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.

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, …

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 …

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.

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). …

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 …

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 …

Opioid Use Disorder: The Timeline For Medication Assisted Therapy, Alexander Cristofori

Capstone Showcase

Opioid Use Disorder is patterns of opioid use leading to withdrawal, giving up important life events in order to use opioids, and excessive time spent using opioids, to name a few diagnostic criteria. The clinical progression of the disorder involves periods of acute exacerbation and remission that are cyclic in nature. Treatment is most effective when it includes both pharmacological and psychosocial modalities, referred to as medication assisted therapy (MAT). Three drugs used commonly in MAT-based treatment for OUD from oldest to newest include Methadone, Buprenorphine-naloxone, and Naltrexone. Treatment program models that prioritize total abstinence from the addictive substance attached …

The Use Of Urine Drug Testing For Risk Stratification And Efficacious Drug Monitoring In Pain Management Settings, Ahmad I. Hasan, Kareem Elhage, Brendan Farley, Khaled J. Saleh

Medical Student Research Symposium

Objective: To understand the current landscape of urine drug testing (UDT) guidelines as part of risk assessment for opioid abuse, and to offer recommendations towards adopting universal screening guidelines.

Background: There has been an opioid epidemic within the United States, and the role of prescription opioids has been well established. Despite proposed recommendations, there has yet to be a published universal screening guideline on the use of UDT in the setting of opioid abuse risk stratification as well as postoperative drug monitoring.

Methods: We explored current guidelines for UDT on two levels. First, we explore general indications for UDT within …

Pharmacist-Prescribed Birth Control: A Policy Analysis, Brianna Full

UNO Student Research and Creative Activity Fair

Although unintended pregnancy in the United States has steadily decreased from 2008, rates are still unacceptably high as almost half (42%) of all pregnancies are not wanted or timed correctly (Finer & Zolna). In 2011, 2.8 million of the 6.1 million pregnancies in the United States each year were unintended. Public health professionals are worried about unintended pregnancy because research shows that unwanted or mistimed pregnancies come with associations to adverse maternal and child health outcomes, such as delayed prenatal care, premature birth, and negative physical and mental health effects for children (Frost, Frohwirth & Zolna, 2016). Also, two-thirds (68%) …

Opioids In The Las Vegas Metro, Elia Del Carmen Solano-Patricio, Caitlin Saladino, William E. Brown

Health

In 2014, Nevada was one of 7 states selected to participate in a national policy coalition to reduce prescription drug abuse. As a result, the Nevada Department of Health and Human Services (DHHS) and the Southern Nevada Health District (SNHD) created a data dashboard to track opioid prescriptions and opioid-involved overdose incidents. This Fact Sheet synthesizes state-level data from the Nevada Opioid Overdose Surveillance Dashboard and focuses on the Las Vegas Metropolitan Statistical Area (MSA). The data track opioid prescription rates as they correlate to opioid-involved overdose deaths, emergency room visits, and hospitalizations.

Opioids In Nevada, Peter Grema, Caitlin Saladino, William E. Brown

Health

This Fact Sheet presents data from the Washington Post’s Drug Enforcement Administration (DEA) database on opioid shipments in the United States and provides information pertaining to Nevada and each of its 17 regions (16 counties and one independent city). This Fact Sheet compares the Washington Post’s opioid shipment data with opioid prescription rates relative to Nevada’s population in 2010.

United States Medicaid And Pharmacy Fraud: An Unintended Consequence Of The Affordable Care Act, Sean Mcdaniel, Drew Blakely

Theses, Dissertations and Capstones

Introduction: The Affordable Care Act (ACA) increased access to health insurance throughout the United States. To date, an estimated 20 million previously uninsured individuals have gained access to coverage since the expansion. As a result, the number of fraudulent schemes reported has been on the rise. Among the many fraudulent activities in the healthcare sector, abuse of pharmacy benefits has been the most prevalent. The misuse and abuse of opioids, and opioid related overdoses has created a widespread epidemic throughout the country, thus extending opportunities for potential fraud within the pharmaceutical industry.

Purpose of the Study: The purpose …

Reflections On The Effects Of Federalism On Opioid Policy, Matthew B. Lawrence

Faculty Articles

One thing we have seen today that we talk about in health law all the time is how the policy, the laws and institutions up at the 10,000 foot level, can so dramatically influence the personal, people’s lived experiences. Our speakers today have done a really great job of drawing out abstract institutional questions and also showing us how those questions have influenced the lives of real people in often tragic ways. Another thing we have seen that we talk about in administrative law all the time is the importance of expertise, especially given how hard it is to trace …

Combatting The Opioid Epidemic In Texas By Holding Big Pharma Manufacturers Liable, Katherine Spiser

St. Mary's Law Journal

Abstract forthcoming

Rethinking Consumer Protection: Escaping Death By Regulation, Thomas L. Tacker

Publications

This book is designed to appeal to anyone who is at all interested in topics related to making life better and safer—for all us consumers. Our current approach to consumer protection is extremely flawed; sometimes costing lives rather than saving them. There are better ways to protect ourselves and the people we love.

Evaluating Ways To Reduce Errors In Medication Reconciliations Performed By Nurses In A Rural Hospital Setting, Kalen T. Freeman

MPA/MPP/MPFM Capstone Projects

Medication reconciliation, also known as “med recs”, are an important part of a patient’s care during their hospitalization. A med rec is when hospital personnel generate a list of the medications the patient takes at home. Med recs are vital in the hospital admission process because home medications need to be restarted at appropriate times to fully care for the patient. Also, mistakes in a home medication list can lead to serious consequences in the patient’s health. This study focuses on med recs being performed at Marcum and Wallace Hospital in Irvine, Kentucky. More specifically, the study explores the different …

Analyzing The Differentiation Among State Medical Marijuana Policies By Examining State Policies & Trends, Richard Furlong

Political Science Theses and Capstones

Support for marijuana has been growing nationwide. This increased support has gained a lot of momentum since the late 1990s when California became the first state to legalize marijuana for medical use by enacting Proposition 215, or the Compassionate Use Act. Since the enactment of Proposition 215, 28 more states and the District of Columbia have legalized marijuana for medicinal use. I look into why states have begun to adopt these laws, and what makes these states differ throughout the country in the timeliness of their actions. I assembled data to examine a variety of state policies to attempt to …

Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim

Faculty Publications By Year

There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval …

Medicaid Managed Care And The Health Care Utilization Of Foster Children, Makayla Palmer, James Marton, Aaron Yelowitz, Jeffery Talbert

Economics Faculty Publications

A recent trend in state Medicaid programs is the transition of vulnerable populations into Medicaid managed care (MMC) who were initially carved out of such coverage, such as foster children or those with disabilities. The purpose of this article is to evaluate the impact of the transition of foster children from fee-for-service Medicaid coverage to MMC coverage on outpatient health care utilization. There is very little empirical evidence on the impact of managed care on the health care utilization of foster children because of the recent timing of these transitions as well as challenges associated with finding data sets large …

Influence Of Pharmaceutical Marketing On Medicare Prescriptions In The District Of Columbia, Susan Wood, Joanna Podrasky, Meghan Mcmonagle, Janani Raveendran, Tyler Bysshe, Alycia Hogenmiller, Adriane Fugh-Berman

Health Policy and Management Faculty Publications

Importance

Gifts from pharmaceutical companies are believed to influence prescribing behavior, but few studies have addressed the association between industry gifts to physicians and drug costs, prescription volume, or preference for generic drugs. Even less research addresses the effect of gifts on the prescribing behavior of nurse practitioners (NPs), physician assistants (PAs), and podiatrists.

Objective

To analyze the association between gifts provided by pharmaceutical companies to individual prescribers in Washington DC and the number of prescriptions, cost of prescriptions, and proportion of branded prescriptions for each prescriber.

Design

Gifts data from the District of Columbia’s (DC) AccessRx program and the …

Pharmaceutical Federalism, Patricia J. Zettler

Faculty Publications By Year

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …

The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler

Faculty Publications By Year

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as …

The International Scientific Association For Probiotics And Prebiotics (Isapp) Consensus Statement On The Definition And Scope Of Prebiotics, Glenn R. Gibson, Robert W. Hutkins, Mary Ellen Sanders, Susan L. Prescott, Raylene A. Reimer, Seppo J. Salminen, Karen Scott, Catherine Stanton, Kelly S. Swanson, Patrice D. Cani, Kristin Verbeke, Gregor Reid

Department of Food Science and Technology: Faculty Publications

In December 2016, a panel of experts in microbiology, nutrition and clinical research was convened by the International Scientific Association for Probiotics and Prebiotics to review the definition and scope of prebiotics. Consistent with the original embodiment of prebiotics, but aware of the latest scientific and clinical developments, the panel updated the definition of a prebiotic: a substrate that is selectively utilized by host microorganisms conferring a health benefit. This definition expands the concept of prebiotics to possibly include non-carbohydrate substances, applications to body sites other than the gastrointestinal tract, and diverse categories other than food. The requirement for selective …

Decreasing Cost Associated Medication Nonadherence, Shawn E. Raymond

Doctor of Nursing Practice Scholarly Project

An Abstract of the Scholarly Project by

Shawn E. Raymond

Medication cost is a major contributor for patient medication nonadherence. Take in the fact that a large population lives in poverty, many cannot afford to pay the retail prices associated with purchasing their medications. By incorporating wholesale medications into a charitable health clinic, the reduced cost of medications for treatment of both acute and chronic illnesses could be passed on to those in need thereby decreasing cost associated medication nonadherence. Nurse Practitioners in the state of Kansas are not afforded the privilege to purchase, repackage and distribute or resell wholesale …

Kentucky Pharmacist Opinions Of The Potential Reclassification Of Pseudophedrine As A Legend Drug, Kathleen E. Monson

MPA/MPP/MPFM Capstone Projects

Methamphetamine is a drug of abuse, which is often produced in clandestine laboratories. Recent efforts to curb methamphetamine abuse are aimed at controlling access to precursors, including pseudoephedrine (PSE), used in illicit methamphetamine production. Currently, access to PSE is controlled in Kentucky by placement behind pharmacy counters, retail quantity limitations and electronic tracking. Recent legislation proposed in Kentucky to change PSE from non-prescription to a legend medication was unsuccessful and highly controversial. The objective of this project is to collect and analyze pharmacists’ opinions on the effectiveness of current precursor controls, proposed legislation to make PSE a legend drug and …