Pharmacy Administration, Policy and Regulation Commons^™

Long-Term Negative Emotional Outcomes Of Warzone Tbi, Jennifer J. Vasterling, Mihaela Aslan, Susan P. Proctor, John Ko, Xenia Leviyah, John Concato

United States Food and Drug Administration: Publications

Objective: Many veterans of the Iraq and Afghanistan Wars have experienced traumatic brain injury (TBI). Although prior work has examined associations between TBI and development of psychi- atric syndromes, less is known about associations between TBI and component emotions constituting these syndromes, especially in the long term. The purpose of this study was to examine the long-term emotional consequences of deployment-related TBI.

Methods: As part of VA Cooperative Studies Program #566, we assessed a sample of n1⁄4456US Army soldiers prior to an index deployment to Iraq, and again an average of 8.3 years (SD1⁄42.4years) after their deployment for a long-term …

Pharmaceutical Manufacturing In The 21st Century: Identification And Analysis Of Key Elements, Robert N. Mills

Honors Program: Senior Projects (Public)

The availability of quality pharmaceutical products impacts the lives of the global population on a daily basis. The importance of product availability and quality within pharmaceutical manufacturing requires that quality systems put into place are capable of accurately and robustly capturing the quality compliance, or lack thereof, of the various stages of production. This review intends to analyze current expert-recommended best practices within key elements of a pharmaceutical manufacturing quality control system and provide recommendations throughout. The quality elements discussed include Quality by Design method validation, necessary equipment determination, and equipment qualification, followed by documentation control and data flow.

Naming Convention, Interchangeability, And Patient Interest In Biosimilars, Mariana P. Socal, Jace B. Garrett, William B. Tayler, Ge Bai, Gerard F. Anderson

Faculty Publications

Although biosimilars may offer cost savings over their comparable biologics, use of biosimilars in the United States remains relatively low. This study investigates two barriers to uptake of biosimilars in the United States. First, the U.S. Food and Drug Administration requires that four-letter suffixes be added to the nonproprietary names of all biosimilars, as well as to the nonproprietary names of all biologics approved after March 2020. Second, biosimilars are not interchangeable with their reference biologic product at the pharmacy counter; a new prescription is needed for the biosimilar to be dispensed in place of the biologic. We conducted two …

Combatting The Opioid Epidemic In Texas By Holding Big Pharma Manufacturers Liable, Katherine Spiser

St. Mary's Law Journal

Abstract forthcoming

Market Claims And Efficacy Information In Direct‐To‐Consumer Prescription Drug Print Advertisements, Kathryn J. Aikin Phd, Kevin R. Betts Phd, Aysha Keisler Phd, Kathryn Schaefer Ziemer Phd

United States Food and Drug Administration: Publications

This study examined the impact of “New” and “#1 Prescribed” market claims and quantitative efficacy information on perceptions of a hypothetical prescription drug in a direct‐to‐consumer (DTC) print advertisement. We examined two market claims (New and #1 Prescribed), two efficacy levels (higher and lower), and a control condition without this information. Participants with diabetes were randomized to review one ad version and asked their perceptions of the ad's message, the drug's benefits, side effects and risks, doctors' opinions about the drug, and behavioral intention to use the drug, as well as recall and recognition of drug benefits and risks. Results …

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 …

Retrospective Review Of Oral Oncolytic Agent Use Within A Community Hospital, Alyssa Donadio, Moe Shwin, Maria Figueroa, Michelle Lamarque

All Publications

No abstract provided.

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 …

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 …

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 …

Pneumonia Vaccines: Current Recommendations And Advocacy Opportunities, Laressa Bethishou

Pharmacy Faculty Articles and Research

"Despite the demonstrated efficacy of these vaccines, only 66.9% of adults over age 65 years have ever received a pneumonia vaccine. Given the consequences of acquiring pneumonia, there is both a need and an opportunity to improve vaccination rates. The pharmacist can play a valuable role in identifying high-risk patients, providing education on benefits and risks, and advocating for pneumonia vaccination when indicated."

Aligning Opioid Prescribing Pathways, Andrea Lai, Outpatient Pharmacy, Haley Pelletier, Suneela Nayak, Stephen Tyzik, Ruth Hanselman

MaineHealth Maine Medical Center

There is a drug epidemic sweeping the State of Maine and it continues to worsen each passing year. In 2017, the Maine legislature passed Public Law Chapter 488 to strengthen the controlled substance prescription monitoring program. An outpatient pharmacy, located in a large acute care hospital, created a performance improvement project to clarify opioid prescription and resolve any non-compliance with Chapter 488.

After a root cause analysis, several KPIs were established to include tracking the number of phone calls made by pharmacists to non-compliant providers to clarify scripts, provide one on one education and ultimately resolve non-compliance. Repeat offenders were …

Analysis Of The Proposed Tpp-Related Patent Linkage System In Taiwan, Ping-Hsun Chen

Journal of Law and Health

The Trans-Pacific Partnership (TPP) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan’s proposal includes both measures. Taiwan’s patent linkage system allows a pioneer drug company to register patents claiming (a) a material, (b) a combination or formula, or (c) pharmaceutical use. The …

Cyclosporine Exacerbates Ketamine Toxicity In Zebrafish: Mechanistic Studies On Drug–Drug Interaction, Bonnie L. Robinson, Melanie Dumas, Syed F. Ali, Merle G. Paule, Qiang Gu, Jyotshna Kanungo

United States Food and Drug Administration: Publications

Cyclosporine A (CsA) is an immunosuppressive drug commonly used in organ transplant patients to prevent allograft rejections. Ketamine is a pediatric anesthetic that noncompetitively inhibits the calcium-permeable N-methyl-^_D-aspartic acid receptors. Adverse drug–drug interaction effects between ketamine and CsA have been reported in mammals and humans. However, the mechanism of such drug–drug interaction is unclear. We have previously reported adverse effects of combination drugs, such as verapamil/ketamine and shown the mechanism through intervention by other drugs in zebrafish embryos. Here, we show that ketamine and CsA in combination produce developmental toxicity even leading to lethality in zebrafish larvae …

Ethical Imperatives Of Timely Access To Orphan Drugs: Is Possible To Reconcile Economic Incentives And Patients’ Health Needs?, Rosa Rodriguez-Monguio, T. Spargo, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

Background

More than 6,800 rare diseases and conditions have been identified in the US, which affect 25–30 million Americans. In 1983, the US Congress enacted the Orphan Drug Act (ODA) to encourage the development and marketing of drugs to treat rare diseases and conditions. This study analyzed all orphan designations and FDA approvals since 1983 through 2015, discussed the effectiveness of incentives for the development of treatments for rare diseases, and reflected on the ethical imperatives for timely access to orphan drugs.

Methods

Study data were derived from the Food and Drug Administration (FDA) Orange Book and the Office of …

Variation In Organ-Specific Pik3ca And Kras Mutant Levels In Normal Human Tissues Correlates With Mutation Prevalence In Corresponding Carcinomas, Barbara L. Parsons, Karen L. Mckim, Meagan B. Myers

United States Food and Drug Administration: Publications

Large-scale sequencing efforts have described the mutational complexity of individual cancers and identified mutations prevalent in different cancers. As a complementary approach, allele specific competitive blocker PCR (ACB-PCR) is being used to quantify levels of hotspot cancer driver mutations (CDMs) with high sensitivity, to elucidate the tissue-specific properties of CDMs, their occurrence as tumor cell subpopulations, and their occurrence in normal tissues. Here we report measurements of PIK3CA H1047R mutant fraction (MF) in normal colonic mucosa, normal lung, colonic adenomas, colonic adenocarcinomas, and lung adenocarcinomas. We report PIK3CA E545K MF measurements in those tissues, as well as in normal breast, …