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Pharmacy Administration, Policy and Regulation Commons

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Patient Perceptions Of Drug Risks And Benefits, Michael S. Brown, Linda J. Wastila, Carol I. Baras, Louis Lasagna 2016 University of New Hampshire

Patient Perceptions Of Drug Risks And Benefits, Michael S. Brown, Linda J. Wastila, Carol I. Baras, Louis Lasagna

RISK: Health, Safety & Environment

This is a report of a pilot study conducted to examine patients' perceptions of drug risks and benefits. While all of the factors influencing such perceptions are important, the findings about the extent to which views are affected by patient understanding of and confidence in regulatory oversight should be of professional interest to an especially broad audience.


A Synthesis Of Current Surveillance Planning Methods For The Sequential Monitoring Of Drug And Vaccine Adverse Effects Using Electronic Health Care Data, Jennifer C. Nelson, Robert Wellman, Onchee Yu, Andrea J. Cook, Judith C. Maro, Rita Ouellet-Hellstrom, Denise Boudreau, James S. Floyd, Susan R. Heckbert, Simone Pinheiro, Marsha Reichman, Azadeh Shoaibi 2016 Group Health Research Institute; University of Washington

A Synthesis Of Current Surveillance Planning Methods For The Sequential Monitoring Of Drug And Vaccine Adverse Effects Using Electronic Health Care Data, Jennifer C. Nelson, Robert Wellman, Onchee Yu, Andrea J. Cook, Judith C. Maro, Rita Ouellet-Hellstrom, Denise Boudreau, James S. Floyd, Susan R. Heckbert, Simone Pinheiro, Marsha Reichman, Azadeh Shoaibi

eGEMs (Generating Evidence & Methods to improve patient outcomes)

Introduction: The large-scale assembly of electronic health care data combined with the use of sequential monitoring has made proactive postmarket drug- and vaccine-safety surveillance possible. Although sequential designs have been used extensively in randomized trials, less attention has been given to methods for applying them in observational electronic health care database settings.

Existing Methods: We review current sequential-surveillance planning methods from randomized trials, and the Vaccine Safety Datalink (VSD) and Mini-Sentinel Pilot projects—two national observational electronic health care database safety monitoring programs.

Future Surveillance Planning: Based on this examination, we suggest three steps for future surveillance planning in health ...


Venous Thromboembolism Prophylaxis Compliance Before And After Electronic Health Record Implementation, Lindsay Saum, David Reeves 2016 Butler University

Venous Thromboembolism Prophylaxis Compliance Before And After Electronic Health Record Implementation, Lindsay Saum, David Reeves

David Reeves

Background: Adherence to American College of Chest Physicians (CHEST) and National Comprehensive Cancer Network (NCCN) guidelines for venous thromboembolism (VTE) prophylaxis helps avoid thromboembolic complications during hospitalization. Electronic health records (EHR) have the potential to make an impact on guideline adherence, but data are lacking.

Objectives: To determine compliance with VTE prophylaxis guidelines in internal medicine and oncology populations and to determine whether EHR implementation had any effect on the rate and appropriateness of prophylaxis practices.

Methods: A retrospective chart review was conducted on medical and oncology patients admitted to the hospital for a 2-month period pre-EHR and post-EHR implementation ...


Assessing The Accuracy And Quality Of Medication History Collection: Effect Of Implementation Of Electronic Health Record, Kena Lanham, Lindsay Saum, David J. Reeves, Colleen Scherer, Beth Johnson, Anthony Antonopoulos, Suellyn Sorenson 2016 Butler University

Assessing The Accuracy And Quality Of Medication History Collection: Effect Of Implementation Of Electronic Health Record, Kena Lanham, Lindsay Saum, David J. Reeves, Colleen Scherer, Beth Johnson, Anthony Antonopoulos, Suellyn Sorenson

David Reeves

Abstract from 2013 ACCP Annual Meeting, Alburquerque, New Mexico.


Evaluation Of The Effectiveness Of A Prescription Drug Abuse Prevention Curriculum For College Students, Danielle M. Colangelo, Alexis K. Sepulveda 2016 California Polytechnic State University, San Luis Obispo

Evaluation Of The Effectiveness Of A Prescription Drug Abuse Prevention Curriculum For College Students, Danielle M. Colangelo, Alexis K. Sepulveda

Kinesiology

The recreational use of prescription drugs has been increasingly common in university communities (Office of National Drug Control Policy, 2015). Students may abuse prescription drugs to get high, study longer or sleep. A survey conducted by Kinesiology students used snowball sampling to assess the number of Cal Poly students recreationally using prescription drugs and their knowledge of prescription drug abuse (Colangelo & Sepulveda, 2015). The assessment showed 30.7% of students had abused prescription drugs in the last six months. There was an increase in abuse between college freshmen (19.2%), college sophomores (41.4%) and juniors (44.3%) (Colangelo & Sepulveda ...


Text Mining From Drug Surveillance Report Narratives, Susmitha Wunnava, Tabassum Kakar, Xiao Qi, Elke A. Rudensteiner 2016 Worcester Polytechnic Institute

Text Mining From Drug Surveillance Report Narratives, Susmitha Wunnava, Tabassum Kakar, Xiao Qi, Elke A. Rudensteiner

UMass Center for Clinical and Translational Science Research Retreat

Analysis of postmarket drug surveillance reports is imperative to ensure drug safety and effectiveness. FAERS (FDA Adverse Event Reporting System) is a surveillance system that monitors Adverse Events (AEs) from drugs and biologic products. The AEs are reported through MedWatch voluntary reports (initiated from patients and healthcare providers) and mandatory reports (initiated from manufacturers). Much of the information in the voluntary AE reports is narratives or unstructured text. The increasing volume of individual reports, estimated at more than one million per year, poses a challenge for the staff to review large volume of narratives for drug clinical review. We are ...


Improving Collaboration Between Pharmacists And Physicians, Paras Patel 2016 Butler University

Improving Collaboration Between Pharmacists And Physicians, Paras Patel

BU Well

Physicians and pharmacists have differing but complementary roles that can optimize patient care when structured effectively. Unfortunately, these two professionals are not collaborating well enough, as patient outcomes, especially in relation to medication adherence, continue to decline. Coordinated care of patients can improve by expanding bidirectional communication and sharing additional patient information with each other. It will be necessary to continue to promote collaborative care in the educational and training stages of these professionals’ careers to build trust and understanding of professional scope. Ultimately, the healthcare infrastructure will have to continue to progress to make collaboration more available and valuable ...


Crizotinib And Ceritinib Induce Apoptosis And Necrosis In Primary Rat Hepatocytes With Distinct Capacity, Alec T. Salminen 2016 University of Arkansas, Fayetteville

Crizotinib And Ceritinib Induce Apoptosis And Necrosis In Primary Rat Hepatocytes With Distinct Capacity, Alec T. Salminen

Biomedical Engineering Undergraduate Honors Theses

Drug development makes up a major portion of biomedical engineering research interests. The FDA oversees the introduction, experimentation, and implementation of all drugs before market approval is granted. Even after market approval is granted, the FDA continues to monitor the safety of all drugs. Crizotinib and ceritinib are two anaplastic lymphoma kinase (ALK) inhibitors recently approved by the FDA. Both drugs are indicated for treatment of non-small cell lung cancers (NSCLC) with abnormal ALK gene, and they are approved with a companion diagnostic test that determines ALK abnormality. Clinical trial data suggest that crizotinib and ceritinib can cause liver injury ...


Assessing The Accuracy And Quality Of Medication History Collection: Effect Of Implementation Of Electronic Health Record [Abstract], Kena Lanham, Lindsay Saum, David Reeves, Colleen Scherer, Beth Johnston, Anthony Antonopoulos, Suellyn Sorenson 2016 Butler University

Assessing The Accuracy And Quality Of Medication History Collection: Effect Of Implementation Of Electronic Health Record [Abstract], Kena Lanham, Lindsay Saum, David Reeves, Colleen Scherer, Beth Johnston, Anthony Antonopoulos, Suellyn Sorenson

Lindsay Saum

Abstract from 2013 ACCP Annual Meeting:

PURPOSE: We hypothesized that pharmacy staff auditing of previously recorded admission medication histories will identify significant and potential medication errors, and that implementation of an electronic medical record [EMR] will not improve the quantity of discrepancies or the quality of admission medication histories, despite showing Joint Commission and Heart Failure Core Measure compliance.

METHODS: At our institution, medication reconciliation is completed at the time of admission through collaboration with prescribers and nursing staff. A pharmacy medication reconciliation team is utilized on the cardiac step down unit and employs pharmacy technicians to obtain an accurate ...


Venous Thromboembolism Prophylaxis Compliance Before And After Electronic Health Record Implementation, Lindsay Saum, David Reeves 2016 Butler University

Venous Thromboembolism Prophylaxis Compliance Before And After Electronic Health Record Implementation, Lindsay Saum, David Reeves

Scholarship and Professional Work – COPHS

Background: Adherence to American College of Chest Physicians (CHEST) and National Comprehensive Cancer Network (NCCN) guidelines for venous thromboembolism (VTE) prophylaxis helps avoid thromboembolic complications during hospitalization. Electronic health records (EHR) have the potential to make an impact on guideline adherence, but data are lacking.

Objectives: To determine compliance with VTE prophylaxis guidelines in internal medicine and oncology populations and to determine whether EHR implementation had any effect on the rate and appropriateness of prophylaxis practices.

Methods: A retrospective chart review was conducted on medical and oncology patients admitted to the hospital for a 2-month period pre-EHR and post-EHR implementation ...


Harmful Or Helpful? Direct To Consumer Advertising, Sally A. Kiss 2016 Bridgewater State University

Harmful Or Helpful? Direct To Consumer Advertising, Sally A. Kiss

The Graduate Review

Policy change in 1997 by the Food and Drug Administration made the United States only one of two countries to allow direct-to-consumer advertising (DTCA). DTCA refers to the promotion of prescription medications through media directly to consumers as opposed to distribution of information only medical professionals. Supporters argue that DTCA educates consumers and helps them to make more informed decisions about their health care. On the other side, opponents argue that it leads to otherwise healthy people believing they are sick, thereby increasing profits for pharmaceutical companies. After reviewing the history of DTCA and literature demonstrating the pros and cons ...


Social Problems, Biomedical Answers? How Causes Of Social Problems Affect Choice Of Solutions, Bianca C. Dreyer 2016 Wilfrid Laurier University

Social Problems, Biomedical Answers? How Causes Of Social Problems Affect Choice Of Solutions, Bianca C. Dreyer

Theses and Dissertations (Comprehensive)

With rapid advances in behavioural genetics, scientists are identifying an increasing array of genetic influences on human behaviour. Public misconceptions about the function of genes often lead to the oversimplification of the role of genes in behaviour (Dar-Nimrod & Heine, 2011). To date, no study has systematically investigated whether simply learning about genetic causes of behaviour affects people’s preferred solutions to problematic behaviours. The present research program includes three studies that were designed to examine the psychological effects of exposure to genetic etiology for problematic behaviour, in particular aggression, and investigated how this information influences endorsement of solutions, rating of ...


Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia Zettler 2015 Georgia State University College of Law

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

Patricia J. Zettler

No abstract provided.


Antibiotic Resistance And The White House Forum On Antibiotic Stewardship, Mary Lou Manning PhD, CRNP, CIC, FAAN 2015 Jefferson College of Nursing

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 2015 Jefferson College of Pharmacy

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 2015 Georgia State University College of Law

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

Faculty Publications By Year

No abstract provided.


The Medicine Shoppe V. Loretta Lynch: Pharmacists’ Corresponding Responsibility With Physicians Under Dea Interpretation Of The “Legitimate Medical Purpose” Standard, Jeffrey Grass 2015 Selected Works

The Medicine Shoppe V. Loretta Lynch: Pharmacists’ Corresponding Responsibility With Physicians Under Dea Interpretation Of The “Legitimate Medical Purpose” Standard, Jeffrey Grass

Jeffrey C. Grass JD, MS, ACLM

The Medicine Shoppe v. Loretta Lynch et al. 14-1223 will assist pharmacists and pharmacy owners in understanding their duties “corresponding responsibility to assure that its prescriptions for controlled substances are issued for a legitimate medical purpose” and “in the practitioner's usual course of professional practice.” In the meantime, pharmacists need to know that they are not immune from administrative, regulatory or criminal prosecution under the CSA solely due to their status. Rather, they are expected to dispense drugs for the bona fide treatment of a patient's disease. Under this regime, he or she must exercise sound professional judgment ...


Medication Affordability Gains Following Medicare Part D Are Eroding Among Elderly With Multiple Chronic Conditions, Huseyin Naci, Stephen Soumerai, Dennis Ross-Degnan, Fang Zhang, Becky Briesacher, Jerry Gurwitz, Jeanne Madden 2015 Harvard Medical School

Medication Affordability Gains Following Medicare Part D Are Eroding Among Elderly With Multiple Chronic Conditions, Huseyin Naci, Stephen Soumerai, Dennis Ross-Degnan, Fang Zhang, Becky Briesacher, Jerry Gurwitz, Jeanne Madden

Jerry H. Gurwitz

Elderly Americans, especially those with multiple chronic conditions, face difficulties paying for prescriptions, which results in worse adherence to and discontinuation of therapy, called cost-related medication nonadherence. Medicare Part D, implemented in January 2006, was supposed to address issues of affordability for prescriptions. We investigated whether the gains in medication affordability attributable to Part D persisted during the six years that followed its implementation. Overall, we found continued incremental improvements in medication affordability in the period 2007-09 that eroded during the period 2009-11. Among elderly beneficiaries with four or more chronic conditions, we observed an increase in the prevalence of ...


Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters 2015 Indiana University Robert H. McKinney School of Law

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 ...


Awareness And Utilization Of The Ohio Automated Rx Reporting System By Physician Assistants, Julia Cathleen Rose 2015 University of New England

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 ...


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