When a clinician prescribes a medication, they do so with the intention of treating a specific condition or ailment approved by the Medicines and Healthcare Products Regulatory Agency (MHRA). In the UK, all medicines are licensed by the MHRA. However, this license only applies to the specific problems that the medicine has been tested on and proven effective for. However, there may be situations where a medication is used for a different condition or ailment that has not been specifically approved for. This is referred to as off-label use of medicine.
Exploring the World of Off-Label Medicine: A Surprising Discovery!
Sometimes, medicines are used in ways that were not originally intended. This is known as off-label use and can occur when new benefits or positive side effects are discovered after many years of use or late in clinical trials. For example, Viagra was originally tested as a treatment for heart failure but was found to also help with erectile dysfunction. Another example is the use of dutasteride for hair loss, which has been shown to be more effective than licensed finasteride in clinical trials. Although dutasteride is commonly prescribed by hair loss clinicians, it does not have a specific license from the MHRA for use in hair loss. We always recommend trying the licensed finasteride before considering the off-label use of dutasteride.
While off-label use of medicine is legal and can be a helpful tool for clinicians to treat patients who have not responded to traditional treatments or for conditions in which there are no approved medications available, it can also be dangerous if not used properly. Therefore, it is important for clinicians to carefully assess the risks and benefits of off-label use of medicine and thoroughly discuss them with their patients.
Using off label medicines: What to look out for:
The guidance from the General Medical Council and General Pharmaceutical Council advises that prescribers take responsibility for the prescribing of off-label medicines. Patients should be informed about any potential side effects that may arise from the off-label use of the medication. In addition, they should be monitored while taking the medication to ensure that it has the intended effect and not causing any unintended harm.
Conclusion
It is worth noting that while off-label use of medicine can be beneficial in some cases, it is essential to remember that it should only be used when necessary and under the guidance of a qualified healthcare provider. Patients should never attempt to use medications off-label on their own, as this can lead to serious health consequences. Therefore, it is essential to always consult with a clinician before using any medication for a condition that has not been specifically approved for.
More information
MHRA Off-label or unlicensed use of medicines: prescribers’ responsibilities
