Pharmacy Administration, Policy and Regulation Commons^™

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

Honors Theses

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

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 …

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 …

Best Practice Proposal To Enhance Application Of The Standardized Antimicrobial Administration Ratio (Saar), Jill Butterfield-Cowper

HCA Healthcare Journal of Medicine

A core element of hospital antibiotic stewardship programs is the tracking of outcomes. It is recommended that hospitals do this by reporting to the National Healthcare Safety Network (NHSN) Antimicrobial Use (AU) Option. With this, hospitals can access the Standardized Antimicrobial Administration Ratio (SAAR) for various antibiotic groupings and locations. While there are benefits to the SAAR, several limitations reduce the interpretation and utility of SAAR values. In particular, the SAAR cannot inform users of antimicrobial appropriateness. This article describes an antimicrobial days of therapy (DOT) report that was developed by a tele-stewardship infectious diseases pharmacist. This article proposes that …

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 …

Utah Pharmacists’ Qualitative Feedback Regarding Licensure Standards., Rebecca Howard

Annual Research Symposium

This project sought to understand current attitudes and perceptions of licensed pharmacists in the state of Utah to the existing occupational licensing standards which govern our profession. Qualitative feedback was gathered from Utah licensed pharmacists for a period of one month.

Pharmacy Law: Pharmacists Awareness Of Licensure Regulations, The Mpje And Nabp - A State-Wide Study, Andrew Holick

Annual Research Symposium

No abstract provided.

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 …

Tech Note 2023-1 Nih Contribution To Phased Clinical Development Of Drugs Approved From 2010-2019, Edward Zhou, Matthew Jackson, Fred Ledley

CISI Publication

This report describes the methods and preliminary results for the manuscript titled, “NIH contribution to phased clinical development of drugs approved from 2010-2019”.

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.

Striving For Appropriate Antibiotic Use: A Biomarker Initiative, And Outcomes Associated With Azithromycin Exposure, Amanda Gusovsky

Theses and Dissertations--Pharmacy

The introduction of antibiotics into clinical practice is considered the greatest medical breakthrough of the 20^thcentury. However, the use of antibiotics can contribute to the development of resistance. In the United States (U.S.), approximately 2.8 million people are infected with antibiotic-resistant bacteria each year, and more than 35,000 people die as a result. Moreover, some antibiotics are known to cause cardiac side effects including QT prolongation, hypotension, and ventricular arrythmias. The U.S. Centers for Disease Control and Prevention (CDC) defines appropriate antibiotic use as the effort to use “the right antibiotic, at the right dose, for the right …

Takeda Pharmaceutical Rare Hematology Strategic Audit, Brian Duval

Honors Theses, University of Nebraska-Lincoln

Takeda Pharmaceutical Company is a large Japanese-based multinational pharmaceutical company that manufactures treatments for many different diseases. It is the largest pharmaceutical company in Asia and has a significant share in markets across the world. This report focuses specifically on Takeda’s treatments for rare bleeding disorders under its Rare Diseases & Hematology division. Using internal and external analysis tools, this report seeks to understand how Takeda has created and sustained competitive advantages in the complex environment of the pharmaceutical industry. Specific tools used to highlight this include Porter’s Five Forces and PESTEL analyses. This report also examines the environment surrounding …

Gabapentin Presents High Potential For Misuse, Alberto Coustasse, Stacie Deslich, Susan W. Lanham, Brittany Riley

Management Faculty Research

The FDA Approved Gabapentin in 1993 as a non-controlled substance and it has remained a non-controlled substance at the federal level. The drug was created as an anticonvulsant and used to treat seizure disorders. The medication has also been used to treat hot flashes, neuropathic pain, pain, postoperative nausea, substance abuse issues, and vomiting. It is estimated that approximately 1% of people in the United States misuse gabapentin. This fact has compelled certain states to generate legislative initiatives designed to monitor the use and/or reclassify gabapentin. In 2019, US pharmacies dispensed 69 million prescriptions for gabapentin.

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.

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 …

Analyzing Factors Impacting Time To Full Approval Of Innovative Drugs Via An Accelerated Approval Pathway In The United States, Eleanor Panico

Seton Hall University Dissertations and Theses (ETDs)

Background and purpose of study: Pharmaceutical drugs are commonly used to treat various ailments and the pharmaceutical industry is increasingly leveraging expedited pathways to market, like the FDA’s accelerated approval pathway. Thus, these pathways are becoming more prevalent and thus more scrutinized for reliability. A consequence from this increased utilization is observed variability in time to reach full approval from the point accelerated approval was received. Variables that may impact time and ability to reach full approval should be further investigated. The purpose of this study was to explore, identify and predict variables that may influence time from accelerated approval …

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 …