Pharmacy Administration, Policy and Regulation Commons^™

Combatting The Opioid Epidemic In Texas By Holding Big Pharma Manufacturers Liable, Katherine Spiser

St. Mary's Law Journal

Abstract forthcoming

Professional Leadership Development, Jena Schlabach, Meagan Brandt, Olivia Vanscoy, Kasie Bellmann, Jenelle Sobotka, Marianne F. Ivey

Pharmacy and Wellness Review

No abstract provided.

Sterile Compounding: Regulations Addressed After The Meningitis Outbreak Of 2012, Kelly M. Dye, Tara M. Tokar, Halle M. Orlinski, Heather Helsel, Marcia M. Worley

Pharmacy and Wellness Review

No abstract provided.

Common Questions And Answers Regarding Oarrs For Pharmacists, Brittany M. Dye, Victoria S. Pennington, Rachel J. Pucel, Lindsay A. Fleegle, Donald L. Sullivan

Pharmacy and Wellness Review

No abstract provided.

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 …

Evaluating A State Opioid Prescribing Limit And Electronic Medical Record Alert, Margaret Lowenstein, Erik Hossain, Wei Yang, Jeanmarie Perrone, Mark D. Neuman, Michael Ashburn, M. Kit Delgado

Research Briefs

Because long-term opioid use has been linked to the length and strength of an initial prescription, 33 states, Medicare, and some private insurers have set limits on the duration of new opioid prescriptions. In May 2017, New Jersey implemented a statewide 5-day limit on new opioid prescriptions and Penn Medicine implemented an Electronic Medical Record (EMR) alert to notify prescribers when a prescription exceeded the limit and provide compliant prescription orders. This study compared outcomes in Penn Medicine outpatient practices in New Jersey with its practices in Pennsylvania not subject to the law. Outcomes included total opioid dose and number …

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 …

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

Operational Excellence

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 …

Safe Injection Facilities, Timothy Kwong

Honors Theses

According to the Center of Disease Control and Prevention (CDC), “In 2016, a total of 63,632 persons in the United States died from drug overdoses; the age-adjusted rate was 19.8 deaths per 100,000 persons.” There have been countless programs with the sole purpose of reducing the amount of drug related deaths. Some with positive outcomes and others with negative outcomes. Since there is no feasible method of eradicating the problem as a whole, the next logical thing to do would to be creating effect prevention programs.

Safe Injection Facilities (SIFs) have been around for over three decades. They are widespread …

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 …