Audits and inspections of pharmacovigilance systems in Russia

Abstract

The implementation of pharmacovigilance activities is impossible in isolation from compliance with the quality requirements of medicines and the activities of pharmaceutical and medical organizations throughout the pharmaceutical practice, as well as without access to sales plans, sales results and full relevance of information on drug conditions in all markets and in all cases of application. Properly conducted audit or inspection evaluation of the pharmacovigilance system makes it possible to identify and prevent drug safety problems at all stages of its life cycle.The aim. Development of a risk-based strategy for planning and passing audits and inspections of the pharmacovigilance system for the subsequent creation of effective programs for assessing the pharmacovigilance system on its basis.Material and methods. The study used structurallogical, empirical methods, general logical methods of scientific knowledge, methods of generalization and extrapolation.Results. The plans and results of audits and inspections of pharmacovigilance systems of Russian and foreign pharmaceutical organizations and their pharmacovigilance vendors were analyzed. A risk-based strategy and a checklist for planning internal and external audits of pharmacovigilance systems of Russian pharmaceutical organizations and their vendors for pharmacovigilance have been developed and recommendations for training internal auditors of pharmacovigilance systems and audit teams have been developed for them.Conclusion. Risk assessment indicators adapted for Russia have been developed, according to which Russian pharmaceutical organizations and their pharmacovigilance vendors can assess the likelihood of the risk of priority inclusion in the plan of Russian inspections of pharmacovigilance systems for compliance with the requirements of the good pharmacovigilance practice of the Eurasian Economic Union. Recommendations were prepared for the executive management and pharmacovigilance specialists of Russian pharmaceutical organizations in terms of assessing regulatory risks for the quality system of the pharmacovigilance system, planning and conducting audits; evaluating the relationship of pharmacovigilance with other good practices and with information from the plans and results of the organization as a whole. The indicators adapted for Russia for assessing the compliance of the pharmacovigilance system with the rules of the NPF EAEU are given.