Pharmacy Administration, Policy and Regulation Commons^™

Evaluating The Market Withdrawal Of Andexanet Alfa, Jordyn Linfield, Addisyn Cooper, Alexander Defranco, Emma Gerding, Jessica Kelley, Tyler Henney, Connor Dains, Brenna Hissong, Brittany Bates

Pharmacy and Wellness Review

The coagulation cascade comprises intrinsic, extrinsic, and common pathways that converge when thrombin converts fibrinogen (factor I) into fibrin, leading to fibrin mesh formation, stabilization of the platelet plug, and ultimately thrombus formation. Inhibition of the coagulation cascade can be achieved with a variety of anticoagulant medications, including direct oral anticoagulants (DOACs). The mechanism of action of DOACs is to inhibit either factor Xa or thrombin. Reversal of anticoagulation remains an important clinical consideration when managing patients on DOACs who experience serious bleeding events. Andexanet alfa is a recombinant, modified human factor Xa protein previously indicated for patients receiving rivaroxaban …

Quality Improvement (Qi) Project Aimed At Reducing Unnecessary Antibiotic Usage Among Older Adult Patients By Addressing Inappropriate Antibiotic Prescribing In Primary And Long-Term Care Settings, Pamela M. Thomas

Seton Hall University Dissertations and Theses (ETDs)

Antibiotic overuse among older adults remains a significant patient safety and public health concern. Recent national data indicate that approximately 30%–50% of outpatient antibiotic prescriptions may be unnecessary, particularly for viral or self-limiting conditions (Chua et al., 2021). Antimicrobial resistance has been associated with more than 1.27 million deaths globally (Murray et al., 2022). This quality improvement project evaluated a multifaceted antimicrobial stewardship intervention in primary and long-term care settings. Baseline review of 167 antibiotic cases revealed 37.1% were inappropriate or questionable, and 28.7% lacked adequate diagnostic documentation. The intervention incorporated provider education, electronic health record decision-support tools, audit and …

2025 Novel Drug Approvals, Katherine Ghattas Pharmd, Amanda Rawa Pharmd

Transformative Medicine

The year 2025 marked another strong chapter in pharmaceutical innovation, with multiple novel therapies gaining approval from the U.S. Food and Drug Administration (FDA). These approvals reflect continued progress in addressing unmet medical needs across a wide range of disease states. This article reviews the FDA’s 2025 novel drug approvals, spotlighting a few therapeutic advancements and emerging trends. A comprehensive table of all approved agents is provided, along with a focused discussion of four particularly impactful therapies: donidalorsen (Dawnzera), taletrectinib (Ibtrozi), delgocitinib (Anzupgo), gepotidacin (Blujepa), etripamil (Cardamyst). Each of these agents represents a step forward in its respective field and …

Patient Information Needs During Ambulatory Medication Changes: A Qualitative Study, Elaine Giletta, Vanessa B. Hurley, Yushi Yang, Jessica L. Schwartz, Rabia Jalalzai, Nicole L. Mollenkopf, Raquel Mayne, Samantha I. Pitts

Journal of Patient-Centered Research and Reviews

Purpose: We performed interviews with patients and caregivers to explore whole-person, whole-regimen information needs at times of routine outpatient medication changes. We categorized information needs in this relatively unstudied context and identified which needs were commonly recognized as insufficiently met.

Methods: We explored the content of the semi-structured interviews, which involved nine patients and two caregivers of pediatric patients, all of whom experienced a recent medication change in the outpatient setting of a large urban academic healthcare system. We used inductive thematic analysis to organize information needs into categories to identify key information gaps.

Results: We identified five categories of …

5x-Multiplier Vs 3-Tier Model For Discharge Opioid Prescriptions After Intra-Abdominal Cancer Surgery: Randomized Clinical Trial Protocol, Brittany C. Fields, Timothy E. Newhook, Heather A. Lillemoe, Wei Qiao, Jose A. Karam, Surena F. Matin, Larissa A. Meyer, Ching-Wei D. Tzeng

Advances in Cancer Education and Quality Improvement

Background

Surgeons provide up to 10% of total opioid prescriptions across all specialties, and more than one-third of surgeon-prescribed medications are opioids. Patient-reported opioid consumption and risk of persistent opioid use beyond the postoperative recovery period correlate with the initial opioid quantity prescribed at discharge. Interventions to reduce postoperative opioid prescribing have demonstrated no adverse effects on pain control or increased need for prescription refill; however, in the absence of standardized prescription protocols, opioid prescribing practices vary widely.

Objective

The study objective is to identify the opioid prescribing model that provides the lowest oral morphine equivalents (OME) volume prescribed at …

Strengthening The Paediatric Clinical Trial Ecosystem To Better Inform Policy And Programmes, James A. Berkley, Judd L. Walson, Glenda Gray, Fiona Russell, Zulfiqar Ahmed Bhutta, Per Ashorn, Shane A. Norris, Ebunoluwa A. Adejuyigbe, Rebecca Grais, Bernhards Ogutu

Institute for Global Health and Development

The first WHO Global Clinical Trials Forum was convened in November, 2023 to develop a shared vision of an effective global clinical trial infrastructure. The Paediatric Clinical Trials Working Group was formed to provide perspectives, identify challenges, and propose solutions to strengthen the paediatric clinical trials ecosystem. Participants represented paediatric disciplines, including infectious diseases, nutrition, neonatology, pharmacology, oncology, neurodevelopment, public health, and policy. Childhood diseases have profound lifelong effects on health, livelihoods, and societies. Investment in early childhood results in highly cost-effective changes to lifelong health, productivity, and human capital returns. Yet, there remain substantial gaps in knowledge on the …

The Chemical Straightjacket: Institutional Over-Use Of Psychotropic Drugs On Children In Lieu Of Therapeutic Community Mental Health Services, Marisa Leib-Neri

Indiana Journal of Law and Social Equality

This Article argues that the abysmal state of children’s mental health in America is in part due to an overreliance on and over prescription of psychotropic drugs inside psychiatric residential institutions in lieu of community based mental health services. This overreliance on residential institutions and psychotropic drugs has allowed a new form of chemical restraint to flourish—the chemical straitjacket. This Article uses the medication lists of twelve children in seven different North Carolina psychiatric residential treatment facilities to demonstrate how the chemical straitjacket operates: the prescription of drugs not approved for pediatric populations, counter to evidence-based practices for particular diagnoses, …

The Revised Cdc Chronic Pain Guidelines And Payer Opioid Analgesic Policies In Michigan, Victoria Tutag Lehr, Cynthia L. Arfken

Michigan Journal of Public Health

Abstract

The 2016 publication of A Guideline for Prescribing Opioids for Chronic Pain by the Centers for Disease Control and Prevention motivated commercial and Medicaid payers to restrict their opioid prescribing policies including the imposition of hard limits on opioid daily dosages and duration. One result of these policies was an increase in abrupt opioid discontinuation and rapid tapering events for patients receiving long-term opioid therapy. Responding to this misapplication of the 2016 guideline, the 2022 revised guidelines emphasized individualized opioid therapy and exclusion of certain chronic diseases. However, it is not known if the payers changed their policies to …

Opioid Prescription Rates Before And After Alto Program And Various Factors Affecting Emergency Department Opioid Prescription Rates, Neel B. Patel, James F. Baird

Rowan-Virtua Research Day

Opioid prescription rates vary between patient population, diagnosis, location, and emergency department characteristics. High prescription rates offer an avenue for potential opioid addiction and overdoses. Alternatives to opioids (ALTO) is a new program already implemented in certain emergency departments to help change opioid prescription rates by introducing new protocols for first line treatments for pain management. With current trends still showing that South Jersey opioids prescription rates are the highest in the state of New Jersey, ALTO was introduced at Inspira Health Network located in South Jersey. This study retrospectively analyzed opioids prescription rates for abdominal pain, renal colic, migraines, …

Effectiveness Of Antibiotic Stewardship For Healthcare Providers At Urgent Care Clinics, Helen T. Adewole

Electronic Theses and Dissertations

Antibiotics have revolutionized modern medicine; however, the overuse in urgent care and primary care significantly contributes to the global burden of infections resistant to available antimicrobial medicines. Approximately 30% of the antimicrobials prescribed in acute care settings are unnecessary. Patient demand for antibiotics has seemingly skyrocketed following the recent COVID-19 pandemic. Practitioners must be knowledgeable about antibiotic stewardship initiatives, such as the wait-and-see approach, to reduce antibiotic overuse and improve the trajectory of antibiotic resistance and patient health outcomes. The gap in practice was the limited awareness of scientific evidence-based tools to partner with patients and improve antibiotic prescription patterns. …

Improving Pharmacist-Led Pediatric Patient Education On Oral Chemotherapy At Home, Anika Patel, Christopher M. Nguyen, Kristin Willins, Elsabella Y. Wang, Grace Magedman, Sun Yang

Pharmacy Faculty Articles and Research

Oral chemotherapy (OC) has been increasingly used in pediatric patients diagnosed with cancer, which is primarily managed in the outpatient setting. Different from adults, pediatric patients face unique challenges in administering these hazardous medications at home. Because of the complexity of pediatric pharmaceutical care and the hazardous nature of chemotherapy agents, comprehensive patient education is imperative to mitigate the potential safety risks associated with OC administration at home. Pharmacists play a vital role in patient education and medication consultations. However, the lack of practice guidelines and limited resources supporting OC counseling are noted. Additional barriers include insufficient knowledge and training …

Medication Cost Reduction And Substitution Strategies Through The Mymetrx Program At Catholic Hospice, Ana M. Sanchez Monroig, Tracy Romanello, Joseph Solien, Sanaz Kashan, Angel E. Sanchez Artiles

East Florida Division GME Research Day 2023

Please see supplemental content for full abstract with references.

Introduction: As healthcare costs continue to rise, and with the growing awareness of the potential harms of polypharmacy, there is an ongoing need to explore strategies to optimize medication use in hospice settings. Strategies include deprescribing and medication substitutions, which ensure the safety and comfort of patients but can also lead to significant medication cost reduction.

Objectives: The primary objective of this study was to evaluate the impact of the MyMetRx program on medication cost reduction and medication substitutions within the context of Catholic Hospice. The program aimed to optimize medication …

Long-Term Prescription Opioid Use, Cancer Stage, And Economic Burden Among Older Cancer Survivors With Non-Cancer Chronic Pain Conditions, Rudi Safarudin

Graduate Theses, Dissertations, and Problem Reports (ETD)

Opioids are commonly prescribed to treat pain conditions, which are highly prevalent among older adults (≥65 years). Recent evidence shows that opioids may have carcinogenic effects through immunosuppression and free-radical pathways, which could promote cancer growth. Two population-based studies have reported an association of opioid use with incident cancer. Many individuals with non-cancer chronic pain conditions (NCPCs) may use opioids for a long term. However, the association of long-term prescription opioid (LPO) use with cancer stage at diagnosis is still unknown. Furthermore, evidence suggests that individuals with cancer and pre-existing NCPCs may persistently use opioids, even in the absence of …

Nurse-Led Education On Oral Chemotherapy Medications, Carmen Lucia Glick Alonso

Master's Projects and Capstones

Problem: Breast cancer is one of the leading causes of cancer death among women in the United States. Annually, around 264,000 breast cancer cases are diagnosed in women and 2,400 in men (Centers for Disease Control and Prevention, 2022). According to the American Cancer Society, the risk of a woman in the United States being diagnosed with breast cancer in their life is around 13% (2022).

Context: Along with a cancer diagnosis comes the need to introduce patient education about new oral chemotherapy treatments. As a treatment team member, the oncology nurse plays a vital role in this …

Gaps In Patient Education On Safe Handling And Disposal Of Oral Chemotherapy Drugs: A Pilot Prospective Cohort Survey Study, Sun Yang, Priya Patel, Alexandra Corcoran, Eric Dobberpuhl, Samantha Isidro, Dustin Le, Analise Klassen, Jay Rho, David Tran, Richard Beuttler, Neda Noori Nassr, Katherine Gruenberg, Siu-Fun Wong

Pharmacy Faculty Articles and Research

Background

Oral anticancer chemotherapy (OC) has been misperceived as being safer than intravenous chemotherapy, leading to its increased risk of improper handling and disposal. This survey study assessed the knowledge, practices and attitudes of pharmacists and patients regarding OC handling and disposal, gaps in knowledge and barriers to patient education. Methods

Surveys were developed based on literature review and pilot study validation results. Patients completed a 33-item paper or electronic survey whereas pharmacists completed a 38-item electronic survey. Descriptive statistics and Fisher’s exact test computed using the R Project were used for analyses. Results

Pharmacist group (16/25, 62.5%) and patient …

Evaluating The 0–10 Point Pain Scale On Adolescent Opioid Use In Us Emergency Departments, Michael T. Phan, Daniel M. Tomaszewski, Cody Arbuckle, Sun Yang, Brooke Jenkins, Michelle A. Fortier, Theodore Heyming, Erik Linstead, Candice Donaldson, Zeev N. Kain

Pharmacy Faculty Articles and Research

Objective: To evaluate trends in national emergency department (ED) adolescent opioid use in relation to reported pain scores. Methods: A retrospective, cross-sectional analysis on National Hospital Ambulatory Medical Care Survey (NHAMCS) data was conducted on ED visits involving patients aged 11–21 from 2008–2017. Crude observational counts were extrapolated to weighted estimates matching total population counts. Multivariate models were used to evaluate the role of a pain score in the reported use of opioids. Anchors for pain scores were 0 (no pain) and 10 (worst pain imaginable). Results: 31,355 observations were captured, which were extrapolated by the NHAMCS to represent 162,515,943 …

Decreasing Unintentional Pregnancies For Tennesseans, Paula M. Todd

Electronic Theses and Dissertations

In 2018, 49% of all pregnancies in the United States were unintended, with women with a lower- income status being five times more likely to experience an unplanned pregnancy. Tennessee has a high rate of unintended pregnancies, particularly among the uninsured, low-income, and rural teen populations; some 22% of these unintended pregnancies end in abortion. Oral or transdermal contraceptives that are affordable and accessible for women of childbearing age can reduce unintentional pregnancies. The addressed gap in clinical practice was that contraceptives are not currently available over the counter in Tennessee pharmacies without a prescription, which necessitates a costly medical …

Racial And Ethnic Disparities In Opioid Use For Adolescents At Us Emergency Departments, Michael T. Phan, Daniel M. Tomaszewski, Cody Arbuckle, Sun Yang, Candice D. Donaldson, Michelle A. Fortier, Brooke Jenkins, Erik Linstead, Zeev N. Kain

Pharmacy Faculty Articles and Research

Background

Racial/ethnic disparities in the use of opioids to treat pain disorders have been previously reported in the emergency department (ED). Further research is needed to better evaluate the impact race/ethnicity may have on the use of opioids in adolescents for the management of pain disorders in the ED.

Methods

This was a cross-sectional study using data from the National Hospital Ambulatory Medical Care Survey from 2006 to 2016. Multivariate models were used to evaluate the role of race/ethnicity in the receipt of opioid agonists while in the ED. All ED visits with patients aged 11–21 years old were analyzed. …

Home Blood Pressure Monitoring To Improve Hypertension Control: A Narrative Review Of International Guideline Recommendations, John Andraos, Luma Munjy, Michael S. Kelly

Pharmacy Faculty Articles and Research

Home blood pressure monitoring (HBPM) is a convenient way to assess out-of-office blood pressure control and is recommended by numerous international guidelines to aid clinicians in the diagnosis and management of essential hypertension. Although available guidelines recommend the use of HBPM in patients receiving antihypertensive medication, their specific recommendations regarding optimal monitoring schedule, duration, and clinician interpretation of home blood pressure readings may differ among guidelines. Purpose: The purpose of this article is to review available international hypertension guideline recommendations related to the use of HBPM to improve hypertension control among patients receiving antihypertensive therapy. We also briefly highlight …

Opioid Use Disorder: The Timeline For Medication Assisted Therapy, Alexander Cristofori

Capstone Showcase

Opioid Use Disorder is patterns of opioid use leading to withdrawal, giving up important life events in order to use opioids, and excessive time spent using opioids, to name a few diagnostic criteria. The clinical progression of the disorder involves periods of acute exacerbation and remission that are cyclic in nature. Treatment is most effective when it includes both pharmacological and psychosocial modalities, referred to as medication assisted therapy (MAT). Three drugs used commonly in MAT-based treatment for OUD from oldest to newest include Methadone, Buprenorphine-naloxone, and Naltrexone. Treatment program models that prioritize total abstinence from the addictive substance attached …

Association Of Incident Cancer To Low-Value Care And Healthcare Cost Burden Among Elderly Medicare Beneficiaries, Chibuzo Iloabuchi

Graduate Theses, Dissertations, and Problem Reports (ETD)

In the United States (US), 25% of healthcare spending is considered wasteful because it is spent reimbursing low-value care. Low-value care is the utilization of healthcare services, medical tests, and procedures that have unclear or no clinical benefit to patients but still exposes them to risk. World-wide, low-value care imposes a significant economic burden on patients, payers, governments, and society. Cancer care among older adults > 65 years is one of the biggest drivers of healthcare expenditure in the US and accounts for nearly 40% of all spending, and low-value care among cancer patients is prevalent and contributes to the financial …

Parent Responses To Pediatric Pain: The Differential Effects Of Ethnicity On Opioid Consumption, Candice D. Donaldson, Brooke N. Jenkins, Michelle A. Fortier, Michael T. Phan, Daniel M. Tomaszewski, Sun Yang, Zeev N. Kain

Psychology Faculty Articles and Research

Objective

Within the context of the United States opioid epidemic, some parents often fear the use of opioids to help manage their children's postoperative pain. As a possible consequence, parents often do not dispense optimal analgesic medications to their children after surgery, putting their children at risk of suffering from postsurgical pain. The objective of this research was to assess ethnicity as a predictor of both pain and opioid consumption, and to examine how Hispanic/Latinx and Non-Hispanic White parents alter their child's opioid consumption in response to significant postsurgical pain.

Methods

Participants were 254 children undergoing outpatient tonsillectomy and/or adenoidectomy …

Crnas And Sugammadex Use: A Qualitative Analysis, Natalia Izquierdo Bsn, Rn, Emily Mancewicz Bsn, Rn

Grace Peterson Nursing Research Colloquium

Background: The availability of Sugammadex has increased options for Certified Registered Nurse Anesthetists’ (CRNAs) and their choice of neuromuscular reversal agents, however administration is impacted by a variety of provider and institutional factors.

Objectives: The purpose of this study was to examine and describe the personal and institutional factors impacting the use of Sugammadex in Illinois by CRNAs.

Method: A qualitative study design using an open-ended survey yielded 209 responses. The three main themes that emerged were 1) Why CRNAs choose to use or avoid Sugammadex 2) How CRNAs dose Sugammadex and 3) Practice variations existing within the clinical setting. …

The Other Epidemic, Bruce Deighton

HCA Healthcare Journal of Medicine

The epidemic level of opioid abuse in the U.S. population continues to present a major challenge to our society and to the medical profession. Medical education has a significant role in improving screening, diagnosis, appropriate treatment and management of opioid use disorder. Addressing the problem of overprescribing opioids through physician education, surveillance and opioid management has resulted in significant improvement, translating to fewer overdose deaths from prescription opioids. Graduate medical education can increase access to care by training more addiction medicine specialists, and training other physicians to prescribe buprenorphine and provide access to medically assisted care.

The Use Of Urine Drug Testing For Risk Stratification And Efficacious Drug Monitoring In Pain Management Settings, Ahmad I. Hasan, Kareem Elhage, Brendan Farley, Khaled J. Saleh

Medical Student Research Symposium

Objective: To understand the current landscape of urine drug testing (UDT) guidelines as part of risk assessment for opioid abuse, and to offer recommendations towards adopting universal screening guidelines.

Background: There has been an opioid epidemic within the United States, and the role of prescription opioids has been well established. Despite proposed recommendations, there has yet to be a published universal screening guideline on the use of UDT in the setting of opioid abuse risk stratification as well as postoperative drug monitoring.

Methods: We explored current guidelines for UDT on two levels. First, we explore general indications for UDT within …

Utilization Of A Community Pharmacy-Based Service For The Treatment Of Uncomplicated Urinary Tract Infections In Scotland, Robert Borchardt

Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.)

Introduction: In November 2013, Scotland piloted a program in Grampian for the treatment of Urinary Tract Infections (UTIs) in community pharmacies, increasing health access for patients and reducing general practitioner workload. This program became known as ‘Pharmacy First’ and was later implemented nationwide in November 2017. This paper seeks to understand utilization of the Pharmacy First program across Scotland by patients and potential barriers to access.

Methods: Using data from the Prescribing Information System collected by the National Health Service of Scotland from July 2013 to April 2019, orders for uncomplicated UTIs were gathered by examining all nitrofurantoin and trimethoprim …

Asthma-Copd Overlap: Economic Burden And Medication Adherence, Mona Nili

Graduate Theses, Dissertations, and Problem Reports (ETD)

In many older adults, asthma and chronic obstructive pulmonary disease (COPD) coexist as “Asthma-COPD overlap” (ACO). This dissertation pursued three Aims: 1) estimate the economic burden of ACO and its contributory factors; 2) evaluate the association of ACO to “cost-related medication nonadherence” (CRN); and 3) identify adherence trajectory patterns and examine the impact of initial maintenance therapies (IMT) type (inhaled corticosteroids monotherapy (ICS) vs. fixed-dose combination of ICS and long-acting beta agonist (ICS/LABA)) on adherence trajectory patterns among older adults Medicare Beneficiaries. The first and second Aims were cross-sectional studies by using Medicare Current Beneficiary Survey data. For the third …

The Impact Of The Fda Warning On Post-Tonsillectomy Opioid Prescribing In Publicly And Privately Insured Children, Dianna J. Soelberg

Theses and Dissertations

Due to reports of significant adverse events, the U.S. FDA placed a Boxed Warning on the opioid codeine in February 2013 – contraindicating its use in pediatric patients undergoing tonsillectomy and/or adenoidectomy. Studies conducted in privately insured children showed a reduction in codeine prescribing and a slight increase in alterative opioid prescribing following the FDA warning, yet the extent to which the FDA warning impacted prescribing in publicly insured children is unknown. Using a quasi-experimental interrupted time series design, this study evaluated codeine and alternative opioid prescribing before and after the FDA warning in both publicly and privately insured children …

Impact Of Required Antibiotic Stop Dates And Indications On Length Of Treatment In Hospitalized Patients With Pneumonia, Amanda Haddad, Kathryn Hernando, Kayihura Manigaba, Abigail Antigua

Infectious Disease

Purpose: The CDC Core Elements of Hospital Antibiotic Stewardship Programs recommends implementing policies to support optimal antibiotic prescribing including documentation of dose, duration and indication. On January 31, 2017, the study institution implemented new physician order entry screens in the electronic health record requiring the input of indication and duration on all antibiotic orders. The objective of this study is to determine if implementation of mandatory indication and duration for antibiotic orders decreases antibiotic duration of therapy in hospitalized patients with pneumonia.

Methods: This study was submitted to the Institutional Review Committee for approval. The clinical pharmacy surveillance platform, …

Utility Of Push Dose Vasopressor In The Emergency Department, Paul Nguyen, Daniel Giddings, Scott Dietrich, Kathryn Merkel

Emergency Medicine

Purpose: The purpose of this study is to evaluate push dose vasopressor (PDV) usage patterns, efficacy, and safety in a single community hospital emergency department when used for rapid sequence intubation (RSI). Pre-intubation hypotension is a positive correlator to incidences of cardiac arrest. Precautions should be in place to prevent and treat hypotension during emergent intubation. The emerging strategy of utilizing PDV in emergency department (ED) patients is an underexplored and potentially efficacious option.

Methods: This study will be submitted to the Institutional Review Board for approval. This retrospective evaluation will identify critically ill patients receiving phenylephrine or epinephrine PDV …