与医疗保健专业人员报告药物不良反应不足相关的因素：系统评价更新。
Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update.
机构信息
Department of Public Health, Faculty of Farmacy, University of Santiago de Compostela, Praza do Seminario de Estudos Galegos, s/n, 15705, Santiago de Compostela, Spain.
Faculdade de Farmácia da, Universidade de Lisboa, Lisbon, Portugal.
出版信息
Drug Saf. 2023 Jul;46(7):625-636. doi: 10.1007/s40264-023-01302-7. Epub 2023 Jun 6.
INTRODUCTION
Underreporting is a major limitation of the voluntary reporting system of adverse drug reactions (ADRs). A 2009 systematic review showed the knowledge and attitudes of health professionals were strongly related with underreporting of ADRs.
OBJECTIVE
Our aim was to update our previous systematic review to determine factors (sociodemographic, knowledge and attitudes) associated with the underreporting of ADRs by healthcare professionals.
METHODS
We searched the MEDLINE and EMBASE databases for studies published between 2007 and 2021 that met the following inclusion criteria: (1) published in English, French, Portuguese or Spanish; (2) involving health professionals; and (3) the goal was to evaluate factors associated with underreporting of ADRs through spontaneous reporting.
RESULTS
Overall, 65 papers were included. While health professional sociodemographic characteristics did not influence underreporting, knowledge and attitudes continue to show a significant effect: (1) ignorance (only serious ADRs need to be reported) in 86.2%; (2) lethargy (procrastination, lack of interest, and other excuses) in 84.6%; (3) complacency (the belief that only well tolerated drugs are allowed on the market) in 46.2%; (4) diffidence (fear of appearing ridiculous for reporting merely suspected ADRs) in 44.6%; and (5) insecurity (it is nearly impossible to determine whether or not a drug is responsible for a specific adverse reaction) in 33.8%, and the absence of feedback in 9.2%. In this review, the non-obligation to reporting and confidentiality emerge as new reasons for underreporting.
CONCLUSIONS
Attitudes regarding the reporting of adverse reactions continue to be the main determinants of underreporting. Even though these are potentially modifiable factors through educational interventions, minimal changes have been observed since 2009.
CLINICAL TRIALS REGISTRATION
PROSPERO registration number CRD42021227944.
引言
药品不良反应（ADR）自愿报告系统的主要局限性是漏报。2009 年的系统评价显示，卫生专业人员的知识和态度与 ADR 漏报密切相关。
目的
我们旨在更新之前的系统评价，以确定与医疗保健专业人员漏报 ADR 相关的因素（社会人口学、知识和态度）。
方法
我们检索了 MEDLINE 和 EMBASE 数据库，以获取 2007 年至 2021 年期间发表的符合以下纳入标准的研究：（1）以英文、法文、葡萄牙文或西班牙文发表；（2）涉及卫生专业人员；（3）目的是通过自发报告评估与 ADR 漏报相关的因素。
结果
共纳入 65 篇论文。尽管卫生专业人员的社会人口学特征并不影响漏报，但知识和态度仍然显示出显著的影响：（1）无知（只有严重的 ADR 需要报告）占 86.2%；（2）懒惰（拖延、缺乏兴趣和其他借口）占 84.6%；（3）自满（认为只有耐受良好的药物才能在市场上使用）占 46.2%；（4）缺乏自信（因报告可疑的 ADR 而感到可笑的恐惧）占 44.6%；（5）不安全感（几乎不可能确定药物是否对特定不良反应负责）占 33.8%，以及缺乏反馈占 9.2%。在本次审查中，无报告义务和保密性成为漏报的新原因。
结论
报告不良反应的态度仍然是漏报的主要决定因素。尽管这些因素可以通过教育干预措施来改变，但自 2009 年以来，变化甚微。
临床试验注册
PROSPERO 注册号 CRD42021227944。
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