(P-295) Drug Utilization Pattern of Antiepileptic Drugs in Pregnancy and the Outcome of Offspring in Asia Population

Background: Little evidence of the safety of antiepileptic drugs use during pregnancy in Asia population. However, insurance for inspection and prenatal care, adherence and health seeking behavior are confounding factors for causal relationship and difference in each countries.

Objectives: This study was aim to evaluate the prenatal AEDs exposure and risk of congenital malformations and neurodevelopment disorders in pregnancy women with epilepsy (WWE) by using linking database in Taiwan.

Methods: A cohort of pregnant women in 2005 to 2016 was identified from Birth Certificate Database which included women with gestational week more than 20 weeks whether a live-birth was given or not. Children were linked to mother by unique anonymous ID through Maternal and Child Health Database. Pregnant women with at least one diagnostic code for epilepsy on separate dates or at least one hospitalization of epilepsy or at least one outpatient visit with diagnostic code for epilepsy combined with a prescription of AEDs within two years prior to conception were defined as active epilepsy and assumed to keep AEDs use during pregnancy. Exclusion criteria were mother with multiple-birth or without AEDs exposure within 2 years prior to conception. WWE with and without AEDs during three trimesters were classified as exposure group and unexposed group, respectively. Congenital defects and neurodevelopment disorders such as seizure, mental retardation, etc. were evaluated as a composite outcome between two groups. Moreover, AEDs adherence pattern was calculated by proportion of days covered (PDC). Calculated PDC≧80%, 79%~50% and <50% were defined as high, moderate and low adherence, respectively.

Results: There were 1,483 and 980 pregnant women met study criteria in exposure and unexposed group, respectively. The study result indicated that AEDs prescription rate was declined after conception, from 14.4 to 7.78 per 10,000 deliveries. However, adherence was better in trimester than pre-pregnant period among WWE continuing AEDs use during pregnancy, the proportion of high adherence was increased from 46% to 60-70%.The psychiatric related comorbidities and co-medications of unexposed women were more frequent but health utilization pattern was no significant difference among two groups. Compared to exposure group, the adjusted hazard ratio for composite outcome in unexposed group was were 0.995 [95% CI: 0.839-1.18].

Conclusions: In Taiwan, the AEDs prescription rate was lower than countries in Western. There is no significant difference on the risk of harmful outcome in offspring who exposed to AEDs in prenatal.