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.

Abstract. Elderly patients are at higher risk of developing infectious diseases that might have more severe progression than those of younger age groups, accompanied by an increased risk of death. These medical conditions in elderly may also present difficulties for diagnosis due to a «blurred» clinical picture. By WHO recommendations the vaccination against influenza is one of the most effective ways to prevent this type of infection in elderly patients. However the use of vaccines may be associated with a risk of adverse drug reactions. In most cases, they have subclinical manifestations and/or non-severe clinical manifestations (adverse reactions), but in a relatively small percentage of cases, the use of vaccines may be associated with a risk of developing serious post-vaccination complications (anaphylaxis, Guillain-Barre syndrome etc.). This article represents data on the safety of influenza vaccines in patients over 60 years old, with due regard to immunosenescence. According to the authors opinion, this will improve the safety of vaccination against influenza patients 60 years and older. At the end of the article, the authors conclude that despite the potential risks, the by the benefits of the use of influenza vaccines continue to overweight potential risks and vaccination of elderly people is effective and safe way to prevent influenza. To improve the effectiveness of vaccination of patients 60 years and older the use of high dose vaccines and adjuvants can be recommended.

Abstract. Valerianа officinalis rhizomes whis roots, monocomponent and complex herbal drugs based on Valerianа officinalis, and the drug Corvalol containing chemically synthesized α-bromizovalerianic acid ethyl ester (ethyl bromovalerianate) are OTC drugs and are widely used. At the same time, in the database of drug adverse effects «Pharmacovigilance» AIS Roszdravnadzor from 2009 to 2018, 147 spontaneous reports of adverse reactions were registered when taking Valeriana rhizomes whis roots and Corvalol. The aim of the study was the analisis of spontaneous reporting about adverse reactions when taking Valeriana rhizomes and roots and the multi-component drug Corvalol in the database «Pharmacovigilance» AIS Roszdravnadzor and assessment of their compliance with the information in the instructions for medical use. It was reactions from the nervous system (lethargy, drowsiness, weakness, apathy, headache, dizziness, depression of consciousness, stupor, neurotoxicity, toxic encephalopathy), from the gastrointestinal tract (nausea, bitterness in the mouth, burning of the mucous membrane, belching, heartburn, appetite disorders), cardiovascular system (tachycardia) and allergic reactions (skin itching, skin flushing, rash, maculo-papular rash, urticaria, dermatitis, cheilitis, aphthous stomatitis, angioedema) in the reports. The sedative and anxiolytic effects of the leading biologically active component of rhizomes with valerian roots, valerenic acid, are mediated through modulation of the function of type-γ-aminobutyric acid receptors A. Experimentally confirmed that the mechanism of action of valerenic acid is similar to benzodiazepine drugs, which cause of a number of reported adverse neurological reactions. However, the range of complaints from patients cited in the reports is significantly wider than in the instructions for the medical use of these drugs. There is a need for further monitoring of reports and analysis of already received data and the addition of prescribing information of Valeriana rhizomes whis roots and Corvalol for ensuring safety requirements.

Abstract. The demographic aging of the population of the earth observed in recent years is associated, inter alia, with the advent of new effective and safe medicines. However, the availability of highly effective drugs on the market also has a reverse side — the appearance of adverse drug reactions (ADRs), in particular as a result of drug-drug interactions. The use of non-pharmacological methods of treatment and prevention of diseases seems particularly relevant for patients of the older age group, as it allows not only to reduce the drug burden, to reduce the risk of ADRs but also to improve the patient’s state in case of diseases that have no effective pharmacotherapy and pharmacological prophylaxis. The aim of the study was to systematize and analyze data on non-pharmacological treatment methods in order to increase the safety of pharmacotherapy and prevent polypragmasia in elderly patients by informing health care providers about non-drug methods of correcting significant geriatric problems. The approaches to the correction of some major geriatric problems (delirium, sarcopenia, pain syndrome), including cognitive training, physical activity, diet, frequent reorientation of patients, placement of patients in specially equipped rooms («delirium room») were presented. The use of non-pharmacological approaches can significantly improve the safety of drug therapy, reduce the risks of ADRs, improve the patient’s prognosis and quality of life, and also effectively prevent polypharmacy.

Abstract. Detection and analysis of drug safety signals in children is a mandatory part of pharmacovigilance. The criteria for evaluating signals of adverse effects were considered. Spontaneous reports databases as a source for detecting signaling information about adverse reactions, including in children were used. More than 17.5 million cases of adverse reactions identified in WHO global database of individual case safety reports — VigiBase which was detected since 1968 in 120 countries — members of the WHO Drug Treatment Control Program. Of these, 1.5 million cases of adverse reactions occur in childhood. Objective: search and analysis for signal information in the post-marketing period of the use of drugs in children to increase the safety of pharmacotherapy in pediatric practice. Results: а causal relationship between desloratadine and weight gain was detected. Desloratadine is an active metabolite of loratadine so the researchers have considered reports on desloratadine and also on loratadine. In VigiBase there are reports of weight gain when taking desloratadine (44 messages) and loratadine (115 messages) in 2016. Among them, 22 reports on weight gain in children from 2 to 11 years. The Pharmacovigilance Risk Assessment Committee of the European Medical Agency (PRAC EMA) recommended marketing authorization holders to add an information about weight gain in children in prescribing information of drugs which contains desloratadine and loratadine. In September 2017, the Committee on Drugs for Human Use, following a review and analysis of VigiBase, approved the recommendations of PRAC EMA. Appropriate changes were made to the instructions for medical use for loratadine tablets. Conclusions. These results confirm the importance of long post-marketing studies, the results of which will provide significant assistance in improving the safety of pharmacotherapy in children.

Abstract. The article describes the case of drug Cushing syndrome as a result of prolonged (for 10 months) endonasal use of dexamethasone and oxymetazoline mixture, which was prepared by the patient’s mother. Medical control was absent. The content of dexamethasone in the vial and the concentration of oxymetazoline was not known. During the examination, in addition to Cushing syndrome, an atrophy of the nasal mucosa as a second side effect was revealed. Thus, in the above case, there were two complications of incorrect using of drugs — local and systemic.