Pharmacy Administration, Policy and Regulation Commons^™

Considering Returns On Federal Investment In The Negotiated “Maximum Fair Price” Of Drugs Under The Inflation Reduction Act: An Analysis, Edward W. Zhou, Paula G. Chaves Da Silva, Debbie Quijada, Fred D. Ledley

Natural & Applied Sciences Faculty Publications

The Inflation Reduction Act (IRA) of 2022 contained landmark provisions authorizing government to negotiate a “maximum fair price” for selected Medicare Part D drugs considering the manufacturer’s research and development costs, federal support for discovery and development, the extent to which the drugs address unmet medical needs, and other factors. This working paper describes federal investment in the discovery and development of the ten drugs selected for price negotiation in the first year of the IRA as well as the health value created through Medicare Part D spending on these drugs. We identified $11.7 billion in NIH funding for basic …

Substance Use Disorder (Sud)- The Impact Of Sud In Utah, Amber Escobedo

Annual Research Symposium

Substance use disorder (SUD) is a manageable mental disorder that causes affected individuals to lose control over their use of substances such as drugs or alcohol. The cost of this disorder leads to the loss of billions of dollars each year. The purpose of this study is to explore ways to minimize the cost SUD bring to Utah and the United States.

Pharmacist Interventions Increase Uptake Of Pneumonia Vaccination In At-Risk Populations: A Review., Kaitlyn Hinton

Annual Research Symposium

Pneumonia is a large burden to healthcare costs and a large cause of hospitalization (Hayes, BH. Chest. 2018, 153(2), 427), and bacterial pneumonia can be prevented through vaccination. While pediatric vaccinations are routinely given, an additional dose is required for adults 65+ years of age or otherwise immune compromised, including diabetics. Only 22.2% of Immunocompromised patients and 65% of the elderly population have received the extra dose (Hung, MC. CDC. 2022). With pharmacist interventions, these vaccination rates could increase significantly. The purpose of this study was to conduct a review of the literature to identify interventions that have yielded higher …

Analysis Of Us Food And Drug Administration New Drug And Biologic Approvals, Regulatory Pathways, And Review Times, 1980–2022, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, John H. Powers Iii

Pharmacy Faculty Articles and Research

U.S. laws enacted since 1983 have aimed to enhance the development and marketing of new pharmaceutical products. We thoroughly characterized all new molecular entities, therapeutic biologics, and gene and cell therapies approved by the US Food and Drug Administration (FDA) during the period 1980–2022 in the context of these laws and regulations. Throughout the study period, the FDA approved 1355 new pharmaceutical products. The median FDA review time decreased from 26.6 months prior to the Prescription Drug User Fee Act (1992), which authorized the FDA to collect fees from drug companies to 9.9 months after the Food and Drug Administration …

Effectiveness Of Antibiotic Stewardship For Healthcare Providers At Urgent Care Clinics, Helen T. Adewole

Electronic Theses and Dissertations

Antibiotics have revolutionized modern medicine; however, the overuse in urgent care and primary care significantly contributes to the global burden of infections resistant to available antimicrobial medicines. Approximately 30% of the antimicrobials prescribed in acute care settings are unnecessary. Patient demand for antibiotics has seemingly skyrocketed following the recent COVID-19 pandemic. Practitioners must be knowledgeable about antibiotic stewardship initiatives, such as the wait-and-see approach, to reduce antibiotic overuse and improve the trajectory of antibiotic resistance and patient health outcomes. The gap in practice was the limited awareness of scientific evidence-based tools to partner with patients and improve antibiotic prescription patterns. …

Neuroprognostication In Patients With A Subarachnoid Hemorrhage: A Quasi-Review Of Anti-Inflammatory Agent Administration Versus Blood Pressure Management, Julia Gabalski, Marcie Mcmahon

Soaring: A Journal of Undergraduate Research

A subarachnoid hemorrhage (SAH) is a type of stoke where a blood vessel bursts and causes the subarachnoid space to become filled with blood. Traditional nursing management of SAH includes close monitoring of blood pressure goals in order to prevent complications such as vasospasm. Vasospasm causes delayed cerebral ischemia and neurological deficits secondary to the initial injury. Recent research has expanded understanding of the underlying mechanisms behind the neuroinflammatory cascade that occurs after a SAH. In this study, a methodical search was conducted through the CINAHL and PubMed databases to form a quasi-review of current research. The comparison of traditional …

A Closer Look At The Humanistic Aspects Of The Opioid Epidemic And Its Implications For Pharmaceutical Ethics And Law, Eriel Burns

Gaines Fellow Senior Theses

This paper elucidates the humanistic elements of this crisis, that is, the ethical challenges it poses and the role of culture in it. The opioid crisis disturbs several bioethics principles as indicated by the fact that it burgeoned out of the health care system as opposed to the illicit environments of the underground market. The book Dreamland by investigative journalist and storyteller, Sam Quinones encapsulates the complexity of the opioid epidemic through research and interviews with important figures related to the crisis such as physicians, people with opioid use disorder, and pharmaceutical sales representatives, among others. Quinones details that the …

Does Federal Preemption Inoculate Us Against The Alarming Prospect Of State Vaccine Bans?, Lars Noah

UF Law Faculty Publications

With growing resistance to vaccinations-premised, for instance, on misplaced fears of side effects or religious objections-it takes little effort to imagine that a state might act to prohibit some or all uses of a particular vaccine licensed by the federal government. Indeed, one year ago, legislators in a couple of states toyed with the idea of banning the primary vaccines against Covid-19, and, twenty years ago, half a dozen states effectively barred certain uses of one flu vaccine formulation. Although federal law should preempt at least some of these types of state restrictions, the Supremacy Clause of the U.S. Constitution …

Recent Trends In Stimulant Prescribing In Kentucky, 2021-2023, Jordan Shannon

Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.)

Abstract

Introduction

Prescription stimulants have a long history of clinical use dating as far back as the 1930s. In the United States stimulant prescribing rates have steadily climbed over the last 3 decades. The primary objective is to describe recent (2021-2023) prescribing trends of stimulant medications in the Commonwealth of Kentucky

Methods

Prescription data collected from Kentucky’s prescription drug monitoring (PDMP) database known as the Kentucky All Schedule Prescription Electronic Reporting System (KASPER). Annual and quarterly trends in stimulant prescribing between 2021-2023 were calculated, examined by age, sex, and geographic location.

Results

Stimulant prescribing increased by ~15% where the majority …

Pharmacy Involvement In Increased Access To Opioid Treatment Programs, Catherine O'Rourke

Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.)

The opioid epidemic still affects many Americans today. Despite approved medication treatments for opioid use disorder (OUD), a majority of the population with OUD have not received treatment. Since pharmacists are the most accessible health care professional and had an important role providing care during the COVID-19 pandemic, there has been a push to expand pharmacists’ scope of practice. The primary purpose of this investigation was to identify the benefits and barriers to community pharmacist-led treatment of OUD. The secondary purpose was to determine whether pharmacist participation in opioid treatment programs (OTPs) or office based opioid treatment (OBOT) would be …

Application Of Interpretable Machine Learning Methods To Study The Disease Characteristics And Healthcare Expenditures In Hodgkin’S Lymphoma, Zasim Azhar Dil Hasan Siddiqui

Graduate Theses, Dissertations, and Problem Reports (ETD)

Hodgkin’s lymphoma (HL) is a rare malignancy of lymphocytes that predominantly occurs in young adults aged 20-30 years or elderly individuals aged 65-75 years. Despite its low incidence, there were an estimated 223,512 HL survivors in the US in 2020. Hodgkin’s lymphoma shows a favorable prognosis among young adults, with a high cure rate of 85-90%; however, older adults experience poor prognosis, with a 5-year overall survival rate of 40-55% in patients over 60 years. HL survivors incur high total and out-of-pocket (OOP) healthcare expenditures, averaging $78,183 and $4,180 per patient in the first year after diagnosis, highlighting a considerable …

An Economic And Regulatory Analysis Of Gene Therapy Products Authorized By The Us Food And Drug Administration And The European Medicines Agency, Buthainah Ghanem

Pharmaceutical Sciences (PhD) Dissertations

Background: Gene therapy has recently emerged as an alternative for preventing and treating disease. Concerns have been expressed about the clinical value and the high cost of gene therapies.

Objective: This study assessed the authorization process of gene therapy products by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), evaluated the post-marketing safety signals reported to the FDA Adverse Event Reporting System (FAERS), and assessed the cost-effectiveness analysis of three gene therapies axicabtagene ciloleucel(axi-cel), lisocabtagene maraleucel (liso-cel), and tisagenlecleucel (tisa-cel).

Research Design: For aim 1; data was collected using regulatory information from the FDA and the …

Geospatial Distribution Of Pharmacist Diabetes Management Within A Patient Centered Medical Home Model In Omaha, Nebraska, Anthony Donovan

Capstone Experience: Master of Public Health

Patients with uncontrolled diabetes, defined as a hemoglobin A1c value greater than 9%, are at an increased risk of diabetes progression. Primary care is often the first point of contact where patients with uncontrolled diabetes are identified and treated. Pharmacists are utilized in diabetes medication management of patients with uncontrolled diabetes as one component of primary care multidisciplinary models of care. This descriptive project describes the geospatial distribution of patients with uncontrolled diabetes from a single institution in the Omaha, Nebraska area who were exposed to pharmacists within a Patient Centered Medical Home (PCMH) model of care compared to those …

Efficacy And Safety Of Ciltacabtagene Autoleucel And Idecabtagene Vicleucel In Multiple Myeloma Patients, Buthainah Ghanem, Marc L. Fleming, Lawrence M. Brown, Rosa Rodriguez-Monguio, Enrique Seoane-Vazquez

Student Scholar Symposium Abstracts and Posters

Background: Ciltacabtagene autoleucel (cilta-cel) and idecabtagene vicleucel (ide-cel) are chimeric antigen receptor (CAR) T-cell therapies used to treat adult patients with relapsed or refractory multiple myeloma (rrMM) after at least four lines of therapy. However, no head-to-head clinical trials to compare them have been conducted.

Objective: To compare between CARTITUDE-1 and KarMMa clinical trials in terms of efficacy, safety, and patient characteristics.

Method: Overall response rate (ORR) and safety signals were compared using reporting odds ratios (RORs) with 95% confidence intervals (CIs) at p < 0.05. Overall survival (OS) and progression-free survival (PFS) were compared using the Kaplan–Meier method with a log-rank test. Patient characteristics were compared using the chi-square test. Statistical analyses were conducted using Microsoft Excel and R version 4.0.5.

Results: Statistically significant differences were observed between cilta-cel and ide-cel in terms of ORR, complete response …

Improving Pharmacist-Led Pediatric Patient Education On Oral Chemotherapy At Home, Anika Patel, Christopher M. Nguyen, Kristin Willins, Elsabella Y. Wang, Grace Magedman, Sun Yang

Pharmacy Faculty Articles and Research

Oral chemotherapy (OC) has been increasingly used in pediatric patients diagnosed with cancer, which is primarily managed in the outpatient setting. Different from adults, pediatric patients face unique challenges in administering these hazardous medications at home. Because of the complexity of pediatric pharmaceutical care and the hazardous nature of chemotherapy agents, comprehensive patient education is imperative to mitigate the potential safety risks associated with OC administration at home. Pharmacists play a vital role in patient education and medication consultations. However, the lack of practice guidelines and limited resources supporting OC counseling are noted. Additional barriers include insufficient knowledge and training …

Phad 780: General Linear Models, John P. Bentley

GMAS Course Syllabi

No abstract provided.

The Role Of Community Pharmacists In The Provision Of Medication For Opioid Use Disorder Treatment In Rio Grande Valley, Tamara Al Rawwad, Ammar Kawaleet, Lydia Aguilera, Adrian Sandoval

Research Symposium

Background: The misuse of opioids, including prescription opioids, heroin, and fentanyl, has reached epidemic proportions in the US, resulting in more than 68,000 overdose deaths in 2020, and a total of $78.5 billion a year of economic burden. In response to this crisis, the US Department of Health and Human Services (DHHS) released a strategic plan to combat opioid abuse and misuse, recommending a multidisciplinary approach, including the inclusion of pharmacists in the efforts. The aim of this study is to examine pharmacists’ perception of their role in the provision of medication for opioid use disorders (MOUD) in addition to …

Artificial Intelligence Is Revolutionizing Controlled Substance Diversion Detection, Brian Cox, Alberto Coustasse, Craig Kimble

Management Faculty Research

In community and institutional health care sectors, artificial intelligence (AI) use is expanding. AI is being tapped broadly in operations, customer service, and scheduling, with major pharmacy chains such as Kroger, CVS, and Walgreens, already starting to implement AI applications in their pharmacies. So far, Kroger has begun to use AI for employee onboarding and training processes, CVS is applying AI in negotiations with suppliers, and Walgreens is using it to streamline vaccine scheduling. With these advances in major pharmacy chains, the next extensive application for AI has become clearer: diversion monitoring. Diversion occurs in health care settings when a …

Authorizations, Prices, And Labeling Differences Of Therapeutic Biologics Marketed In The United States And Saudi Arabia, Turki Altowairgi

Pharmaceutical Sciences (PhD) Dissertations

BACKGROUND: Since 1982, Saudi Arabia (SA) and the United States (US) have seen an increase in therapeutic biologics authorization. However, each country has regulatory regulations governing the approval of these cutting-edge drugs. The high cost of biologics financially burdens healthcare systems and delays patient access to these treatments. Sometimes a company selling the same medications in various countries will have conflicting information on drug labels.

OBJECTIVES: This study compared the characteristics of therapeutic biologics authorization by the Saudi Food and Drug Authority (SFDA) and Food and Drug Administration (FDA) as of December 31, 2021. The study also compared the US …

Comments Re: Workshop On Transforming Discoveries Into Products: Maximizing Nih’S Levers To Catalyze Technology Transfer, Fred D. Ledley M.D., Edward Zhou Pharm. D, Paula Chaves Da Silva, Ph. D.

CISI Publication

We are pleased to offer written comments to this workshop focused on “… making federally funded inventions more accessible to the public… .” These comments are informed by recent research from the Center for Integration of Science and Industry at Bentley University that has:

• Quantified the scope of NIH funding for basic or applied research, clinical development, or patents associated with drugs approved by the FDA 2010-2019. This work identified $187 billion in NIH-funded research directly related to these drugs (applied research – 17%) or their biological targets (basic research – 83%), representing a (discounted) investment comparable to reported levels …