(202) Pediatric Drug Safety Surveillance in Saudi Arabia: A Description of Adverse Drug Reactions from The Saudi Vigilance Database

Publication Number: 1247

Background: The majority of pediatric patients are treated by unlicensed or off-label therapeutic agents because of limited clinical randomized trials address this population at pre-marketing phase by pharmaceutical companies. Drug safety data of children in Saudi Arabia and worldwide are still lacking and yet to be fully investigated.

Objectives: To describe the characteristics of pediatric adverse drug events reported to the Saudi Vigilance system database

Methods: A descriptive analysis of pediatric adverse drug reactions (ADRs) reported to the Saudi Vigilance system database between January 2015 and December 2020. Saudi Vigilance system is a national surveillance system that contains adverse drug events reports originated from different stakeholders such as healthcare providers, marketing authorization holders (MAHs) and public from all Saudi Arabia regions. . ADRs characteristics were compared and stratified by age group ((neonates (≤27 days), infants (28 days-≤23 months), children (2-≤11 years), and adolescents (12-≤17 years)). Most frequently reported drugs, drug therapeutic classes and events were presented in total and in each age group.

Results: A total of 2704 pediatric ADRs were included, in which the majority of them were reported for boys (53.7%) and for children 2-11 years of old (40.2%). The proportion of the reported pediatric ADRs were relatively increasing overtime. Of all reports, 44.3% of the ADRs were classified as non-serious events and the outcome was that they were cured with no consequences. Vancomycin (8.4%), piperacillin with beta-lactamase inhibitor (7.5%) and potassium chloride (7.2%) were the most reported drugs, while antibacterials (38.6%), electrolyte supplements (9.4%) and antiepileptics (7.5%) were the most common reported drug therapeutic classes among all age categories. By event, rash (10.8%), hyperkalemia (7.7%) and erythema (5.9%) were the most reported events in all age groups.

Conclusions: Our study shows that the majority of pediatric adverse drug reactions (ADRs) in Saudi Arabia were associated with antibacterials, electrolyte supplements and antiepileptics. Further studies are needed to investigate whether these agents are correctly used and handled among public and healthcare providers according to instruction of product information or/and national guidelines.