Date of Award
Open Access Thesis
Master of Public Health (MPH)
School of Public Health
Prior to the 1990s, antipsychotic prescribing to children and adolescents was uncommon, given the scarcity of safety data and the high risk of developing extrapyramidal side effects. The emergence of second generation antipsychotics, changes in the epidemiology of pediatric mental health disorders, and expansion of antipsychotic drug use have facilitated the uptake of pediatric prescribing. The speed at which these drugs are being taken up by this vulnerable population is a concern. From 2002 to 2008, antipsychotic use in pediatric patients increased by 65% from 2.9 million to 4.8 million prescriptions. Until 2006, all atypical antipsychotic prescribing was off-label, as these drugs were not approved by the FDA for use among children and adolescents. Using national retail prescription data of children and adolescents ages 0-17 obtained from IMS Health covering the years 2005-2008, the effect of the 2006 and 2007 FDA approvals of Risperdal for specific pediatric use was examined using segmented interrupted time-series regressions. The analysis reveals that the FDA approvals had a statistically significant level effect but no trend effect on Risperdal prescribing. In addition, there was a stronger level effect observed among non-mental health specialists compared to psychiatrists and other mental health specialists. The results of this study suggest that FDA pediatric approvals have an important role in legitimizing and facilitating prescribing, as there are some physicians who are reluctant to weigh the risks and benefits independently through off-label prescribing.
Essick, Connor Joseph, "Examining The Effect Of Fda Approval Of Risperdal For Pediatric Use On Prescribing Trends From 2005-2008" (2012). Public Health Theses. 1082.