Pharmacy Administration, Policy and Regulation Commons^™

Importance Of Awareness Of Adverse Drug Reaction Reporting During The Covid-19 Pandemic, Heather Ellis, Hale Z. Toklu

HCA Healthcare Journal of Medicine

Health care professionals hold the responsibility of reporting any adverse drug reactions in order to learn about new therapy and how best to safely care for our patients. The information derived from case publications and FDA MedWatch reports are essential to accumulate information and increase awareness for the possible risks of new drugs.

Open Drug Discovery Of Anti-Virals Critical For Canada’S Pandemic Strategy, Tania M. Bubela, E. Richard Gold, Vivek Goel, Max Morgan, Karen Mossman, Jason Nickerson, David Patrick, Aled Edwards

Office of the Provost

In the event of the current COVID-19 pandemic and in preparation for future pandemics, open science can support mission-oriented research and development, as well as commercialization. Open science shares skills and resources across sectors; avoids duplication and provides the basis for rapid and effective validation due to full transparency. It is a strategy that can adjust quickly to reflect changing incentives and priorities, because it does not rely on any one actor or sector. While eschewing patents, it can ensure high-quality drugs, low pricing, and access through existing regulatory mechanisms. Open science practices and partnerships decrease transaction costs, increase diversity …

Usp <800> Compliance: A Hazardous Drug Safe Handling Ppe Toolkit For Infusion Nurses, Cynthia Huff

Doctor of Nursing Practice (DNP) Projects

Problem: Safety concerns have existed for more than 40 years about how hazardous drug (HD) exposure contributes to long- and short-term adverse health outcomes for healthcare workers (HCWs). Careless handling may cause toxic residues to infiltrate hospital environments and patient care areas, and can even be traced to patients’ homes. New government regulations will require healthcare organizations to minimize exposure risks to HCWs by fully implementing the U.S. Pharmacopeia (USP) Convention Chapter 800: Hazardous Drugs: Handling in Healthcare Settings (USP, 2016) on December 1, 2019. According to Polovich and Olsen (2017), “The implementation of the USP <800> Standards will represent …

Pharmacy Services Reboot Roadmap: Resiliency During The Covid-19 Pandemic, L. Hayley Burgess, Joan S. Kramer, Brian Moran, Mandelin Cooper, Christine Dunn, Edward Murray, Karla M. Miller

HCA Healthcare Journal of Medicine

Planning for resumption of patient care services during and following the impact of novel coronavirus disease-2019 (COVID-19) while controlling costs are essential for pharmacy services resiliency. Implementation of a pharmacy services reboot roadmap across a 179 hospital health-system is described. The roadmap encompassed eight key areas: pharmacy leadership, staffing and scheduling, clinical pharmacy services, medication safety, medication supply, regulatory and compliance, team support opportunities, and financial stewardship. A supporting checklist and volume-based staffing plan are included as examples to assist pharmacy leaders in planning optimal pharmacy services support as patient volumes increase, particularly in the emergency department, surgical services and …

Pharmacy Internal Controls: A Call For Greater Vigilance During The Covid-19 Pandemic, Andrew N. Mason

Faculty Publications - The LeMoyne Smith School of Business

For businesses that store physical goods, managing product inventories and financial cost accounting controls are critical. Pharmacies are under considerable scrutiny, due to the nature of their merchandise, making internal controls even more vital. Due to the emergence of COVID-19 and government mitigation strategies, the US economy has seen significant macro- and microeconomic effects. COVID-19 has changed the pharmacy working environment, which could theoretically increase rates of employee drug diversion. Therefore, better inventory management could reduce the misuse of pharmaceutical drugs from fraudulent and drug diversion activities. The author explored secondary findings to create a multidisciplinary conceptual analysis of the …

Assessment Of Community Pharmacists’ Involvement In Public Health Promotion Services In Beirut, Lebanon, Mira Medawar, Maha Aboul Ela, Souraya Domiati

BAU Journal - Health and Wellbeing

Background: The role of pharmacists is growing globally; the shift from the traditional role of preparing and dispensing medications, to a role in medication therapy management and public health services is started to be acceptable worldwide.

Objective: The aim of the study was to assess the participation level of community pharmacists’ in certain public health services promotion as well as the barriers that hindered such provision.

Method: A questionnaire based study has been carried targeting Lebanese community pharmacists working in Beirut, Lebanon. Socio-demographic information, types of public health consultations offered in the pharmacy, and the barriers confronted by the community …

The Inclusion Of Health Data Standards In The Implementation Of Pharmacogenomics Systems: A Scoping Review, Don Roosan, Angela Hwang, Anandi V. Law, Jay Chok, Moom Roosan

Pharmacy Faculty Articles and Research

Background: Despite potential benefits, the practice of incorporating pharmacogenomics (PGx) results in clinical decisions has yet to diffusewidely. In this study,we conducted a review of recent discussions on data standards and interoperability with a focus on sharing PGx test results among health systems. Materials & methods:We conducted a literature search for PGx clinical decision support systems between 1 January 2012 and 31 January 2020. Thirty-two out of 727 articles were included for the final review. Results: Nine of the 32 articles mentioned data standards and only four of the 32 articles provided solutions for the lack of …

Availability Of Over-The-Counter Antibiotics In Guatemalan Corner Stores, Purificación Moreno, Alejandro Cerón, Karen Sosa, Marinees Morales, Laura M. Grajeda, Maria Renee Lopez, John P. Mccraken, Celia Cordón-Rosales, Guy H. Palmer, Douglas R. Call, Brooke M. Ramay

Anthropology: Faculty Scholarship

Widespread availability of antibiotics without prescription potentially facilitates overuse and contributes to selection pressure for antimicrobial resistant bacteria. Prior to this study, anecdotal observations in Guatemala identified corner stores as primary antibiotic dispensaries, where people purchase antibiotics without prescriptions. We carried out a cross sectional study to document the number and types of antibiotics available in corner stores, in four study areas in Guatemala. A total of 443 corner stores were surveyed, of which 295 (67%) sold antibiotics. The most commonly available antibiotics were amoxicillin, found in 246/295 (83%) stores, and tetracycline, found in 195/295 (66%) stores. Over the counter …

Parent Responses To Pediatric Pain: The Differential Effects Of Ethnicity On Opioid Consumption, Candice D. Donaldson, Brooke N. Jenkins, Michelle A. Fortier, Michael T. Phan, Daniel M. Tomaszewski, Sun Yang, Zeev N. Kain

Psychology Faculty Articles and Research

Objective

Within the context of the United States opioid epidemic, some parents often fear the use of opioids to help manage their children's postoperative pain. As a possible consequence, parents often do not dispense optimal analgesic medications to their children after surgery, putting their children at risk of suffering from postsurgical pain. The objective of this research was to assess ethnicity as a predictor of both pain and opioid consumption, and to examine how Hispanic/Latinx and Non-Hispanic White parents alter their child's opioid consumption in response to significant postsurgical pain.

Methods

Participants were 254 children undergoing outpatient tonsillectomy and/or adenoidectomy …

Consider Real Costs Before Implementing A 340b Program, Kenneth Maxik, Craig Kimble, Alberto Coustasse

Pharmacy Practice & Administration

The 340B drug pricing program was created to improve access to outpatient medications for low-income and underinsured r uninsured patients. It has exponentially grown with the expansion of the definition of a covered entity and the change to allow multiple contract pharmacies. Still, there are debates about the program’s financial impact and whether the discounts are passed along to enough underinsured or uninsured patients.

Crnas And Sugammadex Use: A Qualitative Analysis, Natalia Izquierdo Bsn, Rn, Emily Mancewicz Bsn, Rn

Grace Peterson Nursing Research Colloquium

Background: The availability of Sugammadex has increased options for Certified Registered Nurse Anesthetists’ (CRNAs) and their choice of neuromuscular reversal agents, however administration is impacted by a variety of provider and institutional factors.

Objectives: The purpose of this study was to examine and describe the personal and institutional factors impacting the use of Sugammadex in Illinois by CRNAs.

Method: A qualitative study design using an open-ended survey yielded 209 responses. The three main themes that emerged were 1) Why CRNAs choose to use or avoid Sugammadex 2) How CRNAs dose Sugammadex and 3) Practice variations existing within the clinical setting. …

The Other Epidemic, Bruce Deighton

HCA Healthcare Journal of Medicine

The epidemic level of opioid abuse in the U.S. population continues to present a major challenge to our society and to the medical profession. Medical education has a significant role in improving screening, diagnosis, appropriate treatment and management of opioid use disorder. Addressing the problem of overprescribing opioids through physician education, surveillance and opioid management has resulted in significant improvement, translating to fewer overdose deaths from prescription opioids. Graduate medical education can increase access to care by training more addiction medicine specialists, and training other physicians to prescribe buprenorphine and provide access to medically assisted care.

Prepare The Pharmacy For The Next Crisis: A Well-Drafted Business Continuity Plan Enables Continued Operations, Mitigates Potential Risks., Kenneth Maxik, Craig Kimble, Alberto Coustasse

Pharmacy Practice & Administration

The purpose of continuity planning is to ensure that dispensing operations continue, that pharmacy information systems’ data remain protected and accessible, and that telecommunications to support critical organization function during and after business interruption. Interruptions can occur for various reasons, such as earthquakes, fires, flooding, hurricanes, pandemics, power loss, tornadoes, and wildfires. Devising a crisis continuity plan can enable pharmacies to continue to provide patient care, ensure staff safety, and maintain financial viability after a disaster. The coronavirus disease 2019 (COVID-19) pandemic and the resulting business closures brought about by the shutdown have highlighted this need to plan for all …

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 …

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 …

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 …

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 …

Phad 795: Section 1 Special Topics: Applied Longitudinal Modeling, John P. Bentley Ph.D.

GMAS Course Syllabi

No abstract provided.

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, …