ArticleThe journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG2022
Pediatric Adverse Drug Reactions: An Observational Cohort Study After Health Care Workers' Training.
Article in The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed, 1 citations in OpenAlex.
- Immunological Mechanisms in Cutaneous Adverse Drug Reactions.Biomolecules & therapeutics · 2024Review
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveAdverse drug reactions (ADRs) in children are an important but underestimated public health issue. This study describes ADRs in a registered pediatric population of Bologna and demonstrates that ADRs might be better detected after health care personnel training.
methodsA prospective cohort was recruited from July 1, 2016, to June 30, 2019, after health care worker sensitization, and compared to a retrospective cohort enrolled from 2013 to 2016. The ADRs are classified by system organ classes and drugs are categorized according to the Anatomical Therapeutic Chemical classification system.
resultsWe retrospectively recruited 78 pediatric patients with ADRs in the 2013 to 2016 period, and we prospectively enrolled 127 children in the 2016 to 2019 period. In both periods, most of the ADRs reported were classified as non-serious reactions (68.8%). The most frequent ADRs were general and administration site disorders. During 2013 to 2016 vaccines were the most frequent cause of ADRs (83.3%;) and the main reporters were health care workers other than physicians (84.6%), whereas during the second period, medical doctors become the main signalers (65.4%) and ADRs related to vaccines significantly decreased (55.1%). During the 2016 to 2019 period the number of drug categories was higher than in the 2013 to 2016 period (24 vs 8). Patients with ADRs due to vaccinations present more frequently a favourable outcome (63%).
conclusionsThis study demonstrates that active pharmacovigilance and health care personnel sensitization are associated with improved ADR detection, providing valuable information about drugs' safety profile in pediatric patients.
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