Publicidad y promoción de medicamentos: regulaciones y grado de acatamiento en cinco países de América Latina / Drug advertising and promotion: regulations and extent of compliance in five Latin American countries

OBJETIVO: Analizar las distintas regulaciones sobre promoción de fármacos y su grado de acatamiento reflejado en piezas publicitarias expuestas al público en Argentina, Colombia, Ecuador, Nicaragua y Perú. MÉTODOS: Se recogieron 683 piezas promocionales expuestas en establecimientos de salud, farmacias y en la vía pública, de las cuales 132 piezas seleccionadas al azar fueron objeto de análisis. Se examinaron las regulaciones sobre publicidad farmacéutica -incluidas sus coincidencias con los criterios éticos de la Organización Mundial de la Salud (OMS)- tomadas de los sitios web oficiales y mediante entrevistas con los responsables de los organismos regulatorios y ministerios de salud de los cinco países del estudio. Se evaluaron los contenidos de los materiales de la muestra para determinar su grado de acatamiento respecto a las regulaciones nacionales y las recomendaciones sobre promoción de medicamentos de la OMS. RESULTADOS: Los países cuentan con regulaciones que incorporan los criterios éticos de la OMS. Más de 80 por ciento de las piezas analizadas incluían las indicaciones del fármaco y más de 70 por ciento omitían información sobre efectos adversos. Cincuenta por ciento de los anuncios de medicamentos de venta libre (MVL) expuestos en farmacias incluían indicaciones no aprobadas por la autoridad sanitaria correspondiente. En los anuncios expuestos en farmacias, no se hallaron diferencias significativas entre los riesgos de la información inadecuada con relación a su condición de venta (MVL o medicamentos de venta con prescripción médica). El riesgo relativo de ausencia de información sobre posología fue de 2,08 (intervalo de confianza de 95 por ciento 1,32-3,39) en las piezas distribuidas en farmacias, comparadas con las expuestas en establecimientos de salud. CONCLUSIONES: Si bien en general los cinco países del estudio incorporan en sus regulaciones sobre promoción y publicidad de medicamentos las recomendaciones de la OMS, con frecuencia dichas ordenanzas no se reflejan en los contenidos de las piezas promocionales.

OBJECTIVE: To analyze differing regulations regarding drug promotion, and the extent of compliance as seen in samples of advertising directed to the public in Argentina, Colombia, Ecuador, Nicaragua, and Peru. METHODS: A total of 683 pieces of promotional material on display in health facilities, pharmacies, and on the street were collected, 132 of which were randomly selected for analysis. The regulations governing pharmaceutical advertising, taken from official websites and interviews with regulatory officials and Ministry of Health staff in the five countries covered, were reviewed, along with their adherence to the ethical criteria of the World Health Organization (WHO). The contents of the materials in the sample were evaluated to determine their degree of compliance with national regulations and WHO recommendations on drug promotion. RESULTS: The countries have regulations incorporating WHO ethical criteria. Over 80 percent of the material analyzed included the indications for the drug, while over 70 percent omitted information on adverse effects. Fifty percent of the advertisements for overthe-counter (OTC) drugs on display in pharmacies listed indications not approved by the relevant health authority. In advertising in pharmacies, the risks from inadequate information were not found to differ significantly for OTC or prescription medications. Compared with materials provided in health facilities, the relative risk of the absence of information on dosage in the material distributed in pharmacies was 2.08 (confidence interval 95 percent 1.32-3.39). CONCLUSIONS: Although regulations on drug promotion and advertising in the five countries studied generally incorporate the WHO recommendations, promotional materials often fail to reflect the fact.

Duas décadas da Norma Brasileira de Comercialização de Alimentos para Lactentes: há motivos para comemorar? / Two decades of the Brazilian Standard for Marketing of Baby Food: are there reasons to celebrate?

OBJETIVO: Avaliar o impacto da Norma Brasileira de Comercialização de Alimentos para Lac tentes no cenário do aleitamento materno e na regulação da comercialização de fórmulas infantis. MÉTODO: O artigo analisou dados de uma pesquisa de âmbito nacional realizada em 2000, na qual foram aplicados questionários estruturados em nove tipos de público-alvo. Foram rea lizadas 2 848 entrevistas em uma amostra selecionada aleatoriamente em 159 municípios, dis tribuídos nos 26 estados brasileiros e Distrito Federal, escolhidos por análise de conglomerado. RESULTADOS: A pesquisa mostrou uma percepção adequada dos agentes quanto à importân cia e duração ideal da amamentação. A duração mediana da amamentação no Brasil aumentou nas 2 últimas décadas, porém ainda se mostrou aquém do desejável. Os fatores responsáveis pelo desmame precoce incluíram trabalho e saúde precária da mãe, crenças sobre insuficiência do leite materno e orientações de profissionais de saúde. O conhecimento sobre a norma brasileira foi bastante restrito, mesmo entre profissionais de saúde. CONCLUSÕES: A promoção do aleitamento materno no país deveria enfatizar a transcendên cia das barreiras culturais, educacionais e econômicas identificadas nos agentes envolvidos. A ação coordenada entre agentes públicos, agentes privados e terceiro setor para a disseminação da informação e do desejo de amamentar é desejável. A resistência à consolidação de parcerias deveria ser suprimida na busca de uma convergência institucional em prol do interesse maior expresso no contexto da norma brasileira: a proteção da saúde do lactente.

OBJECTIVE: To assess the impact that the Brazilian Standard for Marketing of Baby Food (Norma Brasileira de Comercialização de Alimentos para Lactentes) have had on breastfeeding rates and regulating the marketing of breast-milk substitutes. METHOD: Data were retrieved from a national survey conducted in 2000 that administered structured questionnaires to nine different groups. A total of 2 848 surveys were completed. Cluster sampling was employed to randomly select a sample from 159 towns located in the 26 Brazilian states and the Federal District. RESULTS: The survey showed that participants possess satisfactory knowledge regarding the importance of breastfeeding and its ideal duration period. During the past two decades, the median duration of breastfeeding has increased, but it is still below desired levels. The mother's return to work, maternal health issues, perception of insufficient breast milk, and information provided by health professionals were among reasons given for early termination of breastfeeding. Knowledge of the Brazilian standard was very limited, even among health professionals. CONCLUSIONS: Breastfeeding promotion in Brazil should focus on overcoming the cultural, educational, and economic barriers identified from among the various groups assessed. Interagency cooperation should include public, private, and thirdparties, and focus on disseminating breastfeeding information and promoting the desirability of breastfeeding. Barriers to cooperation should be tackled in order to ensure that the main goal of the Brazilian standard-protection of infant health-can be achieved.