Under-qualified prescribing of controlled medicines poses risk to public health

Under new proposals, pharmacists could be cleared to prescribe restricted medicines with only a fraction of the clinical experience and training possessed by doctors. 

That is just one of many red flags raised by the Australian Medical Association’s submission to the Pharmacy Board of Australia’s (PBA) consultation on endorsement for scheduled medicines for pharmacists.

The PBA’s proposal would support pharmacists to prescribe Schedule 4 (prescription only) and Schedule 8 (controlled) medicines, where state and territory legislation allows, after completing an Australian Pharmacy Council (APC) approved program of study. Existing APC-accredited prescriber programs provide only 700–800 hours training, with just an estimated 120-150 hours of clinical experience.

Those figures pale in comparison to the extensive training, supervision, and experience doctors must have to diagnose a patient and prescribe the appropriate medication — more than 5,000 hours of real-world clinical experience.

The PBA’s proposed endorsement also stands in stark contrast to the approach taken by the Nursing and Midwifery Board of Australia (NMBA) in a similar endorsement finalised earlier this year for designated registered nurse prescribers. The NMBA took a strong and explicit stance on the need for collaboration and extensive clinical experience. 

Federal AMA President Dr Danielle McMullen said the AMA was concerned by the scale and pace of the PBA’s proposals, and the serious risks they pose to patient safety.

“Some of the substances covered by these proposals, such as morphine and fentanyl, carry significant potential for misuse, abuse, and addiction. Doctors are extensively trained to mitigate those risks, possessing specialised knowledge and insight into a patient’s medical history and situation,” Dr McMullen said.

“The Therapeutic Goods Administration, whose core role is to evaluate safety and risks around how the public can access these substances, concluded the benefits of oral contraceptives being prescribed by a pharmacist without consultation with a doctor simply does not outweigh the risks to women’s health. The proposed endorsement lacks the rigour required to protect the public, and is contrary to what our national, independent safety watchdog has recommended. 

“This also sets an incredibly dangerous precedent and leaves the community wondering how the TGA can be sidestepped and safety concerns discarded. 

 “The PBA proposal fails to provide sufficient evidence for the significant changes proposed, does not provide an adequate cost, risk, and benefit analysis, and does too little to address concerns over conflicts of interest. These are fundamental flaws in a process that fails to recognise that high-quality healthcare is about much more than prescribing, and that extensive training and clinical experience is a fundamental part of ensuring a patient gets the care they need.

“We risk going down the same ill-conceived path as the National Health Service in the United Kingdom, despite the UK now ranking much lower on healthcare outcomes than Australia, according to the internationally respected Commonwealth Fund.”

Dr McMullen said the AMA acknowledged and appreciated the expert role pharmacists play in the healthcare system, working in collaboration with doctors and other health professionals, where appropriate checks and balances mean the patient’s safety is put first and foremost. 

“This is the type of model of pharmacist prescribing that has generally been adopted in other countries, yet the Pharmacy Board has decided to jump well ahead of these countries without proper regard for the Australian context and the risks posed to patient safety,” Dr McMullen said.

The AMA’s submission was informed by its own nation-wide consultation of member doctors to ascertain the concerns they have around pharmacist prescribing in their local communities. 

Read the submission to the Pharmacy Board 

Notes to editors

Additional quotes from the nominated AMA spokesperson for each state and territory below:

AMA (ACT) President Dr Betty Ge said: “As a GP, I see every day just how complex prescribing can be. It’s not simply a matter of choosing a medicine — it’s understanding the patient’s history, making the right diagnosis, recognising what else might be going on, and being there to manage any complications that arise. Pharmacists are highly valued members of the healthcare team, but when it comes to prescribing, patient safety has to come first and that requires extensive clinical training and experience.

“My biggest concern is always what this means for patients. The medicines covered by this proposal can have significant risks and side effects and prescribing them safely relies on much more than knowledge of the medicine itself. 

“It requires clinical judgement built through years of training and caring for patients. We need to make sure any changes to prescribing arrangements put patient safety and quality of care ahead of everything else.”

AMA (NSW) President Dr Fred Betros said: “I have a pharmacy degree and I see this proposal as potentially disastrous for patients. Doctors study and train for more than a decade to assess a wide range of factors when prescribing these drugs, from medical history to lifestyle choice. 

“This simply cannot — and should not — be replicated in a retail setting. It would do patients a serious disservice and could put them at risk. “

AMA (SA) President Associate Professor Peter Subramaniam said: “Every member of a healthcare team must operate on a shared principle — to deliver safe, evidence-based and contemporary care. The expansion of pharmacy prescribing without a robust evaluation and governance framework may risk patient safety in the short and longer term.”

AMA (Tasmania) President Dr Meg Creely said: “As a GP, I understand the need for timely care, especially in regional Tasmania. The question is how we provide that care safely, especially when prescribing high-risk medicines.

“Pharmacists are important medicines experts, and AMA Tasmania supports genuine collaboration. But Schedule 8 prescribing particularly carries serious risks and must remain subject to strong safeguards, including a single prescriber who has the full clinical picture and is coordinating the patient’s broader care.

“Pharmacy access is not consistent across regional communities either, so this will not solve access gaps on its own. The answer is to invest in general practice and expand team-based care that uses every profession’s strength safely, appropriately and in the best interest of patients.”

AMA (Victoria) President Dr Simon Judkins said: “Pharmacists are valued colleagues, but prescribing Schedule 4 and Schedule 8 medicines is not simply a matter of choosing and supplying a product. Their expertise is in medicines, not in determining the cause of undifferentiated symptoms, and checklists cannot replace clinical judgement. 

“We are concerned these proposals would permit prescribing by people with substantially less training and clinical experience than doctors, while embedding a conflict of interest in which the pharmacist ‘assessing’ the customer is also selling the product. Australia has traditionally separated prescribing and dispensing for good reason.”

AMA (WA) President Dr Kyle Hoath said: “The AMA (WA) is deeply concerned by any further encroachment of pharmacists on medical protocols. Ultimately, it is an admission of defeat by governments when it comes to ensuring all Australians have access to a general practitioner. 

“Doctors deeply value their relationship with pharmacists, which is an intrinsic aspect of patient care. However, the differences in training and areas of expertise require a clear separation of roles. The AMA (WA) has consistently stressed to all levels of government that pharmacy prescribing raises significant patient safety and clinical governance concerns, including an increased risk of missed or incorrect diagnoses, fragmented continuity of care, and avoidable harm in the absence of enforceable safeguards. 

“It's an indication of the seriousness with which we regard our relationship with pharmacists. While we seek a dialogue, respect and cooperation under the right circumstances, our medical role cannot be devalued or diluted in any way. The welfare of patients demands our highest vigilance on these matters.”