Underqualified Prescribing of Controlled Meds Risks 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 

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