Rosebraugh Curtis J, Tsong Yi, Zhou Feng, Chen Min, Mackey Ann Corken, Flowers Charlene, Toyer Denise, Flockhart David A, Honig Peter K
United States Food and Drug Administration, Room 10B-45, HFD-570, 5600 Fishers Lane, Rockville, MD 20857, USA.
Pharmacoepidemiol Drug Saf. 2003 Mar;12(2):97-101. doi: 10.1002/pds.797.
Evaluate whether a 15-minute lecture intervention will improve adverse drug reaction reporting quality on standard MedWatch forms.
Seventy-eight 4th-year medical students were randomized to intervention 'Group-A' or non-intervention 'Group-B' on the first day of a required five-day clinical pharmacology rotation. Group-A participants attended a 15-minute lecture on completing a MedWatch form with quality information considered by the Food and Drug Administration as critical to adequate adverse drug reaction reporting. Group-B participants did not attend this lecture. Both groups then watched a standardized patient interview of a recognizable adverse drug reaction and completed MedWatch forms. Four Safety Evaluators from the Food and Drug Administration (FDA) rated student responses in a blinded fashion for the primary efficacy variable of Overall Impression and six informational domins using a standardized data quality analysis form that was developed within the Office of Postmarketing Drug Risk Assessment of the FDA.
Seventy-eight MedWatch forms were evaluated (Group-A = 40, Group B = 38). Overall MedWatch information quality scores for the intervention group were significantly higher than the non-intervention group (p < 0.004).
As little as a 15-minute intervention can significantly improve the quality of adverse drug reaction reporting by 4th-year medical students. Academic medical centers should consider incorporating adverse drug reaction reporting curriculum into the clinical training of medical students.
评估一次15分钟的讲座干预是否会提高标准MedWatch表格上药物不良反应报告的质量。
在为期五天的临床药理学轮转的第一天，78名四年级医学生被随机分为干预组“A组”或非干预组“B组”。A组参与者参加了一场15分钟的讲座，内容是填写MedWatch表格，其中包含美国食品药品监督管理局认为对充分报告药物不良反应至关重要的质量信息。B组参与者未参加此次讲座。然后两组都观看了一段关于可识别的药物不良反应的标准化患者访谈视频，并填写MedWatch表格。来自美国食品药品监督管理局（FDA）的四名安全评估员以盲法对学生的回答进行评分，评估总体印象这一主要疗效变量以及使用FDA上市后药物风险评估办公室制定的标准化数据质量分析表评估六个信息领域。
共评估了78份MedWatch表格（A组 = 40份，B组 = 38份）。干预组的MedWatch信息总体质量得分显著高于非干预组（p < 0.004）。
仅15分钟的干预就能显著提高四年级医学生药物不良反应报告的质量。学术医学中心应考虑将药物不良反应报告课程纳入医学生的临床培训中。
