Клинические рекомендации уже давно вошли в число рабочих инструментов современного врача, помогая ему быстро ориентироваться в наиболее эффективных доказанных методах лечения и профилактики различных заболеваний, а также адаптировать эти методы к конкретным задачам своих больных и добиваться максимальной персонализации лечения. Клинические рекомендации составляются профессиональными некоммерческими ассоциациями и одобряются научным советом МЗ РФ, при этом нередко одна рекомендация готовится двумя или даже тремя ассоциациями. Особенность предлагаемых вашему вниманию рекомендаций в том, что в профилактику и лечение ожирения вовлекаются не только эндокринологи, но и терапевты, кардиологи, гинекологи, гастроэнтерологи и врачи многих других специальностей. Мультидисциплинарная рабочая группа представляет этот проект в многопрофильном журнале с целью объединения усилий нескольких профессиональных ассоциаций, что связано с необходимостью уделить внимание не только самому ожирению, но и коморбидным состояниям. Мы надеемся на конструктивную критику и разностороннее обсуждение проблемы на страницах нашего журнала.
Since 2010, Russia has been developing new drug legislation, internal quality control and safety of medical organizations, and has developed algorithms for submitting Individual Case Safety Reports (ICSR) using an automated information system. On April 1, 2019, Russia launched an updated national database of ICSR, which uses the international ICH E2B data standard, which may increase the amount of reporting to the Uppsala monitoring center. This publication covers the key aspects of pharmacovigilance system development in the Russian Federation. The analysis of pharmacovigilance structure in the Russian Federation is carried out, its main problems are designated. Presents methods to identify causal relationships between adverse reaction and drug, evaluation of its degree of validity (questionnaires, algorithms, and scale), as already recommended by the WHO, and the new modifi ed versions. The expediency of using a scale for determining the degree of reliability of a causal relationship «an undesirable reaction — drug interaction» when analyzing spontaneous reports of undesirable reactions that may be caused by drug interactions is noted. An effective method of detection and prevention of adverse reactions is presented — the Global Trigger Tool (GTT). The question of the need for motivation and training of medical personnel in the correct design of spontaneous messages, as well as methods of identifying the causal relationship between adverse reactions of drugs. The directions of optimization of pharmacovigilance system are proposed, including methods of more effective active surveillance in the identifi cation and prevention of adverse reactions.
A565Objectives: Orphan diseases such as Huntington's disease (HD), a progressive neurodegenerative disorder, have significant impact on patients and their families, as well as the healthcare systems and societies. The main aim of this study was to perform multicriteria decision analysis (MCDA) to evaluate various aspects of a medicament providing of tetrabenazine (TBZ) for patients with HD. MethOds: Analysis of the published clinical trials was conducted to evaluate efficacy and safety of using TBZ for patients with HD. The initial list of value attributes (5 -impact of rare disease and 5 -impact of the drug) was identified from a literature review and expert's survey. Further experts assigned relative weights to the attributes in 2 groups (the rating scale ranged from 1(less important) to 5 (most importantly)). Then experts rated TBZ against each attribute (the rating scale ranged from 1 (worst score) to 7 (best score)). In the end weighted score for each attribute was identified. Results: Experts considered that the most important attributes are the impact of disease (scores 27.3 versus 24.7). In the both groups the most important attribute was evidence of treatment clinical efficacy and patient clinical outcome (scores 6.67 and 6.00). A total weighted score for attributes of the disease was 85.78, and for attributes of the impact of the drug -78.67. cOnclusiOns: All experts agreed to give slightly more weight to the attributes of the disease than to the impact of the drug. The present study was the first experience of conducting MCDA for HD. This analysis showed the importance of the different kinds of aspects in deciding on funding drug supply patients with HD.
The objective of the study was to conduct a comparative pharmacoeconomic analysis of the treatment with posaconazole in a tablet form for the prevention of invasive fungal infections in patients aged 13 years and older with prolonged neutropenia and hematopoietic stem cell transplant recipients.Study design: pharmacoeconomic study, cost–effectiveness analysis; budget impact analysis; sensitivity analysis to changes in the initial parameters of the model.Results and conclusion. A literature review has shown that the use of the compared drugs for the prevention of invasive fungal infections is effective, with posaconazole being the most effective. Based on pharmacokinetic studies data, we can state the equivalence of the action of various drug forms of posaconazole. A cost analysis of drugs showed that the lowest total costs were for the prevention of invasive fungal infections in patients with acute myeloid leukemia with posaconazole tablets (197,149.37 rub.) and posaconazole suspension (215,911.53 rub.). The lowest cost for the prevention of invasive fungal infections in patients with hematopoietic stem cell transplant was shown by posaconazole in tablets (505,070.37 rub.) and posaconazole in suspension (616,652.01 rub.). Budget impact analysis in acute myeloid leukemia patients showed that with a possible cohort size of 2288 people an increase in the share of posaconazole in tablets from 5 to 15 %, in suspension from 20 to 35 % and with a decrease in the share of voriconazole from 25 to 15 %, and the share of fluconazole from 50 to 35 % in public procurement will reduce budget costs by 30,441,219.72 rub., and in patients with hematopoietic stem cell transplant ‒ by 11,219,243.54 rub. (per 100 patients).
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