College of Medicine and Health, University of Exeter Medical School, Exeter, U.K.
In Vivo. 2022 Mar-Apr;36(2):780-800. doi: 10.21873/invivo.12765.
BACKGROUND/AIM: Adverse drug reactions (ADRs) represent a major concern leading to significant increases in both morbidity and mortality globally. Providing healthcare professionals (HCPs) and patients with real-world data on drug safety is imperative to facilitate informed decision-making. The study aimed to determine the feasibility of creating comparative safety charts for medicines by mapping ADR reporting onto prescribing data.
Data on serious and fatal ADR reports from the Yellow Card database was mapped onto general practice prescription data in England. The rate of serious and fatal ADR reports per million items prescribed was calculated for commonly-prescribed medicines.
Quantitative comparative analyses for 137 medicines belonging to 26 therapeutic classes were conducted. Significant differences were observed within most therapeutic classes for the rate of serious and fatal ADR reports per prescribing unit.
Despite the limitations of ADR reporting and prescribing databases, the study provides a proof-of-concept for the feasibility of mapping ADR reporting onto prescribing data to create comparative safety charts that could support evidence-based decision-making around formulary choices.
背景/目的：药物不良反应（ADR）是一个主要关注点，导致全球发病率和死亡率显著上升。为医疗保健专业人员（HCP）和患者提供有关药物安全性的真实世界数据对于促进明智决策至关重要。本研究旨在通过将药物不良反应报告映射到处方数据来确定为药物创建比较安全性图表的可行性。
将严重和致命药物不良反应报告的数据从黄卡数据库映射到英国的一般实践处方数据上。计算了常用药物的每百万处方单位严重和致命药物不良反应报告的发生率。
对属于 26 个治疗类别的 137 种药物进行了定量比较分析。在大多数治疗类别中，每处方单位严重和致命药物不良反应报告的发生率存在显著差异。
尽管药物不良反应报告和处方数据库存在局限性，但该研究为将药物不良反应报告映射到处方数据以创建支持药物选择决策的基于证据的比较安全性图表的可行性提供了概念验证。
