Improving the quality use of highly specialised drugs

Highly specialised drugs, such as biological therapies, are an increasing challenge for the quality use of medicines (QUM). QUM is a central objective of Australia’s National Medicines Policy. The National Strategy for Quality Use of Medicines aims to make the best possible use of medicines to improve health outcomes for all Australians.¹

To improve QUM the Australian Government has been funding the National Prescribing Service (now called NPS MedicineWise) since 1998 to design, develop, implement and evaluate national programs. From inception, specialist physicians have contributed to NPS MedicineWise programs, for example in developing and endorsing key messages. However, the prescribers of highly specialised drugs have not been a key audience for QUM interventions.

A wide range of interventions has emerged to promote the uptake of research findings and evidence-based practices into routine care.² Given their variable success, research continues with a focus on improving the understanding of how to design and evaluate interventions, and identifying factors that modify their effectiveness.

There is no single strategy to suit all circumstances, nor precise guidance on which combinations of interventions are effective. However, systematic reviews report that interventions aimed at individual professionals, such as audit and feedback, educational outreach (academic detailing), use of local opinion leaders and reminders (for drug dosing), are generally effective.³ These interventions build on undergraduate and postgraduate education.

Audit and feedback are widely used either alone or as a key component of multifaceted interventions. The first national prescriber feedback program was in 1993 by the Department of Veterans’ Affairs.⁴ This provided GPs with information about their individual patients and their prescribed medicines focusing on potentially hazardous drugs or drug combinations. In 1994, the Health Insurance Commission started providing feedback for GPs, comparing their prescribing to that of their peers.

In 1991 the Drug and Therapeutics Information Service began to operationalise and translate into practice a service using the newly described method of academic detailing. Academic detailing is a term used to describe non-commercial-based educational outreach which involves face-to-face individual education of prescribers by trained healthcare professionals, generally pharmacists. NPS MedicineWise has continued to evolve academic detailing, extending the reach and frequency of programs to create a nationwide educational visiting service in primary care.⁵

NPS MedicineWise draws on the evidence base when designing its key interventions of educational visits (academic detailing), clinical and self-audits, prescriber feedback, and peer-group meetings using practice data and case studies that facilitate problem-based learning. Interventions are complemented by consumer resources, incorporating clear educational messages, for use before, during and after the consultation with a health professional.

Over the past 20 years therapeutics has changed significantly with an increasing number of highly specialised drugs. The Pharmaceutical Benefits Scheme (PBS) has also expanded from subsidising drugs used  within the community to include drugs used in public and private hospitals. Most of the top 10 drugs by cost to government are highly specialised drugs⁶ which are often listed with restrictions on their use. These restrictions are variably related to specific patient populations, previous therapy, or type of prescriber, but do not specify protocols or treatment pathways. The specified prescribers are usually specialist physicians. This specification allows programs that aim to enhance prescribing to be tailored to these prescribers.

Interventions similar to those used in primary care have not been comprehensively tried or evaluated with specialist-physician prescribers. The Value in Prescribing (ViP) Biological Disease-Modifying Antirheumatic Drugs (bDMARDs) program, funded by the Australian Government, is now testing and evaluating a QUM program for physician specialists in both public and private practice.⁷ This program aims to optimise the use of bDMARDs. It will engage directly with physician specialists (particularly rheumatologists, gastroenterologists, dermatologists and immunologists), pharmacists, consumers and hospital drug and therapeutic committees.

A multifaceted approach to QUM for physician specialists using prescribing behaviour change principles has been developed. This will identify priority practice areas for prescribers, research underlying practice issues, and barriers and enablers to better practice, and then apply the Theoretical Domains Framework to inform the selection of interventions that are likely to be effective.⁸ This framework is used in implementation research to identify influences on health professional and patient behaviour related to implementing evidence-based recommendations. Several theories of behaviour change are clustered into domains providing a framework through which to view the cognitive, affective, social and environmental influences on behaviour. This then supports the selection of appropriate interventions to address the QUM issue.

Within the program, a consortium has been established to ensure an effective multidisciplinary partnership approach with meaningful and timely input of key experts, and perspectives from stakeholders throughout the development cycle. The Targeted Therapies Alliance consortium includes NPS MedicineWise, Arthritis Australia, the Australia and New Zealand Musculoskeletal Clinical Trials Network, Australian Rheumatology Association, Cochrane Musculoskeletal, Council of Australian Therapeutic Advisory Groups (CATAG), Pharmaceutical Society of Australia, Quality Use of Medicines and Pharmacy Research Centre (University of South Australia) and the Society of Hospital Pharmacists of Australia. It works closely with the Australasian College of Dermatologists and the Gastroenterological Society of Australia. By working with these professional groups, the program has gained insights into the expectations of specialist physicians.

The ViP bDMARDs program has developed living evidence-based guidelines, addressing priority clinical questions for specialists. The other components of the program tailored to specialists include educational webinars and podcasts, individualised PBS prescribing feedback reports and educational visits. The program includes complementary interventions for consumers, specialist nurses, pharmacists and drug and therapeutic committees.

Influencing professional prescribing behaviour requires recognising the complex regulatory, policy and organisational context in which clinical decision-making takes place. The program will evaluate audience uptake of program interventions and activities, audience satisfaction, impact on knowledge, intention to change practice and changes to prescribing. To complement these assessments, a realist evaluation will be undertaken. This is a form of theory-driven evaluation, which centres on explaining the causal links between the context in which a program, intervention or policy is implemented and its related outcomes.⁹ Explaining prescribing behaviour change and characterising its underlying processes will be important in providing insight into ‘what works for whom, why, under which circumstances and to what extent’.⁹

The ViP bDMARDs program seeks to enhance the quality use of highly specialised drugs by working with specialist-physician prescribers using contemporary evidence-based and evaluable processes. Prescribers of highly specialised drugs should benefit from QUM programs, but these need to be carefully tailored to their needs. The outcomes of the ViP bDMARDs program will not be available until 2023. Our experience to date suggests a consortium of stakeholder organisations, with different expertise and interests but agreed goals and roles, is needed when progressing the quality use of highly specialised drugs.

Conflicts of interest: Catherine Hill is a member of the Targeted Therapies Alliance consortium, member of the Pharmaceutical Benefits Advisory Committee, Chair of South Australian Medicines Evaluation Panel, President of Australian Rheumatology Association and has received an educational grant from Vifor Pharmaceuticals. Debra Rowett is a member of the Targeted Therapies Alliance consortium. Jonathan Dartnell is an employee of NPS MedicineWise, which is funded by the Australian Government Department of Health to implement QUM programs.

This article is peer-reviewed.

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