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干预措施以改善药物不良反应报告:范围综述。

Interventions to improve adverse drug reaction reporting: A scoping review.

机构信息

HIV/STI Surveillance Research Center, and WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.

National Institute for Medical Research Development, Tehran, Iran.

出版信息

Pharmacoepidemiol Drug Saf. 2020 Sep;29(9):965-992. doi: 10.1002/pds.4966. Epub 2020 May 19.

Abstract

PURPOSE

Underreporting is the major limitation of a voluntary adverse drug reaction (ADR) reporting system. Many studies have assessed the effectiveness of different interventions designed to improve ADR reporting. The aim of this study was to systematically map interventions and strategies to improve ADR reporting among health care professionals.

METHODS

The six-stage methodological framework of Arksey and O'Malley was used to conduct this scoping review. Ovid MEDLINE, EMBASE, All EBM, and Web of Science were systematically searched from 1999 to February 2019, and the reference lists of the included papers were also searched for gray literature to identify any interventions and strategies that aimed to increase ADR reporting. Two reviewers screened the papers for eligibility based on the inclusion criteria and extracted their key data and analyzed them descriptively.

RESULTS

Ninety out of 14 501 papers met the selection criteria. Using computerized registration and active surveillance can increase ADR reporting significantly. Educational interventions performed individually or combined with sending reminders and/or feedback, awards, and providing easier reporting channels can improve ADR reporting over a short to medium term. Multiple interventions may have more impact than single-component interventions.

CONCLUSION

Multiple interventions could cause a greater increase in ADR reporting rates than single interventions. Although educational interventions appear to be effective, few studies have reviewed their long-term effects to ascertain whether the improvements are sustained over time. Studies with a better methodological quality are required on this subject.

摘要

目的

自愿药物不良反应(ADR)报告系统的主要局限性在于漏报。许多研究评估了旨在提高 ADR 报告的不同干预措施的有效性。本研究旨在系统绘制干预措施和策略,以提高医疗保健专业人员的 ADR 报告率。

方法

采用 Arksey 和 O'Malley 的六阶段方法框架进行这项范围性综述。从 1999 年到 2019 年 2 月,系统地在 Ovid MEDLINE、EMBASE、All EBM 和 Web of Science 中进行搜索,并搜索纳入论文的参考文献列表以确定任何旨在提高 ADR 报告的干预措施和策略。两名审查员根据纳入标准筛选论文是否符合入选标准,并提取其关键数据并进行描述性分析。

结果

在 14501 篇论文中,有 90 篇符合入选标准。使用计算机化登记和主动监测可以显著提高 ADR 报告率。教育干预单独或与发送提醒和/或反馈、奖励以及提供更方便的报告渠道相结合,可以在短至中期内提高 ADR 报告率。多项干预措施可能比单项干预措施产生更大的影响。

结论

多项干预措施可能比单项干预措施更能提高 ADR 报告率。尽管教育干预似乎有效,但很少有研究评估其长期效果,以确定改善是否随着时间的推移而持续。需要在这一主题上开展具有更好方法学质量的研究。

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