Health and Medical Administration Commons^™

Food Safety Traceability, Yimin Wei, Boli Guo, Hongyan Liu, Shuai Wei, Jianrong Zhang

United States Food and Drug Administration: Publications

With globalized economics, it is becoming more frequent to trade food across country and regional borders, which leads to expanding and spreading of all kinds of food safety incidents and hazards. Mad cow disease, foot and mouth disease, avian flu and other zoonotic diseases pose a grave threat to food safety and human health, causing serious economic losses for food industries and causing social panic at the same time. In order to reduce the losses caused by such serious zoonotic diseases, as well as to ensure food safety, many countries have started to implement food safety traceability systems. The European …

Quality By Design: Process Trajectory Development For A Dynamic Pharmaceutical Coprecipitation Process Based On An Integrated Real‐Time Process Monitoring Strategy, Huiquan Wu, Mansoor A. Khan

United States Food and Drug Administration: Publications

Increasing prevalence of poorly water‐soluble drugs in pharmaceutical development provides notable risks of new products demonstrating low and erratic bioavailability. This dissolution‐limited bioavailability may have consequences for safety and efficacy, particularly for drugs delivered by the oral route of administration. Several novel drug delivery technologies have been developed to improve drug solubility, dissolution rates, and bioavailability. Among those are solid dispersion, nanotechnology, supercritical fluid technology, lipid‐based technology, and crystal engineering. Although these strategies are available for enhancing the bioavailability of drugs with low aqueous solubility, the success of these approaches is not yet guaranteed and is greatly dependent on the …

The Impact Of The Boxed Warning On The Duration Of Use For Depot Medroxprogesterone Acetate, Efe Eworuke, Joo-Yeon Lee, Lisa Soule, Vaishali Popat, David G. Moeny

United States Food and Drug Administration: Publications

Objective The objective of this study was to examine the impact of the Food and Drug Administration’s boxed warning on the utilization of depot medroxyprogesterone (DMPA).

Methods From the IMS Lifelink data (2001–2009), we identified DMPA and oral combined hormonal contraceptive (CHC) users without a prescription claim 6 months before and after the first and last claim. Episodes were defined as all contiguous claims with no more than 90- day DMPA or 30-day CHC between claims. Days’ supply (CHC) and 90-day duration (DMPA) was used to determine episodes. We used interrupted time series to evaluate changes in the mean episode …

Modeling And Statistical Issues Related To Salmonella In Low Water Activity Foods, Sofia M. Santillana Farakos, Michelle Danyluk, Donald Schaffner, Régis Pouillot, Linda J. Harris, Bradley P. Marks

United States Food and Drug Administration: Publications

The presence and survival of Salmonella in low water activity (a_w) foods continues to pose a challenge for the food industry. Peer‐reviewed literature data on prevalence and levels of contamination of Salmonella in low water activity foods in the United States are limited. Available published data include those on: Salmonella contamination on nuts and peanuts (Calhoun et al., 2013), almonds (Danyluk et al., 2007; Bansal et al., 2010), pecans (Brar, Strawn, and Danyluk, 2016), and walnuts (Davidson et al., 2015); prevalence and levels of Salmonella on spices (Van Doren et al., 2013); as …

Disparities In Hypertension And Cardiovascular Disease In Blacks: The Critical Role Of Medication Adherence, Keith C. Ferdinand, Kapil Yadav, Samar A. Nasser, Helene D. Clayton-Jeter, John Lewin, Dennis R. Cryer, Fortunato Fred Senatore

United States Food and Drug Administration: Publications

Blacks are two to three times as likely as whites to die of preventable heart disease and stroke. Declines in mortality from heart disease have not eliminated racial disparities. Control and effective treatment of hypertension, a leading cause of cardiovascular disease, among blacks is less than in whites and remains a challenge. One of the driving forces behind this racial/ethnic disparity is medication nonadherence whose cause is embedded in social determinants. Eight practical approaches to addressing medication adherence with the potential to attenuate disparities were identified and include: (1) patient engagement strategies, (2) consumer-directed health care, (3) patient portals, (4) …

Current Practices In Corrosion, Surface Characterization, And Nickel Leach Testing Of Cardiovascular Metallic Implants, Srinidhi Nagaraja, Matthew Di Prima, David Saylor, Erica Takai

United States Food and Drug Administration: Publications

In an effort to better understand current test practices and improve nonclinical testing of cardiovascular metallic implants, the Food and Drug Administration (FDA) held a public workshop on Cardiovascular Metallic Implants: corrosion, surface characterization, and nickel leaching. The following topics were discussed: (1) methods used for corrosion assessments, surface characterization techniques, and nickel leach testing of metallic cardiovascular implant devices, (2) the limitations of each of these in vitro tests in predicting in vivo performance, (3) the need, utility, and circumstances when each test should be considered, and (4) the potential testing paradigms, including acceptance criteria for each test. In …

High Throughput Quantification Of Apolipoproteins A-I And B-100 By Isotope Dilution Ms Targeting Fast Trypsin Releasable Peptides Without Reduction And Alkylation, Bryan A. Parks, David M. Schieltz, Michael L. Andrews, Michael S. Gardner, John C. Rees, Christopher A. Toth, Jeffrey I. Jones, Lisa G. Mcwilliams, Zsuzsanna Kuklenyik, James L. Pirkle, John R. Barr

United States Food and Drug Administration: Publications

Purpose: Apolipoprotein A-I (ApoA-I) and apolipoprotein B-100 (ApoB-100) are amphipathic proteins that are strong predictors of cardiovascular disease risk. The traceable calibration of apolipoprotein assays is a persistent challenge, especially for ApoB-100, which cannot be solubilized in purified form.

Experimental design: A simultaneous quantitation method for ApoA-I and ApoB-100 was developed using tryptic digestion without predigestion reduction and alkylation, followed by LC separation coupled with isotope dilution MS analysis. The accuracy of the method was assured by selecting structurally exposed signature peptides, optimal choice of detergent, protein: enzyme ratio, and incubation time. Peptide calibrators were value assigned by isobaric tagging …

Dental Care For Older Adults: Regulatory Requirements In Long Term Care Settings, American Dental Association

Action for Dental Health

No abstract provided.

Why Does Oral Health In Long-Term Care Residents Matter? Talking Points For Administrators, American Dental Association

Action for Dental Health

No abstract provided.

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).

Discrete Event Simulation Model For Planning Level 2 “Step-Down” Bed Needs Using Nems, Felipe F. Rodrigues, Gregory S. Zaric, David Stanford

Business Publications

In highly congested hospitals it may be common for patients to overstay at Intensive Care Units (ICU) due to blockages and imbalances in capacity. This is inadequate clinically, as patients occupy a service they no longer need; operationally, as it disrupts flow from upstream units; and financially as ICU beds are more expensive than ward beds. Step-down beds, also known as Level 2 beds, have become an increasingly popular and less expensive alternative to ICU beds to deal with this issue. We developed a discrete event simulation model that estimates Level 2 bed needs for a large university hospital. The …

Evolving Workforce Roles In Medicare Next Generation Acos, Clese E Erikson

Health Workforce Research Center Publications

The purpose of this study was to explore key workforce strategies in Next Generation Accountable Care Organizations (Next Gen ACOs), the latest evolution in Medicare ACOs. We conducted semi-structured interviews with leaders from seven of the initial 18 Next Gen ACOs to better understand their perceptions regarding how workforce roles are changing to support the Next Gen ACO model. Key Questions:

1. What new and expanded roles for existing health workforce members are reported by Next Generation ACO leaders?
2. Has use of the health workforce changed as a result of Next Gen waivers for telehealth, home visits, and use of SNFs? …

West Virginia Needle Exchange Program, Briana Washington, Sara Johnson

Theses, Dissertations and Capstones

Introduction: Needle Exchange Programs (NEPs) have been controversial aspects of public healthcare due to conflicting beliefs and opinions for public policies. NEPs allow Injection Drug Users (IDUs) the ability to exchange their used equipment for clean, unused supplies.

Purpose: The purpose of this literature review was to determine the effectiveness of needle exchange programs and the impact it has had on the reduction of HIV and viral hepatitis infections in people who inject drugs. It further explores if these strategies have had a positive impact on the reduction of HIV and viral hepatitis C in West Virginia.

Methodology …

Workplace Violence And Hospital Security Programs: Regulatory Compliance, Program Benchmarks, Innovative Strategies, James D. Blando, Maryalice Nocera, Marilyn L. Ridenour, Daniel Hartley

Community & Environmental Health Faculty Publications

The authors describe the issue of workplace violence in hospitals, a New Jersey state law and regulations regarding workplace violence in healthcare, and some innovative strategies that are being utilized to help reduce the occurrence and risk of violence. The authors also discuss compliance with the New Jersey regulations.

Expanding Dental Practices Into Long-Term Care, American Dental Association

Action for Dental Health

No abstract provided.

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 …

Chronic Kidney Disease Awareness And Quality Of Care In Abuja Nigeria, Patience Eze

Walden Dissertations and Doctoral Studies

Chronic kidney disease (CKD) is a non-communicable progressive disease that can lead to kidney failure or end-stage renal disease. In Nigeria, many people do not have access to health care due to extreme poverty, which means that those suffering from diabetes or high blood pressure, or both diseases, which have been identified as the 2 main risk factors, may not know their health status. The purpose of this phenomenological study was to explore the level of CKD awareness among Nigerians and if cultural beliefs affect individuals' health seeking behaviors because of the diverse nature of the Nigerian population. The protection …

Emergency Department Use Among Asian Adults Living In The United States: Results From The National Health Interview Survey (2006 – 2013), Kathleen M. Sullivan, James Davis, Angela Sy

Asian/Pacific Island Nursing Journal

This paper presents secondary analyses of the National Health Interview Survey data focused on emergency department (ED) utilization among Asian adults residing in the United States. National Health Interview Survey data provided from survey years 2006-2013 was pooled and disaggregated by single-race Asian ethnic subgroups (Filipino, Chinese, Asian Indian, other Asian). We explored trends in reports of an ED visit over the survey years for the purpose of determining whether reports of an ED visit increased or decreased over survey years. We also explored background/biologic, environment, access to care, and behavior factors and their associations with having an ED visit. …

Engaging Parents To Promote Children’S Nutrition And Health: Providers’ Barriers And Strategies In Head Start And Child Care Centers, Dipti A. Dev, Courtney Byrd-Williams, Samantha Ramsay, Brent A. Mcbride, Deepa Srivastava, Ashleigh L. Murriel, Chrisa Arcan, Anna M. Adachi-Mejia

Department of Child, Youth, and Family Studies: Faculty Publications

Purpose: Using the Academy of Nutrition and Dietetics benchmarks as a framework, this study examined childcare providers’ (Head Start [HS], Child and Adult Care Food Program [CACFP] funded, and non-CACFP) perspectives regarding communicating with parents about nutrition to promote children’s health.

Design: Qualitative.

Setting: State-licensed center-based childcare programs.

Participants: Full-time childcare providers (n ¼ 18) caring for children 2 to 5 years old from varying childcare contexts (HS, CACFP funded, and non-CACFP), race, education, and years of experience.

Methods: In-person interviews using semi-structured interview protocol until saturation were achieved. Thematic analysis was conducted.

Results: Two overarching themes were barriers and …

Exploring Job Satisfaction And Preceptorship Capacity Among Applied Epidemiologists, Jessica C. Arrazola

College of Graduate Studies: Theses & Dissertations

Job satisfaction is important to consider when developing strategies for recruitment and retention. The Public Health Workforce Interests and Needs Survey (PH WINS) conducted in 2014 was the first nationally representative assessment of the state public health workforce. Prior to this assessment, the job satisfaction of state agency public health workers and preceptor capacity had not been measured. This study fills the current research gaps by studying the job satisfaction among the applied epidemiology workforce, identifying factors influencing job satisfaction, and the describing the preceptorship capacity among epidemiologists. This research is based on the 2014 PH WINS data. The analysis …

Narratives Of Men Living With Systemic Lupus Erythematosus, Kimberly Vandermark Lynch

Walden Dissertations and Doctoral Studies

While systemic lupus erythematosus (SLE) has been traditionally viewed as a woman's disease, SLE impacts men as well. Although most research on SLE has concentrated on how it affected women, little is known about how it impacts men. The purpose of this phenomenological study was to examine how men who live with SLE perceive its psychological impact. Using the lens of the biopsychological theory, common themes were examined pertaining to how men with SLE perceive the impact that SLE has on their cognitive and emotional functioning. Data were collected via interviews with 9 men with SLE, and the data were …

Barriers And Perceptions Of Black American Men About Prostate Cancer In Georgia, Martins M. Nnoko

Walden Dissertations and Doctoral Studies

In 2016, prostate cancer was the second leading cause of fatality in the United States. However, the population in this study 'Black American men, ages 40 and older, in selected counties in Fulton, DeKalb, Gwinnett, Clayton and Atlanta metropolitan areas' tended to underutilize prostate cancer care. The purpose of this quantitative, nonexperimental descriptive study was to determine whether socio-economic barriers and perceptions of Black American men about prostate cancer reduce their ability to access quality care in this county in Georgia. The Health Belief Model (HBM) was used to inform the predictive validity of perceptions, attitudes, and belief on individual …

Discovering Opportunities To Improve Profitability At A Federally Qualified Health Center, Robert Jackson Jackson

Walden Dissertations and Doctoral Studies

Federally Qualified Health Center (FQHC) organizations, which provide health care services to low-income, underserved patients, are underfunded. From 2000 to 2007, the cost of treating an FQHC patient increased by $146, while federal compensation to FQHCs increased by only $44 per patient. One FQHC organization in rural Alabama experienced financial losses from the fiscal year 2011 through 2014, jeopardizing services to approximately 6,000 low-income patients. The purpose of this qualitative case study was to analyze the subject organization and discover opportunities to improve financial performance. The research question pertained to the opportunities for improving profitability at the subject organization. The …