Pharmacy Administration, Policy and Regulation Commons^™

Antibiotic Resistance And The White House Forum On Antibiotic Stewardship, Mary Lou Manning Phd, Crnp, Cic, Faan

Population Health Matters (Formerly Health Policy Newsletter)

No abstract provided.

Pharmacists On The Front Lines Of Polypharmacy: The Individualized Medication Assessment And Planning (Imap) Project To Improve Medication Use In Senior Adults With Cancer, Ginah Nightingale Pharmd, Bcop, Laura T. Pizzi Pharmd, Mph, Emily Hajjar Pharmd, Bcps, Bcacp, Cgp, Elizabeth Pigott, Margaret Wang, Shannon Doherty, Kristine Swartz Md, Andrew Chapman Do, Facp

Population Health Matters (Formerly Health Policy Newsletter)

No abstract provided.

Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler

Faculty Publications By Year

No abstract provided.

Workload Perceptions Of Pharmacists: Part Of Changing A National Trend, Fadi M. Alkhateeb, Omar F. Attarabeen, David Latif, Rachel Deliere

Pharmacy Practice & Administration

Background: A National Pharmacist Workforce Survey (NPW) survey is being conducted in the US every five years. The 2009- NPW project surveyed 1,391 participants, of which only 12 participants were from West Virginia. Therefore, such a small representation of West Virginian pharmacists may question the validity of extrapolating the results of the 2009 NPW survey to pharmacists in this state. As a result, a separate survey was needed to answer the questions about the perceived workload, work characteristics, and demographics for West Virginian pharmacists.

Objectives: The primary objective of this investigation was to identify the pharmacists’ perceptions of workload in …

The Role Of Community Pharmacy-Based Vaccination In The Usa: Current Practice And Future Directions, Albert Bach, Jeffery A. Goad

Pharmacy Faculty Articles and Research

Community pharmacy-based provision of immunizations in the USA has become commonplace in the last few decades, with success in increasing rates of immunizations. Community pharmacy-based vaccination services are provided by pharmacists educated in the practice of immunization delivery and provide a convenient and accessible option for receiving immunizations. The pharmacist's role in immunization practice has been described as serving in the roles of educator, facilitator, and immunizer. With a majority of pharmacist-provided vaccinations occurring in the community pharmacy setting, there are many examples of community pharmacists serving in these immunization roles with successful outcomes. Different community pharmacies employ a number …

Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters

Indiana Law Journal

Private party oversight has proven to be ineffective at countering inaction by the Food and Drug Administration (FDA). Inaction when regulation is warranted can put the public at continued and increasing risk of harm, but the failure of private enforcement to compel action reverberates beyond this harm to the interests of individuals. It also diminishes the transparency of agency decision making, lessens the opportunity for public participation, and reduces the interaction between the institutions that oversee agencies. Moreover, the benefits afforded to the administrative process by judicial review are weakened.

This Article analyzes two examples of FDA inertia and compares …

Research Proposal: Emrs Changing Patient Medication Errors, Kerry Moore

Applied Research Projects

In 2009 the federal government initiated the American Recovery and Reinvestment Act (ARRA) in efforts to improve timely and quality health care. This new initiative promised to provide great incentives to health care providers who took advantage of the program by implementing electronic medical records (EMRs) within their facilities, clinics, and practices. Coupled with tight deadlines and the incentive of reimbursement, the health care world has been witness to an influx of EMRs being developed by vendors and implemented at health care facilities. The rate at which these EMRs have been implemented has been astounding. So fast, the health care …

Review Of Edison Bicudo, Pharmaceutical Research, Democracy And Conspiracy: International Clinical Trials In Local Medical Institutions, Roberto Abadie

Department of Sociology: Faculty Publications

The pharmaceutical industry is—along with the financial and weapons industries—one of the most globalized and profitable business domains. But they wouldn’t make any profits if they weren’t able to recruit research subjects to test an increasing number of drugs. This global trial economy creates its own assemblages of clinical trials, often run by hired contract research organizations (CROs), who fight among each other in a rat-race competition, promising quick and effective trials; at the same time, enterprising countries, hospitals, and doctors jump on the drug trial economy bandwagon by promising quick, endless access to a large pool of research subjects, …

Awareness And Utilization Of The Ohio Automated Rx Reporting System By Physician Assistants, Julia Cathleen Rose

All Theses And Dissertations

Chronic pain has become a public health epidemic. As pain complaints increase, so does the potential for drug abuse/misuse. Prescription drug monitoring programs (PDMPs) are active in 49 of the 50 states to assist providers in recognizing drug abuse/misuse. There is no clear standardization of who utilizes the PDMP and how. Little is still known about the ways PDMP results are incorporated into clinical decision making, what barriers exist, and how providers may or may not alter their prescribing plans based on the results. Laws surrounding prescribing practices and use of the Ohio Automated Rx Reporting System (OARRS) are constantly …

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

CCAC Theses and Dissertations

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

Bridging The Location Gap: Physician Perspectives Of Physician-Pharmacist Collaboration In Patient Care (Bridge Phase Ii), Keri D. Hager, Donald Uden, Daniel M. Tomaszewski

Pharmacy Faculty Articles and Research

Background: To optimize patient outcomes, the patient-centred medical home model emphasizes comprehensive team-based care. Pharmacists are qualified to enhance appropriate medication use and help improve patient outcomes through provision of medication therapy management (MTM) services. To optimally provide MTM, pharmacists must effectively collaborate with physicians. This study explored factors that influence pharmacist-physician collaboration.

Methods and Findings: A convenience sample of five physicians participated in semi-structured interviews and the resulting data were analyzed using qualitative methods. Transcripts of the interviews were independently coded for themes by two researchers. Five themes emerged: trustworthiness, role specification, relationship initiation, effects on practice, …

Fda Approves 18 New Molecular Entities/Biologics, Rodney Richmond

Faculty Research ​and Publications

No abstract provided.

Customized Order-Entry Sets Can Prevent Antiretroviral Prescribing Errors: A Novel Opportunity For Antimicrobial Stewardship, Yi Guo, Philip Chung, Caryn Weiss, Keith Veltri, Grace Y. Minamoto

Touro College of Pharmacy (New York) Publications and Research

Background: Patients with human immunodeficiency virus (HIV) infection on antiretroviral (ARV) therapy are at increased risk for medication errors during transitions of care between the outpatient and inpatient settings. This can lead to treatment failure or toxicity. Previous studies have emphasized the prevalence of medication errors in such patients, but few have reported initiatives to prevent errors from occurring.

Methods: The study was conducted in a 1,400-bed health care center with a state-designated Acquired Immunodeficiency Syndrome (AIDS) Center in the Bronx, New York. The antimicrobial stewardship team and HIV specialists developed customized order-entry sets (COES) to guide ARV …

Prescriptions For Bedtime Sedatives After The Introduction Of A General Admission Order Set At An Academic Health Center: The Potential And Pitfalls Of Order Sets., Areeba Kara, Alex N. Isaacs, Sarah A. Nisly

Scholarship and Professional Work – COPHS

OBJECTIVE:

This study describes the impact of modifications to a general admission order set on physician prescribing of 2 as-needed or pro re nata (PRN) bedtime sedatives.

METHODS:

The hospitalists at our institution have used a general medical admission order set since 2005. Zolpidem was the only as-needed (PRN) bedtime sedative option on the order set until trazodone was added in December 2008. Trazodone is preferred over zolpidem in the geriatric population. We identified patients admitted by the hospitalists between January 2007 and August 2013 who were prescribed with either zolpidem or trazodone as a PRN sedative. Patient demographics, date …

Standardized Competencies For Parenteral Nutrition Prescribing: The American Society For Parenteral And Enteral Nutrition Model, Peggi Guenter, Joseph I. Boullata, Phil Ayers, Jane Gervasio, Ainsley Malone, Erica Raymond, Beverly Holcombe, Michael Kraft, Gordon Sacks, David Seres, Parenteral Nutrition Safety Task Force, American Society For Parenteral And Enteral Nutrition (A.S.P.E.N.)

Scholarship and Professional Work – COPHS

Parenteral nutrition (PN) provision is complex, as it is a high-alert medication and prone to a variety of potential errors. With changes in clinical practice models and recent federal rulings, the number of PN prescribers may be increasing. Safe prescribing of this therapy requires that competency for prescribers from all disciplines be demonstrated using a standardized process. A standardized model for PN prescribing competency is proposed based on a competency framework, the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.)–published interdisciplinary core competencies, safe practice recommendations, and clinical guidelines. This framework will guide institutions and agencies in developing and maintaining …

Applying The Pharmacists’ Patient Care Process To Immunization Services: A Resource Guide For Pharmacists, Albert Bach, Jeff Goad, Mitchel Rothholz, Brian Wall, Anne Burns, Liza Chapman, Jean-Venable “Kelly” R. Goode, Sheila Seed, Rebecca Snead

Pharmacy Faculty Articles and Research

"This guidance document has been written and formatted to align comprehensive components of a pharmacy-based immunization patient encounter Collect Assess Plan Implement Follow-Up 6 American Pharmacists Association and recommendations from the National Vaccine Advisory Committee (NVAC) the Standards for Adult Immunization Practice with the original framework of the PPCP.5 The colored columns to the right throughout this document are the PPCP steps as they have been published by JCPP, and the main document text describes how to integrate each PPCP step into immunization services."

Compliance To The Consort Statement On Participant Flow Diagrams In Infectious Disease Randomized Clinical Trials, Onyeka P. Godwin, Brandon Dyson, Paul S. Lee, Soon Park, Euni Lee

Pharmacy Faculty Articles and Research

Background: The Consolidated Standard of Reporting Trials (CONSORT) Guidelines were developed to support adequate reporting of randomized controlled trials (RCTs).

Method: A systematic review was conducted including RCTs of infectious diseases published in the top general medical and infectious disease journals in 2010. The level of compliance to flow diagram and its association with the CONSORT endorsement by the journals were evaluated.

Results: A total of 67 studies were included in the analysis and a half of the studies were HIV/AIDS RCTs. About 78% of the studies included the flow diagram and 66% of the studies described …

Justifying The Implementation Of A Collaborative Drug Therapy Management (Cdtm) Protocol In An Outpatient Psychiatric Clinic: A Retrospective Chart Review, Kevin Michael Bozymski

Undergraduate Honors Thesis Collection

Objective

To identify opportunities where pharmacists could intervene and justify the benefits of outpatient clinical pharmacy services through a CDTM protocol within Gallahue Mental Health Center by assessing current antipsychotic monitoring

Methods

A retrospective chart review was performed of patients visiting an outpatient psychiatric clinic over 14 months. A review was also completed of patients followed at two primary care clinics within Community Health Network. Patients were at least 18 years old and had at least one active antipsychotic prescription. A standardized data collection sheet was used to document monitoring frequency and appropriateness as recommended by the 2004 American Diabetes …

Identifying Problems During Transitions Of Care And Reasons For Emergency Department Utilization In Community-Dwelling Older Adults, Antoinette B. Coe

Theses and Dissertations

A mixed methods approach was used for this study. The setting was a low-income, subsidized housing apartment building for community-dwelling older and younger disabled adults identified as a health care hot spot due to high rates of ambulance use. The study purpose was to identify reasons for ED use and problems during transition from ED to home, predictors of zip code 23220 (health care hot spot) in emergent and non-emergent ED visits, and predictors of total ED costs in community-dwelling older adults living in a health care hot spot. Semi-structured interviews with residents who used the ED, an existing database …

Development And Validation Of A Discrete Event Simulation Model To Evaluate The Long Term Use Of Electronic Cigarettes In Us Population, Kunal Saxena

Theses and Dissertations

Introduction: Cigarette smoking is associated with lung cancer, cardiovascular disease, and chronic respiratory conditions. It is responsible for high mortality and morbidity risk in the US population. Smokers find sudden quitting difficult and it is reported that a large number of unassisted quitting attempts are eventually unsuccessful. Electronic cigarette or e-cig is a novel battery-driven, nicotine delivery product, currently being used as a smoking cessation tool by current and former smokers. Since its resemblance to a conventional cigarette, and its non-combustible nature, e-cig use has risen exponentially in the last few years. To address such public health issues, the US …

Descriptive Study Of Prescriptions For Opioids From A Suburban Academic Emergency Department Before New York's I-Stop Act., Lyncean Ung, Ronald Dvorkin, Steven Sattler, David P. Yens

The School of Health Sciences Publications and Research

Introduction: Controlled prescription opioid use is perceived as a national problem attributed to all specialties. Our objective was to provide a descriptive analysis of prescriptions written for controlled opioids from a database of emergency department (ED) visits prior to the enactment of the I-STOP law, which requires New York prescribers to consult the Prescription Monitoring Program (PMP) prior to prescribing Schedule II, III, and IV controlled substances for prescriptions of greater than five days duration.

Methods: We conducted a retrospective medical record review of patients 21 years of age and older, who presented to the ED between July …

Scientific And Regulatory Policy Committee (Srpc) Review*: Interpretation And Use Of Cell Proliferation Data In Cancer Risk Assessment, Charles E. Wood, Renee R. Hukkanen, Radhakrisha Sura, David Jacobson-Kram, Thomas Nolte, Marielle Odin, Samuel M. Cohen

United States Food and Drug Administration: Publications

Increased cell proliferation is a central key event in the mode of action for many non-genotoxic carcinogens, and quantitative cell proliferation data play an important role in the cancer risk assessment of many pharmaceutical and environmental compounds. Currently, there is limited unified information on assay standards, reference values, targeted applications, study design issues, and quality control considerations for proliferation data. Here, we review issues in measuring cell proliferation indices, considerations for targeted studies, and applications within current risk assessment frameworks. As the regulatory environment moves toward more prospective evaluations based on quantitative pathway-based models, standardiza- tion of proliferation assays will …

Medication Misadventures: The Case Of Benzodiazepines, Sarah E. Wixson

Theses and Dissertations--Pharmacy

For patients afflicted with symptoms of anxiety and insomnia, benzodiazepines are generally a safe and effective short-term pharmacological treatment option. Although considered safer than other sedative-hypnotic medications, substantial concern exists regarding the addictive nature and abuse potential of benzodiazepines along with potentially inappropriate prescribing and utilization in clinically vulnerable populations. These medication misadventures can have a significant impact on public health. Examples of medication misadventures as they pertain to benzodiazepines include the prescribing and use in clinically vulnerable populations for whom they are contraindicated or their efficacy has not been evaluated, the development of tolerance or addiction, abuse of the …

Security Of Eprescription: Security Of Data At Rest In Prescription Exchange Services Vs On Mobile Devices, Kyaw Kyaw Htat, Patricia A. H. Williams, Vincent Mccauley

Australian eHealth Informatics and Security Conference

One area of healthcare that has moved more quickly than others in adopting electronic transfer of information is prescribing in the primary care environment. Several Acts and Regulations have been repealed and amended at Commonwealth and State levels to enable this progress over the past decade, as medication provision is a strictly controlled area of healthcare. Further, numerous standards and specifications have been developed and adopted to support and safeguard the regulatory changes and facilitate the electronic transfer of prescriptions. However, the current model of electronic prescription transfer comes with a substantial price tag for ongoing use. With the Nation’s …

Inserting Pharmacists In Primary Care Roles In An Ambulatory Care Setting, Keith Yoshizuka, Katherine K. Knapp, Patricia A. Shane, Debbie H. Lu

Faculty Publications & Research of the TUC College of Pharmacy

In this report, we suggest how pharmacy personnel may be used to alleviate some of the pressures currently impacting health system administrators. We look back to the role(s) of the hospital pharmacy and the hospital pharmacist historically and outline changes that have occurred and how these changes may be helpful to address several problem areas in the ambulatory care venue.

Impact Of Pharmacist-Driven Transition Of Care Program In A Community Hospital, Felicia Seiler, Ana Lopez-Samblas, Maria Rojo-Carlo, Abby Marrero, Aixa Rey

All Publications

No abstract provided.

Impact Of Pharmacy Patient Education Programs On Medication Related Hcahps Scores, Ana Lopez-Samblas, Maria Rojo-Carlo, Aixa Rey, Maria Perez Arias

All Publications

No abstract provided.

Survey Of California Pharmacists' Awareness Of And Readiness For The New Authorities Granted By Sb 493: A Pilot Study, Clipper Young, Kajua B. Lor, Gordon C. Mccarter, Robert J. Ignoffo

Faculty Publications & Research of the TUC College of Pharmacy

The recent passing of Senate Bill (SB) 493 – effective on January 1, 2014 – addresses a primary care provider shortage in California by declaring pharmacists as health care providers and authorizing new roles for them in patient care. The aims of this pilot study were to examine California registered pharmacists’ awareness and knowledge of the expanded authorities granted by SB 493 as well as to assess their perception of their own readiness to exercise these new authorities. A cross-sectional, observational study was designed, and a 40-question survey was administered electronically through Qualtrics to adjunct faculty, clinical faculty, and alumni …