Different indications, warnings and precautions, and contraindications for the same drug—an international comparison of prescribing information for commonly used psychiatric drugs

Pfistermeister, Barbara; Schenk, Christian; Kornhuber, Johannes; Bürkle, Thomas; Fromm, Martin F.; Maas, Renke

doi:10.1002/pds.3389

Cited by 21 publications

(19 citation statements)

References 11 publications

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“…Bei Präparaten anderer Hersteller findet sich exakt der gleiche Hinweis, jedoch im Abschnitt 4.4. Ähnliche Inkonsistenz bei GEG∪WARN bezüglich Wechselwirkungen in verschiedenen Fachinformationen sind bereits bekannt und deutsche und europäische Behörden sollten eine bessere Harmonisierung anstreben [17].…”

Section: Qualität Der Pädiatrischen Informationenunclassified

Wie häufig betreffen Gegenanzeigen und Warnhinweise in deutschen Fachinformationen pädiatrische Patienten

2019

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Zusammenfassung Hintergrund Ambulanten Patienten unter 18 Jahren werden 3,2–3,8% der Arzneimittel nur aufgrund des Alters off-label verordnet. Das Problem nimmt mit niedrigerem Alter zu, sodass bei Neugeborenen lediglich für ein Fünftel der am häufigsten verordneten Wirkstoffe eine Zulassung vorliegt. Ziel dieser Arbeit war es alle deutschen Fachinformationen auf spezifische Gegenanzeigen und Warnhinweise zu pädiatrischen Altersgruppen zu untersuchen. Methodik Alle verfügbaren Fachinformationen wurden aufbereitet, die Abschnitte Gegenanzeigen sowie Besondere Warnhinweise und Vorsichtsmaßnahmen nach pädiatrischen Altersangaben durchsucht und nach Altersgruppen, ATC-Gruppen und Applikationsweg ausgewertet. Ergebnisse Es wurden 13 547 Fachinformationen (22 863 Präparate) erfasst. Für 3603 (15,8%) Präparate lag eine explizite Gegenanzeige für eine pädiatrische Altersgruppe vor, für 9687 (42,4%) eine Gegenanzeige oder ein Warnhinweis. Bei 2833 Präparaten (12,4%) lag für alle Patienten unter 18 Jahren eine Gegenanzeige oder ein Warnhinweis vor. Frühgeborene waren besonders stark betroffen (9581 Präparate, 41,9%). Insbesondere waren Kontrastmittel (89,0%), Husten- und Erkältungspräparate (86,2%) sowie Corticosteroide (topisch 88,2%, systemisch 86,6%) betroffen. Der Anteil lag mit 58,2% bei Tropfen und Säften überdurchschnittlich hoch. Diskussion Es ist davon auszugehen, dass bei den meisten Präparaten kaum echte Kontraindikationen aufgrund altersspezifischer Pharmakodynamik oder -kinetik vorliegen, sondern entsprechende Daten oder geeignete Arzneiformen fehlen. Die EU-Kinderarzneimittelverordnung konnte für nicht mehr patentgeschützte Arzneimittel keine ausreichenden Anreize zur Durchführung entsprechender Studien schaffen.

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Section: Qualität Der Pädiatrischen Informationenunclassified

Wie häufig betreffen Gegenanzeigen und Warnhinweise in deutschen Fachinformationen pädiatrische Patienten

2019

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“…However, when we assessed adverse drug events in an emergency department, we observed that disagreement between raters whether or not an ignored contraindication contributed to an adverse drug event was frequently attributable to the fact that the two raters had consulted SPCs from different manufacturers for the same generic drug 2 . In conjunction with publications on individual aspects of SPCs, this increased our concern that the information provided in SPCs in general may not be as up to date, reliable, and clinically useful as one would expect from officially approved documents 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 . This prompted us to systematically investigate the consistency, comprehensiveness, and clinical applicability of critical information provided in SPCs for three major drug markets (the United States, the United Kingdom, and Germany).…”

mentioning

confidence: 99%

Inconsistencies and Misleading Information in Officially Approved Prescribing Information From Three Major Drug Markets

Pfistermeister

Sass

Criegee-Rieck

et al. 2014

Clin Pharmacol Ther

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The summary of product characteristics (SPC) should provide information for the safe prescription and use of a drug. We evaluated the consistency of critical interaction warnings, the quality of presentation of undesirable effects as well as concordance of critical information of representative drugs marketed in the United States, the UK, and Germany. Reciprocal warnings regarding drug-drug interactions that constitute contraindications were frequently missing in the SPCs of the drugs concerned (all countries >40%). Most SPCs did not explicitly exclude adverse reactions considered not reasonably attributable to the use of the drug. Comparing SPCs of different generic brands of the same drug, only 60, 10, and 20% of the US, UK, and German SPCs, respectively, provided identical contraindications. Current SPCs contain inconsistencies and misleading data that are not compatible with the purpose of SPCs, which is to provide a basis for the safe prescription and use of drugs.

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“…The label is intended to assist healthcare professionals in choosing the most appropriate therapy under their circumstances . However, the safety and efficacy information provided in the label may depend on the country in which a drug is marketed due to different requirements from regulatory authorities in each country as well as in their approaches to pediatric risk‐benefit analysis . In addition, it could be a market‐driven decision by the company to improve labeling information for drugs used in children based on data from clinical trials conducted in domestic or foreign pediatric patients .…”

Section: Discussionmentioning

confidence: 99%

“…26 However, the safety and efficacy information provided in the label may depend on the country in which a drug is marketed due to different requirements from regulatory authorities in each country as well as in their approaches to pediatric risk-benefit analysis. 27,28 In addition, it could be a market-driven decision by the company to improve labeling information for drugs used in children based on data from clinical trials conducted in domestic or foreign pediatric patients. 7 This study indicated that there were limited pediatric indications and narrowly defined age groups based on Korean drug labels compared with pediatric information provided in drug labels approved by the FDA.…”

Section: Discussionmentioning

confidence: 99%

International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States

Song

Han

Burckart

et al. 2019

Clin Pharma and Therapeutics

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The objective of this study was to analyze information on pediatric use in Korean drug product labels and compare it with that in US Food and Drug Administration (FDA) labeling information. Prescription information on pediatric use contained in the commonly used drugs’ product labels approved by Korean government was compared with that approved by the FDA. Among the top 50 commonly prescribed drugs, 20 drugs were deemed to have insufficient prescribing information in Korean drug labels. Pediatric prescribing information regarding indication, approved age, formulations, and safety was insufficient in Korean drug labels compared with those in the FDA. Most important, the adverse events frequently reported in Korean children were not sufficiently presented in drug labels. In conclusion, this study highlights the urgent need for the Korean regulatory agency to encourage and accelerate research and development to increase the extent of pediatric prescribing information to be added to drug labels to promote appropriate drug prescribing for children.

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Different indications, warnings and precautions, and contraindications for the same drug—an international comparison of prescribing information for commonly used psychiatric drugs

Abstract: This substantial variation in key prescribing information across countries highlights the need for a better international cooperation and standardization of prescribing information.

Cited by 21 publications

References 11 publications

Wie häufig betreffen Gegenanzeigen und Warnhinweise in deutschen Fachinformationen pädiatrische Patienten

Wie häufig betreffen Gegenanzeigen und Warnhinweise in deutschen Fachinformationen pädiatrische Patienten

Inconsistencies and Misleading Information in Officially Approved Prescribing Information From Three Major Drug Markets

International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States

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