Pharmacy and Pharmaceutical Sciences Commons^™

Medicare Drug Price Negotiation Program Draft Guidance, Fred Ledley M.D., Edward Zhou Pharmd, Paula Chaves Da Silva Ph.D.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This comment focuses on Section 50.1, provisions 1 & 3 of the draft guidance regarding the negotiation of a “maximum fair price” under the Inflation Reduction Act (IRA), research and development (R&D) costs of the primary manufacturer,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 …

Using A Modified Delphi Panel To Develop Best Practices In Course Evaluations Of Teaching., Ma. Emmanuelle (Ella) Domingo Vogt Pharmd, Robert D. Beckett Pharmd, Monica Miller Pharmd, Ms, Alex N. Issacs Pharmd, Ms

Parkview Pharmacy Department

Presented at AACP Annual Meeting. Boston, MA: July 2024.

This study generated best practices colleges of pharmacy should employ when conducting student evaluations of teaching and courses.

The Impact And Potential Of Digital Health Technologies, Craig Kimble, Thomas Pile, Alberto Coustasse

Pharmacy Practice & Administration

Digital technologies and smart devices are now used in every aspect of our lives. Further innovation in the digital health realm is growing and has the potential to reduce inefficiencies in the health care system by sharing health data with providers, decreasing costs related to unnecessary health care visits and improving patients’ quality of life and clinical outcomes by better tailoring treatment to the individual’s health needs.

Summer 2024 Edition, Southwestern Oklahoma State University

The Sig

GREETINGS FROM THE DEAN'S OFFICE!

Since the last edition of The Sig there has been great progress on the construction of the Jerry & Margaret Hodge College of Pharmacy and Rural Health Center. After calling the third floor of the CPP building home for 50 years, it is exciting to see our new home emerge at the corner of North Davis and Caddo with concrete being poured and steel beams hoisted into place with a crane.

Prenatal Tetrahydrocannabinol And Cannabidiol Exposure Produce Sex-Specific Pathophysiological Phenotypes In The Adolescent Prefrontal Cortex And Hippocampus, Daniel Hardy, Mohammed Sarikahya, Kendrick Lee, Sebastian Vanin, Andrea Kocsis, Steven Laviolette

Data and Test Instruments

Clinical and preclinical evidence has demonstrated an increased risk for neuropsychiatric disorders following prenatal cannabinoid exposure. However, given the phytochemical complexity of cannabis, there is a need to understand how specific components of cannabis may contribute to these neurodevelopmental risks later in life. To investigate this, a rat model of prenatal cannabinoid exposure was utilized to examine the impacts of specific cannabis constituents (Δ9-tetrahydrocannabinol [THC]; cannabidiol [CBD]) alone and in combination on future neuropsychiatric liability in male and female offspring. Prenatal THC and CBD exposure were associated with low birth weight. At adolescence, offspring displayed sex-specific behavioural changes in anxiety, …

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 …

Data-Driven Drug Repurposing For Immune System-Related Diseases, Sabyasachi Mohanty

Department of Biochemistry: Dissertations, Theses, and Student Research

In this research, we explore a data-driven approach for drug repurposing to enhance the immunomodulatory effect by integrating pattern-based search and genome-scale metabolic modeling. This research helps to find a solution to the preexisting problems of drug discovery which includes expenses and a high amount of time consumption. By leveraging the pre-existing data of the approved drugs to identify the major metabolic pathway changes, we can find new drugs with similar effects with less off-target effects.

The focus on the immune system modulating drugs is due to the high prevalence of immune system-involved diseases and the growing demand for effective …

Antioxidant And Anti-Inflammatory Potential Of Engineered Ceria Nanoparticles In The Management Of Alzheimer's Disease, Shanshan Shi

Theses and Dissertations

Alzheimer's disease (AD) is a devastating neurodegenerative disorder that affects millions worldwide. Unfortunately, there are currently no effective therapies available to prevent or cure the disease. While current therapies aim to change AD progression, there is a growing need for novel therapeutic strategies that can effectively penetrate the blood-brain barrier (BBB) to target the underlying pathology of the disease. The BBB is a highly selective semipermeable barrier that separates circulating blood from the brain. It plays a crucial role in amyloid-β (Aβ) homeostasis and clearance dynamics, as Aβ accumulation is a key factor in the pathogenesis of AD. Aβ aggregation …

Improving Drug Repurposing Success: Integrating Large Database Claims Analysis In Drug Discovery, Joseph Magagnoli

Theses and Dissertations

Drug repurposing has emerged as an innovative strategy to identify new therapeutic uses for existing medications. However, with few notable exceptions, repurposing existing drugs has limited overall success, often failing in randomized controlled trials (RCTs) due to inadequate treatment efficacy in new clinical settings. To improve success rates, I propose a framework titled REMIDY: Retrospective and Experimental Methods Integration for Drug DiscoverY. The REMIDY framework incorporates retrospective claims analysis into the drug discovery process. I demonstrate that retrospective analysis can leverage extensive administrative and clinical data to address translational gaps between pre-clinical experimental models and RCTs. For example, pre-clinical experimental …

Medication Adherence Between Long-Acting Injectable And Oral Antipsychotic Medications In South Carolina Medicaid Beneficiaries With Schizophrenia, Pujing Zhao

Theses and Dissertations

Background: Schizophrenia is a chronic and serious mental disorder that affects millions of individuals worldwide. A recent study shows the prevalence of schizophrenia globally is about 1%. The primary schizophrenia treatment goal is to effectively manage symptoms and prevent relapses. Antipsychotic medications are very important for the treatment of schizophrenia. However, the prevalence of nonadherence to antipsychotic medication is high, with mean rates reaching 41.2%. In the realm of schizophrenia treatment, two primary categories of medications are utilized: long-acting injectable antipsychotics (LAI) and oral antipsychotic agents (OAP).LAI are administered at intervals spanning from two weeks to several months and have …

Evaluation Of Mechanism Of Action And Toxicity Of Novel Psychoactive Substances (Nps) Identified As Cannabinomimetics, Robert Michael Sears

Theses and Dissertations

Synthetic cannabinoid receptor agonists (SCRA), also referred to as synthetic cannabinoids (SCs), pose a significant public health risk, create an undue burden on local emergency departments, and present significant challenges for law enforcement officers and forensic laboratories. SCs are a diverse group of compounds sold with the intent to illicit psychoactive responses like tetrahydrocannabinol (THC), the primary psychoactive component in marijuana. Since their initial detection in 2004, illicit use of SCs has grown in popularity. Recognizing the dangers of SC use, the Drug Enforcement Agency has moved to schedule the analytes routinely identified in street drugs. Despite these efforts, the …

Analisis Pembiayaan Berdasarkan Lama Rawat Pasien Bpjs Diabetes Melitus Tipe Ii Komplikasi Sirkulasi Perifer Di Rsu Pku Muhammadiyah Bantul, Firman Firman, Kartika Lestari

Jurnal Ekonomi Kesehatan Indonesia

Length of stay (LOS) can increase hospital rates and become a cost issue for patients, potentially resulting in a discrepancy between hospital rates and INA-CBGs rates at the hospital. This study aims to determine the difference between the actual costs and BPJS claim costs for diabetic patients based on the length of stay and class level. The research method is observational with a descriptive approach. The data collection technique used retrospective medical record data from 50 patients. The results showed that the largest average difference between hospital costs and BPJS claim costs was for patients with a length of stay …

Assessing The Impact Of Tuberculosis On Economic Growth In Asean Countries: A Conceptual Framework And Panel Data Analysis, Agus Fitriangga, Alex Alex

Jurnal Ekonomi Kesehatan Indonesia

Tuberculosis (TB) remains a major global health issue, particularly in Southeast Asia, where its impact extends beyond public health to affect economic performance. This study evaluates the economic implications of TB incidence on gross domestic product (GDP) growth across eight ASEAN countries from 2000 to 2020. We employed a panel data regression approach, utilizing Common Effect Model (CEM), Fixed Effects Model (FEM), and Random Effects Model (REM) to analyze the relationship between TB incidence and economic growth. The dataset included annual GDP figures, TB incidence rates, foreign direct investment (FDI), labor force size, and trade openness, sourced from international databases. …

Analisis Penerapan Activity-Based Costing Tindakan Debridemen Bedah Pada Diagnosis Tunggal Di Kamar Operasi Rskd Duren Sawit Tahun 2022, Reynaldi Fattah Zakaria, Mardiati Nadjib

Jurnal Ekonomi Kesehatan Indonesia

In 2022, RSKD Duren Sawit has officially held operating room services. The demand for more comprehensive operating room services increased rapidly. The temporary operating room rates were set by adapting the rates of other regional hospitals and the Governor of DKI Jakarta's regulations. There is a huge difference in costs between the hospital rates and the INA-CBGs claim rates, especially for surgical debridement performed in the operating room. One of the factors causing the difference is the undetermined cost for debridement based on the unit cost component. Knowing the unit-cost debridement in the operating room according to the cost per …

Method Development, Validation And Forced Degradation Studies Of Dapagliflozin And Pioglitazone Hydrochlorides In Synthetic Mixtures By Rp-Hplc, Tarang Patel, Harpalsinh Rathod

Discovery Day

A simple, sensitive, robust, precise, and efficient RP-HPLC approach for the simultaneous determination of Dapagliflozin and Pioglitazone Hydrochloride in Synthetic Mixture. As per ICH Q2 (R1) guidelines, the final chromatographic conditions were Optimized with a mobile phase ratio of (25:75% v/v) in ACN: Potassium Dihydrogen Phosphate Buffer (pH 4) was adjusted by adding OPA at a flow rate of 1 mL/min, column temperature of 30 °C, injection volume of 20 μL, Kromstar Vertex C18 analytical column, and UV detection at 228 nm wavelength. Dapagliflozin and Pioglitazone Hydrochloride reported retention times of 3 min and 6.5 min, respectively. Validation of a …

Review Of Mpges-1 Inhibitors Based On The Benzoxazole And Its Isostere Scaffold For The Treatment Of Inflammatory Diseases, Abdullah M. Alwagdani

Longitudinal Scholar's Project

The vital role of the prostanoid pathway in inflammation, pain, cancer, Alzheimer’s and many other diseases has attracted the drug discovery community to discover targets for therapeutic development. Although existing non-steroidal anti-inflammatory drugs (NSAIDs) inhibiting cyclooxygenases (COX) are widely used, the side effects of these NSAIDs limit the ling time medication. Microsomal prostaglandin E synthase-1 (mPGES-1) is an attractive target that is overexpressed during inflammations, and it could be a safe alternative to NSAIDs for treating inflammatory diseases.Since the discovery of mPGES-1 in 1997, many inhibitors have been developed since 2001. Only a few compounds were able to make it …

Chemotherapy Drug Release From Hollow Core Polyethyleneimine Nanoparticles, Brian Boyle

Theses and Dissertations

Novel anticancer delivery vehicles are arising from engineered nanostructured materials. This work involved the synthesis, characterization, and release of novel hollow core polymeric nanoparticles (HCPNPs) for controlled drug delivery. Polyethyleneimine (PEI) was bound to AuNPs, forming polymer-shell nanoparticles with dissolution of the gold core via iodine forming HCPNPs with drug intercalated DNA bound to the surface. A high density (85 molecules/particle) of DNA intercalated with daunorubicin was conjugated. Particles were spherical with an average diameter of 105.7 ± 17.3 nm and zeta potential of 20.4 ± 3.54 mV. We hypothesize the DNA backbone electrostatically condensed to the primary amines on …

Direct Oral Anticoagulants: A Review For Health Care Providers, Mary Hoang, Maley Zents, Christina Swiger, Emily Wagner

Transformative Medicine

Direct oral anticoagulants (DOACs) are a novel class of anticoagulants. They include rivaroxaban, apixaban, edoxaban, and dabigatran. Benefits of DOACs over many older anticoagulants include oral administration, quicker onset of action, less monitoring requirements, and fewer drug interactions. Since the DOACs were first introduced, their use has increased tremendously. This article aims to help providers become more familiar with DOACs and the specific factors that may impact prescribing practices. Several drugs used for the reversal of DOACs will also be discussed. Lastly, the article will describe certain situations in which warfarin is preferred over DOACs.

Antimicrobial Peptide Screening For Designing Custom Bactericidal Hydrogels, Matthias Recktenwald, Muskanjot Kaur, Mohammed M. Benmassaoud, Aryanna Copling, Tulika Khanna, Michael Curry, Dennise Cortes, Gilbert Fleischer, Valerie J. Carabetta, Sebastian Vega

Rowan-Virtua School of Translational Biomedical Engineering & Sciences Departmental Research

Staphylococcus aureus (S. aureus) is an opportunistic pathogen that lives on surfaces and skin and can cause serious infections inside the body. Antimicrobial peptides (AMPs) are part of the innate immune system and can eliminate pathogens, including bacteria and viruses, and are a promising alternative to antibiotics. Although studies have reported that AMP-functionalized hydrogels can prevent bacterial adhesion and biofilm formation, AMP dosing and the combined effects of multiple AMPs are not well understood. Here, three AMPs with different antibacterial properties were synthesized and the soluble minimum inhibitory concentrations (MICs) of each AMP against methicillin-susceptible S. aureus (MSSA) and methicillin-resistant …

Cgmp Compliant One-Step, One-Pot Automated [18f]Fbntp Production For Clinical Imaging Of Mitochondrial Activity, Mai Lin, Cong-Dat Pham, Robert T Ta, H Charles Manning

Faculty, Staff and Student Publications

Background

4-[18F]fluorobenzyl-triphenylphosphonium ([18F]FBnTP) is a lipophilic cation PET tracer. The cellular uptake of [18F]FBnTP is correlated with oxidative phosphorylation by mitochondria, which has been associated with multiple critical diseases. To date, [18F]FBnTP has been successfully applied for imaging myocardial perfusion, assessment of severity of coronary artery stenosis, delineation of the ischemic area after transient coronary occlusion, and detection/quantification of apoptosis in various animal models. Recent preclinical and clinical studies have also expanded the possibilities of using [18F]FBnTP in oncological diagnosis and therapeutic monitoring. However, [18F]FBnTP is typically prepared through a tediously lengthy four-step, three-pot reaction and required multiple synthesizer modules; …

Molecular Docking Of The Interaction Between Citrus Amblycarpa Extract Contents And Inflammatory Proteins Of Hepatic Steatosis, Lena Rosida, Dewi Indah Noviana Pratiwi, Roselina Panghiyangani, Juliyatin Putri Utami, Nasrul Idhafi, Muhammad Febriansyah, Andi Azizah Maulidia Budiarman

Makara Journal of Science

Citrus amblycarpa possesses various pharmacological activities, such as antioxidant, anticancer, antitumor, hepatoprotective, anti-inflammatory, antidiabetic, antiviral, antibacterial, and antifungal. The main active compounds in C. amblycarpa (including gamma (γ)-aminobutyric acid [GABA], hesperidin, naringin, neoeriocitrin, poncirin, quercetin, and rutin) show potential to interact with the inflammatory proteins in hepatic steatosis (such as nuclear factor kappa beta [NF-kB], tumor necrosis alpha [TNF-alpha], interleukin-6 [IL-6], c-Jun NH2-terminal kinase [JNK], and adiponectin). Molecular docking simulations were performed using Swiss Dock (http://www.swissdock.ch/), and analysis and visualization were conducted using Discovery Studio 4.1. Rutin, poncirin, hesperidin, and neoeriocitrin exhibit high affinities to NF-κB, TNF-alpha, IL-6, and adiponectin …

Microencapsulation Of Cosmos Caudatus Kunth Extract Using Sodium Alginate And In Vitro Antioxidant Activity Test, Safina Samara Nur Fadlila, Oktavia Eka Puspita, Zubaidah Ningsih, Anna Safitri

Makara Journal of Science

This study aims to encapsulate Cosmos caudatus K. leaf extract in sodium alginate crosslinked with calcium chloride (CaCl₂) as coating materials through freeze-drying. Antioxidant assays were performed to evaluate the applicability of the microcapsules as antidiabetic medicines. Their characteristics, antioxidant activity, and encapsulation efficiency (EE) were also examined. Results indicated that the concentration of sodium alginate and pH influenced the manufacturing process of the microcapsules. The highest EE was obtained at pH 6 and alginate concentration of 2% (w/v). The IC₅₀ for the antioxidant activity of the microcapsules was 139.96 ± 1.094 μg/mL. Scanning electron microscopy confirmed …

Development Of An Educational Brochure About Treatment Options For Pregnant Women With Opioid Use Disorders, Ruth Jeminiwa, Sohyeon Park, Caroline Popielaski, Meghan Gannon, Ronald Myers, Diane J. Abatemarco

College of Pharmacy Faculty Papers

The goal of this study was to describe the development of an educational brochure for pregnant women with opioid use disorders (OUDs) about treatment options. Based on findings from a preliminary review of the literature, we drafted a brochure that addressed the following questions: (1) What are your options (Medication-Assisted Treatment (MAT) versus no treatment)? (2) What are the benefits of MAT? (3) What are the risks of MAT? (4) Can I take buprenorphine or methadone while breastfeeding? (5) Which medication should I choose? Clinicians and doulas (n = 19) who provide care to pregnant women with OUDs were recruited. …

Potent And Selective Small Molecule Mcl-1 Inhibitor Demonstrates Anti-Myeloma Activity And Overcomes Chemotherapy Resistance, Omar Sami Faleh Al-Odat

Theses and Dissertations

Despite a record number of clinical studies investigating various anti-myeloma treatments, the 5-year survival rate for multiple myeloma (MM) patients in the US is only 55%, and nearly all patients relapse. Poor patient outcomes demonstrate that myeloma cells are "born to survive” which means they can adapt and evolve following treatment. Thus, new therapeutic approaches to combat survival mechanisms and target treatment resistance are required. Importantly, Mcl-1, anti-apoptotic protein, is required for the development of MM and treatment resistance. This study looks at the possibility of KS18, a selective Mcl-1 inhibitor, to treat MM and overcome resistance. Our investigation demonstrates …

Hepatic Lrp-1 Plays An Important Role In Amyloidosis In Alzheimer's Disease Mice: Potential Role In Chronic Heavy Alcohol Feeding, Devaraj V. Chandrashekar, G. Chuli Roules, Nataraj Jagadeesan, Urvashi R. Panchal, Adenike Oyegbesan, Oghenetega E. Imiruaye, Hai Zhang, Jerome Garcia, Kamaljit Kaur, Sanda Win, Tin A. Than, Neil Kaplowitz, Moom R. Roosan, Derick Han, Rachita K. Sumbria

Pharmacy Faculty Articles and Research

Background

Methods

Integrated Computational Approaches: Elucidating Molecular Mechanisms Of Pathogenic Proteins And Designing Novel Inhibitors Against Mycobacterium Tuberculosis And Sars-Cov-2, Justin David Carbone

Theses and Dissertations

Chapter 1 introduces computational strategies in computer aided drug design (CADD), focusing on physics-based methodologies to enhance drug discovery. This chapter also discusses the theoretical foundations and practical applications of molecular dynamics (MD) simulations including free energy and stochastic kinetic analysis. In Chapter 2, CADD methods lead to development of inhibitors targeting the RNA Dependent RNA Polymerase (RdRP) of SARS-CoV-2. Inspired by the nucleotide inhibitor Molnupiravir, we aim to design a combinatorial library of 72 novel inhibitors capable of impeding a dual threat inhibition mechanism inducing lethal mutations along with stalling viral replication with specific selectivity to RdRp over Human …

Mechanistic Study Of Antimicrobial Effectiveness Of Cyclic Amphipathic Peptide [R4W4] Against Methicillin-Resistant Staphylococcus Aureus Clinical Isolates, Ajayi David Akinwale, Keykavous Parang, Rakesh Kumar Tiwari, Jason Yamaki

Pharmacy Faculty Articles and Research

Antimicrobial peptides (AMPs) are being explored as a potential strategy to combat antibiotic resistance due to their ability to reduce susceptibility to antibiotics. This study explored whether the [R₄W₄] peptide mode of action is bacteriostatic or bactericidal using modified two-fold serial dilution and evaluating the synergism between gentamicin and [R₄W₄] against Escherichia coli (E. coli) and methicillin-resistant Staphylococcus aureus (MRSA) by a checkered board assay. [R₄W₄] exhibited bactericidal activity against bacterial isolates (MBC/MIC ≤ 4), with a synergistic effect with gentamicin against E. coli (FICI = 0.3) but …

Cost Variation Analysis Of Oral Hypoglycemic Drugs In The Egyptian Market, George G. Abdelmessih, Aya M. Abdelmagid, Samar F. Farid

Bulletin of Faculty of Pharmacy Cairo University

Introduction: Type II diabetes mellitus is a lifelong condition requiring lifelong medication. This study aims to analyze the cost variation of the oral hypoglycemic drugs in the Egyptian pharmaceutical market.

Methodology: Egyptian drug database of the Egyptian Drug Authority was used to get the official prices of drugs in the Egyptian pharmaceutical market analyzed in this study. The cost ratio and the percentage cost variation were calculated. The price was documented using unit dose of 1 tablet per EGP.

Results: Out of 15 oral hypoglycemic drugs in the Egyptian market at closing 2022 (9 monotherapy and 6 combination therapy) of …

Mechanistic Insight Into The Mode Of Inhibition Of Dietary Flavonoids; Targeting Macrophage Migration Inhibitory Factor, Ali Raza Siddiqui, Mamona Mushtaq, Madiha Sardar, Lubna Atta, Mohammad Nur-E-Alam, Aftab Ahmad, Zaheer Ul-Haq

Pharmacy Faculty Articles and Research

Introduction: The Macrophage Migration Inhibitory Factor (MIF), a key pro-inflammatory mediator, is responsible for modulating immune responses. An array of inflammatory and autoimmune diseases has been linked to the dysregulated activity of MIF. The significance in physiological as well as pathophysiological phenomena underscores the potential of MIF as an attractive target with pharmacological relevance. Extensive research in past has uncovered a number of inhibitors, while the ISO-1, or (S, R)-3-(4-hydroxyphenyl)-4,5-dihydro-5-isoxazole acetic acid methyl ester being recognized as a benchmark standard so far. Recent work by Yang and coworkers identified five promising dietary flavonoids, with superior activity compared to the standard …

Association Between Opioid-Benzodiazepine Trajectories And Injurious Fall Risk Among Us Medicare Beneficiaries., Grace Hsin-Min Wang, Juan M. Hincapie-Castillo, Walid F. Gellad, Bobby L. Jones, Ronald I. Shorr, Seonkyeong Yang, Debbie L. Wilson, Jeannie K. Lee, Gary M. Reisfield, Chian K. Kwoh, Chris Delcher, Khoa A. Nguyen, Christopher A. Harle, Zachary A. Marcum, Wei-Hsuan Lo-Ciganic

Pharmacy Practice and Science Faculty Publications

Background/Objectives: Concurrent opioid (OPI) and benzodiazepine (BZD) use may exacerbate injurious fall risk (e.g., falls and fractures) compared to no use or use alone. Yet, patients may need concurrent OPI-BZD use for co-occurring conditions (e.g., pain and anxiety). Therefore, we examined the association between longitudinal OPI-BZD dosing patterns and subsequent injurious fall risk. Methods: We conducted a retrospective cohort study including non-cancer fee-for-service Medicare beneficiaries initiating OPI and/or BZD in 2016-2018. We identified OPI-BZD use patterns during the 3 months following OPI and/or BZD initiation (i.e., trajectory period) using group-based multi-trajectory models. We estimated the time to first injurious falls …