Professor of Pharmacy and Psychiatry
Department of Pharmaceutical Health Service Research
University of Maryland School of Pharmacy
For the past 25 years, I have been engaged in research and training in Pharmacoepidemiology. This research is focused on drugs utilized for mental health treatment in community populations and, more broadly, on pediatric drug utilization studies, an understudied field of pharmacology. My collaborations with clinical researchers and epidemiologists have been especially satisfying as they make clear the importance of such collaborations to advance observational research, a critically important area for effectiveness, safety and drug regulatory science.
Additional collaborative project work... relat[ing] to the safety and appropriateness of second-generation antipsychotics for the treatment of mental disorders. This question will be raised first in the context of known racial/ethnic disparities in the community treatment of Medicaid-insured youth... The second aim addresses monitoring to assess the potential for antipsychotic treatment-emergent adverse events. Finally, at the dispensed prescription level we will assess the impact of a prior authorization policy for pediatric antipsychotic use, which was developed by the Maryland Department of Health and Mental Hygiene (DHMH) in a statewide monitoring program to assure quality of care.
Since 1995, when I instituted a Pharmacoepidemiology course for the curricula of Pharmaceutical Health Services Research (PHSR) and the School of Medicine Epidemiology departments, I have helped to train more than 50 graduates. The course has been developed with the help of experts from FDA CDER as well as department colleagues.
With respect to the FDA public health mission on drug safety, a pediatric population-based study was conducted (Valluri et al. 2010). Reporting on the impact of the FDA suicidality warning on pediatric antidepressant (ATD) the study assessed antidepressant use in a large commercially insured population. Using a generalized estimating equation method to assess new-users of ATDs pre-and post-warning, we found a drop in usage only when all depressions (major and less-impairing) were assessed. When restricted to major depression, there was no pre-post change in use. The findings suggest that clinicians did not reduce usage in those most severely ill and the warning did not adversely affect clinical practice. This is one of more than 100 research papers or book chapters on pediatric psychopharmacologic use in community populations, including national and international studies.