Parental experience of potential adverse drug reactions related to their oral administration of antipyretic analgesics in children in Saudi Arabia.

Background: Oral antipyretic analgesics are commonly used medicines in children with the potential for adverse drug reactions (ADRs). 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 (KSA). 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 to their children in the previous three months. Data were entered and analyzed using SPSS v.21.0 (IBM Corporation, Somers, NY, USA). Simple descriptive and inferential statistics were used. Management and ethical approvals had been gained. Results: In March-April 2017, 661 parents agreed to participate giving a response rate of 66.1%. Of the surveyed sample, 208 parents had observed one or more potential ADRs (31.5%, n=208/661). Parents (n=208) most commonly reported potential ADRs (n=523) were: loss of appetite (23%, n=120/523), stomach ache (20.3%, n=106/523), abdominal colic (13%, n=68/523), and diarrhea (10.3%, n=54/523). Parents described severity of the ADRs as ‘slight’ (71.8%, n=342/476), ‘annoying to the child…’ (7.9%, n=85/476), ‘significant and affecting daily tasks’ (3.6%, n=17/476) and ‘significant and led to the hospital’ (6.7%, n=32/476). Fever was the top ranked reason for using antipyretic analgesics (41.0%, n=271/661), followed by toothache (25.0%, n=165/661) and tonsillitis/laryngitis (24.7%, n=163/661). 34.7% of parents (n=165/476) did not seek medical attention when a potential ADR occurred while 26.3% (n=125/476) 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 KSA, and perhaps more widely, about the optimal use of oral antipyretics and analgesics in children.