Background: In Canada the incidence of Fetal Alcohol Spectrum Disorder (FASD) is estimated to be 1 in 100 live births. FASD is the leading cause of developmental and cognitive disabilities in Canada. Only one study has examined the cost of FASD in Canada. In that study we did not include prospective data for infants under the age of one year, costs for adults beyond 21 years or costs for individuals living in institutions.

Objective: To calculate a revised estimate of direct and indirect costs associated with FASD at the patient level.

Methods: Cross-sectional study design was used. Two-hundred and fifty (250) participants completed the study tool. Participants included caregivers of children, youth and adults, with FASD, from day of birth to 53 years, living in urban and rural communities throughout Canada participated. Participants completed the Health Services Utilization Inventory (HSUI). Key cost components were elicited: direct costs: medical, education, social services, out-of-pocket costs; and indirect costs: productivity losses. Total average costs per individual with FASD were calculated by summing the costs for each in each cost component, and dividing by the sample size. Costs were extrapolated to one year. A stepwise multiple regression analysis was used to identify significant determinants of costs and to calculate the adjusted annual costs associated with FASD.

Results: Total adjusted annual costs associated with FASD at the individual level was $21,642 (95% CI, $19,842; $24,041), compared to $14,342 (95% CI, $12,986; $15,698) in the first study. Severity of the individual's condition, age, and relationship of the individual to the caregiver (biological, adoptive, foster) were significant determinants of costs (p < 0.001). Cost of FASD annually to Canada of those from day of birth to 53 years old, was $5.3 billion (95% CI, $4.12 billion; $6.4 billion).

Conclusions: Study results demonstrated the cost burden of FASD in Canada was profound. Inclusion of infants aged 0 to 1 years, adults beyond the age of 21 years and costs associated with residing in institutions provided a more accurate estimate of the costs of FASD. Implications for practice, policy, and research are discussed. Key words: Alcohol, pregnancy, cost, economic burden, fetal alcohol spectrum disorder.

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