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评估埃塞俄比亚西部公共医药供应链中过期药品的规模和影响因素。

Assessment of the magnitude and contributing factors of expired medicines in the public pharmaceutical supply chains of Western Ethiopia.

机构信息

Pharmaceutical Quality Assurance, and Regulatory Affairs, Madda Walabu University, Goba Referral Hospital, Oromia Regional State, Robe, Ethiopia.

Jimma University Laboratory of Drug Quality (JuLaDQ) and School of Pharmacy, Institute of Health, Jimma University, Jimma, Ethiopia.

出版信息

BMC Health Serv Res. 2023 Jul 25;23(1):791. doi: 10.1186/s12913-023-09776-y.

Abstract

BACKGROUND

The magnitude of expired medicines in supply chains are increasing globally due to lack of strict control of the supply chain, poor storage management and oversupply of medicines. This situation is very serious in resource-poor countries, including Ethiopia, where the supply of medicines is limited. Therefore, this study aimed to assess the magnitude and the contributing factors of expired medicines in the Public Pharmaceutical Supply Chains of Western Ethiopia.

METHODS

Explanatory sequential study design involving mixed quantitative and qualitative approach were employed among 62 public pharmaceutical supply chains of Western Ethiopia from July1 to August 30, 2021. An observational checklist and the self-administered questionnaire were used to review all records of the expired medicine file and to abstract secondary data on the extent, types of expired medicines and its contributing factors. The collected data was cleared, filtered, and coded using Microsoft Excel® 2010, and exported to SPSS version-23 (Amsterdam, Netherland) for statistical analysis. Bivariate logistic regression was used to check association between the outcome and independent variables. Multivariate logistic regression was analyzed when p-value is less than or equal to 0.25 in bivariate binary logistic regression, considering the statistical at p-value < 0.05. Moreover, audio recordings were transcribed and coded for emergent themes using thematic analysis.

RESULTS

The study revealed 5% expire rate over past two financial (2012 up to 2013) years and the total amount of expired drugs is estimated at 20 million Ethiopian Birr (ETB). Tetanus antitoxin (TAT), in terms of single drug value, had the highest drug expiry (4,110,426.43ETB: 20%), followed by liquid dosage forms (11,614,266.11 ETB: 57%). The Binary logistic regression result indicated that, poor store management were more likely associated with the magnitude of expired medicine than those with good store management (COR: 10.706, 95% CI: 2.148, 53.348). Multivariate logistic regression revealed that poor store management (AOR: 9.718, 95% CI: 1.474, 64.082) was a significant contributor to the expire rate at 5% (P < 0.05). Most facilities did not have a procedure, and programme for disposing of expired medicines. According to key informants, inadequate inventory management, lack of policy and implementation of standards are the main contributing factors of the medicine's expiration.

CONCLUSION AND RECOMMENDATIONS

The current study found that the overall rate of medication expiration is high, at a significant cost to the budget. Inadequate inventory management, lack of policy, and implementation of standards are the main contributing factors to the medicine's expiration, as cited by key informants. Further research is necessary to determine the quality and efficacy of these expired drugs to extend their shelf life to ensure adequate access to drugs in resource-limited settings.

摘要

背景

由于供应链缺乏严格控制、储存管理不善和药品供应过剩,导致全球范围内过期药品的数量不断增加。这种情况在资源匮乏的国家非常严重,包括埃塞俄比亚,那里的药品供应有限。因此,本研究旨在评估西埃塞俄比亚公共药品供应链中过期药品的规模及其影响因素。

方法

采用解释性序贯研究设计,于 2021 年 7 月 1 日至 8 月 30 日期间对西埃塞俄比亚的 62 家公共药品供应链进行了混合定量和定性研究。使用观察检查表和自填式问卷,审查过期药品档案的所有记录,并提取有关过期药品的程度、类型及其影响因素的次要数据。使用 Microsoft Excel® 2010 对收集的数据进行清理、筛选和编码,并将其导出到 SPSS 版本 23(荷兰阿姆斯特丹)进行统计分析。二变量逻辑回归用于检查结果与自变量之间的关联。当二变量二元逻辑回归中的 p 值小于或等于 0.25 时,进行多变量逻辑回归分析,考虑到 p 值<0.05 的统计学意义。此外,对音频记录进行转录,并使用主题分析对新出现的主题进行编码。

结果

研究表明,过去两个财政年度(2012 年至 2013 年)的过期率为 5%,过期药品的总金额估计为 2000 万埃塞俄比亚比尔(ETB)。就单一药物价值而言,破伤风抗毒素(TAT)的药品过期率最高(4,110,426.43ETB:20%),其次是液体制剂(11,614,266.11ETB:57%)。二变量逻辑回归结果表明,与储存管理良好的相比,储存管理不善更有可能与过期药品的数量有关(比值比:10.706,95%置信区间:2.148,53.348)。多变量逻辑回归显示,储存管理不善(优势比:9.718,95%置信区间:1.474,64.082)是导致过期率为 5%的一个重要因素(P<0.05)。大多数设施没有处理过期药品的程序和方案。根据关键信息提供者的说法,库存管理不足、缺乏政策以及标准的执行是导致药品过期的主要因素。

结论和建议

本研究发现,药品过期的总体比例很高,这对预算造成了重大损失。库存管理不足、政策和标准执行不力是导致药品过期的主要因素,这是关键信息提供者提到的。有必要进一步研究这些过期药品的质量和疗效,以延长其保质期,确保在资源有限的情况下有足够的药品供应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f8a/10367394/46b975c5e80e/12913_2023_9776_Fig1_HTML.jpg

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