Medicamentos novos registrados no Brasil de 2003 a 2013: Análise da segurança e do valor terapêutico

Abstract

Medicines should be analyzed from the perspective of efficacy and safety. Besides the numerous health benefits in cure and preventing disease and improving quality of life medicines have risk of adverse events. In public health point of view the importance of a new drug is the therapeutic value and benefit that produces for the patient and for society. The aim of the research was to analyze the new drugs registered in Brazil in the period from January 1, 2003, to December 31, 2013, from the perspective of drug safety, The Health System of Brazil and the global burden of disease in the country. Retrospective cohort study with document analysis in databases, technical and scientific publications, and official documents of drug regulatory agencies, the Health Ministry and World Health Organization The following information was collected: drug characteristics, therapeutic innovation, postmarketing safety and incorporation into Health System of Brazil. Data about disease burden in Brazil were obtained from the Global Burden of Disease 2012 Study. To assess new drugs therapeutic innovation value was used the Motola Algorithm published in 2004. A descriptive statistical analysis was performed. A Kaplan Meier survival curve was calculated encompassing the period between the registration date in Health Surveillance Agency of Brazil and the issue postmarketing safety alert or market withdrawn until June 30, 2014, the date of interruption observation period. The cohort consisted of 159 drugs with registration in Health Surveillance Agency of Brazil in study period. Analyzing the DALY (disability adjusted life of years) for overall drugs indications, 88.7% of disease burden is designed to noncommunicable diseases. The cohort of medicines reflects the process of epidemiological and demographic transition underway in the country. However, there is an imbalance among disease burden and number of new drugs registered. The Kaplan Meier curve showed a statistically significant association among time to occur events postmarketing safety and the drug has Risk Evaluation and Mitigation Strategy in Food and Drug Administration, with the rank value of log (Mantel Cox) = 0.002 for new drugs approved by Health Surveillance Agency of Brazil. Strategies to incentive research and development of new drugs from a health system perspective should be prioritized to reduce the imbalance between disease burden and the number of new drugs registered. Brazil still is in the process of implementing a more proactive pharmacovigilance.