A Calculated Risk: Evaluation of QTc Drug-Drug Interaction (DDI) Clinical Decision Support (CDS) Alerts and Performance of the Tisdale Risk Score Calculator.

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-12-01 Epub Date: 2024-07-09 DOI:10.1007/s40264-024-01466-w
Rachel L Wasserman, Diane L Seger, Mary G Amato, Andrew Y Hwang, Julie Fiskio, David W Bates
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Abstract

Introduction: A risk factor for a potentially fatal ventricular arrhythmia Torsade de Pointes is a prolongation in the heart rate-corrected QT interval (QTc) ≥ 500 milliseconds (ms) or an increase of ≥ 60 ms from a patient's baseline value, which can cause sudden cardiac death. The Tisdale risk score calculator uses clinical variables to predict which hospitalized patients are at the highest risk for QTc prolongation.

Objective: To determine the rate of overridden QTc drug-drug interaction (DDI)-related clinical decision support (CDS) alerts per patient admission and the prevalence by Tisdale risk score category of these overridden alerts. Secondary outcome was to determine the rate of drug-induced QTc prolongation (diQTP) associated with overrides.

Methods: Our organization's enterprise data warehouse was used to retrospectively access QTc DDI alerts presented for patients aged ≥ 18 years who were admitted to Brigham and Women's Hospital during 2022. The QTc DDI CDS alerts were included if shown to a physician, fellow, resident, physician assistant, or nurse practitioner when entering the order in inpatient areas for patients with a length of stay of at least 2 days. Variables collected for the Tisdale calculator included age, sex, whether patient was on a loop diuretic, potassium level, admission QTc value, admitting diagnosis of acute myocardial infarction, sepsis, or heart failure, and number of QTc-prolonging drugs given to the patient.

Results: A total of 2649 patients with 3033 patient admissions had 18,432 QTc DDI alerts presented that were overridden. An average of 3 unique QTc DDI alerts were presented per patient admission and the alerts were overridden an average of 6 times per patient admission. Overall, 6% of patient admissions were low risk (score ≤ 6), 64% moderate risk (score 7-10), and 30% high risk (score ≥ 11) of QTc prolongation. The most common QTc DDI alerts overridden resulting in an diQTP were quetiapine and propofol (11%) and amiodarone and haloperidol (7%). The diQTP occurred in 883 of patient admissions (29%) and was more frequent in those with higher risk score, with 46% of patient admissions with diQTP in high risk, 23% in moderate risk, and 8% in low risk.

Conclusion: Use of the Tisdale calculator to assess patient-specific risk of QT prolongation combined with CDS may improve overall alert quality and acceptance rate, which may decrease the diQTP rate.

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计算风险:评估 QTc 药物相互作用 (DDI) 临床决策支持 (CDS) 警报和 Tisdale 风险评分计算器的性能。
导言:潜在致命性室性心律失常 Torsade de Pointes 的一个风险因素是心率校正 QT 间期(QTc)延长≥ 500 毫秒(ms)或比患者的基线值增加≥ 60 毫秒,这会导致心脏性猝死。Tisdale 风险评分计算器利用临床变量来预测哪些住院患者发生 QTc 延长的风险最高:目的:确定每名入院患者QTc药物相互作用(DDI)相关临床决策支持(CDS)警报的超限率,以及这些超限警报在Tisdale风险评分类别中的发生率。次要结果是确定与超载相关的药物诱导 QTc 延长(diQTP)率:方法:使用本机构的企业数据仓库,回顾性访问 2022 年期间布里格姆妇女医院收治的年龄≥ 18 岁患者的 QTc DDI 警报。如果在住院区为住院时间至少为 2 天的患者输入医嘱时向医生、研究员、住院医师、医生助理或执业护士显示了 QTc DDI CDS 警报,则该警报将被包括在内。为 Tisdale 计算器收集的变量包括年龄、性别、是否使用环形利尿剂、血钾水平、入院 QTc 值、急性心肌梗死、脓毒症或心力衰竭的入院诊断,以及为患者使用的 QTc 延长药物的数量:共有 2649 名患者和 3033 名入院患者收到了 18,432 次 QTc DDI 警报,这些警报均被覆盖。每名入院患者平均出现 3 次独特的 QTc DDI 警报,每名入院患者平均有 6 次警报被覆盖。总体而言,6% 的入院患者为低风险(评分≤ 6),64% 为中度风险(评分 7-10),30% 为 QTc 延长的高风险(评分≥ 11)。最常见的导致 diQTP 的 QTc DDI 警报被覆盖的药物是喹硫平和异丙酚(11%)以及胺碘酮和氟哌啶醇(7%)。883例入院患者(29%)发生了diQTP,风险评分越高的患者发生diQTP的频率越高,46%的入院患者为高风险,23%为中度风险,8%为低风险:结论:使用 Tisdale 计算器评估患者 QT 延长的特异性风险并结合 CDS 可提高整体警报质量和接受率,从而降低 diQTP 发生率。
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来源期刊
Drug Safety
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.
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RETRACTED ARTICLE: Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India. A Calculated Risk: Evaluation of QTc Drug-Drug Interaction (DDI) Clinical Decision Support (CDS) Alerts and Performance of the Tisdale Risk Score Calculator. Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling. Examining the Effect of Missing Data and Unmeasured Confounding on External Comparator Studies: Case Studies and Simulations. Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System.
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