Pharmacy Administration, Policy and Regulation Commons^™

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 …

Association Between Dispensing Channel And Chronic Obstructive Pulmonary Disorder Exacerbations Among Medicare Beneficiaries, April S. Prather

Theses and Dissertations--Pharmacy

Elderly patients with chronic obstructive pulmonary disease may be at increased risk of exacerbation due to physical and cognitive deficits that make proper inhaled medication adherence more difficult despite consistent medication access. This retrospective study utilized administrative medical and pharmacy claims data to examine the likelihood of having a COPD exacerbation requiring acute medical care by means of an emergency room visit or hospitalization in elderly patients receiving maintenance COPD medications from mail order and retail pharmacies. It was hypothesized that mail order patients would be more likely to experience exacerbations despite differences in medication access when compared to retail …

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 …

Using The Qbest Equation To Evaluate Ellagic Acid Safety Data: Generating A Qnoael With Confidence Levels From Disparate Literature, Cynthia Rose Dickerson

Theses and Dissertations--Pharmacy

QBEST, a novel statistical method, can be applied to the problem of estimating the No Observed Adverse Effect Level (NOAEL or QNOAEL) of a New Molecular Entity (NME) in order to anticipate a safe starting dose for beginning clinical trials. The NOAEL from QBEST (called the QNOAEL) can be calculated using multiple disparate studies in the literature and/or from the lab. The QNOAEL is similar in some ways to the Benchmark Dose Method (BMD) used widely in toxicological research, but is superior to the BMD in some ways. The QNOAEL simulation generates an intuitive curve that is comparable to the …

Ethics: A Problem In Pharmacy?, Keith I. Yoshizuka

Faculty Publications & Research of the TUC College of Pharmacy

Ethics, or the lack or attenuation thereof, is an important issue facing practicing pharmacists today. There are both statutory and regulatory provisions to support the requirement of ongoing education and training in ethics. Evidence of formal disciplinary actions by the California State Board of Pharmacy faced requiring pharmacists to take a formal course in ethics as a condition of retention of licensure is sufficient to demonstrate that pharmacists are deviating from the expectations consistent with ethical behavior. Periodic review of the principles of beneficence, non-malfeasance, autonomy, and justice would benefit pharmacists in practice, as evidence infers that a pharmacist’s moral …

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 …

Hospital Consumer Assessment Of Healthcare Providers And Systems Scores Relating To Pain Following The Incorporation Of Clinical Pharmacists Into Patient Education Prior To Joint Replacement Surgery, Erik Hefti, Michael Remington, Charles Lavallee

Harrisburg University Faculty Works

Background: Pharmacist involvement has been shown to improve various aspects of patient care. Patients undergoing knee and hip replacement surgery generally experience post-operative pain and discomfort. Pain control can impact patient satisfaction, as reported by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.

Objective: The current pilot study aims to measure the potential impact that incorporating pharmacists into preoperative patient education programs has on the response to select HCAHPS questions.

Methods: Patient responses to two select HCAHPS questions related to pain were recorded for a year prior to pharmacist involvement in a comprehensive preoperative patient education program …

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 …

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 …

Medicaid Managed Care And The Health Care Utilization Of Foster Children, Makayla Palmer, James Marton, Aaron Yelowitz, Jeffery Talbert

Economics Faculty Publications

A recent trend in state Medicaid programs is the transition of vulnerable populations into Medicaid managed care (MMC) who were initially carved out of such coverage, such as foster children or those with disabilities. The purpose of this article is to evaluate the impact of the transition of foster children from fee-for-service Medicaid coverage to MMC coverage on outpatient health care utilization. There is very little empirical evidence on the impact of managed care on the health care utilization of foster children because of the recent timing of these transitions as well as challenges associated with finding data sets large …

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."

Paving The Road To Personalized Medicine: Recommendations On Regulatory, Intellectual Property And Reimbursement Challenges, Lori Knowles, Westerly Luth, Tania M. Bubela

Office of the Provost

Personalized medicine (PM) aims to harness a wave of 'omics' discoveries to facilitate research and discovery of targeted diagnostics and therapies and increase the efficiency of healthcare systems by predicting and treating individual predispositions to diseases or conditions. Despite significant investment, limited progress has been made bringing PM to market. We describe the major perceived regulatory, intellectual property, and reimbursement challenges to the development, translation, adoption, and implementation of PM products into clinical care. We conducted a scoping review to identify (i) primary challenges for the development and implementation of PM identified in the academic literature; (ii) solutions proposed in …

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 …