Pharmacy Administration, Policy and Regulation Commons^™

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. …

Incompatibility Group I1 (Inci1) Plasmids: Their Genetics, Biology, And Public Health Relevance, Steven L. Foley, Pravin R. Kaldhone, Steven C. Ricke, Jing Han

United States Food and Drug Administration: Publications

Bacterial plasmids are extrachromosomal genetic elements that often carry antimicrobial resistance (AMR) genes and genes encoding increased virulence and can be transmissible among bacteria by conjugation. One key group of plasmids is the incompatibility group I1 (IncI1) plasmids, which have been isolated from multiple Enterobacteriaceae of food animal origin and clinically ill human patients. The IncI group of plasmids were initially characterized due to their sensitivity to the filamentous bacteriophage If1. Two prototypical IncI1 plasmids, R64 and pColIb-P9, have been extensively studied, and the plasmids consist of unique regions associated with plasmid replication, plasmid stability/maintenance, transfer machinery apparatus, single-stranded DNA …

Racial And Ethnic Disparities In Opioid Use For Adolescents At Us Emergency Departments, Michael T. Phan, Daniel M. Tomaszewski, Cody Arbuckle, Sun Yang, Candice D. Donaldson, Michelle A. Fortier, Brooke Jenkins, Erik Linstead, Zeev N. Kain

Pharmacy Faculty Articles and Research

Background

Racial/ethnic disparities in the use of opioids to treat pain disorders have been previously reported in the emergency department (ED). Further research is needed to better evaluate the impact race/ethnicity may have on the use of opioids in adolescents for the management of pain disorders in the ED.

Methods

This was a cross-sectional study using data from the National Hospital Ambulatory Medical Care Survey from 2006 to 2016. Multivariate models were used to evaluate the role of race/ethnicity in the receipt of opioid agonists while in the ED. All ED visits with patients aged 11–21 years old were analyzed. …

Clinical Pharmacy Services And Medication Utilization In Hospice Care, Aishwarya Kulkarni

Electronic Theses and Dissertations

Background: As discussed within the guidelines from the American Society of Health-System Pharmacists (ASHP), pharmacists are an integral part of the hospice multidisciplinary team involved in optimizing the treatments. Methadone, a long-active opioid, is particularly useful in this population but may be clinically underutilized. Additionally, the cost share of medication utilization in hospice and palliative care is shifting towards hospice providers. The assessment of medication utilization and methadone use in this setting can help develop overall cost/clinical optimization strategies. Thus, there is a need to understand the use and expenditure of various medications and pharmacists' role in providing methadone …

Detect Adverse Events And Medication Errors Using Technology, Kenneth Maxik, Craig Kimble, Alberto Coustasse

Pharmacy Practice & Administration

Technology has changed the practice of pharmacy. Many systems are now part of an ever increasingly interfaced or integrated health care system allowing the electronic exchange of prescriptions from electronic health records (EHRs) to the pharmacy information system and bidirectional data exchange for many items, such as lab results and test information. With meaningful use of automated distribution cabinet databases, EHR efforts, electronic data exchange, and smart pump technology, the availability of data to use for addressing and preventing adverse medication events has grown. Use of these systems has allowed a data-rich environment to store and retrieve reporting. Mining data …

Mental Health Stigma Among Pharmacy Professionals And The Need For Continuing Education, Victoria Dale

Honors Theses

Background. The mental health stigma of pharmacists, the most accessible health professional, can have a significant impact on not only how these patients seek treatment, but also their quality of life (Mey et al., 2013). This study intends to explore mental health stigma among pharmacists and also examine the need for continuing education focused on mental health.

Methods. This study was a descriptive cross-sectional study that employed a self-administered online survey. The subjects were pharmacist members of the Mississippi Pharmacists Association (MPhA). Demographic characteristics were collected. The level of mental health stigma among the respondents was examined using the Community …

A Comprehensive Examination Of Pharmacy Technician Requirements And Pharmacists’ Perceptions Of The Role Of Technicians, Courtney Hahs

Honors Theses

Pharmacy technicians play a crucial role in assisting pharmacists and allowing a pharmacy to function properly and provide care to patients. While technicians take on many tasks in a pharmacy, their role has started to evolve and expand. The first purpose of this study was to determine how states differ regarding the following pharmacy technician roles and requirements: whether or not technicians are licensed and/or certified, mandated technician-to-pharmacist ratio, whether or not technicians are allowed to take or give verbal prescriptions, verify filled prescriptions, and provide immunizations. The second purpose was to analyze how pharmacists across the United States viewed …

Unlocking Knowledge To Benefit The Patient : How Connecting Km And Qrm Can Strengthen Science And Risk-Based Decision Making, Martin J. Lipa

Doctoral

This thesis explored knowledge management effectiveness in the pharmaceutical sector and included an examination of the critical relationship between knowledge management (KM) and quality risk management (QRM) as the dual enablers of an effective pharmaceutical quality system. The primary research objectives were to improve understanding and effectiveness of the interdependency between KM and QRM and to improve knowledge management across the pharmaceutical product lifecycle, starting with a focus on knowledge transfer during technology transfer. The thesis explored how improved KM across the product lifecycle coupled with thoughtful and intentional connectivity between KM and QRM as defined by this study could …

Proficiency Of Mississippi Pharmacy Staff In Communicating With Spanish-Speaking Patients, Caroline Kreh

Honors Theses

Pharmacists play a crucial role in patient care; they must be able to communicate effectively with patients to convey health information. Given the linguistic diversity of Mississippi, pharmacists will likely encounter Spanish-speaking patients in the course of their practice. Previous studies have investigated various indicators of pharmacists’ ability to communicate with Spanish-speaking patients; however, no existing studies regarding Mississippi pharmacy staff members’ ability to communicate with Spanish-speaking patients were found. The objectives of this study were to measure Mississippi pharmacists’ confidence, satisfaction, proficiency, use of resources, and level of education related to communicating with Spanish-speaking patients. The sample was composed …

The Importance Of Continuity Of Care Among Older Adults On Chronic Opioid Therapy, Max Mauney

Honors Theses

The purpose of this study was to define continuity of care and prescriber characteristics among older adults with chronic non-cancer pain who are on long-term opioid therapy. Also, it will evaluate the connection between continuity of care and prescriber characteristics on the risk of opioid-related adverse events among older adults on chronic opioid therapy. The main goal is to observe the relationship between continuity and the related adverse events that may arise.

This study utilized a nested case-control using a 5% random sample of the National Medicare data between 2012 and 2016. This data used a random sample of beneficiaries …

Prevalence Of Adhd And The Nonmedical Use Of Prescription Stimulants Among College Students, Leah Potate

Honors Theses

Objective: The principal objective in this study is to identify the contextual factors predicting the nonmedical use of prescription stimulants among college students who nonmedically use prescription stimulants (NMUPS) for academic reasons.

Participants: 470 college-aged students from varying undergraduate classes

Methods: This study utilized an observational design, which consisted of repeated surveys administered to a sample of undergraduate students at the University of Mississippi. Descriptive statistics were used to assess frequencies of contextual factors regarding the background and exam surveys. Logistic regression models assessed the correlations between the nonmedical use of prescription stimulants and various contextual factors.

Results: The percentage …

University Of Mississippi Student Perceptions Of The Relationship Between Stimulant Use And Mental Health, Elizabeth Mccutcheon

Honors Theses

College students are situated in a perfect storm for stimulant misuse and mental health issues, while living admits a mental health crisis of never-before-seen proportions, in combination with a global pandemic and the normal amount of stress associated with a university course load. It is important to address college student’s perceptions of the risks and benefits of stimulant use in order to see if they realize the severity of the problem of abuse and address it. The addiction of examining mental health in relation to stimulant abuse can provide new insight to the motivation behind the rise in stimulant abuse …

Measuring Food Consumption Within A Foodrx Program, Katie Howell

Honors Theses

This pilot study set out to assess food consumption measures within the Charleston FoodRx program. Assessments made through this investigation aim to improve the Charleston program as well as provide suggestions for future programs. Charleston FoodRx provides enrolled households with fruits and vegetables in a supply intended to last for two weeks. These goals combine social and pharmaceutical science, by addressing barriers in food environment and insecurity, nutritional health, and preventative treatment. Though the idea behind FoodRx has existed prior to recent pilot programs, research behind FoodRx and its possible integration within the healthcare system lack published and replicable research …

Home Blood Pressure Monitoring To Improve Hypertension Control: A Narrative Review Of International Guideline Recommendations, John Andraos, Luma Munjy, Michael S. Kelly

Pharmacy Faculty Articles and Research

Home blood pressure monitoring (HBPM) is a convenient way to assess out-of-office blood pressure control and is recommended by numerous international guidelines to aid clinicians in the diagnosis and management of essential hypertension. Although available guidelines recommend the use of HBPM in patients receiving antihypertensive medication, their specific recommendations regarding optimal monitoring schedule, duration, and clinician interpretation of home blood pressure readings may differ among guidelines. Purpose: The purpose of this article is to review available international hypertension guideline recommendations related to the use of HBPM to improve hypertension control among patients receiving antihypertensive therapy. We also briefly highlight …

Improving Antibiotic Prescribing For Acute Respiratory Illnesses, Laurinia Hunter

Student Scholarly Projects

Practice Problem: Unwarranted antibiotic prescribing practices when treating acute respiratory illnesses contribute to the national health threat of antibiotic resistance.

PICOT: In a pediatric outpatient setting for patients ages 6-25 who have no documented uncontrolled comorbidities, presenting with an acute respiratory illness (P), does provider utilization of clinical guidelines, and patient and (caregivers) utilization of educational pamphlets, to collectively develop a plan of care (I), compared to providers and patients who do not utilize such strategies(C) result in a reduction in antibiotics prescribed for acute respiratory illnesses (O) in a 6-week timeframe (T)?

Evidence: The evidence reviewed reported the utilization …

Effect Of Free Trade Agreements On Pharmaceutical Market Competition: The Case Of The 2009 Us-Peru Free Trade Agreement And Its Implementation As National Drug Policy, Lita Araujo, Enrique Seoane-Vazquez, Michael Montagne

Pharmacy Faculty Articles and Research

Free Trade Agreements (FTA) are controversial for threatening essential aspects of health, especially access to affordable medicines. The US-Peru FTA required changes in the Peruvian pharmaceutical legislation that resulted in the implementation of the National Drug Policy (NDP) of 2009. The NDP included more robust technical requirements for registration, a Peruvian Good Manufacturing Practices certificate, a longer timeline for drug registration, and an increase in registration fees. This study evaluated the impact of the FTA on the number of registrations and competition in the Peruvian pharmaceutical market.

Data for the period January 2005 to April 2014 were provided by the …

Emergent Trends In The Chinese Counterfeit Pharmaceutical Supply Chain And Opportunities For Public-Private Reform, Mary Monk

Senior Theses

This research seeks to identify and analyze emerging trends in the Chinese counterfeit pharmaceutical trade, extending from the supply chain’s point of origin to domestic and overseas retail dispensary. To aid readability, Chapter 1 of this thesis opens with key conclusions and policy recommendations for various Chinese and U.S. stakeholders based on the shortcomings identified in Chapter 5. Chapter 2 begins with a review of international roadblocks to diagnosing the issue, such as lack of consensus on working definitions and cross-border discrepancies in pharmaceutical oversight regulation. This section also provides a general overview of existing factors driving demand for counterfeit …

Predisposing, Enabling, And Need Factors Associated With The Choice Of Pharmacy Type In The Us: Findings From The 2015/2016 National Consumer Survey On The Medication Experience And Pharmacists’ Roles, Mohamed Rashrash, Suhila Sawesi, Jon C. Schommer, Lawrence M. Brown

Pharmacy Faculty Articles and Research

Background: Knowing the type of pharmacy used by the patient is meaningful to the pharmacist. Previous studies have assessed different factors predicting the kind of pharmacy selection and reached inconsistent findings. Objectives: To identify patient and health-related factors associated with pharmacy type selection. Methods: The Andersen Behavioral Model of Health Service Use was used to organize the selection of patient characteristics and categorize them as predisposing, enabling, and need factors. The dependent variable was the type of pharmacy used. Logistic regression was used to predict the association between patient-related characteristics and the type of pharmacy used. Results: Older age respondents …

A Survey Report On The Current State Of Quality Risk Management (Qrm) And Knowledge Management (Km) Integration, Martin Lipa, Kevin O'Donnell, Anne Greene

Level 3

As part of research to better define and improve the integration between quality risk management (QRM) and knowledge management (KM) as dual enablers of an effective pharmaceutical quality system, a survey was conducted in February 2021 to explore this relationship. The survey explored the current state relationship in theory and in practice, solicited feedback on a proposed framework, the Risk-Knowledge Infinity Cycle, to improve the connection between QRM and KM, associated benefits and potential actions to make progress in this regard. The results suggest QRM and KM are highly interdependent in theory but much less so in practice. Further, …

Mapping Km Methods And Tools Across The Pharmaceutical Product Lifecycle, Martin Lipa, Paige Kane

Level 3

Knowledge management is positioned as an enabler of ICH Q10, and the visibility and availability of product and process knowledge across the entire pharmaceutical product lifecycle is vital to the sustained success of an organization and to the effectiveness of an organization’s pharmaceutical quality system as defined by ICH Q10. This paper illustrates where knowledge management has a role to play within each product lifecycle phase. This paper goes on to further define phase-appropriate KM methods and tools to help address these needs and create end-to-end product and process knowledge visibility and availability.

Change Management Is A Consideration Beyond The Pandemic, Kenneth Maxik, Craig Kimble, Alberto Coustasse

Pharmacy Practice & Administration

Change management (CM) is a well-organized framework for managing the people side of change. It includes practices, processes, and planned activities designed to facilitate and lead organizations to move from the present state to a desired state. The goal of CM is not to eliminate resistance but to anticipate it, proactively plan for it, continuously manage it, and mitigate the consequences.

Obstetrician-Gynecologist Perceptions And Utilization Of Prescription Drug Monitoring Programs: A Survey Study, Amie Goodin, Jungjun Bae, Chris Delcher, Joshua Brown, Dikea Roussos-Ross

Pharmacy Practice and Science Faculty Publications

Query of Prescription Drug Monitoring Programs (PDMPs) is recommended before prescribing opioids by the US Centers for Disease Control and Prevention, to inform clinical practice and aid diversion prevention. Many states mandate prescriber PDMP use; however, little is known about PDMP perception of utility and use among Obstetricians-Gynecologists (OB/GYN), who are the primary provider for most women during pregnancy.

This study examined OB/GYN perceptions and utilization of their state PDMP.

Survey items were developed by expert consensus. A voluntary anonymous survey was emailed to a random sample of 5000 OB/GYNs (adjusted participants n = 1470, minus unread/refusals). Responses were stratified …

Association Of Electronic Prescription In Controlled Substances Used, Archana Suwal, Jemima Akinyi Okonjo

Theses, Dissertations and Capstones

Introduction: Controlled substances have been described as pharmaceuticals or illegal medicines that act primarily on the central nervous system and could cause physical and mental dependence, eventually leading to addiction. Prescription opioids were a significant contributor to the opioid epidemic, accounting for more than 70,000 opioid-related overdose deaths, including illicit and prescription opioids, between 2018 and 2019. The Electronic Prescriptions for Controlled Substances (EPCS) initiative recently aimed to reduce rates of prescription opioid addiction, abuse, diversion, and death. The system for controlled substances had become more widely used as providers and governments trying to combat the opioid problem. Because …

Let Your Pharmacist Be Your Guide: Navigating Barriers To Pharmaceutical Access, Jennifer Ko, Miranda Steinkopf, Sharon E. Connor

Pharmacy Faculty Books and Book Chapters

At the end of this case, students will be able to: • Describe policy, organizational, and individual factors that contribute to barriers to accessing medications and pharmaceutical care • Identify resources to improve access to affordable medications for uninsured and underinsured patients • Recommend appropriate resources for obtaining affordable medications

The Place And Role Of Pharmacy Benefit Management (Pbm) Companies In Us Healthcare System, George Mattis Ii

Electronic Theses and Dissertations

On average, prescription drugs cost US consumers more than any other developed country in the world. US drug makers claim that intermediaries in the prescription drug supply chain, companies called pharmacy benefit managers (PBM), are forcing them to increase their drug prices. PBMs counter that the discounts they receive from drug makers are channeled to insurers. This thesis will examine the role that PBMs play in the prescription drug supply chain and determine what effect they have on drug prices. This thesis will utilize a comparative static model, Structure, Conduct, Performance (SCP) framework to analyze the pharmaceutical manufacturing and the …

Pharmacist Provision Of Contraception Services In Kentucky: Opinions And Policy Interventions, Dustin K. Miracle

Theses and Dissertations--Pharmacy

Unintended pregnancy continues to be a prevalent issue across the United States, impacting millions of women annually. While several states have enacted policies expanding pharmacist services to allow for provision of hormonal contraception, Kentucky has yet to do so. Likewise, although provision of nonprescription hormonal contraception could be authorized under Kentucky regulation, prior to this study, this had yet to be done. The objectives of this study were to 1) understand the opinions of Kentucky pharmacists and student pharmacists regarding provision of hormonal contraception services through a board-authorized protocol, 2) understand the opinions of Kentucky pharmacists and student pharmacists regarding …

Achieving Better Care In Pennsylvania By Allowing Pharmacists To Practice Pharmacy, Travis Murray

Dickinson Law Review (2017-Present)

Traditionally, state legislatures implemented Prescription Drug Monitoring Programs (“PDMPs”) to assist prescribers, pharmacists, and law enforcement in identifying patients likely to misuse, abuse, or divert controlled substances. PDMP databases contain a catalog of a patient’s recent controlled substances that pharmacies have filled, including the date, location, the quantity of medication filled, and the prescribing health care provider. Prescribers in Pennsylvania have a duty to query the PDMP before prescribing controlled substances in most clinical settings. Pharmacists have a similar duty in Pennsylvania to dispense safe and effective medication therapy to patients and to screen patients for potential signs of misuse, …

Guidelines On Prescriptive Authority For Nurses 2021, David Stewart, Madrean Schober, Lisa Nissen, Elissa Ladd, Kimberley Lamarche, Marie-Lyne Bournival, Deborah Gray, Sonia Sevilla, Marieke Kroezen, Frances Wong

Ellmer School of Nursing Faculty Publications

[First paragraph] Nurse prescribing has existed for over 50 years in some regions of the world. The diverse global nurse prescriptive authority landscape will be highlighted in this important publication. A framework embedding core components for safe and competent prescribers necessitates appropriate education, aligned regulatory authority and continuing professional development to uphold competencies. Evidence-informed models of nurse prescribing will weave in organisational and team support considerations required.

Opioid Use Disorder: The Timeline For Medication Assisted Therapy, Alexander Cristofori

Capstone Showcase

Opioid Use Disorder is patterns of opioid use leading to withdrawal, giving up important life events in order to use opioids, and excessive time spent using opioids, to name a few diagnostic criteria. The clinical progression of the disorder involves periods of acute exacerbation and remission that are cyclic in nature. Treatment is most effective when it includes both pharmacological and psychosocial modalities, referred to as medication assisted therapy (MAT). Three drugs used commonly in MAT-based treatment for OUD from oldest to newest include Methadone, Buprenorphine-naloxone, and Naltrexone. Treatment program models that prioritize total abstinence from the addictive substance attached …

Association Of Incident Cancer To Low-Value Care And Healthcare Cost Burden Among Elderly Medicare Beneficiaries, Chibuzo Iloabuchi

Graduate Theses, Dissertations, and Problem Reports (ETD)

In the United States (US), 25% of healthcare spending is considered wasteful because it is spent reimbursing low-value care. Low-value care is the utilization of healthcare services, medical tests, and procedures that have unclear or no clinical benefit to patients but still exposes them to risk. World-wide, low-value care imposes a significant economic burden on patients, payers, governments, and society. Cancer care among older adults > 65 years is one of the biggest drivers of healthcare expenditure in the US and accounts for nearly 40% of all spending, and low-value care among cancer patients is prevalent and contributes to the financial …