Pharmacy Administration, Policy and Regulation Commons^™

Youth Perception Of Harm And Addictiveness Of Tobacco Products: Findings From The Population Assessment Of Tobacco And Health Study (Wave 1), David R. Strong, Karen Messer, Martha White, Yuyan Shi, Madison Noble, David B. Portnoy, Alexander Persoskie, Annette R. Kaufman, Kelvin Choi, Charles Carusi, Maansi Bansal-Travers, Andrew Hyland, John Pierce

United States Food and Drug Administration: Publications

Purpose: We provide a US national assessment of youth perceptions of the harm and addictiveness of six separate tobacco products, identifying a continuum of perceived harm associated with a range of products in relation to patterns of current use, former use, and susceptibility to use tobacco products.

Methods: We evaluated youth respondents (N=13,651) ages 12–17 from Wave 1 (2013–2014) of the Population Assessment of Tobacco and Health (PATH) Study. Analyses (2015–2016) focused on refining mea- sures of perceived harm for each product and delineating youth characteristics (demographic, tobacco use status) associated with beliefs about the harmfulness and addictiveness of tobacco …

Associations Of Risk Factors Of E-Cigarette And Cigarette Use And Susceptibility To Use Among Baseline Path Study Youth Participants (2013–2014), Michael D. Sawdey, Hannah R. Day, Blair Coleman, Lisa D. Gardner, Sarah E. Johnson, Jean Limpert, Hoda T. Hammad, Macieji L. Goniewicz, David B. Abrams, Cassandra A. Stanton, Jennifer L. Pearson, Annette R. Kaufman, Heather L. Kimmel, Cristine D. Delnevo, Wilson M. Compton, Maansi Bansal-Travers, Raymond S. Niaura, Andrew Hyland, Bridget K. Ambrose

United States Food and Drug Administration: Publications

Introduction: Improved understanding of the distribution of traditional risk factors of cigarette smoking among youth who have ever used or are susceptible to e-cigarettes and cigarettes will inform future longitudinal studies examining transitions in use.

Methods: Multiple logistic regression analysis was conducted using data from youth (ages 12–17 years) who had ever heard of e-cigarettes at baseline of the PATH Study (n = 12,460) to compare the distribution of risk factors for cigarette smoking among seven mutually exclusive groups based on ever cigarette/e-cigarette use and sus- ceptibility status.

Results: Compared to committed never users, youth susceptible to e-cigarettes, cigarettes, or …

Selection And Consumption Of Lunches By National School Lunch Program T Participants, Janet G. Peckham, Jaclyn D. Kropp, Thomas A. Mroz, Vivian Haley-Zitlin, Ellen M. Granberg

United States Food and Drug Administration: Publications

The Healthy, Hunger-Free Kids Act of 2010 requires schools participating in the National School Lunch Program (NSLP) to offer a variety of healthy food options each day. Using digital photography data collected from two suburban elementary schools in the spring of 2013, we examine NSLP participant's selection and consumption of all five NSLP lunch components ((1) milk, (2) vegetable, (3) fruit, (4) meat/meat alternate (MA), and (5) grain). We use logit regressions to analyze the selection of the various lunch components by race/ethnicity, gender, grade, and household income level. In addition, ordinary least squares regressions are used to analyze the …

Examining The Role Of Menthol Cigarettes In Progression To Established T Smoking Among Youth, James Nonnemaker, Shari P. Feirman, Anna Macmonegle, Bridget K. Ambrose, Kia J. Jackson, Megan J. Schroeder, Alexandria A. Smith, William Ridgeway, Olga Rass

United States Food and Drug Administration: Publications

Background: Menthol, a flavoring compound added to cigarettes, makes cigarettes more appealing to youth and inexperienced smokers and increases cigarettes' abuse liability. However, limited studies are available on menthol's role in smoking progression.

Methods: To assess the association between menthol in cigarettes and progression to established smoking, we used five waves of data from the Evaluation of Public Education Campaign on Teen Tobacco Cohort Study, a nationally representative longitudinal survey of U.S. youth conducted as part of “The Real Cost” evaluation. We used discrete time survival analysis to model the occurrence of two event outcomes—progression to established, current smoking and …

U.S. Adult Perceptions Of The Harmfulness Of Tobacco Products: Descriptive T Findings From The 2013–14 Baseline Wave 1 Of The Path Study, Geoffrey T. Fong, Tara Elton-Marshall, Pete Driezen, Annette R. Kaufman, K. Michael Cummings, Kelvin Choi, Jonathan Kwan, Amber Koblitz, Andrew Hyland, Maansi Bansal-Travers, Charles Carusi, Mary E. Thompson

United States Food and Drug Administration: Publications

Introduction: This study is the first nationally representative survey of U.S. adults (18+) to examine perceptions of the relative harms of eight non-cigarette tobacco products.

Methods: Data are from Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study Adult Questionnaire, a nationally representative study of 32,320 adults in the United States conducted from September 2013 to December 2014.

Results: 40.7% of adults believed that electronic cigarettes were less harmful than cigarettes, and 17.8% of adults believed that hookah was less harmful than cigarettes. Those less knowledgeable about the health risks of smoking were more likely to believe …

At Risk Alcohol Consumption With Smoking By National Background: Results From The Hispanic Community Health Study/Study Of Latinos, Frank C. Bandiera, Eliseo J. Pérez-Stable, Folefac Atem, Raul Caetano, Denise C. Vidot, Marc D. Gellman, Elena L. Navas-Nacher, Jianwen Cai, Gregory Talavera, Neil Schneiderman, Robert Kaplan

United States Food and Drug Administration: Publications

Introduction: Tobacco smoking and binge or excess drinking are unhealthy behaviors that frequently co-occur. Studies of Hispanics/Latinos have mostly been of Mexican Americans although there are substantial differences in smoking and drinking by heritage background. Associated with co-use by 5 subpopulations.

Methods: Cross-sectional data of 16,412 Hispanics/Latinos from Miami, the Bronx, Chicago and San Diego collected between 2008 and 2011 as part of the HCHS/SOL were analyzed. Smoking and alcohol consumption and demographic data were measured by self-report. Prevalence of smoking and alcohol consumption and co-use were reported. Logistic regression models examined the odds of co-use of smoking and binge …

Comparing Methods For Clinical Investigator Site Inspection Selection: A Comparison Of Site Selection Methods Of Investigators In Clinical Trials, Nicholas Hein, Elena Rantou, Paul Schuette

United States Food and Drug Administration: Publications

Background During the past two decades, the number and complexity of clinical trials have risen dramatically increasing the difficulty of choosing sites for inspection. FDA’s resources are limited and so sites should be chosen with care.

Purpose To determine if data mining techniques and/or unsupervised statistical monitoring can assist with the process of identifying potential clinical sites for inspection.

Methods Five summary-level clinical site datasets from four new drug applications (NDA) and one biologics license application (BLA), where the FDA had performed or had planned site inspections, were used. The num- ber of sites inspected and the results of the …

Evaluating Ways To Reduce Errors In Medication Reconciliations Performed By Nurses In A Rural Hospital Setting, Kalen T. Freeman

MPA/MPP/MPFM Capstone Projects

Medication reconciliation, also known as “med recs”, are an important part of a patient’s care during their hospitalization. A med rec is when hospital personnel generate a list of the medications the patient takes at home. Med recs are vital in the hospital admission process because home medications need to be restarted at appropriate times to fully care for the patient. Also, mistakes in a home medication list can lead to serious consequences in the patient’s health. This study focuses on med recs being performed at Marcum and Wallace Hospital in Irvine, Kentucky. More specifically, the study explores the different …

Pharmacy-Based Travel Health Services In The United States, Keri Hurley-Kim, Jeffery Goad, Sheila Seed, Karl M. Hess

Pharmacy Faculty Articles and Research

The aim of this paper is to review pharmacy laws and regulations, pharmacist training, clinic considerations, and patient care outcomes regarding pharmacy-based travel health services in the United States. Pharmacists and pharmacies in the United States are highly visible and accessible to the public, and have long been regarded as a source for immunization services. As international travel continues to increase and grow in popularity in this country, there is a pressing need for expanded access to preventative health services, including routine and travel vaccinations, as well as medications for prophylaxis or self-treatment of conditions that may be acquired overseas. …

Multiple Sclerosis Drugs Have Been Getting A Lot More Expensive, Ben Jay

Capstones

Multiple Sclerosis is a very expensive disease. According to a 2016 study in the American Journal of Managed Care, treating it can cost patients anywhere from $30,000 to $100,000 per year, which can meet or even exceed the average US household median income, depending on how severe your case is. For a disease that has no known cure, and requires frequent medical attention to manage symptoms that can completely debilitate a person if left untreated, that can mean spending $4.1 million over the course of a lifetime, according to the same study. However, in the last 20 years, that …

From Prison To The Community: Opportunities For Pharmacists To Support Inmate Medication Adherence, Elliott Bosco, Deborah Shelton

Journal for Evidence-based Practice in Correctional Health

The United States correctional system is a vital treatment source for chronic illnesses. Whether treating a chronic mental or physical illness, correctional healthcare requires effective resource utilization. Limited research exists on pharmacists' ability to directly address inmate medication adherence. Thus, this study explores inmate perception of medication adherence and management as part of their treatment plan. Semi-structured interviews were conducted with inmates throughout Connecticut. Diseases of interest were divided into a physical illness group (hypertension, diabetes mellitus, HIV/AIDS) and a mental illness group (depression, bipolar disorder, schizophrenia, substance abuse). A content analysis was conducted on four questions: 1) Do you …

Increase Referrals To Medaccess At The Smhc Pharmacy, Sarah Jones, Kim Beaudoin

Southern Maine Health Care

Problem/Impact Statement: The MedAccess Program is losing referrals at point of sale in the SMHC Pharmacy.

Scope: Patients who are currently serviced by the SMHC Pharmacy that are uninsured or under insured and meet the % Federal Poverty Level for prescription assistance.

Evaluation Of Processes And Procedures For Care Of The Opioid Recipient Patient In The Primary Care Setting, Anne Sproat

Doctoral Projects

Introduction: Chronic non-cancer pain is far reaching, affecting over 100 million Americans (Zgierska et al., 2018). Opioids are commonly prescribed for chronic pain, with approximately 20% of patients presenting to primary care offices with symptoms of pain or pain-related diagnoses (Dowell, Haegerich, & Chou, 2016). As a result, opioid prescribing rates are increasing at a faster rate for primary care practice compared with other specialties (Dowell et al., 2016). Within the United States population, it is estimated that three percent to four percent of the adult population are prescribed long-term opioids for the treatment of chronic non-cancer pain (Dowell et …

Radical Social Ecology As Deep Pragmatism: A Call To The Abolition Of Systemic Dissonance And The Minimization Of Entropic Chaos, Arielle Brender

Student Theses 2015-Present

This paper aims to shed light on the dissonance caused by the superimposition of Dominant Human Systems on Natural Systems. I highlight the synthetic nature of Dominant Human Systems as egoic and linguistic phenomenon manufactured by a mere portion of the human population, which renders them inherently oppressive unto peoples and landscapes whose wisdom were barred from the design process. In pursuing a radical pragmatic approach to mending the simultaneous oppression and destruction of the human being and the earth, I highlight the necessity of minimizing entropic chaos caused by excess energy expenditure, an essential feature of systems that aim …

Analyzing The Differentiation Among State Medical Marijuana Policies By Examining State Policies & Trends, Richard Furlong

Political Science Theses and Capstones

Support for marijuana has been growing nationwide. This increased support has gained a lot of momentum since the late 1990s when California became the first state to legalize marijuana for medical use by enacting Proposition 215, or the Compassionate Use Act. Since the enactment of Proposition 215, 28 more states and the District of Columbia have legalized marijuana for medicinal use. I look into why states have begun to adopt these laws, and what makes these states differ throughout the country in the timeliness of their actions. I assembled data to examine a variety of state policies to attempt to …

Prescription Drug Abuse, Jiaxi Tian

Global Issues in Public Health

Prescription drug abuse is an action that portrayed as misuse or overuse of prescription drugs. It is a prevalent problem all over the world. U.S is a particular country that has drug abuse as a serious problem has several different causes of the drug abuse. In the U.S., most prescription drugs are pain killers. The outcomes of drug abuse vary but may lead to death.

Parent Perspectives On Health And Functioning Of School-Aged Adolescents With Disabilities, Gavin Colquit Edd, Cape, Cscs, Ashley D. Walker Phd, Ches, Moya L. Alfonso Phd, Msph, Maria Olivas Mph, Bethrand Ugwu Mph, Theophile Dipita Dr, Ph

United States Food and Drug Administration: Publications

BACKGROUND: Youth living with disabilities are at risk of experiencing poor health outcomes. Coordinated school health programs have an opportunity to help youth with disabilities and their families through health education, health services, and community engagement. The World Health Organization developed the International Classification of Functioning, Disability, and Health (ICF) as a framework to analyze factors related to health conditions. We used the ICF to examine parental perceptions of health and function among students with disabilities living in rural and urban areas.

METHODS: We surveyed parents (N = 71) using the parent-report versions of the Pediatric Outcomes Data Collection Instrument …

Mental Health Problems And Onset Of Tobacco Use Among 12- To 24-Year-Olds In The Path Study, Victoria R. Green Mhs, Kevin P. Conway Phd, Ches, Marushka L. Silveira Bds, Mph, Phd, Karin A. Kasza Ma, Amy Cohn Phd, K. Michael Cummings Phd, Mph, Cassandra A. Stanton Phd, Priscilla Callahan-Lyon Md, Wendy Slavit Mph, Ches, James D. Sargent Md, Nahla Hilmi Mph, Raymond S. Niaura Phd, Chad J. Reissig Phd, Elizabeth Lambert Ma, Izabella Zandberg Phd, Mary F. Brunette Md, Susanne E. Tanski Md, Nicolette Borek Phd, Andrew J. Hyland Phd, Wilson M. Compton Md, Mpe

United States Food and Drug Administration: Publications

Objective: To examine whether mental health problems predict incident use of 12 different tobacco products in a nationally representative sample of youth and young adults.

Method: This study analyzed Wave (W) 1 and W2 data from 10,533 12- to 24-year-old W1 never tobacco users in the Population Assessment of Tobacco and Health (PATH) Study. Self-reported lifetime internalizing and externalizing symptoms were assessed at W1. Past 12-month use of cigarettes, electronic nicotine delivery systems (ENDS), traditional cigars, cigarillos, filtered cigars, pipe, hookah, snus pouches, other smokeless tobacco, bidis and kreteks (youth only), and dissolvable tobacco was assessed at W2.

Results:In multivariable …

Etiology Of Teen Dating Violence Among Adolescent Children Of Alcoholics, Jennifer A. Livingston, Rina D. Eiden, Jared Lessard, Meghan Casey, James Henrie, Kenneth E. Leonard

United States Food and Drug Administration: Publications

Family processes in early life have been impli- cated in adolescent involvement in teen dating violence, yet the developmental pathways through which this occurs are not well understood. In this study, etiological pathways from parental psychopathology and marital conflict in infancy to involvement in dating violence in late adoles- cence were examined in a sample of children at high-risk due to parental alcohol problems. Families (N = 227) recruited when the child was 12 months of age were assessed at 12-, 24-, 36-months, kindergarten, 6th, 8th, and 12th grades. Slightly more than half of the children were female (51%) and …

Prevalence Of Adhd In Publicly Insured Adults, Yanmin Zhu, Wie Liu, Yan Li, Xi Wang, Almut G. Winterstein

United States Food and Drug Administration: Publications

Objective: To estimate the prevalence of adult ADHD diagnosis and treatment in U.S. Medicaid beneficiaries. Method: Using outpatient, inpatient, and pharmacy billing records for patients eligible for Medicaid fee-for-service benefits within 29 states from 1999 to 2010, we estimated the annual prevalence of ADHD diagnosis and treatment. Results: The prevalence of ADHD diagnosis increased from 2.20 per 1,000 patients in 1999 to 10.57 in 2010. Likewise, prevalence of ADHD treatment increased from 1.95 per 1,000 patients in 1999 to 13.16 in 2010. Between 40% and 65%, patients had ADHD drug prescription fills 6 months after ADHD diagnosis, whereas 45% to …

Co-Occurrence Of Tobacco Product Use, Substance Use, And Mental Health Problems Among Youth: Findings From Wave 1 (2013–2014) Of The Population Assessment Of Tobacco And Health (Path) Study, Kevin P. Conway, Victoria R. Green, Karin A. Kasza, Marushka L. Silveira, Nicolette Borek, Heather L. Kimmel, James D. Sargent, Cassandra A. Stanton, Elizabeth Lambert, Nahla Hilmi, Chad J. Reissig, Kia J. Jackson, Susanne E. Tanski, David Maklan, Andrew J. Hyland, Wilson M. Compton

United States Food and Drug Administration: Publications

Introduction: Cigarette use is associated with substance use and mental health problems among youth, but as- sociations are unknown for non-cigarette tobacco product use, as well as the increasingly common poly-tobacco use.

Methods: The current study examined co-occurrence of substance use and mental health problems across tobacco products among 13,617 youth aged 12–17 years from Wave 1 (2013–2014) of the nationally representative Population Assessment of Tobacco and Health (PATH) Study. Participants self-reported ever cigarette, e-cigar- ette, smokeless tobacco, traditional cigar, cigarillo, filtered cigar, hookah, and other tobacco product use; al- cohol, marijuana, and other drugs; and lifetime substance use, internalizing …

Trends And Economic Drivers For United States Naloxone Pricing, January T 2006 To February 2017, Matthew Rosenberg, Grace Chai, Shekhar Mehta, Andreas Schick

United States Food and Drug Administration: Publications

Anecdotal evidence indicates that naloxone prices have risen in recent years, but limited research has examined the magnitude of these increases and potential causes. We contribute nationally representative evidence to help answer each of these questions, including wholesale pricing data from a proprietary drug sales database span- ning January 2006 to February 2017. We find that all formulations of naloxone increased in price since 2006 except for Narcan Nasal Spray. These cumulative increases totaled 2281% for the 0.4 MG single-dose products, 244% for the 2 MG single-dose products, 3797% for the 4 MG multi-dose products, and 469% for the 0.4 …

Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim

Faculty Publications By Year

There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval …

Communicating Nutrition Information At The Point Of Purchase: An Eye‐Tracking Study Of Shoppers At Two Grocery Stores In The United States, Mike Bartels, Katherin Tillack, Chung‐Tung Jordan Lin

United States Food and Drug Administration: Publications

Providing nutrition information at the point of purchase is one approach that can be used to help consumers adopt and maintain a healthy diet. Previous research has examined consumer self‐reported notice and use of the information as well as how the design of the information affects its attention and use in a laboratory environ‐ ment using eye‐tracking methodology. This study advances the literature by applying eye‐tracking methodology to explore consumer visual and choice behavior in a real shopping environment, and by recognizing that nutrition information competes with other visual stimuli in the store and consumers are vulnerable to a “limited …

Investigating The Role Of Prescription Drug Monitoring Programs In Reducing Rates Of Opioid-Related Poisonings, Nathan James Pauly

Theses and Dissertations--Pharmacy

The United States is in the midst of an opioid epidemic. In addition to other system level interventions, almost all states have responded to the crisis by implementing prescription drug monitoring programs (PDMPs). PDMPs are state-level interventions that track the dispensing of Controlled Substances. Data generated at the time of medication dispensing is uploaded to a central data server that may be used to assist in identifying drug diversion, medication misuse, or potentially aberrant prescribing practices.

Prior studies assessing the impact of PDMPs on trends in opioid-related morbidity have often failed to take into account the wide heterogeneity of program …

Economic Burden Of Renal Cell Carcinoma (Rcc) And Treatment Patterns, Overall Survival And Healthcare Costs Among Older Metastatic Rcc Patients, Hrishikesh P. Kale

Theses and Dissertations

Background

Renal cell carcinoma (RCC) is the most common type of kidney cancer. Patients diagnosed with metastatic RCC (mRCC) have shorter overall survival compared to those diagnosed at earlier stages. Several targeted therapies, which cost from $7,000 - $16,000 per month have been approved since 2005 to treat mRCC. In addition, there is a growing interest in the use of cytoreductive nephrectomy (CN) with targeted therapies among mRCC patients. However, little is known regarding the economic burden of RCC and role of CN and prescribing patterns of targeted therapies among older mRCC patients.

Objectives

1) To assess the economic burden …

Changes In The Utilization Of Osteoporosis Drugs After The 2010 Fda Bisphosphonate Drug Safety Communication, Bander Balkhi, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio

Pharmacy Faculty Articles and Research

Introduction

In October 2010, the US Food and Drug Administration (FDA) issued a safety communication regarding the risks of atypical fractures of the femur, with bisphosphonates drugs. This study evaluated the impact of the bisphosphonates FDA safety communication on the utilization of osteoporosis medications in Medicaid programs.

Methods

Osteoporosis drugs utilization data from the July 2006 to June 2014 were extracted from the national Summary Files from the Medicaid State Drug Utilization Data maintained by the Centers for Medicare & Medicaid Services (CMS). We performed an interrupted time series analyses to evaluate trends in utilization of osteoporosis drugs before and …

Evaluating Patient Preferences For Different Incentive Programs To Optimize Pharmacist-Provided Patient Care Program Enrollment, Daniel M. Tomaszewski, Tim Cernohaus, Rajiv Vaidyanathan

Pharmacy Faculty Articles and Research

BACKGROUND: Employers have increased efforts to engage employees in health and wellness programs. Providing employees with incentives to participate in these programs has been shown to improve overall enrollment and engagement. One program that has had challenges with enrollment and engagement is medication therapy management (MTM).

OBJECTIVES: To (a) determine how individuals evaluate different financial incentives to improve participation in an MTM program and (b) measure the effect of participant characteristics on incentive preference.

METHODS: This study was composed of a paper-based survey administered to participants after focus group sessions. Participants included MTMeligible beneficiaries from 2 employer groups and included …

A Course On Patient Safety: Pharmacy Student And Community Partner Perceptions, Maryam Noureldin, Chelsea M. Anderson, Patricia L. Darbishire

Purdue Journal of Service-Learning and International Engagement

The authors of this article developed and piloted a three-week intensive elective course for students in their third professional years in the Doctor of Pharmacy program. The goal of this course was to provide students with an opportunity to apply patient safety concepts in a real-world setting using service-learning as the pedagogy and to evaluate student perceptions of the course for potential implementation in the curriculum. Seven pharmacy students were enrolled in the pilot course and divided into three groups. Each group of two to three students was assigned to one of three predetermined community partner sites. Students were instructed …

Expanding The Horizon: Global Health Management For Pharmacy Students, Alice C. Chang, Monica L. Miller, Ellen M. Schellhase

Purdue Journal of Service-Learning and International Engagement

The advancement of global engagement opportunities will promote pharmacy students’ cultural awareness and sensitivity, expose students to treatment of diseases not commonly seen in modern Western medicine, and cultivate future leadership for the growth of global pharmacy practice. At Purdue University College of Pharmacy (PUCOP), limited opportunities exist for student pharmacists. As a result, identifying the needs and expanding student pharmacist access to global engagement experiences are critical to meet the changing needs of the US population. A survey was developed and distributed to 460 students at PUCOP, and 148 of them participated. Of those students, 89.2% were interested in …