Pharmacy prescribing: 'Absence of reported harm not evidence of a safe system'

This was one of the main points in the RACGP’s submission to the Pharmacy Board of Australia's consultation on pharmacist registration standards for scheduled medicines.

The proposal would enable suitably qualified pharmacists to obtain a registration-level endorsement to prescribe schedule 8 and 4 medications, something the RACGP has consistently pushed back on.

Within its submission the College identified nine scenarios where patient harm could occur despite protocol-compliant prescribing.

These included situations of domestic violence and symptoms of what could be undiagnosed cancers.

One case study read:

“A patient presents at a community pharmacy with urinary symptoms that appeared consistent with an uncomplicated urinary tract infection and receives antibiotics for UTI.

The patient later presents to their GP for review, where further assessment identifies an underlying serious condition (renal cell carcinoma) that had been contributing to the urinary presentation."

The submission said this situation included symptom-based treatment where prescribing may delay and diffuse harm, but also delay definitive investigation.

“The eventual diagnosis and consequences emerge later, outside the initiating encounter, reducing visibility to complaints-based regulatory detection mechanisms,” the submission read.

Another cast study put forward the following scenario:

“A 30-year-old woman presents to community pharmacy with dysuria and urinary frequency. At presentation symptoms meet protocol criteria for uncomplicated urinary tract infection and no red flags are identified.

“She does not disclose any additional concerns. She is supplied antibiotic treatment. Over the following two months, she presents to multiple pharmacies with recurrent symptoms. At each visit her symptoms meet protocol criteria and treatment is supplied in accordance with guidelines.

“Each encounter occurs as a discrete, time limited interaction without continuity, shared records, or structured follow-up. She later presents to a GP after relocation and is identified as experiencing family and domestic violence with urogenital symptoms associated with physical and sexual harm.”

The College said the lack of continuity limited opportunities for broader clinical or contextual assessment, noting that opportunities for continuity or trust-building often required for disclosure of sensitive issues are not provided within the proposed model.

Some of the other situations provided as examples were where medication providing relief for a patient’s acid reflux symptoms are prescribed, until a patient cannot maintain weight due to an underlying and undiagnosed oesophageal cancer and a renal cell carcinoma diagnosis being delayed due to its symptoms overlapping with those of a ‘simple’ UTI. 

Other scenarios included a patient being prescribed medication for acid reflux symptoms until they cannot maintain their weight due to an underlying and undiagnosed oesophageal cancer.

RACGP President Dr Michael Wright said diagnostic harm is often delayed, diffused, and invisible to complaints-based systems. 

“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 argued 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 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.  

The RACGP stated while it did not support general registration endorsement at all, if required to choose between the options presented, it would support allowing for the prescribing of schedule 2-4 medications only.

“RACGP does not support inclusion of Schedule 8 medicines under a general registration endorsement,” the submission read.

“Schedule 8 prescribing introduces materially higher risks.”

Also echoed in the submission are concerns raised in two independent reports.  

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. 

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. 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,” Dr Wright said. 

The Pharmacy Guild of Australia has been contacted for comment.