Aeshah AlAzmi1,2,3, Zahra Alasmari1,4, Consuela Yousef5, Ahmed Alenazi5, Mohammed AlOtaibi1, Hani AlSaedi1, Adnan AlShaikh1,6, Amani AlObathani1, Omaima Ahmed1,2, Loie Goronfolah1, Mousa Alahmari1. 1. Ministry of National Guard Health Affairs (MNGHA), King Abdulaziz Medical City (KAMC), Jeddah, Saudi Arabia. 2. Princes Noorah Oncology Center, Pediatric Oncology/Hematology/BMT Section, King Abdulaziz Medical City (KAMC), Jeddah, Saudi Arabia. 3. King Abdullah International Medical Research Center (KAIMRC), Jeddah, Saudi Arabia. 4. Specialized Poly Clinic, King Abdulaziz Medical City (KAMC), Jeddah, Saudi Arabia. 5. Imam Abdulrahman Bin Faisal Hospital, MNGHA, Dammam, Saudi Arabia. 6. King Saud bin Abdulaziz University for Health Sciences, Department of Pediatrics, Chemistry Laboratory, Community Medicine, Jeddah, Saudi Arabia.
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.
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.
Authors: Daniel A Frattarelli; Jeffrey L Galinkin; Thomas P Green; Timothy D Johnson; Kathleen A Neville; Ian M Paul; John N Van Den Anker Journal: Pediatrics Date: 2014-02-24 Impact factor: 7.124
Authors: Maher R Khdour; Hussein Othman Hallak; Kawther Shab'an Atallah Alayasa; Qusai Nabeel AlShahed; Ahmed F Hawwa; James C McElnay Journal: Int J Clin Pharm Date: 2011-05-13
Authors: S Conroy; I Choonara; P Impicciatore; A Mohn; H Arnell; A Rane; C Knoeppel; H Seyberth; C Pandolfini; M P Raffaelli; F Rocchi; M Bonati; G Jong; M de Hoog; J van den Anker Journal: BMJ Date: 2000-01-08
Authors: L Lindell-Osuagwu; M Hakkarainen; K Sepponen; K Vainio; T Naaranlahti; H Kokki Journal: J Clin Pharm Ther Date: 2013-12-16 Impact factor: 2.512