Pharmacy Administration, Policy and Regulation Commons^™

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 …

Reliability And Credibility Of Progress Test Criteria, Developed By Alumni, Faculty, And Mixed Alumni-Faculty Judge Panels, H. Glenn Anderson Pharmd, Arthur A. Nelson Phd

H. Glenn Anderson

Objective. To compare the reliability and credibility of Angoff-based, absolute criteria derived by faculty, alumni, and a combination of alumni and faculty judge panels. Methods. Independently, faculty, alumni, and mixed faculty-alumni judge panels developed pass/fail criteria for an 86-item test. Generalizability and decision studies were performed. Root mean square errors (RMSE) and 95% confidence intervals were calculated for reliability and credibility assessment. School graduate performance upon the North American Licensure Examination (NAPLEX) was the comparator for credibility assessment. Results. RMSEs were 1.06%, 1.42%, and 2.32% for the alumni, faculty, and mixed judge panels respectively. The school's NAPLEX pass rate was …

Utilizing Three Years Of Epidemiological Data From Medical Missions In Cambodia To Shape The Mobile Medical Clinic Formulary, Jeany Kim Jun, Junia S. Koo, Amy Y. Kang, Deborah B. Chien, Albert Shim, Dale Knutson, Eda M. Kim

Pharmacy Faculty Articles and Research

Objective: The purpose of this project was to gather epidemiological data on common diseases and medications dispensed during medical mission teams to Cambodia to shape the mobile medical clinic formulary.

Methods: Data for patients seen during week-long, mobile, medical clinics was collected in Cambodia during Septembers 2012 to 2014. Patient’s gender, age, weight, blood pressure, glucose, pertinent laboratory values, diagnoses, and medications dispensed were collected. Blood pressure and glucose were measured in patients 18 years and above. Data collected onto paper intake forms were transferred onto spreadsheets without patient identifying information and analyzed for aggregate means, common diseases, and most …

The Impact Of A Community Pharmacist Conducted Comprehensive Medication Review (Cmr) On 30-Day Re-Admission Rates And Increased Patient Satisfaction Scores: A Pilot Study, Brittany Snodgrass, Charles K. Babcock, Anne Teichman

Charles Babcock

Objective: To determine the impact of pharmacist conducted Comprehensive Medication Review (CMR) follow-up within seven days after discharge on (1) readmission rates, (2) detection of drug related problems, (3) and changes in Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores.

Design: Rates of re-admission for pneumonia, congestive heart failure (CHF), or myocardial infarction (MI), within 30 days of discharge are compared between patients receiving a CMR from the pharmacist to a historical control group not receiving the service. The CMR documentation is reviewed to classify any detected drug related problems. Overall HCAHPS scores for the hospital are compared …

Quetiapine Misuse And Abuse: Is It An Atypical Paradigm Of Drug Seeking Behavior?, Sean Hyungwoo Kim, Gayoung Lee, Eric Kim, Hyejin Jung, Jongwha Chang

Institute for Pharmaceutical Outcomes and Policy Faculty Publications

Recent case reports in medical literatures suggest that more and more second-generation atypical antipsychotics (AAs) have been prescribed for off-label use; quetiapine (Brand name: Seroquel^®) showed increase in its trend for off-label use. Little is known about the reasons behind this trend, although historical sedative and hypnotic prescription patterns suggest that despite relatively superior safety profiles of quetiapine (especially for movement disorders), it may be used for treating substance abuse disorder. In addition, recent studies have shown a strong potential for misuse and abuse (MUA) of quetiapine beyond Food and Drug Administration-approved indications. This includes drug-seeking behaviors, such …

Ethical Imperatives Of Timely Access To Orphan Drugs: Is Possible To Reconcile Economic Incentives And Patients’ Health Needs?, Rosa Rodriguez-Monguio, T. Spargo, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

Background

More than 6,800 rare diseases and conditions have been identified in the US, which affect 25–30 million Americans. In 1983, the US Congress enacted the Orphan Drug Act (ODA) to encourage the development and marketing of drugs to treat rare diseases and conditions. This study analyzed all orphan designations and FDA approvals since 1983 through 2015, discussed the effectiveness of incentives for the development of treatments for rare diseases, and reflected on the ethical imperatives for timely access to orphan drugs.

Methods

Study data were derived from the Food and Drug Administration (FDA) Orange Book and the Office of …

Burden Of Illness And Pharmacoeconomic Evaluation Of Lumacaftor/Ivacaftor In Cystic Fibrosis, Pratyusha Vadagam

Electronic Theses and Dissertations

Objectives: (1) To estimate the burden of illness in cystic fibrosis (CF) using 2010-2014 Medical Expenditure Panel Survey (MEPS) data, and (2) to conduct a pharmacoeconomic evaluation of lumacaftor/ivacaftor in the treatment of CF.

Methods: The study was conducted in two parts. Part 1 involved a retrospective analysis using individuals in MEPS database with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis code of 277.00 for a principal diagnosis of CF. Dependent variables were cumulative and out-of-pocket (OOP) expenditures and independent variables included patient demographics and clinical characteristics. Unweighted and weighted estimates of expenditure in CF group, …

Utilization Of Free Medication Samples In The United States In A Nationally Representative Sample: 2009-2013, Joshua D. Brown, Pratik A. Doshi, Jeffery C. Talbert

Institute for Pharmaceutical Outcomes and Policy Faculty Publications

Background—Manufacturers provide free sample medications as a means to increase use of branded medications. Sample use varies year-to-year as branded product patents expire and new products come to market.

Objective—This study sought to describe the use of sample medications during 2009–2013 and assess individual characteristics associated with sample use.

Methods—Data from the 2009–2013 U.S. Medical Expenditure Panel Survey (MEPS) were used. MEPS asks participants whether they received each medication they are taking as a sample. The top 10 medications and medication classes used each year by volume were identified as well as the proportion of people who …