Pharmacy Administration, Policy and Regulation Commons^™

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 …

Spending On Phased Clinical Development Of Approved Drugs By The Us National Institutes Of Health Compared With Industry, Edward W. Zhou, Matthew J. Jackson, Fred D. Ledley

Natural & Applied Sciences Faculty Publications

The launch of the Advanced Research Projects Agency for Health to advance new cures and address public concern regarding drug prices has raised questions about the roles of government and industry in drug development.

This cross-sectional study examined NIH funding for published research reporting the results of phased clinical trials of drugs approved between 2010 and 2019 and compared the findings with reported industry spending estimates. Data analysis was performed between May 2021 and August 2022 using PubMed data from January 1999 through October 2021 and NIH Research Portfolio Online Reporting Tools Expenditures and Results data from January 1999 through …

Navigating The Path To Safe Compounding In Health Systems, Thomas Pile, Craig Kimble, Alberto Coustasse

Management Faculty Research

Across the country health systems are facing increasing drug shortages that are forcing pharmacists to rely far more heavily on compounding to meet the needs of patients. Additionally, several high-profile compounding incidents have helped highlight the importance of ensuring best practices are followed during sterile and nonsterile compounding to support patient safety and high-quality care. Specifically, in 2022, 160 drug shortages were reported in pharmacies. From January 1, 2023, to March 31, 2023, 47 drug shortages were reported, 55% of which were for injectables. In response, compounding has increasingly become a solution to bridge that gap.

Phad 690: Data Management & Statistical Software, Sujith Ramachandran Ph.D., Yinan Huang, Ms, Ph.D.

GMAS Course Syllabi

No abstract provided.

A Comparative Assessment Of Approvals And Discontinuations Of Systemic Antibiotics And Other Therapeutic Areas, Rosa Rodriguez-Monguio, Enrique Seoane-Vazquez, John H. Powers Iii

Pharmacy Faculty Articles and Research

Since 1980, the US Congress has passed legislation providing several incentives to encourage the development and regulatory approval of new drugs, particularly antibiotics. We assessed long-term trends and characteristics of approvals and discontinuations of all new molecular entities, new therapeutic biologics, and gene and cell therapies approved by the US Food and Drug Administration (FDA), as well as reasons for discontinuations by therapeutic class, in the context of laws and regulations implemented over the past four decades. In the period 1980–2021, the FDA approved 1310 new drugs, of which 210 (16.0%) had been discontinued as of 31 December 2021, including …

Geospatial Analysis Of Opioid Dispensing Patterns In California: A 2021 Real-World Study, Hongxia Lu, Jianwei Zheng, Yun Wang

Pharmacy Faculty Articles and Research

The misuse and abuse of opioids has become a serious public health threat in the United States. The state of California has been hit particularly hard by the opioid epidemic, with a noticeable increase in opioid-related fatalities and hospitalizations. This brief report paper aims to contribute to the growing literature by conducting a geospatial analysis of opioid dispensing patterns in California in 2021. The primary objective was to identify areas characterized by high-risk opioid dispending patterns and explore possible contributing factors. This retrospective study analyzed data from over 7 million records of opioid and benzodiazepine prescriptions dispensed by outpatient pharmacies …

Dentistry And The Law: Accessing/Disclosing Prescription Information On Software Platforms, Dan Schulte Jd

The Journal of the Michigan Dental Association

This article discusses the access and disclosure of prescription information on software platforms like eScribe and MAPS. It highlights that HIPAA regulations govern such access, and as long as the information is obtained through business associate agreements and used for treatment purposes, specific patient consent may not be necessary. The article also mentions that the Michigan Automated Prescription System (MAPS) allows prescribers to access controlled substance prescription information without requiring patient consent.

President’S Address: Dr. Vince Benivegna, Vince Benivegna Dds

The Journal of the Michigan Dental Association

Dr. Vince Benivegna, the outgoing President of the Michigan Dental Association, addressed the House of Delegates, emphasizing the significant progress in enhancing Adult Dental Medicaid coverage and reimbursement in Michigan. He thanked the dedicated individuals who supported him during his tenure and shared his journey. Dr. Benivegna lauded Michigan's accomplishments in reducing opioid prescribing and highlighted the MDA's role as a model state society in advocacy, leadership, mentorship, continuing education, diversity, equity, and inclusion. He praised Michigan's achievements in improving Adult Dental Medicaid, encouraging Michigan dentists to participate and help address oral health disparities. Dr. Benivegna underscored how this aligns …

Mitigating Risks To Improve Hypertension Medication Adherence In A Medically Vulnerable Population, Donna Hales-Teat

Doctor of Nursing Practice Projects

This project assessed the effect of an evidence-based medication adherence intervention on adherence rates at a Northern Indiana clinic led by a sole nurse practitioner, receptionist, and continuous rotation of graduate nursing students from several nursing programs in the Northern Indiana area. Patient education and comprehension were poor in terms of understanding disease process, treatment options, and disease management that led to poor communication with the medical provider. The process and steps in which patients matriculate through was described by Johnson’s (2002) Medication Adherence Model (MAM) with concepts of purposeful action, pattern behavior, and feedback; these helped to construct, steer, …

Scoping Review Of The Best Practices In Drug Courts In The United States, Elise Crumrine, Blakely Camille Culp

Honors Theses

Purpose: Drug courts are reform programs that are utilized in America to reduce the amount of incarcerations due to non violent drug charges. A successful drug court has a high number of graduates and low recidivism rates. To accomplish this, a variety of methods are utilized such as medication assisted therapy (MAT), random and mandatory drug testing, positive reinforcement in the form of words or tangible items, etc. The purpose of our study was to identify the best practices of drug courts, as defined as increased graduation rates and decreased recidivism, so that the findings may be applied in the …

Is My Prescription Ready Yet? A Qualitative Examination Of Patients' Understanding Of The Prescription Filling Process In Community Pharmacies, Maria Sallee

Honors Theses

Long lines at the pharmacy can frustrate patients. Consequently, patients becoming frustrated can add stress to an already overworked pharmacy. Without knowing what patients understand about the often complicated prescription filling process at community pharmacies, it can be difficult for pharmacists and pharmacy technicians to communicate the reason behind any delays in patients receiving their medication. To learn what patients understand about the prescription filling process, fifteen interviews were conducted over the phone after mailing recruitment flyers to members of a diabetes research collaborative in North Mississippi. The interviews revealed that while patients have a positive relationship with their pharmacists, …

Factors Affecting Initiation And Retention Of Medication-Assisted Recovery (Mar) Within A Pilot Pharmacist-Involved Practice Model At A Federally Qualified Healthcare Center (Fqhc) During The Covid-19 Pandemic, Tiffany Nguyen, Thomas Craig Cheetham, Souhiela Fawaz, Richard Beuttler, Sharon Xavioer

Pharmacy Faculty Articles and Research

Background: During the COVID-19 pandemic, opioid-related overdose deaths increased. Although Medication-Assisted Treatment or Recovery (MAT or MAR) is available, initiation and retention rates vary. The goal of this study was to evaluate clinical, demographic, and Social Determinant of Health factors affecting MAR initiation, on-time initiation of medications, and successful retention in the program. The secondary goal was to evaluate the impact of a novel interprofessional practice model incorporating pharmacists. Methods: A retrospective analysis was conducted using electronic health record data from a pilot MAR Program initiated within a California Federally Qualified Healthcare Center. Results: From September 2019 to August 2020, …