advertising of medicines

Question 1

why is the advertising of medicines regulated?

Answer 1

• Medicines should not be considered as ordinary items of commerce
• Lack of knowledge of patients about medical products can be easily exploited
• ill patients are vulnerable to the power of advertising or spurious claims

Question 2

what does the law say about advertising in general?

Answer 2

• Should be of a high standard
• Should not cause offence
• Should not create unrealistic expectation
• Should not be misleading
• i.e. medicines adverts needs to comply with non-medical legislation on advertising too

Question 3

what is an advertisement?

Answer 3

Anything designed to promote the prescription, supply, sale or use of a medicinal product

Question 4

give examples of advertisement?

Answer 4

• In a publication•By display of a notice
• Circular letters
• Letters addressed to particular people
• Visit by a medical rep
• Supply of samples
• Sponsorship of meetings or conferences
• Photographs, Film, sound, recording, Radio, Television, Material posted on the internet

Question 5

what isnt an advertisement?

Answer 5

• Reference material
• Trade catalogues and price lists which do not make a product claim
• Information related to human health or diseases where there is no reference to a medicinal product
• Correspondence to answer a specific question about a medicinal product which is not accompanied by material of a promotional nature
• Medicine package and patient information leaflet (PIL)

Question 6

what must an advertisement for a medicinal product comply with?

Answer 6

• comply with the particulars listed in the SPC
• encourage the rational use of the product by presenting it objectively and without exaggerating its qualities
• not be misleading

Question 7

who is responsible for advertising and promotion of the medicinal product?

Answer 7

The licence holder is primarily responsible for all advertising and promotion of the medicinal product

Question 8

what does the HMR 2012 say about the advertising of a medicinal product?

Answer 8

it is an offence to advertise a medicinal product for which there is no marketing authorisation

Question 9

what is the definition of a practitioner?

Answer 9

persons qualified to prescribe or supply
Defined as to include the employees of those who “in the course of their profession or in the course of a business sell or supply medicinal products”
•Veterinary professionals are excluded

Question 10

when advertising to a practitioner what must it include?

Answer 10

•Marketing authorisation number of the product
•Name and address of the MA holder
•Legal classification of the product
•Name of the product
•List of active ingredients
•Indications of use within the terms of the MA
•Succinct statement of SPC entries clearly visible and correctly placed
- the cost (excluding VAT) of either a specified pack size or a recommended daily dose calculated from a specified pack size

Question 11

what is the SPC?

Answer 11

Summary of Product Characteristics (SPC)
•Prepared by the holder of the MA
•Part of the licensing application
•Regulations list what information the SPC should contain
•SPC is laid out in a standard format
•SPCs are non-promotional

Question 12

what info does an SPC contain?

Answer 12

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
   5 PHARMACOLOGICAL PROPERTIES
5. PHARMACEUTICAL PARTICULARS
6. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION NUMBER(S)
8. DATE OF FIRST AUTHORISATION/
   RENEWAL OF THE AUTHORISATION
9. DATE OF REVISION OF THE TEXT

Question 13

What is a promotional aid?

Answer 13

• Form of advertisement – ‘reminder advertisement’
• Usually given by a drug representative at a visit•e.g. pens, mugs, post-it notes
• Brand name of the product prominently displayed
• Must be relevant to the practice of pharmacy or medicine
• Cost less than £6 (excl VAT)
• Competitions are allowed providing the prize (max 6 if UK-wide) is no more than £130 (excl VAT) and the prize is relevant to the practice of medicine or

Question 14

what must medical sales reps have?

Answer 14

• Must receive adequate training and have sufficient scientific knowledge to provide information that is precise and complete about their products
• Must give a copy or have available a copy of the SPC of the product they are promoting at each visit

Question 15

when can free samples of medicines be supplied ?

Answer 15

Can be supplied to persons qualified to prescribe
•For the purpose of acquiring experience dealing with the product
•Only on an exceptional basis and has to be accompanied by a signed and dated request form by the recipient
•Only a limited number of samples may be supplied in one year
•Sample is the smallest pack size and marked ‘free medical sample – not for resale’ and is accompanied by a copy of the SPC
•The sample cannot contain a controlled drug

Question 16

what medicines cannot be advertised to the public?

Answer 16

• POMs
• what about vaccinations?
• Any product for the treatment of cancer
• Products which contain psychotropic or controlled drugs
• Products used to induce an abortion

Question 17

when advertising to the public what must be included?

Answer 17

• Name of the product
• The common name of the ingredient of a single active ingredient product
• Information necessary for the correct use of the product
• An invitation to read the instructions on the PIL or package

Question 18

what is prohibited in advertising to the public?

Answer 18

• Any advert which offers a diagnosis
• Comparative advertising naming another medicinal product (efficacy, quality)
• Claims that effects of taking it are ‘guaranteed’
• Suggestions that health is improved by taking a product
• Adverts directed at children (< 16 years old)
• Scientific, healthcare professional or celebrity endorsement
• Suggestions that the efficacy or safety is due to the fact that the product is “natural”
• Suggestions of “no side effects”
• Any advert which may lead to an erroneous self-diagnosis (e.g. by using a case history)
• Any advert which refers in improper, alarming or misleading terms to claims of recovery
• Any advert which uses pictures in an improper, alarming or misleading manner

Question 19

how is the advertising of medicines monitored?

Answer 19

• Self-regulation
• Prescription Medicines Code of Practice Authority (PMCPA) part of the Association of the British Pharmaceutical Industry (ABPI)
• Proprietary Association of Great Britain (PAGB)

Question 20

who complains about medicine adverts?

Answer 20

ealth Ministers do have legal powers if they refer a case to Independent Regulator for Communications Industries (OFCOM)

Question 21

what regulations do advertising on the internet require?

Answer 21

Acceptable provided that it complies with the regulations discussed above
•Content should be segregated for public and healthcare practitioners if products are a mixture of POMs, P and GSL
•Adverts for POMs are only acceptable on websites directed at healthcare practitioners
•Access should be restricted to healthcare professionals for content that is related to POMs (e.g. requiring input of registration number or declaration of being a healthcare professional)

Question 22

what about disease campaigne awareness?

Answer 22

• Main aim must be to increase the awareness of a disease
• Should not promote or stimulate a demand for a particular medicine
• Emphasis should be on the condition and its recognition rather than on treatment options

Question 23

how can pharmacy services be advertised?

Answer 23

• Need to follow all legal requirements as per any advert
• Also need to comply with relevant GPhC principles and standards
• Must be professional in nature –should be decent and not bring the profession into disrepute•If medicines are mentioned, need to be careful not to promote inappropriate or excessive use of medicines and only to promote their correct use•Be careful not to try to persuade patients to obtain medicines that are not needed, or quantities substantially in excess of actual need•Adverts should not undermine the service available at other pharmacies or by other pharmacy professionals