Pharmacy Administration, Policy and Regulation Commons^™

Community Pharmacies Face Critical Sustainability Challenges In The United States: Academic Pharmacy Can Help, Karl M. Hess, Peter Lim

Pharmacy Faculty Articles and Research

Community pharmacies in the United States (US) face an increasingly unsustainable future due to declining third-party reimbursement (remuneration) and ongoing cash flow challenges following the elimination of retroactive direct and indirect remuneration (DIR) fees. These pressures have contributed to widespread pharmacy closures, the emergence of pharmacy deserts, and reduced access to care for millions of patients. Despite these challenges, community pharmacy remains the most common employment setting for pharmacy school graduates in the US. However, currently required community pharmacy Advanced Pharmacy Practice Experience (APPE) student rotations may offer limited exposure to business, management, and entrepreneurial activities, potentially leaving students underprepared …

A Quality Improvement Project To Decrease Medication Prior Authorization Approval Times, Amena Guinn Babers

Doctor of Nursing Practice (DNP) Scholarly Projects - Archive

Background: Medication prior authorization requirements add to administrative burden, increase labor costs, and delay patient access to treatment in outpatient specialty settings. This bottleneck directly influences nursing workload and economic performance.

Purpose: To evaluate the fiscal and performance significance of implementing an electronic prior authorization (ePA) process, standardized tracking tools, and staff education in a small orthopedic clinic.

Methods: A pre–post quality improvement design was used. Descriptive statistics and inferential analyses (independent‑samples t tests and Mann–Whitney U tests) were conducted to compare time to approval, staff hours worked, satisfaction scores, and medication pickup timeframes.

Results: Significant reductions were observed in …

Payment Disrupters And Opportunities: Key Trends That Impacted Pharmacy In 2024, Craig Kimble, Thomas Pile, Alberto Coustasse

Management Faculty Research

In 2023, the United States experienced the most significant increase in prescription drug spending (13.6%), totaling $89 billion.1 This was driven by higher utilization and the introduction of new, expensive specialty and biotech drugs. In 2024, other factors continue to drive costs and disrupt the pharmacy landscape, including the implementation of new business models, pharmacy benefit manager (PBM) practices, the rebate system, regulatory changes, advancements in provider status, and potential Federal Trade Commission (FTC) interventions.

Developing Public-Private R&D Consortia To Accelerate Alzheimer’S Disease Drug Development, Joel West, Paul Olk

Management: Faculty Scholarship

Efforts to accelerate Alzheimer's disease (AD) drug development have been spurred on by the creation of open science, public-private R&D consortia. An R&D consortium provides an improved structure for generating and disseminating AD knowledge across a range of organizations while also aligning their interests. Drawing from archival and interview data collected on 46 public-private R&D consortia focused wholly or in part on AD, we uncover two important innovations: the creation of novel consortium types that facilitate coordination beyond the individual consortium, and the practice of organizations joining multiple consortia. Collectively these innovations provide member organizations with different pathways for advancing …

Artificial Intelligence Is Revolutionizing Controlled Substance Diversion Detection, Brian Cox, Alberto Coustasse, Craig Kimble

Management Faculty Research

In community and institutional health care sectors, artificial intelligence (AI) use is expanding. AI is being tapped broadly in operations, customer service, and scheduling, with major pharmacy chains such as Kroger, CVS, and Walgreens, already starting to implement AI applications in their pharmacies. So far, Kroger has begun to use AI for employee onboarding and training processes, CVS is applying AI in negotiations with suppliers, and Walgreens is using it to streamline vaccine scheduling. With these advances in major pharmacy chains, the next extensive application for AI has become clearer: diversion monitoring. Diversion occurs in health care settings when a …

Navigating The Path To Safe Compounding In Health Systems, Thomas Pile, Craig Kimble, Alberto Coustasse

Management Faculty Research

Across the country health systems are facing increasing drug shortages that are forcing pharmacists to rely far more heavily on compounding to meet the needs of patients. Additionally, several high-profile compounding incidents have helped highlight the importance of ensuring best practices are followed during sterile and nonsterile compounding to support patient safety and high-quality care. Specifically, in 2022, 160 drug shortages were reported in pharmacies. From January 1, 2023, to March 31, 2023, 47 drug shortages were reported, 55% of which were for injectables. In response, compounding has increasingly become a solution to bridge that gap.

President’S Address: Dr. Vince Benivegna, Vince Benivegna Dds

The Journal of the Michigan Dental Association

Dr. Vince Benivegna, the outgoing President of the Michigan Dental Association, addressed the House of Delegates, emphasizing the significant progress in enhancing Adult Dental Medicaid coverage and reimbursement in Michigan. He thanked the dedicated individuals who supported him during his tenure and shared his journey. Dr. Benivegna lauded Michigan's accomplishments in reducing opioid prescribing and highlighted the MDA's role as a model state society in advocacy, leadership, mentorship, continuing education, diversity, equity, and inclusion. He praised Michigan's achievements in improving Adult Dental Medicaid, encouraging Michigan dentists to participate and help address oral health disparities. Dr. Benivegna underscored how this aligns …

Dentistry And The Law: Accessing/Disclosing Prescription Information On Software Platforms, Dan Schulte Jd

The Journal of the Michigan Dental Association

This article discusses the access and disclosure of prescription information on software platforms like eScribe and MAPS. It highlights that HIPAA regulations govern such access, and as long as the information is obtained through business associate agreements and used for treatment purposes, specific patient consent may not be necessary. The article also mentions that the Michigan Automated Prescription System (MAPS) allows prescribers to access controlled substance prescription information without requiring patient consent.

Closed-System Transfer Devices Reduce Exposure To Contaminants, Ken Maxik, Craig Kimble, Alberto Coustasse

Management Faculty Research

Closed-system transfer devices (CSTDs) are used during the preparation of hazardous drugs (HDs) as a mechanism to reduce the transfer of drugs or vapors into the environment. When evaluating these systems, pharmacists should consider which drugs in the pharmacy would benefit the safety of health care workers and patients using the systems. Medication types include neoplastic agents, such as bleomycin, cisplatin, and methotrexate, and other agents, such as cyclosporine, oxytocin, and progesterone.

Takeda Pharmaceutical Rare Hematology Strategic Audit, Brian Duval

Honors Program: Senior Projects (Public)

Takeda Pharmaceutical Company is a large Japanese-based multinational pharmaceutical company that manufactures treatments for many different diseases. It is the largest pharmaceutical company in Asia and has a significant share in markets across the world. This report focuses specifically on Takeda’s treatments for rare bleeding disorders under its Rare Diseases & Hematology division. Using internal and external analysis tools, this report seeks to understand how Takeda has created and sustained competitive advantages in the complex environment of the pharmaceutical industry. Specific tools used to highlight this include Porter’s Five Forces and PESTEL analyses. This report also examines the environment surrounding …

Gabapentin Presents High Potential For Misuse, Alberto Coustasse, Stacie Deslich, Susan W. Lanham, Brittany Riley

Management Faculty Research

The FDA Approved Gabapentin in 1993 as a non-controlled substance and it has remained a non-controlled substance at the federal level. The drug was created as an anticonvulsant and used to treat seizure disorders. The medication has also been used to treat hot flashes, neuropathic pain, pain, postoperative nausea, substance abuse issues, and vomiting. It is estimated that approximately 1% of people in the United States misuse gabapentin. This fact has compelled certain states to generate legislative initiatives designed to monitor the use and/or reclassify gabapentin. In 2019, US pharmacies dispensed 69 million prescriptions for gabapentin.

Law Helps Ensure Safety Of The Supply Chain, Kenneth Maxik, Craig Kimble, Alberto Coustasse

Management Faculty Research

The Drug Quality and Security Act was signed into law on November 27, 2013, and included the Title 2 Drug Supply Chain and Security Act (DSCSA). This legislation was introduced to enact a federal prescription drug safety standard to decrease contamination, counterfeiting, diversion, and otherwise harmful illicit activities. It also improves the detection and elimination of potentially unsafe drugs from the drug supply chain to protect US consumers.

J Mich Dent Assoc July 2021

The Journal of the Michigan Dental Association

Every month, The Journal of the Michigan Dental Association brings news, information, and features about Michigan dentistry to our state's oral health community and the MDA's 6,200+ members. No publication reaches more Michigan dentists!

In this issue, the reader will find the following original content:

• A cover story on “Measuring Outcomes to Improve the Quality of Clinical Care”.
• A feature article, “Is Your Office Winning or Losing the Race? You Won’t Know Without Measurement”.
• The feature article, “The DQA and Quality Measurement in Dental Programs and Plans”.
• News you need, Editorial and regular department articles on MDA Foundation activities, Dentistry …

Emergent Trends In The Chinese Counterfeit Pharmaceutical Supply Chain And Opportunities For Public-Private Reform, Mary Monk

Senior Theses

This research seeks to identify and analyze emerging trends in the Chinese counterfeit pharmaceutical trade, extending from the supply chain’s point of origin to domestic and overseas retail dispensary. To aid readability, Chapter 1 of this thesis opens with key conclusions and policy recommendations for various Chinese and U.S. stakeholders based on the shortcomings identified in Chapter 5. Chapter 2 begins with a review of international roadblocks to diagnosing the issue, such as lack of consensus on working definitions and cross-border discrepancies in pharmaceutical oversight regulation. This section also provides a general overview of existing factors driving demand for counterfeit …

Association Of Electronic Prescription In Controlled Substances Used, Archana Suwal, Jemima Akinyi Okonjo

Theses, Dissertations and Capstones

Introduction: Controlled substances have been described as pharmaceuticals or illegal medicines that act primarily on the central nervous system and could cause physical and mental dependence, eventually leading to addiction. Prescription opioids were a significant contributor to the opioid epidemic, accounting for more than 70,000 opioid-related overdose deaths, including illicit and prescription opioids, between 2018 and 2019. The Electronic Prescriptions for Controlled Substances (EPCS) initiative recently aimed to reduce rates of prescription opioid addiction, abuse, diversion, and death. The system for controlled substances had become more widely used as providers and governments trying to combat the opioid problem. Because …

Pharmacy Internal Controls: A Call For Greater Vigilance During The Covid-19 Pandemic, Andrew N. Mason

Faculty Publications - The LeMoyne Smith School of Business

For businesses that store physical goods, managing product inventories and financial cost accounting controls are critical. Pharmacies are under considerable scrutiny, due to the nature of their merchandise, making internal controls even more vital. Due to the emergence of COVID-19 and government mitigation strategies, the US economy has seen significant macro- and microeconomic effects. COVID-19 has changed the pharmacy working environment, which could theoretically increase rates of employee drug diversion. Therefore, better inventory management could reduce the misuse of pharmaceutical drugs from fraudulent and drug diversion activities. The author explored secondary findings to create a multidisciplinary conceptual analysis of the …

How Do Pharmacies Evaluate Cleanroom Automation Systems?, Kenneth Maxik, Craig Kimble, Alberto Coustasse, Chris Booth

Pharmacy Practice & Administration

Many pharmacies have implemented or considered implementing cleanroom automation or compounding systems. Intravenous (IV) admixture automation is one of the newest areas of technology that has been applied to pharmacy workflow. Manufacturers tout systems for reducing errors reaching patients. Clinical literature supports that cleanroom technology can aid in patient safety.

United States Medicaid And Pharmacy Fraud: An Unintended Consequence Of The Affordable Care Act, Sean Mcdaniel, Drew Blakely

Theses, Dissertations and Capstones

Introduction: The Affordable Care Act (ACA) increased access to health insurance throughout the United States. To date, an estimated 20 million previously uninsured individuals have gained access to coverage since the expansion. As a result, the number of fraudulent schemes reported has been on the rise. Among the many fraudulent activities in the healthcare sector, abuse of pharmacy benefits has been the most prevalent. The misuse and abuse of opioids, and opioid related overdoses has created a widespread epidemic throughout the country, thus extending opportunities for potential fraud within the pharmaceutical industry.

Purpose of the Study: The purpose …

340b Program Utilization In Rural Us Clinics, William Finley, Heather M. Kruel

Theses, Dissertations and Capstones

Introduction: The 340B program was an effective strategy in reaching more potential patients, providing more comprehensive services, and limiting the gap between affordability and healthcare. The uninsured and underprivileged often are unable to receive medications at the high market price due to the financial situation they face and inflation. The 340B program seeked to mend this issue to help the public and healthcare organizations. The main purpose of this research was to search and evaluate if the 340B program lived up to its purpose of decreasing the cost of medications in rural based clinics.

Methodology: The research strategy developed …

Pharmaceutical Manufacturing In The 21st Century: Identification And Analysis Of Key Elements, Robert N. Mills

Honors Program: Senior Projects (Public)

The availability of quality pharmaceutical products impacts the lives of the global population on a daily basis. The importance of product availability and quality within pharmaceutical manufacturing requires that quality systems put into place are capable of accurately and robustly capturing the quality compliance, or lack thereof, of the various stages of production. This review intends to analyze current expert-recommended best practices within key elements of a pharmaceutical manufacturing quality control system and provide recommendations throughout. The quality elements discussed include Quality by Design method validation, necessary equipment determination, and equipment qualification, followed by documentation control and data flow.

The 340b Program, Contract Pharmacies, Hospitals, And Patients: An Evolving Relationship Impacting Health Care Delivery, Morgan Ruley, Morgan Belcher, 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 more than 35 000 individual health care facilities and sites certified by the US Department of Health and Human Services, …

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 …

Evaluating Feasibility Of Blockchain Application For Dscsa Compliance, Tracie Scott, Armand L. Post, Johnny Quick, Sohail Rafiqi

SMU Data Science Review

Abstract. We evaluated the feasibility of using a blockchain technology to create a traceability solution for pharmaceutical drugs that would promote compliance with recent legislation. Counterfeit and other illegitimate pharmaceutical drugs threaten patient safety, drug efficacy, and patient trust. The purpose of the Drug Supply Chain Security Act (DSCSA) is to greatly reduce distribution of illegitimate drugs by requiring all pharmaceuticals to be serialized and traceable from the manufacturer through the supply chain to the dispenser. A software application to serialize and track pharmaceuticals must overcome numerous obstacles. In particular, the solution must provide a high degree of trust while …

Radical Social Ecology As Deep Pragmatism: A Call To The Abolition Of Systemic Dissonance And The Minimization Of Entropic Chaos, Arielle Brender

Student Theses 2015-Present

This paper aims to shed light on the dissonance caused by the superimposition of Dominant Human Systems on Natural Systems. I highlight the synthetic nature of Dominant Human Systems as egoic and linguistic phenomenon manufactured by a mere portion of the human population, which renders them inherently oppressive unto peoples and landscapes whose wisdom were barred from the design process. In pursuing a radical pragmatic approach to mending the simultaneous oppression and destruction of the human being and the earth, I highlight the necessity of minimizing entropic chaos caused by excess energy expenditure, an essential feature of systems that aim …

Evaluating Patient Preferences For Different Incentive Programs To Optimize Pharmacist-Provided Patient Care Program Enrollment, Daniel M. Tomaszewski, Tim Cernohaus, Rajiv Vaidyanathan

Pharmacy Faculty Articles and Research

BACKGROUND: Employers have increased efforts to engage employees in health and wellness programs. Providing employees with incentives to participate in these programs has been shown to improve overall enrollment and engagement. One program that has had challenges with enrollment and engagement is medication therapy management (MTM).

OBJECTIVES: To (a) determine how individuals evaluate different financial incentives to improve participation in an MTM program and (b) measure the effect of participant characteristics on incentive preference.

METHODS: This study was composed of a paper-based survey administered to participants after focus group sessions. Participants included MTMeligible beneficiaries from 2 employer groups and included …

Aligning Opioid Prescribing Pathways, Andrea Lai, Outpatient Pharmacy, Haley Pelletier, Suneela Nayak, Stephen Tyzik, Ruth Hanselman

MaineHealth Maine Medical Center

There is a drug epidemic sweeping the State of Maine and it continues to worsen each passing year. In 2017, the Maine legislature passed Public Law Chapter 488 to strengthen the controlled substance prescription monitoring program. An outpatient pharmacy, located in a large acute care hospital, created a performance improvement project to clarify opioid prescription and resolve any non-compliance with Chapter 488.

After a root cause analysis, several KPIs were established to include tracking the number of phone calls made by pharmacists to non-compliant providers to clarify scripts, provide one on one education and ultimately resolve non-compliance. Repeat offenders were …

An Information Privacy Examination Of The Practices Of Pharmaceutical Companies Regarding Use Of Information Collected Through Their Websites, Shonda Dellena Brown

CCAC Theses and Dissertations

Consumers have begun to take a more proactive approach to their healthcare by accessing pharmaceutical companies Websites to obtain health and drug information, support groups, rebates, coupons, as well as free drug trials. In exchange for these benefits, companies require consumers to voluntarily disclose information. However, research has shown that consumers continue to be concerned about how their information is managed, used, and distributed by companies, especially if accessed via the Web. To date, there has been limited empirical research to examine the actual online practices of companies when it comes to privacy, especially those of pharmaceutical companies. Using Delphi …

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 …

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 …

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 …