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| Survey analysis of antiepileptic drugs prescription and off-label use in children with epilepsy |
| YANG Shenghai WANG Jun WANG Liwen CHEN Jinxiao WU Huanhuan XU Cuijuan |
| Department of Neurology, Children′s Hospital, Capital Institute of Pediatrics, Beijing 100020, China |
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Abstract Objective To summarize the situation of antiepileptic drugs (AEDs) administration and off-label use in epileptic children hospitalized in Children′s Hospital, Capital Institute of Pediatrics (CIP Children Hospital), and investigate the reason for off-label use, and provide evidence for the appropriate administration of AEDs in epileptic children. Methods Demographic and clinical diagnosis and therapy information of epileptic children, including gender, age, seizure types, AEDs administration and and so on, were collected in CIP Children Hospital from January 2011 to December 2015. Based on the label and instruction of AEDs, whether the AEDs administration was off-label use of which types were categorized into off-age, off-seizure types, off-dosage, off-mono/add-on therapy and off-administration frequency were evaluated, and the situation of off-label use of AED was statistically analyzed. Results Totally 865 epileptic children were collected, including 500 males and 365 females. The median age was 2.3 years old. Among them, 724 epileptic children received AEDs therapy, while the other 141 did not (including 82 children with Adrenocorticotropic Hormone, Prednisone, and/or Methylprednisolone therapy). 1120 person-times of AEDs were administrated. The numbers of epileptic children who received 1, 2, 3 and ≥4 AEDs were 492, 125, 55 and 52 cases. The percentage rank of types of off-label use was off-age (35.8%), off-mono/add-on therapy (19.7%), off-seizure types (14.6%), off-dosage (4.5%) and off-administration frequency (2.3%). Moreover, top 3 percentage of AEDs in off-age were Topiramate (72.9%), Levetiracetam Tablets (67.0%), and Oxcarbazepine Liquid (56.7%); top 3 percentage of AEDs in off-seizure types were Levetiracetam Liquid (51.9%), Levetiracetam Tablets (40.8%), Topiramate (26.3%); top 3 percentage of AEDs in off-mono/add-on therapy were Levetiracetam Liquid (81.4%), Levetiracetam Tablets (55.5%), Topiramate (23.7%). Conclusion The off-label use of AEDs is widespread in epileptic children, especially in off-age. The most percentage of off-label use in AEDs were Levetiracetam and Topiramate. The main reason for the off-label use in AEDs is the complication of children epileptic therapy. When the administration of AEDs is an off-label use, the adverse effects and benefits should be evaluated, so that get optimal balance of drug efficacy and safety and promote clinical appropriate drug administration.
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