Левофлоксацин: анализ информации об осложнениях фармакотерапии отечественной базы данных спонтанных сообщений

The main objective of this study was to analyze the adverse drug reactions (ADRs) associated with the use of levofloxacin. We analyzed ADR reports submitted to the Russian Spontaneous Report Database from 2009 to 2017. A significant difference in the number of spontaneous reports between different brands of levofloxacin was detected. Almost three quarters (74.1%) of all ADRs occurred in adults (18-64 years of age). Approximately 24% of reported ADRs were serious including two fatal cases. The most frequently reported reactions to levofloxacin involved the skin disorders (32.5%), hypersensitivity reactions (30.8%), gastrointestinal disorders (29.0%), general disorders and administration site conditions (26.3%). The results obtained may indicate a different profile of drug safety, even within the same international nonproprietary name.В статье обсуждаются проблемы безопасности применения препарата левофлоксацин. Проведён анализ спонтанных сообщений российской базы данных за период 2009 по 2017 гг. Установлены значительные отличия в количестве репортируемой информации о HP при применении левофлоксацина разных производителей. Сообщения преимущественно (74,1%) содержали информацию о взрослых пациентах (18-64 лет). Четверть поступивших сообщений содержала информацию о серьёзных HP. Наибольший совокупный удельный вес составили нарушения со стороны кожи и подкожных тканей (32,5%), реакции гиперчувствительности (30,8%), нарушения органов ЖКТ (29,0%), общие расстройства и нарушения в месте введения препарата (26,3%). Полученные результаты могут свидетельствовать о разном профиле безопасности лекарственных препаратов даже в рамках одного международного непатентованного наименования

Левофлоксацин: анализ информации об осложнениях фармакотерапии отечественной базы данных спонтанных сообщений

The main objective of this study was to analyze the adverse drug reactions (ADRs) associated with the use of levofloxacin. We analyzed ADR reports submitted to the Russian Spontaneous Report Database from 2009 to 2017. A significant difference in the number of spontaneous reports between different brands of levofloxacin was detected. Almost three quarters (74.1%) of all ADRs occurred in adults (18-64 years of age). Approximately 24% of reported ADRs were serious including two fatal cases. The most frequently reported reactions to levofloxacin involved the skin disorders (32.5%), hypersensitivity reactions (30.8%), gastrointestinal disorders (29.0%), general disorders and administration site conditions (26.3%). The results obtained may indicate a different profile of drug safety, even within the same international nonproprietary name.В статье обсуждаются проблемы безопасности применения препарата левофлоксацин. Проведён анализ спонтанных сообщений российской базы данных за период 2009 по 2017 гг. Установлены значительные отличия в количестве репортируемой информации о HP при применении левофлоксацина разных производителей. Сообщения преимущественно (74,1%) содержали информацию о взрослых пациентах (18-64 лет). Четверть поступивших сообщений содержала информацию о серьёзных HP. Наибольший совокупный удельный вес составили нарушения со стороны кожи и подкожных тканей (32,5%), реакции гиперчувствительности (30,8%), нарушения органов ЖКТ (29,0%), общие расстройства и нарушения в месте введения препарата (26,3%). Полученные результаты могут свидетельствовать о разном профиле безопасности лекарственных препаратов даже в рамках одного международного непатентованного наименования

Проблема взаимозаменяемости ингаляционных лекарственных препаратов: анализ информации о нежелательных реакциях из федеральной базы данных спонтанных сообщений

The aim of this study was to analyze the possibility of inhaled drug substitutions. Methods. The authors analyzed spontaneous reports from the Federal database of adverse events associated with switching a patient from the reference ipratropium bromide/fenoterol combination to a generic one. Results. The drug substitution within one INN was reported in 15% of all reports about adverse events related to prescription of this INN. A great deal of these reports was related to drug substitution in elderly. Generally, the reference drug was well tolerated, but its substitution to a generic drug resulted in lower efficacy (18.8%) or development of adverse events, mostly respiratory (51.8% of all adverse events). Conclusion. The inhaled drug substitution could be associated with a potential risk of adverse events or lower efficacy. The substitution of inhaled drugs within one INN should be made with caution. © 2018 National Research University Higher School of Economics. All rights reserved.В статье обсуждаются проблемы взаимозаменяемости ингаляционных лекарственных препаратов (ИЛП). Материалы и методы. Проведен анализ спонтанных сообщений (СС) за 2009-2018 гг., взятых из федеральной базы данных СС. Целью данного исследования явилась оценка нежелательных реакций (НР), вызванных заменой ИЛП ипратропия бромид + фенотерол. Информация о замене ЛП в рамках одного международного непатентованного наименования (МНН) составила 15,0 % всех СС о данном препарате в федеральной базе данных, при этом значительный удельный вес составили случаи, связанные с заменами ЛП у пожилых пациентов. Результаты. Референтный ЛП переносился преимущественно хорошо, однако в случае замены на воспроизведенный препарат наблюдалось развитие НР либо отмечалась неэффективность терапии (18,8 % всех НР), при этом преобладали сведения о нарушениях со стороны дыхательной системы (51,8 % всех НР). Заключение. При замене ИЛП подтвердились возможные риски развития НР, неэффективность генерического ЛП, а также необходимость соблюдать особую осторожность при проведении замены ИЛП в рамках одного МНН

Detecting medication errors associated with the use of beta-lactams in the Russian Pharmacovigilance database

Background: Comprehensive analysis of all available data in spontaneous reports (SRs) can reveal previously unidentified medication errors (MEs). Methods: To detect MEs, we performed a retrospective analysis of SRs submitted to the Russian pharmacovigilance database in the period from January 01, 2012, to August 01, 2014. This study evaluated SRs of cases where beta-lactam antibiotics were the suspected drug. Results: A total of 3608 SRs were analyzed. MEswere detected in 1043 reports (28.9% of all cases). The total number of detected errors was 1214. Reporters themselves indicated MEs in 29 SRs. A term denoting an ME was selected in the “Adverse Reactions” section in 18 of these SRs, whereas in the other 11 reports information on the ME was found only in the “Case narrative” section. MEs were associated with wrong indications in 32.5% of the cases; 61.0% of these cases were viral infections. Various dosing regimen violations constituted 29.7% of MEs. A contraindicated drug was administered in 17.3% of all detected MEs, most commonly to a patient with a history of allergy to the suspected drug or severe hypersensitivity reactions to other drugs of the same group. Conclusion: Automatic identification of MEs in the pharmacovigilance database is sometimes precluded by the absence of a code for the respective episode in the “Adverse Reactions” section, even when the error was detected by the reporter. The most frequent types of MEs associated with the use of beta-lactams in Russia are the leading risk factors of growing bacterial resistance. © 2021, The Author(s)

Monitoring of adverse reactions on medicines in children in the Russian federation

Objective of the research - to study safety of medicinal preparations (MP) for children by analyzing a Roszdravnadzor national database of spontaneous reports (SR). This study includes a retrospective analysis of 467 primary SR on severe adverse reactions (AR) in children recorded to database in 2015. Children of preschool age have higher risk of medical therapy complications. Most frequently, skin and whole body (38,7% and 21,1%, respectively) were involved in the pathological process. Unexpected AR were identified in children in 10,8% of cases. They were often caused by antimicrobial system action drugs (43,8%) and drugs for nervous system treatment (26,1%). SR method allows to obtain new information about MP safety in the pediatric population, and to develop measures to reduce risks of medical therapy. © 2017, Pediatria Ltd. All rights reserved

Off-label structure of drugs prescription for children: An analysis of the Russian spontaneous reports database

The use of medicinal products (MP) with contraventions of officially approved instructions regulations (off-label), especially in pediatrics, is an actual problem of health care. This article studies MP off-label use structure in children and role of such drugs use in development of serious adverse reactions (AR), on the basis of Russian spontaneous reports database analysis. The results confirm that off -label MP prescription is an independent factor for AR developing risk. The study proved that spontaneous reports method is effective in studying of medicines use security problems and allows to develop recommendations that can significantly reduce the risk of pharmacotherapy complications, including in pediatric patients. © 2016, Pediatria Ltd. All rights reserved

Medication errors associated with beta-lactam antibiotics: Analysis of Russian spontaneous reporting database

The authors conducted a retrospective analysis of Russian database of spontaneous reports (SRs) for the period from 01.01.2012 to 01.08.2014. They analyzed 3608 SRs concerning adverse drug reactions associated with beta-lactam antibiotics to identify medication errors (MEs). MEs were detected in 1043 (28.9%) SRs, total amount of MEs was 1214. Medication error-related terms were indicated by reporters in 29 (0.8%) SRs. The most common types of identified MEs were inappropriate indication for the antibiotic - 32.5% MEs, deviations from the recommended dosing scheme - 29.7% MEs, and the use of contraindicated drug - 17.3% MEs. The use of antibiotics for viral infections and errors associated with a patient with documented hypersensitivity to administered drug pose a special problem. The highest number of SRs with MEs was associated with the use of cefazolin (50.8% SRs), amoxicillin (40.9% SRs), amoxicillin/clavulanate (40.0% SRs). The study shows the need to develop measures for prevention of MEs associated with the use of beta-lactam antibiotics in clinical practice. © 2019 Media Sphera Publishing Group. All rights reserved

Система фармаконадзора в Евразийском экономическом союзе

The article deals with the main provisions of the basic document - «Rules of good practice of pharmacovigilance of the Eurasian economic Union», which regulates the study and prevention of adverse reactions and other problems associated with drugs in the member States of the Union, including the Russian Federation. Also, the Rules establish requirements for the organization of pharmacovigilance system in pharmaceutical companies, detail the work of manufacturers in the field of risk management, as well as determine the procedure for informing employees of the pharmaceutical industry and specialists of medical institutions of the authorized bodies about the identified safety problems in the use of medicines.В статье рассматриваются основные положения базового документа - «Правила надлежащей практики фармаконадзора Евразийского экономического союза», который регулирует деятельность по изучению и предотвращению нежелательных реакций и других проблем, связанных с лекарственными средствами, в государствах - членах Союза, в том числе в Российской Федерации. Также Правила устанавливают требования к организации системы фармаконадзора в фармацевтических компаниях, детализируют работу производителей в области управления рисками, а также определяют порядок информирования сотрудниками фармацевтической индустрии и специалистами медицинских учреждений уполномоченных органов о выявляемых проблемах безопасности при применении лекарственных препаратов

Off-label structure of drugs prescription for children: An analysis of the Russian spontaneous reports database

The use of medicinal products (MP) with contraventions of officially approved instructions regulations (off-label), especially in pediatrics, is an actual problem of health care. This article studies MP off-label use structure in children and role of such drugs use in development of serious adverse reactions (AR), on the basis of Russian spontaneous reports database analysis. The results confirm that off -label MP prescription is an independent factor for AR developing risk. The study proved that spontaneous reports method is effective in studying of medicines use security problems and allows to develop recommendations that can significantly reduce the risk of pharmacotherapy complications, including in pediatric patients. © 2016, Pediatria Ltd. All rights reserved

Monitoring of adverse reactions on medicines in children in the Russian federation

Objective of the research - to study safety of medicinal preparations (MP) for children by analyzing a Roszdravnadzor national database of spontaneous reports (SR). This study includes a retrospective analysis of 467 primary SR on severe adverse reactions (AR) in children recorded to database in 2015. Children of preschool age have higher risk of medical therapy complications. Most frequently, skin and whole body (38,7% and 21,1%, respectively) were involved in the pathological process. Unexpected AR were identified in children in 10,8% of cases. They were often caused by antimicrobial system action drugs (43,8%) and drugs for nervous system treatment (26,1%). SR method allows to obtain new information about MP safety in the pediatric population, and to develop measures to reduce risks of medical therapy. © 2017, Pediatria Ltd. All rights reserved