遵守现行国家药品法,在不丹的社区药房妥善储存和分配药品

Pelden Chejor, Kinga Jamphel, Tsheten, Zimba Letho, Guru, U. Tshering
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引用次数: 4

摘要

导言:社区药房遵守国家药品法,妥善储存和调剂药品,对确保药品质量和安全至关重要。不丹的社区药店有两种类型:零售药店和批发药店。目的:本研究旨在评估社区药房遵守不丹王国2003年《药品法》和2012年《不丹药品规则和条例》的情况。方法:对2015年1月至2017年12月被检查的社区药店的检查报告进行回顾性横断面研究。使用频率和百分比的描述性统计来报告结果。结果:关键类和次要类监管规定的总体合规水平为90.4%,主要类监管规定的总体合规水平为86.74%。约32.99%的社区药房没有药品储存和调剂的标准操作程序,100%的社区药房拥有药品监督管理局的技术授权。结论:虽然发现不丹社区药房的药品储存和调剂合规水平在80%以上,但仍有几个方面需要纠正,以确保完全合规。这项研究将为政策制定者、管理者和研究人员制定未来干预措施的设计提供基础。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Compliance to current national medicines law for proper storage and dispensing of medicines at community pharmacies in Bhutan
Introduction: Compliance of community pharmacies with the national medicines law for proper storage and dispensing of medicines is crucial for ensuring the quality and safety of medicines. Community pharmacies in Bhutan are of two types: retail pharmacies and wholesale pharmacies. Objective: This study was aimed to assess the compliance of community pharmacies with the Medicines Act of the Kingdom of Bhutan 2003 and Bhutan Medicines Rules and Regulation 2012. Methods: This is a retrospective cross-sectional study from the inspection reports of community pharmacies inspected from January 2015 to December 2017. Descriptive statistics in frequency and percentage was used to report the results. Results: The overall compliance level for the regulatory provisions under critical and minor categories was 90.4% followed by 86.74% for major category. Around 32.99% of community pharmacies were found without standard operating procedures for storing and dispensing of medicines while 100% of community pharmacies had technical authorization from the Drug Regulatory Authority. Conclusion: Although the compliance level of community pharmacies in Bhutan for storing and dispensing of medicines was found to be above 80%, there are several areas that need to be corrected to ensure full compliance. This study will serve as a baseline for policymakers, managers, and researchers in developing designs for future interventions.
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