Pharmacy Administration, Policy and Regulation Commons^™

The Role Of Psilocybin In End-Of-Life Care: Evidence, Mechanisms, And Guidelines, Mackenzie E. Unsworth, Mary Lou Galantino, Robert Sandoval

Oncology Rehabilitation in Practice

This article aims to provide a brief overview of the evidence and mechanisms for psilocybin use in EOL care. Additionally, this article will provide guidelines for clinicians to assess patient use and integrate psilocybin into their clinical practice with respect to its current legal status.

Pharmacist Quality Of Work-Life During Covid-19 Pandemic In Cagayan De Oro, Junnin Gay Labrigas Garay, Rugine Riel D. Barsobia, Zoe Kyra Evasco, Bonnie Louise Elorde

Pacific Journal of Health

During the COVID-19 pandemic, pharmacists have been one of the most accessible healthcare workers working in the frontline providing the medication and drug needs of patients. Their roles and responsibilities in work expanded and to some redefined as the pandemic hit. Adjustments in their work, and workplaces were also implemented in adherence to the pandemic situation. The quality of work life of frontline pharmacists were affected because of the changes brought by the pandemic. A descriptive qualitative study design was used to determine the pharmacist’s quality of work-life during the COVID-19 pandemic in Cagayan de Oro City. The place was …

Continuous Glucose Monitoring Versus Self-Monitoring For Patients With Type 1 Diabetes: A Systematic Review And Meta-Analysis, Prayuth Poowaruttanawiwit, Kwanchai Rattanamanee, Nonnachanok Chaiyot, Saranpreeya Srisinroongruang

The Thai Journal of Pharmaceutical Sciences

Background: Patients with type 1 diabetes mellitus (T1DM) require intensive glucose monitoring to achieve optimal glycemic control and prevent complications. While self-monitoring of blood glucose (SMBG) has long been the standard approach, continuous glucose monitoring (CGM) offers real-time data and trend analysis that may enhance clinical decision-making.

Objective: This study aimed to evaluate whether CGM provides superior glycemic outcomes compared with SMBG in individuals with T1DM.

Materials and Methods: A systematic review and meta-analysis were conducted following preferred reporting items for systematic reviews and meta-analyses guidelines. Four randomized controlled trials involving T1DM patients using either CGM or SMBG were included. …

Assessing Buprenorphine Treatment Utilization And Samhsa Data Waiver Provider Distribution In 2021: A Real-World Analysis In California, Yun Wang, Tao Hu, Chih-Hung Chang, Matthew Heshmatipour, Jeff Jianfei Guo, Moom R. Roosan, Karen A. Miotto

Pharmacy Faculty Articles and Research

Qualified clinicians previously required a practitioner waiver (i.e., “DATA-waiver” or "X-waiver") to offer buprenorphine, a medication for opioid use disorder (OUD). However, many counties in the US experience fewer buprenorphine prescriptions due to factors such as “DATA-waiver” providers underutilizing their buprenorphine prescribing ability. Our study aimed to compare the availability of active buprenorphine-prescribing clinicians in California to the Substance Abuse and Mental Health Services Administration (SAMSHA)-listed DATA waived prescribers under each 5-digit ZIP Code. This study utilized the buprenorphine prescription record data in 2021 from California’s Controlled Substance Utilization Review and Evaluation System (CURES). The list of the locators for …

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 …

Automated Dispensing Cabinet Stocking Schedule And Inventory Management Optimization, Daniel Elkes, Victoria Timmons

HCA Healthcare Journal of Medicine

Background

Prior practice in a 523-bed community hospital required automated dispensing cabinets (ADCs) to be replenished daily by early afternoon to ensure accurate drug ordering. Because of the tight time window, technicians frequently refilled ADCs during peak medication administration times. After a positive report from a smaller facility in the health system, the study facility implemented a quality improvement project to optimize the ADCs. This involved new processes of every-other-day ADC replenishment staggered via shift-specific workflows, and a dedicated technician was assigned to optimize ADC inventories.

Methods

Monthly reports of ADC refilling and dispensing transactions were compiled from inpatient, nonprocedural …

Exploring The Link Between Physicians’ Familiarity And Biosimilar Prescribing In Thailand, Ekapong Kachai, Chaoncin Sooksriwong, Wanruchada Katchamart, Tuangrat Phodha

The Thai Journal of Pharmaceutical Sciences

Background: Despite the availability of various biosimilars in Thailand, the link between physicians’ familiarity and biosimilars prescribing practice remains still unclear.

Objectives: This study aimed to find the association between physicians’ familiarity and biosimilars prescribing practice among physicians in Thailand.

Methods: This research adopted an extended analysis framework, utilizing survey data from a pilot study on the surveillance of Thai physicians regarding biosimilar uptake. The familiarity with biosimilars among respondents was evaluated.

Results: The result showed that 82 respondents were included in the study. There was 79.3% of respondents indicated prescribing biosimilars. Overall, most respondents (75.6%) showed an “adequate” level …

The Use Of Health And Herbal Products For Covid-19 Self-Prevention And Its Affecting Factors According To Theory Of Planned Behavior, Suppachai Insuk, Supanida Kittirattanasak, Mullika Sirithongkaset, Daranee Chiewchantanakit

The Thai Journal of Pharmaceutical Sciences

Introduction: Despite the World Health Organization’s recent declaration of the end of the COVID-19 pandemic, the lessons learned from the outbreak remain crucial for future public health responses. In Thailand, the pandemic’s impact led individuals to explore self-protection methods, including potentially ineffective health products. This study examined the prevalence of health and herbal products used for COVID-19 self-prevention, to identify the types of these products in use and to identify factors influencing their utilization.

Methods: A cross-sectional study surveyed 400 Thai participants aged 25–60 who had never contracted COVID-19. The study employed convenience sampling and self-administered online questionnaires based on …

Review: The Impact Of Insurance Policy On Glp-1 Agonist Treatment, Sunsik Chang

Harrisburg University Dissertations and Theses

This study examines how healthcare system design influences access, adherence, and financial burden associated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in high-income countries. Through a literature review of peer-reviewed articles published between 2020 and 2025, it compares outcomes across universal and multi-payer systems. Findings reveal significant disparities. For example, the 12-month persistence reaches 68% in centralized systems like Denmark, but falls to 32–46% in the U.S., largely due to financial burdens, insurance denials, and administrative barriers. Among uninsured U.S. patients, 45% report significant financial hardship while using GLP-1 RA therapy. However, only 20% of patients enrolled in high-deductible health …

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 …

Over-The-Counter Cold Medication Usage Self-Efficacy Among Undergraduate Students In The United States, Ray Goodwin

Honors Theses

Background

This study looks at the trends in over-the-counter medication usage and self-efficacy among undergraduate college students in the United States. Over-the-counter (OTC) medications serve as the most easily accessible and commonly purchased medications and can be used as a basis to determine this demographic’s attitudes and behaviors towards self-medication. In addition, undergraduates represent a diverse population for analyzing differences among demographic groups.

Methods

A Qualtrics survey was sent out to undergraduates across the US via a panel, and the team received 403 useable responses. As part of a larger study, the survey presented participants with four different scenarios at …

Cross-Cultural Adaptation And Psychometric Validation Of The Medication Compliance Questionnaire (Mcq) For Type 2 Diabetes Mellitus Patients In Indonesia, Much Ilham Novalisa Aji Wibowo, Angelia Yuliana Safitri, Didik Setiawan

Makara Journal of Health Research

Background: Medication adherence is critical for managing type 2 diabetes mellitus (T2DM). The Medication Compliance Questionnaire (MCQ) is a widely recognized tool for assessing adherence but has not been adapted for T2DM in Indonesia. This study aimed to adapt and validate the MCQ in the Indonesian socio-cultural context.

Methods: A cross-sectional study at community health centers (May–Aug 2024) involved forward/back translation, content validation using Aiken’s V, and psychometric assessment among 230 patients. Exploratory Factor Analysis (EFA) assessed construct validity, including convergent, discriminant, and reliability.

Results: Aiken's V index indicated strong content validity (average = 0.881). EFA identified …

Bibliometric Analysis Of Research Trends Related To Human Immunodeficiency Virus., Madyson E. Johnson, Kaitlyn R. Coffman, Valerie Rivas, Elizabeth Barrett

ATU Scholars Symposium

Human immunodeficiency virus poses major health burden across the globe including the United States of America and has its zoonotic origin from the Simian Immunodeficiency viruses of sooty mangabey monkey and chimpanzee in Africa. Epidemiological trends indicate that even though the mortality rates for HIV are falling globally, the rates of new cases have been rising since 2010 in several countries including the USA. An estimated 0.5% of the human population is currently infected with the virus with countries like USA, India, Nigeria and South Africa carrying the highest burden of the disease. Host receptors such as CD4 and coreceptors …

Enhancing Holistic Patient Care Of Black Individuals Diagnosed With Hiv And Comorbid Chronic Conditions, Marc Fleming, Saharnaz Nejdat, Jon C. Schommer, Crystal K. Hodge

Pharmacy Faculty Articles and Research

Background

Pharmacists can play a crucial role in delivering the holistic care model. Research suggests that HIV-positive African American patients particularly benefit from this approach compared to other communities. Typically, pharmacists in community pharmacy settings are limited in their access to a patient's medical record, preventing holistic care delivery.

Objectives

This study addressed the impact of access to medical records on a holistic patient care approach among pharmacists engaged in medication therapy management.

Methods

This was a sub-analysis of a randomized controlled trial of the impact of community pharmacist access to medical records during MTM for African Americans diagnosed with …

Interprofessional Education And Collaboration In The Philippines: Current Landscape, Gaps, And Propositions, Arvie Vitente, Michael Sy, Reeva Ann Sumulong, Anna Causapin, Jocel Regino

Rehabilitation Sciences Department Faculty Articles

Interprofessional education (IPE) is a forward-looking strategy in healthcare education that unites students and professionals from various disciplines to enhance interprofessional collaboration (IPC). IPE is designed to prepare future health and social care professionals to navigate and address the complexities of modern healthcare systems. In the Philippines, despite being a developing country with a fragmented healthcare system, there have been efforts over the last 15 to 20 years to introduce and institutionalize IPE and IPC in both higher education and healthcare settings. However, significant challenges persist, including the dominance of medical professionals, inadequate regulatory mechanisms, and a lack of strong …

Interprofessional Education And Collaboration In The Philippines: Current Landscape, Gaps, And Propositions, Arvie Vitente, Michael Sy, Reeva Ann Sumulong, Anna Karerina Causapin, Jocel Regino

Philippine Journal of Physical Therapy

Interprofessional education (IPE) is a forward-looking strategy in healthcare education that unites students and professionals from various disciplines to enhance interprofessional collaboration (IPC). IPE is designed to prepare future health and social care professionals to navigate and address the complexities of modern healthcare systems. In the Philippines, despite being a developing country with a fragmented healthcare system, there have been efforts over the last 15 to 20 years to introduce and institutionalize IPE and IPC in both higher education and healthcare settings. However, significant challenges persist, including the dominance of medical professionals, inadequate regulatory mechanisms, and a lack of strong …

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 …

Study Of Laws And Regulations Related To The Management Of Florfenicol Detection Cases In Swine, Shinnawat Saengungsumalee

The Thai Journal of Pharmaceutical Sciences

Background: Florfenicol, an antibiotic permitted in veterinary medicine, currently lacks an established maximum residue limit (MRL) in meat products in Thailand, effectively mandating undetectable residue levels. In May 2024, Thailand Pesticide Alert Network reported florfenicol residues in swine, raising concerns about consumer safety, rational veterinary drug use, and the potential for antimicrobial resistance (AMR). Addressing these issues involves multiple laws, decrees, and regulations across various agencies. Objectives: To analyze laws and regulations managing florfenicol residue detection in swine. Materials and Methods: This documentary research examines relevant laws, regulations, and measures for florfenicol in livestock and compares Thailand’s regulations with those …

Brief Of 76 Scholars Of Law, Business, Economics, And Medicine As Amici Curiae, Charles Duan

Amicus Briefs & Court Filings

No abstract provided.

Blended Learning Course In Medical Affairs To Improve Exposure And Interest In Pharmaceutical Industry Careers, Nandini Manne, Gayle Brazeau, Craig Kimble

Pharmacy Practice & Administration

Objective: This study aimed to evaluate students’ knowledge and perceptions of career options and their knowledge of the pharmaceutical industry based on pre-post module quizzes, reflections, and team presentations in a hybrid medical affairs elective certification course.

Methods: A qualitative research design was used to analyze the reflections of 19 students enrolled in the Accreditation Council for Medical Affairs Pharmaceutical Industry Training Certificate elective at Marshall University during spring 2023. The course used 7 modules from the Medical Affairs Competency Certificate offered by the Accreditation Council for Medical Affairs. Students completed premodule and postmodule quizzes, engaged in discussions with industry …

Mergers And Acquisitions (M&As) In Pharmaceutical Markets: Associations With Market Concentration, Prices, Drug Quantity Sold, And Shortages, J. Daniel Mcgeeney M.S., Aylin Sertkaya Ph.D., Leah Ross M.A., Fred Ledley M.D., Cody Hyman Ph.D.

CISI Publication

In recent decades, the pharmaceutical industry has become increasingly concentrated in the United States, in part due to mergers and acquisitions (M&As) between drug manufacturers. This consolidation from M&As has been cited as a key factor affecting drug prices and drug shortages (U.S. Federal Trade Commission, 2022). In this study, we assessed trends in pharmaceutical M&As during 2010–2023 and evaluated the characteristics of drugs and companies involved in those M&As. We considered the effects of M&As on market concentration, drug prices, drug quantity sold, and drug shortages. We also considered how these associations vary by drug characteristics, including brand drugs …

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, …

Optimizing Endogenous Glp-1 Holistically: A Nursing Led Approach To Sustainable Weight Loss Without Glp-1 Agonist Use, Taylee A. Carscadden

Nursing | Senior Theses

The increase in off-label Glucagon-like peptide-1 (GLP-1) receptor agonist drugs, such as semaglutide (Ozempic), for weight loss has sparked concern in regards to the not fully understood drug outcomes and safety. GLP-1 agonists were originally developed to manage Type 2 Diabetes Mellitus, but have been widely prescribed for obesity management despite minimal research on prolonged use in non-diabetic patients. This study explores how off-label use of GLP-1 agonist drugs exacerbate various adverse health outcomes, highlighting gastrointestinal complications, and the very possible dependency on drugs for weight management. It will also examine the efficacy of nursing-led education on the implementation of …

Customary Corruption, Ani B. Satz, Liza Vertinsky

Faculty Articles

For over a hundred years, it has been well-accepted among tort scholars that physicians—as one of the legally recognized professions— determine their own customary practices. Within tort law, and medical malpractice more specifically, customary practice establishes whether physicians breach or uphold the required standard of care toward their patients. The results of our hand-coded examination of decided cases and statutes show a more complex picture. While some states have endeavored to shift the standard away from professional custom, it continues to play a critical, and in many cases a determinative, role in establishing physician liability in most states.

Using illustrative …

Defederalizing Opioid Addiction Care, Matthew B. Lawrence

Faculty Articles

Lack of access to evidence-based care for drug addiction is an urgent problem amid a decades-long overdose crisis that kills tens of thousands of Americans a year. Opioid addiction is the primary driver of overdoses today, and medicines exist to treat such addiction that can dramatically improve quality of life while reducing the risk of deadly overdose by more than half. Yet fewer than one in four of the nine million Americans who need such evidence-based medical care for their addiction receive it. Chief among barriers to access are restrictive and burdensome federal requirements limiting the use of narcotic medications …

Understanding The Impact Of Pharmacist Prescriptive Authority On Hiv Pre-Exposure Prophylaxis At The State Level, Cameron G. King

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

HIV transmission, with relative risk reductions of up to 99%. However, real world data have revealed that even with large increases in PrEP use, new HIV diagnoses may only slightly decline. This disparity suggests that access to PrEP may be suboptimal, especially among high-risk subgroups, who are often hard to maintain on the continuum of HIV care. Pharmacists, because of their accessibility, trusted role in their communities, and growing scope of practice, could serve as an intervention point to improve access to PrEP.

A previously validated algorithm using National Drug Codes (NDCs) and the International Classification of Disease, 10^{th …}

Pharmaceutical-Telehealth Confederacies, Michael S. Sinha

All Faculty Scholarship

Access to prescription pharmaceuticals has historically been controlled by a physician’s pen. As a result, pharmaceutical companies spend billions of dollars on advertising and promotion to mitigate this barrier: first and primarily, to physicians and other prescribers, and more recently, to the general public through direct-to-consumer advertising. The success of these promotional efforts can be seen in greater prescribing of costly brand-name medicines, even in settings where lower-priced generic alternatives exist. Brand-name prescriptions now make up only 10% of all prescriptions written yet account for 87% of drug spending. Despite these substantial returns on investment, companies continue to seek opportunities …

Fda Approval Of Zuranolone: A Breakthrough Treatment For Postpartum Depression, Connor Dains, Makayla Eversole, Kiley Devoll, Daniella Egbujor, Marisa Petrunich, Madilyn Paphanchith, Joshua Honaker, Samantha Mccord, Manoranjan D'Souza

Pharmacy and Wellness Review

Postpartum depression (PPD) is a serious medical condition that increases the risk of postpartum mortality and affects the ability of a postpartum individual to take care of their newborn. Until 2023, intravenously-administered brexanolone was the only Food and Drug Administration (FDA)-approved medication for PPD. Brexanolone’s route of administration poses significant barriers to accessibility and convenience. Other treatment options, such as psychotherapy and antidepressants, often require long-term commitment and may not provide rapid relief for severe symptoms. In August 2023, the FDA approved zuranolone as an oral medication for PPD, which enhances treatment accessibility and offers patients a more flexible, outpatient …

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 …

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.