Irregularities´s drugs marketed in Brazil: an analysis of notifications and sanitary measures from 2012 to 2017

Abstract

Introduction: The drugs available for consumption must have efficacy, safety and quality, being essential their monitoring after registration. Objective: This study analyzed the main irregularities of the medicines, their characteristics, types of sanitary measures, means of verification and therapeutic classes (Anatomical Therapeutic Chemical) that have risks of causing damages to the health of the population. Method: Descriptive and quantitative study using data from the National Product Notification System (Notivisa), Specific Resolutions in the Official Gazette of the Federal Executive and, in addition, data presented in the Management and Activity Reports of the Brazilian Health Regulatory Agency, with retrospective analysis of the notifications and precautionary measures of drugs that presented irregularities in the period from 2012 to 2017. Results: There was a progressive increase in notifications for all products, from 37,419 in 2012 to 54,545 in 2017, and medicines accounted for 38.5% of total notifications. 807 sanitary measures were analyzed, comprising 1,149 drugs and 254 companies. In this universe, 55.9% were medicines that presented quality  deviations, evidenced mainly by laboratory analysis (48.9%) or by on-site verification during sanitary inspection (13.3%) and in only 30.6% of the measures, there was voluntary withdrawal by the company. The most frequent therapeutic classes were antibacterial, analgesic and antiviral drugs with 13.2% of the irregular drugs, and the herbal products led the list of unregistered or companies in irregular situation. Conclusions: Data pointed to the need for a redesign of the post-market surveillance model and for the implementation of a traceability system, so that there is greater responsibility for marketed pharmaceutical products, and an inhibition of counterfeit trade.