Pediatric pharmacovigilance

Current practice and future perspectives

Lise Aagaard*

*Kontaktforfatter for dette arbejde

Publikation: Bidrag til bog/antologi/rapport/konference-proceedingBidrag til bog/antologiForskningpeer review

Resumé

The aim of this chapter was to review published information about ADRs reported in children and adolescents with respect to occurrence, seriousness, type, suspected medicines, age and gender of the child, and type of reporter. Secondly to review experiences with the EU pediatric regulation and its impact on the conduction of pediatric clinical trials in Europe. This literature review showed that occurrence of ADRs in pediatric populations differs between countries, study design, time periods, and age groups. Many serious ADRs were reported including fatal cases. Across studies, the ADRs most commonly reported in children were of the types: skin and subcutaneous disorders, general administration and site conditions, as well as nervous- and psychiatric disorders. The located ADRs were mainly reported by physicians for the therapeutic groups: antibiotics, vaccines (ATC group J), and psychotropic medicine (ATC group N). The EU pediatric regulation has resulted in the establishment of more pediatric clinical trials, but information about whether the regulation has led to more drugs licensed for pediatric use is not available.

OriginalsprogEngelsk
TitelMethods in Pharmacology and Toxicology
RedaktørerAndrew Bate
ForlagHumana Press
Publikationsdato2018
Sider67-85
ISBN (Trykt)978-1-4939-8816-7
ISBN (Elektronisk)978-1-4939-8818-1
DOI
StatusUdgivet - 2018
NavnMethods in Pharmacology and Toxicology
ISSN1557-2153

Fingeraftryk

Pharmacovigilance
Pediatrics
Clinical Trials
Age Groups
Medicine
Physicians
Skin
Pharmaceutical Preparations
Population

Citer dette

Aagaard, L. (2018). Pediatric pharmacovigilance: Current practice and future perspectives. I A. Bate (red.), Methods in Pharmacology and Toxicology (s. 67-85). Humana Press. Methods in Pharmacology and Toxicology https://doi.org/10.1007/978-1-4939-8818-1_4
Aagaard, Lise. / Pediatric pharmacovigilance : Current practice and future perspectives. Methods in Pharmacology and Toxicology. red. / Andrew Bate. Humana Press, 2018. s. 67-85 (Methods in Pharmacology and Toxicology).
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Aagaard, L 2018, Pediatric pharmacovigilance: Current practice and future perspectives. i A Bate (red.), Methods in Pharmacology and Toxicology. Humana Press, Methods in Pharmacology and Toxicology, s. 67-85. https://doi.org/10.1007/978-1-4939-8818-1_4

Pediatric pharmacovigilance : Current practice and future perspectives. / Aagaard, Lise.

Methods in Pharmacology and Toxicology. red. / Andrew Bate. Humana Press, 2018. s. 67-85 (Methods in Pharmacology and Toxicology).

Publikation: Bidrag til bog/antologi/rapport/konference-proceedingBidrag til bog/antologiForskningpeer review

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Aagaard L. Pediatric pharmacovigilance: Current practice and future perspectives. I Bate A, red., Methods in Pharmacology and Toxicology. Humana Press. 2018. s. 67-85. (Methods in Pharmacology and Toxicology). https://doi.org/10.1007/978-1-4939-8818-1_4