Off-label Prescribing

What is off-label prescribing?

When you are prescribed a licenced medication to treat a condition not specifically stated or listed on its product license.

During the development of a medicine by any pharmaceutical company, it goes through a rigorous testing process to ensure it is safe. At the end of this process, the manufacturer applies for a license to treat a specific condition and submits the results of its trials to the Medicines and Healthcare Products Regulatory Agency (MHRA) or the European Medicines Agency (EMA).

If the license is granted, it will specify certain information regarding the medication, such as who can use it, what dosage, storage and usage instructions, side effects and contraindications and what conditions it may be used to treat. This can all be found in the patient information leaflet provided with the medicine.

Prescribing outside of these guidelines included with the license of any medicine means that it is being used “off-label”. Our prescribers at the 7 Day Chemist will only prescribe off-label if they believe that the medication will be effective at treating the condition in question, and that the advantages outweigh any potential risks.

Off-label prescribing is fairly common and is a safe practice as long as the patient’s condition, medical history, allergies and current medicines are taken into consideration. Being prescribed a medicine off-label doesn’t mean that the drug is unlicensed – these two terms mean very different things and shouldn’t be confused with each other. An off-label medicine is simply a medicine that does have a UK or EU license, but not for the purpose that it’s being used for.

Are there any greater risks associated with using this as its off label?

There are potential side effects and risks with all medicines, regardless of whether they are used off-label or not. When it comes to off-label prescribing, you keep the following in mind:

The patient information leaflet is unlikely to have any specific information regarding the reasons why you’re taking it. Ozempic for example is licensed to treat adult patients with type 2 diabetes so all the information available will be focused around that. As long as you stick to the dosing schedule that’s been given to you and read all of the information that you’re provided with, there shouldn’t be much of an additional risk to you if you have been prescribed any medicine for a condition that it isn’t licensed for.

There would be limited information available for the off-label condition. For example, with Ozempic, most of the information will be around diabetes and limited information on its effect in weight loss. Our team is available to answer any additional questions you may have and your GP or consultant should also be able to help you.

If you are prescribed mediation off-label, the prescriber would have evaluated whether or not it is safe and whether the benefits outweigh any possible risks.