Then M, Andrikyan W, Maas R, Fromm M (2021)
Publication Type: Journal article
Publication year: 2021
DOI: 10.1111/bcp.14951
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.
APA:
Then, M., Andrikyan, W., Maas, R., & Fromm, M. (2021). The CredibleMeds® list: Usage of QT interval prolonging drugs in Germany and discordances with prescribing information. British Journal of Clinical Pharmacology. https://dx.doi.org/10.1111/bcp.14951
MLA:
Then, Melanie, et al. "The CredibleMeds® list: Usage of QT interval prolonging drugs in Germany and discordances with prescribing information." British Journal of Clinical Pharmacology (2021).
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