PRESCRIPTION ANALYSIS ON OFF-LABEL DRUGS IN PEDIATRIC PATIENTS USING THE CLAIMS DATA OF THE NATIONAL HEALTH INSURANCE IN KOREA
Author(s)
Park E1, Kim S1, Lee J2, Kim H2, Hahn S1
1Seoul National University College of Medicine, Seoul, Korea, Republic of (South), 2Seoul National University Hospital, Seoul, Korea, Republic of (South)
OBJECTIVES: Among the pediatric patients under 19 years old, clinical trials are restricted and have many obstacles in performing research prospectively. Thus, lots of drugs are prescribed as off-labeled in the real practices for this age group. The purpose of this study is to investigate the off-label usages in pediatric patients using some real-world data in Korea. METHODS: Seventeen off-label drugs mainly used in the pediatric clinical practices were chosen, and prescriptions from November 2010 to October 2015 for those drugs were examined using the Korea Health Insurance Review and Assessment Service database. Frequency of prescriptions for each drug use in the patients under 19 years old and the proportion of off-label prescriptions among them were analyzed. Prescription patterns were investigated according to the types of medical institutions, inpatient or outpatient, medical departments, prescription years, regions, and primary disease codes. RESULTS: Among the 17 off-label drugs considered, Mosapride Citrate Hydrate (13,439,742 prescriptions) was the most frequently used off-label drug, followed by Domperidone Maleate (8,746,901 prescriptions) and Levofloxacin (2,612,328 prescriptions) in pediatric patients. The proportions of off-label use ranged between 84% and 100% except for 5 out of 17 medications. Those drugs as off-labeled were most frequently prescribed in outpatient settings, in the department of pediatric medicine, and in the Seoul metropolitan area. CONCLUSIONS: A large number of prescriptions for off-label drug uses in the pediatric patients were found through the health insurance claims data in Korea. There could be some limitations on such analysis since the claims data may not cover all off-label uses. Nevertheless, the study results bring some important attention to the current state of off-label drug use in those children without appropriate insurance policy.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PIH5
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Multiple Diseases, Pediatrics