Pharmacy Administration, Policy and Regulation Commons^™

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. …

Government As The First Investor In Biopharmaceutical Innovation: Evidence From New Drug Approvals 2010–2019, Ekaterina Galkina Cleary, Matthew J. Jackson, Fred D. Ledley

Natural & Applied Sciences Faculty Publications

The discovery and development of new medicines classically involves a linear process of basic biomedical research to uncover potential targets for drug action, followed by applied, or translational, research to identify candidate products and establish their effectiveness and safety.

This Working Paper describes the public sector contribution to that process by tracing funding from the National Institutes of Health (NIH) related to published research on each of the 356 new drugs approved by the U.S. Food and Drug Administration from 2010-2019 as well as research on their 218 biological targets.

J Mich Dent Assoc July 2021

The Journal of the Michigan Dental Association

Every month, The Journal of the Michigan Dental Association brings news, information, and features about Michigan dentistry to our state's oral health community and the MDA's 6,200+ members. No publication reaches more Michigan dentists!

In this issue, the reader will find the following original content:

• A cover story on “Measuring Outcomes to Improve the Quality of Clinical Care”.
• A feature article, “Is Your Office Winning or Losing the Race? You Won’t Know Without Measurement”.
• The feature article, “The DQA and Quality Measurement in Dental Programs and Plans”.
• News you need, Editorial and regular department articles on MDA Foundation activities, Dentistry …

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

Food and Drug Administration Papers

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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.