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1000 Titel
  • Analysis of the reporting of adverse drug reactions in children and adolescents in Germany in the time period from 2000 to 2019
1000 Autor/in
  1. Leitzen, Sarah |
  2. Dubrall, Diana |
  3. Toni, Irmgard |
  4. Stingl, Julia |
  5. Schulz, Maike |
  6. Schmid, Matthias |
  7. Neubert, Antje |
  8. Sachs, Bernhardt |
1000 Erscheinungsjahr 2021
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2021-03-03
1000 Erschienen in
1000 Quellenangabe
  • 16(3):e0247446
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2021
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1371/journal.pone.0247446 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7928460/ |
1000 Ergänzendes Material
  • https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0247446#sec034 |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • The objective of this study was to analyse reports on adverse drug reactions (ADRs) from Germany in the particularly vulnerable patient group of children and adolescents. Reporting characteristics, demographic parameters and off-label use were examined among others. The ratio of ADR reports per number of German inhabitants and the ratio of ADR reports per number of German inhabitants exposed to drugs were calculated and compared. These parameters were examined to derive trends in reporting of ADRs. 20,854 spontaneous ADR reports for the age group 0–17 years were identified in the European ADR database EudraVigilance for the time period 01.01.2000–28.02.2019 and analysed with regard to the aforementioned criteria. 86.5% (18,036/20,854) of the ADR reports originated from Healthcare Professionals and 12.2% (2,546/20,854) from non-Healthcare Professionals. 74.4% (15,522/20,854) of the ADR reports were classified as serious. The proportion of ADR reports per age group was 11.8% (0–1 month), 11.0% (2 months—1 year), 7.4% (2–3 years), 9.3% (4–6 years), 25.8% (7–12 years), and 34.8% (13–17 years) years, respectively. Male sex slightly dominated (51.2% vs. 44.8% females). Only 3.5% of the ADR reports reported off-label use. The annual number of ADR reports increased since 2000, even if set in context with the number of inhabitants and assumed drug-exposed inhabitants. The pediatric population declined in the study period which argues against its prominent role for the increase in the total number of ADR reports. Instead, among others, changes in reporting obligations may apply. The high proportion of serious ADR reports underlines the importance of pediatric drug safety.
1000 Sacherschließung
lokal Drug administration
lokal Pediatrics
lokal Drug safety
lokal Adverse reactions
lokal Physicians
lokal Pharmacists
lokal Age distribution
lokal Age groups
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0002-1207-4168|https://orcid.org/0000-0002-8763-051X|https://orcid.org/0000-0002-0089-1494|https://frl.publisso.de/adhoc/uri/U3RpbmdsLCBKdWxpYQ==|https://frl.publisso.de/adhoc/uri/U2NodWx6LCBNYWlrZQ==|https://frl.publisso.de/adhoc/uri/U2NobWlkLCBNYXR0aGlhcw==|https://frl.publisso.de/adhoc/uri/TmV1YmVydCwgQW50amU=|https://frl.publisso.de/adhoc/uri/U2FjaHMsIEJlcm5oYXJkdA==
1000 Label
1000 Förderer
  1. Gemeinsame Bundesausschuss |
  2. Bundesinstitut für Arzneimittel und Medizinprodukte |
  3. Universitätsklinikum Bonn |
1000 Fördernummer
  1. -
  2. -
  3. V-16703/68502/2016-2020
1000 Förderprogramm
  1. KiDSafe
  2. -
  3. -
1000 Dateien
1000 Förderung
  1. 1000 joinedFunding-child
    1000 Förderer Gemeinsame Bundesausschuss |
    1000 Förderprogramm KiDSafe
    1000 Fördernummer -
  2. 1000 joinedFunding-child
    1000 Förderer Bundesinstitut für Arzneimittel und Medizinprodukte |
    1000 Förderprogramm -
    1000 Fördernummer -
  3. 1000 joinedFunding-child
    1000 Förderer Universitätsklinikum Bonn |
    1000 Förderprogramm -
    1000 Fördernummer V-16703/68502/2016-2020
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6429507.rdf
1000 Erstellt am 2021-09-28T10:00:46.887+0200
1000 Erstellt von 280
1000 beschreibt frl:6429507
1000 Bearbeitet von 25
1000 Zuletzt bearbeitet Thu Nov 04 07:37:34 CET 2021
1000 Objekt bearb. Thu Nov 04 07:37:14 CET 2021
1000 Vgl. frl:6429507
1000 Oai Id
  1. oai:frl.publisso.de:frl:6429507 |
1000 Sichtbarkeit Metadaten public
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