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Off-label prescribing and unlicensed treaments

Sometimes, our clinical team may prescribe a licensed drug to treat a condition it has not been specifically licensed for. This is called off-label prescribing. They will only do this if there’s evidence to show the medicine will be effective, and that the advantages outweigh the potential risks.

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 or off-label 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. 

Our clinical team will only prescribe off-label if there is evidence to show that doing this is safe and that the treatment is effective.

However, we need to let you know beforehand that the drug is being issued off-label. Whenever we prescribe a medication outside a product license we’ll also tell you about any potential dangers associated with this method of use.

Here at Treated, 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 clinical team.

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