Avaliação do perfil de segurança de medicamentos em fontes de informações oficiais, no Brasil, Europa e Estados Unidos

Abstract

Drug-related morbidity and mortality corresponds to an important public health problem. Despite representing the most cost-effective therapeutic alternative in care, the medication use process is associated with risks. Adverse drug reactions (ADRs), considered unpleasant reactions associated with usual doses of the drug, are important causes of hospitalizations and medical care, as well as intoxications, whether intentional or not. Despite the advent of clinical bases, with detailed and high quality information, the sources of information about medicines still represent today the main, and even the only, basis for clinical decision in many points of health care. Thus, analyzing the quality of safety-related information in official information sources is an imminent need and can contribute to ensuring patient safety. In this work, the completeness of the information on adverse reactions and poisoning management contained in the package inserts of the ten drugs most involved in drug morbidity and mortality was assessed, according to the 36th Annual Report, published by the American Association of Poison Control Centers, in 2018. Such information were compared to those contained in the clinical database UpToDate, on the same drugs. The data were collected through online access to the electronic portal of Brazilian regulatory agencies, the National Health Surveillance Agency (ANVISA); from Europe, the European Medicines Agency (EMA); and the United States, the Food and Drug Administration (FDA). In total, 26 inserts were collected, 8 Brazilian, 8 European and 10 American. The results of the present study indicate that the leaflets of ANVISA and EMA, when compared with those of the FDA and the information contained in UpToDate, present a shortage in the supply of relevant information that can help the health professional to identify and quickly manage the situation and little applicability. However, those of ANVISA proved to be superior when compared to those of EMA, regarding the completeness of the information. Therefore, it is up to the regulatory agencies to invest in strategies that guarantee the improvement of the quality of the information contained in the information sources, as well as improve its applicability in clinical practice, in order to allow a quick decision making, thus reducing the risks of negative clinical outcomes.