On this page, we’ll explain what ‘unlicensed’ or ‘off-label’ use of medicines means, and when a doctor may choose to prescribe a treatment in this way.
What is a medicine license?
When a drug is developed by a manufacturer, it goes through a testing process to ensure it is safe. This process will involve clinical trials, which monitor the performance of the medicine in treating one or more specific conditions. Clinical trials assess a number of criteria, including how well the treatment works, and whether or not it causes side effects.
At the end of this testing process, if the medicine produces successful results, it may be granted a license by the Medicines and Healthcare Products Regulatory Agency (MHRA) or the European Medicines Agency (EMA) to treat the condition it has been tested for.
The license will specify certain information regarding the medication, including:
- who can make it
- who can use it
- storage and usage instructions
- side effects and contraindications
- and what conditions it should be used to treat
This can all be found in the patient information leaflet provided with the medicine.
What is unlicensed use?
Occasionally, a doctor may prescribe a licensed drug to treat a condition which it has not been specifically licensed for. This is also known as off-label prescribing.
A doctor will only prescribe off-label if they believe that the medication will be effective at treating the condition in question, and that the advantages are greater than the potential risks.
However, the prescribing doctor needs to let you know beforehand that the drug is unlicensed or being issued off-label. They should also tell you about any potential dangers associated with this method of use.
Here at Treated.com, your safety is our priority. We will always inform you when a medicine is being prescribed for an off-label use, and provide access to safety information regarding use.
If you have any further questions regarding the above or want further clarification, please feel free to discuss it with our doctor.