Pharmacy Administration, Policy and Regulation Commons^™

Hospital Consumer Assessment Of Healthcare Providers And Systems Scores Relating To Pain Following The Incorporation Of Clinical Pharmacists Into Patient Education Prior To Joint Replacement Surgery, Erik Hefti, Michael Remington, Charles Lavallee

Harrisburg University Faculty Works

Background: Pharmacist involvement has been shown to improve various aspects of patient care. Patients undergoing knee and hip replacement surgery generally experience post-operative pain and discomfort. Pain control can impact patient satisfaction, as reported by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.

Objective: The current pilot study aims to measure the potential impact that incorporating pharmacists into preoperative patient education programs has on the response to select HCAHPS questions.

Methods: Patient responses to two select HCAHPS questions related to pain were recorded for a year prior to pharmacist involvement in a comprehensive preoperative patient education program …

Changes In The Utilization Of Osteoporosis Drugs After The 2010 Fda Bisphosphonate Drug Safety Communication, Bander Balkhi, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio

Pharmacy Faculty Articles and Research

Introduction

In October 2010, the US Food and Drug Administration (FDA) issued a safety communication regarding the risks of atypical fractures of the femur, with bisphosphonates drugs. This study evaluated the impact of the bisphosphonates FDA safety communication on the utilization of osteoporosis medications in Medicaid programs.

Methods

Osteoporosis drugs utilization data from the July 2006 to June 2014 were extracted from the national Summary Files from the Medicaid State Drug Utilization Data maintained by the Centers for Medicare & Medicaid Services (CMS). We performed an interrupted time series analyses to evaluate trends in utilization of osteoporosis drugs before and …

Changes In The Utilization Of Osteoporosis Drugs After The 2010 Fda Bisphosphonate Drug Safety Communication, Bander Balkhi, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio

Pharmacy Faculty Articles and Research

Introduction

In October 2010, the US Food and Drug Administration (FDA) issued a safety communication regarding the risks of atypical fractures of the femur, with bisphosphonates drugs. This study evaluated the impact of the bisphosphonates FDA safety communication on the utilization of osteoporosis medications in Medicaid programs.

Methods

Osteoporosis drugs utilization data from the July 2006 to June 2014 were extracted from the national Summary Files from the Medicaid State Drug Utilization Data maintained by the Centers for Medicare & Medicaid Services (CMS). We performed an interrupted time series analyses to evaluate trends in utilization of osteoporosis drugs before and …

Medicaid Managed Care And The Health Care Utilization Of Foster Children, Makayla Palmer, James Marton, Aaron Yelowitz, Jeffery Talbert

Economics Faculty Publications

A recent trend in state Medicaid programs is the transition of vulnerable populations into Medicaid managed care (MMC) who were initially carved out of such coverage, such as foster children or those with disabilities. The purpose of this article is to evaluate the impact of the transition of foster children from fee-for-service Medicaid coverage to MMC coverage on outpatient health care utilization. There is very little empirical evidence on the impact of managed care on the health care utilization of foster children because of the recent timing of these transitions as well as challenges associated with finding data sets large …

Pneumonia Vaccines: Current Recommendations And Advocacy Opportunities, Laressa Bethishou

Pharmacy Faculty Articles and Research

"Despite the demonstrated efficacy of these vaccines, only 66.9% of adults over age 65 years have ever received a pneumonia vaccine. Given the consequences of acquiring pneumonia, there is both a need and an opportunity to improve vaccination rates. The pharmacist can play a valuable role in identifying high-risk patients, providing education on benefits and risks, and advocating for pneumonia vaccination when indicated."

The Great Pacific Garbage Patch, Andrew Barnhart, Lawrence Bisong, Mckenzie Brittenham, Emma Eccher

Introduction to Public Health Posters

Waste and where it ends up is not a common discussion topic; in fact, it is often treated as a taboo subject. However, it has become necessary to examine this topic due to the growing ecological problems caused by the collection of garbage within our oceans. The Great Pacific Garbage patch, in particular, has grown quite large, and it is now affecting the health of people. This poster explores the ramifications of the Great Pacific Garbage Patch. It discusses the background of the garbage patches and the impact of the issue. It also mentions the different determinants of health that …

Reducing Medication Errors In Pneumonia Patients During Transitions Of Care, Laressa Bethishou, Noah Fang, Lisa Shieh

Pharmacy Faculty Articles and Research

Purpose: At Stanford Health Care, as part of a hospital-wide initiative to reduce pneumonia readmission rates, an interdisciplinary collaborative effort was created between physicians and transitions of care (ToC) pharmacists to optimize discharge planning and medication management for pneumonia patients. The purpose of this study was to describe the impact of the ToC pharmacist in identifying and reducing medication errors on discharge for pneumonia patients.

Methodology: Retrospective chart review was conducted on patients discharged with a pneumonia diagnosis between December 2015 to Feb 2016. Patients were stratified based on whether they received ToC pharmacist medication review vs. standard …

Evaluating Patient Preferences For Different Incentive Programs To Optimize Pharmacist-Provided Patient Care Program Enrollment, Daniel M. Tomaszewski, Tim Cernohaus, Rajiv Vaidyanathan

Pharmacy Faculty Articles and Research

BACKGROUND: Employers have increased efforts to engage employees in health and wellness programs. Providing employees with incentives to participate in these programs has been shown to improve overall enrollment and engagement. One program that has had challenges with enrollment and engagement is medication therapy management (MTM).

OBJECTIVES: To (a) determine how individuals evaluate different financial incentives to improve participation in an MTM program and (b) measure the effect of participant characteristics on incentive preference.

METHODS: This study was composed of a paper-based survey administered to participants after focus group sessions. Participants included MTMeligible beneficiaries from 2 employer groups and included …

A Course On Patient Safety: Pharmacy Student And Community Partner Perceptions, Maryam Noureldin, Chelsea M. Anderson, Patricia L. Darbishire

Purdue Journal of Service-Learning and International Engagement

The authors of this article developed and piloted a three-week intensive elective course for students in their third professional years in the Doctor of Pharmacy program. The goal of this course was to provide students with an opportunity to apply patient safety concepts in a real-world setting using service-learning as the pedagogy and to evaluate student perceptions of the course for potential implementation in the curriculum. Seven pharmacy students were enrolled in the pilot course and divided into three groups. Each group of two to three students was assigned to one of three predetermined community partner sites. Students were instructed …

Expanding The Horizon: Global Health Management For Pharmacy Students, Alice C. Chang, Monica L. Miller, Ellen M. Schellhase

Purdue Journal of Service-Learning and International Engagement

The advancement of global engagement opportunities will promote pharmacy students’ cultural awareness and sensitivity, expose students to treatment of diseases not commonly seen in modern Western medicine, and cultivate future leadership for the growth of global pharmacy practice. At Purdue University College of Pharmacy (PUCOP), limited opportunities exist for student pharmacists. As a result, identifying the needs and expanding student pharmacist access to global engagement experiences are critical to meet the changing needs of the US population. A survey was developed and distributed to 460 students at PUCOP, and 148 of them participated. Of those students, 89.2% were interested in …

Influence Of Pharmaceutical Marketing On Medicare Prescriptions In The District Of Columbia, Susan Wood, Joanna Podrasky, Meghan Mcmonagle, Janani Raveendran, Tyler Bysshe, Alycia Hogenmiller, Adriane Fugh-Berman

Health Policy and Management Faculty Publications

Importance

Gifts from pharmaceutical companies are believed to influence prescribing behavior, but few studies have addressed the association between industry gifts to physicians and drug costs, prescription volume, or preference for generic drugs. Even less research addresses the effect of gifts on the prescribing behavior of nurse practitioners (NPs), physician assistants (PAs), and podiatrists.

Objective

To analyze the association between gifts provided by pharmaceutical companies to individual prescribers in Washington DC and the number of prescriptions, cost of prescriptions, and proportion of branded prescriptions for each prescriber.

Design

Gifts data from the District of Columbia’s (DC) AccessRx program and the …

Furosemide: Properties, Alternatives, And The Medication Approval Process, Heather Brown

Student Writing

No abstract provided.

Managing Risk To The Patient: Recoding Quality Risk Management For The Pharmaceutical And Biopharmaceutical Industries, Kelly Waldron

Doctoral

This thesis explores the application of quality risk management (QRM) in pharmaceutical and biopharmaceutical companies and its effectiveness at managing risk to the patient. The objective of the research described in this thesis was to characterize a maturity state of QRM implementation in which the patient is adequately protected from the risks associated with medicinal products of inadequate quality. The research was conducted over three phases: first, to determine whether patients are better protected since the publication of ICH Q9, a commonly employed guidance on the application of QRM; second, to characterize the industry with regard to QRM maturity, including …

Heroin Use Onset Among Nonmedical Prescription Opioid Users In The Club Scene, Hilary L. Surratt, Steven P. Kurtz, Mance Buttram, Maria A. Levi-Minzi, Maria E. Pagano, Theodore J. Cicero

Center for Health Services Research Faculty Publications

Background—Nonmedical prescription opioid use (NMPOU) is well documented among participants in the club scene, yet prior studies have not examined transition to heroin use. We prospectively examined heroin initiation among a sample of young adults with drug involvement associated with participation in the club scene, to understand factors that influence transition from NMPOU to heroin and to identify opportunities for intervention.

Methods—Data were drawn from a randomized trial that enrolled 750 Miami-based club and prescription drug users through respondent driven sampling, and tested the efficacy of assessment interventions in reducing risk. Participants reported current substance use at baseline, …

Aligning Opioid Prescribing Pathways, Andrea Lai, Outpatient Pharmacy, Haley Pelletier, Suneela Nayak, Stephen Tyzik, Ruth Hanselman

Maine Medical Center

There is a drug epidemic sweeping the State of Maine and it continues to worsen each passing year. In 2017, the Maine legislature passed Public Law Chapter 488 to strengthen the controlled substance prescription monitoring program. An outpatient pharmacy, located in a large acute care hospital, created a performance improvement project to clarify opioid prescription and resolve any non-compliance with Chapter 488.

After a root cause analysis, several KPIs were established to include tracking the number of phone calls made by pharmacists to non-compliant providers to clarify scripts, provide one on one education and ultimately resolve non-compliance. Repeat offenders were …

Leadership And Management Are One And The Same, Neelam Azad, H. Glenn Anderson Jr., Amie Brooks, Oscar Garza, Christine O’Neil, Misty M. Stutz, Jenelle L. Sobotka

Pharmacy Practice & Administration

Defining the attributes of change catalysts within high functioning organizations, including the academic enterprise, is desirable. An understanding of these attributes within our academy may foster faculty interest and engagement in seeking administrative roles and serve to bolster succession planning within our schools. On one hand, there have been numerous publications teasing out the purported differences between leadership and management. On the other hand, does segregating these important characteristics based upon arbitrary distinctions do more harm than good? This commentary represents the work of a group of academic leaders participating in the 2015-2016 AACP Academic Leadership Fellowship Program. This work …

A Cross-Sectional Analysis Of Pharmaceutical Industry-Funded Events For Health Professionals In Australia, Alice Fabbri, Quinn Grundy, Barbara Mintzes, Swestika Swandari, Ray Moynihan, Emily Walkom, Lisa A Bero

Ray Moynihan

OBJECTIVES:

To analyse patterns and characteristics of pharmaceutical industry sponsorship of events for Australian health professionals and to understand the implications of recent changes in transparency provisions that no longer require reporting of payments for food and beverages.

DESIGN:

Cross-sectional analysis.

PARTICIPANTS AND SETTING:

301 publicly available company transparency reports downloaded from the website of Medicines Australia, the pharmaceutical industry trade association, covering the period from October 2011 to September 2015.

RESULTS:

Forty-two companies sponsored 116 845 events for health professionals, on average 608 per week with 30 attendees per event. Events typically included a broad range of health professionals: …

Exploring The Potential For Using Drug Indications To Prevent Look-Alike And Sound-Alike Drug Errors, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, Saad Alqahtani, Gordon Schiff

Pharmacy Faculty Articles and Research

Background: Look-alike, sound-alike (LASA) drug names are a cause of medication errors with resulting patient harm and healthcare costs. This study assessed to which extent the use of the generic drug name, therapeutic class, health problem, and the U.S. Food and Drug Administration (FDA)-approved indications might be used to differentiate LASA drug pairs.

Research design and methods: We collected information about LASA drug pairs reported by the FDA to have look-alike sound-alike similarities. To assess potential for differentiating LASA drug pairs, we compared the following drug characteristics: generic name, therapeutic class, health problem, and FDA-approved indication.

Results: …

Pharmaceutical Federalism, Patricia J. Zettler

Faculty Publications By Year

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …

Analysis Of The Proposed Tpp-Related Patent Linkage System In Taiwan, Ping-Hsun Chen

Journal of Law and Health

The Trans-Pacific Partnership (TPP) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan’s proposal includes both measures. Taiwan’s patent linkage system allows a pioneer drug company to register patents claiming (a) a material, (b) a combination or formula, or (c) pharmaceutical use. The …

An Interdisciplinary Process Change: Conversion Of Picc Line Capping Solution From Heparin To Normal Saline, Angela Colella, Brandon Bodager, Frank Spexarth, Natalie Mcdonough, Deb Kastenholz, Paul Grebe

Aurora Radiology Residents

Background: Heparin-induced thrombocytopenia (HIT) and HIT with thrombosis syndrome (HITTS) are serious conditions. Patients are at increased risk for developing HIT/HITTS with any exposure to heparin, even intravenous line flushes. Patients may be exposed to heparin multiple times each day when they have a peripherally inserted central catheter (PICC) that is flushed and capped with heparin. At Aurora Health Care, heparin is the standard capping solution for PICCs, but with a recent switch to positive pressurized caps, normal saline may be a capping option that reduces patient exposure to heparin. Purpose: To reduce heparin exposure at a single hospital by …

Prevalence Of Prescription Opioid Abuse In Patients With Pain, Samuel Godana, Ankoor Biswas, Nebiyu Biru, Abraham Getenet, Biana Leybishkis

Aurora Internal Medicine Residents

Background: Studies showed that 20% to 30% of opioid analgesic drugs prescribed for chronic pain in the United States are misused, while the rate of opioid addiction is approximately 10%. The study describes methods to identify high-risk behavior and forward recommendations to decrease opioid abuse. Purpose: To assess prevalence and correlate multiple variables with opioid abuse and to forward appropriate recommendation to decrease the prevalence of opioid abuse in the primary care setting. Methods: A prospective study was conducted at a primary health care clinic, Aurora Sinai Medical Center (Milwaukee, WI). Over 6 months, a total of 49 consecutive patients …

An Interdisciplinary Process Change: Conversion Of Picc Line Capping Solution From Heparin To Normal Saline, Angela Colella, Brandon Bodager, Frank Spexarth, Natalie Mcdonough, Deb Kastenholz, Paul Grebe

Aurora Radiology Faculty

Background: Heparin-induced thrombocytopenia (HIT) and HIT with thrombosis syndrome (HITTS) are serious conditions. Patients are at increased risk for developing HIT/HITTS with any exposure to heparin, even intravenous line flushes. Patients may be exposed to heparin multiple times each day when they have a peripherally inserted central catheter (PICC) that is flushed and capped with heparin. At Aurora Health Care, heparin is the standard capping solution for PICCs, but with a recent switch to positive pressurized caps, normal saline may be a capping option that reduces patient exposure to heparin. Purpose: To reduce heparin exposure at a single hospital by …

Authority And Scope Of Vaccination: How States Differ, Sharon Xavioer, Jeff Goad

Pharmacy Faculty Articles and Research

"Despite all this, vaccine rates still fall short of desirable goals, such as those outlined in the Healthy People 2020 national initiative.⁷ Although the CDC and APhA promote the “immunization neighborhood” concept, meaning all appropriate professions should coordinate, communicate, and collaborate to increase immunization rates, challenges are still evident for pharmacies.⁸ One major factor is the variability in state laws and regulations that govern vaccine administration by pharmacists.⁵ Significant regulation differences limit which vaccines are permitted, which age groups of patients can be immunized, and which practice model pharmacists may operate under.⁹"

Pharmaceutical Direct-To-Consumer Advertising: Analyses Of Policy Stakeholders And Supreme Court Of Canada Interveners, Tom T. Eldik

Electronic Thesis and Dissertation Repository

Background: Pharmaceutical direct-to-consumer advertising (DTCA) is a controversial form of advertising that markets prescription pharmaceuticals to patients and consumers. The positions, powers, interests and influence of pharmaceutical DTCA stakeholders shape Canadian DTCA policies; however, no focused analysis of pharmaceutical DTCA stakeholders has occurred.

Methods: This study involved a two-pronged stakeholder analysis: First was a broad analysis of pharmaceutical DTCA stakeholders using Canadian publicly available documents and websites. The second analyzed interveners on pharmaceutical litigation at the Supreme Court of Canada, and the comparisons to a leading tobacco advertising case, RJR-Macdonald v Canada (A.G) and a pharmaceutical DTCA case …

Patients’ Perceptions Of Pharmacist Intervention Through Pre-Screened Medication Therapy Management Service, Danielle E. Baker, Colin J. Behm, Bryan Feldmann, Jeremy Flikkema, Thaddeus T. Franz

The Research and Scholarship Symposium (2013-2019)

Background: The continued challenge of time commitment in a community pharmacy setting is reported by pharmacists as the single largest setback in providing quality patient care. Additionally, when efforts are made by pharmacists to intervene on a patient’s therapy through medication therapy management (MTM), patient “no shows” further challenge an already busy community pharmacy world. Many studies show the value of a pharmacist-patient relationship. However, continued barriers prevent the value of this relationship to take full effect. While numerous methods of comprehensive medication review take place, the issue of establishing a model that best suits the needs of community pharmacy …

Correlation Study: Student Success In Biochemistry As A Prerequisite For Integrated Pharmacology And Medicinal Chemistry, April Filter, Stacy Lin, Sydney Schultz, Rachel Anderson, Tori Twinem, Denise S. Simpson, Melissa J. Beck

The Research and Scholarship Symposium (2013-2019)

Background

A rise in new schools of pharmacy has led to implementation of new curriculums. Pharmacy schools must adhere to standards set by the Accreditation Council of Pharmacy Education in order to provide knowledge of foundational sciences and prepare pharmacy students for the future. Prerequisites are typically foundational science courses taken early in the program so that students have the knowledge necessary to be excellent pharmacists. Within the Cedarville University School of Pharmacy, Biochemistry is a prerequisite course for Integrated Medicinal Chemistry and Pharmacology (PCoMedChem).

Objectives

The goal of this study is to determine if Biochemistry should remain a prerequisite …

Employing “Fdalabel” Database To Extract Pharmacogenomics Information From Fda Drug Labeling To Advance The Study Of Precision Medicine, Ryley B. Uber, Hong Fang, Zhichao Liu, Joshua Xu, Shraddha Thakkar, Shashi Amur, Padmaja Mummaneni, Minjun Chen, Baitang Ning, Steve Harris, Guangxu Zhou, Leihong Wu, Paul Howard, Weida Tong

The Research and Scholarship Symposium (2013-2019)

Pharmacogenomics (PGx) focuses on how genomics and genetic variants (inherited and acquired) affect drug response. A better understanding of the association between genetic markers and individual phenotypes may improve therapy by enhancing drug efficacy, safety, and advance precision medicine. The FDALabel database (https://rm2.scinet.fda.gov/druglabel/#simsearch-0) was developed from the FDA's Structured Product Labeling (SPL) repository to allow users to perform full-text and customizable searches of the labeling section {e.g. Boxed Warning, Warning and Precautions, Adverse Reaction (AR) sections}. In this study, 48 known biomarkers were used to query PGx relevant contents from the FDALabel database, including Indication, Clinical Pharmacology, Clinical Studies, and …

Cyclosporine Exacerbates Ketamine Toxicity In Zebrafish: Mechanistic Studies On Drug–Drug Interaction, Bonnie L. Robinson, Melanie Dumas, Syed F. Ali, Merle G. Paule, Qiang Gu, Jyotshna Kanungo

Food and Drug Administration Papers

Cyclosporine A (CsA) is an immunosuppressive drug commonly used in organ transplant patients to prevent allograft rejections. Ketamine is a pediatric anesthetic that noncompetitively inhibits the calcium-permeable N-methyl-^_D-aspartic acid receptors. Adverse drug–drug interaction effects between ketamine and CsA have been reported in mammals and humans. However, the mechanism of such drug–drug interaction is unclear. We have previously reported adverse effects of combination drugs, such as verapamil/ketamine and shown the mechanism through intervention by other drugs in zebrafish embryos. Here, we show that ketamine and CsA in combination produce developmental toxicity even leading to lethality in zebrafish larvae …

Buprenorphine Physician Supply: Relationship With State-Level Prescription Opioid Mortality, Hannah K. Knudsen, Jennifer R. Havens, Michelle R. Lofwall, Jamie L. Studts, Sharon L. Walsh

Behavioral Science Faculty Publications

Background: Buprenorphine is an effective treatment for opioid use disorder but the supply of buprenorphine physicians is currently inadequate to address the nation’s prescription opioid crisis. Perception of need due to rising opioid overdose rates is one possible reason for physicians to adopt buprenorphine. This study examined associations between rates of growth in buprenorphine physicians and prescription opioid overdose mortality rates in US states.

Methods: The total buprenorphine physician supply and number of physicians approved to treat 100 patients (per 100,000 population) were measured from June 2013 to January 2016. States were divided into two groups: those with rates of …