Lopez-Gonzalez Elena, Herdeiro Maria T, Figueiras Adolfo
Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Santiago de Compostela, Spain.
Drug Saf. 2009;32(1):19-31. doi: 10.2165/00002018-200932010-00002.
A voluntary reporting system of adverse drug reactions (ADRs) is fundamental to drug safety surveillance but under-reporting is its major limitation. This bibliographic review sought to assess the influence of personal and professional characteristics on ADR reporting and to identify knowledge and attitudes associated with ADR reporting. A systematic review was conducted using the MEDLINE and EMBASE databases. We included papers that were published in English, French and Spanish, and covered a study population made up of health professionals. In each case, the following data were extracted: study population; workplace; study type; sample size; type of questionnaire; type of scale for measuring knowledge; response rate; personal and professional factors; and knowledge and attitudes (based on Inman's 'seven deadly sins') associated with reporting. Based on a search of computerized databases, we identified a total of 657 papers in MEDLINE and 973 in EMBASE. In all, the review covered 45 papers that fulfilled the inclusion criteria. Medical specialty was the professional characteristic most closely associated with under-reporting in 76% of studies involving physicians. Other factors associated with under-reporting were ignorance (only severe ADRs need to be reported) in 95%; diffidence (fear of appearing ridiculous for reporting merely suspected ADRs) in 72%; lethargy (an amalgam of procrastination, lack of interest or time to find a report card, and other excuses) in 77%; indifference (the one case that an individual doctor might see could not contribute to medical knowledge) and insecurity (it is nearly impossible to determine whether or not a drug is responsible for a particular adverse reaction) in 67%; and complacency (only safe drugs are allowed on the market) in 47% of studies. While personal and professional factors display a weak influence, the knowledge and attitudes of health professionals appear to be strongly related with reporting in a high proportion of studies. This result may have important implications in terms of public health, if knowledge and attitudes are viewed as potentially modifiable factors.
药品不良反应（ADR）自愿报告系统是药物安全监测的基础，但漏报是其主要局限性。本文献综述旨在评估个人和专业特征对ADR报告的影响，并确定与ADR报告相关的知识和态度。使用MEDLINE和EMBASE数据库进行了系统综述。我们纳入了以英文、法文和西班牙文发表的、涵盖由卫生专业人员组成的研究人群的论文。在每种情况下，提取了以下数据：研究人群；工作场所；研究类型；样本量；问卷类型；测量知识的量表类型；回复率；个人和专业因素；以及与报告相关的知识和态度（基于英曼的“七宗罪”）。通过对计算机化数据库的检索，我们在MEDLINE中总共识别出657篇论文，在EMBASE中识别出973篇论文。该综述总共涵盖了45篇符合纳入标准的论文。在涉及医生的76%的研究中，医学专业是与漏报最密切相关的专业特征。与漏报相关的其他因素包括：95%的研究中存在无知（仅需报告严重的ADR）；72%的研究中存在缺乏自信（担心因报告仅仅是疑似的ADR而显得荒谬）；77%的研究中存在慵懒（拖延、缺乏兴趣或时间去找报告卡以及其他借口的综合表现）；67%的研究中存在冷漠（个别医生看到的一个病例对医学知识没有贡献）和不安全感（几乎不可能确定一种药物是否应对特定的不良反应负责）；以及47%的研究中存在自满（市场上只允许使用安全的药物）。虽然个人和专业因素的影响较弱，但在很大比例的研究中，卫生专业人员的知识和态度似乎与报告密切相关。如果将知识和态度视为潜在的可改变因素，这一结果可能对公共卫生具有重要意义。
