Suppr超能文献

厄立特里亚医疗保健专业人员在打击假冒医疗产品方面的理解、准备情况及应对措施:一项基于人群的调查

Understanding, readiness, and response of healthcare professionals in combating falsified medical products in Eritrea: a population-based survey.

作者信息

Fitsum Yodit, Werede Azania, Mahmud Saleh Abubeker, Tesfamariam Eyasu H, Magombo Francis, Misghina Freminatos, Yemane Hermella, Bahta Iyassu, Abraham Liya, Bahta Merhawi, Debesai Merhawi, Tesfagaber Meron, Ghirmai Michael, Tesfamariam Sirak, Russom Mulugeta

机构信息

National Medicines and Food Administration, Ministry of Health, Asmara, Eritrea.

Product Evaluation and Registration Unit, National Medicines and Food Administration, Ministry of Health, P.O.BOX 212 Asmara, Eritrea.

出版信息

Ther Adv Drug Saf. 2023 Dec 15;14:20420986231213713. doi: 10.1177/20420986231213713. eCollection 2023.

Abstract

BACKGROUND

The circulation of falsified medical products is a global threat and is expected to be higher in low- and middle-income countries.

OBJECTIVE

This study was conducted to assess the understanding, readiness, and response of Eritrea's healthcare professionals (HCPs), and identify potential areas of intervention to combat circulation of falsified medical products.

DESIGN

This was a nationwide population-based cross-sectional survey, conducted in December 2021.

METHODS

This study enrolled representative samples of HCPs working in public and private health facilities. Two-stage stratified cluster sampling was used to select study participants and data were collected through face-to-face interviews. Descriptive statistics, Mann-Whitney test, Kruskal-Wallis test along with their post hoc tests, Jonckheere-Terpstra, and logistic regression analyses were performed as appropriate.

RESULTS

The study enrolled 707 HCPs, and 96.6% were successfully surveyed. The majority of the participants (62.5%) encountered products with suspected quality defects and 63.8% claimed that they had reported the incident(s) at least once. About 85% reported that complaints should be submitted to the Eritrean Pharmacovigilance Centre and 74.0% indicated that it should be reported at the earliest time possible even if the reporter lacks details. The standard reporting form for suspected product quality issues was correctly recognized by 13.8%. Overall, the median knowledge and attitude scores were found to be 9 out of 17 (interquartile range, IQR: 4.0) and 30 out of 35 (IQR: 4.0), respectively. Not knowing how to report (55.6%) and what to report (34.9%), no/delayed feedback from the regulatory authority (30.0%), and unavailability of reporting forms (29.0%) were the frequently reported barriers to reporting. In addition, profession ( = 0.027), no/delayed feedback (adjusted odds ratio [AOR]: 4.70; 95% CI: 2.17-10.18;  < 0.001), and not knowing how to report (AOR: 0.12; 95% CI: 0.05-0.28;  < 0.001) were found to be determinants of reporting suspected product quality defects.

CONCLUSION

The readiness and response of Eritrea's HCPs in detecting and reporting falsified medical products seems promising, although a significant knowledge gap was observed.

摘要

背景

假冒医疗产品的流通是一个全球性威胁,预计在低收入和中等收入国家更为严重。

目的

本研究旨在评估厄立特里亚医疗保健专业人员(HCPs)的理解、准备情况和应对措施,并确定打击假冒医疗产品流通的潜在干预领域。

设计

这是一项于2021年12月进行的全国性基于人群的横断面调查。

方法

本研究纳入了在公共和私立卫生机构工作的HCPs的代表性样本。采用两阶段分层整群抽样方法选择研究参与者,并通过面对面访谈收集数据。根据需要进行描述性统计、Mann-Whitney检验、Kruskal-Wallis检验及其事后检验、Jonckheere-Terpstra检验和逻辑回归分析。

结果

该研究纳入了707名HCPs,96.6%的人成功接受了调查。大多数参与者(62.5%)遇到过疑似质量缺陷的产品,63.8%的人声称他们至少报告过一次此类事件。约85%的人报告称投诉应提交给厄立特里亚药物警戒中心,74.0%的人表示即使报告者缺乏详细信息也应尽早报告。只有13.8%的人正确识别了疑似产品质量问题的标准报告表格。总体而言,知识得分中位数为17分中的9分(四分位间距,IQR:4.0),态度得分中位数为35分中的30分(IQR:4.0)。不知道如何报告(55.6%)和报告什么(34.9%)、监管机构没有/延迟反馈(3图0.0%)以及没有报告表格(29.0%)是报告中经常提到的障碍。此外,职业(=0.027)、没有/延迟反馈(调整后的优势比[AOR]:图.70;95%置信区间:2.17-10.18;<0.001)以及不知道如何报告(AOR:0.12;95%置信区间:0.05-0.28;<0.001)被发现是报告疑似产品质量缺陷的决定因素。

结论

尽管观察到存在重大知识差距,但厄立特里亚HCPs在检测和报告假冒医疗产品方面的准备情况和应对措施似乎很有希望。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7fc/10725142/8ff21e783292/10.1177_20420986231213713-fig1.jpg

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验