Reduction in Use of Risperidone for Dementia in Australia Following Changed Guidelines

Background: Risperidone is the only antipsychotic approved in Australia for the management of the behavioural and psychological symptoms of dementia (BPSD). In June 2015, the Australian Government Therapeutic Goods Administration (TGA) amended the indication to restrict use in BPSD to patients with Alzheimer's dementia for a maximum twelve-week duration. We aimed to determine whether the rate and duration of risperidone use for BPSD decreased following the regulatory changes. Methods: we conducted a study using the Australian Government Department of Veterans' Affairs administrative claims data and Pharmaceutical Benefits Scheme (PBS) 10% sample data. We included people aged 65 years or older and compared the rate and duration of risperidone use before and after the TGA labelling changes. Results: There was a sustained decrease in the trend of risperidone use for BPSD following the TGA labelling changes, with a monthly decrease of 1.7% in the aged care population, 0.5% in the community living population and 1.5% in the general older Australian population. Overall, in the 24 months post the TGA changes the reduction in the rate of use of risperidone ranged from 20% to 28% lower than compared to what the rate would have been without the TGA changes. The median duration of use of risperidone in aged-care residents decreased from 338 days in the year prior to the TGA labelling changes, to 240 days per person in the year after the changes. Conclusion: The TGA labelling changes were associated with a significant reduction in the rate of use of risperidone for BPSD in veterans living in both the aged care and community settings, and in the general older Australian population. The labelling changes were also associated with a reduced duration of risperidone use in aged care residents, although for most people the duration of use still exceeded the recommended 12-week maximum duration.