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‘System level risk’ to Pharmacy Board plans: RACGP

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A Pharmacy Board of Australia plan for the future of pharmacists’ prescribing risks creating ‘a false sense of safety and security’ that may not detect harms until ‘too late for the regulatory system to respond’, the RACGP has said.
 
In a submission responding to the Board’s proposals, the college says a suggested framework would allow prescribing authority ‘without evidence that diagnostic risk can be safely managed or detected at system level’.
 
While acknowledging the importance of healthcare access, the RACGP notes the Board’s obligation under Health Practitioner Regulation National Law ‘to ensure that care is delivered safely and competently’, and that the public is ‘protected from foreseeable harm’.
 
‘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,’ the RACGP concludes.
 
Instead, the submission outlines the college’s support for ‘service-level, collaborative prescribing models’ that ensure continuity and shared accountability, and offer ways of structured review and escalation, real-time governance, audit and feedback.
 
RACGP President Dr Michael Wright says while patient access is important, ‘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,’ he said.
 
‘The key question for regulators is not whether pharmacists are skilled professionals or whether they can follow protocols.
 
‘It is whether the regulatory model ensures diagnostic uncertainty is recognised, and how risk is reassessed and managed over time in a way that protects patients and supports high-quality care.’
 
The RACGP urged the Board to clarify how it will detect, monitor and respond to delayed diagnostic harm if its registration-level endorsement proposal goes ahead.
 
‘Prescribing is not simply about issuing a medicine,’ Dr Wright said.
 
‘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.’
 
In its submission, the college also includes nine case studies illustrating its concerns, including:
 

• 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 that is delayed due to symptoms overlapping with those of a ‘simple’ UTI
• urgent escalation not occurring despite a pharmacist’s advice due to care taking place outside defined clinical responsibility for follow-up, until a delayed medical assessment identifies pancreatitis requiring hospitalisation.

 
It follows two recent analyses carried out by the Grattan Institute and the Sax Institute which have warned about a lack of evidence for pharmacist-led prescribing models.
 
In a rare intervention in June, the medical indemnity insurer Avant also said the changes being considered could lead to an ‘increase in patient harm arising from misdiagnosis or inappropriate prescribing’.
 
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