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i

Improving information exchange

during over-the-counter consultations

in the community pharmacy setting.

Liza Jane Seubert, B Pharm

This thesis is presented for the degree of Doctor of Philosophy

of The University of Western Australia

School of Allied Health

Division of Pharmacy

2019

ii

Thesis Declaration

I, Liza Seubert, certify that:

This thesis has been substantially accomplished during enrolment in this degree.

This thesis does not contain material which has been submitted for the award of any other

degree or diploma in my name, in any university or other tertiary institution.

In the future, no part of this thesis will be used in a submission in my name, for any other

degree or diploma in any university or other tertiary institution without the prior approval of The

University of Western Australia and where applicable, any partner institution responsible for

the joint-award of this degree.

This thesis does not contain any material previously published or written by another person,

except where due reference has been made in the text and, where relevant, in the Authorship

Declaration that follows.

This thesis does not violate or infringe any copyright, trademark, patent, or other rights

whatsoever of any person.

The research involving human data reported in this thesis was assessed and approved by The

University of Western Australia Human Research Ethics Committee. Approval #: RA/4/1/5298

and RA/4/1/6538. Written patient consent has been received and archived for the research

involving patient data reported in this thesis.

This thesis contains published work and/or work prepared for publication, some of which has

been co-authored. This thesis is in agreement with The University of Western Australia Doctor

of Philosophy Rules for the content and format of a thesis (39-45) and is presented as a series

of papers.

Signature:

Date: 04/10/2019

iii

Abstract

Consumers engage in self-care to maintain their health, prevent disease and treat illness. The

World Health Organisation (WHO) defines self-care as “the ability of individuals, families and

communities to promote health, prevent disease, and maintain health and to cope with illness

and disability with or without the support of a health-care provider.”1 Access to over-the-

counter (OTC) medicines facilitates self-care, however consumers may require support for

safe and effective self-medication. Pharmacists and other pharmacy personnel are readily

accessible in community pharmacies and as such ideally placed to support consumers with

self-care.

OTC enquiries can be complex and interventions to improve OTC consultations and support

consumers to engage in self-care have been implemented in the community pharmacy setting

with variable success.2-6 Pharmacists and pharmacy personnel report difficulties in engaging

consumers in dialogue, particularly when the consultation involves a request for a medicine

by name.7,8 Increasing the amount of information exchange during OTC consultations is

significantly associated with positive outcomes such as appropriate medicine supply or

referral.9-12 However, there is substantial evidence that the management of the diverse range

of OTC enquiries encountered in community pharmacies is sub-optimal and that this is mainly

due to inadequate information gathering and/or advice or information provision by pharmacy

personnel.9,13-17

The aim of the research of this Doctor of Philosophy (PhD) was to improve information

exchange during over-the-counter (OTC) consultations in the community pharmacy setting.

Objectives

1. To synthesise evidence of interventions to improve communication during OTC

consultations.

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2. To explore stakeholder perspectives regarding barriers and facilitators for

information exchange during OTC consultations.

3. To develop an intervention to enhance information exchange between pharmacy

personnel and consumers during OTC consultations in community pharmacy.

4. To test the feasibility of interventions to promote information exchange between

pharmacy personnel and consumers during OTC consultations.

To synthesise evidence of interventions to improve communication during OTC consultations,

a systematic literature review was conducted. In the eleven included studies underpinning

theory was not consistently used in the development of the interventions. The main

characteristic of interventions was the use of face-to-face activities to provide information and

training to participants. Target participants for the interventions in all the studies reviewed were

pharmacy personnel.

To explore stakeholder perspectives regarding barriers and facilitators for information

exchange during OTC consultations, focus group discussions were conducted. These found

that consumers expected minimal interaction when they present in community pharmacies

with an OTC enquiry. Several interacting factors influenced this expectation. Consumer

knowledge about the role and responsibility of pharmacists was lacking. Consumers

underestimated the risks associated with taking OTC medicines and viewed them as safe, as

they were available without a prescription. They were also generally confident in their lay

expertise for self-diagnosis and self-care. All participant groups stated it was difficult to identify

the position of pharmacy personnel as pharmacist or pharmacy assistant.

To develop an intervention to enhance information exchange between pharmacy personnel

and consumers during OTC consultations in community pharmacy the methodology described

in the Behaviour Change Wheel (BCW) – a guide to developing interventions 18 was followed

using evidence from previous phases. The intervention strategy developed was to use

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situational cues, in the form of a poster displayed in a community pharmacy (environmental

restructuring), depicting consumers with OTC enquiries engaging in information exchange

(modelling), highlighting the benefit of this behaviour (persuasion) and the reasons why it is

important (education). A second poster depicting a pharmacist and information about the

qualifications and role of a pharmacist was developed. An additional situational cue, in the

form of a badge, was developed to be worn by pharmacy personnel to identify their position

as either pharmacist or pharmacy assistant.

To test the feasibility of interventions to promote information exchange between pharmacy

personnel and consumers during OTC consultations a feasibility study was conducted. Tools

and materials for the interventions and feasibility study were developed. The proposed

interventions and evaluation methods were feasible. The use of posters and badges as

situational cues to address barriers to information exchange during OTC consultations was

practical in the community pharmacy setting.

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Table of contents

Thesis Declaration ………………………………………………………………………...... ii

Abstract.........................................................................................................................iii

Table of Contents..........................................................................................................vi

Publications arising from this research.........................................................................ix

Definitions.....................................................................................................................xi

List of Abbreviations.....................................................................................................xv

List of Figures..............................................................................................................xvi

List of Tables...............................................................................................................xvii

Acknowledgements....................................................................................................xviii

Authorship declaration: Co-authored publications........................................................xx

References..................................................................................................................xxii

Chapter 1: Introduction.................................................................................................1

1.1 Opening statement................................................................................................2

1.2 Background...........................................................................................................4

1.2.1 Self-care........................................................................................................4

1.2.2 The cost of health..........................................................................................5

1.2.3 Community pharmacy...................................................................................9

1.2.4 Community pharmacists..............................................................................12

1.2.5 OTC consultations.......................................................................................13

1.3 Aim......................................................................................................................15

1.4 References..........................................................................................................16

Chapter 2: Methods ................................................................................................... 24

2.1 Introduction.........................................................................................................25

2.2 Rationale for the selected methods....................................................................25

2.3 Research setting.................................................................................................27

2.4 Ethical approvals.................................................................................................28

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2.5 Research methods.............................................................................................28

2.5.1 Phase 1: Systematic literature review.........................................................28

2.5.2 Phase 2: Focus group study.......................................................................33

2.5.3 Phase 3: Development of the intervention strategy....................................38

2.5.4 Phase 4: Feasibility study...........................................................................46

2.5.1.1 Intervention strategy............................................................................47

2.5.4.2 Tool and resource development..........................................................48

2.5.4.3 Pre-test of intervention study procedures............................................51

2.5.4.4 Feasibility study...................................................................................53

2.6 References..........................................................................................................56

Chapter 3: Interventions to enhance effective communication during over-the-

counter consultations in the community pharmacy setting: A

systematic review.....................................................................................61

3.1 Background.........................................................................................................62

3.2 Publication..........................................................................................................63

3.3 Key findings from the systematic literature review..............................................73

3.4 Relevance of findings to PhD research aim........................................................73

3.5 References..........................................................................................................74

Chapter 4: Barriers and facilitators for information exchange during over-the-

counter consultations in community pharmacy: A focus group

study..........................................................................................................75

4.1 Background.........................................................................................................76

4.2 Publication..........................................................................................................77

4.3 Key findings from the focus group study.............................................................89

4.4 Relevance of findings to PhD research aim........................................................89

4.5 References..........................................................................................................91

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Chapter 5: Development of a theory-based intervention to enhance information

exchange during over-the-counter consultations in community

pharmacy...................................................................................................92

5.1 Background.........................................................................................................93

5.2 Publication..........................................................................................................94

5.3 Key findings from the development study.........................................................103

5.4 Relevance of findings to PhD research aim......................................................103

5.5 References........................................................................................................104

Chapter 6: A theory based intervention to enhance information exchange during

over-the-counter consultations in community pharmacy: A feasibility

study........................................................................................................105

6.1 Background.......................................................................................................106

6.2 Publication........................................................................................................107

6.3 Key findings from the feasibility study...............................................................126

6.4 Relevance of findings to PhD research aim......................................................126

Chapter 7: Discussion...............................................................................................126

7.1 Background.......................................................................................................127

7.2 Summary of key findings...................................................................................128

7.3 Strengths and limitations...................................................................................133

7.4 Overall research findings..................................................................................136

7.5 Conclusion........................................................................................................137

7.6 References.......................................................................................................139

Appendix 1: Ethical approvals

Appendix 2: Literature review search strategy

Appendix 3: Focus group Facilitator Guide

Appendix 4: Consumer questionnaire

Appendix 5: Publication – literature review study

Appendix 6: Publication – focus group study

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Appendix 7: Publication – intervention development study

Appendix 8: Publication (accepted) – feasibility study

x

Publications arising from this research

Peer reviewed publications:

Author contributions are listed according to the Contributor Roles Taxonomy (CRediT).19

(https://www.casrai.org/credit.html)

Paper 1: Seubert LJ; Whitelaw K; Hattingh L; Watson MC; Clifford RM. Interventions to

enhance effective communication during over-the-counter consultations in the community

pharmacy setting: a systematic review. Res Social Adm Pharm 2017;14(11);979-988

https://doi.org/10.1016/j.sapharm.2017.12.001

Author contributions. LS: conceptualisation; data curation; formal analysis; methodology;

validation; writing – original draft. KW: formal analysis; methodology; validation; writing –

review & editing. RC, LH, MW: supervision; writing – review & editing.

Paper 2: Seubert LJ; Whitelaw K; Boeni F; Hattingh L; Watson MC; Clifford RM. Barriers and

facilitators for information exchange during over-the-counter consultations in community

pharmacy: a focus group study. Pharmacy 2017, 5, 65. https://www.mdpi.com/2226-

4787/5/4/65



review & editing. FB: writing – review & editing. RC, LH, MW: supervision; writing – review &

editing.

Paper 3: Seubert LJ; Whitelaw K; Hattingh L; Watson MC; Clifford RM. Development of a

theory-based intervention to enhance information exchange during over-the-counter

consultations in community pharmacy. Pharmacy 2018,6,117;

doi.org/10.3390/pharmacy6040117

https://www.casrai.org/credit.html


https://www.mdpi.com/2226-4787/5/4/65

https://www.mdpi.com/2226-4787/5/4/65

http://dx.doi.org/10.3390/pharmacy6040117

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Paper 4: Seubert LJ; Whitelaw K; Hattingh L; Watson MC; Clifford RM. A theory based

intervention to enhance information exchange during over-the-counter consultations in

community pharmacy: a feasibility study. Pharmacy 2019, accepted.




Conference presentations (peer reviewed abstract selection)

1. Seubert LJ, Clifford RM. What helps and what hinders pharmacists to ask health related

questions for over the counter queries in community pharmacies? [Poster]. Proceedings of the

20th Conference of the Health Services and Pharmacy Practice Conference; 2014 Apr 3-4;

Aberdeen, Scotland. West Sussex (United Kingdom): John Wiley & Sons Ltd, Royal

Pharmaceutical Society; 2014. p. 48-49 (poster presentation)

2. Seubert LJ, Whitelaw K, Hattingh L, Watson M, Clifford RM. Enhancing communication

between consumers and community pharmacy staff for over the counter requests: a systematic

review. Proceedings of the International Social Pharmacy Workshop; Int J Pharm Prac 2016;

24 (2): 26 (oral presentation)

3. Seubert LJ, Whitelaw K, Hattingh L, Watson M, Clifford RM. Development of a behaviour

change intervention to enhance over the counter consultations in community pharmacies.

Proceedings of the International Social Pharmacy Workshop; Int J Pharm Prac 2016; 24 (2):

54 (poster presentation)

xii

Definitions

This section presents definitions applied in the context of the research in this PhD.

Community pharmacy

A property registered as a pharmacy, which is under the personal supervision of a

pharmacist at all times. It consists of the provision of pharmaceutical services from which

goods and services relating to the provision of pharmaceutical services may be available.

Consumer

A person visiting a community pharmacy with an OTC enquiry.

General practice

A medical specialty (in some countries called family medicine). The practice area of a

general practitioner.20

General practitioner (GP)

A doctor qualified in general medical practice. GPs provide diagnosis, treatment,

management of acute and chronic conditions, health information or advice, and coordination

of healthcare. They may order screening and medical tests, and refer to specialist health

professionals.20

Minor ailment

A common or self-limiting or uncomplicated condition which can be diagnosed and managed

without medical intervention.

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Multi-disciplinary

The combination of multiple health professionals to build a primary care team. It may include

general practitioners, nurses, community health workers, physician assistants, rehabilitation

workers, nutritionists, care managers, social workers, pharmacists, dentists, traditional

healers and support staff.21

Non-prescription medicines

Medicines available without a prescription.

Over the counter (OTC) medicines

Medicines available without a prescription from a community pharmacy or other retail outlet

(depending on jurisdiction).

OTC consultation

The discussion that occurs between consumers and pharmacy personnel when an OTC

enquiry is made.

OTC enquiry

A health enquiry, not associated with a prescription, for the consumer themselves or on

someone else’s behalf. This could be a request for a specific product by name or for advice

about treatment of a symptom or condition, which occurs in a community pharmacy setting.

Pharmacist Only Medicine (Australia)

A medicine classified in the Standard for Uniform Scheduling of Medicines as Schedule 3:

Substances, the safe use of which requires professional advice but should be available to

the public from a pharmacist without a prescription. Only available in a pharmacy with direct

involvement of the pharmacist.22

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Pharmacy assistant

A non-professional staff member working in a community pharmacy under the supervision of

a pharmacist. These personnel are required to be trained to ask specific questions of

intending purchasers of Schedule 2 and Schedule 3 medicines. Any queries that arise from

the purchaser’s response should be referred to a pharmacist.

Pharmacy Medicine (Australia)

A medicine classified in the Standard for Uniform Scheduling of Medicines as Schedule 2:

Substances, the safe use of which may require advice from a pharmacist and which should

be available from a pharmacy or, where a pharmacy service is not available, from a licensed

person.22

Primary care

Generally the first point of contact consumers have with the health system. It relates to the

treatment of non-admitted patients in the community and can include general practice and

community pharmacy.20

Purchasing Power Parities (PPPs)

The rates of currency conversion that equalise the purchasing power of different currencies

by eliminating the differences in price levels between countries. In their simplest form, PPPs

are simply price relatives which show the ratio of the prices in national currencies of the

same good or service in different countries.23

Self-care

What consumers do for themselves to establish and maintain health, prevent and deal with

illness.1

xv

Self-limiting condition

A condition ultimately resolving itself without treatment.

Self-medication

The selection and use of medicines by consumers to treat self-recognised illness or

symptoms. It is an element of self-care.24

xvi

List of Abbreviations

Abbreviation Expanded term

APEASE Affordability, Practicability, Effectiveness and cost effectiveness, Acceptability, Side-effects/safety, Equity

BCT Behaviour change technique

BCW Behaviour Change Wheel

COM-B Capability Opportunity Motivation – Behaviour

CONSORT Consolidated Standards of Reporting Trials

PhD Doctor of Philosophy

GP General practitioner

GDP Gross Domestic Product

IF Intervention function

MRC Medical Research Council

MAS Minor Ailment Service

OECD Organisation for Economic Co-operation and Development

OTC Over-the-counter

PICOS Participants, interventions, comparators, outcomes, and study designs

PSA Pharmaceutical Society of Australia

PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses

PPP Purchasing power parities

RCT Randomised controlled trial

TIDieR Template for Intervention Description and Replication

UWA The University of Western Australia

TDF Theoretical Domains Framework

TREND Transparent Reporting of Evaluations with Nonrandomised Designs

UK United Kingdom

USA United States of America

WHO World Health Organisation

xvii

List of Figures

Chapter Description

1 Figure 1. OECD annual growth of health expenditure and GDP, in real terms, 2000-17

1 Figure 2. Pharmaceutical spending as % of health spending, 2017 or latest available.

1 Figure 3. Total expenditure on retail pharmaceuticals per capita, 2015 (or nearest year)

1 Figure 4. The patient-centred primary care network

1 Figure 5. Pharmacist consultation process

2 Figure 1. Key elements of the Medical Research Council development and evaluation process

2 Figure 2. Exploratory sequential mixed methods design

2 Figure 3. The COM-B system - a framework for understanding behaviour

2 Figure 4. Thematic map of focus group themes and overlap

2 Figure 5. Factors influencing engagement in OTC consultations

2 Figure 6. Distinctive features of a feasibility study

7 Figure 1. Key elements of the Medical Research Council development and evaluation process

7 Figure 2. Exploratory sequential mixed methods design

xviii

List of Tables

Chapter Description

2 Table 1. Literature review data extraction items

2 Table 2. Focus group semi structured question guide

2 Table 3. Focus group themes coded to COM-B and TDF

2 Table 4. Prioritising information exchange behaviours

2 Table 5. Target behaviour: who needs to do what, when, where and with whom

2 Table 6. Behavioural diagnosis using themes from Phase 2 focus group meetings

2 Table 7. Identifying intervention functions likely to address barriers to information exchange

2 Table 8. Linking intervention functions to Behaviour Change Techniques

2 Table 9. Behaviour Change Technique examples for the interventions

2 Table 10. Stages of the feasibility study

2 Table 11. Semi-structured interview guide for consumers after poster review

2 Table 12. Semi-structured interview guide for pharmacy personnel after the intervention

2 Table 13. Process tasks for the conduct of the pre-test

7 Table 1: Summary of key findings linked to research objectives

xix

Acknowledgements

This research was supported by an Australian Government Research Training Program (RTP)

fees offset Scholarship.

I would like to acknowledge several individuals and organisations who have helped make this

thesis possible. First and foremost, I would like to express my heartfelt thanks for the support

and guidance of my principal supervisor, Professor Rhonda Clifford. This journey was made

possible through the confidence, mentoring, motivation and friendship you provided along the

way. Thank you for your unwavering belief in me. To my co-supervisors, Dr Laetitia Hattingh

and Professor Margaret Watson, I gratefully acknowledge your wisdom and expert knowledge

in community pharmacy practice. You have both provided amazing insight and have inspired

me to develop new skills and understanding. Thank you for the support you continuously

offered me.

I am so grateful for the support and friendship of Kerry Whitelaw. You have been with me

throughout my PhD journey – always there to listen and help. I truly could not have come this

far without you.

Thank you to fellow pharmacist and friend Amanda Bryce. You are an inspiration to

pharmacists and continue to show the way forward for community pharmacy practice. I am

ever grateful for your willingness to be involved and for your advice and wisdom.

I am thankful for the financial support of this research provided by a grant from the

Pharmaceutical Society of Western Australia Ltd, J.M. O’Hara Research Fund.

xx

I would like to acknowledge and thank the staff of the community pharmacies who participated

in this research, along with their customers who also participated. Thank you to the wonderful

Master of Pharmacy students who also helped with various aspects of the research.

Finally, to my wonderful husband Glenn, thank you for your unfailing love and support for all

that I do. To my son Jess, you have been so patient and understanding – thank you.

My research journey has happened because of the fabulous people I have in my life. Thank

you all for your support and faith in me.

xxi

Authorship declaration: Co-authored publications

This thesis contains work that has been published and/or prepared for publication.

Details of the work:

Interventions to enhance effective communication during over-the-counter consultations in the

community pharmacy setting: A systematic review

Location in thesis:

Chapter 3

Student contribution to work:

Conceptualisation; data curation; formal analysis; methodology; validation; writing – original draft.

Co-author signatures and dates:

Rhonda Clifford; Laetitia Hattingh; Margaret Watson; Kerry Whitelaw


Barriers and facilitators for information exchange during over-the-counter consultations in

community pharmacy: A focus group study

Location in thesis:

Chapter 4




Kerry Whitelaw; Fabienne Boeni; Laetitia Hattingh; Margaret C Watson; Rhonda M Clifford


Development of a theory-based intervention to enhance information exchange during over-the-

counter consultations in community pharmacy

Location in thesis:

Chapter 5





xxii


A theory based intervention to enhance information exchange during over-the-counter

consultations in community pharmacy: a feasibility study.

Location in thesis:

Chapter 6





Student signature:

Date: 03/10/2019

I, Rhonda Clifford certify that the student’s statements regarding their contribution to each of the

works listed above are correct.

As all co-authors’ signatures could not be obtained, I hereby authorise inclusion of the co-authored

work in the thesis.

Coordinating supervisor signature:

Date: 03/10/2019

xxiii

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https://apps.who.int/medicinedocs/en/d/Jwhozip32e/

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1. World Health Organization. Self-care in the context of primary health care : report of the regional consultation. Bangkok: World Health Organization; 2009 [cited 05 May 2019]. 2. Watson MC, Cleland JA, Bond CM. Simulated patient visits with immediate feedback to improve the supply of over-the-counter medicines: a feasibility study. Fam Pract. 2009 Dec;26(6):532-42. 3. Schneider CR, Everett AW, Geelhoed E, Padgett C, Ripley S, Murray K, et al. Intern pharmacists as change agents to improve the practice of nonprescription medication supply: provision of salbutamol to patients with asthma. Ann Pharmacother. 2010;44(7-8):1319-26. 4. Ratanajamit C, Chongsuvivatwong V, Geater AF. A randomized controlled educational intervention on emergency contraception among drugstore personnel in southern Thailand. J Am Med Womens Assoc (1972). 2002 Fall;57(4):196-9, 207. 5. Westerlund T, Andersson I-L, Marklund B. The quality of self-care counselling by pharmacy practitioners, supported by IT-based clinical guidelines. Pharm World Sci [journal article]. 2007 April 01;29(2):67-72. 6. Krishnan HS, Schaefer M. Evaluation of the impact of pharmacist's advice giving on the outcomes of self-medication in patients suffering from dyspepsia. Pharm World Sci. 2000 Jun;22(3):102-8. 7. Kelly FS, Williams KA, Benrimoj SI. Does advice from pharmacy staff vary according to the nonprescription medicine requested? Ann Pharmacother. 2009 Nov;43(11):1877-86. 8. Fielding S, Slovic P, Johnston M, Lee Amanda J, Bond Christine M, Watson Margaret C. Public risk perception of non‐prescription medicines and information disclosure during consultations: a suitable target for intervention? International Journal of Pharmacy Practice. 2018;(early review). 9. Watson MC, Hart J, Johnston M, Bond CM. Exploring the supply of non-prescription medicines from community pharmacies in Scotland. Pharm World Sci. 2008 Oct;30(5):526-35. 10. Dwamena F, Holmes-Rovner M, Gaulden CM, Jorgenson S, Sadigh G, Sikorskii A, et al. Interventions for providers to promote a patient-centred approach in clinical consultations. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD003267. 11. Watson MC, Ferguson J, Barton GR, Maskrey V, Blyth A, Paudyal V, et al. A cohort study of influences, health outcomes and costs of patients' health-seeking behaviour for minor ailments from primary and emergency care settings. British Medical Journal. 2015 Feb 18;5(2):e006261. 12. Berger K, Eickhoff C, Schulz M. Counselling quality in community pharmacies: implementation of the pseudo customer methodology in Germany. J Clin Pharm Ther. 2005 Feb;30(1):45-57. 13. Watson M, Bond C, Grimshaw J, Johnston M. Factors predicting the guideline compliant supply (or non-supply) of non-prescription medicines in the community pharmacy setting. Qual Saf Health Care. 2006 [cited 7 November 2013];15:53-7. 14. Watson MC, Bond CM, Johnston M, Mearns K. Using human error theory to explore the supply of nonprescription medicines from community pharmacies. Qual Saf Health Care 2006;15(4):244–250. 15. Schneider CR, Everett AW, Geelhoed E, Kendall PA, Clifford RM. Measuring the assessment and counselling provided with the supply of non-prescription asthma reliever medication: a simulated patient study. Ann. Pharmacother. 2009 Sep;43:1512-8. 16. Schneider CR, Emery L, Brostek R, Clifford RM. Evaluation of the supply of antifungal medication for the treatment of vaginal thrush in the community pharmacy setting: a randomized controlled trial. Pharm Pract (Granada). 2013 Jul;11(3):132-7. 17. Benrimoj SI, Werner JB, Raffaele C, Roberts AS, Costa FA. Monitoring quality standards in the provision of non-prescription medicines from Australian Community Pharmacies: results of a national programme. Qual Saf Health Care. 2007 Oct;16(5):354-8. 18. Michie S, Atkins L, West R. The behaviour change wheel. A guide to designing interventions. 1st ed. Great Britain: Silverback Publishing; 2014.

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19. CASRAI. CRediT (Contributor Roles Taxonomy). [13 June 2019]. Available from: http://casrai.org/CRediT 20. World Health Organisation. Main Terminology. Geneva: World Health Organisation [2019 June 7]. Available from: http://www.euro.who.int/en/health-topics/Health-systems/primary-health-care/main-terminology 21. World Health Organisation and the United Nations Children's Fund. A vision for primary health care in the 21st century. Geneva: WHO and UNICEF; 2018 [cited 13 May 2019]. Available from: https://www.who.int/docs/default-source/primary-health/vision.pdf 22. Therapeutic Goods Administration. The Poisons Standard (the SUSMP). Australian Government, Department of Health [11 June 2019]. Available from: https://www.tga.gov.au/publication/poisons-standard-susmp 23. OECD. Glossary of statistical terms. OECD [10 May 2019]. Available from: https://stats.oecd.org/glossary/detail.asp?ID=2205 24. World Health Organisation. The role of the pharmacist in self-care and self-medication 1998 [Available

http://casrai.org/CRediT






1

Chapter 1:

Introduction

2

1.1 Opening statement

Consumers engage in self-care to maintain their health, prevent disease and treat illness. The

World Health Organisation (WHO) defines self-care as “the ability of individuals, families and

communities to promote health, prevent disease, and maintain health and to cope with illness

and disability with or without the support of a health-care provider.”1 Access to over-the-

counter (OTC) medicines facilitates self-care, however consumers may require support for

safe and effective self-medication. Pharmacists and other pharmacy personnel are readily

accessible in community pharmacies and as such ideally placed to support consumers with

self-care.

OTC enquiries can be complex and interventions to improve OTC consultations and support

consumers to engage in self-care have been implemented in the community pharmacy setting

with variable success.2-6 Pharmacists and pharmacy personnel report difficulties in engaging

consumers in dialogue, particularly when the consultation involves a request for a medicine

by name.7,8 Increasing the amount of information exchange during OTC consultations is

significantly associated with positive outcomes such as appropriate medicine supply or

referral.9-12 However, there is substantial evidence that the management of the diverse range

of OTC enquiries encountered in community pharmacies is sub-optimal and that this is mainly

due to inadequate information gathering and/or advice or information provision by pharmacy

personnel.9,13-17

The aim of the research of this PhD was to improve information exchange during over-the-

counter (OTC) consultations in the community pharmacy setting.

Objectives


consultations.

3







4

1.2 Background

1.2.1 Self-care

Consumers are increasingly accessing information to help them make decisions about all

aspects of their lives including their health. There is recognition that readily available

information empowers consumers to engage in self-care.18,19 The World Health Organisation

(WHO) defines self-care as “the ability of individuals, families and communities to promote

health, prevent disease, and maintain health and to cope with illness and disability with or

without the support of a health-care provider.”1 It involves a consumer taking steps to both

maintain personal health and treat health conditions by means such as self-medication –

therefore intrinsically self-care is a key component of primary care.20

In many countries, an increasing number of prescription medicines are being re-classified to

become available for self-care by consumers as OTC19,21,22 medicines. The advantages of

consumers using OTC medicines include an individual’s feeling of increased personal

empowerment and faster access to vital medicines. A disadvantage can be the potential for

harm from inappropriate or incorrect self-use of OTC medicines19,23 which can occur if

consumers lack an understanding of the responsible use of the medicines being taken. The

WHO estimates that more than 50% of all medicines are sold inappropriately and around 50%

of all patients fail to take their medicines correctly, including prescription medicines.24 This

highlights the pivotal role of community pharmacists. They are readily accessible health

professionals22,25 who can provide healthcare advice and, as the medicine experts, facilitate

the safe and correct use of medicines.

In Australia, OTC medicines are classified as unscheduled medicines, available from

pharmacies or other retail outlets (e.g. supermarkets); Pharmacy Medicines, available only

from community pharmacies; and Pharmacist Only Medicines, also only available from

pharmacies under the supervision of a pharmacist.26,27 A similar system exists in Canada28

5

and New Zealand.29 In the UK, OTC medicines are classified as Pharmacy Medicines

(available only under the supervision of a pharmacist) and General Sales List medicines

(available from pharmacies and other retail outlets).30 In the USA and many European

countries there are two classifications: prescription medicines are prescribed then supplied

through pharmacy, and OTC medicines are available through general retail outlets including

pharmacies.31-33

In Australia, the classification of a medicine is determined by the Therapeutic Goods Advisory

Committee. A set of complex factors are considered including the toxicity; purpose of use;

potential for abuse; safety in use; and need for the medicine. Some medicines may be listed

in a number of categories e.g. paracetamol 500mg tablets in quantities up to 20 tablets are

unclassified and available from general retailers; in quantities of 26 – 100 tablets are classified

Pharmacy Medicines; or in quantities over 100 tablets are classified Prescription Only.27 An

issue of concern is consumer misunderstanding about the safety of OTC medicines which

may be perceived to be safe due to their availability from a supermarket.34

Reclassification of medicines previously available on prescription 35-38 facilitates consumer

self-care and ease of access to medicines, and also shifts some of the cost of medicines from

organisations such as governments and private insurers to the consumer.39

1.2.2 The cost of health

The equitable delivery of appropriate healthcare to the public has an economic cost that is of

primary concern to governments globally.39-41 In the context of having many competing

priorities, governments must balance the health of their people with the cost of delivering

healthcare from finite budget funds. Prioritising healthcare funding is made more challenging

as globally, the cost of healthcare continues to rise at a rate higher than the increase in gross

domestic product (GDP) (Figure 1).42

6

Figure 1. OECD annual growth of health expenditure and GDP, in real terms, 2000-17

(OECD Health Statistics 2018)42

Organisation for Economic Co-operation and Development (OECD) data shows

pharmaceuticals (including prescription and non-prescription medicines expenditure by

government and consumers, but excluding pharmaceuticals consumed in hospitals) as the

third largest health expenditure item.39 In Australia in 2015, 14.5% of health expenditure was

on pharmaceuticals (Figure 2).43

Figure 2. Pharmaceutical spending as % of health spending, 2017 or latest available.43

7

While the majority of pharmaceutical spending is for prescription medicines, an average of

20% is for OTC medicines (Figure 3).42

Figure 3. Total expenditure on retail pharmaceuticals per capita, 2015 (or nearest year)39

*PPP – purchasing power parities are the rates of currency conversion that equalise the purchasing power of

different currencies.44

Maintaining quality healthcare with equitable access in a financially sustainable manner

continues to be challenging. Nations, policymakers and governments continue to identify

opportunities to optimise available health resources. Making better use of primary care

resources and services is one strategy which relieves the high cost of presentations to general

practices and hospital emergency departments.11,45-47 Primary care has traditionally been

defined as consisting of four key functions: (1) first-contact – the first point of contact with the

health system for a health-related issue; (2) care over time – ongoing management of patient

health; (3) comprehensive – able to address the majority of healthcare needs; and (4)

1162

982

798

766

756

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553

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417

413

404

401

387

369

352

326

313

282

0

200

400

600

800

1 000

1 200

1 400

USD PPP* Prescribed medicines Over-the-counter medicines Total (no breakdown)

8

coordination of care provided.48 General practices are well established centres for delivery of

primary care where general practitioners (GPs) are the providers of primary care.45,48,49 The

success of general practice services has seen high demand resulting in difficulties in

accessing the services, over-worked GPs, and decreased time available for GP-patient

interactions.45,50 The overwhelming burden on primary care GPs has led to a broader concept

of primary care which embraces a range of stakeholders including: GPs, nurses, pharmacists,

physiotherapists, dietitians, social workers, specialist doctors, psychologists, non-medical

personnel e.g. social workers, dietitians, and clerical officers, and most importantly

consumers.

A multidisciplinary approach has been evolving in a number of countries to cope with primary

care demands.45,51-53 More than 20 years ago, Rogers et al reported on consumer self-care for

health being a driver of primary care in the United Kingdom (UK).20 Providing information about

the options for healthcare enables consumers to seek appropriate help. Rogers et al discussed

the need for ‘graduated’ health services and provided examples of information available to the

public to influence their health seeking behaviours: ‘When should I call the doctor?’ and

‘Getting the most from your pharmacist’.20 The graduated use of resources includes the

management of less complex, non-urgent health issues by non-medical health professionals

with appropriate competence. Integrating pharmacists,54,55 nurses, dentists, social workers

and other disciplines in the primary care team with suitable training to recognise the limits of

their expertise and the ability to refer appropriately, frees up medical practitioners for the

management of more complex cases.56

Epperly et al in the United States of America (USA) recently published The Shared Principles

of Primary Care49 which reconsiders the doctor-centric model of primary care to embrace the

perspective and contribution of multiple stakeholders. The seven Shared Principles49 of

9

Primary Care are:

1) person and family centred;

2) continuous;

3) comprehensive and equitable;

4) team based and collaborative;

5) coordinated and integrated;

6) accessible; and

7) high value.

1.2.3 Community pharmacy

A large network of community pharmacies exists in many countries, providing a base from

which healthcare services can be offered. In countries such as Canada, England and

Australia, between 87 and 90% of metropolitan consumers live within 5km of a community

pharmacy.57-59 Qualified pharmacists usually need to be on duty in community pharmacies

which provides consumers with easy access to healthcare professionals. Traditional services

offered through community pharmacy include dispensing prescriptions, supply of OTC

medicines, medicines reviews and provision of health information.18,59-61 There is growing

recognition of community pharmacies being ‘healthcare hubs’59,62 which are part of the primary

care network (figure 4). In many jurisdictions, additional clinical services have been

implemented through community pharmacy which employ previously less utilised skills of

pharmacists and extending their scope of practice.53,63-66 Immunisation services are an

example of utilising and extending the skills of pharmacists to meet specific health objectives

for the community.67-70 The success of introducing influenza vaccinations through community

pharmacy has resulted in an extended use and range of vaccines for childhood infections and

pneumococcal infections in aged care.65,67,70,71

10

Figure 4. The patient-centred primary care network

A further example of introducing additional service is the community pharmacy-based

Australian Chronic Pain MedsCheck trial that commenced in 2018 which involves pharmacists

consulting with consumers about their pain and reviewing their use of analgesia. The primary

objective is to increase consumer health literacy and improve their ability to self-manage their

chronic pain.64,72

Community pharmacists have assisted consumers with the management of self-limiting health

conditions for decades.73 Formalised community pharmacy Minor Ailment Services (MASs)

have been introduced in some areas in the UK and Canada to increase access of these

services.74 Eligible consumers are able to consult with community pharmacists about a range

of non-urgent minor ailments which are generally self-limiting, including conditions such as

constipation, cough, head lice and indigestion.55 Pharmacists provide advice to consumers

and may recommend and supply medicines for the management of the condition. In some

MASs, consumers are exempt from payment for medicine from a standard formulary.55

11

Utilising the expertise of pharmacists to manage these conditions can reduce consultations in

general practice and hospital emergency departments.47,63,75

The concepts of the Seven Shared Principles of Primary Care49 are met in community

pharmacy practice:

(1) Person and family centred: consumers as individuals are able to engage in self-care

through the empowerment that availability of information and a range of treatment

options facilitates.19

(2) Continuous: consumers consistently rate pharmacists as highly trusted76,77 health

professionals. It is reported that consumers will travel to a specific pharmacy because

of the trusting relationship that has developed with pharmacy personnel.78

(3) Comprehensive and equitable: the expanding range of services available through

community pharmacy and emerging referral pathways enable comprehensive care to

be delivered.55 Consumers are able to engage with a healthcare professional for an

OTC consultation without cost, or the need for an appointment. This is particularly

helpful for poorer populations who may not be able to access telephones, transport or

funds.66

(4) Team based and collaborative: community pharmacists are qualified to recognise the

limits of their scope of practice and to engage other disciplines in the care of

consumers.53,74

(5) Coordinated and integrated: healthcare information technology is increasingly

facilitating the sharing of health information within the healthcare team. In Australia,

the rollout of My Health Record79 provides an online record of health information for

consumers, healthcare providers and Medicare. This record is designed to assist the

consumer and healthcare team to optimise transitions of care.

(6) Accessible: with the majority of urban populations living within walking distance of

community pharmacy, they are highly accessible.57-59,66

12

(7) High value: utilising the primary care skills of pharmacists’ skills fees up valuable time

for GPs to address more complex cases.66

1.2.4 Community pharmacists

Pharmacists are highly qualified health professionals and Australian pharmacists are required

to maintain professional competency for the duration of their practising career.80 The National

Competency Standards Framework for Pharmacists, 201681 describes community

pharmacists as primary care providers who are readily accessible and often the first health

professional that consumers contact about a health concern. The standards set the

benchmark for meeting the needs of consumers stating that pharmacists must be able to

assess the primary care needs and deliver primary care to consumers, whilst contributing to

therapeutic decision-making and providing ongoing medicine management.25

Community pharmacists and other trained pharmacy personnel are ideally placed to support

consumers with self-care. The WHO describes several functions of pharmacists involved with

self-care requests,82 the primary function being a ‘communicator’. Pharmacists engage with

consumers to obtain information relevant to their enquiry and provide information to assist

consumers to select appropriate medication or treatment, or refer the consumer to another

health professional when necessary. This aligns with guidance published by professional

organisations relating to the pharmacist’s role in primary care, the provision of OTC medicines,

and the supervision of pharmacy personnel in the supply of these OTC products.83 Guidance

is provided by the Pharmacy Board of Australia84 and the Pharmaceutical Society of Australia

(PSA) standards for the provision of OTC medicines.83,85 The Pharmacy Board of Australia

requires non-pharmacist personnel involved in the supply of OTC medicines be trained to ask

questions to elicit information from intending purchasers of OTC medicines about e.g. other

medication they are taking.84 A pharmacist must be available to assist with any queries non-

pharmacist personnel may have and to supervise the supply of Pharmacist Only medicines,

13

subject to establishing a therapeutic need. There are also specific guidelines available from

the PSA for the supply of particular medicines such as emergency contraceptives, short-acting

beta agonists, and the treatment of specific conditions e.g. vaginal thrush, heartburn and

weight loss.86

1.2.5 OTC consultations

Consumers visit a community pharmacy with a broad range of OTC self-care enquires. Their

enquiries can range from seeking information about a symptom, a request for a specific OTC

medicine, to a consultation about suitable treatment for a condition for which the consumer

already takes multiple medicines. Pharmacists have the relevant clinical knowledge that

enables them to manage the complexity of OTC enquiries that consumers present with by

engaging with consumers in a consultation.81,83,87 An OTC consultation requires a two-way

flow of information between pharmacy personnel and consumers. Information exchange in

consultations incorporates information-seeking, information-giving, and information-

verifying.88 Gathering information from consumers about the symptom or condition, the

person’s medical history and current medicines, and their treatment goals assists pharmacy

personnel in providing appropriate recommendations (Figure 5).82,89 Pharmacy personnel

require this information from consumers to make appropriate clinical decisions and therefore

they must also employ effective verbal and non-verbal communication skills. This may include

developing rapport, engaging the consumer, structuring the explanations according to the

needs of the consumer, and use of open- and closed-ended questions.89-91

14

Provide information

Provision of a medicine Dose, administration, duration of treatment, possible adverse effects of a medication.

or

No provision of medicine. Explanation about why a medication is not required.

and / or

Non-medication advice.

For example: bed-rest; elevation of an injured ankle; maintaining hydration; time-frame expected for improvement; signs and symptoms that indicate re-assessment is required.

and / or

Referral to another health professional.

Explanation about why the concern requires referral to another health professional and time-frame for this to occur.

Figure 5. Pharmacist consultation process 89,92

There are many factors which influence the exchange of information during OTC

consultations, including the communication skills of pharmacy personnel, consumer

expectation to purchase an OTC medicine without needing to answer questions, privacy, and

the legal classification of the medicine.2,3,6,7,9,12,13,93-99 Pharmacists and pharmacy personnel

report difficulties in engaging consumers in dialogue, particularly when the consultation

involves a request for a medicine by name.7,8 Increasing the amount of information exchange

during OTC consultations is significantly associated with positive outcomes such as

appropriate medicine supply or referral.9-12 There is substantial evidence that the

Opening the conversation

•Identifying the consumer’s concern.

Gathering information

•Purposeful questioning to elicit relevant clinical information, the consumer’s story

and expectations.

Decision making

•Determine the appropriate course/s of action such as:

15

management of the diverse range of OTC enquiries encountered in community pharmacies is

sub-optimal and that this is mainly due to inadequate information gathering and/or advice or

information provision by pharmacy personnel.9,13-17 The reasons for this lack of engagement

with information exchange require exploration and it is reasonable to suggest that there is not

one simple reason, but rather a range of factors that interact.

1.3 Aim

The aim of the research of this PhD was to improve information exchange during over-the-

counter (OTC) consultations in the community pharmacy setting.

Objectives


consultations.







16

1.5 References

1. World Health Organization. Self-care in the context of primary health care: report of the regional consultation, Bangkok, Thailand [Internet]. Geneva: World Health Organization; 2009 [cited 05 May 2019]. Available from: https://apps.who.int/iris/handle/10665/206352





4. Ratanajamit C, Chongsuvivatwong V, Geater AF. A randomized controlled educational

intervention on emergency contraception among drugstore personnel in southern Thailand. J Am Med Womens Assoc (1972). 2002 Fall;57(4):196-9, 207.

5. Westerlund T, Andersson I-L, Marklund B. The quality of self-care counselling by

pharmacy practitioners, supported by IT-based clinical guidelines. Pharm World Sci. 2007 April 01;29(2):67-72.





8. Fielding S, Slovic P, Johnston M, Lee AJ, Bond CM, Watson MC. Public risk perception

of non‐prescription medicines and information disclosure during consultations: a suitable target for intervention? Int J Pharm Prac. 2018 Oct;26(5):423-432.



10. Dwamena F, Holmes-Rovner M, Gaulden CM, Jorgenson S, Sadigh G, Sikorskii A, et

al. Interventions for providers to promote a patient-centred approach in clinical consultations. Cochrane Database Syst Rev [Internet]. 2012 [cited 2018 September 29]. Available from: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003267.pub2/full

11. Watson MC, Ferguson J, Barton GR, Maskrey V, Blyth A, Paudyal V, et al. A cohort

study of influences, health outcomes and costs of patients' health-seeking behaviour for minor ailments from primary and emergency care settings. BMJ. 2015 Feb;5(2):e006261.



https://apps.who.int/iris/handle/10665/206352

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003267.pub2/full

17

13. Watson M, Bond C, Grimshaw J, Johnston M. Factors predicting the guideline

compliant supply (or non-supply) of non-prescription medicines in the community pharmacy setting. Qual Saf Health Care. 2006;15:53-7.

14. Watson MC, Bond CM, Johnston M, Mearns K. Using human error theory to explore

the supply of nonprescription medicines from community pharmacies. Qual Saf Health Care 2006;15(4):244–250.

15. Schneider CR, Everett AW, Geelhoed E, Kendall PA, Clifford RM. Measuring the assessment and counselling provided with the supply of non-prescription asthma reliever medication: a simulated patient study. Ann Pharmacother. 2009 Sept;43:1512-18.





18. NHS (UK). Choosing health: making healthy choices easier.England (United

Kingdom): NHS (UK); 2004 [cited 05 May 2019]. Available from: https://webarchive.nationalarchives.gov.uk/+/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4094550

19. Hughes CM, McElnay JC, Fleming GF. Benefits and risks of self medication. Drug Saf.

2001;24(14):1027-1037.

20. Rogers A, Entwistle V, Pencheon D. A patient led NHS: managing demand at the interface between lay and primary care. BMJ. 1998;316(7147):1816-1819.

21. Therapeutic Goods Administration (AU). Final decisions and reasons for decisions by

delegates of the secretary to the department of health and ageing [Internet]. Symonston, ACT (Australia): Australian Government Department of Health (AU); 2013 [cited 2013 Nov 6]. Available from: http://www.tga.gov.au/pdf/scheduling/scheduling-decisions-1302-final-01.pdf

22. The Pharmacy Guild of Australia. The roadmap: the strategic direction for community

pharmacy [Internet]. Barton, ACT (Australia): The Pharmacy Guild of Australia; 2010 [cited 2013 Nov 6]. Available from: http://www.guild.org.au/docs/default-source/public-documents/tab---the-guild/Strategic-Direction/here-.pdf?sfvrsn=0

23. Blenkinsopp A, Bradley C. Patients, society, and the increase in self-medication. BMJ

Case Rep. 1996;312(7031):629-32.

24. World Health Organization. Achieving better health outcomes and efficiency gains through rational use of medicine [Internet]. Geneva: World Health Organization; 2011 [cited 2013 October 3]. Available from: http://apps.who.int/medicinedocs/en/m/abstract/Js17575en/

25. Pharmaceutical Society of Australia. National competency standards framework for

pharmacists in Australia [Internet]. 2010. Deakin, ACT (Australia): Pharmaceutical

https://webarchive.nationalarchives.gov.uk/+/http:/www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4094550

https://webarchive.nationalarchives.gov.uk/+/http:/www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4094550

http://www.tga.gov.au/pdf/scheduling/scheduling-decisions-1302-final-01.pdf

http://www.tga.gov.au/pdf/scheduling/scheduling-decisions-1302-final-01.pdf

http://www.guild.org.au/docs/default-source/public-documents/tab---the-guild/Strategic-Direction/here-.pdf?sfvrsn=0

http://www.guild.org.au/docs/default-source/public-documents/tab---the-guild/Strategic-Direction/here-.pdf?sfvrsn=0

http://apps.who.int/medicinedocs/en/m/abstract/Js17575en/

18

Society of Australia; 2010 [cited 2013 Oct 17]. Available from: http://www.psa.org.au/download/standards/competency-standards-complete.pdf

26. Medicines and Poisons Act 2014, WA [statute on the Internet] c2019 [cited 2019 June

13] Available from: https://www.legislation.wa.gov.au/legislation/statutes.nsf/law_a147008.html

27. Therapeutic Goods Administration. The Poisons Standard (the SUSMP). Australian

Government, Department of Health [cited 2019 June 11]. Available from: https://www.tga.gov.au/publication/poisons-standard-susmp

28. National Association of Pharmacy Regulatory Authorities (CA). NDS process and scheduling factors [Internet]. Ottawa, ON (Canada): Canadian Pharmacy Regulatory Authorities (CA); 2019 [cited 2019 May 13]. Available from: https://napra.ca/nds-process-and-scheduling-factors

29. Medsafe (NZ). Classification of medicines [Internet]. Thordon, WLG (New Zealand):

Ministry of Health (NZ); 2019 [cited 2019 May 20]. Available from: https://www.medsafe.govt.nz/profs/class/clascon.asp

30. Medicines Act 1968, UK [statute of the Internet]. c2017 [cited 2017 October 23].

Available from: http://www.legislation.gov.uk/ukpga/1968/67/introduction

31. Food and Drug Administration (US). OTC (nonprescription) drugs [Internet]. Silver Spring, MD (United States): Food and Drug Administration (US); 2016 [cited 2017 October 23]. Available from: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ucm209647.htm

32. Food and Drug Administration (US). Prescription drugs and over-the-counter OTC

drugs: questions and answers [Internet]. Silver Spring, MD (United States): Food and Drug Administration (US); 2017 [cited 2019 May 8]. Available from: https://www.fda.gov/drugs/questions-answers/prescription-drugs-and-over-counter-otc-drugs-questions-and-answers

33. Association of the European Self-Medication Industry (BE). Who we are [Internet].

Brussels (Belgium): Association of the European Self-Medication Industry (BE); [cited 2019 May 13]. Available from: http://www.aesgp.eu/about-us/who-we-are/

34. Mullan J, Weston KM, Bonney A, Burns P, Mullan J, Rudd R. Consumer knowledge

about over‐the‐counter NSAIDs: they don't know what they don't know. Aust N Z J Public Health. 2017 Apr;41(2):210-214.

35. Cohen JP, Paquett C, Cairns CP. Switching prescription drugs to over the counter.

BMJ. 2005;330:39-41.

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64. 6th Community Pharmacy Agreement (AU). Chronic pain medscheck trial [Internet]. Australia: Australian Government Department of Health; 2019 [cited 2019 May 10]. Available from: http://6cpa.com.au/2019/02/chronic-pain-medscheck-trial-2/

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24

Chapter 2:

Methods

25

2.1 Introduction

The research that was undertaken for this PhD comprised four phases, each presented as an

original research paper in Chapters 3 – 6. The first three papers have been published and the

fourth has been accepted for publication. The thesis employed an exploratory mixed methods

research design where analysis of data from each phase informed the development of

subsequent phases.1 Phase one was a systematic literature review (Chapter 3), Phase two

comprised a focus group study (Chapter 4), Phase three included the development of an

intervention strategy (Chapter 5), and Phase four comprised a feasibility study of the

intervention (Chapter 6). This current chapter presents detailed information regarding the

methods used in each of these phases.

2.2 Rationale for the selected methods

Pharmacy practice researchers have investigated OTC pharmacy consultations and ways to

improve OTC consultations with varying success.2-5 A variety of factors have been found to

influence these consultations e.g. the type of enquiry (a specific product requested by name,

advice about a symptom or condition),6-8 clinical knowledge of pharmacy personnel,2, 7, 9

communication skills of pharmacy personnel,8 privacy available for the consultation,8

consumer intention to provide information,10 pharmacist involvement in the consultation,6, 11, 12

and consumer awareness about the questions they can ask pharmacy personnel.10 The many

dimensions of OTC consultations indicate a complexity that prompted in depth investigation.13

The methods for the research followed and presented in this thesis were guided by the revised

framework described in the UK Medical Research Council (MRC) guidance for developing and

evaluating complex interventions (Figure 1).

26

Figure 1. Key elements of the Medical Research Council development and evaluation

process13

To develop strategies to enhance information exchanged during OTC consultations, a rich and

deep understanding of factors influencing these consultations was required. This was

achieved using exploratory sequential mixed methods (Figure 2).1, 14 The literature review

(Chapter 3) identified interventions conducted to improve communication during OTC

consultations. This provided insight into methods used in previous studies and the success of

these strategies. The qualitative approach used in the focus group study (Chapter 4) explored

the perspectives of key participants of OTC consultations: pharmacists, pharmacy assistants,

and consumers. These data were analysed and informed the development of the intervention

(Chapter 5). Materials for the interventions were developed (both quantitative and qualitative)

and a feasibility study conducted (Chapter 6).

Figure 2. Exploratory sequential mixed methods design

Exploratory

Literature review (Phase 1, Chapter 3)

Focus group discussions (Phase 2, Chapter 4)

Intervention strategy (Phase 3, Chapter 5)

Instrument development

Feasibility study (Phase 4, Chapter 6)

Testing

Feasibility study (Phase 4, Chapter 6)

27

The development of the intervention was underpinned by theory. Models, frameworks and

theories can provide greater understanding of the determinants of different behaviours such

as OTC consultation behaviours. The main theoretical elements which were adopted for the

research undertaken for this thesis were the COM-B model15 and the Theoretical Domains

Framework (TDF).16 The COM-B model recognises that behaviour is a result of the interacting

components of capability, opportunity and motivation (COM), and that behaviour (B) in turn

may also influence capability, opportunity and motivation (Figure 3).15, 17 Cane et al. mapped

the COM-B system to the TDF domains when validating the TDF.16 Mapping the TDF to COM-

B can assist researchers to identify the target for interventions that aim to change behaviour.

Figure 3. The COM-B system - a framework for understanding behaviour17

The COM-B model and TDF are validated tools designed to facilitate the application of

behaviour theory in the development of interventions. The Behaviour Change Wheel (BCW)

guide15 was published in 2014 presenting a step-by-step process for developing interventions

based on COM-B and the TDF behaviour theory for use by non-health psychologists. This

provided the process for developing the intervention.

2.3 Research setting

The research of this thesis was conducted in metropolitan Perth, the capital city of Western

Australia (WA), Australia. In the 2016 census the population of Perth was 1,943,858 people.18

28

On 30 June 2017, a total of 458 pharmacies were registered with the Pharmacy Registration

Board of WA in metropolitan Perth.19

2.4 Ethical approvals

Approval for the conduct of all research involving humans in this research was granted by The

University of Western Australia Human Research Ethics Committee. Phase two focus group

ethical approval was granted on 5 April 2012 (RA/4/1/5298), and an amendment granted on 8

March 2013 (Appendix 1). Phases three and four feasibility study ethical approval was granted

on 12 February 2014 (RA/4/1/6538) with three amendments granted on 9 May 2014, 15

September 2015, and 26 November 2015 (Appendix 1).

2.5 Research methods

2.5.1 Phase 1: Systematic literature review (published paper – Chapter 3)

The aim of the literature review was to identify interventions to improve communication

between consumers and pharmacy personnel during OTC consultations in the community

pharmacy setting. To achieve this aim, a systematic literature review was performed and

reported according to the Preferred Reporting Items for Systematic Reviews and Meta-

Analyses (PRISMA) Statement.20 Systematic review methodology was selected as the most

appropriate method to answer the review question. The rigorous methods for data collection

through searching of multiple databases, duplicate independent data extraction, analysis, and

critical appraisal provided a comprehensive objective understanding of the published

literature.20-22

The protocol for the review was developed through consideration of the rationale for the review

and defining the scope of the review by specifying the participants, interventions, comparators,

outcomes, and study designs (PICOS).23 Inclusion and exclusion criteria were proposed,

29

discussed with the research team, and ultimately defined. The protocol was registered and

published on the PROSPERO Database of Systematic Reviews (CRD42014013513).24

Inclusion criteria

Participants: Participants were community pharmacy personnel and/or consumers involved in

OTC consultations (these could be enquiries for themselves or on someone else’s behalf). No

restrictions were imposed on the age of study participants.

Interventions: Only interventions with the objective to improve communication during OTC

consultations in the community pharmacy setting were included.

Comparator: No comparator was relevant.

Outcomes: Interventions were included if they involved a direct measurable communication

outcome. Examples of measures included the: number of questions and/or open questions

asked; types of questions asked (general or specific); information elicited; consumer questions

asked; or consumer providing information without being asked directly.

Types of study included

Studies were included if they used quantitative designs e.g. randomised controlled trials

(RCTs), non-randomised comparative studies, cross-sectional studies, prospective cohort

studies, systematic reviews, interrupted time studies, or before-and-after studies. This review

was limited to full publications of studies.

No language limits were applied. [One of the included articles was published in German. This

was translated into English by two Master of Pharmacy students with German as their first

language. The translation was confirmed by an academic with German as her first language;

however also fluent in English.]

Publications from the year 2000 onwards were considered appropriate to capture recent

studies that were relevant to current patient-centred practice.

30

Exclusion criteria

Studies were excluded if they evaluated interventions conducted in non-community pharmacy

settings. Studies that reported only qualitative measures that were not quantifiable, such as

satisfaction, were excluded. Studies were excluded where the OTC consultation was initiated

by pharmacy personnel rather than the consumer, or if the participants were pharmacy

students involved in simulation learning activities. The process of developing the PICOS and

inclusion and exclusion criteria provided clarity for a precise and focused research aim to be

written.

Processes for data collection, extraction and analysis were developed to reflect the reporting

requirements of the PRISMA statement.23

Data sources and search strategy

The data sources and search strategy were developed (Appendix 2) in consultation with an

information specialist who was experienced in conducting pharmacy practice literature

reviews. Databases were selected that aligned with the scope of the review: Medline, Embase,

Cochrane Systematic Reviews and Cochrane Central. The Psycinfo database was also

searched to capture behavioural studies on communication. Supplementary searches

included: scanning the reference lists of included studies; a search of the Proquest database

for theses; and a ResearchGate post requesting relevant publications.

The search strategy was run in the multiple databases, identified articles were combined in

EndNote™ and duplicates were removed. Independent duplicate screening of titles and

abstracts was conducted (LS & KW). Reviewer interpretation of inclusion and exclusion criteria

was reviewed after the first 300 articles (ordered alphabetically by first author name) were

screened. Reviewers discussed their results until consensus was reached. A third reviewer

(LH) was available if required. The remaining articles were screened independently by the two

reviewers, a full text assessment was conducted on a small number of articles resulting in 11

31

papers meeting the inclusion criteria. The search was originally conducted on 30 October

2014. It was re-run on 18 January 2016 and again on 25 September 2017 to maximise the

currency of the review when it was accepted for publication in December 2017.

Data extraction

Rigorous and objective data extraction and analysis was conducted throughout the review

process using duplicate independent extraction and analysis, with a third reviewer available

when consensus could not be reached. An Excel data extraction tool was developed and

tested independently using three randomly selected papers by two reviewers (LS, KW). When

agreement could not be reached a third reviewer (LH) arbitrated. The tool was subsequently

refined (Table 1).

Table 1. Literature review data extraction items Study title Participant characteristics

Who was the participant?

Number of participants.

Age range of participants

Last name of 1st author

Journal

Year of publication

No. of authors Sampling

How was sample size determined?

How were participants selected or sampled?

How were study conditions assigned?

Were methods used to minimise potential bias induced due to non-randomisation?

Country of study

Language of publication

Was study objective specific to aim?

Were OTC consultations studied?

Was this an intervention study? Funding

Was funding received?

If yes, who provided the funding?

Study design characteristics

Intervention characteristics

Mode

Duration

Content

Theoretical underpinning

Frequency

Where the intervention was delivered.

Who conducted the intervention?

Follow-up? If yes - explain

Were incentives offered to increase compliance or adherence?

# Method of Randomisation

Adequate sequence generation?

# What was the Unit of Randomisation?

# Types of blinding

Allocation concealment?

Participant blinding?

Personnel blinding?

Outcome assessment

Outcome data reported

Incomplete outcome data addressed? Communication outcome measure

What was measured?

How was it measured?

Was the method of measurement validated? And how?

What was the communication outcome finding?

Selective reporting

Free of selective reporting?

Interpretation

Was this selective or comprehensive?

Participant characteristics

Who was the participant?

Number of participants.

Age range of participants

Other information about participants

Any other Bias?

Free of other bias - describe.

# Data extracted for randomised controlled trials

32

Risk of bias and quality of reporting

Duplicate independent risk of bias was completed (LS & KW) for RCTs using the Cochrane

Collaboration Risk of Bias tool.22

Included articles comprised RCTs and nonrandomised interventions. Independent duplicate

assessment of the quality of reporting of included non-RCT intervention studies was

conducted using the Transparent Reporting of Evaluations with Nonrandomised Designs

(TREND) statement and checklist.25 It was intended to assess the quality of reporting of the

RCTs using the Consolidated Standards of Reporting Trials (CONSORT).26 However, for

consistency of analysis, independent duplicate assessment of both RCTs and non-

randomised studies was undertaken using the Template for Intervention Description and

Replication (TIDieR)27 checklist. The TIDieR assessment was reported in the published

literature review.

Data analysis

The study designs and outcomes of included articles were diverse. The complexity and variety

of OTC consultations that may be encountered in community pharmacy were reflected in the

broad range of interventions designed to improve OTC consultation communication identified

in this review. The heterogeneity of study designs and variety of outcome measures made

meta-analysis unsuitable.28 Therefore a narrative synthesis of the data from the included

articles was conducted, as recommended by the MRC. Papers were also examined for

underpinning theory.13 Intervention characteristics were examined and grouped where

possible to identify common features. Independent, duplicate coding was undertaken of

behaviour change techniques15, 29 used in the interventions.

The literature review provided an understanding of the strategies employed in interventions to

improve communication during OTC consultations, and the outcomes of these strategies. An

33

understanding of the strengths and weaknesses of previous studies was the foundation for

the development of the next phases of the research.

2.5.2 Phase 2: Focus group study (published paper – Chapter 4)

The aim of the focus group study was to determine stakeholder perspectives regarding

barriers and facilitators for information exchange during OTC consultations in community

pharmacies. A secondary aim was to understand the behaviours relating to the elicited barriers

and facilitators and who demonstrated them.

The second step of the development phase of the MRC guidance for developing and

evaluating complex interventions13 is to identify or develop theory. This required a detailed

understanding of the processes involved in information exchange during OTC consultations.

To achieve a detailed understanding, additional information regarding stakeholder

perspectives about the barriers and facilitators for information exchange during OTC

consultations was required.30

Qualitative methods were considered appropriate to provide data to inform this step. Focus

group discussions were conducted with key stakeholders: pharmacists, non-pharmacist

personnel, and consumers. In focus group methodology, the groups are the main unit of

analysis.31 To elicit perspectives and enable inter-group comparison, the composition of each

focus group consisted of one type of stakeholder (i.e. only pharmacists, or only consumers, or

only non-pharmacist personnel). Running discussions with one stakeholder group at a time

facilitated exchange of views and experiences without being constrained by perceptions about

other stakeholders’ views or feeling judged about practices and experiences.31, 32 The group

composition was important in creating a safe environment for interactive sharing of opinions

with the aim of eliciting stakeholder perspectives.31-33

34

Participants and sampling

Initially, purposive sampling33 was used to recruit pharmacist participants via an email

invitation sent to contacts on a list of community pharmacies which accepted The University

of Western Australia (UWA) Master of Pharmacy students on placements, and UWA Master

of Pharmacy tutors (all practising pharmacists). Snowballing sampling33 was implemented to

increase recruitment numbers, where researchers followed up asking the initial contact list to

forward the invitation to participate onto other potential participants. Pharmacy assistant

participants were recruited via an invitation to participate provided to pharmacy assistants

working in pharmacies where pharmacist participants worked.

Consumer participants were recruited from two sources, firstly through a poster advertisement

at UWA, and secondly through a poster at a community pharmacy in metropolitan Perth with

links to UWA. The target was to recruit 4-12 participants for each focus group.31, 34 Focus group

meetings were scheduled at different times and days of the week, and in a variety of locations

to optimise participation. Pharmacist focus group meetings were conducted at UWA as this

suited most participants. Consumer focus group meetings were held at UWA and in a

community pharmacy meeting room. The pharmacy assistant meeting was held at a

community pharmacy. Further pharmacy assistant focus group meetings were not convened

as data saturation had been achieved.

Focus group meeting session development

An experienced focus group facilitator was consulted to assist with the development of the

session plan. Lists were created for materials necessary for the session, and for quality control

of the material (e.g. testing of audio-recorders). A focus group Facilitator Guide (Appendix 3)

was developed and followed by the facilitator for consistency across all focus group

discussions. The guide provided a script to welcome participants, provide background

information about the research and the purpose of the focus group discussion, and to set some

ground rules about respectful participation. The experienced focus group facilitator provided

35

training for the three facilitators including strategies for how to keep the discussion focussed,

how to acknowledge vocal participants and engage those less vocal, and how to move forward

with the discussion. A test focus group was conducted with Master of Pharmacy students to

allow the new facilitators to practise their skills. These data were not included in the analysis.

Question development

A semi structured question guide was developed by experienced academics with community

pharmacy experience. One academic was also experienced in delivering communication skills

training to Master of Pharmacy students. The guide predominantly comprised open-ended

questions with additional support or ‘prompting’ questions (Table 2).

Table 2. Focus group semi structured question guide

Participant

Group Main Themes Support Questions

Pharmacist

and pharmacy

assistant

1. How do you feel about asking patients

questions about their health?

- Do you think it is necessary? Why?

2. What hinders patient assessment for

over-the-counter enquiries?

- How does time affect asking questions?

- Do you feel privacy is a factor? Why?

3. What helps patient assessment for

over-the-counter enquiries?

- How do you feel about taking a written

patient history for primary care scenarios?

Consumers 1. How do you feel about being asked

questions about your health by the

pharmacist/pharmacy staff?

- Do you think it is necessary? Why?

2. What closes the conversation about

your health with pharmacist/pharmacy

staff?

- How does time affect asking questions?

- Do you feel privacy is a factor? Why?

3. What helps a conversation about your

health with pharmacist/pharmacy staff?

- How would you feel if the pharmacist

took a written history from you for an over-

the-counter enquiry?

Analysis

Audio-recordings of the focus group discussions were transcribed verbatim and analysed

using two methods. Firstly, independent duplicate inductive analysis35, 36 was performed. The

researchers immersed themselves in the data by repeatedly reading and re-reading

36

transcriptions. Descriptive codes were developed to help organise the information into

categories (Figure 4).

Figure 4. Thematic map of focus group themes and overlap

This analysis confirmed some data from the literature2, 6-8, 37 however a deeper understanding

about why these themes emerged warranted further analysis. This was achieved through the

second analysis where the TDF16, 38 and the COM-B model of behaviour15, 17 were applied to

the data. Independent duplicate analysis (LS; KW) was conducted where quotes in the

transcriptions were coded to capability, opportunity or motivation. The two researchers then

discussed their coding until consensus was reached. A third researcher was not required as

consensus was achieved. Through discussion, each quote was assigned to the applicable

TDF domain and a statement written to explain the quote in behavioural terms (Table 3).

37

Table 3. Focus group themes coded to COM-B and TDF

COM-B: Capability, Opportunity, Motivation – Behaviour model TDF: Theoretical Domains Framework NA: not applicable

38

The second behavioural analysis provided a theoretical foundation for the next phase in

developing the intervention.13

2.5.3 Phase 3: Development of the intervention strategy (published paper – Chapter

5)

The aim of this study was to describe the development of a behaviour change intervention to

enhance information exchange between pharmacy personnel and consumers during OTC

enquiries in community pharmacies. The intervention strategy was developed using the

methodology described in the Behaviour Change Wheel (BCW) – a guide to developing

interventions.15 A systematic process which followed three stages and eight steps was taken

to understand the problem in behavioural terms.

Stage 1: Understand the behaviour

Step 1 – Define the problem in behavioural terms

OTC consultations involve two-way communication “between the pharmacist and the

consumer in which the pharmacist ascertains the needs of the consumer and provides them

with the information required to safely and effectively use medicines and/or therapeutic

devices.”39 This interaction requires clinical knowledge and reasoning, as well as effective

communication. When non-pharmacist personnel are involved, pharmacists must be available

to assist. There is evidence, however, that the management of the diverse range of OTC

enquiries encountered in community pharmacies is sub-optimal and that this is mainly due to

inadequate information gathering and/or advice or information provision by pharmacy

personnel.6-9, 11, 12, 40-46

In behavioural terms the identified problem is:

There is sub-optimal communication during consultations between pharmacy staff and

consumers with OTC enquiries in community pharmacies.

39

Step 2 – Select target behaviour

The OTC consultation process involves two participants: the consumer and pharmacy

personnel. Information exchanged between the two during a consultation can be affected by

many factors. A search of the literature2, 5-12, 37, 47-50 was used to develop an understanding of

some of the factors that influence engagement in OTC consultations that were categorised

into four areas (Figure 5).

Figure 5. Factors influencing engagement in OTC consultations

Information exchange between consumers and pharmacy personnel was identified as the

behaviour to target. To assist with determining whether to focus on consumer information

exchange or pharmacy personnel information exchange the following criteria were assessed

(LS) to be unacceptable; unpromising but worth considering; promising; very promising:

the likely impact that a change in the behaviour would have on OTC consultations;

the likelihood of changing behaviour;

other consequences of a change in behaviour (spillover effect); and

how easy it is to measure the behaviour change to enable evaluation (Table 4).

Pharmacy Personnel Factors:

Communication skills

Knowledge of issue/medicine

Perceived risk of enquiry

Awareness of own skills

Consultation Factors:

Symptom or medicine enquiry

Classification of medicine

Use of checklist

Workplace/environment Factors:

Provision of privacy

Pharmacy image

Busyness/interruptions

Consumer Factors:

Self-diagnosis

Resistance to questioning

Expect purchase without questions

40

Table 4. Prioritising information exchange behaviours

Behaviours with potential to target

Impact of behaviour

change

Likelihood of changing behaviour

Spillover (other consequences)

score

Measurement score

Consumer engaging in information exchange

VP P VP VP

Pharmacy personnel engaging in information exchange

VP U P VP

Unacceptable (U); unpromising but worth considering (UWC); promising (P); very promising (VP)

The systematic literature review (section 2.4.1) identified interventions to improve

communication during OTC consultations in the community pharmacy setting. A number of

studies were identified, all of which targeted pharmacy personnel, with varying degrees of

success. This may have been a result of a paradigm shift to patient-centred healthcare

requiring pharmacists and other pharmacy personnel to develop communication skills that are

quite different to those required for biomedical ‘one-way’ communication.51-54 None of the

interventions identified in the literature review targeted the other participant in consultations,

namely the consumer. For this reason, the target behaviour for the intervention to be

developed was:

Consumers engaging in information exchange.

Given that behaviours do not exist in isolation, by targeting one behaviour a ‘spillover’ effect

on other behaviours was expected. Therefore, by targeting consumer information exchange it

was acknowledged that it was likely that pharmacy personnel information exchange

behaviours would also be affected.

Step 3 – Specify the target behaviour

The process of exploring and prioritising behaviours clarified the problem for the research

team. The third step was to define precisely Who needed to do What, When, Where and with

Whom (Table 5).

41

Table 5. Target behaviour: who needs to do what, when, where and with whom

Target behaviour Behavioural specifications

Who What When Where With whom

Consumer engaging in information exchange

Consumers exchange information

during OTC consultations

in community pharmacies

with pharmacy personnel

Step 4 – Identify what needs to change

To fully understand the target behaviour, Phase 2 (Chapter 4) focus group meeting data was

analysed. Transcripts of the focus groups were themed for barriers and facilitators and

mapped to the COM-B model and TDF (section 2.4.2). This information was then used to

perform a behavioural diagnosis on the target behaviour as described in the BCW15 guide

(Table 6).

42

Table 6. Behavioural diagnosis using themes from Phase 2 focus group meetings

43

Stage 2: Identify intervention options

Step 5 – Intervention functions

The BCW15 guide describes intervention functions that are most likely to bring about the

desired behaviour change and links them to the COM-B and TDF. The intervention functions

likely to overcome the barriers to consumers engaging in information exchange for OTC

enquiries in community pharmacies were identified (Table 6) and then assessed against the

APEASE (Affordability, Practicability, Effectiveness and cost effectiveness, Acceptability,

Side-effects/safety, Equity) criteria.15 Through this pragmatic approach, education,

persuasion, environmental restructuring, and modelling were determined to be potential

intervention functions for the intervention (Table 7).

Table 7. Identifying intervention functions likely to address barriers to information exchange

Relevant intervention functions (IF) Does the (IF) meet the APEASE criteria?

Education – increasing knowledge or understanding Yes

Persuasion – using communication to induce positive or negative feelings or stimulate action

Yes

Incentivisation – creating an expectation of reward Not relevant

Coercion – creating an expectation of punishment or cost Not relevant/practical

Training – imparting skills Not practical

Restriction – using rules to reduce the opportunity to engage in the target behaviour

Not practical

Environmental restructuring – changing the physical or social context

Yes

Modelling – providing an example for people to aspire to or imitate

Yes

Enablement – Increasing means/reducing barriers to increase capability or opportunity

Not affordable/practical

Selected intervention functions: Education; persuasion; environmental restructuring; modelling

44

Step 6 – Policy categories

Appropriate policy can have a significant impact on the success and sustainability of an

intervention. Communication/marketing was considered to be a policy category that would

support the delivery of the intervention. However, when assessed against the APEASE criteria

it was ruled out as an option for the study being developed based on the costs it would have

required.

Stage 3: Identify content and implementation options

Step 7 – Behaviour change techniques (BCT)

Michie and Johnston describe BCTs to be “a systematic procedure included as an active

component of an intervention designed to change behaviour”.55 The BCTs identified to be able

to deliver the four intervention functions that met the APEASE criteria are listed in Table 8.

Table 8. Linking intervention functions to Behaviour Change Techniques (BCTs)

Intervention function BCTs identified as able to deliver the intervention function

Education Information about social and environmental consequences. Information about health consequences. Prompts/cues.

Persuasion Credible source. Information about health consequences.

Environmental restructuring

Adding objects to the environment. Prompts/cues.

Modelling Demonstration of the behaviour.

Ideas for BCTs to address the identified barriers were generated by the research team.

(Table 9).

45

Table 9. Behaviour Change Technique examples for the interventions

Target behaviour: Consumer engaging in information exchange.

COM-B and TDF

Barrier Intervention function

BCT examples

Psychological capability

Knowledge Consumers didn’t understand the role and responsibilities of pharmacists.

Education

E: Explain the role and responsibilities of the pharmacist.

Consumers didn’t understand the qualifications of pharmacists.

E: Explain the qualifications of the pharmacist.

Consumers didn’t understand the risks of medicine use.

E: Explain the risks of OTC medicine use.

Physical Opportunity

Environmental context and resources

Pharmacists were not always identifiable

Environmental restructuring

ER: Pharmacy staff to wear badges identifying their role.

Reflective motivation

Social and professional role and identity

Consumers didn’t trust the person asking questions

Education Persuasion Modelling

E: Explain the role, responsibilities and qualifications of pharmacists. P: Inform consumers about positive health consequences.

Belief about capabilities

Consumers believed they are able to appropriately self-asses their condition before consultation

Education Persuasion Modelling Enablement

E: Explain the risks of OTC medicine use.

Belief about consequences

Consumers didn’t understand the risks of medicine use

Education Persuasion Modelling

E: Explain the risks of OTC medicine use. P: Inform consumers about positive health consequences.

Consumers didn’t know that being asked questions is for their benefit

P: Inform consumers about positive health consequences from information exchange. M: Demonstrate the type of questions that might be asked.

Consumers didn’t know their consultation information will be kept confidential

E: Explain the confidentiality of personal information.

Intentions Consumers expected to purchase an OTC product without exchanging information

Education Persuasion Incentivisation Coercion Modelling

E: Explain the risks of OTC medicine use. P: Inform consumers of positive health consequences from information exchange. M: Demonstrate the type of questions that might be asked.

Consumers expected to answer questions if asking about a symptom


Consumers resisted information exchange if repeatedly requesting the same product


Automatic motivation

Reinforcement Consumers didn’t feel it necessary to be asked questions (not from focus group but an observation of the research group)

Training Incentivisation Coercion Environmental restructuring

ER: Provide cues/prompts for engaging in information exchange.

Education (E), Environmental restructuring (ER), Persuasion (P), Modelling (M).

46

Step 8 – Mode of delivery

Determining how the intervention was to be delivered was based on an APEASE assessment

of face-to-face (individual or group) or distance modes. Face-to-face, individual, and group

delivery of the intervention were all potential modes which met the APEASE criteria.

Intervention strategy:

Situational cues, such as posters, displayed in a community pharmacy (environmental

restructuring) depicting consumers with OTC enquiries engaging in information exchange

(modelling) highlighting the benefit of this behaviour (persuasion) and the reasons it is

important (education) were identified as the most appropriate intervention. Quantitative and

qualitative methods to measure the behaviour change before and after the intervention could

be employed.

2.5.4 Phase 4: Feasibility study (accepted paper – Chapter 6)

The aim of Phase 4 was to test the feasibility of introducing situational cues to promote

information exchange between pharmacy personnel and consumers during OTC

consultations. Following the MRC guidance for developing and evaluating complex

interventions13 a feasibility study of the intervention strategy was conducted.

A number of designs of feasibility and pilot studies are used by researchers.56 The design of

this feasibility study was based on the work of Bowen et al. 56 and the model described by

Orsmond and Cohn (Figure 6).57 The objective was to test if the processes, tools, and

measures of the proposed intervention ‘could work’.56, 57

47

DOES THE INTERVENTION SHOW PROMISE?

FEASIBILITY STUDIES

(Focus on process)

Recruitment and sample characteristics.

Procedures and measures.

Intervention acceptability.

Resources and ability to manage study.

Preliminary evaluation of participant

responses.

PILOT STUDIES

(Focus on outcomes)

Figure 6. Distinctive features of a feasibility study57

2.5.4.1 Intervention strategy

The intervention strategy utilised situational cues in the form of two banner-style posters

addressing barriers to information exchange and an identity badge worn by pharmacy

personnel identifying their position as either pharmacist or pharmacy assistant (definition page

xiii). The stages of the feasibility study are described in Table 10.

Table 10. Stages of the feasibility study

Week 1 baseline data collection: audio-recorded OTC consultations

Week 2 pharmacy personnel wore badges

audio-recorded OTC consultations

consumer questionnaire

consumer validation of posters

Week 3 both posters displayed in the pharmacies

no badges worn


Week 4 both posters displayed in the pharmacies

badges worn


Following four weeks

semi-structured interviews with pharmacy personnel

CAN IT WORK?

48

2.5.4.2 Tool and resource development

Prior to testing the feasibility of the intervention, tools for the interventions were developed.

Poster development

Two posters were developed through a process of drafting, testing and refinement. Initially

key concepts from the focus group data identified as modifiable were drafted into eight posters.

An example of a key concept was increasing the knowledge of consumers about the role and

qualifications of pharmacists. Pharmacy academics and Master of Pharmacy students were

asked to describe the messages the draft posters delivered to them, and also to comment on

words used in the text that they found to be effective. Effective elements of the posters were

consolidated into three posters prior to testing with 10 consumers in a community pharmacy.

Two researchers approached consumers leaving the community pharmacy to participate in

the poster review and interview. A4 sized posters were shown to the consumers who were

asked about the words they thought were effective and not effective, if they had alternate

words that could be used, and the key message that they received from the poster. This

feedback was used to further refine the content into two posters. The first poster addressed

the professional role, qualifications and reason pharmacists ask questions (ProfRole poster),

the second modelled optimal information exchange between a consumer and pharmacist

(InfoExchange poster).

Badge development

Data from the focus group discussions indicated consumers did not know who the pharmacist

was in the pharmacy. To address this a badge was developed to enable consumers to instantly

identify the position of the person they were interacting with. This required a large font, with

no distractors on the badge such as a pharmacy logo. Badges printed with “PHARMACIST”

or "PHARMACY ASSISTANT” were produced in Source Sans Pro Semibold font at 32 point.

49

Consumer questionnaire

A questionnaire was developed to quantitatively measure consumers’ perspectives about the

identified barriers to information exchange during OTC consultations. The questionnaire was

designed to determine changes in consumer perspectives over time in the full-scale study. A

validated generic TDF questionnaire developed by Huijg et al. was adapted for the purposes

of this study. 58 Three items were developed for each TDF domain being assessed except the

“Environmental Context and Resources” domain which related to consumer ability to identify

the pharmacist. One item for this domain was included because this particular barrier was

primarily being addressed through the use of a different environmental cue: a badge denoting

the position of pharmacy personnel. The draft contained 16 items and used a 7-point Likert

scale with options strongly disagree to strongly agree for 14 questions. One item response

was difficult to easy and another not at all strong to very strong. Content validity of the draft

items was assessed by a health psychologist and three experienced pharmacy academics

who provided feedback to refine the items prior to testing the questionnaire on a convenience

sample of five consumers. Consumer participants were recruited through personal networks

who were not associated with the pharmacy profession or research. They were asked to

comment on the face validity and fitness for purpose of each questionnaire item. Feedback

was collated and items further refined prior to randomisation of the order of questions

(Appendix 4).

Poster evaluation interview guide

The feasibility study provided an opportunity to further evaluate interpretation of poster

messages with a larger number of consumers. A semi-structured interview guide consisting of

questions with prompts to explore consumer participants’ interpretation of, and response to

the posters was developed (Table 11). Non-leading questions were developed to elicit

authentic responses from participants and explore their perspectives.

50

Table 11. Semi-structured interview guide for consumers after poster review

1. What is the message you get from the poster?

2. When you looked at the poster, what drew your attention first? Why do you think that?

3. What do you find to be effective in this poster? Are there particular words that are effective? Why?

4. What do you find is NOT effective in this poster? Is there something you don’t agree with or you find confusing? Explain.

5. Now that we’ve talked about the poster a little, please sum up what you think the poster means.

6. Do you have any other comments you’d like to make?

Pharmacy personnel interview guide

To determine the feasibility of the intervention in terms of acceptability and practicality from

pharmacy personnel participant perspective, interviews were conducted with participants after

the four weeks of intervention. Qualitative interview data were collected to explore participant

perceptions about the effects of the interventions on OTC consultations.56 The questions were

developed in consultation with the research team and were guided by feedback from a

registered pharmacist and an intern pharmacist who had participated in the pre-test of the

intervention (see section 2.5.4.3). The first question was an open question asking participants

to share their past experiences with OTC consultations. This was designed to generate an

environment where the participant was comfortable and to indicate a focus on OTC, not

prescription consultations. Then participants were asked a broad, non-leading question to

ascertain if changes in OTC consultations had been noticed during the research period. The

remaining questions related to practical issues about the use of situational cues in community

pharmacy, wearing the audio-recorder, and research processes (Table 12).

51

Table 12. Semi-structured interview guide for pharmacy personnel after the intervention

OTC consultations:

1. What are your past experiences with OTC queries?

2. Thinking about OTC queries, what changes have you seen in the past few weeks?

Experiences with the research process:

3. How do you feel about having research and researchers in the pharmacy?

4. What are your thoughts on wearing the recorder?

5. Do you feel it altered the way you work?

6. Did you encounter any problems with the research process?

7. What worked well with the research process?

8. What would you recommend to improve the process?

2.5.4.3 Pre-test of intervention study procedures

The MRC guidance13 recommends modelling the processes of the intervention before

feasibility testing. Therefore, to inform the processes required for the feasibility study, a pre-

test of pharmacy personnel recruitment, OTC consultation audio-recordings, and consumer

questionnaire recruitment was conducted in a community pharmacy. The Critical Path

Method59 and systems thinking60 were used to develop resources and procedures for the pre-

test. This process required the research team to identify and break down each study activity

into components. Each component was written on a sticky note – the sticky notes were

arranged and rearranged on a wall to reach an optimal process (Table 13). The research team

then went about developing tools for each task in the process.

52

Table 13. Process tasks for the conduct of the pre-test

Component Reason

Audio-recording OTC consultations

Recorder settings sheet To determine optimal recorder settings.

Recorder checking sheet To verify recorders were operating throughout the session.

Logbook Recording of comments or problems not covered by other checklists or data sheets.

Script for training pharmacy personnel (educator’s copy)

To have a consistent and reproducible delivery of information for Pharmacy personnel recruitment purposes.

Script for training pharmacy personnel (observer’s copy)

To record if and when the educator deviated from the script or was interrupted. To record questions and/or comments related to the session.

Pharmacy personnel consent forms and participant information sheets

To comply with ethics approval (informed consent).

Information forms (x3) To provide background information to the proprietor, pharmacy personnel, and consumers.

Equipment (including above)

Recorders (x8).

Lapel microphone.

Chargers for recorders.

Headphones to initially verify the recording quality.

Additional MicroSD cards.

Laptop and 1 TB external Hard drive: o Encrypted and password-protected. o Storage and backup of recorded data at the end of

each session as per ethics requirements.

Pens, clipboards

Consumer questionnaire

Consumer consent forms and participant information sheets

To comply with ethics approval (informed consent).

Consumer questionnaire (previously developed)

Collection of consumer information.

Questionnaire participant data collection sheet

To determine recruitment response rate. To record words used to recruit and effectiveness.

Equipment Chairs (x2 folding)

Table (small folding)

Clipboards

Pens

Folders for questionnaires and data sheets

A convenience sample of one community pharmacy was used for the pre-test. Three

researchers were present in the pharmacy to collect data between 9am and 3pm on two

weekdays (Tuesday and Friday). Processes for recruiting pharmacy personnel participants

were tested using the prepared script. Questions asked by pharmacy personnel were recorded

to enable the script to be enhanced for the feasibility study.

53

Pharmacy personnel participants were asked to wear digital voice recorders on a lanyard

around their necks to record OTC consultations. Researchers checked the recorders every

hour to determine if the settings on the recorder remained unchanged, if the battery was

charged, and if the participant was experiencing any problems. Audio-recorder settings were

noted and quality of recordings checked at the end of the day. These data informed the optimal

recorder settings. The audio was reviewed to determine the number of OTC consultations

recorded per hour. This varied considerably depending on the role of the participant from one

to six OTC consultations per hour.

Researchers also approached consumers to participate in a questionnaire as they were

leaving the pharmacy. A recruitment rate of 32% (n/N) was achieved. Researchers found

words such as UWA, Research, Brief, and Contribute enhanced recruitment, as did wearing

a shirt with the UWA logo, as opposed to a plain shirt.

2.5.4.4 Feasibility study

Sample

A convenience sample of two independent community pharmacies in metropolitan Perth,

Western Australia was recruited. A researcher (LS) contacted proprietors of the pharmacies

and invited them to participate in the study. The researcher met with the proprietors individually

to discuss the study in more detail. Both consented to allow the study to be conducted in their

pharmacies. The feasibility study was conducted concurrently at both pharmacies over four

weeks. During the following four weeks pharmacy personnel interviews were conducted.

Training

Five research assistants attended a session run by lead researcher (LS) for training in the

study methodology and requirements for ethical compliance. They were provided with

background information about the study and the aim. Refined pre-test resources were used to

explain processes for recruiting participants. This included the voluntary nature of pharmacy

54

personnel participation and strategies to eliminate recordings of non-participating personnel

(i.e. pausing the recorder, or deleting the section of recording). Training in the use of the audio-

recorders, optimal settings, download and audio quality check of data was provided.

Consumer recruitment for questionnaire and poster evaluation was explained and consumer

interviewing was practised. A box of materials required for the feasibility study was prepared

for each study site.

Study

Two research assistants were present in each pharmacy for six hours from the beginning of

trade on each Monday, Tuesday and Wednesday over the first four weeks of the study. Their

first task was to provide information to pharmacy personnel about the study and obtain written

consent from those wishing to participate. Pharmacy personnel often started their shifts at

different times, therefore the research assistants needed to repeat this process as required.

A3 sized information posters were displayed on the pharmacy counters to inform consumers

about the study being conducted and that they were able to opt out of being audio-recorded.

During week one, no intervention was introduced to enable baseline audio-recorded OTC

consultations to be collected. Research assistants provided participants with an audio-

recorder to wear on a lanyard around their necks. Lapel microphones were also available to

be used if required. Audio-recording of OTC consultations continued during each of the four

weeks.

In week two, pharmacy personnel were provided with the position badges to wear. Some

chose to wear the badge with their usual badge. Research assistants also recruited

consumers to participate in the questionnaire and evaluation of posters. Consenting

consumers completed the questionnaire, then were asked to view an A4 sized copy of one of

the posters. The research assistant interviewed the consumer about the poster content.

Following the interview the consumer was asked to complete the questionnaire a second time.

55

During week three, research assistants placed both posters (83.5cm x 210cm banner-style)

in both community pharmacies. Pharmacy personnel did not wear the study badges.

During week four, the posters remained in the pharmacies and pharmacy personnel wore the

badges once again.

Over the subsequent four weeks pharmacy personnel participants were interviewed

individually by the lead researcher (LS).

Data handling and analysis

Data from consumer questionnaires were entered into Excel for analysis. Questionnaires

where the participant responded with words instead of using the Likert scale were excluded.

If two numbers on the Likert scale were circled for the same question this was treated as

missing data. Descriptive statistics were used to summarise demographic characteristics. The

mean change in consumer responses was calculated using questionnaire data.

Poster validation was conducted by evaluating data from field notes made during consumer

interviews against the intended messages of the posters.

Pharmacy personnel interviews were transcribed verbatim. Two researchers (LS, KW)

independently read and re-read the transcriptions prior to discussing the emerging themes

and reaching consensus.

56

2.6 References

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