Hartman Jenny, Härmark Linda, van Puijenbroek Eugène
Netherlands Pharmacovigilance Centre Lareb, s-Hertogenbosch, The Netherlands.
Faculty of Mathematics and Natural Sciences, PharmacoTherapy, -Epidemiology and -Economics-Groningen Research Institute of Pharmacy, University of Groningen, Groningen, The Netherlands.
Eur J Clin Pharmacol. 2017 Jul;73(7):891-899. doi: 10.1007/s00228-017-2237-z. Epub 2017 Mar 17.
The aim of this study was to gain insight in current pharmacovigilance educational activities and to gather information on which topics should be included in the undergraduate pharmacovigilance core curriculum.
A web-based questionnaire was carried out containing 45 questions divided over four sections between 28 October 2014 and 31 January 2015. Potential participants working in pharmacovigilance and/or providing training in this field were invited via email and a widespread web link and snowball sampling was used to recruit additional participants.
The questionnaire was filled out by 307 respondents from 88 different countries with a response rate of 29.3% for the email invitation and an unknown rate for the web link. Respondents were mainly pharmacists and physicians. Currently, lectures are the largest proportion of educational activities and all healthcare profession curricula have a mode of 2 h as number of contact hours per course. Respondents rated clinical aspects as the most important subdomain to be included in the core curriculum with prevention of adverse drug reactions as the most important subtopic. This was followed by communication aspects between parties, with communication between regulatory authorities and healthcare professionals, methodological aspects with causality assessment, and regulatory aspects with benefit-risk assessment. This is similar to subjects addressed in current educational activities with little difference between medical and pharmacy curricula.
This study gave a good general impression in current educational activities and the respondents' needs and wishes for future activities worldwide, which both will be used for the development of the undergraduate pharmacovigilance core curriculum.
本研究旨在深入了解当前的药物警戒教育活动,并收集有关本科药物警戒核心课程应涵盖哪些主题的信息。
2014年10月28日至2015年1月31日期间开展了一项基于网络的问卷调查,问卷包含45个问题,分为四个部分。通过电子邮件和广泛传播的网络链接邀请了从事药物警戒工作和/或在该领域提供培训的潜在参与者,并采用滚雪球抽样法招募更多参与者。
来自88个不同国家的307名受访者填写了问卷,电子邮件邀请的回复率为29.3%,网络链接的回复率未知。受访者主要是药剂师和医生。目前,讲座在教育活动中占比最大,所有医疗保健专业课程每门课程的接触时长模式均为2小时。受访者将临床方面评为核心课程中最重要的子领域,其中预防药物不良反应是最重要的子主题。其次是各方之间的沟通方面,包括监管机构与医疗保健专业人员之间的沟通、因果关系评估的方法学方面以及获益风险评估的监管方面。这与当前教育活动中涉及的主题相似,医学和药学课程之间差异不大。
本研究对当前的教育活动以及全球受访者对未来活动的需求和期望给出了很好的总体印象,这些都将用于本科药物警戒核心课程的开发。