Pharmacy Administration, Policy and Regulation Commons^™

3rd Place Contest Entry: "Examining Physicians’ Behaviors Regarding Buprenorphine Prescribing For Opioid Use Disorder", Khashayar Eshtiaghi

Eric M. Scandrett Graduate Library Research Prize

This is Khashayar Eshtiaghi's submission for the 2026 Eric M. Scandrett Graduate Research Prize, which won third place. It contains their essay on using library resources, a summary of their research project on physicians' behaviors regarding buprenorphine prescribing for opioid use disorde, and their bibliography.

Khashayar is a student in the Ph.D. in Pharmaceutical Economics and Policy program at Chapman University. Their faculty mentor is Dr. Marc Fleming.

Community Pharmacies Face Critical Sustainability Challenges In The United States: Academic Pharmacy Can Help, Karl M. Hess, Peter Lim

Pharmacy Faculty Articles and Research

Community pharmacies in the United States (US) face an increasingly unsustainable future due to declining third-party reimbursement (remuneration) and ongoing cash flow challenges following the elimination of retroactive direct and indirect remuneration (DIR) fees. These pressures have contributed to widespread pharmacy closures, the emergence of pharmacy deserts, and reduced access to care for millions of patients. Despite these challenges, community pharmacy remains the most common employment setting for pharmacy school graduates in the US. However, currently required community pharmacy Advanced Pharmacy Practice Experience (APPE) student rotations may offer limited exposure to business, management, and entrepreneurial activities, potentially leaving students underprepared …

Improving Hba1c And Diabetes Preventative Screening Measures In Spanish-Speaking Patients With Clinical Pharmacist Care: A Quality Improvement Initiative, Jennifer Ko, Tila P. Nguyen, Bonnie K. Chen, Richard Beuttler

Pharmacy Faculty Articles and Research

Purpose:

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Assessing Buprenorphine Treatment Utilization And Samhsa Data Waiver Provider Distribution In 2021: A Real-World Analysis In California, Yun Wang, Tao Hu, Chih-Hung Chang, Matthew Heshmatipour, Jeff Jianfei Guo, Moom R. Roosan, Karen A. Miotto

Pharmacy Faculty Articles and Research

Qualified clinicians previously required a practitioner waiver (i.e., “DATA-waiver” or "X-waiver") to offer buprenorphine, a medication for opioid use disorder (OUD). However, many counties in the US experience fewer buprenorphine prescriptions due to factors such as “DATA-waiver” providers underutilizing their buprenorphine prescribing ability. Our study aimed to compare the availability of active buprenorphine-prescribing clinicians in California to the Substance Abuse and Mental Health Services Administration (SAMSHA)-listed DATA waived prescribers under each 5-digit ZIP Code. This study utilized the buprenorphine prescription record data in 2021 from California’s Controlled Substance Utilization Review and Evaluation System (CURES). The list of the locators for …

Enhancing Holistic Patient Care Of Black Individuals Diagnosed With Hiv And Comorbid Chronic Conditions, Marc Fleming, Saharnaz Nejdat, Jon C. Schommer, Crystal K. Hodge

Pharmacy Faculty Articles and Research

Background

Pharmacists can play a crucial role in delivering the holistic care model. Research suggests that HIV-positive African American patients particularly benefit from this approach compared to other communities. Typically, pharmacists in community pharmacy settings are limited in their access to a patient's medical record, preventing holistic care delivery.

Objectives

This study addressed the impact of access to medical records on a holistic patient care approach among pharmacists engaged in medication therapy management.

Methods

This was a sub-analysis of a randomized controlled trial of the impact of community pharmacist access to medical records during MTM for African Americans diagnosed with …

A Tale Of Two Bills: Lessons Learned In Expanding Pharmacist-Led Hiv Pre-Exposure And Post-Exposure Prophylaxis, Jennifer M. Cocohoba, Jerika Lam, Maria Lopez, Betty J. Dong

Pharmacy Faculty Articles and Research

"In December 2023, JACCP published a content analysis of state legislative bills focused on expanding pharmacist scope of practice to provide human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP).¹ All states permit pharmacists to prescribe under a collaborative practice agreement with approximately half of the states granting HIV PrEP and post-exposure prophylaxis (PEP) authority to prescribe either via legislation, standing orders, or statewide protocols.^2-4 New York was the first state to expand pharmacists' specific authority for HIV prevention in 2017; however, California was the first state to pass legislation with Senate Bill 159 …

Impact Of A Pharmacist-Led Hcv Treatment Program At A Federally Qualified Health Center, Jerika T. Lam, Sharon Xavioer

Pharmacy Faculty Articles and Research

Pharmacists are key players who can help to eliminate the hepatitis C virus (HCV) epidemic in the United States. This pilot retrospective study evaluated the impact of a pharmacist-led HCV treatment program in a federally qualified health center (FQHC) primary care clinic setting. The primary outcome was to assess sustained virologic response (SVR) rates 12 weeks after patients were initiated and completed their oral direct acting antiviral (DAA) treatment regimens. Methods: This pilot retrospective study included historical analyses of patients who received DAA treatment in the pharmacist-led HCV treatment program in a FQHC clinic between 1 January 2019 and 31 …

Transitions Of Care Practice Models: Innovations Across Different Health Settings, Laressa Bethishou, Noah Fang

Pharmacy Faculty Articles and Research

"Being discharged from a hospital may be a joyous occasion for a patient with a long length of stay, but this process may also be riddled with medication issues. With a deluge of new medications, unclear instructions, and new costs that may be unaffordable, many patients face challenges that are all too common. Additionally, the medication list may be fraught with discrepancies of missing or inaccurate home medications, duplicate therapies of new medications prescribed, or drug-drug interactions of old and new medications.

Pharmacists and pharmacy personnel who support patients during transitions of care (TOC) are very familiar with the consequences …

The Role Of Pharmacy In Supporting Safe And Effective Transitions Of Care, Laressa Bethishou

Pharmacy Faculty Articles and Research

Goal To inform pharmacists and pharmacy technicians of the importance of and processes for conducting transitions of care when patients are moving among healthcare settings.
Summary A narrative review of recent events and research into transitions of care (TOCs) — the movement of patients from one healthcare setting to another. To be conducted safely and effectively, the entire patient care team must optimize patient care and communicate up-to-date information among its members. As the medication experts on the healthcare team, pharmacists are well poised to receive and share information that impacts medication use and patient safety. Pharmacy technicians can play …

Approvals, Utilization, And Cost Of Biologics For The Treatment Of Rheumatoid Arthritis, Roya Hosseini

Pharmaceutical Sciences (PhD) Dissertations

Introduction: RA treatment has been revolutionized by the development and approval of biologic disease-modifying antirheumatic drugs (bDMARDs). However, the approval status, utilization, and high cost of bDMARDs pose challenges in RA management.

Objectives: This dissertation evaluated the association between the utilization of bDMARDs and the sociodemographic characteristics of the RA patient population. It also identified the FDA approval status of bDMARDs and assessed the annual cost of bDMARDs used in RA treatment, evaluated the factors explaining annual cost at market entry.

Methods: In the retrospective analysis of Medical Expenditure Panel Survey (MEPS) data from 2010-2021, the population includes RA patients …

Perceptions Of Metabolic Syndrome Management Utilization In Relation With Patient Characteristics And Health-Related Quality Of Life, Olajide Adekunle

Pharmaceutical Sciences (PhD) Dissertations

Challenges in managing MetS include untreated risk factors and ineffective management, resulting in poor health-related quality of life (HRQoL). A significant factor contributing to these challenges is the underutilization of management services, possibly due to patients' perceptions of disease management resource utilization (PMU). Therefore, understanding patients' PMU is crucial for improving health outcomes. The study investigated PMU, explored PMU predictors, and investigated the impact of PMU and patients’ demographics on HRQoL. Using a cross-sectional design, data on perceptions of healthcare, medication, and pharmacy service utilization, prior experience with pharmacy services, demographics, and HRQoL were collected from adult individuals with obesity …

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 …

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 …

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 …

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 …

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 …

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, …

An Analysis Of Trends Of Generic Drugs And Biologic Prices In The U.S., Mohammed Jamjoom

Pharmaceutical Sciences (PhD) Dissertations

Introduction: Drug prices are a significant problem for the US healthcare system. Generic and biosimilar market competition reduces drug and biologic prices, results in substantial savings, and improves patient access and outcomes. As the costs of healthcare and prescription drugs continue to rise, the discussion about drug prices has taken a prominent place at the forefront of national discourse. This study assessed impacting trends in prices of generic, biosimilar, and reference products in the US. We also evaluated the effect of the Affordable Care Act (ACA) of 2010 on biologic prices.

Methods: We extracted a list of the new generic …

An Economic And Regulatory Analysis Of Breast Cancer Drugs Approved By The Us Food And Drug Administration, Abdullah Althomali

Pharmaceutical Sciences (MS) Theses

Introduction

Breast cancer is the most common cancer among women and the leading cause of cancer death among women worldwide. The pharmacological options for breast cancer include chemotherapy, hormone therapy, targeted therapy, and immunotherapy, which are used for the prevention or treatment of breast cancer. This study assessed trends in FDA approvals and prices at the market entry of new drugs indicated for breast cancer in the period 1980-2022. The study also evaluated the factors associated with the price of the new breast cancer drugs at market entry.

Material and Methods

Regulatory data were collected from the FDA website, and …

Disentangling The Cost Of Orphan Drugs Marketed In The United States, Hana Althobaiti, Enrique Seoane-Vazquez, Lawrence B. Brown, Marc L. Fleming, Rosa Rodriguez-Monguio

Pharmacy Faculty Articles and Research

The increasing number and high prices of orphan drugs have triggered concern among patients, payers, and policymakers about the affordability of new drugs approved using the incentives set by the Orphan Drug Act (ODA) of 1983. This study evaluated the factors associated to the differences in the treatment cost of new orphan and non-orphan drugs approved by the FDA from 2017 to 2021. A generalized linear model (GLM) with the Gamma log-link analysis was used to ascertain the association of drug characteristics with the treatment costs of orphan and non-orphan drugs. The results of the study showed that the median …

The U.S. Travel Health Pharmacists’ Role In A Post-Covid-19 Pandemic Era, Keri Hurley-Kim, Karina Babish, Eva Chen, Alexis Diaz, Nathan Hahn, Derek Evans, Sheila M. Seed, Karl Hess

Pharmacy Faculty Articles and Research

Background: Many countries have enforced strict regulations on travel since the emergence of the SARS-CoV-2 (COVID-19) pandemic in December 2019. However, with the development of several vaccines and tests to help identify it, international travel has mostly resumed in the United States (US). Community pharmacists have long been highly accessible to the public and are capable of providing travel health services and are in an optimal position to provide COVID-19 patient care services to those who are now starting to travel again. Objectives: (1) To discuss how the COVID-19 pandemic has changed the practice of travel health and …

Pharmacists’ Response To The Opioid Crisis: A California Naloxone Survey, Jerika T. Lam, Moom Roosan, Mary A. Gutierrez, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

This study aimed to assess pharmacists’ response to the current opioid crisis in California, particularly regarding the prevalence of naloxone furnishing (or dispensing without a prescription) and prescriptions for medication-assisted treatment (MAT) drugs for opioid use disorder (OUD) to patients and consumers.

An Exploration Of Ambulatory Visits And Medications Prescribed For Patients Diagnosed With Lupus Erythematosus In The United States, Salena Marie Preciado

Pharmaceutical Sciences (PhD) Dissertations

This dissertation sought to understand the management and treatment of patients diagnosed with lupus erythematosus. To accomplish the objectives of this research, three studies were conducted. First, a systematic literature review was done to assess the current landscape of available clinical guidelines for disease treatment. This research then used the National Ambulatory Medical Care Survey data from 2006-2016 to explore real-world trends in medications prescribed, comorbidities and chronic conditions associated with lupus. Data is weighted to be nationally representative of the U.S. The third study explored sociological influences or nonclinical factors on the prescribing of medications for patients with lupus. …

Approvals And Prices Of Systemic Antibiotics In Saudi Arabia And The United States, Saad Alharthi

Pharmaceutical Sciences (MS) Theses

Introduction

Antibiotics is one of the therapeutic classes with the highest level of consumption in the world. Despite the global diffusion of antibiotics, their availability and prices vary by country. This study assessed differences in the availability and prices of systemic antibiotics marketed in the United States (US) and Saudi Arabia and evaluated the factors associated with the differences in prices of systemic antibiotics marketed in both countries.

Material and Methods

We collected regulatory data from the US Food and Drug Administration (FDA) and the Saudi Food and Drug Authority (SFDA), the National Average Drug Acquisition Cost (NADAC) and the …

Gaps In Patient Education On Safe Handling And Disposal Of Oral Chemotherapy Drugs: A Pilot Prospective Cohort Survey Study, Sun Yang, Priya Patel, Alexandra Corcoran, Eric Dobberpuhl, Samantha Isidro, Dustin Le, Analise Klassen, Jay Rho, David Tran, Richard Beuttler, Neda Noori Nassr, Katherine Gruenberg, Siu-Fun Wong

Pharmacy Faculty Articles and Research

Background

Oral anticancer chemotherapy (OC) has been misperceived as being safer than intravenous chemotherapy, leading to its increased risk of improper handling and disposal. This survey study assessed the knowledge, practices and attitudes of pharmacists and patients regarding OC handling and disposal, gaps in knowledge and barriers to patient education. Methods

Surveys were developed based on literature review and pilot study validation results. Patients completed a 33-item paper or electronic survey whereas pharmacists completed a 38-item electronic survey. Descriptive statistics and Fisher’s exact test computed using the R Project were used for analyses. Results

Pharmacist group (16/25, 62.5%) and patient …

Orphan Drugs: Designations, Approvals, And Prices In The Us, Hana Althobaiti

Pharmaceutical Sciences (PhD) Dissertations

Introduction. Rare disease drug approvals have accelerated significantly in recent years. Even with these advances, patients continue to face challenges in receiving treatment, with most rare diseases lacking any approved treatments. Moreover, even when a treatment is available, it does not always reach the patients who benefit from it.

Objectives. This dissertation assessed the characteristics of orphan drug designations and approvals and the factors associated with the time lag between orphan designation and approval in the US from 1983 to 2021. It also evaluated the treatment cost of orphan and non-orphan drugs and factors explaining the treatment cost of new …

Financial Hardship From Purchasing Prescription Drugs Among Older Adults In The United States Before, During, And After The Medicare Part D “Donut Hole”: Findings From 1998, 2001, 2015, And 2021, Anthony W. Olson, Jon C. Schommer, David A. Mott, Olajide Adekunle, Lawrence M. Brown

Pharmacy Faculty Articles and Research

BACKGROUND: Cost-related nonadherence compromises successful and effective management of chronic disease. The Medicare Modernization Act of 2003 (MMA) and Patient Protection and Affordable Care Act of 2010 (ACA) aimed to increase the affordability of outpatient prescription drugs for older adults (older than age 64 years). The Medicare Part D prescription drug insurance coverage gap (“donut hole”) created by the MMA was fully closed in 2020 by the ACA.

OBJECTIVES: To (1) describe prescription drug coverage and financial hardship from purchasing prescription drugs among older American adults for 2021, (2) compare these results with findings from data collected before the MMA …

Evaluating The 0–10 Point Pain Scale On Adolescent Opioid Use In Us Emergency Departments, Michael T. Phan, Daniel M. Tomaszewski, Cody Arbuckle, Sun Yang, Brooke Jenkins, Michelle A. Fortier, Theodore Heyming, Erik Linstead, Candice Donaldson, Zeev N. Kain

Pharmacy Faculty Articles and Research

Objective: To evaluate trends in national emergency department (ED) adolescent opioid use in relation to reported pain scores. Methods: A retrospective, cross-sectional analysis on National Hospital Ambulatory Medical Care Survey (NHAMCS) data was conducted on ED visits involving patients aged 11–21 from 2008–2017. Crude observational counts were extrapolated to weighted estimates matching total population counts. Multivariate models were used to evaluate the role of a pain score in the reported use of opioids. Anchors for pain scores were 0 (no pain) and 10 (worst pain imaginable). Results: 31,355 observations were captured, which were extrapolated by the NHAMCS to represent 162,515,943 …