What does “off-label” medication mean?

Before a drug company can advertise or sell a medicine, it must obtain a product licence. This licence will state the illness or condition the medicine can be used to treat, what age groups it is suitable for as well as the correct dosage and instructions for use. In the UK, this licence is provided by a government organisation called the MHRA (Medicines and Healthcare products Regulatory Agency).

They must show that the drug works for an illness or condition, and must put the drug through extensive clinical trials to show its safety and efficacy. The company will then show this information to the MHRA to allow them to make a decision on whether the product licence will be granted.

This means that the medicine is being used in a way that is different to that described in the product licence. It does not mean that the medicine is unsafe, or is being used inappropriately. Doctors may have found that the medicine works well for a different condition, but the manufacturers have not extended the licence to cover this.

Please note: The term “unlicensed” means that the medicine does not have a product licence at all or that it only has a product licence in a different country, but not in the UK. Unlicensed medications can be unsafe, and in some cases can be actively harmful.

The medicines that are available from Simple Online Pharmacy are all licensed products in the UK, but may be used for a different indication than on the product licence. These indications are well known within the medical profession.

Yes, it is safe to take the medicine; however, since it has not been tested specifically for the condition it is being used for, there are some potential risks. The medicine will have a licence for use treating a different condition, so its safety and efficacy will have been tested for that condition. There will be less information on potential benefits and risks in the “off-label” condition.

The doctor will carefully consider whether the medicine you are ordering is suitable for you, using the questions you answer on the assessment form. The information leaflet provided will not contain information on the condition you are using the medicine for.

You can contact us directly, and ask to speak to our doctor or pharmacist. They will be more than happy to answer any questions you may have regarding off-label prescribing.