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Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice

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No 1 (2017)
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FROM EDITOR

PHARMACOECONOMICS

4-10 4334
Abstract
For the first time in Russia, the pharmacoeconomic analysis of Flemoclav Solutab(R) use was carried out in the therapy of acute sinusitis in adults based on the data of a prospective observation research in routine out-patient practice. In terms of the results of the pharmacoeconomic model developed on the basis of the research data FlemENT the following regularities were found. The use of medicine of Flemoclav Solutab® as a therapy of acute sinusitis is economically reasonable from the point of view of the cost-effectiveness ratio. The strategy of Flemoclav Solutab® demonstrated high clinical benefits and the best safety profile with the smallest cost of adverse event therapy among the studied medical treatment technologies of this group of patients in comparison with the strategies of Amoksiklav® and Augmentin® SR. The use of Flemoclav Solutab® in comparison with the strategy of Amoksiklav® and Augmentin® SR is more economically preferable technology on the account of budget impact analysis: the use of medicine of Flemoclav Solutab® enables to keep considerable budget funds of health care - up to 5 180 193 rub, and also to treat by means of this strategy up to 725 patients.
11-19 1032
Abstract
Aim. To perform health-economic evaluation of vemurafenib in comparison to dabrafenib in patients with metastatic or unresectable melanoma with BRAF V600 mutation in Russia from the healthcare system perspective. Materials and methods. Mathematical modelling and cost effectiveness analysis with cost-effectiveness ratio (CER) calculation were used. If costs and effectiveness of one drug are higher comparing to another incremental cost-effectiveness ration is calculated. We accounted for following direct medical costs: vemurafenib and dabrafenib, diagnostic procedures, hospital stay, outpatient visits, BRAF mutation test, adverse events correction. Two heath technologies were evaluated: vemurafenib 960 mg BID, dabrafenib 150 mg BID. Results. In patients with metastatic or unresectable melanoma vemurafenib and dabrafenib have comparative effectiveness, but vemurafenib total costs were by 3,7% lower. Vemurafenib CER was by 7% and 18% lower comparing to dabrafenib when median and mean PFS, respectively, are used as effectiveness criteria. Conclusions. The study shows vemurafenib to be a cost-effective strategy. The cost of drug has the maximum influence on the study results.

CLINICAL TRIALS

20-23 5280
Abstract
The article describes post-authorization clinical trials of medicinal products for medical use conducted by pharmaceutical manufacturers after state registration, in order to collect additional data on safety and efficacy, expand indications for use, and identify adverse reactions.

NON-INTERVENTIONAL STUDY

24-33 6628
Abstract
This article describes non-interventional clinical studies in which the researcher collects data by simply observing events in their natural course without actively interfering with them.

PHARMACOEPIDEMIOLOGY

34-41 10761
Abstract
This article describes the methodology of pharmacoepidemiological studies that help to research the efficacy and safety of drugs in real clinical practice at the level of a population or large groups of patients, promoting the rational and economically acceptable use of the most effective and safe drugs.
42-45 3289
Abstract
The article describes the methodology for conducting drug utilization researches that study the sales, distribution and use of drugs in the community, with special attention to the medical, social and economic results.
46-50 976
Abstract
The aim of this study was to evaluate the structure of etiotropic therapy used in the treatment of urinary tract infection in newborns, the frequency of using off-label etiotropic medicines, and assess the incidence of adverse drugs reactions (ADR). The work was carried out by a retrospective pharmacoepidemiology analysis of children hospitalized patient history (form 003/y) with infectious diseases in the period of the newborn. The object of the study is a case history of a stationary patient, the main method of research is the collection and analysis of information, the statistical processing of the data obtained. During the analysis, all the selected medical records were divided into two groups: the first - children, with the course of urinary tract infection, the second - with the course of infectious diseases of other localization. During the study it was demonstrated that the use of etiotropic therapy in children with urinary infection is higher than in children with the course of the infectious process of other localization. The frequency of off-label prescriptions for the treatment of urinary tract infection is 51%, and the incidence of ADR in the case of unadapted appointments is 1,4 times higher.

PHARMACOGENETICS

51-55 1929
Abstract
The article presents modern concepts of genes, polymorphisms which can influence the pharmacological response of the patient receiving antiepileptic drugs.

EXPERT OPINIONS

56-60 7262
Abstract
Polymorphism is a phenomenon of existence of an individual substance in states with different crystalline structure, each of these states is called a polymorphic modification (PM). The possibility of developing new drugs by detecting the biological activity of xenobiotics is considered to be largely exhausted, so recently, along with the search and development of new drugs, the task of improving known drugs, in particular, through the use of medicinal substances (MS) based on a certain PM of the active substance. Such technologies allow improving the properties, ensuring the quality and safety of drugs at a higher level, and also reducing the costs of developing patent-protected drugs, which contributes to the development of the pharmaceutical industry.


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ISSN 2588-0519 (Print)
ISSN 2618-8473 (Online)