Pharmacovigilance: assessment about the implantation and operation at pharmaceutical industry

Abstract

This study aims to evaluate the implementation and operation of a pharmacovigilance program in the pharmaceutical industry in Brazil, taking as a tool a questionnaire with closed questions. The survey was carried out between the second quarter of 2009 and the first quarter of 2010. From 181 pharmaceutical companies that received the questionnaire, 7.18 % did not answer, but reported that they did not have a pharmacovigilance program or said that it was confidential company information, 27.62 % have contributed to the survey by answering the questions. Of these, 82 % said they already have a program of pharmacovigilance and 18 % said the program was under implementation. Moreover, companies considered small businesses represent the majority of which are in the deployment phase of their pharmacovigilance programs. Considering results and comparing with the number of notifications received on the reports from Sistema de Notificações em Vigilância Sanitária (Notifications System in Health Surveillance), it was observed that pharmaceutical companies represent a small portion when compared to hospitals and notifying pharmacies.