Improving Australians' Access to Prescription Medicines - The 6CPA

Improving Australians’ Access to Prescription Medicines: Development of Pharmacy Practice Models

Final Report June 2005 Dr Tracey Bessell Dr Lynne Emmerton

Dr Jennifer Marriott Dr Lisa Nissen

This project is funded by the Australian Government Department of Health and Ageing as part of the Third Community Pharmacy Agreement, and is administered by the Pharmacy Guild of Australia

Executive Summary Improving Australians’ access to prescription medicines

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Executive Summary

Executive Summary In an environment of increasing demands and healthcare costs, the focus of pharmacy must be on the provision of services that improve the quality use of medicines. Health system improvement and redesign includes the need to change workforce roles and responsibilities and such changes must be cost-effective and sustainable. This report defines four practice models that extend the roles of, and services provided by, pharmacists in the Australian health care setting. Each model better utilises pharmacists’ expert knowledge and skills to optimise medication use, and improves consumer access and outcomes without compromising safety. Two models allow pharmacists to modify and/or monitor prescription medicines whilst the remaining models permit pharmacists to initiate therapy. This aim of this research was to develop pharmacy practice models based upon evidence in the literature, and examine their applicability within an Australian health care context in order to: 

provide Australian consumers with improved, responsible and safe access to prescription medicines (particularly consumers with chronic medication needs)



optimise use of pharmacists’ and doctors’ skills and time; and



reduce inefficient use of health resources.

Eight models were identified from a literature review of prescribing models, where pharmacists initiate, modify, or monitor prescription medicines with varying levels of autonomy. These eight models were refined in consultation with the multidisciplinary Steering Committee and four preliminary models applicable to the Australian health care system were proposed. The potential benefits, harms, barriers and facilitators of each of the models were identified using semi-structured interviews with 34 key stakeholders

including

policymakers,

medical

practitioners,

pharmacists

and

consumers. The central themes were further examined using focus groups with metropolitan and rural medical practitioners, pharmacists and consumers. These qualitative data were presented to the Steering Committee and informed further amendments to the preliminary pharmacy practice models. Increasing levels of responsibility demand increasing accountability. The principles underpinning the model development were: 

Patient safety is paramount.

Improving Australians’ access to prescription medicines

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Executive Summary



The separation of prescribing and dispensing will be maintained where possible, and transparent audit mechanisms will become an integral part of the pharmaceutical system.



Practice models will provide more convenient care for consumers, and where possible, offer consumers greater choice.



Dispensing pharmacists, health authorities and the public need to be able to easily identify those individuals entitled to provide extended services.



Pharmacists who independently or dependently prescribe, amend or extend the continuation of supply of a medicine will be expected to act within their professional standards of ethics and competency.



Independent prescribers will take full clinical responsibility for their decisions.



Accreditation for pharmacists undertaking extended roles must be consistent throughout Australia.



Pharmacists’ participation in the delivery of extended services will be voluntary. These models recognise that pharmacists already work in a variety of practice settings. (1)

Model 1: Medication Maintenance This model uses medication reviews to develop a collaborative approach to management of patients in Residential Aged Care Facilities (RACFs). Pharmacists prescribe according to a patient-specific treatment plan devised by the doctor. It can potentially overcome the problems with the existing arrangements for the emergency supply of medicines, by amending legislation to reflect current everyday practice. It also outlines a collaborative approach between medical practitioners and accredited pharmacists to ensure the continuity of supply and ongoing monitoring of medication use in RACFs. The medical practitioner would commence medication while the accredited pharmacist would review, renew and monitor medication use for an agreed time period providing the person’s condition remained stable.

Model 2: Advanced Practitioner In this model senior hospital pharmacists are able to prescribe in a supplementary role in designated areas within the hospital.


iii

Executive Summary

This model would allow accredited clinical pharmacists to prescribe a range of medicines within a hospital setting in collaboration with medical practitioners. It has the potential to be applied in pre-admission and out-patient clinics, ambulatory care and inpatient areas, particularly those with specialised medication needs.

Model 3: Protocol Management This model allows pharmacists to prescribe medication according to a defined population-based protocol. This model would expand the role of accredited pharmacists to monitor and modify the use of medicines using evidence-based protocols and improved communication with consumers and medical practitioners. It could potentially be applied to common disease states with empowered consumers. There is good evidence of improved anticoagulant management in both hospital and community settings.

Model 4: Pharmacists’ Formulary This model enables pharmacists to prescribe medications from a ‘Pharmacists’ Formulary’ (currently Schedule 3 [S3] medicines) and allows them to be claimed via the Pharmaceutical Benefits Scheme (PBS). It is proposed that these medicines should also be PBS listed when the pharmaceutical therapy can demonstrate cost-effectiveness, particularly when population based evidence demonstrates that access is inhibited by out-of-pocket costs. It is also proposed that non-PBS items should be covered within private health insurance programs. However the implementation of this model is dependent upon the introduction of an electronic health record that can be accessed by medical practitioners, pharmacists and consumers to monitor the appropriate use of medicines.

Recommendations The models have both general and specific recommendations: General Recommendations 1. That demonstration projects be undertaken for all Models 2. That a central register of pharmacists able to undertake extended roles be kept by the Council of Pharmacy Registering Authorities


iv

Executive Summary

3. That legislation permit accredited pharmacists to prescribe in designated extended roles 4. That PBS Prescriber Numbers be allocated to pharmacists practising in some extended roles to enable Prescription Medicines (Schedule 4 [S4]) to be prescribed on the PBS 5. That pharmacists in extended roles have access to available medication histories, diagnoses and relevant medical records including pathology and other test results Recommendations specific to Model 1 6. That chronic medications be prescribed in a manner that better meets patient needs with respect to quantity and timeliness 7. That Emergency Supply of medication be extended from three days to a maximum of thirty days or one ‘unbroken’ original pack Recommendations specific to Model 2: 8. To develop national policies and procedures for the operation of the ‘Advanced Practitioner’ pharmacist in hospitals 9. That Pharmacists would need to reach a pre-determined level of practice in hospital before undertaking the Advanced Practitioner role Recommendations specific to Model 3: 10. That protocols that enable pharmacists to manage a particular aspect of patient care be developed Recommendations specific to Model 4: 11. That ‘Pharmacist Only Medicines’ (S3) be renamed Pharmacists Formulary 12. That selected Pharmacists’ Formulary medicines be subsidised by the PBS and reimbursable to pharmacists by the HIC, particularly where out-of-pocket costs may inhibit consumer access to necessary medicines. 13. That manufacturers provide an approved protocol and training package for community pharmacists when medicines are rescheduled from S4 to the Pharmacists’ Formulary. 14. That all Pharmacist’s Formulary Medicines be recorded as part of the electronic health record which should be available to pharmacists, general practitioners, consumers and Government to examine the appropriateness of prescribing.


v

Executive Summary

Significance A central tenet of the National Medicines Policy is to provide better value for taxpayers’ dollars, so that optimal health outcomes and economic objectives are achieved. Health economics, a sub-discipline of economics, seeks to determine the most efficient amount and mix of resources that should be allocated to the health sector to maximise the benefit to society.(2) Given that resources are limited, a guiding principle regarding the allocation of resources is the consideration of efficiency. Efficiency is concerned with getting the most out of any given resource.

The models outlined in this report provide an

opportunity to improve efficiency through addressing aspects of current practice that lead to a less than optimal use of scarce resources. Gains in efficiency, and hence value for money, can be achieved through a better use of pharmacist and medical practitioner time, and a more streamlined approach to medication management. Current Australian prescribing arrangements do not fully meet the needs of the community in terms of timely, cost-effective and convenient access to prescription medicines. This report outlines four models that should form the basis of future demonstration projects which develop each concept model to an operational model in a variety of practice settings. Each demonstration project should measure the impact and cost-effectiveness of the operational model. This report challenges Australian pharmacists to determine their future and work more collaboratively with medical practitioners and policymakers. It is vital that we utilise the capacity of the pharmacy workforce to improve medication management and health outcomes.


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Table of Contents Improving Australians’ access to prescription medicines

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Table of Contents EXECUTIVE SUMMARY...............................................................................................II MODEL 1: MEDICATION MAINTENANCE ...................................................................................... III MODEL 2: ADVANCED PRACTITIONER........................................................................................ III MODEL 3: PROTOCOL MANAGEMENT ........................................................................................ IV MODEL 4: PHARMACISTS’ FORMULARY ..................................................................................... IV RECOMMENDATIONS ............................................................................................................... IV SIGNIFICANCE ........................................................................................................................ VI

1

2

INTRODUCTION................................................................................................... 1 1.1

PRINCIPLES OF ORGANISATIONAL CHANGE .....................................................................2

1.2

AIM ............................................................................................................................2

1.3

OBJECTIVES ................................................................................................................3

1.4

SIGNIFICANCE..............................................................................................................3

LITERATURE REVIEW......................................................................................... 5 2.1

BACKGROUND .............................................................................................................5

2.1.1

Other Health Professionals as Prescribers .........................................................6

2.1.2

Pharmacists as Prescribers................................................................................7

2.2

METHODS ...................................................................................................................7

2.3

RESULTS ....................................................................................................................8

2.3.1

Independent Prescribing Models ........................................................................8

2.3.1.1

Definition................................................................................................................... 8

2.3.1.2

Requirements............................................................................................................ 8

2.3.1.3

Drug Therapy/Groups................................................................................................ 8

2.3.1.4

International Perspective ........................................................................................... 9

2.3.1.5

Pros.......................................................................................................................... 9

2.3.1.6

Cons......................................................................................................................... 9

2.3.1.7

Implementation Issues............................................................................................. 10

2.3.2

Dependent Prescribing Models: Prescribing by Protocol ...................................11

2.3.2.1

Definition................................................................................................................. 11

2.3.2.2

Requirements.......................................................................................................... 11

2.3.2.3

Drug/Therapy Groups.............................................................................................. 12

2.3.2.4

International Perspective ......................................................................................... 12

2.3.2.5

Pros........................................................................................................................ 13

2.3.2.6

Cons....................................................................................................................... 13

2.3.2.7


2.3.3

Dependent Prescribing Models: Prescribing by Patient Group Direction............14

2.3.3.1

Definition................................................................................................................. 14

2.3.3.2

Requirements.......................................................................................................... 14

2.3.3.3



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2.3.3.4


2.3.3.5

Pros........................................................................................................................ 15

2.3.3.6

Cons....................................................................................................................... 15

2.3.3.7


2.3.4

Dependent Prescribing Models: Prescribing by Formulary ................................16

2.3.4.1

Definition................................................................................................................. 16

2.3.4.2

Requirements.......................................................................................................... 16

2.3.4.3


2.3.4.4


2.3.4.5

Pros........................................................................................................................ 17

2.3.4.6

Cons....................................................................................................................... 17

2.3.4.7


2.3.5

Dependent Prescribing Models: Prescribing by Patient Referral.......................18

2.3.5.1

Definition................................................................................................................. 18

2.3.5.2

Requirements.......................................................................................................... 18

2.3.5.3


2.3.5.4


2.3.5.5

Pros........................................................................................................................ 19

2.3.5.6

Cons....................................................................................................................... 19

2.3.5.7


2.3.6

Dependent Prescribing Models: Repeat Prescribing ........................................20

2.3.6.1

Definition................................................................................................................. 20

2.3.6.2

Requirements.......................................................................................................... 20

2.3.6.3


2.3.6.4


2.3.6.5

Pros........................................................................................................................ 21

2.3.6.6

Cons....................................................................................................................... 21

2.3.6.7


2.3.7

Dependent Prescribing Models: Supplementary Prescribing ............................21

2.3.7.1

Definition................................................................................................................. 21

2.3.7.2

Requirements.......................................................................................................... 22

2.3.7.3


2.3.7.4


2.3.7.5

Pros........................................................................................................................ 24

2.3.7.6

Cons....................................................................................................................... 25

2.3.7.7


2.3.8

Collaborative Prescribing Models .....................................................................26

2.3.8.1

Definition................................................................................................................. 26

2.3.8.2

Requirements.......................................................................................................... 27

2.3.8.3

Drug Therapy/Groups.............................................................................................. 27

2.3.8.4


2.3.8.5

Pros........................................................................................................................ 28

2.3.8.6

Cons....................................................................................................................... 29

2.3.8.7



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2.4

DISCUSSION ..............................................................................................................30

2.4.1 2.4.1.1

Professional Development....................................................................................... 31

2.4.1.2

Individual Responsibility .......................................................................................... 31

2.4.1.3

Individual Knowledge............................................................................................... 31

2.4.1.4

Separation of Dispensing and Prescribing................................................................ 32

2.4.1.5

Quality Assurance ................................................................................................... 32

2.4.1.6

Professional Relationships....................................................................................... 32

2.4.1.7

Competence ........................................................................................................... 32

2.4.1.8

Education................................................................................................................ 33

2.4.1.9

Recording ............................................................................................................... 33

2.4.2

Clinical Impact......................................................................................................... 34

2.4.2.2

Changing Medication Range and Complexity ........................................................... 34

2.4.2.3

Patient Issues ......................................................................................................... 34

2.4.2.4

Professional Co-operation ....................................................................................... 35

2.4.3.1

Resource Utilisation and Economics.................................................................35 Identifying efficient models using economic appraisal ............................................... 35

2.4.4

Workload and Workforce Issues .......................................................................36

2.4.5

Legal Issues.....................................................................................................37

2.5

4

Impact of the Changes to Medication Prescribing .............................................34

2.4.2.1

2.4.3

3

Professional Issues ..........................................................................................31

CONCLUSION .............................................................................................................37

METHODS .......................................................................................................... 40 3.1

RESEARCH OUTLINE...................................................................................................40

3.2

LITERATURE REVIEW ..................................................................................................41

3.3

SUMMARY OF IDENTIFIED MODELS ...............................................................................41

3.4

ETHICS APPROVAL .....................................................................................................41

3.5

FORMATION OF STEERING COMMITTEE .........................................................................41

3.5.1

Membership of the Steering Committee............................................................41

3.5.2

Role and function of the Steering Committee....................................................42

3.6

SEMI-STRUCTURED INTERVIEWS WITH KEY POLICY STAKEHOLDERS ................................43

3.7

FOCUS GROUPS WITH PHARMACISTS, DOCTORS AND CONSUMERS .................................44

3.8

QUALITATIVE DATA ANALYSIS ......................................................................................45

3.9

FINAL REPORT ...........................................................................................................46

RESULTS ........................................................................................................... 48 4.1

DEVELOPMENT OF MODELS .........................................................................................48

4.2

INTERVIEWS ..............................................................................................................49

4.3

FOCUS GROUPS ........................................................................................................50

4.4

ANALYSIS OF MODELS ................................................................................................51

4.4.1 4.4.1.1

Model 1............................................................................................................51 Summary of Comments from Stakeholder Interviews and Focus Groups................... 52


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4.4.1.1.1

Benefits ...................................................................................................................... 52

4.4.1.1.2

Harms......................................................................................................................... 52

4.4.1.1.3

Barriers....................................................................................................................... 53

4.4.1.1.4

Facilitators.................................................................................................................. 53

4.4.1.2

Stakeholder interview results ................................................................................... 54

4.4.1.3

Focus group results................................................................................................. 58

4.4.1.4

Economic consideration of current situation.............................................................. 62

4.4.2

Model 2............................................................................................................64

4.4.2.1

Summary of Results from Stakeholder Interviews and Focus Groups:....................... 65

4.4.2.1.1

Benefits ...................................................................................................................... 65

4.4.2.1.2

Harms......................................................................................................................... 65

4.4.2.1.3

Barriers....................................................................................................................... 66

4.4.2.1.4

Facilitators.................................................................................................................. 67

4.4.2.2


4.4.2.3


4.4.2.4

Economic considerations of current situation............................................................ 74

4.4.3

Model 3............................................................................................................75

4.4.3.1

Summary of Comments........................................................................................... 75

4.4.3.1.1

Benefits ...................................................................................................................... 76

4.4.3.1.2

Harms......................................................................................................................... 76

4.4.3.1.3

Barriers....................................................................................................................... 77

4.4.3.1.4

Facilitators.................................................................................................................. 77

4.4.3.1.5

Variety of conditions/settings ...................................................................................... 78

4.4.3.2


4.4.3.3


4.4.3.4


4.4.4

Model 4............................................................................................................87

4.4.4.1

4.5

Summary of Comments........................................................................................... 88

4.4.4.1.1

Benefits ...................................................................................................................... 88

4.4.4.1.2

Harms......................................................................................................................... 89

4.4.4.1.3

Barriers....................................................................................................................... 89

4.4.4.1.4

Facilitators.................................................................................................................. 90

4.4.4.2

Stakeholder interviews ............................................................................................ 90

4.4.4.3


4.4.4.4


IMPLEMENTATION ISSUES ............................................................................................98

4.5.1

Professional and workforce issues ...................................................................98

4.5.1.1

Professional/ethical issues....................................................................................... 98

4.5.1.2

Workforce issues..................................................................................................... 98

4.5.1.3

Workload issues...................................................................................................... 99

4.5.2 4.5.2.1

Communication issues .....................................................................................99 Information technology issues.................................................................................. 99

4.5.3

Alternative solutions .......................................................................................100

4.5.4

Education and credentialing ...........................................................................100


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5

4.5.4.1

Competence ......................................................................................................... 100

4.5.4.2

Training and Continuing Education ........................................................................ 101

4.5.4.3

Credentialing/accreditation .................................................................................... 101

4.5.4.4

Other issues.......................................................................................................... 101

4.5.5

Other comments ............................................................................................102

4.5.6

Stakeholder Interviews ...................................................................................102

4.5.7

Focus group results........................................................................................112

DISCUSSION.....................................................................................................122 5.1

PRINCIPLES FOR EXTENDED PHARMACISTS’ ROLES AND SERVICES ...............................122

5.2

MODEL 1: MEDICATION MAINTENANCE .............................................................123

5.2.1

General Discussion ........................................................................................123

5.2.2

Key Elements of this Model ............................................................................123

5.2.2.1

Stage 1, Part A...................................................................................................... 123

5.2.2.2

Stage 1, Part B...................................................................................................... 124

5.2.2.3

Stage 2: ................................................................................................................ 127

5.2.3 5.3

MODEL 2: ADVANCED PRACTITONER ................................................................131

5.3.1


5.3.2

Key elements of this Model ............................................................................133

5.3.2.1

Stage 1 ................................................................................................................. 133

5.3.2.2

Stage 2 ................................................................................................................. 134

5.3.3

Implementation Requirements........................................................................134

5.3.4

Restrictions on this Model ..............................................................................136

5.3.5

Economic consideration of Model 2 ................................................................138

5.4

MODEL 3: PROTOCOL MANANGEMENT .............................................................140

5.4.1


5.4.2

Key elements of this Model ............................................................................140

5.4.2.1

Stage 1 ................................................................................................................. 140

5.4.2.2

Stage 2 ................................................................................................................. 141

5.4.3


5.4.4

Restrictions on this Model ..............................................................................142

5.4.5

Economic consideration of Model 3 ................................................................144

5.5

MODEL 4: PHARMACISTS’ FORMULARY.............................................................146

5.5.1


5.5.2

Key Elements of this Model ............................................................................146

5.5.2.1

Stage 1 ................................................................................................................. 146

5.5.2.2

Stage 2 ................................................................................................................. 147

5.5.3


5.5.4

Economic considerations of Model 4 ..............................................................149

5.6

6

Economic considerations of model 1 ..............................................................128

LIMITATIONS ............................................................................................................150

CONCLUSIONS.................................................................................................153


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7

8

RECOMMENDATIONS ......................................................................................156 7.1

GENERAL RECOMMENDATIONS ..................................................................................156

7.2

RECOMMENDATIONS FOR SPECIFIC MODELS:..............................................................157

PUBLICATIONS AND PRESENTATIONS..........................................................162 8.1

PUBLICATIONS .........................................................................................................162

8.1.1

Pharmacists and Prescribing Rights: Review of International Developments...162

8.1.2

Editorial - Improving Australians’ Access to prescription medicines .................162

8.2

PRESENTATIONS ......................................................................................................162

8.2.1

Pharmacist Prescribing Models ......................................................................162

8.2.2

Improving Australians’ access to prescription medicines: proposed practice

models and qualitative analysis of key stakeholder interviews........................................163

9

REFERENCES...................................................................................................166

List of Appendices Appendix 1 Invitation to Stakeholders to participate .................................................175 Appendix 2 Explanatory Statement ..........................................................................176 Appendix 3 Informed Consent form ..........................................................................177 Appendix 4 Invitation to Focus group potential participants ......................................178 Appendix 5 Case scenarios for Prescribing Models developed from the Literature, presented to the Advisory Committee prior to Stakeholder Interviews................179 Appendix 6 Presentation of Models for Stakeholder & Focus Group Consideration...186 Appendix 7 Interview guide developed for semi-structured interviews with Stakeholders .........................................................................................................190 Appendix 8 Telephone Interview Guide for Focus groups..........................................192


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List of Tables Table 1 Themes identified from Stakeholder interviews............................................ 50 Table 2 Themes identified from Focus Groups ......................................................... 50 Table 3 Stakeholder Interview results -Model 1 ........................................................ 54 Table 4

Focus Group results -Model 1..................................................................... 58

Table 5 Stakeholder Interview results -Model 2 ........................................................ 68 Table 6 Focus Group results -Model 2...................................................................... 71 Table 7 Stakeholder Interview results -Model 3 ........................................................ 78 Table 8 Focus Group results -Model 3...................................................................... 81 Table 9 Stakeholder Interview results -Model 4 ........................................................ 90 Table 10 Focus Group results -Model 4.................................................................... 93 Table 11 Stakeholder Interview results -Implementation Issues ..............................102 Table 12 Focus Group results -Implementation Issues............................................112 Table 13 Addressing potential harms and barriers –Model 1 ...................................126 Table 14 Addressing potential harms and barriers –Model 2 ...................................137 Table 15 Addressing Potential harms and barriers – Model 3..................................143 Table 16 Addressing Potential harms and barriers - Model 4 ..................................148

List of Figures Figure 1 Figure 1 Prescribing Models showing degree of protocol and ………………31 formulary involvement Figure 2 Research Outline …………………………………………………………………41


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ABBREVIATIONS ADR

Adverse Drug Reaction

AHW

Aboriginal Health Worker

APAC

Australian Pharmaceutical Advisory Council's

CBA

Cost Benefit Analysis

CE

Continuing Education

CEA

Cost Effectiveness Analysis

CER

Cost Effectiveness Ratio

CMA

Cost Minimisation Analysis

CMI

Consumer Medicines Information

CPD

Continuing Professional Development

CUA

Cost Utility Analysis

EHC

Emergency Hormonal Contraception

GP

General Practitioner

HIC

Health Insurance Commission

HMR

Home Medicines Review

IHS

Indian Health Service

INR

International Normalized Ratio

IT

Information Technology

MBS

Medical Benefits Scheme

NDPSC

National Drugs and Poisons Schedule Committee

NHS

National Health Service

NSB

Net Social Benefit

PBAC

Pharmaceutical Benefits Advisory Committee

PBS

Pharmaceutical Benefits Scheme

PGD

Patient Group Direction

QCPP

Quality Care Pharmacy Program

QUM

Quality Use of Medicines

RACF

Residential Aged Care Facility

RMMR

Residential Medication Management Review

SOAP

Subjective Objective Assessment and Planning

S3

Schedule 3

S4

Schedule 4

USA

United Stares of America


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Dr Tracey Bessell BPharm MPH PhD Department of Pharmacy Practice Victorian College of Pharmacy 381 Royal Parade, Parkville 3052

Authors

PROJECT INVESTIGATORS

Dr Jennifer Marriott BPharm, PhD, GCHE, MSHPA Department of Pharmacy Practice Victorian College of Pharmacy 381 Royal Parade, Parkville 3052 Dr Lynne Emmerton BPharm (Hons) PhD MPS School of Pharmacy The University of Queensland Qld 4072 Dr Lisa Nissen BPharm PhD MPS MSHPA School of Pharmacy The University of Queensland Qld 4072

Institution and contact person for correspondence: Name Dr Jennifer Marriott Address Department of Pharmacy Practice, Victorian College of Pharmacy, 381 Royal Parade, Parkville 3052 Ph 03-9903 9533 Fax 03-99039629 Email [email protected]

Back, left to right: Dr Tracey Bessell, Dr Jennifer Marriott Front, left to right: Dr Lynne Emmerton, Dr Lisa Nissen Improving Australians’ access to prescription medicines

xvi

Dr Tracey Bessell:

Dr Jennifer Marriott:

Dr Tracey Bessell is an honorary Senior

Dr Jennifer Marriott is senior lecturer in the

Research Fellow at the Victorian College of

Department of Pharmacy Practice, Victorian

Pharmacy, Monash University. She is also

College of Pharmacy, Monash University.

the Director of Clinical Practice Improvement

Jennifer

Unit at The Canberra Hospital and is an

Victorian College of Pharmacy in 1971 and

honorary Senior Lecturer at the Medical

has had a wide range of practice experience

School, Australian National University. Her

in community and hospital pharmacy. She

qualifications

was awarded her PhD in 2000. Jennifer’s

include

a

Bachelor

of

graduated

Technology),

health

pharmacists with skills that enable them to

(University of Adelaide) and a doctorate in

improve the way patients use and access

Health

their

Services

Public

Research

(Monash

medicines.

Her

on

the

research

of

centres

from

Pharmacy (South Australian Institute of Master

interest

BPharm

providing

research

Liaison

includes

University). She was awarded a Quality Use

Community

of Medicine Scholarship (1999) and Victoria

Health, Palliative care, and the effect of

Fellowship (2002). Her current research

cultural

interests include e-health, quality use of

medication

medicines and clinical governance.

research

into

Electronic

decision

and

Pharmacy,

linguistic

use.

She

Mental

difficulties also

Preceptor

undertakes

training

support.

on

Jennifer

and is

currently President-Elect of the Academic section,

International

Pharmaceutical

Federation (FIP).

Dr Lynne Emmerton:

Dr Lisa Nissen:

Dr Lynne Emmerton has been a Senior

Dr Lisa Nissen is currently a lecturer in the

Lecturer in the School of Pharmacy, The

UQ School of Pharmacy. After a number of

University of Queensland for the past four

years

years. Prior to this, she was a Lecturer in

pharmacist in both rural and metropolitan

the School of Pharmacy, University of Otago,

areas she returned to undertake a PhD which

New Zealand, for eight years. Her Bachelor

she completed in 2002. Her specific area of

of Pharmacy (1987), Honours (1988) and

interest is improving the way medications are

PhD (1993) qualifications were obtained

used in the wider community, particularly

from The University of Queensland.

Her

rural and remote Australia. Her other areas

research interests fall broadly into the theme

of interest include chronic pain management,

of Quality Use of Medicines, with a focus on

toxicology and poisoning, cystic fibrosis and

professional community pharmacy practice,

oncology.

specialist

Society of Australia’s 2002 Young Australian

medicines.

services,

and

non-prescription

working

as

a

clinical

hospital

Lisa was the Pharmaceutical

Pharmacist of the Year, and is the current Chairman

of

the

Society

of

Hospital

Pharmacists of Australia, Queensland State Branch Committee.


xvii

ACKNOWLEDGEMENTS We are grateful to: -

The Project Steering Committee for their input and commitment to the project

-

The Stakeholder Interviewees and Focus Group participants for their valuable contributions

-

Assoc. Prof Chris Doran for providing the Health Economist’s perspective

-

Gayle White for administrative assistance

-

Assoc. Prof. Ros Hurworth for facilitating telephone focus groups

-

Laura Dean for management of the project


xviii

Introduction Improving Australians’ access to prescription medicines

xix

Introduction

1 Introduction Every day, Australian consumers, doctors and pharmacists encounter difficulties associated with access to prescription medicines. These difficulties include, but are not limited to, repeat prescribing in nursing homes, emergency contraception, warfarin monitoring and dosage adjustments, and delayed hospital discharge. Medicines play a major role in the provision of adequate health care for communities; however they must be available, of satisfactory quality, accessible, affordable and properly used. Australia has established key policies and programs to support such endeavours. The National Medicines Policy aims to improve health outcomes for all Australians through their access to, and wise use of, medicines and to fulfil this goal health system reforms are necessary.(3) Continuity of care, equitable access, and quality, including safety and efficiency, remain the major foci for health services management and systems reform. Mindful of the need to improve health care outcomes and support the aim of the National Medicines Policy, it is worth reflecting: Is there a need for new, perhaps radically different, ways of thinking and going about improvement and change?(4) New healthcare models should improve patient access to medical services, resulting in timely initiation or adjustment of treatment. The provision of medicines to consumers should make the best use of professional expertise and scarce health resources. Currently in Australia, medical practitioners, dentists and other health professionals (optometrists, podiatrists and nurses) may prescribe Prescription Medicines (S4) to varying extents. The acceptance of changed roles for health care professional groups by current prescribers is essential and is occurring in countries where wider prescribing rights have been introduced.(5, 6),

(7)

In the UK, Canada and the USA, prescribing rights

have been extended to a variety of professional groups,(8-11) including pharmacists(12). Pharmacists are accessible providers of health information, and have roles in health promotion, disease state management and medication review.(13) They have extensive training in pharmacology, therapeutics, disease-state management and communication skills, skills which are, at present, significantly under-utilised.(14) Pharmacists also have expertise in areas such as pharmacokinetics, drug interactions, adverse effects and dosage forms that have a significant impact upon the quality use of medicines. The number and complexity of medications available in Australia is growing exponentially. Better use of pharmacists’ skills and knowledge in this extended role can potentially


1

Introduction

improve concordance and disease state management. The extension of prescribing rights to pharmacists has the potential to optimise medication management, improve continuity of patient care(5, 15) and improve patient access to medication. It is timely to investigate the feasibility and application of pharmacist prescribing models to improve Australians’ access to medicines in a safe and appropriate manner within the context of the Australian health care system.

1.1

Principles of Organisational Change

If pharmaceutical reform is to be achieved there needs to be consultation and agreement between the government, those who prescribe, dispense and consume medicines, and those who manufacture, market, distribute or supply prescription medicines. (16) Health systems improvement and redesign initiatives undertaken by the NHS Modernisation Agency and the Institute for Health Care Improvement inform us that a systems-based approach to health care reform is the key to successful organisational change. Lessons include the need to: 

change from incremental to ‘big picture’ leadership and conceptual thinking



decrease queues and variation within complex systems



increase consumer involvement and emphasise primary and self care



change workforce roles and responsibilities



plan for sustainability.

Evidence demonstrates that these high impact changes can also:

1.2



improve patient outcomes



decrease patient waiting time and increase patient control



increase staff satisfaction and workforce retention



improve efficiency and safety of service delivery.

Aim

The aim of this research is to develop pharmacy practice models based upon evidence in the literature, and examine their applicability within an Australian health care context, in order to:


2

Introduction



provide consumers with improved, responsible and safe access to prescription medicines (particularly consumers with chronic medication needs)



optimise use of pharmacists’ and doctors’ skills and time



reduce the inefficient use of health resources.

1.3

Objectives

The objectives of this project are to: 

identify and develop pharmacy practice prescribing models that improve consumer access to prescription medicines



identify the professional, logistic and economic issues, including educational, communication/technological and legal requirements necessary to implement each model



identify economic variables for future assessment of alternative practice models



prepare a final report entitled ‘Improving Australians Access to Prescription Medicines’ and inform trials of alterative practice models in diverse Australian pharmacy settings.

1.4

Significance

Current Australian prescribing arrangements may not fully meet the needs of the community in terms of timely, cost-effective and convenient access to prescription medicines. Changing the ways in which consumers could access prescription medicines has the potential to reduce fragmentation within the health system, optimise medication management, improve continuity of patient care(5,

15)

and improve patient access to

medication, especially in rural/remote areas. It may overcome some inherent problems within the current healthy care system and it should make the best use of professional expertise and scarce health resources without compromising safety.


3

Literature Review Improving Australians’ access to prescription medicines

4

Literature Review

2 Literature Review

2.1

Background

There has been significant change in the conduct of the pharmacy profession over the last few decades. The age of technology has made recording of prescriptions less timeconsuming and the storage and access of patient history more reliable. The introduction of services such as medication counselling, Domiciliary Medication Management and Home Medicines Reviews has been possible due to the use of technicians to undertake routine tasks, thus freeing pharmacists to utilise their extensive drug knowledge. The provision of medicines to patients should make the best use of professional expertise and the most effective use of valuable health resources, eliminating inefficiency and duplication of effort (8, 15, 17). Prescribing medications is not a simple process and requires more than knowledge of a drug indications. Knowledge of adverse effects, doses, optimal routes, drug-drug and drug-food interactions, pharmacokinetics, pharmacodynamics and monitoring of effects is needed, and application of this knowledge requires significant expertise – expertise that pharmacists possess(18). A high percentage (~10%) of hospital admissions are due to medication misadventure related to discontinuation of intended therapy or adverse events(17). Involvement of the pharmacist in the prescribing process may reduce this problem by allowing more frequent monitoring of treatment. A large percentage, reportedly 39%, of medication errors occur at the time of prescribing(19). Unfortunately, most interventions by pharmacists occur retrospectively, which logically involves a time delay that may prove detrimental to the patient(20). Earlier involvement of pharmacists in the prescribing process may be an appropriate mechanism by which to optimise the use of medicines(19-21). Pharmacy students are developing a greater range of clinical skills and expertise(17), and are looking for settings in which to utilise those skills(22). Decisions must be made concerning what services pharmacists are prepared to offer and whether these are considered to be part of the core of pharmacists’ services or specialty services(23,

24)

.

Pharmacists are developing expertise in evidence-based practice and patient-centred care that make them ideally suited to taking responsibility for prescribing and


5

Literature Review

monitoring therapy(17). It is time for an assessment of the future direction for pharmacy and the possible roles of the pharmacist(23). There has been considerable discussion in the literature about the pros and cons of new professional practice models for pharmacists, including prescribing. Pharmacist prescribing reportedly has significant benefits for the profession. Allowing pharmacists to prescribe not only utilises their knowledge and skills, but has the potential to improve the efficiency of medical practitioners, freeing up some of their time and therefore improving patient access. Patients with chronic conditions would benefit from fewer doctors visits for routine management(15). With this general acceptance of pharmacist prescribing in the international pharmacy literature, it is timely to investigate the feasibility and application of pharmacist prescribing models within the context of the Australian health care system. Prescribing may involve diagnosing the problem, deciding whether treatment is required, if it is required, selecting appropriate treatment, deciding on dose, route and duration of therapy and ongoing monitoring(17). Many of these roles have been undertaken by pharmacists, particularly those in hospital settings and servicing aged care facilities, and it is important that this role be formalised, legally recognised and reimbursed(21).

2.1.1 Other Health Professionals as Prescribers Currently in Australia, medical practitioners, dentists and other health professionals (optometrists, podiatrists and nurses) may prescribe Prescription (S4) Medicines. These prescribing arrangements may not fully meet community needs in terms of timely, cost-effective and convenient access to Prescription Medicines(8). Overseas, prescribing rights have been extended to a variety of professional groups(810)

,

including pharmacists(12). Nurse practitioners have sought prescribing rights in

order to provide the same services as medical practitioners to a limited group of patients in order to increase access and decrease costs, both to the patient and the health system. Whilst pharmacists would be performing many of the same services provided by other practitioners, they would also provide additional services, such as ongoing management and would be more focussed on optimising medication outcomes(17).


6

Literature Review

2.1.2 Pharmacists as Prescribers Pharmacists have been diagnosing illness and prescribing appropriate medication for many generations. In Australia, this is recognised by scheduling of medications into S2/S3 (Pharmacy Medicines and Pharmacist Only Medicines, respectively), thus recognising the expertise and competence of pharmacists in this area (17). Pharmacists are seen as the most accessible health professional with the skills required to participate in various prescribing models(8,

25)

. It is important that, if pharmacists are

granted the right to prescribe, they do not contribute to polypharmacy with its inherent risks, but rationalise treatment where appropriate, in collaboration with the original prescriber(26, 27). In hospitals, pharmacists are involved in many aspects of the prescribing process – providing advice regarding drug therapy, therapeutic substitution, pharmacokinetics monitoring and evaluation of appropriateness of therapy(28). These are considered core pharmacist’s roles and interventions by pharmacists in these areas are well accepted(28). Extending this process by adding the right to prescribe (select) initial therapy and to manage ongoing therapy by making changes when necessary is a relatively small step, and simply formalises a process that is already beginning (28). In a number of countries, pharmacists are already able to legally prescribe a range of medicines previously only able to be prescribed by medical practitioners (29-31).

2.2

Methods

MEDLINE, International Pharmacy Abstracts and Google were searched using the terms ‘pharmacy’, ‘pharmacist’ and ‘prescribe’ and ‘prescribing’ to identify relevant papers and reports in addition to those publications already known to the researchers. Models that separated the functions of prescribing and supply of prescription medicines were included, ie. where the prescribing pharmacist was not the same pharmacist who dispensed the prescription.

The search was restricted to publications written in

English. One investigator collated and screened all of the papers and initially categorised models as ‘dependent’, ‘independent’ or ‘collaborative’. Pairs of investigators subsequently analysed relevant papers to describe each model in detail.

Any

discrepancies about the further categorisation of papers were resolved by discussion amongst all investigators.


7

Literature Review

2.3

Results

2.3.1 Independent Prescribing Models 2.3.1.1 Definition Independent prescribing occurs where the prescribing practitioner is solely responsible for patient assessment, diagnosis and clinical management(17) and requires legally defined levels of knowledge and skill that are usually monitored through a licensing process(17, 25). 2.3.1.2 Requirements In Australia, the restrictions on certain drug categories such as the Pharmacist Only / Pharmacy Medicines (S3/S2) is recognition that pharmacists have the level of knowledge and skill required to undertake independent prescribing of a wide range of medications. However, this review is limited to the consideration of Prescription Medicines (S4). 2.3.1.3 Drug Therapy/Groups In 1990, 15% of patients of the Indian Health Service (IHS), an agency of the United States of America (USA) Public Health Service, received their care from pharmacy practitioners. The IHS implemented ‘pharmacist patient-care management programs’ where pharmacists have limited prescribing privileges and an expanded professional role. In USA Veteran’s Affairs facilities, the local pharmacy determines the pharmacist’s scope of practice(32). The IHS pharmacists manage patients with selected disease states including(31): 

Otitis media and externa



Urinary tract infections



Venereal diseases



Congestive heart failure



Hypertension



Seizures



Bacterial and fungal infections



Arthritis



Immunisations



Back pain


8

Literature Review



Conjunctivitis.

2.3.1.4 International Perspective In 2000, thirty states in the USA permitted pharmacists to host immunisation sites and administer immunisations to the public(33). In some countries, pharmacists prescribe independently against local law(34). Whilst the illegal prescribing of prescription medicines by pharmacists is not condoned, there is evidence that pharmacists are capable of selecting appropriate therapy based on appropriate diagnosis and in consideration of the individual patient characteristics(34). 2.3.1.5 Pros Clinical Outcomes In 1979, “the results of a two-year study of pharmacists practitioners (US IHS) revealed that the quality of care provided by pharmacist practitioners for patients with the disease states listed above was not significantly different from that provided by physicians as judged by physicians(31)”.a Consumer Access/Satisfaction The IHS model was reported as positive for patient satisfaction, and it reduced the need for physician referral for physical assessment and enabled pharmacists to improve clinic efficiency during peak workloads and medical staffing shortages. Professional Relationships The IHS model was found to have a positive impact on pharmacist-physician relationships. 2.3.1.6 Cons Resource Utilisation and Costs In the 1980’s, the IHS found that the expanded roles of pharmacists sometimes occurred at the expense of services for which pharmacists were uniquely qualified. They found that the use of pharmacists as physicians’ assistants was inefficient due to growing numbers of nurse practitioners, and changed the focus back to providing

a

The statistical data are not included in the paper.


9

Literature Review

services from within the pharmacy itself. Patients received care in the pharmacy setting from pharmacist practitioners for chronic diseases using protocols and standing orders. 2.3.1.7 Implementation Issues Professional and Educational Issues/Credentialingb Pharmacists were required to undergo further training before providing expanded services for the IHS. The original course consisted of three months’ fulltime didactic and clinical training, followed by 240 hours of clinical practice under the direct supervision of a physician(31). The course has since been modified. Competency certification is required, but the assessment varied from informal assessments to written tests and demonstration of clinical skills. The US Veterans Affairs model permitted the local pharmacy to determine the scope of practice and establish the credentials needed for pharmacists’ prescribing. The facility’s Medical Committee or Chief Executive Officer then approved the scope of practice. The scope of practice is based upon competence, not educational attainment. Nonetheless, to be granted prescribing authority, a pharmacist must have a PharmD or MS degree, or equivalent qualification such as completion of an ASHP-accredited residency program, specialty board certification or two years of clinical experience. Legal Issues The following legal issues were raised in the literature: 

The application of formal written protocols and standing orders requires legislative change.



Quality assurance was carried out by retrospective chart reviews by physicians.



With reference to the IHS model, it is not clear whether the functions of prescribing and dispensing are separate. However, as the pharmacists are employees and not pharmacy owners, there is little reason to suspect that moral hazard is likely to occur in this situation.

b

Credentialing and accreditation are used inter-changeably in this document


10

Literature Review

Potential Implementation in the Australian Healthcare System These models of practice would seem well suited to improving the QUM with respect to immunisation, emergency supply and maintenance of supply between clinician visits especially in RACF settings.

2.3.2 Dependent Prescribing Models: Prescribing by Protocol 2.3.2.1 Definition Prescribing by protocol is the most common form of dependent prescribing(5). It involves “delegation of authority from an independent prescribing professional, usually a physician. The delegation of this responsibility involves a formal agreement between the independent and dependent prescribers”(25). Prescribing by protocol is more restrictive than collaborative models, as protocols dictate the exact step-by-step activities that a pharmacist will undertake in managing a patient’s drug therapy(35). 2.3.2.2 Requirements Central to the prescribing arrangement is the protocol, guideline

(25)

,

an explicit,

which is a specific written

detailed document that describes the activities that

pharmacists may perform in their prescriptive authority(5, 25). The protocol lists: 

types of diseases, drugs/drug categories(5, covered by the agreement



25)

and prescriptive decisions

(19)

the procedure, decision criteria or plan that the pharmacist must follow when prescribing(5, 25)



the physician and pharmacists party to the agreement(19)



the time limit for the agreement(19)



the responsibilities of each of the parties involved(25)



the documentation required(19, 25) and feedback mechanisms to the authorising prescriber(25)



policies for review and revision of the protocols(25)



Physicians delegating prescribing privileges must be confident in the skills, knowledge and professional judgement of the dependent prescriber(25).


11

Literature Review

The level of authority should be determined by physicians’ assessments of the pharmacists’ competence, pharmacists’ assessment of their own competence, and pharmacist comfort with these roles(31). Both parties should be willing to share responsibility for patient outcomes(25). 2.3.2.3 Drug/Therapy Groups The therapy groups suitable for prescribing by protocol include: 

nutrition(36)



anticoagulation(25, 36, 37)



pain management(25, 36, 37)



antiemetics(25, 36)



asthma medication(37)



pharmacokinetic dosing, e.g. aminoglycosides, theophylline, vancomycin(25, 36)



chronic conditions(38)



therapeutic interchange(25)



parenteral and enteral nutrition support(25)



insulin and oral hypoglycaemics(25)



antibiotics(25, 37)



antihypertensives(25, 31, 37)



cholesterol-lowering drugs (25, 37)



chemotherapy and prophylaxis for tuberculosis(31)



oral contraceptives(31)



rheumatic fever prophylaxis(31)



clozapine and antipsychotics(25)



antiepileptics(25, 31)



emergency contraceptives(37)



allergy medications(37)



hypoglycaemics(37).

2.3.2.4 International Perspective In New Zealand, nurse prescribing by protocol is common in hospitals, known as ‘standing orders’(39). In New Zealand, any registered health professional can enter into ‘dependent’ prescribing arrangements with authorised prescribers under ‘standing orders’ or protocols(40).


12

Literature Review

In the USA, protocol-based prescribing had been successfully legislated in ≥25 states in 2001(8,

25)

. The prescriptive authority requires prior Board notification of the written

(19, 31)

protocol

.

2.3.2.5 Pros The advantages of prescribing by protocol include: 

containment of drug costs(37)



reduction of General Practitioner (GP) visits(41)



theoretical integration with medication review(41)



tie-in with Pharmacist Only Medicine recommendation (41)



strengthening of professional roles for pharmacists(41)



after-hours access (eg Emergency Hormonal Contraception [EHC])(37).

2.3.2.6 Cons Some disadvantages of the model have been discussed in the literature: 

removal of some interaction with the GP undertaking diagnosis(41)



theoretical integration medication review (both a pro and con)(41)



additional workload(41)



reimbursement complications(37, 41)



some practice outside of the pharmacy, compromising other professional duties(31)



some training (physical assessment and differential diagnosis) being underutilised(31)



limited training capacity(31)



possible denial of patient access to a pharmacist-led pharmaceutical assessment(42)



possibly more room for error from a greater number of prescribers(40)



compromising of pharmacists’ quality assurance role(40).

2.3.2.7 Implementation Issues For successful implementation of this model, the following are required: 

coordination of information and access(40)



accreditation, education, accountability and competency assessment(31, 40)



determination of scopes of practice(40)



access to pharmaceutical benefits(40)



separation of prescribing and dispensing roles(40)


13

Literature Review



gaining of prescriptive authority (political strategies to pursue legislative or regulatory recognition)(36).

2.3.3 Dependent Prescribing Models: Prescribing by Patient Group Direction 2.3.3.1 Definition A Patient Group Direction (PGD) is a written direction signed by a doctor or dentist, and by a pharmacist, relating to supply and administration only of a Prescription Medicine(8, 43)

. The recipients are any patients(8, 43, 44), “who may not be individually identified before

presentation for treatment”(45). The PGD applies if a number of specified requirements are met(44) subject to any specific exclusions set out in the Direction(43). The PGD can be authorised by health authorities, National Health Service (NHS) Trusts (UK) and other NHS bodies(8, 43). 2.3.3.2 Requirements The PGD must(43): 

be patient group-specific



specifically name the Prescription Medicine or class of medicines



name the dosage form(s)



list the applicable dosage or maximum dosage



list the route of administration



list the frequency of dosing



specify any minimum/maximum period for administration



list relevant warnings



list any restrictions on quantity which may be supplied on any one occasion, and if so, the maximum quantity



state the circumstances in which the medicine can be supplied, e.g. EHC to women