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利用低成本至中等成本的现场测试数字技术,对选定的资源有限的初级医疗保健机构中的药品进行质量评估。

Quality assessment of medicines in selected resource-limited primary healthcare facilities using low- to medium-cost field testing digital technologies.

作者信息

Opuni Kwabena Fm, Sunkwa-Mills Gifty, Antwi Maxwell A, Squire Antoinette, Afful George Y, Rinke de Wit Tobias F, Kretchy Irene A

机构信息

Department of Pharmaceutical Chemistry, School of Pharmacy, University of Ghana, Legon, Ghana.

PharmAccess, Accra, Ghana.

出版信息

Digit Health. 2024 Nov 18;10:20552076241299064. doi: 10.1177/20552076241299064. eCollection 2024 Jan-Dec.

Abstract

BACKGROUND

Digital technologies can assess the quality of medicines in resource-challenged health facilities in a timely manner and ensure effective healthcare.

OBJECTIVES

This study assessed the quality of some non-communicable disease medicines, antimalarials, antibiotics, non-steroidal anti-inflammatory drugs and hematinics in selected healthcare facilities as part of their (potential) participation in a digital pharmaceutical supply chain management system (Med4All).

METHODS

All the sampled medicines were screened using TruScan analyzer and GPHF-minilab, that is low-medium field technologies. The quality of a representative subset of the medicines (∼11%) was determined using pharmacopoeia gold standard methods.

RESULTS

About 75% of the medicines were manufactured in Ghana, and 16% were imported from India, with the Ghana Food and Drugs Authority registering 72% of the medicines. There was over 90% availability of medicines in health facilities from the middle and southern sectors, while the northern sector had around 64%. Approximately 87% and 88% of the medicines passed TruScan™ Raman and GPHF-minilab analysis, respectively. There was no significant difference between the two screening methods for assessing the quality of the medicines ( > 0.05). Of the 21 medicine samples, 5 (∼24%) failed, and 16 (76%) passed the pharmacopoeia test. The failed medicines were diclofenac, azithromycin and glibenclamide. Compared to the pharmacopoeia method, the performance of the TruScan™ Raman analyzer and the GPHF-minilab technologies were 71% and 63%, respectively.

CONCLUSION

The study provides insights into the quality of medicines in resource-limited primary healthcare facilities.

摘要

背景

数字技术能够及时评估资源匮乏的医疗机构中药品的质量,并确保医疗保健的有效性。

目的

本研究评估了选定医疗机构中一些非传染性疾病药物、抗疟药、抗生素、非甾体抗炎药和补血药的质量,作为其(潜在)参与数字药品供应链管理系统(Med4All)的一部分。

方法

所有抽样药品均使用TruScan分析仪和GPHF - 微型实验室进行筛选,这两种技术属于中低场技术。使用药典金标准方法确定了代表性药品子集(约11%)的质量。

结果

约75%的药品在加纳生产,16%从印度进口,加纳食品药品管理局对72%的药品进行了注册。中部和南部地区的医疗机构药品供应率超过90%,而北部地区约为64%。分别约有87%和88%的药品通过了TruScan™拉曼分析和GPHF - 微型实验室分析。两种筛选方法在评估药品质量方面无显著差异(P > 0.05)。在21个药品样本中,5个(约24%)不合格,16个(76%)通过了药典测试。不合格的药品为双氯芬酸、阿奇霉素和格列本脲。与药典方法相比,TruScan™拉曼分析仪和GPHF - 微型实验室技术的性能分别为71%和63%。

结论

该研究为资源有限的基层医疗机构中的药品质量提供了见解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8f0e/11571254/092a3699326a/10.1177_20552076241299064-fig1.jpg

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