It’s not about whether individual pharmacists can provide safe care, but about system-level safeguards, the RACGP says.
The RACGP has told the Pharmacy Board of Australia that it opposes general endorsement for pharmacist prescribing outright but would – at most – support prescribing of Schedule 2, 3 and 4 medicines.
“Inclusion of Schedule 8 would represent a regulatory leap that cannot be justified by existing pilots or trials,” the RACGP’s submission read.
The RACGP’s 25-page submission, released publicly today, is the latest response to the Pharmacy Board’s draft endorsement standard for scheduled medicines.
The colleges’ main concern: prescribing without shared records, systematic follow-up or clear diagnostic accountability will drive missed or misclassified diagnoses, antimicrobial resistance, fragmented care, increased hospital use, and higher system costs.
RACGP president Dr Michael Wright said the absence of reported adverse events in pharmacist prescribing pilots doesn’t ensure the model is safe, particularly given trials were rolled out before evidence was available to understand their implications.
“Access and safety are not competing priorities – patients deserve both,” he said.
“The current endorsement model doesn’t adequately account for diagnostic uncertainty,” he told The Medical Republic.
Rather, it risks shifting incomplete or episodic care back to general practice for re-presentation and correction, without GPs understanding pharmacists’ initial prescribing decisions, redistributing clinical risk rather than resolving it, the RACGP said.
“The risk is not that individual clinical decisions are incorrect, but that the model lacks mechanisms to detect and correct error over time,” the submission read.
Despite protocol-compliant prescribing, the RACGP identified nine case-study examples of foreseeable risks stemming from delayed diagnosis of serious conditions.
In one instance, a renal cell carcinoma diagnosis was delayed, with the initial assessment being a ‘simple’ UTI. In another, a patient’s pancreatitis requiring hospitalisation was not urgently escalated despite a pharmacist’s recommendation.
These issues resulted from limited examination methods, lack of long-term oversight – especially for non-specific symptoms – symptom suppression by over-the-counter treatments, repeated prescribing across isolated encounters, overlapping symptoms, and escalation treated as optional rather than a clinical responsibility.
“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,” Dr Wright said.
“Equally important is the ability to recognise, reassess, and manage diagnostic uncertainty over time as symptoms evolve and new information emerges.”
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Fundamentally, the RACGP argued the guidelines “operate downstream of a flawed regulatory assumption”.
Namely, the assumption holds that diagnostic uncertainty can be safely managed through individual competence alone, that individual risk management can substitute enforceable system-level safeguards, and that scope limits will be self-regulated without structural constraints.
Overlapping clinical care with commercial incentives raises diagnostic risks, especially when prescribing and product recommendation occur within the same encounter.
“In the absence of defined early-warning systems, data linkage and intervention pathways, it is unclear how the Board can meet its statutory obligation to proactively protect the public under section 3,” the submission read.
As it stands, the RACGP said the endorsement model relies on enforcement rather than on preventing unsafe prescribing in the first place.
Complaint systems are delayed, difficult to attribute to a single encounter, and require cumulative evidence of harm rather than proactive risk control – diffusing responsibility across the process and complicating investigation and learning from adverse outcomes, the submission read.
Although pharmacist prescribing could enhance access in certain rural, remote, and Aboriginal-controlled areas, the RACGP said the absence of guidance on cultural safety risks is a crucial barrier to ensuring culturally safe, trustworthy, and holistic care.
The college strongly recommended collaborative prescribing models embedded in general practice or co-located arrangements, with models equivalent to designated RN prescribing.
Under the current proposed standards, applicants must complete a PBA-approved program, including coursework and work-integrated learning, to prescribe scheduled medicines, regardless of how long they’ve held general registration.
But the PBA also proposed a second pathway – equivalent training, for example, for pharmacists who have completed an overseas prescribing qualification.
In comparison, nurse prescribers must have general registration and the equivalent of three years’ full-time post-clinical registration experience, approximately 500 hours. This must be followed by typically 6 months of Nurses and Midwives Board (NMBA)-approved units of study.
The RACGP urged for minimum post-registration clinical experience, demonstrated competence in managing diagnostic uncertainty, and a defined, consistent scope and governance.
“We’ve now got two independent reports that have raised concerns about a lack of evidence underpinning these pharmacist-led prescribing models,” Dr Wright told TMR.
The RACGP commissioned an independent review for the Sax Institute, written by the University of Sydney’s Leeder Centre, which found that despite better medication access, evidence on pharmacy prescribing’s clinical effectiveness and safety was lacking.
The Grattan Institute also released a scathing report that found millions of taxpayer funds had been used for unjustified pharmacy payments and dispensing fees under the thirty-year community pharmacy agreement.
It’s far from the first time the RACGP, alongside the AMA, have raised concerns that pharmacy prescribing expansions have occurred without substantial evidence.
With the PBA’s endorsement still unresolved, the Australian Pharmacy Council has begun consulting on accreditation standards for pharmacist prescriber training, which are set to replace the 2023 standards – a move the AMA said raises public safety concerns.
The PBA’s draft endorsement consultations closed on 15 June.
