Research on the Situation and Implications of the Early Postmarketing Phase Vigilance in Japan—Considerations Based on a Questionnaire Survey

Abstract

A questionnaire survey addressed to pharmaceutical companies was conducted to collect information on the situation and issues concerning EPPV (Early Postmarketing Phase Vigilance), which was conducted recently in Japan. It was shown that EPPV is conducted for almost all new drugs (including the cases for which new indication was added to the existing drugs). The result was put into a report and fed back to the medical personnel as a brochure or via a website for many cases. Safety specifications in the Risk Management Plan or materials of information provision including the package insert were revised based on the information obtained in the EPPV for about 15% of the cases. It was not feasible to evaluate the effect of EPPV from the viewpoint of risk-minimization activity. A lot of companies expressed their opinions calling for flexibility in the scope of new drugs for which EPPV is needed as well as in the method and operation of EPPV. It is quite important to implement risk management focusing on the early postmarketing phase of new drugs, and at the same time, we need to consider the balance between the resources for companies/medical institutions to implement safety measures and the performance (improvement of drug safety) demonstrated by EPPV.