Prescribing Off-Label and Medication Safety

Drug companies research and develop new medications for specific illnesses or conditions. They must conduct clinical trials to evaluate the safe dosage and administration of the medication. The process for registering medications in Australia starts with the involvement of therapeutic advisory groups, quality and safety testing, and approval by the TGA and the ARTG.

The Therapeutic Goods Administration (TGA) and the Australian Register of Therapeutic Goods (ARTG) are the regulatory authorities in Australia.

• TGA regulates the supply and manufacturing of medicines via the assessment and monitoring of medicines before their authorisation.
• ARTG is a database of registered medicines. For medicines to be legally supplied in Australia, they have to be registered or listed with the ARTG.

Off-label medication use occurs when a doctor prescribes a medication to address a condition that isn't officially listed in its approved uses. It does not mean that TGA has rejected or unapproved the appropriateness of using the medicine for other uses. The drug company has not evaluated the medication for other conditions and has left off-label use of the medication to doctors' discretion.

An off-label use of medication may be considered in the following:

• If the approved medications have not been effective for the patient,
• If they are too expensive or inaccessible to the patient,
• Due to the side effects or interactions of the approved medication, or
• If there is no approved medication for that condition.

Off-label prescribing is common in practice and can provide additional treatment options when there are limited or no approved alternatives. This is usually seen when treating vulnerable patients. These patient groups usually are children, pregnant women, and palliative patients.

Medications are considered safe and effective based on research and high-quality evidence. In off-label prescribing, the medication has not been tested for its safety and quality in specific conditions, so there may be potential unknown adverse events. Doctors need to weigh the potential risks and benefits before considering this option.

Informed consent is important, and your doctor should engage you in a discussion about why they're suggesting an off-label medication, its suitability, and possible alternatives. They should also discuss the benefits and risks associated with the treatment.

Commonly Used Off-Label Medicines:

Some medications have frequently been used off-label and proven to be highly effective. Two of which are:

Viagra, originally released to treat erectile dysfunction, is effective in other conditions such as Pulmonary Hypertension. It has proven to improve blood flow and relieve the strain on the heart.

Ozempic, initially registered for type 2 diabetes, has found a place within weight management. It controls blood sugar levels and also decreases appetite, making you feel full for a longer time. Medications used differently from the therapeutic guidelines can still be considered promising.

Need More Information?

Contact us directly and speak to one of our doctors or pharmacists. We will be happy to answer any questions regarding the off-label use of medicines.

Resources:

Overview of supplying therapeutic goods in Australia | Therapeutic Goods Administration (TGA)

Off-label use of medical devices: Frequently asked questions | Therapeutic Goods Administration (TGA)

Off-label prescribing - Australian Prescriber (nps.org.au)