Prescribing off-label (and compounding): factors to consider

Off-label prescribing of the diabetes medication Ozempic (semaglutide) for weight management has thrown a spotlight on doctors’ obligations when making these clinical decisions. Compounding of semaglutide has increased decision-making complexity. We look at the key factors to consider when prescribing off-label to ensure the patient’s safety, and that standards of care are met.

In September 2022, Wegovy (semaglutide) was approved for inclusion in the Australian Register of Therapeutic Goods for chronic weight management. Although approval was granted by the Therapeutic Goods Administration (TGA), the manufacturer has not commenced supply of Wegovy to the Australian market. Consequently, doctors resorted to prescribing Ozempic – the same medication, just with different dosage, presentation and approved usage – for this purpose, in an off-label capacity.

Now Ozempic is in short supply and some doctors are prescribing compounded semaglutide for their patients. This increases the factors doctors need to consider before prescribing.

Doctors often prescribe medications ‘off-label’, which means the medication is prescribed for an indication/condition, patient group, dosage, or administration route that is not specifically approved by the TGA.

It’s not illegal for doctors to prescribe off-label when they believe it’s in the patient’s best interest. However, as with any prescription, it’s important doctors follow professional guidelines and the principles of evidence-based medicine to ensure patient safety.

Your professional obligations

Off-label prescribing can range from well-established practices informed by many years of use and experience to more innovative and experimental uses of medications.

While off-label uses have not been subjected to the same level of scrutiny as TGA-registered indications, it does not mean they are automatically inappropriate. If your off-label prescribing were ever questioned, you would need to establish that it met appropriate standards of care.

Your prescribing should comply with good medical practice as set out in the Medical Board of Australia’s Code of Conduct. As with any treatment you recommend, ensure your prescribing is based on the best available information, a reasonable expectation of clinical efficacy, and is in the best interests of the patient.

You should also be comfortable that your peers would consider your prescribing as competent professional practice.

Ensure you have adequate knowledge and skills to provide safe clinical care. This includes recognising the limits of your competence and clinical ability and involving other colleagues or specialties where appropriate.

When your prescribing is experimental and not supported by a high-quality evidence base, it should only be done within an approved clinical trial.

Patient selection and consent

It’s important to be satisfied the patient is a suitable candidate for the proposed medication. Only prescribe where you have enough information about the patient’s past medical history and current medical conditions and medications to satisfy yourself the prescription is appropriate and not contraindicated.

Discuss the risk–benefit profile of the medication with the patient, inform them whether the treatment is recognised or unusual, and what prescribing off-label means. Make sure you are satisfied the patient understands this information and can provide informed consent to treatment. Keep careful records of any information you provide the patient about the treatment.

The complications of compounding

The TGA has warned doctors to consider their individual legal and professional responsibilities in prescribing and dispensing ‘unapproved’ products such as compounded semaglutide-like products.

In particular, the TGA has noted that prescribing and supplying a compounded product may expose medical practitioners and pharmacists to liability if a patient has an adverse outcome, particularly if a TGA-approved product is already available to treat the patient’s initial medical condition.

A joint statement from the Pharmacy and Medical Boards confirms that doctors have responsibilities to assess whether a compounded medicine is safe and appropriate for a patient. This includes considering:

• whether the substances in the compounded medicine are suitable and approved for human use
• whether there is sufficient evidence to support the intended use based on recognised therapeutic standards
• whether the medicine will remain stable for the duration of use
• the possibility of contamination of the medicine and the level of risk that contamination would present (for example, the risk of contamination of injections).

You should also be aware that prescribing compounded semaglutide may infringe the patents for Wegovy and Ozempic owned by Novo Nordisk.

Documentation and communication

As with all treatment you provide, maintain records of your consultations to enable another doctor to take over care of the patient. This includes information about the patient’s history, examination and test results, diagnosis, medications prescribed, outcomes of the treatment and the ongoing treatment plan.

Avant eLearning course: Prescribing principles: Part one: general prescribing issues

A version of this article was originally published in Connect magazine issue 21.