Pharmacy Administration, Policy and Regulation Commons^™

Actionable Patient Safety Solutions (Apss) #3a: Medication Errors, Ron Jordan, Jerika Lam, Peter Antevy, Steven Barker, Linda Beneze, Michel Bennett, Laressa Bethishou, Jim Broselow, John Burnam, Mitchell Goldenstein, Kari Hamlin, Helen Haskell, Christopher Jerry, Edwin Loftin, Ariana Longley, Jacob Lopez, Anne Lyren, Brendan Miney, Sidney Morice, Steve Mullenix, Robert Nickell, Rochelle Sandell, David Shane Lowry, Robin Shannon, Deeba Siddiqui, Charles Simmons, Nat Sims, Robert Stein, Laura Townsend, Jason Yamaki, Sun Yang

Pharmacy Faculty Articles and Research

A medication error is a preventable event in any healthcare setting that may lead to inappropriate medication use while in the control of the healthcare professional or patient, ultimately leading to patient harm and/or death. Medication errors can be classified into five categories: 1) wrong drug, 2) wrong dose, 3) wrong route, 4) wrong frequency and/or 5) wrong patient.

At Risk Alcohol Consumption With Smoking By National Background: Results From The Hispanic Community Health Study/Study Of Latinos, Frank C. Bandiera, Eliseo J. Pérez-Stable, Folefac Atem, Raul Caetano, Denise C. Vidot, Marc D. Gellman, Elena L. Navas-Nacher, Jianwen Cai, Gregory Talavera, Neil Schneiderman, Robert Kaplan

United States Food and Drug Administration: Publications

Introduction: Tobacco smoking and binge or excess drinking are unhealthy behaviors that frequently co-occur. Studies of Hispanics/Latinos have mostly been of Mexican Americans although there are substantial differences in smoking and drinking by heritage background. Associated with co-use by 5 subpopulations.

Methods: Cross-sectional data of 16,412 Hispanics/Latinos from Miami, the Bronx, Chicago and San Diego collected between 2008 and 2011 as part of the HCHS/SOL were analyzed. Smoking and alcohol consumption and demographic data were measured by self-report. Prevalence of smoking and alcohol consumption and co-use were reported. Logistic regression models examined the odds of co-use of smoking and binge …

Comparing Methods For Clinical Investigator Site Inspection Selection: A Comparison Of Site Selection Methods Of Investigators In Clinical Trials, Nicholas Hein, Elena Rantou, Paul Schuette

United States Food and Drug Administration: Publications

Background During the past two decades, the number and complexity of clinical trials have risen dramatically increasing the difficulty of choosing sites for inspection. FDA’s resources are limited and so sites should be chosen with care.

Purpose To determine if data mining techniques and/or unsupervised statistical monitoring can assist with the process of identifying potential clinical sites for inspection.

Methods Five summary-level clinical site datasets from four new drug applications (NDA) and one biologics license application (BLA), where the FDA had performed or had planned site inspections, were used. The num- ber of sites inspected and the results of the …

Regulatory Gaps In Drug Compounding: Implications For Patient Safety, Innovation, And Fraud, Joanna Shepherd

Faculty Articles

Drug compounding is the practice of mixing, combining, or altering drug ingredients to create a product that meets the medical needs of a patient whose needs cannot otherwise be met with commercially-available products. Compounding is essential for patients that are allergic to certain ingredients or cannot tolerate the route of administration or dosage form of a commercially-available drug. Compounding may also enable pharmacists to supply medications when there is a shortage of commercially-available drugs. For example, amid the nationwide shortage of generic liquid Tamiflu and growing flu deaths in early 2018, pharmacists around the country used Tamiflu capsules to compound …

Rethinking Consumer Protection: Escaping Death By Regulation, Thomas L. Tacker

Publications

This book is designed to appeal to anyone who is at all interested in topics related to making life better and safer—for all us consumers. Our current approach to consumer protection is extremely flawed; sometimes costing lives rather than saving them. There are better ways to protect ourselves and the people we love.

Comparative Effectiveness And Safety Of Non-Vitamin K Antagonists Oral Anticoagulants And Warfarin In Elderly Patients With Non-Valvular Atrial Fibrillation And Diabetes, Siddhi Korgaonkar

Electronic Theses and Dissertations

Results: The matched sample consisted of 4578 patients (2291 in each group). NOACs were found to significantly reduce the risk of stroke/SE compared to warfarin (Hazard Ratio (HR): 0.373, 95% confidence interval (CI): 0.247 - 0.564, p<0.001); but, no significant difference was seen between NOACs and warfarin in terms of reducing the risk of MI (HR: 0.864, CI: 0.594 – 1.257, p=0.446). NOACs were found to significantly reduce the risk of ICH (HR: 0.500, CI: 0.300 – 0.834, p=0.008) and OB (HR: 0.608, CI: 0.424 – 0.870, p=0.007); but no difference was seen in the risk of MGB (HR: 0.862, CI: 0.640 – 1.160, p=0.326) between NOACs and warfarin. NOACs were also found to reduce the risk of all-cause mortality (HR: 0.783, CI:0.656 – 0.873, p=0.007). The composite of effectiveness and safety outcomes, and all-cause mortality was statistically significant proving superior overall effectiveness and safety of NOAC therapy to warfarin therapy in terms of risk reduction (HR:0.685, CI:0.587 – 0.801, p<0.001).

Evaluating Ways To Reduce Errors In Medication Reconciliations Performed By Nurses In A Rural Hospital Setting, Kalen T. Freeman

MPA/MPP/MPFM Capstone Projects

Medication reconciliation, also known as “med recs”, are an important part of a patient’s care during their hospitalization. A med rec is when hospital personnel generate a list of the medications the patient takes at home. Med recs are vital in the hospital admission process because home medications need to be restarted at appropriate times to fully care for the patient. Also, mistakes in a home medication list can lead to serious consequences in the patient’s health. This study focuses on med recs being performed at Marcum and Wallace Hospital in Irvine, Kentucky. More specifically, the study explores the different …

Drug Prices, Dying Patients, And The Pharmaceutical Marketplace: A New Conditional Approval Pathway For Critical Unmet Medical Needs, Robert A. Bohrer

Faculty Scholarship

Prescription drugs have been a major topic in the news for much of the past year. There are two issues which appear often: first, the very high prices of new drugs, particularly the "specialty" drugs developed for serious diseases; and second, the time required for FDA approval in relation to the perceived need for earlier access to new therapies for critically ill patients. Much less in the news, but lurking behind both issues, is the need for better information for physicians and patients to use in making decisions about prescribing and taking drugs, and for insurance companies and the government …

Direct-To-Consumer Ads Are Misleading: Concise Statements Of Effectiveness Should Be Required, Robert A. Bohrer

Faculty Scholarship

Direct-to-consumer (DTC) advertising of prescription pharmaceuticals has been the subject of much criticism and the issue has become even more pressing with the Trump administration’s proposal to require the disclosure of prices in DTC ads. In this article I argue that a more powerful approach to the problem of DTC ads would require the disclosure of the effectiveness of the advertised drugs, at least as found in the clinical trials submitted for FDA approval. To support the need for an effectiveness disclosure, I describe the problem of DTC ads and examine representative ads to illustrate the potential of such ads …

Pharmacy-Based Travel Health Services In The United States, Keri Hurley-Kim, Jeffery Goad, Sheila Seed, Karl M. Hess

Pharmacy Faculty Articles and Research

The aim of this paper is to review pharmacy laws and regulations, pharmacist training, clinic considerations, and patient care outcomes regarding pharmacy-based travel health services in the United States. Pharmacists and pharmacies in the United States are highly visible and accessible to the public, and have long been regarded as a source for immunization services. As international travel continues to increase and grow in popularity in this country, there is a pressing need for expanded access to preventative health services, including routine and travel vaccinations, as well as medications for prophylaxis or self-treatment of conditions that may be acquired overseas. …

Community Pharmacists And Substance Use Disorders: Attitudes, Knowledge And Practices, Deepika Rao

Electronic Theses and Dissertations

Background: Substance use disorder (SUD) is a serious health concern affecting a large proportion of the US population. Community pharmacists are well-positioned to prevent, screen, and provide appropriate treatment for SUD. Stigma towards these patients and SUD results in reduced quality of care as well as poor treatment outcomes. It is imperative that pharmacists have the appropriate knowledge of and attitude towards prevention, harm reduction and treatment to develop therapeutic relationships and improve their delivery of pharmacy services

Objective: To assess knowledge, practices (with an emphasis upon screening), stigma and general attitudes of community pharmacists towards SUD and evaluate the …

Multiple Sclerosis Drugs Have Been Getting A Lot More Expensive, Ben Jay

Capstones

Multiple Sclerosis is a very expensive disease. According to a 2016 study in the American Journal of Managed Care, treating it can cost patients anywhere from $30,000 to $100,000 per year, which can meet or even exceed the average US household median income, depending on how severe your case is. For a disease that has no known cure, and requires frequent medical attention to manage symptoms that can completely debilitate a person if left untreated, that can mean spending $4.1 million over the course of a lifetime, according to the same study. However, in the last 20 years, that …

Save The Pharmacy Piggy Bank: Managing Mega High-Cost Drugs, Richard K. Ogden Jr., Jerame Hill, Sam Abdelghany

Pharmacy Presentations

No abstract provided.

Save The Pharmacy Piggy Bank: Managing Mega High-Cost Drugs, Richard K. Ogden Jr., Jerame Hill, Sam Abdelghany

Pharmacy Posters

No abstract provided.

Retrospective Review Of Oral Oncolytic Agent Use Within A Community Hospital, Alyssa Donadio, Moe Shwin, Maria Figueroa, Michelle Lamarque

All Publications

No abstract provided.

From Prison To The Community: Opportunities For Pharmacists To Support Inmate Medication Adherence, Elliott Bosco, Deborah Shelton

Journal for Evidence-based Practice in Correctional Health

The United States correctional system is a vital treatment source for chronic illnesses. Whether treating a chronic mental or physical illness, correctional healthcare requires effective resource utilization. Limited research exists on pharmacists' ability to directly address inmate medication adherence. Thus, this study explores inmate perception of medication adherence and management as part of their treatment plan. Semi-structured interviews were conducted with inmates throughout Connecticut. Diseases of interest were divided into a physical illness group (hypertension, diabetes mellitus, HIV/AIDS) and a mental illness group (depression, bipolar disorder, schizophrenia, substance abuse). A content analysis was conducted on four questions: 1) Do you …

The Pharmaceutical Industry: A Pharmacy Student's Guide, Christian Egly, Yaman Kaakeh

Purdue Journal of Service-Learning and International Engagement

Christian Egly is a fourth-year (P4) pharmacy student in the Purdue University College of Pharmacy. During his years at Purdue, he worked in labs performing bench research in clinical pharmacology and biochemistry. He plans to work in the pharmaceutical industry after graduation. During his fourth year, he completed rotations in business development at Kashiv Pharma, LLC, and was hired there for an internship in 2017. In the article, Christian describes his personal experiences at Kashiv Pharma, LLC, and how industry can positively affect patient communities.

Prescription And Over-The-Counter Medication Record Integration: A Holistic Patient-Centered Approach, Clark D. Kebodeaux

Pharmacy Practice and Science Faculty Publications

Objective: Nonprescription or over-the-counter (OTC) medications play a crucial role in a patient’s ability to make choices to manage his or her own health care. Often these nonprescription choices are unknown to health care practitioners and thus are often not included as part of patients’ health records. The exclusion of these therapies can pose risks to patient safety. There is a significant need to address the capture of OTC medication use in both the physician and pharmacy electronic health records (EHRs) and during the practitionerepatient medication history and reconciliation process.

Data sources: On October 26, 2016, the National Association of …

Increase Referrals To Medaccess At The Smhc Pharmacy, Sarah Jones, Kim Beaudoin

Southern Maine Health Care

Problem/Impact Statement: The MedAccess Program is losing referrals at point of sale in the SMHC Pharmacy.

Scope: Patients who are currently serviced by the SMHC Pharmacy that are uninsured or under insured and meet the % Federal Poverty Level for prescription assistance.

The 340b Program, Contract Pharmacies And Hospitals: An Examination Of The First 25 Years Of Their Increasingly Complex Relationship, David P. Paul Iii, Morgan Cathlene Ludado, Morgan Ruley, Hannah Sayre, Alberto Coustasse

Management Faculty Research

The 340B Drug Pricing Program, created by Congress in 1992 through the Veterans Health Care Act, has provided discounted drug prices to hospitals and other health care organizations serving a wide population of low-income patients. Some 340B programs use contract pharmacies, an arrangement whereby the hospital or health care organization signs a contract directly with a pharmacy to provide covered pharmacy services at discounted prices.

The federal 340B Drug Pricing Program has provided access to reduced price prescription drugs to over 35,000 individual healthcare facilities and sites certified by the U.S. Department of Health and Human Services (HHS), and clinics …