Pharmacy and Pharmaceutical Sciences Commons^™

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 …

Renal Toxicity Warnings And Precautions Of Drugs Marketed In The Us, Mohammad Al Ghamdi

Pharmaceutical Sciences (MS) Theses

INTRODUCTION: The use of drugs can lead to renal adverse effects prompting the need to include warnings and precautions on medication labels. Studies evaluating renal warnings and precautions need to be improved. This study assessed the characteristics of FDA renal toxicity warnings and precautions included in the labels of drugs approved by the FDA and marked in the US. The study also evaluated the potential factors of including a boxed warning on a drug label.

METHODS: We extracted the labels of human prescription drugs with renal toxicity boxed warnings and warnings and precautions from the “FDA Label: Full-Text Search of …

The Impact Of Pharmacy Led Education On The Management Of Heart Failure With Preserved Ejection Fraction In The Primary Care Setting, Laura Kays, Ben Rosati, Trevor Laursen, Maurice N. Tran

Providence Pharmacy PGY2 Program at Providence Medical Group 2023

No abstract provided.

Application Of Informatics Tools To Facilitate The Practice Of Precision Medicine With Genomic Testing And Clinical Data, Michael Sayer

Pharmaceutical Sciences (PhD) Dissertations

The practice of precision medicine considers a variety of sources of information to optimize patient care. Factors such as patient demographics, clinical history, and lab test values have well understood effects on treatment outcomes and influence decision making. However, effective inclusion of biomolecular data such as protein expression and DNA sequencing data within the practice of precision medicine needs continued study. Informatics tools offer solutions to allow these complex data sources to be effectively embraced. Utilization of informatics tools to visualize data pertaining to the gene selection practices of pharmacogenomic (PGx) tests effectively communicated large amounts of information into concise …

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: …

Starch Granule And Crystalline Structures With Relation To Enzyme Digestibility, Ana Isabel Gonzalez Conde

Graduate Theses and Dissertations

Porous starch produced by enzyme hydrolysis has attracted much attention for its adsorption and delivery properties. Porous starch has been successfully prepared from A-type starch, but not from B-type and C-type starches, which is partly attributed to the surface and crystalline structure. The present study aimed to characterize the role of the crystalline structure and the structure-function relationship impacting the susceptibility of starch with different crystalline polymorphs to amylase digestion. The starches were subjected to chemical modification (acid hydrolysis or surface gelatinization), physical modification (heat-moisture treatment, HMT, or high-pressure processing, HPP) or their combinations prior to amylase digestion, and the …

Longitudinal Assessment Of Pharmacy Student Attitudes Towards Mental Illness, Jessica Dillon

Honors Scholar Theses

Background: Mental health stigma in providers is one of the greatest barriers in effective care in psychiatric patients. When patients feel stigma towards them, they have lower levels of self-esteem and lower medication adherence. When training healthcare providers, specifically pharmacists, it is important to assess the effectiveness of training at reducing stigma levels. Previous studies have shown that didactic teaching does not significantly decrease stigma in pharmacy students. However, other studies have shown that students who participated in psychiatric rotations have less stigma surrounding mental health following the rotation. Currently there are no studies that assess the same students’ stigma …

Johnson & Johnson Strategic Audit, Hannah Headley, Lucy Peterkin, Ryan Nyffeler, Joshua Wiemers, Bailey Birkholtz

Honors Program: Senior Projects (Public)

Johnson & Johnson (J&J) is a healthcare company that generates economic value from its three core business segments: Consumer Health, Pharmaceuticals, and Medical Devices. Recent innovations include new pharmaceutical products, remote clinical trials, automated patient recruitment, improved scientific and digital literacy amongst employees, and innovative digitized models for supply chain planning. J&J has a competitive edge in R&D efficiency, with a 4.35 return on research capital ratio. Sociocultural, technological, and economic factors will play a large role in changing the pharmaceutical industry environment, and J&J is well positioned to benefit from sources of growth such as the increase in aging …

An Analysis Of The Prevalence Of Over-The-Counter Painkiller Abuse, Benjamin Yanovich, Benjamin Yanovich

Theses/Capstones/Creative Projects

Pain, aches, fever, and discomfort are a part of the lives of many people. For most people, this pain can be managed using over the counter painkillers. OTC medications have a multibillion-dollar market. In the United States, patients can purchase as much of this medication as they desire to treat their pain. This medication can be easily abused and misused unintentionally. Every year, there are thousands of hospitalizations from misuse of these medications, and several cases of death. When taken incorrectly, these helpful medications can cause detrimental effects such as ulcers, kidney failure, and loss of liver function. The max …

Optimizing Collaboration Among Clinical Pharmacy Specialists And Behavioral Health Providers In The Primary Care Setting To Increase Mental Health Access, Ryan Ferris, Christine Doran, Bonnie Jiron, Dara L. Johnson

Providence Pharmacy PGY2 Program at Providence Medical Group 2023

No abstract provided.

Genetic Mutations Of KCa2.3 And KCa3.1 Channels Affect Ca2+ Sensitivity, Razan Orfali

Pharmaceutical Sciences (PhD) Dissertations

The Ca²⁺-activated potassium channels K_Ca channels are a unique family of potassium channels activated by intracellular calcium. K_Ca channels are critical for maintaining K⁺ homeostasis and modulate several physiological processes, from the firing properties of neurons to the control of the transmitter release. The Ca²⁺ sensitivity of these channels allows intracellular Ca²⁺ to regulate the electrical activity of the cell membrane. Increased Ca²⁺ sensitivity of K_Ca channels caused by gain of function mutations (GOF) in the KCNN genes results in a broad spectrum of human channelopathies, including Zimmermann- Laband syndrome (ZLS), …

Pkpd-Model Based Preclinical Characterization Of The Activity Of Spectinamide 1599 Against Mycobacterial Subpopulations. And The Identification Of Potential Partners For Combination Therapy, Zaid Hanif Temrikar

Theses and Dissertations (ETD)

Tuberculosis is one of the top 10 causes of death worldwide and the leading cause of death from a single infectious agent prior to COVID19. Mycobacterium tuberculosis (Mtb) is the causative agent of TB. The interaction between Mtb and the immune system leads to development of diverse environmental niches and physiology within the lung of the TB patients. Mtb is thought to adapt and thrive in such an environment by transforming to different phenotypic variants. Such variants are difficult to kill and are thought to prolong TB pharmacotherapy. Spectinamide 1599 is a synthetic modification of spectinomycin that has demonstrated excellent …

“Pinkalicious": Outer Membrane Vesicles Isolated From Pseudoalteromonas Rubra Carry Prodigiosin Antibiotics As Cargo, Margaret Hill

Senior Honors Projects

Astrangia poculata, the state coral of Rhode Island, is susceptible to infection by Vibrio coralliilyticus RE22, which is a common marine pathogen affecting various invertebrate species. The settlement of coral larvae prior to the establishment of colonies is mediated by crustose coralline algae (CCA). This process may be induced by CCA-associated protective bacteria that colonize corals in early metamorphosis; furthermore, such bacteria potentially have downstream effects in the susceptibility of corals to pathogens. Strains of Pseudoalteromonas rubra isolated from CCA have been shown to induce larval settlement of tropical corals. We hypothesize that P. rubra induces the settlement of …

One Immune System Plays Many Parts: The Dynamic Role Of The Immune System In Chronic Pain And Opioid Pharmacology, Sanam Mustafa, Juliana E Bajic, Benjamin Barry, Samuel Evans, Kariel R Siemens, Mark R Hutchinson, Peter M Grace

Faculty, Staff and Student Publications

The transition from acute to chronic pain is an ongoing major problem for individuals, society and healthcare systems around the world. It is clear chronic pain is a complex multidimensional biological challenge plagued with difficulties in pain management, specifically opioid use. In recent years the role of the immune system in chronic pain and opioid pharmacology has come to the forefront. As a highly dynamic and versatile network of cells, tissues and organs, the immune system is perfectly positioned at the microscale level to alter nociception and drive structural adaptations that underpin chronic pain and opioid use. In this review, …

Osteoporosis Is Underdiagnosed And Undertreated In Patients With Fragility Femoral Neck And Vertebral Compression Fractures, Philip Zakko, Lauren Eberhardt, Madeline Declercq, Ahyoung Park, Megan Audet, Daniel Park

Conference Presentation Abstracts

Background/Introduction

Femoral neck (FNF) and vertebral compression fractures (VCF) are common fragility fractures (FF) in the elderly population. Defined as fractures from low-energy trauma, FF are diagnostic of osteoporosis and require treatment. The purpose of this study was to assess whether patients were appropriately diagnosed and treated for osteoporosis following fragility FNF and VCF.

Materials/Methods

A retrospective chart review was performed at a single-institution from 1/1/2017 to 12/31/2020 on consecutive patients who sustained fragility FNF treated with closed reduction percutaneous pinning, hemiarthroplasty, or total hip arthroplasty or VCF treated with kyphoplasty. Patients <50 years of age, who sustained a high-energy or a non-osteoporotic pathologic fracture, were treated non-operatively, or deceased within one-year post-op were excluded. Preoperative demographics, ASA, CCI, smoking, alcohol, and glucocorticoid use were obtained. Diagnosis and treatment of osteoporosis, including dual-energy X-ray absorptiometry (DEXA) scans, calcium, vitamin D, bisphosphonates, denosumab, and alternative treatments (teriparatide, calcitonin, raloxifene, estrogen) were assessed pre-op and within one-year post-op. Subsequent FF were recorded.

Results

Of 593 patients, 276 FNF and 94 …

Solid Dispersion Technology For Improving The Solubility Of Antiviral Drugs, Maria Elvina Tresia Butar-Butar, Nasrul Wathoni, Hestiary Ratih, Yoga Windhu Wardhana

Pharmaceutical Sciences and Research

Most drugs, including antiviral drugs, show low solubility in water, which affects dissolution, bioavailability, and therapeutic effectiveness. Therefore, many antiviral drugs are given in very large doses. One of the efforts to overcome these problems is the application of solid dispersions in which polymers and surfactants can trap drug molecules that are in the amorphous phase. Drugs in a hydrophilic carrier will increase wettability, water absorption capacity, and porosity of particles, so that the drug is released better. This review article will discuss the development of technology in solid-state, how solid dispersion overcomes the lack of solubility and the rate …

Beyond Use Date (Bud) Determination Of Ambroxol Hydrochloride Syrup By High-Performance Liquid Chromatography – Uv/Vis Detector, Catur Jatmika, Raditya Iswandana, Indah Dewi Lestari

Pharmaceutical Sciences and Research

Ambroxol HCl is a mucolytic agent often used to treat respiratory disorders associated with excess mucus secretion. This study aims to determine the beyond-use date (BUD) of ambroxol HCl syrup on the market based on analysis of the decrease in drug content using High-Performance Liquid Chromatography (HPLC) – UV/Vis detector. The HPLC conditions were reversed-phase with a C18 column, mobile phase containing acetonitrile - phosphate buffer 0.05 M pH 4.5 (60:40) at a flow rate of 1.0 ml/min using UV detection at 248 nm. To determine BUD, five syrup preparations (brands) obtained from the Jakarta area were analyzed in triplicate. …

Synthesis Of Ferrous Fumarate From Indonesian Iron Sand And In Vivo Body Weight Gain Test In Rats, Taufiq Indra Rukmana, Felicia Natalia Kurniadi, Harmita Harmita

Pharmaceutical Sciences and Research

Iron deficiency anemia (IDA) is a health problem in Indonesia. Prevention and treatment of IDA is carried out by giving fortified foods and oral iron therapy. Both can use ferrous fumarate which is made with reacting bivalent iron and disodium fumarate. Bivalent iron can be obtained from iron sand in Indonesia. This study aims to synthesize ferrous fumarate from Indonesian iron sand, which is from Malang, Sukabumi, and Cianjur area, and to determine its absorption through in vivo body weight gain test in male Wistar white rats (Rattus norvegicus). First, ferrous fumarate was synthesized through reaction of ferrous …

Utilization Of Spent Arabica Coffee Grounds As Raw Material For Activated Charcoal In Liquid Bath Soap Formulation, Hilda Maysarah, Lydia Septa Desiyana, Siti Nurzuhra, Didi Nurhadi Illian

Pharmaceutical Sciences and Research

Arabica coffee (Coffea arabica) is one of the most popular coffees among Acehnese, an ethnic group from Aceh, Indonesia. The amount of coffee consumed is directly proportional to the amount of coffee waste produced. Spent coffee grounds are the residue obtained during the brewing process. Spent coffee grounds can be utilized by converting them into active charcoal adsorbents. This study aimed to produce activated charcoal from spent arabica coffee grounds (SACG), to utilize it as an active ingredient in the liquid bath soap formulations, and to determine the best formula. The characterization of activated charcoal was conducted and …

Adherence Versus Compliance, Tasaduq H. Mir

HCA Healthcare Journal of Medicine

Adherence and compliance are 2 words that are used interchangeably by medical professionals. When we come across a patient who is not taking their medication as advised, we say the patient is non-compliant when the truth is that the patient is non-adherent. Although the terms are used as if they mean the same thing, the 2 words are different in so many ways. In order to understand the difference, it is important to understand the true meaning of these words. According to the literature, “adherence is an active choice of patients to follow through with the prescribed treatment while taking …

Metformin-Associated Lactic Acidosis: A Case Report, Joshua Santoli, Jamie Lee Aldakkour, Hossein Tohidi, Yizhi Lin

HCA Healthcare Journal of Medicine

Introduction

Metformin is considered a first-line therapy for patients with diabetes secondary to its cost efficiency, minimal side effects, and marked improvement in one’s hemoglobin A1c; however, metformin is avoided in patients with renal insufficiency out of concern for drug accumulation and lactic acidosis. In fact, there is a black box warning for metformin, identifying lactic acidosis as the inciting trigger for fatal arrhythmias and death.

Case Presentation

A 62-year-old male presented with multiple episodes of nausea, vomiting, abdominal pain, and decreased urine output for 3 days after working on a roof, all day in the summer heat. He did …

Complete Clearance Of Pustular Psoriasis After A Single Dose Of Risankizumab, Ashleigh E. Hermann, Stephen E. Weis

HCA Healthcare Journal of Medicine

Introduction

Psoriasis is a chronic, multifactorial, inflammatory skin disease with several subtypes, including pustular psoriasis. Pustular psoriasis is characterized by pustules forming lakes of pus on the skin. Pro-inflammatory pathways, such as the interleukin (IL)-17/IL-23 axis, have been shown to play a significant role in the pathogenesis of psoriasis. Biologic therapies directed towards these pro-inflammatory pathways have effectively treated plaque psoriasis, but fewer treatments have shown similar efficacy for pustular psoriasis.

Case Presentation

We present a 45-year-old Black female who presented to the dermatology clinic with generalized pustular psoriasis affecting approximately 70% of her body surface area. She also noted …

Rapid Hepatomegaly From Ruxolitinib Discontinuation Syndrome, Ryan Jansen Van Rensburg, Shayna Hale, Anna Calara, Kulveer Dabb, Uday Dandamudi, Parth Desai

HCA Healthcare Journal of Medicine

Introduction

Ruxolitinib (RUX) is a Food and Drug Administration-approved Janus Kinase (JAK) inhibitor shown to be effective in improving hypercatabolic symptoms and splenomegaly in patients with myelofibrosis (MF). RUX therapy provides symptomatic benefits for MF patients but is often discontinued for various reasons including worsening cytopenias. Ruxolitinib Discontinuation Syndrome (RDS) involves an acute cytokine-storm rebound phenomenon that can manifest as an acute relapse of symptoms, worsening splenomegaly, respiratory distress, systemic inflammatory response syndrome, or disseminated intravascular coagulopathy.

Case Presentation

We present the case of a patient with JAK2-positive post-polycythemia vera MF, whose RUX therapy was discontinued due to an active …

Death Due To Drug Reaction With Eosinophilia And Systemic Symptoms (Dress) Syndrome: A Case Report, Samantha P. Sternad, Jane Pangburn, Chad Johnston, David Rowe

HCA Healthcare Journal of Medicine

Background

Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a life-threatening, multi-organ adverse drug reaction with an incidence of 1 in 1000 to 1 in 10 000 highrisk drug exposures.

Case Presentation

An elderly female presented to the hospital with progressive weakness and a diffuse erythematous macular rash covering most of her body that started 3 days prior. Over the next 3 days, the patient quickly deteriorated, developing disorientation with acute onset left-sided weakness, leukocytosis, thrombocytopenia, eosinophilia, liver and kidney failure, and hypoxia. Clinical and histological changes supported the diagnosis of DRESS syndrome caused by intravenous (IV) ampicillin …

Demonstration Of The Managing For Daily Improvement Quality Improvement Methodology In An Alcohol Withdrawal Protocol Audit, Alex Stephens, Diana Hoot, Amy Cain

HCA Healthcare Journal of Medicine

Background

The Clinical Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar) is an assessment tool designed to standardize care and minimize the risk of complications in patients experiencing alcohol withdrawal. After discovering an increase in medication errors and late assessments under this protocol, pharmacists at a 218-bed community hospital performed an audit of protocol compliance using a performance improvement methodology known as Managing for Daily Improvement (MDI).

Methods

A daily audit of CIWA-Ar protocol compliance was performed across all hospital units, followed by discussions with frontline nurses regarding barriers to compliance. The daily audit included assessments of appropriate monitoring frequency, medication …

Impact Of Inhaled Epoprostenol In Patients On Covid-19 Acute Respiratory Distress Syndrome (Ards), Stacey Nguyen, Stephen Chromi, Mark Decerbo, Surajit Dey, Joseph Mccoy, Jeffrey Murawsky

HCA Healthcare Journal of Medicine

Background

Coronavirus disease 2019 (COVID-19), a novel respiratory disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), can progress to critical illness and the development of acute respiratory distress syndrome (ARDS). Variability in clinical presentation has led to 2 distinct theoretical classifications of COVID-19 ARDS based on different phenotypical presentations. The first of which follows closely to traditional ARDS presenting as severe hypoxemia with markedly reduced lung compliance, whereas the second presents as severe hypoxemia with preserved to high lung compliance. With uncertainty surrounding the specific pathological and mechanistic nature of COVID-19, we designed this study to elucidate the …

Operationalizing A Medication Safety Gap Assessment For A Large Health System, Carley Warren, Joan Kramer, L Hayley Burgess

HCA Healthcare Journal of Medicine

Background

Medication errors continue to be a leading cause of medical errors. In the United States alone, 7000 to 9000 people die annually due to a medication error, and many more are harmed. Since 2014, the Institute for Safe Medication Practices (ISMP) has advocated for several best practices in acute care facilities derived from reports of patient harm.

Methods

The medication safety best practices chosen for this assessment were based on the 2020 ISMP Targeted Medication Safety Best Practices (TMSBP) and health system-identified opportunities. Each month, for 9 months, select best practices were covered with associated tools to assess the …

Implementing Auc Monitoring In A Pharmacist-Managed Vancomycin Dosing Protocol: A Retrospective Cohort Study, Brandon L S Robinson, Blake Bennie, Mahmoud Nasiri, Kieu Nguyen, Reba Forbess, Mallory Gessner-Wharton, Cassie Robertson

HCA Healthcare Journal of Medicine

Background

Consensus guidelines on the therapeutic drug monitoring of vancomycin published in 2020 recognize that using the calculated area-under-the-curve (AUC) to guide dosing maximizes clinical efficacy and minimizes risk when compared to traditional trough-based dosing. The purpose of this study was to determine whether AUC monitoring results in reduced acute kidney injury (AKI) rates in adult patients receiving vancomycin for all indications.

Methods

In this study, patients 18 years or older who received pharmacist-managed vancomycin therapy were selected using pharmacy surveillance software from 2 timeframes. Patients were excluded if they received less than 48 hours of therapy or had unstable …

Scheduled Opioid Administration In Hospice Patients Before And After Targeted Caregiver Education, Katherine G. Hood, Eve B. Woodum, Rebeccah J. Collins

HCA Healthcare Journal of Medicine

Background

Hospice and palliative care have been shown to increase patient satisfaction and improve symptom control at the end of life. Opioid analgesics are typically given around the clock at the end of life to maintain symptom control and prevent the need for larger doses later. Many hospice patients have some degree of cognitive impairment, putting them at risk of being undertreated for pain.

Methods

This was a retrospective, quasi-experimental study at a 766-bed community hospital with hospice and palliative care services. Adult patients admitted to inpatient hospice care with active orders for scheduled opioids for at least 12 hours …

A Retrospective Comparison Of The Effectiveness Of Buprenorphine Versus Baclofen For Acute Opioid Withdrawal, Matthew Hermenau, Benton Stamper, Kitty Leung, Raymond Pomm, Christina Guerrier, Joseph Cammilleri, Brittany Johnson

HCA Healthcare Journal of Medicine

Background

A significant impediment to opioid cessation or dose reduction is mitigating withdrawal severity that has been shown to affect the course of opioid dependence. Current guidelines recommend the use of buprenorphine and methadone over alpha-2 adrenergic agonists. Baclofen, a GABA-B agonist, has promising results as an adjunct agent for opioid withdrawal but has not been compared to buprenorphine. This study compared the ability of buprenorphine and baclofen to mitigate acute opioid withdrawal.

Methods

This was a single-center, retrospective chart review of 63 patients with diagnosed opioid use disorder that received scheduled buprenorphine or baclofen for 3 days, in addition …