Advertising of Medicines

What is an advertisement?

Any activity which is intended to encourage healthcare professionals to prescribe or supply, or the general public to use medicines through means of highlighting qualities of the medicine

What legislations provide the legal framework for advertising of medicines to healthcare professionals and the public?

Human medicines regulations 2012 and veterinary medicine regulations 2013 

Who regulates the advertising of medicines?

Medicines and healthcare products regulatory agency - MHRA

What do pharmaceutical manufacturers use to self-regulate against MHRA guidance?

ABPI code and other bodies

What is the MHRA blue guide?

Produced by the MHRA to summarise the legislation relating to advertising of medicines and to help interpret the legislation

What does the ABPI code stand for?

Associated of British pharmaceutical industry 

What is the ABPI code?

Sets the standard for promotion of prescription medicines to healthcare professionals and administrative staff 

What is the ABPI code based on?

Legal framework and MHRA guidance and standards agreed between members

What does BCAP stand for?

UK Code of Broadcast advertising

What does BCAP apply to?

All adverts and programme sponsorship on radio and TV 

What sections of BCAP are most applicable to medicines?

Sections 11 and 13

What are the rules for an advertisement for a medicinal product?

Comply with particulars in products SPC, encourages rational use of the medicinal product by presenting the medicine objectively and not exaggerating its qualities, not be misleading

What are the only medicines that can be advertised directly to the public?

P or GSL 

What POMs can be advertised directly to the public?

Government-controlled vaccines approved by health ministers

What must medications apply to in relation to its marking authorisation when advertising?

Only medicines with a marketing authorised can be advertised and for licensed indication, must be with MA holders permission

What are some examples of public-facing advertisements?

TV or radio advert, advert in magazine/newspaper, banner adverts on websites/social media platforms 

Who must adverts NOT be directed towards?

Those under 16 years of age

What should be included in a medicines advert to the public?

• name of product

• Name of active ingredient

• Information about what medication is used for - licensed indication

• Instructions- always read the label or accompanying leaflet

What can you NOT do when advertising to the public?

• promote uses for medicines not covered by SPC

• Make misleading claims or use images that may lead to incorrect self-diagnosis

• Suggest a medicine has no side effects/say it is guaranteed to work

• Imply that seeing a doctor/pharmacist not necessary

• Quote endorsements by scientists, healthcare professionals or celebrities

• Imply equivalence or superiority to a rival product

• Claim that a medicines safety or efficacy is due to it being a natural product

• State that normal health can be improved by taking the medicine or be affected by not taking the medicine 

• Advertise to under 16s 

What is a PQPS?

Persons qualified to prescribe or supply

What can be advertised to PQPS?

POM, P or GSL medicines and must be licensed with MA holders permission

How is advertising to PQPS done?

Promotional leaflets, adverts in journals, provision of information in a dedicated section of manufacturer website 

What must advertising include to PQPS?

• name of product

• Name of active ingredient next to the most prominent display of the name

• A summary of key information from SPC - adverse reactions, dosage, method of use, precautions and relevant contraindications

• Conditions the medicine can be used for

• Legal classification

• Details of license number and MA holder

• Cost

What marketing tricks can be used to advertise to PQPS?

Emotive language, selecting favourable statistics, manipulating graphs to look good e.g., changing axis labels or extrapolating data, adverts masquerading as journal articles

What is the legal amount of paracetamol that can be sold?

100 - but OTC 96 may be limit as 3x packs of 32 

Why are BOGOF and 3 for 2 promotions discouraged for analgesics?

May encourage misuse/patients to take analgesic when not needed

What are professional samples?

Samples provided to prescribers for the purpose of acquiring experience in use

When can professional samples e.g., for PQPS be provided?

• Samples given on exceptional basis

• ]limited number supplied to any recipient in any one year

• sample is supplied in response to a written request that is signed and dated

• Supplier maintains control and accountability

• Sample no larger than smallest product pack in the UK

• Labelled correctly and with “free medical samples - not for resale”

• Sample accompanied by a copy of SPC

• Cannot use samples for patients - supply or administration