Thesis abstract:

There is a high prevalence of psychotropic medicine use in paediatric patients with chronic mental health conditions, such as depression and ADHD. Despite this, there is limited research available surrounding the off-label use of psychotropic medicines in children and adolescents, particularly in Australia. As a result, many questions are raised behind the safety, efficacy and education relating to the use of these medicines, as well as the decision making involved during prescribing of these medicines. This research project thus aims to evaluate the off-label use of psychotropic medicines in children and adolescents. The specific objectives include the following:

(1) To conduct a literature review of the current research available on the off-label use of psychotropic medicines in children and adolescents.

(2) To compare the approval of psychotropic medicines for chronic mental health conditions in paediatric patients, across 5 countries (UK, Australia, NZ, Canada, US).

(3) To determine the potential for off-label use of psychotropic medicines in paediatric patients with depression, by comparing the approval information in the summary of product characteristics or equivalent documents against the recommendations of the Maudsley prescribing guidelines in psychiatry.

(4) To compare the approval of ADHD medicines across countries and to determine any variations in the approval information in the drug labelling

(5) To conduct a quantitative database study (BEACH database) which examine GP prescribing trends relating to psychotropic medicine use in paediatric patients.

(6) To conduct a quantitative database study (BEACH database) which determines the rates of off-label prescribing of psychotropic medicines to paediatric patients

This research project may provide the basis for educational programs for healthcare professionals, thereby providing decision-making frameworks. It may also assist in reviewing the appropriateness of psychotropic medicine use across different countries and provide a basis for further research into the topic, particularly for Australia.