智能手机应用程序能否帮助克服报告劣药/假药的障碍？坦桑尼亚和印度尼西亚的试点研究。

Can a Smartphone Application Help Address Barriers to Reporting Substandard/Falsified Medical Products? A Pilot Study in Tanzania and Indonesia.

机构信息

Department of Anthropology, Durham University, Durham, United Kingdom.

World Health Organization, Geneva, Switzerland.

出版信息

Glob Health Sci Pract. 2023 Aug 28;11(4). doi: 10.9745/GHSP-D-23-00034.

DOI:10.9745/GHSP-D-23-00034

PMID:37640491

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10461706/

Abstract

INTRODUCTION

Reporting is an essential component of efforts to combat the distribution and circulation of substandard and falsified (SF) medical products worldwide. However, little is known about why health care professionals (HCPs) do not report suspect products to the national medicine regulatory authority (NMRA) and what measures might address this. This pilot study aimed to assess the utility of a smartphone application for reporting SF medical products in Tanzania and Indonesia.

METHODS

At baseline, in 2017, HCPs completed a survey describing perceived barriers to reporting and received training in the identification of SF products and received use of the smartphone reporting application (N=309). The application reporting system was piloted for 6 months. Evaluations took place with HCPs and NMRA staff at the midpoint and endline of the pilot study (2018).

RESULTS

At baseline, HCPs surveyed (n=254) identified the following key barriers to reporting: difficulties identifying SF products, frustrations with existing reporting systems, and fears that reporting may have personal or reputational repercussions. During the pilot period, HCPs submitted a total of 36 reports of 27 products to the NMRAs in their respective countries; of these, 8 products were determined to be SF and 2 were unregistered. In all 10 cases, appropriate regulatory action was taken. Feedback from HCPs and NMRA staff was positive in both countries, suggesting that the application addressed several barriers to reporting as it was convenient and, importantly, opened a line of communication between HCPs and the NMRA. However, the application did not address all barriers to reporting, such as concerns of repercussions.

CONCLUSION

The findings suggest that this smartphone application may be useful for improving HCPs' reporting of suspected SF products. Developing and piloting similar reporting applications in other countries and contexts is required.

摘要

简介

报告是打击全球不合格和假冒（SF）医疗产品的分发和流通的努力的重要组成部分。然而，人们对医疗保健专业人员（HCPs）为何不向国家药品监管机构（NMRA）报告可疑产品以及可以采取哪些措施来解决这一问题知之甚少。这项试点研究旨在评估在坦桑尼亚和印度尼西亚使用智能手机应用程序报告 SF 医疗产品的效用。

方法

在 2017 年基线时，HCPs 完成了一项调查，描述了报告的障碍，并接受了识别 SF 产品的培训，并获得了智能手机报告应用程序的使用权限（N=309）。该应用程序报告系统进行了 6 个月的试点。在试点研究的中点和结束时（2018 年），对 HCPs 和 NMRA 工作人员进行了评估。

结果

在基线时，接受调查的 HCPs（n=254）确定了报告的以下主要障碍：识别 SF 产品的困难、对现有报告系统的不满以及担心报告可能会产生个人或声誉影响。在试点期间，HCPs 共向各自国家的 NMRAs 提交了 36 份 27 种产品的报告；其中 8 种产品被确定为 SF，2 种产品未注册。在所有 10 种情况下，都采取了适当的监管措施。来自 HCPs 和 NMRA 工作人员的反馈在两个国家都是积极的，这表明该应用程序解决了报告的一些障碍，因为它方便，重要的是，它在 HCPs 和 NMRA 之间开辟了一条沟通渠道。然而，该应用程序并没有解决所有的报告障碍，例如对后果的担忧。