DKICP Student Research Symposium 2024

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https://hdl.handle.net/10790/43633

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Browsing DKICP Student Research Symposium 2024 by Title

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    Analyzing US FDA-Approved Infectious Disease Drugs from 2015-2023
    (2024-11-22) Rizamari May Pascua, Tracy Pham, Dianqing Sun
    Primary Author: Rizamari May Pascua Co-Authors: Tracy Pham, Dianqing Sun, PhD Presentation Title: Analyzing US FDA-Approved Infectious Disease Drugs from 2015-2023 Purpose: In 2019, there are approximately 10.2 million hospital visits for infectious and parasitic diseases in the US. Because of emerging multi-drug resistance and public health threats, new drugs are urgently needed to combat problematic bacterial, viral, fungal, and parasitic infections. The US Food and Drug Administration (FDA) approved drugs play a crucial role in enhancing optimal patient care, improving clinical outcome, and broadening treatment options. The objective of this study is to review all US FDA approved infectious disease (ID) agents from 2015-2023 and analyze their medicinal chemistry properties, mechanism of action, pharmacokinetic (PK) profiles, and clinical applications. Methods: This study utilized prescribing information and online open resources provided by the US FDA’s Center for Drug Evaluation and Research (CDER). Drug information resources such as Lexicomp and Sanford guide were searched for the dosing, route of administration, PK parameters, and indication of the infectious disease medications. Physicochemical properties and Lipinski’s Rule of 5 such as molecular weight, hydrogen bond donor, hydrogen bond acceptor, logP were obtained from ChemSpider & Scifinder databases and subsequently analyzed to evaluate the oral bioavailability of these infectious disease drugs and rationalize their routes of administration and clinical applications. Results: Based on the data collected from 2015-2023, the US FDA has approved a total of 49 novel infectious disease agents including antiviral, antibacterial, antifungal, and antiparasitic. Specifically, 21 antiviral agents were approved to address a wide spectrum of viral conditions, including 7 for human immunodeficiency virus (HIV), 6 for hepatitis C virus (HCV), 2 for SARS-CoV-2, 2 for ebola virus, 1 for respiratory syncytial virus (RSV), 1 for influenza virus, 1 for cytomegalovirus (CMV), and 1 for smallpox virus. Additionally, 18 new antibacterial agents approved include 2 new chemotypes (cephalosporin-siderophore conjugate antibiotic and anti-tuberculosis agent nitroimidazooxazine), 1 nitroimidazole, 2 fluoroquinolones, 1 rifamycin, 3 tetracyclines, 1 pleuromutilin, 1 aminoglycoside, 5 combination therapy (e.g., beta-lactam/beta-lactamase inhibitor), along with 2 biologic monoclonal antibodies (mAbs). Furthermore, 6 antiparasitic agents and 4 antifungal agents have also been approved since 2015. Notably, several of these agents have been subsequently discontinued from the US market due to commercial and/or practice change reasons. Each of these agents will be comprehensively discussed including chemical class, physicochemical property, mechanism of action, route of administration, and dosing regimen. Further, detailed insights into their PK profiles (e.g., Tmax, half-life, bioavailability, protein binding, metabolism, and excretion) will also be presented. Conclusion: Given rising (multi)drug-resistant microorganisms and evolving public health threats, there is an urgent, unmet clinical need for developing new infectious disease drugs with novel mechanism of action. Since 2015, significant new medicine advances have been made in this field, leading to the US FDA approval of 49 new chemical entity ID drugs. Thus, it is imperative for pharmacists, as drug and pharmacotherapy experts, along with other healthcare professionals, to stay updated regarding these new medication therapies, evaluate these expanded treatment options and provide optimal patient care.
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    Assessment of Pharmacy Student Knowledge Before and After a Three Hour Medicare Training Session
    (2024-11-22) Rosalind Wong, Anuhea Sonnenberg, Michelle Kim, Jarred Prudencio
    Title: Assessment of Pharmacy Student Knowledge Before and After a Three-Hour Medicare Training Session Primary Author: Rosalind Wong, P3 Co-Authors: Anuhea Sonnenberg, P2; Michelle Kim, PharmD.; Jarred Prudencio, PharmD., BCACP, BC-ADM Data/Results: Data was collected from a total of 34 DKICP students ranging from first-year to third-years. Participants consisted of eighteen first-year, ten second-year, and four third-year students. The mean total score of pre-questionnaires among all participants was reported as 6.4 compared to post-questionnaires reported as 7.8, with an average increase of 1.4. Comparison between pre- and post-questionnaires provided a two-tailed p-value of 0.0006, with an increase in scores between pre- and post-questionnaires observed between all years. Third-year students had the highest overall average pre- and post-questionnaire scores. First-year students had the largest improvement after the training session, with an average increase of 1.5 points (p-value < 0.0164). Students with previous pharmacy experience scored significantly higher in both pre- and post-questionnaires when compared to those with no experience. Students with no experience had a mean improvement of 2.2 points in their post-questionnaire scores (p-value < 0.0026). Percentage correct increased on all questions when preand post-questionnaires were compared with a mean increase of 12.6% (p-value < 0.0004) on each question after the training sessions were concluded. Conclusion: Overall, there was an increase in post-questionnaire scores in all categories, each showing statistical significance. This demonstrates the positive impact the Medicare training session had on pharmacy students regardless of grade level or prior pharmacy experience and has the potential to increase students’ willingness to engage eligible patients in conversations about Medicare insurance coverage. In the future, other pharmacy schools may consider partnering with their State Health Insurance Assistance Program to deliver a similar service to benefit both pharmacy students and Medicare beneficiaries, proving to be an additional strategy to improve student education and patient care
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    Comparison of Weight Loss Diabetic Medication and Self-reported Obesity Prevalence Rates in the United States in 2021
    (2024-11-22) Neilsen Gazo, Bryce Fukunaga
    Poster Title: Comparison of weight loss diabetic medication prescribing and self-reported obesity prevalence rates in the United States in 2021 Authors: Neilsen Gazo, P3 Student Pharmacist; Bryce Fukunaga, PharmD Purpose - According to the ADA 2023 guidelines, glucagon-like peptide-1 receptor agonists (GLP1RA) and sodium-glucose cotransporter-2 inhibitors (SGLT2i) are effective medications for weight loss in individuals with diabetes. Given the substantial health risks, a focus on weight management is vital. The purpose of this study is to determine if there is an association between the prescribing rates of weight loss diabetic medications, GLP1RA and SGLT2i, and obesity prevalence rates in the United States. Methods - This was a retrospective data analysis, utilizing state prescription information from the 2021 Medicare Provider Utilization and Payment: Part D Prescriber Data. Data on claims and beneficiaries of weight loss diabetic medications across all 50 states available in 2021 were collected, including GLP1RA (Dulaglutide, Exenatide, Liraglutide, Lixisenatide, and Semaglutide) and SGLT2i (Canagliflozin, Dapagliflozin, Empagliflozin, and Ertugliflozin). Prescribing rates for GLP1RA and SGLT2i, both individually and together, were analyzed. Combination medications containing these agents were excluded. Information on the prevalence of self-reported obesity among adults in the United States for 2021 was gathered from the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System (CDC BRFSS). Graphs and heat maps were generated using Microsoft Excel for visual representations. Results - In 2021, the top five states with the highest GLP1RA prescribing rates were Alaska, North Dakota, Massachusetts, North Carolina, and New York. The top five states with the highest SGLT2i prescribing rates were Hawaii, New York, Pennsylvania, Connecticut, and Kentucky. The top five states with the highest GLP1RA plus SGLT2i prescribing rates were New York, Alaska, Hawaii, Pennsylvania, and North Carolina. The top ten states with the highest self-reported obesity prevalence rates were West Virginia, Kentucky, Alabama, Oklahoma, Mississippi, Arkansas, Louisiana, South Dakota, Ohio, and Missouri. Kentucky had one of the highest SGLT2i prescribing rates and was also within the top ten states with the highest self-reported obesity prevalence rates. All other states mentioned in the top five states for GLP1RA, SGLT2i, and GLP1RA plus SGLT2i prescribing rates were not among the top ten states with the highest self-reported obesity prevalence rates. Conclusion - There was no strong correlation between the prescribing rates of GLP1RA and SGLT2i and obesity prevalence rates in the United States in 2021. Some limitations of this study include limited age group populations of Medicare Part D data and the subjectiveness of self-reported obesity prevalence. Further research is warranted to observe larger sample sizes with greater ranges of age groups to further evaluate the correlation of this study
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    Examining US FDA Approved Central Nervous Drugs from 2015-2023
    (2024-11-22) Vincent Tran, Cierra Fujimoto, Dianqing Sun
    Title: Examining US FDA Approved Central Nervous System Drugs from 2015-2023 Vincent Tran, Cierra Fujimoto, Dianqing Sun Department of Pharmaceutical Sciences, The Daniel K. Inouye College of Pharmacy, University of Hawaii at Hilo, Hawaii 96720, United States Purpose: Since 2015, the US Food and Drug Administration (FDA) has approved 400 new chemical entity and biologic drugs with approximately 11 percent of these drugs falling within the central nervous system (CNS) category. CNS drugs mediate the functioning of the brain and spinal cord, and also regulate the human body’s physical and mental well-being. The purpose of this study is to conduct a comprehensive analysis and overview of the medicinal and physicochemical properties, pharmacokinetic (PK) profiles, and clinical applications of these FDA approved CNS drugs from 2015-2023. Methods: This data analysis was conducted using new molecular entity and new therapeutic biological product approval online resources provided by the US FDA’s Center for Drug Evaluation and Research (CDER). Literature review was performed by searching online databases such as Lexicomp and prescribing information document. Physicochemical properties were obtained from ChemSpider and Chemfinder database. Lipinski’s Rule of Five (molecular weight, hydrogen bond acceptor, hydrogen bond donor, and LogP) was used to assess the oral bioavailability, routes of administration, and rationalize their clinical applications of these CNS agents. Results: As of September 2023, the US FDA has approved 400 new chemical entity and therapeutic biologic drugs since 2015 with a total of 44 new CNS drug approvals. Among the CNS drug classes, the highest number of new CNS drugs approvals was for mental disorders (22.7%), followed by migraines (20.5%), anti-seizure (11.4%), sleeping disorders (9.1%), amyotrophic lateral sclerosis (ALS) (6.8%), multiple sclerosis (6.8%), Parkinson’s disease (6.8%), Alzheimer’s disease (4.5%), neuromyelitis optica spectrum disorder (4.5%), Huntington’s disease (2.3%), opioid withdrawal (2.3%), and sedatives (2.3%). Chemically, there are 29 small molecules, 11 biologic monoclonal antibodies (mAbs), 1 antisense oligonucleotide, and 3 combination therapy products. With regard to drug characteristics of these 29 small molecule CNS agents, >70% of these compounds have polar surface area (PSA) values of < 90 Å2, with favorable blood-brain barrier (BBB) penetration profiles; and 19 drugs have logP values ranging from 2 to 5; and 5 drugs had a logP of >5 with more lipophilic profiles. Furthermore, 20 drugs have a basic functionality, with 8 drugs being neutral and 4 being weakly acidic under physiological conditions. Detailed physicochemical properties, PK parameters, and clinical indications, and recommended dosages of these CNS medications will be presented. Conclusion: From 2015-2023, remarkable medicine advances have been made with 400 total new drug approvals from the FDA. Among them, 44 drugs fall within the CNS category, remaining as one of the top 3 drug approval category following oncology and infectious disease. From a medicinal chemistry standpoint, to enable the BBB penetration, most of these CNS approved drugs are lipophilic and basic or neutral as the acidic functionality is not well tolerated due to the negatively charged form under physiological condition. This work serves as a valuable resource and medication information for clinicians and drug discovery researchers.