The origins of the journal Safety and Risk of Pharmacotherapy date back to 1994. The journal was published as Safety of Medicinal Products, Safety of Medicines, and Safety of Medicinal Products and Pharmacovigilance. In Russia, this journal has always been the only specialised scientific publication covering exclusively the safety of pharmacotherapy. Alla V. Astakhova, Candidate of Medical Sciences, headed the journal from 1994 to 2015.The history of the journal is closely intertwined with the history of the pharmacovigilance system in Russia. Vladimir K. Lepakhin, Doctor of Medical Sciences, Professor, Corresponding Member of the Russian Academy of Sciences, has made an outstanding contribution to the development of the Russian pharmacovigilance system. This joint interview with Alla V. Astakhova and Vladimir K. Lepakhin presents the major milestones in the development of the journal and the Russian pharmacovigilance system.

The article presents the results of analysis of the use of drugs in the first trimester of pregnancy from the point of view of safety to the fetus

In this article authors describe some existing methods of benefit / risk assessment.

Paclitaxel is an effective antitumor agent used for treatment of breast cancer, lung, stomach and pancreas. However, its own adverse effects and the use of toxic Cremophor EL as the solvent limit the application range of this drug. Associated with the albumin-bound nanoparticle paclitaxel (paclitaxel SAN) specifically transported into tumor tissue. This leads to an increase in the antitumor effect, and it reduces the severity of side effects.

The article presents the mechanisms of development and methods of correction of myotoxicity associated with use of local anesthetics

The article presents the results of pharmacoeconomic studies of adverse reactions to the drugs in Russian Federation.

Acetaminophen is one of the most commonly used analgesics /anti pyretics. However, taking into account the existing risk of hepatotoxicity,regulatory bodies of a number of the countries made additional adjustments tothe recommendations on the use of this drug. In the article the possible reasonsfor recourse to acetaminophen are discussed

Age-related macular degeneration is the main cause of loss of sight in the world. This review presents a current view on modern drugs used for the treatment of macular degeneration. A comparison effectiveness and safety profile of bevacizumab, ranibizumab, and pegaptanib aflibercept enables us to conclude that each of these compounds has its own advantages and disadvantages. Further study will develop rational schemes of their application.

The safety of interferons was assessed by analyzing 499 spontaneous reports in the Russian database from 2015 to 2017. The results led to the conclusion that the safety profile of systemic interferon preparations that are widely used in medical practice to treat multiple sclerosis is defined by data in spontaneous reports for the development of adverse reactions to them or the ineffectiveness of using them.

Multiple sclerosis is one of the most common neurological diseases of working age population. The last 20 years widely use drugs that change the course of multiple sclerosis. The article is devoted to the problems of the safety of treatment of multiple sclerosis with interferon beta drugs. The aim of the study was to analyze the adverse drug reactions (ADRs) of interferon beta medicines and the assessment of the possibility of identify signals on rare adverse drug reactions based on spontaneous reporting data. A retrospective analysis of reports of ADRs that occur after the use of interferon beta-1a, interferon beta-1b was performed. The results confirm the known risks of developing ADRs of this group of drugs: general disorders and administration site conditions, nervous system disorders, musculoskeletal and connective tissue disorders and psychiatric disorders. Under-reporting of ADR was identified, high level reporting rate from manufacturers was detected. A significant number of received spontaneous reports contained information about serious ADRs (52.9 % — for interferon beta-1a; 29.4 % — for interferon beta-1b). All ADRs corresponded to those specified in the instructions for medical use of drugs. The results of the study confirmed the possibility of identifying signals associated with the occurrence of very common, common, and uncommon ADRs, such as thrombocytopenia.

The article presents data obtained in a retrospective analysis of spontaneous messages (SM) on drug adverse reactions during pregnancy, recieved in the Russian base «Pharmacovigilance» AIS Roszdravnadzor, for the period 1 January 2015 to 31 December 2015 included.

The risk-based approach to pharmacovigilance control implemented in Russia since January 1, 2018 increases the responsibility of manufacturers and developers of medicines. The purpose of the work is to assess the system of Express reporting and Periodic reporting on the safety of drugs in accordance with the relevant requirements of the legislation of the Russian Federation and the Eurasian Economic Union. The article continues a series of publications on recommendations for the preparation of reporting forms on pharmacovigilance. The article presents the results of the assessment of the state of elements of the system of drug safety control in Russia in terms of the preparation of reporting forms in accordance with the current regulatory requirements of national and international legislation for holders of registration certificates of medicines for medical use and developers of medicines. Recommendations for proper preparation of periodic reporting are proposed. The range of problems requiring additional assessment, in particular, the state of the system of regional centers for monitoring the safety of medicines in Russia is highlighted. The article is addressed to clinical pharmacologists, pharmacovigil commissioners, pharmacovigilance specialists, heads of medical and pharmaceutical organizations and medical authors.

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.

Systematic evaluation of management principles by signals on medicinal drugs safety is submitted. The sources of signals, the approaches to the detection signal processing and detection, validation, analysis and prioritization, signal assessment are considered. A review of the individual security reports is demonstrated. A statistical analysis of large databases and processes of their regulation was shown. Practical recommendations for the identification of signals in national and international databases are given.

Comparative evaluation of information about adverse reactions to medicinal products was carried out on the basis of the research data registered in specialized databases WHO, Russia, Switzerland, USA and the Republic of Kazakhstan. Comparative evaluation of the results of safety monitoring medicines showed that in the Russian Federation the average reporting about adverse reactions below the level recommended by WHO and countries with the most effective system of pharmacovigilance, such as the USA or Switzerland, but higher than in the Republic of Kazakhstan.

Hepatitis C virus (HCV) is the leading cause of chronic liver disease, surpassing hepatitis B virus and alcohol. The paradigm for treating HCV has radically changed over the last 20 years. The tolerability and duration of treating HCV patients was altered fundamentally by the emergence of modern and more efficacious treatment regimens and plans. Nevertheless, the risk of developing serious adverse reactions, including those due to drug–drug interactions, remains high. Currently, eight drugs are approved for treating HCV and avoid the use of interferons. The present article reviews these drugs with respect to their efficacy and safety for use in patients with various HCV genotypes.

The article describes the landmarks of control and licensing system development for the purpose of drug evaluation, marketing authorization and circulation in Russia. The need for the development of a state institution for performing expert evaluation of medicines was satisfied in 1990 by the establishment of the All-Soviet Union Scientific Centre for Expert Evaluation of Medicines (renamed in 1992 as the Russian State Centre for Expert Evaluation of Medicines - RSCEEM). The activities of the Centre included expert evaluation of all documents for new pharmaceutical products; organization and monitoring of clinical trials, as well as the assessment of their results; development of the recommendations regarding marketing authorization and medical use of new medicines. It also exercised the functions of the Federal Centre for Adverse Drug Reaction Study. RSCEEM became a basis for modern currently functioning Scientific Centre for Expert Evaluation of Medicinal Products».

The article presents data obtained in a retrospective analysis of spontaneous messages (SM) on drug adverse reactions during pregnancy, recieved in the Russian base «Pharmacovigilance» AIS Roszdravnadzor, for the period 1 January 2015 to 31 December 2015 included.

Systematic evaluation of management principles by signals on medicinal drugs safety is submitted. The sources of signals, the approaches to the detection signal processing and detection, validation, analysis and prioritization, signal assessment are considered. A review of the individual security reports is demonstrated. A statistical analysis of large databases and processes of their regulation was shown. Practical recommendations for the identification of signals in national and international databases are given.