Pharmacy Administration, Policy and Regulation Commons^™

Fda Approval Of Zuranolone: A Breakthrough Treatment For Postpartum Depression, Connor Dains, Makayla Eversole, Kiley Devoll, Daniella Egbujor, Marisa Petrunich, Madilyn Paphanchith, Joshua Honaker, Samantha Mccord, Manoranjan D'Souza

Pharmacy and Wellness Review

Postpartum depression (PPD) is a serious medical condition that increases the risk of postpartum mortality and affects the ability of a postpartum individual to take care of their newborn. Until 2023, intravenously-administered brexanolone was the only Food and Drug Administration (FDA)-approved medication for PPD. Brexanolone’s route of administration poses significant barriers to accessibility and convenience. Other treatment options, such as psychotherapy and antidepressants, often require long-term commitment and may not provide rapid relief for severe symptoms. In August 2023, the FDA approved zuranolone as an oral medication for PPD, which enhances treatment accessibility and offers patients a more flexible, outpatient …

The Revised Cdc Chronic Pain Guidelines And Payer Opioid Analgesic Policies In Michigan, Victoria Tutag Lehr, Cynthia L. Arfken

Michigan Journal of Public Health

Abstract

The 2016 publication of A Guideline for Prescribing Opioids for Chronic Pain by the Centers for Disease Control and Prevention motivated commercial and Medicaid payers to restrict their opioid prescribing policies including the imposition of hard limits on opioid daily dosages and duration. One result of these policies was an increase in abrupt opioid discontinuation and rapid tapering events for patients receiving long-term opioid therapy. Responding to this misapplication of the 2016 guideline, the 2022 revised guidelines emphasized individualized opioid therapy and exclusion of certain chronic diseases. However, it is not known if the payers changed their policies to …

Payment Disrupters And Opportunities: Key Trends That Impacted Pharmacy In 2024, Craig Kimble, Thomas Pile, Alberto Coustasse

Management Faculty Research

In 2023, the United States experienced the most significant increase in prescription drug spending (13.6%), totaling $89 billion.1 This was driven by higher utilization and the introduction of new, expensive specialty and biotech drugs. In 2024, other factors continue to drive costs and disrupt the pharmacy landscape, including the implementation of new business models, pharmacy benefit manager (PBM) practices, the rebate system, regulatory changes, advancements in provider status, and potential Federal Trade Commission (FTC) interventions.

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 …

The Danger Online Pharmacies Pose On Clients With Eating Disorders In The Prescription Of Glp-1 Agonists For Weight Loss, Madyson R. Frisbie

Selected Honors Theses

This literature review explores the prevalence of utilizing online pharmacies to obtain glucagon-like peptide 1 agonist, Semaglutide, for cosmetic weight loss and the danger that route of obtaining medication places on clients with eating disorders such as anorexia nervosa and bulimia nervosa. In addition, research was conducted to establish practice recommendations to eliminate the possibility of a client with an eating disorder from obtaining a GLP-1 agonist when it is inappropriate for their health status. Various articles were used to gain information about the drug in general, its mechanism of action, indications, positive outcomes, and adverse effects. Additional articles were …

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 …

Comments Re: Draft Nih Intramural Research Program Policy: Promoting Equity Through Access Planning, Fred Ledley M.D., Edward Zhou Pharmd., Paula Chaves Da Silva Ph.D.

CISI Publication

We commend the NIH initiative to require that licensees of technologies that enable discovery or development of FDA-approved products arising from the NIH intramural program to include an Access Plan to promote “product affordability, availability, acceptability, and sustainability” and recognition that such protections are essential to ensuring a “return on taxpayers' investment in biomedical research.” Recognizing the complexity of anticipating appropriate terms for products that are in pre-clinical or early clinical development at the time of licensing, we also support the proposal that the Access Plan be submitted in late-stage clinical development, though we argue that …

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 …

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 …

Tech Note 2024-1 A Novel Framework To Estimate Social And Private Value Created Through Commercialization Of A Pharmaceutical Product, Paula Chaves De Silva, Fred D. Ledley

CISI Publication

This framework posits that the value created by a new medicine is embodied in the total health value (health benefit) provided to those using the products. This value is then distributed between social value and private value by the price paid for the product and how these revenues are expensed for different purposes. In this framework, the social value created includes the residual health value (net price paid) along with the scientific value, jobs creation, and social payments to public sector organizations. The private value created includes shareholder value (change in market capitalization plus cash distributions to shareholders) as well …

Kratom Safety And Toxicology In The Public Health Context: Research Needs To Better Inform Regulation, Jack E. Henningfield, Oliver Grundmann, Marilyn A. Huestis, Kirsten E. Smith

Institute of Emerging Health Professions Faculty Papers

Although kratom use has been part of life for centuries in Southeast Asia, the availability and use of kratom in the United States (US) increased substantially since the early 2000s when there was little information on kratom pharmacology, use patterns, and effects, all critical to guiding regulation and policy. Here we provide a synthesis of research with several hundred English-language papers published in the past 5 years drawing from basic research, epidemiological and surveillance data, and recent clinical research. This review of available literature aims to provide an integrated update regarding our current understanding of kratom's benefits, risks, pharmacology, and …

Improving Prolonged Antibiotics Education In A Pediatric Unit, Zerena S. Silva Villamonte

Master's Projects and Capstones

Problem Children’s Hospital A's incidence report tool, iCares, demonstrates that 50% of the issues related to prolonged intravenous (IV) antibiotics are categorized as administration issues. This leads to the medication being delivered at the wrong time or rate. Having these issues increases patient length of stay, increasing hospital costs. Context The microsystems for this quality improvement project include inpatient pediatric patient care units (PCU) 300, 360, and 400. Children’s Hospital A is a 361-bed San Francisco Bay Area hospital. Interventions The Clinical Nurse Leader students implemented a presentation defining prolonged IV antibiotics, their rationale, and a video demonstrating the correct …

Pour Une Diffusion Éthique Des Connaissances De La Médecine Traditionnelle: L’Intersection De La Culture Yoruba Et Des Besoins Médicaux, Isabel Sala

CISLA Senior Integrative Projects

No abstract provided.

Opioid Prescription Rates Before And After Alto Program And Various Factors Affecting Emergency Department Opioid Prescription Rates, Neel B. Patel, James F. Baird

Rowan-Virtua Research Day

Opioid prescription rates vary between patient population, diagnosis, location, and emergency department characteristics. High prescription rates offer an avenue for potential opioid addiction and overdoses. Alternatives to opioids (ALTO) is a new program already implemented in certain emergency departments to help change opioid prescription rates by introducing new protocols for first line treatments for pain management. With current trends still showing that South Jersey opioids prescription rates are the highest in the state of New Jersey, ALTO was introduced at Inspira Health Network located in South Jersey. This study retrospectively analyzed opioids prescription rates for abdominal pain, renal colic, migraines, …

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 …

Factors Predictive Of Postgraduate Residency Placement: A Systematic Review, Hazel Billings-Chiu

Honors Scholar Theses

This systematic review aimed to identify pharmacy student and school characteristics that are associated with higher postgraduate residency placement. Studies had to be an observational or experimental investigation, analyze pharmacy students and/or pharmacy schools, and report the statistical association, correlation, MV regression, propensity score analysis or matched analysis between a student or school variable with match success. Only studies that utilized multivariate analyses were included. The NewsCastle-Ottawa Quality Assessment Form for Cohort studies was used to assess risk of bias in the included studies. Student and school-level factors were then collected and synthesized via full text review. In total, there …

Barriers And Facilitators Of Pharmacists’ Roles During The Pandemic In Malaysia, Thanushiri Palani Velu, Farida Islahudin, Wei Wen Chong

Makara Journal of Health Research

Background: The coronavirus disease 2019 (COVID-19) left a devastating impact on healthcare systems worldwide. The crisis initially emerged as a supply disruption issue but eventually evolved into a myriad of additional challenges, which were attributed mainly to the extensive scale of the pandemic. This study aimed to explore the barriers to the role of hospital pharmacists and related facilitators encountered during the COVID-19 pandemic.

Methods: Pharmacists in Malaysia participated in a cross-sectional online questionnaire-based survey. The participants were recruited using convenient sampling. Cronbach alpha of the questionnaire was analyzed.

Results: The study successfully enrolled 367 pharmacists. The …

Beyond Mitragynine: Composition Survey And Stability Assessment Of Kratom Tea Ordered Via Food Delivery Platforms In Bangkok, Thailand, Yuta Tokuda, Apinya Tubtimrattana, Nat Tansrisawad, Kornvalee Meesilpavikkai, Parath Thirati

Chulalongkorn Medical Journal

Background: Kratom is a native tree to Southeast Asia. Kratom leaves have long been used medicinally and recreationally due to their stimulative and opioid-like effects attributed to high endogenous levels of mitragynine and related alkaloids. Kratom is widely consumed as tea and is now publicly sold, including on food delivery platforms, after recent decriminalization despite selling of kratom products being still considered illegal by other acts.

Objectives: To assess the formulas of kratom teas sold on Thai food delivery platform together with their consistency and the stability of refrigerated teas.

Methods: Kratom alkaloids, mitragynine and 7-hydroxymitragynine, and additive contents of …

Association Between Expedited Review Designations And The Us Or Global Burden Of Disease For Drugs Approved By The Us Food And Drug Administration, 2010–2019: A Cross-Sectional Analysis, Matthew J. Jackson, Gregory Vaughan, Fred D. Ledley

Natural & Applied Sciences Faculty Publications

Pharmaceutical innovation can contribute to reducing the burden of disease in human populations. This research asks whether products approved by the US Food and Drug Administration (FDA) from 2010 to 2019 and expedited review programmes incentivising development of products for serious disease were aligned with the US or global burden of disease.

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

Natural & Applied Sciences Faculty Publications

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

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

Annual Research Symposium

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

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

Annual Research Symposium

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

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

Pharmacy Faculty Articles and Research

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

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

Electronic Theses and Dissertations

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

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

Soaring: A Journal of Undergraduate Research

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

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

Gaines Fellow Senior Theses

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

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

UF Law Faculty Publications

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