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 a pharmaceutical company 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 prescriber 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.