Pharmacy Administration, Policy and Regulation Commons^™

Access To Essential Medicines In Pakistan: Policy And Health Systems Research Concerns., Shehla Zaidi, Maryam Bigdeli, Noureen Aleem, Arash Rashidian

Community Health Sciences

NTRODUCTION:

Inadequate access to essential medicines is a common issue within developing countries. Policy response is constrained, amongst other factors, by a dearth of in-depth country level evidence. We share here i) gaps related to access to essential medicine in Pakistan; and ii) prioritization of emerging policy and research concerns.

METHODS:

An exploratory research was carried out using a health systems perspective and applying the WHO Framework for Equitable Access to Essential Medicine. Methods involved key informant interviews with policy makers, providers, industry, NGOs, experts and development partners, review of published and grey literature, and consultative prioritization in stakeholder's Roundtable. …

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.