In the 1960s, following the Thalidomide Disaster, the World Health Organization (WHO) initiated the development of an international drug safety monitoring programme. The objectives of this WHO programme are to improve the quality and safety of pharmaceuticals, and to support public health programmes by providing information for effective assessment of the risk-benefit ratio of medicinal products. The paper outlines the main focus areas of the programme and the mechanism of interaction between the countries involved. It summarises the functions of the WHO Collaborating Centre for International Drug Monitoring located in Uppsala, namely, accumulation and assessment of data on efficacy, inefficacy and risks of medicinal products, which are communicated by the participating countries, and provision of reliable and coherent data to specialists. The paper provides a review of online resources and methods used by VigiBase — global database of adverse drug reactions — that make it possible to search and analyse the data statistically. It describes the functions of the national monitoring centres located in different regions, and their interaction with the WHO. The dissemination of objective and reliable medical information throughout the world, promotion of pharmacovigilance as a science, creation of international partnerships and pooling of expertise from different countries allow for a significant improvement in the safety of pharmacotherapy.

Обсуждаются проблемы взаимозаменяемости противоэпилептических лекарственных препаратов, имеющих 1 международное непатентованное наименование. Проведен анализ 2562 спонтанных сообщений российской базы данных за период 2009 по 2015 гг. c целью выявления информации о нежелательных реакциях, возникавших при замене указанных препаратов. Преобладали сообщения о нежелательных реакциях при замене препаратов вальпроевой кислоты (21,4 % от всех сообщений на данный препарат в базе данных), ламотриджина (20,0 %), топирамата (18,6 %). Для всех лекарственных препаратов превалировали случаи неэффективности при замене, которые проявлялись учащением судорожных припадков. Преимущественно референтный лекарственный препарат переносился хорошо, а замена на воспроизведенный препарат приводила к снижению эффективности или развитию нежелательных реакций. Результаты исследования показывают, что данные спонтанных сообщений возможно и необходимо использовать при оценке взаимозаменяемости противоэпилептических лекарственных препаратов и для проведения пострегистрационного контроля за лекарственными препаратами, которые уже признаны взаимозаменяемыми.

Myopathy is a life-threatening disease that can be caused, among other things, by the intake of various medications. Despite the fact  that many drug-induced myopathies are well known, however, many  health professionals are not alert to myopathies caused by drug  interactions. Myopathy is a wellknown adverse reaction of statins,  and muscle damage can range from minor muscle pain and  weakness to life-threatening rhabdomyolysis. Colchicine can also  cause myopathy, including rhabdomyolysis. The combination of  colchicine and statins can significantly increase the risk of myopathy  compared with their intake separately. In cases of development of  myopathy in patients receiving colchicine and statins simultaneously, the most common manifestation of drug interaction was muscle  weakness, occurring in almost every case, and in some cases,  muscle weakness was so severe that the patient lost the ability to  move. In a third of cases, the development of muscle weakness was  accompanied by muscular pain, and darkening of urine to tea shade.  One study showed that 40 % of patients received concurrent combinations of drugs that increased the risk of muscle  damage. It is concluded that the simultaneous administration of  colchicine and statins requires an assessment of the “benefit-risk”  ratio, as well as the administration of drugs in minimally effective doses.

In the current conditions of the pandemic, the burden on the healthcare system, including the pharmacovigilance system monitoring the safety of pharmacotherapy, has significantly increased in all countries. An integral component in ensuring the safety of pharmacotherapy is the identification and prevention of the development of adverse drug reactions (ADR), which are a serious health problem worldwide. One of the modern problems of healthcare, including pharmacovigilance, was the lack of vaccines and drugs for the treatment and prevention of COVID-19 in the first waves of the pandemic, which led to the use of off-label a large number of drugs (hydroxychloroquine, azithromycin, ivermectin) for the treatment of patients with COVID-19 despite the fact that scientific data their benefits were of poor quality and based on in vitro studies. The accelerated approval of drugs and vaccines to combat the COVID-19 pandemic also highlighted the need for rapid data on the safety of drugs in the post-marketing period. However, despite the fact that pharmacovigilance is developing, it still lags behind the impressive scientific and technological achievements achieved in other areas of medicine. Unfortunately, spontaneous reporting does not assess the true prevalence of ADR well, since reporting indicators can vary significantly depending on the motivation, availability of time, qualifications, fear of punishment and similar factors of the sender. Given these known limitations of the spontaneous messaging method, additional strategies for detecting ADR are often used, including trigger tools, manual viewing of medical records and automated monitoring.

Обсуждаются проблемы взаимозаменяемости лекарственных препаратов с узким терапевтическим диапазоном в рамках одного международного непатентованного наименования. Проведен анализ 2073 спонтанных сообщений российской базы данных за период 2009 по 2015 гг., c целью выявления информации о нежелательных реакциях, возникавших при замене указанных препаратов. Преобладали сообщения о нежелательных реакциях при замене ингибиторов кальциневрина и синтетических гипогликемических средств: циклоспорин (20,4 % от всех сообщений на данный препарат в базе данных), такролимус (11,3 %) и глибенкламид (16,5 %). При замене препаратов ингибиторов кальциневрина преобладали нарушения со стороны почек и мочевыводящих путей, глибен-кламида — со стороны желудочно-кишечного тракта. Значительный удельный вес составили случаи неэффективности при замене левотироксина, глибенкламида и варфарина. Преимущественно референтный лекарственный препарат переносился хорошо, а замена на воспроизведенный препарат приводила к неэффективности или развитию нежелательных реакций. Результаты исследования показывают, что данные спонтанных сообщений возможно и необходимо учитывать для проведения пострегистрационного контроля за лекарственными препаратами, которые уже признаны взаимозаменяемыми.