【药品销毁作为国家对药品流通控制(监督)效率的一个要素】。

Q3 Medicine
F N Bidarova
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引用次数: 0

摘要

背景:现代国家药品质量管理体系使不符合要求的药品的发现和撤销成为可能。然而,在俄罗斯联邦,伪劣药品的周转和销毁问题仍然十分紧迫。本研究的目的是评价国家药品质量管理的有效性和假药销毁的做法。方法:调查数据包括俄罗斯联邦和北奥塞梯-阿拉尼亚共和国卫生部、俄罗斯卫生检验局、国家药品质量控制和认证中心的官方网站。社会学调查采用非重复抽样法。共编制问卷225份。该研究于2013年至2015年在国家药品质量控制与认证中心的帮助下在北奥塞梯国立医学院进行。结果:分析了国家质量管理在假药销毁规则方面存在的不足。发现不合格假药销毁披露、转移、销毁的永久数据采集监测机制尚未确定。在法律基础严重不足的情况下,控制措施的有效性已得到证实。对表征假药销毁顺序的术语进行了分析。结论:在调查过程中发现的假药销毁国家质量管理规定执行中存在的不足,说明有必要采取措施,建立新的管理职能模式,提高活动成效。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[The Destruction of Pharmaceutical Products as an Element of the Efficiency of State Control (Supervision) Over the Circulation of Medicines].

Background: The modern system of state quality control over medicine makes it possible to reveal and withdraw drugs, that do not meet the requirements. However the problem of the turnover of substandard andfake drug and their destruction in the Russian Federation is still urgent.

The aim of the study: to evaluate the effectiveness of state quality control over medicine and the practice offake medicine destruction.

Methods: data of the official websites of the Ministry of Health of the Russian Federation and the Republic of North Ossetia--Alania, Russian Sanitary Inspection, National Center of Quality control and Certification of Drugs were included in the investigation. Method of unrepeated samples was used in sociological investigations. 225 questionnaires have been worked out. The research was carried out in the North-Ossetian State Medical academy during the periodfrom 2013 to 2015 with the help of the National Center of Quality Control and Certification of Drugs.

Results: The shortcomings of the state quality control over the rules of fake drug destruction were studied. It was found out that the mechanism ofpermanent data collection monitoring of revealing, moving and destruction of substandard and fake drug destruction has not been determined. The ineffectiveness of controlling measures under the condition of critical legal base deficiency has been confirmed. The analysis of terminology characterizing the order of fake drug destruction was carried out.

Conclusion: deficiencies related to the implementation of the state quality control over the fake drug destruction rules revealed during the course of investigations prove the necessity of adopting measures in creating new model of controlfunctions, increasing the results of activity.

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来源期刊
CiteScore
1.50
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0.00%
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31
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