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. 2022;27(4):324-329.
doi: 10.5863/1551-6776-27.4.324. Epub 2022 May 9.

Pediatric Adverse Drug Reactions: An Observational Cohort Study After Health Care Workers' Training

Claudia Balsamo  1 , Chiara Del Bono  2 , Gennaro Pagano  2 , Valentina Valastro  3 , Chiara Ghizzi  1 , Francesca Lombardi  1
Affiliations

Pediatric Adverse Drug Reactions: An Observational Cohort Study After Health Care Workers' Training

Claudia Balsamo et al. J Pediatr Pharmacol Ther. 2022.

Abstract

Objective: Adverse 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.

Methods: A 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.

Results: We 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%).

Conclusions: This 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.

Keywords: adverse drug reactions; childhood; pharmacovigilance.

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Conflict of interest statement

Disclosures. The authors declare no conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts, and honoraria. The authors had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Figures

Figure.
Figure.
Correspondence between ADRs seriousness and outcome (p < 0.05)
See this image and copyright information in PMC

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