UDK: 615.065

DEVELOPMENT OF ADVERSE REACTIONS DATABASES, THEIR INTRODUCTION INTO PHARMACOVIGILANCE SYSTEMS AND SIGNIFICANCE FOR THE DRUG SAFETY IMPROVE

A.E. Krasheninnikov1, .V. Matveev1,2, E.A. Egorova2

1АНО «Национальный научный центр фармаконадзора», г. Москва; 2Медицинская академия имени С.И. Георгиевского ФГАОУ ВО «Крымский федеральный университет им. В.И. Вернадского»

Abstract

Administration of medicines is inextricably linked to the risk of adverse reactions (ADR). A significant increase in the number of spontaneous reports about ADR requires new technologies to improve the power of pharmacovigilance (PV) systems. The history of development of such databases started by VigiBase of Uppsala International Drug Monitoring Center of WHO is presented in the article. Special attention is paid to the need for the systems, which collect and analyze ADR reports on marketing authorization holder“s (MAH) side. Introduction of special PV software allows MAHs to optimize and effectively manage safety systems as well as ensure systemic approach to quality of PV systems and their updates.

Keywords

information technology, database, adverse reaction, drug safety, holder of registration certificate.

Contacts

Егорова Елена Александровна – к. фарм. н., ассистент кафедры внутренней медицины № 1 с курсом клинической фармакологии, Медицинская академия им. С. И. Георгиевского ФГАОУ ВО «Крымский федеральный университет им. В. И. Вернадского», e-mail: elena212007@ram