Friday, February 3, 2023
It can be concerning to hear that the hair loss treatments Dutasteride 0.5mg capsules and oral Minoxidil tablets are unlicensed (also called off-licence) medicines.
When a healthcare provider prescribes an unlicensed medicine or treatment, it doesn’t mean they’re going rogue.
Prescribers can use their professional judgement to safely prescribe unlicensed medicines if they feel it’s the best treatment for their patient.
It might sound like a medicine is being prescribed unethically or unsafely, but off-licence prescriptions are quite common. In some cases, they can be the best treatment option.
The term unlicensed or off-licence is used to describe medicines which are used outside the terms of their UK licence or that have no licence for use in the UK.
Before prescription medicines are introduced to the general public, they’re tested in clinical trials to make sure that they’re safe. These trials also test whether the medicine is effective at treating the condition it’s been designed for.
Researchers collect scientific evidence and set up guidelines for each new drug before the UK Medicines and Healthcare products Regulatory Agency (MHRA) evaluates the data. It’s a complex and costly process that can take years, but once a drug is approved for a given use, it’s considered “licenced” and safe for that specific use.
During the study phase, researchers may observe that the medicine is displaying other positive effects beyond just the intended condition. Although it’s not what the medicine was initially approved for, these are noted in the research and a healthcare professional may prescribe it for those bonus effects in the future.
When we prescribe an unlicensed medicine, it doesn’t mean it’s illegal, nor are you becoming part of some unknown experiment. There are plenty of good reasons for prescribing off-licence.
Why would we prescribe something unlicensed? Here are some of the most common reasons.
This is the principal factor for the unlicensed medicines we supply at Oxford Online Pharmacy.
We have two treatments for male pattern baldness/androgenic alopecia (MPB/AA) which are unlicensed - Dutasteride 0.5mg capsules and Minoxidil 2.5mg tablets.
Because the NHS (the biggest purchaser of prescription medicines in the UK by miles and miles and miles) doesn’t cover treatment for MPB/AA, the manufacturers of these medicines have no real incentive to get these products licensed here in the UK. The demand is likely perceived as too small to spend the time and resource pursuing MHRA licensing.
In order for us to confidently prescribe these treatments, our clinical team undertakes thorough assessments. We look for clinical evidence about our proposed treatment, we consult with other experts in the field and we look for how the product is used or licensed elsewhere in the world.
For example, Dutasteride 0.5mg capsules is a licensed medicine for the treatment of MPB/AA in large parts of the far east, notably in Singapore and South Korea under the brand name Nuvaniv, manufactured by the pharmaceutical company GlaxoSmithKline.
Minoxidil tablets are prescribed commonly in the United States to treat multiple types of alopecia (hair loss), there are dermatology guidelines and many supporting clinical papers demonstrating the treatment effectiveness and safety.
Despite this, Minoxidil tablets also remain unlicensed for the treatment of hair loss in the US, this might be because they are already widely prescribed off-licence so there is little incentive for the manufacturer to pursue one.
Unlicensed prescribing is more common where two very similar drugs have varying licences.
For example, Dutasteride is in the same class (group) of medicines as Finasteride, which is licensed for the treatment of MPB/AA.
Another example, Minoxidil is licensed to treat MPB/AA via topical liquid or foam, but not using oral tablets.
Medicines in the same class frequently have similar or even identical effects on the body. These drugs also share similar side effects, so healthcare providers are often comfortable substituting a licensed medicine which might not have worked for a patient with a similar unlicensed one.
Proper prescribing of an unlicensed medicine relies on the expertise of an experienced clinician who is familiar with the medicine and the condition being treated and is aware of any potential complications or interactions.
We are one of the UK’s leading providers of hair loss treatments with a customer base of thousands and a strong, expert clinical team at our heart. This is why we offer one of the broadest ranges of prescription hair loss treatments available online, including unlicensed medicines.
If you would like to speak to us more about the unlicensed medicines we offer or about finding the right hair loss treatment for you, email us at [email protected] or call us on 01295 262925.