Influence of the legislation on the advertisement of psychoactive medications in Brazil

Abstract

Keywords Resumo DescritoresObjetive: The regulations on the advertisement of medications aim to encourage and promote an improved health care and the rational use of medications. The objective of this paper is to evaluate the influence of three regulations on the advertisement of medications: the "Export act", published in the United States in 1986; the "WHO's Criteria", published in 1988, and the Resolution 102/2000 of the Collegiate Board of Directors of the ANVISA (Agência Nacional de Vigilância Sanitária-Brazilian Sanitary Surveillance Agency), on the advertisement of psychoactive medications. Method: We collected advertisements that were published in Brazilian psychiatric journals before and after the regulations were established. The contents of the advertisements were analyzed according to a program created based on the regulation's demands. Results: In the 118 analyzed issues there were 199 different advertisements on 85 psychotropic drugs. We observed that, regardless the studied medication, the information about restrictions of use, such as adverse drug reactions, interactions, contraindications, warnings and precautions, does not appear very often, and when it does, its print sizes were smaller than that of the information favoring the use, such as indication, presentation and dosage. After the publication of the regulations, only 38.2% of the advertisements had all the essential technical information, and 35.3% were irregular in some way. Conclusion: The data suggest that there was very little influence of the regulations on the advertisement of psychotropic drugs in Brazil. Consequently, other control measures are necessary in addition to the regulations.Advertising. Legislation about drug. Legislation on medication. Psychotropic drugs.Objetivo: Os regulamentos sobre propaganda de medicamentos visam apoiar e fomentar a melhoria da atenção à saúde e o uso racional de medicamentos. O objetivo deste trabalho é avaliar a influência de três regulamentos sobre propaganda de medicamentos: "Export act", publicado em 1986 nos Estados Unidos; os "Critérios da OMS", em 1988 e a Resolução da Diretoria Colegiada n° 102 de 2000 da ANVISA (Agência Nacional de Vigilância Sanitária), sobre os anúncios de medicamentos psicoativos. Método: Foram coletados anúncios em periódicos de psiquiatria nacionais, publicados antes e após cada regulamento. O conteúdo dos anúncios foi analisado de acordo com um roteiro de análise de conteúdo elaborado segundo as exigências dos regulamentos. Resultados: Dos 118 fascículos analisados, foram obtidos 199 anúncios diferentes de 85 medicamentos psicoativos. Observou-se que, independentemente do regulamento estudado, as informações que restringem o uso, como reações adversas ao medicamento (RAM), interações, contra-indicações, advertências e precauções estão presentes em menor freqüência e num tamanho de letra menor do que as informações que favorecem o uso, como indicação, apresentação e posologia. Depois de todos os atos publicados apenas 38,2% dos anúncios continham todas as ...

Propagandas de medicamentos psicoativos: análise das informações científicas

“…18,19,24 In contrast to previous studies that have reported low citation of references in advertising claims, 15,17,22 in the present study, 91% of the materials reviewed had at least one reference. It can be noted that today pharmaceutical companies tend to provide references as marketing strategies of drug promotion.…”

“…Hence, unbalanced information is usually found in advertising claims. 15,17,23 A good number of claims reviewed (67.7%) were consistent with the references because consistency was ascertained when the cited information was identifi ed regardless of any other considerations. RDC 102/00, Art.…”

“…The contents of Brazilian advertisements are more subjective and incomplete compared to same drug materials advertised in the UK and US. 3,15,16 Several studies 1,7,12 and systematic reviews 19,24 have described the effect of drug promotional materials on medical prescription. Above all, it is a more serious issue for psychoactive drug advertising since it tends to be less informative than other medicinal drug promotional materials.…”

“…4,9 In addition, these advertisements usually reinforce stereotypes of the association between gender and psychiatric conditions, showing a disproportion between women and men. 14,15 Studies have also reported both misinformation and unbalanced information in drug promotion supporting their use: indication, presentation and dosage are often included and highlighted by larger font sizes and colorful text, whereas information restraining drug use, such as contraindications, warnings, precautions and adverse reactions, when available, are less evident and not as visible. 15,17,22 However, these studies have not investigated the consistency between promotional claims and related cited references.…”

Fatores associados ao uso de benzodiazepínicos no serviço municipal de saúde da cidade de Coronel Fabriciano, Minas Gerais, Brasil

“…Além desses aspectos, existem outros mais sutis que também devem ser considerados como determinantes da maior prescrição de benzodiazepíni-cos para mulheres. Segundo Mastroianni et al 23 a forma estereotipada como as mulheres são apresentadas na publicidade da indústria farmacêutica interfere na abordagem clínica fazendo com que os prescritores se tornem mais suscetíveis ao diagnóstico de quadros como ansiedade e depressão no gênero feminino. É provável que, mais que uma questão de gênero, os fatores socioculturais sejam determinantes importantes desse panorama 1 .…”