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.

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.

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.

The article summarizes the WHO materials, regulations of normative documents, scientific publications’ data from certain foreign countries and Russia concerning interchangeability of vaccines against viral hepatitis B for immunization of adult population. The implemented analysis of data of foreign and Russian studies demonstrated compatibility of vaccine against viral hepatitis B from different manufacturers by parameters of immunological, preventive and epidemiological effectiveness that permits assuming possibility of their equivalent substitute.

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Vaccine safety is an important aspect of mass immunization of the population. Adverse reactions that occur following vaccination result in a decrease in public confidence. The aim of this research was to identify information on the development of adverse events after immunization with vaccines included into the national vaccination calendars of the USA, European Union (EU), Japan, China, South Korea and India. Particular attention was paid to vaccines that are not included in the vaccination calendar, but are presented in the Russian Federation. During monitoring of vaccination against human papillomavirus information in the European Union, Japan and the United States, according the possible connection with development of autoimmune diseases was refuted. Monitoring of adverse events after vaccination with rotavirus vaccine I generation in the USA, EU and India, allowed to establish a link with the development of intestine invagination and limit the use of this medicinal product in favor of vaccine II generation. After starting vaccination against influenza was detected narcolepsy as a complication of this procedure; and when analyzing the complications of meningococcal vaccination Guillain — Barre syndrome was detected. We also analyzed information on various complications associated with vaccination against Japanese viral encephalitis, which was included into the national vaccination calendar of countries in Asia and the Pacifi c region — China, India, Japan, and South Korea. The main complications registered in the PRC after the introduction of Japanese encephalitis vaccine into the national vaccination calendar included: febrile seizures, thrombocytopenic purpura, encephalitis and meningitis. The main safety concerns about vaccines included into the national vaccination calendars of EU countries, the USA and the Asia-Pacific region concern vaccines that have recently appeared on the pharmaceutical market.

The monitoring of information on the safety of various drugs is becoming more relevant day by day, as the number of drugs on the  pharmaceutical market increases, generic drugs, bio-analogous drugs appear. Long-term post-marketing use of a  medicinal product allows to accumulate a sufficient evidence base  and experience of application in various population groups, to study  the features of the use of this drug. Information on the safe use of  new drugs can be obtained in selected scientific publications. In  addition to publications in the specialized scientific literature,  regulators of different countries on the basis of new information give opinions on the need to make changes in instructions for medical  use. When analyzing the recommendations of Russian and foreign  regulatory authorities on restricting the circulation of medicines and  / or the need to amend the instructions for their medical use in  connection with the change in the assessment of the safety profile,  we identified 16 administrative decisions of foreign regulatory bodies containing information about the following drugs registered in  Russia. We consider all recommendations to be important  information on the safety of medicines, which is addressed to  specialists in the field of medicine, in particular to persons  authorized by pharmacovigilance in pharmaceutical companies. In  addition, this information may be of interest to physicians of various  specialties who in their practice use buprenorphine, venlafaxine,  gadolinium contrast drugs hydroxyethyl starch, daclizumab,  duloxetine, denosumab, cladribine, clomifene citrate, milnacipran, methotrexate, pemetrexet, radium dichloride, rifampicin,  phoebusostat, flupirtine.

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