Off-label Medicines

At Anytime Doctor, we sometimes prescribe medicines that are used in ways not covered by the official licence. This is known as "off-label" use, and it can be an important option when the licensed treatments are not suitable or effective for a specific condition.

Licensed Medicines

All medicines used in the UK must go through a rigorous process to ensure they are both safe and effective. Once a medicine has passed clinical trials, the pharmaceutical company can apply for a licence from the Medicines and Healthcare products Regulatory Agency (MHRA). This licence defines the medical conditions the medicine is approved to treat, the appropriate dosage, and who it can be prescribed to.

The clinical trials required to obtain a licence typically focus on specific conditions and groups of patients, meaning that many medicines are only licensed for the conditions they were originally tested for. However, some medicines may show potential for treating other conditions or used in different dosages after the initial trials.

What Is Off-label Use?

"Off-label" use refers to the practice of prescribing a licensed medicine for a condition, dosage, or patient group that is not specified in the product's official licence.

Examples of off-label use include:

  • Using a medicine for a different condition than the one it was originally approved for. For instance, Amitriptyline, which was initially licensed as an antidepressant, is now commonly prescribed for neuropathic pain even though it was not initially licensed for this purpose.
  • Prescribing a medicine at a different dosage than the one specified in the licence. For example, a medicine that was originally approved for use in higher doses might be prescribed in a lower dose for another condition based on subsequent research.
  • One well-known example is Sildenafil (Viagra), which was initially developed and licensed for treating heart failure but later found to be highly effective for treating erectile dysfunction (ED). Following further trials, it was given a new licence specifically for ED treatment.
  • Circadin (melatonin) is another example. While Circadin is licensed in the UK for the short-term treatment of primary insomnia in adults aged 55 and over, it is often prescribed off-label to treat jet lag in adults under 55. Research has shown that melatonin helps reset the body’s internal clock and reduces the effects of jet lag, especially after long-haul flights.

When Is Off-label Use Prescribed?

Off-label prescribing is considered only after careful consideration of other available treatment options. When our clinical team decides to prescribe a medicine off-label, we ensure that there is sufficient clinical evidence to support its safety and efficacy for the specific condition. This evidence may come from reputable studies, expert recommendations, or established clinical guidelines.

For example, acetazolamide is a drug approved for conditions like glaucoma and epilepsy, but it has also been used effectively for acute mountain sickness (AMS) since the 1980s, despite not being licensed for AMS in the UK. While it is used off-label in the UK, it is still commonly prescribed due to its proven effectiveness and safety profile.

Off-label Dosing Regimens

Sometimes, medicines are used with different dosing regimens than those specified in the licence. A good example of this is the combined contraceptive pill, which was originally tested and licensed for use with a 7-day break every 21 days. However, years of research have shown that continuous or tricycling (skipping the 7-day break) is both safe and effective, as recommended by the Faculty of Sexual and Reproductive Healthcare.

Prescriber Responsibility

When medicines are prescribed off-label, the General Medical Council (GMC) advises that the prescribing clinician must take full responsibility for the decision. They must ensure that an alternative licensed medicine would not be effective, and that there is sufficient evidence to support the off-label use. It is also recommended that clinicians provide patients with clear, transparent information about the off-label nature of the treatment, as this helps patients make informed decisions about their care.

Further Information

If you would like more information about off-label prescribing, we recommend the following resources:

If you have any further questions about off-label medicines, please don't hesitate to reach out via your Anytime Doctor account.