Guiding the promotion of prescription medicines 1
Advertising and promotion are part of everyday life. In the U.S.A., people may be exposed to as many as 5000 advertisements each day. Health professionals are particularly exposed to the promotion of medicines. This appears in our journals, on the pens and notepads on our desks, on displays at the conferences and symposia we attend and it is brought to our attention during the visits of pharmaceutical representatives. It is so pervasive that it is easy to think that it plays no part in our lives nor has any influence on the way we use medicines. Unfortunately, studies tell us otherwise. Promotional practices are influential on our beliefs about medicines and also on prescribing.
The need for regulation of promotion:
Pharmaceutical promotion is a persuasive communication. It involves the conscious attempt to move health professionals from being unaware of a drug product's existence to a stage of repeated prescription. As promotion has the potential to change behaviour and because it is a major source of drug information for health professionals, the messages promoting prescribing should be factual, evidence-based, unambiguous and balanced.
Unfortunately, in many countries, promotion is not factual nor evidence-based. Inaccurate and inappropriate promotional claims abound and this has the potential to contribute to irrational drug use. For example, aspirin is commonly promoted in third world countries as suitable for use in children, while antihistamines are promoted as appetite stimulants and other medicines as brain tonics. Consequently, many countries around the world have regulated the promotion of medicines. The World Health Organization (WHO) advocates the regulation of promotion, urging all its member states to develop guidelines for promotional practice, which are consistent with national health policy and which support rational drug use. The WHO has published `Ethical criteria for medicinal drug promotion' as a model for such guidelines.
How is promotion regulated?:
In Australia, promotion of medicinal drugs is regulated by government legislation including the Therapeutic Goods Act. The Australian Pharmaceutical Manufacturers Association (APMA) Code of Conduct is a guide for industry on how to advertise and promote prescription medicines. Acceptance and observance of the Code is a condition of membership of the APMA. The current membership covers 95% of the prescription medicines industry.
What activities are regulated?:
The APMA Code contains standards for all types of promotional material including all printed and audiovisual promotional material. It also sets standards for pharmaceutical representatives, sample supply, hospitality, industry-sponsored market research and postmarketing surveillance studies, trade displays and communications aimed at the general public.
All promotional claims should be current, accurate, balanced and not misleading either directly, by implication or by omission. The Code also states that promotional material should be in good taste and that comparative information, if provided, should be factual, fair and capable of substantiation. Claims must conform to approved product information or to the scientific literature, but only if the latter does not conflict with the product information.
The Code restricts many activities including those proscribed by legislation. For example, prescription medicines cannot be promoted to the general public and companies cannot promote their products for indications which are not listed in approved product information. Starter packs cannot be left with receptionists unless there is a request form signed by the doctor. In addition, pharmaceutical representatives cannot promote products over the telephone unless you first agree, promotional material must not be marked for urgent attention, unsolicited reprints of journal articles must be consistent with product information and the word `safe' cannot be used unless it is substantiated.
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