对在白俄罗斯共和国境内使用“belmedpreparaterue”生产的医药产品的常规风险最小化措施进行分析

N.V. Marchenkov, H.A. Khutkina, L.V. Diyachkova
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引用次数: 0

摘要

今天,及时告知卫生保健专业人员和患者与使用医药产品(MP)相关的风险是非常重要的,以便最大限度地减少药物治疗不良影响的发展。向最终用户传达这一信息的最简单方法是更改药物制剂(SmPC)和医疗使用说明书(IFU)/包装说明书(PL)的一般特性。为了在SmPC和IFU/PL中保持最新信息,有必要不断监测有关药品有效性和安全性的新信息。本文提供了关于实施常规风险最小化措施的数据,这些措施与RUE«belmedprepare»在2018-2020年发现的与MP相关的新安全信息有关。目前,公司生产的药品种类繁多,因此,对这些信息实施持续监测,进一步更新药品信息是药物警戒部门工作的重要环节。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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
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.
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