Parental Experience of Potential Adverse Drug Reactions Related to Their Oral Administration of Antipyretic Analgesic Medicines in Children in Saudi Arabia.

Background: Oral antipyretic analgesic medicines are commonly used in children and have the potential for adverse drug reactions (ADRs).

Objective: The aim of this study was to explore parental experiences of potential ADRs related to their oral administration of antipyretic analgesics in children in the Kingdom of Saudi Arabia.

Methods: For this cross-sectional survey, a paper-based questionnaire, consent form and information sheet were handed out to 1000 parents who had administered an oral antipyretic analgesic medicine to their children during the previous 3 months. Data were entered and analyzed using SPSS version 21.0 (IBM-SPSS Inc, Armonk, NY). Simple descriptive and inferential statistics were used. Management and ethical approvals were attained.

Results: During March to April 2017, 661 parents agreed to participate, giving a response rate of 66.1%. Of the surveyed sample, 208 parents had observed 1 or more potential ADRs (31.5%, n = 208 out of 661). Parents' (n = 208) most commonly reported potential ADRs (n = 523) were loss of appetite (23%, n = 120 out of 523), stomachache (20.3%, n = 106 out of 523), abdominal colic (13%, n = 68 out of 523), and diarrhea (10.3%, n = 54 out of 523). Parents described severity of the ADRs as slight (71.8%, n = 342 out of 476), annoying to the child (7.9%, n = 85 to of 476), significant and affecting daily tasks (3.6%, n = 17 out of 476) and significant and led to the hospital (6.7%, n = 32 out of 476). Fever was the top-ranked reason for using antipyretic analgesic medicines (41.0%, n = 271 out of 661), followed by toothache (25.0%, n = 165 out of 661) and tonsillitis/laryngitis (24.7%, n = 163 out of 661). Among parents, 34.7% (n = 165 out of 476) did not seek medical attention when a potential ADR occurred, whereas 26.3% (n = 125 out of 476) of parents took their children to hospital clinics.

Conclusions: Although the majority of parentally reported (but not proven) ADRs were mild, a number of significant ADRs were reported. Future research should consider whether there is a role for physicians and pharmacists in educating parents in Saudi Arabia, and perhaps more widely, about the optimal use of oral antipyretic and analgesic medicines in children. (. 2020; 81:XXX-XXX)© 2020 Elsevier HS Journals, Inc.