Promotion and advertising of medicines Flashcards
What is the MHRA BLUE guide?
Details the MHRA role in enforcing the legislation
ο Advice on how to complain about an advertisement/promotional activity
ο Regulations relating to advertising unlicensed medicines
ο Regulations relating to Homeopathic remedies
ο Regulations relating to Traditional Herbal Remedies
ο Advice on sponsorship and samples of medicines
ο Advertising on the internet
ο Advertising to prescribers
ο Medical sales representatives
ο Gifts, inducements and other benefits plus hospitality
ο Interpretation of “inexpensive” and “relevant to the practice of medicine or pharmacy“.
ο Materials for patients
What is the ABPI Code (operated by PMCPA - Prescriptions Medicines Code of Practice Authority)?
ο The ABPI Code covers the promotion of medicines for prescribing to health professionals andother relevant decision makers. The Code also sets standards for information made available to the public about prescription only medicine. Advertising or promoting prescription only medicines to the public is prohibited under the ABPI Code and the UK law
Accepting gifts and hospitality
Can you accept gifts and give hospitality?
ο There is clear guidance concerning accepting gifts and hospitality – it is prudent not to accept gifts from pharmaceutical companies. So- if accepting anything ensure that it is entered into a ‘corporate hospitality’ register. Also, if carrying out any work on behalf of a company ensure that it is not in your own employer’s worktime – take annual leave. Think how things might look if scrutinised at some point by an independent body.
What is an advertisement?
An advertisement is defined as anything designed to promote the prescription, supply, sale or use of that product.
Includes:
Door to door canvassing, visits by medical representatives to prescribers, supply of samples, provision of inducements, offer or promise of any benefit or bonus either money or in kind (e.g. free holiday) unless of minimal value – what does this mean??
Sponsorship of meetings, sponsorship of scientific congresses including payment for travel and accomodation
It does NOT include: the medicines package or pack leaflet, reference material and announcements of a factual or informative nature such as changes to the package or leaflet, ADR warning, trade catalogues or price lists provided no claim is made (so inclusion of a new ADR warning is ok).
What section of the Human medicines Regulation controls advertising?
Section 14
What can you advertise in pharmacies?
ο Vaccination campaigns are exempt if for a vaccine or serum and approved by a Health Minister
ο Advertisements must comply with the particulars listed in the summary of product characteristics (SPC);
ο Adverts in general may include name of product, common name, information for correct use of product plus an invitation to read the instructions on the pack/leaflet.(specific regs. relate to Homeopathic products and also to Herbal medicinal products).
ο Can advertise P & GSL products(the regulations relating to GSL and P medicines are less strict than those covering POM’s eg: adverts for cold remediesand low dose PPI’s etc)
Companies may also provide relavent factual info where is required by:
ο national public advisory or horizon scanning bodies such as the Scottish Medicines Consortium, All Wales Medicines Strategy Group or the National Institute for Health and Care Excellence (NICE)
ο Licensed manufacturers and suppliers of unlicensed medicines (‘specials’) must not advertise specific unlicensed products but this does not preclude them from sending out price lists to healthcare professionals to whom the price of specials may be relevant, such as potential customers and budget managers. Price lists can be sent out at reasonable intervals or in response to an enquiry and must not include product claims.
What is a ‘Prescription Direction’?
ο BMA guidance: ‘Prescription direction’ occurs where a patient is being directed by their GP practice to a certain pharmacy to have their prescription dispensed.
ο Patients have a free choice between any community pharmacy and in some cases, a GP dispensary. Actions by practices seeking to influence a patient’s choice of pharmacy can undermine relationships with patients, as well as damaging trust and cooperation between healthcare professionals. Financial arrangements between community pharmacies and GP practices should be transparent
ο Providing advice that can be seen as prescription direction is against good practice. Whilst most of the following activities would be initiated by the practice, it is recognised that a pharmacy may often be involved. Pharmacy owners and pharmacists are also strongly advised not to request or become complicit in such activities.
