Pharmacy Administration, Policy and Regulation Commons^™

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 …

Utilization Of A Community Pharmacy-Based Service For The Treatment Of Uncomplicated Urinary Tract Infections In Scotland, Robert Borchardt

Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.)

Introduction: In November 2013, Scotland piloted a program in Grampian for the treatment of Urinary Tract Infections (UTIs) in community pharmacies, increasing health access for patients and reducing general practitioner workload. This program became known as ‘Pharmacy First’ and was later implemented nationwide in November 2017. This paper seeks to understand utilization of the Pharmacy First program across Scotland by patients and potential barriers to access.

Methods: Using data from the Prescribing Information System collected by the National Health Service of Scotland from July 2013 to April 2019, orders for uncomplicated UTIs were gathered by examining all nitrofurantoin and trimethoprim …

Dalbavancin In The Community Emergency Department, Wesley Johnson

Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.)

Introduction

Dalbavancin is an antibiotic within the class of medications known as lipoglycopeptides. This medication is given to patients presenting to the hospital with acute skin and skin-structure infections (ABSSSI). This is a unique medication because it is given as a one-time dose in the outpatient setting and it could prevent patients from requiring admission to the hospital.

Methods

The emergency department (ED) at Good Samaritan community hospital performed a trial period with dalbavancin and data was collected from November 2018 to March 2020. Retrospective chart review was performed to obtain patient data and outcomes. Patients would be contacted by …

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 …

The Impact Of Bone Marrow Transplantion On Patients With Psychiatric Diagnoses: Medication Adherence Assessment, Brittany Galop

Theses and Dissertations--Pharmacy

Objectives: We investigated whether there is a measurable difference in medication utilization for psychiatric conditions before and after bone marrow transplantation (BMT). Previous studies have identified a potential association between psychiatric conditions and immune function. We hypothesized that medication utilization for psychiatric diagnoses would be impacted by BMT.

Methods: This study was a retrospective, quasi-experimental cohort design. De-identified data was compiled from the Truven database for patients ranging from January 2009 through December 2016. Two measurements of medication utilization, proportion of days covered (PDC) and medication possession ratio (MPR) were calculated for each included Medispan-defined class of medications before analyzing …

340b Program Utilization In Rural Us Clinics, William Finley, Heather M. Kruel

Theses, Dissertations and Capstones

Introduction: The 340B program was an effective strategy in reaching more potential patients, providing more comprehensive services, and limiting the gap between affordability and healthcare. The uninsured and underprivileged often are unable to receive medications at the high market price due to the financial situation they face and inflation. The 340B program seeked to mend this issue to help the public and healthcare organizations. The main purpose of this research was to search and evaluate if the 340B program lived up to its purpose of decreasing the cost of medications in rural based clinics.

Methodology: The research strategy developed …

Asthma-Copd Overlap: Economic Burden And Medication Adherence, Mona Nili

Graduate Theses, Dissertations, and Problem Reports (ETD)

In many older adults, asthma and chronic obstructive pulmonary disease (COPD) coexist as “Asthma-COPD overlap” (ACO). This dissertation pursued three Aims: 1) estimate the economic burden of ACO and its contributory factors; 2) evaluate the association of ACO to “cost-related medication nonadherence” (CRN); and 3) identify adherence trajectory patterns and examine the impact of initial maintenance therapies (IMT) type (inhaled corticosteroids monotherapy (ICS) vs. fixed-dose combination of ICS and long-acting beta agonist (ICS/LABA)) on adherence trajectory patterns among older adults Medicare Beneficiaries. The first and second Aims were cross-sectional studies by using Medicare Current Beneficiary Survey data. For the third …

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.

The Impact Of The Fda Warning On Post-Tonsillectomy Opioid Prescribing In Publicly And Privately Insured Children, Dianna J. Soelberg

Theses and Dissertations

Due to reports of significant adverse events, the U.S. FDA placed a Boxed Warning on the opioid codeine in February 2013 – contraindicating its use in pediatric patients undergoing tonsillectomy and/or adenoidectomy. Studies conducted in privately insured children showed a reduction in codeine prescribing and a slight increase in alterative opioid prescribing following the FDA warning, yet the extent to which the FDA warning impacted prescribing in publicly insured children is unknown. Using a quasi-experimental interrupted time series design, this study evaluated codeine and alternative opioid prescribing before and after the FDA warning in both publicly and privately insured children …

Multimorbidity, Immune Checkpoint Inhibitor Use, And Healthcare Expenditures Among Older Patients With Late-Stage Melanoma, Pragya Rai

Graduate Theses, Dissertations, and Problem Reports (ETD)

With decades of unchanged cancer care with no added survival benefit, immune checkpoint inhibitors (ICI) changed the treatment landscape of late-stage melanoma in 2011. A key factor in determining the use of ICIs is the presence of pre-existing chronic conditions, which can influence the outcome. However, the prevalence of multimorbidity (defined as presence of two or more chronic conditions) among older patients with late-stage melanoma remains unknown. It also remains unknown if the presence of multimorbidity factors into the use of ICIs. Hospital-related factors associated with ICI use have been studied. Yet, patient-level factors, such as age, sex, marital status, …

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 …

Introducing A Model And A Framework To Unify The Pharmaceutical Quality System Enablers Quality Risk Management & Knowledge Management, Martin J. Lipa, Kevin O'Donnell, Anne Greene

Articles

An organization that effectively manages knowledge should be able to recognize and proactively apply new learnings to better anticipate risks. This is particularly important in the manufacture of medicinal products. Since the publication of ICH Q10 in 2010, Quality Risk Management (QRM) and Knowledge Management (KM) have been positioned as co-enablers to the Pharmaceutical Quality System. The authors of this paper present a Knowledge Management process model to foster greater practical understanding of the practice of knowledge management. This model when joined with the familiar ICH Q9 process model for QRM, should enable a company to better manage their knowledge …