Department of Pharmacology, University of Bologna, Via Irnerio 48, Postal Code 40126, Bologna, Italy.
Eur J Clin Pharmacol. 2013 Feb;69(2):237-44. doi: 10.1007/s00228-012-1321-7. Epub 2012 Jun 17.
Underreporting is a major limitation of spontaneous reporting systems for suspected adverse drug reactions (ADRs). Several interventions to increase the ADR reporting rate have been proposed, but their efficacy remains poorly investigated.
This was a questionnaire study aimed at assessing the knowledge, attitudes, and behavior of general practitioners (GPs) regarding ADR reporting and at evaluating whether a monthly e-mail-based newsletter on drug safety could affect the rate and the quality of the ADR reports submitted by these GPs. Three local health authorities (LHAs) of the Emilia-Romagna region were chosen on the basis of their ADR reporting rate during the period preceding the study: Rimini (high), Ferrara (average), and Piacenza (low reporting rate). All GPs (n = 737) associated with these three LHAs were recruited. The pooled number of ADR reports sent by GPs in the remaining seven LHAs of the region was used as controls. The study covered a period of 3 years and was divided into: (1) identification of the reasons leading to underreporting through a questionnaire (Phase I); (2) the intervention, i.e., sending a newsletter for a 10-month period (Phase II); (3) evaluation of the intervention outcomes during the 10 months following the period in which the newsletter had been received (Phase III).
Among GPs involved, 22.8 % returned the questionnaire. Over 94 % of the respondents considered the spontaneous reporting of suspected ADRs to be part of their professional obligations, but only 6.5 % had submitted at least one report in the previous 6 months. Following the completion of Phase II, the overall number of reports coming from the LHAs subjected to the intervention rose by 49.2 % compared to 2009, while the number of reports coming from the control LHAs increased by 8.8 %. Rimini and Piacenza showed a 200 % increase in the number of ADR reports submitted by GPs, while the number of ADR reported submitted by the control group decreased by 25.5 %. In 2011, the number of overall ADRs reports from the LHAs subjected to the intervention decreased by 6.8 %; this decrease reached 50.0 % of the GPs. Control HLAs showed an overall decline of 4.3 %, while the total number of ADRs from GPs increased by 63.3 %. Ferrara was excluded from the analysis due to confounding factors.
The periodic e-mail update on the safety of drugs represents an effective and inexpensive way to raise the awareness of GPs on the importance of spontaneous ADR reporting. Since the outcome of the intervention seemed to disappear after the intervention was stopped, there appears to be a need to adopt a policy of regular updates and educational strategies for health professionals.
自发报告系统报告疑似药物不良反应（ADR）存在漏报的主要局限性。为提高ADR 报告率，已提出多种干预措施，但这些措施的效果仍未得到充分研究。
这是一项问卷调查研究，旨在评估全科医生（GP）对 ADR 报告的知识、态度和行为，并评估每月基于电子邮件的药物安全通讯是否会影响这些 GP 提交的 ADR 报告的数量和质量。根据研究前期间 Emilia-Romagna 地区各地方卫生当局（LHA）的 ADR 报告率，选择了三个 LHA：里米尼（高）、费拉拉（中）和皮亚琴扎（低）。招募了与这三个 LHA 相关的所有 737 名 GP。该地区其余七个 LHA 的 GP 提交的 ADR 报告数量被用作对照。研究覆盖了 3 年时间，分为三个阶段：（1）通过问卷调查确定导致漏报的原因（第一阶段）；（2）干预措施，即发送通讯 10 个月（第二阶段）；（3）在收到通讯后的 10 个月内评估干预结果（第三阶段）。
参与的 GP 中，22.8% 回了问卷。超过 94%的受访者认为，报告疑似 ADR 是他们的职业义务之一，但只有 6.5%的人在过去 6 个月内提交过至少一份报告。在第二阶段完成后，与干预相关的 LHA 的总体报告数量比 2009 年增加了 49.2%，而对照 LHA 的报告数量增加了 8.8%。里米尼和皮亚琴扎的 GP 提交的 ADR 报告数量增加了 200%，而对照组的报告数量减少了 25.5%。2011 年，干预 LHA 的总体 ADR 报告数量下降了 6.8%；GP 的降幅达到了 50.0%。对照 LHA 总体下降了 4.3%，而 GP 的 ADR 报告总数增加了 63.3%。由于混杂因素，费拉拉被排除在分析之外。
定期电子邮件更新药物安全性是提高 GP 对自发 ADR 报告重要性认识的有效且经济实惠的方法。由于干预停止后，干预的效果似乎消失了，因此似乎需要为卫生专业人员制定定期更新和教育策略的政策。
