Improving Use of Medicines and Medical Tests in Primary Care 9811523320, 9789811523328

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Lynn Maria Weekes Editor

Improving Use of Medicines and Medical Tests in Primary Care

Improving Use of Medicines and Medical Tests in Primary Care

Lynn Maria Weekes Editor

Improving Use of Medicines and Medical Tests in Primary Care

123

Editor Lynn Maria Weekes University of Queensland Brisbane, QLD, Australia Health Strategy and Sciences Sydney, Australia

ISBN 978-981-15-2332-8 ISBN 978-981-15-2333-5 https://doi.org/10.1007/978-981-15-2333-5

(eBook)

© Springer Nature Singapore Pte Ltd. 2020 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Front cover photography by Ms Kimberlee Walker, Walking With Kim Photography, Sydney, Australia 2020 This Springer imprint is published by the registered company Springer Nature Singapore Pte Ltd. The registered company address is: 152 Beach Road, #21-01/04 Gateway East, Singapore 189721, Singapore

This book is dedicated to the passionate and talented people who have worked at NPS MedicineWise over more than two decades. Their skill, willingness to innovate and commitment to both quality care and efficient use of resources have been the essential ingredients for successful programs that demonstrated changes in prescribing, utilisation of medical tests and better health outcomes for patients.

Foreword by Anthony Smith

At its Annual Assembly in 1986, the World Health Organisation (WHO) called on governments to implement a National Medicines Policy. At that time, Australia already had policies and mechanisms to guarantee the quality, safety and efficacy of marketed medicines, to provide equity of access through subsidy of the cost of selected medicines and to maintain the viability of the local pharmaceutical industry. There was one missing ingredient when compared with WHO recommendations—a policy aiming to achieve high-quality use of medicines (QUM) by Australian healthcare providers and consumers. The Consumers Health Forum was concerned that medicines were not being used optimally used and vigorously recruited health professionals and academics (myself among them) to the cause. With support from the Department of Health, Housing and Community Services, a working group was created which published a draft Policy on Quality Use of Medicines in 1992. For the next six years, there was a ferment of activity as stakeholders worked in partnership to explore how QUM might be defined and measured and what mechanisms might lead to improvement. Research grants funded studies of possible interventions—recognising that behavioural change techniques would be central whether in small communities or at a national level. The (then) new strategy of ‘academic detailing’ (educational visiting of health practitioners) in particular emerged as a validated intervention which would translate readily to the Australian context. The results of all this work were collated and presented to federal government which responded with the proposal to create a national incorporated organisation—the National Prescribing Service (NPS)—whose central objective would be the improvement of the quality of use of medicines. Funded by government, the NPS would be run by an independent board which carried forward the principle of partnership between consumers of health care, health professionals, industry and government. NPS later changed its name to NPS MedicineWise and enlarged its scope to include Quality Use of Medical Tests (as many of the methods of measurement and strategies for change overlap those being applied to use of medicines).

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Foreword by Anthony Smith

Dr. Lynn Maria Weekes, the editor and a co-author of Improving Use of Medicines and Medical Tests in Primary Care, was appointed as Chief Executive Officer of NPS in 1998 and held that position until 2018. This book in one sense is a celebration of 20 years of successful and pioneering operation by the organisation and its staff. This is also a strategic moment to take stock of what has been achieved—and of what has and has not worked so well. However, it focuses also on specific issues that have been important in the attempt to improve the use of medicines and medical tests. It moves from initial chapters on underpinning concepts—with especial reference to methods of effecting behavioural change in health professionals and their patients—to the evidence supporting these strategies. In subsequent chapters, more detailed review is presented for five implemented programs. Appropriately, evaluation of programs gets a chapter to itself. Newer means of discovering medicines are rapidly overtaking older methods. The new ‘biologic medicines’ are already providing solutions for many previously inaccessible diseases. Health professionals and others will need to decide how to assess quality use of these new entities. The principles set out in this book will be an invaluable and continuing resource for designing and implementing new programs to achieve QUM. The need for such programs will not change whatever the future brings in this ever-changing field. Emeritus Professor Anthony Smith University of Newcastle Newcastle, Australia

Foreword by Richard Laing

This book Improving Use of Medicines and Medical Tests in Primary Care is a valuable new resource that can be used in rich and poor countries to ensure that when access to medicines is assured that those medicines are used appropriately. At this time, there is a great deal of attention being spent on the price of medicines in both high- and low-income countries. This is not a new concern, but focusing only on price without considering the broader health systems aspects of access and without considering the effective use of medicines is counterproductive. Australia has a long history of being ahead of the world in pharmaceutical access and use issues. The Pharmaceutical Benefits Scheme has been in existence since 1948, and since the 1990s, comparative cost-effective techniques have been used to decide whether a product should be included on the national formulary. Also in the 1990s, Australia was the first high-income country to develop a National Medicinal Drug Policy. Recognising the importance of promoting the quality use of medicines, the National Prescribing Service was launched in 1997 to ensure that when medicines were made available by the NPS that they were used appropriately. Lynn Maria Weekes was the inaugural CEO of NPS MedicineWise as the organisation became over time. She brings a broad depth of practical experience strongly based on a deep understanding of theory to this book which combines general approaches and detailed case studies. The case studies go beyond the use of medicines and includes chapters on appropriate use of testing and imaging. Another strength of NPS MedicineWise was the focus on the community, and the chapters on meaningful engagement with consumers and raising community awareness complements the chapters that focus on professionals. The first two and last two chapters of the book neatly bookend the evidence and case study chapters. The Chap. 1 sets the scene laying out the case for why improving the use of medicines is important. Using a series of short disease and medicine sections, the importance of appropriate use is highlighted for each patient and for society generally. The financial and economic considerations for patients, health systems and society are identified in the context of Universal Health Coverage. This Chap. 1 ends by emphasising the importance of monitoring and measuring combined with publication to share the results. The Chap. 2 on ix

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Theoretical Base of Interventions to improve use of medicines and tests is likely to prove invaluable to practitioners who may be intimidated by the number, range and complexity of theories. This chapter concisely reviews behaviour change theories, mindlines and the Theoretical Domains Framework before coming to a section titled Menu of Behavioral Interventions. This menu describes 15 commonly used interventions with the assumptions and basis for change in a single table. A key point is made that when choosing an intervention or a package of interventions ‘canvassing the full range of options’ is important and that too often an intervention is chosen because it is available whether or not it is suitable for the situation. This clear advice is applicable in all environments! Chapters 3, 4 and 5 provide evidence for commonly used interventions for which substantial experience exists. Chapters 6 to 13 provide a series of detailed case studies of approaches or programs to address specific medicine use, test or imaging problems that provide insights and experiences that could be used in different environments. The final two chapters bring together some of the key experiences and lessons from the twenty plus years of NPS activities. Chapter 14 describes evaluation frameworks in a practical and concise manner. A number of different methods are described each with examples from the varied history of different NPS activities. The chapter emphasises that evaluation occurs at different levels of an organisation and that there is a common sequence of stages. The range of methods that can be used is impressive as are the examples of targeted evaluations. The final chapter on lessons for success is a surprise because it goes beyond Australia and brings together insights from experiences in Ireland, Portugal, California, Scotland, UK and Australia. This chapter is full of gems of experience that are likely to be applicable in many different environments. The global pharmaceutical spend exceeds a trillion dollars each year. In low and middle-income countries, the per capita amounts are much less than in high-income countries but as a proportion of total health expenditure may exceed 40% which is far more than in high-income countries. So focusing on using medicines correctly is important everywhere! Not just for avoiding wasted expenditures but also for avoiding adverse outcomes as well as ensuring that patients receive the medicines they need. This book combines theory with practical experiences that can guide policy-makers, program planners and implementers, clinicians and academics to make use of life-saving resources that are medicines, tests and images in a way that everybody can benefit. Prof. Richard Laing School of Public Health Boston University Boston, USA

Preface

The first World Health Organisation (WHO) essential drugs list was published in 1977, including 186 medicines, and the following year, the Alma-Ata Declaration identified essential medicines as one of eight key components for primary health care. The Essential Medicines Program underpins WHO’s medicines strategy having helped countries ensure access to critical medicines. Once access is addressed, there is then a moral imperative to address appropriate or quality use of the medicines issues and to ensure the best value is derived from scarce health resources. Attempts to improve use of medicines have been long standing, and the importance of the role of primary care in this regard was recognised in the 1970s and 1980s. The National Centre for Health Services Research began a grants program in the USA to encourage research on improving the quality and economy of prescription drug use. Jerry Avorn and Stephen Soumerai in Boston described the novel intervention of academic detailing and using opinion leaders, while William Schaffner was able to demonstrate changes to antibiotic prescribing through in-office visits from a medication advisor. Ground-breaking work by Hugh McGavock using pharmaceutical claims data for general practice in Northern Ireland highlighted unexpected prescribing practices and market penetration for new drugs that could not be readily explained. This showed the power of interventions based on audit and feedback using administrative data. Concerns about overuse and inappropriate use of antibiotics and consequent development of antimicrobial resistance have been a feature of the literature and a concern in most countries for decades. Mentions of the onset of a ‘pre-antibiotic era’ can be found as early as the 1950s soon after widespread us of antibiotics began. Richard Grol taught us that writing guidelines was not enough, nor their passive dissemination. He demonstrated the necessity of well-executed implementation plans to successfully influence a physician’s behaviour. Others drew on diffusion of innovation theory, particularly Rogers who pointed to five concepts as prerequisites for successful guideline implementation: relative advantage, compatibility, complexity, trialability and observability. In the 1980s and 1990s, researchers were identifying evidence–practice gaps where it was possible to improve the quality of xi

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patient care. More recently, concepts of overdiagnosis and use of unnecessary tests and procedures have shone the spotlight on low-value care. So we have known for a long time that improving use of medicines and medical tests is important and that primary care is a critical setting for this work. Yet, around the world we know there remains much to be done to systematically support improvements and sustain successes. This book seeks to provide a practical guide for how to design and implement interventions that will improve the use of medicines and medical tests in primary care. It has a focus on influencing the behaviours of doctors and patients, predominantly using bottom-up approaches that are based on sound theoretical frameworks. It provides case studies and examples from experience to share lessons learnt and tips for success. The book does not cover clinical interventions for individual patients such as medication review by pharmacists or other clinical services provided to patients whether by dispensing or non-dispensing pharmacists. While there is an extensive evidence base for interventions that change behaviour, the interventions themselves are not always adequately described, partly because of space limitations in journals. This book seeks to fill that gap by providing a fulsome description of interventions with accompanying materials that allow readers to understand exactly what was done.

NPS MedicineWise Australia’s response to quality use of medicines problems is long standing. My experience at NPS MedicineWise, also known as the National Prescribing Service in Australia, has informed my thinking and this publication. It may be helpful to understand how the organisation came into existence as this provides context for some of the case studies in this book. NPS MedicineWise (NPS) has been working to improve the use of medicines and tests since 1998, supporting health professionals, consumers, policy-makers and health systems to achieve better outcomes of care. It was essentially an experiment in creating change, at a national scale, at ‘arms-length’ from government authorities. Its structure, governance and operations were all innovative at the outset, and some elements remain unique even today. Australia has a long history in quality use of medicines (QUM). As early as 1975, a national therapeutics journal, Australian Prescriber, was established, and it continues to be published with strong readership. In 1978, an Antibiotic Guideline was published to address the emerging problem of antibiotic resistance, and it became the first of a successful series of Therapeutic Guidelines. These publications have continued to guide practice across therapeutic areas and have become indispensable tools for health professionals. In the late 1980s, the World Health Organisation promoted the concept of Rational Use of Drugs and called on member states to establish a National Medicinal Drug Policy. The Consumers’ Health Forum of Australia, which was

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formed in 1987, published a document titled Towards a National Medicinal Drug Policy in Australia which identified three critical components: quality of the product; quality use and equitable access to medicines. This early leadership from health consumers has been repeated many times in subsequent decades and is integral to the quality use of medicines movement in Australia. A watershed international meeting in 1991, co-hosted by the Consumers’ Health Forum and the Australasian Society of Clinical and Experimental Pharmacology and Toxicology (ASCEPT) on rational prescribing, called for a national drug policy, production of national therapeutic guidelines, a prescribing curriculum for medical students, an increased clinical pharmacology workforce and development of appropriate sources of consumer information on medicines. The meeting galvanised activity, and the Pharmaceutical and Rational use of Medicines (PHARM) Committee was established in 1991 with funds from the Australian government for educational interventions that would promote quality use of medicines. More than $10 million for 153 projects fostered the development of activities that improved the use of medicines and the health care of consumers. Commentators noted, however, that when projects ended, there was no means for sustaining effective interventions. Also in 1991, Australian Pharmaceutical Advisory Council was set up to advise the Federal Minister of Health on the National Medicinal Drug Policy. This was a representative council which developed guidance on: medication management in aged care; Consumer Medicines Information; privacy and health data; and continuum of care from hospital to the community. Based on recommendations for a national centre to coordinate quality use of medicines activity, the National Prescribing Service was announced in 1997 and its mandate was to improve health outcomes for consumers by supporting quality prescribing in Australia. The medical profession and other prescribing stakeholders identified a need for access to a range of coordinated and independent prescribing support services. For this reason, NPS would not be a part of government and would provide a mechanism for prescribers to work in partnership with other stakeholders to achieve a national approach to quality prescribing. An Advisory Group, chaired by Prof. Tony Smith, oversaw the establishment of NPS. This group, which included representatives of medical, pharmacy and consumer organisations, commissioned a national consultation to help shape the design and operation of NPS. The consultation identified the need for NPS to establish credibility, create early ‘wins’, build on existing work and be clear about its role delineation. The strategy recommendations included a national academic detailing service, telephone drug information services for consumers, mass audience campaigns to increase community awareness of medicines issues and education for health professionals. The company limited by guarantee with 26 member organisations was incorporated and launched in March 1998. The original members were drawn from six categories of stakeholders: government, general practice, specialist prescribers, consumers, pharmacy, and the pharmaceutical industry. The not-for-profit model, receiving funding from government, responsible for its own strategy and

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accountable to its membership and the Australian people, was and is unique, but it has served the company well. NPS MedicineWise is very well connected in the health and government policy environments, has the flexibility to act in its own right and has been able to build credibility with health professionals and consumers through its products and services. It can variously play the role of thought leader, ‘honest broker’ and program implementation expert. This book reflects the work that has evolved from this national implementation model.

Australian Health System and the Pharmaceutical Benefits Scheme (PBS) Much of the work presented in this book has been undertaken in the Australian health system. Having a basic understanding of that system will allow readers to interpret the case studies more accurately and assist in translating the work to other settings. Australia has a strong health system, and responsibility for care is divided among governments and the private sector. Medicare and the public hospital system provide free or low-cost access for all Australians to many healthcare services. Private health insurance provides choice outside the public system. Consumers and patients contribute to funding for health care both through taxes and when specific services are being used. For private health care both in and out of hospital, you contribute towards the cost of your health care. Medicare is Australia’s universal healthcare scheme, and it has been in operation since 1984. Its three major parts are: • medical services, including most diagnostic tests • public hospitals • medicines. Medicare covers the full cost of public hospital services, and it is the responsibility of the Australian government. It also covers some or all of the costs of other health services. These can include services provided by general practitioners and medical specialists. Limited coverage is also provided for physiotherapy, community nurses and basic dental services for children. The Medicare Benefits Schedule (MBS) is the list of all health services that the government subsidises. A team of medical experts keeps the list up to date, safe and aligned with best practice. The MBS has a safety net which is the maximum amount that any person will pay in one year for medical services. The Pharmaceutical Benefits Scheme (PBS) subsidises most medicines used in ambulatory care. The PBS lists brand name, generic, biologic and biosimilar medicines. There are over 5,200 products on the PBS. All products must be first approved by the Therapeutic Goods Administration as safe and effective before

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being considered for the PBS. An independent panel of experts, the Pharmaceutical Benefits Advisory Committee (PBAC), advises the Minister for Health on if a medicine should or should not be listed on the PBS. The PBAC’s advice is based on an assessment of the comparative safety and effectiveness of the medicine and its cost-effectiveness compared with alternative treatments. The Minister cannot list a medicine that the PBAC has not recommended. Patients pay a co-payment for most medicines, and this payment is less than the total cost of the medicine. Like Medicare, the PBS has a safety net to ensure that there is an upper limit to the amount that any patient would have to pay in a year. Public hospitals are generally overseen by state governments, but the Australian government remains responsible for some agreed services. For example, the cost of medicines for patients in emergency departments and when they are discharged from hospitals is covered under the PBS and so is the responsibility of the national government. Many Australians also have private health insurance. This allows access to private hospitals and to a private room in a public hospital. It also covers some services not covered by Medicare such as dentistry. In 2016–2017, Australia spent nearly $181 billion on health: • 41% by the Australian government • 27% by state and territory governments • 17% by individuals (for products and services that are not fully subsidised or reimbursed) • 9% by private health insurers • 6% by non-government organisations. Health spending was about 10% of gross domestic product. The Australian government funds most of the spending for medical services and subsidised medicines. State and territory governments fund most of the spending for community health services. The Australian government and state and territory governments share funding of public hospital services. Sydney, Australia

Lynn Maria Weekes

Acknowledgements

This book draws heavily on the work of NPS MedicineWise particularly in the period from 1998 until 2018. The program plans and evaluation reports provided the background materials for the chapters outlining examples of programs that effect change. All of this work was guided by experienced personnel and ably assisted by advisory committees. The wise and generous counsel of the clinicians, academics and health consumers on those advisory committees ensured that programs were relevant and evidence-based, both precursors to program effectiveness. The strong support and funding provided by the Australian Government have been critical elements in ensuring the success and sustainability of the work. Program participants such as doctors, pharmacists, nurses and health consumers who accepted a detailing visits, received feedback on their own prescribing, used social media or visited a website, have provided essential feedback for ongoing program development and improvement. Without the collaborative effort of all stakeholders and partners, the programs described in this text could not have been provided. Special thanks to Karen Kaye, Sharene Jackson, Gloria Antonio, Kerren Hosking, Jonathan Dartnell, Suzanne Blogg, Aine Heaney, Jane London, Kylie Easton, Clare Weston and Robyn Lindner who have lead teams responsible for creating and implementing programs. The DATIS team were inspirational collaborators and colleagues standing beside their NPS counterparts. Stephen Phillips, Andrea Mant, Jan Donovan, Frank May, Tim Driscoll, Janette Randall, Diane Walsh and Debra Kay provided extraordinary leadership for program staff as they chaired and contributed to formative work of NPS MedicineWise. Similarly, the work of all the Board Directors over this period has ensured strong governance and accountability. Thanks to my co-authors who have brought international perspectives to this book as well as a deep understanding of what is really needed to change professional and health consumer behaviours for the better. Finally, thanks to my husband, Iqbal Ramzan, and family who have sustained me while I have been completing this manuscript.

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About This Book

This book is made up of 14 chapters that provide a comprehensive insight into development of programs that have been shown not only to change the behaviour of health professionals but also to deliver better outcomes for patients.

Chapter 1. Introduction: Why Is Improving Use of Medicines and Medical Tests Important? The problem, its scope, the consequences for patient outcomes and health system resource utilisation are outlined in this chapter. It draws on literature from high- and low-income countries to compare and contrast the relevant issues. It explores individual (patient), health system and societal perspectives in addressing the problem.

Chapter 2. Theoretical Bases of Interventions to Improve Use of Medicines and Tests The theoretical bases for behaviour change programs directed at health professionals are explored and summarised. The chapter outlines how to choose the theoretical base that best serves a particular problem or context. It also describes the types of intervention that have been shown to be effective in creating changes in prescribing and test ordering. The effect size, barriers and enablers for success and a comprehensive reference list will assist readers to apply the theory in their own setting.

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Chapter 3. Interventions Supporting Consumers to Achieve the Best from Medicines and Tests This chapter reviews the evidence for interventions that have been shown to support patients and health consumers make the best decisions about medicines and medical tests, to adhere to therapy, to self-manage and to monitor their own responses to care. It considers how health professionals and the health system can evolve to support patients and their carers as active members of their own care team.

Chapter 4. Evidence for and Implementation of Academic Detailing The theory, process and evidence for effectiveness of academic detailing are described in this chapter. It provides examples of the types of topics, collateral materials and messaging that have been used to improve practice in a range of medical areas to change practice. The authors also offer one model for training and supporting health professionals to become academic detailers.

Chapter 5. Evidence for Audit and Feedback The authors explain the evidence base for audit and feedback as an intervention, how to use different type of data and how to deploy the feedback most effectively for behaviour change. There are examples to assist the reader design their own audit and feedback project.

Chapter 6. Choosing Wisely: Clinicians as Agents for Change This chapter describes the genesis and spread of the social movement known as Choosing Wisely. The reasons for variable implementation in difference health settings is discussed, and the global consequences of this variation are explored. The authors suggest criteria for success and ways to nurture and sustain local champions.

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Chapter 7. A Program to Improve Management of Patients with Type 2 Diabetes This is a detailed example of how a program was designed, implemented and evaluated. The use of academic detailing alongside clinical audit and guidelines to improve management of diabetes in general practice is described through a series of interventions spanning several years.

Chapter 8. Program to Improve Antibiotic Prescribing in Primary Care The aim of this chapter is to provide a detailed example of how a program was designed, implemented and evaluated. The program was run on repeated occasions to reduce antibiotic prescribing by almost 20%. Examples of the program materials are included, and the outcomes of the program are described.

Chapter 9. Raising Community Awareness: The Role of Public Relations in Health Communication This chapter describes the design and implementation of community campaigns, public relations approaches and use of media to engage consumers and raise awareness of quality use of medicines and medical tests. It uses the NPS MedicineWise experience from antibiotic resistance campaigns, Be MedicineWise Week and Choosing Wisely to exemplify the approach.

Chapter 10. A Program to Improve Use of Antithrombotic Medicines and Reduce the Incidence of Stroke The aim of this chapter is to provide a detailed example of how a program was designed, implemented and evaluated. It includes examples of the program materials and describes the outcomes of the program and how these were measured. The chapter also outlines a health outcome approach to evaluation.

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Chapter 11. A Program to Reduce Imaging for Acute Low Back Pain This chapter describes a program to reduce referrals from general practitioners for unnecessary imaging for uncomplicated low back pain. The interventions required for changing “one off” diagnostic test ordering decisions proved to be simpler than those required for changing prescribing of chronic medications.

Chapter 12. A Program to Reduce Ankle and Knee Imaging Use of the Ottawa rules for imaging of ankle and knee sprains and strains can reduce the number of X-rays and scans undertaken in primary care. This chapter describes a program to increase uptake of the Ottawa rules.

Chapter 13. Evaluation of Multifaceted Programs This chapter summarises methods for evaluating changes in prescriber knowledge and attitudes with pre- and post-intervention testing. It illustrates use of interrupted time series to show changes in prescribing behaviour, including tips on how to use administrative data sets to best advantage. It will also briefly describes how economic benefits and health outcomes can be assessed in the longer term.

Chapter 14. Lessons for Success This chapter summarises the key lessons and recommendations of the authors. The enablers, barriers and capability requirements for delivering programs at scale will be explored. It suggests one model for topic selection and recommends development of partnerships and collaboration for sustainability. Both starting out and seasoned practitioners will find this a useful summary.

Terminology Throughout this book, a range of terms are used: rational use of medicines, responsible use of medicines, quality use of medicines and medical tests, low-value care, unnecessary tests, procedures and treatments, appropriate use of medicines and tests. While each of these terms come with a specific nuance in general, they are

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referring to practices which if not optimised are wasteful, harmful or undesirable and which we seek to change. Similarly, different authors use the terms patient, health consumer, client and citizen, depending on the context. In general, we have used the term patient or consumer to refer to someone actively participating in or directly receiving health care and citizen, community or society to refer to the general public.

Disclaimer The views expressed in this book are those of the individual authors and not necessarily that of their organisations, employers or funders.

Contents

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Introduction: Why Is Improving Use of Medicines and Medical Tests Important? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lynn Maria Weekes 1.1 Why Improving Use of Medicines Is Important . . . . . . . . . 1.2 Why Improving the Use of Medical Tests Is Important . . . . 1.3 Financial and Economic Considerations: Patients, Health Systems and Society . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.4 Measuring and Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . 1.5 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Theoretical Bases of Interventions to Improve Use of Medicines and Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lynn Maria Weekes 2.1 Why Is Theory Important? . . . . . . . . . . . . . . . . . . . . . . . . . 2.2 Behavioural Influences, Decision Making and Adopting Change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3 Behaviour Change Theories . . . . . . . . . . . . . . . . . . . . . . . . 2.4 Menu of Behavioural Interventions . . . . . . . . . . . . . . . . . . 2.5 Using Theory to Design Interventions: Some Brief Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Interventions Supporting Consumers to Achieve the Best from Medicines and Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Elizabeth Manias 3.1 Using Interventions to Support Decisions by Consumers and Carers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2 Types of Interventions Supporting Decisions About Tests and Medicines Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Interventions for Adherence to Medicines . . . . . . Support by Health Professionals and Proponents of the Health System . . . . . . . . . . . . . . . . . . . . . 3.5 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Evidence for and Implementation of Academic Detailing . . . Debra Rowett 4.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2 Evidence for Academic Detailing . . . . . . . . . . . . . . . . . 4.3 When to Use Academic Detailing . . . . . . . . . . . . . . . . 4.4 Workforce Selection and Training . . . . . . . . . . . . . . . . 4.5 Evaluating the Effectiveness of the NPS MedicineWise Detailing Visits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.6 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Evidence for Audit and Feedback . . . . . . . . . . . . . . . . . . Jane London 5.1 What Is Audit and Feedback? . . . . . . . . . . . . . . . . 5.2 What Is the Evidence for Audit and Feedback? . . . . 5.3 When and Why Does Audit and Feedback Work? . 5.4 Practical Advice for Designing Audit and Feedback 5.5 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Choosing Wisely: Clinicians as Agents for Change . Robyn Lindner, Wendy Levinson and Daniel Wolfson 6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 6.2 The Origins of Choosing Wisely . . . . . . . . . . 6.3 Why We Need Better Conversations . . . . . . . 6.4 A Growing International Campaign . . . . . . . . 6.5 Enabling Change . . . . . . . . . . . . . . . . . . . . . . 6.6 Measuring the Impact of Choosing Wisely . . . 6.7 Future Challenges and Opportunities . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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A Program to Improve Management of Patients with Type 2 Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lynn Maria Weekes and Kirsty Anne Lembke 7.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.2 Rationale for Topic Selection . . . . . . . . . . . . . . . . . . . . . 7.3 Quality Use of Medicines Issues . . . . . . . . . . . . . . . . . . 7.4 Program Goal, Objectives and Audiences . . . . . . . . . . . . 7.5 Key Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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7.6 Selection of Behavior Change Interventions 7.7 Program Implementation and Impact . . . . . 7.8 Conclusions . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

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Program to Improve Antibiotic Prescribing in Primary Care . Lynn Maria Weekes and Clare Weston 8.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.2 Problem Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.3 Quality Use of Medicines Issues . . . . . . . . . . . . . . . . . . 8.4 Scope and Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.5 Desired Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.6 Key Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.7 Selection of Behaviour Change Interventions . . . . . . . . . 8.8 Program Implementation . . . . . . . . . . . . . . . . . . . . . . . . 8.9 Program Impact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.10 Using Evaluation for Program Improvement . . . . . . . . . . 8.11 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Raising Community Awareness: The Role of Public Relations in Health Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . Kerren Hosking 9.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9.2 What Is Public Relations? . . . . . . . . . . . . . . . . . . . . . . . 9.3 The Importance of Third-Party Channels . . . . . . . . . . . . 9.4 Leveraging Public Relations to Drive Stakeholder Engagement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9.5 Public Relations as an Enabler for Broader Health Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9.6 Public Relations as a Tool to Build Health Literacy . . . . 9.7 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10 A Program to Improve Use of Antithrombotic Medicines and Reduce the Incidence of Stroke . . . . . . . . . . . . . . . . . Jonathan Dartnell, Aine Heaney and Zhixin Liu 10.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.2 Rationale for Topic Selection and Problem Definition for the Therapeutic Program . . . . . . . . . . . . . . . . . . 10.3 Formative Research and Stakeholder Engagement . . . 10.4 Quality Use of Medicine Issues . . . . . . . . . . . . . . . . 10.5 Program Design . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.6 Program Goal and Objectives . . . . . . . . . . . . . . . . .

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10.7 Key Messages . . . . . . . . . 10.8 Program Interventions . . . 10.9 Program Implementation . 10.10 Program Evaluation . . . . . 10.11 Lessons and Conclusions . References . . . . . . . . . . . . . . . . .

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11 A Program to Reduce Imaging for Acute Low Back Pain Lynn Maria Weekes and Clare Weston 11.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.2 Rationale for Topic Selection and Problem Definition 11.3 Quality Use of Medical Tests . . . . . . . . . . . . . . . . . 11.4 Program Objectives . . . . . . . . . . . . . . . . . . . . . . . . . 11.5 Key Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.6 Selection of Interventions . . . . . . . . . . . . . . . . . . . . 11.7 Program Implementation . . . . . . . . . . . . . . . . . . . . . 11.8 Program Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . 11.9 Lessons and Conclusions . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 A Program to Reduce Ankle and Knee Imaging . . . . . . . . Lynn Maria Weekes, Rachel Holbrook, Ashutosh Todkar and Jane London 12.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.2 Rationale for Topic Selection and Problem Definition 12.3 Quality Use of Medical Tests . . . . . . . . . . . . . . . . . 12.4 Program Goal and Objectives . . . . . . . . . . . . . . . . . 12.5 Key Messages and Calls to Action . . . . . . . . . . . . . . 12.6 Selection of Interventions . . . . . . . . . . . . . . . . . . . . 12.7 Program Implementation . . . . . . . . . . . . . . . . . . . . . 12.8 Program Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . 12.9 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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13 Evaluation of Multifaceted Programs . . . . . . . . . . . . . . . . . . . Suzanne Blogg and Leanne Atkins 13.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2 Evaluation Frameworks . . . . . . . . . . . . . . . . . . . . . . . . . 13.3 Evaluating Changes in Prescriber Knowledge and Attitudes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.4 Evaluating Economic Benefits . . . . . . . . . . . . . . . . . . . . 13.5 Evaluation of the Asthma Program: Methodology Case Study 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.6 Evaluating Health Outcomes of a Heart Failure Program: Methodology Case Study 2 . . . . . . . . . . . . . . . . . . . . . .

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13.7 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 314 14 Lessons for Success . . . . . . . . . . . . . . . . . . . . . . . . Lynn Maria Weekes 14.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . 14.2 The Local Culture and Health System . . . . . 14.3 Designing Interventions: Adapting Evidence and Incorporating Theoretical Frameworks . . 14.4 Scaling for Widespread Implementation . . . . 14.5 Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . 14.6 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Appendix : Interventions Used Routinely by NPS MedicineWise and Referred to in Exemplar Programs in This Book . . . . . 331 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 333

Contributors

Leanne Atkins Program and Product Evaluation Lead, NPS MedicineWise, Sydney, NSW, Australia Suzanne Blogg Health Intelligence Manager, NPS MedicineWise, Sydney, NSW, Australia Jonathan Dartnell Manager Programs and Clinical Services, NPS MedicineWise, Melbourne, NSW, Australia Aine Heaney Manager Client Relations, NPS MedicineWise, Sydney, NSW, Australia Rachel Holbrook Northern Sydney Local Health District, St Leonards, NSW, Australia Kerren Hosking Corporate Affairs and Communication, NPS MedicineWise, Sydney, NSW, Australia Kirsty Anne Lembke NPS MedicineWise, Surry Hills, NSW, Australia Wendy Levinson Department of Medicine, University of Toronto, Toronto, ON, Canada Robyn Lindner NPS MedicineWise, Sydney, NSW, Australia Zhixin Liu Consultant Statistician, NPS MedicineWise, Sydney, NSW, Australia Jane London NPS MedicineWise, Melbourne, NSW, Australia Elizabeth Manias School of Nursing and Midwifery, Centre for Quality and Patient Safety Research, Institute for Health Transformation, Deakin University, Burwood, VIC, Australia; Department of Medicine Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, Australia

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Debra Rowett Drug and Therapeutics Information Service, Southern Adelaide Local Health Network, Adelaide, SA, Australia; Discipline Leader Pharmacy, University of South Australia, Adelaide, SA, Australia Ashutosh Todkar NPS MedicineWise, Sydney, NSW, Australia Lynn Maria Weekes University of Queensland, Brisbane, QLD, Australia; Health Strategy and Sciences, Sydney, NSW, Australia Clare Weston NPS MedicineWise, Sydney, NSW, Australia Daniel Wolfson American Board of Internal Medicine Foundation, Philadelphia, PA, USA

Abbreviations

ABIM

AF AUD CALD CMI

CT scans DDD

ECG GP HbA1c ICS LABA LDL-cholesterol MBS MRI NVAF

American Board of Internal Medicine is not a membership society, but a physician-led, non-profit, independent evaluation organisation. ABIM certifies physicians in 20 subspecialties including about 25% of practising physicians in the USA. Certification means that internists have demonstrated that they have the clinical judgment, skills and attitudes essential for the delivery of excellent patient care Atrial fibrillation Australian dollars Culturally and linguistic diverse. Also sometime referred to as multicultural Consumer Medicine Information is a leaflet that contains information on the safe and effective use of a prescription or specified over-the-counter medicine. It is written by the pharmaceutical company and is a requirement of the regulator Computerised tomography scans Defined daily dose is a standardised measure of drug consumption. It is used to allow comparisons between different drugs Electrocardiogram General practitioner Haemoglobin A1c or glycosylated haemoglobin is a test used to monitor management of diabetes Inhaled corticosteroids such as beclomethasone Long-acting beta-agonist medications for asthma Low-density lipoprotein—cholesterol Medical Benefit Schedule for Medicare. More information is provided in the Preface Magnetic resonance imaging Non-valvular atrial fibrillation

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OECD PBS PSA QUM RDU RUD TDF

TIA

Abbreviations

Organisation for Economic Co-operation and Development Pharmaceutical Benefits Scheme. More information is provide in the Preface Prostate-specific antigen is a screening test for prostate cancer Quality use of medicines Rational drug use; responsible drug use As for RDU The Theoretical Domains Framework was developed by behavioural scientists and implementation researchers who identified theories relevant to implementation and grouped constructs from these theories into domains Trans-ischaemic attack

Chapter 1

Introduction: Why Is Improving Use of Medicines and Medical Tests Important? Lynn Maria Weekes

Abstract The use of medicines and medical tests sits at the heart of health systems globally. Whether considered from the perspectives of patient benefits and harms, health expenditure or the most common practices of health professionals, prescribing of medicines and ordering of medical tests are critical behaviours that determine the quality of care, health outcomes and value for money in health systems. A range of interventions to improve prescribing and use of medical tests have been advocated for decades, yet we continue to see suboptimal use of medicines and medical tests. This includes both underuse and overuse of these precious resources against an evidence base that is compelling in demonstrating missed opportunities for benefits, unnecessary exposure to harms and poor value for money when utilization is not appropriate. The arguments for programs that support health professionals and patients to make the best use of medicines and medical tests are based on data from high-, middle- and low-income countries. These data show the variation that cannot be explained by patient and clinical factors alone. Other considerations such as attitudes and beliefs, geography, previous experience, peer norms and socioeconomic factors are important when we seek to improve the use of medicines and medical tests. Keywords Appropriate use of medicines · Responsible use of medicines · Rational use of medicines · Quality use of medicines · Low-value care · Overuse · Underuse · Cost-effective · Behaviour change · Unexplained variation Key Points 1. Healthcare systems globally invest heavily in medicines and medical tests. 2. There is evidence that the use of medicines and medical tests could be more effective and more cost-effective and hence lead to better health outcomes for patients. 3. Many non-clinical factors have been associated with variations in practice including the attitudes and beliefs of individuals, demography and geography. Some L. M. Weekes (B) University of Queensland, Brisbane, QLD, Australia e-mail: [email protected] Health Strategy and Sciences, Sydney, NSW, Australia © Springer Nature Singapore Pte Ltd. 2020 L. M. Weekes (ed.), Improving Use of Medicines and Medical Tests in Primary Care, https://doi.org/10.1007/978-981-15-2333-5_1

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of these factors are susceptible to change through carefully planned intervention programs.

1.1 Why Improving Use of Medicines Is Important Medicines play a major role in curing, preventing and managing illness. They are the most common and usually most affordable mode of therapy available, whatever the country setting. The World Health Organization (WHO) has noted that the continuous provision of appropriate medicines of assured quality in adequate quantities and at reasonable prices is a concern for all national governments (Hoebert, van Dijk, Mantel-Teeuwisse, Leufkens, & Laing, 2013) This concern is underscored by recent global medicine shortages and one which national medicines policies, bottom-up initiatives and international cooperation can assist (Bochenek et al., 2018; Gray, 2014; Gray & Manasse, 2012). This means that a precursor to the quality use of medicines is access to medicines. The Nairobi Conference in 1985, on Rational Use of Drugs, recommended that national medicines policies should be defined in each country to ensure that essential medicines of suitable quality could be accessed. Commentators said that there is a need for these policies to be based on universal principles and to be adapted to national contexts and population needs. Cultural and historical factors including the country’s capacity to regulate and enforce quality assurance, the political values of the government and the actual level of spending were all said to be important (Hoebert et al., 2013). Central to the implementation of a national medicines policy is the concept of essential medicines, a concept that has more traction in low- and middle-income countries. However, even in high-income countries, decisions must be made about the relative value of medicines, their cost-effectiveness and affordability. A report from the WHO argues that implementing a list of priority medicines is necessary to ensuring access to medicines, saying that ‘the identification and promotion of a limited list of priority medicines stimulate evidence-based medical practice and optimize the efficiency of expenditure on medicines’ and that ‘government commitment to providing access to and reimbursing essential medicines naturally decreases the use of obsolete or suboptimal medicines and can improve health outcomes’ (World Health Organization, 2012). This report went on to call for: • • • • • •

Implementation of evidence-based treatment guidelines Initiatives that support patients to optimally adhere to therapy Methods for monitoring utilization of medicines Methods for monitoring the outcomes of therapy Bottom-up engagement of doctors, patients and pharmacists Sustained commitment from national authorities (World Health Organization, 2012).

1 Introduction: Why Is Improving …

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Increasing use of generic medicines is one means of improving the affordability of medicines. Therapeutically equivalent generic medicines are up to 90% less expensive than originator brands but the exact amount of discount is dependent on the policy and pricing levers available in different countries. It has been estimated, for example, that use of generic medicines in Europe saves 25 billion Euros each year (Babar, Kan, & Scahill, 2014). For developing countries, it was estimated that switching to generic medicines would result in average savings of 60% on annual drug budgets (range 9– 89%) (Cameron, Mantel-Teeuwisse, Leufkens, & Laing, 2012). Yet we continue to see doctors preferring to prescribe branded products for a range of reasons, carefully designed programs are needed to help shift practice to generic prescribing. At the same time, there is recognition of many new drugs which are progressing through the regulatory process earlier in their development and with less data available about likely benefits or harms. Patients and prescribers want early access to new drugs for cancer, rare diseases and other conditions with poor prognosis and limited treatment options. It is a challenge to balance comprehensive and objective appraisal of these new medicines with access that is both equitable and early. There is a need to ensure medical advances that remain affordable and available, while taking account of patient perspectives about the value of likely outcomes (Hill, Bero, McColl, & Roughead, 2015). It can also be a challenge to collect data after a medicine is made available in order to build an understanding on what outcomes are actually being achieved in the real world. Earlier registration places even greater importance on appropriate carefully tailored and well explained prescribing of medicines.

1.1.1 Critical Role of Medicines Medicines have had a significant impact on health in the modern era. They have reduced morbidity and disease burden of many conditions, prevented or cured some illnesses, improved quality of life and contributed to greater longevity. Our increasing reliance on medicines can be exemplified with data from the UK, where in 1989 the average number of prescriptions per person per year was 8.0 compared with 18.7 in 2012 (Busfield, 2015). A medicines census conducted by NPS MedicineWise in Australians over 50 years of age in 2009–2010 found that 87% of respondents had used at least one medicine in the past 24 h and 43.3% had taken five or more. Older age, being female and a self-reported health status of ‘fair’ or ‘poor’ were predictors for polypharmacy Fig. 1.1 (Morgan et al., 2012). It was concerning in 2002 that the WHO contended more than 50% of all medicines were prescribed, dispensed or sold inappropriately and that 50% of patients failed to take them correctly Fig. 1.2 (World Health Organization, 2002). Inappropriate or suboptimal use of medicines has been variously categorized and can be considered to include:

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80

72.4 66

70 60 50.2

49.4

50 40

36.4

35.3

32.2

30 20 10 0 Male

Female

50-64 years

65-74 years

75 years and older

Excellent or Good health status

Fair or Poor health status

Percentage respondents

Fig. 1.1 Self-reported use of five or more medicines in a survey of 4500 Australians (Morgan et al., 2012)

ContribuƟon to overall avoidable costs (USD billion)

18

12

27

33 172 39

Non-adherence

UnƟmely medicine use

AnƟbioƟc misuse

MedicaƟon error

SubopƟmal generic subsƟtuƟon

Unnecessary polypharmacy

Fig. 1.2 Global avoidable costs of using medicines better (World Health Organization, 2002)

1. Taking a medicine when other measures including lifestyle changes (smoking, diet, exercise and alcohol consumption) or non-drug therapies (counselling, surgery, etc.) would be more appropriate 2. Not taking a medicine that is clinically needed as determined by the evidence, the prescriber and the patient

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3. Taking a medicine that is not effective for the condition in general or this patient in particular 4. Taking a medicine for which there is no clinical need either because the condition will resolve without it or there is no clinical condition to be treated 5. Taking the right medicine but in the wrong dosage regimen or with inappropriate combination of therapies 6. Taking an expensive medicine when a cheaper one would be equally or more effective.

1.1.2 Realizing Benefits and Avoiding Harms Randomized controlled trials are rarely powered to fully assess safety of a new medicine. Moreover, because of the way patients are included or excluded in clinical trials, it can be difficult to be sure precisely where boundaries of a medicine’s value fall for a given condition. Which patients are most likely to benefit and which to experience more harm is not usually apparent until a therapy has been used for some time. A useful measure to assist in decision-making is the number needed to treat (NNT). This is the number of people who need to be treated in order to prevent an adverse outcome such as death, heart attack or hospitalization in one person over a specific period of time. Against this, we consider the number need to harm, or the number of people who would need to be treated to see one significant adverse outcome over the same period of time. Weighing these up can help objectify the relative merits of a new medicine. Ideally, doctors and patients consider these together taking account of the patients’ concerns, values and priorities. In clinical practice, we continue to see unexplained variation that suggests there is more to be done to achieve optimal use of medicines. The Australian Commission for Safety and Quality in Health Care has published reports exploring healthcare variation (Australian Commission on Safety and Quality in Health Care, 2015, 2017). These reports have raised questions about prescribing of: – Antimicrobials (20-fold variation between lowest and highest regions) – Antidepressants especially for patients 65 years old (sevenfold variation between lowest and highest regions) – Medicines for attention deficit hyperactivity disorder (75-fold variation between lowest and highest regions) – Asthma, diabetes and heart failure medications in rural and remote areas where it is lower than expected. The following section outlines five examples of well-established treatments that if more fully implemented would increase longevity and improve quality of life. These

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are areas of medicine and prescribing where we know there is often an evidencepractice gap. They provide a basic case for quality use of medicines interventions to improve the quality of patient care.

1.1.3 Secondary Prevention of Myocardial Infarction and Stroke Cardiovascular disease is the leading cause of morbidity and premature death, accounting for 31% of all deaths globally. In 2015, this amounted to 17.7 million deaths and the number is projected to rise to 23.3 million by 2030. Three quarters of these deaths occur in low- and middle-income countries (World Health Organization, 2017). The estimated cost of disability from cardiovascular disease is USD 450 billion annually (Parekh, Galloway, Hong, & Wright, 2013). Partly because of reduced smoking rates but also because of the adoption of new technologies, mortality rates from myocardial infarction are falling. However, recurrent cardiovascular events are common. Around 50% of patients who survive a first myocardial infarction will have a second one within a year, and 75% will have a second one within three years (Andres et al., 2012). We have clear evidence for effective interventions for secondary prevention of cardiovascular disease—lifestyle modifications such as smoking cessation, weight control, increased physical activity and healthy eating, as well as, pharmacotherapy with statins, antihypertensives and aspirin (Baigent et al., 2010; Law, Morris, & Wald, 2009; Parekh et al., 2013). Yet the factors associated with a higher risk of recurrent myocardial events (older age, socioeconomic status, lack of access to revascularisation procedures, the presence of comorbidities and poor adherence to medication) include factors that also make prescription of the appropriate medicines less likely. In clinical practice, most patients should be treated with aspirin or another antiplatelet, a statin and an antihypertensive following a cardiovascular event (Therapeutic Guidelines, 2018). The guidelines are clear and except for aggressive therapy targets for lower blood pressures, and cholesterol levels are not contentious. This is an area where agreement is generally good, evidence is clear, diagnosis is obvious, and yet we have seen poor adherence to the guidelines. Avezum and colleagues found that 3–4% of post-hospital chronic cardiovascular disease patients in four South American countries received all recommended medication and that only 31% of those with ischaemic heart disease and 54% of stroke patients received any of the recommended medications (Avezum, Oliveira, & Lanas, 2017). In high-income countries, around 60% of patients are prescribed antiplatelet therapy, 50% beta blockers, 40% ACE inhibitors and 70% statins (Yusuf et al., 2011). A range of reasons has been found for these low levels of compliance with guidelines. In Italy, authors found that people over 74 years were 40% less likely to be prescribed a statin than younger patients and that being female and married were

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positive predictors for prescribing (Gnavi et al., 2007). Interesting Heeley and colleagues noted a large treatment gap in the secondary prevention of cardiovascular disease in primary care in Australia when they looked at the management of patients with cerebro- and coronary artery disease. They found that while 73% of patients with coronary heart disease received treatment with all three recommended pharmacotherapies, only 42% of patients with cerebrovascular disease did so (Heeley et al., 2012). Other factors influencing prescribing and use of these medicines include regular changes to guidelines and associated biometric targets (e.g., blood pressure targets), the cost of medicines and especially out-of-pocket costs for the patient, poor tolerance to the drugs, forgetfulness and lack of support from health systems (Bansilal, Castellano, & Fuster, 2015). Secondary prevention of cardiovascular disease is a clear example of where we need more action to close the evidence-practice gaps. Patients will have more productive and longer lives if effective guideline implementation strategies can be coupled with tailoring medication to the needs of the patient.

1.1.4 Management of Type 2 Diabetes Mellitus The prevalence of diabetes has increased rapidly over recent decades with the International Diabetes Federation estimating that 425 million people were diagnosed with the condition in 2017. Many more remain undiagnosed. The 10 countries with the greatest numbers of newly diagnosed diabetic patients were China, India, USA, Brazil, Mexico, Indonesia, Russia, Egypt, Germany and Pakistan (International Diabetes Federation, 2017) Fig. 1.3. Risk factors for Type 2 diabetes include increasing age, having a family history of the condition and certain ethnic backgrounds, such as Southern Asian, Middle Eastern, Polynesian or many minority indigenous groups, including Aboriginal populations in Australia, Canada and the USA. Indeed there is evidence of increasing socioeconomic inequality in Type 2 Diabetes prevalence. In the UK and Canada, this was observed for women of lower socioeconomic means, especially those with the least education (Brown, Nevitte, Szeto, & Nandi, 2015; Imkampe & Gulliford, 2011). In addition, a number of lifestyle factors are implicated in the development of Type 2 diabetes, including obesity, physical inactivity and an unhealthy diet. As these lifestyle risk factors are modifiable, Type 2 diabetes can be considered preventable, and certainly, good management reduces complications. The burden of disease is high especially if not well managed with micro- and macrovascular complications that compromise the quality and length of life. People with diabetes have a higher risk of developing macrovascular complications including coronary heart disease, stroke and peripheral vascular disease, and there is a higher prevalence of cardiovascular risk factors such as high blood pressure and dyslipidemia in people with diabetes. Australian data exemplify this (Barr et al., 2006; Dunstan et al., 2001; Tanamas et al., 2013).

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180 160 140 120 100 80 60 40 20 0 North America Middle East and Carribean and North Africa

Europe

South and Central America

Africa

South East Asia

Western Pacific

Million People

Fig. 1.3 Estimated number of people with all types of diabetes worldwide (International Diabetes Federation, 2017)

The AusDiab study showed that nearly 10% of Australians aged 25 years and over with diabetes had coronary heart disease compared with 6% of people without diabetes. Furthermore, age standardised rate of heart attack among people with diabetes was more than twice as high as that among people without diabetes (3.1% and 1.5% respectively). An estimated 5% of people aged 25 years and over with diabetes had had a stroke compared with 2% of people without diabetes.

Microvascular complications of diabetes, which affect the small blood vessels in the body, include retinopathy, nephropathy and neuropathy. The AusDiab study noted above found that 22% of people with newly diagnosed diabetes had retinopathy, that nephropathy was four times more prevalent than in non-diabetics and that up to 10.3% of diabetics had signs of neuropathy.

There are many evidence-based guidelines to support the management of diabetes. A literature search conducted by NPS MedicineWise in Australia in 2011 found 23 Australian guidelines alone (Easton et al., 2011). Important common elements of most guidelines are summarized in Table 1.1. Yet clearly demonstrated clinical need of what is being described as a global pandemic and broad agreement among multiple guidelines have not been enough to ensure the right medicines are available for all patients. Support for appropriate prescribing and use of medicines in diabetes remains critical, and clinicians should be encouraged to regularly monitor HbA1c, blood pressure and other clinical markers to ensure good treatment outcomes are being achieved. Sharma and colleagues looked across 13 years in primary care in the UK and found high prescribing of metformin peaked in 2013 at 83.6% of all diabetes prescriptions compared with 41.4% for sulphonylureas. Thiazolidinediones and incretin-based

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Table 1.1 Common pharmacotherapeutic recommendations for the management of Type 2 diabetes Metformin is the oral antidiabetic agent of the first choice A sulfonylurea can be added as a second-line agent Low dose insulin is an option if blood sugars are not controlled by two agents Other third-line treatments can include acarbose, dipeptidyl peptidase 4 (DPP 4) inhibitors or a glitazone. SGLT-2-inhibitors (gliflozins) appear to produce a reduction in cardiovascular risk especially for secondary prevention Aspirin to reduce cardiovascular events in those with Type 2 diabetes but without evidence of clinical cardiovascular disease is controversial with use recommended if indicated Management of dyslipidaemia includes statins as first-line therapy ACE inhibitors or angiotensin receptor antagonists are first-line for hypertension

medicines were reserved as add-on therapies consistent with guidelines (Sharma, Nazareth, & Petersen, 2016). However, while Stone and colleagues in Europe also found good compliance with process indicators such recording of HbA1c, there were poorer intermediate outcomes with only 53.6% of patients having an HbA1c at target. Lower prescribing rates for lipid-lowering medicines were associated with a lower likelihood of meeting targets (Stone et al., 2013). Another study in Denmark looked more specifically at a prescription for lipid-lowering medicines in general practice. They found wide variation in prescribing with the proportion of eligible individuals being treated varying between practices (0–100%) and a higher risk of cardiovascular events among patient in practices in the lowest quartile compared with the highest quartile (adjusted odds ratio 3.4, 95% CI 1.6–7.3) (Simmons et al., 2014). Researchers in Spain noted progress in improving the management of diabetes and also room for further improvement. In Catalonia in 2009, 56% of patients had a HbA1c below 7%; 31% had blood pressure measurements below 130/80 mmHg; and 37.9% had LDL-C values below 100 mg/L (Vinagre et al., 2012). Toth and colleagues reported results from two rural health regions in Canada and found that for patients not at target levels, 14.4, 27.5 and 86.7% reported no pharmacotherapy for hyperglycaemia, hypertension and dyslipidaemia, respectively. Of those taking a hypoglycaemic 65% were receiving monotherapy (Toth et al., 2003). Even for patients admitted with an acute coronary syndrome, diabetics have been reported to be less likely to be prescribed statins, antiplatelet therapy and renin– angiotensin system blockers (Deedwania et al., 2017). Finally, there can be an issue of adherence to any long-term therapy. Estimates of patients’ adherence to diabetes medicines vary. One systematic review of adherence to medicines in both Type 1 and Type 2 diabetic patients reported adherence rates varying from 31 to 87% in retrospective studies and from 53 to 98% in prospective studies (Odegard & Capoccia, 2007). Another systematic review reported the overall rate of adherence with oral hypoglycaemic agents was 36–93% and that insulin adherence among Type 2 diabetes patients was 64% (Cramer, 2004).

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A more recent review (García-Pérez, Álvarez, Dilla, Gil-Guillén, & OrozcoBeltrán, 2013) found that for diabetic patients on hypoglycaemic medications, 50% had high adherence, 41% moderate adherence and 9% poor adherence. For those taking antihypertensive, there were high rates of adherence in 75% patients and this was associated with better blood pressure control. For those patients also prescribed lipid-lowering medicines, high levels of adherence at 3 months were found in 87% of patients, dropping to 50% at six months. Sustaining the improvements in diabetes management, addressing prescribing gaps and supporting patients to take their medicines must be a priority for programs to improve the use of medicines.

1.1.5 Vaccines The WHO launched a report in July 2018 based on household health surveys in 10 low-income countries (World Health Organization, 2018). Factors such as household income, birth order and mother’s education were important factors in determining if children were immunized. It has been estimated (Music, 2005) that failure to vaccinate children contributes to an extra: – – – –

745,000 dying from measles each year 600,000 tetanus deaths 45 million cases of pertussis, with approximately 409,000 deaths Invasive meningitis and pneumonia (Hib disease) leading to 400–700,000 deaths annually.

Resurgence of diphtheria has been reported in the former Soviet Union and in the UK, Germany and the USA 20–50% of adults are susceptible to diphtheria as immunity declines with age (Hann, 1999). More recent data from a tracking study of childhood vaccination with three-dose diphtheria, tetanus and pertussis found immunization rates are increasing but that there is still a substantial gap: crude coverage was 59% in 1986, 65% in 1990, 70% in 2000 and 74% in 2006 (Lim, Stein, Charrow, & Murray, 2008). Timing of vaccinations has also been seen as a problem with late or incomplete vaccination common (Clark & Sanderson, 2009). It would be wrong to think that under-immunization of children is a problem solely for low-income countries. Measles outbreaks in Europe in 2018 underscore this. Commentators have noted underutilization of rabies, pneumococcal, human papillomavirus and shingles vaccines in at risk populations (Dodet, Durrheim, & Rees, 2014; Durando et al., 2009; Jin, Lipold, Sikon, & Rome, 2013; Jones et al., 2010). The antivaccination advocates are also very vocal further countering the efforts of those trying to raise immunization rates (Kata, 2012). Human health and particularly childhood health can be significantly improved through the appropriate use of vaccines. It is likely that influencing health consumer behaviours and the beliefs of parents will be most important in this endeavour.

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1.1.6 Appropriate Use of Antibiotics Antimicrobial resistance is recognized today as a complex problem and a global threat to human, animal and environmental health (World Health Organization, 2015). According to a WHO report, >700,000 people die of infections caused by resistant organisms each year and the World Bank has linked this with potential declines in GDP for all nations by 2050 (O’Neill, 2016; The World Bank, 2017). While antimicrobial resistance has been more evident and troublesome in hospitals, it now occurs with increasing frequency in the community. The volume of prescribing and the emergence of community-acquired resistant organisms bring our attention to prescribing in primary care. Respiratory infections are the group of illnesses most commonly treated with antibiotics and yet most of these infections are spontaneously remitting diseases, frequently caused by viruses. Even for bacterial infections, evidence from Cochrane reviews shows an average reduction in symptoms of less than a day (Del Mar, 2016). In Australia, there has been data for over 20 years that antibiotic prescribing was inconsistent with both national guidelines and the research base. McManus and colleagues found in the 1990s that 57% of urban and 73% or rural Australian patients received an antibiotic prescription for a new episode of upper respiratory tract infection or pharyngitis (McManus et al., 1997). This was despite well-promulgated evidence that most respiratory infections are viral in origin, self-limiting and resolve in the same timeframe whether or not an antibiotic is prescribed. Upper respiratory tract infections (URTI), comprising tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media and the common cold, are frequently presenting conditions in primary care and the most common reason for prescribing antibiotics. Australian data showed that URTI was the second most common presentation in general practice accounting for 6.9% of encounters in metropolitan practices, 5.1% in large rural centres and 4.3% in small rural centres (Britt, Miller, & Valenti, 2001). The antibiotic prescribing rates ranged from 90.3 prescriptions per 100 problems managed for sinusitis to 39 prescriptions per 100 problems for generalized URTI (Pan, Henderson, & Britt, 2006). In the UK, Dolk and colleagues found that 8.8–23.1% of all systemic antibiotic prescriptions in primary care were inappropriate. Almost 50% of prescribing was for conditions of the respiratory tract (Dolk, Pouwels, Smith, Robotham, & Smieszek, 2018). A second study of prescribing for children in general practice found improvements consistent with guidelines but still high levels of prescribing for upper respiratory tract infection and tonsillitis, and these findings were more pronounced in children from less deprived areas and in older children (Williams et al., 2018). This is a global problem and data from India show treatment for URTI in both public and private facilities for about 50% of cases with the most commonly used antibiotics being cephalosporins and fluoroquinolones (Kotwani & Holloway, 2014). These findings also highlight the problem with antibiotic selection as well as the initial decision to prescribe.

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In France, about 90% of antibiotic prescriptions are written in the community and 27.5% of all patient encounters result in an antibiotic prescription (Devillers et al., 2018). While in Malaysia, prescribing rates for URTI are reported at over 30% and for urinary tract infection at 57% (Teng et al., 2011). In Poland, antibiotics were prescribed in 78.7% of cases of acute pharyngitis, tonsillitis, upper respiratory tract infection and the common cold (Panasiuk et al., 2010). Clearly, there remains much to do to improve the prescribing of antibiotics in primary care worldwide and especially for respiratory infections. Factors related to overprescribing antibiotics are well documented. General practitioners cite reasons for prescribing antibiotics (Butler, Rollnick, Pill, Maggs-Rapport, & Scott, 1998) that include – a feeling that patients expect a prescription – antibiotics might help some patients and do little harm – a concern to preserve and build the therapeutic relationship that they have with a patient – time pressures and a feeling that it takes longer to explain why an antibiotic is not needed than to write a prescription – concerns that something serious might be missed leading to poor patient outcomes and/or litigation as a result. Successful interventions to influence antibiotic prescribing include • • • •

Guidelines that are locally implemented and adapted to regional circumstances Computer-assisted prescribing and prompts not to prescribe Swifter diagnostic testing Antibiotic stewardship that addresses professional accountability, using gatekeepers such as microbiologists and • Initiatives to address patient and community expectations and attitudes. Sustained quality use of medicines programs in all countries will be critical to reducing the prescribing and the use of antibiotics, and these will need to target health professionals, patients and the community at large (Fig. 1.4).

1.1.7 Anticholinergic Burden in Elderly Older people are at increased risk of medication-related problems and adverse events for both pharmacokinetic and pharmacodynamic reasons. Polypharmacy as consequence of multiple morbidities adds to that risk. Analysis of data from medication reviews (Elliott & Booth, 2014) identified a number of issues for older people prescribed medicines including untreated indications, adherence issues, need for closer monitoring, drug interactions, unnecessary medicines, inappropriate drug selection and adverse drug reactions. Overuse of benzodiazepines, antipsychotics, acid-suppressing medicines, antidepressants, analgesics and vitamin D was common.

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Fig. 1.4 NPS MedicineWise advertising for the community as part of a larger campaign to reduce antibiotic prescribing [Reproduced with Permission, NPS MedicineWise]

One particular consequence of inappropriate use of medicines in older people is the so-called anticholinergic burden which can lead to adverse events. Anticholinergic medicines are known to be associated with functional decline, falls, delirium, cognitive impairment and disability. Despite this, the prevalence of anticholinergic use ranges from 8 to 37% (Lattanzio, Onder, et al., 2018) Anticholinergic burden has been associated with increased risk of death among older patients discharged from hospital especially in those with a pre-existing functional deficit (Lattanzio, Corica, et al., 2018). In spite of this evidence, we continue to see high levels of anticholinergic use in older people. In a community living over 65-year-old people in the USA, 47.8% were identified as having a high anticholinergic burden (West, Pruchnicki, Porter, & Emptage, 2013). This is consistent with data from Ireland where being female and having multiple conditions were further predictors of high anticholinergic burden scores (Byrne et al., 2018). In New Zealand, it was found this trend continues in patients dispensed anticholinesterase inhibitors (Narayan, Hilmer, Horsburgh, & Nishtala, 2013). In Slovenia, psychotropic medication was found to be the main problem and consistent with other studies (Gorup, Rifel, & Petek Ster, 2018). There is also evidence that pharmaceutical care-based interventions improve appropriate polypharmacy in older people. These interventions lead to a reduction in inappropriate prescribing especially when there are several health professionals involved in a person’s care (Cooper et al., 2015). Appropriate prescribing for our oldest patients is an important opportunity for quality use of medicines programs.

1.2 Why Improving the Use of Medical Tests Is Important There are claims that only 10–20% of health care is based on good evidence although the documented basis for these assertions is slim (Buchan et al., 2006). Early

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work from the RAND Corporation demonstrated that, in reality, probably closer to 50% of health care is evidence-based (McGlynn et al., 2003). Certainly, this is an improvement but there remains a significant gap in the quality of care. Overuse of medical services and especially medical tests and procedures are gathering increasing attention around the world. Brownlee and colleagues note that there are data to suggest widespread overuse in countries as diverse as Australia, Brazil, Iran, Israel and Spain (Brownlee et al., 2017). These authors argue overuse can be considered along a continuum with universally beneficial utilization and universally harmful or futile utilization at either extreme and the vast majority somewhere in between. This ambiguous ‘grey zone’ is where most unnecessary services are provided, and it can be difficult to navigate. Inappropriate use of diagnostic tests can lead to delayed diagnosis, incidental findings that lead to unnecessary treatment (incidentalomas) and diagnostic error due to the limitation of test sensitivity and specificity. Unnecessary exposure to radiation or invasive procedures may also cause direct patient harms. At the same time, underuse of tests for hypertension, diabetes and HIV can lead to missed diagnoses and delays in treatment (Glasziou et al., 2017). Health systems already under fiscal pressure cannot afford overuse of diagnostic tests. For example, in the USA a study in patients with prostate cancer found that bone scans in low and moderate risk patients added USD 11.3 million to the cost of Medicare (Falchook, Salloum, Hendrix, & Chen, 2014). Overuse of diagnostic tests appears to be relatively common. In Australia, vitamin D testing, imaging for lower back pain, testing for C-reactive protein, chest X-ray in acute coronary syndrome, exercise ECG for angina, blood tests for fatigue including folate and vitamin B testing and PSA testing in low-risk men have been shown to be overused (Elshaug, Watt, Mundy, & Willis, 2012). The Australian Atlas of Healthcare Variation looked at variability in ordering some medical tests across geographical regions. Data from 2015 showed that the number of CT scans ranged from 209 per 100,000 population to 2464 per 100,000 population with a 2.7 times variability when outliers were excluded. Some of this variation is due to access to CT equipment and some to variations in referral by general practitioners (Australian Commission on Safety and Quality in Health Care, 2015). Others have commented on excessive ultrasound for ankle and knee sprain: ‘MRI is rarely indicated, as it is an expensive investigation that is generally not recommended for the routine assessment of acute knee pain (although it may be indicated, if/when there is a history of true “knee locking” or of the knee “giving way”). CT scans are indicated if there is a complex fracture involving the knee’ (NPS MedicineWise, 2016). There are reports that doctors rely heavily on imaging for the diagnosis and management of shoulder pain. In one Australian study, GPs were asked to respond to a scenario of a patient with a history consistent with rotator cuff tendinopathy. Some 69% of GPs ordered a shoulder X-ray and 82% ordered ultrasound (Buchbinder, Staples, Shanahan, & Roos, 2013). However, the diagnostic utility of imaging is limited in non-traumatic shoulder pain and imaging is unlikely to alter management (Brun, 2012).

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In Korea, ultrasound screening for thyroid cancer resulted in a 15-fold increase in the incidence and treatment with no change in death rates from the cancer. It has been estimated that some 99% of cases of thyroid cancer in Korea represent overdiagnosis (Anh, Kim, & Welch, 2014). Chua reported overuse of low-value care in almost 10% of children, including vitamin D screening, allergy testing for atopic dermatitis, respiratory syncytial virus testing for bronchiolitis, blood work for febrile seizures, testing for Group A streptococcal infection in children 10 countries implementing local campaigns including Australia, Canada, Italy, New Zealand, The Netherlands, Switzerland and the UK. The spread of Choosing Wisely has been attributed to six core principles:

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1. The campaign must be clinician-led (as opposed to payer/government led). This is important for building and sustaining the trust of clinicians and patients. 2. Key messages in the campaign must emphasise quality of care and harm prevention, rather than cost reduction. 3. The campaign must be patient focused and involve efforts to engage patients in the process, as communication between clinicians and patients is central to Choosing Wisely. 4. The recommendations issued by the campaign must be evidence-based and must be reviewed on an ongoing basis. 5. The programs must be multi-professional which involves encouraging physicians, nurses, pharmacists and other health care professionals to participate. 6. Transparency is critical for success including use of well described and explained processes to create the recommendations based on clearly cited supporting evidence. Any campaign wishing to use the Choosing Wisely branding must agree to these principles. In this way, the ABIM Foundation and the International Choosing Wisely Community are seeking to ensure that any campaign adheres to the original intent of the Choosing Wisely campaign. There are various examples of prior efforts to shift medical culture that had early momentum and resulted in significant changes but have met with challenges around influence and outcomes (Levinson, Born, & Wolfson, 2018). Such efforts have often been criticised for not sufficiently engaging health care professionals, for being too “top down” in their approach, and for not considering local context in which improvements are implemented. Choosing Wisely has sought to distinguish itself from such campaigns through the above key principles (Levinson et al., 2018) and the following: • Alignment with Values: Choosing Wisely messaging aligns with the values of both health professionals and consumers with a focus on improving quality of care. It also has a focus on professionalism and health professional autonomy in making decisions with consumers (Box 6.3). Choosing Wisely focuses on conversations between health professionals and consumers which is the basis of all clinical interactions. • Simplicity of Message: Compared with other health quality and safety innovations, the name “Choosing Wisely” and the statement “5 things health professionals and patients should question” are plain language. Consistency in these terms is important to help ensure that health professionals and consumers associate addressing the overuse of tests, procedures and treatments with conversations and shared decision making. • Supporting Uptake: Innovations have a higher uptake if people can adapt or “reinvent” them into their own setting (Greenhalgh, 2005). This is in contrast to traditional top-down quality improvement implementation strategies. Internationally, Choosing Wisely activities are focussed on enabling implementation at a local level.

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Box 6.3 The social process by which recommendations are developed and implemented matters as much as the technical content of the recommendations. Reducing overuse is only one relevant outcome; another is the state of the practitioners as they reduce overuse: are they left feeling proud of their work, respected, and efficacious or are they feeling micromanaged and disrespected? (Wolfson & Suchman, 2016)

6.5 Enabling Change The founders of Choosing Wisely understood that the recommendations alone would be insufficient to change culture and clinical practice. Rather, they hoped to create an effective platform from which behaviour change interventions could be locally implemented (Wolfson et al., 2014). The lists are an important first step because they provide clear goals, legitimise the case for change and are generated by the medical societies themselves. However, clinicians also need support to do the right things. This might include interventions at the macro-policy level such as modifying financial incentives, encouraging audit and feedback, building prompts into electronic health records or changing order sets, or providing training programmes on how to share decisions with patients (Elshaug et al., 2017). Promoting clinical champions thereby providing intrinsic motivation over financial incentives is also important. An International Choosing Wisely Community (supported through Choosing Wisely Canada and a grant from The Commonwealth Fund) has collaborated on the development and publication of frameworks to inform both the implementation and evaluation of Choosing Wisely campaigns (Bhatia et al., 2015; Born et al., 2017; Levinson et al., 2015). Table 6.3 summarises some of the key implementation and evaluation approaches being employed in Choosing Wisely campaigns around the world. To date, the most effective Choosing Wisely campaigns (in terms of scale of engagement and impact) have a central coordinating agency for high-level communications, measurement, management of brand and adherence to Choosing Wisely principles. The approaches being undertaken across country campaigns can be broadly categorised into three groups: • Recognition and empowerment • Networks and peer-to-peer communication • Enablement. Some examples of these approaches are provided below.

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Table 6.3 Key elements of Choosing Wisely Objective

Activities/outputs

Evaluation

Change clinician attitudes to practice

• Engaging health care providers in list development and implementation • Incorporation into continuing professional development, curriculum and education • Integration into existing programs • Medical and mainstream media campaigns, journal articles, conferences, partner newsletters • Local health network pilots

Foster consumer engagement and acceptance

• Mainstream and social media • Partnerships with consumer organisations • Consumer resources

Multifaceted approaches including: process indicators, short-term and intermediate-term impacts and longer-term outcomes Short-term measures: • Participation • Reach • Baseline surveys of attitudes and awareness Medium to long term: • Changes to attitudes and awareness • Curriculum changes • Rates of use of low value services • Influence on policy and systems

Change key clinical practices

• Promotion of the “conversation” and improved shared decision making • Local pilots

Promote alignment with the health care system

• Recruit partners among clinics, hospitals, local and State health regions • Advocate for incorporation into systems and policy

Source Adapted Levinson et al. (2015)

6.5.1 Recognition and Empowerment Across the world, several initiatives are actively engaging and empowering clinicians and community to take a leadership role in Choosing Wisely.

6.5.1.1

Choosing Wisely Champions

Through this program supported by the ABIM Foundation, specialty societies have recognised the work of their members, either as individuals or as a team, who are working to reduce unnecessary care at the institutions where they work. Champions are selected by participating societies and include clinicians or teams of clinicians

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whose work in their respective specialties represents significant contributions to advancing the goals of the campaign. Such contributions can include: • Creation of an intervention to implement Choosing Wisely in their clinical practice • Designing local initiatives to educate colleagues • Playing a leadership role in developing society recommendations. The work of the champions is then showcased via the Choosing Wisely website and associated communications. Australia has recently launched a similar initiative.

6.5.1.2

Choosing Wisely STARS (Students and Trainees Advocating for Resource Stewardship)

This program aims to catalyse grassroots, student-led initiatives to advance teaching about health care value in medical education. The program originated in Canada in 2015, where Choosing Wisely Canada hosted a forum with medical students who had been selected and funded by their respective medical schools around the country to attend. A number of student-led projects resulted from the forum, including the development of a list of “Six things medical students and trainees should question?” (Choosing Wisely Canada, 2015). Students are empowered and encouraged to go back to their medical schools and be voices for change. The forum continues to be held each year with new intakes of students. The program has now spread to the USA where they have incorporated a local faculty mentor. Similar initiatives are also emerging in Italy, Japan, the USA, New Zealand, The Netherlands and Norway.

6.5.2 Networks and Peer-to-Peer Communication One of the models most commonly employed to support the diffusion of Choosing Wisely is that of creating communities or networks for sharing of learnings. This takes a number of forms across countries. • Stakeholder Engagement. The majority of Choosing Wisely campaigns employ a model that engages a growing number of stakeholders in the initiative. This includes health professional colleges and societies, health system organisations, consumer or patient organisations, and medical associations. Typically, these organisations engage as implementation partners in some capacity by leveraging their networks, channels and activities to support and drive implementation of Choosing Wisely. • Learning Networks. Many countries employ learning networks that aim to bring together key stakeholders, including clinicians, community health educators and quality improvement professionals to actively discuss and learn about Choosing Wisely and high value care. For example, Choosing Wisely Canada and Australia host monthly webinars that share innovations and implementation programs. In

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the USA, the ABIM Foundation hosts a regular learning network forum. Such networks and forums typically include: • Regular webinars or interactive discussions • Online discussion forums • Regular communications. • National Forums. Several countries, (including Canada, New Zealand and Australia) host annual Choosing Wisely forums to bring together key stakeholders to network, share learnings and maintain momentum.

6.5.3 Choosing Wisely Champion Health Services Initiative In Australia, the Choosing Wisely Champion Health Services initiative was established by NPS MedicineWise (lead agency for Choosing Wisely in Australia) to encourage and support local implementation. The initiative involves regular webinars to enable sharing of knowledge, learnings and resources and provides a platform for adaptation of Choosing Wisely to address local issues and priorities. Participating organisations commit to the Choosing Wisely principles and must have the support of their management executive and medical directors. They also commit to implementation and evaluation of projects that support the principles of Choosing Wisely. Because it was established as a direct response to interest from Australian health services, clinicians saw Choosing Wisely as a potential mechanism to unite a disparate number of quality improvement activities under one umbrella. They responded positively to it being clinician-led and having a focus on quality of care for their patients (Box 6.4). Box 6.4 A Whole of Hospital Approach As a Choosing Wisely Australia Champion Health Service, Royal Brisbane and Women’s Hospital has employed a whole of organisation connected network approach. The whole organisation was challenged to “think differently about the way that they care for their patients”. In doing so, they identified Choosing Wisely opportunities to address unnecessary imaging, alternative models of care, improved processes and alternative medicine options across ~130 projects. Further, with a view to embed the principles of Choosing Wisely into the organisational culture, it incorporated Choosing Wisely into performance frameworks, hospital orientations, policy statements and role descriptions. “If we can reduce the time, energy and resources tied up in delivery of low value care, we can redirect the capacity into new and innovative high value care that we want but currently can’t afford” (Emergency Physician). The initiative

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has resulted in a diverse range of models and outcomes reflecting the diversity of the organisations and individuals involved (Choosing Wisely Australia, 2017).

6.5.4 Enablement One of the biggest barriers to implementation is the need for resources to initiate, support and drive the effort over time. Several countries are enabling implementation through funding that supports innovation and scalability at a local level. Individual campaigns are also developing toolkits, education programs and supporting resources as enablers for implementation. State-wide Choosing Wisely programs exist in several states and provinces in the USA and Canada, respectively. In Australia, a Choosing Wisely Scaling Collaboration has been funded through the Better Care Victoria Innovation Fund. In partnership with NPS MedicineWise and Austin Health (a Choosing Wisely Champion Health Service), the collaboration brings together 11 health services interested in becoming Choosing Wisely champion hospitals. It uses a hub and spoke model where Austin Health provides clinical mentorship to health services. NPS MedicineWise provides support through capability building workshops and development of toolkits to support long-term scalability and sustainability. The primary objectives of the collaboration are to: • Establish a sustainable framework to measure low value care and impact of interventions designed to reduce low value care practices • Decrease the proportion of low value care practices delivered in health services by reducing unnecessary requesting of tests, treatments and procedures. Funding allows for a dedicated project manager and clinical time for clinical leads to be allocated to the project. A key deliverable is that health services demonstrate the sustainability of their projects beyond the life of the project funding. In the USA, the ABIM Foundation, through funding from the Robert Wood Johnson Foundation, has provided grants to support projects designed to increase awareness of both community and health professionals of Choosing Wisely recommendations and support better conversations. Importantly, the Grantees program has sought to engage the key stakeholders in its programs including the delivery agency, consumer groups and local medical societies. Funded activities ranged from educational programs for practising and trainee physicians, development of applications (apps) to support in-clinic decision making through community forums and announcements. Several countries are supporting implementation through the development of patient and clinician resources and toolkits. • Both the USA and Canada provide a comprehensive suite of patient information pamphlets developed to support conversations between clinicians and patients around specific Choosing Wisely recommendations. Other countries may link to

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existing resources rather than develop new patient materials. In Australia, following significant consultation with consumers and consumer organisations, the campaign has focussed on the 5 Questions (Box 6.2) as a key resource, rather than developing bespoke information sheets for individual recommendations. Further, countries are actively seeking ways to engage consumers in their campaigns through direct engagement in strategy development through to co-design of resources and active engagement in development of recommendations. A toolkit developed by the International Choosing Wisely Community on patient engagement is expected to be released shortly. • Choosing Wisely Canada has developed toolkits to help clinicians and their organizations learn from one another about implementation of recommendations. Each toolkit was developed by a clinician who has successfully implemented a Choosing Wisely recommendation in their setting and achieved significant impact. Toolkits include suggested interventions, measurement tools and patient education materials. They are intended as a starting point for like-minded clinicians to implement their own projects. Enablement through education is another strategy used. NPS MedicineWise is an independent, not for profit organisation that delivers national educational programs to support and promote quality use of medicines and tests. NPS MedicineWise facilitates Choosing Wisely in Australia. With its role as a national implementation organisation, NPS MedicineWise has taken responsibility for implementing relevant Choosing Wisely Australia recommendations as part of its national education and quality improvement programs in primary care and for demonstrating the impact of this implementation (Box 6.5). NPS MedicineWise has also integrated Choosing Wisely messaging and principles into its online National Prescribing Curriculum (undertaken by the majority of undergraduate medical, pharmacy and nursing students) and seeks opportunities to promote implementation through existing products and services where possible. Box 6.5 Educational Programs: Reducing Over-Imaging of Ankle and Knee Injuries (NPS MedicineWise, 2018) In 2016, NPS MedicineWise launched its first national educational visiting program that incorporated Choosing Wisely recommendations. The aim of the program was to reduce inappropriate referrals for ultrasound and x-ray for acute ankle and knee injuries, and MRI for acute knee injuries. The program included information on how to talk to patients about what care might be most appropriate and manage their expectations regarding possible testing. • • • • •

The multifaceted program included 7000 face-to-face educational visits with GPs. Provision of feedback on test requesting behaviour for ~20,000 GPs, Online case studies, Videos for health professionals and consumers on management

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• A patient action plan to support GP-patient conversations. Key evaluation findings: The program resulted in changes to GP knowledge, confidence and practice in the diagnosis and management of acute ankle and knee injuries. GPs who took part in an educational visit were more likely to: 1. Apply Ottawa ankle and knee rules 2. Know that a history and physical examination can be as good as MRI for certain injuries 3. Be more confident communicating to patients that imaging will not change management 4. Be more confident using physical examination to diagnose the cause of acute knee and ankle pain as a result of injury.

6.6 Measuring the Impact of Choosing Wisely Measurement of the impact of Choosing Wisely campaigns is based on an integrated measurement framework (Bhatia et al., 2015) that aims to assess impacts on patient attitudes and behaviours, provider attitudes and behaviours, utilisation of low value care services and evidence of systems changes. Use of patient and health professional surveys is a cost-effective way to reach large numbers of participants and allow cross-site comparisons. Many participating countries are using surveys to measure campaign awareness as well as the impact of Choosing Wisely on their reported behaviours. Countries such as Australia provide surveys to allow individual health services to effectively benchmark the attitudes and “culture” of a health service prior to commencing a Choosing Wisely program. Awareness of the campaign has increased year on year with health professionals, as has their awareness that there is a problem with unnecessary tests, treatments and procedures (Choosing Wisely Australia, 2017). In 2016, 88% of Canadian physicians knew about Choosing Wisely and 42% said they used it in daily practice (Canadian Medical Association, 2015). Furthermore, health professionals who are aware of Choosing Wisely were more likely to select evidence-based practices when surveyed compared to those that were not aware of Choosing Wisely Australia (2017) (Table 6.4). In comparison to health professional awareness, consumer awareness of Choosing Wisely remains comparatively low (Canadian Medical Association, 2015; Choosing Wisely Australia, 2017). Eleven per cent of Canadian patients surveyed in 2015 knew what the campaign was about (Canadian Medical Association, 2015). This is not unexpected given that the majority of implementation activities have targeted health professionals and the costs associated with the implementation of large-scale consumer campaigns are prohibitive for most participating organisations.

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Table 6.4 Health professional practice and awareness of Choosing Wiselya General practitioners

Specialists

Aware of CWA (%)

Unaware of CWA (%)

Aware of CWA (%)

Unaware of CWA (%)

I would rarely advocate routine self-monitoring of blood glucose for people with type 2-diabetes who are on oral medication only

37

13

–

–

I would “always” of “often” have conversations around prognosis, wishes, values and end of life planning in patients with advanced disease

–

–

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40

a Australian general practitioners and specialists were surveyed for both their awareness of Choosing

Wisely Australia (CWA) and their practices as related to specific Choosing Wisely Australia recommendations (Choosing Wisely Australia, 2017)

Growing participation in Choosing Wisely, as evidenced by increasing numbers of recommendations being published by health professional organisations as well as an increasing number of implementation partners joining the initiative, supports the potential for the campaign to effect system-level changes that embed Choosing Wisely principles into education, training and policy. Medical colleges are embedding Choosing Wisely principles on resource stewardship into education, competencies and standards (Choosing Wisely Australia, 2017; Coulter, 2017; Royal College of Physicians and Surgeons of Canada, 2018) health service organisations are providing the 5 Questions to patients and increasingly both consumer and health professional organisations, advocates and researchers are supporting the Choosing Wisely message of encouraging clinician–patient conversations as a mechanism to enhance efforts to support and improve health literacy (Jessup & Buchbinder, 2018). Further, researchers are undertaking studies to both measure and better understand the potential drivers of overuse and propose solutions (Ries, 2017). Of greatest interest to policy makers and payers is the impact of Choosing Wisely on the utilization of low value care. Measuring the impact of the campaign on use of specific Choosing Wisely recommendations is challenging for a number of reasons including:

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• The clinical complexity of many recommendations does not easily lend itself to translation into clinical indicators that can be readily measured (Bhatia et al., 2015; Schwartz, Landon, Elshaug, Chernew, & McWilliams, 2014) • Administrative data sets can lack the granularity required to adequately assess and measure the appropriateness of use (Bhatia et al., 2015) • Interrogation of clinical data sets can be resource-intensive and yet it is essential as a means of providing the context against which appropriateness of use can be assessed (Bhatia et al., 2015). Despite these limitations, across many countries, health services have reported significant impacts on unnecessary testing and prescribing through multifaceted interventions (Box 6.6). Reductions in inappropriate use in the vicinity of 20–50% have been achieved in local projects (Choosing Wisely Australia, 2017; Choosing Wisely Canada, 2015; Coulter, 2017). For example, a program funded through the ABIM Foundation and Robert Wood Johnson Foundation Grantees program saw 14 health systems operating in seven regions across the USA, achieve significant reductions in overuse, particularly in the utilization of antibiotics to treat viral infections in adults. Using a mix of interventions, including providing feedback data at the provider and practice levels, small group and individual peer-to-peer education and data presentations, use of order sets and engagement of clinical champions resulted in all 14 health systems reducing their use of antibiotics and 12 achieving reductions of 20% or more (Wolfson, 2018). Box 6.6 Choosing Wisely Pathology Project. A Case Study (Pedersen & Wilkinson, 2019) Gold Coast Health was the first Australian health service to join Choosing Wisely Australia. They employed a data-analytic-supported e-Health system to identify low value care and monitor impacts of any interventions. The project was adopted by staff within the Adult Intensive Care Unit—a challenging health environment. Initially, staff engagement was poor due to competing priorities, concerns about the impacts that changing pathology testing practices may have on the health of critically ill patients and challenges of limited time to engage in new programs. However, a team of health professionals began challenging their own norms around pathology ordering behaviour. Motivated in part to better understand how their current approaches were impacting on their most critically ill patients, the intensive care team establishing their own Choosing Wisely Pathology working group. This team identified key tests of focus. Communication was through repeat messaging at structured education sessions and safety huddles, and when handing over patients to incoming shifts. A multifaceted program saw a significant reduction in unnecessary pathology testing (~2.6%) despite a 10% increase in patient activity. Central to the project was that data analytics were used as a clinical tool, not a management directive. Further, any cost reductions linked to the project were linked to more effective uses of pathology resources rather than simple

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reductions in testing. In addition to the reductions in unnecessary pathology testing reported, Gold Coast Health has reported a number of ongoing program benefits: • Greater collaboration between stakeholders • Enabling clinicians to keep up-to-date with contemporary clinical standards by working closely with the medical colleges and societies, and their recommendations • Fostering a learning organisation approach to resolving matters • Sustained clinical practice improvements in pathology ordering • More effective pathology ordering. Continuing to learn from the lessons of implementation science will be critical to long-term impact of Choosing Wisely campaigns. Experimentation at a local level can be used to adapt and evaluate levers for local contexts. Sharing these experiences across the international community will be critical.

6.7 Future Challenges and Opportunities Choosing Wisely has expanded beyond anything anticipated when it first launched as the US campaign in 2012. The international spread is a reflection of the value of the core principles, resonating with both health professionals and consumers. The primary challenge for the campaign is demonstrating lasting impact in improving outcomes and making a difference on measures of quality and safety that matter to both clinicians and patients (Levinson et al., 2018). There have been a number of effective interventions, primarily at a local level. Effectively supporting scalability of these interventions will be critical for achieving the desired reach and impact of the campaign. Similarly, being able to demonstrate significant changes in the culture of health care delivery will be important so that change is supported beyond the life of an individual program of work. At the same time, it will be essential to manage the interests of governments and other payers to ensure that the campaign is not exploited simply as a mechanism to reduce expenditure in a time of heightened pressure on health budgets. Engaging consumers in the campaign is a challenge. Consumers can be difficult to reach with health care messaging until they need medical care, and then they are at their most vulnerable. Ultimately, Choosing Wisely seeks to support improved health literacy for all. The opportunity for the campaign is to work with like-minded organisations (locally and nationally) who share this goal as a way to maximise reach and potential impact. Globally, there is an increasing interest in the delivery of value-based health care, where the emphasis in delivering on value is what matters to patients. It might be supposed that those individuals and health service organisations that are adopting

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Choosing Wisely principles in their care delivery will be best placed to rise to this challenge. Choosing Wisely’s clinician-led, patient-centred approach is a potential vehicle to effect the culture changes required to support this shift in health care delivery.

References American Academy of Family Physicians. (2014). Fifteen things physicians and patients should question. Retrieved from http://www.choosingwisely.org/societies/american-academy-offamily-physicians/. Berwick, D. M., & Hackbarth, A. D. (2012). Eliminating waste in US health care. JAMA, 307(14), 1513–1516. https://doi.org/10.1001/jama.2012.362. Bhatia, R. S., Levinson, W., Shortt, S., Pendrith, C., Fric-Shamji, E., Kallewaard, M., … Kerr, E. A. (2015). Measuring the effect of Choosing Wisely: An integrated framework to assess campaign impact on low-value care. BMJ Quality & Safety, 24(8), 523. https://doi.org/10.1136/bmjqs-2015004070. Born, K. B., Coulter, A., Han, A., Ellen, M., Peul, W., Myres, P., … Levinson, W. (2017). Engaging patients and the public in Choosing Wisely. BMJ Quality & Safety, 26(8), 687. https://doi.org/ 10.1136/bmjqs-2017-006595. Brody, H. (2010). Medicine’s ethical responsibility for health care reform—The top five list. New England Journal of Medicine, 362(4), 283–285. https://doi.org/10.1056/NEJMp0911423. Brownlee, S., Chalkidou, K., Doust, J., Elshaug, A. G., Glasziou, P., Heath, I., … Korenstein, D. (2017). Evidence for overuse of medical services around the world. The Lancet, 390(10090), 156–168. https://doi.org/10.1016/S0140-6736(16)32585-5. Campbell, E., Regan, S., Gruen, R., Ferris, T., Rao, S., Cleary, P. D., & Blumenthal, D. (2007). Professionalism in medicine: Results of a national survey of physicians. Annals of Internal Medicine, 147(11), 795–802. Canadian Medical Association. (2015). Choosing Wisely Canada e-panel survey summary. Retrieved from http://www.cma.ca/En/Pages/choosing-wisely-canada-nov-2016.aspx. Choosing Wisely Australia. (2017). Choosing Wisely Australia 2017 report. Retrieved from Sydney. Choosing Wisely Canada. (2015). Six things medical students and trainees should question. Retrieved from https://choosingwiselycanada.org/medical-students/. Coulter, A. (2017). Choosing Wisely: Learning from the international experience. Retrieved from https://www.bertelsmann-stiftung.de/en/publications/publication/did/choosing-wisely-2/. Duckett, S. J., Breadon, P., & Romanes, D. (2015). Identifying and acting on potentially inappropriate care. Medical Journal of Australia, 203(4), 183–183. https://doi.org/10.5694/mja15. 00025. Elshaug, A. G., Rosenthal, M. B., Lavis, J. N., Brownlee, S., Schmidt, H., Nagpal, S., … Saini, V. (2017). Levers for addressing medical underuse and overuse: Achieving high-value health care. The Lancet, 390(10090), 191–202. https://doi.org/10.1016/S0140-6736(16)32586-7. Greenhalgh, T. (2005). Diffusion of innovations in health service organisations: A systematic literature review. Malden, MA: Blackwell. Jessup, R. L., & Buchbinder, R. (2018). What if I cannot choose wisely? Addressing suboptimal health literacy in our patients to reduce over-diagnosis and overtreatment. Internal Medicine Journal, 48(9), 1154–1157. https://doi.org/10.1111/imj.14025. Kullgren, J., Clark, S., Singer, D., Solway, E., Kirch, M., & Malani, P. (2018). Too much of a good thing? Overuse of health care. University of Michigan National Poll on Healthy Aging. Retrieved from Michigan http://hdl.handle.net/2027.42/143213. Levinson, W. (2017). Unnecessary care in Canada. Ottawa: Canadian Institute for Health Information.

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Levinson, W., Born, K., & Wolfson, D. (2018). Choosing Wisely campaigns: A work in progress. JAMA, 319(19), 1975. https://doi.org/10.1001/jama.2018.2202. Levinson, W., Kallewaard, M., Bhatia, R. S., Wolfson, D., Shortt, S., & Kerr, E. A. (2015). Choosing Wisely: A growing international campaign. BMJ Quality & Safety, 24(2), 167–174. Mafi, J. N., & Parchman, M. (2018). Low-value care: An intractable global problem with no quick fix. BMJ Quality & Safety, 27(5), 333. https://doi.org/10.1136/bmjqs-2017-007477. NPS MedicineWise. (2018). Annual evaluation report 2017. Retrieved from Sydney. OECD. (2017). Tackling Wasteful Spending on Health. Paris: OECD. Pedersen, J., & Wilkinson, A. (2019). Big Data: Promise, Application and Pitfalls. Edward Elgar Pub (November 29, 2019) Ries, N. M. (2017). Choosing Wisely: Law’s contribution as a cause of and cure for unwise health care choices (Australia). Journal of Law and Medicine, 25(1), 210–228. Royal College of Physicians and Surgeons of Canada. (2018). CanMED resource stewardship curriculum toolkit series. Retrieved from http://www.royalcollage.ca/resite/canmeds/resourcestewardship-e. Schwartz, A. L., Landon, B. E., Elshaug, A. G., Chernew, M. E., & McWilliams, J. M. (2014). Measuring low-value care in medicare. JAMA Internal Medicine, 174(7), 1067–1076. https://doi. org/10.1001/jamainternmed.2014.1541. Shepherd, H. L., Barratt, A., Trevena, L. J., McGeechan, K., Carey, K., Epstein, R. M., … Tattersall, M. H. N. (2011). Three questions that patients can ask to improve the quality of information physicians give about treatment options: A cross-over trial. Patient Education and Counseling, 84(3), 379–385. https://doi.org/10.1016/j.pec.2011.07.022. Wolfson, D., Santa, J., & Slass, L. (2014). Engaging physicians and consumers in conversations about treatment overuse and waste: A short history of the Choosing Wisely campaign. Academic Medicine, 89(7), 990–995. https://doi.org/10.1097/ACM.0000000000000270. Wolfson, D., & Suchman, A. (2016). Choosing Wisely®: A case study of constructive engagement in health policy. Healthcare, 4(3), 240–243. https://doi.org/10.1016/j.hjdsi.2016.05.004. Wolfson, D. B. (2018). A narrow view of choosing wisely. American Journal of Managed Care, 24(11), 501.

Chapter 7

A Program to Improve Management of Patients with Type 2 Diabetes Lynn Maria Weekes and Kirsty Anne Lembke

Abstract Type 2 diabetes is responsible for a large burden of disease globally and in Australia, it is most commonly managed in general practice. For this reason, NPS MedicineWise has run sequential programs since 2000 in primary care to support optimal management of the condition. This chapter outlines the program implemented in 2016–2017. The objectives of the program were to improve adherence to diabetes medicines, especially metformin; to promote use of sulfonylureas second line; and to support the use of a treatment algorithm for stepping up management if diabetes was not controlled. The program included educational outreach visits, clinical audits, feedback of prescribing data and a shared decision-making tool for general practitioners. There were also patient materials to encourage sound understanding of diabetes medicines and the long term benefits they bring. Design briefs and analysis of the relevant enablers and barriers to change are provided to explain the selection of interventions. The program had record participation rates among general practitioners and improvements were found in the knowledge and confidence of participating GPs who said they had a clearer plan for stepping up treatment appropriately. There were also improvements in clinical indicators such as HbA1c and LDL-cholesterol targets being met. Keywords Diabetes · Type 2 diabetes · Diabetes management · Metformin · Sulphonyureas · Glitazones · Flozins · Gliptins · Insulin · Shared decision making · Educational outreach visit · Blood Glucose Treatment Algorithm

L. M. Weekes (B) University of Queensland, Brisbane, QLD, Australia e-mail: [email protected] Health Strategy and Sciences, Sydney, NSW, Australia K. A. Lembke NPS MedicineWise, Surry Hills, NSW, Australia e-mail: [email protected] © Springer Nature Singapore Pte Ltd. 2020 L. M. Weekes (ed.), Improving Use of Medicines and Medical Tests in Primary Care, https://doi.org/10.1007/978-981-15-2333-5_7

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Key Points 1. Type 2 diabetes contributes to the health burden of all countries and appropriate management is critical for both patients and societies. 2. Well planned and implemented programs can be conducted to improve uptake of first-line medicines and raise the confidence of clinicians to use insulin therapies earlier. 3. Adherence to treatment is particularly important for this condition and including a patient intervention alongside education for health professionals will strengthen an intervention program.

7.1 Introduction Diabetes is recognized as a global threat to health and in Australia it was designated a national health priority in 1996. In 2010, diabetes in Australia was estimated to be the sixth leading cause of disease and injury , responsible for about 6.6% of the total disease burden in the country. This is likely to underestimate its impact as it does not include the contribution of diabetes complications such as coronary heart disease and stroke or those people who remain undiagnosed. Type 2 diabetes is the most common and fastest-growing form of diabetes accounting for 85–90% of all cases (Australian Institute of Health and Welfare, 2010). The prevalence of diabetes has been escalating over the last three decades, with rates tripling in this period. Diabetes affected around 1.2 million people in 2014–2015. Rates of diabetes are generally higher among males, the elderly, Indigenous Australians and people living in remote and socioeconomically disadvantaged areas (Australian Institute of Health and Welfare, 2018). Other risk factors for diabetes include family history and some ethnicities such as Southern Asian, Middle Eastern, and Pacific Islanders. Modifiable lifestyle factors are implicated in the development of type 2 diabetes such as obesity, physical inactivity, and an unhealthy diet. Data from a survey in 2007 estimated that 4% of Australians had diabetes and 88% of these had Type 2 diabetes. Prevalence was higher for people born overseas (4.2%), the most socio-economically disadvantaged fifth of the population (5.9%) and people living in outer regional, remote and very remote areas (4.1%) (Australian Bureau of Statistics, 2009). The rising prevalence of type 2 diabetes is partly due to an increased incidence but also a result of better detection and longer survival of patients with the condition. Complications of diabetes are the major causes of associated morbidity and mortality and they include macrovascular complications (coronary heart disease, stroke, and peripheral vascular disease) and microvascular complications (retinopathy, nephropathy, and neuropathy). Patients with type 2 diabetes are generally managed in general practice in Australia. It is the fourth most common chronic condition seen in general practice

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accounting for almost 7% of all consultations (Britt et al., 2010). Given the significant burden of disease and impact on health resource utilization it has been the subject of much guidance. Indeed in 2011, NPS MedicineWise identified 24 Australian guidelines related to the prevention, detection or management of diabetes. Moreover, the targets and thresholds for treatment were noted to have shifted over time, and anecdotally clinicians reported being unclear about which of the current guidance to follow. The pharmacological agents available for management of type 2 diabetes in Australia at the time of planning for this program are listed in Table 7.1. Metformin and sulfonylureas were the most commonly used oral medicines and insulin glargine had a large share of the total insulin market. NPS MedicineWise ran programs to improve various aspects of diabetes management in primary care in 2001, 2005, 2008 and 2012. Key messages centred around reducing the risk of complications of type 2 diabetes, ensuring that metformin is first-line choice of therapy, reviewing use of glitazones with reference to potential adverse effects and considering earlier use of insulin. These programs were well received by general practitioners with high participation rates compared with other therapeutic topics (Table 7.2). Evaluation of previous programs informed program development for 2016. All of the previous programs showed changes in knowledge and attitudes and the 2005 program demonstrated an increase in metformin prescribing (Easton et al., 2011).

7.2 Rationale for Topic Selection The rationale for making management of type 2 diabetes a topic to be addressed through an NPS MedicineWise behavior change program included a range of factors as assessed by an expert advisory group. These included: • Diabetes is common and contributes to significant morbidity and mortality for individual patients and high health care costs for the community. • New medicines had become available since previous programs such as the sodiumglucose co-transporter-2 inhibitors (commonly known as flozins) and some other agents were coming off patent. The introduction of biosimilar medicines particularly insulin analogues was forecast for the period when the program would be implemented. New combination products had also been added to the Pharmaceutical Benefits Schedule (PBS)1 and these were not recommended for initiation in new patients for continuation therapy when alternatives had failed, were not adequate or were not tolerated. • Pathology testing was for patients with type 2 diabetes was high; there were new recommendations regarding reduced routine monitoring of blood glucose; and, 1 Pharmaceutical

Benefits Scheme is a national, government funded insurance scheme that heavily subsidises the cost of medicines for all Australians.

164 Table 7.1 Diabetes medicines available in Australia at the time of program implementation (PBSa schedule 2016)

L. M. Weekes and K. A. Lembke Insulins and analogues

Insulin aspart Insulin glulisine Insulin lispro Insulin neutral Insulin isophane Insulin neutral + isophane Insulin aspart + aspart protamine Insulin lispro + lispro protamine Insulin detemir Insulin glargine

Sulfonylureas

Glibenclamide Gliclazide Glimepiride Glipizide

Thiazolidinediones (glitazones)

Pioglitazone Rosiglitazone

Dipeptidyl peptidase-4 (DPP-4) inhibitors (gliptins)

Alogliptin Linagliptin Saxagliptin Sitagliptin Vildagliptin

Sodium-glucose cotransporter-2 (SGLT-2) inhibitors (flozins)

Dapaflozin Empagliflozin

Glucagon-like peptide-1 (GLP-1) analogue

Exenatide Liraglutide

Other oral agents

Acarbose Metformin Repaglinide

Combination products

Glibenclamide + metformin Rosiglitazone + metformin Alogliptin + metformin Linagliptin + metformin Saxagliptin + metformin Sitagliptin + metformin Vildagliptin + metformin Dapaflozin + metformin Empagliflozin + metformin

a Pharmaceutical

benefits scheme

glycated haemoglobin (HbA1c) tests for use as a diagnostic tool was about to become a subsidized item under Medicare.2

2 Medicare is the universal health insurance scheme funded by the Australian government for medical

services.

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Table 7.2 Previous Type 2 diabetes programs implemented by NPS MedicineWise Year

Key messages

Interventions and participation (Number Unique GPs)

2001

Metformin is the preferred first line treatment unless contraindicated Metformin and sulfonylureas remain the drugs of choice in Type 2 diabetes Assess and manage all cardiovascular risk factors Individualize lifestyle interventions, targets, and monitoring

Case study (1673) Clinical audit (1626) Educational outreach (4211) Small group discussions and workshops (1535) Prescribing feedback (≈21,000)

2005

Encourage intensive lifestyle changes Assess and manage overall cardiovascular risk early Metformin remains the drug of choice, especially in overweight patients Consider insulin early when blood glucose is not controlled by oral agents

Case study (1769) Clinical audit (1369) Educational outreach (3922) Small group discussions and workshops (2830) Prescribing feedback (≈25,000)

2008

Early and continuing lifestyle interventions slow disease progression Initiate insulin early by adding night time basal insulin to oral hypoglycaemics (ensure use of glitazones does not delay initiation of insulin) Ensure metformin is part of ongoing therapy Review glitazones in patients with heart failure or ischaemic heart disease

Case study (2073) Clinical audit (1473) Educational outreach (5963) Small group discussions and workshops (5274) Prescribing feedback (≈25,000)

2012

Adherence is a critical issue to address for patients prescribed metformin Sulfonylureas are still preferred as the standard option for addition to metformin Treatment algorithms reflect the complexity of treatment decisions but offer consistent guidance on stepping up management to control blood glucose

Case study (935) Clinical audit (640) Educational outreach (6233) Small group discussions and workshops (4689) Prescribing feedback (≈25,000) Webinar for practice nurses Pharmacists clinical audit

• The topic was routinely in the top three identified as of interest to general practitioners. In particular, there was concern among clinicians about low targets for blood glucose and blood pressure to manage diabetes complications and cardiovascular risk especially for older patients who may not tolerate such aggressive treatment. • Better treatment should deliver better outcomes of care and more cost-effective resource utilization. Government expenditure on medicines for type 2 diabetes was about AUD500 million in 2013, an 8% increase over the previous year and 385% more than was spent in 2000.

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The clinical audits conducted by general practitioners in 2012, during the previously implemented program, reported improvements in clinical indicators of diabetes care by participants but with significant opportunity for further improvement: • HbA1c levels were at target for 50% of patients prior to the audit cycle and 68% at the end of the cycle. • Blood pressures were at target for 48% of patients prior to the audit cycle and 79% at the end of the cycle. • Cholesterol levels were at target for 53% of patients prior to the audit cycle and 73% at the end of the cycle. For all of these indicators, the participating clinicians had the flexibility to tailor the target for clinical indicators for individual patients and therefore performance against guideline recommendations would be lower.

7.3 Quality Use of Medicines Issues The NPS Medicinewise’s design team and expert advisory committee systematically outlined specific quality use of medicines issues which the program should seek to address for both health professionals and consumers. Australian data and studies were used where available to ensure relevance to the local health care environment and context (Tables 7.3 and 7.4). This process clarified the problem(s) that the program was addressing so that interventions and key messages could be honed for maximum effect. In addition to the primary issues set out below, there were some secondary issues which were topical, added interest for general practitioners and for which information provision was considered adequate. These included: use of insulin glargine which had risen rapidly and which was eclipsing use of cheaper isophane insulins as basal insulin therapy; use of blood glucose strips for routine self-monitoring consistent with changes to guidelines; and, use of HBA1C tests for diagnosis of diabetes given changes in reimbursement rules by the national insurer, Medicare.

7.4 Program Goal, Objectives and Audiences Taking account of the formative evaluation and with advice from the expert group, it was decided that the 2016 diabetes program would cover the use of blood glucoselowering medicines in adults with type 2 diabetes. The emphasis of the program would be on selection of oral agents and to a lesser extent use of insulin, exenatide, and liraglutide. There was an active decision to exclude management of gestational diabetes because of controversy surrounding diagnostic criteria at the time which could have undermined other relevant messages.

Supporting evidence Treatment guidelines recommend a sulfonylurea as the standard choice of additional agent in two treatment algorithms (after metformin). Drug utilization data show that the rate of prescribing of sulfonylureas has plateaued while newer agents and metformin continue to increase (Australian Diabetes Society, 2014; Royal Australian College of General Practitioners & Diabetes Australia, 2014) Patients prescribed a fixed-dose combination product are significantly less likely than other patients not to have had a previous prescription for metformin or a sulfonylurea. This is relevant for a small but growing cohort of patients (Department of Health, 2014; Drug Utilisation Sub-Committee, 2014) Up to 30% of prescriptions for third line medicines for Type 2 diabetes were for indications outside the PBS restrictions which are based on a cost-effectiveness assessment by the national insurer (Australian Medicines Handbook, 2015; Drug Utilisation Sub-Committee, 2014) Insulin initiated is frequently delayed and may not be used optimally once initiated (Fulcher, Roberts, Sinha, & Proietto, 2015)

Quality use of medicines issue

Use of medicines for Type 2 diabetes that is inconsistent with guidelines

(continued)

Newer medicines were heavily promoted by pharmaceutical companies, including claims that new agents slow disease progression and sulfonylureas ‘wear out’ the pancreas (NPS MedicineWise, 2015c; Tudball, 2015) There are a large number of diabetes guidelines (24 nationally) at various stages of currency and large number of new agents with new mechanisms of action. This creates confusion and diminishes confidence in guidelines Belief among clinicians that prescribing restrictions according to the Pharmaceutical Benefits Scheme is inconsistent with best practice and clinical need (Department of Health, 2014) Weight pain and potential for hypoglycaemia with sulfonylureas given more emphasis and/or better known than side effects of new agents (Tudball, 2015) Insulin not initiated as early as desirable because of lack of clinician confidence or knowledge, confusion over roles (general practitioner, specialist, diabetes educator), uncertainty about guidelines, practical concerns (Cassimatis, Kavanagh, & Smith, 2014; Forbes, Ling, Jones, & McDermott, 2012; Furler, Spitzer, Young, & Best, 2011; Thepwongsa, Kirby, Paul, & Piterman, 2014) Patients are frequently reluctant to commence insulin seeing it as a sign of failure or last therapeutic option (Furler et al., 2011) Specialist prescribing and advice from diabetes educators is well regarded by general practitioners (NPS MedicineWise, 2015c)

Influencing factors (barriers and enablers)

Table 7.3 Insights from formative evaluation: Major quality use of medicines issues for health professionals

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Supporting evidence Audits of clinical records report that people with diabetes are not reaching blood glucose, blood pressure and lipid targets (Barlow & Krassas, 2013; Kellow & Khalil, 2013; Krass et al., 2011; Porter, Greenfield, Larson, & Gilles, 2009) Among 32,351 patients with type 2 diabetes, one third had HBA1C levels