W5 Advertising Medicines (AT) Flashcards
What is the Blue guide?
Produced by the MHRA
A guide on advertising and promotion of medicines in the UK
Prohibition on Advertising
Prescription Medicines to the Public:
What medicines are not allowed to be advertised to the public?
- Part 14 HMR2012
- Promotion in any media
- No advertising POMs to the public
- Prevent patient demand
- Applies to any person, not just pharmaceutical companies
- Limited exemptions e.g. public health campaigns approved by Government
Providing Information to the Public
- Factual, non-promotional information on POMs permitted to inform public
- Needs to be objective, non-sensationalised tone and medically accurate
e.g. A news article or a documentary
Compliance with the SPC
- Only promote therapeutic indications listed in the SPC
- Only promote to the patient group not indicated. (broad audience)
- May include statements not included in the SPC
-Must be substantiated and are not inconsistent with the SPC information. - Information about planned or ongoing trials
-Likely to be seen as promoting unlicensed indications.
Encouraging rational use:
Not misleading:
- Correct and proper use
-This might include when a medicine should be taken, how much should be taken, the route of administration, by whom it should be taken and special precautions. - Must present information which is factually correct
- Do not exaggerate
Not misleading
* Leading to an erroneous belief
* Unrealistic or inappropriate images can be misleading
The following must be included when advertising to the public..? (3)
- Name of product
- How to use
- Reference to the PIL
When advertising to the public, information about trials must be included if they are registered with the clinical trials database.
True or false?
False
Members of the public must be advised to speak to their doctor before purchasing a P medicine.
True or False?
False
Advertising to Healthcare Professionals:
- Prescription only and over-the-counter medicines can be advertised
- “Persons qualified to prescribe or supply“
-doctors, dentists, nurses, pharmacists, pharmacy assistants, optometrists,
chiropodists, midwives and other ancillary healthcare workers and retail staff
The following must be included when advertising to HCPs? (8)
- Licence number
- Legal classification
- Name and address of the business
- Name of product (and active ingredient)
- Indication
- Side-effects
- Dosage
- Cost
Advertising on the Internet:
- Nature and content directed at healthcare professionals.
- Access restricted
Merchandise:
What is the only merchandise that is allowed to be supplied?
“Pens/pencils and notepads are the only items that can be provided to health professionals and other relevant decision makers for them to keep and then only at bona fide meetings.
They cannot be provided, for example, by
representatives when calling upon health
professionals.
Compliance and Enforcement
- MHRA investigates complaints, monitors advertising and can require changes
- Sanctions include requiring companies to issue corrections in journals etc.
- Independent Review Panel provides scrutiny of cases/input to MHRA decisions
Self-Regulation
- The control of medicines advertising in the UK is based on a long-established system of self-regulation.
- The statutory powers of the MHRA, acting on behalf of Health Ministers, underpin and support this system.
Regulatory Codes of Practice: (5)
- Prescription Medicines Code of Practice Authority (PMCPA)
- Proprietary Association of Great Britain (PAGB)
- Health Food Manufacturers’ Association (HFMA)
- Office of Communications (Ofcom)
- Advertising Standards Authority (ASA) and Committees of Advertising Practice
