Bulas de medicamentos usados por idosos com hipertensão: adequação da informação à regulamentação sanitária e possíveis implicações para a saúde

Abstract

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.