Pharmacy and Pharmaceutical Sciences Commons^™

Microbial Ecology Of Fresh Vegetables, J. Zheng, A. De Jesus, S. Sahu, A. E. Hayford, Y. Luo, A. R. Datta, E. W. Brown, R. Bell

United States Food and Drug Administration: Publications

The total consumption of fresh and processed vegetables has exceeded 123 kg per capita in the United States and 118 kg per capita in the European Union (http://www.helgilibrary.com/ indicators/index/vegetable‐consumption‐percapita) in 2009. Changes in lifestyles and consumption trends have prompted the sustained growth of fresh‐cut or minimally processed vegetables that are fresh and ready‐to‐eat (RTE). In 2011, for example, total US fresh‐cut produce sales through both food service and retail channels were estimated to surpass $27 billion (Cook et al., 2012).

Burden Of Illness And Pharmacoeconomic Evaluation Of Lumacaftor/Ivacaftor In Cystic Fibrosis, Pratyusha Vadagam

Electronic Theses and Dissertations

Objectives: (1) To estimate the burden of illness in cystic fibrosis (CF) using 2010-2014 Medical Expenditure Panel Survey (MEPS) data, and (2) to conduct a pharmacoeconomic evaluation of lumacaftor/ivacaftor in the treatment of CF.

Methods: The study was conducted in two parts. Part 1 involved a retrospective analysis using individuals in MEPS database with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis code of 277.00 for a principal diagnosis of CF. Dependent variables were cumulative and out-of-pocket (OOP) expenditures and independent variables included patient demographics and clinical characteristics. Unweighted and weighted estimates of expenditure in CF group, …

A Guide To The California Immunization Registry And Its Use To Enhance The Delivery Of Immunization Services, Albert Bach, Jeffery A. Goad, Steven P. Nickell

Pharmacy Faculty Articles and Research

Pharmacists in California are assuming a greater role as independent providers of immunizations for children and adults under Senate Bill 493 (SB 493). One of the requirements for pharmacists as independent providers of immunizations in California is that they must report their administered doses to the California immunization registry system (CAIR). The National Vaccine Advisory Committee Standards for Immunization Practice also supports this practice by recommending that all immunizing providers report vaccinations to their local and state immunization information systems (IIS). This document presents background and specific features of CAIR; best practice recommendations for the use of IIS lookup, forecasting, …

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 …

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 …

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 …

Gastrointestinal Bleeding Events And Statin Use: A Large Propensity Score-Matched Retrospective Cohort Study, Ashley I. Martinez

Theses and Dissertations--Pharmacy

Literature is conflicting regarding the association between statin use and gastrointestinal (GI) bleeding. This study sought to determine whether there is an association between statin use and GI bleeding by comparing incidence of gastrointestinal events between statin users and an active comparator group.

Data was obtained from a large administrative claims database composed of subjects enrolled in a selection of insurance plans throughout the United States from 2009-2014. New statin users (exposed) and thyroid medication users (active comparator, unexposed) were followed from the baseline period (one year prior to medication initiation) until first event, discontinuation, or disenrollment. Subjects were matched …

Uganda Retail Audit: Analysis And Report, The Evidence Project

Reproductive Health

This brief presents results of a retail audit, carried out in January 2016, that was commissioned as part of PATH’s work under the USAID-funded Evidence Project to conduct a landscape assessment of the feasibility of a Total Market Approach (TMA) in Uganda. This project also involved key informant interviews with stakeholders on their attitudes toward TMA principles and the collection of a Uganda Market Research Summary of existing family planning knowledge. The approach is based on an understanding that equitably meeting the diverse needs of different population segments requires increased coordination across sectors, including the public, private for-profit, and not-for-profit …

The International Scientific Association For Probiotics And Prebiotics (Isapp) Consensus Statement On The Definition And Scope Of Prebiotics, Glenn R. Gibson, Robert W. Hutkins, Mary Ellen Sanders, Susan L. Prescott, Raylene A. Reimer, Seppo J. Salminen, Karen Scott, Catherine Stanton, Kelly S. Swanson, Patrice D. Cani, Kristin Verbeke, Gregor Reid

Department of Food Science and Technology: Faculty Publications

In December 2016, a panel of experts in microbiology, nutrition and clinical research was convened by the International Scientific Association for Probiotics and Prebiotics to review the definition and scope of prebiotics. Consistent with the original embodiment of prebiotics, but aware of the latest scientific and clinical developments, the panel updated the definition of a prebiotic: a substrate that is selectively utilized by host microorganisms conferring a health benefit. This definition expands the concept of prebiotics to possibly include non-carbohydrate substances, applications to body sites other than the gastrointestinal tract, and diverse categories other than food. The requirement for selective …

Understanding Over-The-Counter Medication Use And Decision-Making Among Community-Dwelling Us Older Adults: A Mixed-Methods Approach, Yoshita Paliwal

Theses and Dissertations

Introduction

Older adults are regular consumers of over-the-counter (OTC) medications. OTC medications are generally considered safe, and convenient to use without requiring a prescription. However, the safety of an OTC medication and the final health outcome depends in part upon consumers’ perceptions, beliefs, and their decision-making about OTC medication use. The main objectives of this study were: 1) to examine the prevalence and characteristics of OTC medication use among community-dwelling US older adults (65 years and older), 2) to explore older adults’ knowledge, attitudes, beliefs and experiences about OTC medications, and 3) to elicit the OTC medication decision-making process in …

Pharmacovigilance In Post-Marketing: Risk Assessment And Reporting Standards, Tiffany Jee

Master's Projects and Capstones

While there has been new targeted drug therapies released into the market over the recent years, pulmonary arterial hypertension (PAH) remains to be a rapidly progressive disease with poor prognosis. Over time the arteries stiffen and tighten subsequently leaving the heart to pump harder to try and provide enough blood to the body. The extra stress of the increased pumping leads to weakening and enlargement of the heart. The endothelin targeted therapy, Letairis (ambrisentan), is an oral tablet proven to improve quality of life in patients suffering from PAH, WHO Group I – functional class II and III by helping …

Differences In Amphetamine/Dextroamphetamine Prescriptions In Areas With & Without Large Universities, Heather Bacon

Honors Theses

This investigative study is examining trends in stimulant prescribing for several Michigan counties. An ex-post facto design was used to determine trends in the amount of amphetamine/dextroamphetamine dispensed in four Michigan counties containing large universities and two Michigan counties not containing large universities over the years 2007-2012. The study found suggestive evidence that there is an increasing trend of amphetamine/dextroamphetamine prescriptions filled in both counties with and without large universities. Suggestive evidence was also found that counties with large universities display a greater average amount of amphetamine/dextroamphetamine dispensed than counties without large universities for the years 2007-2012. Because the study …

Sneaky Salt Contributes To High Blood Pressure, Rodney Richmond

Faculty Research ​and Publications

No abstract provided.

Volumetry Of Low-Contrast Liver Lesions With Ct: Investigation Of Estimation Uncertainties In A Phantom Study, Qin Li, Yongguang Liang, Qiao Huang, Min Zong, Benjamin Berman, Marios A. Gavrielides, Lawrence H. Schwartz, Binsheng Zhao, Nicholas Petrick

United States Food and Drug Administration: Publications

Purpose: To evaluate the performance of lesion volumetry in hepatic CT as a function of various imaging acquisition parameters.

Methods: An anthropomorphic abdominal phantom with removable liver inserts was designed for this study. Two liver inserts, each containing 19 synthetic lesions with varying diameter (6–40 mm), shape, contrast (10–65 HU), and both homogenous and mixed-density were designed to have background and lesion CT values corresponding to arterial and portal-venous phase imaging, respectively. The two phantoms were scanned using two commercial CT scanners (GE 750 HD and Siemens Biograph mCT) across a set of imaging protocols (four slice thicknesses, …

Decreasing Cost Associated Medication Nonadherence, Shawn E. Raymond

Doctor of Nursing Practice Scholarly Project

An Abstract of the Scholarly Project by

Shawn E. Raymond

Medication cost is a major contributor for patient medication nonadherence. Take in the fact that a large population lives in poverty, many cannot afford to pay the retail prices associated with purchasing their medications. By incorporating wholesale medications into a charitable health clinic, the reduced cost of medications for treatment of both acute and chronic illnesses could be passed on to those in need thereby decreasing cost associated medication nonadherence. Nurse Practitioners in the state of Kansas are not afforded the privilege to purchase, repackage and distribute or resell wholesale …

Connecting Volunteerism To A Career: My Journey With The American Cancer Society And Pharmacy, Christine Kane

Purdue Journal of Service-Learning and International Engagement

Christine Kane is a 2016 graduate from the Purdue College of Pharmacy. In this article, she describes how two passions, the profession of pharmacy and volunteerism with the American Cancer Society, became intertwined to change the course of her career. She implores fellow students to never underestimate the impact an extracurricular activity can have on the rest of your life.

Cross-Sectional Survey Of Perceived Barriers Among Community Pharmacists Who Do Not Immunize, In Wayne County, Michigan, Sarah E. Kelling, Anthony Pattin, Abdulbaset Salim, Paul Kilgore, Steven R. Erickson

Department of Pharmacy Practice

Introduction: The goal of the study was to identify perceived barriers to implementation of vaccination services encountered by independent and small-chain community pharmacies in an urban setting.

Methods: Pharmacists in independent and small-chain pharmacies located in 29 Michigan ZIP codes were visited and asked to complete a 5- to 10-min semi-structured interview.

Results: A total of 93 independent and 12 small-chain pharmacies participated (n = 105; 61%). The pharmacies filled an average of 700 prescriptions each week with 1.1 pharmacist full-time equivalents and 57 h of technician time. The most common services that participating pharmacies provided were dispensing outpatient …

Using Scientific Inquiry To Increase Knowledge Of Vaccine Theory And Infectious Diseases, Zachary Walls, John B. Bossaer, David Cluck

ETSU Faculty Works

Background: The aim of this study was to design and evaluate a laboratory activity based on scientific inquiry to educate first-year pharmacy students in the U.S. about vaccination theory and the attributes of common pathogens. Methods: The laboratory activity had two principal sections. The first consisted of an interactive game during which students rolled a die to determine outcomes based on a set of pre-determined criteria. In the second section, students generated and tested hypotheses about vaccine theory using a computer simulation that modeled disease transmission within a large population. In each section students were asked to evaluate epidemiological data …

Keeping An Eye On The Fda, Rodney Richmond

Faculty Research ​and Publications

No abstract provided.

Drug-Induced Nutrient Depletion, Rodney Richmond

Faculty Research ​and Publications

No abstract provided.

Predictors Of Neonatal Abstinence Syndrome In Buprenorphine Exposed Newborn: Can Cord Blood Buprenorphine Metabolite Levels Help?, Darshan Shah, Stacy Brown, Nick Hagemeier, Shimin Zheng, Amy Kyle, Jason Pryor, Nilesh Dankhara, Piyuesh Singh

ETSU Faculty Works

Background

Buprenorphine is a semi-synthetic opioid used for the treatment of opioid dependence. Opioid use, including buprenorphine, has been increasing in recent years, in the general population and in pregnant women. Consequently, there has been a rise in frequency of neonatal abstinence syndrome (NAS), associated with buprenorphine use during pregnancy. The purpose of this study was to investigate correlations between buprenorphine and buprenorphine-metabolite concentrations in cord blood and onset of NAS in buprenorphine exposed newborns.

Methods

Nineteen (19) newborns who met inclusion criteria were followed after birth until discharge in a double-blind non-intervention study, after maternal consent. Cord blood and …

Delinking Investment In Antibiotic Research And Development From Sales Revenues: The Challenges Of Transforming A Promising Idea Into Reality, Kevin Outterson, Unni Gopinathan, Charles Clift, Anthony So, Chantal Morel, John-Arne Røttingen

Faculty Scholarship

1. The current business model for antibiotics is plagued by market failures and perverse incentives that both work against conservation efforts and provide insufficient rewards to drive the development of much-needed new treatments for resistant infection.

2. Many new incentive mechanisms have been proposed to realign incentives and support innovation and conservation over the long term. The most promising of these are based on the idea of delinking rewards from sales volume of the antibiotic — the notion of “delinkage.”

3. Some critical design issues for delinkage remain, such as how to secure access to badly needed new products when …

Calcium Phosphate As A Key Material For Socially Responsible Tissue Engineering, Vuk Uskoković, Victoria M. Wu

Pharmacy Faculty Articles and Research

Socially responsible technologies are designed while taking into consideration the socioeconomic, geopolitical and environmental limitations of regions in which they will be implemented. In the medical context, this involves making therapeutic platforms more accessible and affordable to patients in poor regions of the world wherein a given disease is endemic. This often necessitates going against the reigning trend of making therapeutic nanoparticles ever more structurally complex and expensive. However, studies aimed at simplifying materials and formulations while maintaining the functionality and therapeutic response of their more complex counterparts seldom provoke a significant interest in the scientific community. In this review …