Pharmacy Administration, Policy and Regulation Commons^™

Medication Safety During Transitions Of Care:The Importance Of Checklists In Preventing Patient Harm, Laressa Bethishou, Olivia Lounsbury, Donna Prosser

Pharmacy Faculty Articles and Research

There is a need to optimize patient safety as patients navigate through the healthcare system. With each transition of care, patients are vulnerable to changes that may cause adverse effects, including changes in their healthcare team, health status, and medications. The Centers for Medicare & Medicaid Services (CMS) defines a transition of care as “the movement of a patient from one setting of care to another.” While the concept itself may seem simple, this definition fails to capture the many potential handoff complications which classify these transitions as high risk for patients. With 67% of patients facing unintended medication discrepancies …

An Evaluation Of The Treatment Of Asthma In The State Of Mississippi Using Hedis Quality Control Measures, Kyle Kantor

Honors Theses

Introduction: Asthma is an inflammatory condition of the lungs that can have significant impacts on a patient’s quality of life. Asthma attacks can be very uncomfortable and even deadly in some cases. The objective of this study is to evaluate the treatment of asthma in the state of Mississippi and to describe the disparities between demographics to help healthcare providers identify patients who might be at risk for poor treatment and help those patients receive quality healthcare. Methods: The data was retrospectively collected from January to December 2014 Mississippi Centers for Medicare and Medicaid Services claims data. This study is …

Improving Diabetes Self-Management Developing A Patient Decision Aid To Improve Patient Education, Morgan Baker

Honors Theses

Type 2 diabetes is a complex disease that affects a large population of people. It is imperative that efforts are made to develop more effective and inclusive treatment strategies for patients with this condition. A promising approach being studied is the utilization of community pharmacists to individualize and implement diabetes self-management training and education. The objective of this study is to develop a preliminary version of a patient decision aid (PDA) designed to evaluate patient knowledge and behavior towards diabetes self-management for use in the community pharmacy setting. The study design used to achieve this objective was a cross-sectional survey …

Does It Get Any Worse Than Acne? It Does, Actually. An In-Depth Review Of Accutane’S Regulatory History., Bridget A. Betts

Honors Theses

Isotretinoin, most often recognized by the brand name Accutane®, is regarded by many patients and prescribers as the miracle cure for acne. Its unsurpassed efficacy is paired with serious risk of adverse events and birth defects, which poses ethical questions regarding its safety and necessity. Its regulatory history established precedent in Food and Drug Administration Risk Evaluation and Mitigation Strategies and brought awareness to the sharp dangers of teratogenic drug use.

This medication came as a breakthrough solution to patients that suffered years of unsuccessful regimens for the treatment of acne vulgaris. Some question the risk-benefit evaluation of such a …

The Teaching Of Performance Enhancing Drugs In U.S. Schools And Colleges Of Pharmacy, Sara Dorothy Green

Honors Theses

The teaching of performance enhancing drugs in U.S. schools and colleges of pharmacy is necessary to better help patients who are athletes especially those who compete in high-level athletics such as the Olympics or the National Collegiate Athletic Association (NCAA). There is no master list for banned substances, they differ for each organization and have many exceptions. Pharmacists can play a key role in preventing unintentional disqualifications of athletes as there are many medications considered performance enhancing drugs including some supplements and stimulants. For example, commonly used cold medications may contain pseudoephedrine hydrochloride, a banned substance in the world of …

Feasibility And Acceptability Of A Proposed Pharmacy-Based Harm Reduction Intervention To Reduce Opioid Overdose, Hiv And Hepatitis C, Beth E. Meyerson, Jon D. Agley, Wasantha Parakrama Jayawardene, Lori Ann Eldridge, Prachi Arora, Carriann Smith, Nina Vadiei, Amy K. Kennedy, Taylor J. Moehling

Scholarship and Professional Work – COPHS

Background: Evidence-based harm reduction intervention components which might benefit pharmacy patients have not been integrated and studied.

Objective: To investigate the feasibility and acceptability of a proposed pharmacy-based harm reduction intervention to reduce opioid overdose, HIV and hepatitis C called PharmNet.

Methods: Indiana managing pharmacists were surveyed in 2018 to assess the feasibility and acceptability of an intervention for opioid misuse screening, brief intervention, syringe and naloxone dispensing, and referrals provision. The Consolidated Framework for Implementation Research informed the survey development and analysis.

Result: The sample included 303 (30.8%) pharmacists; 215 (70.9%) provided detailed written comments. Intervention Characteristics: 83.3% believed …

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%) …

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.

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

Food and Drug Administration Papers

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

Food and Drug Administration Papers

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 …

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

Food and Drug Administration Papers

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

Food and Drug Administration Papers

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 …

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

Food and Drug Administration Papers

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 …

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

Food and Drug Administration Papers

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 …

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

Food and Drug Administration Papers

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 …

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

Honors Theses, University of Nebraska-Lincoln

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.