Pharmacy Administration, Policy and Regulation Commons^™

How Do Pharmacies Evaluate Cleanroom Automation Systems?, Kenneth Maxik, Craig Kimble, Alberto Coustasse, Chris Booth

Pharmacy Practice & Administration

Many pharmacies have implemented or considered implementing cleanroom automation or compounding systems. Intravenous (IV) admixture automation is one of the newest areas of technology that has been applied to pharmacy workflow. Manufacturers tout systems for reducing errors reaching patients. Clinical literature supports that cleanroom technology can aid in patient safety.

The Use Of Urine Drug Testing For Risk Stratification And Efficacious Drug Monitoring In Pain Management Settings, Ahmad I. Hasan, Kareem Elhage, Brendan Farley, Khaled J. Saleh

Medical Student Research Symposium

Objective: To understand the current landscape of urine drug testing (UDT) guidelines as part of risk assessment for opioid abuse, and to offer recommendations towards adopting universal screening guidelines.

Background: There has been an opioid epidemic within the United States, and the role of prescription opioids has been well established. Despite proposed recommendations, there has yet to be a published universal screening guideline on the use of UDT in the setting of opioid abuse risk stratification as well as postoperative drug monitoring.

Methods: We explored current guidelines for UDT on two levels. First, we explore general indications for UDT within …

Assessing The Dyadic Relationship Between Sleep And Health-Related Quality Of Life In Pd Patients And Their Caregivers Using The Actor-Partner Interdependence Model (Apim), Sushmitha Inguva

Graduate Student Council Research Grants

Overview: My name is Sushmitha Inguva. I am a 4th year doctoral student in the Department of Pharmacy Administration in the School of Pharmacy. My primary area of interest is in Health Economics and Outcomes Research. For my dissertation, I am focusing on sleep disorders and their impact on health-related quality of life (HRQoL) in Parkinson’s disease (PD) patients and caregivers.

Intellectual Merit: PD is caused by loss of dopaminergic neurons in the brain. PD patients experience motor and non-motor symptoms (NMS). Among NMS, sleep disorders are the most common, occurring in about 60-90% of patients. Sleep disorders in patients …

Pharmacist-Prescribed Birth Control: A Policy Analysis, Brianna Full

UNO Student Research and Creative Activity Fair

Although unintended pregnancy in the United States has steadily decreased from 2008, rates are still unacceptably high as almost half (42%) of all pregnancies are not wanted or timed correctly (Finer & Zolna). In 2011, 2.8 million of the 6.1 million pregnancies in the United States each year were unintended. Public health professionals are worried about unintended pregnancy because research shows that unwanted or mistimed pregnancies come with associations to adverse maternal and child health outcomes, such as delayed prenatal care, premature birth, and negative physical and mental health effects for children (Frost, Frohwirth & Zolna, 2016). Also, two-thirds (68%) …

Characterizing The Public Sector Contribution To Drug Discovery And Development: The Role Of Government As A First Investor, Ekaterina Galkina Cleary, Matthew Jackson, Andrew Acevedo, Fred D. Ledley

CISI Publication

This research is focused on examining the role of the public sector as an early investor in biopharmaceutical discovery and development. In the United States, the National Institutes of Health (NIH) is the primary source of funding for basic biomedical research designed to elucidate fundamental mechanisms of biology, health, and disease. This research is expected to establish the scientific foundation for the discovery and development of new biopharmaceutical products. This interim report reviews the linear model of innovation underlying these expectations, and evidence for the effectiveness of this pathway. We also describe new data demonstrating that every new drug approved …

Opioids In The Las Vegas Metro, Elia Del Carmen Solano-Patricio, Caitlin Saladino, William E. Brown

Health

In 2014, Nevada was one of 7 states selected to participate in a national policy coalition to reduce prescription drug abuse. As a result, the Nevada Department of Health and Human Services (DHHS) and the Southern Nevada Health District (SNHD) created a data dashboard to track opioid prescriptions and opioid-involved overdose incidents. This Fact Sheet synthesizes state-level data from the Nevada Opioid Overdose Surveillance Dashboard and focuses on the Las Vegas Metropolitan Statistical Area (MSA). The data track opioid prescription rates as they correlate to opioid-involved overdose deaths, emergency room visits, and hospitalizations.

Opioids In Nevada, Peter Grema, Caitlin Saladino, William E. Brown

Health

This Fact Sheet presents data from the Washington Post’s Drug Enforcement Administration (DEA) database on opioid shipments in the United States and provides information pertaining to Nevada and each of its 17 regions (16 counties and one independent city). This Fact Sheet compares the Washington Post’s opioid shipment data with opioid prescription rates relative to Nevada’s population in 2010.

Evaluation Of Antibiotic Use And Duration For Febrile Neutropenia, Kayla Jensen, Patricia Aubert, Joy Ward, Ann Wigton

Pharmacy Posters

Introduction:

• Febrile neutropenia (FN) affects over 80% of patients with hematologic cancer and 10% to 50% of patients with solid tumors
• National Comprehensive Cancer Network (NCCN) guidelines recommend empiric broad-spectrum monotherapy until the absolute neutrophil count (ANC) is over 500 cells/uL.
• Extended durations with broad-spectrum agents leads to increased risk of antibiotic resistance, toxicity and C. difficile infection.

Purpose

• To evaluate antibiotic prescribing patterns for patients with FN to optimize antibiotic stewardship.

United States Medicaid And Pharmacy Fraud: An Unintended Consequence Of The Affordable Care Act, Sean Mcdaniel, Drew Blakely

Theses, Dissertations and Capstones

Introduction: The Affordable Care Act (ACA) increased access to health insurance throughout the United States. To date, an estimated 20 million previously uninsured individuals have gained access to coverage since the expansion. As a result, the number of fraudulent schemes reported has been on the rise. Among the many fraudulent activities in the healthcare sector, abuse of pharmacy benefits has been the most prevalent. The misuse and abuse of opioids, and opioid related overdoses has created a widespread epidemic throughout the country, thus extending opportunities for potential fraud within the pharmaceutical industry.

Purpose of the Study: The purpose …

Survival Of A Serotype 4b Strain And A Serotype 1/2a Strain Of Listeria T Monocytogenes, Isolated From A Stone Fruit Outbreak Investigation, On Whole Stone Fruit At 4 °C, Antonio J. De Jesus, Ishani Sheth, Hee Jin Kwon, Zhujun Gao, Jessica Palmer, Minji Hur, Thomas S. Hammack, Dumitru Macarisin, Yi Chen

United States Food and Drug Administration: Publications

In the summer of 2014, a multistate outbreak of listeriosis associated with contaminated stone fruit (peach and nectarine) was reported. A serotype 4b variant Listeria monocytogenes (Lm) strain of singleton Sequence Type (ST) 382 was isolated from clinical samples and stone fruit associated with the outbreak. A serotype 1/2b Lm strain of ST5, Clonal Complex 5 was isolated only from outbreak-associated stone fruit, not from clinical samples. Here we investigated the fate of the serotype 4b and 1/2b strains, at two inoculation levels (high level at 3.7 logCFU/fruit and low level at 2.7 logCFU/fruit), on the surfaces of white peach, …

Adult Perceptions Of The Relative Harm Of Tobacco Products And Subsequent T Tobacco Product Use: Longitudinal Findings From Waves 1 And 2 Of The Population Assessment Of Tobacco And Health (Path) Study, Tara Elton-Marshall, Pete Driezen, Geoffrey T. Fong, K. Michael Cummings, Alexander Persoskie, Olivia Wackowski, Kelvin Choi, Annette Kaufman, David Strong, Shannon Gravely, Kristie Kristie, Jonathan Kwan, Maansi Bansal-Travers, Mark Travers, Andrew Hyland

United States Food and Drug Administration: Publications

Objectives: To examine: (1) How perceptions of harm for seven non-cigarette tobacco products predict sub- sequent use; (2) How change in use is associated with changes in perceptions of product harm; (3) Whether sociodemographic variables moderate the association between perceptions and use.

Methods: Data are from the adult sample (18+) of the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative longitudinal cohort survey conducted September 2013-December 2014 (Wave 1 (W1) n = 32,320) and October 2014-October 2015 (Wave 2 (W2) n = 28,362).

Results: Wave 1 users and non-users of e-cigarettes, filtered cigars, cigarillos, and pipes, who …

An Evaluation Of The Usda's Policy To Reduce Listeria Illnesses In Ready‐To‐Eat Meat And Poultry Products, Travis Minor, Matt Parrett

United States Food and Drug Administration: Publications

Using 1998–2008 data collected by the Centers for Disease Control and Prevention on foodborne illnesses and outbreaks, we examine the economic impact of the United States Department of Agriculture's proposed and final rules to reduce the incidence of Listeria monocytogenes (Lm) in ready‐to‐ eat meat and poultry products. Using a difference‐in‐ differences approach, we find that these rules together reduced meat‐related Lm illnesses by about 60 per year, which we attribute to reductions in both the number and average size of meat‐related Lm outbreaks. We then monetize this illness reduction using an underreporting and underdiagnosis multiplier of 2.3 and an …

Genomics-Based Re-Examination Of The Taxonomy And Phylogeny Of Human And Simian Mastadenoviruses: An Evolving Whole Genomes Approach, Revealing Putative Zoonosis, Anthroponosis, And Amphizoonosis, June Kang, Ashrafali Mohamed Ismail, Shoaleh Dehghan, Jaya Rajaiya, Marc W. Allard, Haw Chuan Lim, David W. Dyer, James Chodosh, Donald Seto

United States Food and Drug Administration: Publications

With the advent of high-resolution and cost-effective genomics and bioinformatics tools and methods contributing to a large database of both human (HAdV) and simian (SAdV) adenoviruses, a genomics-based re-evaluation of their taxonomy is warranted. Interest in these particular adenoviruses is growing in part due to the applications of both in gene transfer protocols, including gene therapy and vaccines, as well in oncolytic protocols. In particular, the re-evaluation of SAdVs as appropriate vectors in humans is important as zoonosis precludes the assumption that human immune system may be na€ıve to these vectors. Additionally, as impor- tant pathogens, adenoviruses are a model …

The Impact Of The Abuse-Deterrent Reformulation Of Extended-Release T Oxycontin On Prescription Pain Reliever Misuse And Heroin Initiation, Carolyn Wolff, William N. Dowd, Mir M. Ali, Chandler Mcclellan, Angelica Meinhofer, Lukas Glos, Ryan Mutter, Matthew Rosenberg, Andreas Schikc

United States Food and Drug Administration: Publications

The introduction of abuse-deterrent OxyContin in 2010 was intended to reduce its misuse by making it more tamper resistant. However, some studies have suggested that this reformulation might have had unintended consequences, such as increases in heroin-related deaths. We used the 2005–2014 cross-sectional U.S. National Survey on Drug Use and Health to explore the impact of this reformulation on intermediate outcomes that precede heroin-related deaths for individuals with a history of OxyContin misuse. Our study sample consisted of adults who misused any prescription pain reliever prior to the reformulation of OxyContin (n = 81,400). Those who misused OxyContin prior to …

Development Of A Nicotinic Acetylcholine Receptor Nachr Α7 Binding Activity Prediction Model, Sugunadevi Sakkiah, Carmine Leggett, Bohu Pan, Wenjing Guo, Luis G. Valerio Jr., Huixiao Hong

United States Food and Drug Administration: Publications

Despite the well-known adverse health effects associated with tobacco use, addiction to nicotine found in tobacco products causes difficulty in quitting among users. Nicotinic acetylcholine receptors (nAChRs) are the physiological targets of nicotine and facilitate addiction to tobacco products. The nAChR-α7 subtype plays an important role in addiction; therefore, predicting the binding activity of tobacco constituents to nAChR-α7 is an important component for assessing addictive potential of tobacco constituents. We developed an α7 binding activity prediction model based on a large training data set of 843 chemicals with human α7 binding activity data extracted from PubChem and ChEMBL. The model …

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 …

Reflections On The Effects Of Federalism On Opioid Policy, Matthew B. Lawrence

Faculty Articles

One thing we have seen today that we talk about in health law all the time is how the policy, the laws and institutions up at the 10,000 foot level, can so dramatically influence the personal, people’s lived experiences. Our speakers today have done a really great job of drawing out abstract institutional questions and also showing us how those questions have influenced the lives of real people in often tragic ways. Another thing we have seen that we talk about in administrative law all the time is the importance of expertise, especially given how hard it is to trace …

Timely Follow Up Care After Initiation Of Adhd Medication In Children: A Quality Improvement Project, Rebecca Haas

DNP Scholarly Projects

Background: Enhancing medication safety, strengthening compliance and mitigating side effects requires close monitoring. A child, defined by Centers for Medicare and Medicaid Services, as being between the ages of 6 years and 12 years of ages, with Attention Deficit Hyperactivity Disorder (ADHD) must have an initial medication visit within 30 days of a first-time trial of ADHD medication. Increasing staff awareness of organizational policy of expected timeframe for medication checks and annotating appointment slots as initial medication checks will decrease the number of days between the first-time trial of ADHD medication and a child’s medication assessment. Methods: The Model for …

Meaningful Measurement Matters: Defining Potentially Inappropriate Medication Use To Target Cognitive Outcomes, Ashley I. Martinez

Theses and Dissertations--Pharmacy

Preventable and unintended consequences of medication use occur in more than 25% of ambulatory and hospitalized patients, and nearly half of long-term care patients. Unfortunately, many medications used to treat common health conditions in older adults (such as anxiety, behavioral disturbances, incontinence, insomnia, depression, and pain) have also been linked to cognitive impairment and decline. Recently, substantial efforts to investigate medications and medication classes that may be associated with cognitive impairment and decline in older adults have been undertaken. Unfortunately, studies have used a wide variety of different tools to define “potentially inappropriate medication” (PIM) use, and no published literature …

Relationship Between Initial Prescription Opioid Exposure Length And Future Opioid Use Disorder Diagnosis In Opioid Naive Adolescents, Eric Lindahl

Theses and Dissertations--Pharmacy

Objectives: The long-term risks associated with the use of short-term prescription opioids in opioid naïve adolescents in not well characterized. The purpose of this study was to explore the potential association between the days’ supply of the initial prescription opioid exposure and the rates of diagnosed OUD in the subsequent 3-year period. Methods: We conducted a retrospective cohort study using a nationwide database of commercially-insured adolescents aged 12-17 at the time of the index opioid fill. A multivariable Cox Proportional Hazard regression model was developed to analyze the association of interest while accounting for known risk factors for the development …