Reporting Adverse Drug Events: A Comparison of an Online Patient Tool Versus Telephone-Based Monitoring in Community Pharmacy Patients in the Netherlands.

IF 4 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Safety Pub Date : 2025-06-14 DOI:10.1007/s40264-025-01571-4

Henok D Habtemariam, Henk-Jan Guchelaar, Lisanne E N Manson, Jesse J Swen, Agnes C Kant, Stefan Böhringer

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引用次数: 0

Abstract

Background: Adverse drug events (ADEs) are events occurring after the administration of a drug. Several authorities are involved in capturing these ADEs to improve pharmacovigilance. These ADEs are reported directly to healthcare professionals or via the telephone, online, or e-mail and are crucial for maintaining drug safety.

Objective: Patient-reported adverse drug events (ADEs) are collected using various tools, though not much is known with regard to the comparability of these different methodologies. It is known that telephone-based surveys result in a higher report rate, although it is not known if this has an effect on the type of ADEs that are reported. In this prospective study, we aimed to investigate if there are differences in the number, type, and severity of ADEs reported via telephone and online in an event monitoring setting.

Methods: Patients included in Dutch community pharmacies were asked whether they experienced any ADEs via telephone and online (Lareb Intensive Monitoring) surveys as part of the PREPARE study. The PREPARE study was a multicenter study, researching the effect of genotype-guided dosing on the incidence of clinically relevant adverse drug reactions. With the paired data acquired in the PREPARE study, we investigated differences in the number, type, and severity of the reported ADEs.

Results: Patients (N = 525) completed both the telephone and online surveys. Of the 525 patients who completed both surveys, 326 reported ADEs via telephone and 239 online. A visual comparison showed a similar distribution in the type of ADEs among the methods except for less commonly reported types of ADEs and cardiac disorders. The perceived severity of ADEs were proportionally reported as more severe during the telephone survey versus the online survey.

Conclusions: Our study showed a clear difference in the number of ADEs reported during telephone and online monitoring. Additionally, the differences in the type of ADEs and the severity distribution of both tools shows that the tools are not exchangeable (CT.gov identifier: NCT03093818).

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报告药物不良事件：在线患者工具与电话监测在荷兰社区药房患者的比较。

背景：药物不良事件（ADEs）是指服用药物后发生的事件。一些权威机构参与捕获这些ade以提高药物警惕性。这些不良事件直接报告给医疗保健专业人员或通过电话、在线或电子邮件，对维持药物安全至关重要。目的：使用各种工具收集患者报告的药物不良事件（ADEs），尽管对于这些不同方法的可比性知之甚少。众所周知，基于电话的调查导致更高的报告率，尽管不知道这是否对报告的ade类型有影响。在这项前瞻性研究中，我们旨在调查在事件监测设置中，通过电话和在线报告的ade的数量、类型和严重程度是否存在差异。方法：作为prep研究的一部分，通过电话和在线（Lareb强化监测）调查询问荷兰社区药房的患者是否经历过不良反应。PREPARE研究是一项多中心研究，旨在研究基因型引导给药对临床相关药物不良反应发生率的影响。利用PREPARE研究中获得的配对数据，我们调查了报道的ade的数量、类型和严重程度的差异。结果：525例患者完成了电话和在线调查。在完成两项调查的525名患者中，326名通过电话报告不良反应，239名通过网络报告。视觉比较显示，除了不常报道的ade和心脏疾病类型外，不同方法之间的ade类型分布相似。在电话调查中，与在线调查相比，人们对不良事件严重程度的感知比例更高。结论：我们的研究显示，在电话监测和在线监测期间报告的不良事件数量有明显差异。此外，两种工具的ade类型和严重性分布的差异表明，这两种工具是不可交换的（CT.gov标识符：NCT03093818）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Safety 医学-毒理学

CiteScore

7.60

自引率

7.10%

发文量

112

审稿时长

6-12 weeks

期刊介绍： Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.