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- W2790277114 endingPage "180" @default.
- W2790277114 startingPage "171" @default.
- W2790277114 abstract "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." @default.
- W2790277114 created "2018-03-29" @default.
- W2790277114 creator A5027962311 @default.
- W2790277114 creator A5036143753 @default.
- W2790277114 creator A5062010180 @default.
- W2790277114 creator A5065871425 @default.
- W2790277114 date "2018-04-01" @default.
- W2790277114 modified "2023-10-18" @default.
- W2790277114 title "Pharmacovigilance in pediatrics" @default.
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