groups.

Compared to OP users, pharmacy DAA users tended to have greater numbers of

different prescribers of the medicines dispensed.

Non-pharmacy DAA users tend to have fewer GP services than pharmacy DAA or

OP users, at a significantly lower cost. The cost of GP services was not different

between pharmacy DAA and OP users.

Non-pharmacy DAA users had significantly fewer emergency doctor attendance

items than pharmacy DAA users. The rate for OP users was approximately half

that of pharmacy DAA users, although the overall rate is low.

When specialist attendances were added to GP services, the cost of these doctor

attendances was significantly lower for non-pharmacy DAA users compared to

either pharmacy DAA or OP users.

Pharmacy DAA users received more Enhanced Primary Care (EPC) service items

than non-pharmacy DAA users or OP users (although the latter effect was a trend).


While there was no significant difference in the sum of PBS and MBS costs in the

year prior to the home visits between the 3 groups, non-pharmacy DAA users had

the highest mean costs (with a higher interquartile range) followed by pharmacy

DAA users then OP users.

There was no significant difference between the groups (either the 3 group or the 2

group comparison) for the number of people using any hospital, any

monitoring/pathology or any other MBS service items or the proportion having used

only one pharmacy to dispense all their medications in the year prior to the home visit.

The number of people using an emergency doctors attendance service approached

significance for the 2 group comparison (p=0.096) with 17.0% of Pharmacy DAA users

using these emergency medical services compared with 8.9% of OP users (and no

non-pharmacy DAA users).

7.2.2 COMPARISON BETWEEN PHARMACY DAAS AND OP USERS BEFORE AND AFTER

DAA STARTED

This analysis included 34 pharmacy DAA users and 62 users of original packs. Service

use was compared for the two groups for the periods 1/7/01 to 30/6/02 and 1/7/03 to

30/6/04 (post DAA). Some 47.1% of the DAA users started using the DAA within the

period of the post-DAA service use data; a further 41 % started using DAAs 6 months

prior to the post-DAA data period and 3 patients started a DAA within 3 months of the

pre-DAA data period.

Table 7.2 summarises the service use in both the pre- and post-DAA periods for D

community patients who went on to start using a DAA and for a comparison group who

continued to use original packs. In the pre-DAA or baseline period, there were no

significant differences in service use except for the number of patients requiring

emergency doctor attendances. There were trends however in baseline service use.

Patients who became DAA users tended to use more pharmacies to supply their

prescription medicines, generate higher costs for GP services outside of hospital and

had more monitoring or pathology that might be associated with medication

management monitoring than OP users.

Some 34% of OP users had any MBS items provided in hospital in the pre- period

compared with 24% of DAA users (p=0.291 2).

5% and 6% of OP and DAA users had emergency doctor attendances (p=1.000

Fisher exact test).

Enhanced primary care items were claimed for 19% of OP users and 32% of DAA

users in the pre-DAA period (p=0.154 2). In the period between July 2001 and

June 2002, two of these items were home medicines reviews (HMRs) (1 each OP

and DAA group), 10 patients had multidisciplinary care planning items (6 for DAA)

and 15 patients had health assessments conducted by their GP (7 DAA).

In the post-DAA period, DAA users had higher service use relative to OP users in a

number of areas. In some cases, the pattern was opposite to that observed pre-DAA:

DAA users has significantly more PBS items and incurred greater PBS costs than

OP users with a slight (p=0.103) increase in the number of medicines regularly

taken (using the number of different items supplied more than once and those not

antiinfectives as a proxy).

The number of different prescribers of medicines also tended to be higher.

27% of OP users and 29% of DAA users has MBS items in hospital (p=0.835 2).


Table 7.1 Summary of unadjusted HIC service use for consenting non-veterans from Phase 2, where HIC data extracted

considered reliable

HIC service use variable for

the year prior to the home

visit

Group Mean SE

Mean

Median Interquartile

range

N Kruskall Wallis

test: 3 groups

(2, df, p value)

ANOVA

test of 3

groups***

Mann Whitney U

test: Pharmacy

DAA vs OP (U, p)

t-test: Pharm

-acy DAA vs

OP***

Pharmacy DAA 88.67 3.60 84.50 63.50-108.75 106 0.092 4070, 0.077 0.056

Non-pharm DAA 93.75 8.62 92.50 53.25-115.25 28

No. PBS items

**transformed

Original pack 79.08 3.69 75.50 54.75-97.25 90

3.71, 2, 0.156

Pharmacy DAA 2675.17 169.70 2431.71 1491.57-3192.43 106 0.011† 4169, 0.129 NS

Non-pharm DAA 3292.47 288.78 2928.20 1999.60-4465.60 28

Total $ PBS benefit

*transformed

Original pack 2320.03 152.01 2113.52 1401.22-2833.88 90

9.79, 2, 0.008

Pharmacy DAA 17.16 0.74 16 12-21 106 NS 4348, 0.286

Non-pharm DAA 16.18 1.48 14 10-21.75 28

No. different PBS items

**transformed

Original pack 16.10 0.78 14 10-21 90

1.39, 2, 0.499

Pharmacy DAA 11.25 0.45 11 8-14 106 NS 4302, 0.236 NS

Non-pharm DAA 11.82 1.18 11 7-15.5 28

No. different PBS items >1

supply (not antiinfectives

ATC J), **transformed Original pack 10.36 0.47 10 7-13.25 90

1.48, 2, 0.476


Non-pharm DAA 4.07 0.45 4 2-5 28

No. different prescribers

**transformed

Original pack 3.87 0.26 3 2-5 90

2.75, 2, 0.252

Pharmacy DAA 3.56 0.20 3 2-5 106 4256.5, 0.187

Non-pharm DAA 3.39 0.33 3 2-4.75 28

No. PBS prescribers of

items prescribed >1 (and

not ATC J) Original pack 3.28 0.22 3 2-4.25 90

1.78, 2, 0.410


Non-pharm DAA 2.14 0.24 2 1-3 28

No. different dispensers

**transformed

Original pack 2.11 0.17 2 1-3 90

0.46, 2, 0.797

Pharmacy DAA 58.52 5.20 43 26-67.5 106 4603, 0.673

Non-pharm DAA 43.11 6.04 32 20-60.25 28

Total No. MBS items

Original pack 51.70 4.09 43.5 25-66.25 90

2.08, 2, 0.354


Table 7.1 continued



visit

Group Mean SE

Mean


range

N Kruskall Wallis

test: 3 groups

(2, df, p value)

ANOVA

test of 3

groups***

Mann Whitney U

test: Pharmacy

DAA vs OP (U, p)

t-test: Pharm

-acy DAA vs

OP***

Pharmacy DAA 2036.11 195.01 1434.30 942.15-2210.66 106 NS 4696, 0.852 NS

Non-pharm DAA 1610.24 260.21 1174.50 595.20-2316.68 28

Total $ MBS benefit

*transformed

Original pack 1935.68 158.92 1601.80 824.86-2754.19 90

1.68, 2, 0.433

Pharmacy DAA 13.92 3.61 0 0-3 106 NS 4467.5, 0.335 NS

Non-pharm DAA 5.82 2.94 0 0-0 28

No. MBS items in hospital

**transformed

Original pack 5.26 1.75 0 0-3.25 90

1.39, 2, 0.500


Non-pharm DAA 1691.36 529.34 1516.55 496.28-2842.59 6

Cost MBS items in

hospital

*transformed Original pack 1368.42 271.96 942.20 476.90-1545.60 23

0.46, 2, 0.793


Non-pharm DAA 14.00 1.97 11 7.25-16 28

No. GP items

(nonhospital)

**transformed Original pack 17.70 1.29 15 10-22 90

4.95, 2, 0.084

Pharmacy DAA 650.63 41.75 552.45 361.80-782.88 105 0.006‡ 4285, 0.263 NS

Non-pharm DAA 404.16 52.01 342.73 237.74-428.96 28

Cost $ GP items

(nonhospital)


13.72, 2,

0.001

Pharmacy DAA 0.25 0.06 0 0-0 106 4392, 0.105

Non-pharm DAA 0.00 0.00 0 0-0 28

No. emergency

attendances

Original pack 0.13 0.05 0 0-0 90

7.14, 2, 0.028

Pharmacy DAA 110.40 16.38 79.65 79.65-95.39 18 63, 0.606

Non-pharm DAA - - - --- 0

Cost emergency

attendances

Original pack 118.48 19.29 88.65 79.65-169.09 8

0.27, 1, 0.606

Pharmacy DAA 20.11 1.06 18 13-24 106 NS 4610.5, 0.687 NS

Non-pharm DAA 17.00 2.12 14.5 9-20.75 28

No. Dr attendance items

(nonhospital GP+

Specialist) **transformed Original pack 22.08 1.53 18 13-27.25 90

4.41, 2, 0.110


Table 7.1 continued



visit

Group Mean SE

Mean


range

N Kruskall Wallis

test: 3 groups

(2, df, p value)

ANOVA

test of 3

groups***

Mann Whitney U

test: Pharmacy

DAA vs OP (U, p)

t-test: Pharm

-acy DAA vs

OP***

Pharmacy DAA 826.05 51.36 734.95 472.23-942.90 105 0.013‡ 4580, 0.712 NS

Non-pharm DAA 560.99 67.12 442.83 322.43-740.85 28

Cost Dr attendances

(nonhospital GP+

Specialist) *transformed Original pack 836.50 63.77 670.25 455.94-1022.35 90

9.24, 2, 0.010

Pharmacy DAA 17.42 2.04 9 4-19.25 106 NS 4606.5, 0.679 NS

Non-pharm DAA 13.00 2.20 9.5 4-19.5 28

No. monitoring/ pathology

items (nonhospital)

**transformed Original pack 15.09 1.84 10 3-18.5 90

0.21, 2, 0.899


Non-pharm DAA 201.61 29.34 160.45 71.78-296.20 25

Cost $ monitoring/

pathology (nonhospital)


1.78, 2, 0.410

Pharmacy DAA 259.08 71.34 0 0-128.27 104 NS 4599.5, 0.924 0.040

Non-pharm DAA 152.69 72.35 0 0-0 28

Other MBS costs (not GP,

hospital or monitoring/

pathology), *transformed Original pack 279.49 61.06 0 0-29.48 89

0.93, 2, 0.629

Pharmacy DAA 0.41 0.07 0 0-1 106 4343.5, 0.159

Non-pharm DAA 0.07 0.05 0 0-0 28

No. Enhanced Primary

Care items

Original pack 0.29 0.07 0 0-0 90

7.08, 2, 0.029


Non-pharm DAA 4902.70 421.28 4643.87 2932.96-6601.38 28

Sum PBS+MBS costs,

*transformed

Original pack 4255.71 241.50 3740.63 2401.40-5530.76 90

2.59, 2, 0.274

***for transformed (transformation Ln* or square root**) variables approaching significance

†Sheffe post hoc test: OP different to nonpharmacy DAA

‡Sheffe post hoc test: Non-pharmacy DAA different to OP and pharmacy DAA


Table 7.2 Comparison of service use pre and post use of DAA – OP users versus community patients starting a pharmacy supplied DAA

Pre DAA 1Jul 2001 - 30 Jun 2002 Post DAA 1 Jul 2003 - 30 Jun 2004 Service use in 1 year

Group Mean SE Median IQR N P* Mean SE Median IQR N P*

No. PBS items OP 71.29 4.92 66.5 40.75-85.25 62 0.951 80.11 4.74 77.5 54-99.5 62 0.033

DAA 70.59 6.27 60.5 44.75-92.75 34 98.00 6.80 91 69-121 34

Total $ PBS benefit OP 2006.42 194.93 1472.81 998.95-2462.74 62 0.753 2432.11 210.98 2049.10 1422.19-2886.50 62 0.023

DAA 1789.56 189.66 1380.75 1004.35-2440.54 34 2924.54 231.59 2593.79 1887.01-3747.49 34

No. different PBS items OP 15.81 0.95 14.5 10-21.25 62 0.690 16.08 0.89 14.5 11-21.25 62 0.187

DAA 16.74 1.48 16 10.75-20.25 34 18.32 1.38 15.5 13-23.75 34

OP 9.69 0.61 8.5 6-12.25 62 0.636 10.52 0.62 10 7-14 62 0.103 No. different PBS items (>1xsupply & not ATC J) DAA 10.06 0.81 9.5 6-13.25 34 12.21 0.81 11 9-14.25 34

No. different prescribers OP 3.97 0.31 4 2-5.25 62 0.585 3.56 0.26 3 2-4.25 62 0.055

DAA 4.15 0.42 4 2-6 34 4.26 0.35 4 3-5 34

No. different dispensers OP 2.13 0.24 1 1-3 62 0.072 1.82 0.15 1 1-2 62 0.337

DAA 2.50 0.26 2 1-4 34 2.00 0.20 2 1-2.25 34

Total No. MBS items OP 41.69 3.41 33.5 20-63.25 62 0.430 55.84 4.96 43 27.75-71.75 62 0.354

DAA 49.03 6.22 38.5 23.75-61.25 34 66.68 10.08 47 29-90.5 34

Total $ MBS benefit OP 1732.50 199.33 1335.20 764.48-2345.48 62 0.486 1851.47 171.51 1274.90 774.54-2576.18 62 0.426

DAA 1937.87 305.30 1510.55 835.48-1909.50 34 2209.71 345.59 1580.45 1118.06-2389.85 34

No. MBS items in hospital OP 5.52 1.47 0 0-3.5 62 0.396 4.82 2.13 0 0-3.25 62 0.598

DAA 8.50 4.19 0 0-0.75 34 12.26 4.96 0 0-5 34

Cost MBS items in hospital OP 1158.47 252.73 672.75 306.73-1626.93 21 0.558 875.49 237.13 662.10 262.23-858.08 17 0.228

DAA 2328.05 835.35 1589.93 161.18-5076.50 8 1706.97 456.81 1561.40 269.08-3003.76 10

No. GP items (nonhospital) OP 15.53 1.35 12.5 8-19.5 62 0.210 18.26 1.64 16 10.75-22 62 0.730

DAA 18.38 2.55 15.5 10.75-21 34 17.50 1.63 15.5 10-23.25 34

Cost $ GP items (nonhospital) OP 480.56 39.13 392.75 241.14-679.53 62 0.093 640.32 62.24 473.78 331.78-801.59 62 0.180

DAA 621.79 77.98 435.45 364.85-843.33 34 728.25 85.26 629.10 401.54-832.73 34

No. emergency attendances OP 0.05 0.03 0 0-0 62 0.804 0.05 0.03 0 0-0 62 0.006

DAA 0.15 0.12 0 0-0 34 0.26 0.09 0 0-0.25 34


Table 7.2 continued

Pre DAA 1Jul 2001 - 30 Jun 2002 Post DAA 1 Jul 2003 - 30 Jun 2004 Service use in 1 year

Group Mean SE Median IQR N p Mean SE Median IQR N p

Cost emergency attendances OP 77.70 0.00 77.70 77.70-77.70 3 1.000 82.43 8.10 79.65 70.00-. 3 0.834

DAA 168.78 102.18 168.78 66.60-. 2 88.48 10.87 81.65 72.41-81.65 8

OP 19.32 1.50 18 10.75-24.25 62 0.294 22.10 1.91 18 12-26 62 1.000 No. Dr attendance items (nonhospital) DAA 21.71 2.47 19 14.75-24.25 34 21.24 2.41 17.5 13.5-24 34

OP 659.27 48.71 609.95 402.06 -883.79 62 0.131 838.13 78.76 609.58 457.93-1037.84 62 0.297 Cost Dr attendances (nonhospital) DAA 788.82 78.17 702.93 453.04 -1035.31 34 962.52 151.88 719.43 522.85-940.40 34

OP 9.35 1.46 5.5 2-12.25 62 0.098 15.42 2.08 11.5 3-20.25 62 0.319 No. monitoring or pathology items (nonhospital) DAA 11.53 1.99 8 4-15.5 34 21.24 4.55 12 5.75-20 34

OP 173.62 23.27 102.15 64.53-231.43 49 0.762 255.73 29.78 190.60 73.10-363.50 55 0.611 Cost $ monitoring or pathology (nonhospital) DAA 173.86 26.71 127.55 70.95-227.65 33 302.45 55.98 202.40 108.53-298.68 33

OP 0.34 0.11 0 0-0 62 0.117 0.34 0.11 0 0-0 62 0.117 No. Enhanced Primary Care items DAA 0.47 0.13 0 0-1 34 0.47 0.13 0 0-1 34

OP 3738.92 296.97 3482.18 1831.82-4714.94 62 0.915 4283.59 294.93 3707.82 2479.84-5536.72 62 0.061Sum PBS+MBS $ benefit

DAA 3727.43 368.53 3057.13 2401.68-4414.47 34 5134.25 428.19 4643.94 3407.62-6406.75 34 * Mann Whitney U test


5% of OP users and 24% of DAA users had emergency doctor attendances

(p=0.015 Fisher exact test) and the mean number of attendances per patient

receiving these services was significantly higher in the DAA group.

Enhanced primary care items were claimed for 19% of OP users and 35% of DAA

users in the post-DAA period (p=0.085 2). For the post-DAA period (July 2003 to

June 2004), 5 HMRs were claimed (2 for DAA users), 5 patients had

multidisciplinary care planning items (36 for DAA) and 20 patients had health

assessments conducted by their GP (9 DAA).

Overall, the cost of services provided under PBS and MBS tended to be higher

(p=0.061) for people who had started a DAA in the preceding period.

7.2.3 ADJUSTING HIC SERVICE COSTS FOR COVARIATES

Multivariate modelling was used to adjust for covariates between groups and

covariates of service cost for the year prior to the home visit. All final models were

significant explaining between 14.8% and 40.9% of variance in costs. After adjusting

for available covariates and between group differences, there were significant

differences in modelled healthcare costs for PBS costs and MBS service costs incurred

in hospital; costs associated with monitoring or pathology that might be done for

medication management monitoring approached significance (Table 7.3).

Table 7.3 Summary of multivariate cost models

Cost Groups Model (variance explained) p#

PBS benefit costs DAA 3 group R Squared = 0.380 (Adjusted R Squared = 0.347)

0.030

Pharmacy DAA vs OP R Squared = 0.345 (Adjusted R Squared = 0.315)

0.040

GP (non-hospital) benefit costs

DAA 3 group R Squared = 0.434 (Adjusted R Squared = 0.398)

0.371


0.243


0.085MBS services in hospital benefit costs


0.028


0.050Monitoring/pathology (non-hospital) benefit costs Pharmacy DAA vs OP R Squared = 0.211

(Adjusted R Squared = 0.148) 0.058


0.673Other MBS benefit costs (not GP, hospital or monitoring / pathology


0.595

*All models significant to the p<0.0001 level #p value for DAA and control group as an independent predictor for other covariates

The details of the cost models can be found in Appendix I.

The modelled mean costs for each group were calculated. These retransformed costs

are those predicted by the models after adjusting for covariates in the models. The

adjusted means based on the model were converted back to dollars (from Ln dollars)

as were the confidence intervals for the estimated mean. Figure 7.1 to Figure 7.6

compare adjusted costs (3 group and 2 group comparisons) with unadjusted costs in

the period.


Users of medicines in original packs had lower PBS costs than either users of

pharmacy supplied DAAs or non-pharmacy DAA users, adjusted or unadjusted (Figure

7.1). Adjusting for age, health status, symptom frequency, the number of current

medicines at home, the number of different dispensing pharmacies and any

hospitalisation in the previous 12 months suggested that non-pharmacy DAA users

actually had higher PBS costs than they should have given their characteristics in the

model. Pharmacy DAA users actually had slightly lower PBS costs than might be

expected given the model. However, the models explained between 30 and 35% of the

variance in PBS costs so that there may be further differences in characteristics

(unmeasured) between the groups for which adjustment would be required.

0

500

1000

1500

2000

2500

3000

3500

4000


$ P

BS

be

ne

fits

in

ye

ar

pri

or

to h

om

e v

isit

Adjusted PBS benefits - 3 group

Adjusted PBS benefits - Pharmacy DAA vs OP

Unadjusted PBS benefits

Figure 7.1 Adjusted and unadjusted PBS costs (mean and 95%CI) for the year prior to

home visit

For GP costs (Figure 7.2), there were no significant differences between the groups

and the effect of adjusting for covariates (living alone, the number of GP visits in the

previous 2 weeks, health status, age, prior ADR, number of different prescribers, any

hospitalisation in last 12 months, gender and disorganised non-adherence) slightly

lowered OP and pharmacy DAA costs while increasing non-pharmacy DAA (i.e. given

the characteristics of the non-pharmacy DAA users, they should have incurred higher

GP costs that they did).

Adjusted MBS costs in hospital were significantly lower for pharmacy DAA users

compared to OP users (Figure 7.3). Adjusting for age, OARS IADL score, the number

of different prescribers and dispensing pharmacies and any hospitalisation in the

previous 12 months suggested that pharmacy DAA users actually had higher MBS

hospital costs than they should have given their characteristics in the model and OP

users actually had lower costs than might be expected given the model. However, the

models explained about 40% of the variance in costs so that there may be further

differences in characteristics (unmeasured) between the groups for which adjustment

would be required. Further, it is possible that uncaptured hospital costs (public and

patient/insurer paid) were not equally distributed between the groups.


0

100

200

300

400

500

600

700


$ c

ost of G

P ite

ms b

enefits

in y

ear

prior

to h

om

e v

isit Adjusted GP costs - 3 group

Adjusted GP costs - Pharmacy DAA vs OP

Unadjusted GP costs

Figure 7.2 Adjusted and unadjusted MBS costs for nonhospital GP services (mean

and 95%CI) for the year prior to home visit

0

500

1000

1500

2000

2500

3000

3500

4000


Co

st $

MB

S ite

ms in

ho

sp

ita

l in

ye

ar

prio

r to

ho

me

vis

it

Adjusted MBS Hospital costs - 3 group

Adjusted MBS hospital costs - Pharmacy DAA vs OP

Unadjusted MBS hospital costs

Figure 7.3 Adjusted and unadjusted MBS costs for services provided in hospital for

those who used these services (mean and 95%CI) for the year prior to

home visit

The costs of monitoring/pathology services that might assist monitoring of medication

management was higher in the pharmacy DAA group compared to the other two

groups (Figure 7.4). After adjusting for health status, the number of doctors seen, the

number of illnesses reported by the patient, any ADR, memory related non-adherence,

the number of GP visits in the last 2 weeks, comparative health rating, impaired IADL,

living alone and regular use of community health services, the predicted cost of

monitoring/pathology services was higher in the pharmacy DAA group than actual

costs, however the variance on costs explained by these models was the lowest

among the cost models (15-18%).


0

50

100

150

200

250

300


$ c

ost of M

BS

monitoring/p

ath

olo

gy ite

ms

(no

nh

osp

ita

l) in

ye

ar

prio

r to

ho

me

vis

it

Adjusted cost of monitoring/pathology items - 3 group

Adjusted cost of monitoring/pathology items - Pharmacy DAA vs OP

Unadjusted cost of monitoring/pathology items

Figure 7.4 Adjusted and unadjusted MBS costs for nonhospital monitoring/ pathology

services for those who used these services (mean and 95%CI) for the year

prior to home visit

Other MBS costs incurred outside hospital were highest for OP users but adjusting for

health status, the number of GP visits in the last 2 weeks and regular use of community

health services brought the predicted service use for OP and pharmacy DAA users

closer together (Figure 7.5).

0

200

400

600

800

1000

1200

1400

1600

1800

2000


Cost $ o

ther

MB

S ite

ms (

nonhopsital,

no

t G

P o

r m

on

ito

rin

g/p

ath

olo

gy)

Adjusted cost other MBS items - 3 group

Adjusted cost other MBS items - Pharmacy DAA vs OP

Unadjusted cost other MBS items

Figure 7.5 Adjusted and unadjusted other nonhospital MBS costs for those who used

these services (mean and 95%CI) for the year prior to home visit

Since it was possible that pharmacy DAA users had higher service use prior to starting

a DAA as well as more disability and poorer health, the total HIC cost (Ln PBS+MBS

benefits) in the post-DAA period (extending from 3 to 6 months after the home visit

date) was modelled with adjustment for covariates (any hospitalisation in the 12


months prior to the home visit, health status, the number of GP visits in the last 2

weeks, the number of current medicines in the home, gender and age) and the cost of

service use in the pre-DAA period. The model explained 56.6% of variance in HIC

costs (R Squared = 0.604, Adjusted R Squared = 0.566) and DAA use was not a

significant predictor of cost in the post-DAA period (p=0.107). The adjusted mean and

unadjusted mean post-DAA costs are shown in Figure 7.6.

0

1000

2000

3000

4000

5000

6000

Original pack Pharmacy DAA

$ M

BS

+P

BS

benefits

Baseline period

Unadjusted post

Adjusted post

Figure 7.6 Unadjusted baseline, unadjusted post-DAA and adjusted post-DAA HIC

costs (mean and 95%CI) for subset in the pre-post analysis

Baseline costs were a strong predictor of post-DAA costs (accounting for 22.6% of

variance after adjusting for other variables in the model) followed by the person’s rating

of their health status (10.3% of variance after adjusting for other variables in the

model).

8. CHARACTERISING COMMUNITY PATIENTS

WHO USE A DAA

The question of just who will benefit from using a DAA has not been fully defined. The

literature and guidelines suggest patients with a range of characteristics benefit but the

nature of “benefit” varies from the view that certain patients who are nonadherent will

benefit through to the assumption that patients who can use the device successfully will

have improved adherence. Few studies have examined benefit in terms of outcomes.

In this section, the characteristics that distinguished between Phase 2 community

patients who continued to use pharmacy-provided DAAs and those who used original

packed (OP) medicines are examined. While the study conducted in Phase 2 was a

cross-sectional study and was not designed to establish a causal link between outcome

and DAA use, the results may be helpful in developing more defined criteria for

potential community-based recipients of a DAA service. A randomised controlled trial

and/or a longitudinal study would allow patient characteristics that predict likely benefit

from a DAA to be better defined, however, a comparison of two groups of community

patients who self-selected to use either medicines in original packs or have medicines

packed by a pharmacy into a DAA can still inform the question of who would benefit


from a DAA. Continued DAA use by patients implies some perception of ‘benefit’ when

merely using original packs could reduce patient cost and inconvenience.

8.1 METHODS

In Phase 2, information was collected by data collectors who visited participating

community patients in their homes. The data was collected using a combination of

patient interview and patient questionnaire.

To summarise the patient recruitment (described in full in the Phase 2 Final Report,

section 3.3), patients were recruited by pharmacists who were participating in the

study. Pharmacists were asked to recruit four community based DAA users and four

matched non-DAA users. Pharmacists were given the following criteria for matching:

age, gender, number and type of medications and living arrangements. Participants

also had to be regular customers of the pharmacy, living in the community (i.e. not

residing in a hostel or residential care facility) and capable of answering interview

questions and completing a questionnaire (with the help of a carer if necessary). In

total, 353 community patients were recruited by 75 pharmacies, with eight pharmacies

unable to recruit any community patients.

Usable patient demographic (age, gender, living arrangements), clinical (use of

medications, compliance, health status and some health service use) and functional

(Instrumental Activities of Daily Living (IADL) and ability to use medicines) were

available for 348 Phase 2 community patients. The patient subset for whom models

were developed for the economic analyses included 312 patients who gave valid

consent for the retrieval of Health Insurance Commission (HIC) data and for whom

there were sufficient details to match to an identifier used by HIC for data retrieval.

8.1.1 PREPARATION OF MODEL VARIABLES

Only patient characteristics collected in Phase 2 were used in models because data

from Phase 3 would not be available for people who had died, been admitted to

residential care or were otherwise lost to follow-up. A number of dichotomous

variables were taken from the interview and questionnaires:

Living alone.

Having a regular carer.

Community health worker visits on a regular basis (e.g. nurse, meals-on-wheels, therapist).

Gender.

Any Adverse Drug Reactions (ADR) – symptoms or health problems patient thinks were

caused by medicines.

The four Meichenbaum questions: Do you ever forget to take your medications; Are you

careless about taking your medicines; When you feel better do you stop taking your

medicines; If you feel worse do you stop taking your medications.

Continuous variables were:

The number of doctors (GPs or specialists) usually seen.

The number of times a GP was seen in the last 2 months.

The number of different illnesses reported by the patient.

The number of different prescribers of current medicines (taken from packs) – median

substitution (median=1) was used for 58 cases.

The number of different dispensing pharmacies of current medicines (taken from packs).

Several ordinal variables were also used:


Self-rating of health (poor, fair, good or excellent).

Comparative health (worse than others, about the same, better).

Frequency of illness symptoms in the past week (4 levels: not at all to most days (4-

7days/week)) – also recoded into a high/low dichotomous variable.

Rating of illness symptom severity in the past week (5 levels: nil to severe) – also recoded

into a high/low dichotomous variable.

Some variables were calculated or recoded from interview or questionnaire responses:

Age in years was calculated as at the home visit.

The number of days in hospital and the number of admissions in the last year was recoded

to “any hospitalisation in the last year”.

Older Americans Resource Scale for Instrumental Activities of Daily Living (OARS-IADL)

score (range 0-14).

The days since the last medication change were calculated.

The total number of current medicines, the number of solid (potentially packable) medicines

and the number of non-solid current medicines were derived from the list of medicines

identified at home visit. Only two of these variables were used in a model at one.

A Principal Components analysis with varimax rotation was also conducted in relation to

several compliance measures to determine factors for participants resulting in 3 variables

(the sum of scores for the questions loading on a given factor): memory-related non-

adherence, deliberate non-adherence and disorganised non-adherence. Each variable was

later recoded as dichotomous variables: any non-adherence or no non-adherence.

The use of drugs in various therapeutic categories were aggregated from the current

medicines in the home for 306 patients (Table 8.1). These classes are indicative of mental

health problems (where noncompliance is a problem), dementia (where cognitive

impairment may affect medication management ability), physical limitations to open

medicine packs, treatments for cardiovascular diseases (hypertension and dyslipiaemia,

asymptomatic conditions where treatment reduces morbidity and mortality, and heart failure,

a symptomatic condition), diabetes type II (where good glycaemic control through good

compliance to drugs and diet prevents complications) and respiratory medicines (because

many of these are in dose forms that cannot be packed into a DAA). The drug classes,

beta blockers and drugs acting on the angiotensin system were aggregated separately as

these medicines can be used to treat hypertension and/or heart failure.

Table 8.1 Aggregated variables for use of specific classes of drugs

Drug use marker ATC codes % Frequency

Any antianxiety medicines (yes/no) starting N05B Y=13.4 Any antidementia medicines starting N06D Y=2.3 Any antidepressant medicines starting N06A Y=27.8 Any antipsychotic medicines starting N05A Y=9.5 Any medicine used to treat rheumatoid arth-ritis or Parkinson’s disease (a potential for physical problems with packs)

starting N04 or M01C, L01B01, A07EC01, L04AA11 to 14, L04AA01, L04AX01, P01BA01

Y=6.5

Any lipid lowering medicines starting C10 Y=42.8 Any oral hypoglycaemic medicines starting A10B Y=11.8 The number of respiratory medicines starting R03A or R03B or

R03CC or R03D 1=9.8; 2=4.2; 3=2.6; 4=1.3; 5=1.3; 6=0.3

Any beta blocker medicines starting C07A Y=27.1 Number of medicines acting on angiotensin II (a potential marker of disease severity)

starting C09 1=52.0; 2=5.2; 3=0.7

Any other antihypertensive medicines starting C02 or C08, C03AA03 Y=31.7 Number of other medicines used to treat heart failure (a potential marker of severity)

C01AA05, starting C03C, C03DA01

1=21.9; 2=7.2; 3=1.0

A square root transformation of age and the total number of current medicines was

used the propensity model as the economic analysis also involved multiple linear


regression where variables whose distribution approaches the normal distribution.

Untransformed age and numbers of medicines were used in other models as logistic

regression more robust to violations the assumption of normality for continuous

variables.

8.1.2 LOGISTIC REGRESSION MODELS

Binary logistic regression (SPSS for Windows version 12.0.1) with backward

elimination was used to develop a number of models to predict the use of pharmacy-

provided DAAs versus medicines in original packs. A significance level of 0.05 was

used for all analyses. All of the medication related risk factors were considered a priori

to potentially impact on health outcomes.

The various models included slightly different variables initially, before backward

elimination of variables until a model that was parsimonious but maximised the

explanatory (Cox & Snell R square and Nagelkerke R square) and predictive power of

the model (the percentage of cases correctly classified). The goal of the first model

used to generate propensity scores for the economic analysis was to rank cases on

variables that were related to health service use. As Phase 2 was a cross-sectional

study where causation could not be attributed, a number of other logistic models were

developed that omitted some variables that may well be the consequence of DAA use

rather than a predictor of DAA use:

Any ADR.

Number of GP visits in the last 2 months (DAA users have fewer visits just to get a

prescription written).

Number of different pharmacies and different prescribers – DAA users have a packing

relationship with a pharmacy and a prescription writing relationship with a GP to ensure

continuity of supply (often managed by the pharmacy).

The self-reported non-compliance (Meichenbaum) questions “When you feel better do you

stop taking your meds?” and “If you feel worse, do you stop taking your medicine?” were

excluded in some cases as having medicines packed in multi-dose DAAs makes if more

difficult to stop taking a specific medicine.

The time since the last medication change was excluded from some models as this

variable was missing for 49 cases. The variables included initially in each model are

shown in Table 8.2.

Table 8.2 Variables initially included in the logistic regression models

Propensity Model

Model 2

Model 3

Model 4

Model 5

Model 6

Living alone Having a regular carer Regular community health worker visits No. doctors usually seen Self-rating of health No. times a GP was seen in last 2 months No different illnesses reported by patient Patient reports any hospitalisation in last year Comparative health Frequency of illness symptoms in past week score Severity of illness symptoms in past week score Symptoms in past week (high/low) Symptom severity in past week (high/low) Any ADRNo. different prescribers (median substitution)


No. different dispensing pharmacies OARS-IADL score Square root (94-Age) AgeGender Total No. of current medicines Square root total No. of current medicines Total No. of current solid medicines Total No. of current non-solid medicines Memory-related non-adherence score Any memory-related non-adherence Deliberate non-adherence score Any deliberate non-adherence Disorganised non-adherence score Any disorganised non-adherence Any antianxiety medicines Any antidementia medicines Any antidepressant medicines Any antipsychotic medicines Any rheumatoid or Parkinson’s disease medicine Any lipid lowering medicines Any oral hypoglycaemic medicines No. respiratory medicines Any beta blocker medicines No. medicines acting on angiotensin II Any other antihypertensive medicines No. other medicines used to treat heart failure Days since last medication change Do you ever forget to take your medications Are you careless about taking your medicines When you feel better do you stop taking your medicines If you feel worse do you stop taking your medicines

8.1.3 NON-LINEAR MACHINE LEARNING MODELS

The logistic regression models presented in 8.2.2 assume that the relationship between

the decision to use a DAA and the predictors is linear. An alternative modelling

strategy, machine learning, was trialled to overcome the limitations of a logistic model

and to better reflect the combination of patient characteristics that might describe an

individual DAA user. The machine learning technique trialled was that of a decision

tree as this was felt to lend itself better to ‘eligibility’ assessment than other types of

machine learning.

Non-linear models were generated using the same initial combination of variables as

those included in the logistic regression models 2, 5 and 6 to illustrate the technique.

Thus , the Phase 2 data was used as an initial training set for decision tree generation.

Note that because of the cross-sectional nature of the study in Phase 2, model 2

includes variables that may be ‘caused’ by DAA rather than predicting their use;

models 5 and 6 exclude these variables.


An additional tree was generated that incorporated the probability score from the

logistic model 2 to examine the validity of the tree i.e. whether the tree and the logistic

regression model the same underlying construct.

All trees were generated using Ross Quinlan’s C5 algorithm, available in the See5

package for Windows on the Rulequest website

(http://www.rulequest.com/download.html).

One of the options available when building trees is that of boosting. When a tree is

generated it makes some errors of prediction on the training set. Boosting generates a

succession of trees giving higher weightings to cases that have been previously

misclassified in an attempt to rectify the errors made. When a new case is to be

classified, each of the trees generated votes for a predicted class. These votes are

counted and the final prediction is made. This gives a better overall predictive accuracy

but at the expense of interpretability as many trees are being consulted to give the final

prediction. For each tree generated a boosting of 50 was used in conjunction was cross

validation to try and assess the best possible predictive accuracy in real world

conditions.

In each case, the overall accuracy of the tree is predicted by using cross-validation.

With all machine learning techniques there is a danger of over-learning on the training

set in which case the models produced may not generalize well into the greater

community. Therefore to check this we used ten-fold cross validation. This technique

splits the data into 10 random parts. The model is trained on 9 parts and tested on the

10th. Therefore there are 32 randomly chosen test cases held out from training on the

model and used to test predictive accuracy.

For each case the pruning was left at 25%. Fuzzy thresholds were not used.

Both decision trees and equivalent rule sets were generated.

8.2 RESULTS

8.2.1 LOGISTIC REGRESSION MODEL USED TO DERIVE PROPENSITY SCORES FOR

ECONOMIC ANALYSIS

The logistic regression model (Chi-square=98, df 12, p<0.001, n=249) included the

variables collected in Phase 2 (Table 8.3) and correctly predicted 72.3% of cases

(probability cut point 0.5) as belonging to DAA (77.4%) or OP (66.1%) groups (Cox &

Snell R Square=0.326 and Nagelkerke R Square=0.436). The variables, living alone

and self-rated health status were included as they improved the predictive ability of the

model.

The logistic regression model used to adjust for between group differences in the

propensity of using a DAA over using medicines in original packs also provided

information on the characteristics of community patients electing/choosing to use a

DAA after adjusting for the effect of any covariates in the characteristics. In addition to

willingness to use a DAA (these patients made the choice to start the DAA), the

characteristics of community patients that independently predicted DAA use compared

to use of original packs were:


Having a regular carer increased the odds of using a DAA by 313% compared to

not having a regular carer. This determinant may point to other benefits of a DAA

in easing carer burden.

Having community health workers visit on a regular basis increased the odds of

using a DAA by 226% compared to not having a regular carer, suggesting that DAA

users make greater use of community support.

Seeing fewer doctors. For each additional doctor (GP or specialist) regularly

visited, a community patient is 24% less likely to use a DAA. This could reflect a

more interventionist approach to treatment in the less disabled OP group or that the

pharmacy is more likely to act as the primary medical care provider for DAA users.

If the patient indicated that they had been to hospital at least once in the preceding

year, the odds of using a DAA were increased by 351%, compared to those

reporting no recent hospital admission.

Community patients experiencing an adverse reaction to medications were 66%

less likely to be DAA users.

Increasing age - older community patients were more likely to use a DAA.

Community patients who were 79 years (50th percentile of the people in this study

OP, pharmacy DAA and non-pharmacy DAA) were 37% less likely than someone

85 years old (approximately 80th percentile) to use a DAA; a 69 year old (~ 20th

percentile) was 37% less likely to use a DAA than a 79 year old; a 58 year old (~ 5th

percentile) was 37% less likely to use a DAA than a 69 year old.

The number of medicines used and the number of solid medicines (that could

be packed into a DAA). The effect of these variables on the probability is opposite

and reflects the underlying effects of the number of non-solid medicines a person

might take. Increasing the total number of solid medicines increases the odds of

using a DAA but this probability is ameliorated by how many non-solid medicines

are taken. For example, moving 1 unit on the square root of the number of current

medicines at home (includes non-solid medicines) from 1.41 to 2.45 (a move from 2

to 6 medicines at home) and all of these 4 extra medicines were solid medicines,

the odds of using a DAA are 5.8 times (1.48x4 – 0.14) more likely than not using a

DAA but if one of the extra medicines was non-solid, the odds of using a DAA are

4.3 times more likely than not using a DAA. If only 1 of the extra medicines was a

solid medicine, the odds of using a DAA would be only 1.34 times more likely than

not using a DAA for a community patients where all other characteristics are

similar.

Community patients who had visited the GP more frequently in the previous 2

months were less likely to use a DAA. For each additional GP visit, the odds of

using a DAA was 21% less. Prescription management by pharmacies may reduce

the number of GP visits to obtain new prescriptions.

Having medicines prescribed by more doctors reduce the likelihood that the

community patient would use a DAA. For each additional prescriber (as reported by

the patient), the odds of using a DAA was 47% less. Again, the prescription

management by pharmacies may rationalise the prescribing responsibilities (as the

logistic regression adjusts for the number of doctors seen regularly).

Living alone and self-rated health status approach significance as DAA predictors:

Community patients who lived alone were 176% more likely to use a DAA than

those not living alone


Better self-rated health reduced the likelihood of using a DAA. A change in health

rating from ‘poor’ to ‘fair’ or from ‘fair’ to ‘good’ or from ‘good’ to ‘excellent’ reduced

the odds of using a DAA by 35%.

Table 8.3 Logistic regression model of using a pharmacy supplied DAA (versus OP)

Variables in the logistic regression

model

B Std.

Error

Wald

statistic

df Sig. OR OR 95% CI

Having a regular carer 1.141 0.344 10.990 1 <0.001 3.131 1.594 - 6.148

Regular community health visits 0.815 0.374 4.756 1 0.029 2.260 1.086 - 4.704

No. GP's/doctors regularly visited -0.279 0.131 4.562 1 0.033 0.756 0.585 - 0.977

Any hospital in last 12mths reported by patient

1.256 0.369 11.610 1 <0.001 3.512 1.705 - 7.235

Experienced adverse reactions -

any symptoms or problems caused

by medicines

-1.069 0.335 10.183 1 0.001 0.343 0.178 - 0.662

Square root of (94 – age (years)) -0.459 0.163 7.938 1 0.005 0.632 0.459 - 0.870

Square root of the total number of current medicines in home

-1.971 0.707 7.782 1 0.005 0.139 0.035 - 0.556

Total No. current solid medicines 0.392 0.134 8.545 1 0.004 1.481 1.138 - 1.926

No. times visited GP in past 2 mths -0.235 0.085 7.731 1 0.005 0.790 0.670 - 0.933

How many different doctor

prescribing medicines per patient

(with median substitution (1) of 41

missing values)

-0.637 0.242 6.906 1 0.009 0.529 0.329 - 0.851

Living alone 0.568 0.343 2.731 1 0.098 1.764 0.900 - 3.458

Self-rated health (poor - excellent) -0.424 0.225 3.535 1 0.060 0.654 0.421 - 1.018

Constant 6.320 1.660 14.497 1 <0.001 555.606

8.2.2 LOGISTIC REGRESSION MODELS INCLUDING DRUG USE VARIABLES

The logistic regression model 2 (Chi-square=123.94, df 12, p<0.001, n=235) correctly

predicted DAA use for 78.7% of cases (probability cut point 0.5) as belonging to DAA

(81.6%) or OP (75.5%) groups (Cox & Snell R Square=0.410 and Nagelkerke R

Square=0.547, Hosmer & Lemshow test p>0.05). Table 8.4 shows those variables

retained in the model as independently significant predictors of DAA use.

Table 8.4 Logistic regression model 2 of using a pharmacy supplied DAA (versus OP)

Variables in the logistic regression model

B Std. Error

Wald statistic


Living alone 0.843 0.385 4.788 1 0.029 2.324 1.092 - 4.948 Having a regular carer 1.197 0.384 9.737 1 0.002 3.311 1.561 - 7.023 Regular community health visits 1.281 0.421 9.239 1 0.002 3.599 1.576 - 8.219 No. GP's/doctors regularly visited -0.709 0.167 17.988 1 <0.001 0.492 0.354 - 0.683 Any hospital in last 12mths reported by patient

0.958 0.394 5.921 1 0.015 2.606 1.205 - 5.638

Age 0.057 0.020 7.719 1 0.005 1.058 1.017 - 1.102 Total No. current medicines in home

-0.129 0.062 4.346 1 0.037 0.879 0.779 - 0.992

Any current antidepressants 1.606 0.470 11.682 1 0.001 4.983 1.984 - 12.517Any current anti-rheumatic or Parkinson’s disease medicines

3.610 1.055 11.703 1 0.001 36.968 4.673 - 292.467

No. other current medicines to treat CCF

1.020 0.319 10.237 1 0.001 2.774 1.485 - 5.181


Do you ever forget to take your medications

1.247 0.431 8.361 1 0.004 3.480 1.494 - 8.103

If you feel worse do you stop taking your medicines

-4.236 1.022 17.177 1 <0.001 0.014 0.002 - 0.107

Constant -4.542 1.700 7.140 1 0.008 0.011

The findings for Model 2 were similar to the propensity score model that:

Living alone, having a regular carer or having regular community health worker

visits increased the odds of using a DAA by 232%, 331% and 360% compared to

not living alone, having a regular carer or receiving community health visits.

Seeing fewer doctors. For each additional doctor (GP or specialist) regularly visited,

a community patient is 51% less likely to use a DAA.

Any hospitalisation in last year and greater age increased the odds of using a DAA

Contrary to what might be expected, as the more current medicines a person takes

increases by 1, the odds of using a DAA are 12% less

The odds of using a DAA are also increased if a person takes any antidepressant or a

medication for rheumatoid arthritis or Parkinson’s disease, or if they require more

additional (non-beta blocker or drugs affecting angiotensin II) medications to control

heart failure (CCF). Patient admission of being forgetful about medicines increased the

odds of using a DAA while admission of deliberate non-compliance (stopping a

medicines because you feel worse) reduced the odds of a DAA by 99% in this model.






The pattern of effects is similar to model 2, however, model 3 shows that the number of

non-solid medications is a better predictor of DAA use as the correct classification of

cases was higher in model 3 than model 2, and confirms the underlying variable in the

propensity model. For an increase of 1 in the number of non-solid medicines, the odds

of using a DAA are 26% lower. Thus the actual number of medicines packed is NOT

an independent predictor of DAA use.



B Std. Error

Wald statistic


Living alone 0.874 0.389 5.047 1 0.025 2.396 1.118 - 5.134

Having a regular carer 1.230 0.386 10.164 1 0.001 3.421 1.606 - 7.287


No. GPs/doctors regularly visited -0.684 0.167 16.742 1 <0.001 0.504 0.364 - 0.700


0.912 0.398 5.235 1 0.022 2.488 1.140 - 5.432

Age 0.062 0.021 8.746 1 0.003 1.064 1.021 - 1.108

No. non-solid current medicines -0.305 0.130 5.491 1 0.019 0.737 0.571 - 0.951

Any current antidepressants 1.353 0.463 8.521 1 0.004 3.867 1.560 - 9.589

Any current anti-rheumatic or Parkinson’s disease medicines

3.312 1.024 10.467 1 0.001 27.445 3.690 -

204.123


0.891 0.304 8.612 1 0.003 2.437 1.344 - 4.418



1.242 0.432 8.261 1 0.004 3.461 1.484 - 8.071

If you feel worse do you stop taking your medicines

-4.330 1.020 18.010 1 <0.001 0.013 0.002 - 0.097

Constant -5.716 1.698 11.332 1 0.001 0.003








B Std. Error

Wald statistic


No. GPs/doctors regularly visited -0.536 0.148 13.165 1 <0.001 0.585 0.438 - 0.781


0.921 0.394 5.449 1 0.020 2.511 1.159 - 5.441

OARS-IADL score -0.286 0.086 11.006 1 0.001 0.751 0.634 - 0.889

Age 0.050 0.020 6.435 1 0.011 1.051 1.011 - 1.092

No. non-solid current medicines -0.309 0.121 6.478 1 0.011 0.734 0.579 - 0.931

Any current antidementia drugs 2.996 1.492 4.034 1 0.045 20.005 1.075 - 372.31


No. current angiotensin II drugs -0.623 0.319 3.816 1 0.051 0.536 0.287 - 1.002


1.044 0.326 10.250 1 0.001 2.840 1.499 - 5.379


1.076 0.408 6.952 1 0.008 2.934 1.318 - 6.531

Constant 0.098 2.034 0.002 1 0.961 1.103

Excluding carer and community health visits from the model meant that OARS-IADL

score became an independent predictor of DAA use. For each increase in score

(better function), the odds of using a DAA were reduced by 25%. Similarly, without

carer and community health visits, the use of specific antidementia medicines

(indicated for mild to moderate Alzheimer’s disease) became a significant independent

predictor of DAA use. This effect is likely to be due to strong covariance between the

increased care needs reflected by the carer and community health visit variables, and

IADL score or having mild to moderate Alzheimer’s disease.

As the number of angiotensin II drugs increased, the odds of using a DAA were

reduced by 46%, perhaps reflecting a more interventionist approach to treatment of

hypertension of heart failure. The number of angiotensin II drugs was retained in the

model as it increased the model fit. However, removal of this variable led to the

removal of antidementia drugs as a predictor. Adding antirheumatic/Parkinson’s

medicines back to the model improved fit again. The final model was the same as

model 6.









B Std. Error

Wald statistic


Having a regular carer 0.993 0.349 8.110 1 0.004 2.698 1.363 - 5.344


No. GPs/doctors regularly visited -0.674 0.159 17.995 1 0.000 0.510 0.373 - 0.696

No. illnesses reported by patient -0.176 0.081 4.744 1 0.029 0.839 0.716 - 0.983


0.955 0.370 6.676 1 0.010 2.600 1.259 - 5.366

Age 0.052 0.019 7.468 1 0.006 1.053 1.015 - 1.094



2.630 0.952 7.637 1 0.006 13.871 2.148 - 89.562


0.871 0.291 8.991 1 0.003 2.390 1.352 - 4.224


1.156 0.399 8.380 1 0.004 3.177 1.453 - 6.950

Constant -4.256 1.559 7.454 1 0.006 0.014

The number of different illnesses reported by the patient (a crude measure of illness

burden) appeared in model 5 as an independent predictor, but its effect was opposite

to that expected – as the number of illnesses increased, the odds of using a DAA were

reduced. It is possible that more illnesses reflect an unstable condition where

medication changes are more frequent, and so that DAAs become more trouble than

they are worth. This explanation is supported by the significant correlations between

the number of illnesses and symptom severity (rho=0.39, p<0.001) and frequency

(rho=0.34, p<0.001) in the past week, the number of days since the last medication

change (rho= -0.16, p<0.006) and the number of medication changes in the last 6

months (rho=0.24, p<0.001).








B Std. Error

Wald statistic


No. GPs/doctors regularly visited -0.593 0.162 13.417 1 0.000 0.553 0.403 – 0.759


1.010 0.390 6.721 1 0.010 2.747 1.280 – 5.897

OARS-IADL score -0.295 0.088 11.272 1 0.001 0.745 0.627 – 0.885

Age 0.057 0.020 7.745 1 0.005 1.058 1.017 – 1.102

No. non-solid current medicines -0.250 0.119 4.397 1 0.036 0.778 0.616 – 0.984

Any current antidepressants 1.480 0.451 10.784 1 0.001 4.392 1.816 – 10.623


0.901 0.317 8.079 1 0.004 2.462 1.323 – 4.582


1.011 0.403 6.304 1 0.012 2.749 1.248 – 6.052


2.080 0.909 5.238 1 0.022 8.003 1.348 – 47.506

Constant -0.715 2.128 0.113 1 0.737 0.489


Comparison of models 4 to 6 shows that there is more than one potential set of

characteristics to predict DAA use. Indeed, model 5 does not include a variable about

medication burden i.e., the total number of current medicines (either solid or non-solid).

The variables included and retained in the various models is summarised in Table 8.9.

Table 8.9 Variables initially included in the logistic regression models

Propensity Model

Model 2

Model 3

Model 4

Model 5

Model 6

Living alone Having a regular carer

Community health worker visits on a regular basis

No. doctors usually seen Self-rating of health No. times a GP was seen in last 2 months No different illnesses reported by patient Patient reports any hospitalisation in last year Comparative health Frequency of illness symptoms in past week score Severity of illness symptoms in past week score Symptoms in past week (high/low) Symptom severity in past week (high/low) Any ADRNo. different prescribers (median substitution) No. different dispensing pharmacies OARS-IADL score Square root (94-Age) Age

Gender Total No. of current medicines Square root total No. of current medicines Total No. of current solid medicines Total No. of current non-solid medicines Memory-related non-adherence score Any memory-related non-adherence Deliberate non-adherence score Any deliberate non-adherence Disorganised non-adherence score Any disorganised non-adherence Table 8.9 continued Propensity

Model Model

2Model

3Model

4Model

5Model

6

Any antianxiety medicines Any antidementia medicines Any antidepressant medicines Any antipsychotic medicines Any rheumatoid or Parkinson’s disease medicine

Any lipid lowering medicines Any oral hypoglycaemic medicines No. respiratory medicines Any beta blocker medicines No. medicines acting on angiotensin II Any other antihypertensive medicines No. other medicines used to treat heart failure

Days since last medication change Do you ever forget to take your medications

Are you careless about taking your medicines When you feel better do you stop taking your


medicines If you feel worse do you stop taking your medicines

Included initially but removed; Retained in the final model

8.2.3 NON-LINEAR MACHINE LEARNING MODELS

8.2.3.1 Interpreting output

Two types of output of the decision tree approaches to machine learning, decision

trees and a rule set technique, were generated. To read a decision tree, start with the

left most variable and it’s conditional statement. As extra branches are added to the

tree the conditional statements in all parent branches must be met. There are numbers

at the end of each leaf node, (n/m) or just (n). ‘n’ is the number of cases which fall

under that branch and ‘m’ is the number of cases incorrectly classified under that rule.

Fractions can exist because “(A non-integral number of cases can arise because, when

the value of an attribute in the tree is not known, See5 splits the case and sends a

fraction down each branch.)” (See 5 instructions)

Consider the leaves of the tree below in italics as an example. IADL <= 10: :...HVNUMRES > 2: : :...LIVING = 0: 0 (5/0.4) : : LIVING = 1: 1 (2.6/0.3) : HVNUMRES <= 2: : :...REGULAR CARER = 1: 1 (74.4/11) : REGULAR CARER = 0: : :...NUMBER OF NON-SOLID MEDICATIONS > 1: 0 (2) : NUMBER OF NON-SOLID MEDICATIONS <= 1: : :...LIVING = 1: 1 (9.9/1.4) : LIVING = 0: : :...TOTSOLID <= 6: 0 (3.9) : TOTSOLID > 6: 1 (2.7)

This would be read as:

If independent activities of daily living (IADL) is less than or equal to 10 and the

number of respiratory medications is greater than 2 (HVNUMRES) and the patient is

living alone then a dose aid should be assigned; 2.6 cases were classified under this

branch with 0.3 errors.

Or

If independent activities of daily living score (IADL) is less than or equal to 10 and the

number of respiratory medications is less than or equal to 2 and there is no regular

carer (CARER) and the number of non-solid medicines (NUM_NSME) is less than or

equal to 1 and the patient is living alone (LIVING) and has more than 6 solid

medicines (TOTSOLID) then a dose aid should be assigned: 2.7 cases were correctly

assigned to this branch of the tree.

For each leaf node on the tree a value of:

0 indicates that the person would be assigned to no dose aid group.

1 indicates that the person would be assigned to the dose aid group.

Another option that could lead to easier interpretation is rule-sets. For every tree

model that is learned an equivalent rule-set can be generated. These rule sets could be

easier to read and assess by health care professionals. Here is an example of a rule

set generated in the same way as the trees above. For each rule the following are

given:


Statistics (n, lift x) or (n/m, lift x) that summarize the performance of the rule.

Similarly to a leaf, n is the number of training cases covered by the rule and m, if it

appears, shows how many of them do not belong to the class predicted by the rule.

The rule's accuracy is estimated by the Laplace ratio (n-m+1)/(n+2). The lift x is the

result of dividing the rule's estimated accuracy by the relative frequency of the

predicted class in the training set.

One or more conditional statement(s) that must all be satisfied for the rule to be

applicable.

A class predicted by the rule.

A value between 0 and 1 that indicates the confidence with which this prediction is

made. (Note: If boosting is used, this confidence is measured using an artificial

weighting of the training cases and so does not reflect the accuracy of the rule.) (Copied from See5 help files)

8.2.3.2 Decision trees

The following figures show the decision trees generated from the same variables

included initially in the logistic regression models 2, 5 and 6.

Tree 1 used all the logistic regression model 2 variables and included 311 cases in the

training data. A tree with 20 leaf nodes was generated (Figure 8.1). Overall, 17.7% of

cases were miss-classified i.e. correct classification for 82.3% with correct classification

for 71.0% OP users and 91.3% pharmacy provided DAA users. The first node was

IADL score with a cut point of less than or equal to 10 versus greater than 10. People

who had a lower IADL score and did not stop taking their medicines if they felt worse

were assigned to the DAA group (87 cases met these criteria with 18% error). The

node where IADL is low, the person stops taking their medicines if they felt worse

(deliberate non-adherence) but have not been to hospital in the last 12 months were

also classified to the DAA group (10% error) makes less sense when taken in

conjunction with the logistic regression. This may be because the variable “when feel

worse, stop taking medicines” is potentially caused by DAAs rather than predicting

DAAs. Similarly, the variable “stop medicines if feel better” further down the tree may

be misleading as the DAA group responses do not represent their behaviour prior to

starting a DAA. Were patient behaviours prior to starting a DAA included in the tree,

the result may have been different.

activities of daily living <= 10: :...when feel worse stop taking medications = no: 1 (87/16) : when feel worse stop taking medications = yes: : :...hospital visit in last 12 months = no: 1 (3/0.3) : hospital visit in last 12 months = yes: 0 (10.4/3.5) activities of daily living > 10: :...when feel better stop taking medications = yes: 0 (3.1) when feel better stop taking medications = no:

:...ever forget to take meds = yes: 1 (46.1/13.6) ever forget to take meds = no: :...age > 86: 1 (16.3/2.8) age <= 86: :...regular community health workers visits = yes: :... when feel worse stop taking medications = yes: 0 (5.9/0.8) : when feel worse stop taking medications = no: : :...number of illnesses <= 4: 1 (19.7/5.3) : number of illnesses > 4: 0 (4.4/0.2)


regular community health workers visits = no: :...antirheumatoid or parkinsons meds = yes: :...number of angiotensin II meds <= 0: 1 (5.7/0.4) : number of angiotensin II meds > 0: 0 (3.4/0.3) antirheumatoid or parkinsons meds = no: :...when feel worse stop taking medications = yes: 0 (11.7/0.6) when feel worse stop taking medications = no: :...number of regular doctors visited > 4: 0 (7.3/0.1) number of regular doctors visited <= 4: :...memory related non-adherence > 0: 1 (9.5/3.8) memory related non-adherence <= 0: :...antidepressant meds = no: :...age <= 71: 1 (5.9/1.3) : age > 71: : :...number of illnesses <= 0: 1 (4.1/1.1) : number of illnesses > 0: 0 (53.5/8) antidepressant meds = yes: :...activities of daily living <= 12: 1 (3.8/0.3) activities of daily living > 12: :...number of regular doctors visited <= 1: 1 (2.9/0.3) number of regular doctors visited > 1: 0 (7.2/0.6)

Figure 8.1 Decision tree generated using the same variables as Regression Model 2

Tree 2 (Figure 8.2) excludes the potentially confounding ‘causal’ Meichenbaum

variables related to deliberate non-adherence. It included 311 cases in the training

data. A tree with 28 leaf nodes was generated. Overall, 83.9% of cases were correctly

classified with correct classification for 77.5% OP users and 89.0% DAA users. Again,

IADL was the first node. For people with a low IADL, the next node was number of

respiratory medicines where people with more than 2 were classified as OP users

(error 35%). This makes teleological sense as respiratory medicines are more likely to

be dose forms (aerosols, nebulisers) that cannot be packed into a DAA, so that in this

case the difficulties associated with using a DAA when lots of other medicines are not

packed may well override any advantage of DAAs. Note that the number of non-solid

medications appears further down the tree with a similar effect.

activities of daily living <= 10: :...number of respiratory drugs > 2: 0 (7.5/2.6) : number of respiratory drugs <= 2: : :...regular carer = yes: 1 (74.4/11) : regular carer = no: : :...number of non-solid medications > 1: 0 (2) : number of non-solid medications <= 1: : :...living alone = yes: 1 (9.9/1.4) : living alone = no: : :...total number of solid medications <= 6: 0 (3.9) : total number of solid medications > 6: 1 (2.7) activities of daily living > 10: :...ever forget to take meds = yes: 1 (48.2/15.6) ever forget to take meds = no:

:...number of illnesses <= 0: 1 (8.3/1.2) number of illnesses > 0: :...regular carer = no: :...number of non-solid medications > 2: 0 (15.3/0.5)


: number of non-solid medications <= 2: : :...number other heart failure meds > 0: : :...regular community health workers visits=yes: 1 (4.6/0.4) : : regular community health workers visits = no: : : :...oral hypoglycaemic meds = no: 0 (11/3.2) : : oral hypoglycaemic meds = yes: 1 (3.3/0.2) : number other heart failure meds <= 0: : :...other antihypertensive meds = yes: 0 (22/2.1) : other antihypertensive meds = no: : :...hospital visit in last 12 months = no: 0 (29.8/8.1) : hospital visit in last 12 months = yes: : :...age <= 79: 0 (5.1/1.2) : age > 79: 1 (3.9/0.2) regular carer = yes: :...number of illnesses <= 1: 1 (6.1/0.2) number of illnesses > 1: :...oral hypoglycaemic meds = yes: 1 (5.1/1) oral hypoglycaemic meds = no: :...number of angiotensin II meds > 1: 0 (3/0.2) number of angiotensin II meds <= 1: :...community health workers visit regularly = yes: :...number of illnesses <= 3: 1 (8.3/0.8) : number of illnesses > 3: 0 (3.2) community health workers visit regularly = no: :...deliberate non-adherence > 2: 1 (2) deliberate non-adherence <= 2: :...number other heart failure meds > 1: 1 (4/0.8) number other heart failure meds <= 1: :...number of regular doctors visited > 2: 0 (9/0.5) number of regular doctors visited <= 2: :...memory related non-adherence > 0: 1 (2.1/0.1) memory related non-adherence <= 0: :... activities of daily living > 12: 0 (7.1) activities of daily living <= 12: :...living alone = no: 0 (4.4/0.7) living alone = yes: 1 (5/1)


Tree 3 (Figure 8.3) started with the same variables as tree2 except that regular carer

and community health visits were excluded – these two variables overshadowed the

effect of IADL in the logistic regression models and use of these services may be

driven, in part, by service availability rather than direct need for a carer or community

health visitor. It included 311 cases in the training data. A tree with 18 leaf nodes was

generated. Overall, 80.1% of cases were correctly classified with correct classification

for 70.3% OP users and 87.9% DAA users. Again, IADL was the first node but all other

nodes after the number of respiratory medicines were omitted (due to the exclusion of

carer and community health worker), there were 18.3 errors in the low number of

respiratory medicines arm compared to 12.4 in tree 2.

activities of daily living <= 10: :...number of respiratory drugs <= 2: 1 (92.9/18.3) : number of respiratory drugs > 2: 0 (7.5/2.6) activities of daily living > 10: :...ever forget to take meds = yes: 1 (48.2/15.6) ever forget to take meds = no:

:...number of illnesses <= 0: 1 (8.3/1.2)


number of illnesses > 0: :...number of respiratory drugs > 1: 0 (12.9/1.1) number of respiratory drugs <= 1: :...oral hypoglycaemic meds = 1: :...other antihypertensive meds = no: 1 (14.7/4.8) : other antihypertensive meds = yes: 0 (2.3/0.2) oral hypoglycaemic meds = no: :...hospital visit in last 12 months = no: :...past week self-rated symptom severity level = 1: 0 (23.9/3.8) : past week self-rated symptom severity level = 2: 0 (9.5/3) : past week self-rated symptom severity level = 3: 0 (9.8/1.6) : past week self-rated symptom severity level = 4: : :...age <= 80: 0 (9.6/1.3) : : age > 80: 1 (6/0.4) : past week self-rated symptom severity level = 5: : :...number of angiotensin II meds <= 0: 1 (4.2/1) : number of angiotensin II meds > 0: 0 (7.7/1.9) hospital visit in last 12 months = yes: :...number of regular doctors visited > 2: 0 (19.6/3.6) number of regular doctors visited <= 2: :...number of non-solid medications > 1: 0 (6.7/1.8) number of non-solid medications <= 1: :...number of illnesses <= 4: 1 (21.3/3.4) number of illnesses > 4: 0 (5.9/1.5)


Also of interest are the medication classes included in the nodes – these nodes are

printed in grey in the figures. In tree 1 (Figure 8.1), three different drug classes were

included in the model whereas tree 2 included 6 classes of drugs including oral

hypoglycaemics, not included in any logistic model. Here a person with type II diabetes

with a higher IADL score, no a regular carer or community health visits, low numbers of

non-solid medicines, at least one ‘other heart failure medicine’ were classified as DAA

users (error 6%).

The predictive accuracy of the trees was examined through a process of cross

validation and boosting with results shown in Table 8.10. Overall, these figures

suggest that including all of the relevant variables (Model 2) produces the most

accurate prediction when cross-validated but overall there is little variation in the cross-

validation figures. Note also, the potentially misleading results associated with the

deliberate non-adherence variables that had been included in the tree from Model 2.

In terms of utility, another point that is important to consider is the size of the tree. A

smaller tree is likely to be easier to interpret. Using a reduced set of variables (Model 6)

the tree that is generated has only 18 leaf nodes whereas including all variables

produces a slightly larger tree with 20 leaf nodes, and tree 2 had 28 nodes.

Table 8.10 Predictive Accuracy of Decision Tree Models

Initial Tree Cross-validated 10 Fold Boosted 50 + Cross-validated 10 x

Model2

Size Errors20 55(17.7%)

(a) (b)<-classified as ---- ---- 98 40 (a): class 0 15 158 (b): class 1 Sensitivity: 87%

Mean 27.9 35.1% SE 2.0 2.1%


Mean Errors 29.9% SE 1.9%



False Alarm: 21% False Alarm: 31% False Alarm: 18%

Model5

Size Errors 28 50(16.1%)

(a) (b)<-classified as ---- ---- 107 31 (a): class 0 19 154 (b): class 1 Sensitivity: 85% False Alarm: 17%

Mean Errors 21.5 36.9% SE 1.8 3.3%




Model6

Size Errors18 62(19.9%)


Mean Errors 21.6 38.0% SE 1.4 2.6%



(a) (b) <-classified as ---- ---- 83 55 (a): class 0 43 130 (b): class 1 Sensitivity: 65% False Alarm: 30%

8.2.3.3 Rule sets

As an example, a rule set was generated using the same variables (and 311 training

cases) as in the logistic regression model 5 (and tree 2). The rules are presented

below and sorted by utility (5 bands). The rule set classified 79.1% of cases correctly

(71.7% OP and 85.0% DAA) – this is less than tree 2.

Rule 1: (155/48, lift 1.2) CARER = 1 If have regular carer -> class 1 [0.688] then assign dose aid.

Rule 2: (195/89, lift 1.2) IADL > 10 If activities of daily living are more than 10 -> class 0 [0.543] then no dose aid.

Rule 3: (76/22, lift 1.3) BMQ1A1 = 1 If ever forget to take medicine -> class 1 [0.705] then assign dose aid.

Rule 4: (71/21, lift 1.3) NUM_NSME <= 2 If number of non-solid medicines is <=2 HVNUM_OT > 0 and number of other heart failure medicines is >0 -> class 1 [0.699] then assign dose aid.

Rule 5: (72/23, lift 1.5) LIVING = 0 If don’t live alone CARER = 0 and don’t have a carer -> class 0 [0.676] then no dose aid.

Rule 6: (10, lift 2.1) CARER = 1 If have a carer COM_HLT = 0 and community health workers don’t visit regularly NUM_ILL > 0 and the number of illnesses is greater than 0


IADL > 12 and activities of daily living are more than 12 F1_MEM <= 0 and there is no memory related non-adherence F2_DELIB <= 2 and the rating of deliberate non-adherence is <=2 HVNUM_OT <= 1 and number of other heart failure medicines is <=1 -> class 0 [0.917] then no dose aid.

Rule 7: (27, lift 2.2) COM_HLT = 0 If community health workers don’t visit regularly NUM_GP > 2 and the number of regular doctor is greater than 2 NUM_ILL > 0 and the number of illnesses is greater than 0 IADL > 10 and activities of daily living are more than 10 HVORAL_H = 0 and oral hypoglycaemic medicines are used HVNUM_OT <= 1 and number of other heart failure medicines is <=1 BMQ1A1 = 0 and don’t forget to take your medicines -> class 0 [0.966] then no dose aid.

Rule 8: (28/6, lift 1.4) COM_HLT = 1 If community health workers do visit regularly HVNUM_OT > 0 and number of other heart failure medicines is >0 -> class 1 [0.767] then assign dose aid.

Rule 9: (14/4, lift 1.5) HVNUMRES > 2 If number of respiratory medicines is greater than 2 -> class 0 [0.688] then no dose aid.

Rule 10: (14/1, lift 1.6) NUM_ILL <= 0 If the number of illnesses is less than or equal to 0 -> class 1 [0.875] then assign dose aid.

Rule 11: (36/10, lift 1.6) CARER = 0 If don’t have regular carer NUM_NSME > 1 and the number of non-solid medicines is >1 -> class 0 [0.711] then no dose aid.

Rule 12: (33/2, lift 1.6) LIVING = 1 If you live alone IADL <= 10 and activities of daily living are <= 10 NUM_NSME <= 1 and the number of non-solid medicines at home<=1 -> class 1 [0.914] then assign dose aid.

Rule 13: (11/2, lift 1.7) IADL > 10 activities of daily living are more than 10 HV_NUM_A > 1 number of medicines acting on angiotensin II is >1 -> class 0 [0.769] then no dose aid.

Default class: 1 (dose aid)

The following rule utility summary shows that including rules 1 to 10 correctly classifies

77.5% of cases with the last 3 rules only improving the correct classification by 1.6%

Rules Errors -------- --------------- 1-3 100(32.2%) 1-5 88(28.3%) 1-8 73(23.5%) 1-10 70(22.5%)

Looking at the predictive accuracy of the rule set, with Boost 50 and 10 fold cross-

validation, the mean error rate was 28.0% (SE 1.9%) (78% correct overall; 64.5% OP

and 78.0% DAA correct) with sensitivity at 70% and a false alarm rate of 26%.

Compared to the decision tree based on model 5 in Table 8.10, the error rate and false


alarm rate for the boosted + cross-validated rule set were lower and the sensitivity was

higher.

8.2.3.4 Comparison of logistic and decision tree classification

To examine how well the two modelling techniques related to the same underlying

construct, a decision tree was generated that include the probability of using a DAA

score calculated from the logistic model 2 (Figure 8.4). In the resulting tree the overall

error rate was 14.1% (77.5% OP and 92.5% DAA correct). Looking at the predictive

accuracy of the rule set, with Boost 50 and 10 fold cross-validation, the mean error rate

was 27.7% (SE 2.1%) (61.6% OP and 81.0 DAA correct) with sensitivity at 72% and a

false alarm rate of 27%.

The first branching of the tree was on the new variable indicating that in this tree, it is

the most important for predicting whether or not a patient will be using a pharmacy

dose aid. This tree is the most accurate machine learning model developed in this

study as assessed by cross-validation. This suggests that both methods of prediction

are exploring the same underlying factors. The tree that adds in the logistic regression

probability also:

Includes self-rated health status and symptom frequency in the past week

Includes antianxiety and antipsychotic drugs as nodes

Some variables, however, have an unexpected impact on the classification. For

example, people with a logistic regression probability score of 0.5 (the cut point where

<0.5=OP in the logistic models) whose IADL score was >10 who did not forget to take

medicines but had a community health worker visit were classified as DAA is they did

NOT live alone and OP if they lived alone. This seems counter-intuitive in that a

person with less in-home support is classified as using original packed medicines. As it

is possible that a person not living alone lives with an spouse who may also have

greater care needs, the reason of this type of anomaly requires further exploration.


logistic regression predicted probability <= 0.50456 (0.59694): :...activities of daily living <= 9 (9.5): : :...days since last medication change <= 365 (912.5): 1 (16.6/2.8) : : days since last medication change >= 1460 (912.5): 0 (2.5/0.4) : activities of daily living >= 10 (9.5): : :...ever forget to take meds = no: : :...community health workers visit regularly = no: : : :...oral hypoglycaemic meds = no: : : : :...total number of solid medications <= 2 (2.5): 1 (4.9/1.5) : : : : total number of solid medications >= 3 (2.5): 0 (82.2/12.9) : : : oral hypoglycaemic meds = yes: : : : :...number of illnesses <= 3 (3.5): 0 (6.1/1.3) : : : number of illnesses >= 4 (3.5): 1 (3.4/0.4) : : community health workers visit regularly = yes: : : :...activities of daily living <= 10 (10.5): 1 (3.4/0.3) : : activities of daily living >= 11 (10.5): : : :...living alone = no: 1 (4.2/1.2) : : living alone = yes: 0 (9.5/0.4) : ever forget to take meds = yes: : :...antianxiety meds = yes: 0 (2.2) : antianxiety meds = no: : :...self-rated health status = 1: 0 (1.6) : self-rated health status = 3: 1 (10.5/3.6) : self-rated health status = 4: 0 (0.5) : self-rated health status = 2: : :...deliberate non-adherence <= 3 (3.5): 1 (9.6/1.7) : deliberate non-adherence >= 4 (3.5): 0 (2) logistic regression predicted probability >= 0.60312 (0.59694): :...logistic regression pred. probability >= 0.89669 (0.89613): 1 (57.1/6.4) logistic regression predicted probability <= 0.81316 (0.89613):

:...antirheumatoid or parkinsons meds = yes: 1 (6.7/0.6) antirheumatoid or parkinsons meds = no: :...past week symptom frequency = 3: 1 (16.9/4.6) past week symptom frequency = 1: :...age <= 76 (77): 0 (3.8/0.4) : age >= 83 (77): 1 (20.4/3.8) past week symptom frequency = 2: :...number of non-solid medications <= 0 (0.5): 0 (3.9) : number of non-solid medications >= 1 (0.5): 1 (2.6/0.3) past week symptom frequency = 4: :...number of non-solid medications >= 4 (3.5): 0 (3.3/0.4) number of non-solid medications <= 3 (3.5): :...days since last medication change <= 61 (76): 1 (22.1/1) days since last medication change >= 242 (76): :...antipsychotic meds = yes: 1 (2.4/0.2) antipsychotic meds = no: :...number of solid medications <= 10 (10.5): 0 (9.2/1.6) number of solid medications >= 11 (10.5): 1 (3.2/0.4)


plus the predicted probability of DAA use from the logistic regression

model 2


9. COMMUNITY SETTING ECONOMIC ANALYSIS

9.1 OVERVIEW

The following section utilises the comparative costs of providing medication to

community customers in original packs (OPs) or DAAs as measured and costed from

the pharmacists’ perspective in Phase 2 (Ientile et al. 2004). An extension to the

decision analytic model comparing the frequency of outcomes between DAA and OP

customers as a result of an ADR is presented using Phase 3 data. The economic

implications of reductions in ADRs are explored in terms of a cost-effectiveness

analysis and a cost-benefit analysis. In addition, the consequences of using OPs and

DAAs in terms of wider healthcare costs, as measured in Phase 3, is explored with

results of preliminary economic evaluations presented. Finally, we consider the key

findings of this section in terms of data limitations and reflect on the policy implications.

9.2 BACKGROUND

Dose administration aids (DAAs) are devices or packaging systems where doses of

one or more solid oral medications (tablets or capsules) can be organised according to

the time of administration. DAAs offer a number of potential advantages over taking

medicines packaged in their original manufacturer’s packs. For a person who must take

a number of different solid oral medications each day, at a number of different times

per day, using medications packed in original packs would involve:

Remembering that a dose time is due;

Correctly retrieving the packs for each of the medications to be taken;

Opening each pack and taking out the required number of tablets or capsules

prescribed for a particular dose time, and;

Repeating the above for each dose time in a day.

Clearly, the above process becomes more complicated as the medication routine

becomes more complex, leading to a higher chance of non-compliance. Since these

aids indicate the intended dosing time for the medications, they can act as a memory

aid to remind a person to take a medication, or to indicate that a medication has

already been taken (reducing the chance of double dosing) (Rivers 1992; School of

Pharmacy and Medical Sciences at University of South Australia et al. 1997). In DAAs,

all of the medications to be taken at a given dose time are organised together, and the

correct number of tablets or capsules required to make the prescribed dosage are

packaged together for that dose time. Thus, theoretically, using DAAs should help

people to take their medications correctly and safely.

9.3 COST OF SUPPLYING DAAS

The methods for calculating the costs involved in providing DAAs is reported in Phase

2 (Ientile et al. 2004). The results of these workings and a sensitivity analysis follow.

9.3.1 SUMMARY OF COST RESULTS

In Phase 2, the measurement of costs of OP and DAA provision was based on a

detailed content analysis of workflow observations from 83 pharmacists. A summary of

the costs for the various resource use categories is presented in Table 9.1. Using a

base case of 30 customers using an average of 8 prescriptions per week, total costs for


in OPs is estimated at $543.88, compared to $1,070.50 for customers using DAAs.

This equates to $18.13 per customer for OPs and $35.75 per customer using DAAs, or

an additional $17.62 per customer.

With the exception of the costs of dispensing, the costs incurred in all cost categories

were greater for DAA customers than for OP customers. As expected, the cost of

packing and checking DAAs was the key cost in providing DAAs to community

customers, accounting for 67% of the total weekly cost difference in providing DAAs or

OPs. For OP customers, the key cost driver was the actual cost of dispensing.

Table 9.1 Summary of the comparison between DAA customer and OP customer

costs across the resource use categories

Cost categories Cost OP Cost DAA Difference*

Prescription management by pharmacy $12.07 $23.01 $10.94

Dispensing medication $415.39 $415.39 $0.00

Packing and checking $0.00 $354.86 $354.86

Delivery of medication $15.42 $86.93 $71.51

Counselling $4.73 $4.89 $0.15

Account management $7.14 $19.32 $12.19

Additional costs † $89.13 $168.10 $78.97

TOTAL for 30 customers $543.88 $1,072.50 $528.61

Total cost per customer $18.13 $35.75 $17.62 *Cost for DAA minus Cost for OP † Salary on-costs

9.3.2 SENSITIVITY ANALYSIS

Sensitivity analysis has been used to explore the uncertainty around key assumptions

made during the identification and valuation of resource use and outcomes. From the

above results we have identified a number of key factors that appear to influence the

costs of providing DAAs. As indicated earlier, an important cost driver is the value of

pharmacy staff time. While the value used in the above costing of the award wage plus

25% equates to an hourly cost of $35.33, in practice, however, pharmacist wages have

been reported to be approximately $40. Sensitivity analysis 1 examines variations in

costs of award wages plus 40%, which equates to an hourly rate for pharmacists of

$39.56. This increase in staff costs translates to an additional cost per DAA customer

per week of $19.08.

Another important cost driver is the time taken to pack and check a DAA. The times per

pack measured in Phase 2 of this study varied according to who does the packing,

what type of pack is used, the size of the pharmacy’s DAA operations, the number of

medicines packed, whether the measurement of time included interruptions or not and

even the particular methods and procedures utilised by the pharmacy staff in packing

(see (Ientile et al. 2004) Section 4.3.1.2). Sensitivity analyses 2 and 3 were undertaken

to test the potential cost implications of varying the time taken to pack and check

DAAs, who does the packing (sensitivity analysis 4), the type of DAAs used (sensitivity

analysis 5), and the level of additional services such as delivery included in the

provision of DAAs (sensitivity analysis 6). The details of the variations and the results

are presented in Table 9.2.

Sensitivity analyses 2 and 3 indicate that an increase in packing and checking time (i.e.

5 minutes per pack) resulted in an increase in the cost difference between DAA and

OP provision to the magnitude of $3.75 per customer per week. However, to reduce


the cost of difference by a similar amount ($3.84), packing and checking time needs to

be reduced by 7 minutes. Similarly, with sensitivity analysis 4, when 100% of the

packing and checking was done by the pharmacists, the cost of DAA provision

increased by $2.80 per patient per week. Sensitivity analysis 5 showed that packing

compartmentalised boxes (e.g. Dosett) exclusively cost $29.27 per customer per week

compared with blisters ($16.93) and automated packing ($17.48). Compartmentalised

boxes were more expensive than blister and automated due to longer packing times

and the greater likelihood of the pharmacist doing the packing. Automated were more

expensive than blister due to increased equipment costs that is likely to be off-set with

larger volume DAA supply (i.e. >500 customers per week). Finally, sensitivity analysis 6

shows the cost difference between DAAs and OPs when a bare bones - just packing

and checking DAA service ($12.57) is provided or a full DAA service including

prescription and account management, and delivery ($20.05) is provided. Table 9.2

shows the incremental cost of a DAA (the cost per DAA customer minus the cost per

OP customer) ranges between $12.57 and $29.27 depending on variations in packing

time, the type of pack used, who packs and the level of additional services provided.

Table 9.2 Description of the sensitivity analysis variations for the cost of DAA and

OP medication provision and results

Area of sensitivity Description of Variation Total Cost Cost/ customer

CostDifference

1. Pharmacy salaries

DAA base case Award wages plus 25% on-costs $1,070.50 $35.75

OP base case Award wages plus 25% on-costs $543.88 $18.13

$17.62

DAA salary on-costs Award wages plus 40% on-costs $1,169.40 $38.98

OP salary on-costs Award wages plus 40% on-costs $597.04 $19.90

$19.08

2. Packing Time

DAA base case ~11 min/customer $1,070.50 $35.75 $17.62

Single packing time excludes interruptions

Mean packing time of 9.66 minutes $1,059.72 $35.32 $17.20

packing time 75th percentile – 11.26 minutes $1,089.63 $36.32 $18.20

packing time 25th percentile – 4.05 minutes $954.87 $31.83 $13.71

Single packing time include interruptions

Mean packing time of 12.62 $1,115.04 $37.17 $19.05

packing time 75th percentile – 16.23 minutes $1,182.51 $39.42 $21.30

packing time 25th percentile – 4.94 minutes $971.69 $32.39 $14.27

3. Checking Time

Single checking time exclude interruptions

Mean checking time - 3.44 minutes $1,049.20 $34.97 $16.85

checking time 75th percentile – 3.95 minutes $1,060.25 $35.34 $17.22

checking time 25th percentile – 0.81 minutes $992.20 $33.07 $14.95

Single checking time include interruptions

Mean checking time - 4.67 minutes $1,075.85 $35.86 $17.74

checking time 75th percentile – 5.14 minutes $1,086.04 $36.20 $18.08

checking time 25th percentile – 1.11minutes $998.70 $33.29 $15.17

4. Who packs

Pharmacist only 100% pharmacist packing $1,151.93 $38.40 $20.28

Dispensing technician only

100% dispensary technician packing

$1,030.17 $34.34 $16.22

5 Type of Pack

Blisters only 100% of blister packs used $1,051.50 $35.05 $16.93

Dosett type only 100% of Dosett-type boxes used $1,421.66 $47.39 $29.27

Automated only 100% automated packing used $1,068.00 $35.60 $17.48


Table 9.2 continued

Area of sensitivity Description of Variation Total Cost Cost/ customer

CostDifference

6. Level of services

DAA pack only - no other services

DAA service included dispensing meds, packing and checking and additional cost

$921.09 $30.70 $12.57

DAA pack as part of a complete service

100% of customers receive all services i.e. as above plus prescription management, delivery, counselling and account management

$1,145.28 $38.18 $20.05

9.4 POTENTIAL COST SAVINGS FROM PREVENTING ADRS

The rate of adverse drug reactions (ADRs) was lower in both Phase 2 and Phase 3 for

the DAA sample compared to the OP group. It is hypothesised that using DAAs will

decrease costs associated with ADRs and that these savings will off-set the cost of

supplying DAAs in the community setting. The purpose of this section is to model the

potential cost-savings due to reduced ADRs reported for DAA patients compared to OP

patients, from the perspective of the health service funding body (namely the Australian

Government). These costs savings will then be considered in terms of the cost-

effectiveness of DAAs in avoiding an ADR and the net social cost of DAAs compared

with OPs.

9.4.1 METHODS

The rate of adverse drug reactions (ADRs) was lower in both Phase 2 and Phase 3 for

the DAA sample compared to the OP group. In Phase 2, 48% and 33% of OP and DAA

patients, respectively, suffered from an ADR (p=0.007). In Phase 3, the corresponding

proportions were 32% and 22% (p=0.147). This apparent improvement is due in part to

the greater proportion of ADR experienced by people who had exited the study by

Phase 3 - 67% of OPs who exited the study to enter an RCF reported an ADR in Phase

2 and 50% of those who died had reported an ADR in Phase 2 compared with 17% and

31% respectively for DAA users.

The decision analytic model developed in Phase 2 to simulate the potential costs and

outcomes of using the intervention (DAA) versus no intervention (OP) over a one year

period was adjusted to reflect the consequences of ADRs as reported by community

patients in the Phase 3 follow-up (see Phase 2 Final Report for methodology details

(Ientile et al. 2004)). The model was designed using a “branching tree format”, with the

beginning decision (using DAA or OP) branching into further pathways or nodes

(Drummond et al. 1997). End points determined for this model were the percentage of

GP visits, medication changes, hospitalisations, community nurse visits, and RCF

admission due to adverse drug reactions (ADRs), with or without the use of DAAs.

These end-points and pathways differ from those chosen in Phase 2 because of the

availability of data collected in the follow-up that was not available in the literature on

the consequences of ADRs. Medication changes were included in this model as they

were a frequently reported consequence of an ADR but were not included in the Phase

2 model as there was not data available on medication changes in the literature. The

Phase 2 model also included the percentage of patients that died as a result of an ADR

(mean frequency of 7%, range 0.2% to 18.2%) (Classen et al. 1997; Dartnell et al.

1996; Naranjo et al. 1981; White 1999). However, as this revised model is based on


self-report, patients who died from an ADR were not available to complete the Phase 3

follow-up. Consequently this branch has been excluded from the revised decision

analytic model.

The model was applied to a sample population of 30 community customers (to reflect

the costs of one pharmacy providing DAAs), with the probability of each event being

determined using actual data obtained from the current study (i.e. rate of ADRs in DAA

and OP customers). The rates of adverse events and probability of service use as a

result of an ADR were obtained from the community patient follow-up interview.

Contributions of each end point to the total cost were then calculated by multiplying the

final probability in population terms by the average cost of each end point of the

decision-analytic model. The value of the resources utilised in the provision of

healthcare as a result of an ADR are presented in Table 9.3.

Table 9.3 Resources utilised in the provision of healthcare resulting from an ADR

Cost item Value of cost item Description Cost Reference

Hospital $774.16/day 3.29 days (avg. visit length) $2,547 1 GP visit $57/consultation 2 long consults (MBS items 36) $115 2 Nurse visit $56/hour Weekly visits @ 30 min/visit for

6 months $728 3

RCF $69/day Mid year admission (180 days) $12,417 4 Medication change $19.89 per

medicine Mean dispensed price for medication use by this sample

$19.89 5

1. NHCDC:Cost Report - Round 4 (1999-2000); 2. Medicare Benefits Schedule - updated July 2004; 3. Rates of visit length = community nurse survey4. Commonwealth Department of Health and Aging 2002 5. PBS listing and Phase 2 data set

9.4.2 RESULTS

In the sample of community customers followed up in Phase 3, ADRs were reported by

17 of 78 DAA pts (21.8%) compared with 28 of 88 OP pts (31.8%) ( 2 =102 p=0.147).

For the purpose of this model, it was assumed ADRs were experienced only once

within the year. The frequency of outcomes was used to populate the decision analytic

model presented in Figure 9.1. This diagram shows the likelihood of an event and the

number of community customers experiencing a particular event for both the DAA and

OP branches based on 30 community customers in each arm. The events included in

this model were GP visits, medication changes, hospitalisation, community nursing

services and RCF admission. The Phase 2 model was altered to reflect the reported

health service use resulting from ADRs such that all patients who received treatment

utilised GP services and some experienced medication changes, hospitalisation, RCF

respite and community nursing services (in addition). Unlike the Phase 2 model based

on the literature, different consequences of ADRs were reported by DAA and OP

patients. Further, the treatment path in Phase 3 stemmed from GP visits rather than in

Phase 2 where literature estimates for treatment included either GP, hospital or RCF

visits.

The difference in the number of customers experiencing outcomes between the DAA

and OP branches stems from the 10% difference in the rates of ADRs but was

mediated by the increased likelihood of DAA patients seeking treatment for an ADR,

compared with OP patients. In addition, DAA patients were less likely to report

additional treatment (other than GP services) for an ADR compared with OP patients.


Table 9.4 compares the health and cost implications for both DAA and OP customers

and the difference. The total cost of treating ADRs for OP customers minus the cost of

treating ADRs for DAA customers ($5,040) represents the potential cost savings of

DAA for the government, based on 30 community patients over 12 months.

DAA

ADR

No treatment

GP visit

32

68

56

44

30

30

9.6

20.4

5.4

4.2

5.4

Community customers on

multiple medications

OP

No ADR

Treatment

Med changes

Hospital7

5.0

0.4

RCF admission7 0.4

Comm. Nurse0 0

ADR

No treatment

22

78

82

186.5

23.5

5.4

1.2

No ADR

Treatment

100

93

GP visit

5.4

Med changes

Hospital0

3.8

0

RCF admission0 0

Comm. Nurse7 0.4

71

100

Figure 9.1 Phase 3 decision analytic model comparing the frequency of outcomes as a

result of an ADR based on patient report - DAA versus OP customers

Table 9.4 Comparison between 30 DAA and OP customers of the costs to the

healthcare system incurred as a result of ADRs

Outcome DAA cost OP cost Difference

ADR + conseq + GP $618.11 $608.40 $9.71

ADR + conseq + GP+ Med change $76.53 $98.43 -$21.90

ADR + conseq + GP+ Hosp $0 $905.16 -$905.16

ADR + conseq + GP+ RCF $0 $4,412.71 -$4,412.71

ADR + conseq + GP+ nurse $290.31 $0 $290.31

Total cost $984.96 $6,024.70 -$5,039.74Key: conseq=consequence, hosp=hospitalisation, GP=GP visit, med change=medication changed,

nurse=Community nursing care, RCF=admission to a residential care facility

9.4.3 SENSITIVITY ANALYSIS OF HEALTHCARE COST SAVINGS

Sensitivity analysis has been used to explore the uncertainty in the proportion of

customers experiencing ADRs, hospitalisation, and RCF use. Sensitivity analysis 1

explores variation in the proportion of patients experiencing an ADR. There was a

greater difference in the rates of ADRs reported by community patients in Phase 2

compared with the sample followed-up in Phase 3. In Phase 2, 33% of community

patients using DAAs reported experiencing an ADR compared with 48% of OP

community patients ( 2=7.39, p=0.007). Sensitivity analysis was preformed using this

data to evaluate the cost implications of a higher rate of ADRs.

Sensitivity analysis 2 explores variations in the cost of hospitalisation based on data

extracted from HIC on treatment costs in hospital in addition to the accommodation

costs in hospital utilised in the base case. Sensitivity analysis 3 explores variations in

the cost of RCF care. The costs of RCF care were varied by multiplying the daily rate

by 30 days to reflect respite care only compared with the base model where permanent


admission was assumed to occur mid-year (180 days). Finally, sensitivity analysis 4

examines the uncertainty around the probability of different consequences between

DAA and OP customers. The difference in outcomes was not significantly different due

to the small sample size for Phase 3 and the lower rates or reported ADRs for both

groups. In sensitivity analysis 4, the consequences of ADRs are assumed to be the

same for both groups. The results of the analysis are presented in Table 9.5.

Sensitivity analysis 1 indicates that savings in healthcare costs resulting from a

reduction in ADRs at the rate observed in Phase 2 would be an additional $2,184.

Similarly increases in the cost of hospitalisation when treatments are included in

addition to accommodation, increases the potential cost savings from DAAs by

$824/year per 30 patients. Sensitivity analysis 3 indicates that a reduced length of stay

in an RCF (respite rather than permanent admission) reduces the total cost savings to

$1,362. Sensitivity analysis 4 indicates that if there is no difference in the likelihood of

hospitalisation and residential care admissions, the savings due to reduced ADRs in

the DAA group translates to just $370/year per 30 customers.

The cost difference varied between $370 and $7,583 (base model $5,039) when ADR

rates and consequences, hospitalisation and RCF cost were varied. The model was

most sensitive to change in the rates of RCF admission and hospitalisation (Table 9.5).

Table 9.5 Sensitivity analysis of healthcare cost savings

Area of sensitivity Description of Variation Total Cost Cost Difference

1. Frequency of ADRs

DAA base case 22% experience ADRs $984.96 OP base case 32% experience ADRs $6,024.70

-$5,039.74

33% experience ADRs $1,472.92 Rates of ADRs in Phase 2 data 48% experience ADRs $9,055.99

-$7,583.07

2. Hospitalisation

DAA base case $2,547 per admission $984.96 OP base case $2,547 per admission $6,024.70

-$5,039.74

DAA hosp costs $4,867 per admission $984.96 OP hosp costs $4,867 per admission $6,849.19

-$5,864.23

3. RCF admission

DAA base case Mid-year admission (180 days) $984.96 OP base case Mid-year admission (180 days) $6,024.70

-$5,039.74

DAA days in RCF Respite care (30 days) $984.96 OP days in RCF Respite care (30 days) $2,347.44

-$1,362.48

4. Same consequence

DAA base case Med =71%, Hosp& RCF=0%, CN=7% $984.96 OP base case Med =93%, Hosp& RCF=7%, CN=0% $6,024.70

-$5,039.74

DAA consequences $5,940.69 OP consequences

Med =93%, Hosp &RCF=7%, CN=7% $6,310.45

-$369.76

Key: Med = medication changes, hosp =hospitalisation, RCF=RCF admission, CN=Community nursing

care,

9.4.4 COMPARISON WITH PHASE 2 RESULTS

The savings from reduced costs associated with ADRs based on the follow-up

community patient interviews are about a third of the savings estimated in Phase 2

utilising the literature values for the consequences of ADRs ($15,316 versus $5,039).

This difference is in part due to the lower rates of ADRs reported in Phase 3 by both

OP and DAA patients but is largely attributable to the increased likelihood of

hospitalisation and RCF admission as indicated in the literature, compared with the


rates reported by community patients in Phase 3. Note that patients who were lost to

follow-up (e.g. by death or RCF admission) by Phase 3 were generally sicker with

greater care needs (see section 6.2.8) and so potentially more likely to need

hospitalisation or RCF admission as a consequence of ADRs, than those remaining in

the community. Further, of those who died or were admitted to an RCF, OP users were

more likely to have an ADR compared to DAA users. Nevertheless, Phase 3 results are

derived from actual treatment patterns in response to ADRs (for people not exiting the

study through death, RCF admission or loss to follow-up) and therefore are more

reliable than Phase 2 literature based estimates. The true rate of ADR consequences

may fall between the Phase 2 and Phase 3 estimates.

9.4.5 COST-EFFECTIVENESS ANALYSIS OF USING DAAS TO AVOID ADRS AND DEATHS

Cost effectiveness analysis (CEA) allows us to compare alternatives by calculating the

cost per unit effect, where costs are related to a single common effect which may differ

in magnitude between the alternatives (Drummond et al. 1997). In the current analysis,

two outcome measures are adopted: the number of patients with ADRs and number of

deaths. Table 9.6 provides the results of CEA based on 30 community customers in

each alternative medication delivery programme (i.e. DAA and OP) over one year. The

results of the cost-effectiveness analysis can be interpreted as the additional cost to

prevent one ADR (see section 9.4.2) and to avoid one death using DAA. From Table

9.6, the incremental cost effectiveness ratio using the first outcome measure is

estimated to be $9,163. Using the second outcome measure, the incremental cost

effectiveness ratio is estimated to be $16,361.87.

Table 9.6 Results of cost-effectiveness analysis comparing 30 DAAs customers to 30

OP customers based on the frequency of ADRs and deaths avoided

Outcome measure Percent of customers achieving outcome

Number of customers achieving outcome

Total cost of alternatives

Cost/ event avoided

No ADR for OP 68.2% 20.5 $28,281.93 No ADR for DAA 78.2% 23.5 $55,769.87 Difference -10.0% -3.0 $27,487.94

$9,162.65

Deaths/year OP 4.6% 1.4 $28,281.93 Deaths/year DAAs 10.2% 3.1 $55,769.87 Difference -5.6% -1.7 $27,487.94

$16,361.87

9.4.6 COST-BENEFIT ANALYSIS OF USING DAAS TO AVOID AN ADR

Cost-benefit analysis (CBA) aims to quantify both the costs and the consequences of

DAAs and OPs and thus facilitates the comparison of the net benefit (loss) of DAAs

with OPs. A CBA was undertaken to compare the cost of DAAs, and subsequent

reduction in healthcare costs given the decrease in ADRs, with the benefits to

consumers of using the DAAs.

9.4.6.1 Costs

Costs and cost-offsets calculated for the CEA are used in the present analysis.

9.4.6.2 Benefits of DAA

Willingness-to-pay (WTP) is an accepted economic technique used to value heath

benefits. The technique is based on the principle that the maximum amount of money

an individual is willing to pay for a commodity is an indicator of the value to him/her of

that commodity. Direct measurement of WTP can be assessed by asking people


directly how much they would be willing to pay for a specific product or service. This

approach allows individuals to take account of all factors (e.g. disposable income,

severity of illness, perceived need, preference etc.) which are important to them in the

provision of a service (Drummond et al. 1997). In the context of the current study, DAA

customers were asked three questions focusing on different aspects of willingness to

pay. These questions were:

How much would you be willing to pay to have your medicines packed in a device

that would make remembering to take your medications easier?


and delivered to you so that your medication taking was easy and convenient?


that would reduce your risk of experiencing and adverse drug event?

As there was no difference in willingness to pay across the three questions a mean

response to the three questions was calculated.

In Phase 3, community customers using DAAs were willing to pay a mean of $5.87 per

DAA per week (95% CI $4.57-$7.16), a result slightly higher than the willingness to pay

reported in Phase 2 of $5.25 per DAA/per week (95%CI $4.62-$5.87).

9.4.7 COST-BENEFIT ANALYSIS OF USING DAAS TO AVOID AN ADR

Table 9.7 shows the costs to pharmacy of providing medicines in OPs and DAAs, the

potential costs and consequences of OPs and DAAs and the benefits of DAAs to

customers (WTP). To provide DAAs to 30 customers for one year, it costs $27,487

more than when supplying OPs. However, the use of DAAs has the potential to save

$5,040 for the healthcare system in reduced costs associated with ADRs, again based

on 30 customers over one year. In addition, community customers valued pharmacy

provided DAAs at $5.87 per week, which equates to $9,157 per year for 30 customers.

Based on these values, the costs of providing DAAs to 30 community customers

outweigh the benefits of DAAs by $13,291 per year or $443.03 per DAA customer.

Table 9.7 Cost and benefits of DAAs and OPs

Cost to pharmacy (C) Total cost Cost per customer

Total cost OP per year $28,281.93 $942.73 Total cost DAA per year $55,769.87 $1,859.00

Total cost OP-DAA -$27,487.94 -$916.26 Cost savings to healthcare system (B1)

Cost ADR + consequence OP $6,024.70 Cost ADR + consequence DAA $984.96

Cost ADR + consequence OP-DAA $5,039.74 $167.99WTP (benefits to customer) (B2)

WTP per week for DAA per person $5.87 WTP per year for DAA $305.24

N * WTP / yr $9,157.20 $305.24

Costs (C) + costs savings (B1) + benefits (B2) -$13,291.00 -$443.03

9.4.7.1 Sensitivity Analysis

Sensitivity analysis was performed to explore the impact of variation in WTP (lower and

upper 95%CI), variations in cost of healthcare due to ADRs as examined in Section

9.4.3 and the cost of providing DAAs as examined in Section 9.3.2. The cost benefit

ratio (Benefits – Costs) varied between -$5,746 and -$17,414 (base model -$13,697)

when the benefits to the patient and the healthcare system and the costs to the


pharmacists were varied. The model was most sensitive to variations in the cost of

DAAs, as seen in Table 9.7.

Table 9.8 Sensitivity analysis of cost-benefit ratios

Area of sensitivity Description of Variation Value Benefit-Cost

1. WTP

DAA base case $5.87 per week per customer $9,157.20 -$13,291 WTP (lower 95%CI) $4.57 per week per customer $7,129.20 -$15,319 WTP (upper 95%CI) $7.16 per week per customer $11,169.60 -$11,279

2. Cost of healthcare

OP-DAA base case ADR: 22% DAA & 32% OP $5,039.74 -$13,697OP-DAA Phase 2 rates ADR: 33% DAA & 48% OP $7,583.07 -$11,153OP-DAA days in RCF Respite care (30 days) $1,434.77 -$17,302OP-DAA hospital cost $4,867 per admission $5,936.52 -$12,8003. Cost of DAAs

OP-DAA base case See 9.3.1 $27,487.94 -$13,697OP-DAA packing time 25th percentile – 4.05 minutes $21,387.60 -$7,524DAA pack only DAA service includes dispensing

meds, packing and checking only $19,609.20 -$5,746

DAA pack – complete service

100% of customers receive all serv-ices i.e. as above plus prescription management, delivery, counselling and account management

$31,278.00 -$17,414

9.5 COST SAVINGS AND ECONOMIC EVALUATION

ASSOCIATED WITH PATTERNS OF HEALTH SERVICE

UTILISATION

The benefits of DAAs are thought to be more far-reaching than reducing ADRs. It was

hypothesised that savings from reduced health service use for DAA patients may offset

the cost of supplying DAAs in the community. The purpose of this section is to model

the potential cost-savings due to differences in service use of DAAs compared to OP,

from a wider health care perspective.

9.5.1 METHODS

A costing model was constructed based on patient data on resource use and outcomes

collected in Phases 2 and 3, and health service use, Medical Benefits Schedule (MBS)

and Pharmaceutical Benefits Scheme (PBS) data extracted from the Health Insurance

Commission (HIC) (now Medicare Australia). Additional cost data (not available

through HIC) were also included in the cost model to provide a more complete picture

of health service use. These additional costs included residential care and community

care. The following resource use was accounted for in this model: PBS drug costs, GP

service items not provided in hospital, MBS Monitoring and Pathology costs that might

be incurred in monitoring medication management (not provided in hospital), other

MBS services (not provided in hospital), MBS hospital costs (cost of MBS items

received in hospital not including accommodation costs or other patient costs),

community care (including community nursing, home care and meals-on-wheels), and

residential care. These resources were assumed to be utilised over a 12-month period

and cost estimates reflect costs to the health care system, i.e., no patient co-payments

are included.


9.5.1.1 HIC data

Health service use data (MBS and PBS service) was obtained from the HIC for

consenting community patients from Phase 2, to inform the economic model of DAA

provision to community patients by pharmacies. The details of data retrieval and data

analysis can be found in section 7.1.

Due to the differences observed between the DAA group and the original pack groups

both at baseline (Ientile et al. 2004) and at follow-up (see Community patient results

section 6.2), propensity score methods have been utilized to adjust for sampling bias.

This method involves comparing service costs and outcome probabilities from a

matched sample of DAA and OP patients. Matching involves pairing together treatment

and comparison units that are similar in terms of their observable characteristics. When

the relevant differences between any two units are captured in the observable (pre-

treatment) covariates (i.e., outcomes are independent of assignment to treatment,

conditional on pre-treatment covariates), matching methods can yield an unbiased

estimate of the treatment impact (Dehejia et al. 1998).

Propensity scores were calculated from an algorithm using the Beta weights derived

from a logistic regression model to predict group membership (DAA or OP). The logistic

regression model (Chi-square=98, df 12, p<0.001, n=249) included the variables

collected in Phase 2 (see Table 9.9) and correctly predicted 72.3% of cases overall

(probability cut point 0.5) as belonging to DAA (77.4%) or OP (66.1%) groups (Cox &

Snell R Square=0.326 and Nagelkerke R Square=0.436). The variables, living alone

and self-rated health status were included as they improved the predictive ability of the

model.

Table 9.9 Logistic regression model of using a pharmacy supplied DAA (versus OP)


B Std. Error

Wald statistic


Having a regular carer 1.141 0.344 10.990 1 <0.001 3.131 1.594 - 6.148Having regular community health worker visits

0.815 0.374 4.756 1 0.029 2.260 1.086 - 4.704

Number of GPs/doctors regularly visited

-0.279 0.131 4.562 1 0.033 0.756 0.585 - 0.977


1.256 0.369 11.610 1 <0.001 3.512 1.705 - 7.235

Experienced adverse reactions - any symptoms/problems caused by medicines

-1.069 0.335 10.183 1 0.001 0.343 0.178 - 0.662

Square root of (94 – age (in years)) -0.459 0.163 7.938 1 0.005 0.632 0.459 - 0.870Square root of the total number of current medicines in home

-1.971 0.707 7.782 1 0.005 0.139 0.035 - 0.556

Total number of current solid medicines

0.392 0.134 8.545 1 0.004 1.481 1.138 - 1.926

Number of times visited GP in past 2 months

-0.235 0.085 7.731 1 0.005 0.790 0.670 - 0.933

How many different doctor prescribing medicines per patient (with median substitution (1) of 41 missing values)

-0.637 0.242 6.906 1 0.009 0.529 0.329 - 0.851

Living alone 0.568 0.343 2.731 1 0.098 1.764 0.900 - 3.458Self-rated health status (poor-excellent)

-0.424 0.225 3.535 1 0.060 0.654 0.421 - 1.018

Constant 6.320 1.660 14.497 1 <0.001 555.606


The cases included in the model were divided into 7 equal groups based on the

probabilities derived from the model. Within each of the septiles, the DAA and OP

groups were compared to test equality of the covariates (from variables collected in

Phase 2) and probability score per the model. In strata 5 only was there any significant

difference – the number of illnesses reported by the patient was (OP 4.8, DAA 2.9,

p=0.048). The stratum was considered to be matched however, as there was no

significant relationship between the number of illnesses and outcome (RCF admission

or death) or HIC costs.

The number of cases in each of the Pharmacy DAA and OP groups were examined for

each stratum (Figure 9.2). In the lowest and highest strata, there were insufficient

cases with overlapping probability for comparison.

1 2 3 4 5 6 7Probability of DAA strata

0

10

20

30

40

No

. c

ase

s i

n e

ac

h s

tra

ta

Original pack

Pharmacy DAA

Figure 9.2 The number of cases in each stratum of the propensity score based on the

probability of using a pharmacy supplied DAA after adjusting for covariates

The pharmacy-supplied DAA and OP groups were then compared on HIC costs and

outcome at 1 year follow-up. The mean of the natural logarithm of each cost type

(where a patient incurred a cost) was calculated for the DAA and OP groups within the

strata 2 to 6. The mean was then converted back into dollars to make the result more

interpretable for use in the cost models. The lower and upper 95% confidence intervals

of the mean were also converted into dollars (giving a non-symmetrical confidence

interval when expressed at the non-transformed value). There was no significant

difference in the Ln costs for any cost in any stratum. The number of patients admitted

to RCFs by 1 year follow-up was significantly higher (Fisher’s exact test p=0.045) for

stratum 4 but there were no other significant differences in the outcome of RCF

admission or death by 1 year follow-up.

A sub-sample of patients with a propensity score within the strata 2 to 6 were selected

from the sample of patients with HIC data. The probability of service use and mean

costs were calculated for both the DAA and OP groups based on this sample matched

on propensity scores (see Table 9.10).

Differential costing for the DAA and OP arms have been included to reflect the health

service use data that was collected for this sample in this study. The methods used to


derive these costs and the results of service use for the full sample are shown in

section 7.1. The mean cost per patient per year was calculated after excluding

veterans for whom cost data was not available.

Table 9.10 Resources use and cost data assumptions for matched sample

(strata 2-6): Mean and 95% CI

Service/ Resource

Description Group $Mean Cost

Percentile5th

Percentile95th

OP $2,089.54 $1,796.73 $2,430.07PBS Drug Costs

Mean cost for 12 month supply of medicines listed on PBS DAA $2,423.46 $2,096.54 $2,801.37

OP $504.51 $423.80 $600.58GP services (MBS)

Mean cost for 12 months of GP services. DAA $510.10 $431.51 $603.00

OP $145.17 $106.38 $198.10Pathology(MBS)

Mean cost for 12 months of pathology (excluding those who had no pathology).

DAA $189.93 $148.32 $243.22

OP $978.79 $720.95 $1,328.85Other MBS costs

Mean cost for 12 months of other MBS services (not pathology, GP services, or MBS services delivered in hospital – excluding those who had no additional MBS services)

DAA $577.16 $237.62 $1,401.86

OP $1,117.19 $737.85 $1,691.54Hospital Costs

Mean MBS item hospital costs for 12 months (excludes those who had no hospital services)

DAA $844.48 $501.20 $1,422.87

9.5.1.2 Patient reported service use and outcomes

Additional cost data (not available through HIC) were also included in the cost model to

provide a more complete picture of health service use. These additional costs included

residential care and community care.

Residential care

In assigning a cost for residential care admission, admission was assumed to occur at

the beginning of the 12 month period (i.e. service use for a full 365 days). The costs of

residential care in nursing homes and hostels was estimated as the average basic

subsidy cost per bed-day (Resident Classification Scales 1 to 7) in the 2004 financial

year of $68.98 multiplied by 365 days. When compared with the literature, the cost

estimates for residential care appear to be highly conservative even after excluding

patient contributions. Reported costs for residential care have ranged from $64 to $180

per bed day (not adjusted for inflation); between 72% and 87% of the cost is born by

the Commonwealth government (Liu 1999; Smith et al. 1993; Zinn 2002). The actual

amount that the government pays for each aged care facility place depends on the

residents care needs, extra service requirements, the facilities location (urban/rural),

the facilities policy regarding accommodation bonds and charges and the resident’s

income and assets. For simplicity, however, the average daily care fee has been used

as the basis for residential care costs in this model, i.e., $68.98 x 365 = $25,178 (with

rounding).

Community care

Community care resource use is an aggregate measure of a number of different

community services including community nursing, home care and meals-on-wheels. In

the current study, patients were asked about their use of community care services in


the previous four weeks. The cost data was extrapolated to reflect a 12 month period

(see Table 9.11).

Table 9.11 Valuation of different types of community support services

Cost item Value attached to cost item

Description Cost/year Reference

Cleaning $40.00 Once/week for 12 months $2,080 Patient reported use and cost*

Meals $30.00 Meals provided 5/week for 12 months@$30/week

$1,560 Patient reported use and cost*

Personalcare

$200. 1 visit per day @$200/month

$2,400 Patient reported use and cost*

Community Nurse visit

$56 Weekly visits @ 30 min/visit for 12 months

$1,456 Department of Health and Aging**

* Patients were asked to describe support service use and costs for the past 4 weeks. For the purposes of this model it

was assumed that the rates of service use and cost were constant over the full 12 month period (i.e. reported cost per

month multiplied by 12).

A model was constructed to reflect differences in both the probability of support service

use and the type of services used (see Table 9.11 and Table 9.12). The frequency of

use within the sub-set of the OP and DAA groups between strata 2 to 6 was multiplied

by the cost to produce an aggregate measure of support service use that reflects the

fact that many of the patients receiving community care used a variety of services. A

mean cost per patient receiving community care was derived for both the OP and DAA

groups (see Table 9.12). The assumptions underlying this model are that 47.1% of OP

patients received support services and 58.9% of DAA patients (as per patient reports

for strata 2-6) therefore in a sample of 30 OP and 30 DAA patients, 14.13 OP patients

and 17.67 DAA patients would incur some cost.

Table 9.12 Probability of using support services and total cost of service for matched

sample (strata 2-6)

OP % Number Cost Cost of service Cleaning 75.0% 10.6 $2,080.00 $22,042.80 Meals 12.5% 1.8 $1,560.00 $2,755.35 Personal care 4.2% 0.6 $2,400.00 $1,424.30 Community Nursing 16.7% 2.4 $1,456.00 $3,435.74 $29,658.19

Mean cost per OP patient receiving care = $29, 658.19/14.13 = $2,098.95 DAA % Number Cost of service Cleaning 72.7% 12.8 $2,080.00 $26,719.87 Meals 30.3% 5.4 $1,560.00 $8,352.26 Personal care 6.1% 1.1 $2,400.00 $2,586.89 Community Nursing 9.1% 1.6 $1,456.00 $2,341.20

$40,000.22

Mean cost per DAA patient receiving care = $40, 000.22/17.67 = $2,513.78

9.5.1.3 Health service use consequences

The probabilities of occurrence assigned to each event are presented in Table 9.13.

The probability of an event occurring was based on the observed frequency of the

event occurring during the 12 months prior to Phase 2 data collection for health service

use or in the 12 months post Phase 2 data collection with respect to community care,

RCF care or death for strata 2-6.


9.5.2 RESULTS

Results of the cost analysis model are presented in Table 9.13. The cost per patient

per year in the OP arm was $5,156 compared with $7,966 per patient using a DAA.

Over a 12-month period, the DAA use strategy resulted in 0.7 fewer deaths but cost an

additional $45,040 in health service and support costs. In this model, the cost of PBS

drugs was the highest service cost for the original pack arm of the model but residential

care was the highest service cost for the DAA arm. The biggest difference between the

two arms in costs for a single resource was also in residential care use, with the DAA

arm estimated to cost 1.9 times more than the original pack arm reflecting the fact that

7.4% of DAA patients were admitted to a RCF compared with 3.8% of OP patients.

Overall, 83% of the total difference in costs between the groups was accounted for by

non-medical support (RCF care and community care).

Table 9.13 Results of the cost model comparing DAA use to OP with 30 patients in

each arm

ARM EVENT Probability No. of patients Cost per patient Total Cost

OP PBS Drugs 100.0% 30.0 $2,089.54 $ 62,686.20 GP services 100.0% 30.0 $504.51 $15,135.30 Pathology 87.9% 26.4 $145.17 $3,828.13 Other MBS 22.4% 6.7 $978.79 $6,577.47 MBS Hospital 24.1% 7.2 $1,117.19 $8,077.28 Community Care 47.1% 14.1 $2,098.95 $29,658.19 RCF admission 3.8% 1.1 $25,178.35 $28,703.32 Death 7.6% 2.3

Total Cost for all Events $154,665.90

DAA PBS Drugs 100.0% 30.0 $2,423.46 $72,703.80 GP services 98.5% 29.6 $510.10 $15,073.46 Pathology 85.3% 25.6 $189.93 $4,860.31 Other MBS 20.6% 6.2 $577.16 $5,218.89 MBS Hospital 23.5% 7.1 $844.48 $5,953.58 Community Care 58.9% 17.7 $2,263.74 $40,000.22 RCF admission 7.4% 2.2 $25,178.35 $55,895.94 Death 5.3% 1.6


9.5.2.1 Sensitivity analysis

Sensitivity analysis has been used to explore the uncertainty in the probability and

mean costs of health service and support service use. Sensitivity analysis 1 explores

variation in the proportion of patients and cost by utilising the unadjusted values or raw

data for the full sample instead of the matched sample data from septiles 2 to 6 and

then by examining the model using data from single strata between septiles 2 and 6.

Sensitivity analysis 2 explores variations in RCF costs where the cost is based on 6

months care in a RCF instead of a full year. Sensitivity analysis 3 examines the

consequences of including hospital accommodation costs in the model.

Sensitivity analysis 1 (Table 9.14) indicates that the modelled health care costs for the

DAA group exceed the OP group in all comparisons with the exception of the sample of

patients that fall in septile 6. When the unadjusted mean costs and probabilities are

used, the difference between the DAA and the OP group (where the DAA group cost

more) is more than twice the difference observed in the base model (using adjusted


data and selective sampling (strata 2-6 only). In sensitivity analysis 2, reducing RCF

costs reduces the total costs for both groups and also the difference between the

groups. Similarly increases in the cost of hospitalisation when accommodation is

included, increases the total costs for each group and also the difference between the

DAA and OP arms such that the DAA arm cost an additional $57,227.

The cost difference (DAA arm minus OP arm) varied between -$37,472 and $111,652

(base model $45,040) when sample selection, adjustment for group differences, and

RCF and hospitalisation costs were varied. The model was most sensitive to sample

selection, as seen in Table 9.14. For patients with higher propensity scores (reflecting

higher care needs), DAA users had lower modelled healthcare resource use than OP

users.

Table 9.14 Sensitivity analysis of healthcare resource use

Area of sensitivity Description of Variation Total Cost Cost Difference

1. Selection of sample

DAA base case (2-6) $199,706

OP base case (2-6) $154,666

$45,040

DAA all cases $252,969

OP all cases $141,318

$111,652

DAA Septile 2 $154,612

OP Septile 2 $129,097

$25,515



$59,148



$49,906



$1,929



-$37,472

RCF Costs

DAA base case (2-6) 365 days @ $69 per day $199,706

OP base case (2-6) 365 days @ $69 per day $154,666

$45,040

DAA RCF costs 180 days @ $69 per day $171,375

OP RCF costs 180 days @ $69 per day $140,118

$31,358

Hospital costs

DAA base case (2-6) MBS hospital costs only $199,706

OP base case (2-6) MBS hospital costs only $154,666

$45,040

DAA + hosp. accom $222,231

OP + hosp. accom

Any patient reported hospitalisation

for 3.29 days@ $774 per day $165,003

$57,227

9.5.2.2 Health service use consequences for patients still living in community

setting

Data from Phase 3 (where patients had valid HIC cost data) suggest that 92% (N=83)

and 75% (N=79) of OP and DAA patients, respectively, were still living in the

community. Given that RCF admission was a key cost driver in results for the DAA

arm, the cost analysis model outlined above has been re-analysed using data for only

Phase 2 patients who remained in the community. Table 9.15 outlines the probabilities

and associated cost estimates for these patients. The cost per patient per year living in

the community in the OP arm was $3,461 compared with $3,163 per patient using a

DAA. Over a 12-month period, the DAA use strategy cost $8,950 less in health service


and support costs. In this model, the cost of PBS drugs was the highest service cost for

both original pack and DAA.

Table 9.15 Results of the cost model comparing DAA use to OP with 30 patients still

living in the community

ARM EVENT Probability No. of patients*Cost per patient Total Cost

No DAA PBS Drugs 100% 28 $2,285 $63,205.91 GP services 100% 28 $578 $15,997.50 Pathology 92% 25 $231 $5,853.82 Other MBS 27% 7 $1,131 $8,291.52 MBS Hospital 28% 8 $1,368 $10,491.22 Community Care 47% 13 $2,099 $27,293.37 RCF admission 0% 0 $25,178 $0.00 Death


DAA PBS Drugs 100% 22 $2,805 $62,708.97 GP services 99% 22 $674 $14,877.33 Pathology 84% 19 $278 $5,191.10 Other MBS 20% 5 $910 $4,119.33 MBS Hospital 23% 5 $1,569 $7,993.61 Community Care 59% 13 $2,264 $29,862.09 RCF admission 0% 0 $25,178 $0.00 Death

Total Cost for all Events $94,890.33 * people still in the community from base model of 30

9.5.3 COST BENEFIT ANALYSIS OF DAAS USING HEALTH SYSTEM DATA FOR ALL PATIENTS

When the cost benefit analysis is done utilising a full range of health service use data

extracted from HIC and patient data as collected in Phase 3 follow-up (see sections

7.1.4 and 6.2.5), the costs of providing DAAs to 30 community customers outweigh the

benefits of DAAs by $63,371 per year (see Table 9.16). ADRs are not included in this

analysis given that the costs associated with treatment are explicitly covered by the

inclusion of HIC costs.

Table 9.16 Results of cost-benefit analysis utilising HIC data and patient outcomes

Formula Value Perspective

Total cost OP $28,281.93 to pharmacist

Total cost DAA $55,769.87 to pharmacist

Net cost of DAA -$27,487.94 to pharmacist

Total HIC and support costs OP $154,665.90 to healthcare system

Total HIC and support costs DAA $199,706.19 to healthcare system

Net HIC and support costs -$45,040.29 to healthcare system

Willingness to pay for DAA $9,157.20 to patient

Net social benefit (or cost) -$63,371.03

9.5.4 COST BENEFIT ANALYSIS OF DAAS USING HEALTH SYSTEM DATA FOR PATIENTS

LIVING IN THE COMMUNITY

For patients living in the community, when the cost benefit analysis is done utilising a

full range of health service use data extracted from HIC and patient data as collected in

Phase 3 follow-up (see section 6.2.5) the costs of providing DAAs to 30 community

customers outweigh the benefits of DAAs by $9,381 per year (see Table 9.17).


Table 9.17 Results of cost-benefit analysis utilising HIC data and patient outcomes

Formula Value Perspective

Total cost OP $28,281.93 to pharmacist

Total cost DAA $55,769.87 to pharmacist

Net cost of DAA -$27,487.94 to pharmacist

Total HIC and support costs OP $103,839.96 to healthcare system

Total HIC and support costs DAA $94,890.33 to healthcare system

Net HIC and support costs $8,949.62 to healthcare system

Willingness to pay for DAA $9,157.20 to patient

Net social benefit (or cost) -$9,381.12

9.6 DISCUSSION OF ECONOMIC ANALYSIS

9.6.1 OVERVIEW OF PURPOSE

This evaluation utilises a systematic approach to explore the issues of cost and effect

of pharmacists supplied DAAs and builds on the work done in Phase 2 by addressing

many of the limitations identified (see section 9.9.2 in the Phase 2 Final report (Ientile

et al. 2004)). We have utilised accepted guidelines for costing and innovative

techniques such as decision analytic modelling to allow comparisons between

medication provision by the pharmacy in DAAs or OPs. In the process of evaluating

these alternatives, we have produced a detailed and flexible model that can be

improved as more data becomes available in the future.

9.6.2 LIMITATIONS

In conducting these analyses a number of methodological challenges were

encountered.

A wider social viewpoint is often preferred in economic evaluations. A societal

perspective incorporates costs (and benefits/consequences) to patients, health

professionals, carers, the health care system and other non-health sectors. In

considering the components of economic evaluation in health care (Drummond et al.

1997) (Figure 2.2), costs are those for the health care sector, patients and family, and

other sectors. The consequences can be:

Health state change that can be lead to a measurable effect or measured by WTP.

Other value created measured by global WTP for a whole program.

Cost savings between two alternatives to the health care sector, patients and

family, and other sectors.

While the study proposal indicated that a societal perspective was to be used in a cost

benefit analysis, the detailed study plan and the decision analytic model developed in

Phase 2 was focused on better understanding the healthcare use for DAA and OP

users. In the economic evaluation in this study, the perspective was primarily

concerned with resources used by the pharmacy in preparing and dispensing OPs and

DAAs combined with costs and (potential) benefits to the healthcare system (from the

commonwealth budget perspective) and to patients (health benefits (ADEs), willingness

to pay and various out of pocket expenses for health care). Other predominantly

indirect and intangible costs (and hence related cost savings) were not readily

captured, were limited by the time, resource and study design constraints and

complicated the model. Costs and benefits not reflected in the model included:


Carer indirect costs such as travel and time spent (including lost productivity), their

opportunity costs and intangible benefits on carer burden and peace of mind.

Phase 2 showed DAA users were more likely to have a carer overall but where care

needs (IADL) and ill health were similar (any hospitalisation in the previous year),

there was not difference the probability of having a carer. Further, carer costs and

burden were likely to be lower for DAA patients as pharmacies were more likely to

deliver medications (see section 9.3.4 in the Phase 2 Final report (Ientile et al.

2004))and carer burden was lower compared to OP.

State public hospital and health insurer costs although reports of patient

hospitalisation were used as a proxy. Patients were from various states and

potentially used various insurers that made collecting this data impractical.

Patient expenses not covered by MBS or PBS although some costs were captured

by self-report

GP administrative costs in communicating with the pharmacy. The opportunity

costs of this activity would potentially be balanced by fewer visits by DAA users to

GPs, thus allowing the GP to consult with other patients.

Intangible benefits to the patient such as increased confidence in being able to

manage at home and reduced concern over RCF admission and increased

productivity although these aspects may have been included in part, in WTP data.

Productivity gains for community nursing. In phase 2, community nurses reported

that DAA use reduced the frequency of visits and the duration of visits. The

proportion of patients who had received a community nurse visit in the preceding 4

weeks in phase 3 was not different for DAA and OP users.

Benefits in delayed or prevented RCF admission or deaths. These effects would be

delayed and not measurable in this study.

Given resource constraints and the exploratory nature of this research, we believe the

limited perspective (that of the main payer, the main provider and the main beneficiary)

used in the current study was appropriate particularly since these perspectives were

likely to reflect those of decision makers and possible payers (George et al. 1999) and

sheds light on a number of pertinent issues to be addressed in subsequent studies.

Another limitation was that data was missing for some of the Phase 2 patients. The

data on patient medicine and healthcare costs collected in Phase 3 (see 6.2.5) was not

available for those lost to follow-up (a greater number of DAA users had died or moved

into residential care) and not all that collected was included as the response rate to

some of these items was low and responses were often ambiguous. A review of this

data in 6.2.5 suggests that DAA patients incur greater costs than OP patients and the

inclusion of these costs would likely indicate that the societal cost of DAAs is even

higher than the results presented above. These costs however, were unadjusted for

health status but after adjusting for differences such as care needs and age using

propensity scores (see 8.2.1), use of these services was not different.

The lack of baseline data and the non-random nature of the study impacts on the

usefulness of comparison between OP and DAA patients. As the study was cross-

sectional and patients in the DAA group had already started using DAAs, change in

costs and benefits could not be assessed. This difference between groups is reflected

in the fact that there appears to be a fundamental difference (in this study) between

people who use a DAA and people who do not. We found that DAA users (in this study)

were generally sicker and had a greater need for assistance and care as reported in

Section 6.2.


The comparison of alternative strategies for enhancing medication provision to

community customers was restricted to DAAs and OPs. Other studies that have

assessed the cost-effectiveness of pharmacy based medication management

interventions in the community have examined Home Medicine Reviews (HMRs)

(Sorensen 2004), payment and training for pharmacist in providing proactive clinical

interventions (Benrimoj 2000) and pharmacy based education and monitoring for at-risk

community patients (Sturgess 2003). In comparison to DAAs, HMRs appear to be a

more cost-effective intervention (incremental cost-effectiveness in reducing ADEs was

AUS$69 (1999 figures) compared with $9,163 in the current study and $6,028 in Phase

2. This is in part explained by differences in intervention costs (one HMR per year is

less than a third of the cost of providing DAAs for a year) and also because the

apparent difference in effectiveness in reducing ADEs (the HMR intervention group

appear to have a 27% reduction in ADEs compared to a 10% reduction in the DAA

group at Phase 3 and 15% in Phase 2). The authors also observed a trend in savings

in health service use for the intervention group of a similar magnitude to the cost of the

intervention. Others (Benrimoj 2000; Sturgess 2003) have also reported trends in

savings in health service use but did not report the total costs of the interventions. A

review of 16 studies on the economic benefits of clinical pharmacy services found that

for every $1 invested in clinical pharmacy services, more than $4 in benefit is expected

(U.S dollars) (Schumock 2003).

Finally, the HIC data included in the models did not include service use for the DVA

gold card holders in the sample. These data were not received in time for this study

due to delays in providing approval for the release of the data and then delays in

extraction of the data. Veterans represented 23.6% of the Phase 2 sample. As

veterans have access to a potentially wider range of subsidised services, their

healthcare costs may be higher than the community patients who were not veterans.

There were some differences in characteristics of veterans and non-veterans (Table

9.18) but from these data, it does not seem that the veteran’s would have a significantly

higher burden of disease than the people included in this analysis as there was no

difference in the proportion of veterans and non-veterans using a DAA (p=0.380) and

no significant difference between veterans and non-veterans overall or within the DAA

and OP groups for the propensity score used to create the septiles (intended to adjust

for differences in care needs) used in the economic analyses. Any higher cost,

therefore, may be related to access to services.

Logistic regression found no significant difference between veterans and non-veterans

overall or within the DAA and OP groups for the following variables: Number of

GPs/doctors regularly visited; How would you rate your health status (poor to

excellent)?; Number of times visited GP in past 2 months; Number of different illnesses

patient reports having; Compared to other people your age how would you rate your

health?; Over the PAST WEEK, how frequently did you experience symptoms?; Over

the PAST WEEK, how would you rate the symptoms you experienced?; How many

different doctors prescribing?; How many different pharmacies have dispensed

medicines?; Total number of current medicines in home; Number of current non-solid

medicines at home; and EQVAS z-scores.


Table 9.18 Veterans compared to non-veterans: differences in Phase 2 and certain

Phase 3 variables (shaded variables used in propensity score for economic

analysis)

Overall DAA OP More likely to live alone (p=0.014) NS More likely to live alone

(p=0.038) No difference for regular carer (NS) or regular community health visits (NS)

NSNS

NSNS

Any hospital in last year (NS) NS NSADR in Phase 2 (NS) NS NSADR in Phase 3 (NS) NS NS Fewer females (p=0.056) Fewer females (p=0.012) NS OARS IADL (NS) NS NS More likely to have health problems limiting independence (Phase 3 EQ-5D) (p=0.004); worse mobility (p=0.039) and usual activity score (p=0.074); a lower EQ-5D score (p=0.057)

NS for any problems, NS for sub-scales; NS for EQ-5D score

More likely to have health problems limiting independence (Phase 3 EQ-5D) (p=0.037); worse mobility (p=0.045); a lower EQ-5D score (p=0.087)

No difference in service use (including any hospitalisation) reported in Phase 3 except veterans more likely to have been in a private hospital (p=0.003)

Same pattern as overall (private hospital p=0.016)

NS for any service type

Less likely to take antianxiety and antidepressant medicines (p=0.003 and p=0.045)

Antianxiety medications (NS), Antidepressants lower (p=0.071)

Less likely to take antianxiety drugs (p=0.040); antidepressants (NS)

No difference for any antihypertensives, antipsychotics, heart failure medicines, lipid lowering drugs, oral hypoglycaemics or respiratory medicines

Same as overall Same as overall except more likely to take antipsychotics (p=0.046)

Slightly more deaths at 1 year (p=0.089), no difference in admission to RCF but more likely to have a worse outcome (death or RCF) (p=0.037)

Deaths (NS) and RCF (NS) but worse outcome more likely (p=0.046)

Deaths (NS), RCF (NS) and worse outcome (NS)

Meichenbaum adherence questions (NS)

NS NS

Generally older (p<0.001) Generally older (p=0.049) Generally older (p=0.002) No. total current solid medications (NS)

NS Lower total current solid medications (p=0.096)

Lower disorganized non-adherence score (p=0.018); memory-related (NS) and deliberate (NS)

Lower disorganized non-adherence score (p=0.054) ; memory-related (NS) and deliberate (NS)

Higher deliberate non-adherence score (p=0.054) ; memory-related (NS) and disorganized (NS)

Health at Phase 3 relative to Phase 2 (NS)

Health generally worse (p=0.072)

NS

- Willingness to pay (Phase 2) (NS)

Willingness to pay (Phase 2) (NS)

Willingness to pay (Phase 3) (NS) NS Higher willingness to pay (p=0.010)


9.6.3 MAIN FINDINGS

The provision of DAAs by pharmacist is a labour-intensive and costly exercise. It is

expected to cost $27,488 extra to supply DAAs to 30 community customers for one

year, compared with supplying 30 community customers with OPs. The cost of DAA

provision may be offset by some savings to the healthcare system due to the

prevention of ADRs. A difference in the rate of ADRs and consequences in terms of

service use translates to a potential saving for the DAA group of $5,040 in one year.

However, this is only a third of the savings estimated in Phase 2. Considering a full

range of service use (HIC and patient support services) failed to result in cost savings

to offset the cost of DAA supply. The DAA group costs exceeded the OP group costs

by over $45,040 in one year. DAAs were considered to have direct benefits to the

customers using them that were measured through WTP. Community customers using

DAAs were willing to pay a mean of $5.61 per DAA/per week (compared with $5.25 in

Phase 2). This equates to a total of $8,752 per 30 customers per year. A closer

investigation of costs and benefits to patients living in the community suggest a

considerable reduction in additional costs of DAAs, a net social cost of $9,381 for 30

patients over 12 months. Sensitivity analyses confirmed that costs associated with

DAAs were considerably higher than benefits to the health care system where benefits

are measured by patient willingness-to-pay for a service for which they have been

traditionally undercharged (pharmacies charged an average of $3.50/week in Phase 2

despite average costs to the pharmacy of $17.62/week).


10.DISCUSSION AND CONCLUSIONS

In Phase 3 of the study of effectiveness and cost-effectiveness of dose administration

aids, there were two main aims (1) to develop best practice models for the community

and RCF settings that could support safe, effective and efficient DAA services, and (2)

to re-examine the cost-effectiveness of DAA services by using additional health service

use data and techniques to value benefits to the health care system from DAA services

pharmacies provide to community patients. Effectively, two related, but distinct sub-

studies were undertaken.

In developing best practice models, research is combined with experience. Since both

research and experiences (and practice situations) can change, best practice models,

by their very nature, undergo continuous change. In this study, almost two circuits of

the ‘plan, do, check and act’ steps of the continuous improvement cycle (Mitchell 1992)

have been completed, acting on the previous work, such as the PSA DAA guidelines

and standards [Pharmaceutical Society of Australia, 1999 #272;Pharmaceutical Society

of Australia, 2006 #321]. The research component in this study included the findings of

Phase 2, literature research related to drug stability and legal implications, and further

analysis of data collected in Phase 2 that allowed the characteristics of community

patients currently provided DAA by community pharmacy to be defined. The

experiences of stakeholders were garnered through extensive consultation using a

variety of qualitative techniques. To this was added an examination of the body of

existing documentation impacting on DAA service delivery. Practitioners’ views on

problems or barriers and how these might be solved or overcome were used, in

conjunction with the research findings, as the basis for the preparation of two

preliminary best practice models. Consultation was again used to evaluate the

feasibility and likely impacts of the various aspects of each model together with

suggested changes or areas for improvement in the next iteration of the best practice

models. The next action in the cycle would be the incorporation of these suggestions

into the models, however, the evaluation of the preliminary models revealed differences

of opinion that will need further resolution before the models can be revised.

The Phase 3 economic modelling involved the including of actual service use data for

community patients into decision analytic models (stochastic rather than deterministic

analysis) and using a more sophisticated methodology for assessing the benefits to the

health care system from a societal perspective. The use of services subsidised by the

Australian government were extracted from the (then) Health Insurance Commission

(HIC) and the Department of Veterans Affairs (DVA) (although the latter was not

received in time for analysis). Information on other health service use and benefits of

using DAAs was collected by conducting a follow-up survey of Phase 2 community

patient participants. To adjust for the inherent differences between DAA users and

users of medication in their original packs (OP) arising from the non-random sampling,

multivariate modelling of baseline characteristics was used. This multivariate modelling

also allowed us to examine in detail the characteristics that determine to whom

community pharmacies currently provide DAAs, and to relate these findings to the

implementation of any future DAA program for community patients.


10.1 DEVELOPING THE BEST PRACTICE MODELS

Best practice is a common approach to practice improvement used in the health care

sector where individual variations in practice are widespread. Often, this variation is in

response to a set of specific combination of circumstances. Managing essential

variation is the key to safety and efficiency in many health care settings (after all, each

patient is an individual). Consequently, the approach taken by many agencies

recommending best practice strategies in health care is to specify what needs to or

should be done rather than prescribing in detail, how it should be done. This approach

has been taken by APAC in its residential care and continuity of care guidelines

(Australian Pharmaceutical Advisory Council 2002; Australian Pharmaceutical Advisory

Council 1998) and in the Australian government’s Aged Care Standards (Department

of Health and Ageing Aged and Community Care Division 2004), and has been used in

developing the DAA best practice models.

10.1.1 DEVELOPMENT OF THE PRELIMINARY MODELS

The data collected in Phase 2 and in the Phase 3 initial consultations showed that the

administration of prescription medications subsidised under the PBS repackaged into

DAAs is complex. Conceptually, the step of repacking (the difference between DAAs

and original pack) seems simple, but as one member of the expert panel pointed out,

“It is not simple because of the system issues and problems when the system fails

(e.g. doctors don't write charts or scripts in time, medication changes are not

communicated in an unambiguous and timely manner). To limit the problems with

these issues, complex processes have been put into place”.

In developing the models, the goal of best practice in DAA service provision is to

identify strategies that could be used to prevent or minimize disruptions to the

medication administration system so that the safety, effectiveness and efficiency of the

overall system are improved. The focus was on incremental improvements in current

practices rather than a paradigm shift.; something useful to people working within the

current system.

As a result of the Phase 2 literature review, examination of existing DAA-related

documents and the findings of Phase 2, expert consultation and canvassing the

opinions of a wide range of stakeholders prior to the development of the initial models,

the factors that were identified as contributing to unsafe practices, reduced

effectiveness of DAA services for patients with special needs, and inefficiencies in

service provision. These issues have been synthesised in section 4.4. There were six

factors underlying problems encountered in the provision of DAAs:

Poor communication and timely information sharing particularly about medication

changes and at hospital discharge. This contributed to patient risk (through error or

discontinuity of supply), increased cost through the time needed to solve problems

and, rework and medication wastage.

Poor awareness of responsibilities and obligations of the various parties that

caused systems to fail leading to rework, interruptions to workflow, no payment for

dispensed prescriptions for pharmacies and an increased risk to the patient (either

through error or discontinuity of supply). A lack of understanding or awareness by

the various people involved in the DAA service about each other’s roles and

constraints or practices contributed to these problems. In RCFs in particular,

facilities, pharmacies and doctors do not have an mutual understanding of


profession-specific regulations, experiences and perceptions, practices and costs of

involved in the provision and use of DAAs. This lack of understanding gives rise to

unrealistic expectations that lead to relationship and communication breakdown,

and ultimately to an unsafe, ineffective and inefficient DAA service.

Lack of a systematic approach to patient assessment as to whether a DAA was

appropriate, monitoring of patients and the service quality itself and accountability

for the service and its outcomes.

Patients using DAAs had high levels of dependency on others for help with

medication management and the risks of disempowerment, reduced medication

knowledge and other medication management problems were not routinely

addressed or monitored.

The situation where the costs incurred are borne largely by the community

pharmacies without adequate means of remuneration.

That the information available about the stability of medications in the various DAAs

is limited.

Many of the facility management and staff, community and hospital pharmacists, and

doctors had developed various solutions to the problems (although not always

completely successful) that they had encountered. These solutions are described in

sections 4.1.2, 4.1.3.2,4.1.4 and 4.1.5. The potential solutions strategies that

practitioners are using or propose to use to overcome the barriers to safe and efficient

DAA provision is synthesised in section 4.4.

Two best practice models were prepared, one for each setting, using the APAC

guidelines as a model. Firstly the steps and input required to operate a DAA service

were defined, based on the observations and work of Phase 2 and reports from

practitioners in focus. This clearly articulated the aspects of the service covered by the

documents and identified the tasks performed by the various participants. The context

of the models was also specified; that the recommendations were restricted to issues

relating specifically to DAA use that would not arise were OPs to be used; that the aim

was not to dictate standards; and that it reflected the situation at the time (e.g. no

subsidies for DAAs, use of PBS prescriptions for supply and no widespread ICT

information sharing mechanisms). Wide-ranging recommendations for strategies to

overcome the barriers to safe, effective and efficient DAA provision and use were

included. Recommendations reflected three key domains (1) communication/

information flows; (2) addressing perceptions and promotion of mutual awareness,

obligation and shared responsibility ; and (3) accountability and monitoring.

Recommendations addressed:

Initial structured assessment of community patient need and potential risks

associated with DAAs.

Tendering for DAA services to show that both RCF and DAA providers had roles in

the implementation of a DAA service and to support the negotiation of a charge that

was fair to both parties.

Service agreements to promote mutual awareness of roles, responsibilities and

obligation to ensure that all parties were aware of what was involved in DAA

services and could discuss preferences for how to carry out the requirements of

providing DAAs prior to beginning this service.

A communication framework that included a patient-held template, strategies for

communicating and documenting medication changes, and facilitating continuity of

care when DAA users were admitted to and discharged from hospitals.


Quality measures, documentation and monitoring of DAA production within the

pharmacy, including recommendations related to drug stability and education about

medication storage.

Strategies to reconcile drug regimen records held by various parties; a necessary

step in the absence of an electronic central health record.

Strategies to improve the efficiency of DAA service provision in the pharmacy.

Other risk reduction strategies involving community patient monitoring and check of

packs in RCFs when non-trained staff or self-medicating patients were to use the

packs.

Remuneration for community pharmacies so that the service can be adequately

resourced and deliver a high quality DAA service that represents best practice.

Models for the implementation of a DAA service for a new community patient and for a

new RCF were also developed that included key components of the model

recommendations.

In developing the preliminary best practice models, the main limitation was that of data

or stakeholder omission (for example, community nurses). There may have been key

documents or information that was not identified by the snowball methods used. There

was a potential for bias by seeking opinions from those involved in DAA provision who

were willing to be involved. As the focus groups and consultation progressed,

however, few new themes emerged, so that it is unlikely that key issues were

overlooked. In this qualitative work, we were interested in both problems and solutions

and if a person was not motivated to participate in this work, would they be motivated

to solve the complex problems associated with DAA use.

The result of this part of the study was to produce preliminary documents for wider

comment, a process that was intended to overcome any omissions in the preliminary

consultation round.

10.1.2 EVALUATION OF THE PRELIMINARY BEST PRACTICE MODELS

On review of the preliminary best practice models, responses overall were favourable

and supportive although areas for revision and aspects where opinions were divided

were identified. The models were generally felt to be feasible, although in some cases

with considerable reservation. Implementing the recommendations in certain areas

were felt to be more problematic as the recommendations represented a greater

change in current systems and would require the development of new systems. The

more radical departures from current practice for the community model were the

tripartisan agreement (5.2.2.2), the use of the patient template (5.2.2.3) and the

continuity of care recommendations (5.2.2.5), the latter being the most problematic. For

the RCF model, while implementation of the continuity of care was also considered to

be the most problematic (5.2.3.4), barriers to recommendations about communication

of medication changes (5.2.3.3) were also felt to be more substantial.

In the community model, some recommendations had already been adopted while

others required formalisation. Patient assessment for example, was often undertaken

but this was largely informal, unstructured and unrecorded. Development of tools and

procedures to aid assessment would facilitate the uptake of this aspect of best practice

(5.2.2.1). Assessment is likely to be required for a subsidised DAA service for

community patients and may be a reasonably straightforward task with which to start

an implementation process.


The tripartisan agreement was well supported by community patients (5.2.2.2) but the

main concerns expressed by others related to the extent to which the GP needed to be

involved or was willing to be involved in such a written agreement.

The intention of the patient held template was to give pharmacists packing DAAs more

reliable information about a patient’s current drug regimen by using the template to

capture medication changes for community patients (in RCFs these are recorded on a

medication chart). The template would also act as a communication tool with the GP

and to improve concordance. The main concerns about this recommendation related to

patient reliability as a conduit for drug regimen information (supported by a desire of

patients for less responsibility in this area (Table 5.2)) and the extent of willingness or

co-operation to use the template, particularly without a funding model. Government e-

health initiatives6 and implementation of electronic patient records such as the Smart

Care could facilitate implementation of this recommendation.

The recommendations for continuity of care were considered the most problematic in

both models. The problem is not limited to the Australian setting. Variability in practices

and communication about DAAs by hospitals to primary carers at discharge has also

been reported in the United Kingdom, together with calls for formal systems and

improved information transfer (Green et al. 2005). It is evident that political drivers will

be needed to promote this aspect of best practice. These are already in place with the

imperatives for hospitals to implement the APAC continuity of care guidelines

(Australian Pharmaceutical Advisory Council 1998) and government e-heath policies.

Perhaps the main problem with the continuity of care recommendations in the best

practice models is that they are too soon, and represent more than just an incremental

step.

The best practice models were intended to support service quality and quality

improvement but application of these concepts was not consistent. In the RCF model,

building in expectations of services quality and quality assurance into the tendering

process was novel but the emphasis on quality was not seen to go far enough by

some. Conversely, the value of monitoring and record keeping aspects of the models

for quality improvement and risk reduction was not always appreciated and often seen

as increasing costs or the time taken to provide a DAA service.

There were costs associated with the changes that would be required to implement the

models but in many cases, there were felt to be offset by other efficiency and safety

gains such as those from improved communication. From a pharmacy perspective

(both community and hospital), the main barriers were cost, lack of funding and

involving a busy GP, although many pharmacies had good relationships with patients’

GPs and already had some systems in place to facilitate consultation and

communication. More GP input into the best practice models is required, however, to

address some of the concerns related to GP roles and responsibilities (see 5.2.2.10

and 5.2.3.9), especially increased GP involvement in the steps associated with DAAs in

RCFs was preferred by many (see Table 5.5).

6

nehta is the "National E-health Transition Authority" tasked to establish the e-health

infostructure for Australia (e.g. terminologies, catalogue of medicines, provider directories, client

identification, privacy, secure messaging, electronic health record architecture and clinical data

(event summaries – e.g. discharge summaries)). www.nehta.gov.au


From a GP perspective, the RCF model was of most interest perhaps because ordering

medications in RCFs caused the most headaches e.g. owing prescriptions and

requests for prescriptions and medication chart re-writes. These problems are not

solely due to the use of DAAs but are part of a larger problem concerning GP

involvement in RCFs. The Aged Care program of the Divisions of General Practice are

working in this area and the preliminary best practice model has already been used by

one division as part of the problem solving process.

Written agreements outlining service expectations and obligations were not as strongly

embraced by GPs as by others. Alternative means of reaching the desired

understanding and mutual awareness may be required. This might be addressed by

separate agreements for the elements of the service where the GP interacts with the

RCF and where the GP interacts with the pharmacy. Improvements in the

recommendation about mutual awareness and written agreements requires more

consultation. This consultation could be carried out under the auspices of the Divisions

of General Practice Aged Care Program.

Legal opinion also supported the recommendations in the best practice models,

particularly those for clear communication and expectations, formal procedures and

documentation (4.2). The review of stability of medication in DAAs highlighted the

dearth of information that is useful to pharmacists packing DAAs (4.3). Strategies to

use existing information were provided in section 4.3.5 and the use of these was

mentioned in the best practice models together with a call for more evidence about

medication stability in DAAs to be acquired. This is addressed more fully in 10.2.

10.1.2.1 Limitations of the evaluation of best practice models substudy

There were three main limitations of the evaluation of the best practice models. Firstly,

the majority of respondents had contributed to earlier stages so that many of the

recommendations arose out of practices or solutions to problems they had developed.

This may have led to more favourable attitudes towards the feasibility and benefits of

the models. Secondly, while the evaluation did trigger the suggestion of other

strategies or improvements, some effective solutions to problems affecting the safety,

effectiveness and efficiency may have been overlooked. The third limitation is that

input from certain key stakeholders is limited or missing. In particular, GP exposure to

and comments on the community model are extremely limited, nor was input from

community nurses sought. Further consultation is required to fill in this gap.

While the absolute numbers of study participants was small, the focused observation is

in keeping with the best practice methodology used. Best practices research is a form

of “inductive practice-to-principles research” (Overman et al. 1994) where practice

observations can be “more selective, less direct” and the principles derived “more

prescriptive and less constrained” than other observation methods. Best practice has

been defined as “the selective observation of a set of exemplars across different

contexts in order to derive more generalizable principles and theories” (Overman &

Boyd 1994). In this study, the best practice models were derived from innovative

practices drawn from interested and engaged practitioners. Other best practice projects

have also sought out innovative providers rather than representing a sector (Jeffcoate

et al. 2002). The latter approach is closer to benchmarking rather than defining best

practice.


Selective sampling is part of the best practice model and while there may be limitations

with respect to the representativeness of the participants, in developing the best

practice models, there was a convergence of concepts that indicated that the full range

of issues had emerged. With each successive focus group or interview, the number of

new, previously unrecorded issues that emerged became smaller. The later groups,

meetings or interviews supported issues already raised.

Rather than the absolute number of responses, the variation in the level of input from

the different stakeholders was a limitation that would need to be addressed in further

refinements. The variation in response rates across the different stakeholder groups

reflects the saliency of the topic (“the apparent relevance, importance and interest … to

the respondent”) (McColl et al. 2001) supporting the our’ assertion that DAA provision

is essentially pharmacy centric.

10.1.3 FUTURE DEVELOPMENT AND IMPLEMENTATION OF BEST PRACTICE MODELS

The comments from the reviewers of the best practice models highlighted areas of

disagreement that are yet to be resolved. One key area was that of standardisation of

practices and templates; there were calls for both standardisation and flexibility and

individualisation. More consultation is required among stakeholder peak bodies to

reach a consensus or at least agreement such core issues, and to overcome the main

barriers to implementation identified in section 5.2.4.1. Once a position of the areas of

difference is reached, changes arising from the evaluation of the preliminary models

and additional consultation or working groups should be incorporated into a revision of

the models. This is desirable as ‘best practice’ is not a static concept and models

should undergo periodic revision and continuous improvement.

Future changes in the context in which DAA services a provided could also require a

revision to the best practice models. It is possible that substantial changes to the

regulatory and funding framework and the way medication-related services would have

a significant impact on the efficiency and therefore the costs associated with DAA

services. Possible developments that may occur are:

Changes to the PBS that would allow claims for payment from pharmacies to be

made on the basis of a doctor’s order written on a medication chart in an RCF. This

single change would greatly improve the efficiency of a DAA service. There are

currently trials underway of this concept.

The introduction of a shared electronic medication profile and e-prescribing would

also improve safety and efficiency by improving communication, the accuracy and

currency of medication regimen information and the efficiency of the prescribing,

dispensing and packing processes.

Other changes to the PBS rules that either positively or negatively affect continuity

of supply for people requiring chronic medication management. The latest change

to the PBS 20-day rule creates additional hurdles in an already inefficient system.

Pharmacist prescribing for chronic therapy under certain conditions and with certain

safeguards may improve efficiency.

A range of strategies have been suggested to facilitate widespread adoption of the

models (5.2.4.2). These include funding, integration with existing program (e.g. aged

care standards and assessment, QCPP) and systems (e.g. dispensing software), wider

stakeholder consultation and, involvement and support of peak bodies. Organisations,

governments and individuals who will assist with implementation and develop a specific


dissemination plan will be required. More details need to be worked out before

widespread adoption.

For the community best practice model, the inclusion of funding for DAAs to community

patients in the Fourth Community Pharmacy Agreement between the Commonwealth

of Australia and the Pharmacy Guild of Australia (http://www.guild.org.au/public/cpa/

fourthcpa.pdf) provides an imperative for best practice implementation. The best

practice model includes recommendations to assure quality and provide accountability

as well as strategies to ensure that a safe, effective and efficient service is provided.

The way forward and the motivators for implementing best practice in RCF is less

clear, indeed, it is possible that RCFs could not implement all aspects of the best

practice models until some of these changes occur (e.g. change to PBS claims using a

medication chart and some communication and e-health initiatives). And, in the

absence of a specific government funding model, adequate remuneration for

pharmacists will require a change of attitude by RCF management about payment for a

quality DAA service. Possible strategies to support later implementation would be to

start discussions with the Aged Care Standards Agency about the inclusion of best

practice elements into the standards assessed in RCFs. The best practice model

should also be considered in the revision of the QUM program for RMMRs.

10.2 STRATEGIES TO IMPROVE THE STABILITY INFORMATION

AVAILABLE TO PHARMACISTS PROVIDING A DAA

SERVICE

A key area for DAA best practice is the stability of medicines packed in the various

DAAs. In section 4.3, we the examined theory and practice contexts that influence the

potential impact of the exposure of drug products repackaged into DAAs to heat, light,

air (oxygen) and moisture.

The repackaging of medicines into unit-dose and multi-dose DAAs is a practice that is

widespread. Given the perceived benefits from the use of DAAs in RCFs and for

community patients, the practice is likely to continue. Currently, there is little

information to support pharmacists who must make an informed judgement as to the

suitability of a given drug product for inclusion in a DAA for provision to a patient. While

acknowledging the lack of research into the stability of drug products stored in DAAs,

there are specific recommendations that can improve the application of currently

available stability information. A risk assessment and risk management approach is

needed. We have presented supporting information (as revision) of the

physicochemical stability issues surrounding the repackaging of medications into DAAs

to empower pharmacists to exercise sound professional judgement in this area and to

assist in improving their packing methods/ procedures to take into consideration the

various stability issues. One approach to risk assessment is a decision tree using

existing information. Risk management might involve:

good packing practices

encouraging pharmacists to educate patients and other health care workers on the

importance of not only maintaining proper storage conditions, but also to be vigilant

and monitor that the integrity of the DAA is maintained throughout the dosage

period.


Attention to risk management and further improvement in the available stability

information at will improve risk assessment. Many research questions have been

raised concerning the repackaging of medications in DAAs. It will take some time and a

significant amount of work before our understanding of the complex physicochemical

stability issues pertaining to the repackaging of medications in DAAs is sufficient to

enable us to develop and implement evidence-based “current Good Packing

Practices”. The following strategies, however, will allow incremental improvement in the

quality of packing decisions and provide a foundation for the development and

implementation of evidence-based “current Good Packing Practices”.

10.2.1 IMPROVING DRUG STABILITY IN DAAS IN THE CURRENT SITUATION

In the short term, pharmacists can use currently available information in more

structured decision making. The risk assessment-risk management approach to drug

stability can be applied to the current level of information. In section 4.3.2 and

Appendix E, the science of the physicochemical stability issues surrounding the

repackaging of medications into DAAs is revised to support pharmacists’ professional

judgement in this area and to assist in improving their packing methods/ procedures to

by considering the various stability issues. A risk assessment decision-tree has been

developed in this study, based on the science relating to physicochemical stability

issues and currently available information (e.g. package inserts; CMI’s) for repackaging

medications in DAAs, to provide some guidance to the pharmacists repackaging drug

products into DAAs. Risk management strategies have been described in 4.3.3 and

4.3.5. Patient education on the preferred storage and use of DAAs is also important.

10.2.2 GATHERING MORE EVIDENCE OF DRUG INSTABILITY AND DRUG STABILITY

In preparing this report, it is evident that many research questions have been raised

concerning the repackaging of medications in DAAs. It will take some time and a

significant amount of work before sufficient evidence on the physicochemical stability of

medications packaged in DAAs is available. The following are three strategies to

increase the information base.

10.2.2.1 Gather reports of suspected physicochemical instability observed in

DAAs

In solid dosage forms, evidence of physicochemical instabilities often present with an

associated change in appearance (e.g. colour changes/mottling, tablet softening/

hardening, odour, disintegration) and can thus be detected upon simple visual

inspection of the product (Aulton 2002). For example, photochemical processes usually

take place on the product surface and photochemically induced interactions in tablets

may frequently lead to discolouration even when chemical transformation is modest or

undetectable (Tønnesen 2001).

Information about apparent changes in appearance should be gathered from

pharmacists and pharmacy staff, other health professional and patients/carers

(especially where patients are encouraged to report any visual or other problems,

which may be related to the medication’s stability, to their health care provider) . This

information, if centrally collated, could become a reference for other pharmacists in the

same way that voluntary adverse drug reaction reporting has informed prescribers and

other health professionals about medication risks. Such a register could also identify

targets for DAA “in-use” stability testing.


It is certainly possible for pharmacies to report suspected physicochemical instability

for medicines in DAAs, plus any risk management strategies a pharmacist has put into

place to address possible instability. A brief list offered by pharmacy staff who pack a

heat-sealed blister multi-dose pack in a coastal tropical area of Australia included

(personal communication with Karalyn Huxhagen, 25/10/05 & 28/10/05): Salt tablets (for renal patients) are hygroscopic. They go ‘bumpy’ and leach out to ‘salt’

neighbouring products. The maximum time before this occurred was 2 weeks.

Bioglan melatonin capsules – go transparent after 2 to 3 weeks in a DAA.

Bioorganics cranberry capsules – the powder in the capsule changes colour to dark maroon

and shrinks away from the sides of the capsule after about 3 weeks in a DAA.

Slow K™ tablets go ‘slimey’ after 2-3 weeks in a DAA.

Halved Solprin™ tablets are better protected by the DAA blister pack than wrapping the

halved tablet back in foil and storing it in the original box.

Other observed physical changes that lead to practice changes (deblistering

immediately prior to repackaging) for a DAA provider using sachets include (personal

communication with Dawn Woodward, APHS, 7/11/05): Enalapril tablets – these go soft and crumbly after 2 weeks in a sachet

Hiprex ™ tablets - absorb moisture

Cavedilol

Nicorandil (Ikorel)

Omeprazole (Hexal brand, has 4 layer coating that breaks down/gets cracks after 21 days)

– not seen with Acimax™ or Losec™ brands

Interestingly, the UK manufacturer of Slow K ® and Nicorandil indicated that Slow K

“May absorb water; probably stable in an airtight compliance aid for 14 days” and

Ikorel® was “Stable for at least 7 days in a dry environment” (Church & Smith 2006),

suggesting that caution may be required in interpreting data from the UK situation.

Other drugs (including some of those mentioned above) have been reported as being

sensitive to moisture (personal communication with John Parke, Queen Elizabeth II

Hospital, 14/11/05) – changes were observed when patients using various DAAs

brought the packs into hospital: Amoxycillin/clavulante – note that these products are packaged in a tropicalised pack by the

manufacturers and according to the risk assessment in 4.3.5.3, should not be packed)

Aspirin 100mg non-enteric coated

Felodipine

Moclobemide

Perindopril

The provision of an easily accessible reporting tool for pharmacists, nurses and other

health care workers would be valuable for acquiring evidence of potential medications

and/or combinations of medications that have displayed apparent physicochemical

instability when packed in DAAs. Figure 10.1 shows a possible reporting form.

The form in Figure 10.1 is modelled on the form used by the Adverse Drug Reactions

Advisory Committee’s (ADRAC) “Report of Suspected Adverse Reaction to Drugs and

Vaccines” and the Australian and New Zealand Medical Device Incident Report

Investigation Scheme’s “Medical Device Incident Report” (DAAs are not considered a

device according to the TGA definition (http://www.tga.gov.au/devices/devinfo2.htm)).

The proposed form contains questions to collect information specifically relevant to

assessments of instability. It could be web-based and potentially redesigned to be a

web-based database searchable by pharmacists.


Since TGA administers drug and device reporting schemes and is responsible for

assessing drug stability data submitted by manufacturers in the regulatory process and

therefore has the expertise to evaluate reports, it would be reasonable that TGA act as

a repository for reports of suspected DAA drug instability. In the interim, a pharmacy

organisation like PSA or the Pharmacy Guild of Australia under the auspices of QCPP

could develop the web-based databases and store reports of suspected instability. The

data could be derived from voluntary reports of instability. Alternatively, many

pharmacies providing DAAs have their own in-house list of medicines with stability

concerns that relate to the environmental conditions in which a specific type of DAA is

used – a survey of pharmacies providing DAAs would allow collation of empirical

evidence of instability.

10.2.2.2 Stability studies on the most commonly packed solid dosage forms

There are a number of techniques for assessing the stability of medicines but these

can be time-consuming and costly, particularly where stability in each type of DAA

would need to be assessed (even without the complication of testing for possible

interactions within a DAA blister, compartment or sachet). It would therefore be prudent

to prioritise any such studies to target medicines or medicine combinations most

commonly packed in DAAs and where there is a higher index of known/reported

stability concerns. The stability of drug products meeting these criteria could be

investigated under both experimental and in-use conditions in DAAs to begin to provide

the pharmacist with specific stability data. In one approach, the USP used a “Open

Dish Tests“ (accelerated open-dish testing conditions of 30°C and 75% relative

humidity for 7 days, 30°C and 75% relative humidity for 3 weeks and 25°C and 60%

relative humidity for 6 weeks in an open dish ) to screen solid medicines for changes in

appearance, average mass, and dissolution behaviour (Bempong et al. 1999b;

Bempong et al. 1999c) and products showing changes were then assayed for drug

content (Adkins et al. 1999; Bempong et al. 1999a). Procedures for conducting open

dish studies have been published (Medwick et al. 1998a).

Open dish studies would provide data on the worst case scenario and could have the

potential to be a useful screening method. Open dish studies may, however, produce

many ‘negative’ results that would not reflect stability in the more protected

environment within a DAA, and so unnecessarily complicate the ‘screening’ process.

To facilitate the completion of stability studies to reflect repackaging in DAAs and to

reflect the Australian situation, an easily accessible (widely disseminated) guideline

outlining the methodology for conducting these physicochemical stability studies should

be developed in consultation with the various regulatory authorities, manufacturers of

DAAs and experts in the field. This would assist researchers in the field and provide a

standardised approach to acquiring in-use stability evidence.

In this study, it was possible to identify the most commonly dispensed medicines for

patients using DAAs, thus providing a starting point for prioritised stability studies. In

Phase 2 of this study, 136 community patients who used pharmacy-packed DAAs

consented to the release of their Pharmaceutical Benefits Scheme (PBS) claims data

for the period July 2001 to June 2004 (for most patients). This type of data has also

been used in other study analyses and details of its extraction can be found in 7.1.2.


Report of Suspected Physicochemical Instability Observed in

Dose Administration Aids

Patient identifier (e.g. Record no.) _____________________

Visual description of observed/ suspected instability problem: __________________

________________________________________________________________________

When did you first notice the problem? ______________________________________

When was the DAA: Packed? ___/___/____ Issued? ___/___/____

Where was the DAA stored? (e.g. kitchen, bathroom etc.)_________________________

Possible patient-contributing factors? (e.g. DAA left in car etc.)___________________

Did you use your records to obtain this information? __________________________

Name of drug products packed in affected

blister of DAA

Dosage form (e.g.

capsule, tablet)Strength Quantity Other?

Name and manufacturer of DAA: ___________________________________________

Blister pack Multi dose Sachet packet

Compartmentalised box Unit dose

Any strategies used to minimise apparent instability: __________________________

________________________________________________________________________

Reporting Nurse, Pharmacist, Doctor etc:

Name:

Address: Postcode _ _ _ _

Contact number:

Signature____________________________/___/___

Identities of all reporters, patients and institutions will remain CONFIDENTIAL

Figure 10.1 Report of suspected physicochemical instability observed in DAAs

To identify the most commonly packs items, the number of people using each type of

solid dosage form suitable for packing (excluding effervescent, dispersible or sublingual

tablets, wafers or lozenges) was calculated. The frequency was calculated aggregated

on the Anatomic, Therapeutic and Chemical (ATC) classification code to show the main


types of drugs that were packed in DAAs (i.e. a patient taking two strengths of one drug

would be counted once) (Table 10.1).

The 136 patients had items that were coded under 3910 ATC codes. Items with these

40 ATC codes in Table 10.1 accounted for 1599 (41%) ATC codes. Thus, examining

the stability of these 40 drugs would provide evidence of packing stability for some 40%

of medicines likely to be packed on a regular basis.

Table 10.1 Percentage of DAA users with PBS item (by ATC code) claimed any time

between July 2001 and June 2004, where items taken by > 15% of patients

ATC code Generic name % of patients on a drug with ATC code

N05CD07 Temazepam 61.8

N02BE01 Paracetamol 60.3

N02AX02 Tramadol hydrochloride 60.3

C03CA01 Frusemide 55.9

B01AA03 Warfarin sodium 55.1

B01AC06 Aspirin 54.4

A02BA02 Ranitidine hydrochloride 38.2

C09CA04 Irbesartan 35.3

N02AA59 Codeine phosphate with paracetamol 34.6

A02BC01 Omeprazole magnesium 33.1

C10AA01 Simvastatin 33.1

C09AA04 Perindopril erbumine 32.4

H03AA01 Thyroxine sodium 30.9

C08CA01 Amlodipine besylate 30.9

M01AH01 Celecoxib 30.1

H02AB06 Prednisolone 30.1

C10AA05 Atorvastatin calcium 29.4

C01DA14 Isosorbide mononitrate 27.9

A02BC02 Pantoprazole sodium sesquihydrate 27.2

M01AH02 Rofecoxib 27.2

A04AD Prochlorperazine 24.3

A12BA01 Potassium chloride 24.3

C01AA05 Digoxin 22.8

C10AA03 Pravastatin sodium 20.6

A10BA02 Metformin hydrochloride 20.6

C07AB02 Metoprolol tartrate 19.9

A02BC05 Esomeprazole magnesium trihydrate 19.9

B01AC04 Clopidogrel hydrogen sulfate 19.9

C07AB03 Atenolol 19.9

N05BA01 Diazepam 19.1

N05BA04 Oxazepam 19.1

A03FA01 Metoclopramide hydrochloride 18.4

N06AB06 Sertraline hydrochloride 17.6

C03BA11 Indapamide hemihydrate 17.6

C09AA05 Ramipril 16.9

M05BA04 Alendronate sodium 16.9

A12AA04 Calcium 16.9

C08DB01 Diltiazem hydrochloride 16.2

M04AA01 Allopurinol 16.2

N03AG01 Sodium valproate 15.4


In order to examine the nature of the dosage forms packed, the frequency was also

calculated, aggregated on ATC code and dosage form and strength, so that a patient

taking two strengths of one drug would be counted twice; once for each strength. The

results are shown in Table 10.2. Anti-infectives were excluded from the frequency

calculations.

Table 10.2 Percentage of DAA users with a PBS item (by name, strength and dosage

form) claimed any time between July 2001 and June 2004, where items

taken by > 5% of patients

ATC code Generic name Form and strength % patients on item

N02BE01 Paracetamol Tablet 500 mg 60.3

C03CA01 Frusemide Tablet 40 mg 44.9

B01AC06 Aspirin Tablet 100 mg 40.4

N05CD07 Temazepam Tablet 10 mg 39.0

N02AA59 Codeine phosphate with paracetamol

Tablet 30 mg-500 mg 34.6

A02BC01 Omeprazole magnesium Tablet 20 mg (base) 33.1

N02AX02 Tramadol hydrochloride Capsule 50 mg 31.6

A02BA02 Ranitidine hydrochloride Tablet 150 mg (base) 30.9

A02BC02 Pantoprazole sodium sesquihydrate

Tablet (enteric coated), equivalent to 40 mg pantoprazole

25.0

A04AD Prochlorperazine Tablet 5 mg 24.3

M01AH01 Celecoxib Capsule 200 mg 23.5

N05CD07 Temazepam Capsule 10 mg 22.8

A12BA01 Potassium chloride Tablet 600 mg (sustained release) 22.8

C01DA14 Isosorbide mononitrate Tablet 60 mg (sustained release) 21.3

B01AA03 Warfarin sodium Tablet 1 mg 20.6

C07AB03 Atenolol Tablet 50 mg 19.9

B01AC04 Clopidogrel hydrogen sulfate Tablet 75 mg (base) 19.9

C10AA01 Simvastatin Tablet 20 mg 19.1

A03FA01 Metoclopramide hydrochloride Tablet 10 mg 18.4

C07AB02 Metoprolol tartrate Tablet 50 mg 17.6

A10BA02 Metformin hydrochloride Tablet 500 mg 17.6

C09AA04 Perindopril erbumine Tablet 4 mg 17.6

C01AA05 Digoxin Tablet 62.5 micrograms 16.9

C09CA04 Irbesartan Tablet 300 mg 16.9

C08CA01 Amlodipine besylate Tablet 10 mg (base) 16.2

A12AA04 Calcium Tablet 600 mg (as carbonate) 15.4


H03AA01 Thyroxine sodium Tablet equiv. to 100 micrograms anhydrous thyroxine sodium

14.7

M05BA04 Alendronate sodium Tablet equiv. 70 mg alendronic acid 14.7

C08CA01 Amlodipine besylate Tablet 5 mg (base) 14.7

N02AX02 Tramadol hydrochloride Tablet 100 mg (sustained release) 14.0

H03AA01 Thyroxine sodium Tablet equivalent to 50 micrograms anhydrous thyroxine sodium

14.0

M01AH02 Rofecoxib Tablet 25 mg 14.0

M01AH02 Rofecoxib Tablet 12.5 mg 13.2

M09AA Quinine sulfate Tablet 300 mg 13.2

H02AB06 Prednisolone Tablet 5 mg 13.2


C09AA04 Perindopril erbumine Tablet 2 mg 12.5


Table 10.2 continued



N05BA01 Diazepam Tablet 5 mg 12.5

N05BA04 Oxazepam Tablet 30 mg 12.5

H02AB06 Prednisolone Tablet 25 mg 12.5

C10AA05 Atorvastatin calcium Tablet 40 mg (atorvastatin) 11.8

A02BC05 Esomeprazole magnesium trihydrate

Tablet (enteric coated), equivalent to 40 mg esomeprazole

11.8

A07DA03 Loperamide hydrochloride Capsule 2 mg 11.8

C03DA01 Spironolactone Tablet 25 mg 11.8

N06AB05 Paroxetine hydrochloride Tablet 20 mg (base) 11.8

C03BA11 Indapamide hemihydrate Tablet 2.5 mg 11.8

N06AB06 Sertraline hydrochloride Tablet 50 mg (base) 11.0

C10AA03 Pravastatin sodium Tablet 40 mg 11.0

A07DA01 Diphenoxylate hydrochloride with atropine sulfate

Tablet 2.5 mg-25 micrograms 11.0

A10BB09 Gliclazide Tablet 80 mg 11.0

B03AD03 Ferrous sulfate dried with folic acid

Tablet 250 mg-300 micrograms (sustained release)

10.3

C03CA01 Frusemide Tablet 20 mg 9.6

M04AA01 Allopurinol Tablet 100 mg 9.6

C09DA04 Irbesartan + hydrochlorothiazide Tablet 300 mg-12.5 mg 8.8

C08CA13 Lercanidipine hydrochloride Tablet 10 mg 8.8

B01AC30 Dipyridamole with aspirin Capsule 200 mg (sustained release)-25 mg

8.8

C09BA04 Perindopril erbumine with indapamide hemihydrate

Tablet 4 mg-1.25 mg 8.8

N03AG01 Sodium valproate Tablet 200 mg (enteric coated) 8.8


A02BC05 Esomeprazole magnesium trihydrate

Tablet (enteric coated), equivalent to 20 mg esomeprazole

8.1

N06AB04 Citalopram hydrobromide Tablet 20 mg (base) 8.1

N06AA09 Amitriptyline hydrochloride Tablet 25 mg 8.1

C01BD01 Amiodarone hydrochloride Tablet 200 mg 7.4

C09AA02 Enalapril maleate Tablet 20 mg 7.4

A02BC04 Rabeprazole sodium Tablet 20 mg (enteric coated) 7.4



C08DB01 Diltiazem hydrochloride Capsule 240 mg (controlled delivery) 7.4

C10AA03 Pravastatin sodium Tablet 20 mg 7.4

H02AB07 Prednisone Tablet 25 mg 7.4

A02BA02 Ranitidine hydrochloride Tablet 300 mg (base) 7.4

N06AX11 Mirtazapine Tablet 30 mg 7.4


N05BA04 Oxazepam Tablet 15 mg 6.6

M04AA01 Allopurinol Tablet 300 mg 6.6

N05BA01 Diazepam Tablet 2 mg 6.6

C01DA14 Isosorbide mononitrate Tablet 120 mg (sustained release) 6.6



M01AH01 Celecoxib Capsule 100 mg 6.6


Table 10.2 continued


N06AB06 Sertraline hydrochloride Tablet 100 mg (base) 6.6

C10AB04 Gemfibrozil Tablet 600 mg 6.6

G03CA57 Oestrogens-conjugated Tablet 625 micrograms 5.9

C08CA02 Felodipine Tablet 5 mg (extended release) 5.9

C01AA05 Digoxin Tablet 250 micrograms 5.9

N06AA16 Dothiepin hydrochloride Capsule 25 mg 5.9

M01AB05 Diclofenac sodium Tablet 50 mg (enteric coated) 5.9

C09AA05 Ramipril Tablet 5 mg 5.9

C03BA11 Indapamide hemihydrate Tablet 1.5 mg (sustained release) 5.9

A02BC03 Lansoprazole Capsule 30 mg 5.9

M01AC06 Meloxicam Tablet 7.5 mg 5.9

N06AX16 Venlafaxine hydrochloride Capsule 75 mg (modified release) 5.9

C03AA03 Hydrochlorothiazide Tablet 25 mg 5.1

G04BD04 Oxybutynin hydrochloride Tablet 5 mg 5.1


C08DB01 Diltiazem hydrochloride Capsule 180 mg (controlled delivery) 5.1


C08DA01 Verapamil hydrochloride Tablet 240 mg (sustained release) 5.1

B03BB01 Folic acid Tablet 5 mg 5.1

N05CD02 Nitrazepam Tablet 5 mg 5.1

M09AA Quinine bisulfate Tablet 300 mg 5.1

Of these items in Table 10.1 and Table 10.2, the recently published UK survey (Church

& Smith 2006) provided stability information potentially useful to Australian pharmacists

for only 27 items. This evidence could also be supplemented by physicochemical

stability studies on the commonly reported medications displaying instability (using the

reporting tool outlined in 10.2.2.1). Studies could be performed on the medications

alone in the blisters/ sachets of the various commercially available DAAs, and in

commonly observed combinations.

10.2.2.3 Other sources of stability information

Stability of a drug product in the original packaging is the responsibility of the

manufacturer – it is not a current regulatory requirement for manufacturers to provide

stability tests on the performance of medicines when stored in DAAs although the

regulatory approach to obtain information about the stability of medicines in DAAs was

recommended in 1997 in a report on the use of DAAs (School of Pharmacy and

Medical Sciences at University of South Australia & Australian Association of

Consultant Pharmacy 1997). Transfer to any type of compliance device (DAA) can not

be approved without a full assessment of the stability of the product in the device in

question being carried out, and the product licence adjusted accordingly. When

repackaging medications, stability of a drug product upon removal from the original

packaging is therefore currently the pharmacist’s responsibility and is based on

available evidence and professional judgment7.

7 The interpretation of stability data based on available evidence and professional judgment is at

the concept behind the setting of ‘beyond-use’ dates that applies to medicines not dispensed

directly from manufacturers Kommanaboyina B, Rhodes CT. Trends in Stability Testing, with

Emphasis on Stability During Distribution and Storage. Drug Dev Ind Pharm 1999; 25 (7):857 -


To make a judgement on the suitability of a medicine for packing into a specific DAA,

information is required on the stability outside the manufacturers’ packs and the air,

light and moisture protection of the manufacturers’ packaging and the protection

offered by the DAA to be used. Manufacturers and the TGA hold information on the

stability in original packs of prescription medicines registered in Australia (Therapeutic

Goods Administration 2004) (see http://www.tga.gov.au/pmeds/argpmap14.pdf, p 11).

For registration, the TGA requires the sponsor to generate data to

”establish the effect of high humidity on solid dosage forms packaged in containers that

are likely to be permeable to moisture. Examples of containers that would generally be

considered moisture-permeable include…. polyvinyl chloride blisters and low density

polyethylene bottles” p11. Polyvinyl choride and low density polyethylene are materials

used in some DAAs, so that access to the results of high humidity testing could aid

pharmacist’s DAA repackaging decision making. Note that this information does not

cover all products - aluminium/aluminium blisters are “generally considered to be

moisture-impermeable” p11 and so sponsors would not be required to conduct high

humidity studies for products in aluminium blisters.

It would be extremely valuable if manufacturers or the TGA could indicate those

products for which there is an absolute contradiction to short-term storage in the

absence of the original packaging. Further, any short-term stability data derived under

defined conditions and without the protection of the original packaging would also be

very useful to the pharmacist (an issue raised in the 1997 report on DAA use (School of

Pharmacy and Medical Sciences at University of South Australia & Australian

Association of Consultant Pharmacy 1997)). Such information would permit the

pharmacist, doctor, health care worker or patient to assess the true significance of

stability problems should a drug product need to be removed from its original pack


Given the widespread and likely continuing use of DAAs (in the majority of the

approximately 3000 residential aged care services providing over 156,580 residential

aged care places (Australian Institute of Health and Welfare (AIHW) 2005) alone),

there needs to be agreement between the TGA and manufacturers on the

dissemination of original pack stability testing results that may indicate a stability

concern if medicines were to be repacked into a DAA. In the absence of specific

stability studies for medicines repackaged into DAAs, the dissemination of original pack

stability information could be added to the current regulatory framework, so that TGA

could allow pharmacists to access more detailed information thus assisting

pharmacists’ decision making processes on whether or not to repackage a specific

medicine into a specific DAA.

In order that to assess the applicability of any original pack stability information, the

specific light, air and moisture protection properties of the various DAAs also needs to

68., including repackaged medicine and medicines compounded or dispensed by the

pharmacist. Criteria other than the expiry date of the manufactured medicines are used to set a

conservative beyond-use date as these medicines are intended for short term storage

Kommanaboyina B, Rhodes CT. Trends in Stability Testing, with Emphasis on Stability During

Distribution and Storage. Drug Dev Ind Pharm 1999; 25 (7):857 - 68.. Methods for obtaining

information including using the results of open dish studies as a basis for assigning a ‘beyond-

use’ date have been described Medwick T, Okeke C, Grady LT. A Scientific Basis for Beyond-

use Dating. Pharmacopeial Forum 1998b; 24 (1):5643-44..


be known. In a study by Walker (Walker 1992) where manufacturers of medicines were

asked to indicate which solid oral dose forms were not suitable for transfer to a DAA,

manufacturers commented that while there was stability study data, it was difficult to

answer the question of ‘suitability’ without knowing the specific protective properties of

the DAAs. Suppliers of materials used to manufacture DAAs typically provide

quantitative data, obtained from well-established test methods, to highlight the

protective properties of their material. However, these data are often based on sheets

of the film, for example, and not on the formed container (i.e. DAA) (USP <1146>

2005). It is critical to understand that, for example, once the film is formed, protective

properties change because the overall thickness of the film decreases as the blister

cavity is formed (USP <1146> 2005). Further, a suboptimal seal closure on the formed

container will decrease the protective properties of the container (Saville 2001; USP

<1146> 2005). Currently, there is limited moisture permeation data based on studies of

conducted on 10 different monitored dosage systems available in the United Kingdom

in 1993 (Report of the moisture permeability testing of monitored dosage systems.

1994). It is not clear from this study just which devices are used in Australia; newer

devices are on the market now and information on protection from air, heat and light is

also needed. Any current information on the stability implications and protective

properties of the various devices/ DAAs, made available by the commercial suppliers of

DAAs, would significantly assist pharmacists, and possibly regulatory authorities and

medicines manufacturers in the decision-making process with respect to the stability

issues concerning repackaging medications.

Due to an increase in repackaging activities in the United States, a new USP chapter

on Good Repackaging Practices (USP <1178> 2005) has recently been published to

provide guidance to those engaged in removing drugs from the original manufacturer’s

container and repackaging them into a different container-closure system for resale or

for distribution to hospitals or other pharmacies (i.e. “Repackagers” – see definitions in

Appendix E). These functions are beyond the regular practice of a pharmacist but can

provide a framework for quality DAA packing practices. A repackager is required to

register with the FDA and comply with current Good Manufacturing Practices (cGMPs)

regulations in 21 CFR 210 and 211 [USP<1178>, 2005 #137]. Since stability studies

are performed on the drug product in the original manufacturer’s containers to establish

an expiration date, the product’s expiration date is altered or interrupted when a drug is

repackaged into a different container. Repackagers are required to either perform

stability studies on the repackaged products to establish an expiration date for the

product based on scientific evaluation of the drug product in the container-closure

system to which it is to be marketed; or they may use the manufacturer’s original

expiration date without additional stability testing if the drug product is repackaged into

an equivalent container-closure system that is at least as protective as, or more

protective than, the original system and complies with the criteria established for

equivalency. The definition of an “equivalent container-closure system” and detailed

criteria for the assignment of a beyond-use-date are given in the new chapter on Good

Repackaging Practices (USP <1178> 2005).

Until recently, in the absence of stability information about a specific product, it was

recommended that “the maximum beyond-use date should not be later than 25% of the

time remaining until the product’s expiration date or 6 months, whichever was earlier”

(Kommanaboyina & Rhodes 1999). This assumed that the product was packed in tight,

light-resistant containers and stored at a controlled room temperature. The latest USP


standards on beyond-use date setting for repackagers of unit-dose packs requires that

the original bulk container has not previously been opened, that the unit-dose packs

meet USP standards and meets or exceed the manufacturers’ specifications for light

resistance, the storage conditions meet the manufacturers’ specifications. In these

situations, a beyond-use date should not exceed 6 months after the date of

repackaging, the manufacturers expiry date or 25% of the time remaining until the

product’s expiration date (USP <1178> 2005). These conditions are not met by the

usual DAA preparation practices in community pharmacies and while the USP

standards could provide a basis for determining how long a medicine can be in a unit-

dose DAA, substantial modification would be required to reflect the Australian situation,

particularly the use of multi-dose packs.

10.2.3 CURRENT GOOD PACKING PRACTICES

The risk management approach to minimising the risks of drug instability for products

packed in DAAs requires a system to ensure good packing practices are followed. The

current PSA Guidelines (Pharmaceutical Society of Australia 1999) address some of

these good packing practice issues that are important in producing a quality “product”

but the concepts are scattered throughout the document and integrated with

professional service components. For example, comments on the availability of

“appropriate and motivated staff” is in a different section to comments about the

qualification and experience of these staff. The nature of the training is not addressed.

In providing a DAA service, there are two distinct but related components:

The preparation of the DAA (including personnel, premises/space, equipment,

correct materials, appropriate procedures, suitable storage) and,

The services needed to support appropriate use of the device (e.g. assessment of

the patient prior to initiating a DAA, determining the current drug regimen and

counselling patients on the medicines).

Creating a specific document to guide packing practices would allow more details on

how to implement good practice to be included, i.e. an implementation model. The

Australian Code of Good Manufacturing Practice takes a systematic approach to

quality control and quality assurance (Therapeutic Goods Administration 2002) and this

document could provide a framework for a working party to develop a new code for

“current Good Packing Practices” for pharmacy DAA providers. The recently released

United States Pharmacopoeia supplement (United States Pharmacopeial Convention

2005) has new chapters on:

<1136> Packaging: Unit-of-Use;

<1178> Good Repackaging Practices;

<1177> Good Packaging Practices;

<1079> Good Storage and Shipping Practices;

that could also inform the new code. The working party could be co-convened by the

PSA (as the organisation responsible for setting professional practice standards) and

the TGA (as the organisation responsible for GMP, with the technical expertise related

to drug stability and the repository of much unpublished information about drug product

stability (see 10.2.2.3)).

The current PSA Professional Guidelines for Dose Administration Aids gives little

specific advice on the stability of medicines in DAAs. It states

“Only medication free of incompatibilities (due to being in close contact with other

medication), and medication whose removal from its original pack does not


adversely affect its action shall be suitable for use in DAAs. Some examples of

medication unsuitable for packaging in a multi-dose pack include effervescent

tablets, dispersible tablets, buccal tablets, sublingual tablets, significantly

hygroscopic preparations and solid dose cytotoxic preparations. Consideration

must also be given to the effect of heat sealing the backing on some dosage

forms (e.g. soft gel capsules).” (Pharmaceutical Society of Australia 1999)

This guideline poses a problem for the pharmacist in terms of their ability to assess

incompatibilities and although information is provided on the type of medications

adversely affected by removal from the original packaging, there is a lack of detail

pertaining to the individual drug substances. A more detailed list that can be updated

as more information on drug instability in DAAs becomes available, could be included

as an appendix to the “Good Packing Practices” code.

10.3 POLICY AND PRACTICE IMPLICATIONS FOR

COMMUNITY-BASED RECIPIENTS OF PHARMACY DAA

SERVICES

In Phase 3, additional HIC data and follow-up of community patients at one year gave

additional insights into the characteristics of current community patients being provided

DAAs by community pharmacies and suggested other potential benefits from DAAs

that might arise from closer relationships within the patient care team. An

understanding of the characteristics of current DAA service recipients could inform

future policy and practice.

10.3.1 CURRENT RECIPIENTS

Current community patients who use DAAs represent a subset of the population who

have high care needs across many domains compared to users of medicines in original

packs. In section 8.2, the characteristics of DAA users collected in Phase 2 are

modelled – pharmacy-provided DAA users require more assistance with care, were

older and more likely to have been hospitalised in the preceding 12 months than OP

users. The community patients in this study are self-selected. While DAA use was

initially recommended by the pharmacy for 46% of pharmacy-provided DAA users (with

the doctor made the recommendation for 25% and the family for 11%) (Ientile et al.

2004), in this case, continued use of a DAA can reflect perceived net benefit. Using a

DAA has some negative impact on patients: Patients using a DAA have to give up

control of their medicines, to fit the processes of getting packs and dealing with

medication changes (when the whole pack has to be changed if only one medicine is

altered) into their lifestyle and in many cases, pay for the service. Further, as the

economic analyses in Phase 2 illustrate, pharmacies have few incentives to offer a

DAA service to a community patient that does not have a “need” for the service.

The data obtained from HIC service use data and the follow-up of analysis of

community patients has been used in the economic modelling in Chapter 9 but it also

gives more insight into the characteristics of DAA users and the effect of DAA use on

outcome.

In Chapter 7, HIC service use was examined for the year prior to the day of Phase 2

data collection. Despite having greater care needs and acuity/severity of illness (as

suggested by a higher rate of emergency doctor attendances (Table 7.1)) compared to


OP users and non-pharmacy DAA users, community patients using pharmacy supplied

DAAs had the same service use costs (PBS+MBS costs). This may reflect better

control of medication management and service use associated with the enhanced

relationships within the health care team needed to provide a DAA service. Further,

non-pharmacy DAA users had the highest combined PBS+MBS costs yet were more

able and younger than pharmacy DAA users (Ientile et al. 2004). This group also had

the highest number of PBS items, the highest levels of disorganised and memory-

related non-adherence despite but the lowest number of GP MBS items (Table 7.1).

Some non-pharmacy DAA users may have benefited from the closer monitoring

associated with a pharmacy DAA service as they actually had higher PBS costs and

lower GP costs than would be expected after adjusting for covariates (Figure 7.1 and

Figure 7.2).

A small sub-analysis allowed the impact of starting a pharmacy DAA on HIC costs to

be examined. In the post-DAA period, DAA users had higher service use in a number

of areas relative to OP users. In some cases, the pattern was opposite to that

observed in the pre-DAA period (Table 7.2). Continuity of supply (or possible wastage)

increased and/or there was a decline in health between pre- and post-DAA timeframes.

DAA users has significantly more PBS items and incurred greater PBS costs than OP

users with a slight (p=0.103) increase in the number of medicines regularly taken

(using the number of different items supplied more than once and those not

antiinfectives as a proxy) and emergency doctor attendances were higher.

Even though many of the covariates in the HIC data models are proxies for greater

disability and/or poorer health, the pattern of costs and the difference between adjusted

and unadjusted costs for the 1 year cross section (Table 7.1) and the pre-post analysis

(Table 7.2) suggests that some key driver of cost, such as a significant decline in

function, occurred for pharmacy DAA users that did not happen for people capable of

using original packs or non-pharmacy DAAs.

The follow-up of community patients 1 year after Phase 2 further demonstrated that

self-selected users of pharmacy supplied DAA are quite different to either non-

pharmacy packed DAA users or users of medicines in original packs in terms of care

needs, disability and markers of illness burden. Pharmacy DAA users were more likely

to be lost to follow-up due to death, RCF admission and ill health (Figure 6.1). As seen

in Phase 3 (Figure 6.4), compared to OP users, pharmacy-provided DAA users who

remained living in the community also had higher care needs at Phase 2. There are

several findings of interest:

Using a pharmacy provided DAA maintains people with higher care needs in the

community (at Phase 2 and in Phase 3 (Table 6.8 and Figure 6.4));

People using OPs who went to residential care had higher care needs and poorer

health status (e.g. more likely to receive regular community health visit and have a

lower IADL score) compared to DAA users who were admitted to RCFs.

For a person using OP, those living alone had a greater rate of death (9.1%) versus

those OP users who did not alone (1.3%). This compares with 10.9% for DAA users

who lived alone and 9.2% who did not live alone.

OP users who died had a better IADL score, younger age, fewer illnesses and

better self-rated health than DAA users i.e. they died despite having better function,

etc,.

One possible explanation for these patterns (Table 6.13) is that greater communication

with the GP, better rapport (as reported in Phase 2) and the closer monitoring involved


with profile updating and prescription management together with closer patient/carer

and pharmacist relationship secondary to the provision of pharmacy DAA services may

promote greater collaboration in the health care team compared to the care team of OP

users. This in turn may lead to earlier recognition of patient health problems or inability

to cope so that appropriate management can be put into place (thereby delaying

transfer to RCFs or death). Pharmacy DAA users who were followed up in Phase 3

(and therefore continued to live in the community) still had greater care needs (as

indicated by support service and other care facility use) compared to OP users (Table

6.9). The value-added effects of a more collaborative health care approach associated

with DAA use warrants further longitudinal study.

10.3.2 POLICY AND PRACTICE IMPLICATIONS

It is difficult to evaluate the key economic findings from this research given the

significant differences between groups, patients lost to follow-up, lack of randomisation

and lack of baseline data to monitor improvements in health associated with using a

DAA. DAA patients in this study were sicker, had higher health service utilisation rates

and higher costs. From a quality use of medicine point, the fact that DAA patients are

utilising health services more frequently than OP patients could suggest that DAA

patients are more proactive in maintaining their health and are therefore more likely to

frequent a health professional or that better monitoring with appropriate action is taken.

The PBS data (Table 7.1) suggest that using a pharmacy-provided DAA has an impact

on continuity of medication supply. As might be expected with improved compliance

(plus the potential for wastage when DAAs have to be changed), pharmacy DAA users

tended to use more PBS items than OP users despite taking a similar number of

regular medicines (using the number of PBS items supplied more than once and

excluding anti-infectives as a proxy).

A finding from Phase 2 of this study was that community pharmacy appear to be

providing a much needed service to a fairly specific needs group largely at a cost to

themselves. The continuation of DAA use by all 80 DAA users contacted after 1 year

and that 20% of OP users has started using some form of DAA during that year (Table

6.1) suggests that patients believe that the benefits of the service outweighs the costs

and inconvenience to them. Further, analysis of HIC data (7.2.1), data from Phase 2

and the follow-up consumer survey (6.2.4) suggests that the cost of health services to

the Australian government is not different for DAA and OP users when the former

group have greater care needs and would be expected to have higher costs. Because

of the vulnerable nature of this group of DAA users, it is important that funding is made

available to ensure that DAA users are afforded the best care possible by the

community pharmacy.

To better understand the economics of providing DAA versus OP in a community

setting it is desirable that a randomised controlled trial is undertaken with appropriate

consideration given to the inclusion of economic data collection instruments. For

comparability purposes, the data collection instruments used in the current study

should be implemented but supplemented with more costing specific questionnaires

including a custom designed health service utilisation survey. It is also imperative that

health related utility instruments (such as the EQ5D) are used and administered at

intermittent data collection intervals to enable change in health to be monitored. A more

robust version of contingent valuation (i.e., the willingness to pay questions) would also


provide more reliable and useful indicators of social benefit. Economic appraisals are a

useful policy tool but output is dependent upon quality data input.

10.4 FUTURE PROVISION OF DAAS TO COMMUNITY PATIENTS

DAAs have been provided by pharmacies to community patients in the belief that a

DAA will improve adherence and medication management, reduce care needs and

bring health and/or quality-of-life benefits ((Ientile et al. 2004) p 84). There are,

however, disadvantages and risks for the patient and for some, not using a DAA may

be the best option and safest for the patient. In providing a DAA service, pharmacies

need to target recipients to maximise patient benefits and design the service provided

(e.g. start up training on how to use a specific device correctly or regular patient

education to counteract loss of medication regimen knowledge) to minimise risks to the

patients. Since the status and medication management abilities of community patients

using a DAA may change over time, pharmacies need to re-assess the situation

periodically to ensure that any risks continue to be addressed by the DAA service.

Targeting of DAA use to people most likely to benefit may maximise the effectiveness

of DAAs in improving adherence and medication management, with resulting health

benefits. The effect on adherence is, however, likely to be modest. In a Cochrane

review of randomised controlled trials (RCTs) that measured the adherence and

disease outcome effects of interventions aimed helping patients follow prescribed drug

therapy for medical problems, Haynes et al (Haynes et al. 2002) concluded that

“current methods of improving adherence for chronic health problems are mostly

complex and not very effective”. When improving compliance of older community

patients was the focus of a systematic review (van Eijken et al. 2003), there were two

findings of interest:

That in this group, compliance rates in many studies were over 80% even in the

control subjects.

That multifaceted interventions or those tailored to the problems of an individual

were often more effective at improving compliance.

Interventions that provide a form of social support, directive guidance, have also been

shown to improve adherence, knowledge and outcome (Caplan et al. 1980; Levy

1983). Directive guidance activities include providing information, instruction and

advice and, giving feedback on patient behaviours, thoughts and feelings (in this case

as they relate to health, illness, medication taking and medication management)

(Barrera et al. 1983).

The type of DAA service described in the best practice model (see section 4.5) is

multifaceted (including the device, written information, counselling, and follow-up,

possibly via a home visit; all facets allow directive guidance to be provided) but at the

same time, the needs of the individual are recognised in the assessment process. The

current targeting of community-based DAA recipients is discussed in 10.4.1.1 and the

implications for future on-line eligibility assessment and service evaluation is discussed

in 10.4.2. Targeting of those DAA recipients with the greatest need and those most

likely to benefit from a DAA is particularly important now that a finite pool of funding for

DAA services has been negotiated in the Fourth Community Pharmacy Agreement

between the Commonwealth of Australia and the Pharmacy Guild of Australia

(http://www.guild.org.au/public/cpa/fourthcpa.pdf viewed 10/5/06) signed 16 Nov 2005.


10.4.1 TARGETING COMMUNITY PATIENTS FOR DAA SERVICES

To date, the community patients who are receiving a DAA service from their community

pharmacy have had the device recommended by their pharmacy, their GP, family or

other health care providers or in response to a serious health event (e.g.

hospitalisation). The limited pre-post comparison of HIC data supports the argument

that a serious health event or decline in health or function triggers DAA use (see

10.3.1). As mentioned in 10.3.1, continued use of a DAA in these circumstances

suggests perceived net benefit from the service. To identify the characteristics of

people likely to benefit (using continued use as a proxy in the absence of specific

health outcome measures), in chapter 8, the characteristics of Phase 2 community

patients who used either pharmacy-provided DAAs or OPs were examined to see

which characteristics predicted DAA use. The logistic and non-linear modelling

reported in this chapter suggest that it may be possible to target specific community

patients for a DAA but that criteria are probably complex. In this section, we examine

the nature of the DAA predicting characteristics, compare the results of the two

modelling strategies trialled and discuss the limitations of the models.

10.4.1.1 Predicting DAA use

In the literature and current Australian guidelines, there are similarities and differences

in the criteria used to predict who would benefit from a DAA. In the Phase 2 literature

review where the type of patients who might benefit from a DAA was discussed, those

said to receive possible benefit from DAAs were assumed to be the same as those with

adherence problems. These are summarised as follows:

Unintentional non-adherence – forgetful or confused by complex regimen (Bond et

al. 1991).

Decreased manipulative skills or short term memory loss or confusion (Cramer

1998; Pharmacists develop compliance aid for the elderly. 1988).

Psychiatry patients if anxiety/mood affect adherence but not if any cognitive

dysfunction (Bazire 1984).

Living alone or more than 2 drugs or pre-dementia (MMSE score <24) (Barat et al.

2001).

Elderly because polymedicine and complex regimens more are likely rather than

older age itself (Cramer 1998; Lorenc et al. 1993; Pillans et al. 1999).

To assist carer to monitor meds and decrease carer burden (Rivers 1992).

Certain patient subgroups: respiratory pts; cardiovascular, neurology, renal, HIV,

diabetes patients; starting anticoagulants; others with lots of solid medications

(Naughton et al. 1993; Peterson et al. 2003; Simmons et al. 2000).

DAAs are not suitable if frequent medication changes (Sprey 1995).

Note that the literature is somewhat contradictory in that people starting anticoagulants

are more likely to have frequent medication changes as the dose of the anticoagulant is

adjusted.

The variability in the literature describing the characteristics of people who may benefit

from using DAAs is reflected in the PSA guidelines that emphasise the importance of

individual assessment in determining the need for a DAA. Never the less, the following

criteria are included in the guidelines for consideration (Pharmaceutical Society of

Australia 1999):

Patients who take five or more medications;

Patients who have a history of problems managing medication;


Patients with complex medication regimens, and;

Patients showing signs of cognitive or physical impairments affecting their

medication management abilities.

Given that pharmacists were the main instigator of DAA use by the community-based

patients in Phase 2 who used a pharmacy-provided DAA, it is also important to

consider the type of patients who pharmacists believe would benefit most from a DAA

Elderly;

Multiple medications;

Confused or with cognitive impairment ;

Unable to coordinate their medications correctly;

Physical barriers to medication taking;

Limited support.

The criteria pharmacists used to decide whether a patient should be offered a DAA

were more varied but matched the type of patient pharmacists believe would more

benefit. Evidence of confusion or cognitive impairment displayed by the patient was the

most common trigger to offer a DAA (Ientile et al. 2004) p86.

The characteristics predicting DAA use based on models of community patient choice

to continue to use a DAA are summarised in Table 10.3. In this study, two modelling

techniques were used to model DAA and OP use based on various initial sets of

characteristics. Its is important to recognise that the variables initially included in the

models can affect the final predictive model. For example, including regular community

health visits and having a carer in a logistic model accounts for all the independent

predictive power of IADL – excluding community health visits and carer means that

IADL becomes an important predictor. There are, however, three variables that are

important predictors in each of the models shown in Table 10.3:


Age;

Response to the question “Do you ever forget to take your medications”.

Whenever it was initially included in a model, “regular community health worker visits”

was also an important predictor of DAA use.

Interestingly, certain characteristics were not predictors in any of the models in Table

10.3:

Self rating of health

Comparative health

Gender

Disorganised non-adherence score

Any antidementia medicines – although any antidementia medicines was an

independent predictor in logistic model 4 (Table 8.9) and so a decision on the value

of antidementia medicines as a predictor should be reserved

Any lipid lowering medicines

Any beta blocker medicines

Are you careless about taking your medicines

The patient characteristics predictive of DAA use derived from the modelling

summarised in this chapter generally agree with the literature and guidelines but with

some exceptions:


The Meichenbaum question about forgetting to take medicines and the memory-

related adherence score support unintentional adherence where this is

acknowledged as a predictor of DAA use.

The IADL score and antirheumatoid/anti-Parkinson’s medications as predictors

support decreased manipulative skills as a predictor.

Living alone was a predictor in Model 2 and 3 and the tree based on Model 5 but

may well be less important than predictors of higher care need such as IADL,

having regular carer or community health visits, as living alone appears towards the

bottom of two tree branches in a single non-linear model.

The number of solid medicines a person took was not as important a predictor of

DAA use as the number of non-solid medicines. As the number of non-solid

medicines increases, the inconvenience in using a DAA plus a range of other non-

solid packs increases and the added complexity in the medication taking routine

increases risks of non-adherence. In the decision trees, the number of solid

medicines was a moderator only after other care needs characteristics and the

number of non-solid medicines were considered.

The literature suggests that older people were likely to need a DAA because of

underlying factors related to polymedicine and complex regimens but in the models

in this study, older age was an independent predictor of DAA use after adjusting for

higher care needs in logistic regression models and was a node only after higher

care needs and non-adherence were considered. The importance given to age in

these models needs to be interpreted with caution, however, as 46% of DAA users

in Phase 2 had had their DAA recommended by their pharmacist. That age was a

predictor of DAA use may merely reflect the beliefs of pharmacists in Phase 2

where 48% indicated that being elderly was a characteristic of patients who would

benefit most from using a DAA (Ientile et al. 2004) p 85.

Having a regular carer was a predictor of DAA use in logistic models and two trees.

Phase 2 patients with less frequent medication changes were more likely to use a

DAA. Patients with more illnesses, seeing more doctors, higher symptom

frequency and severity and needing multiple medicines affecting Angiotensin II or

additional other antihypertensives may well be more unstable so that the problems

caused by changes outweigh perceived benefit from DAAs.

Contrary to the literature suggestion, respiratory patients were less likely to use a

DAA (possibly because more of these medicines are non-solid).

Apart from other medicines to treat heart failure, use of other cardiovascular drugs

did not predict DAA use. Indeed, for medicines affecting Angiotensin II or additional

other antihypertensives, greater use was associated with a greater probability of

using medicines in original packs. Use of lipid lowering agents and beta blocker

were not predictors. Nitrates as antiangina medicines were not modelled.

Renal and neurology patients with epilepsy were not modelled, nor were people

with human immunodeficiency virus therapy or those on anticoagulants.

Use of oral hypoglycaemic agents was a predictor in trees but not in logistic

regression models, perhaps because other care needs variables were stronger

influences on the decision to use a DAA.

The effects of confusion or cognitive impairment on the decision to use a DAA was not

well addressed by this modelling for three reasons:

It is likely that few cognitively impaired community patients were recruited into

Phase 2. At recruitment, Phase 2 participants had to be capable of answering


interview questions and completing a questionnaire (with the help of a carer if

necessary);

There was no explicit measure of cognitive function included in the Phase 2 data;

Only 7 patients were taking specific antidementia medicines, although possible

effects were noted even for this small number of cases.

Table 10.3 Variables initially included in the logistic and decision tree models

Model

2

Tree

2

Model

5

Tree

5

Model

6

Tree

6

Tree +

Prop

Living alone

Having a regular carer

Regular community health worker visits

No. doctors usually seen

Self-rating of health

No. times a GP was seen in last 2 months

No different illnesses reported by patient

Patient reports any hospitalisation in last year

Comparative health

Frequency of illness symptoms in past wk score

Severity of illness symptoms in past wk score

OARS-IADL score

Age

Gender

Total No. of current medicines

Total No. of current solid medicines

Total No. of current non-solid medicines

Memory-related non-adherence score

Deliberate non-adherence score

Disorganised non-adherence score

Any antianxiety medicines

Any antidementia medicines

Any antidepressant medicines

Any antipsychotic medicines

Any antirheumatoid/Parkinson’s disease drugs

Any lipid lowering medicines

Any oral hypoglycaemic medicines

No. respiratory medicines

Any beta blocker medicines

No. medicines acting on angiotensin II

Any other antihypertensive medicines

No. other medicines used to treat heart failure

Days since last medication change


Are you careless about taking your medicines

When you feel better do you stop taking your

medicines

If you feel worse do you stop taking your

medicines

Included initially but removed; Retained in the final model Prop=propensity score

10.4.1.1.1 Comparison of linear, logistic models and non-linear models

The non-linear modelling technique may better capture the complex decision making

involved in DAA use and certainly better reflects the tenor of the PSA guidelines that


recommend an individualised approach to assessment. Table 10.4 compares the

accuracy, sensitivity and false negative rates for the various models used to predict

DAA use or not. Only the results from the initial decision tree model in this table are

directly comparable with the logistic regression results as the others involve additional

techniques8 to increase the robustness of the initial tree. These techniques test how

well the tree would generalise to unseen data (i.e. data not in the training set). Logistic

regression models will almost certainly not generalize as well when applied to unseen

data.

In part, the more sensitive non-linear models may be related to the nature of the mainly

categorical predictor variables used. In general, logistic regression techniques cannot

easily handle categorical variables and they are weak at detecting interactions between

variables. Decision trees handle interactions between variables much more robustly as

cases are partitioned and then analysed in each group separately. Decision trees are

also robust when dealing with missing and noisy data. About 10% of data is missing

within this data set and some variables are highly skewed therefore decision trees will

be suited well for this data. Decision trees also handle both categorical and continuous

variables. The target value must have discrete values which is true in this case (using

original pack medicines or a pharmacy packed DAA) but unlike logistic regression more

than two responses can be used.

Table 10.4 A comparison of specificity and false alarm rates

Logistic Regression

Initial Decision Tree

Decision Tree with Boost 50 and ten-fold Cross Validation

Combined Logistic Regression and Decision Tree

Model2

Accuracy: 78.7% Sensitivity: 78% False Alarm: 21%


Accuracy: 70.1% Sensitivity: 67% False Alarm:18%


Model5



Accuracy: 63.1% Sensitivity: 65% False Alarm:30%

Model6



Accuracy: 62% Sensitivity: 65% False Alarm:30%

The trees do include many of the same predictor variables as the logistic regression

models indicating that they both model the same underlying concept, however, the

trees also highlight the importance of some other variables in making accurate

predictions. For example, variables about the number of medicines, total, solid or non-

solid do not appear in trees 2, 5 and 6 because any predictive ability they have is

already covered by other variables but the trees use more classification nodes based

on specific drug classes compared to logistic models. It is possible that these factors

are less linear in nature than the main factors of the logistic regression. It is also

possible that there is some covariance between these factors to which logistic

regression is not as sensitive to as the decision tree algorithm. In the future some

combination of the two methods may produce the most accurate classifiers.

8 The accuracy of these initial trees could be increased by boosting but this would lead to over-

fitting of the decision tree to the training data. This means that the error rate when predicting

new cases would be higher. In an attempt to estimate the predictive accuracy for new cases,

cross-validation has been used in the decision tree models.


10.4.1.1.2 Limitations of models

While the models provided a greater understanding as to the characteristics of

community patients who continue to use a DAA, there are limitations. In interpreting

these models, it is important to recognise that the outcome being modelled is a proxy,

‘choice’ not ‘benefit’ directly. ‘Choice’ may be influenced by factors other than benefit,

such as access and availability. To model ‘benefit’, random assignment to DAA or not

would have been required. This type of experiment was beyond the scope of this study.

As found in this study, the resulting model depends on the training data set and the

following limitations should be considered:

Subjects were also recruited by community pharmacists, and while there was

approximate case matching to users of original packs, systematic bias is possible

Some potential DAA users were under-represented (e.g. people with mental illness,

cognitive impairment and the intellectually disabled).

Some potentially important predictors were:

Not captured e.g. a measure of cognitive function and more objective measures

of burden of illness or severity, a measure of medication regimen complexity.

Excluded from models because the use of a DAA may influence the response

(as these predictors were not measured at baseline but after DAAs were used)

(e.g. intentional non-adherence).

Had low prevalence in the training set (e.g. use of antidementia medications).

The size of the training set was small and there was no validation set for the logistic

regression. For the trees, this may lead to overlearning which, for example, might

account for the inclusion of the number of illnesses in Tree 2.

Care also needs to be taken in interpreting models that include having a carer or

regular community nurse visits as access to these services may be affected by

availability and eligibility, rather than reflecting a need for a DAA.

These models do provide an insight into who has a perceived benefit from using a DAA

in the community (using choice as a proxy) and could be used as a basis for the

development of eligibility criteria for a subsidised DAA service. Further refinements of

the models and more cases are desirable, however, in order to more reliably predict

likely benefit from a DAA in an unseen case, i.e. a person being assessed for eligibility

for a subsidised DAA service.

10.4.2 BUILDING FUTURE EVALUATION AND RESEARCH INTO THE IMPLEMENTATION OF

DAA SERVICES FOR COMMUNITY PATIENTS

The cross-sectional studies carried out in Phase 2 and 3 of the study into the

effectiveness cost-effectiveness of DAA services have not been designed to assess

health outcome effects (i.e. change in adherence and change in health outcome). The

Cochrane review (Haynes et al. 2002) suggests that such effects are modest as

measured by changes in disease markers (although in the Cochrane review only 2

studies included interventions that might be considered as a DAA). It may well be that

the wrong effects or benefits are being measured in the studies included in the review

as the work in Phase 2 describes more humanistic outcomes such as better

satisfaction and confidence in managing medications and reduced carer burden.

A DAA service that is provided over an extended period is a mutifaceted and diffuse

intervention. The service may impact on medication management more generally with

subtle consequences. It is possible that the effects of DAAs in these areas (as reported


by community patients in Phase 2) are mediated by mechanisms other than improved

compliance alone, similar to the social and psychosocial aspects suggested to be

responsible for positive effects of pharmaceutical care (Bernsten et al. 2001). More

research is required to establish whether there is a causal link between DAA use and

better outcome as well as providing additional data for economic evaluation of any

future DAA service (as mentioned in 10.3.2). With the introduction of a subsidised DAA

program, there is an opportunity to collect evidence of benefit following the introduction

of the service while increasing the quality and reducing the cost of subsequent

evaluation by collecting data prospectively. While an RCT is a well recognised means

of attributing causality, more recently, longitudinal multivariate analysis of large

datasets (e.g. the clinical practice improvement methodology used by Susan Horn (see

http://www.isisicor.com/Detailed_Overview_of_CPI.html)) has been used to may inform

practice-based research questions. The key elements of the longitudinal data approach

are:

Recording the nature of ‘treatments’, in the case of DAAs, the type of service

provided (e.g. 6 monthly in-home medication counselling) with any additional

services such as HMR, episodes of hospitalisation or aged care admission and

other health service use.

Standardised recording of patient covariates including demographics, illness

severity or burden, function, complexity or psychosocial factors such as cognitive

function. For DAA services, baseline adherence would be included.

Outcomes of interest e.g. health status, quality of life and the humanistic outcomes

such as those measured in Phase 2. Measures used to evaluate the economics of

the service would also be included such as willingness to pay and health utility

measures would also be important.

Data is collected at multiple points in time.

In 10.4.1.1, we suggested that, by and large, pharmacists have been applying best

available evidence in selecting community DAA recipients. The data elements collected

in Phase 2 provide a starting point to create for formalised decision rules to target DAA

services to those in need (and by proxy, those who benefit). Using machine learning,

the decision rules can be improved as more cases are added and, if implemented as

an on-line eligibility check or registration system, the data can become the basis of the

future evaluation of the service. An introduction to machine learning can be found in

Appendix J.

In order that only the most necessary data are collected prospectively, namely that

needed for eligibility checking and a minimum evaluation dataset, a plan for future

evaluation should be developed in parallel with any program implementation plan.

In the community patient best practice model, structured patient assessment is

recommended together with re-assessment or review and concordance checks 6-

monthly. These are opportunities for data collection that informs both the care of an

individual patient and the effects of the program overall. Assessment should include

validated instruments (e.g. OARS-IADL, the BMQ (Svarstad et al. 1999)) and more

objective measures such as those used in this study (this would also allow comparison

with data collected in this study). The adherence measures used in this study were the

4 Meichenbaum questions and seven other questions developed in Australia and used

and validated in this and another study. Other measures omitted in this study could


also be included e.g. a measure of cognitive function such as the Mini-Mental State

Exam (MMSE).

In order of evaluate the future DAA program, other measures to include in data

collection from the patient that might be useful to a health economic evaluation would

be:

Confidence in medication management abilities.

A health utility measure, EQ5D.

Other health measures such as perceived health and health transition.

A custom designed health service utilisation tool to capture information on service

use.

A more robust version of contingent valuation (willingness to pay) as a measure of

benefit.

Consent to access health service use data held centrally (e.g. by Medicare

Australia, formerly HIC) could also be sought.

Collection of data on other health outcomes would also inform the evaluation, such as:

Measures of disease severity.

Any admission to an RCF and the date of this admission (allowing survival

analysis).

Whether a person died and the date of death (for survival analysis).

These additional data for evaluation might be collected using a sampling plan.

The evaluation design will need to take into account:

That a comparison group would be required.

That the outcome effects of the intervention are likely to be delayed (e.g. delay in

disease progression, hospitalisation avoided, RCF admission delayed, death

delayed).

That the immediate effects may well be of a small magnitude in a study population

which has many potential covariates for which adjustment will be required.

That there is potential for variation in the level of intervention (i.e. the DAA service

provided).

That any sampling may involve a stratified (one means of adjusting for certain

covariates) and/or clustered design (clustered on the pharmacy providing the DAA).

A comprehensive evaluation plan is needed that addresses data collection and planned

analysis to capitalise on the opportunities for prospective data collection offered by the

implementation of a program of subsidised DAA services for community patients.

10.5 CONCLUSIONS

The preliminary best practice models for the provision of DAA services to RCFs and

patients living in the community developed in this study address the key barriers to the

provision of safe, effective and efficient DAA services. An evaluation of these models

has found that, they are likely to be beneficial in achieving improvements in practice

and generally feasible. Implementation of some recommendations in the models would

require only small changes to existing systems but others would require substantial

change, and particularly in the case of continuity of care guidelines, time. The

evaluation of the models also identified aspects of the models and recommendations

that could be improved but also highlighted areas of disagreement among stakeholders

about what direction changes should take, for example, about standardisation versus

flexibility and individualisation. Agreement among stakeholders on such key principles


needs to be reached to provide direction for further revision of the preliminary best

practice models.

While individual practitioners have and could implement aspects of the best practice

models, further development of the best practice models, supporting tools, resources

(such as improved access to information about drug stability in DAAs) and procedures

with the consultation and participation of stakeholders is required before wide spread

implementation. Revision of the model will also be required with the advent of changes

to the health care system such as changes to the PBS and the introduction of e-health

initiatives.

In developing the best practice models, a review of the evidence supporting the stability

of medication in DAAs was undertaken. The stability information available to

pharmacists is extremely limited. A range of strategies to acquire more evidence on

which to make decisions about the likely stability of medications in DAAs have been

suggested.

The modelling of the provision of DAA services to community patients highlighted that

people receiving DAA services from community pharmacies are fundamentally sicker

and have greater care needs that patients using medications in original packs (OP).

Analysis of HIC (now Medicare Australia) service use showed that users of pharmacy-

provided DAAs had the same service use costs (pharmaceutical and medical benefit

scheme costs) despite having greater care needs and illness burden than OP users.

Follow-up of community patients from Phase 2 at one year supported these findings.

As expected for a group with higher care needs, there was a higher rate of death and

RCF admission at one year for DAA users, but OP users who had died at one year had

better function and health in Phase 2 compared to DAA users. This suggests an

additional benefit of DAA use that using a pharmacy-provided DAA maintains people

with higher care needs in the community. This may reflect better control of medication

management and service use associated with the enhanced relationships within the

health care team needed to provide a DAA service.

The characteristics of community patients receiving DAAs largely agrees with current

recommendations and literature. Characteristics of community patients found to predict

perceived benefit as indicated by a choice to continue DAA use included:


Age;

Response to the question “Do you ever forget to take your medications”;

Greater care needs as indicated by regular community health worker visits and

impaired instrumental activities of daily living (IADL) score.

The economic modelling indicated that community pharmacies appear to be providing

a much needed service to a fairly specific needs group largely at a cost to themselves.

In Phase 2, the use of DAAs in RCFs was shown to minimised overall costs. For

community patients outcomes such as better satisfaction and confidence in managing

medications and reduced carer burden were described in Phase 2, however, the cost

effectiveness for community patients was less favourable than for RCFs. Follow-up at

one year and analysis of HIC service use data suggests additional benefits but the

additional economic modelling undertaken in this phase did not alter the conclusions

regarding the cost effectiveness of DAA services for community patients derived in

Phase 2. With the negotiation of funding for a subsided DAA service for community


patients, there is an opportunity to better understand the cost-effectiveness of the

service by developing an evaluation plan in parallel with the implementation plan for

this service and collecting data prospectively as the new program is rolled out. The

preliminary best practice model for the provision of DAA services to community patients

should be used to inform the implementation plan for this new service.

10.6 RECOMMENDATIONS

The following recommendations relate to both services to community patients and to

RCFs. The recommendations are shown separately for convenience although a

number of recommendations are duplicated.

Recommendations for DAA service provision to community patients

1. Dose Administration Aids (DAAs) should be targeted to community patients with a

need for and likelihood of benefit from the service.

2. Criteria need to be defined to assess need and likelihood of benefit for community

patients. Modelling conducted in this and other studies should be used to inform the

criteria.

3. A structured patient assessment protocol for community patients should be

developed to determine need for a Dose Administration Aid. This assessment

should be repeated at intervals to monitor the effects of the service.







programs.








the patient care team including the doctor, the pharmacist and community nurses,

patients and carers, and government.





quality initiatives such as the APAC guidelines (continuity of care and community),

PSA guidelines, QCPP, Aged Care Assessments, Divisions of General Practice

Aged Care, Home and Community Care, Commonwealth Department of Health and

Ageing, Department of Veterans’ Affairs and state health programs.






12. The preliminary best practice model and findings of its evaluation should be used to

inform the development of the implementation plan for a subsidised DAA service for

community patients.

13. The Pharmacy Guild of Australia should convene a working party including

appropriate stakeholder representation (see 5.2.4.2) and participation to develop an

implementation plan for a community DAA service that embraces best practice,


14. An evaluation plan should be developed in parallel to an implementation plan to

prospectively collect data to inform future program evaluation. Patient assessment

can provide data for both eligibility checking and future evaluation.

15. The implementation working party should seek input from, and convene technical

advisory panels of experts to advise on (1) further development of the knowledge

base about drug stability in DAAs, (2) the evaluation of the health economics of the

subsidised community DAA service, and (3) refinement of eligibility criteria.

16. Any business rules developed for subsidised DAA service to community patients

should embrace the principles of best practice described in the preliminary best

practice model developed in this study or any subsequent revision.

17. It is recommended that an online system be used to register and assess eligibility

for subsidised DAA provision to increase efficiency and to capture data for later

evaluation.

18. The development of documents and protocols to support best practice in the

implementation of a subsidised DAA service should include trialling and use

document/web design expertise.

19. It is recommended that the government support the use of Dose Administration

Aids services in the community where patients meet the appropriate access criteria

and the service provided reflects best practice.

Recommendations for DAA service provision to RCFs

1. Appropriate Dose Administration Aids services should be encouraged in RCFs and

the role of the service in minimising overall medication management costs in RCFs

should be recognised for appropriate funding to the suppliers of the service.







programs.









the patient care team including the doctor, the pharmacist, RCF staff, patients and

carers, and government.

7. Systems whereby a legal order on a medication chart can act as a prescription as

part of a supply claim mechanism should be established to improve the safety,

effectiveness and efficiency of DAA provision to RCFs. This may require changes

to state and commonwealth regulations, and current Medicare payment claim

procedures. Any new system should address accountability, safety and regular

medication review.





quality initiatives such as the APAC guidelines (residential care and continuity of

care), Aged Care Standards, PSA guidelines, QCPP, Divisions of General Practice

Aged Care, Commonwealth Department of Health and Ageing, Department of

Veterans’ Affairs and state health programs.





11. The Pharmacy Guild should convene a working party including appropriate

stakeholder representation (see 5.2.4.2) and participation to develop an

implementation plan for an RCF DAA service that embraces best practice,


12. The requirement for the operation for a best practice DAA service should be

included into existing programs for RCF accreditation, recognising that best

practice is not solely the responsibility of the pharmacy providing the DAA services.


11.REFERENCES

Adkins RE, Mirza T, Bempong DK et al. Open-dish study to identify labile preparations (2). Pharmacopeial Forum 1999; 12 (5).

Allen LV, Popovich NG, Ansel HC. Ansel's pharmaceutical dosage forms and drug delivery systems. 8th ed. Philadelphia: Lippincott Williams & Wilkins; 2005. 1-738 p.

Al-Zein H, Riad LE, Abd-Elbary A. Effect of packaging and storage on the stability of carbamazepine tablets. Drug Development and Industrial Pharmacy 1999; 25 (2):223-7.

Aulton ME. Pharmaceutics: The science of dosage form design. 2nd ed. Edinburgh: Churchill Livingston; 2002. 1-679 p.

Australian Institute of Health and Welfare (AIHW). Residential aged care in Australia 2003-04. A statistical overview. Canberra: AIHW.; 2005. (Aged Care Statistics Series).

Australian Pharmaceutical Advisory Council. Guidelines for medication management in residential aged care facilities. 3rd ed: Commonwealth Department of Health and Ageing; 2002. 105 p.

Australian Pharmaceutical Advisory Council. Integrated best practice model for medication management in residential aged care facilities. 2nd ed: Commonwealth Department of Health and Aged Care; 2000.

Australian Pharmaceutical Advisory Council. National guidelines to achieve the continuum of quality use of medicines between hospital and community. Canberra: Australian Government Publishing Service; 1998.

Badawy SI, Gawronski AJ, Alvarez FJ. Application of sorption-desorption moisture transfer modelling to the study of chemical stability of a moisture sensitive drug product in different packaging configurations. Int J Pharm 2001; 223 (1-2):1-13.

Barat I, Andreasen F, Damsgaard EM. Drug therapy in the elderly: what doctors believe and patients actually do. Br J Clin Pharmacol 2001; 51 (6):615-22.

Barrera MJ, Ainlay SL. The structure of social support: a conceptual and empirical analysis. J Community Psychol 1983; 11:133-43.

Bayoumi AM. The measurement of contingent valuation for health economics. Pharmacoeconomics 2004; 22 (11):691-700.

Bazire S. An assessment of the "Dosett" compliance aid in psychiatric patients. Br J Pharm Pract 1984; 6 (Oct):316-18.

Bempong DK, Mirza T, Bradby S et al. Open-dish study to identify labile preparations (1). Pharmacopeial Forum 1999a; 12 (5).

Bempong DK, Mirza T, Grady LT et al. Accelerated screening studies to identify labile preparations (1). Pharmacopeial Forum 1999b; 12 (5).

Bempong DK, Mirza T, Grady LT et al. Accelerated screening studies to identify labile preparations (2). Pharmacopeial Forum 1999c; 12 (5).

Benrimoj S, Langford, J., Berry, G., Collins, D., Lauchlan, R., Stewart, K., Aristides, M., & Dobson, M. Economic impact of increased clinical intervention rates in community pharmacy. Pharmacoeconomics 2000; 18 (5):459-68.

Bernsten C, Bjorkman I, Caramona M et al. Improving the well-being of elderly patients via community pharmacy-based provision of pharmaceutical care: a multicentre study in seven European countries. Drugs Aging 18:63-77, 2001.

Blister-strip warning. Pharm J 1996; 256:85.

Bond WS, Hussar DA. Detection methods and strategies for improving medication compliance. Am J Hosp Pharm 1991; 48 (9):1978-88.

Bowling A. Research methods in health: investigating health and health services. Philadelphia, US: Open University Press; 1997.

Brown LH, Krumperman K, Fullagar CJ. Out-of-hospital medication storage temperatures: a review of the literature and directions for the future. Prehosp Emerg Care 2004; 8 (2):200-6.


Caplan RD, VanHarrison R, Wellons RV et al. Social support and patient adherence: experimental and survey findings. Anne Arbor, MI: Institute for Social Research.; 1980.

Chen Y, Li Y. A new model for predicting moisture uptake by packaged solid pharmaceuticals. Int J Pharm 2003; 255 (1-2):217-25.

Church C, Smith J. How stable are medicines moved from original packs into compliance aids? Pharm J 2006; 276 (21 January):75-81.

Classen DC, Pestotnik SL, Evans RS et al. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. Jama 1997; 277 (4):301-6.

Corlett AJ. Aids to compliance with medication. Brit Med J 1996; 313 (7062):926-9.

Cramer JA. Enhancing patient compliance in the elderly. Role of packaging aids and monitoring. Drugs Aging 1998; 12 (1):7-15.

Dartnell JG, Anderson RP, Chohan V et al. Hospitalisation for adverse events related to drug therapy: incidence, avoidability and costs. Med J Aust 1996; 164 (11):659-62.

Dean DA. Packaging, package evaluation, stability, and shelf-life. Drugs Pharmaceut Sci 2000; 107:483-513.

Dehejia RH, Wahba S. Propensity score matching methods for non-experimental causal studies.: National Bureau of Economic Research, Inc; 1998. (NBER Working Papers).

Department of Health and Ageing Aged and Community Care Division. Standards for Aged Care Facilities - Standard 2 Health and Personal Care. 2004 [http://www.health.gov.au/internet/wcms/publishing.nsf/Content/ageing-standard-facility-std2.htm cited 10/5/2006].

Devlin N, Hansen P, Herbison P. Variations in self-reported health status: results from a New Zealand survey. N Z Med J 2000; 113 (1123):517-20.

Drummond M, O'Brian B, Stoddart G et al. Methods for the economic evaluation of health care programmes. 2nd edition. ed. New York: Oxford University Press Inc; 1997.

Florence AT, Attwood D. Physicochemical principles of pharmacy. 3rd ed. Hampshire: Palgrave; 1998. 1-564 p.

George B, Silcock J. Economic evaluation of pharmacy services - fact or fiction? Pharm World Sci 1999; 21 (4):147-51.

Glass BD, Novák C, Brown ME. The thermal and photostability of solid pharmaceuticals. Journal of Thermal Analysis and Calorimetry 2004; 77 (3):1013-36.

Green CF, McCloskey S. UK Survey of the provision of multicompartment compliance aids and medicines reminder charts on discharge from hospital. Int J Pharm Prac 2005; 13 (1):85-9.

Haynes RB, McDonald H, Garg AX et al. Interventions for helping patients to follow prescriptions for medications (Cochrane Review). Cochrane Database Syst Rev 2002; (2):Cd000011.

Ientile C, Lewis G, Stokes J et al. Effectiveness and cost-effectiveness of dose administration aids (DAAs) Final Report. Brisbane: Quality Medication Care Pty Ltd in conjunction with the Therapeutics Research Unit, University of Queensland.; 2004. 450 p.

Jeffcoate J, Chappell C, Feindt S. Best practice of SME adoption of e-commerce. Benchmarking: An international journal. 2002; 9 (2):122-32.

Kommanaboyina B, Rhodes CT. Trends in Stability Testing, with Emphasis on Stability During Distribution and Storage. Drug Dev Ind Pharm 1999; 25 (7):857 - 68.

Kononenko I. Machine Learning for medical diagnosis: history, state of the art and perspective. Artif Intell Med 2001; 23:89-109.

Larkin C, Murray R. Assisting Aboriginal patients with medication management. Aust Prescr 2005; 28 (5):123-5.

Lavrac N. Selected techniques for data mining in medicine. Artif Intell Med 1999; 16:3-23.

Levy RL. Social support and compliance: a selective review and critique of treatment integrity and outcome measurement. Soc Sci Med 1983; 17:1329-38.


Liu Z. Expected length of stay in nursing homes and hostels over a lifetime in Australia. Canberra: Australian Institue of Health and Welfare Report No.: Welfare Division Working Paper No. 23.

Lorenc L, Branthwaite A. Are older adults less compliant with prescribed medication than younger adults? Br J Clin Psychol 1993; 32 (Pt 4):485-92.

MacLaughlin EJ, Raehl CL, Treadway AK et al. Assessing medication adherence in the elderly - Which tools to use in clinical practice? Drugs & Aging 2005; 22 (3):231-55.

McColl E, Jacoby A, Thomas L et al. Design and use of questionnaires: a review of best practice applicable to surveys of health service staff and patients. Health Technology Assessment 2001; 5 (31).

Medwick T, Bailey LC. A procedure for conducting open-dish studies. Pharmacopeial Forum 1998a; 24 (3):6315-16.

Medwick T, Okeke C, Grady LT. A scientific basis for beyond-use dating. Pharmacopeial Forum 1998b; 24 (1):5643-44.

Mitchell JL. CQI: changing systems to improve quality. American Pharmacy 1992; 32 (Sep):47-53.

Morrison A, Wertheimer AI. Compilation of quantitative overviews of studies of adherence. Drug Information J 2004; 38 (2):197-210.

Naranjo CA, Busto U, Sellers EM et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30 (2):239-45.

Naughton MJ, Wiklund I. A critical review of dimension-specific measures of health-related quality of life in cross-cultural research. Qual Life Res 1993; 2 (6):397-432.

Overman ES, Boyd KJ. Best practice research and postbureaucratic reform. J PART 1994; 4:67-83.

Peterson G, Naughton M, Fitzmaurice K. The drugs could be OK, but do not forget problems with dosage forms. Aust Pharm 2003; 22 (3):212-15.

Pharmaceutical Society of Australia. Australian Pharmaceutical Formulary and Handbook. 19th ed. Canberra: Pharmaceutical Society of Australia; 2004. 1-509 p.

Pharmaceutical Society of Australia. Dose Administration Aids Guidelines. Canberra: Pharmaceutical Society of Australia, July 1999.

Pharmaceutical Society of Australia. Professional Practice Standards [version 2]. Canberra: Pharmaceutical Society of Australia; 2002. 136 p.

Pharmaceutical Society of Australia. Professional Practice Standards [version 3]. Canberra: Pharmaceutical Society of Australia; 2006. 147 p.

Pharmacists develop compliance aid for the elderly. Pharm J 1988; 241 (Oct 8):474.

Pillans PI, Roberts MS. Overprescribing: have we made any progress? Aust N Z J Med 1999; 29 (4):485-6.

Reamer JT, Grady LT. Moisture permeation of newer unit dose repackaging materials. Am J Hosp Pharm 1978; 35 (Jul):787-93.

Report of the moisture permeability testing of monitored dosage systems. Pharm J 1994; 252:18-9.

Richards G, Rayward-Smith VJ, Sonksen PH et al. Data Mining for indicators of early mortality in a database of clinical records. Artif Intell Med 2001; 22:215-31.

Rivers PH. Compliance aids-do they work? Drugs Aging 1992; 2 (2):103-11.

Ryan M. A comparison of stated preference methods for estimating monetary values. Health Economics 2004; 13:291-6.

Saville DJ. Influence of storage on in-vitro release of ibuprofen from sugar coated tablets. Int J Pharm 2001; 224 (1-2):39-49.

School of Pharmacy and Medical Sciences at University of South Australia, Australian Association of Consultant Pharmacy. Dose Administration Aids. Adelaide: School of Pharmacy and Medical Sciences at University of South Australia, 31 October 1997.


Schumock G, Butler, m., Meek, P., Vermeulen, L., Arondekar, M., & Bauman, J. Evidence of the economic benefits of clinical pharmacy services: 1996-2000. Pharmacotherapy 2003; 23 (1):113-32.

Shiell AG, L. If the price is right: vagueness and values clarification in contingent valuation. Health Economics 2003; 12:909-19.

Simmons D, Upjohn M, Gamble GD. Can medication packaging improve glycaemic control and blood pressure in Type 2 diabetes? Diabetes Care 2000; 23:153-56.

Smith B, O'Malley S, Lawson J. The costs and experiences of caring for sick and disabled geriatric patients-Australian observations. Aust J Public Health 1993; 17 (2):131-4.

Sorensen L, Stokes, J., Purdie, D., Woodward, M., Elliott, R., & Roberts, M. Medication reviews in the community: results of a randomized, controlled effectiveness trial. British Journal of Clinical Pharmacology 2004; 58 (6):648-64.

Sprey LS. Monitored dosage systems. Pharm J 1995; 254:767-70.

Sturgess I, McElnay, J., Hughes, C., & Crealey, G. Community pharmacy based provision of pharmaceutical care to older patients. Pharm World Sci 2003; 25 (5):218-26.

Svarstad B, Chewning B, Sleath B et al. The brief medication questionnaire: A tool for screening patient adherence and barriers to adherence. Patient Educ Couns 1999; 37:113-24.

Therapeutic Goods Administration. Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002). Canberra: Therapeutic Goods Administration.; 2002.

Therapeutic Goods Administration. Australian Regulatory Guidelines for Prescription Medicines. Australian Government Department of Health and Ageing, June [http://www.tga.gov.au/pmeds/argpm.htm].

Tønnesen HH. Formulation and stability testing of photolabile drugs. Int J Pharm 2001; 225 (1-2):1-14.

United States Pharmacopeial Convention. USP 28 - NF 23 supplement 2. Supplement to 28th rev. of the U.S. Pharmacopeia & 23rd ed. of The National Formulary. Rockville, Maryland: United States Pharmacopeial Convention, 2005; 2005.

USP <661>. US Pharmacopeia. National Formulary (USP-28/NF-23). <661> Containers. Rockville, MD: United States Pharmacopeial Convention; 2005.

USP <671>. US Pharmacopeia. National Formulary (USP-28/NF-23). <671> Containers - Permeation. Rockville, MD: United States Pharmacopeial Convention; 2005.

USP <1146>. US Pharmacopeia. National Formulary (USP-28/NF-23). <1146> Packaging Practice - Repackaging a single solid oral drug product into a unit-dose container. Rockville, MD: United States Pharmacopeial Convention; 2005.

USP <1150>. US Pharmacopeia. National Formulary (USP-28/NF-23). <1150> Pharmaceutical Stability. Rockville, MD: United States Pharmacopeial Convention; 2005.

USP <1178>. US Pharmacopeia. National Formulary (USP-28/NF-23) Second Supplement. <1178> Good Repackaging Practices. Rockville, MD: United States Pharmacopeial Convention; 2005.

USP <1191>. US Pharmacopeia. National Formulary (USP-28/NF-23). <1191> Stability considerations in dispensing practice. Rockville, MD: United States Pharmacopeial Convention; 2005.

van Eijken M, Tsang S, Wensing M et al. Interventions to improve medication compliance in older patients living in the community. A systematic review of the literature. Drugs Aging 2003; 20 (3):229-40.

Walker R. Stability of medicinal products in compliance devices. Pharm J 1992; 25:124-6.

White TJ, Arakelian, A., & Rho, J. Counting the costs of drug-related adverse events. Pharmacoeconomics 1999; 15 (5):445-58.

Whynes DK, Wolstenholme, J.L. & Frew, E. Evidence of range bias in contingent valuation payment scales. Health Economics 2004; 13:183-90.

Zinn C. Australian Government subsidises long term care by up to 22,000 pounds a year. Br Med J 2002; 324:1543.


APPENDIX A: ETHICAL APPROVALS

PAH Ethical Approval

University of Queensland Ethical Approval


APPENDIX B: DAA EXPERT PANEL MEETING

Consultation and Feedback Meeting Agenda

Consultation and Feedback Meeting materials

Consultation and Feedback Meeting Minutes

CONSULTATION & FEEDBACK ON THE DEVELOPMENT OF

BEST PRACTICE FOR DAAS

Meeting to be held on 4th March, 2005, 11.30am – 12.45pm

VENUE: Meeting Room 4, First Floor

Gold Coast Convention and Exhibition Centre (Map attached)

Lunch will be provided

Proposed Agenda

11.30 am Welcome, Introductions & Objectives

11.40 am Results of Phase 1 & 2 Rationale for Phase 3

11.50 am Preliminary Drafts of

Best practice in a Community setting

Best practice in an RCF setting

12.10 pm Our research plan

12.15 pm Feedback & Discussion

12.40 pm Meeting close


Meeting Materials - Consultation & Feedback on the development of Best

Practice for DAA

The results of Phases 1 and 2 indicate that DAAs are effective in helping community patients

and RCFs to manage medications, and that the stakeholders value DAAs, as evidenced by their

high levels of satisfaction. While the economic evaluations indicated that DAAs were a more

cost efficient system for medication provision for RCFs compared with original packs, the use of

DAAs in the community setting was cost-ineffective. However, there were a number of

opportunities for further research identified with respect to the economic evaluation

methodology and in the development of best practice guidelines to maximise the efficiency and

effectiveness of DAA provision.

We see this Phase as an important opportunity to develop:

(3) Best practice guidelines and tools to facilitate improvements in the way DAAs are used

in the RCF and community settings.

(4) A more sophisticated methodology to re-examine the cost-effectiveness of DAAs in the

community setting by measuring and valuing the benefits to the health care system utilising

additional data on health service use.

Best Practice for DAA provision

Aims and objectives

In Phase 3, we propose to develop best practice guidelines for DAA use in the community and

RCF settings by expanding on the recommendations in Phase 2, and identifying quality

improvement methods in consultation with key stakeholders.

Rationale

Presently, while there are a range of guidelines and standards that relate to DAA use, there are

no specific best practice guidelines for DAA provision. Best practice is defined as a technique or

methodology that, through experience and research, has been proven to reliably lead to a

desired result. The development of best practice guidelines, through a synthesis of Phase 1

and 2 findings and the experience of key stakeholders, will provide strategies and tools to

maximise the efficiency of DAA provision and the probability of positive patient outcomes. The

results of Phase 1 and 2 indicate that there are a number of issues in current practice that could

be improved upon. The quality of DAA services currently provided by pharmacies is

inconsistent and does not conform to all Pharmaceutical Society of Australia (PSA) guidelines

and PSA/Quality Care Pharmacy (QCP) standards. In addition, there were a number of

problems identified in the literature and through data collection that are not adequately

addressed by existing guidelines.

The underlying issues with DAA provision and use are essentially the same across the two

settings (community and RCF) but there are differences related to who the key stakeholders are

and what the priorities are. Issues common for both settings include:

DAA users are not adequately informed about what is involved or trained in how to

maximise the benefits of DAA use.

The frequency and quality of communication between stakeholders (pharmacy, patients,

RCF staff and GPs) regarding medication changes and errors is inadequate.

DAA packing sessions did not optimally utilise the skills and experience of pharmacists.

The processes involved in packing and checking were not clearly identified in the pharmacy.

During packing sessions, pharmacists and pharmacy staff had limited resources to which to

refer regarding the effect of DAAs on the stability of medications.

Community pharmacy bears the burden of medication management and professional

responsibility without adequate remuneration.

Specific issues with respect to DAA use in RCFs include:


The observed rate of errors in DAAs.

The accuracy of medication administration and the professional de-skilling of registered

nurses (RNs).

The lack of standard operating procedures for effective handling of medication

administration when DAAs are used in RCFs.

Specific issues for DAA use in the community are:

Community patient loss of ownership with respect to medication management, as

evidenced by the lower levels of medication knowledge and high levels of dependence on

the pharmacy.

DAAs are highly relied upon in the RCF and community settings, and are effective provided that

the limitations of supplying and using DAAs are addressed. The development of best practice

guidelines will resolve some of the effectiveness and practice issues surrounding DAA use in

the community and RCF settings.

Methods

In Phase 3 we propose to use a variety of qualitative and quantitative techniques to develop and

evaluate best practice guidelines for the RCF and community settings with respect to the areas

identified above. We intend to develop on the preliminary best practice guidelines identified in

the Phase 1 and 2 using the methodology presented in Figure 1. Best practice requires

collaboration between stakeholders, and the synthesis of research and experience. In the

development of guidelines, we will use the Consensus Development Panel technique, as

described by Bowling (Bowling 1997), populating a series of panels with key stakeholders from

our target populations.

The following stakeholders are the proposed participants:

Doctors that prescribe medications for DAA patients in RCFs and the community.

Pharmacists that supply DAAs to RCFs and community patients.

Nursing staff from RCFs using DAAs.

DAA manufacturers and suppliers.

Community nurses with patients who use DAAs.

Community patients and carers who use DAAs.

Therapeutic Goods Administration (TGA).

It is well recognised that the TGA has a pre-eminent role in the approval of manufacturer goods

and packing and have had a long track record of improving outcomes in terms of the quality use

of medicines mission of the Australian government. Discussions have been held with officers of

TGA (senior officer Dr John McEwen) and enthusiastic support has been offered for further

consultations, should the tender be successful.

To assess the feasibility of implementing the best practice guidelines devised by the expert

panel, we propose to develop survey tools designed to evaluate the anticipated impact of these

guidelines on the following areas:

Impact of adhering to best practice guidelines with respect to changes in current practice.

Changes in workloads and associated costs.

Perceived outcomes with respect to changes in the quality of DAA service provision.

Surveys will be circulated among samples of doctors, pharmacists, RCF staff, community

nurses, community patients and carers.


RESEARCH EXPERIENCE+


Phases 1 & 2



Focus groups





stakeholders


practice



guidelines

Survey stakeholders


Appendix Figure 1 Proposed methodology for the development of best practice.

Economic evaluation of the benefits of DAAs use in the community

Aims and objectives

In Phase 3, we propose to re-examine the cost-effectiveness of DAAs in the community setting

by measuring and valuing the benefits to the health care system utilising additional data on

health service use.

Rationale

The results of Phase 1 and 2 indicate that DAAs are effective in helping community patients to

manage medications and that community patients value DAAs, as evidenced by their high

levels of satisfaction and willingness to pay for the service. Despite these findings, the economic

evaluations indicated that DAAs are not cost-effective in the community setting as the costs of

DAA provision exceeded the benefits of DAAs. This is largely because the provision of DAAs

by pharmacy is a labour-intensive and costly exercise. Sensitivity analysis, however, suggests

that variations in the magnitude of the benefits and/or the efficiency of the service provision may

provide an alternative view on cost-effectiveness.

In Phase 2, the measurement of costs of DAA provision was based on a detailed content

analysis of work flow observations from 83 pharmacies providing DAAs, and interviews with 353

community patient to ascertain the probability and quantity of the DAA related services provided

by the pharmacy. Due to time and resource limitations, it was not possible to collect the same

level of data to measure and evaluate the benefits of DAAs with respect to healthcare savings.

Instead, the benefits of DAAs with respect to healthcare resource savings were identified and

measured using literature values imputed into a decision analytic model, rather than actual

service use. The literature values indicated the probability of service use and the cost of service

use resulting from adverse drug reaction (ADR) when DAAs or OPs were used by community

patients. The rate of adverse drug reactions was based on the community patients’ reports.


While this technique was valuable for exploring the potential savings to the healthcare system

from using DAAs, further research is required to establish the true magnitude of these savings.

The technique utilised in Phase 2 may underestimate the magnitude of the savings to the

healthcare system in the following ways:

(1) the literature does not include probabilities or values for the full range of services used (i.e.

does not include the purchase of additional medications, specialists appointments etc).

(2) DAAs may actually have a wider impact than just reducing rates of ADRs (i.e. may reduce

service costs by preventing unnecessary alterations to therapy due to non-compliance).

(3) Benefits of DAAs may not be observed in a one year timeframe.

A great deal of uncertainty remains regarding the effect of DAA use on the costs of medicines

and the cost of health service resource use. The cost of medications was not included in the

economic evaluation in Phase 2 due to uncertainty regarding the impact of DAAs on medication

use. It was found that DAA patients reported being less likely to run out of medications and less

likely to forget to take their medications, than non-DAA patients. In effect, this means that over

the course of a year a DAA patient may require more prescriptions filled and cost more to the

government through PBS. On the other hand, the evidence suggests that DAA patients are

likely to visit their GP less often than non-DAA patients (possibly due to the pharmacy

requesting repeat prescriptions on the patients behalf instead of the patient visiting the doctor).

This would result in DAA patients placing less of a burden on the healthcare system. From an

economics viewpoint, it is beneficial to take a stochastic9 approach to assess the overall effects

of DAA on health service resource use.

The inclusion of the full range of health service use over a longer timeframe may alter the cost-

benefit ratio such that the use of DAAs in the community proves to be cost-effective. We

propose to re-evaluate the cost-effectiveness of DAAs in the community through the collection

of retrospective service use data from the community patients that participated in Phase 2.

Methods

Data will be collected through interviews with community patients and by requesting four years

of health service expenditure for those patients. The Health Insurance Commission (HIC) is a

potential source of additional data on health services use (subsidised under the Medical

Benefits Scheme (MBS)) and medications dispensed (subsidised under the Pharmaceutical

Benefits Scheme (PBS)) for the sample of community patients recruited for Phase 2. As a

condition of participation in Phase 2, community patients consented to the release of their

records: of services provided between 1 January 2000 and 30 June 2004. We intend to request

these records from HIC and match treatment data with DAA use status and demographics. This

data will be aggregated to produce total costs of service use and compared for community

patients using DAAs and original packs after adjusting for potential covariates of health service

use (i.e. number of medicines used, age and health status).

Additional service use including community nursing, respite and long term care will be collected

through telephone interviews with the sample community patients and/or carers that participated

in Phase 2. This is also an opportunity to follow-up participants and to collect patient –specific

data on costs and outcomes for economic analysis.

Figure 2 shows how the HIC health service data and the patient-specific outcome data will be

combined to allow for comparison between community patients using DAAs and community

patients not using DAAs. The collection of this data allows for stochastic analysis where both

the costs and effects are determined from data sampled from the same patients. In addition,

9 Stochastic data: where both costs and effects are determined from data sampled from the

same patients in a study.


formal statistical testing can be performed on any observed differences in costs and risk

adjustment strategies such as cohort selection can be utilised to control for covariates of

healthcare costs.

Cost-benefits analysis will be conducted from a societal perspective to evaluate the full range of

costs associated with DAA use. Cohorts of community patients who benefit most from DAA (in

terms of savings in healthcare costs) may be identified and sensitivity analysis and threshold

analysis will be conducted to assess the precision around the costs and effects of DAA use.

No DAA

Respite care

Respite care

RCF admittance

RCF admittance

GP services

GP services (MBS)

Pathology (MBS)

RPBS drug costs

Pathology (MBS)

PBS drug costs

Death

%

%

Total cost

%

%

%

%

%

%

%

%

%

% Community Nursing

% Hospitalisation

Total cost

% Death Number

% Hospitalisation

Community Nursing%

DAA

Matched sample of community

patients

Number

Appendix Figure 2 Evaluation plan for the comparison of community patients using

DAAs or original packs on a combination of health service resource

use collected through HIC and through interview with community

patients.

PRELIMINARY BEST PRACTICE

Best practice in the community setting

Current tasks and activities performed in the provision of a DAA service to community patients

are shown in the following table. The initial set-up of a DAA service requires the involvement of

all stakeholders. In contrast, once the DAA service is established, the majority of tasks can be

conducted by the pharmacist with minimal input from these sources. However, if pharmacies

are no longer having regular contact with GPs and community nurses, this could potentially be

detrimental to the quality of the DAA service and the patients’ therapeutic outcomes.


Appendix Table 1 Tasks and activities involved in the provision of DAAs in the

community

Who is involved? Tasks and activities When Pharm Dr Pt Carer

Initial Set-up for new community patients

Identify potential DAA users Any time Is the patient willing to use a DAA? Any time Explain what is involved for the patient? Prior to

starting DAA Arrange for the patients’ medicines and prescriptions to be stored at the pharmacy.

Day 1 of DAA service

Determine which medicines should be packed and how they should be packed (develop medication profile).

Day 1

Pack the DAA (generally 1 week supply of medicines)

Day 1

Attach labels to the DAA with the patients, pharmacy name, days of the week, dose time and list of packed and unpacked medicines.

Day 1

Check that the pack is correct Day 1 Arrange to deliver the pack to the patient or have the pack collected

Day 1

Advise the patient to inform the pharmacy of any medication changes

Day 1

Administer medicines from DAA following the Day & Time prompts

Day 1 - Day 7

Managing continuity of supply

If no changes to medication regimen, pack another weeks supply as per previous week

Day 6

If medication regimen changes, change medication profile to reflect this.

As it happens

Where original pack supply is insufficient to fill next weeks supply, dispense new supply as per normal.

Day 6

Where there is no repeat prescription avail-able to dispense required medicines, request a repeat prescription from the doctor or advise the patient to obtain the repeat prescription

Obtainrepeat prior to Day 6

Arrange to deliver the pack to the patient or have the pack collected before previous supply runs out

Day 6

Collect previous DAA when the new DAA is delivered or collected.

Day 6

DAA packing and individual prescriptions charged to the patients account

Day 6

Key: Pharm = Pharmacists, Dr = Doctor, Pt = Patient, Carer = Carer, patients’ family and/or community

nurses (if involved).

Many of these tasks are covered by existing standards or guidelines whoever, the previous

results regarding evidence of compliance with standards, indicate the need to develop best

practice guidelines for the implementation of DAA provision to new patients in the community

setting. A synthesis of the above findings was used to develop the following implementation

strategy with the goal of resolving some of the effectiveness and practice issues surrounding

DAAs. There are three key aspects to this model. First, a tripartisan agreement between the

pharmacy, patient/carer and GPs/specialists with the goal of formalising the obligations and

expectations of the parties. Second, the model requires the development of a template by the

pharmacist, in conjunction with other stakeholders, for the packing and checking of patients

DAAs. This template will reflect the patients’ optimal medication schedule and aim to maximise


therapeutic benefits and minimise risks. The template would be approved by all stakeholders

and subject to regular update and six-monthly review. Third, the patient or carer is given the

responsibility of ensuring the template reflects their current medication status. This strategy

encourages the patient to take ownership of their medication management and is a valuable

resource for enhancing patient medication knowledge. Where the patient is unable to perform

this role a carer or family member will act as a proxy. Copies of the templates will also be held

by the patient’s pharmacist and doctor(s). The Best Practice implementation model is

presented in Figure 3.

New patient to start DAA(need already assessed)


formalcheck?

Yes

No

Pa

tien

t-h

eld

te

mp

late

kep

t u

p-t

o-d

ate

by

pa

tien

t, c

are

r &

GP

Inclu

din

g m

edic

ations c

hanges n

ot needin

g p

rescription



DAA sent to patient











Pre

scriptions

dis

pensed


Template copy to GPNew patient to start DAA(need already assessed)


formalcheck?


formalcheck?

Yes

No

Pa

tien

t-h

eld

te

mp

late

kep

t u

p-t

o-d

ate

by

pa

tien

t, c

are

r &

GP

Inclu

din

g m

edic

ations c

hanges n

ot needin

g p

rescription



DAA sent to patient











Pre

scriptions

dis

pensed


Template copy to GP

Break out box

Issues to address in agreement Obligations of parties - examples In simple language





obligations


negotiated



stored















practice


if any cost





Appendix Figure 3 Best Practice model for the operation of a DAA service for

community patients


The benefit of this Best Practice model is that it addresses the problems reported by

stakeholders with existing processes for DAA provision. This model proposes the following

solutions to problems reported with existing processes:

1. The tripartisan agreement addresses the issue of poor provision of information and training

to DAA stakeholders. The advantage of this formal agreement is that it ensures the

patient, GP and pharmacist are all aware of their obligations as part of the DAA provision

process (see breakout box, Appendix Figure 3). These obligations may include the

provision of information to new patients and ensuring that patients receive adequate

training in the use of their DAA.

2. The patient medication template addresses a variety of issues, these include: the accuracy

and adequacy of patients’ current medication profiles; the suitability of patients’

medications for packing in DAAs; and the roles of all parties in the DAA provision process.

With respect to the accuracy and adequacy of patients’ current medication profiles, the

template ensures that the pharmacist has a current and complete list of medications from

which to pack and check the patient’s DAA, including the suitability of each medication for

packing in the DAA. The template acts to alleviate confusion with regards to patients’

dosing times and directions. It also provides a central record for all communication

regarding patients’ current medication status and any medication changes. The process

by which doctors approve the medication template ensures that the patients’ current

regimen is reviewed with the aim of optimising therapeutic benefits and minimising

medication risks.

3. The strategy of having patient held medication templates has a twofold effect. First, this

strategy encourages the patient to take ownership of their medication management by

increasing their responsibility in that process and improving their knowledge of

medications. Second, this ensures that any medication changes, especially those not

requiring a prescription (i.e. ceased medications or changes to medication dosages), are

communicated in a timely and accurate manner, to the pharmacist.

This model is based on the current situation whereby no subsidies are available for the

provision of DAAs. Were funding to become available in the future for DAA provision, the

patient template and/or tripartisan agreement could be incorporated as part of the system of

check and balances that would be necessary to ensure accountability with respect to the quality

and quantity of DAA services offered. An additional benefit is that these documents could also

be used to form part of a program evaluation of any future DAA implementation.

Best practice in the RCF setting

The provision of DAA services to RCF residents requires the collaboration of the following

stakeholders: the RCF staff, the community pharmacy, the residents’ doctors (GP and

specialists), the resident and their family or carer. The minimum set of activities that are

required for DAAs to be provided by pharmacists to RCF residents are shown in the following

table. While the pharmacist is involved in all these tasks, the RCF staff have a fairly limited

involvement and the resident and their families are often overlooked by the current processes.

In the RCF setting, the use of DAAs relies on the collaboration of RCFs and pharmacies.

However, both parties are governed by different and sometimes conflicting regulatory and

business limitations. Best practice guidelines should again maximise effectiveness and

efficiency while addressing the regulatory and business issues. A best practice model should

address the following issues:

The need to redefine professional responsibilities for pharmacy and RCF staff with the goal

of ensuring that the use of DAAs results in a minimisation of packing and medication

administration errors.

The need to implement strategies to ensure that RCF staff maintain and develop their

knowledge of medications when using DAAs; and


The need to develop standard operating procedures for situations that arise when DAAs are

used instead of original packs (i.e. when a tablet is lost and no additional supply is

available).

Appendix Table 2 Tasks and activities involved in the provision of DAAs in the RCF

setting

Who is involved? Tasks and activities When Pharm. Dr RCF Res &

Family

Initial Set-up for a new resident

Arrange for the residents’ medicines and prescriptions to be stored at the pharmacy.

Day 1 of DAA service

Determine which medicines should be packed and how they should be packed based on the residents medication chart (develop a medication profile).

Day 1

Who is involved? Tasks and activities When Pharm. Dr RCF Res &

Family

Initial Set-up for a new resident

Pack the DAA (generally one week supply of medicines)

Day 1

Attach labels to the DAA as per RCF standards.

Day 1

Check that the pack is correct Day 1 Deliver the pack to the RCF Day 1

Administer medicines from DAA following the day and time prompts

Day 1 - Day 7

Managing continuity of supply

If no changes to medication regimen, pack another weeks supply as per previous week

Day 6

If medication regimen changes, RCF faxes changes to the pharmacy. Pharmacy changes the medication profile and packs to reflect these changes.

As it happens

Where original pack supply is insufficient to fill next weeks supply, dispense new supply as per normal.

Day 6

Where there is no repeat prescription available to dispense required medicines, request a repeat prescription from the doctor or advise the RCF to obtain the repeat prescription from the doctor

Obtain repeat prior to Day 6

Deliver the pack to the RCF before previous supply runs out

Day 6

Collect previous DAA when the new DAA is delivered.

Day 6

DAA packing and individual prescriptions charged to the residents account (DAA may also be charged to facility)

Day 6

Key: Pharm = Pharmacists, Dr = Doctor, RCF = Residential care facility staff, Res. & family =

Resident and their family.

The standard operating procedures should be based on a best practice model that should

address the following issues:

The need to redefine professional responsibilities for pharmacy and RCF staff with the goal

of ensuring that the use of DAAs results in a minimisation of packing and medication

administration errors.

Ensuring that RCF staff receive adequate training in the use of DAAs.


Ensuring that the frequency and quality of communication between pharmacies, patients,

RCFs and GPs regarding medication changes is adequate.

The packing of PRN (as needed) medication for RCF residents.

The need to implement strategies to ensure that RCF staff maintain and develop their

knowledge of medications when using DAAs; and

The need to develop standard operating procedures for situations that arise when DAAs are

used instead of original packs (i.e. when a tablet is lost and no additional supply is

available).

The need to ensure that DAA provision by pharmacy is efficient by developing and

promoting strategies to improve efficiency. These strategies may include:

Reminder notices sent to GPs about owing prescriptions,

Set ordering times/procedures,

Routine delivery procedures, and

Optimal utilisation of the skills and experiences of pharmacists and the appropriate

utilisation of less qualified staff in the DAA packing process.

The following figure contains some preliminary ideas on the best practice model by considering

the flow of information. To increase efficiency, these steps need to be optimised. For

effectiveness, timely and correct medication supply also depend on information flows and the

provision of training and support.

Medication Information flows in RCF

GP


New resident

RCF

*assumes main supplying pharmacy but resident has choice to choose separate one


Order toadminister drug

Medication chart


supply system,

obligations &

expectations

Order to supply

Medication chart

Authorising

payment for

supply

PBSprescription

Reminder on

continuity of

supply

RCFmedicatio

n system

including DAAre

fillschedule





expectations


[Draft] Minutes of meeting at APP 4 March 2005, 11.30am

Consultation & Feedback on the development of Best Practice for DAAs

Present: Gary Lambrides and Simon James (APHS), Klaus Pertulis (Persocare), Gerard

Stevens and Paul Hannan (Webstercare), John Proper (MPS), Karalyn Huxhagen (Community

Pharmacist & PSA representative), Andrew Petrie (Qld Health), Debbie Rigby (MMR facilitator &

pharmacist), Mark Hickey (Community pharmacist and Reference Panel member, Phase 2), Bill

Kelly (AACP), Gilbert Yeates (Guild Qld Branch Committee representative, community

pharmacist), Kay Davison (Community Pharmacist, Phase 2 participant), Ric Lord (community

pharmacist, DAA researcher), Julie Stokes and Clare Ientile (Research Team)

Apologies: Chris Clarke (MPS), Emma Jordon (Mayo Healthcare – Nomad), Danielle

Stowasser (Qld Health), Lisa Nissen (SHPA), Robert Peck (Pharmacist), Glenn Houghton &

Sean Warren (Pyxis), Michael Watson and Brian King (Community Pharmacists, Phase 2

participants), Rollo Manning (Pharmacist, DAA researcher)

Others invitated but not attending: Dianne Grant (Douglas), Lance Emerson (Guild

Secretariat), Kos Sclavos (Guild, Qld Branch)

Meeting commenced 11.45am. The following minutes incorporate the presentation images and summarise the comments from the panel.

Effectiveness & Cost Effectiveness of DAAs

in RCF & Community settings – Phase 3

Consultation & Feedback on the development of

best practice for DAAs

Agenda

Welcome, Introductions & Objectives

Phase 1 & 2 results to inform Phase 3

Preliminary models

Research Plan

Feedback & Discussion

The Panel members were welcomed and introduced to each other. The plan for the meeting was outlined.

This meeting is aimed at seeking the panel’s comments and feedback that will be used to achieve a best practice model.

What is Phase 3 about?

Improving the effectiveness & efficiency of provision of DAAs by pharmacy to RCFs & community patients through best practice

Best practice: a technique/methodology that, through experience & research, has been proven to reliably lead to a desired result

synthesis of Phase 1 and 2 findings

experience of key stakeholders

strategies & tools to maximise DAA provision efficiency & probability of +ve patient outcomes

Phase 3 is about finding a way to improve efficiency and effectiveness of DAA service provision through a best practice approach (see definition). In phases 1 (a literature review) and 2 (study capturing data on effectiveness and cost effectiveness of current services), a number of issues were identified that affected both sides of the cost-effectiveness equation. A best practice model could be developed that is feasible to use in practice, and that gives strategies and tools that can be used to maximise outcomes and minimise cost.

The approach in Phase 3 builds on research such as the findings from the literature review, observations of packing and checking, observations at RCFs, interviews/questionnaires completed with RCF staff, pharmacy staff, patients at home, GPs and community nurses. There have been a number of limitations mentioned. Gerard Stevens identified many of these in his presentation at the AACP workshop on 3 March. Best practice is about finding solutions to these limitations. The model needs to have enough definition so that there is not too much uncertainty in rolling out the model.


Phase 3 approachRESEARCH EXPERIENCE+


Phases 1 & 2



Focus groups





stakeholders


practice



guidelines

Survey stakeholders


See later

A preliminary best practice model has been developed for community patients. A very early model has been developed for RCFs focusing on the information flows as poor communication was identified as a cause of many problems with systems. The RCF systems are more complicated than community patient systems. An iterative process will be used as well as the development of potential tools e.g. communicat -ion log, tools to monitor packing time or quality. Then drafts will be circulated more widely to the various states as legislation and practices vary from state to state. Plan is to survey peak bodies, RCFs and pharmacies more widely

Any best practice model needs to keep costs down and not be a huge paperwork burden; it needs to be usable, user-friendly, and not cost more to implement. People will want to implement the model because it will have an immediate positive effect. It was noted that there was much variation in what people (pharmacies & RCFs etc) did. The aim of this best practice model would not be to prescribe what had to be done but to give a range of strategies that do reliably lead to the best outcome. Phase 2 showed that in some areas, people (pharmacists) did have enough things to refer to and in others, there were too many. The model has to be flexible enough to account for some variation, such as the variation needed for the different device types.

Evidence to date is that people did not follow guidelines and the team needed to look at conduits to help people use guidelines. It was suggested that collaboration with the PSA team working on new DAA guidelines was desirable. PSA guidelines would then feed into QCPP guidelines as a way of increasing awareness and a roll-out methodology. The researchers felt that if the best practice model was successful in leading to a better, more reliable outcome that pharmacies should be interested in adopting core parts of the model. However, engendering people (pharmacists) to reflect on their practice was most challenging. People must see benefit for their business if they are to adopt the models. The phase 2 data on just what it costs to provide a DAA service may be a motivator for implementation.

The panel felt that the model needs to be in the format of an implementation model and not a guideline. People don’t read guidelines when they are setting up a service but would use an implementation template model (cookbook approach). This should be the goal of the model and from a QCPP viewpoint, it needs to be about implementation.

A question was asked how the proposed guideline would fit into existing guidelines already out there. Guidelines are usually under the auspices of organisations such as APAC. There was no mission or charter for the work but the proposal was in response to a need and there was an obvious opportunity. The model would be expected to be built into community pharmacy procedures like QCPP as the goal of the model was the same as QCPP i.e. to improve the quality of service provision in both the efficiency and effectiveness of the DAA service provided. There was coverage in the various APAC guidelines to give a “head of power” to be developing local professional guidelines that fit with APAC guidelines yet develop concepts further, spelling them out in more detail. There have been guidelines before but “Best Practice” is new. Pharmacists would accept guidelines, guidance/mentoring but “best practice” was another level again. The problem with the existing guidelines is that there are a plethora of them, they are not read and if so, people find it difficult to work out which one to comply with or what they need to do. There needs to be more specific details for implementation; a road map with tools and resources to aid implementation and operation. PSA are currently reviewing DAA guidelines and it has been difficult to find evidence for each recommendation. Phases 1 and 2 (and other DAA studies) could provide some evidence and this phase 3 could marry with the PSA standards which could then be a reference point for pharmacies through QCPP and reference to several APAC guidelines. There is a need for more research/evidence for example about the stability of drugs in the packs. Where did the 6 week statement come from? The issue of stability information is part of Phase 3 best practice. [Non-minute note: Karalyn has provided a contact with the PSA team].


It is envisaged that Phase 3 will produce a best practice model with a systems focus rather than guidelines.

The panel went on to discuss whether the goal was “best” or “better” practice since best practice implies the ultimate model but best practice changes over time. It was decided that “best practice” should be retained as it encapsulated the approach as defines in Slide 2.

Objectives of today’s session –

our perspective

You are our DAA ‘experts’

Range of backgrounds & perspectives

Gain a shared understanding of findings & issues to date

What we are asking of you:

Support for project by contributing ideas, information & contacts

Feedback on model development

Aid getting support of other people we should talk to

The objectives of the meeting were outlined. The researchers sought input on others who should be contacted. A pharmacist DAA expert in Western Australia was identified for consultation.

The findings on cost-effectiveness were described together with planned refinements in the community model to be part of Phase 3.

Phase 2 Cost effectiveness in community

Cost-benefit ratio components & results based on 30 community customers using pharmacy supplied DAAs

Cost to pharmacy

Providing DAAs to 30

community patients/ year

=Cost DAA-Cost OP

=-$27,487

-

Cost-savings to Government

DAAs preventing 15% of ADRs

= Healthcare OP-Healthcare DAA

=$15,316

+Benefits to customers

Measured by willingness to pay (WTP)

=$5.25 x 30 x 52

=$8,190

= -$3,982

Phase 2 Cost effectiveness in RCFs

Cost-minimisation results: overall savings for DAAs and a shift in costs between the pharmacy and RCF

RCF Costs

$236,724

Pharmacy Costs

$175,704

43% of total cost

RCF Costs

$388,609

Pharmacy Costs

$109,127

22% of total cost

Total $497,736 Total $412,428

Cost Shift

OPs DAAs

Among staff of RCFs, there was an attitude about paying pharmacies for DAAs that was at odds with the value placed on the service. There was a perception that pharmacists make enough income from the prescriptions. Preliminary modelling suggests that this is not the case and that many pharmacies provide the service at a loss. The panel felt that this information might be valuable in changing behaviour of pharmacies (with respect to charging) and the attitudes of RCF staff. More work and consultation is required on the break-even point.

RCFs do depend on the pharmacy service and often abdicated medication management responsibility to the pharmacy. This seems to be a wide spread view even among assessorswho indicated (through preliminary discussions) that they did not feel the need for more guidelines and that provided the RCF “had a really good pharmacy looking after you” there was no problem meeting the medication management standards.

Assessors needed facilities to demonstrate that their system, whatever it is, is safe, and that current standards were general to allow facilities to choose their own system. Part of the best practice project is to raise awareness among RCFs.

The issues to be addressed in the best practice model (see following 4 slides) were discussed. DAAs are a service not just a device. Some community patients got DAAs for convenience but did not pay, blurring the cost-effectiveness of the service. Existing PSA guidelines refer to many things that are part of the service but there is a need for explicit implementation models e.g. helping pharmacies deal with issues such as deliveries, what to do when the pharmacy delivers or starting a new person (the initial set-up as an opportunity for review) and continuity of supply. There are risks to community DAA users of poor information –


25% never see the pharmacy and the risk that if the pharmacy does prescription management, the patient might not see their GP. The panel mentioned the link to home medicines review (HMR) where a recommendation to start a DAA was often an outcome. It will be important that the best practice model links to other programs like HMR (which might also make both programs more financially viable from a pharmacy viewpoint). Conducting an HMR prior to starting a DAA would also provide an opportunity for the patient to be assessed and trained on the appropriate use of the device and how the service would operate, so increasing the potential effectiveness of the service.

Patient assessment for DAAs should also include assessment by their GP or the community nurses. The initial draft community model does not cover assessment but starts once the patient is identified. Assessment could be included. A trial of teaching pharmacists to target patients for HMR and whether a DAA was required was described as a suggested input into the model.

Phase 2: Issues to be addressed

Targeting of DAA community recipients & service components

DAA users are not adequately informed about what is involved or trained in how to maximise the benefits of DAA use

CPs not trained & expectations not clear

Observed rate of errors in DAAs

Accuracy of medication administration

Lack of standard operating procedures for effective medication administration when DAAs used in RCFs

Issues from Phase 2

Deskilling

Loss of medication knowledge (CPs)

RCF staff deskilled & reliance on pack not chart

Pack issues wrt identifying medicines

Frequency & quality of communication between stakeholders (pharmacy, patients, RCF staff and GPs) about medication changes & errors is inadequate

Regulatory, business pressures not appreciated

Address relationship issues (GPs, RCF)

Phase 2 Issues

DAA packing sessions did not optimally utilise skills & experience of pharmacists

Processes involved in packing & checking were not clearly identified in pharmacy

Need systems for monitoring error trends

During packing sessions, pharmacists & staff had limited resources about medication stability in DAAs

Issues Phase 2

Community pharmacy bears burden of medication management & professional responsibility without adequate remuneration

Procedures to increase efficiency

• Handling changes, continuity of supply, ordering, delivery etc

The nature of errors and the error detection methodology of phase 2 was discussed (comparison of chart and pack). Errors were a mixture of pharmacy and nurse error in RCFs – most did not reach the patient. The error rate among community patients (either DAA or original pack users) was not measured as observers did not know what the

patient should have been taking, although qualitative information about poor pack use was available. The baseline error rate by community patients should be the comparator for errors associated with DAAs. A key performance indicator of 0% errors for DAA users was unrealistic.

The panel felt that it was important to recognise that in some cases, especially in hostels or independent living areas, that the DAA was correct and the chart was wrong. Strategies to minimise errors needed to be included in the model. These strategies are also needed for the administration point; there are no standard operating procedures (SOP) for staff, for example, who drop a dose – what do you do? Use tomorrow’s dose? Procedures are needed for what to do when things go wrong, so that effectiveness and efficiency can be maintained. One panel member mentioned recent NSW Pharmacy Board bulletin about checking DAAs including checking the label on the original pack dispensed. A list of things that should be checked is not explicit in standards.

The panel then went on to discuss system factors that were not the pharmacy’s responsibility but reflected on the pharmacy e.g. maintenance of current resident photos. One RCF organisation


expected the pharmacy to organise the Therapeutic Drug Committee meetings (required under APAC guidelines).

Many problems with the system were due to poor communication especially of expectations and obligations, e.g. the doctor’s responsibility, expectations of responsiveness to changes. Two draft models were presented and feedback and comment was invited from panel members (see following 3 slides). The models need to address establishing the nature of the service and agreeing on expectations and obligations up front. Strategies were required to maintaincurrency of the medication profile (especially where a change was not associated with a new prescription e.g. stopping a medication). Safety issues such as patient or carer deskilling with respect to medication knowledge need to be addressed. The panel felt that it was important to measure this knowledge at baseline, before commencing DAAs as a means of monitoring knowledge loss, as many people started DAAs just because they had poor medication knowledge.

The panel raised other issues to be addressed: Situations where 2 pharmacies are used each providing DAAs or where one pharmacy

provides a DAA and another fills the occasional prescription and so that item is not packed. Patients getting medicines from either hospitals (e.g. outpatients for specialist items) or

mental health clinics – not from the pharmacy packing DAAs. The pharmacy needs to maintain the profile but decisions on best practice of packing these non-pharmacy sourced medications are needed

What happens with non-packed medications (also an issue for RCFs)

Preliminary Community model draftNew patient to start DAA(need already assessed)


formalcheck?


formalcheck?

Yes

No

Patien

t-he

ld t

em

pla

te k

ept

up-t

o-d

ate

by

pa

tient,

ca

rer

& G

PIn

clu

din

g m

ed

ica

tions c

ha

nge

s n

ot

nee

din

g p

rescrip

tio

n



DAA sent to patient











Pre

scrip

tio

ns

dis

pen

se

d


Template copy to GP

Issues & obligations for community DAA use

Break out box

Issues to address in agreement Obligations of parties - examples

In simple language





obligations


negotiated



stored















practice


if any cost





Preliminary RCF model draft

Medication Information flows in RCF

GP


New resident

RCF

*assumes main supplying pharmacy but resident has


Order to

administer drug

Medication chart


supply system,

obligations &

expectations

Order to supply

Medication chart

Authorising

payment for

supply

PBS prescription

Reminder on

continuity of

supply

RCFmedicatio

n system

including DAAre

fillschedule





expectations

The RCF model was based on information flows and was less well developed because the system was more complex. Note that carers in some RCFs administering medications don’t have to be able to read the chart and that there is only so much a pharmacist can do in this situation.

More input on the RCF model was sought from the panel. It was suggested that it was hard to put all components in one model and that several models may be required.

The RCF model needs to be explicit in what is involved in service provision to address unrealistic expectations about responsiveness and the paperwork trail. The RCFs and GPs need to understand what it takes for the pharmacy to provide the service, what information is needed and how things can go wrong. One of the “best practice” tools could be a promotional brochure or similar to explain these aspects.


DAA Best practice consultation framework

RCF Personnel

Nursing Management

Staff

Other Aged Care Stakeholders

NIMAC (peak body)

Residents & Family

Assessors (ACS)

Community patients

Consumer representative organisations

DAA users

Carers/family

GPs perspective

GPs

AMAQ, RACGP (peak bodies)

GP Divisions

DAA Expert Panel

Manufacturers

Pharmacy practitioners

Pharmacy peak bodies (PGA, PSA, SHPA, AACP, QCPP)

Other Stakeholders

TGA (stability)

Health Depts (state, federal)

DVA

Pharmacy Personnel

Pharmacists

Dispensary Assistants

Pharmacy Assistants

Community nurses

Iterative development of models

The consultation plan was presented. The panel indicated two groups missing from the stakeholder consultation plan: Support people like the pharmacy IT

dispensing program companies, Healthconnect, other IT players e.g. Palm, Medical Director; and medication chart people (e.g. Compact Business Systems)

Hospital pharmacists working with DAAs

Initial development will be done on the model then wider consultation.

General methodology for consultation

Initial development

Local consultation – primary stakeholders

• Group techniques, structured interviews

• Explore issues, how things could be done better

• Examine feasibility, usability & potential impact of preliminary model

Second draft

Wider consultation of 1o stakeholders; consult 2o stakeholders

• Structured interview, national surveys

Consultation with peak bodies, consumers, carers and families, GPs and community nurses will test the acceptance of and interest in the models, what sort of problems might they see with the models and possible solutions. The next draft of models will be circulated more widely to each state as the legislation differs from state to state. Example questions might be: what would this model do to your costs, what is the impact on your practice.

The research team plan to feedback to the panel and use the panel as a sounding board.

Tools will be developed in parallel and input is welcome.

Meeting closed at 12.50pm


APPENDIX C: FOCUS GROUP AND INTERVIEW

MATERIALS AND REPORTS

RCF FOCUS GROUPS

RCF MANAGEMENT FOCUS GROUP MATERIALS

SESSION: AAPT Hosted telephone conference on the XXXXX 2005

TIME: XXXXX The session is expected to take 1 ½ hours and participants

will be remunerated $100 for their time on receipt of an invoice.

DISCUSSION QUESTIONS:

1. Have there been situations where the use of DAAs has resulted in inefficiencies or

unsafe practices? Please describe.

2. What practices or solutions have been implemented to overcome these problems?

3. We have attached a model of medication supply when using DAAs, please refer to

this model on Page 2. From your perspective what are the missing steps?

1. Medication order on chart



2a. Support activities• Prescription management*

• Accounts• Pack-chart audit†


4. Pack medication

4a. Pack medication


4b. Check medication

4c. Deliver to pharmacy

3a. Send profile +/-medications to external packer

6. Deliver medication

7. Medication receipt & storage

7a. Counsel self-medicating residents



† Could be done independent of pharmacy

Non-packed medications


Different procedures needed for:• New resident• Medication change• Respite (in & out)• Going to & returning from hospital

• Death• Other permanent separation• Other temporary absences

In RCF In PharmacyKEY: External packer

4. What can go wrong at each step that may affect the safety and efficiency of

medication supplied in DAAs? What are some possible solutions?

5. How much education and training is currently provided to facility staff with respect

to administering medication from DAAs and managing the continuity of supply of

medications? How much training should be provided?

6. Are there any issues or barriers to efficient DAA use related to existing standards

and legalities (i.e. Poisons Board, Nursing regulations, Aged Care standards)?


7. What impact would the following hypothetical changes have on your current

practices (in terms of quality of care, time, staffing, costs etc):

a. Doctors orders on a medication chart alone are sufficient for the pharmacy to

dispense medication (i.e. prescriptions not required)?

b. The initial supply of DAAs to new residents is integrated with the provision of an

Medication Management Review (MMR)?

c. The residents medication profile is updated via an electronic interface that can

be accessed by the facility, pharmacy and doctor?

RCF STAFF FOCUS GROUP MATERIALS

SESSIONS: April 2005

TIME: XXXXX The session is expected to take 1 hour and participants will be

remunerated $60 for their time on receipt of an invoice.


In responding to the following questions, please draw upon your day to day

experiences administering medications using dose administration aids.

In your responses, please think about all steps in your medication administration

system as shown in the diagram on the next page.

1. What are the problems you have experienced with the dose administration aids

system used in your facility? How have these problems been dealt with?

Consider steps 0 to 9 in the diagram.

2. Are there any problems that occur particularly when a new resident enters the

facility? What strategies have helped reduce these problems?

3. Are there any other specific problems related to medication administration in the

following situations and how have these been addressed?:

A change in medication orders

Telephone orders

Residents going to and from hospital or other temporary absences

Respite care

Particular medications such as non-packed medications, PRN medications or

Schedule 8 drugs

Death or other permanent separation

Other specific situations

4. Does the medication administration policy at your facility help you in your job? Are

there any aspects of the policy that make it harder to administer medications?

What would you change if you could?

5. Why would a staff member find it difficult to follow all the procedures and guidelines

related to medication management in RCFs?

6. What procedures are in place to ensure that the facility’s policies are complyd to by

staff? How effective are these procedures in minimising the risk of errors or other

problems?

7. Do agency staff have problems following your procedures? What strategies do you

have in place to deal with this situation?

8. Have the attitudes or behaviours of residents and/or their family caused difficulties

with the medication system? How were these problems addressed?

9. Among the GPs who attend residents in your facility, what kind of attitudes or

behaviours do you find helpful in working with your facility’s medication system?


What kind of GP attitudes or behaviours do you think make this part of the job

harder? What kind of strategies have been used to address problems?


practices (in terms of quality of care, time, staffing, etc):

a) Doctor’s orders on a medication chart alone are sufficient for the pharmacy to


b) The initial supply of DAAs to new residents is integrated with the provision of a


c) The residents’ medication profile is updated via an electronic interface that can



0. GP orders medication on chart + writes prescription

2. Communicate medication order to pharmacy

+/- sending any prescription forms

3. Pharmacy delivers medication

5. Medication storage• Packed medications• Non-packed medications

5a. Give medications to self-medicating residents



In RCF

In Pharmacy

KEY:


5b. Counsel self-medicators on medications use

6a. Check self-medicators took medications

7. Record medication administration on chart

RCF MANAGEMENT AND STAFF FOCUS GROUP REPORT

Inefficiencies and unsafe practices resulting from DAA use

Participants in the RCFs focus groups noted several causes of unsafe and inefficient

practice arising from DAA use. The most commonly cited of these were potentially

unsafe situations due to difficulties experienced by RCFs in accessing medications

after hours (10 responses) – either when emergency supplies were needed or when

medication changes took place. Inability to access medications after hours has the

potential to adversely impact patient health, either through patients not receiving the

necessary medications or through receiving an incorrect dose of medication. This

problem was reported by many participants and was independent of the type of DAA

used. One DON stated that when medication changes occurred after hours, it was

often impossible for the RCF to arrange for a supply of the new medication until the

next day - potentially leading to nurses giving patients incorrect medication dosages. In

terms of system specific practices, one RCF using 5 week Webster multi-dose DAAs,

stated that because medications were packed so far in advance, changes were not

only problematic but also led to substantial medication wastage.


Another DAA related problem was the occurrence of packing errors by the pharmacy (7

responses). Where errors occur but are undetected, the patient may again be at risk of

receiving the incorrect type of dosage of medication. Interestingly, during the focus

group it emerged that while some DONs considered packing errors to be of paramount

importance, others were barely concerned at all. Many DONs reasoned that packing

errors would be noted by nurses upon administration and as such there was no need to

check for errors packs upon receipt at the facility. However, as one DON commented,

“if errors aren’t detected first up, they tend to be perpetuated until the pack runs out”.

Detection of errors was also a major concern in low care facilities where Personal Care

Assistants (PCAs) administer medications. Three participants, both DONs and RCFs

staff, noted that checking DAAs for errors was a time consuming and inefficient

practice, especially in cases where DAAs were checked multiple times: once, upon

receipt and once before each medication administration. Another issue DONs reported,

was instances where nurses using DAAs had cut corners to save time (2 responses).

One DON recounted the story of an RN she described as a ‘cowboy’, who had been

administering all medications during the round as per usual, but had been waiting until

after the round finished to sign off on the medications for each patient.

Nursing staff also noted that temporary nurses (from agencies) were typically lax when

it came to signing for medication administration. An interesting adjunct to the

occurrence of packing errors in DAAs was the perception by some nursing staff that

they actually bore the brunt of responsibility for errors made by the pharmacy. One RN

stated that, “once the pills are popped out (of the DAA) there’s no way for us to prove

that they were wrong. It’s demoralising”.

Solutions to inefficient and unsafe DAA practices

All but three of the participating RCFs had implemented solutions to overcome the

unsafe and inefficient practices identified. The most commonly used approach, was to

ensure that staff were thoroughly trained to check DAAs for errors (11 responses).

Most DONs stressed to staff the importance of being aware that pharmacies do make

packing errors and that thorough checking is required. As one DON stated, “we have a

zero tolerance policy for medication administration errors, any errors in administration

are sufficient to trigger extra education or training for the staff member”’. Similarly, one

RN reported that the facility she worked at administered nursing staff with yearly

medication competency testing. As well as training, many RCFs also had auditing and

incident report systems in place for when errors were detected (9 responses).

Generally, RCF protocol was to inform the pharmacy of the error immediately and to

make a notation in the facility register regarding the nature of the error.

To overcome the issue of after-hours medication supply, most RCFs had pre-existing

arrangements with their pharmacy or kept emergency supplies of medication on hand

(6 responses). These facilities reported that while after-hours medication changes

could be inconvenient, they posed no threat to patient welfare, as medications were

generally available in time. There was one RCF that reported great difficulty in dealing

with their pharmacy, especially regarding after-hours medication supply, and noted

several instances where the pharmacy had simply refused to supply medications after-

hours. This also related to the assertion from some DONs and nursing staff that good

communication with the pharmacy could prevent the need for after-hours supply of

medication (2 responses). Indeed, one RCF had never required medication supply after


hours – something the DON attributed to good communication with the supplying

pharmacy.

Model of medication supply

Delivery of medication

All participants in the focus groups agreed that existing procedures for the delivery and

receipt of medication are sufficient and that no changes need be made to these. The

only problem encountered was by one RCFs that had been unable to negotiate with

their pharmacy regarding the time of medication delivery, as a result they often

received medications at a highly inconvenient time for them – during the middle of a

medication round.

Medication receipt and storage

RCF respondents were almost evenly split as to whether or not DAAs were checked

upon delivery (5 checked and 5 not checked). Of those who did check, most felt that it

was important to remain vigilant about the possibility of errors and to do as much as

possible to prevent these reaching the patient. Of those who did not check, most

believed that it was the pharmacists’ role to ensure that DAAs were packed correctly

and that and that if any errors had occurred, nurses were likely to pick these up during

the process of administering the medications to the patients. As mentioned previously,

some nurses felt that checking DAAs twice was unnecessary and an inefficient use of

time. Regarding storage of DAAs, none of the participants had received any

information from their pharmacy regarding specific storage conditions, and as far as

they were aware, standard medication storage conditions were adequate. Note

however, that in three instances, DONs and RCF staff from rural areas observed that

on occasions medications would stick to each other, or to the DAA itself, during

transport.

Medication administration

The vast majority of DONs (12/14) reported that DAAs were preferable to Original

Packs (OPs). Five respondents noted not problems with medication administration.

Interestingly this sentiment was not shared by the nursing staff actually administering

medications from DAAs, with one RN stating “DAAs are not a time saving modality, we

are more certain of the medication dispensed if we do it ourselves from the original

packs”. Among the problems that DONs and staff reported with DAAs were: unclear

and confusing medication labeling (9 responses); staff experiencing repetative strain

injury (RSI) from popping DAA blisters (3 responses); and uncertainty about the

suitability of medications for crushing (3 responses). With respect to labeling, problems

with DAAs can be categorised into four groups. First, nurses reported that DAAs could

be difficulty to identify and expressed a preference for DAAs where patient photos were

included (as with some Webster packs). Second, “generic” brand medications were

often not labeled adequately and nurses preferred packs labeled with both the

“generic” brand name supplied and prescribed brand name.

This issue was particularly salient to the nursing staff, with almost all commenting that

DAAs packed and labeled with generic medicines were more time consuming to check

and administer from, as often the medication chart would contain the name of the

originator brand, while the DAA contained only the generic name. Third, patient and

drug information can occasionally be obscured by the frame of the DAA, making it

more challenging for nurses to identify medications. Fourth, DAAs do not typically


contain information regarding the suitability of medication for crushing. In the case of

sachets where medications are often crushed in the DAA itself, it was reported that

packing of crushable and non-crushable medication in the same pack created

inefficiencies for nurses who had to identify and remove those medications unsuitable

for crushing. DONs also reported that when patients refused medications, or when

medications were lost or dropped by nurses, DAA use typically meant that there was

not a ready replacement available (2 responses). In these instances nurses would

often remove the lost medication from the last blister on the patients pack, then arrange

for the pharmacy to repack the DAA – resulting in increased medication wastage and

cost. Indeed, one RCF was actually considering changing from DAAs back to OPs

because of the problems caused by advance packing and medication changes.

However, this RCF was using the five week Webster multi-dose pack and was not

representative other participating RCFs.

Return of medications to the pharmacy

All participants reported that pharmacies provided a service for the return of unused

medication. Typically unused medications were collected by the pharmacy when

delivering a new supply. All participants reported satisfaction with this service.

Current and optimal levels of staff training for DAA use

There was a substantial amount of variation between facilities in the type and amount

of training provided to staff (Appendix Table 3). At the lower end of the scale, DONs

reported that no specific DAA training was necessary and that training in DAA use was

incorporated into the nurses’ orientation at the RCF. At the upper end, one DON

reported that 2.5 days worth of training was provided to PCAs who were administering

medications from DAAs. Generally training was done in house - only three of the

participating RCFs had pharmacy input into the training program. Another important

issue regarding DAA use is the potential ‘deskilling’ of RCF staff. This refers to the

widely held view that using DAAs removes the necessity for RCF staff to develop

further skills and knowledge regarding medications, and in fact that using DAAs may

reduce the skills and knowledge of nurses. Interestingly, the majority of participants

(both DONs and nursing staff) felt that this was not an issue, as resources such as

MIMS are readily available and nurses have the ability to contact the pharmacy in

situations of uncertainty. However, one DON strongly disagreed commenting that

DAAs “add to the concept RNs have that administering medications isn’t important, it

takes away their professional responsibility”. This particular facility had been proactive

in addressing the issue of deskilling and had arranged for the pharmacist to send

fortnightly drug information sheets.

Appendix Table 3 Levels of training provided to RCF staff

Theme Frequency

Training is provided by the RCF without pharmacist input 7 Training provided to new staff and initially DAAs were implemented 6 Yearly training, refresher courses or information sheets are provided 5 Training is provided to staff on an ‘as needed’ basis 3 Training is provided with pharmacist input 3 Temporary staff not properly trained 3 Staff are trained through a mentoring system 2

These sheets were then distributed to each nursing staff member to read and sign off

on, to affirm their knowledge. Nurses who had signed the drug information sheet then


agreed to be tested about that information at any time. A related issue to that of

training, and one that was posed only to nurses, was the extent to which temporary

nursing staff followed medication administration procedures at the facility. Nurses

reported that temporary staff often did not follow medication administration errors, with

some facilities ceasing to use them as a result. At those facilities that continued to use

temporary nursing staff, there was a real sense of frustration among the permanent

staff that procedures weren’t being followed, as one nurse stated “they have the same

problems as us but they don’t actually live them – they don’t have the same standards”.

Issues and barriers to DAA use resulting from existing standards and legislation

DONs and nursing staff raised several issues and barriers to DAA use that they felt

were due to current legislative restrictions (Appendix Table 4). Most commonly, it was

cited that requiring doctors to write prescriptions, despite already having placed an

order on the patient’s medication chart, was an inefficient and potentially unsafe

practice. Several DONs also noted that the current poisons act, which is from 1968, is

outdated and needs updating to allow for the electronic transfer of records. An issue of

importance to nursing staff, but one that was not mentioned by any of the participating

DONs, was the inability of nurses to make notations on patient charts. Several nurses

commented that they would like to be able to write alternative drug names on

medication charts (e.g. the “generic” brand equivalent of the prescribed brand name),

but they are unable to do so due to legislative restrictions. Another important issue,

primarily for DONs, was the level of inconsistency between states regarding

medications that RCF staff can and cannot administer. DONs expressed a preference

for a national standard of medication administration. It should also be noted, several of

the participants were satisfied with current legislation and did not believe that any

changes were strictly necessary – although as some conceded, they would be nice.

Appendix Table 4 Legislative issues and barriers to DAA use

Theme Frequency Medication charts should be allowed to act as a prescription 8 No changes required 4 Poisons act is outdated 4 Nursing staff unable to make notations on medication charts 3 Confusion as to which medications in what pack type can be administered by which staff (RN, EN, PCA)

3

Differing requirements across state nursing boards 3

Nursing staff also noted problems obtaining a legal and current medication chart in a

timely manner when residents were discharged back to the facility from hospital.

Discharge procedures varied between hospitals (as to information flow and whether

discharge medicines were supplied) and the timing of discharges, GP ability or

willingness to write a new medication chart and prescriptions for the pharmacy to

dispense new medications all complicated the timely administration of the correct

medicines to a recently returned resident. These problems occurred irrespective of

whether medicines were used in original packs or DAAs but repacking medications into

a DAA was an added complication.

Impact of hypothetical changes

As part of the focus group discussions, the facilitator suggested to participants a

number of hypothetical scenarios that arose of out the Phases 1 and 2 report ((Ientile

et al. 2004)).


Hypothetical change 1: Doctors orders on a medication chart are sufficient for

the pharmacy to dispense medication

DONs and nursing staff were asked about the potential impact on efficiency and safety

if patients’ medication charts were allowed to act as a prescription. The overwhelming

response from ten focus group participants was that changes to allow medication

charts to act as prescriptions would result in greatly increased efficiency of medication

supply. As one DON stated “it would be great, it would really save us a lot of time and

reduce the amount of paperwork needed”. Only two participants felt that this change

would make no difference to the efficiency of medication supply.

Hypothetical change 2: The initial supply of DAAs to new residents is integrated

with the provision of an Medication Management Review (MMR)

Participants were also asked about the potential impact of incorporating a MMR into

the initial supply of a DAA to patients. Reactions to this suggestion were mixed. A

response typical of most nurses (6) was that while it was a good idea in theory, in

practice it would be, as one DON stated, “a logistical nightmare”. Overall, all

participants agreed that current standards regarding MMRs and DAAs are suitable and

as long as MMRs are conducted within a reasonable time frame (most DONs stated

between one and three months), there is no need for such a change.

Hypothetical change 3: The residents medication profile is updated via an

electronic interface that can be accessed by the facility, pharmacy and doctor

Participants were asked about the potential impact of an electronically based patient

medication profile, that can be accessed by all necessary parties (RCFs, pharmacists

and doctors). Overall, the majority of DONs and nurses were in favour of electronic

medication profiles. As one nurse commented “that would have lots of advantages”.

However, there were several caveats identified: First, participants (particularly DONs)

expressed concern about who would pay for the implementation and upkeep of the

system (9 responses). As one DON noted “it’s a great idea, but that sort of thing always

requires upkeep and support and the facilities just can’t afford it”. Second, there was a

high level of concern about the level computer literacy required by RCF staff,

pharmacists and doctors, to operate such a system work (7 responses). One DON

commented that staff at her facility were currently receiving computer training (for a

separate reason) and that training had proven difficult, as many nurses were not

computer literate. Similar concerns were raised about the computer literacy of doctors,

many of whom both nurses and DONs felt, might not have the requisite skills to use

such a system. Third, several nurses noted that the proposed system would need

safeguards to ensure the accuracy and security of patient information (3 responses).

PHARMACY MANAGEMENT FOCUS GROUPS

COMMUNITY PHARMACIST FOCUS GROUP MATERIALS

SESSIONS: AAPT Hosted telephone conference on the XXXXX April 2005

TIME: XXXXX The session is expected to take 1 hour and participants will be

remunerated $140 for their time on receipt of an invoice.


1. What are some of the problems or issues that the residential care facilities (or

community patients) have come to you with? What practices or solutions have been

implemented to overcome these problems?


2. What problems or issues related to DAA provision and use have arisen within your

business and how have you addressed these?

3. We have attached a model of medication supply when using DAAs; please refer to

this model below. From your perspective what are the missing steps?




and legalities (i.e. Poisons Board, PSA guidelines, Aged Care standards)?




2a. Support activities• Prescription management*

• Accounts• Pack-chart audit†


4. Pack medication

4a. Pack medication


4b. Check medication

4c. Deliver to pharmacy

3a. Send profile +/-medications to external packer

6. Deliver medication

7. Medication receipt & storage

7a. Counsel self-medicating residents



† Could be done independent of pharmacy

Non-packed medications


Different procedures needed for:• New resident• Medication change• Respite (in & out)• Going to & returning from hospital

• Death• Other permanent separation• Other temporary absences

In RCF In PharmacyKEY: External packer

6. The results of phase 2 suggest that pharmacies and facilities are not always

complying to the existing standards and guidelines. Why do you think this may be

happening? How can this be fixed?

7. Describe the templates, tools or materials (i.e. PSA templates, DAA supplier forms,

IT solutions) you use to facilitate DAA supply to RCFs? What are the problems with

the existing tools and what tools would be useful to you?


practices (in terms of quality of care, time, staffing, costs etc):

a) Doctor’s orders on a medication chart alone are sufficient for the pharmacy to


b) The initial supply of DAAs to new residents is integrated with the provision of a


c) The residents’ medication profile is updated via an electronic interface that can



COMMUNITY PHARMACIST FOCUS GROUP REPORT

Problems and issues related to DAA supply

Pharmacists reported a number of DAA supply issues that RCFs had raised with them

and that they had encountered while supplying DAAs to both RCFs and community

patients (CPs) (Appendix Table 5). The most frequently cited and important issue that

pharmacists faced with regard to DAA supply was ensuring that patient medication

charts were unambiguous and up-to-date. As one pharmacist noted “communication in

forms or charts faxed [from RCFs/GPs] are often illegible…some are really shocking”.

The issue of up-to-date medication charts was particularly important. Current charts are

necessary to ensure that the pharmacist provides the patient with the correct

medications, in the correct dosages, as well as allowing pharmacists to identify

potentially dangerous interactions between medications.

Another issue of concern for pharmacists was the amount of time required to supply

DAAs, due to constantly switching between the pharmacy’s dispensing program and

the DAA manufacturer’s DAA supply program. This particular problem occured

because pharmacists must conduct the activities of DAA supply, such as updating the

patients medication information, including dosage time and strength and printing the

DAA label in the DAA manufacturers software, as well as updating much of this same

information, plus additional dispensing and payment information, in the pharmacy’s

own dispensing software. As a result the efficiency of DAA supply was greatly reduced

and a significant amount of pharmacists time was wasted duplicating their activities.

For this reason, several pharmacists voiced the need for an integrated dispensing and

DAA system.

Other frequently cited issues included supply of DAAs to RCFs, where the RCF, CP or

GP didn’t supply prescriptions on time, and inefficiencies in supply caused by frequent

medication changes. In both of these cases DAA supply became inefficient due to

factors that were largely outside the pharmacy’s control. For instance, where the RCF

or GP had failed to supply a prescription prior to packing, the pharmacy must then

spend time following up these sources to ensure that the pharmacist has a prescription

to legally dispense. This problem contributed to the situation known as “owing scripts”

where some pharmacists dispensed a regular medication needed at a particular time to

fill a DAA, before the prescription for the item had arrived from the doctor or RCF.

Community patients not informing the pharmacy of changes or not bringing new

prescriptions to the pharmacy in time also contributed to these inefficiencies.

When medication changes occur during the DAA supply cycle (between DAA packing

and delivery), pharmacists will often have to dispense extra medicine or discard certain

medicines and then repack and reseal the patient’s DAA – resulting in a great deal of

time spent conducting activities which would be unnecessary had the pharmacist

received all of the pertinent information prior to packing the DAA.

Several pharmacists also commented on problems associated with hospital admission

for both RCF residents and community patients. When patients went to hospital, the

pharmacy was not notified and so packed a DAA when it was not needed. When

patients were discharged, establishing the current drug regimen so that a new DAA

could be prepared in a timely manner for a recently discharged patient was difficult, as

was obtaining prescriptions in time for medications that had to be dispensed before


packing. The amount and types of medications supplied by hospitals varied as did the

pharmacist’s decision as to whether to repack medications dispensed by the hospital.

One issue which was not explicitly mentioned by many pharmacists, but that was

implicated in many of the problems that were identified (such as frequent medication

changes), was poor communication. Poor communication between RCFs and

pharmacies also resulted in costly inefficiencies when of un-needed DAAs were

supplied. Supply of un-needed DAAs occurs when the pharmacy packs a DAA for a

patient that no longer requires that DAA (either because the patient no longer has need

for sufficient medicines to warrant DAA use or because the patient has moved on from

the RCF). The supply of un-needed DAAs arises because pharmacies will often pack

DAAs in a cycle, and if the RCF has failed to inform the pharmacy that a patient no

longer requires a DAA, but the pharmacy packs on the assumption that they do. This

leads to increased medication wastage and inefficient use of pharmacy staff time

packing DAA unnecessarily.

Pharmacists also reported various other issues that customers had raised with them, or

that they themselves had encountered. These included: frequency of medication audits

in RCFs (pharmacists noted that RCFs conducted audits on an infrequent basis); and

complaints from RCFs and CPs about the costs of DAAs (pharmacies reported that

despite the cost they incurred supplying DAAs, in terms of both labour and materials,

many RCFs and CPs felt that pharmacies were charging too much for DAAs and

should either reduce or eliminate their fees).

Problems internal to the pharmacy were also raised with limited room for packing DAAs

and potential for interruption increasing the potential for packing errors.

Appendix Table 5 Problems and issues related to DAA supply

Problem/issue with DAA supply Frequency

Ambiguous and out of date medication charts 9 Inefficiencies caused by current IT process 5 Ongoing supply of medications without prescriptions to RCFs 4 Inefficiencies caused by frequent medication changes 4 Inefficiencies caused by hospital admission and discharge 4 Community patients not informing pharmacy in time of changes 3 Insufficient room in the pharmacy to adequately pack DAAs 2

Solutions to problems and issues of DAA supply

Pharmacists had a diverse range of solutions to the problems they encountered. In

response to the most common issue of ambiguous and out of date medication charts:

seven pharmacies had introduced a new drug chart system to RCFs and doctors, while

two had worked with doctors to ensure that chart instructions were clearly noted and

kept up to date. Similarly, to overcome issues such as drug changes during the packing

cycle, supply of un-needed DAAs and supply of medications without prescription, six

pharmacies implemented improved and structured communication systems. Improved

communication procedures was a solution for continuity of care problems when

patients were admitted and discharged from hospital. This included changing RCF

practices so that the pharmacy was notified. In several cases, improved communication

procedures at hospital discharge were actually initiated by the hospital pharmacy.

In one pharmacy, an automated prescription reminder system was implemented, to

remind both RCF staff and doctors when medication refills and repeat prescriptions


were due. As a result, the owing prescriptions rate fell from 40%-50% to 2%-3%. This

pharmacist also took the novel approach of dispensing medications privately when

prescriptions were not received on time, and charging the RCF accordingly – he noted

“that really gets them into gear”. Two pharmacists improved internal organisation and

use of staff time.

Review of the best practice model of DAA supply

Pharmacists were asked to review the flow diagram of DAA supply developed from the

findings of Phase 2 study (sent to the participants in advance) and to provide

information on any additional steps that should be included to the model, or on aspects

of the model they felt required improvement.

Five of the pharmacists stated that they were satisfied with the model and felt that it

accurately reflected the steps involved in DAA supply. Others suggested

improvements. One area that many pharmacists felt should be included in the DAA

best practice model, was a component allowing for an assessment of the suitability of a

given medication for packing in DAAs (4 responses). In terms of suitability, pharmacists

were interested in information about the stability of medications once removed from

their original packs - primarily any possible adverse effects on medications through

close contact with other medications or potentially increased exposure to a

warm/humid environment. Three participants felt that for model to function as intended,

it should include the provision of up to date, current drug regimen information to

pharmacies by the doctor. Other issues which pharmacists raised included: a provision

in the model for medication changes during the packing process (2 responses),

notation of where accounts should be sent to (i.e. the patient or the RCF); and inclusion

of a step between the dispensing of medication and packing of the DAA, for the

pharmacist to check that the correct medications have actually been dispensed.

Events that may affect the safety and efficiency of DAA supply

Pharmacists identified numerous issues that can impact on the safety and efficiency of

DAA supply. Appendix Table 6 contains a list of the most common barriers to safe and

efficient DAA supply and the solutions pharmacists use to overcome these. The

majority of pharmacists had developed solutions to offset one or more of these

problems, however, such solutions were not seen as foolproof and there still exists the

very real problem of the unsafe medication supply. Pharmacists primarily cited

problems with poor communication, especially related to medication changes, with only

two pharmacies offering solutions to this issue – in the form of detailed records of

communication regarding medication changes and changes to patients’ DAA status.

This solution was designed to ensure that accurate records were kept regarding any

changes involving patient DAAs and that these records would be accessible to all staff

involved in the supply of DAAs.

Another problem related to medication changes, was the inefficiencies that occurred

due to GPs being unaware of the effect that medication changes can have on the

workflow of the pharmacy. One pharmacist noted that most GPs do not know that once

the DAA packing has begun, changes can often involve increased demands on the

time of DAA packing staff and increased wastage of medications. Solutions to this

problem essentially involved educating GPs about the impact that medication changes

have on pharmacy workflow and setting guidelines regarding making medication

changes. These guidelines focused on raising GPs awareness of the DAA packing


cycles for their patients and attempting to schedule patient appointments so that any

likely medication changes would occur just prior to the pharmacy beginning a new

packing cycle. GPs were also encouraged to consider the urgency of any proposed

medication change. However, as one pharmacist emphatically remarked “it doesn’t

always work”.

Appendix Table 6 Problems/issues with DAA supply and solutions implemented by

pharmacies

Problem/issue Frequency Solution(s) to problem Frequency

Poor communication, especially in relation to medication changes

6 Keeping detailed record of changes and patient DAA status

2

5 Development of medication change guidelines for GPs

2

Having separate staff packing and checking DAAs

7

Training of DAA staff 4 Keeping clear and accurate medication charts

2

Lack of understanding from GPs about the effect of med changes Packing errors 4

Dedicated area and minimise interruptions

2

Finally, pharmacists identified the potential for unsafe medication supply due to DAA

packing errors. The majority of pharmacies attempted to minimise errors in packs

leaving the pharmacy by having different staff involved in the packing and checking

roles, by training staff regarding the procedures to follow when packing and checking

DAAs and by ensuring that clear and accurate medication charts are available for staff,

from which to pack DAAs. Some pharmacies also set up a dedicated DAA area in

which the packing and checking of DAAs could be conducted with minimal risk of

interruption.

Issues and barriers to efficient DAA use related to current standards and

legislation

Pharmacists commented upon a variety of barriers to effective DAA supply that they

felt were due to the impact of legislation and pharmacy and nursing body standards.

The most common among these, and a problem that was identified by almost every

participant across all focus groups, was the issue of owing prescriptions. As one

pharmacist summarised this issue, “when the prescriptions aren’t available you have to

dispense the medicine as an owing script, which often isn’t legal, but the patient needs

their medication to go on with and if you have their best interests in mind then you must

break the guidelines in order to continue doing your job”.

With respect to the impact of differing RCF guidelines on the use of DAAs, a number of

pharmacists expressed real frustration with this issue (Appendix Table 7). Some felt

that nurses only selectively interpreted the guidelines, others felt that occasionally

nurses avoided taking professional responsibility for medication administration, while

one pharmacist commented that ultimately many of the present pharmacy and nursing

guidelines concerning DAA use are simply not consistent with the real world situation.

Other reported barriers to efficient DAA supply were: keeping profiles up to date

following patients’ release from hospital back into the community; and concerns for

pharmacists regarding carers who administer from DAAs and whether the pharmacist

is then legally responsible for the occurrence of errors. It should also be noted that


three of the participating pharmacists were satisfied with the current guidelines and

legislations, while others had only minor issues.

Appendix Table 7 Legislation and standards as barriers to efficient DAA supply

Barriers to efficient DAA supply Frequency

Problems with nurses interpretation of guidelines, professional responsibility and consistency

4

Transition of patients from hospital back to the community – ensuring profiles are kept up to date

4

Current guidelines have unrealistic expectations of what pharmacists should be doing

3

Reasons for pharmacies not complying to current guidelines

The reasons pharmacists might have difficult complying to legislation, standards or

guidelines were explored (Appendix Table 8). The most commonly cited reason for

pharmacists not complying to guidelines and standards was that, as one pharmacist

put it, “sometimes you have to bend the rules to make it work”. Other pharmacists

noted that if the business was not dedicated to supplying DAAs on a large scale,

complying to the standards while still attempting to perform all the tasks of a regular

pharmacist was almost impossible. Pharmacists also cited confusion brought about by

different interpretations by different regulatory bodies and a lack of standards regarding

communication procedures between RCFs and pharmacies. One pharmacist also

observed that as pharmacies are not paid for the work, there is little incentive to

perform it at the highest possible standard.

Pharmacists did make a number of recommendations that might make compliance with

standards easier, including: making payment to cover cost of DAA provision a

requirement; hiring staff dedicated solely to DAA packing; and greater flexibility with

regard to the standards pharmacists are required to meet. Overall, participants felt that

provided guidelines were followed and interpreted sensibly, the problems of DAA

supply caused by these guidelines and standards were not insurmountable. Ultimately,

however, the issue of safe and efficient DAA supply was viewed as one of professional

responsibility more than a rigid compliance to guidelines and standards, as one

pharmacist stated “it really all comes down to the standards of each individual

pharmacist”.

Appendix Table 8 Reasons cited by pharmacists for not complying with existing

standards and guidelines

Reasons for contravention of standards Frequency

Pharmacies must bend the rules to make DAA supply possible 4 Time constraints make it difficult to incorporate DAA supply into pharmacies 3 Confusion caused by different interpretations of guidelines and standards by different bodies

2

No standards of communication between RCFs & pharmacies leads to confusion 2

Materials presently used to supply DAAs and improvements in materials that

may facilitate greater efficiency in supply

Pharmacists were asked what materials or tools they presently used in the supply of

DAAs and what, if any, improvements could be made to these to make supply more

efficient. The tools or materials mainly used were those provided by the DAA


manufacturer (9 responses). The other tools identified by 3 participants were the

Quality Care Pharmacy Program delivery log and the PSA packing/checking log.

In terms of improvements, some suggestions were:

A portable (laptop based) IT solution that could be used by pharmacists when

visiting RCFs to check charts and profiles, that could also store images of

medications to aid their identification; and

An IT solution to assist in keeping all charts, packs and signing sheets up to date

and consistent across the board.

Additionally, one pharmacy had already devised their own IT solution to facilitate

communication between the pharmacy and RCFs. This pharmacy had developed the

IT solution as they supplied multiple DAA types and needed the ability to separate

customers by DAA types during the ordering and packing processes.

Impact of hypothetical changes to current DAA practices

Pharmacies were presented with four scenarios in which they were asked to assess

the impact of hypothetical changes to DAA practices in terms of quality of care, time,

staffing costs and general impact on the supply of DAAs.

Hypothetical change 1: Doctors orders on medication charts are sufficient for

pharmacies to dispense medications

Pharmacists were asked to consider the hypothetical impact on DAA supply of changes

that would make doctors orders on medication charts sufficient for the pharmacy to

dispense medications i.e. separate prescriptions would not be required. Theoretically,

this change would eliminate the need for pharmacists to spend time following up owing

prescriptions and should result in greater efficiency of DAA supply. Responses to this

suggestion were mixed (Appendix Table 9). Many pharmacists believed that it would

greatly streamline the supply of DAAs and dramatically reduce the burden on the

pharmacy of owing prescriptions. Conversely, a number of pharmacists expressed

concern about this proposition, with one citing the number of errors that occur on

medication charts as a major problem and also noting that prescriptions were more

“legally satisfying” than simply dispensing from the chart. One pharmacist also felt that

that this scenario should be extended to all chronic care situations.

Appendix Table 9 Hypothetical impact of changes to pharmacy dispensing

requirements

Hypothetical impact of change Frequency

Proposed change would save time and money and reduce owing prescriptions 8 Proposed change is positive however should be approached with caution 3 Proposed change is not appropriate due to the potential for errors 3

Hypothetical change 2: Integration of MMR/DMR with the provision of DAAs to

new customers

Most pharmacists agreed that while the idea of integrating medication review with DAA

initiation was sound in theory, it was unlikely to work in the real world (Appendix Table

10). As one pharmacist stated, “an initial review will improve quality of care but the

practicality will be the main barrier”. Other common responses by pharmacists were

that: provided the MMR/DMR was conducted within a reasonable timeframe (most

nominated one month or less), there was no need to integrate it into DAA supply; and,

the idea might work well in the community setting, but was unlikely to be of benefit in


the RCF environment where there were a large number of patients and those patients

often needed medications supplied in DAAs immediately.

Appendix Table 10 Hypothetical impact of changes to integrate MMR/DMR into DAA

supply


Theoretically sound idea but not practical for real world application 6 Unnecessary provided DMR/MMR done within a reasonable timeframe 4 Sound idea in the community setting but not in the RCF environment 2

Hypothetical change 3: Development of a medication profile that can be updated

electronically by RCFs, doctors and pharmacists

Responses were overwhelmingly positive to the idea of having an online medication

profile for each patient, that could be electronically updated by pharmacists, doctors

and RCFs. Most pharmacists (8 responses) commented that it would improve

communication between the relevant parties and/or facilitate the efficient supply of

DAAs. All respondents were in favour of this proposal and felt that it would be of great

benefit in the DAA supply process. Two respondents indicated that it would lead to

improved timing and quality of supply. Some caveats that were mentioned were: the

need to maintain patient privacy; a system to alert all parties as soon as medication

changes occur; and ensuring that all intended users of the system possess the

necessary technical proficiency.

Hypothetical change 4: Implementation of a formal tripartisan agreement for DAA

supply between doctors, customers/RCFs and pharmacies

Pharmacists were asked to consider the impact of implementing a formal tripartisan

agreement pertaining to the supply of DAAs between the patient/RCFs, any doctor(s)

seeing the patient and the supplying pharmacy. It was suggested to pharmacists that

the tripartisan agreement could cover areas such as the type of service to be supplied

as well as the expectations and obligations of each party. Overall pharmacists were in

favour of the idea (Appendix Table 11), with most agreeing that it would assist in

formalizing the responsibilities of each party and clarify the obligations of each within

the DAA supply process, as one pharmacist stated “we don’t tend to use agreements

for a lot of things that we should do, but certainly it is easy for someone to comply if

they know what their responsibilities are in the first place”. Other pharmacists

supported the idea but stated that they would prefer for the agreement not to be legally

binding, as it raised the possibility that pharmacists could be held legally responsible

for the misuse of DAAs by patients or RCFs. Still others noted the need to exercise

caution when entering into agreements with community patients as they may not fully

understand the nature of the agreement or may feel pressure to enter into such

agreements.

Appendix Table 11 Hypothetical impact of implementing a formal tripartisan agreement

for DAA supply


Good idea, would help to formalise responsibilities of each party 7 Sound idea but prefer agreement not to be legally binding 2 Caution must be exercised when entering into agreements with patients 2


HOSPITAL PHARMACISTS FOCUS GROUPS

HOSPITAL PHARMACIST FOCUS GROUP MATERIALS

SESSIONS: AAPT hosted telephone conference

The session is expected to take 1 hour and participants will be remunerated $140 for

their time on receipt of an invoice.


1. What are some of the problems or issues that arise in discharge planning when a

patient is returning to a residential care facility where they use a DAA? What

practices or solutions have been implemented to overcome these problems?

2. Are specific guidelines required for patients admitted from and discharged to

residential care?

3. What are some of the problems or issues that arise in discharge planning when a

community based patient has been using a DAA service? What practices or

solutions have been implemented to overcome these problems?

4. What problems or issues arise in compiling a current medication profile for a new

admission and consulting with the patient’s general practitioner? What strategies

have been used to facilitate this process? Describe the templates, tools or materials

you use (i.e. RACGP health summary form, IT solutions).

5. When a patient is admitted from a RCF, what medication information is provided to

the hospital and who provides this information? Is this adequate?

6. What information is provided to the RCF when the patient is discharged? Who else

is provided with information (i.e. patient, doctors, community pharmacists). How

would you improve this communication process?

7. Do you recommend and/or provide DAAs as part of a discharge plan? If yes, how

often and in what circumstances? What are the procedures involved in

arranging/providing this service and could they be improved?

8. What is your hospitals’ policy relating to the use of the patient’s own medication

and does this differ when a patient brings in their medication in a DAA?

9. The APAC guidelines state that prior to discharge, adequate/sufficient medication

should be dispensed? How do you know what is adequate and does a patients’ use

of a DAA affect this judgment?

10. How can medication wastage be minimized when a patient is admitted to hospital

or discharged from hospital?

11. Are there any issues or barriers to efficient DAA provision related to existing

standards and legalities (i.e. Poisons Board, APAC guidelines, hospital standards,

patient health charters and Medicare agreements)?



happening? How might compliance to guidelines be enhanced?

HOSPITAL PHARMACIST FOCUS GROUP REPORT

Problems and issues with discharge planning for patients returning to RCFs and

solutions implemented by hospital pharmacies

Hospital pharmacists were asked to consider the types of issues that arose during

discharge planning for patients returning to RCFs where DAAs were used. Essentially,


pharmacists noted that the core problem encountered was one of communication,

especially with respect to the RCF informing the hospital of what medications the

patient was on originally, how many remain, and in turn, the hospital pharmacy letting

the RCF know what medications have changed. This was particularly important if

patients had been prescribed new medications while in hospital and would be

continuing to use these following discharge. In terms of practices and solutions used by

hospital pharmacies to overcome this issue, the two most commonly used were: 1.

Supply of a discharge sheet for patients returning to RCFs (four responses); and 2.

Faxing RCFs a copy of any new prescriptions and providing verbal and/or written

updates of any new information about patients’ medications (three responses). Other

strategies used included: supplying prescriptions only for new medications, not all

medications the patient received while in hospital; and developing a hospital database

to match patients and RCFs with their pharmacies, to ensure continuity of care and

ongoing supply of medications.

Proposed requirement for specific admission and discharge procedures for RCF

patients

Participants were asked whether or not they felt that specific patient guidelines should

be developed for patients regarding admission from, and discharge to, RCFs.

Theoretically, such guidelines should would provide standardised procedures for

patient admission and discharge, and ensure a uniformly high standard of patient care.

Overall, hospital pharmacists were divided on this issue, with some believing that

specific procedures would help to reduce inconsistencies in the admission and

discharge of patients from different RCFs, while others felt that standardised

procedures were unnecessary, provided common sense was allowed to prevail (see

Appendix Table 12). Of those pharmacists that favoured the development of formalised

guidelines, many expressed concern about the likelihood that their implementation

would place extra demands on the time of all involved, but felt that the benefits

outweighed the costs. There was also a large group of pharmacists who were

ambivalent about the prospect of introducing formal guidelines, because, as one

pharmacist stated: “I don’t think formal guidelines would necessarily change anything”.

Appendix Table 12 Proposed requirement for specific guidelines for patients requiring

admission from, or discharge to, RCFs

Requirement for specific guidelines Frequency

Yes – inconsistencies across hospitals make guidelines necessary 5 Ambivalent - formal guidelines are unnecessary 3 No - a common sense approach is sufficient 2

Problems and issues in discharge planning for community patients and

practices and solutions to overcome these

The problems experienced at discharge planning for community patients were diverse.

The only problem cited by more than one pharmacist was: patients not being able to

answer questions about their DAA and not bringing their DAA to hospital with them

(two responses). This was problematic for pharmacists for two reasons: (1) as they

could not be sure of the medications that patients were taking and meant that,

potentially, patients may be at increased risk of adverse drug events, and (2) if the

hospital pharmacist did not know that a patient usually used a DAA, appropriate plans

for discharge supplies were not made. Other problems pharmacists had encountered

included: patients using old DAAs instead of their latest one; planning ongoing


medication supply for patients living in remote areas – especially indigenous

communities; and ensuring the availability of prescriptions for ongoing supply.

While the range of problems was diverse, the range of solutions was not.

Overwhelmingly, the most common solution utilised by pharmacists was, simply,

improved communication (five respondents). Commonly employed strategies to

improve communication were: liaison with the patient’s pharmacy to ensure a DAA was

packed ready for discharge (with any new medications if necessary); and ensuring a

consistent flow of information between the hospital, patient and pharmacy regarding

medication changes. One hospital pharmacist placed specially made stickers on

patients DAAs upon discharge, which read “not to be used until checked by local

pharmacy”. This served the dual purpose of providing the patient with a reminder and

reminding the community pharmacist that they should check the patient’s DAA and

current prescriptions (including any added while in hospital) before allowing the patient

to continue use of that DAA.

Problems and issues for compiling medication profiles for new patients and

practices and solutions used to overcome these

Incomplete, missing or unreliable patient information was the main problem faced by

hospital pharmacists when compiling medication profiles for new patients; it was the

only problem raised in the focus groups (six respondents). Complete medication

information for patients is necessary, as it allows pharmacists to ensure all appropriate

medications are written on the hospital drug chart, to detect potentially risky drug-drug

interactions, as well as helping them plan for patient discharge.

The solutions used to address this issue varied. To do this, some pharmacists had

junior doctors at the hospital chase missing information from the patient’s community

pharmacist, others developed medication reconciliation forms, while some used the

patients’ DAAs as a source of information (see Appendix Table 13). In any case, the

only satisfactory solution was for pharmacists to acquire the missing information from

whatever sources available.

Appendix Table 13 Practices and solutions for overcoming missing information when

compiling medication profiles for new patients

Practice/solution Frequency

Pharmacist delegates work to other hospital staff 6 Development of a medication reconciliation form 2 Use of patient DAAs as a source of information 2

Information, and adequacy of information, provided to hospital following patient

admission from RCF

When asked about the type and adequacy of information hospital pharmacies received

following patient admission from an RCF, responses were generally positive. Six of the

pharmacists felt the information they received was adequate (e.g. a patient transfer

form and a fax of the patient’s medication profile, from the RCF). Two pharmacists

reported that the information they received was inadequate. Additional information they

felt should be supplied were: the name of the patient’s GP and supplying pharmacy;

and, having the patient bring their DAA with them upon admission.


Information provided to RCFs and other sources upon patient discharge and

potential improvements to the communication process

Hospital pharmacists were also asked to report on the type of information they provided

to RCFs, doctors and community pharmacists following patient discharge together with

any improvements they felt could be made to the communication process. Appendix

Table 14 contains a list of the most common types of information provided by hospital

pharmacists to RCFs and other sources. The majority of pharmacists provide RCFs

with a discharge summary but do not routinely provide any information to the patient’s

community pharmacist. While it was desirable, to include the community pharmacy in

the communication loop, it was not generally actively initiated by hospital pharmacists.

As one pharmacist stated “when we get involved with RCF patients, the charts go to

the nursing home but we don’t contact the community pharmacy. If the community

pharmacy didn’t receive a copy it’s a bit of work for us, so we would like to know

whether that communication is happening [between the RCF and community

pharmacy]”.

There were a number of hospital pharmacists who did provide discharge summaries to

both the RCF and the community pharmacy. Several of these pharmacists noted that it

was essential to ensure that the patient’s community pharmacist was kept up-to-date

on all medication changes. Finally, there were some hospital pharmacists that simply

provided the patient with a medication profile and requested that the patient pass it

onto the relevant parties as reflected by the comment: “the patient is also given a folio

which contains what the hospital pharmacy believe to be a complete and accurate

record, which we assume is then passed on to the RCF or carer”. There was some

discussion that in this situation, there was a reasonable possibility that the intended

party(s) might not receive important patient information.

Appendix Table 14 Type of information provided on patient discharge and source

information is provided to

Information provided and source provided to Frequency

Doctor’s letter/ discharge summary – provided to RCFs, no information provided to community pharmacy

6

Doctor’s letter/ discharge summary – provided to RCF and community pharmacy 4 Medication profile– provided to patient to pass on to RCF/carer 4

Recommendation/provision of DAAs as part of patient discharge and

circumstances and procedures involved in any such recommendation

The issue of whether hospital pharmacists recommended or provided DAAs for

patients upon discharge was explored, and if so, under what circumstances this might

occur and the procedures followed in those cases. As Appendix Table 15 shows, the

majority of hospital pharmacies did not have an official policy regarding DAA provision,

but in some cases provided patients with a DAA if both the patient and the hospital

pharmacist agree it upon it: “we have no set policy regarding DAA supply so it’s just up

to the ward pharmacist and whether the patient agrees to using a DAA”. A greater

number of hospital pharmacies did not actually provide DAAs themselves, but were

willing to recommend patients to pharmacies that would. Reasons for not providing

DAAs through the hospital pharmacy were, characteristically: “yes we will recommend

DAAs if appropriate – but we [hospital pharmacy] don’t fill them ourselves as it is too

time consuming and its also confusing for the patient if they have to change the type of

DAA later on ”.


Appendix Table 15 Provision of DAAs upon discharge and circumstances surrounding

provision or recommendation of DAA use

Recommendation and circumstances for DAA provision Frequency

Hospital has no formal policy regarding provision or recommendation of DAAs 6 Hospital will not provide DAAs but will recommend a pharmacy that does 6 Hospital will provide DAAs if agreed by both the hospital pharmacist and the patient

3

Hospital policy regarding patients own medication and own DAAs

A critical factor in the wastage of medications is what happens to those medicines that

patients bring with them to hospital, either in original packs (OPs) or in their DAAs.

Responses to this issue were polarised, with six pharmacists stating that patient

medications were not used when bought to hospital (regardless of whether in OP or

DAA), while four pharmacists stated that patient medications could be administered

from DAAs providing certain criteria were met (those criteria and frequency of response

are contained in Appendix Table 16). There were no standard criteria for use of

medications in DAAs among those hospitals that allowed it; however, in all cases, use

of the DAA was dependant upon inspection and approval by a hospital pharmacist. Of

those hospitals that did not permit the use of medications from DAAs, the most

frequently cited reason was that once medications were packed in DAAs, they all

looked similar and could be confused by nurses during administration.

Appendix Table 16 Criteria for use of patient DAAs following hospital admission

Criteria for DAA use Frequency

DAA use not permitted in hospital 6 DAA can be used if quality judged as good by a hospital pharmacist 2 DAA can be used if a hospital pharmacist has individually removed and identified each medication

1

DAA can be used by nurses with the approval of a hospital pharmacist until the hospital’s supply of the medication is available

1

Judgment of adequate/sufficient medication supply upon discharge and relation

to DAA use

According to APAC guidelines (Australian Pharmaceutical Advisory Council 1998),

hospital pharmacists are required to provide patients with ‘adequate/sufficient’

medications upon discharge from hospital without the meaning of “adequate or

sufficient” being defined. Pharmacists were asked what they considered to be an

adequate/sufficient supply and whether or not this definition changed for patients using

DAAs. The definition of adequate/sufficient adopted by the different hospital

pharmacies could be categorised into three groups (Appendix Table 17). Hospitals

were split almost equally between the three length of supply groups, with each of the

pharmacists stating that the timeframe of supply defined as being adequate was

determined as a matter of hospital policy without input from the dispensing pharmacist.

No pharmacist reported differences in the length of medication supply for DAA versus

non-DAA patients.

Appendix Table 17 Length of time for which supply of discharge medication is deemed

adequate/sufficient

Adequate/sufficient supply Frequency

Supply of 5 days or less 4 Supply of 7 days 3 Supply of standard PBS dispensed medication quantity 3


Methods for minimising medication wastage during patient admission to, and

discharge from, hospital

In addressing the issue of medication wastage, hospital pharmacists advocated a

variety of approaches, many of which, subject to hospital policy, could most likely be

implemented immediately. The most commonly cited means of minimising medication

wastage, was returning to patient’s the medications they brought with them on

admission to hospital (3 responses). However, one obstacle to this approach was

actually locating a given patient’s medication – as one pharmacist said “we try to

minimise wastage by returning the patient’s medications to them, but we can’t always

find them”. Another suggested strategy to minimise wastage was to make it compulsory

for community pharmacies providing a post-discharge DAA to use patients’ discharge

medications rather than disposing of these and dispensing new prescriptions (2

responses). One pharmacist stated that this was her ”biggest gripe”; she believed that

community pharmacies were using the dispensing fee as a means of subsidising the

cost of DAA supply, instead of trying to minimise medication wastage. One final

suggestion for reducing wastage was to have hospitals use the medications patients

bring with them on admission (a practice already occurring in some locations) (2

responses).

Issues and barriers to DAA provision based on current standards and legislation

Hospital pharmacists were asked to consider whether any of the current standards and

legislation regarding DAA provision, acted as barriers to the efficient supply of DAAs. A

number of pharmacists felt that there were no legislative barriers to efficient DAA

provision (3 responses), while others felt that stricter guidelines regarding who could fill

DAAs (2 responses). The guidelines or legislation about who can fill DAAs were

inconsistent and ambiguous, and there was disagreement among pharmacists. One

pharmacist who stated, “sometimes nurses fill them instead of pharmacists, but it’s

better to have strict guidelines as to who can fill”, alternately there was a pharmacist

who said “we investigated DAA provision and found that a pharmacist has to label and

dispense them, but I see no reason why someone else can’t do it”. In both of these

cases the pharmacists were advocating more defined guidelines for the packing of

DAAs, but approached this issue from different angles.

Increased resources and money for DAA provision, was also thought to help make

DAA supply more efficient (2 responses). Hospital pharmacists noted that most often

DAAs were filled under sub-optimal conditions, by over-worked pharmacists and

pharmacy staff, for little or no monetary reward. Hospital pharmacists expressed the

opinion that increased remuneration for DAAs would improve all DAA related activities,

including streamlining the process of patient admission and discharge from hospital.

Reasons why pharmacies are not complying to current guidelines and ways

compliance may be improved

Finally, hospital pharmacists were asked to consider the reasons why pharmacists may

not always comply to the current guidelines for DAA provision, and ways in which

compliance to these guidelines might be enhanced. Pharmacists voiced a variety of

opinions, the most common being that there is simply insufficient time and resources

available to supply DAAs and follow all necessary guidelines and standards (three

respondents). One pharmacist noted, “time is the key feature – there’s a lot of things to

be done in a short period – it is one big problem”. Another reason stated for non-


compliance to guidelines in the hospital setting was that all of the discharge protocols

when DAAs were involved were “not practical to follow” and that often the guidelines

were unclear. Only one pharmacist actually suggested a solution to enhance

pharmacists’ compliance to DAA provision guidelines, and this was, quite simply, “to

make the guidelines more clear”.

PHARMACY DISPENSARY ASSISTANTS/TECHNICIANS

INTERVIEWS

DISPENSARY TECHNICIAN INTERVIEW MATERIALS

1. We have attached a model of medication supply when using DAAs; please refer to

this model below. From your perspective, are there any missing steps? What

activities are you involved in?



3. What kind of training did you receive to help you perform the tasks you need to do

to pack DAAs (how much, what kind). Could the training have been better? In

what way could it be improved?

1. Medication order• Prescription from GP• Medication chart from RCF



2a. Support activities

• Prescription management*

• Accounts





11. Medication receipt &/or storage



Non-packed

medications


Different procedures needed for:• New resident• Medication change• Other situations eg. going to &

returning from hospital

External Internal to PharmacyKEY:




9. Store packed medication

4. How much detail was there in the instructions you were given or the procedure you

were asked to follow? Is there flexibility for performing tasks differently?

5. On top of your initial training, what other skills and knowledge have you gained to

help you in your role of providing DAAs i.e. things you learned while doing the job?

6. What is your involvement in starting people on DAAs? Do you hand out DAAs or

deliver them? Are these processes working well? How could they be improved?


7. What guidelines, standards or regulations that relate directly to DAA services are

you familiar with?


and legalities (i.e. Poisons regulations, PSA guidelines, Aged Care standards)?



happening? How can this be fixed?

10. Describe the templates, tools or materials (i.e. PSA templates, DAA supplier forms,

IT solutions) you use to facilitate DAA supply? What are the problems with the

existing tools and what tools would be useful to you?


APPENDIX D: LEGAL OPINION

HYPOTHETICAL DAA SITUATIONS FOR CONSIDERATION OF

LIABILITY

The following information and hypothetical situations were provided to Guild Legal to

highlight issues related to best practice and to provide a framework for comment

Background: The steps involved in arranging for medications to be packed into dose

administration aids (DAAs) including the administration of medications is shown in the following

figure.

1a. GP writes medication order• On medication chart in RCF as order to administer• Records full current drug regimen for community patients
















13a. RCF stores medications (packed & non-packed)

13b. RCF self-medicator residents given medications

13c. Counsel on medications (community patients & RCF self-medicators)

14. Administer medication (packed & non-packed) 15a. Check medications taken by RCF self-medicators

15. Record administered medications on RCF chart

16. Return unused medication to pharmacy• Pharmacy records & monitors missed doses,

taking action as needed; deals with medications

Non

-pa

cke

d m

ed

ica

tio

ns

In Residential Care Facilities, medications can be administered by Registered Nurses (who

have their own duty of care including checking medications against a medication chart that is

the doctor’s authorisation to administer a medication), Medication-endorsed Enrolled nurses

(not as much training as RNs but certified to administer medications). In some RCFs, a

Personal Care Assistant (PCA) or carer (a facility staff member unregistered and unqualified to

administer medications under the regulations of the various states) assists a resident to take the


contents of a dose aid blister, or certain residents self-medicate. Pack types used can be blister

unit dose or multi-dose packs, or unit or multi-dose sachets (untrained staff and self-medicators

will only use a multi-dose pack). Dosett type boxes are not used in RCFs.

For people in the community using DAAs, they take the content of the blister in the pack without

reference to any medication chart. In some cases, a carer (often a spouse) assists them to take

medications. In this case, the carer is generally not trained. Multi-dose devices of all 3 types

might be used at home.

In developing a best practice model, we are focusing on maximising safety (prevention of

errors), effectiveness (in improving compliance and management of medications) and efficiency

(e.g. in packing and minimising rework, for example, when changes are made).

Situation 1: A pharmacy supplies a residential care facility with a DAA that is erroneous and a

Personal Care Assistant (PCA) or carer assists a resident to take the contents of a dose aid

blister with the wrong medicine or wrong dose, and the resident has a negative outcome. The

error is due to discordance between the pharmacy profile and the facility chart either due to the

failure of the facility to adequately communicate changes to the resident’s regimen to the

pharmacy or due to the failure on behalf of the pharmacy to update the resident’s profile and

revise any packed medication. How would the following procedures or practices impact on the

relative liability of the pharmacy and/or facility?

The pharmacy and facility have an agreement in place that clearly defines that it is the facility’s responsibility to ensure that changes to medications are communicated to the pharmacy in time for changes to be made to packs versus no formal understanding.

The pharmacy maintains written records of all communications from the facility about medication changes but has no records relating to this particular medication change versus the pharmacy keeps no documentation of communication.

The facility maintains a record of all communication with the pharmacy about patients medication changes and has a record of communication relating to this incident versus the facility keeps no documentation.

The medication change is a substitution of one drug for another (one stopped and another started) but both drugs are packed and administered (like a double dose), because the facility notified the pharmacy of the new drug only versus communicating the whole revised drug regimen to the pharmacy.

The pharmacy has a procedure and documentation as evidence of regularly reviewing medication charts to ensure the pharmacy profile is accurate versus the pharmacy has no policy or documentation of reviewing charts.

The facility has a policy of having an RN check packs prior to administration by unqualified staff versus the facility has no procedure or documentation of checking packs that will be administered by unqualified staff.

Situation 2: A pharmacy supplies a facility with a DAA that is erroneous and the error is

administered to the resident by a RN and the resident has a negative outcome. The error is due

to human factors; mistake made by packer in the pharmacy (i.e. wrong drug/dose is packed)

and the error is administered as the RN didn’t detect the error because the RN failed to check

the chart, but followed the pack label or just administered the contents of the blister due to be

administered. How would the following procedures or practices impact on the relative liability of

the pharmacy and/or facility?

The pharmacy maintains records of checking the packs before delivering to the facility versus the pharmacy checks the pack but maintains no records of checking packs.

The facility has documentation to indicate that the RN did check the residents chart (i.e. chart is signed by RN) versus the facility has no documentation to support the RN checking the pack against the chart.

The facility has internal monitoring/auditing procedures for medication administration by RNs

Situation 3: A pharmacy supplies a community patient with a DAA that is erroneous and the

community patient takes the medication according to the pack and has a negative outcome.


The error is due to the fact that the patient’s profile (from which the pharmacy prepares the

packs) does not reflect the patients current regimen either due to the failure of the patient/doctor

to adequately communicate medication changes to the pharmacy or due to the failure on behalf

of the pharmacy to update the patient’s profile and reflect these changes in the packs. How

would the following procedures or practices impact on the comparative liability of the pharmacy?

The pharmacy maintains written records of all communications from the patient or doctor about medication changes but has no records relating to this particular medication change versus the pharmacy keeps no documentation of communication. The patient, doctor and pharmacy have a formal agreement stipulating whose responsibility it is to communicate changes to the pharmacy versus there is no formal agreement. The medication change is a substitution of one drug for another (one stopped and another started) but both drugs are packed and administered (like a double dose), because the change was made by providing the pharmacy with a prescription for the new medication only versus communicating the whole revised drug regimen to the pharmacy.

REPORT FROM GUILD LEGAL LTD: DOSE ADMINISTRATION

AIDS (DAAS) - SOME LIABILITY CONSIDERATIONS

The following summary of liability issues surrounding the provision of DAA services

was prepared by Elizabeth McDowell, Principal Solicitor, Guild Legal Limited (28 June

2005)

Introduction

In this paper, we consider:

1. The areas of professional responsibility requiring particular focus in arranging for

medications to be packed into DAAs.

2. By reference to a number of scenario’s involving the packaging of medications in

DAAs, to review:

a. Liability issues which may arise in arranging for medications to be packed in to

“DAAs” by a pharmacist to be supplied either to a patient within a residential

care facility or to a community patient.

b. Some strategies which could be implemented by pharmacists in relation to

ensuring the minimisation of claims against pharmacists in supplying

medication packed into DAAs.

Pharmacist’s Professional Obligations- some matters requiring particular

attention

The provision of medications packed into DAAs is a service provided by pharmacists to

the community benefiting in particular the elderly, the infirm and those who are

responsible for their care. The provision of this service is at a cost to the pharmacist

which is often significant (Refer Effectiveness and Cost Effectiveness of Dose

Administration Aids – Final report 5/11/2004 – Project conducted by Quality Medication

Care Pty Limited in conjunction with the Therapeutics Research Unit, University of

Queensland, Princess Alexandra Hospital) but the costs pressures placed on the

pharmacist do not diminish in any way the professional obligations of the pharmacist in

relation to the dispensing of medication. At all times appropriate protocols and

procedures must be observed and in this regard, reference is made to published

standards in relation to appropriate protocols to be maintained in the pharmacy

Some of the professional consideration that arise in particular in relation to the

packaging of medications in DAAs include:


1. The requirement at all times that appropriately trained and supervised persons are

involved in the packaging of medications into DAAs.

The pharmacist at all times remains responsible in relation to the medications so

packed and appropriate systems (including the checking of medication charts, the

reviewing of original packaging of medications, the keeping of appropriate records,

ensuring the integrity of packed medications) must be maintained and recorded.

The Pharmacy Board of NSW has published in Bulletin VIII some timely reminders

in relation to those matters necessary to ensure sound professional practice.

2. Whilst the practical considerations in relation to counselling may differ in the

context of supply of medication to patients within a residential care facility, the

professional obligations in relation to medications dispensed which are packaged in

the DAAs by the pharmacist remain. It is important that the pharmacist ensures that

proper information and counselling is provided to residents within the residential

care facility and their carers to ensure that medication regimes are fully understood

so as to be safe and effective. In relation to patients resident within a residential

care facility, the facility must have in place appropriate procedures to ensure that

medication is appropriately administered and this is a separate liability which rests

with the facility. It is important that the pharmacist who is involved in the provision of

medication packaged within DAAs to patients within a residential care facility

ensures that, as a separate obligation, effective communications are maintained

with appropriately qualified staff in the facility and that the facility at all times has

access to accurate and up-to-date information in relation to medications. It is

important that the fact of the provision of this information be recorded and records

retained within the pharmacy.

Proper and effective counselling is also critical in relation to DAAs used by

community patients and the pharmacist must at all times ensure that the patient, or

their carer, knows how to use the medication correctly and is provided with

accurate and up to date information in relation to the medication. Particular

attention is required in the context of patients who return to their own homes after

being in a residential care facility (and who no longer have their medication

packaged in a DAA) and in those patients who change from having their medication

packaged in a DAA to collecting the medication in original packaging. When

medications belonging to a patient which have not been included in DAAs are

collected by the patient, particular care is required in relation to checking the

medication provided to the patient and to ensuring that the patient or their carer

understands how to use the medication correctly. In this situation it would be

important to keep a record in the pharmacy of the medication which was provided

and the counselling which was given. In addition to maintaining copies of

dispensed prescriptions it would be useful to record on the patient’s records the

medication which was collected by the patient and some details of the counselling

provided.

3. An issue which unfortunately arises with some frequency in the context of

medication packaged in DAAs is the recycling of medications previously dispensed

in a DAA which is returned to the pharmacy, normally by a residential care facility.

The re-use of previously dispensed medication (dispensed for one patient and then

subsequently “re-dispensed” for another patient) constitutes not only a fraud

against the Health Insurance Commission in terms of a double claim being made

for pharmaceutical benefits in respect for the same medication, but also a breach of

the pharmacist’s professional and ethical obligations to each of the patients of the


pharmacy. A pharmacist simply can not be properly satisfied that, in the case of

returned medication, the integrity of that medication has not been compromised by

incorrect storage or tampering. Likewise, using one patient’s (unwanted) medication

which is stored for that patient within the pharmacy (and for which payment has

been made by that patient) for another patient is not acceptable, even though the

original medication may not have been taken outside the pharmacy. If medication is

no longer required by a patient, it must be disposed of in the appropriate container

for unwanted medication. It is critical that a pharmacist have well documented

procedures in relation to the proper disposal of returned medication and that the

RUM system is properly utilised.

Some liability issues involving the use of DAAs and strategies for consideration

The following are presented as examples of matters which occur in professional

practice involving the packaging of medications in DAAs highlighting some of the

liability issues which may arise and some strategies for consolidation.

Situation 1

A pharmacy supplies a residential care facility with a DAA that is incorrect. The error is

due to a difference between the pharmacy profile maintained in relation to the patient

and the facility chart maintained by the residential care facility. Such an error would

arise as a result of either the facility failing to adequately communicate to the pharmacy

changes to the resident’s medication regime or due to a failure by the pharmacist to

update the patient’s profile and revise the packed medication. A personal care

assistant or carer, assists the resident to take the contents of the DAA, the wrong

medication (type or dose) and the patient has a negative outcome.

Some strategies which would minimise the risks of such an error occurring and which

would assist in clarifying the professional responsibilities of the pharmacist vis-a-viz the

residential care facility in the event of such an error occurring would include the

following:

1. The Contract for provision of pharmacy services to the residential care facility

should clearly set out that it is the residential care facility’s responsibility to ensure

that changes to medication are communicated to the pharmacy in a clear and

unequivocal way and in a timely manner to enable any changes to be made to

medication packs. This would reinforce the obligation of the residential care facility

in its dealings with the pharmacist and it would be of assistance in the relationship

between the pharmacist and the facility that this be set out in the contract.

2. In relation to the contract with the residential care facility, it would obviously be of

assistance to all parties if the agreement stated each party’s professional

responsibilities and obligations. It is important that proper consideration be given to

the way in which these responsibilities are described so that additional burdens are

not placed on the parties. Some pharmacists may have a concern that entering

into such agreements may place on them an additional liability over and above their

own professional responsibilities – for example, that they may in some way be

liable for misuse of DAAs by patients or residential care facilities. A contract which

properly sets out the obligations of the parties in relation to the supply of DAAs

would not in itself create such additional burdens and indeed would reinforce the

separate obligations of the residential care facility in relation to DAAs.

3. The pharmacist should have in place appropriate protocols to ensure maintenance

of written records of all communications from the facility about medication changes.


This would be a useful risk management tool for the pharmacy in the event that the

facility asserts that a medication change was communicated which is disputed by

the pharmacy.

4. The residential care facility maintains a record of all communications with the

pharmacy about medication changes. Again, this would be a useful risk

management tool for the residential care facility in the event that receipt of a

medication change is disputed by the pharmacist.

5. Where the medication change involves the cessation of one medication and the

commencement of another medication, this must be clearly and unequivocally

stated in the direction to the pharmacist. The pharmacist should, as part of their

sound professional practice, have careful regard to any medication changes and, if

in doubt, verify the medication requirements of the patient with the qualified person

who has authorised the medication. If the prescriber has ordered that a medication

is to be ceased, such remaining medication should be removed from the medication

currently stored for that patient within the pharmacy and either appropriately

disposed of or separately stored. It is appreciated that, where the prescriber is

altering a patient’s medication regime on a regular basis, an appropriate protocol

may include the separate storage of previously dispensed medication for a patient

and, provided that appropriate protocols are maintained (including that close regard

is had to the expiry dates of medication) it is felt that this is a reasonable step for

the pharmacist to take. Consideration shall be given to the patient assigning its

rights to the pharmacy to undertake the disposal of such medication in the

circumstances. The removal of the medication (either by disposal or separate

storage from currently dispensed medication) will assist in ensuring that errors do

not occur.

6. The pharmacy should have in place a procedure for regularly reviewing medication

charts to ensure the pharmacy profile is accurate. This should be in conjunction

with the residential care facility in the event of a patient who is resident within such

facility or, in the case of a community patient, in consultation with the patient’s

general practitioner.

Situation 2

A pharmacy supplies a residential care facility with a DAA which is incorrect. The

wrong medication is administered to the resident by a registered nurse and the resident

has a negative outcome. The error in the medication dispensed in the DAA is due to a

mistake within the pharmacy in that the wrong medication (type or dosage) is

dispensed in the DAA. The error is compounded as the registered nurse failed to

check the medication chart, following instead the pack label or simply administered the

contents of the DAA.

Some practices and protocols which would limit the possibility of the error initially

occurring, and in turn being compounded with the residential care facility include that:

1. In relation to the packaging of the DAA, if the DAA is not packed by a pharmacist,

the packer of the DAA be an accredited pharmacy technician properly supervised

by a pharmacist. The use of unqualified staff who have not been properly trained is

not appropriate professional practice. It is important that the training of the staff

and the policies and procedures in relation to the dispensary using DAAs be

properly documented and that these policies include appropriate checking and

supervision and that the communications of these policies be properly documented


(for example, on induction of new staff, the recording of the holding of regular staff

meetings and so). It is also important that records in relation to checking and

supervision in the dispensary be maintained so that, if necessary, the pharmacist is

able to provide objective contemporaneous proof in relation to these matters. This

can be critical not only in the context of a civil claim arising out of the error, but also

in respect of any disciplinary proceedings.

2. The pharmacist must check the prepared DAA by sighting the original packaging

from which the medication was taken. The check must be a thorough check to

ensure that the proper medication is being supplied in accordance with that which

has been prescribed (both in terms of medication type and dosage). It is again

important that the checking procedures be properly set out in the pharmacists

written policies and protocols and that there are records maintained of the regular

communication and enforcement of these policies and protocols in the pharmacy.

The communication of these matters to staff should also be recorded (for example,

minutes of regular staff meetings new employees acknowledging receiving and

reading the pharmacy’s policies and protocols, and so on).

3. Particular care needs to be given in relation to medication which is to be taken

weekly rather than daily. Dispensing errors involving DAAs not infrequently involve

the inclusion in the DAA of medications which are not to be taken daily but which

are wrongly included as part of daily medication in the DAA. The computer systems

used in packing the DAAs need to be correctly configured in relation to the way that

weekly medication is supplied. More importantly, however, no system can be an

effective substitute for a proper checking being undertaken by the pharmacist to

ensure that such errors do not occur. The importance of this cannot be overstated

in relation to dispensing medications of a narrow therapeutic index, where the

consequences of an error can be fatal.

4. The pharmacist having checked the DAA for delivery to the facility keeps a signed

record of the DAA having been checked by the pharmacist.

5. To prevent the error being compounded by the registered nurse, appropriate

protocols and procedures must be in place within the residential care facility to

ensure that the registered nurse checks the medication chart and records that the

medication chart has been checked.

Situation 3

A pharmacy supplies a community patient with a DAA that contains an error. The

community patient takes the medication according to the pack and has a negative

outcome. The error occurs because the patient’s profile (from which the pharmacy

prepares the pack) does not reflect the patient’s current medication regime. This is

either due to the failure of the patient/doctor to adequately communicate medication

changes to the pharmacy or the failure of the pharmacy to update the patient’s profile

and reflect any communicated changes in the DAA.

Some protocols and procedures which could prevent the error occurring would include:

1. The patient, doctor and pharmacist have a written agreement setting out clearly the

responsibility in respect of communicating changes in the patient’s medication to

the pharmacy and how those changes are to be communicated. In this regard, it is

important that any such agreement be properly explained to the patient and the

patient not feel pressured into entering into any agreement. It would be useful to


include the patient’s carer or a close relative in the discussions about the

agreement so that matters are fully understood.

2. The pharmacy maintain proper written records of all communications from the

patient/doctor about medication changes. Most pharmacy software packages are

capable of having such entries separately recorded in relation to patients and a

central storage system of all data in relation to a patient is encouraged. This would

be an effective protection to the pharmacy in the event about there being a dispute

in respect of the communication of a medication change.

3. Where the medication change involves the substitution of one drug for another, this

should be unequivocally stated in a direction from the patient and the doctor. If

there is a written agreement in place between the doctor and the pharmacist, it

would be important to include this in the agreement and how such medication

changes are to be communicated. If the pharmacist is in any doubt as to the

medication regime, appropriate enquiries should be made of the prescriber of the

medication. If medication previously supplied is to be ceased, all supplies of that

medication held on behalf of the patient should be removed and either separately

stored for the patient (again keeping a careful note of expiry dates) or appropriately

disposed of to prevent an error occurring. Again, in the situation where the

prescriber is altering a patient’s medication regime on a regular basis, separate

storage from the regularly supplied medication may be more appropriate than

disposal but it is crucial that appropriate protocols are maintained and recorded. It

would be critical, in the case where a patient ceases to use DAAs for the packaging

of their medication and arrangements are made to collect their medication from the

pharmacy (either because they move to a different residential facility or into the

community) that the previously supplied medication is not given to them (or is only

given after appropriate counselling and advice) to ensure that errors in the taking of

the medications do not occur.

4. It is important in the supply of all medications to community patients that proper and

effective counselling be given to ensure that the patient understands how the

medication is properly to be taken. Often, the counselling process will alert the

pharmacist to an error in the medication being dispensed.

The examples above include elements of matters which have arisen in practice in

relation to the use of DAAs. They reflect the most common issues which arise in a

pharmacy context. However, we include the following as some less typical example of

the types of issues which can arise in a pharmacy involving the supply of medications

packaged in a DAA.10

Situation 4

An elderly patient receives medication packaged in a DAA whilst a resident of a

residential care facility. Upon discharge from that facility to home, the patient attends

the pharmacy which had supplied the DAA and requests that she be supplied with the

balance of her medication which had not been packaged within the DAA. All

medication is the subject of a valid prescription. The medication is given to the patient

who is counselled by the pharmacist in relation to the appropriate use of medication.

The patient’s carer is also present in the pharmacy and the pharmacist forms the view

that the patient understands the directions for use. Shortly thereafter the patient takes

10

We appreciate the assistance of Guild Insurance Limited in allowing us to extract information from claims received in

the preparation of this paper.


their own life by an overdose using the medication. In the investigations which follow

there is no adverse finding in relation to the conduct of the pharmacist but the matter,

and its subsequent investigation, is obviously a matter of grave concern for the

pharmacist.

This matter is illustrative of the need for counselling at the time of supply of all

medication and particularly when a patient is discharged from a residential care facility

to their own home and no longer has medication supplied in a DAA.

Situation 5

A matter arose in respect of a complaint involving the supply of previously dispensed

medications to nursing homes, such medications being included within DAAs. The

matter arose out of a routine inspection of the pharmacy by State authorities who

raised concerns about the quantities of previously dispensed and returned medication

in the dispensary (for example, medications in original packs dispensed by other

pharmacies, medicines dispensed to patients who had either died or ceased using

DAAs) The allegations were disputed by the pharmacist who was able to defend the

charges brought against the pharmacy by reference to strictly enforced and

documented protocols and procedures within the pharmacy in relation to compliance

with Commonwealth and State requirements prohibiting the recycling of returned

medications and evidence being able to be brought of the communication of those

procedures to staff in the pharmacy. As a result of these rigorously enforced and

documented procedures, the complaint was dismissed. The matter highlights however

the importance of ensuring appropriate protocols and procedures within a pharmacy,

and documentation of the communication of these policies and procedures to all

employees within the pharmacy.

Situation 6

A matter arose in relation to the labelling of medications which were used in a DAA.

This incident involved the packing of a DAA with medication for patient A. Additional

medication was needed to be dispensed. The pharmacist had however commenced

preparing a DAA for patient B and incorrectly labelled the medication which he was

dispensing for patient A with patient B’s name. The DAAs for both patient A and patient

B were correct and no dosage errors occurred. However, when patient B was

transferred to a different residential care facility, patient B’s medication was supplied to

the new nursing home and it was then discovered that a container of patient A’s

medication, labelled as having been dispensed to patient B, was wrongly included in

that package of medication. Fortunately, there was no incorrect medication ingested

by either patient as the protocols and procedures within the pharmacy in relation to

current treatment sheets and the packaging of DAAs were well established and

followed. This example indicates the ease with which a mistake can occur when DAAs

are being packaged, particularly when a pharmacy is under time pressures in relation

to the supply of the DAA. This matter also raises the need to ensure, when

medications are being transferred by direction either to the patient or to another

residential care facility, that the details of each medication so supplied are carefully

checked.


APPENDIX E: THEORETICAL CONSIDERATIONS

IN REPACKING DRUG PRODUCTS INTO A DAA

This appendix provides supplementary information on the various theoretical aspects

pertaining to drug stability in addition to that provided in section 4.3.2.

UNSUITABLE SOLID DOSAGE FORMS

Sublingual and buccal tablets are solid dosage forms used for drug release in the

mouth (under the tongue and in the side of the cheek, respectively) followed by

systemic uptake of the drug. They are often small and porous, the latter facilitating fast

disintegration and drug release (Aulton 2002). Chewable tablets are softer than

conventional tablets as they are designed to be chewed and thus mechanically

disintegrate in the mouth (Allen et al. 2005). Rapidly dissolving tablets (RDT’s) or

Instant-release tablets or wafers are characterised by dissolving in the mouth within

one minute. These tablets are prepared using highly water-soluble excipients designed

to absorb water into the tablet for rapid disintegration or dissolution. They are also quite

friable (Allen et al. 2005). Lozenges are used for local medication in the mouth and

throat (Aulton 2002). The excipients utilised to form the sweetened confectionery-type

base are hygroscopic and the lozenge is likely to become sticky upon exposure to

moisture. Effervescent tablets are designed to undergo rapid dissolution when in

contact with water due to internal liberation of carbon dioxide. The effervescent carbon

dioxide is created by a reaction in water between a carbonate or bicarbonate excipient

and a weak acid excipient such as citric or tartaric acid (Aulton 2002). Dispersible

tablets are designed to disperse (disintegrate and/or dissolve) rapidly in water. These

solid dosage forms by design are softer, more friable and porous in nature and/or

contain excipients that are designed to absorb water and swell resulting in tablet

disintegration and/or contain excipients that are highly hygroscopic. For these reasons,

any exposure to moisture during storage and handling will result in deterioration in

physical integrity of the solid dosage form, including possible changes in appearance

and potential microbial contamination.

MOISTURE-SENSITIVE SOLID DOSAGE FORMS

Ambient relative humidity (RH) (0% desert, 55% temperate and 87% tropics) can vary

widely and continually depending on the weather and air temperature, and these cyclic

changes lead to constant variations in the moisture content of unprotected drug

products. The constant sinusoidal change in day and night temperatures is a major

contributing factor. For this reason pharmaceutical air conditioning is usually set below

50% RH, and very hygroscopic products are manufactured below 40% RH (Aulton

2002). Temperature cycling can also lead to increased condensation in DAAs with

suboptimal seals/ closures, resulting in increased physicochemical stability issues and

also an increased potential for microbial contamination. In use, DAAs may be subjected

to a reasonable degree of handling, during which accidental rupture of nearby blister

seals may occur (Saville 2001), allowing further exposure to humidity.

Water-soluble drugs present in a solid dosage form will dissolve in any moisture which

has been adsorbed on the solid surface and may then be subject to hydrolysis – the

most common form of chemical degradation of drugs in aqueous solution (Allen et al.


2005; Aulton 2002; Florence & Attwood 1998). Drugs that are a derivative of carboxylic

acid or contain functional groups based on this moiety (e.g. ester, amide, lactone,

lactam, imide, carbamate) are liable to hydrolytic degradation. Common examples

include: chloramphenicol, ergometrine, benzylpenicillin sodium, nitrazepam and

chlordiazepoxide (Florence & Attwood 1998). In addition to causing chemical

degradation in susceptible actives or excipients, moisture can cause tablets to harden

(or soften) with subsequent effect on disintegration and dissolution behaviour. Certain

drugs and excipients are unstable when exposed to moisture (elevated humidity). For

example, the anhydrous form of carbamazepine (CBZ) has been shown to transform to

a more thermodynamically stable, less soluble, dihydrate form when in contact with

moisture. Studies have shown that CBZ tablets, on exposure to humidity, harden and

may dissolve poorly and may lose as much as one-third of their potency (Al-Zein et al.

1999).

It is essential that the packaging material and closure of the DAA offers sufficient

moisture protection for moisture-sensitive solid dosage forms. The USP describes the

various packaging materials commonly utilised in DAAs and refers to them broadly as

having nominal, medium, high, and extreme barrier properties (USP <1146> 2005).

The USP also describes how to determine and classify moisture permeation rates and

states that if the manufacturer’s labelling includes “Protect from Moisture”, the

repackager shall utilise a high barrier film (USP <671> 2005). A repackager is detailed

in the USP (USP <1146> 2005) as “an establishment that repackages drugs and sends

them to a second location in anticipation of need. Repackaging firms repackage

preparations for distribution (e.g., for resale to distributors, hospitals or other

pharmacies), a function that is beyond the regular practice of a pharmacy. Distribution

is not patient specific in that there are no prescriptions. Unlike dispensers

(pharmacies), repackaging firms are required to register with the FDA and to comply

with the current Good Manufacturing Practice regulations in 21 CFR 210 and 211”,

where repackaging is “the act of removing a preparation from its original primary

container and placing it into another primary container, usually of smaller size” (USP

<1146> 2005) and package “is the term synonymous with that of the term ‘container’”

(USP <1146> 2005).

SOLID DOSAGE FORMS SENSITIVE TO AIR (OXIDATION)

Drug substances and/or excipients that are subject to oxidative degradation may

undergo a greater degree of degradation when packaged in plastic (gas-permeable) as

opposed to glass (Allen et al. 2005). Oxidation involves the removal of an

electropositive atom, radical or electron, or addition of an electronegative atom or

radical. The molecular structures most likely to oxidise are those with a hydroxyl group

directly bonded to an aromatic ring (e.g. phenol derivatives such as catecholamines

and morphine), conjugated dienes (e.g. vitamin A and unsaturated free fatty acids),

heterocyclic aromatic rings, nitroso and nitrite derivatives and aldehydes (e.g.

flavourings) (Aulton 2002; Florence & Attwood 1998; USP <1191> 2005). Products of

oxidation usually lack therapeutic activity (USP <1191> 2005).

LIGHT-SENSITIVE SOLID DOSAGE FORMS

Photochemical decomposition may cause oxidation (photo-oxidation) and scission

(photolysis) of covalent bonds. Nifedipine, nitroprusside, riboflavin, phenothiazine

tranquilisers, prednisolone, hydrocortisone, ascorbic acid and folic acid are light-


sensitive (Florence & Attwood 1998; Glass et al. 2004; USP <1191> 2005). In

susceptible drug substances, photochemical energy creates free radical intermediates

which can perpetuate chain reactions (USP <1191> 2005). Additionally, excipients can

initiate, propagate or participate in photochemical reactions resulting in degradation of

the active ingredient or formation of degradation products that may compromise safety

and tolerance (Tønnesen 2001).

SOLID DOSAGE FORMS SENSITIVE TO HEAT

Heat can be a stability issue at the time of repackaging (i.e. DAAs utilising a heat

sealing process) and with subsequent storage and delivery of the repackaged

medications.

DAAs can be formed and sealed in a variety of ways. Larger scale repackagers may

use thermoformers that accomplish these functions in-line, while smaller repackagers

may purchase preformed blister material (USP <1146> 2005). Preformed unit-dose

packagers are sealed either by heat or by adhesion. Heat sealers may be manual units

requiring hand pressure application or automated units that provide a more controlled

pressure for sealing. Critical parameters with these devices are the pressure and

temperature control, since any undesirable variation in these parameters may yield

inadequate seals (USP <1146> 2005).

The USP requires that the repackager or dispenser shall store preparations under

required environmental conditions (USP <1146> 2005) (e.g. controlled room

temperature with a mean kinetic temperature (MKT) not higher than 25ºC – note that

this in the USA). “Controlled room temperature” limits the permissible excursions (i.e.

transient spikes in temperature) to those consistent with the maintenance of a MKT.

MKT is defined as the single calculated temperature at which the total amount of

degradation over a particular period is equal to the sum of the individual degradations

that would occur at various temperatures. Thus, MKT may be considered as an

isothermal storage temperature that simulates the nonisothermal effects of storage

temperature variation (USP <1150> 2005). This is a multifaceted and complex

definition that cannot be easily described as a simple range of accepted temperatures,

or even as an average temperature (MKT is a logarithmic mean) (Brown et al. 2004). A

flowchart has been designed by Brown et al (Brown et al. 2004) to assist in determining

whether medications are stored at “controlled room temperature” – it provides a more

visual and logical summarisation of the above definition (Brown et al. 2004).

PACKAGING AND/OR DRUG INTERACTIONS

The packaging components of the DAA (e.g. film, plastic blister) could potentially sorb

(adsorb and/or absorb) certain drug substances and preservatives. Examples include:

diazepam, phenothiazines, warfarin sodium, vitamin A acetate and preservatives such

as the methyl and propyl parabens (Florence & Attwood 1998). Additionally, there are

numerous possible combinations of drug products being packed in a single blister/

sachet of a DAA with the potential to interact with each other. An example is the

discolouration of Prozac® (dispersible) tablets when packed with Lamisil® tablets.


APPENDIX F: DRAFT TOOLS TO SUPPORT BEST

PRACTICE MODELS

Prescription request form

Patient held template

Hospital pharmacy database

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APPENDIX G: TOOLS USED TO GUIDE

FEEDBACK ON THE BEST PRACTICE MODELS

A number of instruments were developed to give some structure to the feedback

sought from various stakeholders on the best practice models. The questions asked of

the various stakeholders are show (for space and formatting constraints, these

questions are shown without the space/dotted lines for responses that had been

include in the questionnaires distributed).

Community patient feedback materials

Community pharmacist best practice feedback questions

Hospital pharmacists feedback questions Expert Panel Questions

General Practitioner feedback questions

RCF management feedback questions

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COMMUNITY PATIENT FEEDBACK MATERIALS

Covering letter

The Project Officer

Dose Administration Aid Study

PO Box 6067

Buranda, QLD, 4102.

Dear XXXXXXX,

Thank you for your continued participation in the Pharmacy Guild of Australia Dose

Administration Aids (DAAs) study run by the University of Queensland/ Princess

Alexandra Hospital. We are pleased to inform you that this is the last stage of this

study which has been a great success thanks to your time and effort.

We are asking you to:

read the summary of the recommendations to improve DAA services,

to complete the enclosed survey, and

return it in the reply paid envelope to the study office.

We expect that the survey will take approximately 15 minutes. The purpose of this

survey is to find out what you think and how you would be affected by our

recommendations to improve the way DAAs are provided. To show our appreciation for

you continued support we will send you a $20 Coles Myer gift card if you return the

completed survey by the 10th of August if at all possible. If you have any questions

please call the study office (free of charge) on 1800 555 803.

Thanks again for your assistance and we look forward to receiving your comments.

James Leslie

Project Officer

COMMUNITY PATIENT BEST PRACTICE ISSUES SUMMARY

AND SURVEY

Recommendations to improve the provision and use of Dose

Administration Aids (DAAs) in the community

Introduction

Dose administration aids (DAAs) are devices packed by your pharmacy to help

organise your medicines. The provision and use of DAAs is a complex process

involving a number of steps and the input and collaboration of different parties (the

pharmacy, doctors, patients, carers and sometimes community support services such

as community nurses).

334

Through consultation with pharmacists, doctors and patients using DAAs we have

come-up with a number of recommendations to provide a range of strategies and tools

to ensure that DAAs are:

safe (DAA is packed without errors),

effective (help patients manage their medicines at home) and

efficient (minimise the costs to pharmacy and to the patient).

Recommendations

The key recommendations that may impact on you as a community patient include:

1. That all community patients be formally assessed to ensure that they are able

to use a DAA and that they would benefit from this service before it is

provided by the pharmacy.

This assessment would involve documenting:

(1) Your knowledge and understanding of your medicines

(2) How a DAA might help you manage your medicine

(3) Whether you might have any problems using a DAA, and

(4) What type would be best for you?

2. That community patients sign an agreement with their community pharmacy

before being provided with a DAA.

Before signing the agreement, the pharmacy would spend some time explaining

what is involved in having a DAA packed by the pharmacy and how to use the DAA.

The purpose of this agreement is to ensure that patients and doctors receive all the

information they need about how this service will work and what they will have to do

to make sure that the DAA is available on time and contains your current

medicines. The sort of things that would be covered by this agreement includes:

What type of DAA will you get and how many packs you will need?

How long will each pack last (weekly, fortnightly, monthly)?

What medicines will be packed (prescription, over-the-counter medicines,

vitamins and supplements?)

Will you pick it up or will the pharmacy deliver, when and how?

What is the cost of this service and who should the pharmacy charge?

Your consent to sharing information about your medicines between the

pharmacy, GPs, carers and hospital if required?

Who will tell the pharmacy about any changes to your medicines (you or your

doctor) and how will the pharmacy be notified of the changes?

Will the pharmacy keep your prescriptions at the pharmacy or will you keep

them at home?

Will the pharmacy remind you to visit the doctor when you need a new

prescription or will the pharmacy request prescriptions from your doctor on your

behalf?

What you should do if you drop/lose a tablet or if you open the wrong blister?

What to do if you go away (e.g. holidays or to hospital).

What will happen and what should you do if you have a prescription filled at a

different pharmacy (i.e. a hospital pharmacy).

How the pharmacy will provide you with information about your medicines?

Your consent to re-assess how you are managing with your DAA after a

specified time (e.g. 6 months).

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3. The community pharmacy should provide you with a written medicine

template (see example on page 3) that is a current and accurate record of all

the medicine you are using (those packed in the DAA as well as non-packed

medicine).

You should carry this sheet with you and present it to your GP and/or any other

doctors and the hospital. Any medicine changes can be written on the template by

the doctor so that you can show this to your pharmacy. The pharmacy should then

update their records and print you a new sheet to reflect your new medicines. The

pharmacy would use this information provided on the form to help ensure your

current medicines are packed in your DAA.

4. The doctor should put any medicine changes in writing for community

patients using a DAA to pass on to their pharmacy (e.g. using the written

medicine template).

5. A fair amount should be paid for DAA services as they take some time to

prepare and cost the pharmacy a lot to provide.

6. Community patients using a DAA should see their GP at least once every

three months (even if it is just to have a prescription renewed).

7. Community patients using DAAs should return the used DAA to the

pharmacy containing any unused medicines so that the pharmacy can

confirm that they are using the DAA correctly.

8. The pharmacist and doctor should regularly (6 monthly) review the currency

of the patient’s medicines and the community patient’s ability to use a DAA.

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Example patient held template (size reduced)

337

Survey Questions

1. Did your pharmacy assess your ability to use a DAA before providing this service

(e.g. give you a sample DAA to try)? Yes No

Please describe any assessment you may have had:

2. Do you currently have a formal agreement with you pharmacy detailing what is

involved in your DAA service? Yes No

3. Would you be willing to sign an agreement like the one explained in

Recommendation 2? Yes No

4. Please tell us which parts of the agreement you would like to change or leave out

(and why)?

5. Thinking back to when you started your DAA, how helpful would it have been to

have your pharmacist discuss all the topics covered in Recommendation 2?

Extremely helpful Some what helpful Not at all helpful

6. Which of the issues covered in Recommendation 2 did your pharmacist discuss

with you before you started using a DAA?

7. Below is a list of tasks that are required to ensure that DAAs are packed accurately

and to make sure that you don’t run out of medicines. For each task, please

indicate who (e.g. you, your carer, your doctor, your pharmacy or a community

nurse) looks after this task currently and who you believe should look after this task

(you may indicate more than one person). Task Who currently does

this task?

Who should do this

task?

1. Tell the pharmacy about any changes

to your medicines.

2. Store the repeat prescriptions

3. Ask the doctor for a new prescription

when you have no more repeats

8. Does your pharmacy currently provide a full and complete list of your medicines to

you? Yes No

9. Would a medicine template as explained in Recommendation 3 and like the

example on page 3 be useful/helpful to you? Yes No

Why or why not?

10. Would you be willing to carry a medicine information sheet with you when you are

going to your doctors, pharmacy or to the hospital? Yes No

11. Does your doctor currently communicate medicine changes (i.e. ceased medicine

or changes in doses) to you in writing? Yes No

12. Would you consider not having medicines packed in a DAA by your pharmacy if the

price increased? Yes No

13. At what price would you no longer be able to continue to get this service? _ _

per/week

14. Do you currently see your GP at least once every three months (even if it is just to

have a prescription renewed)? Yes No

338

15. Would you be willing to return your used DAA to the pharmacy, including any

unused medicines so that the pharmacy can confirm that you are using the DAA

correctly? Yes No

If No, why not?

16. Would you be happy for your community pharmacist/ and or GP to conduct regular

reviews (e.g. 6 monthly) of your medicine management? This review may involve a

visit to your home? Yes No

If No, why not?

What other comments would you like to make about the recommendations listed on

pages 1 and 2?

17. Please comment on any problems you have experienced with DAA services. Do

you have any suggestions for improving the way DAA services are currently

provided?

Please place this completed survey in the reply paid envelope provided.

Thank you for you assistance with this study.

339

COMMUNITY PHARMACIST BEST PRACTICE FEEDBACK

SURVEY

Pharmacist Feedback on “BEST PRACTICE RECOMMENDATIONS FOR THE PROVISION

AND USE OF DOSE ADMINISTRATION AIDS IN THE COMMUNITY”

The following questions are intended to give structure to the feedback we are requesting from you. The questionnaire is 4 pages, reflecting the pharmacy’s central role in providing DAAs. You may need to refer to the “best practice” document to complete the questions We have targeted some specific areas of the best practice model where we would appreciate your specific comments. We are, however, interested in any other comments about the model, it’s potential advantages and disadvantages, its feasibility and the impacts on your practice were the model to be adopted.

1. For recommendation 1.3.1 on assessing patients’ need for a DAA (see also Figure 1.2):

a) How feasible are recommendations related to structured patient assessment? If not feasible, please indicate why.

b) Currently, do you consult the patient’s GP when making the decision to initiate DAA services for a community patient? Yes No?

c) What if any, are the advantages and disadvantages of the community pharmacy consulting with the GP prior to initiating DAA services for a community patient?

d) What changes would you need to make to your DAA initiation process to adopt this ‘best practice’ model? What are the cost, staffing and other impacts?

e) How could Recommendation 1.3.1 be improved?

2. Would you be willing have a written tripartisan agreement as specified in 1.3.2 prior to your community pharmacy beginning to provide a DAA service? Yes No

3. Given that the purpose of this agreement is to ensure that all parties are aware of what is involved in DAA services and can discuss preferences for how to carry out the requirements of providing DAAs prior to beginning this service, which aspects of this agreement would you consider important/useful?

4. Which aspects of this agreement would you change or leave out and why?

5. How feasible is recommendation 1.3.2? What are the likely cost, staffing and other impacts on your pharmacy were you to adopt this ‘best practice’ model?

6. Below is a list of tasks that are required to ensure that DAAs are packed accurately and provided on time. For each task, please indicate who (e.g. the patient, doctor, surgery staff, pharmacy or a community nurse) currently looks after this task and who you believe shouldbe responsible for this task (you may indicate more than one person).

Task Done now by? Should do it?

Recommend that a patient use a DAA Assess a patient’s ability to use a DAA Ensure that the pharmacy has a current and complete record of a patient’s medicines Decide what should be packed in the DAA Decide what is the optimal schedule for the patient (times of day for each medicine) Store the patient’s repeat prescriptions Provide the patient with a current and complete written record of their medicines Tell the pharmacy about any changes to a patient’s medicines Making sure prescriptions are available to ensure continuity of supply of packed medicines Inform the doctor when a repeat prescription is required Assess how patients are managing with the DAA

340

7. For Recommendation 1.3.3, the use of a patient held template to facilitate communication medication changes to the pharmacy:

a) Would a patient held medicine template (as per Recommendation 1.3.3) be useful/helpful to you in your pharmacy using DAAs? Yes No

Why or why not?

b) Would a patient held medicine template (as per Recommendation 1.3.3) be useful/helpful to your community patients using DAAs? Yes No

Why or why not?

c) What would be the advantages and disadvantages of doctors approving a patient’s medication template/pharmacy packing profile prior to the pharmacy packing the patients medicines into a DAA?

d) What changes would you need to make to your DAA service processes? What are the likely cost, staffing and other impacts?

e) Overall, how feasible is the recommendation? Do you see this process as beneficial in promoting safe, effective and efficient DAA services? In your view, what are the barriers to adopting the patient template and how might these be overcome?

f) How could Recommendation 1.3.3 be improved?

8. For Recommendation 1.3.4, keeping a record of communication about medication changes:

a) How feasible is the recommendation? Will it be beneficial in promoting safe, effective and efficient DAA services? Do you believe it will act as legal risk reduction?

b) What changes would you need to make to your medication change communication process? What are the cost, staffing and other impacts?

c) How could Recommendation 1.3.4 be improved?

9. How often do you receive a discharge summary, when a patient using a DAA is discharged from hospital? Never Rarely Sometimes Mostly Always

10. For Recommendation 1.3.5, about continuity of care between hospitals and the community:

a) Do you see the model in Figure 1.3 as beneficial in promoting safe, effective and efficient DAA services? Is this feasible? If not, please indicate why.

b) What changes would you need to make to your processes related to hospitalisation of patients? What are the cost, staffing and other impacts?

c) Does the recommendation 1.3.5 and model in Figure 1.3 address your reservations about packing a DAA for a community patient based on discharge information? If not, why?

d) How could Recommendation 1.3.5 be improved? Think about any circumstances that might complicate or delay the processes.

11. For Recommendation 1.3.6, about Quality Control (QC) and Quality Assurance (QA):

a) Do you believe that record keeping and monitoring can be beneficial in promoting safe, effective and efficient DAA services, and be a form of legal risk-reduction? If not, why?

b) What changes would you need to make to your QC & QA processes? What are the cost, staffing and other impacts?

c) How could Recommendation 1.3.6 be improved? What process guides, tools or other support would you see as helpful to you in adopting recommendation 1.3.6?

12. Would you be willing to check concordance between the pharmacy packing profile, the GP’s records and the patient’s reports 6-monthly as part of a DAA service? Yes No

If No, why not?

13. Do you believe that the recommendations related to prescription management, packing procedures and roles for staff (see section 1.3.7)

a) Promote safe, effective and efficient DAA services? If not, why?

b) What are the cost, staffing and other impacts?

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c) How could recommendations in section 1.3.7 be improved?

14. Should a ‘best practice’ model include recommendations about fair payment? Yes No

15. What do you believe would be the impacts of negotiating a realistic price for the provision of DAAs to appropriate patients?

16. Is Recommendation 1.3.9 feasible? If not, why? What barriers would need to be overcome?

17. What changes would you need to make to your DAA processes were you to adopt this recommendation 1.3.9? What are the likely cost, staffing and other impacts?

18. This ‘best practice’ document has recognised the role of the General Practitioner in a number of processes.

a) Overall, to what extent are the GPs you interact with in providing DAAs to community patients already following best practice processes?

Never Rarely Sometimes Mostly Always

Comments?

b) How feasible is the recommendations involving GPs? How central do you see GP roles in ‘best practice’ to the delivery of safe, effective and efficient DAA services? What, if anything, would you change in the ‘best practice’ document to improve the interaction between community pharmacies providing DAAs and GPs providing care to community patients?

19. What do you believe would be the main barriers and implications to implementing these recommendations (1.3.1 to 1.3.9) in your DAA service?

20. What strategies or support (e.g. from pharmacy peak bodies, etc) do you believe would be necessary lead to widespread adoption of this best practice model?

21. Please comment on any other problems you have experienced with DAA services that are not addressed by these recommendations. Do you have any other suggestions for improving the way DAA services are currently provided?

Pharmacist Feedback on “BEST PRACTICE RECOMMENDATIONS FOR THE PROVISION AND USE OF DOSE ADMINISTRATION AIDS IN RESIDENTIAL CARE FACILITIES (RCFs)”

The following questions are intended to give structure to the feedback we are requesting from you. The questionnaire is 4 pages, reflecting the pharmacy’s central role in providing DAAs in RCFs. You may need to refer to the “best practice” document to complete the questions We have targeted some specific areas of the best practice model where we would appreciate your specific comments. We are, however, interested in any other comments about the model, it’s potential advantages and disadvantages, its feasibility and the impacts on your practice were the model to be adopted.

1. After considering the steps involved in a DAA service (Figure 1.1) and the implementation model (Figure 1.2):

a) How feasible are the implementation model and recommendations related to tendering for a DAA service? If not feasible, please indicate why.

b) What changes would you need to make to your tendering process? What are the cost, staffing and other impacts?

c) How feasible are the implementation model and recommendations related to monitoring and quality assurance for DAA service quality within the pharmacy and the RCF, and by external assessors? If not feasible, please indicate why.

d) What changes would you need to make to address QA for pharmacy DAA processes? What are the cost, staffing and other impacts?


2. Would you be willing have a written agreement as specified in 1.3.2 prior to your community pharmacy beginning to provide a DAA service to a facility? Yes No

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5. Below is a list of tasks that are required to ensure that DAAs are packed accurately and provided on time. For each task, please indicate who (e.g. facility staff, doctor, Dr’s surgery staff, or pharmacy) currently looks after this task (choose a representative RCF) and who you believe should be responsible for this task (you may indicate more than one person).

Task Who does it now?

Who should do it?

Assess a self-medicating residents ability to use a DAA Ensure that the pharmacy has a current and complete record of residents’ medicines Decide what should be packed in the DAA Decide what is the optimal schedule for a resident (times of day for each medicine) Store the residents’ repeat prescriptions Tell the pharmacy about any changes to residents’ medicines Making sure prescriptions are available to ensure continuity of supply of packed medicines Inform the doctor when a repeat prescription is required

6. For Recommendation 1.3.3, the process of communicating medication changes to the pharmacy in writing AND keeping a record of that communication:

a) How feasible is the recommendation? Do you see this process as beneficial in promoting safe, effective and efficient DAA services?



7. How often do you receive a discharge summary, when a resident using a DAA is discharged from hospital? Never Rarely Sometimes Mostly

Always

8. For Recommendation 1.3.4, about continuity of care between hospitals and RCFs:


b) What changes would you need to make to your processes related to hospitalisation of residents? What are the cost, staffing and other impacts?

c) Does the recommendation 1.3.4 and model in Figure 1.3 address your reservations about packing a DAA for an RCF resident based on discharge information? If not, why?

d) How could Recommendation 1.3.4 be improved? Think about any circumstances that might complicate or delay the processes.

9. For Recommendation 1.3.5, about Quality Control (QC) and Quality Assurance (QA):

a) Do you believe that record keeping an monitoring can be beneficial in promoting safe, effective and efficient DAA services, and be a form of legal risk-reduction? If not, why?

b) What changes would you need to make to your QC & QA processes? What are the cost, staffing and other impacts?

c) How could Recommendation 1.3.5 be improved? What process guides, tools or other support would you see as helpful to you in adopting recommendation 1.3.5?

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10. Would you be willing to check concordance between the pharmacy packing profile, the GP’s records and the residents’ chart 6-monthly as part of a DAA service? Yes No

If No, why not?

11. Do you believe that the recommendations related to prescription management, packing procedures and roles for staff (see section 1.3.7)

a) Promote safe, effective and efficient DAA services? If not, why?

b) What are the cost, staffing and other impacts?

c) How could recommendations in section 1.3.7 be improved?

12. This ‘best practice’ document has recognised the role of the General Practitioner in a number of processes.

a) Overall, to what extent are the GPs you interact with in providing DAAs to RCFs already following best practice processes?


Comments?

b) How feasible is the recommendations involving GPs? How central do you see GP roles in ‘best practice’ to the delivery of safe, effective and efficient DAA services? What, if anything, would you change in the ‘best practice’ document to improve the interaction between community pharmacies providing DAAs and GPs providing care to RCF patients?

13. What do you believe would be the main barriers and implications to implementing these recommendations (1.3.1 to 1.3.8) in your DAA service?

14. What strategies or support (e.g. from Aged Care, pharmacy peak bodies, etc) do you believe would be necessary lead to widespread adoption of this best practice model by the Residential Aged Care Sector?


Thank you for you assistance with this study.

HOSPITAL PHARMACISTS FEEDBACK QUESTIONS

Hospital Pharmacist Feedback on “BEST PRACTICE RECOMMENDATIONS FOR THE PROVISION AND USE OF DOSE ADMINISTRATION AIDS IN THE COMMUNITY” and “BEST PRACTICE RECOMMENDATIONS FOR THE PROVISION AND USE OF DOSE

ADMINISTRATION AIDS IN RESIDENTIAL CARE FACILITIES (RCFs)”

The following questions are intended to give structure to the feedback we are requesting from you. You may need to refer to the “best practice” document to complete the questions We have targeted some specific areas of the best practice model where we would appreciate your specific comments. We are, however, interested in any other comments about the model, it’s potential advantages and disadvantages, its feasibility and the impacts on your practice were the model to be adopted.

1. For recommendation 1.3.1 on assessing community patients’ need for a DAA (also Figure 1.2):

a) When a community patient is discharged with a recommendation that a DAA be started, is it feasible for the hospital pharmacists to undertake structured patient assessment? If not feasible, please indicate why.

b) Currently, do you consult the patient’s GP when making the decision to initiate DAA services for a community patient? Yes No?

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c) Currently, do you consult the patient’s usual pharmacy when making the decision to initiate DAA services for a community patient? Yes No?

d) What changes would you need to make to your DAA initiation process to adopt this ‘best practice’ model? What are the cost, staffing and other impacts?


2. The community model recommends a written tripartisan agreement as specified in 1.3.2. Given that the purpose of this agreement is to ensure that all parties are aware of what is involved in DAA services and can discuss preferences for how to carry out the requirements of providing DAAs prior to beginning this service, which aspects of this agreement would you consider important/useful?


4. For Recommendation 1.3.3 in the community model, the use of a patient held template to facilitate communication medication changes to the pharmacy:

a) Would a patient held medicine template (as per Recommendation 1.3.3) be useful/helpful to you in your hospital pharmacy practice? Yes No

b) Why or why not?

c) What changes would need to be made to the recommendation to improve how useful such a the template would be to you?

d) Overall, how feasible is the recommendation? Do you see this process as beneficial in promoting safe, effective and efficient DAA services? In your view, what are the barriers to adopting the patient template and how might these be overcome?

5. How often do you send a discharge summary, when a community patient using a DAA is discharged from hospital?


6. How often do you receive a discharge summary, when a resident using a DAA is discharged from hospital? Never Rarely Sometimes Mostly Always

7. For Recommendations 1.3.5 (community) and 1.3.4 (RCF model), about continuity of care between hospitals and the community:


b) What changes would you need to make to your processes related to hospitalisation of patients? What are the cost, staffing and other impacts?

c) To what extent do the best practice model documents (and model in Figure 1.3) address your reservations about using medication regimen information from RCFs or from the DAA pack or patient held template? If not, why?

d) How could Recommendation 1.3.5/1.3.4 be improved? Think about any circumstances that might complicate or delay the processes.

8. These ‘best practice’ documents have recognised the role of the General Practitioner in a number of processes. How feasible is the recommendations involving GPs? How central do you see GP roles in ‘best practice’ to the delivery of safe, effective and efficient DAA services?

9. What do you believe would be the main barriers and implications to implementing these recommendations (1.3.1 to 1.3.9, where relevant for community and RCF patients) in your practice?

10. Do you think that these ‘best practice’ models compliment and integrate with other hospital-based initiatives related to continuity of care? Why or why not?

11. What strategies or support (e.g. from pharmacy peak bodies, etc) do you believe would be necessary lead to widespread adoption of this best practice model?


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EXPERT PANEL QUESTIONS

Dear Expert Panel member,

Re: Effectiveness and cost-effectiveness of DAAs – Phase 3 feedback on models

We have prepared two ‘best practice’ models (one for community patients and one for RCFs), attached with this email (together with some of the supporting tools). We hope that you will be able to give us feedback on the models. The documents are detailed, and while we hope you will comment on both, we understand if you concentrate on only one of the documents.

These models have arisen out of broad consultation including consultation with RCF management and staff, pharmacy management and staff, hospital pharmacy staff, peak pharmacy bodies and the Phase 2 GP survey and community patients. We have also sought a legal opinion on aspects of the model as they relate to legal risk. On the question of stability of medications in DAAs, we have sought input from TGA and colleagues from Griffith and James Cook University. We will be undertaking more consultation based on these draft models.

The documents are written from a multidisciplinary perspective but as a community pharmacy has a key role in service provision, many recommendations relate to pharmacy.

We are interested in comments about the models, their potential advantages and disadvantages, their feasibility and the impacts on practice were the models to be adopted.

The following questions are intended to give some structure to the feedback we are requesting from you. You may need to refer to the “best practice” document to complete the questions. We have targeted some specific areas of the best practice model where we would appreciate your specific comments. You will note that certain of the recommendations are almost the same in the two model documents (as they reflect core activities), so you may wish to make a single comment that that covers the sections common to both models (e.g. Community model recommendations 1.3.6 & 1.3.7 and RCF model recommendations 1.3.6 & 1.3.7 ). For simplicity, we have included separate questions.

Part 1: Feedback on “BEST PRACTICE RECOMMENDATIONS FOR THE PROVISION AND

USE OF DOSE ADMINISTRATION AIDS IN THE COMMUNITY”

1. For recommendation 1.3.1 on assessing patients’ need for a DAA (see also Figure 1.2): f) How feasible are recommendations related to structured patient assessment? If not

feasible, please indicate why. What are the cost, staffing and other impacts? g) How could Recommendation 1.3.1 be improved? Note that as more research on criteria

for patient selection becomes available, the model can be updated.

2. Recommendation 1.3.2 covers a written tripartisan agreement prior to a community pharmacy beginning to provide a DAA service. a) Given that the purpose of this agreement is to ensure that all parties are aware of what

is involved in DAA services and can discuss preferences for how to carry out the requirements of providing DAAs prior to beginning this service, which aspects of this agreement would you consider important/useful?

b) Which aspects of this agreement would you change or leave out and why? c) How feasible is recommendation 1.3.2? What are the likely cost, staffing and other

impacts on pharmacies were this ‘best practice’ model to be adopted?

3. For Recommendation 1.3.3, the use of a patient held template to facilitate communication medication changes to the pharmacy: a) Overall, how feasible is the recommendation? Do you see this process as beneficial in

promoting safe, effective and efficient DAA services? In your view, what are the barriers to adopting the patient template and how might these be overcome?

b) Do you believe a patient held medicine template (as per Recommendation 1.3.3) would be useful/helpful to: community patients using DAAs? Yes No pharmacies providing DAAs? Yes No GPs caring for patients who use a DAA? Yes No

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c) What would be the advantages and disadvantages of doctors approving a patient’s medication template/pharmacy packing profile prior to the pharmacy packing the patients medicines into a DAA?

d) If not already mentioned above, what are the likely cost, staffing and other impacts? How could Recommendation 1.3.3 be improved?

4. For Recommendation 1.3.4, keeping a record of communication about medication changes: a) How feasible is the recommendation? Will it be beneficial in promoting safe, effective

and efficient DAA services? Do you believe it will act as legal risk reduction? b) What are the cost, staffing and other impacts? How could Recommendation 1.3.4 be

improved?

5. For Recommendation 1.3.5, about continuity of care between hospitals and the community: a) Do you see the model in Figure 1.3 as beneficial in promoting safe, effective and

efficient DAA services? Is this feasible? If not, please indicate why. b) What are the cost, staffing and other impacts? How could Recommendation 1.3.5 be

improved?

6. For Recommendation 1.3.6, about Quality Control (QC) and Quality Assurance (QA): a) Do you believe that record keeping and monitoring can be beneficial in promoting safe,

effective and efficient DAA services, and be a form of legal risk-reduction? If not, why? b) What are the cost, staffing and other impacts? If applicable to you, what changes would

you need to make to your QC & QA processes? c) How could Recommendation 1.3.6 be improved? What process guides, tools or other

support would you see as helpful to you in adopting recommendation 1.3.6?

7. Should a DAA service include a 6-monthly concordance check between the pharmacy packing profile, the GP’s records and the patient’s reports? Yes No If No (or conditional answer) why not?

8. Do you believe that the recommendations related to prescription management, packing procedures and roles for staff (see section 1.3.7) a) Promote safe, effective and efficient DAA services? If not, why? b) What are the cost, staffing and other impacts? c) How could recommendations in section 1.3.7 be improved?

9. Should a ‘best practice’ model include recommendations about fair payment? Yes No

10. What do you believe would be the impacts of negotiating a realistic price for the provision of DAAs to appropriate patients?

11. Is Recommendation 1.3.9 feasible? If not, why? What barriers would need to be overcome?

12. What are the likely cost, staffing and other impacts of recommendation 1.3.9?

13. This ‘best practice’ document has recognised the role of the General Practitioner in a number of processes. How feasible is the recommendations involving GPs? How central do you see GP roles in ‘best practice’ to the delivery of safe, effective and efficient DAA services? What, if anything, would you change in the ‘best practice’ document to improve the interaction between community pharmacies providing DAAs and GPs providing care to community patients?

Part 2: Feedback on “BEST PRACTICE RECOMMENDATIONS FOR THE PROVISION AND

USE OF DOSE ADMINISTRATION AIDS IN RESIDENTIAL CARE FACILITIES (RCFs)”

1. After considering the steps involved in a DAA service (Figure 1.1) and the implementation model (Figure 1.2): a) How feasible are the implementation model and recommendations related to tendering

for a DAA service? If not feasible, please indicate why.

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b) How feasible are the implementation model and recommendations related to monitoring and quality assurance for DAA service quality within the pharmacy and the RCF, and by external assessors? If not feasible, please indicate why. What are the cost, staffing and other impacts?


2. Recommendation 1.3.2 covers a written agreement prior to a community pharmacy beginning to provide a DAA service to an RCF: a) Given that the purpose of this agreement is to ensure that all parties are aware of what

is involved in DAA services and can discuss preferences for how to carry out the requirements of providing DAAs prior to beginning this service, which aspects of this agreement would you consider important/useful?

b) Which aspects of this agreement would you change or leave out and why? c) How feasible is recommendation 1.3.2? What are the likely cost, staffing and other

impacts on pharmacies were this ‘best practice’ model to be adopted?

3. For Recommendation 1.3.3, the process of communicating medication changes to the pharmacy in writing AND keeping a record of that communication: a) How feasible is the recommendation? Do you see this process as beneficial in

promoting safe, effective and efficient DAA services? b) How could Recommendation 1.3.3 be improved? What are the cost, staffing and other

impacts?

4. For Recommendation 1.3.4, about continuity of care between hospitals and the RCF (note that the needs of an RCF for a legal order to administer are included in the model: a) Do you see the model in Figure 1.3 as beneficial in promoting safe, effective and

efficient DAA services? Is this feasible? If not, please indicate why. b) What are the cost, staffing and other impacts? How could Recommendation 1.3.4 be

improved?

5. Recommendation 1.3.5 in the RCF model is similar to 1.3.5 in the community model. The difference relates to educating RCF staff about medication storage and involving them in capturing evidence of drug instability. How feasible is the recommendation?

6. How feasible is a 6-monthly concordance check between the pharmacy packing profile, the RCF charts and the GP’s records suggested in Recommendation 1.3.6? What are the cost, staffing and other impacts?

Recommendation 1.3.7 in the RCF model essentially the same as 1.3.7 in the community model.

Overall Comments on the models

Of all the issues you have raised in response to the preceding questions, what do you believe would be the main barriers and implications to implementing these recommendations (1.3.1 to 1.3.9) in a DAA service for an RCF? And the main barriers/implications for community patients?

What strategies or support (e.g. from pharmacy peak bodies, etc) do you believe would be necessary lead to widespread adoption of this best practice model?

Any other comments?

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GENERAL PRACTITIONER FEEDBACK QUESTIONS

BEST PRACTICE RECOMMENDATIONS FOR THE PROVISION AND USE OF DOSE

ADMINISTRATION AIDS IN THE COMMUNITY

1. In current practice are you consulted in the decision to initiate DAA services for a community patient? Yes No

2. From your perspective, what would be the benefits of the community pharmacy consulting with you prior to initiating DAA services for a community patient?

3. Please describe how you foresee your role, as a GP, in a structured assessment of a community patient (as per Recommendation 1.3.1) prior to starting DAA services?

4. Would you be willing to be involved in a tripartisan agreement as specified in 1.3.2 prior to a community patient beginning a DAA service? Yes No



7. Under what circumstances would you be willing to write a prescription for a community patient using a DAA without seeing the patient and at what if any cost?

8. What information do you believe should be included on a prescription reminder/request to promote best practice?

9. What would you add/change in the recommendations to address the issues you may have with prescription management for DAA patients and to improve the interaction you have with community pharmacies providing DAAs for your patients?

10. Below is a list of tasks that are required to ensure that DAAs are packed accurately and provided on time. For each task, please indicate who (e.g. the patient, doctor, surgery staff, pharmacy or a community nurse) currently looks after this task and who you believe shouldbe responsible for this task (you may indicate more than one person).

Task Who currently does this task?

Who should do this task?

Recommend that a patient use a DAA Assess a patient’s ability to use a DAA Ensure that the pharmacy has a current and complete record of the patient’s medicines Decide what should be packed in the DAA Decide what is the optimal schedule for the patient (times of day for each medicine). Store the patient’s repeat prescriptions Provide the patient with a current and complete written record of their medicines Tell the pharmacy about any changes to the patient’s medicines Making sure prescriptions are available to ensure continuity of supply of packed medicines. Inform the doctor when a repeat prescription is required Assess how patients are managing with the DAA

11. Would a patient held medicine template (as per Recommendation 1.3.3) be useful/helpful to your community patients using DAAs? Yes No

Why or why not?

12. Would a patient held medicine template (as per Recommendation 1.3.3) be useful/helpful to you in your practice? Yes No

Why or why not?

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13. What would be the advantages and disadvantages of doctors approving the patients’ medication template/pharmacy packing profile prior to the pharmacy packing the patients medicines into a DAA?

14. Do you currently communicate changes to the drug regimens of patients who use a DAA (including those changes not needing a prescription i.e. ceased medicine or changes in doses) in writing? Yes No

If Yes, please describe when you would do this and what is the format:

15. How often do you receive a discharge summary, when a patient using a DAA is discharged from hospital? Never Rarely Sometimes Mostly Always

16. When a patient is discharged from hospital with new medicines do you communicate with the community pharmacy packing the patients DAA about what should be packed/changed (as per Figure 1.3) and do you believe this step is necessary?

17. Would you be willing to conduct 6-monthly concordance checks between your records and the pharmacies packing profile for patients receiving DAA services? Yes No

If No, why not?

18. What do you believe would be the main barriers and implications to implementing these recommendations (1.3.1 to 1.3.9) in your practice?


BEST PRACTICE RECOMMENDATIONS FOR THE PROVISION AND USE OF DOSE

ADMINISTRATION AIDS IN RESIDENTIAL CARE FACILITIES (RCFs)

1. From your perspective, what would be the benefits of a RCF (where you provide care for residents) involving you in the process of tendering/ contracting DAA services from a community pharmacy?

2. Would you be willing to be involved in a written agreement as specified in 1.3.2 prior to a community pharmacy beginning to provide a DAA service to a facility where you provide care for residents? Yes No



5. Below is a list of tasks that are required to ensure that DAAs are packed accurately and provided on time. For each task, please indicate who (e.g. facility staff, doctor, your surgery staff, or pharmacy) currently looks after this task and who you believe should be responsible for this task (you may indicate more than one person).



Assess a self-medicating residents ability to use a DAA Ensure that the pharmacy has a current and complete record of the residents medicines Decide what should be packed in the DAA Decide what is the optimal schedule for the resident (times of day for each medicine). Store the residents repeat prescriptions Tell the pharmacy about any changes to the residents medicines Making sure prescriptions are available to ensure continuity of supply of packed medicines. Inform the doctor (you) when a repeat prescription is required

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6. Under what circumstances would you be willing to write a prescription for a resident using a DAA without seeing the resident and at what if any cost?

7. What information do you believe should be included on a prescription reminder/request to promote best practice?

8. What would you add/change in recommendation 1.3.7.1 to address the issues you may have with prescription management for DAA patients and to improve the interaction you have with community pharmacies providing DAAs for your patients?

9. What would be the advantages and disadvantages of doctors approving the residents’ medication template/pharmacy packing profile prior to the pharmacy packing the patients medicines into a DAA?

10. Do you currently communicate changes to the drug regimens of residents who use a DAA (including those changes not needing a prescription i.e. ceased medicine or changes in doses) in writing? Yes No

If Yes, please describe when you would do this and what is the format:

11. How often do you receive a discharge summary, when a resident using a DAA is discharged from hospital? Never Rarely Sometimes Mostly Always

12. When a resident is discharged from hospital with new medicines do you communicate with the community pharmacy packing the patients DAA about what should be packed/changed (as per Figure 1.3) and do you believe this step is necessary?

13. When a resident is discharged from hospital to a RCF with new medicines what is your procedure for updating the residents chart and in what timeframe can you preform this task?

Please describe any circumstances that complicate or delay this process:

14. Would you be willing to conduct 6-monthly concordance checks between your records, the residents chart and the pharmacies packing profile for patients receiving DAA services? Yes No

If No, why not?

15. What do you believe would be the main barriers and implications to implementing these recommendations (1.3.1 to 1.3.8) in your practice?

Please comment on any other problems you have experienced with DAA services that are not addressed by these recommendations. Do you have any other suggestions for improving the way DAA services are currently provided?

RCF MANAGEMENT FEEDBACK QUESTIONS

RCF Feedback on “BEST PRACTICE RECOMMENDATIONS FOR THE PROVISION AND USE OF DOSE ADMINISTRATION AIDS IN RESIDENTIAL CARE FACILITIES (RCFs)”

The following questions are intended to give structure to the feedback we are requesting from you. You may need to refer to the “best practice” document to complete the questions We have targeted some specific areas of the best practice model where we would appreciate your specific comments. We are, however, interested in any other comments about the model, it’s potential advantages and disadvantages, its feasibility and the impacts on your facility were the model to be adopted.

1. After considering the steps involved in a DAA service (Figure 1,1) and the implementation model (Figure 1.2):

a) How feasible are the implementation model and recommendations related to tendering for a DAA service? If not feasible, please indicate why.

b) What changes would you need to make to your tendering process? What are the cost, staffing and other impacts?

c) How feasible are the implementation model and recommendations related to monitoring and quality assurance for DAA service quality within the RCF and by Aged Care assessors? If not feasible, please indicate why.

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d) What changes would you need to make to address QA for RCF processes that support the use of DAAs in medication administration? What are the cost, staffing and other impacts?


2. Would you be willing have a written agreement as specified in 1.3.2 prior to a community pharmacy beginning to provide a DAA service to a facility? Yes No



5. Below is a list of tasks that are required to ensure that DAAs are packed accurately and provided on time. For each task, please indicate who (e.g. facility staff, doctor, Dr’s surgery staff, or pharmacy) currently looks after this task and who you believe should be responsible for this task (you may indicate more than one person).



Assess a self-medicating residents ability to use a DAA Ensure that the pharmacy has a current and complete record of the residents’ medicines Decide what should be packed in the DAA Decide what is the optimal schedule for the resident (times of day for each medicine). Store the residents’ repeat prescriptions Tell the pharmacy about any changes to residents’ medicines Making sure prescriptions are available to ensure continuity of supply of packed medicines. Inform the doctor when a repeat prescription is required

6. For Recommendation 1.3.3, the process of communicating medication changes to the pharmacy in writing AND keeping a record of that communication:

a) How feasible is the recommendation? Do you see this process as beneficial in promoting safe, effective and efficient DAA services?



7. For Recommendation 1.3.4, about continuity of care between hospitals and RCFs:


b) What changes would you need to make to your processes related to hospitalisation of residents? What are the cost, staffing and other impacts?

c) How could Recommendation 1.3.4 be improved? Think about any circumstances that might complicate or delay the processes.

8. What changes would you need to make to your processes related to Recommendation 1.3.8? What are the cost, staffing and other impacts

9. What do you believe would be the main barriers and implications to implementing these recommendations (1.3.1 to 1.3.8) in your facility?

10. What strategies or support (e.g. from Aged Care peak bodies, etc) do you believe would be necessary lead to widespread adoption of this best practice model by the Residential Aged Care Sector?


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RCF RESIDENT INTERVIEW

My name is XXXXXX and I am working in a research project being conducted by the School of Medicine at the University of Queensland.

The project is about defining the best way to provide medicines packed in dose administration aids to Aged Care facilities. [Show picture of DAA]

Dose administration aids (DAAs) are devices packed by your pharmacy to help the nurses administer medications to residents.

In this interview, I want to ask about your experiences when you first moved to This facility and how the move affected things related to your medicines. Your participation is voluntary and you can stop at any time in the interview

Your responses will be confidential. In any report on the study, no-one will be able

to identify who said what.

To help me report what you say accurately, it would help me to make a tape recording of our conversation. After I transcribe your responses and correct my notes, the tape will be wiped.

Do I have your permission to tape?

1. How long ago did you move to this facility?

2. Where were you just before you moved to this facility (e.g. at home, hospital, other

RCF)

3. Who looked after your medicines there, making sure that you had a supply and that

you had a current prescription when you needed it?

When you moved to this facility:

4. Were the process involved in a smooth transition to ensure you had your correct

medicines available when you needed them explained to you by the Nurses?

5. (a) Did you have to change your usual Doctor?

(b) Did you have to change your usual Pharmacy?

6. Were there any initial problems for you and/or your carer/family related to

transferring your medicine supply and current prescriptions to This facility and to

the usual This facility Pharmacy? In the early days of your move to This facility,

were the medicines and prescriptions you needed always available when required?

Or did it take some work to organise? Please describe what happened.

7. If YES to Q6 and NO to Q4, would it have been helpful and prevented or reduced

these problems if you had had the steps needed to make a smooth transition

explained to you?

8. Were you aware of any problems the Nurses had with your medicine supply and

prescriptions when you first moved to This facility? If so, please describe.

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In the best practice Dose Administration Aids service, we have suggested that at the

time a person moves into an aged care facility, that there is an agreement that

specifies up front the following details of the service to be provided [give large print

version to resident]:

Who is the pharmacy providing the DAA service.

What are the costs of the service and who should the pharmacy charge

What the person’s costs are (for dispensed medicines and any other pharmacy

items like vitamins)

What the billing or account procedures are.

What type of DAA will be provided? How long will each pack last (weekly,

fortnightly, monthly)?

What medicines will be packed (prescription, over-the-counter medicines, vitamins

and supplements?)

Your consent to sharing information about your medicines between the pharmacy,

GPs, carers and hospital if required?

Who will tell the pharmacy about any changes to your medicines (you, the Nurses

or your doctor) and how will the pharmacy be notified of the changes?

What will happen to medicines in a pack that has to be changed and returned to the

pharmacy.

Will the pharmacy keep your prescriptions at the pharmacy or will you or the nurses

keep them?

Will the pharmacy remind you or the nurses to arrange a doctor’s visit when you

need a new prescription or will the pharmacy request prescriptions from your doctor

on your behalf?

What to do if you go away (e.g. holidays or to hospital).

What will happen and what should you do if you have a prescription filled at a

different pharmacy (i.e. a hospital pharmacy).

Procedures for returning unused medicines to the pharmacy.

How the pharmacy will provide you with information about your medicines?

9. Do you currently have a formal agreement with you pharmacy detailing

what is involved in your DAA service? Yes No

If YES, what aspects are covered/were discussed with you?

10. Would you be willing to sign an agreement that covered the things above?

Yes No

11. Please tell us which parts of the agreement you would like to change or leave out

(and why)?

12. How helpful to you think such an agreement would be to people moving into an

aged care facility? (Think back to the time you moved into This facility, how helpful

would it have been to have all the topics discussed)

Extremely helpful Some what helpful Not at all helpful

13. Did the pharmacist at your usual pharmacy, the one you used before moving to

This facility, give you (or your carer as applicable) information either verbally, in

conversation or as a leaflet or brochure about your various medicines? [show CMI

example]

If yes, what was it, how often and did you find this helpful?

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14. Have you ever received information about your medicines either verbally, in

conversation or in writing (e.g. Medicines Information for Consumers brochure)

since you have lived in This facility?

If yes, who provided the information, what was it, how often and did you find this

helpful?

15. Do you think it is important that you receive information about your medicines (for

example, what your medicines are for, how to take them, any precautions and

possible side effects).

16. If family/carer has involvement in medicines, is it important that your family/carer

receives information about your medicines?

17. In what situations would you like to be given written information like the package

inserts or Medicines Information for Consumers [show CMI example]? In which of

the following situations?

Only when you start a new medicine

When the information has significantly changed

When, for example, you change from a tablet to a capsule of the same medicine

When there are special reasons to remind you about how to use the medicine and

its precautions

Only when you request this information

For long term treatments, routinely, say every 6 months just as an update.

Not required: (please give details of reason/s why not)

Are there any other comments you would like to make about how to make the provision

of medicines packed in Dose Administration Aids a better service?

Thank you for your time and input today.

RCF/Patient identifier:

Date of Interview:

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APPENDIX H: COMMUNITY PATIENT FOLLOW-UP

SURVEY

Community patient Phase 3 introduction letter

Community patient telephone interview script

Community patient mail-out version

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The Project Officer

Dose Administration Aid Study

PO Box 6067

Buranda, QLD, 4102.

««AddressBlock»»

1 February 2005

««GreetingLine»»

We are writing to thank you for your participation in the Pharmacy Guild of Australia

Dose Administration Aids (DAAs) study run by the University of Queensland/ Princess

Alexandra Hospital. We are pleased to inform you that this study was a great success

thanks to your time and effort and the time and effort of all the community pharmacies

and their customers who participated around Australia.

The information you provided helped us a lot and also raised some more questions that

we would like to collect information on, so that we can better understand how helpful

DAAs are. We are contacting you to ask for your continued assistance with this study.

WHAT IS REQUIRED OF YOU

We are asking you to participate in a telephone interview conducted by a project staff

member. We expect that the interview will take approximately 15 minutes and we

would like to ask you questions about DAAs, your health, your medicine use and your

health care visits. Your participation is entirely voluntary and you may stop the

interview at any point. All personal information collected for the trial will be treated

confidentially and will not be disclosed to any person body or agency.

Your decision about being involved in the study will not in any way affect your

pension, benefits or any health services you are entitled to.

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A project staff member will telephone you in February or early March to ask you to

participate in the interview or to make an appointment to talk with you at a convenient

time. It is also possible for us to mail you a survey to be completed at your leisure and

returned in a reply paid envelope.

For one of the questions about your health we ask you to look at a scale from 0 to 100.

This scale has been included with this letter. If possible please keep this scale near

the telephone as we will refer to it when we call.

The study office will call you so you will not incur any expenses. We also have a free

call number if you would like to contact us free of charge 1800 555 803.

We would also like to let you know that if you are interested in the results of this study

they will be available from the Pharmacy Guild of Australia website (www.guild.org.au)

or you can call us here at the study office and we will send you a summary of our

findings.

Thank you for you assistance and we look forward to talking with you soon.

Regards,

Clare Ientile

Project Officer

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DAA STUDY Phase 3 – Patient Telephone interview

PHONE NUMBER: XXXXXXXXX Gender: Pt ID: XXXXX

1. My name is ____________; I am calling from the School of Medicine University of

Queensland. I would like to speak to XXXXXXXX about a study on Dose Administration

Aids (a device supplied by the pharmacy to help you take you medicine) that XXXXXXXX

participated in last year with XXXXXXX Pharmacy.

Verify that you are talking to participant and go to 3. If you are unable to speak to the participant

go to 2.

2. We would like to follow-up with XXXXXXX, to see how he/she is doing and to ask if they

would be willing to do another brief survey. Would you be able to let us know when/how

would be best to contact XXXXXXX?

Record new contact details

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

If it is not possible to speak with the participant, please record reason in detail.

Participant is deceased: Date:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Participant has moved (new address unknown)

Participant has moved to an RCF (record date of admission or time since of admission):

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Participant is currently in hospital (details if possible to include are date of admission and

length of time admitted for): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Participant is too sick to talk on the telephone (check to see if it is viable to mail a survey to

the participant) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Other explanations _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Participant has hearing/speech difficulties: Would it be possible to mail a survey to you (or

participant) for XXXXXXX to complete at home (with your help if needed)?

3. You may remember receiving a visit from our data collectors early last year and completing

an interview and questionnaire on Dose Administration Aids. This information helped us a

lot and also raised some more questions that we would like to collect information on, so that

we can have a better understanding of whether of not DAAs are helpful. We would like to

interview you over the telephone today if possible. We recently sent you a letter telling you

about the study we are conducting. Did you receive and read that letter?

YES (go to 5) NO (go to 4)

4. The letter was thanking you for you participation in the last stage of the study and telling you

about why we are contacting you for more information. We have been given the opportunity

to continue to study the different ways people living in the community manage their

medications and how this impacts on their lifestyle. The Pharmacy Guild of Australia is

funding this study. Your help would be greatly appreciated and many people may benefit

from the outcomes of this study. (go to 5)

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5. We would like to interview you over the phone and ask you some questions about DAAs,

your health, your medicine use and your health care visits. We expect that the interview will

take approximately 15 minutes. Your participation is entirely voluntary and you may stop the

interview at any point. All personal information collected for the trial will be treated

confidentially and will not be disclosed to any person body or agency.

6. Would you be willing to participate in the telephone interview now?

YES (go to 10) NO (go to 7)

7. Could we call you back at a more convenient time?

YES :when_ _ _ _ _ _ NO (go to 8)

8. Would you prefer us to mail you the survey for you to complete and return in the reply paid

envelope? YES (confirm postal address) NO (go to 9)

XXX St

XXXXXXX State Postcode

9. Well thank you for your time and we appreciate your participation in the first study.

10. I would like to begin by confirming your details (circle Yes if correct):

Your full name is: XXXX XXXX YES NO ___________________

Your date of birth: XX/XX/XXXX YES NO:___________________

PART A – These questions are about Dose Administration Aids and Medication Use

Previous DAA Status: (inserted from Phase 2)

1. Do you have a Dose Administration Aid?

YES NO Don’t know

If YES, what type of Dose Administration Aid do you use? Tick the ONE that applies

Webster Multidose Pack MPS Sachet Roll Mediplanner

Webster Unit Dose Pack PersoCare Pack Nomad Pack

Medico Pack Dosette Box APHS The Sachet System

Other (Please specify) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

2. Who packs your Dose Administration Aid? Please tick ONE box that best

applies

Pharmacist Nurse Carer I do Other _ _ _ _ _ _

Only ask Questions 3 and 4 if DAA status has changed.

3. How long ago did you start/stop using a Dose Administration Aid? _ _ _ years _ _ _ months

4. Why did you start/stop using a Dose Administration Aid? (If stop go to 5/if start go to B)

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

5. If you stopped using a DAA, do you have another system for managing your medications?

YES (go to 6) NO (go to Part B)

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6. Could you please describe your daily routine for how you manage your medications?_ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

PART B - This part of the survey asks you about the medicines that you may have use in

the last four weeks. We are also interested in how much you estimate you have spent on

medicines in the last four weeks.

Medicine use Number Total $

1. How many different prescription medicines have you

used regularly (every day) in the last four weeks?


used occasionally (as needed) in the last four weeks?

3. How many different types of medicine, such as vitamins,

headache tablets, antacids, herbal remedies etc have

you taken regularly in the last four weeks?

4. How many different types of medicine, such as vitamins,

headache tablets, antacids, herbal remedies etc have

you taken occasionally in the last four weeks?

5. Have you had a Safety Net Medication Card in the last four years (since 2000)?

YES (which years?_________) NO

PART C –These questions are about any problems you may have had with your

medicines

1. Since February 2004 how would you rate your level of health (circle patients answer)?

A lot Worse Worse About the Same Better A lot Better

2. In the last 12 months, have you had any symptoms or health problems that you think

have been caused by your medicines? (including side effects and allergies)

YES (go to 3) NO (go to Part D).

3. Please describe the symptom or health problems you had and which medicine caused

this event: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

4. Did you require treatment for these symptoms or health problems caused by your

medicines? YES (go to 5) NO (go to Part D)

5. I will list different types of treatments one at a time and ask you to tell me whether you

had that treatment and the number of visits or duration of the treatment: I am interested in

the type of treatment you had in the last 12 months for the medicine related symptoms only.

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ADE related health service use in last 12 months No. of Times Total no. days

Did you see your GP?

Did you start a new medication or increase your dose? YES NO

Did you visit a hospital emergency department?

Were you admitted to hospital?

Did you require respite care?

Were you admitted to a residential care facility?

Did you require assistance from community nurses?

Any additional treatment: ______________________

PART D – This part of the survey is about your current health status

1. Have you experienced any of the following conditions in the past four weeks? (Read

through the list and indicate YES or NO in the middle column. If YES, ask “have you

experienced this condition in the last two days?” and indicate YES or NO in the far right

column).

Condition Past four weeks Past two days

Falls

Dizziness

Headaches

Fever

Feeling depressed or blue

Pain (back, chest, joints/limbs or abdominal)

Extreme fatigue/tiredness

Shortness of breath

Nausea, constipation or diarrhoea

Feeling anxious or worried

Vision problems

Trouble sleeping

Memory trouble

Hearing problems

Do you have the letter with the picture of the EQ-5D scale from 0-100 (looks like a

thermometer)? YES (please refer to this now) NO (go to 2)

2. To help people say how good or bad their health state is, we ask people to think of a

scale (rather like a thermometer) on which the best health state you can imagine is marked

100 and the worst health state you can imagine is marked 0. Using that scale, could you

please tell us a number, from 0 to 100, that tells us, in your opinion, how good or bad your

own health is today?

Score: _______

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The following five questions are about a number of areas related to your level of functioning. In

each case please tell us which statement best describes you today

2a. Which of the following 3 categories best describes your level of mobility today?

I have no problems in walking around

I have some problems in walking around

I am confined to bed

2b. Which of the following 3 categories best describes your ability to conduct your personal

care activities today?

I have no problems with personal care

I have some problems washing or dressing myself

I am unable to wash or dress myself

2c. Which of the following 3 categories best describes your ability to conduct your usual activities today (e.g. work, study, housework, family or leisure activities)? I have no problems with performing my usual activities

I have some problems with performing my usual activities

I am unable to perform my usual activities

2d. Which of the following 3 categories best describes the level of pain or discomfort you have

experienced today (e.g. back pain/discomfort, headaches etc.)?

I have no pain or discomfort

I have moderate pain or discomfort

I have extreme pain or discomfort

2e. Which of the following 3 categories best describes your mood today in relation to feelings of

depression or anxiety?

I am not anxious or depressed

I am moderately anxious or depressed

I am extremely anxious or depressed

PART E - Health service use in last four weeks.

This part of the survey is about your health care services, the cost to you (or your family) and

the level of support you have had in the last 4 weeks. (Write 0 if no visits or no days)

Health services used in the last four weeks No. of

times

Total $ to pt.

1. In the last four weeks, how many times have you seen a doctor

(GP or specialist) at home, in the surgery or elsewhere?

2. In the last four weeks, how many times have you seen a

community nurse?

3. In the last four weeks, how many times have you seen a health

professional other than a doctor (eg physiotherapist, podiatrist,

chiropractor, dietician, naturopath or similar? (NOTE: DO NOT

INCLUDE PHARMACISTS IN THIS FIGURE)

4. In the last four weeks, how many times have you been treated

in casualty or the emergency department of a hospital but not

admitted?

5. In the last four weeks, how many times have you been treated

as an outpatient or at clinics at the hospital (seen a Dr. or other

healthcare professional)?

6. Have there been any other costs needed to meet your health

care needs in the last four weeks such as pathology (eg blood

tests), biopsies, x-rays, etc.?

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Health services used in the last four weeks No. of times Total $ to pt.

7. Have you used in the last four weeks any support services

(home nursing, Meals-on-wheels, home help)? Please

describe:_______________________

8. Have you had any other types of health care in the last four

weeks? ____________________________

Hospitalisation in the last 12 months No. of times Total $ to pt.

9. In the last 12 months, how many times have you been

admitted to a public hospital?

10. In total, how many days were you in a public hospital?

11. In the last 12 months, how many times have you been

admitted to a private hospital?

12. In total, how many days were you in a private hospital?

13. In the last 12 months, how many days did you spend in other

care facilities (eg respite care or hostel)?

PART F- These questions are how much a DAA would be worth to you.

[Note: the order in which these questions are asked varies from interview to interview]

1. How much would you be willing to pay to have your medicines packed in a device and

delivered to you so that your medication taking was easy and convenient?

$----------/week

2. How much would you be willing to pay to have your medicines packed in a device that

would make remembering to take your medications easier?

$----------------------- /week

3. An adverse drug event is an illness related to medicines (including side effects and

allergies) or injury resulting from using a medicine. How much would you be willing to

pay to have your medicines packed in a device that would reduce your risk of

experiencing an adverse drug event? $----------------------- /week

Thank you for your participation in this interview. If we have any further questions that we’d like

to follow up, would it be ok for us to contact you again? YES NO

364

DAA STUDY Phase 3 – Patient Questionnaire

Name: «Given_Name» «Family_Name» ID:«Patient_ID»

PART A – These questions are about Dose Administration Aids and Medication Use

1. Do you have a Dose Administration Aid?

YES NO (go to Part B) Don’t know

If YES, what type of Dose Administration Aid do you use? Tick the ONE that applies

Webster Multidose Pack MPS Sachet Roll Mediplanner

Webster Unit Dose Pack PersoCare Pack Nomad Pack

Medico Pack Dosett BoxAPHS The Sachet

System

Other (Please specify) _ _ _ _ _ _ _ _ _ _ __ _ _ _ _

2. Who packs your Dose Administration Aid? Please tick ONE box that best applies

Pharmacist Nurse Carer I do Other _ _ _ _ _

3. How long ago did you start using a Dose Administration Aid? _ _ _ years _ _ _

months

4. Why did you start using a Dose Administration Aid? _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

5. Could you please describe your daily routine for how you manage your

medications?_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

PART B - This part of the survey asks you about the medicines that you may

have used in the last four weeks. We are also interested in how much you estimate

you have spent on medicines in the last four weeks.

Medicine use in the last four weeks? Number of

medicines

Total Cost

to you ($)


used regularly (every day) in the last four weeks?


used occasionally (as needed) in the last four weeks?

3. How many different types of medicine, such as

vitamins, headache tablets, antacids, herbal remedies

etc have you taken regularly in the last four weeks?

4. How many different types of medicine, such as

vitamins, headache tablets, antacids, herbal remedies

etc have you taken occasionally in the last four weeks?

5. Have you had a Safety Net Medication Card in the last four years (since 2000)?

YES (which years?_______________________) NO

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PART C –These questions are about any problems you may have had with your medicines

1. Since February 2004 how would you rate your level of health?

A lot Worse Worse About the Same Better A lot Better

2. In the last 12 months, have you had any symptoms or health problems that you

think have been caused by your medicines? (including side effects and allergies)

YES (go to 3) NO (go to Part D).

3. Please describe the symptoms or health problems you had and which medicines

caused these events: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

4. Did you require treatment for these symptoms or health problems caused by your

medicines? YES (go to 5) NO (go to Part D)

5. We are interested in the type of treatment and the number of times you had this

treatment in the last 12 months for the medicine related symptoms only. Please

refer to the table below and indicate whether you had this type of treatment and

how many times you required this treatment for your medicine related symptoms.

Health services used in last 12 months for medicine

related symptoms only.

Had this type

of treatment?

Number of

times?

a) Did you see your GP? YES NO

b) Did you start a new medication or increase your dose? YES NO

c) Did you visit a hospital emergency department? YES NO

d) Were you admitted to hospital? YES NO

e) Did you require respite care? YES NO

f) Were you admitted to a residential care facility? YES NO

g) Did you require assistance from community nurses? YES NO

h) Any additional treatment: ______________________ YES NO

PART D– This part of the survey is about your current health status

1. Have you experienced any of the following conditions in the past four weeks? If

YES, have you experienced this condition in the last two days?

(Please circle YES or NO in each column).


Falls YES NO YES NO

Dizziness YES NO YES NO

Headaches YES NO YES NO

Fever YES NO YES NO

Feeling depressed or blue YES NO YES NO

Pain (back, chest, joints/limbs or abdominal) YES NO YES NO

Extreme fatigue/tiredness YES NO YES NO

Shortness of breath YES NO YES NO

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Part B, Question 1 (continued)


Nausea, constipation or diarrhoea YES NO YES NO

Feeling anxious or worried YES NO YES NO

Vision problems YES NO YES NO

Trouble sleeping YES NO YES NO

Memory trouble YES NO YES NO

Hearing problems YES NO YES NO

2. To help people say how good or bad a health state is, we

have drawn a scale (rather like a thermometer) on which the

best state you can imagine is marked 100 and the worst state

you can imagine is marked 0.

We would like you to indicate on this scale how good or bad

you health is today, in your opinion. Please do this by

drawing a line from the box below to whichever point on the

scale indicates how good or bad your health state is today.

Worst

imaginable

health state

Your own

health state

today

Best imaginable health state

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3. By placing a tick in one box in each group below, please indicate which statement best describes your own health state today.

3a. Which of the following 3 categories best describes your level of mobility today?I have no problems in walking around I have some problems in walking around I am confined to bed

3b. Which of the following 3 categories best describes your ability to conduct your personal care activities today?I have no problems with personal care I have some problems washing or dressing myself I am unable to wash or dress myself

3c. Which of the following 3 categories best describes your ability to conduct your usual activities today (e.g. work, study, housework, family or leisure activities)?I have no problems with performing my usual activities I have some problems with performing my usual activities I am unable to perform my usual activities

3d. Which of the following 3 categories best describes the level of pain or discomfort you have experienced today (e.g. back pain/discomfort, headaches etc.)?I have no pain or discomfort I have moderate pain or discomfort I have extreme pain or discomfort

3e. Which of the following 3 categories best describes your mood today in relation to feelings of depression or anxiety? I am not anxious or depressed I am moderately anxious or depressed I am extremely anxious or depressed

PART E - Health service use in last four weeks.

This part of the survey is about your health care services, the cost to you (or your family) and the level of support you have had in the last 4 weeks. (Write 0 if no visits or no days)

Health services used in the last four weeks Number of times

Total cost to you

1. In the last four weeks, how many times have you seen a doctor (GP or specialist) at home, in the surgery or elsewhere?

2. In the last four weeks, how many times have you seen a community nurse?

3. In the last four weeks, how many times have you seen a health professional other than a doctor (eg physiotherapist, podiatrist, chiropractor, dietician, naturopath or similar? (NOT INCLUDING PHARMACISTS)

4. In the last four weeks, how many times have you been treated in casualty or the emergency department of a hospital but not admitted?

5. In the last four weeks, how many times have you been treated as an outpatient or at clinics at the hospital (seen a Dr. or other healthcare professional)?

6. Have there been any other costs needed to meet your health care needs in the last four weeks such as pathology (eg blood tests), biopsies, x-rays, etc.?

368

Health services used in the last four weeks No. of times

Totalcost.

7. Have you used in the last four weeks any support services (home nursing, Meals-on-wheels, home help)? Please

describe:_______________________

8. Have you had any other types of health care in the last four weeks? Please describe:_______________________

Hospitalisation in the last 12 months No. of times

TotalCost.

9. In the last 12 months, how many times have you been admitted to a public hospital?

10. In total, how many days were you in a public hospital?

11. In the last 12 months, how many times have you been admitted to a private hospital?

12. In total, how many days were you in a private hospital?

13. In the last 12 months, how many days did you spend in other care facilities (eg respite care or hostel)?

PART F- These questions are how much a DAA would be worth to you.

There is no right or wrong answer to these questions and we ask you to estimate the

value of the different potential benefits of DAAs given your needs and what you can

afford to pay per week for this service.

1. An adverse drug event is an illness related to medicines (including side effects and

allergies) or injury resulting from using a medicine. How much would you be willing

to pay to have your medicines packed in a device that would reduce your risk of

experiencing an adverse drug event? $----------------------- /week

2. How much would you be willing to pay to have your medicines packed in a device

and delivered to you so that your medication taking was easy and convenient?

$----------/week

3. How much would you be willing to pay to have your medicines packed in a device

that would make remembering to take your medications easier?

$----------------------- /week

Thank you for your participation in this interview. If we have any further questions that

we’d like to follow up, would it be ok for us to contact you again?

YES NO

Please place this questionnaire in the Reply Paid envelope provided.

369

APPENDIX I: HIC DATA DISTRIBUTIONS AND

MODELS

DISTRIBUTIONS OF AGGREGATED HIC SERVICE USE

VARIABLES

The following figures show the untransformed and transformed service use variables

used in analyses. Cost variables were transformed using a natural logarithm

transformation while variables concerning the number of items were transformed by a

square root transformation or by recoding into a dichotomous variable (e.g. received a

particular service or not).

0 50 100 150 200

No. PBS items in last yr

0

10

20

30

Fre

qu

en

cy

Mean = 85.45Std. Dev. = 37.682N = 224

2.0 4.0 6.0 8.0 10.0 12.0 14.0

Sqrt No. PBS items last year

0

10

20

30

40

Fre

qu

en

cy

Mean = 9.0192Std. Dev. = 2.03075N = 224

0 200

0

400

0

600

0

8000

10

00

0

$ PBS benefit in last yr

0

10

20

30

40

Fre

qu

en

cy

Mean = 2609.6423Std. Dev. = 1626.15511N = 224

6.00 7.00 8.00 9.00

Ln $ PBS benefit in last yr

0

10

20

30

40

50

Fre

qu

en

cy

Mean = 7.6802Std. Dev. = 0.64621N = 224

5 10 15 20 25 30 35 40

No. different PBS items in last year

0

10

20

30

Fre

qu

en

cy

Mean = 16.61Std. Dev. = 7.538N = 224

2.00 3.00 4.00 5.00 6.00

Sqrt No. different PBS items last yr

0

5

10

15

20

25

Fre

qu

en

cy

Mean = 3.9741Std. Dev. = 0.90635N = 224

Appendix Figure 4 PBS service use variables for services in the year before the homes

visit (untransformed and transformed)

370

2 4 6 8 10 12 14

No. different prescribers in last yr

0

10

20

30

40

50F

req

uen

cy

Mean = 4.08Std. Dev. = 2.395N = 224 2 4 6 8

No. different dispensers in last yr

0

20

40

60

80

100

120

Fre

qu

en

cy

Mean = 2.08Std. Dev. = 1.462N = 2241.00 1.50 2.00 2.50 3.00 3.50 4.00

Sqrt No. different prescribers last yr

0

10

20

30

40

50

Fre

qu

en

cy

Mean = 1.9406Std. Dev. = 0.56594N = 224

Appendix Figure 5 PBS service use providers for services in the year before the homes


0 2000 4000 6000 8000

Cost MBS items in hospital last yr

0

5

10

15

20

25

30

Fre

qu

en

cy

Mean = 1734.8828Std. Dev. = 1807.31821N = 61

5.00 6.00 7.00 8.00 9.00

Ln MBS costs in hospital last yr

0

2

4

6

8

10

Fre

qu

en

cy

Mean = 6.9989Std. Dev. = 0.97019N = 61

0 10 20 30 40 50 60

No. GP items (nonhospital) last yr

0

10

20

30

40

50

Fre

qu

en

cy

Mean = 16.8Std. Dev. = 10.765N = 224 0 500 1000 1500 2000 2500

Cost $ GP items (nonhospital) last yr

0

10

20

30

40

50

Fre

qu

en

cy

Mean = 601.7193Std. Dev. = 419.19789N = 223

5.00 6.00 7.00

Ln GP costs (nonhospital) last yr

0

5

10

15

20

25

30

Fre

qu

en

cy

Mean = 6.1899Std. Dev. = 0.6614N = 223

0.00 2.00 4.00 6.00 8.00

Sqrt No. GP items in last yr

0

10

20

30

40

Fre

qu

en

cy

Mean = 3.9156Std. Dev. = 1.21583N = 224

Appendix Figure 6 MBS service use variables for services in the year before the homes


371

0 20

0

40

0

60

0

80

0

10

00

12

00

Cost $ monitoring or pathology (nonhospital) last yr

0

10

20

30

40

50

60

Fre

qu

en

cy

Mean = 253.1158Std. Dev. = 242.14763N = 199

2.00 3.00 4.00 5.00 6.00 7.00

Ln monitoring/pathology costs (nonhospital) last yr

0

5

10

15

20

25

Fre

qu

en

cy

Mean = 5.1418Std. Dev. = 0.9091N = 199

0 20 40 60 80 100

No. monitoring or pathology items (nonhospital) last yr

0

10

20

30

40

50

60

70F

req

uen

cy

Mean = 15.93Std. Dev. = 18.671N = 224

0.00 2.00 4.00 6.00 8.00 10.00

Sqrt No. monitoring/pathology items in last yr

0

10

20

30

40

Fre

qu

en

cy

Mean = 3.3732Std. Dev. = 2.13886N = 224

0 1 2 3 4

No. emergency attendances last yr

0

50

100

150

200

Fre

qu

en

cy

Mean = 0.17Std. Dev. = 0.55N = 224

0 1 2 3 4

No. EPC items in last year

0

50

100

150

200

Fre

qu

en

cy

Mean = 0.32Std. Dev. = 0.691N = 224

0 1000 2000 3000 4000 5000

Other MBS costs last year (not GP, hospital or

monitoring/pathology)

0

5

10

15

20

Fre

qu

en

cy

Mean = 1001.6875Std. Dev. = 915.29596N = 56

3.00 4.00 5.00 6.00 7.00 8.00

Ln Other MBS costs last yr (no GP, hospital,

monitor/pathology)

0

5

10

15

20

Fre

qu

en

cy

Mean = 6.4859Std. Dev. = 1.08774N = 56

0.0

0

10

.00

20

.00

30

.00

40

.00

50

.00

60

.00

70

.00

Sqrt Other MBS costs last yr (no GP, hospital,

monitor/pathology)

0

50

100

150

200

Fre

qu

en

cy

Mean = 7.3218Std. Dev. = 14.18179N = 221

Appendix Figure 7 MBS service use variables for services in the year before the homes


372

-30 0 30 60 90

Change in No. PBS items post-pre

0

3

6

9

12

15F

req

uen

cy

Mean = 15.4062Std. Dev. = 25.06311N = 96

-1000.00

0.001000.00

2000.00

3000.00

Change in PBS cost post-pre

0

5

10

15

20

Fre

qu

en

cy

Mean = 676.9005Std. Dev. = 1012.72242N = 96

-10 0 10 20

Change in No. different PBS items post-pre

0

5

10

15

20

Fre

qu

en

cy

Mean = 0.7396Std. Dev. = 6.09097N = 96

-5 0 5 10

Change in No. different PBS items (excl1xsupply,

antiinfectives) post-pre

0

2

4

6

8

10

12

14

Fre

qu

en

cy

Mean = 1.2917Std. Dev. = 3.63584N = 96

-4.0

0

-2.0

0

0.00

2.0

0

4.00

6.0

0

Change in No. different prescribers post-pre

0

5

10

15

20

25

Fre

qu

en

cy

Mean = -0.2187Std. Dev. = 2.336N = 96

-8.00

-6.0

0

-4.0

0

-2.0

0

0.0

0

2.0

0

Change in No. different dispensers post-pre

0

10

20

30

40

Fre

qu

en

cy

Mean = -0.375Std. Dev. = 1.70603N = 96

Appendix Figure 8 Change (post-pre) for certain PBS and MBS service use variables

for the subset with complete data for both periods (excludes non-

pharmacy DAA users)

373

-60.0

0

-40

.00

-20

.00

0.0

0

20

.00

40

.00

Change in No. GP items post-pre

0

10

20

30

40

50F

req

uen

cy

Mean = 1.4479Std. Dev. = 11.43022N = 96

-2000 -1000 0 1000 2000

Change in cost of GP items post-pre

0

10

20

30

40

Fre

qu

en

cy

Mean = 140.8885Std. Dev. = 444.74087N = 96

-20.0

0

0.0

0

20

.00

40

.00

60

.00

80

.00

Change in No. monitoring/pathology items

post-pre

0

10

20

30

40

Fre

qu

en

cy

Mean = 7.3542Std. Dev. = 17.01329N = 96

-300.00

0.00300.00

600.00

900.00

1200.00

Change in cost of monitoring/pathology items

post-pre

0

5

10

15

20

25

30

Fre

qu

en

cy

Mean = 119.3883Std. Dev. = 236.78336N = 77

0.001000.00

2000.00

3000.00

4000.00

5000.00

6000.00

Cost MBS items in hospital - pre

0

5

10

15

20

Fre

qu

en

cy

Mean = 1481.1103Std. Dev. = 1623.8029N = 29

0.001000.00

2000.00

3000.00

4000.00

Cost MBS items in hospital - post

0

2

4

6

8

10

Fre

qu

en

cy

Mean = 1183.4407Std. Dev. = 1215.73674N = 27

Appendix Figure 9 Change (post-pre) for certain PBS and MBS service use variables

374

MULTIVARIATE MODELING OF COSTS

Appendix Table 18 Multiple linear regression model of Ln $ PBS benefit in last year

Model Source Sig. (p) B Partial Eta2

Best model including covariates: Ln $ PBS benefit in last yr

Corrected Model <0.001 0.345

Intercept <0.001 6.471 0.710

Self rated health status (poor -excellent) 0.023 -0.134 0.029

Symptom frequency (not at all, rarely or sometimes vs most days)

0.027 Low=-0.190 High=0 0.027

Sqrt (94-age) <0.001 0.165 0.112

No. different pharmacies dispensing medicines (per pt)

0.052 0.133 0.021

Sqrt total No. current medicines at home <0.001 0.304 0.096

R Squared = 0.345 (Adjusted R Squared = 0.323)

Any hospital admission last yr per pt 0.101 No=-0.133 Yes=0 0.015

Best model including covariates + 3 group DAA: Ln $ PBS benefit in last yr


Intercept <0.001 6.389 0.697

Self rated health status 0.017 -0.139 0.032

Symptom frequency 0.013 Low=-0.212 High=0 0.035

Sqrt (94-age) <0.001 0.165 0.103


0.024 0.154 0.029




DAA 3 group 0.022 Pharm DAA=0.190 Non-pharm DAA=0.288 OP=0

0.043

Best model including covariates + 2 group DAA: Ln $ PBS benefit in last yr


Intercept <0.001 6.512 0.700



Sqrt (94-age) <0.001 0.161 0.093


0.047 0.153 0.026




DAA 2 group 0.040 OP=-0.192 Pharm DAA=0 0.027

Best model with between group covariates + 3 group DAA: Ln $ PBS benefit in last yr


Intercept <0.001 6.448 0.701



Sqrt (94-age) <0.001 0.158 0.093


0.013 0.173 0.036



DAA 3 group 0.030 Pharm DAA=0.178 Non-pharm DAA=0.300 OP=0

0.041


Reported disorganised nonadherence 0.407 Low=-0.069 High=0 0.004

No additional between group covariates improved the model for Pharmacy DAA vs OP

375

Appendix Table 19 Multiple linear regression model of Ln $ nonhospital GP MBS

services in last year


Best model including covariates: Ln $ GP MBS services in last yr


Intercept <0.001 6.461 0.848

Living alone 0.013 No=-0.190 Yes=0 0.029

Self-rated health status 0.031 -0.105 0.022

No. GP visits in last 2 wks <0.001 0.152 0.294


Sqrt (94-age) 0.012 -0.082 0.030

Best model including covariates + 3 group DAA: Ln $ GP MBS services in last yr


Intercept <0.001 6.400 0.829




Sqrt (94-age) 0.040 -0.069 0.020


DAA 3 group 0.227 Pharm DAA=0.025 Non-pharm DAA=-0.172 OP=0

0.013

Best model including covariates + 2 group DAA: Ln $ GP MBS services in last yr


Intercept <0.001 6.277 0.829




Sqrt (94-age) 0.059 -0.066 0.020



Best model with between group covariates + 3 group DAA: Ln $ GP MBS services in last yr


Intercept <0.001 6.580 0.817




Sqrt (94-age) 0.048 -0.069 0.024

DAA 3 group 0.372 Pharm DAA=0.058 Non-pharm DAA=-0.143 OP=0

0.012

Any ADR 0.024 No=-0.202 Yes=0 0.032

Any hospital in last yr per pt 0.946 No=0.006 Yes=0 0.000

Reported disorganised nonadherence 0.026 No=-0.199 Yes=0 0.031


No. different prescribers per pt 0.500 -0.035 0.003

Best model with between group covariates + 2 group DAA: Ln $ GP MBS services in last yr


Intercept <0.001 6.204 0.804




Sqrt (94-age) 0241 -0.048 0.010


Any hospital in last yr per pt 0.675 No=0.041 Yes=0 0.001

Any ADR 0.147 No=-0.138 Yes=0 0.015

Gender 0.339 Male=-0.101 Female=0 0.007



No. different dispensers per pt 0.196 0.119 0.012

376

Appendix Table 20 Multiple linear regression model of Ln $ MBS services in hospital in

last year


Best model including covariates: Ln $ MBS hospital services in last yr

Corrected Model 0.005 0.177

Intercept 0.000 8.528 0.746

Any hospital in last yr per pt 0.031 No=-0.647 Yes=0 0.084


OARS IADL score 0.034 -0.114 0.080

Best model including covariates + 3 group DAA: Ln $ MBS hospital services in last yr


Intercept <0.001 9.078 0.731


OARS IADL score 0.016 -0.141 0.107


DAA 3 group 0.440 Pharm DAA=-0.362 Non-pharm DAA=-0.049 OP=0

0.031

Best model including covariates + 2 group DAA: Ln $ MBS hospital services in last yr


Intercept <0.001 8.785 0.728


OARS IADL score 0.022 -0.149 0.107



Best model with between group covariates + 3 group DAA: Ln $ MBS hospital services in last yr


Intercept <0.001 10.688 0.843


OARS IADL score 0.002 -0.175 0.221

DAA 3 group 0.085 Pharm DAA=-0.628 Non-pharm DAA=-0.112 OP=0

0.122




Sqrt (94-age) 0.005 -0.298 0.193

Best model with between group covariates + 2 group DAA: Ln $ MBS hospital services in last yr


Intercept <0.001 10.032 0.792


OARS IADL score 0.031 -0.164 0.137

DAA 2 group 0.028 OP=0.701 Pharm DAA=0 0.142



Sqrt (94-age) 0.016 -0.286 0.169


Regular carer 0.401 No=-0.272 Yes=0 0.022

377

Appendix Table 21 Multiple linear regression model of Ln $ nonhospital monitoring/

pathology MBS services in last year


Best model including covariates: Ln $ monitoring/pathology MBS services in last yr


Intercept <0.001 5.312 0.634

No. doctors seen regularly 0.007 0.139 0.040


No. different illnesses per pt 0.180 0.045 0.010

No. GP visits in last 2 wks 0.148 0.041 0.012

Any ADR 0.274 No=-0.145 Yes=0 0.007

Health compared to others 0.069

Worse= -0.184 same= 0.205 better=0 0.030


Reported memory-related nonadherence 0.184 No= -0.211 Yes=0 0.010

Best model including covariates + 3 group DAA: Ln $ monitoring/pathology MBS services in last yr


Intercept <0.001 5.144 0.612





Any ADR 0.210 No= -0.167 Yes=0 0.009

Comparative health status 0.096




DAA 3 group 0.305

Pharm DAA=0.207 Non-pharm DAA=0.033 OP=0 0.013

Best model including covariates + 2 group DAA: Ln $ monitoring/pathology MBS services in last yr


Intercept <0.001 5.516 0.608





Any ADR 0.203 No=-0.138 Yes=0 0.011






Best model with between group covariates + 3 group DAA: Ln $ monitor/pathol MBS services last yr


Intercept <0.001 4.615 0.612





Any ADR 0.300 No=-0.142 Yes=0 0.007


Worse= 0.024 same= 0.267 better=0 0.025


DAA 3 group 0.050

Pharm DAA=0.355 Non-pharm DAA=-0.043 OP=0 0.037

Living alone 0.208 No= 0.178 Yes=0 0.010

Regular community health visits 0.297 No= 0.169 Yes=0 0.007


Impaired IADL 0.084 No= 0.282 Yes=0 0.019

378

Appendix Table 21 continued


Best model with between group covariates + 2 group DAA: Ln $ monitor/pathol MBS services last yr


Intercept <0.001 5.115 0.599





Any ADR 0.315 No=--0.157 Yes=0 0.007







Impaired IADL 0.219 No= 0.227 Yes=0 0.011

Appendix Table 22 Multiple linear regression model of Ln $ other nonhospital MBS

services in last year


Best model including covariates: Ln $ other nonhospital MBS services in last yr


Intercept <0.001 6.020 0.782

No. doctors seen regularly <0.001 0.340 0.260




Best model including covariates + 3 group DAA: Ln $ other nonhospital MBS services in last yr


Intercept <0.001 6.209 0.753





DAA 3 group 0.673

Pharm DAA=-0.172 Non-pharm DAA=-0.334 OP=0 0.016

Best model including covariates + 2 group DAA: Ln $ other nonhospital MBS services in last yr


Intercept <0.001 5.899 0.721






No additional between group covariates improved the model for the 3 group

comparison or the pharmacy DAA vs OP comparison.

379

APPENDIX J: INTRODUCTION TO MACHINE

LEARNING

Recently many different machine learning techniques have been gaining popularity

including naïve Bayesian Classifiers, k-nearest neighbour or clustering algorithms,

Artificial Neural Networks and decision tree generators. Within medicine they have

been used in areas such as oncology, liver pathology, thyroid disease, rheumatology,

cardiology and neuropsychology and this list is by no means exhaustive (Kononenko

2001).

Which technique is most appropriate for each of these areas or indeed individual

projects is a difficult question to answer. The ‘no free lunch’ principal that has been

discovered in machine learning suggests that there is no one technique which is best in

all situations and thus a variety of approaches should be attempted.

Kononenko suggests that a number of specific requirements need to be met in order to

apply machine learning techniques in the field of medicine.

1. Good performance: Should do better than physicians to be useful.

2. Deal with missing data well: as is often the case in medical databases.

3. Dealing with noisy data: again, this is usual in medicine and machine learning is

better for this than traditional linear stats.

4. Transparency of diagnosis: The physician has to be able to see how the solution

was generated. Should be able to generate new ideas to be later tested.

5. Should be able to explain how it comes to decision when classifying new cases.

6. Reduce the number of diagnostic tests needed for each patient.

In terms of meeting these guidelines Kononenko made a comparison of 7 different

machine learning algorithms on 8 different medical data sets. He assessed the results

in general for each algorithm and found that decision trees were the best algorithm for

use in medicine.

Decision trees are a type of supervised machine learning which graphically represent

relationships found in data sets. A decision tree is made up of nodes and branches. At

each step of the construction of a tree nodes are selected by calculating the attributes

and values that reduce the average entropy by the greatest amount at each split in the

tree.

Kononenko also pointed out that decision trees are the only method that automatically

select appropriate attributes from the data set and are the only technique that fulfils the

reduction of tests needed criteria.

The transparency of the inner workings of the various techniques has been mentioned

as being important by a number of researchers (Kononenko 2001; Lavrac 1999).

Richards et al. (Richards et al. 2001) make the point that for patterns found by machine

learning algorithms to be accepted by the medical community they must be capable of

human interpretation, and that techniques which generate rules will be most useful.

In terms of transparency Bayesian classifiers and Decision Tree generators give the

best results. The Bayesian classifier gives a list of how much information each input

380

gives about making the decision for or against, which physicians found to be much like

how they made their diagnosis (Kononenko 2001). Kononenko also found that when

using decision trees the amount of conditional statements needed to be neither too

short nor long to satisfy physicians.

The different algorithms performed at a similar level of accuracy. Kononenko points out

that the naïve Bayesian classifier was more accurate in making correct classifications

in 5 out of the 8 medical diagnosis problems. However, Bayesian techniques can only

be used with discrete and not continuous values for all variables making them less

suitable for this research.

In one of the 8 studies carried out by Kononenko which involved classifying ischemic

heart disease, Decision Tree algorithms improved decision making by up to 16% in

positive cases and 37% in the correct prediction of negative cases compared to

diagnoses made by medical experts in the field.

Lavrac (Lavrac 1999) argues that merely looking at percentage gains such as this is

not enough in terms of performance evaluation and that other selected measures must

be used depending on the task at hand. Even though diagnosis or prognosis

classification accuracy is most often used it is not necessarily the most interpretable or

best approach.

Classification Accuracy is a simple statistic used to determine which rules are included

in decision trees etc. There are four different sets that can be used to classify results,

True Positives (TP), True Negatives (TN), False Positives (FP) and False Negatives

(FN). Classification accuracy is measured by the equation ‘Classification accuracy =

TP+TN/TP+TN+FP+FN’ (Lavrac pp15).

Two other measures that are generally of use in considering the performance of

machine learning algorithm are sensitivity and specificity: ‘Sensitivity measures the

fraction of positive cases that are classified as positive. Specificity measures the

fraction of negative cases classified as negative. Therefore, ‘Sensitivity = TP/TP+FN,

and Specificity = TN/TN+FP’ (Lavrac pp 15). Lavrac states that these measures are

considered more important than accuracy alone in the medical setting. In any

classification problem the aim is to maximise sensitivity and minimise the false alarm

rate (1-specificity).

effectiveness and cost effectiveness of dose administration aids

Documents