Advertising rules for unlicensed medicines, do you knows

by | Sep 1, 2022 | Blog, MHRA

Advertising rules for unlicensed medicines, do you knows – Following the MHRA and Commitees of Advertising Practice (CAP) releasing a joint enforcement notice regarding advertising Kenalog injections for an unlicenced use, are you as a wholesaler or end user such as clinic aware of the rules around advertising medicines?

The enforcement notice was issued after a number of organisations have been advertising the use of Kenalog for Hay fever treatment across social media. Kenalog which is a brand for Triamcinolone Acetonide, is a steroid that is licensed to treat several conditions however, hay fever is not one of them.

Kenalog is prescribed ‘off-label’ to treat allergic rhinitis in both children and adults. Allergic rhinitis is caused by an allergy which irritates the nose and causes cold-like symptoms such as sneezing and a blocked or runny nose.

Triamcinolone acetonide falls under a class of drugs known as corticosteroids. Corticosteroids function by entering cells and forming a steroid-receptor complex. This modifies the functions of skin cells, epidermal cells and white blood cells reducing their proliferation and involvement in the inflammatory response.

Why is this a problem?

Medicines that are unlicensed or used in an unlicensed manner are not allowed to be advertised in accordance with the blue guide produced by the MHRA. https://www.gov.uk/government/publications/blue-guide-advertising-and-promoting-medicines

A medicine can be used in an unlicensed manner under the supervision of an individual prescriber where the patient has provided a medical history and a clinical assessment has been made to ensure the patient is clinically indicated to benefit from the medicine. The advertisement of a medicine used in this manner is strictly prohibited.

Furthermore, Kenalog is a prescription only medicine which is also subject to the same restrictions of advertising.

Why are we not allowed to advertise?

You are not allowed to advertise prescription only medicines or unlicensed medicines because a patient is not allowed to decide if they are clinically suitable for a prescription only medicine. The decision to prescribe must be made by a suitable trained and qualified healthcare professional who is authorised to prescribe.

What do you need to do if you are advertising a prescription only medicine or an unlicenced medicine?

Stop immediately, this is a breach of UK advertising laws and as such we suggest you should review your advertising immediately and remove all advertising of this nature. There is a deadline for the advertisers of the 29th August 2022 to remove all adverts for Kenalog including any descriptive phrases such as Hay Fever jab.

What if I am a patient wanting to receive the medicine as a treatment for Hay Fever?

Firstly, if you witness advertising for a prescription only medicine or unlicenced medicine the MHRA and Advertising Standard Authority are requesting you to report the advert. This is to ensure it is removed.

Secondly, should you wish to receive this type of treatment, you should seek medical professional help. This allows for an appropriately trained and competent healthcare professional to assess your personal situation correctly and decide if you would be a suitable candidate for the medicine. An advert can not induce you into a medicine that may not be suitable for your specific needs. Do you need help with your website to ensure you do not breach advertising laws? Contact Pharmacy Consulting now.

Testimonials

Great training session provided by Jackie. Could consider providing additional training material (sample forms and documents) for clients apart from the GDP guidelines.
Shish from SprinBio