Doctor of Philosophy, The Ohio State University, 2009, Pharmacy

The pharmaceutical industry serves societal needs by bringing innovative products and therapies to market. However, innovation does not guarantee market longevity. Consequently, some products are evaluated and considered for market discontinuation. Safety, efficacy, and financial concerns are important considerations when evaluating the reasons for market discontinuation of drugs. In this study, market discontinuation of new molecular entities (NMEs) approved by the FDA from 1980 to 2008 were analyzed. The independent variables considered for the analysis were drug characteristics (route of administration, therapeutic class), sponsor characteristics (sponsor country, sponsor with single NME during study period), drug policy (orphan drug status, accelerated review, priority review and Prescription Drug User Fee Act (PDUFA) enactment). Data were derived from the FDA, Micromedex, Medline, Lexis-Nexis and Medicaid Drug Utilization Data. A drug was considered discontinued if it was deleted from the FDA's Orange book. Withdrawals of approval were also included in the study. Descriptive statistics, chi-square tests, logistic regression and survival analysis were performed for the study. A total of 703 NMEs were approved during the study period. In December 31, 2008, 71.8% NMEs remained in the market; 14.4% were discontinued; 5.4% NMEs had the brand discontinued, but the generic was available; 7.0% had changes in route, dosage form or strength; 0.7% were never marketed and 0.9% were over-the-counter drugs. Safety was the primary reason for withdrawal of 29 (27.4%) NMEs; 4 (3.8%) NMEs had Federal Register determination for not being discontinued for safety or efficacy reasons; 5 NMEs were never marketed (4.7%) and 68 (64.2%) had no reasons stated by the FDA. Compared to other classes anti-infectives were more likely (p<0.05) to be discontinued. Analyses of priority review, orphan drug status, and sponsor company's country (US or non-US) with respect to market withdrawal we (open full item for complete abstract)

Committee: Sheryl Szeinbach PhD, RPh (Advisor); Enrique Seoane-Vazquez PhD (Advisor); Kurt Stevenson MD, MPH (Committee Member) Subjects: Biostatistics; Economics; Epidemiology; Finance; Health Care; Pharmaceuticals; Public Health

MS, University of Cincinnati, 2019, Pharmacy: Pharmaceutical Sciences

Objective: Diabetes is one of the most prevalent chronic diseases. This study aimed to examine geographic variation and temporal trends in the utilization of antihyperglycemic therapies among the U.S. Medicaid population compared to diabetes prevalence at state-level using Geographic Information system. Methods: A descriptive, retrospective study design was performed for 2011,2014, and 2016. Study drugs were categorized into biguanides, sulfonylureas-meglitinides, DPP-4 inhibitors, SGLT2-inhibitors, GLP-1 receptor agonists, insulins, and others. The annual number of prescriptions for antihyperglycemic therapies were extracted from the national Medicaid pharmacy database provided by the Centers for Medicare & Medicaid Services. Spatial analysis using ArcMap 10.5.1 was performed to create choropleth maps for diabetes prevalence and point maps for the total number of prescriptions for each antihyperglycemic therapy. The percent change in drug utilization during the study period was calculated per therapeutic class per state. Pearson's correlation test was also performed to evaluate the correlation between diabetes prevalence and antihyperglycemic therapies' usage at state level. Results: Utilization of most antihyperglycemic therapies were increased from 2011 to 2016. States with high utilization trends were NY, CA, PA, NJ, AZ, FL, IL, OH, MA, and TX, ranging from 1-fold to 50-fold overall. The five most prescribed antihyperglycemic therapies in 2016 were biguanides (41.95%), long and intermediate-acting insulins (18.9%), short and rapid-acting insulins (12.87%), sulfonylureas-meglitinides (11.37%), and DPP-4-inhibitors (7.87%). Rapidly increasing utilization trends were for GLP-1-receptor agonists, DPP-4-inhibitors, and SGLT2-inhibitors around all states. SGLT2-inhibitors usage in the northeastern states increased by 4 to 26-fold higher than its use in 2014. Sulfonylureas-meglitinides usage decreased in the southeast part of the US by 20%-58% in 2016. There is (open full item for complete abstract)

Committee: Jianfei (Jeff) Guo Ph.D. (Committee Chair); Diego Cuadros Ph.D. (Committee Member); Nicholas Messinger (Committee Member) Subjects: Pharmaceuticals