The RACGP has provided a submission to the Pharmacy Board of Australia in response to its consultation on the proposed Registration Standard and Guidelines for Scheduled Medicines for Pharmacists.
The proposal would enable suitably qualified pharmacists to obtain a registration-level endorsement to prescribe scheduled medicines. The RACGP recognises the potential benefits of improving access to care, particularly in rural and underserved communities. However, our submission raises significant concerns about whether the proposed model includes sufficient safeguards to ensure patient safety across diverse practice settings.
Continuity of care and follow-up are not aspirational features; they are a foundational safety mechanism. The absence of reported adverse events in pharmacist prescribing pilots created a false sense of safety.
What does the submission say
The submission is structured around a central question: can the proposed endorsement model protect patients if prescribing occurs outside integrated, team-based care?
The RACGP deliberately focused its submission on system design, governance and patient safety safeguards rather than comparisons between professional training pathways or examples of individual practitioner errors. While education, training and clinical competence are important considerations, the Pharmacy Board's role is to determine whether the proposed regulatory model can safely operate across the health system. The key question is therefore not whether individual pharmacists can provide safe care in defined circumstances, but whether the endorsement model embeds the safeguards needed to manage diagnostic uncertainty, support continuity of care, ensure accountability and detect emerging risks over time. This systems-based approach reflects the view that patient safety depends not only on the capability of individual practitioners, but also on the strength of the clinical and regulatory frameworks within which they work.
The submission reflects this focus through three key elements.
1
A clear statement of RACGP's concerns
Prescribing is not a standalone technical activity and is intrinsically linked to diagnostic capability. It is the culmination of a diagnostic process that often unfolds over time. Primary care routinely involves undifferentiated presentations at first contact, overlapping symptoms between benign and serious conditions, diagnostic uncertainty as a baseline state, rather than an exception, and reassessment, review and revision as integral components of care.
We outline why systems of care – not just individual capability – are critical to patient safety. Safe expansion of prescribing and diagnostic authority must be built on systems that manage uncertainty, ensure continuity of care and maintain clear accountability over time. Diagnostic harm is characteristically delayed, diffuse and frequently attributed outside the original prescribing encounter. Strong governance and care models that can detect and respond to harm early are crucial. There are also structural pecuniary conflicts of interest for pharmacist prescribing in retail pharmacy settings.
2
Nine case studies illustrating system-level risk
The submission includes nine case studies showing how harm can emerge when prescribing occurs without access to relevant clinical information, continuity of care or clear diagnostic accountability.
3
Responses to the Pharmacy Board's consultation questions
The RACGP provides detailed feedback on the proposed registration standard, guidelines, scope of endorsement, safeguards, clinical governance and consumer-facing materials.
The case studies: what they show
The RACGP included 9 case studies to illustrate how patient safety risks arise in real-world practice when prescribing occurs without clear diagnostic accountability, continuity of care, or reliable escalation pathways.
The case studies are not presented as isolated clinical examples but predictable system-level failure modes in environments where diagnostic responsibility, continuity and follow-up are not structurally embedded. They have been included to assist the Pharmacy Board, Ahpra and National Boards to consider whether the proposed endorsement model includes the system-level safeguards needed to protect the public.
| Case study theme |
What it illustrates |
| Jurisdictional implementation without defined clinical scope |
Risks where clinical boundaries are not clearly defined |
| Diagnostic misclassification |
Protocols do not eliminate diagnostic risk |
| Symptom suppression delaying recognition of serious disease |
Symptom treatment can mask progression and delay escalation |
| Fragmented care across protocol compliant encounters |
Multiple isolated encounters can obscure the full clinical picture despite protocol compliance |
| Diagnostic ambiguity |
Similar and overlapping symptoms can have very different causes |
| Vulnerability and system invisibility |
At-risk patients may be missed without context or continuity |
| Escalation failure |
Time-critical symptoms require clear referral pathways and enforceable mechanisms |
| Symptom overlap delaying recognition of serious disease |
Common "uncomplicated" symptoms may obscure serious diagnoses |
| Delayed harm arising from fragmented prescribing and absence of diagnostic accountability |
Harm may emerge over time without accountability for reassessment |
Read the submission
Related evidence and advocacy
The RACGP's submission should be read alongside recent evidence and advocacy highlighting the need for stronger safeguards, transparency and accountability in pharmacy prescribing reform.
Independent evidence review: community pharmacist prescribing
The RACGP commissioned an independent Evidence Check, brokered by the Sax Institute, to examine the evidence for independent pharmacist prescribing in community pharmacy settings in Australia and comparable international health systems. The review found that while pharmacist prescribing may improve access to medicines in limited circumstances, evidence on clinical effectiveness, safety, continuity of care and broader health system impacts remains limited.
Read the Sax Institute Report
Pharmacy reform and evidence-based regulation
The Grattan Institute report, Future pharmacy: A better deal for patients and taxpayers, argues that pharmacy policy should be based on independent, evidence-based decision-making, competition, transparency and patient outcomes. The report supports expanding pharmacists' clinical role where there is proven value, while recommending rigorous trials before broader expansion of many additional pharmacy services.
Read the Grattan Institute Report
Joint open letter on safe expansion of prescribing roles
This submission aligns with the concerns outlined in a joint open letter from a cross-sector coalition of healthcare leaders and organisations regarding the safe expansion of prescribing and diagnostic authority in Australia.
The open letter outlines a shared position from leaders across medicine, nursing, primary care and healthcare organisations, calling for strong safety systems, continuity of care and clear accountability before diagnostic and prescribing authority is expanded.
Read the open letter
Read the accompanying principles paper