Pharmacy Administration, Policy and Regulation Commons^™

Analysis Of Us Food And Drug Administration New Drug And Biologic Approvals, Regulatory Pathways, And Review Times, 1980–2022, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, John H. Powers Iii

Pharmacy Faculty Articles and Research

U.S. laws enacted since 1983 have aimed to enhance the development and marketing of new pharmaceutical products. We thoroughly characterized all new molecular entities, therapeutic biologics, and gene and cell therapies approved by the US Food and Drug Administration (FDA) during the period 1980–2022 in the context of these laws and regulations. Throughout the study period, the FDA approved 1355 new pharmaceutical products. The median FDA review time decreased from 26.6 months prior to the Prescription Drug User Fee Act (1992), which authorized the FDA to collect fees from drug companies to 9.9 months after the Food and Drug Administration …

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 …

A Comparative Assessment Of Approvals And Discontinuations Of Systemic Antibiotics And Other Therapeutic Areas, Rosa Rodriguez-Monguio, Enrique Seoane-Vazquez, John H. Powers Iii

Pharmacy Faculty Articles and Research

Since 1980, the US Congress has passed legislation providing several incentives to encourage the development and regulatory approval of new drugs, particularly antibiotics. We assessed long-term trends and characteristics of approvals and discontinuations of all new molecular entities, new therapeutic biologics, and gene and cell therapies approved by the US Food and Drug Administration (FDA), as well as reasons for discontinuations by therapeutic class, in the context of laws and regulations implemented over the past four decades. In the period 1980–2021, the FDA approved 1310 new drugs, of which 210 (16.0%) had been discontinued as of 31 December 2021, including …

Geospatial Analysis Of Opioid Dispensing Patterns In California: A 2021 Real-World Study, Hongxia Lu, Jianwei Zheng, Yun Wang

Pharmacy Faculty Articles and Research

The misuse and abuse of opioids has become a serious public health threat in the United States. The state of California has been hit particularly hard by the opioid epidemic, with a noticeable increase in opioid-related fatalities and hospitalizations. This brief report paper aims to contribute to the growing literature by conducting a geospatial analysis of opioid dispensing patterns in California in 2021. The primary objective was to identify areas characterized by high-risk opioid dispending patterns and explore possible contributing factors. This retrospective study analyzed data from over 7 million records of opioid and benzodiazepine prescriptions dispensed by outpatient pharmacies …

Factors Affecting Initiation And Retention Of Medication-Assisted Recovery (Mar) Within A Pilot Pharmacist-Involved Practice Model At A Federally Qualified Healthcare Center (Fqhc) During The Covid-19 Pandemic, Tiffany Nguyen, Thomas Craig Cheetham, Souhiela Fawaz, Richard Beuttler, Sharon Xavioer

Pharmacy Faculty Articles and Research

Background: During the COVID-19 pandemic, opioid-related overdose deaths increased. Although Medication-Assisted Treatment or Recovery (MAT or MAR) is available, initiation and retention rates vary. The goal of this study was to evaluate clinical, demographic, and Social Determinant of Health factors affecting MAR initiation, on-time initiation of medications, and successful retention in the program. The secondary goal was to evaluate the impact of a novel interprofessional practice model incorporating pharmacists. Methods: A retrospective analysis was conducted using electronic health record data from a pilot MAR Program initiated within a California Federally Qualified Healthcare Center. Results: From September 2019 to August 2020, …

Disentangling The Cost Of Orphan Drugs Marketed In The United States, Hana Althobaiti, Enrique Seoane-Vazquez, Lawrence B. Brown, Marc L. Fleming, Rosa Rodriguez-Monguio

Pharmacy Faculty Articles and Research

The increasing number and high prices of orphan drugs have triggered concern among patients, payers, and policymakers about the affordability of new drugs approved using the incentives set by the Orphan Drug Act (ODA) of 1983. This study evaluated the factors associated to the differences in the treatment cost of new orphan and non-orphan drugs approved by the FDA from 2017 to 2021. A generalized linear model (GLM) with the Gamma log-link analysis was used to ascertain the association of drug characteristics with the treatment costs of orphan and non-orphan drugs. The results of the study showed that the median …

The U.S. Travel Health Pharmacists’ Role In A Post-Covid-19 Pandemic Era, Keri Hurley-Kim, Karina Babish, Eva Chen, Alexis Diaz, Nathan Hahn, Derek Evans, Sheila M. Seed, Karl Hess

Pharmacy Faculty Articles and Research

Background: Many countries have enforced strict regulations on travel since the emergence of the SARS-CoV-2 (COVID-19) pandemic in December 2019. However, with the development of several vaccines and tests to help identify it, international travel has mostly resumed in the United States (US). Community pharmacists have long been highly accessible to the public and are capable of providing travel health services and are in an optimal position to provide COVID-19 patient care services to those who are now starting to travel again. Objectives: (1) To discuss how the COVID-19 pandemic has changed the practice of travel health and …

Pharmacists’ Response To The Opioid Crisis: A California Naloxone Survey, Jerika T. Lam, Moom Roosan, Mary A. Gutierrez, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

This study aimed to assess pharmacists’ response to the current opioid crisis in California, particularly regarding the prevalence of naloxone furnishing (or dispensing without a prescription) and prescriptions for medication-assisted treatment (MAT) drugs for opioid use disorder (OUD) to patients and consumers.

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 …

Financial Hardship From Purchasing Prescription Drugs Among Older Adults In The United States Before, During, And After The Medicare Part D “Donut Hole”: Findings From 1998, 2001, 2015, And 2021, Anthony W. Olson, Jon C. Schommer, David A. Mott, Olajide Adekunle, Lawrence M. Brown

Pharmacy Faculty Articles and Research

BACKGROUND: Cost-related nonadherence compromises successful and effective management of chronic disease. The Medicare Modernization Act of 2003 (MMA) and Patient Protection and Affordable Care Act of 2010 (ACA) aimed to increase the affordability of outpatient prescription drugs for older adults (older than age 64 years). The Medicare Part D prescription drug insurance coverage gap (“donut hole”) created by the MMA was fully closed in 2020 by the ACA.

OBJECTIVES: To (1) describe prescription drug coverage and financial hardship from purchasing prescription drugs among older American adults for 2021, (2) compare these results with findings from data collected before the MMA …

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 …

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 …

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 …

Predisposing, Enabling, And Need Factors Associated With The Choice Of Pharmacy Type In The Us: Findings From The 2015/2016 National Consumer Survey On The Medication Experience And Pharmacists’ Roles, Mohamed Rashrash, Suhila Sawesi, Jon C. Schommer, Lawrence M. Brown

Pharmacy Faculty Articles and Research

Background: Knowing the type of pharmacy used by the patient is meaningful to the pharmacist. Previous studies have assessed different factors predicting the kind of pharmacy selection and reached inconsistent findings. Objectives: To identify patient and health-related factors associated with pharmacy type selection. Methods: The Andersen Behavioral Model of Health Service Use was used to organize the selection of patient characteristics and categorize them as predisposing, enabling, and need factors. The dependent variable was the type of pharmacy used. Logistic regression was used to predict the association between patient-related characteristics and the type of pharmacy used. Results: Older age respondents …

The Inclusion Of Health Data Standards In The Implementation Of Pharmacogenomics Systems: A Scoping Review, Don Roosan, Angela Hwang, Anandi V. Law, Jay Chok, Moom Roosan

Pharmacy Faculty Articles and Research

Background: Despite potential benefits, the practice of incorporating pharmacogenomics (PGx) results in clinical decisions has yet to diffusewidely. In this study,we conducted a review of recent discussions on data standards and interoperability with a focus on sharing PGx test results among health systems. Materials & methods:We conducted a literature search for PGx clinical decision support systems between 1 January 2012 and 31 January 2020. Thirty-two out of 727 articles were included for the final review. Results: Nine of the 32 articles mentioned data standards and only four of the 32 articles provided solutions for the lack of …

Medication Safety During Transitions Of Care:The Importance Of Checklists In Preventing Patient Harm, Laressa Bethishou, Olivia Lounsbury, Donna Prosser

Pharmacy Faculty Articles and Research

There is a need to optimize patient safety as patients navigate through the healthcare system. With each transition of care, patients are vulnerable to changes that may cause adverse effects, including changes in their healthcare team, health status, and medications. The Centers for Medicare & Medicaid Services (CMS) defines a transition of care as “the movement of a patient from one setting of care to another.” While the concept itself may seem simple, this definition fails to capture the many potential handoff complications which classify these transitions as high risk for patients. With 67% of patients facing unintended medication discrepancies …

Using Community Pharmacy Immunization Screening Forms To Identify Potential Immunization Opportunities, Albert T. Bach, Jeffery A. Goad

Pharmacy Faculty Articles and Research

Immunization screening forms are completed for each patient that is to be vaccinated in the pharmacy. Screening forms contain demographic and health questions, which are used to determine if a patient is contraindicated to receive a vaccine. The objective is to determine if patient responses to questions on these forms can be used to identify potential vaccine indications. De-identified data was retrospectively collected from 11 community pharmacies in California and Michigan that included basic demographics, answers to immunization screening questions, and vaccine(s) administered during that visit. The Advisory Committee on Immunization Practices (ACIP) recommendations were used to forecast vaccine needs …

Improving Medication Information Presentation Through Interactive Visualization In Mobile Apps: Human Factors Design, Don Roosan, Yan Li, Anandi Law, Huy Truong, Mazharul Karim, Jay Chok, Moom Roosan

Pharmacy Faculty Articles and Research

Background: Despite the detailed patient package inserts (PPIs) with prescription drugs that communicate crucial information about safety, there is a critical gap between patient understanding and the knowledge presented. As a result, patients may suffer from adverse events. We propose using human factors design methodologies such as hierarchical task analysis (HTA) and interactive visualization to bridge this gap. We hypothesize that an innovative mobile app employing human factors design with an interactive visualization can deliver PPI information aligned with patients’ information processing heuristics. Such an app may help patients gain an improved overall knowledge of medications.

Objective: The …

Drug Safety Scientometrics Overview Highlights Public Health Issues, Philippe Gorry, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

"Drug Safety (DS) also known as Pharmacovigilance, is the science of monitoring ADR (Cobert, 2012). Despite that DS has a social welfare function, it has not been the study of any scientometrics analysis... Our goal is to fill this gap by mapping the DS literature. This analysis might highlight some trends, the role of drug regulatory and firms in diffusing information, understand better some DS controversial events, help scholars in mastering pharmacovigilance literature, and it contribute to further development on literature-based discovery of ADR [adverse drug reactions] with the help of natural language processing."

The Power Of Pharmacist-To-Pharmacist Handoffs During Transitions Of Care, Jessica Wooster, Laressa Bethishou

Pharmacy Faculty Articles and Research

"Hospital readmissions are often medication-related and potentially preventable. Pharmacists can play a vital role in improving medication outcomes during transitions of care (TOC). Although numerous TOC practice models have been described, it remains unclear what practices will promote optimal continuity of care."

The Landscape Of Cellular And Gene Therapy Products: Cost, Approvals, And Discontinuations, Vaishali Shukla, Enrique Seoane-Vazquez, Souhiela Fawaz, Lawrence M. Brown, Rosa Rodriguez-Monguio

Pharmacy Faculty Articles and Research

Background The past 10 years witnessed a significant increase in the approval of cellular and gene therapy products worldwide. The US Food and Drug Administration (FDA) approved 3 gene therapy products within the last 4 months of 2017. The objective of this study was to examine the approval characteristics, discontinuations and cost of all cellular and gene therapy products approved worldwide. Data and Methods We conducted an electronic search of approved cell and gene therapy products from the databases of the main drug regulatory agencies including the US Food and Drug Administration, the European Medicines Agency (EMA), the Korea Ministry …

The Importance Of Goal Setting: Why Every Pharmacist Should Make Goal Setting A Habit, Albert Bach, Laressa Bethishou

Pharmacy Faculty Articles and Research

"But how many of us actually practice what we preach? We have pledged to apply our knowledge, experience, and skills to the best of our ability to assure optimal outcomes for our patients. As the pharmacy profession evolves, and as we train future generations of pharmacists, we have increased opportunities to expand our role and impact as a pharmacist. Goal setting is an important and valuable tool to support us in our personal and professional growth."

2018-2019 Acip Immunization Updates: Highlights For Pharmacists, Laressa Bethishou, Luma Munjy, Jeff Goad

Pharmacy Faculty Articles and Research

"Vaccinations have significantly reduced the burden of infectious diseases, preventing almost 6 million deaths worldwide.^1,2 In the United States, vaccines have led to a decrease in incidence of vaccine-preventable illness, mortality, and disease sequelae.³ Despite the proven benefit of vaccines, misinformation and failure to vaccinate has led to outbreaks of vaccine-preventable diseases. As of December 29, 2018, 372 cases of measles (from 17 outbreaks) and 2251 cases of mumps were reported in the United States in 2018.^4,5 These outbreaks support the need for continued education of patients and active immunization by pharmacists."

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

Pharmacy Faculty Articles and Research

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

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

Pharmacy Faculty Articles and Research

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

Assessing Vancomycin Dosing Per Pharmacy In Elderly Patients Over The Age Of 74 Years, Lee H. Nguyen, Martin Breen, Jason Yamaki, Geraldine Cadalin, Nilomi Shah, Linda Lumintaintang

Pharmacy Faculty Articles and Research

Vancomycin has a complex pharmacokinetic profile and carries potential risks for nephrotoxicity and ototoxicity. The pharmacokinetic profile in elderly patients significantly differs from that of younger patients. It is common practice in many institutions for pharmacists to intentionally round serum creatinine levels to 1 mg/dl in elderly patients with levels <1 mg/ dl to avoid overestimating clearance and toxicities. This can potentially lead to underestimation of creatinine clearance, and subsequently lead to vancomycin under dosing. The aim of this study was to evaluate vancomycin target trough attainment and the time to trough attainment with vancomycin dosing per pharmacy in elderly patients.

Earlier Identification Of Medications Needing Prior Authorization Can Reduce Delays In Hospital Discharge, Thomas Lew, Laressa Bethishou, Lisa Shieh

Pharmacy Faculty Articles and Research

"Based on our experience, there are no studies that evaluate delays due to discharge medications needing to undergo the PA process. Thus, in our pilot study, we both aim to define the scope of this problem by surveying resident physicians as well as provide an intervention to identify earlier medications that will need to undergo a PA process. Pharmacy-led interventions in processing PAs have resulted in a statistically significant benefit in improving time to PA approval, fill, and pickup.5 Therefore, in our intervention, we utilize a specialized 'transitions of care' (TOC) pharmacist to analyze the medications of patients who are …

Changes In The Utilization Of Osteoporosis Drugs After The 2010 Fda Bisphosphonate Drug Safety Communication, Bander Balkhi, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio

Pharmacy Faculty Articles and Research

Introduction

In October 2010, the US Food and Drug Administration (FDA) issued a safety communication regarding the risks of atypical fractures of the femur, with bisphosphonates drugs. This study evaluated the impact of the bisphosphonates FDA safety communication on the utilization of osteoporosis medications in Medicaid programs.

Methods

Osteoporosis drugs utilization data from the July 2006 to June 2014 were extracted from the national Summary Files from the Medicaid State Drug Utilization Data maintained by the Centers for Medicare & Medicaid Services (CMS). We performed an interrupted time series analyses to evaluate trends in utilization of osteoporosis drugs before and …

Changes In The Utilization Of Osteoporosis Drugs After The 2010 Fda Bisphosphonate Drug Safety Communication, Bander Balkhi, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio

Pharmacy Faculty Articles and Research

Introduction

In October 2010, the US Food and Drug Administration (FDA) issued a safety communication regarding the risks of atypical fractures of the femur, with bisphosphonates drugs. This study evaluated the impact of the bisphosphonates FDA safety communication on the utilization of osteoporosis medications in Medicaid programs.

Methods

Osteoporosis drugs utilization data from the July 2006 to June 2014 were extracted from the national Summary Files from the Medicaid State Drug Utilization Data maintained by the Centers for Medicare & Medicaid Services (CMS). We performed an interrupted time series analyses to evaluate trends in utilization of osteoporosis drugs before and …