The pharmacovigilance system plays one of the key roles in ensuring safety and efficacy of medicine use. The risk management process helps to ensure the most favourable benefit/risk ratio of a medicine or combination of medicines both for the target populations and the general public. Unavailability of a risk management process for medicines may adversely affect the health of the general population. One of the major documents in medicine risk management is the risk management plan (RMP).The aim of the study was to analyse compliance of RMPs submitted as part of registration dossiers with the requirements of the Eurasian Economic Union (EAEU), and to analyse problems arising during their preparation.Materials and methods: the authors analysed 200 RMPs submitted from January 1 until August 31, 2021.Results: it was determined that the most frequent mistakes made by pharmacovigilance officers are related to medicine summaries in RMPs covering several medicines, medicine safety specification parts of RMPs, description of risks in the pharmacovigilance plan and description of risk minimisation measures, and insufficient representation of the key elements of the medicine efficacy and safety overview in the RMP summary. For instance, RMPs often lack information on the epidemiology of indications for target populations in the EAEU, or RMPs may lack some of the major risks reflected in the patient information leaflets, or lack assessment of safety risk minimisation actions, etc.Conclusions: proper preparation of RMPs that would comply with the EAEU Good Pharmacovigilance Practice is inconceivable without further professional training of pharmacovigilance officers.

The experts of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of foreign regulatory authorities on the recalls of antibacterial and antiprotozoal medicinal products and/or the need for labelling updates due to changes in the safety profile. The analysis revealed 16 decisions containing information on the following medicines registered in Russia: ertapenem, сeftriaxone, cefazolin, аmoxicillin, сefoperazone+sulbactam, piperacillin+tazobactam, сlindamycin, teicoplanin, rifampin, co-trimoxazole, hydroxychloroquine.

Aminoglycosides are broad-spectrum antibacterial agents used  in the treatment of urinary  tract infections, tuberculosis, visceral leishmaniasis, sepsis in newborns, as well as cystic fibrosis. However, the use of aminoglycosides is limited due to their ototoxicity — the risk of developing serious adverse  reactions, in particular, persistent irreversible hearing loss and vestibular disorders associated with the death of hair cells in the inner ear. The review analyzes scientific data on the possible mechanisms of aminoglycosides’ damaging effect  on the hair cells  of the inner  ear. Genetically determined causes contributing to the manifestation of ototoxic properties of drugs of this group are described. The necessity of genetic screening for the carriage  of mutations m.1555A>G  and m.1494C>T in the MT-RNR1 gene  of mitochondrial DNA is substantiated in order to minimize the risk of hearing disorders in patients with hereditary predisposition. Understanding the mechanisms of ototoxicity of aminoglycosides will make it possible to find ways to prevent and correct hearing loss after their use.

В соответствии с Решением Совета Евразийской экономической комиссии от 19.05.2022 № 81 «О внесении изменений в Правила надлежащей практики фармаконадзора Евразийского экономического союза» 6 декабря 2022 г. вступила в силу новая редакция Правил надлежащей практики фармаконадзора (GVP) Евразийского экономического союза (ЕАЭС). Одним из ключевых документов системы фармаконадзора, предоставляемым в составе регистрационного досье лекарственного препарата, является план управления рисками (ПУР). Цель работы: провести экспертный анализ изменений требований Правил GVP ЕАЭС к структуре, содержанию и порядку представления ПУР для лекарственных препаратов. Результаты проведенного анализа показали, что в требования, предъявляемые уполномоченными органами в области обращения лекарственных средств к документу о системе управления рисками для лекарственного препарата в ЕАЭС, внесены существенные изменения. В частности, уточнены и расширены требования к информационному наполнению частей и модулей ПУР. Введено требование обязательного соответствия между информацией, приведенной в модулях и частях ПУР и в модулях регистрационного досье лекарственного препарата. Представлено подробное описание, при каких условиях, процедурах и в каких исключительных ситуациях держателю регистрационного удостоверения необходимо представлять ПУР в составе регистрационного досье. Новые требования позволят держателям регистрационных удостоверений усовершенствовать и оптимизировать процесс управления рисками.Ключевые слова: план управления рисками; фармаконадзор; регистрация лекарственных средств; Правила надлежащей практики фармаконадзора; Евразийский экономический союз; GVP ЕАЭС; держатель регистрационного удостоверения

Background. Drug-drug interactions can seriously affect the safety profile of a drug and are an important problem worldwide. Due to the aging of the population, the increasing frequency of polypharmacy, as well as the spread of self-medication, adverse events that are difficult to identify may occur. It is hard to establish a causal relationship between the administration of a certain drug and the occurrence of an adverse event; it may also lead to the conversion of the adverse event into an adverse drug reaction. The risk of drug-drug interactions increases with combination therapy, as a result of misuse of a drug (off-label use), as well as in the absence of full disclosure from physician and patient about potential drug-drug interactions.One of the ways to detect an adverse reaction to a drug is a method of «spontaneous messages», when notification cards issued according to the regulated form are sent from subjects of drug circulation to the national centers for pharmacovigilance, then to the global database of the World Health Organization VigiBase.The aim of the work was a comprehensive analysis of the content compliance of the information presented in the instructions for the medical use of antibacterial drugs on potential drug-drug interactions with validated signals from the WHO global VigiBase database.Material and Methods. The study used information and analytical comparative non-quantitative, graphical, logical methods of analysis, as well as regression analysis. Objects of the study: instructions for medical use for international generic drugs ampicillin, amoxicillin, azithromycin, clarithromycin.Results. The contents of the instructions for use concerning possible interactions of ampicillin, amoxicillin, azithromycin, clarithromycin upon administration with other drugs were studied. Subsequently, a comparative analysis of the obtained data on drug-drug interactions of antibiotics with other drugs was carried out with signals of drug-drug interactions were validated by VigiBase.Conclusion. The study showed that a detailed description of the risks of potential drug-drug interactions in the instructions for medical use with the aim of informing doctors, patients, and caregivers helps to prevent the use of undesirable combinations, thereby reducing the risk of adverse reactions when drugs are used together. The study found that most of the identified information on the safe use of drugs was missing in the instructions for medical use.