Active Extraction of Experience of Adverse Drug Reactions in Children
Insights
Japanese children experienced adverse drug reactions (ADRs), with antibacterials causing the most frequent issues like rashes. Guardians need education on reporting these medication side effects through the Direct Patient Reporting System.
Area of Science:
- Pediatric Pharmacology
- Pharmacovigilance
- Public Health
Background:
- Limited safety data exists for medications, over-the-counter drugs, and supplements used by Japanese children.
- Understanding adverse drug reaction (ADR) experiences in pediatric populations is crucial for ensuring medication safety.
Purpose of the Study:
- To investigate and clarify the incidence of ADRs in Japanese children.
- To evaluate efficient methods for collecting ADR data in this demographic.
Main Methods:
- A questionnaire survey was administered to guardians of 20,412 preschool and kindergarten children in Warabi and Toda cities, Saitama Prefecture.
- Data collected included guardian-reported ADR experiences, suspected drugs, and specific reactions.
Main Results:
- Responses were obtained from 15,076 children (49.5% girls, average age 8.2 years).
- 1.3% of guardians (196) reported ADRs, with 243 suspected drugs and 284 ADRs documented.
- The most common medication-reaction pair involved systemic antibacterials causing rashes.
Conclusions:
- The study identified a significant number of potential ADRs in children, consistent with known side effects from clinical trials.
- Findings provide valuable data on ADR frequency in the general pediatric population.
- Enhanced education for guardians on reporting ADRs via the Direct Patient Reporting System is recommended.
Objective:
Safety information regarding the use of medication, over-the-counter drugs, and supplements for Japanese children is scarce. The aim of this study was to clarify adverse drug reaction (ADR) experiences in children and consider the method to collect ADRs efficiently.
Methods:
We conducted a questionnaire survey regarding the ADR experiences of 20,412 children who were attending a preschool or kindergarten in the cities of Warabi and Toda, Saitama Prefecture, in May 2013.
Results:
Responses were received from the guardians of 15,076 children (49.5% girls; 8.2 ± 3.5 yr). A total of 196 guardians (1.3%) responded that their children had experienced ADRs. Among them, a total of 243 suspected drugs and 284 ADRs were reported. Of the 243 suspected drugs, 2.5% were associated with a vaccine. The most frequently reported medication, reaction, and "medication-reaction pair" were antibacterials for systemic use, rash, and "antibacterials for systemic use and rash," respectively.
Conclusions:
In this study, we clarified that there were many potential ADRs among children, but all "medication-reaction pairs" reported were consistent with adverse events reported in the clinical trials available in the prescribing information of each medication. This study provides data respective to the frequency of these adverse events in the general pediatric population. Additional education is needed to enlighten guardians of the importance to report ADRs through the Direct Patient Reporting System.
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