REMEDIUM

Among the most important requisites for marketing medicines within the Single pharmaceutical market of the Eurasian Economic Union is the bringing into compliance of all pharmaceuticals authorized based on national provisions with the new requirements developed based on international principles and policies for demonstrating drug safety, efficacy, and quality. Statutory wording used to legally outline this procedure needs thorough discussion and clarification and are addressed in this paper. Moreover, we emphasize the paramount importance of ensuring that the basic goals of the Agreement on the common principles and rules of medicinal products circulation within the Eurasian Economic Union are reached. They envisage authorising only those medicines for marketing that demonstrated their safety, efficacy, and quality in accordance with state-of-the-art scientific standards, and the rules for bringing into compliance play an instrumental role here while a formalis-tic approach should be abandoned.

Одним из наиболее частых и опасных осложнений сахарного диабета (СД) признана диабетическая полинейропатия (ДПН) - болезнь, характеризующаяся прогрессирующей гибелью нервных волокон и приводящая пациента к инвалидности. О мерах, позволяющих снизить риск заболеваемости, возможностях современной диагностики и терапии ДПН мы решили поговорить с Гагиком ГАЛСТЯНОМ, заведующим отделением диабетической стопы ФГБУ «Эндокринологический научный центр» Минздрава России, профессором, д.м.н.

Based on both the high effectiveness of anaplastic lymphoma kinase (ALK) inhibitors in treatment of advanced or metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer and high medication costs, the pharmacoeconomic analysis of ceritinib and crizotinib in Russia is needed. Objective: to conduct a cost-effectiveness analysis and budget impact analysis of 1st line treatment (ALK inhibitors - ceritinib vs crizotinib) of advanced or metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer in Russian healthcare circumstances. Methods: To conduct cost-effectiveness analysis (including cost-utility analysis) and budget impact analysis, a Markov model was developed. Using results of matching adjusted indirect comparison (MAIC), the model compared progression-free survival, life years (LY), quality adjusted life years gained (QALY) and treatment costs. Cost-effectiveness analysis considered direct medical costs (costs of medication treatment with ceritinib and crizotinib; costs of adverse event management; costs of inpatient and outpatient treatment due to progression of the disease). Budget-impact analysis considered only medication treatment with ceritinib and crizotinib costs. Time horizon was limited to local state budget planning approach - three years. The number of patients for budget impact analysis was derived from local statistics. Results: Annual cost of treatment with ceritinib (1,36 Mln. RUB or $20,8 thousands per patient) is 55% less than with crizotinib (3,03 Mln RUB or $55,05 thousands per patient). Total costs of three-years' treatment with ceritinib (2,1 Mln. RUB or $32,5 thousands per patient) is 41% less than with crizotinib (3,6 Mln. RUB or $55,05 thousands per patient). Lower costs together with higher PFS, LY and QALY led to dominant cost-effectiveness of ceritinib in comparison with crizotinib. In case of concurrent increasing of using ceritinib in clinical practice up to 45% and decreasing of using crizotinib down to 25%, the total medication cost savings in group of 240 patients will be up to 56,5 Mln RUB or $864,5 thousands. Conclusion: Dominant cost-effectiveness and significant budget savings of ceritinib in comparison with crizotinib is the rationale for increasing prescribing of the former in 1st line treatment of advanced or metastatic anaplastic lym-phoma kinase-positive non-small cell lung cancer in Russia.

The purpose of the study To analyze the causes of violations of the rules of prescription drugs from pharmacy organizations. Research problem. The problem of prescription drugs in the Russian Federation is very acute. The population of the Russian Federation the main part of medicines, except subject to subject-quantitative accounting and received preferential categories of patients, acquires in pharmacies without a doctor's prescription, which leads to total self-treatment of the population, the consequence of which is a decrease in the safety of the use of medicines. This article is devoted to the study of the level of awareness of pharmaceutical specialists on compliance with the requirements of existing regulations for the release of prescription drugs from pharmacies. Methods. The study was conducted by an anonymous survey of 100 pharmaceutical specialists engaged in the sale of medicines from pharmacies in Irkutsk. Results. The most frequent violation is the release of prescription medicines without a doctor's prescription. The survey of specialists showed that only 33% of respondents know the current regulatory document on the issue of medicines, 40% of specialists as a source of information about medicines called the Internet and 40% of respondents do not consider it necessary to release prescription drugs strictly according to prescriptions. 42% of respondents do not know the rules of registration of prescriptions for medicines containing narcotic drugs, psychotropic substances and subject to subject-quantitative accounting. Among the factors that lead to violation of the rules of medicines, 67% of respondents named the dependence of wages on turnover and 57% - high competition between pharmacies. Conclusion The widespread non-compliance with the rules of prescription medicines from pharmacies dramatically reduces the safety of their use by patients, leading to the further spread of self-medication.

Performance analysis of industry enterprises is conducted using the national statistics reports: Form No. P-1, term (monthly), Form No. P-2 Information on Investments in Non-Financial Assets (quarterly), Form No. P-3 Information on Company Financial Status (monthly).

В середине мая в Санкт-Петербурге в ходе XXV Российского фармацевтического форума состоялся брифинг Ассоциации международных фармпроизводителей (AIPM), отмечающей в этом году 25-летие. Участники обменялись мнениями о роли ассоциации в развитии национальной экономики и повышении уровня российского здравоохранения, обозначили круг актуальных проблем и стоящие перед индустрией ключевые задачи.

Более 60 журналистов из 19 стран мира собрались в апреле на традиционной конференции компании «Берингер Ингельхайм». В ходе встречи в Ингельхайме руководители компании проинформировали гостей о результатах ее работы за последний год, приоритетных направлениях деятельности, а также поделились опытом применения технологий искусственного интеллекта - инструмента, позволяющего решать ранее не разрешимые проблемы медицины и фармацевтики.