Analysis of the domestic list of otc medicines and development of approaches to its improvement

Л. О. Гала, А. О. Чубай
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Abstract

In recent decades, every citizen tries for an active position regarding his own health. Such factors as improving the general level of medical literacy and quality of life of the population, developing of pharmaceutical market contribute to the spread of self-medication. The formation of the concept of responsible self-medication, which includes the free use by consumers of effective and safe over-the-counter (OTC) medicines has been the solution to the specified needs of society. The purpose of the study was to develop modern organizational approaches to the formation of the List of OTC medicines in Ukraine to ensure the proper level of pharmaceutical care. The objects of the study were the Lists of OTC medicines approved by orders of the Ministry of Health of Ukraine during 2010–2019; the register of medicines allowed to be dispensed without a prescription (according to the State Register of Medicines of Ukraine, as of February 2022); protocols of the pharmacist. The methods of marketing analysis, analytical-comparative, systematic, graphic and method of generalization were used. Based on the analysis of the Lists of OTC medicines valid in Ukraine in the relevant years (2010–2022), it was established that the number of OTC medicines and the specific weight of it in the registered drugs on the pharmaceutical market decrease annually (from 26.0% to 21.2%). According to the results of the comparative marketing analysis of the current List of OTC medicines (order of the Ministry of Health of Ukraine dated April 18, 2019 N 876) and the register of OTC medicines (according to the State Register of Drugs of Ukraine, as of February 2022), only insignificant differences were found in the distribution of assortment items by composition, ATC classification, countries of origin, dosage forms. Deficiencies of the current List of OTC medicines were identified, such as the presence of medicines with expired registration in 2019–2022; duplication of positions; the presence of trade names of the prescription group. According to the results of the research, organizational approaches that will contribute to the proper formation of the next edition of the domestic List of OTC medicines and its rational use by pharmacists and consumers to realize the possibilities of responsible self-medication are proposed. The results of the research can be used in the formation of a legal framework in Ukraine, which regulates the circulation of OTC medicines on the pharmaceutical market.
我国非处方药清单分析及改进途径
近几十年来,每个公民都试图在自己的健康方面占据积极的地位。提高人们的总体医学知识水平和生活质量、发展药品市场等因素有助于自我用药的传播。负责任的自我用药概念的形成,包括消费者免费使用有效和安全的非处方药,是社会特定需求的解决方案。这项研究的目的是制定乌克兰非处方药清单的现代组织方法,以确保适当的药物护理水平。该研究的对象是2010-2019年期间乌克兰卫生部命令批准的非处方药清单;允许无处方配药的药品登记册(根据乌克兰国家药品登记册,截至2022年2月);药剂师的协议。采用市场分析法、分析比较法、系统法、图解法和归纳法。根据对乌克兰相关年份(2010-2022年)有效的非处方药清单的分析,据证实,药品市场上非处方药的数量及其在注册药品中的比重每年都在下降(从26.0%下降到21.2%)。根据现行《非处方药清单》(乌克兰卫生部2019年4月18日第876号命令)和非处方药登记册的比较营销分析结果(根据乌克兰国家药品登记册,截至2022年2月),在成分、ATC分类、原产国和剂型的分类项目分布上只发现了微不足道的差异。发现了现行非处方药清单的不足之处,例如2019-2022年存在注册过期的药品;职位重复;处方组商品名称的存在。根据研究结果,提出了有助于下一版国内非处方药目录的正确形成以及药剂师和消费者合理使用非处方药的组织方法,以实现负责任的自我用药的可能性。研究结果可用于在乌克兰建立一个法律框架,规范非处方药在药品市场上的流通。
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