Pharmacy Administration, Policy and Regulation Commons^™

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.

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.

The Incidence Of Hip Fracture Associated With Proton Pump Inhibitor (Ppi) And/Or H2 Receptor Antagonist (H2ra) Use In The Kentucky Medicaid Population, Timothy C. Umeh

MPA/MPP/MPFM Capstone Projects

No executive summary.

Should Pseudoephedrine (Pse) Be Moved From Behind The Counter To Prescription-Only? An Analysis Of Pse As An Otc Medication And A Precursor For Methamphetamine Production, Jerry Dillon

MPA/MPP/MPFM Capstone Projects

Kentucky State Senator Tom Jensen recently sponsored Senate Bill 45, which would change pseudoephedrine (PSE) from an over-the-counter to a schedule V prescription-only drug. The bill failed, but the debate continues as to whether Kentucky should make PSE, a precursor required to manufacture illicit methamphetamine, a controlled drug that is available by prescription only.

Methamphetamine abuse has been increasing in Kentucky as well as in the rest of the country, despite efforts to control the sale of PSE through federal and state legislation. The Combat Methamphetamine Epidemic Act (CMEA) of 2006 and Kentucky’s initiative to electronically monitor the sales of …

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

Counseling and School Psychology 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 …

Fairness-Trust-Loyalty Relationship Under Varying Conditions Of Supplier-Buyer Interdependence, Thani Jambulingam, Ravi Kathuria, John R. Nevin

Business Faculty Articles and Research

Relationship marketing plays a significant role in supply chain practice and academic studies. Using the resource advantage theory within the relationship marketing framework, we studied the mediating role of trust as a governance mechanism in the fairness-loyalty relationship under different types of interdependence structure between suppliers (wholesalers) and buyers (retailers). Our findings, based on data from retail pharmacies, demonstrate that only under conditions of symmetric independence, trust, as a governance mechanism, completely mediate the relationship between fairness and loyalty. Under conditions of both perceived independence (i.e., lack of interdependence) and asymmetric buyer dependence, however, trust does not mediate but fairness …

The Effects Of Pharmaceutical Marketing And Promotion On Adverse Drug Events And Regulation, Guy David, Sara Markowitz, Seth Richards-Shubik

Health Care Management Papers

This paper analyzes the relationship between postmarketing promotional activity and reporting of adverse drug reactions (ADRs) by modeling the interaction between a regulator (the FDA) and a pharmaceutical firm. Promotion-driven market expansions enhance profitability yet may involve the risk of inappropriate drug prescriptions, leading to regulatory actions against the firm. We empirically test the relationship between drug promotion and reporting of ADRs using an innovative combination of commercial data on pharmaceutical promotion and FDA data on regulatory interventions and ADRs. We provide some evidence that increased levels of promotion and advertising lead to increased reporting of ADRs for certain conditions.

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 …

Diagnosing Conflict-Of-Interest Disorder, Lisa Cosgrove

Counseling and School Psychology Faculty Publication Series

In June 2010, the Association of American Medical Colleges issued the third and final portion of its conflict-of-interest policy initiatives. The task force on “Conflicts of Interest in Clinical Care” did not mince words when it described the impetus for these initiatives: “It is imperative that the possibility or perception of [financial conflict of interest] be advertently examined and appropriately evaluated to ensure that academic medicine in all of its missions is fundamentally dedicated to the welfare of patients and the improvement of public health.”

This report is especially timely because of recent questions raised by investigative journalists and policy …

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.

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 …

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).

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 …

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. …