Advertising Medicines Flashcards
Why does the advertising of medicines need to be regulated?
- Medicines shouldn’t be considered as ordinary items of commerce
- Risk of exploitation - patient lack of knowledge
- All patients are vulnerable to advertisement
It is the law that any advert for anything should be:
- Of a high standard
- Not cause offence
- Not create unrealistic expectation
- Not be misleading
What classes as a medicinal advertisement?
Anything designed to promote the prescription, supply, sale or use of a medicinal product
What is the human medicines regulation 2012 offence?
It is an offence to advertise a medicinal product for which there is no MA
What must an advertisement for a medicinal product have?
- Not be misleading
- Comply with the particulars listed in the SPC
- Encourage the rational use of the product by presenting it objectively and without over exaggerating its qualities
Who is responsible for all advertising and promotion of the medicinal products?
The license holder
What is advertising to practitioners?
To include the employees of who in the course of their profession/ in course of a business sell/supply medicinal products
What must advertising to practitioners include?
- MA no. of products
- Name and address of MA holder
- Legal classification of product
- Name of product
- List of active ingredients
- Indications of use within the terms of the MA
What is the SPC?
Summary of product characteristics
What does the SPC do?
- Prepared by the holder of the MA, part of licensing application
- Regulations list, standard format
- SPCs are non-promotional
Name two exampled of promotional aids
Pens
Mugs
Name four characteristics of promotional aids
- ‘Reminder advertisement’ usually given by a drug representative
- Brand name of product prominently displayed
- Must be relevant to the practice of pharmacy/ medicine
- Cost <£6, competitions - no more than £30 prize
What are the two things that drug reps must do?
- Must have training and knowledge to provide info that is precise and complete about their products
- Must give a copy/have available a copy of the SPC of the product they are promoting at each visit
What are the reasons free samples of medicines can be supplied by a prescriber?
- Cannot be a CD
- Smallest pack size and marked ‘free medical sample - not for resale’
- Limited no. of samples can be supplied per year
- Exceptional basis - signed and dated request by recipient
- Purpose to acquire experience
What are the medicines not advertised to the public?
- POMs
- Cancer treatment
- Products containing psychotropic/ CDs
- Products used to induce abortion