{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T12:23:06Z","timestamp":1790770986199,"version":"4.1.0"},"reference-count":54,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2021,7,13]],"date-time":"2021-07-13T00:00:00Z","timestamp":1626134400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002347","name":"Bundesministerium f\u00fcr Bildung und Forschung","doi-asserted-by":"publisher","award":["01ZZ1910O"],"award-info":[{"award-number":["01ZZ1910O"]}],"id":[{"id":"10.13039\/501100002347","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100005972","name":"Deutsche Krebshilfe","doi-asserted-by":"publisher","award":["70114066\/70114067"],"award-info":[{"award-number":["70114066\/70114067"]}],"id":[{"id":"10.13039\/501100005972","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>\n                      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\n                      <jats:sup>\u00ae<\/jats:sup>\n                      database of the German outpatient drug prescription market and to evaluate discrepancies between German SmPCs\/US PI and CredibleMeds\n                      <jats:sup>\u00ae<\/jats:sup>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Drugs listed on CredibleMeds\n                      <jats:sup>\u00ae<\/jats:sup>\n                      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\u2010 (DDD\u2010) based prescriptions of the German outpatient drug prescription market of the public health insurance system. German SmPCs and US PI of 253 CredibleMeds\n                      <jats:sup>\u00ae<\/jats:sup>\n                      \u2010listed drugs were evaluated for contents regarding QT interval prolongation.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of the drugs currently listed on CredibleMeds\n                      <jats:sup>\u00ae<\/jats:sup>\n                      , 59.7% (95% confidence interval [CI] 53.5\u201365.5%) were listed after 2012. Due to newly listed drugs, the proportion of DDDs of CredibleMeds\n                      <jats:sup>\u00ae<\/jats:sup>\n                      drugs among all prescriptions increased from 4.6% in 2013 to 21.1% in 2019. DDD\u2010based usage of the CredibleMeds\n                      <jats:sup>\u00ae<\/jats:sup>\n                      drugs already listed in 2013 was similar in 2019. Among the drugs with known QT risk according to CredibleMeds\n                      <jats:sup>\u00ae<\/jats:sup>\n                      , 7.5% (95% CI 2.6\u201319.9%) of German SmPCs and 21.1% (95% CI 11.1\u201336.3%) of US PI had no mention of QT issues whatsoever.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      A significant proportion of all drugs prescribed in the outpatient sector is associated with QT risks according to CredibleMeds\n                      <jats:sup>\u00ae<\/jats:sup>\n                      . SmPCs and PI should systematically be evaluated for concordance with the widely used CredibleMeds\n                      <jats:sup>\u00ae<\/jats:sup>\n                      database to increase medication safety.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bcp.14951","type":"journal-article","created":{"date-parts":[[2021,6,22]],"date-time":"2021-06-22T02:51:03Z","timestamp":1624330263000},"page":"226-236","source":"Crossref","is-referenced-by-count":12,"title":["The CredibleMeds\n                    <sup>\u00ae<\/sup>\n                    list: Usage of QT interval prolonging drugs in Germany and discordances with prescribing information"],"prefix":"10.1111","volume":"88","author":[{"given":"Melanie I.","family":"Then","sequence":"first","affiliation":[{"name":"Institute of Experimental and Clinical Pharmacology and Toxicology Friedrich\u2010Alexander\u2010Universit\u00e4t Erlangen\u2010N\u00fcrnberg  Erlangen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wahram","family":"Andrikyan","sequence":"additional","affiliation":[{"name":"Institute of Experimental and Clinical Pharmacology and Toxicology Friedrich\u2010Alexander\u2010Universit\u00e4t Erlangen\u2010N\u00fcrnberg  Erlangen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renke","family":"Maas","sequence":"additional","affiliation":[{"name":"Institute of Experimental and Clinical Pharmacology and Toxicology Friedrich\u2010Alexander\u2010Universit\u00e4t Erlangen\u2010N\u00fcrnberg  Erlangen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0334-7478","authenticated-orcid":false,"given":"Martin F.","family":"Fromm","sequence":"additional","affiliation":[{"name":"Institute of Experimental and Clinical Pharmacology and Toxicology Friedrich\u2010Alexander\u2010Universit\u00e4t Erlangen\u2010N\u00fcrnberg  Erlangen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,7,13]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1124\/pr.110.003723"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMcp0706513"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2015.12.063"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2005.08.067"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2015.07.011"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehi312"},{"key":"e_1_2_11_8_1","unstructured":"ICH S7B.The non\u2010clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals S7B. Step 4.https:\/\/database.ich.org\/sites\/default\/files\/S7B_Guideline.pdf. Published 2005. Accessed 2 March 2021."},{"key":"e_1_2_11_9_1","unstructured":"ICH E14.The clinical evaluation of QT\/QTc interval prolongation and proarrhythmic potential for non\u2010antiarrhythmic drugs E14. Step 4.https:\/\/database.ich.org\/sites\/default\/files\/E14_Guideline.pdf. Published 2005. Accessed 2 March 2021."},{"key":"e_1_2_11_10_1","unstructured":"EMA.ICH topic E14: The clinical evaluation of QT\/QTc interval prolongation and proarrhythmic potential for non\u2010antiarrhythmic drugs. Step 5.https:\/\/www.ema.europa.eu\/en\/documents\/scientific\u2010guideline\/ich\u2010e\u201014\u2010clinical\u2010evaluation\u2010qt\/qts\u2010interval\u2010prolongation\u2010proarrhythmic\u2010potential\u2010non\u2010antiarrhythmic\u2010drugs\u2010step\u20105_en.pdf. Published 2005. Accessed 2 March 2021."},{"key":"e_1_2_11_11_1","unstructured":"EMA.ICH guideline E14\/S7B on clinical and nonclinical evaluation of QT\/QTc interval prolongation and proarrhythmic potential\u2014questions & answers. Step 2b.https:\/\/www.ema.europa.eu\/en\/documents\/scientific\u2010guideline\/ich\u2010guideline\u2010e14\/s7b\u2010clinical\u2010nonclinical\u2010evaluation\u2010qt\/qtc\u2010interval\u2010prolongation\u2010proarrhythmic\u2010potential\u2010questions\u2010answers\u2010step\u20102b_en.pdf. Published 2020. Accessed 2 March 2021."},{"key":"e_1_2_11_12_1","unstructured":"FDA.Guidance for industry: E14 clinical evaluation of QT\/QTc interval prolongation and proarrhythmic potential for non\u2010antiarrhythmic drugs.https:\/\/www.fda.gov\/media\/71372\/download. Published 2005. Accessed 2 March 2021."},{"key":"e_1_2_11_13_1","unstructured":"FDA.Guidance for Industry: E14 Clinical evaluation of QT\/QTc interval prolongation and proarrhythmic potential for non\u2010antiarrhythmic drugs\u2014questions and answers (R3).https:\/\/www.fda.gov\/media\/71379\/download. Published 2017. Accessed 2 March 2021."},{"issue":"15","key":"e_1_2_11_14_1","first-page":"255","article-title":"Implementation of warnings from Dear Doctor Letters (Rote\u2010Hand\u2010Briefe): an analysis of medication data from a large cohort of elderly patients","volume":"111","author":"Sch\u00e4chtele S","year":"2014","journal-title":"Dtsch Arztebl Int"},{"key":"e_1_2_11_15_1","unstructured":"WoosleyRL HeiseCW GalloT TateJ WoosleyD RomeroKA.CredibleMeds\u00ae: QTdrugs list.https:\/\/www.crediblemeds.org. Published 2020. Accessed 2 March 2021."},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tcm.2017.07.010"},{"key":"e_1_2_11_17_1","unstructured":"Overview of CredibleMeds\u00ae.https:\/\/www.crediblemeds.org\/everyone\/about-crediblemeds. Published 2021. Accessed 7 May 2021."},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/eut018"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0155649"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-662-43487-1"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-662-47186-9"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-662-50351-5"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-662-54630-7"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-662-57386-0"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-662-59046-1"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-662-62168-4"},{"key":"e_1_2_11_27_1","unstructured":"PharMaAnalyst.Wissenschaftliches Institut der AOK;2020.https:\/\/arzneimittel.wido.de\/PharMaAnalyst. Accessed 2 March 2021."},{"key":"e_1_2_11_28_1","unstructured":"WHO.Defined Daily Dose (DDD).https:\/\/www.who.int\/tools\/atc-ddd-toolkit\/about-ddd. Accessed 2 March 2021."},{"key":"e_1_2_11_29_1","unstructured":"Anatomisch\u2010therapeutisch\u2010chemische Klassifikation mit Tagesdosen. Amtliche Fassung des ATC\u2010Index mit DDD\u2010Angaben f\u00fcr Deutschland im Jahre 2020. DIMDI.https:\/\/www.dimdi.de\/dynamic\/.downloads\/arzneimittel\/atcddd\/atc-ddd-amtlich-2020.pdf. Published 2020. Accessed 21 December 2020."},{"key":"e_1_2_11_30_1","unstructured":"PharmNet.Bund.AMIS Arzneimittel\u2010Informationssystem. 2020.https:\/\/www.pharmnet-bund.de\/dynamic\/de\/arzneimittel-informationssystem\/index.html. Accessed 2 March 2021."},{"key":"e_1_2_11_31_1","unstructured":"Drugs.com.2020.https:\/\/www.drugs.com. Accessed 28 October 2020."},{"key":"e_1_2_11_32_1","unstructured":"Drugs@FDA: FDA\u2010approved drugs. FDA.https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm. Published 2020. Accessed 2 March 2021."},{"key":"e_1_2_11_33_1","unstructured":"Drugs.com: FDA professional drug information.2020.https:\/\/www.drugs.com\/pro. Accessed 28 October 2020."},{"key":"e_1_2_11_34_1","unstructured":"Epitools Epidemiological Calculators. Ausvet.https:\/\/epitools.ausvet.com.au\/ciproportion. Published 2021. Accessed 1 June 2021."},{"key":"e_1_2_11_35_1","unstructured":"FDA.Drug safety communication: FDA recommends against the continued use of propoxyphene.https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-drug-safety-communication-fda-recommends-against-continued-use-propoxyphene. Published 2021. Accessed 7 May 2021."},{"key":"e_1_2_11_36_1","unstructured":"EMA.European Medicines Agency recommends withdrawal of dextropropoxyphene\u2010containing medicines.https:\/\/www.ema.europa.eu\/en\/news\/european-medicines-agency-recommends-withdrawal-dextropropoxyphene-containing-medicines. Published 2009. Accessed 7 May 2021."},{"key":"e_1_2_11_37_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11096-017-0446-2"},{"key":"e_1_2_11_38_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13740"},{"key":"e_1_2_11_39_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-014-1665-2"},{"key":"e_1_2_11_40_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3853"},{"key":"e_1_2_11_41_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12012-017-9416-0"},{"key":"e_1_2_11_42_1","doi-asserted-by":"publisher","DOI":"10.1177\/2045125317721662"},{"issue":"1","key":"e_1_2_11_43_1","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/1753-2000-6-2","article-title":"A systematic review of the safety information contained within the Summaries of Product Characteristics of medications licensed in the United Kingdom for Attention Deficit Hyperactivity Disorder. How does the safety prescribing advice compare with national guidance?","volume":"6","author":"Savill N","year":"2012","journal-title":"Child Adolesc Psychiatry Ment Health"},{"key":"e_1_2_11_44_1","doi-asserted-by":"publisher","DOI":"10.1177\/2168479018759662"},{"key":"e_1_2_11_45_1","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2019-0698"},{"key":"e_1_2_11_46_1","doi-asserted-by":"publisher","DOI":"10.3233\/JRS-140612"},{"key":"e_1_2_11_47_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2014.156"},{"key":"e_1_2_11_48_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2020.09.067"},{"key":"e_1_2_11_49_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40801-020-00187-7"},{"key":"e_1_2_11_50_1","unstructured":"Directive 2010\/84\/EU of the European Parliament and of the Council.https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-1\/dir_2010_84\/dir_2010_84_en.pdf. Published 2010. Accessed 7 May 2021."},{"key":"e_1_2_11_51_1","unstructured":"FDA.Providing postmarketing periodic safety reports in the ICH E2C(R2) format (periodic benefit\u2010risk evaluation report). Guidance for industry.https:\/\/www.fda.gov\/media\/85520\/download. Published 2016. Accessed 7 May 2021."},{"key":"e_1_2_11_52_1","unstructured":"Regulation (EC) No 726\/2004 of the European Parliament and of the Council. Article 41(4).https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=CELEX:32004R0726%26from=DE. Published 2004. Accessed 7 May 2021."},{"key":"e_1_2_11_53_1","unstructured":"FDA.Prescribing information and application holder responsibilities.https:\/\/www.fda.gov\/drugs\/laws\u2010acts\u2010and\u2010rules\/prescription\u2010drug\u2010labeling\u2010resources#Prescribing%20Information%20Requirements%20and%20Rules. Published 2021. Accessed 7 May 2021."},{"key":"e_1_2_11_54_1","unstructured":"FDA.Code of Federal Regulations. 21 CFR 201.56.https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/cfrsearch.cfm?fr=201.56. Published 2020. Accessed 7 May 2021."},{"key":"e_1_2_11_55_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3395"}],"container-title":["British Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcp.14951","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/bcp.14951","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcp.14951","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,28]],"date-time":"2023-08-28T13:03:51Z","timestamp":1693227831000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1111\/bcp.14951"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7,13]]},"references-count":54,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,1]]}},"alternative-id":["10.1111\/bcp.14951"],"URL":"https:\/\/doi.org\/10.1111\/bcp.14951","archive":["Portico"],"relation":{},"ISSN":["0306-5251","1365-2125"],"issn-type":[{"value":"0306-5251","type":"print"},{"value":"1365-2125","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,7,13]]}}}