Aboriginal and Torres Strait Islander peoples' perspectives on community pharmacists prescribing: a co-designed study protocol

International and national context for pharmacist prescribing

In Australia, various non-medical professions have been granted expanded prescribing rights to enhance the accessibility of medicines and promote equity. This includes nurse practitioners, midwives, dentists, optometrists, and podiatrists, and each profession (excluding podiatrists) are able to prescribe medicines subsidised under the Pharmaceutical Benefits Scheme (PBS) within their scope of practice.¹ Medications for most conditions are subsidised by the Australian Government under the PBS, providing a cost-effective way for Australians to access a wide range of medicines (Pharmaceutical Benefits Scheme (PBS) | Home). Currently, Australia’s healthcare system is facing a crisis due to a workforce shortage of general practitioners (GPs), nurses, and pharmacists, which is contributing to an increase in the time and resource demands on both primary and secondary health services.² The workforce shortage, and subsequent long wait times to see a GP, has made it difficult for many Australians to access diagnoses and prescriptions in a timely manner.³

Until recently, Australian pharmacists have been limited to prescribing Schedule 2 and 3 medications. This differs to other countries, where prescribing by pharmacists of certain medications and antibiotics has become routine practice, and there has been an overall positive impact in terms of improving patient outcomes, improving access to care, decreasing the workload of primary care physicians, and reducing the likelihood of antibiotic resistance. We did not find any peer-reviewed evidence of patient safety issues as a result of the expanded scope of practice for pharmacists.⁴

The New South Wales (NSW) Government recently initiated a trial to examine the statewide implementation, and the clinical and economic impact, of pharmacists to manage and prescribe medications for urinary tract infections, dermatological conditions (mild to moderate atopic dermatitis, herpes zoster (shingles), impetigo, and mild plaque psoriasis), and resupply of contraceptives.⁵ In May 2023, the first stage of the trial was rolled out via a feasibility study in 100 community pharmacies across NSW. In July 2023, the trial was expanded to include over 1100 community pharmacies.⁶ Concerns about the risks associated with an expanded scope of practice for pharmacists include: a potential conflict of interest for diagnosis and prescribing; pharmacists’ knowledge and experience as a diagnostician;⁷ and concerns that the push for the expanded scope of pharmacists may be motivated by commercial interests rather than patient well-being.⁸ The evaluation of the trial being undertaken in NSW will examine these specific issues, including patient safety.⁹

Aboriginal and Torres Strait Islander peoples and access to medications

The PBS has been comparatively underused by Aboriginal and Torres Strait Islander peoples in Australia despite having higher mortality and morbidity rates than non-Indigenous Australians.¹⁰ From July 2010, Aboriginal and Torres Strait Islander peoples were provided access to subsidised medications under the Close The Gap (CTG) PBS co-payment program which was designed to improve access for Aboriginal and Torres Strait Islander peoples to affordable medicines.¹¹ This has significantly improved access to medicines for Aboriginal and Torres Strait Islander peoples.¹² Aboriginal Community Controlled Health Organisations (ACCHOs) and other healthcare providers help facilitate access to CTG PBS medicines for Aboriginal and Torres Strait Islander patients and research shows the obvious health benefits of improving access generally.¹³ The pharmacist direct prescribing pilot in NSW did not take any CTG into consideration; a substantial difference to getting a script from the doctor and having the medication discounted through CTG. It is not clear whether this is factored into the longer-term plan.

There will likely be specific benefits and risks that need to be considered and mitigated for Aboriginal and Torres Strait Islander peoples due to expanded scope of practice for pharmacists. Aboriginal and Torres Strait Islander peoples may face barriers accessing medicines including geographic and financial constraints, with many having complex chronic conditions and associated medication requirements that need to be monitored and managed.^14–16 While pharmacist prescribing has the potential benefits of improving patient access to medication and patient care, and more equitable access to healthcare,¹⁷ consideration needs to be placed on ensuring mechanisms are in place to best ensure that pharmacies offering expanded scope of practice services are culturally safe spaces.

This study will explore the perceptions of Aboriginal and Torres Strait Islander community members, ACCHOs, and clinicians working with Aboriginal and Torres Strait Islander peoples about the risks and opportunities for Aboriginal and Torres Strait Islander peoples of expanded scope of practice for pharmacists. Specifically, it will examine the issues unique to Aboriginal and Torres Strait Islander peoples and explore how these could be managed and mitigated to increase safety and continuity of care. The primary aim of this research is to understand the perspectives of Aboriginal and Torres Strait Islander peoples and organisations in NSW regarding the expanded scope of pharmacists and including better understanding the risks, issues, and opportunities for Aboriginal and Torres Strait Islander peoples accessing medications through a community pharmacy and ways to optimise care. This study is a sub-study of a larger, separate study, the ‘Expansion of the NSW Government-Sponsored Clinical Trial: Management of Urinary Tract Infections by Community Pharmacists to include oral contraception and management of minor skin conditions’ (the Trial). This sub-study will operate independently from the Trial. The specific objectives of this sub-study are:

Project design

Data collection will be conducted with leaders, clinicians working with Aboriginal and Torres Strait Islander peoples (GPs, nurses, Aboriginal health workers), Elders, and community members to understand the risks, benefits, opportunities, and issues associated with an increased scope for pharmacists prescribing for Aboriginal and Torres Strait Islander peoples and organisations. These yarns will be conducted until data saturation is reached. There is negligible risk for any individual, community, or Aboriginal-controlled health organisation, and the benefits are potentially significant for informing the Trial to increase the likelihood that pharmacist practices are culturally safe and acceptable for Aboriginal and Torres Strait Islander peoples if implemented in policy.

Recruitment of communities and consent

Three ACCHOs in New South Wales will be invited to collaborate as partners, with their participation and leadership being pivotal to the success of the project. The research team has established longstanding partnerships with the ACCHOs involved in this study. The Modified Monash Model (MMM) is used to define whether a location is a city, rural, remote, or very remote. There are seven categories: Modified Monash (MM) category MM 1 through MM 7, with MM 1 being a major city and MM 7 being very remote.¹⁸ One of the research sites will be very remote with an MM category of MM 7 (2019), a second site will be a rural community (MM 4 – 2019) and a third site will be regional (MM 3 – 2019).

After establishing partnerships with ACCHOs, we will seek their support in recruiting Aboriginal and Torres Strait Islander adults from the clinic, clinicians who work with Aboriginal and Torres Strait Islander peoples, and participants from the communities served by the ACCHOs, including Elders and other community members. We would be guided by the ACHHO as to participant numbers but would anticipate there being three to 12 people in each group, and between 15 and 30 participants per community. The yarning circles of the different groups will be separate, so as to avoid influence within feedback. The study will be described to those who express interest in participating, and a detailed participant information sheet and consent form will be provided to potential participants. Participants may withdraw their consent for the study without consequence to their treatment (if a community member/patient) or employment (if staff). Participants will be offered a A$25 voucher as an honorarium to thank them for their time.

Rambaldini Model of Collective Impact: our framework for co-design

The Rambaldini Model of Collective Impact (a co-design methodology with five stages) will be applied (Figs 1 and 2). The model is measurable and structured and requires sharing of power and resources.

Fig. 1.

The Rambaldini Model of Collective Impact.

Fig. 2.

Details regarding the stages of the Rambaldini Model of Collective Impact.

The features of the model align with the National Health and Medical Research Council guidelines for conducting ethical research with Indigenous communities.¹⁹ This model emphasises the collective, rather than individuals and hierarchies, aligns well with respectful engagement and decision making, and has enabled significant and measurable improvement to seemingly intractable problems.²⁰ The Rambaldini Model of Collective Impact²¹ has been authenticated for health research with Indigenous communities and aligns with Indigenous ways of knowing, being, and doing. This model has been successfully used in translational research to improve Indigenous oral health,²² Indigenous health workforce development,²³ and to detect and treat atrial fibrillation.²⁴

Yarning circles

Yarning (group yarning circles and one-on-one yarns) will be applied as a key technique to collect, analyse, and interpret data. Yarning is a recognised and validated Indigenous research method for qualitative research which encourages respectful and honest interactions in a safe place to be heard and to respond (Box A1, Appendix 1).²⁵ The yarning will be facilitated by Aboriginal and Torres Strait Islander investigators who will prompt the conversation with open-ended questions to stimulate discussion (Box A2, Appendix 1). Each yarning session will begin with a quick summary of the sub-study and knowledge check regarding the practice of pharmacists providing scripts directly to clients. However, the direction and contents of the discussions will be ultimately determined by the participants.

Once the initial yarning sessions with participants have been completed, the research team will consolidate and summarise the themes and generate draft findings based on these themes. The team will then present the themes and the draft findings to participants in a second round of yarns to check our analysis and provide the opportunity for further development of themes and findings. Respectful adherence to cultural protocols, obligations, and understanding the Indigenous ways of being, doing, and knowing, including knowledge sharing, mean that this process is often not a linear progression of data collection, analysis followed by the documentation of outcomes. See Box A3, Appendix 1 for sample prompts used for data and interpretation checking.

Dissemination

Once themes and recommendations are finalised, the findings will be amplified to the investigators on the Trial and to policymakers. In addition to publishing the findings in peer-reviewed journals, a checklist or other communication tool will be created to convey the findings to researchers and policymakers. The findings will also be shared through social media and other mechanisms recommended by participants.

Research governance

The Djurali Centre for Aboriginal and Torres Strait Islander Health Research and Education Research Advisory Panel provides governance, advice, and support to Djurali researchers. The Research Advisory Panel members ensure cultural oversight to each specific project.

Ethics

Ethics approval was obtained through the Aboriginal Health and Medical Research Council of NSW, Reference 2096/23: KG00193.