Pharmacy Administration, Policy and Regulation Commons^™

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 …

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. …

Ozempic (Semaglutide) Versus Nonpharmacologic Interventions For Weight Management In Overweight Individuals, Elena N. Jacey, Lily Jennings, Callie Gillmore, Emily Kane, Emma Digirolamo

Non-Thesis Student Work

Ozempic (semaglutide) is a medication prescribed for individuals managing Type 2 Diabetes Mellitus by mimicking the action of a hormone called GLP-1, helping to regulate glucose levels by stimulating insulin secretion and reducing glucagon secretion. Many patients with Type 2 Diabetes Mellitus rely on Ozempic (semaglutide) as a weight loss aid as opposed to implementing healthy lifestyle changes. This information proposes the question: in overweight individuals taking Ozempic (semaglutide), a medication prescribed for those with Type 2 Diabetes Mellitus, for the management of weight loss, does the use of Ozempic (semaglutide) compared to non-pharmacologic weight loss strategies exaggerate the occurrence …

Geospatial Distribution Of Pharmacist Diabetes Management Within A Patient Centered Medical Home Model In Omaha, Nebraska, Anthony Donovan

Capstone Experience

Patients with uncontrolled diabetes, defined as a hemoglobin A1c value greater than 9%, are at an increased risk of diabetes progression. Primary care is often the first point of contact where patients with uncontrolled diabetes are identified and treated. Pharmacists are utilized in diabetes medication management of patients with uncontrolled diabetes as one component of primary care multidisciplinary models of care. This descriptive project describes the geospatial distribution of patients with uncontrolled diabetes from a single institution in the Omaha, Nebraska area who were exposed to pharmacists within a Patient Centered Medical Home (PCMH) model of care compared to those …

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 …

The Role Of Community Pharmacists In The Provision Of Medication For Opioid Use Disorder Treatment In Rio Grande Valley, Tamara Al Rawwad, Ammar Kawaleet, Lydia Aguilera, Adrian Sandoval

Research Symposium

Background: The misuse of opioids, including prescription opioids, heroin, and fentanyl, has reached epidemic proportions in the US, resulting in more than 68,000 overdose deaths in 2020, and a total of $78.5 billion a year of economic burden. In response to this crisis, the US Department of Health and Human Services (DHHS) released a strategic plan to combat opioid abuse and misuse, recommending a multidisciplinary approach, including the inclusion of pharmacists in the efforts. The aim of this study is to examine pharmacists’ perception of their role in the provision of medication for opioid use disorders (MOUD) in addition to …

Artificial Intelligence Is Revolutionizing Controlled Substance Diversion Detection, Brian Cox, Alberto Coustasse, Craig Kimble

Management Faculty Research

In community and institutional health care sectors, artificial intelligence (AI) use is expanding. AI is being tapped broadly in operations, customer service, and scheduling, with major pharmacy chains such as Kroger, CVS, and Walgreens, already starting to implement AI applications in their pharmacies. So far, Kroger has begun to use AI for employee onboarding and training processes, CVS is applying AI in negotiations with suppliers, and Walgreens is using it to streamline vaccine scheduling. With these advances in major pharmacy chains, the next extensive application for AI has become clearer: diversion monitoring. Diversion occurs in health care settings when a …

Spending On Phased Clinical Development Of Approved Drugs By The Us National Institutes Of Health Compared With Industry, Edward W. Zhou, Matthew J. Jackson, Fred D. Ledley

Natural & Applied Sciences Faculty Publications

The launch of the Advanced Research Projects Agency for Health to advance new cures and address public concern regarding drug prices has raised questions about the roles of government and industry in drug development.

This cross-sectional study examined NIH funding for published research reporting the results of phased clinical trials of drugs approved between 2010 and 2019 and compared the findings with reported industry spending estimates. Data analysis was performed between May 2021 and August 2022 using PubMed data from January 1999 through October 2021 and NIH Research Portfolio Online Reporting Tools Expenditures and Results data from January 1999 through …

Navigating The Path To Safe Compounding In Health Systems, Thomas Pile, Craig Kimble, Alberto Coustasse

Management Faculty Research

Across the country health systems are facing increasing drug shortages that are forcing pharmacists to rely far more heavily on compounding to meet the needs of patients. Additionally, several high-profile compounding incidents have helped highlight the importance of ensuring best practices are followed during sterile and nonsterile compounding to support patient safety and high-quality care. Specifically, in 2022, 160 drug shortages were reported in pharmacies. From January 1, 2023, to March 31, 2023, 47 drug shortages were reported, 55% of which were for injectables. In response, compounding has increasingly become a solution to bridge that gap.

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 …

Mitigating Risks To Improve Hypertension Medication Adherence In A Medically Vulnerable Population, Donna Hales-Teat

Doctor of Nursing Practice Projects

This project assessed the effect of an evidence-based medication adherence intervention on adherence rates at a Northern Indiana clinic led by a sole nurse practitioner, receptionist, and continuous rotation of graduate nursing students from several nursing programs in the Northern Indiana area. Patient education and comprehension were poor in terms of understanding disease process, treatment options, and disease management that led to poor communication with the medical provider. The process and steps in which patients matriculate through was described by Johnson’s (2002) Medication Adherence Model (MAM) with concepts of purposeful action, pattern behavior, and feedback; these helped to construct, steer, …

President’S Address: Dr. Vince Benivegna, Vince Benivegna Dds

The Journal of the Michigan Dental Association

Dr. Vince Benivegna, the outgoing President of the Michigan Dental Association, addressed the House of Delegates, emphasizing the significant progress in enhancing Adult Dental Medicaid coverage and reimbursement in Michigan. He thanked the dedicated individuals who supported him during his tenure and shared his journey. Dr. Benivegna lauded Michigan's accomplishments in reducing opioid prescribing and highlighted the MDA's role as a model state society in advocacy, leadership, mentorship, continuing education, diversity, equity, and inclusion. He praised Michigan's achievements in improving Adult Dental Medicaid, encouraging Michigan dentists to participate and help address oral health disparities. Dr. Benivegna underscored how this aligns …

Dentistry And The Law: Accessing/Disclosing Prescription Information On Software Platforms, Dan Schulte Jd

The Journal of the Michigan Dental Association

This article discusses the access and disclosure of prescription information on software platforms like eScribe and MAPS. It highlights that HIPAA regulations govern such access, and as long as the information is obtained through business associate agreements and used for treatment purposes, specific patient consent may not be necessary. The article also mentions that the Michigan Automated Prescription System (MAPS) allows prescribers to access controlled substance prescription information without requiring patient consent.

Scoping Review Of The Best Practices In Drug Courts In The United States, Elise Crumrine, Blakely Camille Culp

Honors Theses

Purpose: Drug courts are reform programs that are utilized in America to reduce the amount of incarcerations due to non violent drug charges. A successful drug court has a high number of graduates and low recidivism rates. To accomplish this, a variety of methods are utilized such as medication assisted therapy (MAT), random and mandatory drug testing, positive reinforcement in the form of words or tangible items, etc. The purpose of our study was to identify the best practices of drug courts, as defined as increased graduation rates and decreased recidivism, so that the findings may be applied in the …

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, …

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, …

The Great Transition: A Qualitative Examination Of The Transition From Pharmacy Student To Pharmacist, Jessica Marlee Wilson

Honors Theses

Background: Over the years, community pharmacy practice has expanded and increased the number of responsibilities pharmacists must manage. Tasks such as managing the pharmacy, counseling patients, and administering vaccines are among the duties that pharmacists must carry out. The recent Covid-19 pandemic placed a significant strain on the retail pharmacy work environment and acted as an obstacle to the jobs of community pharmacists. Recent pharmacy graduates are often thrown into this variable work environment, and it seems that there is limited literature regarding the preparedness that they feel in this area of pharmacy work.

Objectives: To uncover the level of …

Medical Cannabis In Mississippi: Practitioner Education And Continuing Research, Andrea Cleveland

Honors Theses

Use of medical cannabis in Mississippi was legalized in February 2022 following many years of cannabis research at the University of Mississippi. Issues immediately became apparent, beginning with the lack of education about medical cannabis among providers. A 2017 study showed that the majority of physicians are not exposed to information about medical cannabis despite its legalization in 37 states. Another issue with Mississippi’s medical cannabis program is the cost of the product itself. The most effective way to decrease spending on medication is for patients to have access to medication that is guaranteed to work. Further research on cannabis …

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 …

The Association Of Long Working Hours And The Use Of Prescription Sedatives Among U.S. Workers., Emmanuel Ezekekwu

Electronic Theses and Dissertations

BACKGROUND: Meeting the needs of a round-the-clock and globalized society has led to an increase in long working hours. This trend has been accompanied by a corresponding rise in sleep disorders and subsequent use of sedating medications. Overtime hours have been associated with adverse health outcomes such as cardiovascular diseases, symptoms of psychological distress, and health behaviors, including risky intake of alcohol and smoking. Hence, the main objectives of this three-paper dissertation were to examine the multi-faceted relationship between working hours, the use of prescription sleep aids, the onset of psychological distress, and the use of health care services. METHODS: …

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 …

Pharmacists’ Perceptions And Knowledge Of The Legalization Of Medical Marijuana In Mississippi, Faith Houston

Honors Theses

The legalization of medical cannabis in Mississippi was a debated topic among all citizens. This thesis specifically explored pharmacists’ perceptions and knowledge as medical professionals who will be involved with patients certified to use medical cannabis. Information was gathered using a voluntary online survey on the Qualtrics platform to produce a cross-sectional, descriptive study.

From the information gathered, it was apparent that pharmacists in Mississippi have varying opinions regarding medical marijuana. Some are in favor of using these products, and some are not. However, as cannabis has been officially accepted and put into patient's medical plans both current and future …

Closed-System Transfer Devices Reduce Exposure To Contaminants, Ken Maxik, Craig Kimble, Alberto Coustasse

Management Faculty Research

Closed-system transfer devices (CSTDs) are used during the preparation of hazardous drugs (HDs) as a mechanism to reduce the transfer of drugs or vapors into the environment. When evaluating these systems, pharmacists should consider which drugs in the pharmacy would benefit the safety of health care workers and patients using the systems. Medication types include neoplastic agents, such as bleomycin, cisplatin, and methotrexate, and other agents, such as cyclosporine, oxytocin, and progesterone.