Güner Müberra Devrim, Ekmekci Perihan Elif
Department of Medical Pharmacology, TOBB ETU Medical School, Ankara, Turkey.
Department of History of Medicine and Ethics, TOBB ETU Medical School, Ankara, Turkey.
J Drug Assess. 2019 Jan 5;8(1):13-20. doi: 10.1080/21556660.2019.1566137. eCollection 2019.
Spontaneous adverse drug reaction (ADR) reports prepared by healthcare professionals (HCPs) are the backbone of collecting post-marketing safety data. However, underreporting is a global problem creating health, economic, and ethical burden. To determine the factors limiting ADR reporting rates from the HCPs' point of view. A questionnaire containing 43 questions evaluating sociodemographic characteristics, pharmacovigilance knowledge and activities, and prescription behaviors was prepared on "surveymonkey.com." The link was distributed mainly by professional organizations. Although this survey aimed to reach all HCPs, most of the respondents were physicians and nurses. Of the 259 (69.6%) participants who encountered ADR at least once, only 105 (40.5%) reported ADR. The term "pharmacovigilance" was heard for the first time in this survey by 35.5% ( = 132) of the participants. Only 34.7% ( = 129) of the participants knew where to find the ADR reporting form, and 25.5% ( = 95) had previously filled the form and/or read it. Only 28.5% ( = 106) of the participants were aware of the ADR reporting and monitoring system of their institutions and related professionals. Almost all the participants agreed that pharmacovigilance and ADR reporting training are necessary. The main reason for underreporting is limited pharmacovigilance knowledge of HCPs. Training activities based on the needs and preferences of HCPs and close follow-up by authorities are the main steps to improve pharmacovigilance activities.
医疗保健专业人员(HCPs)编制的自发药品不良反应(ADR)报告是收集上市后安全数据的支柱。然而,漏报是一个全球性问题,会造成健康、经济和伦理负担。从HCPs的角度确定限制ADR报告率的因素。在“surveymonkey.com”上编制了一份包含43个问题的问卷,用于评估社会人口统计学特征、药物警戒知识与活动以及处方行为。该链接主要由专业组织分发。尽管本次调查旨在覆盖所有HCPs,但大多数受访者是医生和护士。在259名(69.6%)至少遇到过一次ADR的参与者中,只有105名(40.5%)报告了ADR。35.5%(=132)的参与者在本次调查中首次听说“药物警戒”一词。只有34.7%(=129)的参与者知道在哪里可以找到ADR报告表,25.5%(=95)的参与者之前填写过该表格和/或阅读过。只有28.5%(=106)的参与者了解其机构及相关专业人员的ADR报告和监测系统。几乎所有参与者都认为药物警戒和ADR报告培训是必要的。漏报的主要原因是HCPs的药物警戒知识有限。根据HCPs的需求和偏好开展培训活动以及当局进行密切跟进是改善药物警戒活动的主要步骤。