The results of evaluating information in the Periodic safety update reports (PSUR) submitted by marketing-authorisation holder indicate a lack of understanding of regulatory requirements for the preparation of this document. As a result PSURs submitted by some marketing authorisation holders are returned to them for correction. The purpose of this article is to present the standard forms of PSUR, which will allow you to adequately prepare this reporting document.

Problems of interchangeability of systemic interferons for treatment of multiple sclerosis are described. An analysis of 1,643 spontaneous reports existing in the Russian database for the period 2009 to 2015 was made in order to identify information on adverse reactions that occurred after replacement of systemically used interferons. Since 2010-2011 there have been reports on adverse reactions and lack of efficacy caused by the replacement of one systemic interferon for treatment of multiple sclerosis with another one with the same INN. Most of the reports indicated a «possible» degree of reliability of the cause-effect relationship. Most of the spontaneous reports of adverse reactions when replacing interferons beta-1a and beta-1b contained information about adult patients. More than half of the spontaneous reports of adverse reactions contained information on clinically signifiant events. When interferons beta-1a and beta-1b were replaced, there were mainly general disorders, reactions at the injection site, musculoskeletal disorders and neurologic disorders observed. The reference medication was well tolerated but replacing for a bioanalogous drug resulted in ineffectiveness or development of adverse reactions. The results of the study demonstrated that the data of spontaneous reports are important for making decision on the interchangeability of systemic interferons for the treatment of multiple sclerosis.

The number of patients receiving statins is increasing every year. Considering the need for life-long intake of drugs of this group, the problem of improving safety and efficacy of their use becomes especially important. There is a large amount of data on the influence of various genetic factors on the safety of statins and the frequency of side effects peculiar to this group of drugs, such as statin-induced myopathy and rhabdomyolysis. The article presents the long-term results of a study devoted to the evaluation of the effect of the carriage of various polymorphic variants of SLCO1B1 on the safety and efficacy of statin therapy in terms of long-term treatment outcomes.

We have prepared this review of the domestic and foreign scientific literature on how to use the social media for pharmacovigilance purposes. We examined the complexities that are connected with this kind of monitoring and how to extract information on adverse drug reactions from the Internet. The importance of a systematic approach in assessing the safety of drugs and the benefits of social networks is underlined. A description of applications for smartphones, which allow you to easily and quickly report drug adverse reactions is provided.

Apremilast is a new selective inhibitor of phosphodiesterase 4 (PDE4) of the class of small molecules, approved for treatment of psoriatic arthritis and psoriasis. The efficacy and safety of apremilast in the treatment of moderate to severe plaque psoriasis have been demonstrated in multicenter, randomized, double-blind, placebo-controlled clinical trials of ESTEEM 1 and ESTEEM 2 (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis). These studies describe adverse reactions such as mental disorders: depression, suicidal thoughts, suicidal behavior. However, data on the increase in the incidence of these adverse reactions during longer treatment with apremilast were not obtained. The article presents the reports from the UK regulator (MHRA) and international database VigiBase on the increased risk of developing suicidal thoughts, suicide attempts, completed suicides and suicidal behavior during treatment with apremilast.