Off-Label Drug Use in Pediatric Out-Patient Care: A Multi-Center Observational Study. (December 2021)

• Record Type: Journal Article
• Authors: AlAzmi, Aeshah; Alasmari, Zahra; Yousef, Consuela; Alenazi, Ahmed; AlOtaibi, Mohammed; AlSaedi, Hani; AlShaikh, Adnan; AlObathani, Amani; Ahmed, Omaima; Goronfolah, Loie; Alahmari, Mousa
• Is Part Of: Hospital pharmacy. Volume 56:Number 6(2021)
• Page Start: 690
• Page End: 696
• Publication Date: 2021-12
• Subjects: pediatrics -- medication safety -- medication errors; Hospital pharmacies -- Periodicals; Pharmacy Service, Hospital; Hospital pharmacies; Periodicals; Periodicals; 615.1
• DOI: 10.1177/0018578720942226
• Languages: English
• ISSNs: 0018-5787

Abstract

Objective: Prescribing a drug for a child is not an easy task and requires using the best available evidence as a guide, especially when a drug is used off-label. The practice of prescribing a drug for off-label use is fairly widespread worldwide. The FDA does not regulate prescribing patterns or practices of individual practitioners and, therefore, allows off-label use. The main objective of this study is to evaluate off-label prescribing among the pediatric population in the Kingdom of Saudi Arabia (KSA). Method: This is a retrospective, simple random selection observational study of children (≤15 years) who visited pediatric clinics and had at least 1 drug prescribed over a 12-month period (January to December 2018). Results: A total of 865 drugs (mean 1 and SD 0.24) were prescribed to 326 children. Off-label was identified in 39.4% of the drugs with a frequency of 512 (as 1 drug may belong to more than 1 off-label category). The most common reason for off-label prescribing was related to doses that were "higher or lower than the recommended use" (48.6%), and the most frequently identified drug class prescribed for off-label use was anti-infective drugs for systemic use (39.9%). The percentage of off-label drug use was found to be higher in girls and in the age group of 1 month to 2 years ( P = .001) for both variables. In addition, a significant association was found between off label drug use and the total number of drugs prescribed, P < .001. Conclusion: The findings of this study showed a high incidence of off-label prescribing mainly related to dosing and indication. The results of this observational study support the need to establish a unified national pediatric dosing formulary guide to ensure safe drug use in pediatrics.