The Royal Australian College of GPs (RACGP) has called on the Pharmacy Board of Australia and state and territory health ministers to put patient safety at the centre of prescribing reforms, following the release of two independent reports that raised concerns about a lack of evidence underpinning autonomous pharmacist prescribing.
Analyses by the Grattan Institute and the Sax Institute identified significant gaps in the evidence base for pharmacist-led prescribing models, prompting renewed calls for stronger safeguards and rigorous evaluation to protect patients and ensure cost-effective high-quality care.
These warnings are echoed within the RACGP's submission to the Pharmacy Board of Australia, which identifies nine examples where patient harm can occur despite protocol-compliant prescribing. This occurs because protocols alone do not adequately account for diagnostic uncertainty, follow-up or accountability over time.
In its submission, the RACGP outlines how the proposal to allow registered pharmacists to prescribe will occur without sufficient system-level safeguards to manage diagnostic uncertainty, continuity of care, follow-up or accountability.
RACGP President Dr Michael Wright said access to healthcare must not come at the expense of patient safety.
"Access and safety are not competing priorities – patients deserve both," he said.
"Access is important, but so is safety and continuity. Patients need care that is not only timely, but connected, informed by their clinical history, and supported by appropriate follow-up."
The RACGP is calling on the Pharmacy Board to clarify how it would detect, monitor and respond to delayed diagnostic harm should a registration-level endorsement proceed.
"The key question for regulators is not whether pharmacists are skilled professionals or whether they can follow protocols," Dr Wright said.
"It is whether the regulatory model ensures diagnostic uncertainty is recognised, and how risk reassessed and managed over time in a way that protects patients and supports high-quality care.
"Prescribing is not simply about issuing a medicine. It is the end point of a diagnostic process, and safe prescribing depends on continuity of care, follow-up, access to a patient's clinical history, and clear accountability for outcomes. Equally important is the ability to recognise, reassess, and manage diagnostic uncertainty over time as symptoms evolve and new information emerges.
"It is critical that the Pharmacy Board of Australia provides independent, fearless advice to governments and regulators, and ensures robust safety measures are embedded in any prescribing model. Patient safety must be the overriding priority in all decisions about prescribing reforms.
"Our submission highlights nine scenarios that demonstrate how the current system is failing patients and falling short on safety safeguards."
The scenarios in the RACGP submission demonstrate how a pharmacist prescribing even in strict adherence to protocols can unintentionally contribute to serious negative outcomes for patients, such as:
a female patient's domestic violence with sexual harm becoming 'invisible' as she's taken to different pharmacies for treatment without examination
medication providing relief for a patient's acid reflux symptoms, until they cannot maintain weight due to an underlying and undiagnosed oesophageal cancer
a renal cell carcinoma diagnosis being delayed due to its symptoms overlapping with those of a 'simple' UTI
urgent escalation not occurring despite a pharmacist's advice due to this care occurring outside defined clinical responsibility for follow-up, until a delayed medical assessment identifies pancreatitis requiring hospitalisation.
"Diagnostic harm is often delayed, diffuse, and invisible to complaints-based systems," Dr Wright said.
"A patient may receive treatment that appears appropriate at the time, only for a more serious underlying condition to emerge weeks or months later. Without continuity, shared records and structured reassessment, those risks can go undetected.
"Risks are amplified in episodic, fragmented models lacking continuity, shared records, and diagnostic accountability.
"Our concern is not whether individual pharmacists can safely work within well-defined protocols. The issue is whether this proposal from the Pharmacy Board provides the safeguards needed to manage diagnostic uncertainty over time.
"The absence of reported harm is not the same as evidence a system is safe."
The RACGP says prescribing should occur within collaborative models that provide continuity, shared records, clear accountability and established clinical governance.
"Where prescribing is embedded within a coordinated healthcare team, with shared records, clear escalation pathways and defined accountability, there can be significant benefits for patients," Dr Wright said.
The College has also raised concerns about the inclusion of Schedule 8 medicines under the proposed framework, citing risks associated with dependence, misuse, diversion and the need for comprehensive longitudinal care.
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