Healthy Skepticism Library item: 1186

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Publication type: Journal Article

Mastroianni Pde C, Galduroz JC, Carlini EA.
Influence of the legislation on the advertisement of psychoactive medications in Brazil.
Rev Bras Psiquiatr 2003 Sep; 25:(3):146-55

Abstract:

OBJECTIVE: 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 (Agencia Nacional de Vigilancia Sanitaria- 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.

Keywords:
Advertising/legislation & jurisprudence* Brazil Drug Industry/legislation & jurisprudence* Psychotropic Drugs* Research Support, Non-U.S. Gov't United States World Health Organization