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Pediatric Adverse Drug Reactions: An Observational Cohort Study After Health Care Workers' Training
Claudia Balsamo1, Chiara Del Bono2, Gennaro Pagano2
1Pediatric Department (CB, CG, FL), Maggiore Hospital Carlo Alberto Pizzardi, Ospedale Maggiore Carlo Alberto Pizzardi, Bologna AUSL, Bologna, Italy.
Insights
Training healthcare professionals improves the detection of adverse drug reactions (ADRs) in children. This active pharmacovigilance approach enhances drug safety monitoring in pediatric populations.
Area of Science:
- Pediatric Pharmacology
- Public Health
- Pharmacovigilance
Background:
- Adverse drug reactions (ADRs) in children represent a significant public health concern.
- Effective detection and monitoring of ADRs are crucial for ensuring pediatric patient safety.
Purpose of the Study:
- To describe ADRs in a pediatric population in Bologna.
- To evaluate the impact of healthcare personnel training on ADR detection rates.
Main Methods:
- A prospective cohort study (2016-2019) was compared with a retrospective cohort (2013-2016).
- Healthcare worker sensitization preceded the prospective enrollment.
- ADRs were classified by system organ classes, and drugs by the Anatomical Therapeutic Chemical system.
Main Results:
- The prospective cohort identified more ADRs (127 children) than the retrospective cohort (78 children).
- Non-serious reactions were most common (68.8%). General and administration site disorders were frequent ADRs.
- Following training, physician reporting increased, vaccine-related ADRs decreased, and the diversity of drug categories involved in ADRs rose.
Conclusions:
- Active pharmacovigilance and staff sensitization significantly improve ADR detection in pediatric patients.
- This approach provides critical data for understanding the safety profiles of drugs used in children.
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.
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