Institute of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Br J Clin Pharmacol. 2022 Jan;88(1):226-236. doi: 10.1111/bcp.14951. Epub 2021 Jul 13.
A substantial number of Summaries of Product Characteristics (SmPCs)/Prescribing Information (PI) have warnings or contraindications on QT interval prolongation. The goal of this work was to quantify usage of QT interval prolonging drugs according to the CredibleMeds database of the German outpatient drug prescription market and to evaluate discrepancies between German SmPCs/US PI and CredibleMeds .
Drugs listed on CredibleMeds with known, possible or conditional risk for torsade de pointes were evaluated from 2000 to 2020. The German drug prescription report was used as source for defined daily dose- (DDD-) based prescriptions of the German outpatient drug prescription market of the public health insurance system. German SmPCs and US PI of 253 CredibleMeds -listed drugs were evaluated for contents regarding QT interval prolongation.
Of the drugs currently listed on CredibleMeds , 59.7% (95% confidence interval [CI] 53.5-65.5%) were listed after 2012. Due to newly listed drugs, the proportion of DDDs of CredibleMeds drugs among all prescriptions increased from 4.6% in 2013 to 21.1% in 2019. DDD-based usage of the CredibleMeds drugs already listed in 2013 was similar in 2019. Among the drugs with known QT risk according to CredibleMeds , 7.5% (95% CI 2.6-19.9%) of German SmPCs and 21.1% (95% CI 11.1-36.3%) of US PI had no mention of QT issues whatsoever.
A significant proportion of all drugs prescribed in the outpatient sector is associated with QT risks according to CredibleMeds . SmPCs and PI should systematically be evaluated for concordance with the widely used CredibleMeds database to increase medication safety.
大量的产品说明书（SmPC）/处方信息（PI）都对 QT 间期延长有警告或禁忌症。本研究的目的是根据德国门诊药物处方市场的可信药物数据库（CredibleMeds）量化 QT 间期延长药物的使用情况，并评估德国 SmPC/美国 PI 与 CredibleMeds 之间的差异。
评估了 2000 年至 2020 年可信药物数据库中列出的已知、可能或有条件引起尖端扭转型室性心动过速风险的药物。德国药物处方报告被用作公共医疗保险系统德国门诊药物处方市场的基于限定日剂量（DDD）的处方来源。评估了 253 种可信药物列出的药物的德国 SmPC 和美国 PI，以评估其 QT 间期延长内容。
目前在可信药物中列出的药物中，59.7%（95%置信区间[CI] 53.5-65.5%）是在 2012 年后列出的。由于新列出的药物，可信药物药物的 DDD 占所有处方的比例从 2013 年的 4.6%增加到 2019 年的 21.1%。2013 年已列出的可信药物的 DDD 使用量在 2019 年相似。根据可信药物，已知有 QT 风险的药物中，7.5%（95%CI 2.6-19.9%）的德国 SmPC 和 21.1%（95%CI 11.1-36.3%）的美国 PI 根本没有提到 QT 问题。
根据可信药物，在门诊部门开出的相当一部分药物都与 QT 风险相关。为了提高用药安全性，应系统地评估 SmPC 和 PI 是否与广泛使用的可信药物数据库一致。
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