Pharmacy Administration, Policy and Regulation Commons^™

Pharmacy Access Is Out Of Reach For One In Six South Carolinians, Bryan L. Love Pharm.D., Tessa J. Hastings Phd, Abby Davies

CORE Research Briefs

A cross-sectional geospatial analysis mapped active South Carolina community pharmacies and used 2020 Census tract data to estimate the population residing within and beyond five-mile pharmacy service areas. About one in six South Carolinians lives more than five miles from an active community pharmacy, with limited access disproportionately affecting rural communities.

Quality Improvement (Qi) Project Aimed At Reducing Unnecessary Antibiotic Usage Among Older Adult Patients By Addressing Inappropriate Antibiotic Prescribing In Primary And Long-Term Care Settings, Pamela M. Thomas

Seton Hall University Dissertations and Theses (ETDs)

Antibiotic overuse among older adults remains a significant patient safety and public health concern. Recent national data indicate that approximately 30%–50% of outpatient antibiotic prescriptions may be unnecessary, particularly for viral or self-limiting conditions (Chua et al., 2021). Antimicrobial resistance has been associated with more than 1.27 million deaths globally (Murray et al., 2022). This quality improvement project evaluated a multifaceted antimicrobial stewardship intervention in primary and long-term care settings. Baseline review of 167 antibiotic cases revealed 37.1% were inappropriate or questionable, and 28.7% lacked adequate diagnostic documentation. The intervention incorporated provider education, electronic health record decision-support tools, audit and …

Quantifying Black Carbon Concentrations In Georgia And Analyzing Associated Public Health Risks, Khloe R. Osborne

Honors Theses

Quantifying Black Carbon Concentrations in Georgia and Analyzing Associated Public Health Risks

One of the most daunting challenges of the industrial world is air pollution. Within this broad spectrum, there is an inhalable particle group named PM2.5, which contains black carbon. Black carbon has evidence that supports the generation and worsening of adverse health impacts, which may include birth complications, cognitive deficits in children, pulmonary aggravation, asthma, cardiovascular issues, neurological degenerative patterns, and cancer risk. This is especially seen in vulnerable populations, like children, elderly, and those who already suffer from weakened health, many of which reside in the southern …

Self-Medication And Pharmaceutical Dispensing In Egypt: Practices, Policies, And Regulatory Challenges, Lobna Fawzy Ali Shaheen

Theses and Dissertations

Access to safe and appropriate medications is a critical component of public health, particularly in low- and middle-income countries. In Egypt, self-medication and informal pharmaceutical dispensing have become deeply embedded practices shaped by systemic, economic, and cultural factors. This research explores the complex interplay between self-medication behaviors, pharmaceutical regulation, and healthcare access in Egypt. Through qualitative interviews with policymakers, pharmacists, physicians, industry professionals, and citizens, the research uncovers widespread informal dispensing of prescription-only medicines, driven by high out-of-pocket costs, limited insurance coverage, and high public reliance on pharmacists as primary care providers. Despite the presence of regulatory frameworks, weak enforcement, …

Pharmacist Quality Of Work-Life During Covid-19 Pandemic In Cagayan De Oro, Junnin Gay Labrigas Garay, Rugine Riel D. Barsobia, Zoe Kyra Evasco, Bonnie Louise Elorde

Pacific Journal of Health

During the COVID-19 pandemic, pharmacists have been one of the most accessible healthcare workers working in the frontline providing the medication and drug needs of patients. Their roles and responsibilities in work expanded and to some redefined as the pandemic hit. Adjustments in their work, and workplaces were also implemented in adherence to the pandemic situation. The quality of work life of frontline pharmacists were affected because of the changes brought by the pandemic. A descriptive qualitative study design was used to determine the pharmacist’s quality of work-life during the COVID-19 pandemic in Cagayan de Oro City. The place was …

Patient Information Needs During Ambulatory Medication Changes: A Qualitative Study, Elaine Giletta, Vanessa B. Hurley, Yushi Yang, Jessica L. Schwartz, Rabia Jalalzai, Nicole L. Mollenkopf, Raquel Mayne, Samantha I. Pitts

Journal of Patient-Centered Research and Reviews

Purpose: We performed interviews with patients and caregivers to explore whole-person, whole-regimen information needs at times of routine outpatient medication changes. We categorized information needs in this relatively unstudied context and identified which needs were commonly recognized as insufficiently met.

Methods: We explored the content of the semi-structured interviews, which involved nine patients and two caregivers of pediatric patients, all of whom experienced a recent medication change in the outpatient setting of a large urban academic healthcare system. We used inductive thematic analysis to organize information needs into categories to identify key information gaps.

Results: We identified five categories of …

The Use Of Health And Herbal Products For Covid-19 Self-Prevention And Its Affecting Factors According To Theory Of Planned Behavior, Suppachai Insuk, Supanida Kittirattanasak, Mullika Sirithongkaset, Daranee Chiewchantanakit

The Thai Journal of Pharmaceutical Sciences

Introduction: Despite the World Health Organization’s recent declaration of the end of the COVID-19 pandemic, the lessons learned from the outbreak remain crucial for future public health responses. In Thailand, the pandemic’s impact led individuals to explore self-protection methods, including potentially ineffective health products. This study examined the prevalence of health and herbal products used for COVID-19 self-prevention, to identify the types of these products in use and to identify factors influencing their utilization.

Methods: A cross-sectional study surveyed 400 Thai participants aged 25–60 who had never contracted COVID-19. The study employed convenience sampling and self-administered online questionnaires based on …

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 …

Study Of Laws And Regulations Related To The Management Of Florfenicol Detection Cases In Swine, Shinnawat Saengungsumalee

The Thai Journal of Pharmaceutical Sciences

Background: Florfenicol, an antibiotic permitted in veterinary medicine, currently lacks an established maximum residue limit (MRL) in meat products in Thailand, effectively mandating undetectable residue levels. In May 2024, Thailand Pesticide Alert Network reported florfenicol residues in swine, raising concerns about consumer safety, rational veterinary drug use, and the potential for antimicrobial resistance (AMR). Addressing these issues involves multiple laws, decrees, and regulations across various agencies. Objectives: To analyze laws and regulations managing florfenicol residue detection in swine. Materials and Methods: This documentary research examines relevant laws, regulations, and measures for florfenicol in livestock and compares Thailand’s regulations with those …

Customary Corruption, Ani B. Satz, Liza Vertinsky

Faculty Articles

For over a hundred years, it has been well-accepted among tort scholars that physicians—as one of the legally recognized professions— determine their own customary practices. Within tort law, and medical malpractice more specifically, customary practice establishes whether physicians breach or uphold the required standard of care toward their patients. The results of our hand-coded examination of decided cases and statutes show a more complex picture. While some states have endeavored to shift the standard away from professional custom, it continues to play a critical, and in many cases a determinative, role in establishing physician liability in most states.

Using illustrative …

Defederalizing Opioid Addiction Care, Matthew B. Lawrence

Faculty Articles

Lack of access to evidence-based care for drug addiction is an urgent problem amid a decades-long overdose crisis that kills tens of thousands of Americans a year. Opioid addiction is the primary driver of overdoses today, and medicines exist to treat such addiction that can dramatically improve quality of life while reducing the risk of deadly overdose by more than half. Yet fewer than one in four of the nine million Americans who need such evidence-based medical care for their addiction receive it. Chief among barriers to access are restrictive and burdensome federal requirements limiting the use of narcotic medications …

Developing Public-Private R&D Consortia To Accelerate Alzheimer’S Disease Drug Development, Joel West, Paul Olk

Management: Faculty Scholarship

Efforts to accelerate Alzheimer's disease (AD) drug development have been spurred on by the creation of open science, public-private R&D consortia. An R&D consortium provides an improved structure for generating and disseminating AD knowledge across a range of organizations while also aligning their interests. Drawing from archival and interview data collected on 46 public-private R&D consortia focused wholly or in part on AD, we uncover two important innovations: the creation of novel consortium types that facilitate coordination beyond the individual consortium, and the practice of organizations joining multiple consortia. Collectively these innovations provide member organizations with different pathways for advancing …

Medicare Drug Price Negotiation Program Draft Guidance, Fred Ledley M.D., Edward Zhou Pharmd, Paula Chaves Da Silva Ph.D.

CISI Publication

This comment focuses on Section 50.1, provisions 1 & 3 of the draft guidance regarding the negotiation of a “maximum fair price” under the Inflation Reduction Act (IRA), research and development (R&D) costs of the primary manufacturer, and prior federal financial support for novel therapeutic discovery and development. Specifically, we argue that a negotiated, “maximum fair price” must consider both public sector (federal) and private sector (manufacturer) investments and provide returns to both commensurate with the scale and risk of their investments. This comment addresses three issues and makes specific recommendations regarding each:

1. In negotiating a “maximum fair price,” both …

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 …

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. …

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 …

Treatment Of Oral Vascular Malformations With Ethamolin: A Report Of Two Cases, Maria Clara De Moura Santos Coelho Ferreira, Marco Vinícius De Sales Lima, Anna Laura Almeida Barreto, Dárcio Kitakawa, Alexandre Do Prado Scherma, Felipe Peralta, Luis Felipe Das Chagas E Silva De Carvalho

Journal of Dentistry Indonesia

A hemangioma is a benign vascular neoplasm, relatively common in the head and neck. In the oral region, it affects the tongue, gums, mucosa, palate, and lip. Its size can vary from millimeters to centimeters, characterized as a purplish or reddish lesion. The present study aims to present two clinical cases of hemangiomas, the first of a male patient treated by sclerotherapy and the second of a female patient in which she was treated with ethamolin and later surgical treatment. It was concluded that sclerotherapy, in addition to being a safe treatment, managed to drastically reduce the initial size of …

Prescription Drug Retail Sales In The Mountain West, Caren Royce Yap, Caitlin J. Saladino, William E. Brown Jr.

Health

This fact sheet synthesizes data on prescription drug retail sales in the Mountain West (Arizona, Colorado, Nevada, New Mexico, and Utah). "Retail Sales for Prescription Drugs Filled at Pharmacies by Payer," a 2019 report by the Kaiser Family Foundation, includes data on the amount of retail sales for prescription drugs made in each state by dollar amount, along with the method of coverage, including commercial, Medicare, Medicaid and cash payment.

Redlining And Opioid Overdose Outcomes: Do Historical Housing Policies Still Impact Health Today?, Sahana Paravantavida

Honors Theses

This study examines the relationship between historical housing policies and current health outcomes, specifically the impact of redlining on opioid overdose rates. Using data collected from the state of New Jersey, neighborhoods with a history of redlining have higher rates of opioid overdose deaths. My findings suggest that historical housing policies, which systematically excluded certain populations from accessing affordable housing and resources, continue to impact health outcomes today.

Interrogating Race And Place-Based Inequities In Hiv And Covid-19, Rohan Khazanchi

MD Honors Theses

Over the last four years, I have developed a research focus examining the intersections of race, place, and health. My M.D. Honors Thesis reflects a snapshot of these efforts. In this collection of brief research reports, I leverage area-based measures to investigate structural inequities in three contexts: the HIV epidemic in our hyperlocal community, the early stages of the COVID-19 pandemic, and clinical trials for novel COVID-19 therapeutics. I apply novel social epidemiologic tools to measure and explore disparate outcomes. And, in reflecting upon my findings, I discuss concrete implications for clinicians, researchers, and policymakers alike.

Chapter 1: Neighborhood-Level Deprivation …

Sources Of Patient Information For Type 2 Diabetes Self-Care In Northern Mississippi, Minh-Sang La

Honors Theses

Given the prevalence of Type 2 Diabetes Mellitus in the United States and the continuous rise of cases, especially within Mississippi, there is an increasing need to identify if, and how, patients with Type 2 Diabetes receive information about self-care. While there is data available on the topic of where patients receive their information and the influence it has on their health in other countries of the world, the research on the source of Type 2 Diabetes education in the United States is scarce. Therefore, this study aims to bridge the gap of understanding where patients with Type 2 Diabetes …

Pharmacists Provision Of Non-Dispensing Services In Health Professional Shortage Areas, Haley L. Kessinger, Emily R. Landis

ONU Student Research Colloquium

Background: Individuals living in primary care health professional shortage areas (PCHPSAs) experience health inequities. Community pharmacists are healthcare professionals with an opportunity to provide care to underserved populations. The objective of this study was to compare non-dispensing services provided by Ohio community pharmacists in PCHPSAs and non-PCHSPAs.

Methods: An electronic, IRB-approved 19-item survey was sent to all community pharmacists practicing in full PCHPSA counties and a random sample practicing in non-PCHPSA counties in Ohio (n=324). Questions assessed current provision of non-dispensing services as well as interest and barriers regarding such services.

Results: Seventy-three usable responses were received (23% response rate). …

Interrogating Race And Place-Based Inequities In Hiv And Covid-19, Rohan Khazanchi

EMET Projects

Over the last four years, I have developed a research focus examining the intersections of race, place, and health. My M.D. Honors Thesis reflects a snapshot of these efforts. In this collection of brief research reports, I leverage area-based measures to investigate structural inequities in three contexts: the HIV epidemic in our hyperlocal community, the early stages of the COVID-19 pandemic, and clinical trials for novel COVID-19 therapeutics. I apply novel social epidemiologic tools to measure and explore disparate outcomes. And, in reflecting upon my findings, I discuss concrete implications for clinicians, researchers, and policymakers alike.

Chapter 1: Neighborhood-Level Deprivation …

Analysis Of Step Therapy Reform On Floridians With Autoimmune Conditions, John M. Kirkley Iii, Eren Tatari

Florida Public Health Review

Background: Step therapy is a cost-saving measure employed by insurance companies to reduce rising drug costs; however, studies have indicated this policy has neutral or – in some cases – negative effects on patients. Specifically for indivdiuals with autoimmune diseases, the delay of proper treatment, increased risk of negative, irreversible side effects, and an underdeveloped preferred drug lists harm autoimmune patients because of the disconnect between the heterogeneity of autoimmune disease and the one-size-fits-all approach of step therapy. Objective: To determine the most effective policy for dealing with the harms of step therapy as they currently affect Floridians. Methods: Five …

Lessons Learned From The Hiv/Aids Pandemic And Access To Medicines For Covid-19 Treatment, Thalia Le

Independent Study Project (ISP) Collection

There is an imminent need to address the healthcare disparities in accessing all COVID-19 medicinal products in developing countries. While logistical issues like inadequate production facilities such as the lack of vaccines administration capacity, storage issues, gap between supply and demand as well as vaccine hesitancy can certainly play a part in impeding COVID19 medicines distribution, patent monopolies and intellectual property protection laws further exacerbated the problem, especially when vaccines were at its early stages of authorization. Historical and contemporary case studies of efforts to challenge patents on HIV AVRs treatment provide a useful lens through which we may glean …

Measuring Routine Childhood Vaccination Coverage In 204 Countries And Territories, 1980–2019: A Systematic Analysis For The Global Burden Of Disease Study 2020, Release 1, Natalie C. Galles, Patrick Y. Liu, Rachel I. Updike, Stephen S. Lim, Jonathan F. Mosser, Asma Tahir Awan, Gbd 2020, Release 1, Vaccine Coverage Collaborators

Environmental & Global Health Faculty Research

Background: Measuring routine childhood vaccination is crucial to inform global vaccine policies and programme implementation, and to track progress towards targets set by the Global Vaccine Action Plan (GVAP) and Immunization Agenda 2030. Robust estimates of routine vaccine coverage are needed to identify past successes and persistent vulnerabilities. Drawing from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2020, Release 1, we did a systematic analysis of global, regional, and national vaccine coverage trends using a statistical framework, by vaccine and over time. Methods: For this analysis we collated 55 326 country-specific, cohort-specific, year-specific, vaccine-specific, and dose-specific …

Racial And Ethnic Disparities In Opioid Use For Adolescents At Us Emergency Departments, Michael T. Phan, Daniel M. Tomaszewski, Cody Arbuckle, Sun Yang, Candice D. Donaldson, Michelle A. Fortier, Brooke Jenkins, Erik Linstead, Zeev N. Kain

Pharmacy Faculty Articles and Research

Background

Racial/ethnic disparities in the use of opioids to treat pain disorders have been previously reported in the emergency department (ED). Further research is needed to better evaluate the impact race/ethnicity may have on the use of opioids in adolescents for the management of pain disorders in the ED.

Methods

This was a cross-sectional study using data from the National Hospital Ambulatory Medical Care Survey from 2006 to 2016. Multivariate models were used to evaluate the role of race/ethnicity in the receipt of opioid agonists while in the ED. All ED visits with patients aged 11–21 years old were analyzed. …

Measuring Food Consumption Within A Foodrx Program, Katie Howell

Honors Theses

This pilot study set out to assess food consumption measures within the Charleston FoodRx program. Assessments made through this investigation aim to improve the Charleston program as well as provide suggestions for future programs. Charleston FoodRx provides enrolled households with fruits and vegetables in a supply intended to last for two weeks. These goals combine social and pharmaceutical science, by addressing barriers in food environment and insecurity, nutritional health, and preventative treatment. Though the idea behind FoodRx has existed prior to recent pilot programs, research behind FoodRx and its possible integration within the healthcare system lack published and replicable research …

Effect Of Free Trade Agreements On Pharmaceutical Market Competition: The Case Of The 2009 Us-Peru Free Trade Agreement And Its Implementation As National Drug Policy, Lita Araujo, Enrique Seoane-Vazquez, Michael Montagne

Pharmacy Faculty Articles and Research

Free Trade Agreements (FTA) are controversial for threatening essential aspects of health, especially access to affordable medicines. The US-Peru FTA required changes in the Peruvian pharmaceutical legislation that resulted in the implementation of the National Drug Policy (NDP) of 2009. The NDP included more robust technical requirements for registration, a Peruvian Good Manufacturing Practices certificate, a longer timeline for drug registration, and an increase in registration fees. This study evaluated the impact of the FTA on the number of registrations and competition in the Peruvian pharmaceutical market.

Data for the period January 2005 to April 2014 were provided by the …

Emergent Trends In The Chinese Counterfeit Pharmaceutical Supply Chain And Opportunities For Public-Private Reform, Mary Monk

Senior Theses

This research seeks to identify and analyze emerging trends in the Chinese counterfeit pharmaceutical trade, extending from the supply chain’s point of origin to domestic and overseas retail dispensary. To aid readability, Chapter 1 of this thesis opens with key conclusions and policy recommendations for various Chinese and U.S. stakeholders based on the shortcomings identified in Chapter 5. Chapter 2 begins with a review of international roadblocks to diagnosing the issue, such as lack of consensus on working definitions and cross-border discrepancies in pharmaceutical oversight regulation. This section also provides a general overview of existing factors driving demand for counterfeit …