Background Comprehensive analysis of all available data in spontaneous reports (SRs) can reveal previously unidentified medication errors (MEs). Methods To detect MEs, we performed a retrospective analysis of SRs submitted to the Russian pharmacovigilance database in the period from January 01, 2012, to August 01, 2014. This study evaluated SRs of cases where beta-lactam antibiotics were the suspected drug. Results A total of 3608 SRs were analyzed. MEswere detected in 1043 reports (28.9% of all cases). The total number of detected errors was 1214. Reporters themselves indicated MEs in 29 SRs. A term denoting an ME was selected in the “Adverse Reactions” section in 18 of these SRs, whereas in the other 11 reports information on the ME was found only in the “Case narrative” section. MEs were associated with wrong indications in 32.5% of the cases; 61.0% of these cases were viral infections. Various dosing regimen violations constituted 29.7% of MEs. A contraindicated drug was administered in 17.3% of all detected MEs, most commonly to a patient with a history of allergy to the suspected drug or severe hypersensitivity reactions to other drugs of the same group. Conclusion Automatic identification of MEs in the pharmacovigilance database is sometimes precluded by the absence of a code for the respective episode in the “Adverse Reactions” section, even when the error was detected by the reporter. The most frequent types of MEs associated with the use of beta-lactams in Russia are the leading risk factors of growing bacterial resistance.

Thus, replacement of the original preparation of valproic acid with generics should be considered as an independent risk factor for development of complications of drug therapy. In clinical practice, in case of successful seizure control substitutions of different preparations of valproic acid should be avoided.

Serious adverse drug reactions (ADRs) to medicinal products can cause death. It is an immediate challenge for modern medicine to prevent the possibility of this outcome and to improve the safety of pharmacotherapy. The aim of this study was to identify and analyse the main methodological approaches to studying the prevalence, patterns, and risk factors of fatal ADRs. The authors identified three main methods for studying such reactions: analysis of death certificates, monitoring of spontaneous reports, and review of clinical trials with a particular focus on safety. Each of these methods has its advantages and limitations. Clinical trials provide the most accurate information on the prevalence of fatal ADRs. For inpatients, this value ranged from 0.05 to 0.95% of the total number of hospital admissions. Data from death certificates may be particularly useful for identifying the groups of medicinal products posing a high risk of death and for making longitudinal comparisons. Monitoring of spontaneous reports is very effective in rapidly identifying fatal adverse reactions to new medicinal products. According to the authors, not only the choice of a data collection method, but also its application can affect the results of an ADR study. It was noted that the data varied across clinical trials conducted in different countries. Such variations indicate the importance of studying the problem of fatal ADRs at the national level, as well as the need for initiating such studies in the Russian Federation.

The article considers problems of evaluation of interchangeability of referent and reproduced medicines inhibitors of calcalcineurin. The analysis of 849 spontaneous reports in the Russian database from 2009 to 2015 containing information about undesirable reactions occurring at replacement of mentioned medicines. The clinical picture of undesirable reactions and their distribution by systemic organ classes is assessed. Various alternatives of replacement are considered. The implemented analysis demonstrated that problems mostly occurred ad replacement of original medicine to reproduced one that required returning to initial therapy. It is established that 20.9% of all entered reports about cases of undesirable reactions at replacement of medicines of cyclosporine and 12.2% of medicines of tacrolimus contained information about problems occurred at replacement of medicine within the framework of one international unlicensed item.

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