annual report 2010/11web).pdf · 2012. 10. 18. · 16 yellow card reports received by yccny since...

2010/11

REGIONAL DRUG AND THERAPEUTICS CENTRE - NEWCASTLE

ANNUAL REPORT

n

Annual Report2010/11

n

Re

gio

na

l D

ru

g &

Th

er

ap

eu

tic

s C

en

tr

e -

Ne

wc

as

tl

e

Aims

“The aims of the Regional Drug and Therapeutics Centre are to promote

the safe, effective and economical use of medicines in the National

Health Service in the former Northern and Yorkshire Region; and other

stakeholder areas to promote the highest quality of care for people

exposed to the toxic effects of drugs or chemicals; and to disseminate

and develop knowledge in these areas through teaching and research”

Contents

Page No.

FOREWORD 6

EXECUTIVE SUMMARY 7

INTRODUCTION 9

QUALITY IMPROVEMENT 10

OVERVIEW 10

Prescribing Support 10

Medicines Information / NHS Direct 17

Poisons Information 18

Teratology 21

INNOVATION 24

OVERVIEW 24



Teratology 27

IMPROVING PRODUCTIVITY 30

OVERVIEW 30



Teratology 40

PREVENTION OF HARM 42

OVERVIEW 42



Yellow Card Centre 46

Teratology 48

APPENDICES

APPENDIX I Prescribing Support Publications 54

APPENDIX II Financial Summary 56

APPENDIX III External Training and Development 57

APPENDIX IV In-House Training and Development 58

APPENDIX V Contributions to External Courses 59

APPENDIX VI Lectures, Workshops and Presentations 60

APPENDIX VII Publications in Scientific and Medical Journals 62

APPENDIX VIII Staffing Establishment 64

APPENDIX IX External Positions Held 66

APPENDIX X Business Plan 68

Contents

Page No.

FIGURES

1 Example of practice-level QOF data relating to cost/patient of lipid lowering drugs to QOF target achievement

11

2 Example of stakeholder PCTs’ ezetimibe prescribing cost trends April 2007 to September 2010

12

3 Expenditure and cost growth of the top 20 drugs (by cost) in the North of England - January - April 2011

31

4 Example of the estimated potential monthly savings from switching formulation 32

5 Example of total extra costs incurred by stakeholder PCTs as a result on NCSO and conces-sionary price increases April 2010 to February 2011

33

6 Medicines Information enquiries 2010/11 by local origin 35

7 General Medicines Information enquiries from Primary Care 2010/11 by enquirer 35

8 All Medicines Information enquiries 2010/11 by enquiry subject 36

9 Therapeutic pregnancy enquiries from the North East and Yorkshire 2010/11 37

10 Total number of NHSD MI calls for 2010/11 by site 38

11 Total number of NHSD MI calls for 2005/06 to 2010/11 39

12 Total number of NHSD calls for 2010/11 by enquirer subject 39

13 Example of weighted prescribing of low-dose antipsychotics by stakeholder PCTs April 2008 - March 2010

43

14 Example of weighted quinine prescribing in stakeholder PCTs April 2007 - September 2010 43

15 Weighted cephalosporin prescribing in the North of England SHAs April 2007 - September 2010

44

16 Yellow Card reports received by YCCNY since April 2005 46

17 Yellow Cards received by YCCNY in 2010/11 47

18 Total number of exposures by category of exposure during financial year 2010/11 49

19 Top 10 enquiries to UKTIS for financial years 2006/07, 2007/08, 2008/09, 2009/10, 2010/11 50

20 Telephone enquiries and TOXBASE® sessions from 2006/07 to 2010/11 51

TABLES

1 Telephone Quality Assurance survey satisfaction scores 20

2 Summary of UKTIS enquirer satisfaction scores 23

3 New and updated pregnancy-related monographs added to TOXBASE® in 2010/11 41

4 Drugs most commonly involved in ADR reports during 2010/11 47

5 Telephone enquiries to UKTIS by exposure category in 2010/11 50

6 Top 20 most accessed pregnancy summaries on TOXBASE® in 2010/11 52

Foreword

6

In the ever changing environment of the modern NHS, provision of high quality information and expert advice is key to the commissioning and delivery of safe, clinically excellent and cost-effective healthcare.

This applies across the NHS from individual GP practices through NHS Trusts to the specialist network level.

The unique blend of services and proactive support provided by the Regional Drug and Therapeutics Centre allows knowledge and expertise to be shared across stakeholders

reducing duplication of effort and facilitating best and equitable use of limited resources.

Staff within the centre have responded to the challenges posed by changes in NHS structure with their usual dedication and professionalism and we are proud to work

alongside them.

The centre as a whole continually strives to provide the best services possible. As the NHS moves to a new model of commissioning in the coming months

we will seek to identify and meet the needs of evolving organisations whilst continuing to work in partnership with existing commissioners and service

providers.

We commend the 2010/11 annual report as a means of reviewing our work over the past 12 months and welcome any comments and sug-gestions from stakeholders for future work priorities and development opportunities.

Sue Brent Director of Pharmacy

Simon ThomasMedical Director and Consultant Physician

Sage Building, Gateshead - Photographer Rob Gourlay- Regional Drug & Therapeutics Centre

Executive Summary

7

During 2010/11 the Regional Drug and Therapeutics Centre (RDTC) met Business Plan targets, delivered a range of high quality services and provided tailored support to commissioners across a range of Service Level Agreements.

Quality Improvement

Work to improve the quality of prescribing reports and data analysis has resulted in increased responsiveness to needs, • changing circumstances and improved timeliness of information. Practice level information is now available across a range of reports and continues to be further developed in line with ongoing organisational changes within the wider NHS. Short analysis reports with accompanying evidence based reviews were distributed for the first time along with reviews to support local QIPP initiatives.

Medicines information staff delivered training to a range of individuals from NHS Direct Nurses and Health Information • Advisers to local pre-registration trainees and PCT pharmacists, at locations ranging from RDTC offices to call centres or PCT training facilities. The RDTC was externally audited as part of the UKMi governance process with informal feedback commending internal training and checking procedures.

Over 17,000 poisons calls were answered during 2010/11 with accidental poisoning accounting for almost half (46%) of • enquiries. Overall satisfaction ratings, determined by questionnaire remained high with 96% of respondents rating the service as very good or excellent; an increase on 2009/10.

Teratology monographs were revised to improve accessibility of information through the use of a concise detailed • summary, tabulation of data and new operating procedures for the production process. Satisfaction scores from enquirers remain high with over 93% being highly satisfied with the service received.

Innovation

The RDTC offers a unique set of tools combining prescribing analysis data with critical appraisal of the underpinning • knowledge base thus providing medicines management teams with information to meet some of the current challenges around quality and cost effectiveness of prescribing. A newly developed section of the RDTC website now offers a secure area for stakeholders to access reports and shared support materials allowing innovative approaches to be employed across a wider geographical area with greater ease.

Two new publication series, ‘Hot Topic’ and ‘Medicines Management Briefings’ were launched in 2010/11 in response • to stakeholders’ requests for information to assist in influencing and challenging prescribing behaviours and also to medicines management issues not covered under the existing publication portfolio. Selected prescribing reports in Excel format were also produced to facilitate further work at local level in tailoring information to organisational requirements.

Executive Summary

Quayside, Newcastle upon Tyne - Photographer Rob Gourlay- Regional Drug & Therapeutics Centre

8

Improving Productivity

Streamlining internal data analysis systems allowed the production of increased numbers of ad hoc reports and wider • analysis at practice level freeing up resources and reducing duplication of effort across stakeholder organisations. Individualised QIPP reports for the three north of England SHAs were produced for the first time allowing benchmarking and trend data in key areas to be monitored. NCSO (‘no cheaper stock obtainable’) reports alerted medicines management teams to the risks of increased costs associated with price fluctuations of generic medicines in short supply.

During 2010/11, RDTC medicines information staff continued to support NHS Direct complex medicines information • calls through enquiry answering and provision of training to NHS Direct staff with the aim of allowing patients and their families to remain in the home environment whenever possible and avoiding referral to other high demand services such as A&E or GP services.

UKTIS produced 100 new and updated pregnancy monographs during 2010/11, a 100% increase on the previous year • as well as introducing new software allowing more efficient logging of data, improved enquiry handling speeds and peer review checking.

Prevention of Harm

Two prescribing reports focussed on patient safety issues - appropriate use of low-dose antipsychotics, and quinnine • prescribing. Reports to assist in the monitoring of both controlled drugs and antimicrobials were also prepared and distributed to stakeholders. Support and advice on implementing controlled drugs legislation was part of the ongoing service level agreement with the North East Ambulance Service (NEAS) covering medicines management issues specific to this specialist Trust.

Reporting of suspected adverse drug reactions to the Yellow Card Centre Northern and Yorkshire (YCCN&Y) by GPs • and hospital doctors increased by 27% and 11% respectively and reporting from nurses by a further 5% on figures for 2009/10. PCTs receiving tailored support from the YCCN&Y with the aim of raising awareness of Yellow Card reporting demonstrated increases of up to three times baseline reporting levels.

Conclusion

During 2010/11, in response to organisational changes and increased financial pressures across the wider NHS, the RDTC maintained its ongoing programme of engagement and consultation with stakeholders, continually reviewing and further developing a unique portfolio of support materials to provide a responsive, clinically effective and cost-effective service.

Introduction

9

The Newcastle based Regional Drug and Therapeutics Centre (RDTC) is responsible for a range of issues relating to medicines use and drug safety. These include monitoring and advising on prescribing and medicines use in primary and secondary care, and the provision of quality assurance for medicines in Northern and Yorkshire.

The Centre was established in 1991 as collaboration between the University and the former Northern Regional Health Authority. Over the course of the last eighteen years, services provided by the Centre have developed and increased in volume as the Centre has acquired larger contracts and has expanded the geographical area it covers. The Centre is housed on Newcastle University campus and is hosted by the Newcastle upon Tyne Hospitals NHS Foundation Trust, which is responsible for employing most of the staff.

Core funding for the Centre is obtained from local Primary Care Trusts under a Service Level Agreement, the Centre also has substantial contracts with other organisations (e.g. the Health Protection Agency) which allows a more cost-effective delivery of services for all stakeholders.

The Centre delivers a broad range of services relating to prescribing and the use of medicines. These include:

National Poisons Information Services (NPIS)The UK Teratology Information Service (UKTIS)Regional Yellow Card Centre Northern and YorkshireRegional Medicines Information ServicesPrescribing Analysis and Support Services

The Centre is also active in education and training and in research relating to all aspects of medicines and therapeutics, with a particular focus on safe and effective utilisation of medicines, management of poisoning, prevention of adverse drug reactions and the appropriate use of medicines during pregnancy.

10

Quality Improvement

Overview

High quality care for patients remains a central theme for workstreams across the RDTC activities. Supporting decision making for commissioners and prescribers around new drugs and therapies coming to market as well as licence changes and extensions has been a core activity for a number of years. Working across a wide geographical area and with local consortium to SHA-and national-level groups facilitates sharing of good practice and an in depth understanding of current issues for our expert teams in Prescribing Support, Medicines Information, Poisons and Teratology information. Established quality assurance processes monitor feedback from stakeholders and enable a prompt response to any issues which may arise.

Prescribing Support

Work has continued to improve the quality of the prescribing report and data analysis service provided to our stakeholders. This centres on being responsive to needs, and changing circumstances, by providing information in a timelier manner. For example, short ad hoc reports are produced to accompany some of our evidence-based publications and also cover particular areas of prescribing raised by one or more stakeholders. We have also been able to produce more practice-level reports and prescribing data charts.

Prescribing quality and cost effectiveness

QOF report

This report presents comparative PCT-and SHA-level data on prescribing costs per patient on QOF disease registers against QOF target achievement, disease prevalence and hospital admission data for relevant disease areas (against prescribing cost, where appropriate). It continues to be well received, and has led to stakeholder requests to replicate the charts at practice level.

Practice-level QOF charts have been very well received by both prescribing advisers, GPs and other practice staff and often form the basis of discussions around prescribing costs and quality at practice meetings. They provide a starting point for peer review, discussion and sharing of practice among prescribers, practices and groups of practices, which will be of value when clinical commissioning groups assume commissioning roles in the future. Presenting data for QOF target achievement against prescribing costs and prescribing costs against hospital admissions highlights “outliers”. Further discussion around apparent “outliers” may help identify differing patterns of service provision, and areas of prescribing where cost effectiveness of prescribing and quality of care could be improved. See Figure 1.

Short-prescribing reports

These provide more in-depth analysis than is possible in our regular prescribing reports, and cover other therapeutic areas. For example:

11

Quality Improvement

105

100

95

90

85

80

75

70

65

6030 40 50 60 70 80 90 100 110 120

% ta

rget

met

NIC / patient (£) Lower % patients at target - High prescribing costLower % patients at target - Low prescribing cost

Higher % patients at target - Low prescribing cost Higher % patients at target - High prescribing cost

Figure 1 Example of practice-level QOF data relating to cost/patient of lipid-lowering drugs to QOF target achieve-ment (percentage of patients with coronary heart disease, transient ischaemic attack/stroke and diabetes whose last

recorded cholesterol within the previous 15 months was 5 mmol/l or less).

Ezetimibe prescribing report

In January 2011, a short report on ezetimibe prescribing cost trends (see Figure 2, page 12) was produced to complement our ‘Hot Topic’ document and its accompanying Academic Detailing Aid. Information was provided about work already undertaken by medicines management teams to audit and reduce ezetimibe prescribing, and shared support materials were included. This report was particularly well received with a lot of interest in the support materials.

Vitamin supplements for age-related macular degeneration (AMD)

In January 2011, we produced comparative data on prescribing of vitamin supplements that are used for AMD. A number of nutritional supplements containing antioxidants and/or zinc, which are promoted for the improvement of ocular health, are available over-the-counter. Whilst not licensed for AMD, some can be prescribed on the NHS though the evidence for their efficacy is limited. Data on prescribing costs and frequencies of such supplements were requested by a stakeholder, so charts were produced for all stakeholders to highlight this issue, and serve as a starting point for further investigation at a local level.

Managing the entry of new drugs

New Drug Evaluation Publications

The RDTC remains committed to promoting high quality care for patients. One of the most important objectives of our various publications is to manage the introduction of new medicines into the NHS. The New Drug Evaluations are concise, structured reviews of new drugs recently launched within the NHS which are considered to be primary care orientated and have a large financial or clinical impact. In addition, drugs that are likely to be initiated in secondary care but transferred to primary care are also evaluated. In line with current QIPP national initiatives new drug evaluations are designed to support quality and efficacy at a local level by guiding primary care organisations in promoting appropriate, effective and efficient prescribing. Recent publications include evaluations of newly licensed Denosumab and Ticagrelor.

Quality Improvement

12

PCT A

PCT B

PCT C

PCT D

PCT E

PCT F

PCT G

PCT H

PCT I

PCT J

North of England

England

SHA

11.0

10.0

9.0

8.0

7.0

6.0

5.0

4.0

3.0

0708

Q1

0708

Q2

0708

Q3

0708

Q4

0809

Q1

0808

Q2

0809

Q3

0809

Q4

0910

Q1

0910

Q2

0910

Q3

0910

Q4

1011

Q1

1011

Q2

Figure 2 Example of stakeholder PCTs’ ezetimibe prescribing cost trends April 2007 - September 2010

Key: NIC: Net Ingredient Cost, i.e. the price to the NHS; Statins STAR-PU: specific therapeutic age-related prescribing unit, a weighting unit based on costs within therapeutic groups, which relates to the age and sex of patients for whom drugs in specific

therapeutic groups are usually prescribed

NIC

(£)/1

00 s

tatin

s ST

AR

-PU

Quality Improvement

13

Detailed evidence based reviews

Effective Medicines Management is central to the quality of patient care and has never been more important given the financial pressures that the NHS is likely to face in the future. The RDTC is ideally placed to support the commissioning of medicines locally. Detailed guidance to support the NHS with rational decision-making about medicines is contained in our evaluation reports. These evaluation reports give a comprehensive appraisal of the efficacy, adverse events, place in treatment and arrangements for prescribing of drugs that are likely to have a significant clinical or financial impact on the NHS. The evaluation reports provide advance objective appraisals of the clinical and cost effective use of medicines in secondary care before NICE (National Institute of Health and Clinical Excellence) issues guidance. These reports describe in more detail the important clinical aspects of a particular disease and also aim to give commissioners estimates of the potential uptake across a population, service and financial implications, where possible. Recent topics have included a comprehensive evaluation of new treatments for Human Immunodeficiency Virus (HIV) infections and the use of sunitinib for the treatment of Pancreatic Neuroendocrine Tumours (PNETs).

Quality Improvement

North East Treatment Advisory Group (NETAG)

The RDTC in its collaborative arrangement with the NETAG has acted as the lead author in the production of a number of detailed treatment appraisal reports. Such appraisal reports are the principal source of evidence used by NETAG members to make recommendations on the commissioning of treatments within NHS North East. The principal aims of the work undertaken by NETAG are to provide regionally consistent advice to primary care organisations within NHS North East and to ensure that patients requiring non-NICE-approved treatments receive equitable access to a clinically defined and appropriate range of treatments. Although NETAG has a remit to consider drug and non-drug treatments such as medical devices and interventional procedures, the majority of treatment appraisals reports produced by the RDTC have assessed new or unlicensed pharmaceutical treatments. Recent topics have included the use of Sativex® for spasticity due to Multiple Sclerosis and the use of tocilizumab for juvenile idiopathic arthritis. In light of the significant changes planned for the commissioning structure of the NHS, the RDTC will continue to work with NETAG to identify potential new treatments and provide commissioners with advance notice of developments, through horizon scanning, signposting and critical appraisal of evidence, safety and cost-effectiveness as appropriate.

Attendance at meetings of groups involved in new drug approvals

Senior prescribing team pharmacists attend specific new drugs meetings such as the Greater Manchester Interface and New Therapies meeting. The RDTC provides independent advice alongside local medical and pharmaceutical representation to make recommendations on new drugs and the Red-Amber-Green status to the parent medicines management Group (GMMMG) and local Drug and Therapeutics Committees of Greater Manchester NHS organisations. Recommendations are based on clinical evidence in order to manage the introduction of new medicines which have health economy-wide implications for primary, secondary and specialist care. This group provides prescribers with guidance on newly licensed therapies and indications with regard to the product’s place in treatment. This will ensure that prescribers have balanced information with which to inform their prescribing decisions. A drug’s priority for funding is also discussed. Other groups where the RDTC provides independent advice on new drugs include the North of Tyne APC and the County Durham and Darlington D&T.

Support to the Greater Manchester Cancer Commissioning Process

The RDTC continues to provide advice and support to the Greater Manchester Cancer Commissioning process in partnership with the GM&C Cancer Network ensuring that innovative and cost effective new cancer medicines are prioritised and commissioned through a GM wide development process. The aim of the process is to have a prioritised list created by clinicians that supports PCTs by provision of a clear and robust commissioning tool. This process is supported intensively by the RDTC through the provision of evidence based evaluations and considered recommendations made by senior staff.

Support to formulary groups

The RDTC provides support to the Greater Manchester Formulary Subgroup. This group was tasked with producing a joint primary and secondary care formulary for implementation across Greater Manchester by April 2011. The formulary is one of five main work-streams of the medicines management QIPP plan (optimising use of the drug of choice) with the aim being to maximise safe, effective and economic prescribing. The formulary will also ensure that patients receive seamless care across the primary-secondary care interface and reduce the

14

Quality Improvement

need for switching programmes. The RDTC facilitated the process, coordinating the writing and commenting of the chapters, developing the process and designing and managing the website that hosts the formulary. A ‘do not prescribe’ list is also being finalised alongside the formulary which suggests specific drugs that are disinvestments for a trust or area.

Prescribing reports

Charts showing comparative prescribing (at north of England-, PCT- and SHA-level) of new drugs continue to be included in the Quarterly Prescribing Report. Comparative data on frequency of prescribing of new drugs that NICE has approved in its technology appraisals (TAs) are presented in the annual Prescribing of Drugs Subject to NICE Guidance Report.

In addition, in 2010/11 the RDTC has produced specific data on request, examples of which are outlined below.

The North East Treatment Advisory Group (NETAG) reviews new drugs that are either the first drug of a new chemical class, subject to specialised commissioning or in response to requests from North East PCOs, and isses recommendations on whether these drugs should be used in the North East’s health economy. The RDTC produced prescribing data and analysis of a number of NETAG-reviewed drugs (agomelatine, bosentan, roflumilast, novel fentanyl formulations, deferasirox, ulipristal, sodium oxybate).

In June 2010, the Northern Cancer Network and the Palliative care Physicians Group requested prescribing data on novel fentanyl presentations, the use of which had not been recommended by NETAG. If such presentations were prescribed, the prescriber was required to complete an audit form. The prescribing data enabled the enquirers to establish where they had been prescribed. They were then able to request further information at local level to monitor whether the agreed audit procedure had been followed.

Provision of Strategic Medicines Management Advice and Support

Members of the RDTC prescribing support team work with medicines management groups across the North of England. This includes direct support in the form of attendance at meetings of groups involved in medicines management by senior members of the prescribing support team and also the provision of general support and advice. Some specific examples of this strategic advice and support are as follows:

Report interpretation

Key prescribing reports are presented at some meetings (e.g. County Durham and Darlington D&T) outlining the areas for the group to focus on and areas of potential improvement. This localised, specific interpretation of data is highly useful to group members because it is immediately relevant and points out key areas to consider in improving care of their patients.

Provision of overviews of comparative budgetary performance

Highlighting areas where costs could be reduced and cost effectiveness improved. This very specific interpretation of local data at meetings accompanied by ad hoc email and telephone queries allows our respective NHS colleagues to be aware of key issues they might otherwise have missed. Information is presented in a variety of formats ensuring the data is understandable and easily interpreted.

15

Quality Improvement

Local Decision Making (LDM)

The NHS in the North East recently embarked on a comprehensive review of LDM processes and structures. Support for the process was provided by staff at the RDTC, with additional support provided by the then NPC LDM Facilitator role. Arrangements for making decisions about the use of medicines in the NHS in the North East of England have evolved with existing commissioning processes and have many recognised strengths. Nonetheless, the NHS in the North East, as elsewhere, will need to adapt arrangements for making decisions about drugs to contribute to QIPP plans and to take account of planned changes to commissioning arrangements. Chief Executive approval and SHA level leadership was secured and the LDM review incorporated into the medicines management work stream of the NE regional QIPP programme. The review was overseen by a steering group drawn from the local Senior Pharmacy Managers group and co-ordinated by the RDTC. Steering group members came from both commissioning and provider organisations with all four commissioning clusters in the North East represented.

Review aims were to provide stakeholders with a clear map of current decision-making processes in the region, to ensure widespread adoption of good practice, and to identify key principles and potential options for LDM development for new commissioning organisations.

The RDTC provided support and advice to facilitate a review of local procedures and ensure compliance with the NHS constitution and DH directions, support development of a local ethical framework for decision making groups to ensure consistency of approach and to ensure transparency of decisions made. The report has been presented to the NE Chief Executives and the way forward is currently being finalised. Details of the review were presented at the NICE conference in May 2011.

Support to Clinical Commissioning Groups

With the forthcoming changes clinical commissioning groups will become increasingly interested in promoting cost effective, evidence-based prescribing, as a means of quickly freeing limited resources to reinvest in other services. Strategic support can be provided to individual commissioning groups to help them in achieving this objective. A senior member of RDTC staff provides regular strategic medicines management advice to a practice-based commissioning (PBC) consortium in Sheffield. This support is in addition to local medicines management team support and includes independent advice on specific projects such as utilising the decision support tool ScriptSwitch®, education and training events and in-depth evaluation of prescribing data.

Strategic meetings that the RDTC prescribing team support include:The North of Tyne APC• County Durham and Darlington APC• County Durham and Darlington D&T• The North East SHA Heads of Medicines Management meeting• Yorkshire & Humber Prescribing Leads• Central Sheffield Commissioning Consortium Prescribing Subgroup• Greater Manchester Medicines Management Group• Greater Manchester Formulary Subgroup• Greater Manchester Interface and New Therapies Subgroup• Greater Manchester and Cheshire Cardiac Network•

16

Quality Improvement

Greater Manchester Prescribing Advisers Group• Greater Manchester & Cheshire Cancer Network•

Education and Training

The RDTC prescribing support team have provided, when requested, training on various topics over areas such as critical appraisal, academic detailing, management of prescribing and prescribing data. Further details of specific training provided can be found on the RDTC website.

Medicines Information / NHS Direct

During 2010/11 the RDTC provided medicines information support to both health care professionals and members of the public (via NHS Direct). A multidisciplinary staff team including pharmacists, information scientists and nurses answer enquiries. All enquiry answering staff undertake initial locally-delivered training and assessment in medicines information, teratology and management of poisoning; ongoing learning is supported by regular CPD sessions, courses and attendance as appropriate at national training events such as the UKMi National MI training course and UKMi Professional Development Seminars.

Call recording was introduced in other areas of the RDTC during this period and medicines information enquiries were identified as suitable for this development. The opportunity for call review is now available in response to any complaints but also as a reflective training tool.

National Medicines Information Activities

As in previous years, we have contributed to the work of the UKMi network. Developments from this collaboration included:

The senior MI Pharmacist (Pharmacovigilance) is a member of the UKMi Clinical Governance • Working Group. Her contribution included writing the draft UKMi Risk Management Policy for NHS Medicines Information Services which is due to be ratified by the UKMi Executive.

Three external audits of MI centres were completed this year, two local hospital MI Services • (Royal Victoria Infirmary, St Nicholas Hospital part of Northumberland, Tyne and Wear NHS Foundation Trust) and Ninewells Hospital, Dundee as part of the UKMi Regional MI Centre auditing process. The RDTC itself was also audited in March 2011 as part of this process and whilst the final written report is still awaited, initial feedback has been positive with no causes for concern identified.

In addition to enquiry answering support the Centre, through its NHS Direct Pharmacist Lead, has played an active role in delivering the National NHS Direct / UKMi SLA. This work included:

Collaboration with national colleagues within the UKMi NHS Direct Working Group, to • develop national training packages and guidance documents which support the National NHS Direct Medicines, Poisons and Pharmacy procedures and Best Practice documents.

Continuing support of the local site in implementing national protocols, ‘best practice’ and • training.

17

Quality Improvement

18

Induction, role preparation and refresher training sessions for nurse advisers, health • information advisers and health advisers. Our training has focussed on Health Information Advisers (HIAs) as Newcastle is one of five sites with this staff group and it is part of NHS Direct Strategy to ensure all HIAs have successfully completed the medicines training to enable them to handle non-symptomatic medicines calls.

Contributing to the NHS Direct action plan in response to their audit of toxic ingestion calls.•

Medicines Information training delivered during 2010/11 included:•

NHS DirectNA, DA and HIA Medicines training• Poisons ‘Train-the-Trainer’ package•

RDTCInternal comprehensive initial training and assessments, ongoing CPD attendance at • courses and relevant conferencesCall recording enabling reflective learning and follow up of any complaints•

Pre-Registration Trainee PharmacistsRegional half day training session and workshop and• Three week RDTC MI rotation for a local Trust’s Pre-registration trainee pharmacists • where in-house MI expertise and appropriate supervision is unavailable

For PCT PharmacistsProvision of a PCT Pharmacists and Technicians Medicines Information Resource Pack• Training session and workshop for Leeds and nearby PCTs •

Poisons Information

The Newcastle unit of the National Poisons Information Service, commissioned by the Health Protection Agency, provides a telephone poisons information service to users in Northern and Yorkshire, Greater London and Kent during normal office hours (9am-6pm). The unit works in cooperation with the other NPIS units in Birmingham, Cardiff and Edinburgh as well as the Northern Ireland Regional Medicines and Poisons Information Service in Belfast and the National Poisons Information Centre in Dublin. Since July 2005, the Newcastle unit has participated in a national rota with the other NPIS units in Birmingham and Cardiff for provision of out of hours services to the United Kingdom and Ireland.

During 2010/11, 17,233 poisons enquiries were answered by the unit. The service continues to be most frequently accessed by doctors (46%), with 32% of the calls received from hospitals and a further 28% and 20% from primary care and NHS Direct/24 respectively. Childhood poisoning remains an issue with 29% of enquiries involving children under 5 years. Accidental poisoning comprised 46% of total calls followed by deliberate exposures accounting for 24%. As with previous years, most episodes (85%) occurred in the home. Pharmaceuticals are involved in the majority of incidents (64%) with industrial chemicals accounting for 14% and household products 12%. The most common pharmaceuticals ingested are simple analgesics such as paracetamol and ibuprofen, antidepressants and hypnotics.

The severity of cases is routinely recorded using a system developed by the European

Quality Improvement

Association of Poisons Centres and Clinical Toxicologists (EAPCCT). The Poisons Severity Score (PSS) defines the patient’s clinical state at the time of the call as none, minor, moderate or severe. As well as recording the PSS at the time of the call the maximum PSS is recorded. This defines the most severe symptoms the patient has experienced from the time he/she was poisoned up until NPIS received the call. Of the calls taken 88% were recorded as having a PSS of none or minor and 1.7% as having severe features. The more severe scoring enquiries will often require clinical input reflecting NPIS policy of ensuring that severely poisoned patients receive optimal treatment by making available to the enquirer the expertise and experience of a NPIS Consultant Clinical Toxicologist. During 2010/11, 549 cases were referred to a Consultant Toxicologist.

The follow up of cases with severe features or when an NPIS consultant had been contacted to determine outcome remains a priority as this can help to influence clinical management guidance on a national level. Follow up of calls relating to exposure to toxic alcohols was also undertaken as part of a prospective study. During 2010/11, a total of 938 (5%) cases were followed up, of which complete outcome data is available for 398 cases.

TOXBASE® is the online poisons information database maintained by NPIS. All NPIS units including Newcastle contribute to TOXBASE® by updating, reviewing and producing new monographs. In addition, senior staff play an active role in the TOXBASE® editing group and provide comments on new monographs prepared by all units. 322 monographs were submitted by the Newcastle unit (48 new, 42 checked, 15 revised and 217 updated) covering the management of poisoning with insulin, antiarrhythmic and anti-hypertensive drugs as well as new recreational drugs of abuse, reflecting a significant increase in TOXBASE® monograph activity compared with previous years.

19

Quality Improvement

NPIS (Newcastle) aims to provide a very high quality service and continually seeks to improve the quality of its service by collecting the views of users and stakeholders. At least 5% of telephone enquiries for the unit are randomly selected and a nationally agreed quality assurance questionnaire is used to collect data. During 2010/11, NPIS Newcastle sent out 870 questionnaires with a good response rate of 41% (359 returned) achieved; almost 27% of respondents were from GP/Primary Care and 18% from NHS Direct Nurses. The overall satisfaction ratings were high with 95.7% of users rating the service as very good and excellent, an increase compared to 2009/10. User satisfaction across all domains remained at least above 90%, except for the time for phone to be answered (Table 1).

Rank Question *Satisfaction Score (%)

1 e). The person I spoke to was polite and pleasant 97.1

2 d). The information was given to me at an appropriate speed 96.0

3 a). The reply from NPIS was relevant and useful 95.1

3 g). I had confidence in the reply I was given 95.1

3 c). Once my call was answered by a specialist in Poisons Information the enquiry was dealt with promptly

95.1

6 f). I was given an appropriate amount of information for my needs 93.4

7 b). My telephone call was answered without delay by a Specialist in Poisons Information 88.7

*Satisfaction score is the proportion of respondents who agree ‘completely’ or ‘a lot’

Table 1: Telephone Quality Assurance Survey Satisfaction Scores

20

Quality Improvement

Teratology

During 2010/11 both new and existing staff have worked together to improve and implement new strategies of working across the UK Teratology Information Service (UKTIS). This year the team have concentrated on improving the quality of data collection and storage, disseminating information to service users and education amongst the staff at the RDTC. As in previous years feedback has been sought from service users.

Monographs

UKTIS monographs provide a summary of all available information relating to the teratogenicity or reproductive toxicology of a specific exposure in pregnancy. During the year we have improved the accessibility of this information by reformatting the monograph design to include a detailed summary that can act as a concise stand alone document and tabulating information on the findings of meta analyses, cohort and case control studies, and case reports, to facilitate rapid access to data allowing more efficient dissemination of information by enquiry answerers and ease of healthcare provider-patient discussion.

New operating procedures have been implemented to ensure that all relevant data can be identified and incorporated into the monographs in the face of rapidly changing information. An updated in-house review system is in place to ensure quality of content and maintenance of the standard of excellence that end users demand.

Staff training and development

In the past year all staff within UKTIS were required to undergo Good Clinical Practice (GCP) and Regulatory Requirements training due to their involvement in clinical research. This training ensures that employees have a thorough understanding of EU directives and UK legislation, their roles and responsibilities, data storage and protection and ethical considerations to provide high quality research within the NHS.

21

Staff in UKTIS have also maintained their continuing professional development (CPD) by attending national and international meetings, conferences and teratology specific training courses to discuss the functioning of other services which will enable future streamlining of UKTIS. In addition to gaining knowledge of current research in the area of reproductive toxicology, and suspected new human teratogens, information obtained from these meetings has been incorporated into monographs and training materials and will continue to be disseminated via in-house CPD sessions, enabling telephone staff to remain up to date with current developments which underpin the quality of the service.

Operating Procedures

This year UKTIS focused on reviewing their working practices and in doing so have produced new, and reviewed existing operating procedures for the service. Operating procedures aimed at staff working at the RDTC have been updated to ensure that the team are logging, answering and peer reviewing enquiries with consistency and accuracy, and in line with clinical governance standards. In light of the increasing involvement in research there is scope for UKTIS to increase their publication portfolio; therefore, guidelines have also been developed to help with producing peer reviewed journal articles.

Software

Improvements have been made to the way in which UKTIS store and collect pregnancy outcome data. The service has developed new questionnaires to capture information concerning maternal health and exposures during pregnancy from healthcare professionals who telephone the service for patient specific advice. The data that has been returned using these forms, since their introduction in January 2011, is more detailed and comprehensive. It is hoped that these improved questionnaires will encourage service users to report more detailed case histories of patients and pregnancies to increase the quality of data collected by UKTIS.

The new software also allows adverse pregnancy outcomes to be categorised using internationally recognised International Classification of Disease (ICD) codes, enabling surveillance of congenital malformations and ensuring that UKTIS data is consistent with international surveillance methods.

Clinical governance

As part of our interest in service user satisfaction UKTIS regularly asks for feedback from service users. During 2010/11 a random sample of 412 (11%) enquiries, 35 per month, made directly to UKTIS was selected for quality assurance monitoring. Questionnaires were sent out to enquirers between 1-4 weeks after the enquiry. As of May 2011, 187 (45%) of these forms had been returned.

The responders were hospital consultants (20), junior hospital doctors (12), pharmacists (49), GPs (78), nurses (18), pharmacy technicians (4), and health advisors (NHS Direct) (2). The occupation of four responders was not reported. The majority of responders (36%) had used the service between 1 and 5 times previously, with a further 26% being first time enquirers. Satisfaction scores were high, in particular 93% of responders agreed or strongly agreed that they were highly

Quality Improvement

22

Quality Improvement

23

satisfied with the service they received, with 94% agreeing that they found it easy to contact UKTIS. The majority were happy with the amount of information they received from the service (84%). Ninety three percent of the enquirers reported that they spoke to someone who was polite and pleasant, and 91% had confidence in the reply that they were given.

Rank Question *Satisfaction Score (%)

1 The person I spoke to was polite and pleasant (agree) 93

2 I had confidence in the reply I was given (agree) 91

3 The information was sufficient for my needs (agree) 84

4 The reply from UKTIS was relevant and useful (agree) 86

5 Once I got through, the enquiry took a long time to be dealt with (disagree) 79

6 The information was given to me too quickly (disagree) 70

*Satisfaction score is the proportion of respondents who scored 5 and 6 (in agreement) or 1 and 2 (in disagreement)

Table 2: Summary of UKTIS enquirer satisfaction scores

Innovation

Overview

Increasing responsiveness to stakeholders’ needs and changes in national policy, utilising new technologies and seeing new ways of presenting available data to improve patient care are evident from work produced during 2010/11. New publication series and a revised format for the production of prescribing reports were developed as well as decision support tools for the NHS Direct staff and a regular newsletter for frontline primary healthcare professionals. New software came on stream for surveillance of possible teratogens and research work continued in the areas of swine flu and epigenomic signature identification.

Prescribing Support

A novel package of medicines management and prescribing support has been devised and will continue to be further developed. The service is now much more responsive to stakeholder needs and to changes in national policy. Regular review and staff development has ensured that outputs continue to remain fit for purpose and are not duplicated elsewhere. The RDTC is unique in that it combines prescribing analysis data with critical appraisal of current evidence base. This type of support helps organisations meet some of the challenges associated with the medicines management agenda and aims to help improve the quality and cost effectiveness of prescribing.

All primary care prescribing reports and support materials are now available in a secure area of the RDTC website under password protection to enable easy access by stakeholders. Two new publications, ‘Hot Topic’ and ‘Medicines Management Briefing’ documents (for stakeholders only) were launched in 2010/11. Both documents form the basis of a package of support materials (e.g. evaluation documents, academic detailing aids, prescribing reports and local resources) for medicines management teams to help them promote good prescribing practice. Regularly updated cost comparison charts also complement the support package. This represents a new approach for the RDTC.

Hot Topics

These documents were introduced in response to stakeholder requests for rapidly produced evidence-based overviews of current medicines management-related issues, many of which have major financial implications for PCTs, and some of which may be controversial in nature. Such documents were identified as needed to assist advisers, commissioners and/or prescribers in deciding what course of action to recommend for the health economies. The subject of the first in this series to be produced, in April 2010, was NICE Clinical Guideline (CG) 96 Neuropathic Pain with an expected increased usage of pregabalin predicted to result in a considerable increase in prescribing expenditure at a time of financial constraint.

The second ‘Hot Topic’ (published in December 2010) examined ezetimibe and was accompanied by an academic detailing aid. The document reviewed the evidence for ezetimibe, summarised NICE guidance for various groups of patients and outlined examples of work carried out to manage ezetimibe prescribing. The academic detailing aid included key messages about appropriate ezetemibe prescribing. In addition, as described above, a short report showing

24

Innovation

prescribing trends of ezetimibe in all the stakeholder PCTs, and including examples of good practice was produced.

Briefing Documents

The aims of these publications are to assist medicines management teams and other healthcare professionals in influencing and changing prescribing behaviour (for clinical, financial and/or safety reasons) and to facilitate sharing of experience, good practice and locally developed support materials,

The first Briefing Document examined the evidence and guidance for prescribing of escitalopram compared with other anti-depressants, examples of successful change of prescribing behaviour and estimated savings that could result from prescribing citalopram instead. An academic detailing aid reinforcing the key messages was produced, and reference made to the RDTC’s reports covering antidepressant prescribing and potential savings.

During 2011/12, such packages will be available to stakeholders (under password protection) on the RDTC’s new NHS website.

Prescribing reports in Excel

Stakeholders often request the data presented in the RDTC’s prescribing reports in Excel format, in order to manipulate the data and presentation and to facilitate copying and pasting into their own reports. The first report to be presented entirely in Excel was the Q2 QIPP report for Yorkshire & The Humber stakeholders.


As part of our SLA with NHS Direct the RDTC has a remit to support the safe effective and efficient management of poisons enquiries within NHS Direct. This has involved:

designing and delivering training•

reporting or commenting on poisons-related serious untoward incidents•

designing decision support tool and the training packs to support their introduction•

supporting the NHS Direct Pharmacy Director in dealing with poisons related issues•

liaising with NPIS/ TOXBASE• ®

contributing to the negotiations for changes in practice as part of the action plan in response • to the audit of toxic ingestion calls

During 2010/11 three decision support tools (or ‘checkers’) were designed to allow more efficient handling of dental calls where the patient has taken analgesics above the recommended dose. Two of these decision support tools enable dental nurses to complete dental calls where the patient has taken over the recommended amount of paracetamol and / or ibuprofen. Such calls

25

Innovation

26

would historically have had to be referred to a nurse adviser. The third is at final draft stage and is intended to be a decision support tool for support nurses handling calls involving paracetamol overdose. NHSD nurses are required to make a decision whether to refer to medical care or not and so this simple document is written in a format similar to an algorithm leading them safely to a final disposition - refer, discuss with NPIS or home care advice.

In response to a detailed audit of ‘toxic ingestion’ calls done by NHS Direct, a need was identified for a document which would make the process of handling poisons calls more lean by excluding the need for a full personal medical history (PMH) for all calls. A document was prepared outlining those instances when it is considered safe not to take a full PMH such as when it is clear that the amount taken requires referral to A&E.

Within the Regional Medicines Information arrangements, work has been undertaken to prepare for an upgrade to version 3 of MiDatabank which has several improvements on earlier versions. Perhaps the most innovative is that of enabling submission of adverse drug reaction data directly to the Medicines and Healthcare Regulatory Authority from enquiries received as part of our routine medicines information activities.

Promotional activities have included developing the medicines information section of the RDTC website, supplying promotional material for distribution at conferences, medicines management meetings etc, attendance and presentations about our service at LPC meetings and securing advertisements in their newsletters as well as producing ‘The Medicines Information News Today’ (The MINT) newsletter for frontline primary care healthcare professionals.

Innovation

27

Teratology

Modernisation of the service came to the forefront of priorities in 2010/11. Opportunities to advance the scope of the service were achieved with the introduction of a new web based database, increasing involvement in primary research and exploring novel methods of service promotion. UKTIS have also embarked on preparation work in support of the London 2012 Olympics and Paralympics.

Software development

In January 2011 the new UKTIS database went live. The new software was designed to enable more rapid and accurate data entry and to allow more efficient checking and follow up of enquiries than could previously be achieved. The software is used by staff at the RDTC to record, answer and follow up pregnancy related enquiries. The new system offers a more user friendly interface, more automated functioning, drop down menus, improved searching facilities and batch processing. A function for generating automated reports also allows rapid analysis of the data and improved ability for UKTIS to continue surveillance.

Research & Development

During 2010/11, a number of funding applications were submitted and are currently in progress. Whilst the service awaits the outcome of these applications, work continues with colleagues on data surveillance and projects to investigate novel methods of data collection and the safety of therapeutics in pregnancy.

During the H1N1 influenza (‘swine flu’) pandemic of 2009, UKTIS obtained research grants from NIHR and the H1N1 manufacturers Glaxo Smithkline and Baxter, to carry out a prospective observational study examining the effects of swine flu antivirals and vaccination during pregnancy. Pregnancy outcome data has now been obtained from over 650 women and the study is coming to a conclusion, with data collection due to end in September 2011. A detailed statistical analysis of the data will be carried out at the end of the study, and it is anticipated that full analysis of the study findings will be available in advance of the 2011/12 influenza season.

In the past financial year UKTIS have continued to collaborate in a European multicentre research project with 31 public and private partners. The project, Pharmacoepidemiological Research on Outcomes on Therapeutics (PROTECT) has been funded by IMI to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. PROTECT will trial direct patient data collection using web-based and telephone systems. It will test the transferability of the data into a common language and explore linkages to data from electronic health records.

During 2010/11 UKTIS initiated and led on a collaborative project to improve understanding of molecular mechanisms that orchestrate gene expression during fetal development. This work aims to identify epigenomic signatures during development and then to further interrogate these signatures in relation to exposures known to influence pregnancy outcomes (e.g. potential teratogens, maternal obesity).

The ultimate goals are two fold:

To define epigenetic signatures that may have clinical utility as early biomarkers of exposure 1. and thus assist in more accurate and specific risk prediction and counselling

To increase our understanding of the molecular mechanisms occurring in fetal development 2. and thus the pathogenesis of health problems later in the lifecourse that have antecedents in utero, therefore informing appropriate interventions.

An NIHR FSF grant and Newcastle Healthcare Charity award have been secured to fund the pilot work necessary to establish reference epigenetic signatures. It is hoped that this work will generate preliminary data that will underpin further funding applications and collaborations.

Promotion of the Service

In response to comments from service users regarding the overall profile of the service, UKTIS has acted to increase awareness of the service in the UK. Promotional material including pregnancy calculators, posters, flyers and information cards have been designed by staff to distribute throughout the UK and at specifically targeted audiences. In November 2010 UKTIS promoted their service by exhibiting at a stand at the Royal College of Midwives annual conference.

Innovation

28

Innovation

29

Preparations for the London 2012 Olympic and Paralympic Games

The Olympic Games in London next year provide an opportunity to develop practices and improve systems of working within UKTIS that will be of benefit for the future in managing public health threats associated with large events. Staff at the RDTC need to be prepared to offer information on a variety of agents that may pose a threat to pregnant women, either through accidental or deliberate release and of exposures including treatment and prophylaxis of communicable diseases that may be associated with mass gatherings. As part of the Health Protection Agency’s emergency planning, UKTIS are currently updating existing, and preparing new pregnancy related monographs regarding these agents and in addition, information on exposure in pregnancy to antidotes and drugs used in the treatment of poisonings.


30

Overview

System changes resulting in increased capacity for the production of ad hoc reports and practice level reports, have been successfully introduced. Highlighting areas where improved cost effectiveness may be possible can allow improvements in productivity by commissioners through the treatment of more patients or targeting of limited NHS resources in other areas of prescribing or services. Reports specifically monitoring QIPP plan prescribing indicators were produced for stakeholders enabling benchmarking and trend data to be monitored. Whilst an increase in medicines information enquiries from primary care was recorded, RDTC staff gained accreditation to lead on Medicines Questions and Answers part of the UKMi portfolio of products designed to reduce national duplication of effort in enquiry answering.

Prescribing Support

Service delivery

We have continued to improve the productivity of our prescribing report and ad hoc data provision and analysis service to stakeholders. The streamlined systems now in place for data analysis have increased capacity and we can now produce more ad hoc short reports on particular areas of prescribing. In addition we have been able to deliver increased numbers of practice-level reports and data analysis allowing stakeholders to direct their resources elsewhere.

Support provided by the RDTC in prescribing and medicines management aims to help primary care organisations address some of the challenges associated with high deprivation and high disease prevalence and the impact this has on the prescribing budget. Regular prescribing data comparing organisations motivates organisations to make changes to prescribing, particularly in areas where they may be considered to be outliers. Highlighting areas where savings could be made and cost effectiveness improved assists stakeholders to target therapeutic areas in their localities where further investigation may yield cost savings that enable more patients to be treated, and / or can be invested in other areas of prescribing or services.

Prescribing budget management

The data presented in our Monthly Performance Summaries and Quarterly Reports assist advisers and commissioners in identifying drugs and therapeutic areas where investment or conversely, disinvestment may be required.

The Monthly Performance Summary continues to show comparative information on SHA, PCT, North of England and national level prescribing outturn against budget, cost and item growth, generic prescribing rates, per capita prescribing cost and frequency, and expenditure and cost growth of the Top 20 most costly drugs (see Figure 3).

The Quarterly Report shows comparative information focussing on therapeutic areas accounting for the highest expenditure. PCT-level cost and item growth charts presented in an addendum identify each stakeholder PCT’s highest cost and item expenditure and growth to help focus


31

on BNF sections that may require further more detailed investigation at local level. Overall cost trends and detailed breakdowns of the drugs in the therapeutic classes prescribed (cost and frequency) help to highlight where review of drug choice may be appropriate.

Two Cost Savings Reports were produced in 2010/11. They covered a range of drugs (glucosamine, triptans, enteric-coated prednisolone, mesalazine, ferrous sulphate, homeopathic drugs, atypical antipsychotics, bisphosphonates, anti-depressants, opioid analgesics, isosorbide mononitrate and silver dressings). These reports presented: prescribing cost trends, estimates of potential savings that could result from switching one drug to another in the same therapeutic class or to another formulation of the same drug (see Figure 4, page 32), practice points, hints and tips to help reduce prescribing costs, plus examples of work done and materials produced by stakeholders to facilitate sharing of good practice

Actual Cost (£)

£29,704,904 £28,827,653Fluticasone Propionate (Inh) (3.04%)

£25,140,985 £24,512,483Atorvastatin (-2.5%)

£14,266,272 £14,785,272Enternal Nutrition (3.64%)

£10,033,459 £11,635,431Tiotropium (15.97%)

£9,027,109 £11,579,726Pregabalin (28.28%)

£10,810,939 £11,538,675Budesonide (6.73%)

£9,588,821 £9,876,737Glucose Blood Testing Reagents (3%)

£8,198,727 £8,765,469Olanzapine (6.91%)

£6,578,627 £6,782,686Beclometasone Dipropionate (3.1%)

£5,890,348 £6,552,125Quetiapine (11.23%)

£6,189,216 £6,057,761Co-Codamol (Codeine Phos/Paracetamol) (-2.12%)

£5,650,708 £5,848,147Fentanyl (3.49%)

£5,129,735 £5,774,952Paracetamol (12.58%)

£1,263,408 £5,470,547Citalopram Hydrobromide (333%)

£6,587,843 £5,377,459Salbutamol (-18.37%)

£5,511,326 £5,173,005Ezetimibe (-6.14%)

£3,821,181 £5,081,633Pioglitazone Hydrchloride (32.99%)

£4,405,161 £4,986,140Metformin Hydrochloride (13.19%)

£4,526,619 £4,974,209Candesartan Cilexetil (9.89%)

£3,410,679 £4,889,647Prednisolone (43.36%)

0 5,000,000 10,000,000 15,000,000 20,000,000 25,000,000 30,000,000 35,000,000

Jan - Mar ’11 Jan - Mar ’10

Figure 3: Expenditure and cost growth of the top 20 drugs (by cost) in the North of England - January - April 2011


Many of the drugs and therapeutic areas covered in these (and last year’s) savings reports have now been included in stakeholders’ QIPP plans to reduce prescribing costs.

In addition, the therapeutic report Primary care Prescribing of Analgesics (one of the top 5 BNF therapeutic areas, by cost in all three North of England SHAs) produced in March 2011 included prescribing cost trend data for the top eight (by cost) analgesic drugs in the North of England, and hints, tips and information on cost effectiveness and potential savings.

QIPP reports

Individualised reports for stakeholders in the three North of England SHAs were produced for the first time during 2010/11. In the North East, the RDTC started working with and supporting the Heads of Medicines Management in this area by monitoring their QIPP high-level prescribing indicators at PCT level, and in one locality, at practice level. The North West SHA highlighted specific QIPP indicators that required quarterly monitoring. A bespoke report was developed that provided benchmarking and trend data in key areas highlighting changes and allowing PCTs to monitor prescribing in areas where changes in practice have been initiated. Within the Yorkshire & The Humber SHA, stakeholders requested a quarterly report covering prescribing of drugs in the 15 therapeutic areas in the National Prescribing Centre’s Key Therapeutics Topics for QIPP. This report provides benchmarking and trend data, enabling medicines management teams to monitor prescribing in areas of interest.

32

£27,107 £6,356

£24,745 £4,316

£16,580 £3,101

£13,454 £3,081

£13,214 £2,365

£9,867 £2,136

£9,817 £2,163

£9,041 £2,178

£8,490 £2,276

£6,970 £1,341

£6,652 £1,160

£6,206 £1,157

£3,573 £1,517

£0 £5,000 £10,000 £15,000 £20,000 £25,000 £30,000 £35,000 £40,000

PCT 11 (£33,463)

PCT 8 (£29,060)

PCT 5 (£19,681)

PCT 2 (£16,534)

PCT 4 (£15,579)

PCT 7 (£12,003)

PCT 1 (£11,980)

PCT 12 (£11,218)

PCT 6 (£10,766)

PCT 13 (£8,311)

PCT 10 (£7,811)

PCT 9 (£7,363)

PCT 3 (£5,090)

Potential Savings (£)

Prednisolone_Tab E/C 5mg Prednisolone_Tab E/C 2.5mg

Figure 4: Example of the estimated potential monthly savings that could result if 70% of all prednisolone enteric-coated tablets were switched to generic prednisolone 5 mg tablets based on June 2010 prescribing data


33

£400,000

£350,000

£300,000

£250,000

£200,000

£150,000

£100,000

£50,000

£0

Add

ition

al C

osts

(£)

PCT 10PCT 9

PCT 3PCT 6

PCT 1

PCT 12PCT 5

PCT 4PCT 7

PCT 13PCT 2

PCT 8

PCT 11

Citalopram Hydrob_Tab 20mg

Gabapentin_Cap 300mg

Prednisolone_Tab 5mg

Sertraline HCI_Tab 50mg



Others

Figure 5: Example of total extra costs incurred by stakeholder PCTs as a result of NCSOand concessionary price increases April 2010 – February 2011

‘NCSO’ reports

These reports were first produced in January 2011 to alert medicines management teams, commissioners, and prescribers of the potential cost impact of unexpected / temporary price increases of generic drugs where the Department of Health agreed to allow “no cheaper stock obtainable” (NCSO) endorsements and concessionary price increases to apply due to supply shortages. Most of the drugs involved are commonly prescribed, and many are those which PCTs have been promoting prescribing of in efforts to reduce prescribing costs as part of their QIPP plans (e.g. citalopram, prednisolone 5mg conventional release tablets). The increased costs are significant, and PCTs need to accommodate these increased costs at a time of financial constraint. An example of the data presented at PCT level is shown in Figure 5.

To further support the QIPP agenda our Drug Updates are produced in response to regular multidisciplinary scoping exercises to identify topics that have the potential to improve the quality of care and release substantial efficiency savings, whilst maintaining or improving patient safety. With the aim of reducing variation in care and outcomes Drug Updates provide concise, structured reviews of drugs which have been available within the UK for some time. Many of these publications include clear cost charts comparing the range of appropriate products for that particular disease state. These provide a powerful message to prescribers about the wide variation in costings that is often seen. To help support the delivery of QIPP a number of academic detailing aids have been produced to complement the Drug Updates series. Through its horizon scanning role the RDTC aims to identify further areas where it is possible to improve the quality of care and release substantial efficiency savings.


34

Cost Comparison Charts

Updated quarterly, these charts show, at-a-glance, comparative treatment costs of drugs in therapeutic classes (BNF sections).

Switch Saving Calculators (SSCs)

The RDTC continued to provide this web-based tool that calculates savings that will result from switching one drug or formulation to another with the same / similar therapeutic effect or constituents respectively. A more flexible downloadable Excel® version that includes all our SSCs is in development and will be available on the RDTC’s new NHS website early in 2011/12.


While the RDTC hosts the UK Teratology Information Service (UKTIS), our Medicines Information service also acts as the UKMi national specialist medicines information service for teratology enquiries, providing information on the effects of drug exposures on the fetus. Because of the large volume of enquiries and the requirement of the HPA, all enquiries, except those referred from NHS Direct, are handled and reported separately to MI enquiries. NHS Direct pregnancy enquiries were recorded with the general MI enquiries.

In the year 2010/11 the RDTC answered 1245 general, non-pregnancy enquiries from all stakeholders in the former Northern and Yorkshire region. This is very similar to last year’s total of 1206. An additional 684 therapeutic pregnancy enquiries were received from NHS healthcare professionals based in this area. A total of 1211 enquiries were from primary care (782 general MI and 429 therapeutic pregnancy enquiries).

Most general medicines information enquiries originated from primary care (Figure 6). During 2010/11, not only did the number of general, non-pregnancy enquiries from primary care increase (812 from 625) but the percentage of enquiries coming from primary care also increased (to 65% from 50%). The number of enquiries from secondary care remained similar to 2009/10 (58 compared with 64). NHS Direct accounted for 29% of MI enquiries received representing a decrease of 11% from 2009/10.

Most of the non-pregnancy enquiries from primary care came from community pharmacists (292 compared with 204 in 2009/10), general practitioners (210 compared with 208 in 2009/10), PCT pharmacists (171 compared with 103 in 2009/10), and primary care nurses (41 compared with 31 in 2009/10) (Figure 7). “Other NHS” represents enquirers where each had a low number of enquiries. This includes enquiries from dentists and allied healthcare professionals. “Non NHS” includes prison pharmacists and the police.

All medicines information enquiries received are reviewed monthly to identify any common issues facing the PCTs that commission our services. This information is then discussed in our regular publications meetings, with consideration given to an in depth review of evidence following which a UKMi Q&A or Drug Update on the topic may be published.


35

Primary Care Non NHSOther NHSSecondary CareNHS Direct

NHS Direct 28.9%

Secondary Care 4.7%

Other NHS 0.9%

Non NHS 0.3%

Primary Care 65.2%

Figure 6: Medicines Information Enquiries* 2010/11 by local origin

Note* these figures exclude all pregnancy enquiries

2%

1%

1%

1%

Community Pharmacy Staff

37%

GP 27%

PCT Adviser 14% Practice

Pharmacist 8%

5%

4%

5%

Community Pharmacy Staff

PCT Adviser

Practice Pharmacist

Primary Care Nurse/Midwife

Other

Community Hospital Staff

Profession allied to medicine

Dentist

Walk-in Centre Staff

GP

Figure 7: General Medicines Information Enquiries from Primary Care* 2010/11 by Enquirer


36

Pregnancy- Primary & Secondary care 32%

Pregnancy - NHSD only 4%

Interactions 14%

Administration/Dosage 13%

Choice/Indications/Contra-Ind 8%

Adverse Effects 6%

6%

5%

12%

4%

3%

3%

2%

Pregnancy- Primary & Secondary care

Pregnancy - NHSD only

Interactions

Administration/Dosage

Choice/Indications/Contra-Ind

Adverse Effects

Other

Pharmaceut/Pharmacol/Pharmacokin

Availability/Supply/Formulary

Complementary Medicine

Identification

Lactation

Figure 8: All Medicines Information Enquiries 2010/11 by Enquiry Subject

Figure 8 provides detail of the types of enquiries answered during 2010/11 and includes the therapeutic pregnancy enquiries from primary and secondary care in the former Northern and Yorkshire region. “Other” enquiries include those categorised as non-clinical enquiries, reference requests, reviews and non-NPIS toxicity enquiries.

The number of therapeutic pregnancy enquiries from stakeholders appears to have decreased from 1065 in 2009/10 to 684 during 2010/11. However, flu-study cases recorded under the same heading as the therapeutic enquiries and the introduction of a new database during the year mean that these figures are not likely to be comparable. These enquiries involve requests for information on the likely effects on the fetus from maternal exposure to prescription drugs, complementary medicines and advice on the treatment of choice for different indications during pregnancy. 429 such pregnancy enquiries originated from primary care within the former Northern & Yorkshire region. These included enquiries from GPs (n=250), community pharmacists (n=95), and also midwives, primary care nurses and PCT pharmacists. A significant proportion (23%) of all enquiries came from hospital pharmacists (Figure 9).

The RDTC contributed to the Medicines Question and Answer documents which are available on the NeLM website (www.nelm.nhs.uk). Medicines Q&As are evidence based, fully referenced answers to commonly asked MI enquiries. In 2010/11 the RDTC completed eleven Q&As and comfortably exceeded our UKMi target of six. This year our senior MI pharmacist attained accreditation to lead on, check and sign off Q&As. Certain Q&As are used by NHS Direct and are available on their intranet. We also produced a document on Travel Health as part of the UKMi ‘Thinking Ahead’ series.


37

GP 38%

Hospital Pharmacist 23%

Community Pharmacist 14%

Consultant/ Hospital Doctor 12%

PCT Pharmacist 7%

Practice Nurse 2%

Midwife Community Nurse 2%

Other Primary Care 2%

GP

Hospital Pharmacist

Community Pharmacist

Consultant/Hospital Doctor

PCT Pharmacist

Practice Nurse

Midwife/Community Nurse

Other Primary Care

Figure 9: Therapeutic Pregnancy Enquiries from the North East and Yorkshire 2010/11

Those Q&As produced by the RDTC include:How do the different types of enteral feeding tubes available affect drug administration?• Can the use of proton pump inhibitors increase the risk of community acquired pneumonia • infection?What is the evidence for an increased rate of myocardial infarction associated with • calcium supplements?What are the safety concerns surrounding use of black cohosh?• What Drugs can cause Neuroleptic Malignant Syndrome?•

We are one of the authoring centres for the New Medicines Section of the Prescribing Outlook Series - a horizon-scanning publication providing independent and evaluated information on new drugs and reducing duplication of effort across the UK.

Regular meetings of the local MI Network have been held at the RDTC to promote national UKMi activity, deliver CPD and encourage and support collaboration between MI specialist pharmacists and their respective centres.

NHS Direct

During 2010/11 we continued to provide support to NHS Direct in a number of key areas through a national NHS Direct / UKMi service level agreement. This included support for medicines and therapeutic teratology enquiries referred from NHS Direct sites throughout England in accordance with a national UKMi rota. The skill mix at each site determines how calls are handled and what proportion are referred to the UKMi Regional Centre. NHSD enquiries come from members of the public who have contacted NHS Direct for information and advice about medicines. NHS Direct staff assess each enquiry and refer complex questions to UKMi; where appropriate answers are provided directly to the member of public making the original enquiry.


38

East Midlands 25.8%

North East- Newcastle

18.3%

Hamps, Isle of Wight 11.7%

NHSD - Other Sites 7.2%

Avon, Glos & Wiltshire 20.3%

West Yorks (Wakefield)

16.6%

East Midlands

North East-Newcastle

West Yorkshire (Wakefield)

Hamps, Isle of Wight

NHSD - Other Site

Avon,Glos & Wiltshire

Figure 10: Total Number of NHSD MI calls for 2010/11 by site

One of the primary aims of our NHS Direct support (via UKMi, NPIS and UKTIS) is to ensure that NHSD can deal with calls as far as possible and avoid referral onwards to other “high demand” services such as GP, GP Out of Hours and A&E, allowing patients and their carers to remain in the home environment wherever possible.

A total of 349 (509) medicines information enquiries were referred from NHSD to the RDTC in 2010/11 with the greatest number coming from the East Midlands site (Figure 10).

This represents a decrease of 31% on last year (Figure 11). As referrals are allocated by a national rota, all other participating UKMi centres experienced similar decreases. Reorganisation and cost improvement measures at NHSD led to the call referral part of the SLA being reduced over the past two years with the out of hours weekend and bank holiday support ending in 2010. Daytime enquiry referral under the national UKMi rota was formally ended on 31 March 2011.

In anticipation of this development alternative support mechanisms (such as additional UKMi prepared factsheets and Q&As) were put in place during 2010/11.

The majority of NHSD MI enquiries were categorised as interaction, pregnancy or administration / dosage related. The increase in interaction related enquiries is anecdotally reported to be due to an increase in alternative medicines interaction enquiries and multiple medicines enquiries which due to the time required and lack of effective resources were passed to the UKMi support service (Figure 12).


39

47

185

26

225

319

461

602

606 509

0

0

3540

200

400

600

800

1000

1200

1400

2005/06 2006/07 2007/08 2008/09 2009/10 20010/11

Year

No.

of c

alls OOH

Normal Hours

Figure 11: Total Number of NHSD MI calls for 2005/06 to 2010/11

Figure 12: Total Number of NHSD calls for 2010/11 by Enquiry Subject *NB these figures exclude pregnancy enquiries relating to poisoning, overdose, environmental and chemical exposure

Interactions 31%

Complementary Medicine 7%

Adverse Effects 10%Other 6%

Admin/ Dosage 14%

Pregnancy 17%

15%

2%

6%

5%

2%

Interaction

Pregnancy

Admin/ Dosage

Other

Adverse Effects

Complementary

Pharmaceut/ Pharmacol/ Pharmacokin

Choice/ Indications/ CI’s

Drugs in Breast Milk

Availability / Supply/ Formulary


40

Teratology

During 2010/11 UKTIS introduced the staff of the RDTC to a more efficient data processing and storage system . Outreach work was also increased by UKTIS staff providing education via lectures, training courses, presentations of primary data and attendance at meetings and conferences. The service also produced more written information and collected more pregnancy outcome data than in previous years.

Outreach

Staff within UKTIS have increased the amount of outreach work with user groups in the past financial year. Increased awareness of the service has been raised among clinicians by delivery of spoken presentations at national training courses including the Drug and Safety Research Unit, the Education and Research Course and the Theoretical Course in Fetal Medicine organised by the Royal College of Obstetricians and Gynaecologists. A number of presentations using UKTIS surveillance data have also been delivered at national and international teratology and poisoning conferences, as well as at the annual British Isles Network of Congenital Anomaly Registers (BINOCAR) meeting.

Spoken and poster presentations on the H1N1 in pregnancy study have been delivered at regional days for GPs across the UK, as well as at international conferences. Interim results of this research have been published and the article circulated to all participating GP practices. A talk to the Regional Midwifery Neonatal Screening Committee has also been provided. Attendance by the UKTIS staff at the local Fetal Pathology Meetings has increased visibility of the service amongst local Obstetricians, Fetal pathologists and Geneticists.

Monographs

UKTIS strive to ensure continued excellence of the service and regularly review comments given by users regarding suggestions for improvement of the service. These comments consistently request more monographs as a top priority. In light of these requests, UKTIS produced 100 new and updated pregnancy monographs during 2010/11 (Table 3), a 100% increase on the previous year. The increase in new and updated monographs, alongside the new monograph format has enabled increased productivity by allowing staff to quickly locate the relevant information and reduce the need for extensive literature reviews for agents where monographs are available, thereby providing a more rapid response to enquiries.

Software development

Introduction of the new UKTIS software in January 2011 has enabled more efficient logging of data and has improved the speed of enquiry handling and peer review checking. The new logging and follow up system commissioned by the HPA also has enabled more efficient processing of recorded data.

Surveillance data

Limited data exist on the potential fetotoxicity of many drug and chemical exposures in pregnancy. Follow up data is invaluable to add to the often inadequate, existing literature via publication and can enable more accurate risk assessment when little or no published data exists. Until


41

Table 3 New and updated pregnancy-related monographs added to TOXBASE® in 2010/11

Acebutolol Cyanoacrylate Methotrexate Ectopic Pivmecillinam

Acetazolamide Dichlorvos Methotrexate High Dose Pizotifen

Aciclovir Diclofenac Methotrexate Low Dose PPHN

Alcohol Diquat Methotrexate (Paternal) Promethazine

Amitriptyline Escitalopram Methylene blue Promethazine OD

Ammonia Esmolol Migraine Proton Pump Inhibitors

Amoxycillin Esomeprazole Misoprostol Pyridoxine

Anthrax Vaccine Ethylenethiourea Mycophenolate mofetil Rabeprazole

Atropine Firelighters Naphthol Ranitidine

Azathioprine Flucloxacillin Naratriptan Ribavirin

Azathioprine (Paternal) Fluoxetine Natural gas Sauna and steamrooms

Bendiocarb Formaldehyde Neomycin Sertraline

Benzylpenicillin Heroin Omeprazole Sibutramine

Bleach Hot tub Oseltamivir Sodium Cromoglicate

Botox Infections Pantoprazole SSRI’S

Bupropion Iodine 131 Paracetamol Sulphasalazine

Carbon disulphide Iron OD Paracetamol OD Sumatriptan

Carvedilol Labetalol Paroxetine Topiramate

Chickenpox Lamotrigine Penicillin V Tramadol

Chloramphenicol Lansoprazole Penicillins Tramadol UKTIS data

Chloroflurocarbons Lead Penicillins UKTIS data Trastuzumab

Citalopram Lead Treatment Phenoxymethylpenicillin Venlafaxine

Coamoxiclav Leflunomide Pindolol Vitamin B12

Cocaine Mephedrone Piperacillin Warfarin

Consitpation Meptazinol Piperazine Zanamivir

recently UKTIS has only followed up new (black triangle) drugs, known or potential teratogens, and exposures occurring either through poisoning, the environment or via occupational exposure. The return rate of pregnancy outcome questionnaires from enquiries the service have attempted to follow up has increased steadily in the past six years rising from 23% to 34% in 2009/10. Due to our increased activity in 2009/10 where the service attempted to obtain pregnancy outcome details for all enquiries where sufficient patient identification is provided, UKTIS saw an absolute increase in successful follow up of 44% compared to the average follow up rate of the previous five years (26%).

Prevention of Harm

42

Overview

Integrated across all activities of the RDTC is the core principle of assuring patient safety. Analysis of prescribing in key areas of concern such as antipsychotics, encouraging reporting of adverse drug reactions through our partnership with the MHRA as well as the longstanding research into the effects of medicines or chemicals in pregnancy serve to demonstrate this aspect of our work.

Prescribing Support

This year, we produced two prescribing reports focussing specifically on patient safety (antipsychotics and quinine), and a Safer Medication Use (SMU) review. This was in addition to regular work - further detail of which can be found below.

Antipsychotic prescribing

The Primary Care Prescribing of Low-dose Antipsychotics Report was issued in June 2010, and the SMU ‘Antipsychotics in the Elderly with Dementia’ was published in September 2010 (No.9). They were produced in the light of the Department of Health’s (DH) report (‘The use of antipsychotic medication for people with dementia: Time for action. November 2009). The DH report examined the use of low-dose antipsychotics in elderly patients with dementia and described an unacceptable level of elderly people with dementia dying as a result of being prescribed antipsychotic medication.

The RDTC report provided an overview of data (See Figure 13) on low-dose antipsychotic prescribing to enable PCTs to benchmark this. In order to facilitate sharing of good practice, where there was evidence of a decline in prescribing (e.g. PCT 4 in Figure 13), the medicines management teams of the relevant PCTs were contacted for information as to how this had been achieved, and who to contact about this. Low-dose antipsychotic prescribing is one of the therapeutic areas included in the NPC’s key therapeutic areas for the QIPP agenda but, unlike other therapeutic areas, nationally produced benchmarking data are not available on ‘Toolkit’ (introduced Q3 2010/11). Therefore, this report will be repeated in future to ascertain whether prescribing has declined.

The SMU covered the efficacy and risks of antipsychotics in this patient group, when and what to use if prescribing is necessary, and the safest way to use these agents in such patients.

Quinine for nocturnal leg cramps

This report was first produced in June 2010 to promote the safety advice issued by the Medicines and Healthcare products Regulatory Agency (MHRA) in its June 2010 Drug Safety Update. The advice recommended that quinine should not be prescribed routinely for nocturnal leg cramps, and the RDTC report provided benchmarking data (up to March 2010) on quinine prescribing. It was updated six months later to ascertain whether prescribing had changed. Where it had, the relevant PCTs were contacted to find out how, and information that could be shared with other stakeholders was requested. Figure 14 shows prescribing by a group of stakeholder PCTs. PCTs 4 and 11 had carried out work to reduce prescribing and shared their experience and support materials.

Prevention of Harm

43

0809Q1 0809Q2 0809Q3 0809Q4 0910Q1 0910Q1 0910Q3 0910Q41500

1700

1900

2100

2300

2500

2700

2900

3100

3300

DD

D/1

00 d

emen

tia p

atie

nts

PCT 1PCT 2PCT 3PCT 4PCT 5PCT 6PCT 7PCT 8PCT 9PCT 10PCT 11PCT 12

Figure 13: Example of weighted prescribing of low-dose antipsychotics* by stakeholder PCTs April 2008 - March 2010 (Key: *Olanzapine (2.5mg & 5mg), Risperidone (500 micrograms & 1mg), Haloperidol (500 micrograms & 1mg & 1.5mg), Quetiapine (25mg) and Aripiprazole (5mg &

10mg); DDDs: defined daily doses, a volume measure that is independent of prescription length)

PCT 1PCT 2PCT 3PCT 4PCT 5PCT 6PCT 7PCT 8PCT 9PCT 10PCT 11PCT 12England

0708Q1 0708Q2 0708Q3 0708Q4 0809Q1 0809Q2 0809Q3 0809Q4 0910Q1 0910Q2 0910Q3 0910Q4 1011Q1 1011Q21.5

2

2.5

3

3.5

4

4.5

item

s/10

0 pa

tient

s

Figure 14: Example of weighted quinine prescribing in stakeholder PCTs April 2007 - September 2010

Prevention of Harm

44

Controlled drug (CD) prescribing

The quarterly Controlled Drug Prescribing Report presents, at PCT level, trends in prescribing frequency and breakdowns of prescribing of drugs in the various controlled drug (CD) schedules. These reports can provide a starting point for further local analysis at practice level.

In Q3 2010/11 information on PCT level prescribing of individual CDs by non-medical prescribers was included in this report for the first time. Which CDs these prescribers are allowed to prescribe depends on whether the prescriber is an independent prescriber (in which case the permitted CDs allowed are listed by the Department of Health) or supplementary prescriber (in which case CDs not on the Department of Health’s list can be prescribed as part of an agreed clinical management plan). Alerting Accountable Officers, prescribers and / or advisers of the CDs prescribed in the PCTs may lead to review of non-medical prescribing by individual prescribers to ensure that prescribing is in accordance with the Department of Health’s list, standard operating procedures, and the professional competence and expertise of the non-medical prescribers involved.

Antimicrobial prescribing report

This biannual report presents comparative data including prescribing frequency trends of various types of antibiotics. In particular, the cephalosporin and quinolone prescribing frequency trend charts enable PCTs to monitor changes in their prescribing, as reduced prescribing of these two classes of antibiotic is included in the National Prescribing Centre’s QIPP document. An example of such a trend chart is shown in Figure 15.

SHA 1SHA 2SHA 3North of EnglandEngland

0708Q1 0708Q2 0708Q3 0708Q4 0809Q1 0809Q2 0809Q3 0809Q4 0910Q1 0910Q2 0910Q3 0910Q4 1011Q1 1011Q216

21

26

31

36

Item

s/10

00 A

ntib

acte

rial S

TAR

-PU

Figure 15: Weighted cephalosporin prescribing in the North of England SHAs April 2007 - September 2010

Prevention of Harm

45

Non-medical prescribing report

This report is produced annually, and highlights general trends in prescribing costs across all BNF sections, and also focuses on therapeutic areas that are most prescribed by non-medical prescribers.

NICE report

This report is now produced annually, and shows comparative data on prescribing frequencies of drugs approved in NICE Technology / Appraisals (TAs), and selected clinical guidelines that have superseded TAs.


The RDTC has continued with the additional NHSD SLA for poisons support. This involves, amongst other work, providing poisons-related advice to inform policy decisions, clinical governance issues and development of decision support tools.

We use and promote IRMIS (Incident Reporting in Medicines Information System), a secure national database for incident reporting in MI centres hosted by NHS net. This is used to collate data on errors and near-misses within MI to identify common themes and provide recommendations to avoid future incidents.

A clear referral SOP and timely checking procedure, which is supported by the senior pharmacists, has been introduced this year to ensure that RDTC staff work safely within their competence and workload.

The RDTC contributed to the preparation of both the UKMi tool to help implement the NPSA rapid response report (RRR) on preventing fatalities associated with loading doses and the UKMi tool to help implement the NPSA RRR on omitted and delayed medicines.

The RDTC has a SLA with the North East Ambulance Service for provision of medicines management advice. This work has been undertaken and developed over the past year by the Principal Pharmacist for Medicines Information. This involves

Input into the annual CD report•

Attendance at LIN Meetings as a deputy when necessary (quarterly meetings)•

Contributing to the development of medicines related policies and procedures, in particular in • relation to the relevant legal and national regulatory frameworks

Regular attendance at, and contributions to, the NEAS clinical advisory group and Quality • Committee meetings

Chair of the NEAS Medicines Management Meetings which addresses any medicines related • issues across NEAS.

Approving and developing patient group directions for use by the occupational health • department

Prevention of Harm

46

2005/06 2006/07 2007/08 2008/09 2009/10 2010/110

500

1000

1500

2000

2500

Swine Flu PortalOther*PatientNurseHospital nursePharmacist unknownCommunity PharmacistHospital PharmacistPhysician unknownHospital DoctorGP

Num

ber o

f rep

orts

Figure 16: Yellow card reports received by YCCNY since April 2005

Contributing to the annual CD report and attending Local Intelligence Network meetings • (County Durham and Darlington) as a deputy for the NEAS AO.

Member and proactive contributor to the Ambulance Pharmacist Network•

Ad hoc support for procurement or tendering of contracts for medicines as required•

Yellow Card Centre

The Yellow Card Centre Northern and Yorkshire (YCCNY) encourages the appropriate reporting of adverse drug reactions (ADRs) from the North East of England, Yorkshire and Cumbria. During the 2010/11 financial year 1577 reports were received from these areas, a 13% decrease from 2009/10. The decrease in reports appears to be largely due to the absence this year of reports via the swine flu portal, which accounted for 16% of total reports in 2009/10 (Figure 16). Reporting from GPs and hospital doctors increased by 27% and 11% respectively, and reporting from nurses increased a further 5% on figures for 2009/10.

As part of its promotional activities, the centre produced a short version of the 2009/10 annual report which summarised Yellow Card reporting in each PCT. This was sent to the Heads of Medicines Management of each PCT. It is difficult to compare this year’s reporting to 2009/10, since reports from the swine flu portal last year were not attributed to PCTs. However PCTs that were priority areas for raising Yellow Card awareness this year all saw increased reporting, with numbers doubling in North Lincolnshire and tripling in Hull Teaching PCT and Redcar & Cleveland (Figure 17).

Prevention of Harm

47

NewcastleNorth Yorkshire and York

MiddlesbroughNorth Tyneside

SheffieldDarlington

GatesheadSunderland Teaching

NorthumberlandHull Teaching

LeedsBradford & Airedale

BarnsleySouth Tyneside

Stockton-on-Tees TeachingKirklees

East Riding of YorkshireNorth Lincolnshire

RotherhamRedcar and Cleveland

DoncasterCounty Durham

WakefieldCalderdale

North East LincolnshireCumbria Teaching

Hartlepool

0 50 100 150 200 250 300 350 400 450

Number of reports per million population

Number of reports by PCT per million population

Figure 17: Yellow cards received by YCCNY in 2010/11

The ten most frequently reported suspect drugs during 2010/11 are shown in Table 4. During this period varenicline was the most reported drug in Northern and Yorkshire, contributing 7% of all reports.

Drug No. of reports

1 Varenicline (Champix®q) 111

2 HPV vaccine (Cervarix®q & Gardasil®q) 97

3 Simvastatin 29

4 Implanon® 24

5 Citalopram 23

6 Adalimumab (Humira®q) 22

7 Rivaroxaban (Xarelto®q) 21

8 Exenatide (Byetta®q) 19

9 Sitagliptin (Januvia®q) 19

10= Ramipril 18

10= Co-amoxiclav 18

Table 4: Drugs most commonly involved in ADR reports during 2010/11

Prevention of Harm

48

Patients have been able to report ADRs since November 2005. Encouragingly, this year there has been an increase in patient reporting of 2%. We continue to seek to raise awareness of patient reporting through our educational work directed at healthcare professionals, who are also encouraged to continue reporting themselves.

The centre also delivered yellow card training as part of medicines information sessions to nurse assessors, health information advisors and dental nurse advisors at NHS Direct. The training focused on informing patients that they may fill in a Yellow Card should they contact NHS Direct regarding an adverse drug reaction.

The centre has continued to publish the bulletin series Safer Medication Use which promotes safer prescribing, highlights emerging or significant drug safety problems and raises awareness of adverse drug reaction detection and reporting. This year has also seen the introduction of The MINT (Medicines Information News Today) which discusses drug news relevant to primary care health professionals as well as promoting use of Yellow Card.

The YCC Northern and Yorkshire website has recently undergone an improvement and is regularly updated with information regarding safety problems and recently published papers in the field of Pharmacovigilance. The site also contains educational materials developed by the centre. All users accessing the site for information on the completion of a Yellow Card are encouraged to use the electronic form.

We continue to encourage ADR reporting by health professionals, providing support and education, targeted according to local reporting patterns. The centre has promoted the Yellow Card scheme at a number of local training events for healthcare professionals. We also continue to work closely with local universities offering educational resources and specialist speakers on ADRs and Yellow Card.

The YCC Northern and Yorkshire has continued to work closely with the MHRA and other YCCs to develop training materials for use nationally.

Teratology

Exposure to medications or other chemicals may occur in the peri-conception period before a woman is aware that she is pregnant. This may give rise to maternal concerns as to whether this exposure may cause adverse pregnancy outcomes such as miscarriage or birth defects. Also, there is evidence to suggest that prescription rates increase during pregnancy, primarily for pregnancy related symptoms. It is therefore essential that accurate information on drug use in pregnancy is available to confirm or refute suspicions of possible teratogenicity. UKTIS plays an important role in this process by providing up to date evidenced based written information and patient specific risk assessments via the telephone to NHS health professionals throughout the UK. During 2010/11 UKTIS answered 3,722 pregnancy related enquiries.

To optimise treatment during pregnancy and reduce fetal harm enquirers are encouraged to contact the service before their patient conceives or before a drug is prescribed. In 2010/11 UKTIS saw similar rates as in previous years of these types of enquiries with only 11% of risk assessments being provided for women in the preconception period risk and 27% being for pre-prescription risk assessments. The opportunity to offer advice at this early stage and thereby reducing the potential for adverse maternal and fetal outcome remains a challenge for healthcare professionals and UKTIS as approximately 50% of pregnancies are unplanned.

Prevention of Harm

49

The majority of calls (45%) were regarding pregnant women who had already been exposed to a drug or chemical. In these scenarios UKTIS provide advice about risk to the fetus and if required, recommendations for prenatal monitoring (Figure 18).

Pregnancy 45.0%

Prescription 27.1%

Retrospective 0.6%

Not recorded 0.5%

General Information 12.8%

Lactation 0.6%

Paternal 3.0%

Preconception 10.8%

Figure 18: Total number of exposures by category of exposure during financial year 2010/11

Data showing trends in enquiries answered by UKTIS over a five year period show that enquiries related to antidepressants have continued to be the most frequent type of call. In 2010/11 seven out of the top 10 of most frequent enquiries to the service were regarding these classes of medications. The three most frequent being the SSRIs - citalopram, sertraline and fluoxetine. (Figure 19, page 50). The prevalence of calls regarding these types of antidepressant medications reflects their high level of use and recent publications about safety during pregnancy.

Staff at the RDTC are not only trained in the safety of therapeutic medications in pregnancy, but have extensive specialist experience of providing advice regarding the poisoned patient as part of their role in the National Poisons Information Service. This means that UKTIS were able to offer information and advice for the poisoned pregnant patient (either deliberate or accidental) in 212 cases in 2010/11. Extensive knowledge of chemicals via training, specialist reproductive toxicology databases and because of close ties to teratology specialists around the world means the service are also well placed to answer enquiries about pregnant women who have been exposed through environmental and occupational circumstances. This year we provided risk assessments for 59 of these types of enquiries (Table 5).

Prevention of Harm

50

Type of exposure Number of enquiries % of enquiries

Therapeutic 3360 90.3

Drug overdose 95 2.6

Poisoning 117 3.2

Substance abuse 23 0.6

Complementary medicines 6 0.1

Occupational 35 1

Environmental 24 0.6

Miscellaneous 62 1.6

Total 3,722 100

Table 5: Telephone enquiries to UKTIS by exposure category in 2010/11

Monographs

Monographs are updated as new data becomes available or on a rolling basis with priority given to agents commonly involved in telephone enquiries. This year UKTIS produced a number of detailed monographs on the serotonin selective re-uptake inhibitors (SSRIs) in light of the controversy regarding their use in pregnancy. This year the service also completed documents regarding potential teratogens such as mycophenolate mofetil, leflunomide, and misoprostol to help provide practical advice when exposure has occurred.

Figure 19: Top 10 enquiries to UKTIS for financial years 2006/07, 2007/08, 2008/09, 2009/10, 2010/11

2010/11

2009/10

2008/09

2007/08

2006/07

Cita

lopr

am

Sertr

alin

e

Fluo

xetin

e

Para

ceta

mol

Venl

afax

ine

Met

hotre

xate

Trim

etho

prim

Amitr

ipty

line

Met

roni

dazo

le

Que

tiapi

ne

Mirt

azap

ine

Chl

orph

enira

min

e

Ola

nzap

ine

Ose

ltam

ivir

Zana

miv

ir

0

20

40

60

80

100

120

140

180

200

220

240

260

160

Prevention of Harm

51

It is important to provide a balanced document discussing both the risks and benefits of using drugs in pregnancy, and good examples of when this is required. For example, balanced information is needed for teratogenic medications that have important therapeutic benefits, such as methotrexate or warfarin, as some women will need to continue with these throughout pregnancy to control chronic conditions. UKTIS has published documents regarding these drugs and others this year.

TOXBASE®

TOXBASE® is the primary clinical toxicology database of the National Poisons Information Service. UKTIS monographs on maternal and paternal exposures to drugs and chemicals are hosted on this site. The availability of these monographs allows immediate access at the time of prescribing or consultation for all UK-based NHS healthcare professionals and provides an opportunity for reducing harm to the unborn fetus. The pregnancy summaries (monographs) hosted by the TOXBASE® website had approximately 37,600 hits during 2010/11, a 4.5% increase compared to 2009/10.

Since the service was commissioned in Newcastle in 1995, access to pregnancy related information has increased year on year. Figure 20 shows the rise in access to information by health professionals in the past 5 years and the change in the way that information is obtained. This long term increase demonstrates the continuing demand for high quality information regarding exposure to drugs and chemicals in pregnancy both in the immediately online accessible monographs and also in the highly detailed patient-specific risk management advice provided via our telephone service.

2006/2007 2007/2008 2008/2009 2009/2010 2010/2011

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

45,000

ToxbaseTelephone

Enquiry volume

Figure 20: Telephone enquiries and TOXBASE® sessions from 2006/07 to 2010/11

Prevention of Harm

52

Pregnancy Monograph Number of hits

Nausea and Vomiting 1,725

Antibiotics 1,227

Citalopram 933

Malaria Prophylaxis 842

Codeine 821

SSRIs 742

Corticosteroids 685

Amitriptyline 673

Insect Repellents 591

Metronidazole 566

Chlorphenamine 531

Loratadine 486

Fluoxetine 477

Trimethoprim 473

Cephalosporins 470

Migraine 464

Cetirizine 449

Antispasmodics 444

Quetiapine 435

Swine Flu 428

Table 6: Top 20 Most accessed pregnancy summaries on TOXBASE® in 2010/11

Health professionals most frequently accessed TOXBASE® for documents relating to antidepressants, anti-infectives and antihistamines as well as general documents on nausea and vomiting, migraine, malaria prophylaxis and insect repellents. The top twenty most accessed

TOXBASE ® monographs for 2010/11 are listed in table 6.

UKTIS pregnancy outcome data

UKTIS continue to disseminate their research findings on an international level. In July 2010 preliminary data from the UKTIS Influenza A/H1N1v in pregnancy study was published in the

Prevention of Harm

53

ukt suk teratology information service

Drug & chemical exposure during pregnancy Information for healthcare professionals

( 0844 892 09098 www.uktis.org

Promotional Leaflet for UKTIS

peer reviewed literature; this important information for prescribers was also presented at various meetings and conferences in the UK, Europe and the US. UKTIS pregnancy outcome data was disseminated to teratology specialists from around the world after the UKTIS was awarded a scholarship to present their data at the International Conference of the Organisation of Teratology Information Specialists in the US. UKTIS overdose data was also presented at the International Congress of the European Association of Poisons Centres and Clinical Toxicologists in 2010.

New Drug Evaluations 2010/11

Drug No Date

Denosumab 105 June 10

Indacaterol 106 July 10

Prucalopride 107 Sep 10

Combodart 108 Nov 10

Ticagrelor 109 Jan 11

Drug Updates 2010/11

Drug No Date

Aspirin for primary prevention of cardiovascular disease 65 July 10

Insulin Analogues 66 Mar 11

Evaluation Reports 2010/11

Drug Date

New treatments for Human Immunodeficiency Virus (HIV) infection May 10

The use of nanoparticle albumin-bound paclitaxel in the management of metastatic breast cancer May 10

Vandetanib in locally advanced or metastatic medullary thyroid cancer Feb 11

Sorafenib for the treatment of locally advanced or metastatic medullary thyroid cancer Feb 11

Cabazitaxel for the treatment of metastatic hormone-refractory prostate cancer Feb 11

Bendamustine for rituximab-refractory non-hodgkin’s lymphoma Feb 11

Abiraterone for the treatment of castration-resistant prostate cancer Feb 11

Sunitinib for the treatment of pancreatic neuroendocrine tumours (PNETs) Mar 11

North East Treatment Advisory Group (NETAG)

Appraisals 2010/11 Date

Roflumilast for COPD June 10

Toclizumab for juvenile idiopathic arthritis July 10

Sativex for spasticity due to MS Oct 10

Adacolumn in Inflammatory Bowel Disease Jan 11

54

Appendix I Prescribing Support Publications

Safer Medication Use Reports 2010/11

Document No Date

Oral Antiplatelet Drugs 07 May 10

Using Strong Opioids Safely 08 May 10

Antipsychotic Use in the Elderly with Dementia 09 Sep 10

Hot Topics 2010/11

Document No Date

NICE CG96 - Neuropathic Pain 1 Apr 10

Ezetimibe 2 Dec 10

Briefing Documents 2010/11

Document No Date

Escitalopram 1 Dec 10

Self-Monitoring of Blood Glucose in Type 2 Diabetes Melitus 2 Mar 11

Prescribing Monitoring Reports

Regular Reports

Monthly Performance Summary

Quarterly Prescribing Report with Stakeholder Addendum-Top 20 therapeutic areas (BNF sections)

Quality and Outcomes Framework Prescribing Report

Controlled Drug Prescribing Report

Antimicrobial Prescribing Report with Stakeholder Addendum (Top 20 item growth)

NICE Prescribing Report

Non-medical Prescribing Report

OtherCost comparison charts

Monthly Horizon Scanning document

55

Appendix I Prescribing Support Publications

Regional Drug & Therapeutics Centre Final outturn for the 12 month period to 31st March 2011 Centre Poisons Total

Income

Income - Regional core PCTs 698,836 698,836

Income - Regional core - other 308,492 12,133 320,625

Income - HPA 1,154,635 1,154,635

Deferred income

Information Portal 35,000 35,000

GMMMG Conference 25,000 25,000

Diploma Advertising 5,378 5,378

Consultant Support NPIS (provisional) 5,420 5,420

Computer Software (provisional) 30,000 30,000

Adjust for Deferred Income to 11/12 -107,189 -159,862 -267,051

Subtotal 965,517 1,042,325 2,007,842

Notional Income

Madel-Newcastle PCT 66,547 66,547

Clinical excellence 15,393 21,456 36,849

Superannuation all staff 47,358 47,358

Adjust for on call notional recharge 5,000 -5,000 0

TOTAL ANNUAL INCOME 1,099,814 1,058,782 2,158,595

Expenditure

Pay - Managers 41,543 63,607 105,150

Pay - Medical 106,433 234,071 340,505

Pay - Nursing 0 0 0

Pay - Scientific and Professional 611,313 445,003 1,056,316

Pay - A&C 121,431 85,267 206,698

Total Pay 880,720 827,948 1,708,668

NP - S & S Clinical 42 1,370 1,412

NP - Supplies & services general 3,455 3,260 6,715

NP - Establishment services 51,279 46,287 97,566

NP - Premises & fixed plant 58,837 80,192 139,029

NP - External Contract Staff & Consultancy 4,656 0 4,656

NP - NHS Exp - non H’care 425 380 805

NP - Miscellaneous 16,203 13,874 30,077

NP - Recharges Non & Inter-Company -38 360 322

Total Non Pay 134,859 145,723 280,582

Expenditure sub total 1,015,579 973,671 1,989,250

Overheads (7% of income) 76,987 72,963 149,950

TOTAL EXPENDITURE 1,092,566 1,046,634 2,139,200

Surplus/(Deficit) -7,248 -12,148 -19,395

Surplus/(Deficit) % of income 0.68% 1.16% 0.69%

56

Appendix II Financial Summary

Academic Training

Certificate in Medical Toxicology (Cardiff University) - Sep 2010- Jun 2011

Diploma in Medical Toxicology (Cardiff University) - Sep 2009 - Jun 2010

‘Quality and Value. Are you eQIPPed?’ Attendance at National Prescribing Centre’s annual conference for Prescribing Advisers - 17 - 18 Jun 2010

‘Equity and Excellence - what the Public Health Observatory can do to support GP Commissioning’ North East Public Health Observatory, Wolfson Research Institute, University of Durham, Stockton - 20 Sep 2010

Masters in Medical Toxicology (Cardiff University) October 2009 - Sep2011

NICE Guidance Interactive Workshop meeting, University of Manchester - 21 Oct 2010

National Audit Office (NAO) Influencing prescribing cost and quality in primary care - a suggested communication plan for prescribing advisers. Weetwood Hall, Leeds University - 28 Feb 2011

Local Decision Making North East Meeting. National Prescribing Centre. North East SHA, Newcastle - 2 Mar 2011

Human Teratogens - Postgraduate Course. Harvard Medical School, Boston MA, US - 25-27 Apr 2010

Conferences

The European Association of Poisons Centres and Clinical Toxicologists International Congress, Bordeaux, France - May 2010

Organisation of Teratology Information Specialists 24th International Conference, Louisville, Kentucky, US - Jun 2010

The Teratology Society 50th Annual Meeting, Louisville, Kentucky, US - Jun 2010

Health Protection Agency Pandemic Influenza conference - ‘H1N1: The world responds to a 21st century’ London - 21-22 Jun 2010

21st Annual Meeting of the European Network of Teratology Information Services, Barcelona, Spain - Sep 2010

38th Annual Meeting of the European Teratology Society, Barcelona, Spain - Sep 2010

Health Protection 2010 Conference, Warwick - 14 Sep 2010

Joint NorCAS Annual Meeting / BINOCAR Scientific Conference 2010, Centre for Life, Newcastle upon Tyne, UK - Oct 2010

London Cancer New Drugs Conference - 24 Nov 2010

‘Medicines Management: a New Era’ Greater Manchester Medicines Management Group Conference, Manchester Conference Centre, Manchester - 20 Mar 2011

Professional and Technical Training

Medical Toxicology Update Course, Manor House Hotel, Cardiff - 1-3 Nov 2010

Good Clinical Practice (GCP) and Regulatory Requirements Training, Newcastle upon Tyne

Research Seminar: Health Economics: Contradiction in terms of unifying research theme? Royal Victoria Infirmary - Apr 2010

Study days / Workshops / Lectures

NPIS Study Day, Birmingham - 2 Jul 2010

NPIS Study Day, Edinburgh - 11 Nov 2010

NPIS Study Day, Newcastle - 15 Mar 2011

57

Appendix III External Training and Development

Training

In-house

Coaching Skills for Managers - 3 August 2010

Appraisal Skills for Managers and Supervisors

Recruitment and Selection

Induction Training in Poisons

Induction Training in Teratology

Good Clinical Practice (GCP) and Regulatory Requirements Training

Critical Appraisal Skills - Nov 2010

CPU Seminar - Sativex - Nov 2010

Mandatory Training

Fire Safety

Infection Prevention and Control Level 1

Equality and Diversity

Moving and Handling (Office Staff)

Introduction to Information Governance

Child Protection (Core)

Safeguarding Adults Level 1

Regular three weekly information service meetings

Teratology case presentation

Cyanide antidotes in smoke inhalation

SSRI use in pregnancy

Quick silver self harm

Case Study: Chinese Herbal

Paracetamol overdose during labour

Hormone therapy and hypertension

Talking to members of the public

Ivory wave case presentation

Clinical Governance

MDAI case presentation

Impact of poisoning on public health and our role

Ricin poisoning

Benzodiazepines versus Z drugs

Mushroom case presentation

Titropium case presentation

Arterial blood gases

The art of being nice to people

58

Appendix IV In-House Training and Development undertaken by staff

59

Erhorn S, Thomas S, Dyker A, Hill, S, Acheampong P, Development of IMI PharmaTrain module - Article based learning

Erhorn S, Module Leader - Evidence based therapeutics, Design of clinical trials; Basic Pharmacoeconomic analysis; Critical appraisal / interpretation of clinical evidence and statistics, Diploma in Therapeutics, Newcastle University, Nov 2010

Erhorn S, Clinical and cost-effectiveness, 3rd Year Undergraduate pharmacology students, Nov 2010

Erhorn S, Evidence Based Medicine, GP Specialty Training Registrars (GPSTR’s), Jan 2011

Erhorn S, Evidence based practice, MSc Medicines Management, University of Sunderland, Feb 2011

Erhorn S, Critical evaluation of clinical trials and other experimental research, MRes Medical & Molecular Biomolecular Sciences, Jul 2011

Jones D, Drug safety in pregnancy. Medical Aspects of adverse drug reactions. Drug Safety and Research Unit, Southampton, Jul 2010

Macfarlane K, Evidence based therapeutics, Influences on Prescribing. Diploma in Therapeutics, Newcastle University, Nov 2010

McDermott D, Health Economics & Decision-Making, Inaugural meeting of County Durham & Darlington APC, 1 Mar 2011

McDermott D, ‘Prescribing in the North of England - Epidemiology of Prescribing’ and ‘Prescribing Data - interpretation and usage’, 21 Oct 2010

Stephens S, Drug safety in pregnancy. Medical Aspects of adverse drug reactions. Drug Safety and Research Unit, Southampton, Jan 2010

Stephens S, Drugs in pregnancy and lactation. Diploma in Therapeutics. Newcastle University. Feb 2010

Thomas SHL, James DA, Toxicology update for the College of Emergency Medicine / National Poisons Information Service, British Library, London, Feb 2011

Thanacoody HKR, Poisoning Core Medical Trainees Training Programme. Freeman Hospital, Newcastle upon Tyne

Thanacoody HKR, Drug Absorption, Distribution, Metabolism and Elimination. MRes Experimental Medicine and Therapeutics, Newcastle University, Oct 2010

Thanacoody HKR, Introduction to Biomarkers. MRes Experimental Medicine and Therapeutics, Newcastle University, Oct 2010

Thanacoody HKR, Research Governance in the UK. MRes Experimental Medicine and Therapeutics, Newcastle University, Dec 2010

Thanacoody HKR, Good Clinical Practice. MRes Experimental Medicine and Therapeutics, Newcastle University, Dec 2010

Thanacoody HKR, Late phase (III/IV) clinical trial methodology. MRes Experimental Medicine and Therapeutics, Newcastle University, Oct 2010

Thanacoody HKR, Use of appropriate comparators and end-points. MRes Experimental Medicine and Therapeutics, Newcastle University, Oct 2010

Thanacoody HKR, Evaluation of cost and clinical effectiveness. Certificate/Diploma in Clinical Research, Newcastle University, Mar 2011

Thanacoody HKR, Prescribing Indications, Epidemiology and High Risk Patient Groups. BSc (Pharmacology), Newcastle University, Mar 2011

Thanacoody HKR, Drugs used for Hypertension and Heart Failure. Clinical Sciences and Investigative Medicine 1 Module, MBBS, Newcastle University, Feb 2011

Thanacoody HKR, Management of Specific Poisons. Clinical Sciences and Investigative Medicine 3 Module, MBBS, Newcastle University, September 2010

Thanacoody HKR, Adverse Drug Reactions and Pharmacovigilance. Clinical Sciences and Investigative Medicine 3 Module, MBBS, Newcastle University, Nov 2010

Thanacoody HKR, General Pharmacology. Certificate / Diploma in Therapeutics, Oct 2010

Thanacoody HKR, Pharmaceutical Research and Development. Certificate / Diploma in Therapeutics, Oct 2010

Thanacoody HKR, Drug Interactions. Certificate / Diploma in Therapeutics, Oct 2010

Appendix V Contributions to External Courses undertaken by staff

Erhorn S,. Critical Appraisal Skills presentation to Pre-Registration pharmacists, North East SHA, Sep 2010

James D, Treatment and complications of ethylene glycol poisoning, NPIS CPD Day, Newcastle,15 March 2011

Macfarlane K, Local Decision Making Focus Group Events (4 across the North East)

Macfarlane K, Presentation at the Local Decision Making Regional Event, 3 March 2011

Macfarlane K, Reddy B, Organised and arranged stands at the Greater Manchester Medicines Management Group (GMMMG) Conference, 10 March 2011

Reddy B, Prescribing report reviews at meetings of Greater Manchester Medicines Management Group Meetings (GMMMG)

Reddy B, GMMMG Overview to GM Chief Executives (July 2010)

Reddy B, GMMMG Overview to GM PEC Chairs Meeting (September 2010)

Thanacoody HKR, What is the evidence for Added benefit from Hemoperfusion? Con EAPCCT, Bordeaux, May 2010

Thanacoody HKR, Clinical Trials using thioridazine for XDR-TB. ESF EMRC Exploratory Workshop Multidisciplinary consortium for the development of effective, but non-toxic drugs against MDR-TB and XDR-TB, Lisbon (Portugal), 30 November - 4 December 2010

Thanacoody HKR, Antidote stocking audit NPIS CPD Day, Newcastle, 15 March 2011

Thanacoody HKR, Toxic Alcohols Audit, NPIS CPD Day, Newcastle, 15 March 2011

Thanacoody HKR, Scorpion Stings, NPIS CPD Day, Edinburgh, 11 November 2010

Thomas SHL, Clinical toxicology perspecfive of drug safety. IUPHAR Meeting, Copenhagen, 21 July 2010

60

Appendix VI Lectures, Workshops and Presentations

Thomas SHL, NPIS Clinical Standards Group Update. NPIS CPD Day, Newcastle, 15 March 2011

Thomas SHL, Epidemiology and management of poisoning. NPIS/CEM Study Day, London, 17 February 2011

Thomas SHL, Management of the complications of toxicity caused by cocaine and other newer recreational stimulants. Irish Congress of Anaesthesia, Dublin, 21 May 2011

Thomas SHL, Risk factors for paracetamol (acetaminophen) hepatotoxicity, EAPCCT, Bordeaux, 26 May 2010

Thomas SHL, Update on NPIS, CRCE Seminar, Chilton, 17 November 2010

White S, Prescribing report reviews at meetings of NHS County Durham and Darlington Drug and Therapeutics Committee

White S, Controlled drug prescribing report review at North East SHA Accountable Officers’ meeting, 13 April 2010

White S, Prescribing Support Services. Presentation to medicines management analytical and finance staff at North East Lincolnshire Care Trust Plus, 7 June 2010

White S, Reddy B, Table hosting session of RDTC’s Prescribing Support materials and publications at ‘Quality and Value. Are you eQIPPed?’ National Prescribing Centre’s annual conference for Prescribing Advisers, 17-18 June 2010

White S, Prescribing Data. Presentation at ‘Learn and Lunch’ meeting at Yorkshire and The Humber Public Health Observatory, 28 October 2010

Yates LM, HPA Pandemic Influenza conference - at ‘H1N1: The world responds to a 21st century, London, 21-22 June 2010

Yates LM, Influenza A/H1N1v in pregnancy: an investigation of the characteristics and management of affected women and the relationship to pregnancy outcomes for mother and infant H1N1 Health Protection Conference 2010, Warwick, 14 September 2010 - H1N1

61

Appendix VI Lectures, Workshops and Presentations

Peer-reviewed Papers

Crocq MA, Naber D, Lader MH, Thibaut F, Drici M, Everitt B, Hall GC, Le Jeunne C, Mittoux A, Peuskens J, Priori S, Sturkenboom M, Thomas SHL, Tanghoj P, Toumi M, Mann R, Moore ND. Suicide attempts in a prospective cohort of patients with schizophrenia treated with sertindole or risperidone. European Neuropsy-chopharmacology 2010; 20: 829-38

James D, Adams R, Spears R, Cooper G, Lupton DJ, Thompson JP, Thomas SHL. Clinical characteristics of mephedrone toxicity reported to the UK National Poisons Information Service. Emerg Med J 2010; Published on line 25 August 2010 - doi 10.1136/emj/2010.096636)

James D, Varty A, Varty D. Nurses as information scientists. Nursing Standard, September 2010

Mackin P, Thomas SHL. Atypical antipsychotic drugs. Brit Med J 2011; 342: d1126

Thanacoody HRK. Monograph for BMJ Best Evidence/Point of Care June 2010. Opiate Overdose http://bestpractice.bmj.com/best-practice/monograph/339.html

Windfuhr K, Turnbull P, While D, Swinson N, Mehta H, Hadfield K, Hiroeh U, Watkinson H, Dixon C, Flynn S, Thomas S, Lewis G, Ferrier IN, Amos T, Skapinakis P, Shaw J, Kapur N, Appleby L. The incidence and associated risk factors for sudden unexplained death in psychiatric in-patients in England and Wales. Journal of Psychopharmacology 2010; Published on line 15 October 2010 - doi 10.1177/0269881110379288

Yates L, Pierce M, Stephens S, Mill AC, Spark P, Kurinczuk JJ, Valappil M, Brocklehurst P, Thomas SH, Knight M. Influenza A/H1N1v in pregnancy: an inves-tigation of the characteristics and management of affected women and the relationship to pregnancy outcomes for mother and infant. Health Technol Assess. 2010; 14934: 109-82

Book Chapters

Russell P, Yates L, Grant E, and Golightly P. Drugs in pregnancy and lactation in Clinical Pharmaccy and Therapeutics, 5th edition, Walker RS, Whittlsea C (Eds). Churchill Livingstone, 2010

Thanacoody HKR. Drug Interactions in Clinical Pharmacy & Therapeutics, 5th edition, Walker RS, Whittlesea C (Eds). Churchill Livingstone, 2012

Thomas SHL, White J. Poisoning. In ‘Davidson’s Principles and Practice of Medicine’, Colledge, Walker, Ralston (Eds). 21st edition (2010)

62

Appendix VII Publications in Scientific and Medical Journals

Published Congress Abstracts

Hill SL, EL-Khayat R, Sandilands E, Thomas SHL. Methylphenidate toxicity: a study of dose dependent adverse drug effects using patients with methlphenidate overdose, Clinical Toxicology 2010; 48: p 260

Hill SL, Jefferson R, Thomas SHL. Neutropenia and cardiac enzyme elevation following inhalational aluminium phosphide exposure. Clinical Toxicology 2010; 48: p316

Hill SL, El-Khayat R, Sandilands E, Thomas SHL. Clinical and ECG effects of methylphenidate overdose. Brit J Clin Pharmacol 2010; 70: p296

James DA, Bradley S, Thomas SHL. A poisoning and prescribing data analysis for mefanamic acid. Clinical Toxicology 2010; 48: p286

Jones D, Stephens S, Richardson JL, Yates L, Thomas SHL. The fetal effects of ibuprofen overdose in the third trimester of pregnancy and the risk of premature closure of the ductus arteriosus. Clinical Toxicology 2010; 48: p297

Perera N, Eddleston M, Hill SL, Aldridge G, Thomas SH. Characteristics and management of poisoning with ethylene glycol and methanol in the United Kingdom. Clinical Toxicology 2010; 48: p290

Pettie JM, Dow MA, Thanacoody HKR, Sandilands EA, Bateman DN, Integrated care pathway for the management of the paracetamol poisoned patient. Abstract. EAPCCT XXXI International Congress, Bordeaux, May 2010 Clin Toxicol 2010; 48: 276-277

Richardson JL, Stephens S, Jones D, Yates L. Fetal effects of diazepam overdose during pregnancy. Clinical Toxicology, 2010; 48 (3): 281

Stephens S, Yates L, Chincholkar V, Thomas SHL. Outcome of pregnancy after maternal exposure to mifepristone. Birth Defects Reseach Part A: Clinical and Molecular Teratology, 2010; 88 (5); 433

Thomas SHL. Risk factors for paracetamol (acetaminophen) hepatotoxicity. Clinical Toxicology 2010; 48: p266

Thomas SHL, Good AM, Spears R, Cooper G, Weatherall I. UK trends in toxicity relating to drugs of misuse from National Poisons Information Service data. Clinical Toxicology 2010; 48: p304

Waring WS, Good AM, Thomas SHL, Thompson JP, Vale JA, Bateman DN. Enquiries to the National Poisons Information Service regarding dextromethorphan toxicity. Clinical Toxicology 2010; 48: p262

63

Appendix VII Publications in Scientific and Medical Journals

64

Appendix VIII Staffing Establishment

Medical Director Professor SHL Thomas

Director of Pharmacy Ms SL Brent

Consultant in Clinical Pharmacology Dr AG Dyker

Consultant Physician/Clinical Toxicologist Dr HRK Thanacoody

Locum Consultant Clinical Pharmacologist Dr S Hill

Head - Prescribing Support Ms B Reddy

Assistant Head - Prescribing Support Dr S White

Principal Pharmacist - Prescribing Support Mrs K Macfarlane

Lead Pharmacist - Prescribing Support Mrs M Mason

Senior Pharmacist - Prescribing Support Mr D McDermott

Clinical Editor - Prescribing Support Dr S Erhorn

Senior Medical Information Scientist - Prescribing Support Ms H Gates

Medical Information Scientist - Prescribing Support Ms N Kane

Medical Information Scientist - Prescribing Support Ms H Millington

Lead Pharmacist - NHS Direct Ms P Russell

Senior Pharmacist - Pharmacovigilance Mrs S Smith

Senior Pharmacist - Medicines Information Ms H Johnson

Medical Information Scientist - Medicines Information Mr V Cassidy

Information Services Manager Mrs S Bradley

Senior Medical Information Scientist - Poisons Information Mr D James

Medical Information Scientist - Poisons Information Mrs V Chincholkar

Medical Information Scientist - Poisons Information Mrs J Furness

Medical Information Scientist - Poisons Information Mr N George

65

Appendix VIII Staffing Establishment

Medical Information Scientist - Poisons Information Ms C Gilfillan

Medical Information Scientist - Poisons Information Mr D Gwynnette

Medical Information Scientist - Poisons Information Mr P Holmes

Medical Information Scientist - Poisons Information Mr H Lam

Head of Teratology Dr L Yates

Assistant Head - Teratology Dr S Stephens

Senior Medical Information Scientist - Teratology Ms D Jones

Senior Medical Information Scientist - Teratology Dr H Dunstan

Medical Information Scientist - Teratology/Poisons Mr J Richardson

Service Manager Mrs J Wood

Information Officer Mr B Khazaeli

Statistician Dr G Masters

Senior IT Support Officer Mr G Ayres

Web Developer/Designer Mr R Gourlay

Personal Assistant to the Medical Director Mrs A Makepeace

Personal Assistant to the Director of Pharmacy Mrs J Metcalf

Secretary, Medicines and Poisons Information Service Ms S Harvey

Personal Assistant to the Head of Teratology Ms J Ingram

Senior Medical Information Scientist (Externally Funded) Dr A Greenall

Data Administrator (Externally Funded) Ms A Hayes

66

Dr S Erhorn

Associate Lecturer Faculty of Medical Sciences Graduate School at Newcastle University

Professor SHL Thomas

INTERNATIONAL SOCIETIES

President, European Association of Poisons Centres and Clinical Toxicologists

Expert Panel Member: European Medicines Agency

INTERNATIONAL JOURNALS

Senior Editorial Board Member: Clinical Toxicology

International Editorial Board Member: British Journal of Clinical Pharmacology

ADVISORY COMMITTEES

Member: Commission for Human Medicines

Member: MHRA Paracetamol ad hoc group

Co-opted Member: Technical Committee, Advisory Council on the Misuse of Drugs

Member: Expert Advisory Group on Management of Casualties caused by Chemical Terrorism (Blain II)

Member: Ministry of Defence Advisory Committee on Military Medicine

Member: Ministry of Defence Research Ethics Committee

UK NHS COMMITTEES

Director: Yellow Card Centre Northern and Yorkshire

Medical Director: Regional Drug and Therapeutics Centre, Newcastle

Member: North East Treatment Advisory Group

Member: North of Tyne Area Prescribing committee

Chair: North of Tyne Area Prescribing committee, formulary subcommittee

UK ACADEMIC ACTIVITIES

Chair: Specialist Training Committee, Clinical Pharmacology and Therapeutics, Northern Deanery

Degree Programme Director: Certificate / Diploma in Therapeutics, Newcastle University

Strand leader: Master of Research (Translational Medicine and Therapeutics), Newcastle University

Member: British Pharmacology Society

Member: British Toxicological Society

Appendix IX External Positions Held

67

Dr HKR Thanacoody


Member: European Association of Poison Centres and Clinical Toxicologists

ADVISORY COMMITTEES

Member: Independent Scientific Advisory Committee, Medicines and Healthcare products Regulatory Agency (MHRA)


Member: Question Writing Group: Joint Royal Colleges MRCP (Part1) Examining Board

Module Leader: Certificate / Diploma in Therapeutics, University of Newcastle

External Examiner: Certificate / Diploma / MSc in Medical Toxicology, Cardiff University

Member: RCPath Toxicology Specialist Advisory Committee

Dr LM Yates


Member: European Network of Teratology Information Services (ENTIS)

Member: The Teratology Society

Member: Organisation of Teratology Information Specialists

Member: European Teratology Society

Member: British Society of Human Genetics (BSHG)


Honorary Clinical Senior Lecturer, Institute of Genetic Medicine, Newcastle University

Dr S Stephens


Member: European Network of Teratology Information Services (ENTIS)

Member: The Teratology Society

Member: Organisation of Teratology Information Specialists

Dr AG Dyker

National Institute of Health and Clinical Excellence Single Technology Appraisal Committee D. Manchester October

Prescribing process Review Walker Medical Group Newcastle. An analysis of the primary secondary care interface

Appendix IX External Positions Held

68

Service Area ObjectivesTarget Date

Status

Internal Management and Administration

Ensure that an up-to-date SLA between RDTC and commissioners is maintained

Met Completed

Ensure that an up-to-date SLA between RDTC and Greater Manchester Medicines Management Group is maintained

Met Completed

Agree a mechanism for annual review of SLA’s Met Completed

Ensure contact databases are up-to-date and maintained following NHS reorganisation

Met Completed

Ensure strategic objectives of Centre are supported through appraisal process and individual objective setting

Met Completed

Support clinical governance to pharmaceutical services locally Met Completed

Ensure that the Drug Alert Cascade system remains robust and fit for purpose

Met Completed

Maintain IT strategy to meet rapid change in IT and needs of the RDTC in order to meet the requirements of the unit

Met Completed

To further develop the new enquiry management system (EMS) within the RDTC to ensure continued fitness for purpose

Met Completed

Contribute to the development of TOXBASE Met Completed

Contribute to the development of UKPiD Met Completed

Support updating of UKPID source and agent lists nationally Met Completed

Assist in the implementation of the NHS ESR system Met Completed

Ensure RDTC staff receive training appropriate to needs Met Completed

Support continued staff development Met Completed

Internal financial controls established with formalised budget setting process

Met Completed

Monitor expenditure against income Met Completed

Appendix X Business Plan


Status

Prescribing and Medicines Usage Medicines Management

Increase awareness of prescribing support activities to stakeholders

Met Completed

Support for the NEAS in the implementation of national guidance / policy around medicines as per SLA

Met Completed

Linking outcome data to Prescribing Met Completed

Provide continued support for performance management or primary care prescribing

Met Completed

Provide primary care organisations with tools to promote cost effective prescribing and make prescribing savings

Met Completed

Prepare and distribute a range of documents for primary care prescribers and medicines management teams, including: summary monographs on new active substances introduced to the UK market, existing drugs / groups of drugs and safety of medicines; strategic documents concentrating on therapeutic areas; and brief documents to assist with effecting prescribing change

Met Completed

Improve provision of evidence-based advice on new drugs for commissioners and horizon scanning for new developments

Met Completed

Link publications to QIPP agenda to support prescribing reports Met Completed

Prepare and distribute detailed reports on agents not covered by the NICE work program, and are excluded from the ‘Payment by Results’ (PBR) tariff

Met Completed

Provide academic detailing aids to accompany relevant publications Met Completed

Produce strategic documents on therapeutic areas of current interest / concern to medicines management teams, area prescribing committees / drug & therapeutic committees and commissioners

Met Completed

Develop website to allow increased access to the range of publications, and prescribing information / reports

Met Completed

69




Status

Education and Training

Continue to provide input into national training events in medicines information and poisons services

Met Completed

Provide continuing professional development to staff within the RDTC Met Completed

Deliver training to increase region-wide ADR reporting by patients Met Completed

Provision of specialist study days (eg New Drugs, Adverse Drug Reactions, Drugs in Pregnancy, Critical Appraisal and Academic Detailing)

Met Completed

Research and Development

Contribute to data collection for research projects carried out by NPIS, HPA, EAPCCT or WHO

Met Completed

Provide Seminars / Study Days on management of poisoning and TOXBASE use for NHS Direct staff in the region and nationally

Met Completed

Carry out research in prescribing and medicines management Met Completed

Medicines Information

Maintain RDTC support for UKMi SLA with NHS Direct delivering against objectives

Met Completed

Ensuring UKMi clinical governance standards for enquiry answering are adhered via external audit of local medicines information centres

Met Completed

Provide professional development seminars for medicines information pharmacists

Met Completed

Provide regular communication to PCTs on types of enquiries received Met Completed

Contribution to UKMi MI Questions and Answers series Met Completed

Contribution to abstracts to the Pharmline / NeLM database Met Completed

Develop working relationship with Local Hospitals to support local MI services

Met Completed

Maintain current Medicines Information enquiry services and manage anticipated growth

Met Completed

Develop working relationship with Local Hospitals to deliver MI services and support publications processes

Met Completed

70



Status

NPIS Maintain poisons information service in accordance with contract with the Health Protection Agency

Met Completed

Continue to review amended draft TOXBASE monographs as requested - approximately 6 + per month

Met Completed

Maintain and update poisons information monographs on TOXBASE Met Completed

Monitor advice provided to callers for content and appropriateness Met Completed

Monitor and report user satisfaction of poisons information service Met Completed

UKTIS Maintain support to Chemical Hazards and Poisons Division of HPA in accordance with contract with the Health Protection Agency

Met Completed

Continue to deliver the National UK Teratology Information Service in accordance with contract with the Health Protection Agency

Met Completed

Maintain and update the database of summaries on the fetal effects of drugs and chemicals in pregnancy in accordance with our Service Level Agreement with the Health Protection Agency

Met Completed

Maintain research profile of Teratology Service Met Completed

Provision of education in teratology and poisoning Met Completed

Yellow Card Centre In conjunction with the Commission on Human Medicines, develop and implement strategy to increase reporting rates by both healthcare professionals and patients

Met Completed

Increase awareness of Yellow Card Centre Northern and Yorkshire to stakeholders

Met Completed

71

Wolfson UnitClaremont Place

Newcastle upon TyneNE2 4HH

Phone: 0191 260 6181Fax: 0191 260 6191www.nyrdtc.nhs.uk

REGIONAL DRUG AND THERAPEUTICS CENTRE - NEWCASTLE