Pharmacy and Pharmaceutical Sciences Commons^™

The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler

Faculty Publications By Year

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as …

Utilization Of Free Medication Samples In The United States In A Nationally Representative Sample: 2009-2013, Joshua D. Brown, Pratik A. Doshi, Jeffery C. Talbert

Institute for Pharmaceutical Outcomes and Policy Faculty Publications

Background—Manufacturers provide free sample medications as a means to increase use of branded medications. Sample use varies year-to-year as branded product patents expire and new products come to market.

Objective—This study sought to describe the use of sample medications during 2009–2013 and assess individual characteristics associated with sample use.

Methods—Data from the 2009–2013 U.S. Medical Expenditure Panel Survey (MEPS) were used. MEPS asks participants whether they received each medication they are taking as a sample. The top 10 medications and medication classes used each year by volume were identified as well as the proportion of people who …

Discovering Small Molecule Inhibitors Targeted To Ligand-Stimulated Rage-Diaph1 Signaling Transduction, Jinhong Pan

Legacy Theses & Dissertations (2009 - 2024)

The receptor of advanced glycation end product (RAGE) is a multiligand receptor of the immunoglobulin superfamily of cell surface molecules, which plays an important role in immune responses. Full-length RAGE includes three extracellular immunoglobulin domains, a transmembrane domain and an intracellular domain. It is a pattern recognition receptor that can bind diverse ligands. NMR spectroscopy and x-ray crystallization studies of the extracellular domains of RAGE indicate that RAGE ligands bind by distinct charge- and hydrophobicity-dependent mechanisms. It is found that calgranulin binding to the C1C2 domain or AGEs binding to the V domain activates extracellular signaling, which triggers interactions of …

Benzylideneoxymorphone: A New Lead For Development Of Bifunctional Mu/Delta Opioid Receptor Ligands, Jason R. Healy, Padmavani Bezawada, Nicholas W. Griggs, Andrea L. Devereaux, Rae Reiko Matsumoto, John R. Traynor, Christopher W. Cunningham

Faculty Publications & Research of the TUC College of Pharmacy

Opioid analgesic tolerance remains a considerable drawback to chronic pain management. The finding that concomitant administration of delta opioid receptor (DOR) antagonists attenuates the development of tolerance to mu opioid receptor (MOR) agonists has led to interest in producing bifunctional MOR agonist/DOR antagonist ligands. Herein, we present 7-benzylideneoxymorphone (6, UMB 246) displaying MOR partial agonist/DOR antagonist activity, representing a new lead for designing bifunctional MOR/DOR ligands.

Implementing Pharmacy-Based Travel Health Services: Insight And Guidance From Frontline Practitioners, Tania Gregorian, Albert Bach, Karl Hess, Keri Hurley, Edith Mirzaian, Jeff Goad

Pharmacy Faculty Articles and Research

PURPOSE In California, the passage of SB493 in July of 2013 was a milestone in advancing pharmacy practice. Among other things, the new legislation allows pharmacists to provide routine immunizations without a protocol and furnish medications for international travelers for conditions not requiring a diagnosis. When developing a pharmacist-run travel health service, consideration must be given to multiple important factors, including pharmacist training, physician partnership, logistics, from scheduling to documentation, and the resources necessary to provide a travel health service.5 This article sets out to provide guidance and insight to pharmacists seeking to implement a travel health service.

SUMMARY Travel …

Actionable Patient Safety Solution (Apss) #3a: Medication Errors, Ron Jordan, Jerika Lam, Anne Lyren, Nathaniel Sims, Coco Yang

Pharmacy Faculty Articles and Research

This report presents a plan of action for introducing a program to reduce medication errors, which are a major cause of patient morbidity and mortality.

Demerol, Christena G. Stephens

Natural Sciences Student Research Presentations

This is a poster presented at the Natural Sciences Poster Session at Parkland College, which provides the chemical makeup, dosage, and the body's response to Demerol (Meperidine Hydrochloride) a narcotic analgesic for the relief of acute pain and used in support of preoperative anesthesia.

Zyrtec, Ebru Tasken

Natural Sciences Student Research Presentations

This is a poster presented at the Natural Sciences Poster Session at Parkland College, which provides the chemical makeup, dosage, and the body's response to Zyrtec (Cetirizine) an antihistimine, receptor antagonist used to treat seasonal or perennial allergic rhinitis and chronic idiopathic urticarial.

Emend, Melissa Kramer

Natural Sciences Student Research Presentations

This is a poster presented at the Natural Sciences Poster Session at Parkland College, which provides the chemical makeup, dosage, and the body's response to Emend (Aperpitant) , a selective substance receptor antagonist used in the prevention of acute and delayed nausea and vomiting associated with chemotherapy.

Naloxone Therapy In Opioid Overdose Patients: Intranasal Or Intravenous?, Leiah Carney

Natural Sciences Student Research Presentations

This slide presentation for the Natural Science Poster Session at Parkland College describes the chemical makeup and effect of Naloxone, an opioid antagonist used in the treatment opioid overdose and summarizes a study comparing intravenous and intranasal delivery methods. Concludes that although there are conflicting studies, evidence supports intranasal delivery.

Recent Analytical Methods For The Analysis Of Sweeteners In Food: A Regulatory Perspective, Romina Shah, Lowri S. De Jager

United States Food and Drug Administration: Publications

Non-nutritive or low calorie sweeteners are commonly used worldwide in the food industry, often in combination in order to limit undesirable tastes. The list of allowable sweeteners varies among countries and it is important for regulatory agencies and food safety laboratories to monitor these highly consumed products to ensure compliance with worldwide regulations. Current analytical methods for confirmation and quantification of sweeteners must allow for confirmation of analyte identity in order to be compatible with today’s standards. Various methods for the determination of non-nutritive sweeteners have been reported in the literature. Th e most common multi-sweetener methods involve high performance …

Cannabinoid Disposition In Oral Fluid After Controlled Smoked, Vaporized, And Oral Cannabis Administration, Madeleine J. Swortwood, Matthew N. Newmeyer, Maria Andersson, Osama A. Abulseoud, Karl B. Scheidweiler, Marilyn A. Huestis

United States Food and Drug Administration: Publications

Oral fluid (OF) is an important matrix for monitoring drugs. Smoking cannabis is common, but vaporization and edible consumption also are popular. OF pharmacokinetics are available for controlled smoked cannabis, but few data exist for vaporized and oral routes. Frequent and occasional cannabis smokers were recruited as participants for four dosing sessions including one active (6.9% Δ⁹-tetrahydrocannabinol, THC) or placebo cannabis-containing brownie, followed by one active or placebo cigarette, or one active or placebo vaporized cannabis dose. Only one active dose was administered per session. OF was collected before and up to 54 (occasional) or 72 (frequent) h …

Certain Dyes As Pharmacologically Active Substances In Fish Farming And Other Aquaculture Products, Eric Verdon, Wendy C. Andersen

United States Food and Drug Administration: Publications

The last 40 years have brought enormous changes to the aquaculture industry. The farming of fish and of seafood products has been continuously increasing from 3.9% by weight in 1970 to 36% in 2006 according to theWorld Health Organization (WHO) and Food and Agriculture Organization (FAO) of the United Nations.¹ The global trend of aquaculture development gaining importance in total fish supply has remained uninterrupted. Farmed food fish contributed a record 42.2% of the total 158 million tonnes of fish produced by capture fisheries and aquaculture in 2012 (Figure 9.1). This compares with just 13.4% in 1990 and 25.7% …

Color And Power Doppler Combined With Fetal Intelligent Navigation Echocardiography (Fine) To Evaluate The Fetal Heart, L. Yeo, R. Romero

United States Food and Drug Administration: Publications

Objective To evaluate the performance of color and bidirectional power Doppler ultrasound combined with Fetal Intelligent Navigation Echocardiography (FINE) in examining the fetal heart.

Methods A prospective cohort study was conducted of fetuses in the second and third trimesters with a normal heart or with congenital heart disease (CHD). One or more spatiotemporal image correlation (STIC) volume datasets, combined with color or bidirectional power Doppler (S-flow) imaging, were acquired in the apical four-chamber view. Each successfully obtained STIC volume was evaluated by STICLoop™ to determine its appropriateness before applying the FINE method. Visualization rates for standard fetal echocardiography views using …

Salmonella Inactivation During Extrusion Of An Oat Flour Model Food, Nathan M. Anderson, Susanne E. Keller, Niharika Mishra, Shannon Pickens, Dana Gradl, Tim Hartter, Galen Rokey, Christopher Dohl, Brian Plattner, Stuart Chirtel, Elizabeth M. Grasso-Kelley

United States Food and Drug Administration: Publications

Little research exists on Salmonella inactivation during extrusion processing, yet many outbreaks associated with low water activity foods since 2006 were linked to extruded foods. The aim of this research was to study Salmonella inactivation during extrusion of a model cereal product. Oat flour was inoculated with Salmonella enterica serovar Agona, an outbreak strain isolated from puffed cereals, and processed using a single-screw extruder at a feed rate of 75 kg/h and a screw speed of 500 rpm. Extrudate samples were collected from the barrel outlet in sterile bags and immediately cooled in an ice–water bath. Populations were determined using …

An Overview Of The Role Of Mathematical Models In Implementation Of Quality By Design Paradigm For Drug Development And Manufacture, Sharmista Chatterjee, Christine M.V. Moore, Moheb M. Nasr

United States Food and Drug Administration: Publications

A model is a representation of an underlying physical–chemical phenomenon. In the pharmaceutical industry, mathematical‐based models can be applied at all stages of development, starting with formulation design, continuing through process development and scale‐up, and extending into process monitoring and control of the commercial process. Implementation of models offers many benefits. These include, but are not limited to, (i) enhanced process understanding, (ii) reduction of experimentation cost, and (iii) improvement of productivity and product quality.

Models can be broadly categorized as either qualitative or quantitative. The focus of this chapter is quantitative models. These can be classified into three broad …

The Mechanism Of Cirp In Inhibition Of Keratinocytes Growth Arrest And Apoptosis Following Low Dose Uvb Radiation, Yi Liao, Jianguo Feng, Yi Zhang, Liling Tang, Shiyong Wu

United States Food and Drug Administration: Publications

UV induces CIRP expression and subsequent Stat3 activation, but the biological function and mechanism of CIRP and Stat3 in mediating UVB-induced skin carcinogenesis have not been fully elucidated. In this study, we demonstrate that CIRP is elevated in all tested melanoma and non-melanoma skin cancer cell lines; and the expression of CIRP is upregulated in keratinocytes after being irradiated with relatively low dose (<5 mJ/cm²), but not high dose (50 mJ/cm²), UVB acutely and chronically. The increased expression of CIRP, either induced by UVB or through overexpression, leads to resistance of keratinocytes to UVB-induced growth arrest and …

Monitoring Harm Perceptions Of Smokeless Tobacco Products Among U.S. Adults: Health Information National Trends Survey 2012, 2014, 2015, Shari P. Feirman, Elisabeth A. Donaldson, Mark Parascandola, Kimberly Snyder, Cindy Tworek

United States Food and Drug Administration: Publications

Introduction: Changes to the U.S. smokeless tobacco landscape in recent years include a change to health warnings on packages, the implementation of bans in some stadiums, and the launch of a federal youth pre- vention campaign. It is unclear whether such changes have impacted consumer beliefs about smokeless tobacco. This study examines relative harm perceptions of smokeless tobacco compared to cigarettes among adults and assesses changes in smokeless tobacco harm perceptions over time.

Methods: We analyzed data from three cycles (2012, 2014, 2015) of the Health Information National Trends Survey (HINTS). Using 2015 data, we assessed bivariate associations between smokeless …

Preparation And Characterization Of Acitretin-Loaded Niosomes For Psoriasis Treatment, Marey Abdulmootani Almaghrabi

Electronic Theses and Dissertations

Psoriasis is a chronic skin disease that manifests as impaired epidermal differentiation. The disease is typically treated with acitretin, an effective oral cytotoxic agent. However, due to its side effects, its use is highly limited. Topical delivery of acitretin may decrease the systemic toxicity and increase the drug’s bioavailability at the pathological site. However, this approach has some limitations. The decrease in skin integrity due to psoriasis could lead to escape of drug into the systemic circulation system and consequently compromise the topical approach. Also, the high instability of acitretin in the presence of heat could limit its topical application. …

Burden Of Depression Among Individuals With Irritable Bowel Syndrome(Ibs) In The Medicaid Population, Kaustuv Bhattacharya

Electronic Theses and Dissertations

Objective: to determine the period prevalence of IBS and comorbid depression among individuals with Irritable Bowel Syndrome (IBS) in multi-state Medicaid population, and to assess the impact of comorbid depression on healthcare utilization and costs among individuals with IBS enrolled in fee-for-service Medicaid program. Methods: a retrospective cohort study was conducted using 2006-2008 Medicaid analytic extract files for 39 states. Beneficiaries with IBS were identified based on any medical claims for the disease. Beneficiaries with one or more medical claims for depression during the study period were considered to have had comorbid depression. For each beneficiary, the first claim for …