Advertising & Promotion of Medicinal Products

Question 1

Regulation of advertisements

Answer 1

• Medicines advertising in the UK is regulated through national and EU legislation
• This sets out requirements and restrictions for who medicines can be advertised to, how it can be advertised and the type of information that can be included
• MHRA regulates the advertising of medicines in the UK

Question 2

Regulation helps to:

Answer 2

• Prevent manufacturers misleading members of the public or healthcare professionals
• Prevent disparaging comments being made about a rival product
• Provide the necessary information for patients to make informed and clinically appropriate decisions

Question 3

Rules on advertising

Answer 3

• Unlicensed medicinal products cannot be advertised for medicinal purposes
• All advertised medicinal products must have a marketing authorisation
• No advert may be issued without the consent of the MA holder

Question 4

An advert for a medicinal product must:

Answer 4

• Comply with the particulars listed in the SPC
• Encourage the rational use of the medicinal product by presenting the medicine objectively and without exaggerating its qualities
• Not be misleading

Question 5

What is required in a SPC?

Answer 5

• Name of product
• Qualitative and quantitative composition
• Pharmaceutical form
• Clinical particulars
• Pharmacological properties
• Pharmaceutical particulars
• Marketing Authorisation (MA) holder
• Date of approval and revision of SPC
• Legal category

Question 6

Advertising to the public

Answer 6

• Only medicines classified as P or GSL can be advertised to the public
• Adverts should not claim:
– The medicine is safe and efficacious because it is a
“natural” product
– There are no side effects
– “Fast acting” or “24 hour relief” etc. without clinical
evidence

Question 7

Advertising to the public

• For medicines promoted during pregnancy:

Answer 7

– SPC must support use in pregnancy
– Advertisements should not imply that it is usual for
pregnant women to take medicines
– Advice on non-pharmacological measures should be
included
– Encourage seeking advice, including license warning
statements and general warning message e.g. “Medicines can affect the unborn baby. Always talk to your doctor or pharmacist before taking any medicines in pregnancy”

Question 8

Advertising to the public

Adverts should not refer to recommendations made by:

Answer 8

• Scientists or health care professionals
• Celebrities
Or suggest the product is superior to others because it has a marketing authorisation

Question 9

Advertising to PQPS

Answer 9

• Persons Qualified to Prescribe or Supply (PQPS) include persons who in the course of their profession or business may lawfully prescribe, sell by retail or supply in circumstances corresponding to retail

Question 10

Advertising to doctors and dentists

Answer 10

• Requires consent of MA holder
• Advertisements in publications must include:
– MA number
– Details of MA holder
– Active ingredients
– Licensed indications
– Dose and method of use
– Side-effects
– Cautions and warnings
– Contraindications
– Cost

Question 11

current guidance on advertising medicines

Answer 11

Comply with advice within The Blue Guide and relevant sections of the ABPI Code of Practice

-MHRA

Question 12

1) Discuss briefly the legal basis of medicine advertising in the UK

Answer 12

Medicine advertising in the UK is regulated by a combination of national and European legislation. The UK Regulations that form the basis of the law surrounding advertising of medicines is Part 14 of the Human Medicines Regulations 2012 (“the Regulations” – SI 2012/1916).
The Regulations lay out different requirements for advertising to the public and advertising to health professionals.

Question 13

2) Describe the role of the MHRA in relation to medicines advertising

Answer 13

The Medicines and Healthcare products Regulatory Agency (MHRA) works with other statutory regulators and self-regulatory bodies to ensure advertising is fully compliant with EC and UK medicines law, namely:

i. Advertising Standards Authority (ASA) – statutory regulator of general advertising matters
ii. Proprietary Association of Great Britain (PAGB) – self-regulates advertising over-the-counter medicines
iii. Prescription Medicines Code of Practice Authority (PMCPA) – self-regulates advertising prescribed medicines

The Regulations allow the MHRA to see advertising material before it is issued.

Question 14

List five examples of promotional activity as defined in the ABPI Code of Practice

Answer 14

a. Journal and direct mail advertising
b. Activities of representatives including any print or electronic material used by them
c. Provision of inducements to prescribe, supply, administer, recommend, buy or sell medicines by the gift, offer or promise of any benefit or bonus, whether in money or kind
d. Provision of hospitality for promotional purposes
e. Sponsorship of promotional meetings
You could also have chosen “the sponsorship or scientific meetings including payment of travelling and accommodation expenses in connection therewith” or
“sales promotion… participation in exhibitions, the use of audio or video recordings…broadcast media, non-print media, the internet, interactive data systems or social media.”
From p6 of ABPI Code of practice

Question 15

advertising to the public

Answer 15

Both pharmacy sale (P) and General Sale List (GSL) legally classified medicines can be advertised to the public. Advertising of prescription only medicines (POMs) is not allowed.

Advertisements to the public must not state or imply that a product is recommended by or used by a health professional, scientist or celebrity. Sometimes ‘celebrities’ or ‘look-a-likes’ are used in advertisements but only when they do not imply that the person is using or endorsing the products featured.

Question 16

5) State the standard set by the General Pharmaceutical Council in relation to retail pharmacies advertising and promoting pharmacy medicines and services

Answer 16

“Be satisfied that any advertising and promotional
activity for professional services or medicines is legal,
decent and truthful and complies with appropriate
advertising codes of practice”

Advertising by pharmacists should:
• Be accurate, truthful and not misleading
• Comply with relevant legislation
• Be decent and not bring the profession into disrepute
• Be trustworthy and not abuse the trust or exploit the lack of knowledge of the public
– Be presented in a manner that does not undermine
the service of other pharmacies or pharmacy
professionals
– Not promote inappropriate or excessive use of
medicines, or promote their misuse, injudicious or
unsafe use which may be injurious to health
– Not seek to persuade patients to obtain medicines not
needed, or in excessive quantities
– Ensure that style, presentation and content is
professional in the eyes of the general public
– Segregate advertisements dealing with professional
and non-professional services
– Comply with advice within The Blue Guide and
relevant sections of the ABPI Code of Practice
– Use professional judgement for multiple pack
promotions, considering factors such as clinical
condition, pack size, likely period of treatment, abuse
potential and risks of supply
– Consider appropriateness of having advertisements
or promotions approved by legal advisors

Question 17

Why do you think it might be necessary for the MHRA to vet advertising material?

Answer 17

Reasons including, but not limited to:
• To prevent misleading information from reaching the public domain
• To ensure compliance with regulations
• To ensure advertising material meets the professional standards expected of the pharmacy profession
• To prevent legal issues through disparaging remarks about a competitor

Question 18

What are the four main courses of action available to the MHRA if a breach of the legislation is identified?

Answer 18

Request the company

a. amends the advertisement
b. Withdraw the advertisement
c. Issues a corrective statement and/or
d. Submit future advertising for the product to the MHRA for review prior to issue (vetting)

From p35 of the Blue Guide

Question 19

List five examples from the ABPI Code of Practice that would not be considered promotional activity

Answer 19

a. Replies made in response to individual enquiries from health professionals
b. Factual, accurate, informative announcements and reference material concerning licensed medicines and relating to pack changes, adverse reaction warnings, trade catalogues and price lists, provided they do not
include product claims
c. Price lists relating to unlicensed medicines provided they include no product claims and they make clear that the products are unlicensed
d. Information supplied by pharmaceutical companies to national public organisations provided the information is factual, accurate and not misleading
e. Measures or trade practices relating to prices, margins or discounts which were in regular use by a significant proportion of the pharmaceutical industry on 1st January 1993

You could also have chosen “Summary of product Characteristics”, “European public assessment reports”, the labelling of medicines and their package leaflets” or “information relating to human health or diseases provided there is no reference to specific medicines.

From p6 of ABPI Code of Practice.

Question 20

define promotion

Answer 20

‘Promotion’ has been defined within the ABPI Code of Practice as “any activity undertaken by a pharmaceutical company or with its authority which promotes the prescription, supply, sale or administration of its medicine.”

Question 21

Any new medicinal product must have a ..

Answer 21

Any new medicinal product must have a valid marketing authorisation (MA) before it can be advertised for medicinal purposes. This means that no promotional material for a new product can be disseminated to prescribers until the MA has been granted. An
exception to this is when limited factual information can be given to the budget holders of health authorities or hospital trusts who may need to plan for expenditure of drugs over future years.

Question 22

According to the Advertising Regulations, the following three quality standard provisions must be met within an advertisement:

Answer 22

i. Comply with the particulars listed in the summary of product characteristics (abbreviated to either SPC or SmPC)
ii. Encourage rational use by presenting the medicine objectively and without exaggerating its qualities
iii. Not be misleading

Question 23

records of advertising materials should normally be kept for a..

Answer 23

Records of advertising materials should normally be kept for a minimum of 3 years after either the last use of the advertising material, or the conclusion of any regulatory or self regulatory action.

Question 24

Name three medicinal products that have been reclassified from POM to P in the last five years:

Answer 24

a. Ullipristal Acetate 30mg Tablet (ellaOne) - 2015
b. Zolmitriptan 2.5mg Orodispersible Tablet (Zoming) - 2014
c. Esomeprazole 20mg Gastro-resistant Tablets (Nexium Control) -2013

Question 25

Why do you think a Pharmaceutical company might want their product declassified? What are the implications for
pharmacists and the wider NHS?

Answer 25

Reasons could include increasing patient access to drugs (= more profit) and increased product awareness.
Implications for pharmacists include increased questioning requirements to determine suitability for sale and refusal of supply to patients groups not included in MA (e.g. BMI requirement with Orlistat and completion of checklist for Imigran Recovery supply)
NHS benefits from increased patient access to medicines so may reduce pressure for GP appointments however patients can access medicines that are unsuitable for them so NHS has to handle management of complications e.g. treating renal or GI issues with Ibuprofen

Question 26

List the items of essential information that advertisements to the public must contain (Use the Blue Guide to help you with this):

Answer 26

a. Name of the medicinal product
b. If the product contains only one active ingredient, the common name of the medicinal product
c. The information necessary for correct use of the medicinal product, i.e. one or more indications
d. An express and legible invitation to read carefully the instructions in the leaflet or on the label
e. For products with a traditional herbal registration only, the approved wording

Question 27

State five ways that advertisements to the public could be potentially misleading according to the PAGB:

Answer 27

a. The nature of the product, its ingredients or indications
b. Unevidenced claims
c. Claims about pharmacokinetic properties
d. Claims about duration of action
e. Novelty (newness) of product

Question 28

Briefly discuss the controls that exist around advertising to the public on the internet. What are the implications of the internet being a world-wide source of information?

Answer 28

Material posted on UK websites and/or aimed at the UK audience must follow UK advertising legislation therefore only P or GSL meds can be advertised. The implications of “being a worldwide source of information” is that those intending advertising to a UK audience must adhere to UK legislation and those with multiple countries covered on their site must make users aware that they are
accessing material aimed at users from other countries.

Question 29

Why might a pharmaceutical company promote their product / advertise to a community pharmacist?

Answer 29

Increase pharmacist awareness – promote sales of P and GSL products, feedback on adverse events for new POMs

Question 30

Advertising to Persons Qualified to Prescribe or Supply (PQPS)

Answer 30

Persons Qualified to Prescribe or Supply (PQPS) include persons (and their employees) who, in the course of their profession or in the course of a business, may sell or supply medicinal products. The Blue Guide distinguishes three separate groups that could be described as a PQPS:
i. Persons who in the course of their profession or business sell or supply medicinal products (e.g. pharmacists)
ii. Persons who are entitled to choose which medicinal product is supplied (including all persons “legally entitled” to prescribe e.g. doctors, dentists, nurse and
pharmacist independent prescribers)
iii. Any person who is capable of influencing or determining which product is purchased by or supplied to an end customer at point-of-sale (e.g. pharmacy
assistants)

Question 31

Advertisements directed at PQPS must include specific information relating to the identity of the product, namely

Answer 31

i. Licence number
ii. Supply classification: POM, P or GSL
iii. Name and address of MS holder
iv. Name of the product and list of its active ingredient(s) with the common (generic) name placed by the most prominent product (brand) name.

Question 32

Advertisements to PQPS must also include information relating to the use of the product.

Answer 32

a. Indication
b. Side-effects, precautions and contraindications
c. Dosage and method of use
d. Warnings
e. Cost excluding VAT

Question 33

According to The Blue Guide a professional sample is a..

Answer 33

free sample of a medicinal product that is provided to a PQPS for the purpose of acquiring experience in its use. Samples can only be supplied under strict conditions, including:

i. They should be supplied on an exceptional basis only
ii. A limited number of samples for each product in any one year to any one recipient
iii. They shall be no larger than the smallest pack size available for sale in the UK

Question 34

What specific target group within the NHS do you think
might be most influential to promote medicines to and
why?

Answer 34

Prescribers – they are the ones writing the prescriptions. Other would be bodies producing prescribing guidance and practice pharmacists as they will be reviewing prescribing by all prescribers within each surgery – these two groups would have influence over what is being
prescribed, so promoting directly to these groups would increase the chances of a particular product being incorporated into prescribing guidance

Question 35

Hospitality can be offered to ..

Answer 35

Hospitality can be offered to PQPS at events when purely for professional or scientific purposes. Conditions imposed are that hospitality is strictly limited to the main objective of the meeting; it should not be offered to non-health professionals e.g. partners, and should be ‘reasonable’ in level.