Pharmacy and Pharmaceutical Sciences Commons^™

Unpatenting Product Hops, Michael S. Sinha

All Faculty Scholarship

On July 9, 2021, President Joseph R. Biden signed Executive Order 14036 (“Promoting Competition in the American Economy”), which directed the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) to collaborate on new approaches to increasing competition and lowering prices in the pharmaceutical marketplace. In response, the USPTO outlined several new initiatives, among them an intent to improve the robustness and reliability of issued patents.

A major impetus for the Executive Order was the pervasive nature of pharmaceutical product hopping, which occurs when manufacturers introduce new follow-on versions of lucrative pharmaceutical products to the …

Use Of Artificial Intelligence In Drug Development, Louise C. Druedahl, Nicholson Price, Timo Minssen, Dipl Jur, Ameet Sarpatwari

Articles

Considerable focus has been placed on the health care applications of artificial intelligence (AI). Already, machine learning, a subset of AI that involves “the use of data and algorithms to imitate the way that humans learn” has been used to predict diseases, while AI-powered smartphone apps have been developed to promote mental health and weight loss. Owing in part to such successes, the market for AI in health care has been forecasted to increase more than 1000% between 2022 and 2029, from $13.8 billion to $164.1 billion. One area of substantial promise is drug development, which is poised to benefit …

Ai Renaissance: Pharmaceuticals And Diagnostic Medicine, Ty J. Feeney, Michael S. Sinha

All Faculty Scholarship

The explosive growth of Artificial Intelligence (AI) in the modern era has led to significant advancements in the world of medicine. In drug discovery, AI technology is used to classify proteins as drug targets or non-targets for specific diseases, more accurately interpret and describe pharmacology in a quantitative fashion, and predict protein structures based on only a protein sequence for input. AI methods are used in drug development to generate predictive models for drug screening purposes, refine and modify candidate structures of drugs to optimize compounds, and predict a drug’s physiochemical properties, bioactivity, and toxicity. For medical devices, the advancement …

Outpatient Fall Prevention In Ambulatory Adults 65 Years Old And Over, Dorothy L. Osborne-White

Doctor of Nursing Practice (DNP) Scholarly Projects

Abstract

Background: In the United States (U.S.), falls are the leading cause of injury among adults 65 and over, resulting in 36 million falls yearly (Moreland et al., 2020). According to the Centers for Disease Control and Prevention (CDC, 2023), one in four older adults experiences a fall each year. Falls are the world's second most prominent cause of accidental deaths (World Health Organization [WHO], 2021). Falls are the leading cause of both fatal and non-fatal injuries among older adults (Moreland et al., 2020).

Methods: A quality improvement project that included a fall bundle was implemented in a primary clinic. …

J Mich Dent Assoc December 2023

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:

• A cover story on “New Dentists’ Most Asked Legal Questions”
• A case report on “Endodontic Therapy, Crown Amputation, and Soft Tissue Advancement to Treat a Hopeless Tooth”
• A feature “Be a Leader in Your Practice: What’s Your Style?”
• 2023 Author/Title Index to the Journal of the Michigan Dental Association
• News you need, a Guest Editorial and regular …

The Price Of Competition: Analyzing Anticompetitive Tactics In Pharmaceutical Markets During The Hatch-Waxman Era, William Ulrich

Notre Dame Journal on Emerging Technologies

Pharmaceutical manufacturers can delay the generic entry for a blockbuster drug. In order to keep the generic system on track, it is critical to expose the various avenues of generic delay. Part I of this Note briefly describes the generic entry process as prescribed by the Hatch-Waxman Act. Part II details four well-known tactics used by brand-name manufacturers to block or delay the entry of generic competition, highlighting how the tactics are successful. Part III concludes by examining the nature of the various problems and arguing that the first step towards ending the different forms of anticompetitive behavior is through …

The High Cost Of Pharmaceutical Acquisitions: Increasing Social Welfare Or Furthering Inequality?, Timothy J. Haltermann

Notre Dame Journal on Emerging Technologies

This note will argue that government and regulatory authorities should focus on easing access to downstream innovation by broadening research exemptions to patent infringement. Part I of this note will focus on the current state of patent protection and exclusivity afforded to pharmaceutical companies. Part II will discuss incentives created that lead rational actors to engage in M&A instead of through internal R&D. Part III will address the development of innovation as a standalone theory of harm in merger review, and the fallacies associated with labeling certain transactions as “killer acquisitions.” Finally, Part IV of the note will look at …

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.

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 …

Utah Pharmacists’ Qualitative Feedback Regarding Licensure Standards., Rebecca Howard

Annual Research Symposium

This project sought to understand current attitudes and perceptions of licensed pharmacists in the state of Utah to the existing occupational licensing standards which govern our profession. Qualitative feedback was gathered from Utah licensed pharmacists for a period of one month.

Pharmacy Law: Pharmacists Awareness Of Licensure Regulations, The Mpje And Nabp - A State-Wide Study, Andrew Holick

Annual Research Symposium

No abstract provided.

The Nih-Moderna Vaccine: Public Science, Private Profit, And Lessons For The Future, Christopher J. Morten

Faculty Scholarship

This commentary highlights the scientific history of the NIH-Moderna COVID-19 vaccine and corroborates Sarpatwari’s theme of private capture of value created by the public. The commentary also identifies missteps by the Trump and Biden Administrations and offers policy recommendations: better contracts with and incentives for pharmaceutical manufacturers and a not-for-profit “public option” for pharmaceutical development.

Public Health Product Hops, Michael S. Sinha

All Faculty Scholarship

Pharmaceutical product hops are anticompetitive maneuvers that often represent a last-ditch effort by brand manufacturers to preserve market share in the face of generic competition. An integral part of product life cycle management strategies, product hops may offer marginal benefits to patients but can substantially increase costs to payers and patients alike. Yet industry advocates maintain that this is essential follow-on research and development, resulting in the development of novel products that would otherwise never reach the market.

Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they furthered …

Redlining And Opioid Overdose Outcomes: Do Historical Housing Policies Still Impact Health Today?, Sahana Paravantavida

Honors Theses

This study examines the relationship between historical housing policies and current health outcomes, specifically the impact of redlining on opioid overdose rates. Using data collected from the state of New Jersey, neighborhoods with a history of redlining have higher rates of opioid overdose deaths. My findings suggest that historical housing policies, which systematically excluded certain populations from accessing affordable housing and resources, continue to impact health outcomes today.

Cultivating Health, Not Wealth In The United States' Healthcare System: Comprehensive Revisions For The Orphan Drug Act Of 1983, Kayla Smith

Regis University Student Publications (comprehensive collection)

This thesis explores the way in which the Orphan Drug Act of 1983, originally instituted in response to a lack of treatments for rare diseases in the United States of America, has failed to achieve its initial objectives in the 40 years since its implementation. In evaluating various successful examples of government subsidization programs designed to intervene in private industry, this thesis composes the criterion required for funding-based legislation which maximize market outcomes while minimizing tax-payer burden. An analysis of the synthetic organic chemistry industry – and a case study into the production of a particular orphan treatment for a …

10-Minute Ebd: Stimulant Medications, Rampant Caries, And Prevention, Madison Thomas Bs, Nancy Poznick Dds, Melanie E. Mayberry Dds, Ms-Hcm

The Journal of the Michigan Dental Association

The 10-Minute Evidence-Based Dentistry Column illustrates how to implement the evidence-based dentistry search process to quickly identify and apply the best literature to answer a clinical question. Through critical appraisal, the author of this article answers the clinical question of a connection between stimulant medications, rampant caries, and prevention, with a focus on the impact of ADHD medication on oral health. The term "meth mouth" often associated with dental decay is discussed in the context of xerostomia (dry mouth), a common side effect of stimulant medications. The article uses the PICO (Population, Intervention, Comparison, Outcome) system to formulate a research …

Analyzing Factors Impacting Time To Full Approval Of Innovative Drugs Via An Accelerated Approval Pathway In The United States, Eleanor Panico

Seton Hall University Dissertations and Theses (ETDs)

Background and purpose of study: Pharmaceutical drugs are commonly used to treat various ailments and the pharmaceutical industry is increasingly leveraging expedited pathways to market, like the FDA’s accelerated approval pathway. Thus, these pathways are becoming more prevalent and thus more scrutinized for reliability. A consequence from this increased utilization is observed variability in time to reach full approval from the point accelerated approval was received. Variables that may impact time and ability to reach full approval should be further investigated. The purpose of this study was to explore, identify and predict variables that may influence time from accelerated approval …

10-Minute Ebd: Preferred Analgesia For Orthodontic Tooth Movement: Acetaminophen Or Nsaids?, Ryan N. Mcgovern

The Journal of the Michigan Dental Association

This 10-Minute EBD column explores the choice between acetaminophen and NSAIDs for managing pain during orthodontic tooth movement. The author presents a scenario involving a patient's discomfort after archwire adjustment and delves into the impact of tooth movement on the periodontium. The PICO question focuses on the effectiveness of NSAIDs and acetaminophen in controlling discomfort without impeding tooth movement. The literature search reveals varying recommendations on analgesics, with some studies favoring acetaminophen. The evidence suggests that acetaminophen and short-term celecoxib are suitable choices for orthodontic analgesia. However, caution is advised in extrapolating findings from animal studies to human conditions.

Penicillin Allergy Assessment And Medical Referral To Promote Antibiotic Stewardship, Elaine Bailey Pharmd, Mackenzie Connell, Marie Fluent Dds, Erinne Kennedy Dds, Mph, Mmsc

The Journal of the Michigan Dental Association

Antibiotic stewardship is an integral practice for the dental team to ensure a safe dental visit for patients. Now, with clinical practice guidelines and state toolkits, more dentists are aware of and actively practicing antibiotic stewardship. With the application of antibiotic stewardship practices, dentists are identifying the need for additional tools to enhance practice. For example, one need that has been identified is a tool for screening patients for true penicillin allergies. The Penicillin Allergy Assessment Tool (PAAT) is a decision-making tool that can be used chairside to screen patients who report an allergy to penicillin. After screening, dentists can …

Lessons Learned From The Hiv/Aids Pandemic And Access To Medicines For Covid-19 Treatment, Thalia Le

Independent Study Project (ISP) Collection

There is an imminent need to address the healthcare disparities in accessing all COVID-19 medicinal products in developing countries. While logistical issues like inadequate production facilities such as the lack of vaccines administration capacity, storage issues, gap between supply and demand as well as vaccine hesitancy can certainly play a part in impeding COVID19 medicines distribution, patent monopolies and intellectual property protection laws further exacerbated the problem, especially when vaccines were at its early stages of authorization. Historical and contemporary case studies of efforts to challenge patents on HIV AVRs treatment provide a useful lens through which we may glean …

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 …

J Mich Dent Assoc June 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 “Team-Based Treatment of Oral Cancer: The U-M Experience”.
• A feature article, “Dental Management of the Head and Neck Cancer Patient Treated with Radiation Therapy: Update 2021”.
• A feature article on “Understanding Cyber Threats and the Risk they Pose to Your Practice”.
• "A Train-the-Trainer Education Model and Rural Dental Opioid Prescribing Outcomes”, a …

Effect Of Free Trade Agreements On Pharmaceutical Market Competition: The Case Of The 2009 Us-Peru Free Trade Agreement And Its Implementation As National Drug Policy, Lita Araujo, Enrique Seoane-Vazquez, Michael Montagne

Pharmacy Faculty Articles and Research

Free Trade Agreements (FTA) are controversial for threatening essential aspects of health, especially access to affordable medicines. The US-Peru FTA required changes in the Peruvian pharmaceutical legislation that resulted in the implementation of the National Drug Policy (NDP) of 2009. The NDP included more robust technical requirements for registration, a Peruvian Good Manufacturing Practices certificate, a longer timeline for drug registration, and an increase in registration fees. This study evaluated the impact of the FTA on the number of registrations and competition in the Peruvian pharmaceutical market.

Data for the period January 2005 to April 2014 were provided by the …

Giving Pharmacists Provider Rights, Tanya E. Karwaki

Texas A&M Law Review

Changes to our health care system, robotics and health care mergers among them, are forcing pharmacists into expanded provider roles, yet federal policymakers are failing to act on these changes. State lawmakers are acting but not swiftly enough. A federal response, including recognizing pharmacists as health care providers and making them eligible for independent Medicare reimbursement, will be necessary to enable pharmacists to fill their role in our health care system. Policymakers have an opportunity now to respond proactively to a changing climate in health care by clarifying the boundaries on pharmacists’ services, particularly those boundaries regarding direct patient care …

Achieving Better Care In Pennsylvania By Allowing Pharmacists To Practice Pharmacy, Travis Murray

Dickinson Law Review (2017-Present)

Traditionally, state legislatures implemented Prescription Drug Monitoring Programs (“PDMPs”) to assist prescribers, pharmacists, and law enforcement in identifying patients likely to misuse, abuse, or divert controlled substances. PDMP databases contain a catalog of a patient’s recent controlled substances that pharmacies have filled, including the date, location, the quantity of medication filled, and the prescribing health care provider. Prescribers in Pennsylvania have a duty to query the PDMP before prescribing controlled substances in most clinical settings. Pharmacists have a similar duty in Pennsylvania to dispense safe and effective medication therapy to patients and to screen patients for potential signs of misuse, …

Social Media Self-Regulation And The Rise Of Vaccine Misinformation, Ana Santos Rutschman

All Faculty Scholarship

This essay examines the main characteristics and shortcomings of mainstream social media responses to vaccine misinformation and disinformation. Parts I and II contextualize the recent expansion of vaccine information and disinformation in the online environment. Part III provides a survey and taxonomy of ongoing responses to vaccine misinformation adopted by mainstream social media. It further notes the limitations of current self-regulatory modes and illustrates these limitations by presenting a short case study on Facebook—the largest social media vehicle for vaccine-specific misinformation, currently estimated to harbor approximately half of the social media accounts linked to vaccine misinformation. Part IV examines potential …

Rethinking Fda Regulation Of Complex Products, Philip E. Alford

Minnesota Journal of Law, Science & Technology

No abstract provided.

Reflections On The Effects Of Federalism On Opioid Policy, Matthew B. Lawrence

Faculty Articles

One thing we have seen today that we talk about in health law all the time is how the policy, the laws and institutions up at the 10,000 foot level, can so dramatically influence the personal, people’s lived experiences. Our speakers today have done a really great job of drawing out abstract institutional questions and also showing us how those questions have influenced the lives of real people in often tragic ways. Another thing we have seen that we talk about in administrative law all the time is the importance of expertise, especially given how hard it is to trace …

Vaccine Hesitancy: Experimentalism As Regulatory Opportunity, Ana Santos Rutschman, Timothy L. Wiemken

All Faculty Scholarship

This symposium on patient innovation has prompted us to explore problems related to departures from official vaccination schedules. At a time in which vaccine confidence has been plummeting across the world, we argue that a more granular understanding—and ultimately a more finely tuned regulatory framework—is needed to reflect the current behavioral heterogeneity among indicated patients who choose to forego or delay administration of recommended vaccines. In particular, we focus on a phenomenon we term “vaccine staggering:” a departure from vaccination schedules in the form of delays in receiving one or more vaccines, which is motivated by the desire to boost …

Combatting The Opioid Epidemic In Texas By Holding Big Pharma Manufacturers Liable, Katherine Spiser

St. Mary's Law Journal

Abstract forthcoming