Results of a Sociological Survey on the Needs of Drug Safety Monitoring Specialists for Information on the Creation of the Pharmacovigilance System Master File

Abstract

The Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union oblige developers and marketing authorisation holders to implement a pharmacovigilance system that has to be described in the pharmacovigilance system master file (PSMF). Analysis of public sources revealed lack of data describing the creation of a PSMF. Therefore, the creation of a PSMF and keeping it up to date may prove challenging for pharmacovigilance specialists.The aim of the study was to identify information needs of pharmacovigilance specialists by carrying out a sociological survey.Materials and methods: the authors used information analysis methods (review and analysis of regulatory documents and scientific literature) and sociological methods (a questionnaire for pharmacovigilance specialists).Results: the analysis helped to identify the following master file sections that present problems for specialists: sources of safety data; annexes to the master file; quality system; changes in the pharmacovigilance system that may result in an additional request from the competent authorities, etc.Conclusions: the authors identified the most relevant topics for additional training: “Pharmacovigilance system documents” and “Pharmacovigilance system master file”. The results of the study are helpful for elaboration and updating of additional training programmes for pharmacovigilance specialists.

Keywords

• master file
• pharmacovigilance system
• medicinal product
• risk management system
• pharmacovigilance quality system
• sources of safety data
• annexes to master file