Pharmacy Administration, Policy and Regulation Commons^™

Stemming The Global Trade In Falsified And Substandard Medicines, Lawrence O. Gostin, Gillian J. Buckley, Patrick W. Kelley

Georgetown Law Faculty Publications and Other Works

Drug safety and quality is an essential assumption of clinical medicine, but there is growing concern that this assumption is not always correct. Poor manufacturing and deliberate fraud occasionally compromises the drug supply in the United States, and the problem is far more common and serious in low- and middle-income countries with weak drug regulatory systems. An Institute of Medicine consensus committee report identified the causes and possible solutions to the problem of falsified and substandard drugs around the world.

The vocabulary people use to discuss the problem is itself a concern. The word counterfeit is often used innocuously to …

Warum Gesunde Menchen Immer Häufiger Fur Psychisch Krank Erklärt Werden, Lisa Cosgrove

Counseling, School Psychology & Sport Faculty Publication Series

zuerst einmal nicht schaden": Das ist der wohl wichtigste Grundsatz der Medizin. Aber diese Mission droht durch den Einfluss großer Pharmafirmen unterhöhlt zu werden. Der Vorwurf einer Verstrickung von Ärzten und Arzneimittelherstellern ist schon in fast allen medizinischen Fachrichtungen aufgekommen. Vor allem aber die Psychiatrie steckt in einer Glaubwürdigkeitskrise. Das zeigt sich in der aktuellen Debatte um die neue Auflage des "Diagnostischen und Statistischen Manual Psychischer Störungen" (DSM).

Dieses von der US-Psychiater-Vereinigung APA herausgegebene Handbuch definiert, was eine psychische Erkrankung ist. Die Bedeutung dieser Wertung geht weit über die USA hinaus - das Handbuch nimmt oft Definitionen der Weltgesundheitsorganisation vorweg. …

Industry’S Colonization Of Psychiatry: Ethical And Practical Implications Of Financial Conflicts Of Interest In The Dsm-5, Lisa Cosgrove, Emily E. Wheeler

Counseling, School Psychology & Sport Faculty Publication Series

The revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM), scheduled for publication in May 2013 by the American Psychiatric Association (APA), has created a firestorm of controversy because of questions about undue industry influence. Specifically, concerns have been raised about financial conflicts of interest between DSM-5 panel members and the pharmaceutical industry. The authors argue that current approaches to the management of these relationships, particularly transparency of them, are insufficient solutions to the problem of industry’s capture of organized psychiatry. The conceptual framework of institutional corruption is used to understand psychiatry’s dependence on the pharmaceutical industry and …

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

Pharmacy Practice & Administration

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 …

Medication Utilization Evaluation Of Dabigatran And Rivaroxaban Within A Large, Multicenter Health System., Sarah A. Nisly, Alex N. Issacs, Meagan Doolin, Courtney Morse, Erin Shiltz

Scholarship and Professional Work – COPHS

Objective. The objective of this medication utilization evaluation (MUE) was to determine the appropriateness of dabigatran and rivaroxaban while also reviewing outcomes for safety and effectiveness within a large, multi-center health system.

Methods. A retrospective chart review was performed using the system’s electronic medical record. A data inquiry was requested and generated for dabigatran usage from July 28, 2011 through July 28, 2012 and for rivaroxaban from March 1, 2012 to July 31, 2012 at eight health system hospitals. All patients receiving at least one dose were eligible for inclusion in the MUE.

Results. For dabigatran, 78 of 390 unique …

Assessing The Accuracy And Quality Of Medication History Collection: Effect Of Implementation Of Electronic Health Record, Kena Lanham, Lindsay Saum, David J. Reeves, Colleen Scherer, Beth Johnson, Anthony Antonopoulos, Suellyn Sorenson

Scholarship and Professional Work – COPHS

Abstract from 2013 ACCP Annual Meeting, Alburquerque, New Mexico.

Shrinking Drug Costs Without Silencing Pharmaceutical Detailers: Maryland's Options After Sorrell V. Ims Health, Kristina L. Miller

Journal of Health Care Law and Policy

No abstract provided.

Kentucky Pharmacist Opinions Of The Potential Reclassification Of Pseudophedrine As A Legend Drug, Kathleen E. Monson

MPA/MPP/MPFM Capstone Projects

Methamphetamine is a drug of abuse, which is often produced in clandestine laboratories. Recent efforts to curb methamphetamine abuse are aimed at controlling access to precursors, including pseudoephedrine (PSE), used in illicit methamphetamine production. Currently, access to PSE is controlled in Kentucky by placement behind pharmacy counters, retail quantity limitations and electronic tracking. Recent legislation proposed in Kentucky to change PSE from non-prescription to a legend medication was unsuccessful and highly controversial. The objective of this project is to collect and analyze pharmacists’ opinions on the effectiveness of current precursor controls, proposed legislation to make PSE a legend drug and …

Pharmaceutical Policy Process: Lessons From The Newly Independent States, Irina Ghazaryan

Muskie School Capstones and Dissertations

Although the pharmaceutical sector in Armenia is currently mainly established, some challenges still cause a big concern. Such facts as a lack of important policies on pharmaceuticals, an outdated legislation and a lack of regulation suggest that the pharmaceutical policy process in Armenia is not effective enough and its insufficient effectiveness is one of the most important barriers for successful implementation of pharmaceutical reforms in the country. The goal of this capstone was to analyze pharmaceutical policy process in Armenia and other Newly Independent States and to develop recommendations for Armenia. Data and information were obtained from publication searches and …

Relationship Between Clandestine Methamphetamine Laboratory Seizures And Burns In Kentucky, David A. Wittmer

MPA/MPP/MPFM Capstone Projects

Methamphetamine is a highly addictive stimulant that is synthetically produced using equipment and chemicals available in the community. Its burden to society may be determined through a number of mechanisms, including the imposed strain on healthcare systems. The evolution of methamphetamine use and production methods has led to reports of increased methamphetamine related burn admissions among hospital burn units[1-3] . Current literature identifies an increase in injury severity, comorbid complications, and cost of care associated with methamphetamine related burn injuries[1-5]. The intent of this study is to identify burn injuries in Kentucky and assess whether a statistically significant association exists …

Opinion: Bias Is Unavoidable, Lisa Cosgrove

Counseling, School Psychology & Sport Faculty Publication Series

It is part of the human condition to have implicit biases—and remain blissfully ignorant of them. Academic researchers, scientists, and clinicians are no exception; they are as marvelously flawed as everyone else. But it is not the cognitive bias that’s the problem. Rather, the denial that there is a problem is where the issues arise. Indeed, our capacity for self-deception was beautifully captured in the title of a recent book addressing researchers’ self-justificatory strategies, Mistakes Were Made (But Not by Me).

Surgical Delay For Hip Fracture Clients And The Use Of Clopidogrel: An Integrative Review, Phoebe Genevieve Waller

Senior Honors Theses

Abstract

Hip fractures in elderly patients have very high postoperative mortality rates and the number of hip fractures in the United States is expected to increase exponentially before 2030. Early surgery is essential to improve outcomes, but patients on clopidogrel (Plavix) have a high risk for increased bleeding if surgery is performed within the usual 72 hour window. This paper presents literature and research addressing the dangers of delaying surgery versus undergoing surgery before the effects of the clopidogrel are gone. Based on articles published after 2006, most researchers advocated earlier surgical intervention than previously recommended and emphasized an individualized …

Implementing Who Hand Hygiene In A U.S. Pharmacy School, Jill Lavigne

Pharmacy Faculty/Staff Publications

No abstract provided.

Medication Therapy Management, Challenges: The Pharmacist’S Emerging Role, Parth D. Shah, Jeffery A. Goad, Edith Mirzaian, Melissa Durham

Pharmacy Faculty Articles and Research

"The pharmacist's role on the healthcare team has received much attention lately as the new Affordable Care Act (ACA) healthcare legislation creates opportunities for pharmacists. lnterprofessional collaboration will transform the way pharmacists deliver health services to patients with respect to their medications. In the community, pharmacist-provided services have been moving away from the traditional role of dispensing to cognitive services that maximize the patient's safe and effective use of medications. The current movement in medical care within the United States is to adopt a model that is patient-centric. The Patient-Centered Primary Care Collaborative (PCPCC) recognizes that "patient-centric" systems are evolving, …

The American Psychiatric Association’S Guideline For Major Depressive Disorder: A Commentary, Lisa Cosgrove, Allen F. Shaughnessy, Emily E. Wheeler, Kirsten E. Austad, Irving Kirsch, Harold J. Bursztajn

Counseling, School Psychology & Sport Faculty Publication Series

The American Psychiatric Association (APA) published a new guideline for Major Depressive Disorder (MDD) which will undoubtedly be used by many practitioners to guide clinical decision-making. In fact, it is non-psychiatrist clinicians who prescribe the majority of antidepressants (AD). We review the APA’s most recent guideline on MDD and report on our observations.

A Comparison Of Dsm-Iv And Dsm-5 Panel Members’ Financial Associations With Industry: A Pernicious Problem Persists, Lisa Cosgrove, Sheldon Krimsky

Counseling, School Psychology & Sport Faculty Publication Series

All medical subspecialties have been subject to increased scrutiny about the ways by which their financial associations with industry, such as pharmaceutical companies, may influence, or give the appearance of influencing, recommendations in review articles and clinical practice guidelines. Psychiatry has been at the epicenter of these concerns, in part because of high-profile cases involving ghostwriting and failure to report industry-related income, and studies highlighting conflicts of interest in promoting psychotropic drugs. The revised Diagnostic and Statistical Manual of Mental Disorders (DSM), scheduled for publication in May 2013 by the American Psychiatric Association (APA), has created a firestorm of controversy …

System-Wide Implementation Of The Use Of An Extended-Infusion Piperacillin/Tazobactam Dosing Strategy: Feasibility Of Utilization From A Children's Hospital Perspective, Kristen R. Nichols, Chad A. Knoderer, Elaine G. Cox

Scholarship and Professional Work – COPHS

Background

Use of extended infusions of piperacillin/tazobactam (PT) in adult patients has been described, but data in children are limited.

Objective

The goal of this study was to determine the feasibility of using an extended-infusion PT dosing strategy as the standard of care in a children's hospital.

Methods

This was a prospective observational study of patients aged >30 days who received PT after admission to a freestanding, tertiary care children's hospital. After institution of an extended-infusion PT dosing protocol as the standard dosing option, patients receiving PT were prospectively assessed for presence of and reasons for changes in dosing regimen. …

Nonclinical Development Needs And Regulatory Requirements For Multipurpose Prevention Technologies: A Primer, Joseph W. Romano, Martha Brady, Judy Manning

HIV and AIDS

This summary outlines key development elements that will be necessary for various configurations of multipurpose prevention products for the simultaneous prevention of HIV, sexually transmitted infections, and/or pregnancy.

Shaping The Operations Research Agenda For Antiretroviral-Based Prevention Products For Women: Gels And Rings, Martha Brady, C. Elizabeth Mcgrory

HIV and AIDS

This report summarizes discussions from a two-day international experts consultation meeting in 2012 on preparing for the successful introduction of women-centered antiretroviral-based HIV prevention methods. It examines the limits and expectations of operations research in antiretroviral health technologies.

Characterization Of Pasteurella Multocida Strains Isolated From Geese, Zsuzsanna Varga, Dmitriy V. Volokhov, Laszlo Stipkovits, Akos Thuma, Boglarka Sellyei, Tibor Magyar

United States Food and Drug Administration: Publications

Phenotypic and genotypic diversity of forty-two Pasteurella multocida isolates from geese were characterized by analysis of their capsular type, Heddleston serotype, biotype, fimbrial gene allele type, comparative outer membrane protein (OMP) electrophoresis patterns, and were analyzed using PCR for the presence of virulence-associated genes (toxA, tbpA, pfhA, hgbA, hgbB, nanH, nanB, fimA, hsf-1, and pmHAS). A sequence comparison of the thdF and rpoB housekeeping genes of twenty representative P. multocida strains from three different OMP groups demonstrated that seventeen strains were closely related phylogenetically to previously published strains of P. multocida subsp. multocida and P. multocida subsp. gallicida, and only …

Dynamic Informed Consent Processes Vital For Treatment With Antidepressants, Abilash A. Gopal, Lisa Cosgrove, Itay Shuv-Ami, Emily E. Wheeler, Melissa J. Yerganian, Harold J. Bursztajn

Counseling, School Psychology & Sport Faculty Publication Series

Advances in technology and transparency have greatly accelerated the ability of clinicians to remain current with regards to being informed and informing patients about the risk/benefit ratio when considering antidepressant medication. In spite of this, the current climate of pharmaceutical industry influence on medical practice does much to hinder informed consent processes. Recent findings of previously unknown and potentially dangerous adverse effects of the second- and third-generation classes of antidepressants underscore the importance of enhancing the practice of informed consent. After considering the concept of informed consent as it has evolved over time, the authors summarize some of the newer …

Influence Of Oncotype Dx® On Chemotherapy Prescribing In Early Stage Breast Cancer Patients: A Claims-Based Evaluation Of Utilization In The Real World, Kenneth Neil Kennedy

Theses and Dissertations--Pharmacy

The decision for adjuvant therapy in women with early stage breast cancer (ESBC) has historically been guided by the presence or absence of specific biological markers (hormone and HER2 receptors), age, and extent of nodal involvement. Oncotype DX® is a validated assay that quantifies protein expression that can predict the risk of cancer recurrence. This study evaluates if the use of Oncotype DX® impacts chemotherapy prescribing in ESBC. This retrospective, cohort study identified patients with ESBC from a large commercially insured population from January 2007 through June 2009. Patients were identified as having ESBC by utilizing procedure and diagnosis codes …

Influence Of Prescription Drug Monitoring Programs On Acetaminophen-Related Liver Toxicity, Aaron Barcelo

MPA/MPP/MPFM Capstone Projects

No executive summary.

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

Pharmacy Practice & Administration

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 …

A System Dynamics Model Of Pharmaceutical Opioids: Medical Use, Diversion, And Nonmedical Use, Teresa Schmidt, Wayne Wakeland, J. David Haddox

Complex Systems Faculty Publications and Presentations

A dramatic rise in the nonmedical of pharmaceutical opioids has presented the United States with a substantial public health problem. Nonmedical use of prescription pain relievers has become increasingly prevalent in the US over the last two decades, and diversion of medicines obtained by prescription is assumed to be a major source of supply for nonmedical opioid use. Policymakers striving to protect population health by ameliorating the adverse outcomes of nonmedical use of opioid analgesics could benefit from a systems-level model which reflects the complexity of the system and incorporates the full range of available data. To address this need, …

The Role Of Situated Learning In Experiential Education: An Ethnographic Study Of The Knowledge-Construction Process Of Pharmacy Students During Their Clinical Rotations, Paul Difrancesco

Graduate Doctoral Dissertations

The purpose of this study was to explore learning through the social construction of new knowledge by pharmacy students engaged in experiential learning. Academic leaders and practitioners are responding to calls for the redesign of experiential education that will better prepare future pharmacists for practice. This has broad implications for educational programs and health care delivery.

Situated learning theory served as the theoretical framework for this study. The previous research of Lave and Wenger (1991); Bailey, Hughes, and Moore (2004); and others guided this research. Situated learning theory informed the research questions, which focused on understanding how students constructed knowledge …

Evaluating Consumer Preferences For Medicare Part D Using Conjoint Analysis, La'marcus Wingate

Theses and Dissertations (ETD)

The establishment of an outpatient prescription drug benefit in Medicare, Medicare Part D, was one of the more significant events in United States healthcare reform history. Many seniors have chosen to enroll in the plan as the program has an enrollment of over 27 million. One central premise of Medicare Part D was that the plan would be administered entirely through private insurance plans. Because many plans would be competing against one another for potential beneficiaries, it was expected that companies would offer seniors plans with high quality benefits at lower costs that would presumably be attractive to seniors. However, …

Facilitating Regulatory Approval Of Multipurpose Prevention Technologies For Sexual And Reproductive Health, Martha Brady

HIV and AIDS

This brief describes multipurpose prevention technologies (MPTs) that address women's sexual and reproductive health (SRH) needs, and how to go about facilitating regulatory approval of this technology. It outlines a strategic framework to examine current regulatory guidance, as well a product development pathway to bring MPTs to market.

Constructing A Critical Path For Product Development, Commercialization, And Access, Martha Brady

HIV and AIDS

This brief discusses the Council's health technologies development and the product development path from conceptualization to market. It defines the steps in the Critical Path Framework, and examines activities at the preclinical and clinical stage.

Conflicts Of Interest In Clinical Practice Guidelines, Lisa Cosgrove, Allen F. Shaughnessy

Counseling, School Psychology & Sport Faculty Publication Series

Clinical practice guidelines are used increasingly across medical specialties and settings, making evaluation of their utility and validity a critical public health issue. In this paper, we describe some of the challenges that specialty organizations face as they try to ensure that their guidelines are trustworthy and useful. We examine the practice guidelines for Major Depressive Disorder recently published by the American Psychiatric Association (APA), identify five sources of potential bias that may affect the guideline development process and offer suggestions based on our review. For example, even for mild depression, this guideline privileges pharmacotherapy over other interventions, despite questions …