WHO Drug Information Vol. 9, No. 1, 1995
Personal Perspectives OTC advertising: in whose interest? A consumer's viewpoint Andrew Chetley Research Consultant and Freelance Journalist For several years, the World Health Organization has been encouraging the rational use of medicines. lt was with this aim in mind that, in 1988, WHO updated and expanded its resolution on ethical and scientific criteria for pharmaceutical advertising (1) into the Ethical Criteria for Medicinal Drug Promotion (2). One form of promotion, advertising of over-thecounter (OTC) products to the general public, warrants careful consideration. Does this advertising enable consumers to make rational choices in dealing with self-medication? According to the World Federation of Proprietary Medicine Manufacturers (WFPMM) it cannot: "Our research and common knowledge of advertising demonstrates that advertising is an ineffective means of communicating full and proper information on OTC medicines" (3). The WFPMM maintains that including detailed information about the product in any public advertising "simply reduces the effectiveness of the main messages which are: the name of the product, what it can be used for and an express invitation to read the label or leaflet as appropriate" (4). The "name" being talked about is the brand namenot the International Nonproprietary Name (INN) or generic name. Its "use" refers to the provision of one or more possible indications, without any evidence of the efficacy of the product compared to other drug and non-drug therapies. The third message about reading the label or enclosed leaflet, although a good idea, will still not provide the consumer with comparative information. And the consumer has to purchase the product to get access to even this somewhat limited information. With the purchase, the goal of the manufactureranother sale - has been achieved. Perhaps we should turn this argument on its head and question the need for OTC advertising in the first place. The yardstick should be, as the WHO Ethical Criteria point out, the contribution that advertising and other promotional material make to rational drug use. If that contribution is negligible, . then the advertising is unnecessary and could even be considered harmful, in the sense that it is not in the best interests of public health. If the WFPMM is really prepared to focus only on the three main messages it identifies, then all OTC advertising in the future could take the following form: "A new/reformulated product for (indication), called (brand name), which contains (INN for all active ingredients), is now available. Ask your pharmacist or doctor for details about the usefulness and safety of this drug. If, after consultation, you decide to use the product, please read the label/leaflet carefully." Such advertising, of course, would not be designed to persuade consumers with partial information, suggestive illustrations, clever headlines and slogans and it would not contain illustrations, graphics, or images of people who, having taken the product, then look happy, more active, more able to cope with life. Unfortunately, however, there is little likelihood that such advertising would ever be agreed to by the OTC manufacturers. There is considerable evidence that manufacturers are not interested in providing useful information to help consumers make rational choices. The latest study, called A searching look at advertisements comes from Consumers International (formerly the International Organisation of Consumers Unions- IOCU) and the Scienceshop for Medicines at Groningen University in the Netherlands. The study analyses magazine and newspaper advertisements for OTC medicines and health products in 11 industrialized countries (5). lt compared the advertisements to the requirements of the European Union (EU) Directive on the Advertising of Medicinal Products for Human Use and the WHO Ethical Criteria. The study was carried out two weeks before the EU directive was made a legal requirement in its member states; none the less, the provisions were widely known
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and the study provides a useful baseline from which to judge future compliance. Certainly there is room for improvement. The study found that only three of the 183 advertisements contained all the required information and avoided all the prohibited items as set out in the two international standards. Other major findings were:
• 91 advertisements failed to include instructions for use, or advice to read the instructions;
included in a product. The WFPMM points out that the EU Directive requires this only in singleingredient products. Others might reasonably assume that it is perhaps even more important to provide the name of all the active ingredients in a multi-ingredient product. With some ingredients, such as paracetamol, access to this information could ensure that a consumer stays safely below the maximum recommended daily dosage and alive, rather than being hospitalized with an overdose and possibly dying. This latest study provides another indication that stronger medicine may be needed to deal with the excesses of promotional practices. Without some constraints on OTC advertising, consumers will have little or no protection from being led into irrational use of medicines. References
• 53 advertisements failed to give the INN or generic name;
• 41 advertisements made medical claims for products not registered as medicines; • 18 advertisements used a celebrity or well-known person to endorse and promote the product. An interesting finding was that in some countries, including the United Kingdom, the amount of space devoted to pictures or illustrations was much greater than that for text. In advertising terms, this means that advertisers are relying much more on a picture to sell the product than the words. This has implications for the future direction of advertising controls as existing guidelines focus on the words, not the pictures. There are, of course, problems with studies of this type, although the methodology developed by researchers at Groningen is quite rigorous. A major difficulty with all such studies is that a certain amount of interpretation is called for: judgements have to be made about whether a particular way of presenting information is in line with both the spirit and letter of what are often very general guidelines. Indeed, one criticism that the industry makes of the study involves the decision by the researchers to interpret the provision in the European Union Directive that "the information necessary for correct use of the medicinal product" included the provision of "contraindications, side effects and warnings" which the WHO Ethical Criteria already calls for. Despite the industry's objections, such an interpretation seems reasonable, particularly if we are striving for rational use of drugs. Another criticism levelled at the study is that it claims that the EU Directive calls for, as do the WHO Ethical Criteria, the inclusion in advertisements of the names of all active ingredients
1. World Health Assembly resolution WHA21.41. Official Records of the World Health Organization, 1.11 , 144 (1968). 2. Ethical Criteria for Medicinal Drug Promotion. WHO Geneva, 1988. ISBN 92 4 154239 X. 3. WFPMM. "WFPMM comments on IOCU Report on OTC Drug Advertising", Press Release. September 1994. 4. Reinstein, J. "Statement to the 47th World Health Assembly on WHO Ethical Criteria for Medicinal Drug Promotion". May 1994. 5. Kaldeway, H. et al. A searching look at advertisements, IOCU and the Scienceshop for Medicines. London and Groningen, 1994
The manufacturer's viewpoint Jerome A. Reinstein Director-General World Federation of Proprietary Medicine Manufacturers Because they so directly affect health, medicines and their advertising, especially advertising of nonprescription (OTC) medicines to the public, are highly regulated. In addition to government regulation, there are various guides to practice such as the WHO Ethical Criteria for Medicinal Drug Promotion, national codes and industry selfregulatory codes, which respect the intent of the Ethical Criteria. And companies have their own internal standards. 11
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WHO Drug Information Vol. 9, No. 1, 1995
The WHO Ethical Criteria state, inter alia, "advertisements to the general public should help people to make rational decisions on the use of drugs determined to be legally available without a prescription". Although the Ethical Criteria were written mainly with prescription medicines and their promotion in mind, the interpretation of the clauses on advertising to the general public by almost all governments is mainly that the advertising material must be truthful and not misleading, and claims made must be in line with the licence or monograph issued by the competent authority. The complete information needed for proper use of a medicine is contained in the drug information sheet as indicated in the appendix to the WHO Ethical Criteria themselves. This is supplied in labelling and/or in the leaflet of nonprescription medicines. Governments and industry understand that consumer advertising is different from advertising to professionals and thus the requirements must take these differences into consideration. Advertising is a low-involvement medium. Advertising experts know that the most an OTC can hope to communicate effectively is a recognition that the product exists and what it should be used for. Additionally, the industry feels that there should be a reminder to always read the label/leaflet or to follow the directions carefully. The recent European Union Directive now requires this reminder. In one major European country where television advertising for ten years required contraindications, warnings and side-effects to be scrolled throughout the 30second commercial, it was realized that this was counterproductive and it is no longer required. Research in advertising has clearly shown that overload of detailed information on the use of the product cannot be effectively communicated to the consumer in advertising (1, 2). Needless to say, the advertising of a medicine is by brand name denoting a particular product of a particular manufacturer. The manufacturer's reputation is at stake and therefore great pains are taken to guarantee the quality of the product which bears his brand name. In addition, evaluation and regular review of drug registrations by governments in most countries help assure that the quality, safety and efficacy are maintained to appropriate scientific standards. There are several steps leading to a person taking an OTC medicine. The first, by far, is the successful previous use of the product or its recommendation by family, pharmacist or doctor. Then there come
other factors, such as advertising, which would make the consumer aware of the availability of a product and what it can be used for or remind him or her of the product. Should the person ask for the medicine in a pharmacy or other outlet, the outer package labelling can be read before purchase to let the consumer know whether the product is suitable for his or her particular needs. Additional information may be available on a package leaflet. The label and the leaflet information must be carefully written to be understood by the lay public, while still being accurate and complete, and industry- with national governments- works towards this end. Thus the total information package is a complex of a number of factors taken in order, which allows the medicine to be appropriately utilized. Consumer advertising of medicines is ill-served to provide detailed comparisons of a product with competing products or with non-drug therapies. This is instead the role of independent drug bulletins and consumer organizations. In any event, advertising has, in all developed and most developing countries, had either direct government approval or the approval after examination by a delegated body according to an accepted selfregulation code. As a further control, misleading or false advertising can be brought to the attention of the government or other authority and stopped if earlier control mechanisms fail to work as they should. The fact that this happens very seldom for OTC advertising suggests that the system of controls works well. I believe it is demeaning to consumers to suggest that an OTC medicine advertisement with attractive illustrations makes people go out and buy and use a product without having read the label to decide whether this is the proper product for them to take. In fact, if one experiences the symptoms described, an advertisement can spark curiosity and lead to questioning in the pharmacy. A check on appropriateness comes then, if it is needed. When a government authority has agreed that a given medicine is safe enough to be used without professional supervision, why should a consumer necessarily need to question the pharmacist or doctor for details about its usefulness and safety? The labelling has already been designed to be and is accepted as sufficient for most people's needs in making this decision. Obviously pharmacists, doctors and other health care professionals are available for information, should people have
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additional questions. But it is surely not required in all cases. Should it really happen, pharmacists and doctors would be spending a good part of the time answering questions which are clearly answered already on labels and leaflets of products. This would not be in the interest of the professionals, or of governments, or, most importantly, of consumers themselves. Research with consumers has shown repeatedly that people do read the label and that OTC medicines are used responsibly and appropriately (3-5). The recent study by Consumers International (formerly IOCU) on OTC advertising in 11 developed countries (6) stated that "only three advertisements out of the 183 analysed completely fulfilled the requirements" suggested by international "standards". There were a number of methodological faults with this study, but in any case, one must wonder that when all the advertisements for medicines (and not all of the advertisements evaluated in the study were in fact for medicines) were according to national laws, regulations and codes, why only three were deemed completely acceptable. The fact is that essentially all of these advertisements were acceptable by the regulations, criteria and codes of the country in which they appeared. Our industry feels that detailed information is necessary for the consumer. lt is useful before purchase of the product on the outside label and before taking the product which then includes the information on labels and leaflets. This is where detailed information about side-effects, warnings and contraindications is effectively communicated to the user. While there is considerable information from consumer research to indicate that people use OTC medicines appropriately (3-5), there is little information to suggest that a significant amount of misuse occurs and is harmful.
They find out about what products are available and this gives them the choice to deter-mine for themselves which to purchase. Choice is one of the five basic consumer rights in the United Nations Charter on Consumer Protection, the others being access, information, redress and safety, all of which are characteristic of advertised OTC medicines. Secondly, it is in the professionals' interest: doctors, because they will not have their time taken up with minor ailments and can concentrate on more serious medical problems, and pharmacists because it increases their professional role. Since many OTC medicines are sold in pharmacies it gives the pharmacists an opportunity to advise consumers on medications they learn of through advertising. Thirdly, it is in governments' interest since OTC products are purchased with the consumers own money which makes them careful about what they buy and does not engage the governments' healthcare budget for minor ailments. lt also encourages self-reliance for less serious health problems. Finally it is in industry's interest because it allows consumers to know that products which could be useful to them are available and allows good products to continue on the market. References 1. Taylor Nelson Research, Information or Communication? A consumer study of television advertising. London, 1990.
2. Kepplinger, H.M. How far can advertising be used to inform? Swiss Pharma, 12: 73-77 (1991). 3. Reinstein, J.A. Worldwide studies on self-medication: what do they show? Swiss Pharma, 13:21-25 (1991).
In whose interest is OTC advertising? lt is in the interest of all the stakeholders: consumers, professionals, governments and industry. lt is first and foremost in the consumers' interest.
4. BMRB. Everyday health care: a consumer study of selfmedication in Great Britain. London, 1987.
5. Helier Research Group. Self-medication in the '90s: practices and perceptions. Washington, 1992. 6. Kaldeway, H. et al. A searching look at advertisements. IOCU and the Scienceshop for Medicines. London and Groningen, 1994.
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