The Australian Health Practitioner Regulation Agency (Ahpra) has issued new guidance warning registered health practitioners against the unsafe prescribing of off-label or unapproved medicines, including peptides, medicinal cannabis and GLP-1 weight-loss drugs.
Ahpra says it has been investigating unsafe prescribing practices, particularly in high-volume and single-treatment business models, and is concerned over growing consumer demand for certain medicines, coupled with undue commercial influence, that has led to some practitioners “departing from established professional standards”.
In a bid to prevent harm, Ahpra have published new guidance for practitioners when prescribing off-label, unapproved or medicines to be compounded.
According to Ahpra, these medicines help meet specialised patient needs, provide treatment options for people not eligible for clinical trials, or support access when another medicine is unavailable. However, they can also come with risks and unknowns that patients must understand before being able to consent to the treatment.
A series of case studies as part of the guidance outline specific examples of good vs poor practice when prescribing such medicines, including an endorsed midwife working in a hospital who was caring for a woman who had recently given birth and was experiencing low breast milk supply. The woman had tried a range of non-medicinal options, including support from a lactation consultant, frequent feeding and pumping.
After these non-medicinal approaches were unsuccessful, the midwife considered prescribing domperidone to help increase milk supply. As this is an off-label use of the medicine, the midwife reviewed the available evidence and relevant policies, assessed the potential risks and benefits and confirmed that prescribing was within their scope of practice.
The midwife explained that the medicine was being prescribed off-label and discussed the expected benefits, possible risks and alternative options. The woman provided informed consent which was documented.
The medicine was prescribed at the lowest effective dose, with a clear plan for monitoring and follow-up. The midwife would review the woman’s progress regularly and discontinue the medicine if it was not effective or once breastfeeding was established.
According to this case study, key lessons for practitioners include:
Before prescribing a medicine off-label:
- make sure there is a clear clinical need and that your decision is supported by appropriate evidence
- explain to the patient that the medicine is being used off-label and what this means
- discuss the potential benefits, risks and alternative treatment options so the patient can make an informed decision about their care
- document your clinical reasoning and the patient’s consent, and
- put monitoring and review arrangements in place to ensure the treatment remains safe and effective.
Ahpra warned it can take regulatory action against practitioners over unsafe prescribing, with the most serious cases referred to tribunals. Individual prescribers are also being asked to share their clinical judgement and decision-making and correct any failings.
“Anyone with concerns about a practitioner should alert us so that we can take appropriate action,” said Ahpra CEO Justin Untersteiner.
“We don’t need to wait for a notification to be received. If we see red flags, such as unusual prescribing patterns or inappropriate advertising, we can take it up with the practitioner directly or notify other agencies where businesses are involved.”
Ahpra will also shortly release new conflict of interest guidance, as well as information for patients on what to expect from telehealth. This follows last year’s compliance initiatives in relation to medicinal cannabis and non-surgical cosmetic procedures.
“People should not be taking chances on black-market peptides or advice from online influencers with zero clinical knowledge or training. They should be supported by registered health practitioners who exercise sound clinical judgment and justify the trust placed in them by the community,” Mr Untersteiner said.
Access the new guidance here
