Avaliação de plano de farmacovigilância para o registro de medicamento no Brasil: uma ferramenta proativa de farmacovigilância

Abstract

Every drug, despite its benefits, has the potential to cause harm, which can be avoided or minimized by ensuring quality, safety and efficacy at registration, and rational post-registration use. Historically, pharmacovigilance has focused on post-registration, but as science and legislation have evolved, it has needed to move towards a precautionary approach, including a pre-market look at establishing risk management strategies to be implemented in the aftermarket. In this context comes the Pharmacovigilance Plan (PFV), which provides the safety specifications and the description of the risk management system that the company will adopt to monitor the post-registration use of the product. In Brazil, the PFV is required by the National Health Surveillance Agency (Anvisa) from the new drug registration companies and the evaluation is carried out by the Pharmacovigilance Management (GFARM). During the review, GFARM checks whether pharmacovigilance actions proposed by companies for post-market product monitoring are acceptable in light of identified and potential risks, or if additional actions are required. The objective of this paper is to verify if the Pharmacovigilance Plans presented by the drug registration holders in Brazil, from July 1st to December 31st, 2017 present sufficient risk mitigation measures to control or eliminate these risks in the Brazilian market. To this end, a descriptive study of the requirements of GFARM to the pharmaceutical companies based on PFV analyzes during the established period was performed. This is a cross-sectional, descriptive, retrospective study, with a qualitative and quantitative approach, with convenience sampling, using 63 (sixty three) PFV analyzed as a global sample and a final sample of 52 (fifty two) requirements drawn from the analysis of these plans. Data analysis was performed using descriptive statistics, using Excel® statistical tools. As a result, it was observed that of the 63 (sixty three) plans analyzed in the period, 11 (eleven) were approved without requirements, only with post-market monitoring recommendation, and 52 (fifty two) generated some requirement for the company. Thus, in the present study, a percentage of 82.54% of Pharmacovigilance Plans requiring adjustments were observed. Regarding the qualitative and quantitative profile of the requirements, it was observed that the 52 (fifty two) requirements included 107 (one hundred and seven) requested items, distributed in 15 (fifteen) categories. Among these categories, the one that refers to the textual adequacy of package insert was predominant, present in 45 (forty five) of the 52 (fifty two) requirements evaluated in the study. Considering that the package leaflet is the main risk communication instrument for patients and prescribers, it is essential to bring the most adequate and complete information possible. From the results obtained in this work, it can be concluded that the Pharmacovigilance Plans presented by the drug registration holders in Brazil, from July 1st to December 31st, 2017, showed no sufficient risk mitigation measures to control or eliminate these risks in the Brazilian market. This highlights the importance of pre-market analysis of these plans as a proactive pharmacovigilance tool, favoring post-market risk minimization.