sales promotion of medicinal products

Question 1

advertisement

Answer 1

any thing of any activity which is intended to encourage prescription or supply by health care professionals and use of medicines by the general public generally by means of highlighting “product claims”

Question 2

examples of activities that are classified as advertisements

Answer 2

> visits by medical sales reps
supply of samples
provision of inducements to prescribe or supply medicines

Question 3

Human medicines regulation 279

Answer 3

a person may not publish an advertisement for a medicinal product unless ;
the product has a
>marketing authorisation
>homeopathic registration
>traditional herbal registration

Question 4

advertisements must

Answer 4

comply with the particulars listed in the summary of the product characteristics
encourage the rational use of the product by presenting it objectively and without exaggerating its properties
a person may not publish an advertisement for a medicinal product that is misleading

Question 5

special requirements for traditional herbal medicinal products

Answer 5

all advertisements for herbal medicinal products should include the following statement :
“traditional herbal medicinal product for use in (specify one or more indications for the product consistent with the terms of the registration) exclusively based upon long-standing use as a traditional remedy

Question 6

Duties of licence holders

Answer 6

appoint qualified signatories to compile and collate all information relating to the product
must ensure that any medical sales representative who promotes the product is given sufficient training and has sufficient knowledge to enable the representative to provide information about the product that is as precise and complete as possible
update all advertising so that it is consistent with the current SPC for product

Question 7

Qualified signatories must retain records of

Answer 7

(a) a sample of any advertisement for which the person is responsible relating to the product
and
(b) a statement indicating the persons to whom the advertisement ,the method of its publication and the date when it was 1st published

Question 8

advertising to the public

Answer 8

advertising to the public is permitted for medicines legally classified pharmacy sale (p) or general sale list (GSL) subject to compliance with the regulations
the regulations prohibit the issue of any advertisement wholly or mainly directed to the general public which is likely to lead to the use of a pom
advertising of medicines should be directed exclusively or principally at children (under 16s) . nor should advertising material aimed at parents and carers be included in non-promotional material aimed at children.

Question 9

a person may not publish an advertisement

Answer 9

that is likely to lead to the use of a medicinal product for the purpose of inducing an abortion
that is likely to lead to the use of a pom
that contains an offer to treat any person for cancer , or prescribe any remedy for its treatment , or to give any advice in connection with the treatment of the condition .
that a medical consultation or surgical operation is unnecessary
that offers to provide a diagnosis or suggest a treatment by post or by means of an electronic communications network within the meaning of the communications act 2003
that might , by a description or detailed representation of a case history lead to erroneous self-diagnosis
suggests that the effects of taking the medicinal product -
are guaranteed
are better than or equivalent to those of another identifiable treatment or medicinal product
are not accompanied by an adverse reaction

Question 10

Human medicines regulation 283

Answer 10

A person may not publish an advertisement that is likely to lead to the use of a medicinal product for the purpose of inducing an abortion.

Question 11

human medicines regulation 292

Answer 11

Regulations 284 (prescription only medicines), 285 (narcotic and psychotropic substances) and 287(4)(b) (material about effects of medicinal products) do not apply to an advertisement as part of a vaccination campaign that—

(a)relates to a medicinal product that is a vaccine or serum; and

(b)has been approved by the Ministers.

Question 12

human medicines regulation 287

Answer 12

(1) A person may not publish an advertisement relating to a medicinal product that suggests that the effects of taking the medicinal product—

(a)are guaranteed;

(b)are better than or equivalent to those of another identifiable treatment or medicinal product; or

(c)are not accompanied by any adverse reaction.

(2) A person may not publish an advertisement relating to a medicinal product that uses in terms that are misleading or likely to cause alarm pictorial representations of—

(a)changes in the human body caused by disease or injury; or

(b)the action of the medicinal product on the human body.

(3) A person may not publish an advertisement relating to a medicinal product that refers in terms that are misleading or likely to cause alarm to claims of recovery.

(4) A person may not publish an advertisement relating to a medicinal product that suggests that—

(a)the health of a person who is not suffering from any disease or injury could be enhanced by taking the medicinal product; or

(b)the health of a person could be affected by not taking the medicinal product.

(5) Paragraph (4)(b) is subject to [F1regulation 291A (campaigns relating to the suspected or confirmed spread of pathogenic agents etc.) and] regulation 292 (exception for approved vaccination campaigns).

Question 13

a person may not publish an advertisement relating to a medicinal product that refers to a recommendation by

Answer 13

a scientist
a health care professional
a person who because of their celebrity status could encourage the use of the medicinal product

Question 14

prohibition of supply of samples to the public for promotional purposes

Answer 14

a person who carries on a medicines business may not sell or supply a medicinal product for a promotional purpose to a person who is not qualified to prescribe medicinal products
this regulation applies regardless of whether the promotional purpose is that of the seller or supplier or of a third party

Question 15

person qualified to prescribe or supply medicinal products (PQPS)

Answer 15

(a) persons who in the course of their profession or in the course of a business sell or supply medicinal products
(b) persons who are entitled to choose which medicinal product is supplied
(c) any person who is capable of influencing or determining which product is purchased by or supplied to an end consumer at point of sale
examples : doctors dentists nurses pharmacists optometrists ……….

Question 16

the code of practice for the pharmaceutical industry 2019

Answer 16

the code regulates the advertising of medicines for prescription to health professionals and administrative staff. it also covers information about pom made available to the general public.

Question 17

prescribing information and other obligatory information

Answer 17

the name of the medicine
a quantity list of the active ingredients using approved names where such exist or other nonproprietary names
at least one authorised indication for use consistent with the summary of product characteristics
a succinct statement of the information in the summary of the product characteristics relating to the dosage and method of use relevant to the indications quoted in the advertisement and where not otherwise obvious the route of administration
a succinct statement of common adverse reactions likely to be encountered in clinical practice , serious adverse reactions and precautions and contra-indications relevant to the indications in the advertisement , giving , in an abbreviated form, the substance of the relevant information in the summary of product characteristics , together with a statement that prescribers should consult the summary of product characteristics in relation to other adverse reactions
any warning issued by the medicines commission, the commision on human medicines, the committee on safety of medicines or the licensing authority , which is required to be included in advertisements
the code of either a specified package or recommended daily dose
the legal classification of the product
the number of the relevant marketing authorisation and the name and the address of the holder of the authorisation
the date the prescribing information was drawn up or last revised

Question 18

advertising of pharmaceutical services

Answer 18

it is in the public interest to publish information about pharmacy opening hours and pharmaceutical services
all information or publicity material regarding pharmacy services must be honest and accurate and reflect the professional nature of pharmacy
promotional material and advertisements come in various formats

Question 19

information and publicity standards of PSNI

Answer 19

information and publicity for good and professional pharmacy services including publicity issued by a this chart on the pharmacists behalf must
> be accurate, legal , decent and truthful
>not bring the profession into disrepute
>be presenting and distributed in a way that allows the recipient to decide independently whether or not to use a service
>not involve the inappropriate use of patient information held in a patients medication record
>not abuse the trust or exploit the lack of knowledge of the public
>be presented in a manner that does not disparage the service of other pharmacies or pharmacy professionals