April 3, 2018

Study: Off-Label Use and Manipulations of Antiepileptic Drugs in Children – Analysis of the Outpatient Prescriptions in a Tertiary Center

Conclusion: Off-label use and manipulations of AEDs remains an important problem in home care of children with epilepsy. This is mainly a concern for the most vulnerable groups, i.e., young patients, patients undergoing polytherapy, and patients with developmental and epileptic encephalopathy (DEE). International initiatives have been launched to improve the availability of labeled and adapted drugs in this population.

Objectives: Little is known about off-label use and manipulations to achieve the prescribed dose of antiepileptic drugs (AEDs) in outpatient prescriptions. This study aimed to evaluate this practice in a tertiary center for child epilepsy.

Methods: We reviewed off-label use and manipulations of AEDs delivered to the outpatient’s epilepsy clinic. Multivariate logistic regressions were used to determine the factors associated with off-label and manipulated uses.

Results: Five hundred eleven consultations generated 897 AED deliveries (1.75/consultation). Off-label use involved 182 (20.3%) of prescribed AEDs. Factors associated with off-label use were polytherapy and new AEDs while increase of age and nondevelopmental and structural-metabolic etiologies have a protective effect. Among the 1725 doses of AEDs prescribed per day, 33.5% generated manipulations (n=582): 40% inadequate (n=237) and 60% adequate (203 syrups, 112 scored tablets, 30 drops medicine). Polytherapy (p<10-4) and the absence of market authorization significantly favored manipulations whereas the increase in age restricted them.

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