RESUMEN
The medication leaflets represent the main source of written information supplied to the patients, in special to the elderly. This study aimed to analyze the content of the leaflets of drugs often prescribed for elderly people with hypertension, as well as their adequacy to the sanitary regulations and possible health implications. A descriptive study was conducted in two stages: A, in July 2002, and B, in July 2007. In each stage were analyzed 34 medication leaflets of seven antihypertensive drugs of the National Essential Drugs List (2006). Among the 68 leaflets analyzed, most did not contain all the information required by Portaria nº 110/1997 (89.5%) in the stage A and the RDC nº 140/2003 (100%) in B. In 100% of the leaflets, the legislation had not been fulfilled. Some important topics as way of administration, how to use and overdose had been absent in 76% of the leaflets, the lack of this information has an impact in the security of the antihypertensive users. Based on these data, it was possible to evidence inadequate contents of the medication leaflets. So, it is necessary greater surveillance by Anvisa, to ensure the rational use of medicines and the reduction of the risks to the elderly health.
Asunto(s)
Prescripciones de Medicamentos/normas , Hipertensión/tratamiento farmacológico , Educación del Paciente como Asunto/legislación & jurisprudencia , Anciano , Brasil , HumanosRESUMEN
As bulas representam a principal fonte de informação escrita fornecida aos pacientes, especialmente aos idosos. O presente trabalho visou analisar o conteúdo das bulas dos medicamentos frequentemente prescritos para idosos com hipertensão, bem como a sua adequação à regulamentação sanitária e possíveis implicações para a saúde. Foi realizado um estudo descritivo em duas etapas: etapa A, em julho de 2002, e B em julho de 2007. Em cada etapa foram analisadas 34 bulas de sete fármacos anti-hipertensivos que constam na Relação Nacional de Medicamentos Essenciais (2006). Entre as 68 bulas analisadas, a maioria não continha todas as informações exigidas pela Portaria n° 110/1997 na etapa A (89,5 por cento) e pela RDC n°140/2003 na B (100 por cento). Alguns itens importantes como via de administração, modo de uso e superdose não constavam em 76 por cento das bulas analisadas. A falta dessas informações é relevante para a segurança dos pacientes. Com base nos dados obtidos, foi possível constatar o não cumprimento da legislação vigente nas duas etapas do estudo. Logo, é necessária maior atuação da Anvisa para assegurar o uso racional dos medicamentos e a redução dos riscos à saúde dos idosos.
The medication leaflets represent the main source of written information supplied to the patients, in special to the elderly. This study aimed to analyze the content of the leaflets of drugs often prescribed for elderly people with hypertension, as well as their adequacy to the sanitary regulations and possible health implications. A descriptive study was conducted in two stages: A, in July 2002, and B, in July 2007. In each stage were analyzed 34 medication leaflets of seven antihypertensive drugs of the National Essential Drugs List (2006). Among the 68 leaflets analyzed, most did not contain all the information required by Portaria nº 110/1997 (89.5 percent) in the stage A and the RDC nº 140/2003 (100 percent) in B. In 100 percent of the leaflets, the legislation had not been fulfilled. Some important topics as way of administration, how to use and overdose had been absent in 76 percent of the leaflets, the lack of this information has an impact in the security of the antihypertensive users. Based on these data, it was possible to evidence inadequate contents of the medication leaflets. So, it is necessary greater surveillance by Anvisa, to ensure the rational use of medicines and the reduction of the risks to the elderly health.