Key result
Among drugs with known QT risk on CredibleMeds, 7.5% of German SmPCs and 21.1% of US prescribing information had no mention of QT issues whatsoever.
Why the study?
A substantial number of product labels carry warnings or contraindications on QT prolongation, but the usage of such drugs in outpatient care and discrepancies with CredibleMeds required evaluation.
Observational (n=253)
A significant proportion of outpatient prescriptions involve QT-prolonging drugs, and there are notable discrepancies between official prescribing information and the CredibleMeds database, highlighting a need for systematic evaluation to improve medication safety.
Answers are grounded in this paper and cite their sources.
Discrepancies in QT-prolonging drug labeling warrant prescribing caution; leaves open need for database harmonization.
Aims 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 ® . Methods 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. Results 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. Conclusion 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.
No takes yet. Share an insight, caveat, or question.
Then et al. (2021) conducted an observational in QT interval prolongation (n=253). QT interval prolonging drugs was evaluated on No mention of QT issues in German SmPCs among drugs with known QT risk (95% CI 2.6-19.9). Among drugs with known QT risk on CredibleMeds, 7.5% of German SmPCs and 21.1% of US prescribing information had no mention of QT issues whatsoever.
Synapse has enriched 10 related papers. Consider them for comparative context: