Pharmacy Administration, Policy and Regulation Commons^™

Decoding The Prescription, Kim Baucher, Jessica Langhals, Ross Robison, Kristen Finley Sobota

Pharmacy and Wellness Review

No abstract provided.

Understanding Drug Shortages As A Pharmacist, Heather Helsel, Thomas Otroba, Juliana Zschoche, Elizabeth Dodds-Ashley

Pharmacy and Wellness Review

No abstract provided.

Legislation Across The Nation And The Impact On Pharmacy Practice, Sabrina Hamman, Hannah Lamb, Jennifer Harklerode, Elizabeth Kramer, Steven Martin

Pharmacy and Wellness Review

Pharmacy legislation is constantly being updated, giving pharmacists a larger role in the health care field. In the past 20 years, pharmacists have seen expansions to legislation involving contraceptive authority, medical marijuana, vaccines and provider status. There is a greater pharmacist impact from legislation passed on the state level in comparison to the national level. As a result, pharmacists have different opportunities to provide new and advanced services to patients based on the state in which they are practicing. Comparing these various laws across the nation allows the profession to determine which sections of the law are problematic and which …

Changing Roles In Leadership For Today's Pharmacist - A Look Into The New Acpe Draft Leadership Standards, Maureen Moynihan, Sabrina Hamman, Rachel Muhlenkamp, Steven Martin, Jenelle Sobotka

Pharmacy and Wellness Review

With the advancement of the profession of pharmacy, the demand for pharmacist leadership continues to rise. In order for pharmacists to acquire the necessary leadership skills for the profession, there is a call for colleges of pharmacy to incorporate leadership development into their academic programs. The Accreditation Council for Pharmacy Education (ACPE) has released the new 2016 Standards and Guidance Documents for institutions to follow in order for their pharmacy students to graduate with leadership skills.

Achieving Provider Status For Pharmacists, Kasie Bellmann, Alexandra Dimit, Kelsey Weisenburger, Donald L. Sullivan

Pharmacy and Wellness Review

In order to receive payment for medical services through Medicare Part 8, health care professionals must be identified as "providers" under the Social Security Act. Pharmacists currently are not included in the list of providers and, therefore, cannot provide many services to patients. Through their extensive education and training, accessibility and immense trust in their profession, pharmacists are the ideal health care professionals to help expand the continuity of care of our nation's patients. On Jan. 1, 2014, Senate Bill 493 was passed into law recognizing pharmacists in the state of California as providers. With this new legislation, the pharmacists' …

Legislation Editorial, Kent Wilin, Kaitlin Horton, Maria Laikos

Pharmacy and Wellness Review

No abstract provided.

An Update On Acetaminophen Labeling Changes: A Pharmacist's Call To Action, Rebecca Airel, Kayla Durkin, Taylor Gauthier, Jamie Amero, Natalie A. Dipietro

Pharmacy and Wellness Review

Due to the number of acetaminophen overdoses each year, the Food and Drug Administration and the National Center for Prescription Drug Programs made changes and recommendations regarding the labeling of acetaminophen-containing products. It is important for pharmacists to understand these changes and to educate patients on the correct use of these products.

Rems: Risk Management Strategies, Current Issues, And The Pharmacist's Role, Kristen Thatcher, Megan Stojic

Pharmacy and Wellness Review

Risk Evaluation and Mitigation Strategies (REMS) are the most recent risk management initiative put forth by the Food and Drug Administration (FDA) that decreases the risk associated with certain medications. They may be mandatory by the FDA or can be produced voluntarily by the manufacturer in order for a drug associated with significant risk to be approved. REMS may include one or multiple elements, including a Medication Guide (MedGuide), Communication Plan, Elements to Assure Safe Use (ETASU), Implementation Plan, and Timetable for Submission of Assessments. Although REMS enhance patient care by reducing risk and maintaining patient safety, an unbalanced burden …

The 340b Program, Contract Pharmacies, Hospitals, And Patients: An Evolving Relationship Impacting Health Care Delivery, Morgan Ruley, Morgan Belcher, Hannah Sayre, Alberto Coustasse

Management Faculty Research

The 340B Drug Pricing Program, created by Congress in 1992 through the Veterans Health Care Act, has provided discounted drug prices to hospitals and other health care organizations serving a wide population of low-income patients. Some 340B programs use contract pharmacies, an arrangement whereby the hospital or health care organization signs a contract directly with a pharmacy to provide covered pharmacy services at discounted prices. The federal 340B Drug Pricing Program has provided access to reduced price prescription drugs to more than 35 000 individual health care facilities and sites certified by the US Department of Health and Human Services, …

Implementation Of Trauma Service Guideline For The Use Of Phenobarbital In The Management Of The Non-Icu Trauma Patient At Risk Or Experiencing Severe Alcohol Withdrawal, Joseph Rappold, Julianne Ontengco, Stephen Tyzik, Suneela Nayak, Ruth Hanselman, Amy Sparks

Operations Transformation

The trauma service in a large academic tertiary medical center admits a large proportion of patients with the secondary diagnosis of alcohol use disorder. Given the successful use of phenobarbital in the critical care unit for withdrawal prophylaxis and treatment of acute withdrawal, a quality improvement project was established to create and implement guidelines for the non ICU patient.

A root cause analysis demonstrated several issues to include inconsistent clinical decision documentation. As a result, several countermeasures were initiated to address the various issues.

Post implementation of countermeasures, a decrease in the amount of severe alcohol withdrawal as well as …

Drug Safety Scientometrics Overview Highlights Public Health Issues, Philippe Gorry, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

"Drug Safety (DS) also known as Pharmacovigilance, is the science of monitoring ADR (Cobert, 2012). Despite that DS has a social welfare function, it has not been the study of any scientometrics analysis... Our goal is to fill this gap by mapping the DS literature. This analysis might highlight some trends, the role of drug regulatory and firms in diffusing information, understand better some DS controversial events, help scholars in mastering pharmacovigilance literature, and it contribute to further development on literature-based discovery of ADR [adverse drug reactions] with the help of natural language processing."

The Power Of Pharmacist-To-Pharmacist Handoffs During Transitions Of Care, Jessica Wooster, Laressa Bethishou

Pharmacy Faculty Articles and Research

"Hospital readmissions are often medication-related and potentially preventable. Pharmacists can play a vital role in improving medication outcomes during transitions of care (TOC). Although numerous TOC practice models have been described, it remains unclear what practices will promote optimal continuity of care."

Co-Located Retail Clinics And Pharmacies: An Opportunity To Provide More Primary Care., Katherine K. Knapp, Keith Yoshizuka, Debra Sasaki-Hill, Rory Caygill-Walsh

Faculty Publications & Research of the TUC College of Pharmacy

This paper proposes that co-located retail clinics (RCs) and community pharmacies can increase opportunities to provide more accessible, affordable, and patient-friendly primary care services in the United States. RCs are small businesses of about 150-250 square feet with a clientele of about 10-30 patients each day and most frequently staffed by nurse practitioners (NPs). Community pharmacies in the U.S. at ~67,000 far outnumber RCs at ~2800, thereby opening substantial opportunity for growth. Community pharmacies and pharmacists have been working to increase on-site clinical services, but progress has been slowed by the relative isolation from other practitioners. An ideal merged facility …

Association Of Naloxone Coprescription Laws With Naloxone Prescription Dispensing In The United States, Minji Sohn, Jeffery C. Talbert, Zhengyan Huang, Michelle R. Lofwall, Patricia R. Freeman

Institute for Pharmaceutical Outcomes and Policy Faculty Publications

Importance: To mitigate the opioid overdose crisis, states have implemented a variety of legal interventions aimed at increasing access to the opioid antagonist naloxone. Recently, Virginia and Vermont mandated the coprescription of naloxone for potentially at-risk patients.

Objective: To assess the association between naloxone coprescription legal mandates and naloxone dispensing in retail pharmacies.

Design, Setting, and Participants: This was a population-based, state-level cohort study. The sample included all prescriptions dispensed for naloxone in the retail pharmacy setting contained in IQVIA's national prescription audit, which represents 90% of all retail pharmacies in the United States. The unit of observation was state-month …

The Landscape Of Cellular And Gene Therapy Products: Cost, Approvals, And Discontinuations, Vaishali Shukla, Enrique Seoane-Vazquez, Souhiela Fawaz, Lawrence M. Brown, Rosa Rodriguez-Monguio

Pharmacy Faculty Articles and Research

Background The past 10 years witnessed a significant increase in the approval of cellular and gene therapy products worldwide. The US Food and Drug Administration (FDA) approved 3 gene therapy products within the last 4 months of 2017. The objective of this study was to examine the approval characteristics, discontinuations and cost of all cellular and gene therapy products approved worldwide. Data and Methods We conducted an electronic search of approved cell and gene therapy products from the databases of the main drug regulatory agencies including the US Food and Drug Administration, the European Medicines Agency (EMA), the Korea Ministry …

Improving Physician Office Quality Measures By Evaluating Statin Prescribing In Type 2 Diabetic Patients, Choniece Phillips, Kathleen Dawson, Lindsay Roberts, Jamie Mcconaha, Megan Bookser

Undergraduate Research and Scholarship Symposium

Abstract

Objective

The focus of this study was to evaluate the impact of pharmacist’ intervention on quality metrics focusing on patients with a diagnosis of diabetes mellitus type II (T2DM) not currently prescribed statin therapy.

Methods

This retrospective cohort investigational study was conducted in four lowest performing office locations of a nineteen regional primary care physician group practice. Inclusion criteria were diagnosis of T2DM without active statin therapy. Data was excluded from analysis for patients younger than age 40 or older than age 75, or if the most recent LDL documented was less than 70 mg/dL. Recommendations for initiation of …

The Importance Of Goal Setting: Why Every Pharmacist Should Make Goal Setting A Habit, Albert Bach, Laressa Bethishou

Pharmacy Faculty Articles and Research

"But how many of us actually practice what we preach? We have pledged to apply our knowledge, experience, and skills to the best of our ability to assure optimal outcomes for our patients. As the pharmacy profession evolves, and as we train future generations of pharmacists, we have increased opportunities to expand our role and impact as a pharmacist. Goal setting is an important and valuable tool to support us in our personal and professional growth."

Evidence-Based Toolkit For Reduction Of Overdose Risk In Primary Care Patients On Opioid Therapy, Katelin A. Aris

Doctoral Projects

Introduction: Opioids are powerful pain killing medications that can be highly addictive and can cause risk for overdose and even death (Michigan Prescription Drug and Opioid Task Force, 2015). Many primary care providers treat patients with acute and chronic pain, although it is recognized that many receive inadequate training in pain management and feel unprepared in the complexities of caring for these patients (Becker, Bair, Picchioni, Starrels, and Frank, 2018). To treat these patients safely, provider education and adherence to guidelines put forward by these initiatives is essential.

Methods: An evidence-based prescribing toolkit was devised using guidance from the literature …

2018-2019 Acip Immunization Updates: Highlights For Pharmacists, Laressa Bethishou, Luma Munjy, Jeff Goad

Pharmacy Faculty Articles and Research

"Vaccinations have significantly reduced the burden of infectious diseases, preventing almost 6 million deaths worldwide.^1,2 In the United States, vaccines have led to a decrease in incidence of vaccine-preventable illness, mortality, and disease sequelae.³ Despite the proven benefit of vaccines, misinformation and failure to vaccinate has led to outbreaks of vaccine-preventable diseases. As of December 29, 2018, 372 cases of measles (from 17 outbreaks) and 2251 cases of mumps were reported in the United States in 2018.^4,5 These outbreaks support the need for continued education of patients and active immunization by pharmacists."

Evaluating Naloxone Access And Prescribing Requirements In The Opioid Epidemic Across The United States, Krista Brooks, Tom Davis, Khoa Nguyen, Ngan-Dinh Nguyen, Tashrique Rahman, Lucero Villa

Faculty Articles & Research

• Deaths related to opioid overdose has been an increasing problem in the United States
• Deaths related to opioid overdoses can be prevented by the use of naloxone which reverses the effects of opioids
• Approaches to promote naloxone access have been described by federal agencies, including the Substance Abuse and Mental Health Services Administration

Meta-Analysis To Identify And Evaluate Factors Associated With Regulatory Approval Of Orphan Drugs (Od) To Develop An Algorithm For Predicting Regulatory Approval (Success) And To Develop A Standardized Tool To Improve Orphan Drug Portfolio Decision-Making, Milky C. Florent

Seton Hall University Dissertations and Theses (ETDs)

Background and Purpose of the Study: Developed an algorithm (AODI) for predicting probability of regulatory success (PRS) for new orphan drugs after phase II testing has been conductedwith the objective of providing a tool to improve drug portfolio decision-making.Methods: Examined 132 studies from recent publications (2005 onwards). Data on safety, efficacy, operational, market, and company characteristics were obtained from public sources. Meta-analysis and meta-regressions were used to provide an unbiased approach to assess overall predictability and to identify the most important individual predictors.Results: Found that a simple three-factor model (disease prevalence, clinical trial duration and clinical trial …

Icatibant Is Not Helpful For The Treatment Of Ace Inhibitor-Induced Angioedema, Samantha R. Schwartz

Clinical Research in Practice: The Journal of Team Hippocrates

A critical appraisal and clinical application of Sinert R, Levy P, Bernstein JA, et al. Randomized trial of icatibant for angiotensin-converting enzyme inhibitor-induced upper airway angioedema. J Allergy Clin Immunol Pract. 2017; 5(5): 1402-1409. doi: 10.1016/j.jaip.2017.03.003.

The Latest And Greatest On Usp 797/800 - An Update, Alyssa Donadio

All Publications

No abstract provided.

Market Claims And Efficacy Information In Direct‐To‐Consumer Prescription Drug Print Advertisements, Kathryn J. Aikin Phd, Kevin R. Betts Phd, Aysha Keisler Phd, Kathryn Schaefer Ziemer Phd

United States Food and Drug Administration: Publications

This study examined the impact of “New” and “#1 Prescribed” market claims and quantitative efficacy information on perceptions of a hypothetical prescription drug in a direct‐to‐consumer (DTC) print advertisement. We examined two market claims (New and #1 Prescribed), two efficacy levels (higher and lower), and a control condition without this information. Participants with diabetes were randomized to review one ad version and asked their perceptions of the ad's message, the drug's benefits, side effects and risks, doctors' opinions about the drug, and behavioral intention to use the drug, as well as recall and recognition of drug benefits and risks. Results …

Youth Perception Of Harm And Addictiveness Of Tobacco Products: Findings From The Population Assessment Of Tobacco And Health Study (Wave 1), David R. Strong, Karen Messer, Martha White, Yuyan Shi, Madison Noble, David B. Portnoy, Alexander Persoskie, Annette R. Kaufman, Kelvin Choi, Charles Carusi, Maansi Bansal-Travers, Andrew Hyland, John Pierce

United States Food and Drug Administration: Publications

Purpose: We provide a US national assessment of youth perceptions of the harm and addictiveness of six separate tobacco products, identifying a continuum of perceived harm associated with a range of products in relation to patterns of current use, former use, and susceptibility to use tobacco products.

Methods: We evaluated youth respondents (N=13,651) ages 12–17 from Wave 1 (2013–2014) of the Population Assessment of Tobacco and Health (PATH) Study. Analyses (2015–2016) focused on refining mea- sures of perceived harm for each product and delineating youth characteristics (demographic, tobacco use status) associated with beliefs about the harmfulness and addictiveness of tobacco …

Associations Of Risk Factors Of E-Cigarette And Cigarette Use And Susceptibility To Use Among Baseline Path Study Youth Participants (2013–2014), Michael D. Sawdey, Hannah R. Day, Blair Coleman, Lisa D. Gardner, Sarah E. Johnson, Jean Limpert, Hoda T. Hammad, Macieji L. Goniewicz, David B. Abrams, Cassandra A. Stanton, Jennifer L. Pearson, Annette R. Kaufman, Heather L. Kimmel, Cristine D. Delnevo, Wilson M. Compton, Maansi Bansal-Travers, Raymond S. Niaura, Andrew Hyland, Bridget K. Ambrose

United States Food and Drug Administration: Publications

Introduction: Improved understanding of the distribution of traditional risk factors of cigarette smoking among youth who have ever used or are susceptible to e-cigarettes and cigarettes will inform future longitudinal studies examining transitions in use.

Methods: Multiple logistic regression analysis was conducted using data from youth (ages 12–17 years) who had ever heard of e-cigarettes at baseline of the PATH Study (n = 12,460) to compare the distribution of risk factors for cigarette smoking among seven mutually exclusive groups based on ever cigarette/e-cigarette use and sus- ceptibility status.

Results: Compared to committed never users, youth susceptible to e-cigarettes, cigarettes, or …

Selection And Consumption Of Lunches By National School Lunch Program T Participants, Janet G. Peckham, Jaclyn D. Kropp, Thomas A. Mroz, Vivian Haley-Zitlin, Ellen M. Granberg

United States Food and Drug Administration: Publications

The Healthy, Hunger-Free Kids Act of 2010 requires schools participating in the National School Lunch Program (NSLP) to offer a variety of healthy food options each day. Using digital photography data collected from two suburban elementary schools in the spring of 2013, we examine NSLP participant's selection and consumption of all five NSLP lunch components ((1) milk, (2) vegetable, (3) fruit, (4) meat/meat alternate (MA), and (5) grain). We use logit regressions to analyze the selection of the various lunch components by race/ethnicity, gender, grade, and household income level. In addition, ordinary least squares regressions are used to analyze the …

Examining The Role Of Menthol Cigarettes In Progression To Established T Smoking Among Youth, James Nonnemaker, Shari P. Feirman, Anna Macmonegle, Bridget K. Ambrose, Kia J. Jackson, Megan J. Schroeder, Alexandria A. Smith, William Ridgeway, Olga Rass

United States Food and Drug Administration: Publications

Background: Menthol, a flavoring compound added to cigarettes, makes cigarettes more appealing to youth and inexperienced smokers and increases cigarettes' abuse liability. However, limited studies are available on menthol's role in smoking progression.

Methods: To assess the association between menthol in cigarettes and progression to established smoking, we used five waves of data from the Evaluation of Public Education Campaign on Teen Tobacco Cohort Study, a nationally representative longitudinal survey of U.S. youth conducted as part of “The Real Cost” evaluation. We used discrete time survival analysis to model the occurrence of two event outcomes—progression to established, current smoking and …

U.S. Adult Perceptions Of The Harmfulness Of Tobacco Products: Descriptive T Findings From The 2013–14 Baseline Wave 1 Of The Path Study, Geoffrey T. Fong, Tara Elton-Marshall, Pete Driezen, Annette R. Kaufman, K. Michael Cummings, Kelvin Choi, Jonathan Kwan, Amber Koblitz, Andrew Hyland, Maansi Bansal-Travers, Charles Carusi, Mary E. Thompson

United States Food and Drug Administration: Publications

Introduction: This study is the first nationally representative survey of U.S. adults (18+) to examine perceptions of the relative harms of eight non-cigarette tobacco products.

Methods: Data are from Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study Adult Questionnaire, a nationally representative study of 32,320 adults in the United States conducted from September 2013 to December 2014.

Results: 40.7% of adults believed that electronic cigarettes were less harmful than cigarettes, and 17.8% of adults believed that hookah was less harmful than cigarettes. Those less knowledgeable about the health risks of smoking were more likely to believe …

Rethinking Consumer Protection: Escaping Death By Regulation, Thomas L. Tacker

Publications

This book is designed to appeal to anyone who is at all interested in topics related to making life better and safer—for all us consumers. Our current approach to consumer protection is extremely flawed; sometimes costing lives rather than saving them. There are better ways to protect ourselves and the people we love.