Pharmacy Administration, Policy and Regulation Commons^™

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 …

Measuring Routine Childhood Vaccination Coverage In 204 Countries And Territories, 1980–2019: A Systematic Analysis For The Global Burden Of Disease Study 2020, Release 1, Natalie C. Galles, Patrick Y. Liu, Rachel I. Updike, Stephen S. Lim, Jonathan F. Mosser, Asma Tahir Awan, Gbd 2020, Release 1, Vaccine Coverage Collaborators

Environmental & Global Health Faculty Research

Background: Measuring routine childhood vaccination is crucial to inform global vaccine policies and programme implementation, and to track progress towards targets set by the Global Vaccine Action Plan (GVAP) and Immunization Agenda 2030. Robust estimates of routine vaccine coverage are needed to identify past successes and persistent vulnerabilities. Drawing from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2020, Release 1, we did a systematic analysis of global, regional, and national vaccine coverage trends using a statistical framework, by vaccine and over time. Methods: For this analysis we collated 55 326 country-specific, cohort-specific, year-specific, vaccine-specific, and dose-specific …

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

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 …

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 …