Guiding the promotion of prescription medicines 1

Introduction:

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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Attitudes do not necessarily match behaviour

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Several studies show that finding out what people think about promotion may not be a good way to predict their behaviour. For example, Peay & Peay’s 1984 paper suggests a doctor’s view of the worthiness of an information source may not be reflected in how often s/he uses it.

Sales representatives and other commercial sources were not evaluated highly, but sales representatives were the most frequent source of first information about medicines, and were one of the most frequently mentioned sources of information needed to prescribe.

Other commercial sources were also frequently mentioned as sources of first information about a drug. Similarly, Gambrill and Bridges-Webb found that 56% of the Australian doctors in their study reported that they used sales representatives as a regular source of information, but only 17% ranked them as the most useful .

McCue et al. surveyed GPs, internists and surgeons in North Carolina, about their attitudes toward and use of different sources of information about new drugs. Although only 27.7% of the respondents viewed drug sales representatives as accurate and accessible sources of information about new drugs, they were used more frequently than other sources. This study had a low response rate.

What attitudes do people (professional and lay) have to promotion?

Finding out what people think about promotion, and what effect they think it has on them, is important because it can help us develop educational interventions about promotion. However, research on this topic cannot provide evidence about the actual effects of promotion. Promotion may affect people in ways that they do not know about, or are reluctant to tell others about.

Research on attitudes to promotion relies heavily on survey methods. It tends to provide estimates of how many people agree with or disagree with certain statements, mostly about the appropriateness and effect of various forms of promotion. There are some more complex studies, which attempt to explore other variables associated with different attitudes to promotion. That is, they try to find out what kinds of people have different attitudes to promotion.

These studies are more useful. There is little qualitative research on people’s attitudes to promotion, and this is a major gap. In order to understand people’s attitudes and values more clearly, in-depth interviews are needed. People should be able to talk in their own words about what they think about promotion and how it affects them. Ethnographic research, in which the researcher spends time with doctors and tries to understand how promotion fits into their working lives, would also be useful.

Drug promotion does more harm than good?

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Seven good reasons to be concerned about drug promotion:

Drug companies spend on average around 35% of sales on promotion.

Companies would not spend such massive amounts on promotion if it were not effective at influencing prescribing. In Australia spending on drug promotion has now reached somewhere between $ 1.3 billion to $ 2.0 billion per year.

Promotion influences prescribing much more than most health professionals realise.
Many advertisements and statements from pharmaceutical representatives are misleading.
Promotion which exaggerates benefits and glosses over risks, threatens optimal treatment.
Reliance on promotional information may endanger lives and expose prescribers to the risk of litigation.

Thirteen observational studies have found that exposure to pharmaceutical promotion and doctors positive attitudes towards pharmaceutical promotion both correlate with harmful use of pharmaceuticals.