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AMAN - Pharmacy Law and Ethics > Advertising and promoting of meds and services > Flashcards

Advertising and promoting of meds and services Flashcards

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1
Q

Definition of Med Advertisement

A

-advertisement is any thing or activity which is intended to encourage prescription or supply by healthcare professionals and use of medicines by the general public, generally by means of highlighting qualities of the medicine

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2
Q

Regulatory Framework

A

-statutory:
-HMR and MHRA
-Blue guide: advertising and promotion of meds in the UK
-Legislation for controlling advertising :
Trade Descriptions Act
Control of Misleading Advertisements Regulations
Communications Act
Bribery Act

Self Regulatory bodies

  • ABPI (association of British pharmaceutical industry)
  • PAGB (proprietary association of GB)
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3
Q

ABPI Code

A
  • applied to promotion of meds to uk health professionals and administrative staff
  • it includes all activities undertaken by pharmaceutical companies
  • journal and direct mail advertising
  • Drug company representatives
  • supply of samples
  • sponsorship of meetings
  • also includes non promotional info made available to public on POMs
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4
Q

ABPI Clauses

A
  • activities or materials associated with promotion must never be such as to bring discredit upon, or reduce confidence in the pharmaceutical industry
  • medicine can’t be promoted prior to MA which permits sale or supply
  • prescribing info must be made clear and legible manner in all promotional material for med except for abbreviated advertisements
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5
Q

PAGB

A
  • code of practice for advertising PTC med including herbal
  • consumer code: advertising aimed directly at consumers and those persons who may purchase med on behalf of consumer
  • professional code: aimed wholly or mainly at PQPS, where object of the advertising is to influence sales and or recommendations to public
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6
Q

What is advertising and promotion of meds?

A 
Applies to all media
-journals, magazines, newspapers
-posters
-radio
Internet

Excluded:

  • reference material, factual informative statements or announcements, provided that they do not make a product claim
  • info relating to human health or diseases where there is no reference to med products
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7
Q

General Rules for Advertising Medicine

A
  • product must have MA, certificate of registration or herbal registration to be advertised for med purposes
  • responsibility for advertising and promotion of med lies with MA, certificate of reg or traditional herbal reg holder
  • need consent of MA holder to issue an advert for their med product
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8
Q

Advertising to Health Professionals

A
  • aimed at HCP who are PQPS
  • POM only for PQPS
  • PQPS include doctor, dentist, pharmacy
  • professionals qualified to supply PFS, including dieticians, OP, SLT
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9
Q

What must the advertisement contain for HCP?

A
  • essential info compatible with SPC about adverse reactions, dosage and method of use, precautions and relevant contraindications.
  • License number
  • Name and address of MA holder
  • Classification of product
  • Name of product and list of active ingredients
  • Indications
  • Pharmaceutical precautions
  • Cost, excluding VAT
  • Be legible, accurate, up-to-date, verifiable and sufficient to allow the recipient to form own opinion of the medicines therapeutic value
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10
Q

Medical Sales Representatives

A
  • Training and sufficient scientific knowledge
  • High standard of ethical conduct
  • Not employ any inducement or subterfuge to gain a meeting
  • Not cause inconvenience to health professionals
  • Provide a copy of the SPC to all persons whom they visit
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11
Q

Free Samples

A

“A small supply of a medicine provided to health professionals so that they may familiarise themselves with it and acquire experience in dealing with it”

A sample of a medicine must:

  • only be given to a health professional qualified to prescribe it
  • not be a narcotic / psychotropic drug
  • only be supplied in response to written requests
  • only be supplied on exceptional and limited basis
  • be no bigger than the smallest pack available in the UK
  • be marked ‘free medical sample – not for resale’
  • include a copy of the SPC
  • Free samples of OTC medicines are not permitted
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12
Q

Gifts

A

No gift, benefit or financial advantage shall be offered or given to health professions as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine unless it is

  • inexpensive, and
  • relevant to the practice of medicine or pharmacy.

Health professionals may be provided with items which are to be passed on to patients and which are part of a formal patient support programme

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13
Q

Professional codes on gifts

A

General Medical Council
‘You must act in your patients’ best interests when making referrals and when providing or arranging treatment or care. You must not ask for or accept any inducement, gift or hospitality which may affect or be seen to affect the way you prescribe for, treat or refer patients’.

General Pharmaceutical Council
‘Do not ask for or accept gifts, rewards or hospitality that may affect, or be seen to affect, your professional judgement’.

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14
Q

Hospitality

A
  • Companies must not provide hospitality to members of the health professions and appropriate administrative staff except in association with scientific meetings, promotional meetings, scientific congresses and other such meetings, and training
  • The meeting must have a clear educational content
  • The venue must be appropriate and conducive to the main purpose of the meeting
  • Hospitality should be “reasonable” in level
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15
Q

Advertising of medicinesto the public

A

-“Advertisers have a responsibility to ensure that advertising of medicines available for self medication does not in any way put patient and consumer safety at risk.” (MHRA)

Advertising is permitted for:

  • P and GSL to the public
  • Government controlled vaccination campaigns that have been approved by the Health Minister

-Must be clear it is an advertisement and that the product being advertised is a medicine

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16
Q

NO advertising to thepublic of:

A

POM

  • The Cancer Act 1939 (“the Cancer Act”) prohibits any advertisement to the public that contains an offer to treat any person for cancer, or to prescribe any remedy for its treatment, or to give any advice in connection with the treatment of the condition
  • CD Schedule I, II or IV (Narcotic Drug Convention) or Schedule I-IV (Psychotropic Substances Convention)
  • Products for the purpose of inducing abortion
17
Q

What must advertisement of medicine include?

A

Must include

  • The name of the medicinal product
  • If the product contains only one active ingredient, the common name
  • The information necessary for correct use of the medicinal product, i.e. one or more indications
  • An express and legible invitation to read carefully the instructions in the leaflet or on the label
18
Q

Advertising to the public must:

A
  • NOT be aimed at children (under 16s)
  • NOT be recommended by a celebrity, scientist or healthcare professional
  • NOT include improper, alarming or misleading terms to claims of recovery
  • NOT include detailed case history or use pictures that may lead to erroneous self-diagnosis
  • NOT refer to any medicine as “essential”

NOT imply that:
-seeing a doctor or pharmacist is not necessary

  • one product is better than (or equivalent) to another treatment or product
  • the effects of taking the product are guaranteed
  • a product has no side effects or that safety and efficacy is due to fact it is natural
  • health can be enhanced by taking the product or harmed by not taking the product
  • Public health campaigns are encouraged but must not make product claims otherwise it becomes an advertisement
  • promotion of services provided by clinics is allows but where treatment of disease is mentioned, this must be balanced with na range of therapeutic options available ie should not be drawn to a specific product
    eg. treatment for lines and wrinkles as its not specific but mention of botox is not allowed
19
Q

Advertisement of alternative therapies and supplements

A

-medicine claims cannot be claimed for products that don’t have MA or are not registered

20
Q

Rules regarding homeopathic products:

A
  • must be based on its traditional use
  • only info specified in labelling may be used in advertising of registered homeopathic products
  • no mention of a specific indication should be made
  • contain ‘homeopathic product without approved indications’
  • Should state a warning advising the user to consult a doctor if the symptoms persist during use of the product
21
Q

Rules Regarding Traditional Herbal Meds:

A
  • must include statement: “Traditional herbal medicinal product for use in [indication] exclusively based on long standing use as a traditional remedy”
  • must not claim that the effectiveness of a traditional herbal medicine has been demonstrated eg. clinically proven
  • All suppliers of herbal products are encouraged to either have an MA or participate in the traditional herbal meds reg scheme
22
Q

Advertising of meds and services by pharmacists

A

Principle 1: the governance arrangements safeguard the health, safety and wellbeing of patients and the public

Principle 2: Staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public

23
Q

Pharmacist specific when advertising meds and services

A
  • comply with relevant legislation and codes of practice
  • when a product is a herbal or homeopathic, promotions must be consistent with the MHRA registration scheme
  • be carried out with respect to the special nature of meds
  • not promote a med by way of endorsement by a pharmacist or pharmacy technician except in response to a request for advice
  • not promote inappropriate or excessive consumption or use of meds, promote their issues, or unsafe use which may be cause harm in health
  • not seek to persuade patients to obtain meds that are not needed, or quantities substantially in excess of those needed
24
Q

Characteristics when giving patient advice on goods

A
  • recipient should decide independently whether or not to use the service after info for good and professional services have been provided
  • be decent and not bring the profession into disrepute
  • be presented in a manner that does not undermine the service and other pharmacies or pharmacy professionals
  • ensure style, presentation and content is professional in the eyes of the general public
  • segregate advertisements dealing with professional and non-professional services
25
Q

Volume-based price promotions

A
  • sale and supply of large quantities of analgesics or volume-based price promotions of them undermines the intention of the legislation on pack-size restrictions
  • Best Practice: sales of meds for pain relief should be restricted to max 2 packs in one transaction, don’t use offers that encourage more than one pack
26
Q

MHRA advertising standards unit

A
  • MHRA has a statutory duty on behalf of ministers to consider breaches of human medicines regulation on the promotion of meds
  • offers to review a material for regulated meds and scrutinise advertisement for compliance
  • may ask to see advertising before its published
  • works closely with advertising standards agency and prescription meds code of practice authority (PMCPA)
  • Publishes findings in current probs and annual report (name and shame)
  • publishes ‘the blue guide’
27
Q

Types of complaints seen by MHRA

A
  • advertising of botox products, POMS and OTC products to the public (especially on website and social media), unlicensed products, disguised promotions, med promotions undertaken by pharmacists
  • more than 75% complaints from competitor companies, rest anonymous or from public or healthcare professionals
  • sometimes result in withdrawal of advert, rest have to make changes
  • breach of med advertising regulations has possible penalty of fine or imprisonment for up to 2 years

AMAN - Pharmacy Law and Ethics (20 decks)

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