Usage of PCSK9 inhibitors is a new approach of lipid lowering therapy allowing overcomes as well insusceptibility of standard statins’ therapy as their intolerance. In last case PCSK9 inhibitors can substitute statins in the treatment program. Introduction to the Russian clinical practice the new PCSK9 inhibitor alirocumab (INN) requires it’s economic evaluation. Aim: To evaluate of alirocumab reasonability from pharmacoeconomic point of view to the Governmental program of free medical aid and others programs of reimbursement for the treatment of high cardiac risks patients also. Materials and methods. Retrospective comparative economic analysis of published data on efficacy and safety of new technology with alirocumab using and standard statin therapy. Budget impact analysis has been performed in according to Methodological guidelines for evaluation of influence on the Governmental program of free medical aid and coat of illness of the Russian Ministry of Health with Markov’s model usage with direct medical costs calculation. Costs were calculated on 1 000 pts and then recalculated on one patient. For stability results checking the sensitivity analysis has been performed. Cost of illness has been calculated as sum of direct costs (remedies, cost of one case of cardiac event etc.) and indirect cost (GDP loss due to temporary and permanent disability or premature death due to cardiac events). Results. Alirocumab during two years could save at least 6,635 bln RUR of budget’s funds and decrease on 45,52% of Governmental budget impact in a treatment of high cardiac risks patients in case of it’s inclusion into the Governmental program of free medical aid. This result was stable in sensitive analysis on 25%. Cost of illness analysis with evaluation of indirect costs has shown that alirocumab could lead to burden of illness decreasing on 9,04 bln RUR in the frames of targeted group of patients (or 58,92% vs current methodology of the treatment) during two years. Conclusion. Alirocumab has pharmacoeconomics evidences to be included into the Governmental program of free medical aid, Essential Drug List and different reimbursement programs.

Diabetic polyneuropathy (DP) occupies the third place among the most common neurological disorders, affecting a significant portion of diabetes patients, and is characterized by progressive lesions of nervous fibers. While normalizing carbohydrate metabolism is crucial for treating DP, metabolic compounds that integrate into nervous tissue metabolism have received considerable attention. Despite their therapeutic attractiveness and significant spread in clinical practice, the amount of data pertaining to pharmacoeconomic properties of these compounds remains limited. Given significance of this problem and due to availability of new clinical data on comparative effectiveness of two of such drugs, a research effort was undertaken to evaluate the pharmacoeconomic properties of Cocarnit combination drug compared to Milgamma drug, as well as with components of Cocarnit purchased separately. Aim. To evaluate comparative pharmacoeconomic performance of therapy using Cocarnit combination drug, Milgamma, and Cocarnit components purchased and administered separately in the context of Russian healthcare. Methodology. Current analysis was performed from perspective of Russian state healthcare system within context of mandatory medial insurance system. Modelling horizon was 3 years. Randomized clinical trial directly comparing the safety and efficacy of investigated drugs (Cocarnit and Milgamma) as well as long-term randomized clinical trials of other metabolic drugs for treatment of diabetic neuropath and general dynamic of diabetic neuropathy response to metabolic treatment were used as data sources for this PHe. The number of patients in each simulated group was 1000 people. A Markov model was constructed to assess the costs and utility effects of treating diabetic neuropathy with comparator compounds, with simulated treatment protocols being based on existing Russian standards of diabetic neuropathy treatment. The model accounted for existing data regarding long-term outcomes and recurrence rates of diabetic neuropathy undergoing metabolic treatment. Model did not account for mortality resulting from diabetes proper and treatment costs associated with addressing the underlying primary condition (Type I and Type II diabetes). The cycle length was 1 week. QALY improvements were used as surrogate endpoints, since the existing clinical trial data indicates that the only significant difference between the drugs being compared is their quality of life effects. Since clinical trial data contained only SF-36 quality of life data, a widely used mapping algorithm found in peer-reviewed literature was utilized to convert from SF-36 to EQ-5D in order to properly evaluate QALY differences. Upon completion of modelling, the following types of analysis were performed: cost minimization analysis (CMA) for “Cocarnit/Cocarnit components purchased separately” comparator pair (CMA was used here since utility, efficacy and safety values for this case will be strictly equal), budget impact analysis (BIA) for “Cocarnit / Cocarnit components purchased separately” comparator pair, Cost-utility analysis for “Cocarnit / Milgamma” pair. Sensitivity analysis was used to verify the robustness of the results. Discounting was performed at rate of 5%. Results. Cocarnit has demonstrated promising results, showing superiority over separately purchased and administered components in CMA (with CMA factor of -2 752 082 rubles) and budget impact analysis, which indicated that use of Cocarnit instead of separate metabolite components would result in reduction of budget burden totaling 1 458 603 per 100 000 of Russian Federation population (accounting for prevalence of diabetic neuropathy) within 3 years. During cost-utility analysis it was found that Cocarnit is superior to Milgamma demonstrating greater overall quality of life and a CUR of 552,34 rubles (while Milgamma has a less favorable CUR of 555,41 rubles) per patient. It also had ICUR of 208,88 rubles per patient, indicating a low cost per one QALY gained and high pharmacoeconomic expediency within context of pharmacoeconomic expediency analysis. Sensitivity analysis has shown that results remain robust to price increases up to 25%. Conclusion. These results demonstrate that Cocarnit has favorable pharmacoeconomic characteristics and indicates high expediency of using it in Russian healthcare system, and allows us to recommend further research into clinical and pharmacoeconomic properties of this drug.

We conduct a comparative cost-effectiveness and budget impact analysis of atypical antipsychotics for the treatment of schizophrenia - sertindole versus quetiapine, paliperidone. The primary outcome of interest was rehospitalization rates. The cost of the annual treatment of patients with schizophrenia in the outpatient setting was calculated, costs of hospital readmission and total costs.

This article covers important aspect of methodology of clinical trials - source medical documents. Special attention is always paid to source medical records in phase 1 trials when the future of novel medicinal product is at stake. Authors discuss some issues of development and application of trial-specific forms as part of source medical documentation on the basis of practical experience in conducting phase 1 studies on healthy volunteers. Primary focus is on the structure and content of these forms with respect to specific procedures and study population in early phase research. Authors believe that implementation of trial-specific forms improves the quality of clinical trials.

This article discusses the role of pharmacist in early phase clinical trials. Authors emphasize that in Russian phase I units pharmacists are rarely involved in clinical research activities. Probably the lack of regulatory documentation in this field is one of the main reasons. The opposite situation occurs abroad where pharmacist is key member of investigational team. This problem is particularly relevant because number of phase I studies in Russia steadily increases over the last years. Based on their practical experience authors describe the range of pharmacist functions and responsibilities when working in early phase research. Qualification requirements and skills of such specialist are pointed out as well. Due to the fact that not only number of trials but also number of phase I units increases (including private departments) the value of pharmacist in clinical research will grow.

This article is about efficiency of online systems for pharmacovigilance (PV) processes management based on case study of implementation of PV system by Flex Databases. Automation of PV processes is a topic of interest for R&D companies in EurAsEC countries as the EEC (Eurasian Economic Commission) adopted guidelines for Good Pharmacovigilance Practice (GVP). This article describes principles of operation of the system, provides analyses of implementation process and demonstrates results of case study of implementing PV system in several leading Russian pharmaceutical companies.

Purpose. The purpose of this study was to discover the prevalence and types of medication errors associated with the use of carbapenems. Materials and methods. We analyzed 161 spontaneous reports concerning adverse drug reactions associated with the carbapenems. All the reports were submitted to the Russian pharmacovigilance database between 01.01.2012 and 01.08.2014. Approved prescribing drug information, standards of medical care and practical guidelines for certain conditions were used to identify medication errors associated with specific products. Results. The prevalence of medication errors associated with the use of carbapenems was 24,8%. The reporters indicated medication error-related term only in 5,0% of these cases. The most common types of identified medication errors (44,0%) were deviations from the recommended dosing scheme, in most cases (20,0%) medication errors resulted from wrong frequency of administration of the antibiotic. Conclusions. The results of this study show that the reporters rarely recognize and identify medication errors. We suggest emphasizing the importance of compliance with the dosage regimen of antibiotics; the frequency of administration of carbapenems is critical.

Purpose. To study and compare the structure of off-label drug use in children in 2012 and 2015 by means of analysis of the national pharmacovigilance database. Materials and methods. We conducted a comparative analysis of 341 spontaneous reports about serious adverse reactions in children, submitted to the Russian pharmacovigilance database in 2012, and 467 suchlike spontaneous reports registered in 2015. Approved in the Russian Federation prescribing drug information was used to identify «off label» drug use. Results. It was established that 58,7% of suspected medicines in 2012 and 47,5% in 2015, the use of which was associated with the development of serious complications in pharmacotherapy in children, were prescribed with deviations from the recommendations of approved prescribing drug information. Systemic antimicrobial agents and drugs for the treatment of nervous system diseases were the most common groups of drugs prescribed off-label in pediatric practice. The main types of off-label violations were inappropriate indications, deviations from the recommended dosage regimen and the use of a drug in the age group of patients, wherein the drug has not been approved. Conclusion. Our research confirms, that the practice of off-label drug use in children is not safe. It is shown that spontaneous reporting is an effective method of study the problems of drug safety in children.

LLC Novartis Pharma, Moscow, Russian Federation Abstract. The problem of off-label use is still unsolved during the pharmacotherapy in children. In connection with the above, the need to stimulate the conduct of specially organized clinical studies, the purpose of which will be to evaluate the efficacy and safety of using drugs in children in different age groups, becomes evident. However the complexity of the organization of clinical studies in pediatrics is associated not only with regulatory aspects but also with lack of understanding of the importance of these studies by pediatricians and parents. The authors conducted a study aimed at finding out the frequency of off-label prescriptions in the Russian Federation in pediatric practice and doctors’ and parents’ attitude to this kind of use of medications. The study has shown the evidence that the off-label prescription practice is widely-used in healthcare in Russia and is routine for most respondents. The highest frequency of off-label prescriptions is observed in the group of children from 0 to 5 years. The majority of physicians and parents don’t consider themselves responsible for popularization of clinical trials which indicates that this problem should be widely discussed in the society. Parents trust physicians in terms of therapy choices or their recommendations regarding participation in clinical trials. A portrait of a typical “staunch opponent” of clinical trials among parents.