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  • Unlicensed and off-label use of medication

Unlicensed and off-label use of medication

Your doctor may prescribe you a treatment that is categorised as "off-label". Why would this happen and what does it mean for you? Find out all about it here.

How is medication licensed?

Any manufacturer wishing to market a new medication needs to make a substantial investment, both financially and in man-hours, to get it approved for general use. During development, the chemical compounds of the medicine have to be comprehensively tested for efficacy and safety.

Usually, this is done with large clinical trials where patients taking the new medicine are compared to a control group receiving placebos. There is also often a third group receiving a comparable pre-licensed medication, if available. The purpose of these tests is to establish how well the medication actually treats the indicated conditions, how well the compound is tolerated by patients, and if there are any previously unknown or potentially dangerous side effects.

Once trials conclude that the medication is suitable for effective treatment of a particular condition, it can be licensed for general use by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, or the European Medicines Agency (EMA) on the British and/or European market.

When a license is granted, it includes specific restrictions about who can manufacture the medication and what treatments it is indicated for. It also specifies which patients are suited to be treated with the medicine, how it should be stored and what side effects or interactions should be expected.

All of the license information is available to the public and the details can also be found in the patient information sheet.

What does unlicensed or off-label use mean?

An unlicensed medication is one that has not been approved for use by a regulatory medical body. Therefore a doctor will not prescribe an unlicensed medication except in very specific circumstances, such as when the medication is initially being tested in clinical trials.

Often medications that are licensed for a specific use can have additional effects on the body. Some of these can be 'positive side effects' which are taken into account when prescribing the treatment, such as most contraceptive pills alleviating menstrual pain.

However, in some cases, a medicine might be intentionally prescribed for a condition for which it isn't licensed. For example, when the usual first-line treatments of a condition are deemed unsuitable for that patient. This could be due to the patient's pre-existing conditions making the treatment risky or dangerous. Similarly, interactions with other medications the patient is already taking may make conventional medications unsuitable.

This practice is known as off-label prescribing as the medicine is not licenced for the indicated condition. However, your doctor will only prescribe you a medication off-label if the treatment will be just as effective as those designed to treat the same condition, or if other treatments are unavailable. The advantages of using an off-label medication must outweigh any potential dangers.

Is off-label use illegal?

No. The prescribed medications are licensed and not illegal themselves. Plus, as long as safety regulations and ethical guidelines are considered, this is an effective means for healthcare providers to use available medicines to the best of their efficiencies.

Using a medicine off-label merely means that the relevant government organisations have not formally approved its use to treat a specific condition. This does not mean that the medication is not at all suitable. In fact, the medication may already have a valid license in other countries and have a wealth of evidence supporting its validity for effective and safe treatment of the condition.

When am I allowed to use a medication off-label?

For prescription medications, you still need a valid prescription from your doctor, even if it is for off-label use. You doctor also has to inform you that the medicine is unlicensed for the specific condition that you have and is being prescribed off-label. Additionally, your doctor should warn you about any potential risks or side effects of the treatment.

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