Assessment of quality assurance capability for medicines in community pharmacies in two cities in Nigeria

Background: Medicine quality is a global concern and lack of reliable quality assurance (QA) system for medicines may be contributory to the high level of spurious medicines in many developing countries. Objectives: The study evaluated the level of institutionalization of QA components for medicine inventory in community pharmacies in two cities of Osun State in Nigeria as a measure of QA capability and explored for factors influencing QA capability.

Methods: A set of pretested semi-structured questionnaire was administered to community pharmacists practicing in Oshogbo and Ile-Ife. The instrument sought information on the level of institutionalization of essential components of QA, and explored for factors influencing QA, both on ordinal scales with weighting scores of 1-5 and 0-4 respectively. Descriptive statistics were used to summarize the data. Chi square, Spearman's rank correlation as well as multiple and ordinal regressions were used to evaluate the respondents' opinions at 5% level of significance.

Results: Only two (12.5%) of the essential components of QA had been implemented (WA≈ 4) and none institutionalised (WA≈5). The three most prominent factors influencing QA capability were management commitment, suppliers and government regulatory control all with median score of 4.

Conclusion: Quality assurance capability for medicine inventory in the community pharmacies was low.

背景：药品质量是全球关注的核心议题，在众多发展中国家中，缺乏可靠的药品质量保障（Quality Assurance, QA）体系，或是导致假药泛滥的重要诱因。
目的：本研究以尼日利亚奥孙州两座城市的社区药房为研究对象，评估其药品库存QA相关组成部分的制度化程度，以此作为QA能力的衡量指标，并探究影响QA能力的相关因素。
方法：本研究向在奥绍博（Oshogbo）与伊莱伊费（Ile-Ife）执业的社区药师发放经预测试的半结构化问卷。该问卷用于收集药品库存QA核心组成部分的制度化程度，以及影响QA能力的相关数据，两项指标分别采用1~5分与0~4分的序数量表进行加权评分。研究采用描述性统计对数据进行汇总，并通过卡方检验、斯皮尔曼秩相关分析，以及多元回归与序数回归模型，在5%的显著性水平下对受访者的观点进行评估。
结果：仅2项（占比12.5%）QA核心组成部分得到实施（加权得分WA≈4），且无任何一项实现制度化（WA≈5）。影响QA能力的三大主要因素分别为管理层承诺、供应商与政府监管管控，三者的中位数评分均为4分。
结论：社区药房的药品库存QA能力整体偏低。