WHAT DOES OFF-LABEL USE MEAN?

For healthcare professionals


For healthcare professionals

Healthcare professionals should feel empowered to make decisions regarding care based on the patient’s medical condition and prognosis. This lies at the heart of medical ethics.

The prescription of off-label medicines is an established and potentially beneficial practice, if applied in specific circumstances.

When physicians decide, based on a medical assessment of the patient’s therapeutic needs, to prescribe an off-label medicine, they should take the time to explain their choice, including potential for adverse events, to allow the patient to make an informed decision.

It is also necessary for the healthcare professional to put in place the mechanisms needed to ensure close monitoring and prompt reporting of adverse events.


Under no situation, should healthcare professionals be pressed to prescribe the use of a medicine off-label for reasons other than that of the patient’s individual medical need. Pushing healthcare professionals to base their decisions on factors other than the medical need of the individual patient exposes patients to an increased risk and healthcare professionals to liability.


Ultimately, physicians need to be given the freedom to uphold their pledge towards their patients to act ethically and put the patient’s interest first.