General recommendations for planning and implementing of a risk-based approach to audits of pharmacovigilance systems of Marketing Authorisation Holders are presented. A review of the general requirements for audits and audit reporting is given. The role of the pharmacovigilance system master file in the planning of audits and inspections is discussed. The article contains practical recommendations for the Qualified Person Responsible for Pharmacovigilance in Marketing Authorisation Holders.

Recommendations for the Marketing Authorisation Holders for the preparation of the document containing the results of the monitoring of safety of the drug, which is presented as part of the dossier at the state registration confirmation in 5 years after the initial registration of the drug in Russia are given. Links to legal documents, and specific examples of the proper execution of the relevant sections of the document are represented.

Search for new safe analgesics is an urgent task that will increase the safety and efficiency of anesthesia. The aim of this study was to investigate the analgesic effect of intrathecally administered physostigmine. Antinociceptive effect was evaluated by using the method «plantar» stimulation. Administered intrathecally physostigmine caused analgesic action in the early postoperative period. Efficiency of physostigmine may be due to the influence on cholinergic links of afferent gate control system at spinal level.

The main types of hematological complications related to ongoing pharmacotherapy - (different types of cytopenia, as well as coagulopathy) are presented. The risk factors and mechanisms of development of these disorders are discussed. The authors emphasize the importance of awareness by doctors of the existence of drug induced pathology (disease) as a separate type of iatrogeny.

Active development of pharmacology in recent decades and the potential emergence of a large number of new drugs not only expanded the possibilities of treatment, but also increased the risk of adverse effects. That is the risk of severe, often irreversible complications due to drug therapy are attracted to the problem of drug safety the attention of practitioners and other health professionals. This article presents practical recommendations on possible sources for screening of information on the drug safety, which can operate in their activity as health professionals.