Public Health Commons^™

Multiple Imputation To Evaluate The Impact Of An Assay Change In National Surveys, Maya Sternberg

United States Food and Drug Administration: Publications

National health surveys, such as the National Health and Nutrition Examination Survey, are used to monitor trends of nutritional biomarkers. These surveys try to maintain the same biomarker assay over time, but there are a variety of reasons why the assay may change. In these cases, it is important to evaluate the potential impact of a change so that any observed fluctuations in concentrations over time are not confounded by changes in the assay. To this end, a subset of stored specimens previously analyzed with the old assay is retested using the new assay. These paired data are used to …

Rapid Testing Of Food Matrices For Bacillus Cereus Enterotoxins, Sandra M. Tallent, Jennifer M. Hait, Ann M. Knolhoff, Reginald W. Bennett, Thomas S. Hammack, Timothy R. Croley

United States Food and Drug Administration: Publications

Nine different food products frequently associated with Bacillus cereus outbreaks were chosen as representative matrices to be evaluated with end-point polymerase chain reaction (PCR), enzyme linked immunosorbent assay, lateral flow device and mass spectrometry for detection of enterotoxins associated with human illness. Testing was performed on food portions inoculated with a bacterial strain and incubated at 30C for either 5 h or 24 h. A screening end-point multiplex PCR targeting enterotoxin genes including the emetic toxin and three diarrheal toxins, hemolytic hemolysin BL (Hbl), nonhemoltyic enterotoxin (Nhe), and cytolysin K. Commercially available kits were used to determine the presence/absence of …

Antiemetic Use Among Pregnant Women In The United States: The Escalating Use Of Ondansetron, Lockwood G. Taylor, Steven T. Bird, Leyla Sahin, Melissa S. Tassinari, Patty Greene, Marsha E. Reichman, Susan E. Andrade, Katherine Haffenreffer, Sengwee Toh

United States Food and Drug Administration: Publications

Purpose To examine ondansetron use in pregnancy in the context of other antiemetic use among a large insured United States population of women delivering live births.

Methods We assessed ondansetron and other antiemetic use among pregnant women delivering live births between 2001 and 2015 in 15 data partners contributing data to the Mini-Sentinel Distributed Database. We identified live birth pregnancies using a validated algorithm, and all forms of ondansetron and other available antiemetics were identified using National Drug Codes or procedure codes. We assessed the prevalence of antiemetic use by trimester, calendar year, and formulation.

Results In over 2.3 million …

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 …

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).

Benefits Of The 340b Drug Discount Program, Jarrett Gerlach, Sarah Mcsweeney, Angela Swearingen, Nitesh Patil, Alberto Coustasse

Management Faculty Research

Introduction: The 340B Drug Discount Program required drug manufacturers provide discounted outpatient drugs to healthcare organizations which serve vulnerable patient populations to allow these institutions to offer more services to more people. As the 340B program expanded, controversy has centered on which entities have benefited from the program. Many healthcare organizations sold 340B drugs to well-insured patients at full price, and thus have been financially rewarded. Amendments to the program have permitted 340B providers to utilize contract pharmacies to dispense 340B medication, which has furthered the debate over which stakeholders are benefiting from the program.

Purpose of the Study: The …

Baltimore, Md: Creating A Coalition To Improve School Climate In Inner City Baltimore, The Center And Health Care In Schools

Center for Health and Health Care in Schools

Serving one of the largest, and poorest, inner city school districts in the country, grant makers and service organizations have been helping children in Baltimore City Public Schools (City Schools) for years. In 2014, a diverse group of grant makers, government organizations, school personnel, and community groups started meeting to learn more about existing mental health programs, structures, and challenges in the schools. Still developing at the time of this study in spring 2015, the group has coalesced and grown under the umbrella term School Climate Network and, as of February 2016, is creating strategic plans and work groups to …

Developing A Business Plan For Sustaining School Mental Health Services: Three Success Storiess, Donna Behrens, Julia Graham Lear, Olga Acosta Price

Center for Health and Health Care in Schools

Imagine an America where children arrive at their school desks, ready to learn and succeed. They have coping skills to address their everyday worries, concerns and stressors, as well as the more difficult challenges life may present. They have social skills to establish positive relationships with their peers, teachers and parents. They make healthy choices that allow them to focus on their education and prepare for future success. And if a problem arises, they have access to early intervention and treatment. Now, imagine having sustainable funding to make all of this a reality.

Currently, however, barriers, particularly financing issues, restrict …

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 …

Building Community Schools In Upstate New York: Connecting With The Policy Environment, Center For Health And Health Care In Schools

Center for Health and Health Care in Schools

Broome County, New York is known statewide for its strong collaboration across organizations and sectors. In particular, schools and community agencies have been working together for many years to address the needs of low-income children, families, older adults and communities. When Binghamton University created the College of Community and Public Affairs in 2006, it became an important partner in securing funding for this work. Initial grants were small (e.g., $5K) and from the local community, but after collecting and analyzing data showing the impact of their efforts, the collaborative received a large multi-year federal grant. When that grant ended, the …

Partner Build Grow: An Action Guide For Sustaining Child Development And Prevention Approaches, The Center For Health And Health Care In Schools

Center for Health and Health Care in Schools

The Action Guide is intended to facilitate the implementation of a long-term plan for sustaining child development and prevention approaches necessary to achieve better child health and education outcomes.

The Changing Roles Of Community Health Workers, Mary-Beth Malcarney, Patricia Pittman, Leo Quigley, Naomi Seiler, Katie B. Horton

Health Workforce Research Center Publications

Community Health Workers (CHWs) have been gaining attention from policymakers because of their unique role in addressing health disparities and socioeconomic drivers of disease, and because of their potential integration into the health care delivery system. To date, there has been limited research specifically describing the variation in CHWs’ roles and relationships, and how that variation relates to management, to financing, to health system integration, and to the competencies CHWs should have in different contexts.

This report provides a snapshot of the varied landscape of CHW programs to better understand how CHWs are integrating with the health system both in …

Repealing Federal Health Reform: Economic And Employment Consequences For States, Leighton C. Ku, Erika Steinmetz, Erin Brantley, Brian K. Bruen

Health Policy and Management Issue Briefs

Issue: The incoming Trump administration and Republicans in Congress are seeking to repeal the Affordable Care Act (ACA), likely beginning with the law’s insurance premium tax credits and expansion of Medicaid eligibility. Research shows that the loss of these two provisions would lead to a doubling of the number of uninsured, higher uncompensated care costs for providers, and higher taxes for low-income Americans.

Goal: To determine the state-by-state effect of repeal on employment and economic activity.

Methods: A multistate economic forecasting model (PI+ from Regional Economic Models, Inc.) was used to quantify for each state the effects of the federal …

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 …

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, …

The Association Between Clinical Recognition Of Depression And Unplanned Hospital Readmission Among Older Adults, Karen M. Jones

Theses and Dissertations

Purpose

The likelihood of a depression diagnosis may differ based on whether the patient was seen in an inpatient or outpatient setting. Depression has been associated with an increased risk of a 30-day readmission. The purpose of this study was to determine the level of agreement (concordance) between depression diagnosis as identified by inpatient and outpatient records and examine the relationship between depression diagnostic concordance and 30-day readmission.

Methods

Using universal administrative claims data from South Carolina, we examined inpatient and outpatient records. The analysis was restricted to Medicaid recipients aged 55 years and older with a primary admitting diagnosis …

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.

University Of Montana Students And The Gardasil Vaccine, Markie C. Glidewell

Undergraduate Theses, Professional Papers, and Capstone Artifacts

Gardasil^® is a vaccine for human papilloma virus (HPV), a sexually transmitted virus that can cause genital warts, cervical cancer, and other diseases. Males and females ages 9-26 are recommended to receive the Gardasil^® vaccination. Most students attending the University of Montana (UM) are within the recommended age range for Gardasil^® vaccination and would benefit from receiving it if they have not yet done so. Gardasil^® is available at the Health Services Pharmacy on the UM campus and is often covered by insurance plans with no patient copay. In the fall semester of 2016, surveys were …

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 …