Pharmacy Administration, Policy and Regulation Commons^™

Psychiatric Taxonomy, Psychopharmacology And Big Pharma, Lisa Cosgrove

Counseling and School Psychology Faculty Publication Series

Clinicians practicing today need to be aware of the ways in which the current industry-dominated climate may undermine the integrity of the scientific process and, thus, may compromise patient care. In the mental health field, corporate sponsorship bias can affect psychiatric taxonomy and clinical Practice Guidelines (CPG). Financial conflicts of interest (FCOI) can occur when there are financial associations between researchers, authors, or panel members developing psychiatric diagnostic and treatment guidelines, and the pharmaceutical industry, or when randomized clinical trials (RCTs) are industry funded. Therefore, clinicians need to be especially vigilant about the informed consent process when patients are prescribed …

Undue Pharmaceutical Influence On Psychiatric Practice, Lisa Cosgrove, Harold J. Bursztajn

Counseling and School Psychology Faculty Publication Series

Within the past few years, increasing concerns have arisen about the ways in which corporate sponsorship of clinical trials and continuing medical education activities may bias the information that is published and disseminated about the benefits and risks of medications. Questions have also been raised about the extent of industry influence on the American Psychiatric Association’s diagnostic and treatment guidelines—namely, its DSM and Clinical Practice Guidelines.

More Than A Prescription, Marc A. Sweeney

Pharmacy Practice Faculty Publications

No abstract provided.

Pharmaceutical Philanthropic Shell Games, Lisa Cosgrove, Harold J. Bursztajn

Counseling and School Psychology Faculty Publication Series

In response to increasing public distrust and congressional concerns regarding pharmaceutical company influence on medical research and education, professional organizations have taken steps to phase out or regulate industry-sponsored educational support. A related problem is industry funding of philanthropic organizations, such as patient advocacy groups. Thus, when the office of Sen Charles Grassley (R-Iowa) recently reported that the National Alliance for the Mentally Ill received substantial pharmaceutical funding, there was concern among the membership’s psychiatric patients and their families.

What Is The Impact Of Kentucky’S Pharmacy Recovery Network?, Benjamin Paul Clark

MPA/MPP/MPFM Capstone Projects

Problem Statement: This capstone will focus on Kentucky’s Pharmacy Recovery Network (PRN). In general, professional recovery networks are organizations that act as a liaison between professional state boards and the health professionals who are dealing with substance abuse and addictions that sometimes result in negative consequences to that individual and/or their profession. Instead of a “one-strike and you are out” approach, these organizations recognize that there is a disease process occurring. Thus, as opposed to engaging in strictly punitive measures, a rehabilitative approach is chosen to allow the health professional an opportunity to recover and successfully reenter into their profession. …

Evaluation Of Pharmacy-Implemented Medication Reconciliation Directed At Antiretroviral Therapy In Hospitalized Hiv/Aids Patients [Letter], Megan A. Corrigan, Kendra Atkinson, Beverly E. Sha, Christopher W. Crank

Scholarship and Professional Work – COPHS

Short communications published in Annals of Pharmacotherapy, 44(1).

21st Century Healthcare - A New Scenario Needs New Rules Of The Game, Mian Atif Saeed

Mian Atif Saeed

We are witnessing a changing paradigm of healthcare sector in view increasing pressure on governments to provide free healthcare to citizens and increasing cost-consciousness of governments/payers to address this public issue. This changing paradigm in healthcare requirements requires a holistic review of the legislative framework in which industry operates. All stakeholders and all applicable regulatory and legal frameworks need to be appraised in order to address the requirements of 21st century healthcare. Drug development is very risky, costly and lengthy process and inventors and investor deserve financial gains for their efforts. Pharmaceutical industry requires the money to keep investing back …

Impact Of Levalbuterol Versus Albuterol In Kentucky Medicaid Patients, Velma Henry

MPA/MPP/MPFM Capstone Projects

Problem:

Asthma is a chronic pulmonary disease that occurs in approximately 10 percent of the population worldwide and is associated with a significant increase in direct medical expenditures. Levalbuterol and racemic albuterol are two short-acting β2-agonists (SABA) prescribed for the treatment of asthma. Racemic albuterol has been used for more than 40 years but is associated with several side effects including tremor. When levalbuterol was approved in 2005 its manufacturer and several studies suggested that using levalbuterol results in better respiratory parameters, fewer hospitalizations, less adverse effects and therefore, lower overall treatment costs and hence less need for β-adrenergic agonist …

Addition Of Levalbuterol To A Pediatric Emergency Department Automated Medication Management System Does Not Increase Its Use., Gregory P. Conners, Daniel P. Hays, Thomas Richardson, Frank L. Zwemer

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Although adding a drug to an emergency department-based automated medication management system is known to increase how frequently it is ordered, little is known about this effect when the added drug does not offer substantial benefit over a substitute drug that was already available.

AIMS: We studied the effect of adding nebulized levalbuterol to a pediatric emergency department-based automated medication management system that already included albuterol.

METHODS: All completed orders for nebulized levalbuterol or nebulized albuterol from our academic pediatric emergency department were retrospectively identified using a computerized pharmacy database. We compared ordering of these drugs for the year …

Analysis And Evaluation Of Participation By Prescibers And Dispensers In The Maine State Prescription Monitoring Program, Marcella H. Sorg, Sharon Labrie, William Parker

Anthropology Faculty Scholarship

As part of a Department of Justice, U.S. Attorneys Office grant for the analysis and evaluation of participation in the Prescription Monitoring Program (PMP), the Margaret Chase Smith Policy Center mapped and analyzed spatial patterns of prescriber and pharmacy locations as well as PMP participation, and conducted a survey of licensed prescribers and dispensers of controlled substances in Maine. The PMP, implemented beginning July 1, 2004, monitors all drugs in Schedules II, II, and IV, and any pharmacy that is licensed to dispense prescriptions in or into the state of Maine is required by law to report to the program. …

Toward Credible Conflict Of Interest Policies In Clinical Psychiatry, Lisa Cosgrove, Harold J. Bursztajn

Counseling and School Psychology Faculty Publication Series

A recent letter to the American Psychiatric Association (APA) from Sen Chuck Grassley about the APA’s financial relationship with pharmaceutical companies raises concerns about undue industry influence. By instituting a disclosure policy for DSM-V, the APA took a halting first step in restoring public trust in the most influential text on psychiatric taxonomy in the world. Unfortunately, the APA’s efforts at creating a conflict of interest (COI) policy have failed to ensure that the process for revising diagnostic and therapeutic guidelines is one that the public can trust. The need for more safeguards was evidenced when the APA reported that …

Rethinking The Role Of Clinical Trial Data In International Intellectual Property Law: The Case For A Public Goods Approach, Jerome H. Reichman

Faculty Scholarship

This article is a later version of the author's presentation at the Eleventh Annual Honorable Helen Wilson Nies Memorial Lecture March 26, 2008. Clinical trials are currently used to test drugs; however, the risk and cost of clinical trials are increasing so drastically that the clinical trials may become unsustainable. This article evaluates the legal and economic trends of intellectual property protection for pharmaceutical clinical trial data. The protection of clinical trials has become an alternative to patents as market exclusivity encourages the development and testing of unpatentable pharmaceuticals. This author argues that clinical trials should be treated as a …

Consumer Protection In An Era Of Globalization, Cary Coglianese, Adam M. Finkel, David T. Zaring

All Faculty Scholarship

With expanding global trade, the challenge of protecting consumers from unsafe food, pharmaceuticals, and consumer products has grown increasingly salient, necessitating the development of new policy ideas and analysis. This chapter introduces the book, Import Safety: Regulatory Governance in the Global Economy, a multidisciplinary project analyzing import safety problems and an array of innovative solutions to these problems. The challenge of protecting the public from unsafe imports arises from the sheer volume of global trade as well as the complexity of products being traded and the vast number of inputs each product contains. It is further compounded by the …

How Fairness Garners Loyalty In The Pharmaceutical Supply Chain: Role Of Trust In The Wholesaler-Pharmacy Relationship, Thani Jambulingam, Ravi Kathuria, John R. Nevin

Business Faculty Articles and Research

Purpose

– The purpose of this paper is to understand how fairness garners loyalty by breeding trust in the pharmaceutical wholesaler‐pharmacy relationship. Specifically, the paper seeks to understand if the two dimensions of fairness – procedural and distributive – contribute differently in fostering the two types of trust – credibility and benevolence. The paper further aims to examine how the two dimensions of trust mediate the fairness‐loyalty relationship.

Design/methodology/approach

– Data from 156 retail pharmacies on their relationship with the pharmaceutical wholesalers are used to test the hypotheses. The mediation models are tested using the Barron and Kenny procedure.

Findings …

Incentives For Orphan Drug Research And Development In The United States, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, Sheryl L. Szeinbach, Jay Visaria

Pharmacy Faculty Articles and Research

Background: The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007.

Methods: Primary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during …

Why Pharmacists Choose To Seek Or Not Seek Board Certification In Pharmacy Practice: A Comparison Of Motivation And Motivating Factors, Mark Tankersley

Theses and Dissertations (ETD)

The stated mission of the Board of Pharmaceutical Specialties (BPS) with regard to specialization is, via board certification, to recognize specialty areas, define skill standards for those specialty areas, and evaluate the knowledge and skills of individual Pharmacy specialists. The perceived or real benefits to the pharmacist of pursuing board certification are unknown. These benefits can be evaluated by separating into values (valences) and instrumentalities, the latter of which is the perceived or known probability that a performance will lead to an outcome. The primary purpose of this study was to determine the differences in values and instrumentalities perceived by …

Drug Selection And Adverse Drug Reactions: Balancing Outcomes And Costs, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

"Regulatory agencies approve drugs for marketing when the ratio of risk to benefit of the drugs is positive, i.e. the potential benefit of using the drug justifies the risk of drug related adverse reactions (ADR). At the point of approval of a drug there is not adequate information about all possible negative outcomes arising from its use in clinical practice. The information is even more limited for patient subgroups, diseases and treatment combinations that were not evaluated in the clinical trials required for approval. Therefore, performing post-marketing pharmacoepidemiological studies is necessary for a better understanding of drug use in usual …

Ky Pharmacists’ Perceptions On Medication Errors (Me): A Tool For Legitimate Discussions With The Kentucky Board Of Pharmacy?, J. D. Hammond

MPA/MPP/MPFM Capstone Projects

No executive summary.

Entrepreneurial Orientation As A Basis For Classification Within A Service Industry: The Case Of Retail Pharmacy Industry, Thanigavelan Jambulingam, Ravi Kathuria, William R. Doucette

Business Faculty Articles and Research

To date, service classification research has primarily taken a macro view, creating service typologies or taxonomies by using dimensions such as customer contact or degree of labor intensity. Such classification schemes, though helpful in deciphering critical management issues and positioning strategies between service industries, tend to treat an entire industry, such as airlines, as a single homogenous entity. However, organizations in the same industry often use intangible resources, such as entrepreneurial orientation processes, to compete with one another. Resource-advantage theory suggests that organizations utilize intangible resources to build long-term strategies and a sustainable competitive advantage leading to superior performance. We …

Purchasing Pharmaceuticals (Health, Nutrition And Population (Hnp) Discussion Paper), Ulrika Enemark, Anita Alban, Enrique Seoane-Vazquez

Pharmacy Faculty Books and Book Chapters

This paper discusses the purchasing of pharmaceuticals as a key component of costeffective and equitable healthcare delivery. Pharmaceuticals account for a high, sometimes the dominant share of health expenditures in developing countries, but the desired health outcomes can only be achieved if the adequate medicines reach the right people and are used in the correct way. This requires purchasing arrangements that take into account the information asymmetry between patients and providers, ensure selection of effective, safe and affordable medicines and set economic incentives in a way that encourages rational drug use. The organizational and institutional frameworks define the roles of …

Health, Human Rights And The Pharmaceutical Industry, Gerald Montgomery

Human Rights & Human Welfare

The pharmaceutical industry is a crucial touchstone in the discussion of corporate responsibility to promote human rights. This relationship is, however, problematic at best and, at worst work in opposition to each other. At the same time that drug producers are instrumental in promoting a basic level of human welfare, the outlook of major pharmaceutical corporations are mitigated by unfiltered lenses of profit. With hundreds of millions of dollars spent on research and development, patenting, and marketing, they understandably develop strategies for handling reoccurring costs. But should a morally responsible international community redirect these costs to the developing world or …

Rising Prescription Drug Costs: What Is Involved And What Can Be Done?, James Carroll

Maine Policy Review

The rapid rise of prescription drug costs in the United States has triggered heated debate at the federal and state levels about how to control costs and expand access for those in need. In part, the United States finds itself in this situation because, unlike most countries throughout the world, the federal government thus far has refused to exact federal price restrictions on pharmaceutical products. James Carroll argues that this has left each state in the difficult position of trying to leverage lower costs and expanded access for its citizens. In this article, Carroll provides an overview of these attempts, …

Price Of Pharmaceuticals, Value, R&D, And Intergenerational Equity, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

"A few issues are more debated today than the price of pharmaceuticals. The debate is prompted by the lack of drug access for the world's population, the high expenditures of pharmaceutical companies in marketing and profits, and the need for research and development of new drugs."

Retirees And Pharmaceutical Costs: Is There Really A Crisis?, Justine Maiello

Seton Hall University Dissertations and Theses (ETDs)

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Timing Of New Black Box Warnings And Withdrawals For Prescription Medications, Karen Lasser, Paul D. Allen, Steffie Woolhandler, David U. Himmelstein, Sidney M. Wolfe, David H. Bor

Publications and Research

Context Recently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs.

Objective To determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market.

Design and Setting Examination of the Physicians' Desk Reference for all new chemical entities approved by the US Food and Drug Administration between 1975 and 1999, and all drugs withdrawn from the market between 1975 and 2000 (with or without a prior black …

Pharmaceuticals: Access, Cost, Pricing, And Directions For The Future, Patricia M. Danzon, Stephen B. Soumerai

Center for Policy Research

Prescription drug expenditures make up less than 10 percent of total personal health care expenditures in the United States, but over the last decade the amount that Americans spend on prescription drugs has grown much faster than any other component of personal health care. For example, between 1999 and 2000, hospital care costs rose about 5 percent, physicians and clinical services 6 percent, while prescription drug expenditures climbed more than 17 percent. In dollar amounts, prescription drug expenditures doubled, from $61 billion to $122 billion, between 1995 and 2000. Is this an unwarranted expense that needs to be controlled, or …

White Paper: Certification, Credentials, And Credentialing In Pharmacy, Donald Kishi, Jeffery A. Goad, Nancy Korman, Teresa Miller, Mary Ferrill, Holly Strom

Pharmacy Faculty Articles and Research

The rapid evolution of the health care system has provided the pharmacy profession with opportunities to expand existing and develop new direct patient care roles. Two critical challenges that the pharmacy profession must contend with to ensure the continued expansion and acceptance of pharmacists in advanced practice roles (e.g. direct patient care roles) are: (1) To develop and implement a credible, systematic, standards-based, and profession-wide plan that includes a system for identifying the types of pharmacists' practices requiring credentials, a validated certification process, and a computerized credentialing process that is current, comprehensive, and easily accessible; (2) To establish the credibility …

Reimbursement For Pharmaceutical Care Services: The California Experience, Jeffery A. Goad, Kathleen Johnson, Michael Rudolph

Pharmacy Faculty Articles and Research

"While it is true that pharmacists are changing their practice habits, they are doing so for the betterment of their patients’ drug therapy outcomes and the healthcare system. The pharmacist serves as the vital link between the patient, physician, and healthcare system. By working with patients and physicians, pharmacists have demonstrated in the literature that they can improve patient drug therapy outcomes, thus preventing unnecessary healthcare expenditures (Fincham, 1998). Pharmacists have long been held in highest esteem by patients, being voted the number one trusted professional for 10 consecutive years. The evidence is clear that pharmacists provide a valuable service …

Perceptions Regarding Knowledge Management: An Exploration Of Characteristics And Components Of Knowledge Management With Application In The Pharmaceutical Industry, Michael D. Sutch

Seton Hall University Dissertations and Theses (ETDs)

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Fda Reform And The European Medicines Evaluation Agency, Theodore Ruger

All Faculty Scholarship

No abstract provided.