Pharmacy Administration, Policy and Regulation Commons^™

Identification Of Community Knowledge On Lead Contamination And Analysis Of Lead Level In Fish, Sita Nurwulan, Sophi Damayanti, Lia Amalia

Pharmaceutical Sciences and Research

Poisoning is an event of human exposure to poisonous substances that are harmful to the body at certain doses. Lead is a heavy metal that can cause toxicity, including neurotoxic effects, hypertension, digestive system disorders, bone and tooth growth disorders, immune system disorders, infertility, and fetal disorders. Fish is a source of nutrients that are often consumed by people, however can also accumulate lead. This study aimed to analyze the lead level in fish and identify the community knowledge level regarding lead contamination in fish. Identification of community knowledge levels regarding lead. Identification of community knowledge levels regarding lead contamination …

Pharmacists Provision Of Non-Dispensing Services In Health Professional Shortage Areas, Haley L. Kessinger, Emily R. Landis

ONU Student Research Colloquium

Background: Individuals living in primary care health professional shortage areas (PCHPSAs) experience health inequities. Community pharmacists are healthcare professionals with an opportunity to provide care to underserved populations. The objective of this study was to compare non-dispensing services provided by Ohio community pharmacists in PCHPSAs and non-PCHSPAs.

Methods: An electronic, IRB-approved 19-item survey was sent to all community pharmacists practicing in full PCHPSA counties and a random sample practicing in non-PCHPSA counties in Ohio (n=324). Questions assessed current provision of non-dispensing services as well as interest and barriers regarding such services.

Results: Seventy-three usable responses were received (23% response rate). …

Student Self-Developed Wellness Goals Before And During Covid, Han Pham, Dalen Foster

ONU Student Research Colloquium

Background: This study aims to investigate the change over time in student developed well-being related goals based on the definition of “The 8 dimensions of wellness”. It is expected that the changes experienced by students during the COVID 19 pandemic will impact the type of wellness goals students develop for themselves.

Method: All pharmacy students at ONU are required to complete an annual goal setting assignment as part of their co-curricular requirement each academic year. Personal goals were extracted from submissions from 2019 to 2021. The goals were classified into 8 categories (emotional, financial, intellectual, occupational, physical, social, spiritual, and …

Incorporation Of National Safety Standards For Oral Chemotherapy Patient Education At An Ambulatory Cancer Center: A Quality Improvement Project, Danielle Giles

Epsilon Sigma at-Large Research Conference

Abstract

Purpose: An evaluation of the oral chemotherapy patient education process at one ambulatory cancer center identified a deficit in documentation in the electronic medical record (EMR) of many recommendations from the American Society of Clinical Oncology (ASCO) and Oncology Nursing Society (ONS) chemotherapy administration and safety standards. Aims: The aim of this quality improvement project is to evaluate the effectiveness of the implementation of two newly developed templates into the EMR at one ambulatory cancer center. Process: The project will evaluate effectiveness by comparing the frequency in documentation of 16 key elements pre and post implementation …

Interrogating Race And Place-Based Inequities In Hiv And Covid-19, Rohan Khazanchi

EMET Projects

Over the last four years, I have developed a research focus examining the intersections of race, place, and health. My M.D. Honors Thesis reflects a snapshot of these efforts. In this collection of brief research reports, I leverage area-based measures to investigate structural inequities in three contexts: the HIV epidemic in our hyperlocal community, the early stages of the COVID-19 pandemic, and clinical trials for novel COVID-19 therapeutics. I apply novel social epidemiologic tools to measure and explore disparate outcomes. And, in reflecting upon my findings, I discuss concrete implications for clinicians, researchers, and policymakers alike.

Chapter 1: Neighborhood-Level Deprivation …

Protocol: A Scoping Review Of Graduate Student Education, Curriculum Impact, And Interest In Interdisciplinary Research Training, David D. Allen Iii

Faculty and Student Publications

Title: PROTOCOL: A Scoping Review of Graduate Student Education, Curriculum Impact, and Interest in Interdisciplinary Research Training

Background: Alongside traditional graduate education practices, implementing curriculum focused on providing interdisciplinary research training to graduate students may help support their academic development. This additional educational focus can bolster graduate student understanding of methodological practices, develop alternative routes of thinking or approaching a problem/ issue/ topic, may assist in developing student professional socialization skills, and may positively impact student internal motivations, beliefs, and perceptions.

Methods: Our scoping review protocol was developed a priori utilizing the Joanna Briggs Institute guidance, by …

Analysis Of Step Therapy Reform On Floridians With Autoimmune Conditions, John M. Kirkley Iii, Eren Tatari

Florida Public Health Review

Background: Step therapy is a cost-saving measure employed by insurance companies to reduce rising drug costs; however, studies have indicated this policy has neutral or – in some cases – negative effects on patients. Specifically for indivdiuals with autoimmune diseases, the delay of proper treatment, increased risk of negative, irreversible side effects, and an underdeveloped preferred drug lists harm autoimmune patients because of the disconnect between the heterogeneity of autoimmune disease and the one-size-fits-all approach of step therapy. Objective: To determine the most effective policy for dealing with the harms of step therapy as they currently affect Floridians. Methods: Five …

Analysis Of Potential Facilitators To Use Of Hiv Pre-Exposure Prophylaxis (Prep) In A Young Transgender Population, Noah Dixon

Theses and Dissertations--Pharmacy

Pre-exposure prophylaxis for HIV prevention (PrEP) is heavily under-utilized in transgender youth, a population which experiences high risk factors for contracting HIV and exhibits unique barriers to care. This retrospective study used a secondary data analysis of survey results from transgender youth between 16-and 24-years-old to analyze various exposures for association with PrEP use. It was hypothesized that medical gender affirming therapy, mental health care treatment, and HIV programming would be independently associated with increased use of PrEP in transgender youth. It was found that only HIV prevention services and programming related to HIV or gender identity were associated with …

Pharmacists' Role In Opioid Use Disorder And Overdose Prevention And Treatment And Their Attitudes And Perceptions Towards Distributing Naloxone Under A Standing Order, Stephen C. Ijioma

Theses and Dissertations

Background: Opioids are a class of drugs that bind to opioid receptors (mu, delta, and kappa), located in the central and peripheral nervous systems, to exert responses such as analgesia, respiratory depression, euphoria, and miosis. The opioid epidemic is characterized in large part by an increase in opioid overdose deaths. Community pharmacists are one of the most accessible healthcare professionals who frequently interact with patients and can implement OUD and opioid overdose prevention strategies. Treatment for opioid overdose and OUD include naloxone for overdose deaths as well as medication-assisted treatment for OUD.

Objective: The specific aims of this thesis include …

At War With A Silent Killer: An Ipa Study Of The Lived Experiences Of Community Pharmacists In Ireland During Covid-19, Regina Brady, Niamh Imbusch

Articles

Objectives: The purpose of this research was to give voice to the unique lived experiences of community pharmacists who continued to work in patient-facing roles throughout the COVID-19 pandemic. Research objectives sought to understand how they felt about working during this time including any risks felt, why they choose to continue working, and what the post-COVID future might hold for them and their profession. Method: The study was guided by the principles of traditional interpretative phenomenological analysis (IPA). Primary research was collated using semi-structured interviews of a small, purposively selected homogenous group of pharmacists. The research context was a …

Evaluating The 0–10 Point Pain Scale On Adolescent Opioid Use In Us Emergency Departments, Michael T. Phan, Daniel M. Tomaszewski, Cody Arbuckle, Sun Yang, Brooke Jenkins, Michelle A. Fortier, Theodore Heyming, Erik Linstead, Candice Donaldson, Zeev N. Kain

Pharmacy Faculty Articles and Research

Objective: To evaluate trends in national emergency department (ED) adolescent opioid use in relation to reported pain scores. Methods: A retrospective, cross-sectional analysis on National Hospital Ambulatory Medical Care Survey (NHAMCS) data was conducted on ED visits involving patients aged 11–21 from 2008–2017. Crude observational counts were extrapolated to weighted estimates matching total population counts. Multivariate models were used to evaluate the role of a pain score in the reported use of opioids. Anchors for pain scores were 0 (no pain) and 10 (worst pain imaginable). Results: 31,355 observations were captured, which were extrapolated by the NHAMCS to represent 162,515,943 …

“Holistic Risk-Based Site Surveillance – A Data-Based Approach To Site Quality Risk Identification And Assessment In The Pharmaceutical Industry”, Matteo Bernasconi, Thomas Friedli, Nuala Calnan (Editor)

Level 3

Effective quality risk management is fundamental in guaranteeing the development and manufacture of high-quality drugs, reducing drug shortages, and avoiding harm to patients’ health. The ability to accurately assess the actual risk environment, predict potential product quality or supply disruption issues and act to eliminate, prevent, reduce or mitigate them is key to improvements in quality management maturity. This paper illustrates a just-launched research project aimed at developing a comprehensive framework for how to assess and predict risks by leveraging a range of diverse factors.

Characteristics Contributing To A Pharmacy Services Excellence Model In A Large Health System, L. Hayley Burgess, Sara Fletcher, Mandelin K. Cooper, Elizabeth Wiggins, Susan S. Horton, Joan S. Kramer

HCA Healthcare Journal of Medicine

Objective

To identify characteristics that contribute to and promote a pharmacy services center of excellence model in a large health system.

Methods

In 2019, a survey was conducted of 161 acute care pharmacy departments of health system-affiliated hospitals. Information captured included pharmacy practice models, pharmacist resource allocation, training of pharmacy residents, postgraduate training and pharmacist certifications. Results were combined with clinical pharmacy metric performance and centralized electronic data to identify features of top performing pharmacy departments.

Results

Survey results were received from 141 of 161 affiliated hospitals (88%). Hospitals with 100 to 299 beds comprised 54% (n = 16 of …

Lessons Learned From The Hiv/Aids Pandemic And Access To Medicines For Covid-19 Treatment, Thalia Le

Independent Study Project (ISP) Collection

There is an imminent need to address the healthcare disparities in accessing all COVID-19 medicinal products in developing countries. While logistical issues like inadequate production facilities such as the lack of vaccines administration capacity, storage issues, gap between supply and demand as well as vaccine hesitancy can certainly play a part in impeding COVID19 medicines distribution, patent monopolies and intellectual property protection laws further exacerbated the problem, especially when vaccines were at its early stages of authorization. Historical and contemporary case studies of efforts to challenge patents on HIV AVRs treatment provide a useful lens through which we may glean …

Decreasing Unintentional Pregnancies For Tennesseans, Paula M. Todd

Electronic Theses and Dissertations

In 2018, 49% of all pregnancies in the United States were unintended, with women with a lower- income status being five times more likely to experience an unplanned pregnancy. Tennessee has a high rate of unintended pregnancies, particularly among the uninsured, low-income, and rural teen populations; some 22% of these unintended pregnancies end in abortion. Oral or transdermal contraceptives that are affordable and accessible for women of childbearing age can reduce unintentional pregnancies. The addressed gap in clinical practice was that contraceptives are not currently available over the counter in Tennessee pharmacies without a prescription, which necessitates a costly medical …

Listening To Current Practice: Patient Involvement In The Pharmaceutical Packaging Design Process, Giana Carli Lorenzini, Annika Olsson, Andreas Larsson

Journal of Applied Packaging Research

Multiple functional challenges in the use of pharmaceutical packaging reveal a great need of packaging to be designed inclusively. This study investigates patient involvement in the pharmaceutical packaging design process by analysing interview data from representatives of the pharmaceutical and packaging industry. Four main themes related to patient involvement were uncovered: patient expertise levels, patient involvement modes, factors encouraging patient involvement, and factors discouraging patient involvement. Passive patient involvement modes were found to be dominant due to regulations and a traditional perspective regarding physical testing. However, active patient involvement modes were identified, motivated by empathy and understanding of the lives …

Law Helps Ensure Safety Of The Supply Chain, Kenneth Maxik, Craig Kimble, Alberto Coustasse

Management Faculty Research

The Drug Quality and Security Act was signed into law on November 27, 2013, and included the Title 2 Drug Supply Chain and Security Act (DSCSA). This legislation was introduced to enact a federal prescription drug safety standard to decrease contamination, counterfeiting, diversion, and otherwise harmful illicit activities. It also improves the detection and elimination of potentially unsafe drugs from the drug supply chain to protect US consumers.

Value Of Systematic Approach To Assess Health-System Pharmacy Services, Sonnia Zambrano, Radha Patel, L. Hayley Burgess, Kimberly Heath

HCA Healthcare Journal of Medicine

Health-system pharmacy leaders are tasked with determining key staffing decisions based on evolving patient care needs and present-day staffing capacity. A systematic approach to evaluate patient care needs, current model and potential gaps enables leaders to allocate resources in patient care need expansions or sudden fluctuations of patient volumes. Resource management, preparedness and ongoing maintenance form principles used by pharmacy leaders to create an optimal operational environment and elevate clinical pharmacy services. Use of this approach for multiple sites of care across a large network of health systems resulted in identification and improvement in pharmacist coverage and retention of clinical …

Cost-Effectiveness Analysis Of Tisagenlecleucel, Blinatumomab, And Clofarabine For Treatment Of B-Cell Precursor Acute Lymphoblastic Leukemia, Kamron Lotfi

Pharmaceutical Sciences (MS) Theses

Acute lymphoblastic leukemia (ALL) is a common type of adolescent and young adult leukemia in the United States (U.S.). Patients who are refractory or relapsed after receiving two or more lines of systemic therapy have the option of taking tisagenlecleucel. Due to the high cost of this treatment, a cost-effectiveness analysis was performed to assess the treatments for tisagenlecleucel, clofarabine combination, and blinatumomab. Objectives

The objective of this study is to evaluate the cost-effectiveness of tisagenlecleucel; clofarabine, etoposide, cyclophosphamide; and blinatumomab for the treatment of relapse- refractory ALL for adolescents and young adults from the U.S. health care payer perspective. …

Application Of Lean Six Sigma To Reduce The Cost Of Regulatory Noncompliance., Reham Nour, Chad Laux

International Conference on Lean Six Sigma

1. Purpose

This research focused on the adoption of Six Sigma within FDA-regulated pharmaceutical companies to create an effective CAPA system for reducing the cost of noncompliance and supporting organizational performance.

2. Design/Methodology/Approach

This study utilized the DMAIC methodology, in a case study, to improve the CAPA process within a medical device company regulated by the FDA. All the critical requirements for compliance CAPA system was being defined from the FDA sources and the DMAIC model was be applied to improve and maintain CAPA performance.

3. Findings

Using the DMAIC approach supported identifying the bottlenecks and process variation. within CAPA. …