Medikamentensicherheit bei Kindernotfällen

Kaufmann, Jost

doi:10.1007/s15014-022-4753-2

Cited by 2 publications

(2 citation statements)

References 9 publications

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“…In the past, German courts have acknowledged the existence of evidence-based off-label use [ 40 ]. Moreover, a guideline by the German Society of Pediatrics and Adolescent Medicine concludes that off-label use can even be the most appropriate treatment [ 41 ]. In routine pediatric care, treatment guidelines are of crucial importance for physicians, as those guidelines efficiently facilitate evidence-based treatment decisions [ 42 ].…”

Section: Discussionmentioning

confidence: 99%

Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics

Herzig,

Eisenhofer,

Ruschkowski

et al. 2024

Pharm Med

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Purpose The Summary of Product Characteristics (SmPC) is required to provide unambiguous information on the authorized use of a medicinal product. Therefore, we performed a structured analysis of the information provided for pediatric patients in current SmPCs. Methods In the German SmPC of the medicinal products of 452 active substances, we analyzed for each of the listed indications whether information on pediatric use was available in Sects. 4.1–4.4 of the SmPC and, if so, whether it was unambiguous. Information was considered unambiguous if it indicated an exact age- or weight-related specification. The analysis also considered the type of marketing authorization and the date of marketing authorization, either before or after the Pediatric Regulation 2007 came into force. Results Among the 30,354 identified indications in 8464 SmPCs, unambiguous information was found for 72.4% (21,974/30,354) of the indications. Of these, 45.4% (9967/21,974) disclosed a contraindication for the entire population under 18 years of age. The proportion of unambiguous information was higher for medicinal products with centralized marketing authorization (86.5% [1449/1676]) than for those with a national one (71.6% [20,525/28,678]; p < 0.001). A higher proportion of unambiguous information was found for the marketing authorization period 2007–2021 compared with 1996–2006 (1996–2006: 63.8% [7466/11,694]; 2007–2021: 82.1% [12,349/15,040]; p < 0.001). Conclusion For about a quarter of all indications, no or only ambiguous information was available for pediatric patients. The measures initiated in recent years to increase pediatric-specific information in SmPCs should be intensified in order to improve drug safety in children and adolescents. Supplementary Information The online version contains supplementary material available at 10.1007/s40290-024-00519-w.

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Section: Discussionmentioning

confidence: 99%

Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics

Herzig,

Eisenhofer,

Ruschkowski

et al. 2024

Pharm Med

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“…Kinder haben ein Recht auf adäquate Schmerztherapiejedoch bleiben Sorgen zu Wirksamkeit, Sicherheit und Haftung. Die S2k-Leitlinie "Medikamentensicherheit bei Kindernotfällen" konstatiert: Ein grundsätzlicher Verzicht auf Off-Label-Use gefährdet Kinder, eine sachgemäße Behandlung wird unmöglich [14]. Europäische Fachgesellschaften haben in einer Grundsatzerklärung Empfehlungen für den Umgang mit Off-Label-Medikation bei Kindern veröffentlicht [15].…”

Section: Off-label-useunclassified

Perioperative Schmerztherapie bei Kindern

Oppitz¹,

Hindriks-Keegstra²,

Kaufmann³

2023

Pädiatrie up2date

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Medikamentensicherheit bei Kindernotfällen

Cited by 2 publications

References 9 publications

Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics

Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics

Perioperative Schmerztherapie bei Kindern

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