DOI: https://doi.org/10.22263/2312-4156.2022.1.110
Marchenkov N.V.1, Khutkina H.A.2, Diyachkova L.V.1
The analysis of routine risk minimization measures of the use of medicinal products produced by RUE «Belmedpreparaty» on the territory of the Republic of Belarus
1RUE «BELMEDPREPARATY», Minsk, Republic of Belarus
2Vitebsk State Order of Peoples’ Friendship Medical University, Vitebsk, Republic of Belarus
Vestnik VGMU. 2022;21(1):110-120.
Abstract.
Today, it is of great importance to timely inform health care professionals and patients about the risks associated with the use of medicinal products (MP) in order to minimize the development of undesirable effects of pharmacotherapy. The easiest way to convey this information to the end-user is to make changes in the general characteristics of a medicinal preparation (SmPC) and the instruction for medical use (IFU)/package leaflet (PL). To maintain up-to-date information in the SmPC and IFU/PL, it is necessary to constantly monitor new information on the efficacy and safety of medicinal products.
The article presents data on the implementation of routine risk minimization measures associated with the discovery of new and relevant information on safety in relation to MP produced by RUE «Belmedpreparaty» in 2018-2020. At the moment, the company produces a wide range of medicines, therefore, the implementation of constant monitoring of such information for further updating of information about the drug is an important link in the work of the pharmacovigilance department.
Key words: medicinal product, adverse reaction, new safety information, pharmacovigilance, drug safety monitoring, general characteristics of a medicinal product, package leaflet, marketing authorization holder, pharmaceutical market.
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Information about authors:
Marchenkov N.V. – pharmacist of the 2nd category of the pharmacovigilance department of RUE «Belmedpreparaty», postgraduate student of the Chair of Organization and Economics of Pharmacy with the course of the Faculty for Advanced Training and Retraining, Vitebsk State Order of Peoples’ Friendship Medical University;
Khutkina H.A. – Candidate of Pharmaceutical Sciences, associate professor, head of the Chair of Organization and Economics of Pharmacy with the course of the Faculty for Advanced Training and Retraining, Vitebsk State Order of Peoples’ Friendship Medical University;
Diyachkova L.V. – Candidate of Pharmaceutical Sciences, deputy chief technologist of RUE «Belmedpreparaty».
Correspondence address: Republic of Belarus, 220007, Minsk, 30 Fabricius str., RUE «Belmedpreparaty». E-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра. – Nikita V. Marchenkov.
