Since 2010, Russia has been developing new drug legislation, internal quality control and safety of medical organizations, and has developed algorithms for submitting Individual Case Safety Reports (ICSR) using an automated information system. On April 1, 2019, Russia launched an updated national database of ICSR, which uses the international ICH E2B data standard, which may increase the amount of reporting to the Uppsala monitoring center. This publication covers the key aspects of pharmacovigilance system development in the Russian Federation. The analysis of pharmacovigilance structure in the Russian Federation is carried  out, its main problems are designated. Presents methods to identify causal relationships between adverse reaction and drug, evaluation of its degree of validity (questionnaires, algorithms, and scale), as already recommended by the WHO, and the new modifi ed versions. The expediency of using a scale for determining the degree of reliability of a causal relationship «an undesirable reaction — drug interaction» when analyzing spontaneous reports of undesirable reactions that may be caused by drug interactions is noted. An effective method of detection and prevention of adverse reactions is presented — the Global Trigger Tool (GTT). The question of the need for motivation and training of medical personnel in the correct design of spontaneous messages, as well as methods of identifying the causal relationship between adverse reactions of drugs. The directions of optimization of pharmacovigilance system are proposed, including methods of more effective active surveillance in the identifi cation and prevention of adverse reactions.

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.

Nanoscale drugs differ in special physicochemical, biological, pharmacokinetic parameters. These properties can be used to provide targeted delivery, prolong the action of drugs, as well as reduce their side effects. An important problem that needs attention is the study of the potential risks arising from the treatment of such drugs. The aim of the study: analysis of the requirements of domestic and foreign regulators for the safety of nanoscale drugs. The paper presents the classification of the most promising nanosystems containing drugs, and an analysis of the existing principles for assessing their safety in Russia and abroad has been carried out. It was shown that when assessing the safety of nano-sized drugs, along with the properties of the active substance, it is necessary to take into account the properties of the nanosystem (polymer coating, carrier, etc.), related to its size, distribution pattern, charge of nanoparticles, and ability to induce oxidative stress. Domestic and foreign regulatory documents governing the procedure for assessing the safety of pharmacological substances derived from nanotechnology was analyzed. Conclusions: Despite the availability of recommendations from regulatory authorities, further improvement of the requirements for registration and safety assessment of nanoscale drugs is necessary. Further development of the regulatory framework governing the development, quality, efficiency and safety of nanomaterials in medicine is necessary, taking into account the structural issues of the active substance and nano-carriers.

Despite the inadequate evidence of effi cacy and safety of opioid use for the treatment of migraine, it has been reported that patients with moderate to severe migraine headaches are prescribed opioids. Migraineurs may experience serious health impacts from opioids such as headache-related disability, psychiatric and cardiovascular comorbidities. The reduction of the risk of opioid abuse and prevention of an opioid epidemic are important public health challenges. The aim of this study was to assess the awareness of opioid therapy for migraine and the frequency of use among Turkish patients with episodic and chronic migraine. Materials and methods: consecutive migraine patients were enrolled in this cross-sectional study. A semi-structured questionnaire was developed and used by the researchers to assess the patients’ awareness of an opiod treatment option and the frequency of use of opioids for migraine treatment. Results. One hundred two patients were enrolled, of which 72 had episodic migraine and 30 had chronic migraine. All subjects reported that they had not been offered or prescribed any kind of opioids by general practitioners and neurologists for their headache. Besides, only 7 % of patients declared that they had heard of opioid treatment for migraine but they had never consulted their doctors about its effects. Conclusions. Our fi ndings demonstrated that opioids were not preferred as an option for acute or preventive migraine treatment by Turkish migraineurs and their physicians. The reduction of opioid prescription will help to prevent the development of medication overuse and opiate-induced headaches and drug addiction.

Drug induced liver injury is one of the most frequent reasons for stopping treatment and the main cause of the onset and progression of acute liver failure, requiring liver transplantation. In children antibacterial drugs are on the first place in terms of hepatotoxicity, and the hepatocellular type is the most common type of liver damage. Often there is crosssensitivity within the same group of antibiotics, for example, beta-lactams. The aim: to analyze the causes of drug hepatotoxicity in the infant child while taking antibacterial agents. The article presents a clinical case of multiple hepatotoxicity caused by antibacterial agents such as beta-lactams, fluoroquinolones, sulfanilamides in one infant child, which suggests its genetic basis. It was shown that during therapy it is important to take into account the risk factors for hepatotoxicity (age, concomitant pathology, potential drug interactions with simultaneous use) and regularly evaluate the patient’s condition taking into account possible liver damage (including laboratory tests).

 Analysis of administrative decisions of foreign regulatory authorities on the limitation of circulation of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profi le, conducted by experts of the Scientifi c Centre for Expert Evaluation of Medicinal Products revealed 27 administrative decisions of foreign regulatory authorities. These decisions contained information on the following medicines registered in Russia: sartans (irbesartan, candesartan, losartan, olmesartan), hydrochlorothiazide, dimethylfumarate, human normal immunoglobulin, omalizumab, tacrolimus, terifl unomide, tofacitinib, ustekinumab, fi ngolimod, everolimus, atezolizumab, pembrolizumab, vinorelbine, daratumumab, imatinib, ipilimumab, lenalidomide, lenvatinib, methotrexate and ramucirumab.