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Pharmacovigilance in pediatrics
CHRU Tours, Univ Hosp, Dept Clin Pharmacol, F-37044 Tours, France;CHRU Tours, Univ Hosp, Reg Pharmacovigilance Ctr, F-37044 Tours, France.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Caring Sciences. Uppsala Monitoring Ctr, S-75140 Uppsala, Sweden.
CHRU Tours, Univ Hosp, Dept Clin Pharmacol, F-37044 Tours, France;CHRU Tours, Univ Hosp, Reg Pharmacovigilance Ctr, F-37044 Tours, France.
Toulouse Univ Hosp, Fac Med, Dept Med & Clin Pharmacol, 37 Allees Jules Guesde, F-31000 Toulouse, France.
2018 (English)In: Therapie (Paris), ISSN 0040-5957, E-ISSN 1958-5578, Vol. 73, no 2, p. 171-180Article in journal (Refereed) Published
Abstract [en]

The characteristics of pharmacology and drug evaluation in the pediatric age group highlight the necessity for the pharmacovigilance community to adjust to the specific features of children. At the time of marketing a medicinal product intended for children, the product's safety profile is sometimes less well known than for adults due to fewer or small sample clinical trials. Furthermore, the frequent off-labeled drug use, the use of unsuitable dosage forms and the need for continuous dose adjustments increase the risk of medication errors and thus lead to avoidable adverse drug reactions (ADRs). The occurrence of child-specific ADRs (such as growth disorders) or ADRs more commonly occurring in children than in adults make it necessary to monitor the safety of child-specific drugs. Pediatric pharmacovigilance includes also the consequences of in utero exposure, whether manifestations are present from birth or occur in early childhood (such as neurodevelopmental disorders). The incidence of ADRs varies with age, setting of medical care (in- or out-patients, pediatric specialties) and by country in which the study was carried out. The drugs most frequently reported with ADRs are those most commonly used in the pediatric age group, i.e. antibiotics and vaccines. The ADRs most often reported are skin, neurological and general disorders. As in adults, spontaneous notification is essential to generate alerts and child-specific pharmacoepidemiological studies are necessary and should be developed. (C) 2018 Societe francaise de pharmacologie et de therapeutique. Published by Elsevier Masson SAS. All rights reserved.

Place, publisher, year, edition, pages
ELSEVIER SCIENCE BV , 2018. Vol. 73, no 2, p. 171-180
Keywords [en]
Pharmacoyigilance, Children, Adverse drug reactions, Pharmacoepidemiology
National Category
Pharmacology and Toxicology
Identifiers
URN: urn:nbn:se:uu:diva-387245DOI: 10.1016/j.therap.2017.11.012ISI: 000430052300009PubMedID: 29598957OAI: oai:DiVA.org:uu-387245DiVA, id: diva2:1328281
Available from: 2019-06-20 Created: 2019-06-20 Last updated: 2019-06-20Bibliographically approved

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