Pharmacy Administration, Policy and Regulation Commons^™

The 340b Program, Contract Pharmacies And Hospitals: An Examination Of The First 25 Years Of Their Increasingly Complex Relationship, David P. Paul Iii, Morgan Cathlene Ludado, Morgan Ruley, Hannah Sayre, Alberto Coustasse

Alberto Coustasse, DrPH, MD, MBA, MPH

The 340B Drug Pricing Program, created by Congress in 1992 through the Veterans Health Care Act, has provided discounted drug prices to hospitals and other health care organizations serving a wide population of low-income patients. Some 340B programs use contract pharmacies, an arrangement whereby the hospital or health care organization signs a contract directly with a pharmacy to provide covered pharmacy services at discounted prices.

The federal 340B Drug Pricing Program has provided access to reduced price prescription drugs to over 35,000 individual healthcare facilities and sites certified by the U.S. Department of Health and Human Services (HHS), and clinics …

Limiting Antibiotic Use In Acute Sinusitis: Partly A Matter Of Vocabulary?, Dennis J. Baumgardner

Dennis J. Baumgardner, MD

In his issue introduction, the editor-in-chief of Journal of Patient-Centered Research and Reviews comments on an included article that describes the successful use of an electronic medical record best practice alert to reduce the rate of antibiotic prescription for acute sinusitis. Various methods previously tried to improve antibiotic stewardship in this illness are briefly reviewed. Borrowing on the model of acute bronchitis, it is suggested that a change in conveyed diagnostic vocabulary to “sinus cold” when describing acute sinusitis may help limit antibiotics for this predominantly viral infection.

Fellowships In Community Pharmacy Research: Experiences Of Five Schools And Colleges Of Pharmacy, Margie E. Snyder, Caitlin K. Frail, Stephanie A. Gernant, Jennifer L. Bacci, Kim C. Coley, Lauren M. Colip, Stefanie P. Ferreri, Nicholas E. Hagemeier, Melissa Somma Mcgivney, Jennifer L. Rodis, Megan G. Smith, Randall B. Smith

Nicholas E. Hagemeier

Objective To describe common facilitators, challenges, and lessons learned in 5 schools and colleges of pharmacy in establishing community pharmacy research fellowships. Setting: Five schools and colleges of pharmacy in the United States. Practice description: Schools and colleges of pharmacy with existing community partnerships identified a need and ability to develop opportunities for pharmacists to engage in advanced research training. Practice innovation: Community pharmacy fellowships, each structured as 2 years long and in combination with graduate coursework, have been established at the University of Pittsburgh, Purdue University, East Tennessee State University, University of North Carolina at Chapel Hill, and The …

A Cross-Sectional Analysis Of Pharmaceutical Industry-Funded Events For Health Professionals In Australia, Alice Fabbri, Quinn Grundy, Barbara Mintzes, Swestika Swandari, Ray Moynihan, Emily Walkom, Lisa A Bero

Ray Moynihan

OBJECTIVES:

To analyse patterns and characteristics of pharmaceutical industry sponsorship of events for Australian health professionals and to understand the implications of recent changes in transparency provisions that no longer require reporting of payments for food and beverages.

DESIGN:

Cross-sectional analysis.

PARTICIPANTS AND SETTING:

301 publicly available company transparency reports downloaded from the website of Medicines Australia, the pharmaceutical industry trade association, covering the period from October 2011 to September 2015.

RESULTS:

Forty-two companies sponsored 116 845 events for health professionals, on average 608 per week with 30 attendees per event. Events typically included a broad range of health professionals: …

An Interdisciplinary Process Change: Conversion Of Picc Line Capping Solution From Heparin To Normal Saline, Angela Colella, Brandon Bodager, Frank Spexarth, Natalie Mcdonough, Deb Kastenholz, Paul Grebe

Aurora Radiology Residents

Background: Heparin-induced thrombocytopenia (HIT) and HIT with thrombosis syndrome (HITTS) are serious conditions. Patients are at increased risk for developing HIT/HITTS with any exposure to heparin, even intravenous line flushes. Patients may be exposed to heparin multiple times each day when they have a peripherally inserted central catheter (PICC) that is flushed and capped with heparin. At Aurora Health Care, heparin is the standard capping solution for PICCs, but with a recent switch to positive pressurized caps, normal saline may be a capping option that reduces patient exposure to heparin. Purpose: To reduce heparin exposure at a single hospital by …

Prevalence Of Prescription Opioid Abuse In Patients With Pain, Samuel Godana, Ankoor Biswas, Nebiyu Biru, Abraham Getenet, Biana Leybishkis

Aurora Internal Medicine Residents

Background: Studies showed that 20% to 30% of opioid analgesic drugs prescribed for chronic pain in the United States are misused, while the rate of opioid addiction is approximately 10%. The study describes methods to identify high-risk behavior and forward recommendations to decrease opioid abuse. Purpose: To assess prevalence and correlate multiple variables with opioid abuse and to forward appropriate recommendation to decrease the prevalence of opioid abuse in the primary care setting. Methods: A prospective study was conducted at a primary health care clinic, Aurora Sinai Medical Center (Milwaukee, WI). Over 6 months, a total of 49 consecutive patients …

An Interdisciplinary Process Change: Conversion Of Picc Line Capping Solution From Heparin To Normal Saline, Angela Colella, Brandon Bodager, Frank Spexarth, Natalie Mcdonough, Deb Kastenholz, Paul Grebe

Aurora Radiology Faculty

Background: Heparin-induced thrombocytopenia (HIT) and HIT with thrombosis syndrome (HITTS) are serious conditions. Patients are at increased risk for developing HIT/HITTS with any exposure to heparin, even intravenous line flushes. Patients may be exposed to heparin multiple times each day when they have a peripherally inserted central catheter (PICC) that is flushed and capped with heparin. At Aurora Health Care, heparin is the standard capping solution for PICCs, but with a recent switch to positive pressurized caps, normal saline may be a capping option that reduces patient exposure to heparin. Purpose: To reduce heparin exposure at a single hospital by …

Reliability And Credibility Of Progress Test Criteria, Developed By Alumni, Faculty, And Mixed Alumni-Faculty Judge Panels, H. Glenn Anderson Pharmd, Arthur A. Nelson Phd

H. Glenn Anderson

Objective. To compare the reliability and credibility of Angoff-based, absolute criteria derived by faculty, alumni, and a combination of alumni and faculty judge panels. Methods. Independently, faculty, alumni, and mixed faculty-alumni judge panels developed pass/fail criteria for an 86-item test. Generalizability and decision studies were performed. Root mean square errors (RMSE) and 95% confidence intervals were calculated for reliability and credibility assessment. School graduate performance upon the North American Licensure Examination (NAPLEX) was the comparator for credibility assessment. Results. RMSEs were 1.06%, 1.42%, and 2.32% for the alumni, faculty, and mixed judge panels respectively. The school's NAPLEX pass rate was …

The Impact Of A Community Pharmacist Conducted Comprehensive Medication Review (Cmr) On 30-Day Re-Admission Rates And Increased Patient Satisfaction Scores: A Pilot Study, Brittany Snodgrass, Charles K. Babcock, Anne Teichman

Charles Babcock

Objective: To determine the impact of pharmacist conducted Comprehensive Medication Review (CMR) follow-up within seven days after discharge on (1) readmission rates, (2) detection of drug related problems, (3) and changes in Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores.

Design: Rates of re-admission for pneumonia, congestive heart failure (CHF), or myocardial infarction (MI), within 30 days of discharge are compared between patients receiving a CMR from the pharmacist to a historical control group not receiving the service. The CMR documentation is reviewed to classify any detected drug related problems. Overall HCAHPS scores for the hospital are compared …

An Interdisciplinary Process Change: Conversion Of Picc Line Capping Solution From Heparin To Normal Saline, Angela Colella, Brandon Bodager, Frank Spexarth, Natalie Mcdonough, Deb Kastenholz, Paul Grebe

Angela Colella, PharmD, BCPS

Background: Heparin-induced thrombocytopenia (HIT) and HIT with thrombosis syndrome (HITTS) are serious conditions. Patients are at increased risk for developing HIT/HITTS with any exposure to heparin, even intravenous line flushes. Patients may be exposed to heparin multiple times each day when they have a peripherally inserted central catheter (PICC) that is flushed and capped with heparin. At Aurora Health Care, heparin is the standard capping solution for PICCs, but with a recent switch to positive pressurized caps, normal saline may be a capping option that reduces patient exposure to heparin. Purpose: To reduce heparin exposure at a single hospital by …

Evaluation Of Pharmacy-Implemented Medication Reconciliation Directed At Antiretroviral Therapy In Hospitalized Hiv/Aids Patients [Letter], Megan A. Corrigan, Kendra Atkinson, Beverly E. Sha, Christopher W. Crank

Kendra Damer

Short communications published in Annals of Pharmacotherapy, 44(1).

Correlation Of Adherence To The 2012 Infectious Diseases Society Of America Practice Guidelines With Patient Outcomes In The Treatment Of Diabetic Foot Infections In An Outpatient Parenteral Antimicrobial Programme, L. M. Pence, C. M. Mock, M. B. Kays, Kendra M. Damer, E. W. Muloma, S. M. Erdman

Kendra Damer

Aim To evaluate adherence to the 2012 Infectious Diseases Society of America practice guidelines for the management of patients with diabetic foot infections and to determine an association between adherence and clinical outcome. Methods A retrospective chart review was performed to evaluate the management and clinical outcomes of patients with diabetic foot infections treated with outpatient parenteral antimicrobial therapy between 1 January 2011 and 30 June 2012 at Wishard Health Services/Eskenazi Health. Adherence to individual Infectious Diseases Society of America diabetic foot infection treatment guideline recommendations was measured, and then assessed in relation to clinical outcome. Results A total of …

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

David Reeves

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

A.S.P.E.N. Parenteral Nutrition Safety Consensus Recommendations: Translation Into Practice, Phil Ayers, Stephen Adams, Joseph Boullata, Jane Gervasio, Beverly Holcomb, Michael D. Kraft, Neil Marshall, Antoinette Neal, Gordon Sacks, David S. Seres, Patricia Worthington, Peggi Guenter

Jane M. Gervasio

Parenteral nutrition (PN) serves as an important therapeutic modality that is used in adults, children, and infants for a variety of indications. The appropriate use of this complex therapy aims to maximize clinical benefit while minimizing the potential risk for adverse events. Despite being classified and acknowledged as a high-alert medication,1 only 58% of organizations have precautions in place to prevent errors and patient harm associated with PN.2 Complications can occur as a result of the therapy and as the result of the PN process. The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Parenteral Nutrition Safety Consensus Recommendations are …

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

Jane M. Gervasio

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 …

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

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 when evaluating …

Implementation Of A Pharmacy-Based Adult Vaccine Benefit: Recommendations For A Commercial Health Plan Benefit, Jeffery A. Goad, Kelly J. Ko, Rolin L. Wade, Hsing-Ting Yu, Ross M. Miller, Bruce Sherman

Jeff Goad

BACKGROUND: Although vaccination rates in children exceed 90% in the United States, adults are vaccinated at far lower rates. In order to address this issue, additional community immunizers are needed, and pharmacists are in an ideal position to fill this void. OBJECTIVES: To explore issues and barriers related to implementation of a pharmacy-based adult vaccine benefit and develop recommendations supporting a pathway for benefit expansion. METHODS: A literature review on the current environment surrounding pharmacy-based adult vaccinations and structured interviews were conducted to inform an expert panel meeting using a modified Delphi process (pre/post survey). The goal was to develop …

Medication Therapy Management, Challenges: The Pharmacist’S Emerging Role, Parth D. Shah, Jeffery A. Goad, Edith Mirzaian, Melissa Durham

Jeff Goad

"The pharmacist's role on the healthcare team has received much attention lately as the new Affordable Care Act (ACA) healthcare legislation creates opportunities for pharmacists. lnterprofessional collaboration will transform the way pharmacists deliver health services to patients with respect to their medications. In the community, pharmacist-provided services have been moving away from the traditional role of dispensing to cognitive services that maximize the patient's safe and effective use of medications. The current movement in medical care within the United States is to adopt a model that is patient-centric. The Patient-Centered Primary Care Collaborative (PCPCC) recognizes that "patient-centric" systems are evolving, …

Reimbursement For Pharmaceutical Care Services: The California Experience, Jeffery A. Goad, Kathleen Johnson, Michael Rudolph

Jeff Goad

"While it is true that pharmacists are changing their practice habits, they are doing so for the betterment of their patients’ drug therapy outcomes and the healthcare system. The pharmacist serves as the vital link between the patient, physician, and healthcare system. By working with patients and physicians, pharmacists have demonstrated in the literature that they can improve patient drug therapy outcomes, thus preventing unnecessary healthcare expenditures (Fincham, 1998). Pharmacists have long been held in highest esteem by patients, being voted the number one trusted professional for 10 consecutive years. The evidence is clear that pharmacists provide a valuable service …

White Paper: Certification, Credentials, And Credentialing In Pharmacy, Donald Kishi, Jeffery A. Goad, Nancy Korman, Teresa Miller, Mary Ferrill, Holly Strom

Jeff Goad

The rapid evolution of the health care system has provided the pharmacy profession with opportunities to expand existing and develop new direct patient care roles. Two critical challenges that the pharmacy profession must contend with to ensure the continued expansion and acceptance of pharmacists in advanced practice roles (e.g. direct patient care roles) are: (1) To develop and implement a credible, systematic, standards-based, and profession-wide plan that includes a system for identifying the types of pharmacists' practices requiring credentials, a validated certification process, and a computerized credentialing process that is current, comprehensive, and easily accessible; (2) To establish the credibility …

System-Wide Implementation Of The Use Of An Extended-Infusion Piperacillin/Tazobactam Dosing Strategy: Feasibility Of Utilization From A Children's Hospital Perspective, Kristen R. Nichols, Chad A. Knoderer, Elaine G. Cox

Kristen R. Nichols

Background Use of extended infusions of piperacillin/tazobactam (PT) in adult patients has been described, but data in children are limited. Objective The goal of this study was to determine the feasibility of using an extended-infusion PT dosing strategy as the standard of care in a children's hospital. Methods This was a prospective observational study of patients aged >30 days who received PT after admission to a freestanding, tertiary care children's hospital. After institution of an extended-infusion PT dosing protocol as the standard dosing option, patients receiving PT were prospectively assessed for presence of and reasons for changes in dosing regimen. …

A Retrospective Comparison Of Daptomycin Thrice-Weekly Versus Q48h Dosing In Hemodialysis Patients With Vancomycin-Resistant Enterococcus (Vre) Or Methicillin-Resistant Staphylococcus Aureus (Mrsa) Bacteremia, Katie L. Axford, Dane L. Shiltz

Dane L. Shiltz

Background. Multi-drug resistant bacteria are a growing concern in healthcare. Daptomycin is being used with increasing frequency in the treatment of vancomycin-resistant enterococci (VRE) and methicillin-resistant Staphylococcus aureus (MRSA) bacteremias in hemodialysis (HD) patients. Thrice-weekly dosing of daptomycin in this population would allow for coordination of dosing with common outpatient HD schedules. The aim of this study is to determine if thrice-weekly dosing of daptomycin is equivalent to dosing every 48 hours in patients receiving chronic intermittent hemodialysis. Equivalence will be assessed with regard to microbiological cure, clinical cure, hospital length of stay, and mortality. Methods. All patients with positive …

System-Wide Implementation Of The Use Of An Extended-Infusion Piperacillin/Tazobactam Dosing Strategy: Feasibility Of Utilization From A Children's Hospital Perspective, Kristen Nichols, Chad Knoderer, Elaine Cox

Chad A. Knoderer

Background

Use of extended infusions of piperacillin/tazobactam (PT) in adult patients has been described, but data in children are limited.

Objective

The goal of this study was to determine the feasibility of using an extended-infusion PT dosing strategy as the standard of care in a children's hospital.

Methods

This was a prospective observational study of patients aged >30 days who received PT after admission to a freestanding, tertiary care children's hospital. After institution of an extended-infusion PT dosing protocol as the standard dosing option, patients receiving PT were prospectively assessed for presence of and reasons for changes in dosing regimen. …

Medication Utilization Evaluation Of Dabigatran And Rivaroxaban Within A Large, Multicenter Health System., Sarah A. Nisly, Alex N. Issacs, Meagan Doolin, Courtney Morse, Erin Shiltz

Sarah A. Nisly

Objective. The objective of this medication utilization evaluation (MUE) was to determine the appropriateness of dabigatran and rivaroxaban while also reviewing outcomes for safety and effectiveness within a large, multi-center health system. Methods. A retrospective chart review was performed using the system’s electronic medical record. A data inquiry was requested and generated for dabigatran usage from July 28, 2011 through July 28, 2012 and for rivaroxaban from March 1, 2012 to July 31, 2012 at eight health system hospitals. All patients receiving at least one dose were eligible for inclusion in the MUE. Results. For dabigatran, 78 of 390 unique …

An Evaluation Of Pharmacogenomic Information Provided By Five Common Drug Information Resources, K.T.L. Vaughan, Kelly L. Scolaro, Heidi N. Anksorus, Mary W. Roederer

K.T. L. Vaughan

Active Presecription Drug Safety Surveillance: Exploring Omop 2011-2012 Experiments, Susan Gruber, James M. Robins

Susan Gruber

The Observational Medical Outcomes Partnership (OMOP), a consortium of pharmaceutical, FDA, and academic researchers focuses on developing and evaluating electronic records-based methods for enhancing post-market drug safety surveillance. The OMOP 2011-2012 experiment consists of applying variants of seven analysis methods to five different EMR or claims databases to estimate the increase (decrease) in risk associated with drug-outcome pairs whose causal association has been previously established, and serves as a gold standard for comparison. Variants of each method can produce very different effect estimates, sometimes at odds with the gold standard. We explore the reasons behind this heterogeneity, and in doing …

A System Dynamics Model Of Pharmaceutical Opioids: Medical Use, Diversion, And Nonmedical Use, Teresa D. Schmidt, Wayne W. Wakeland, J. David Haddox

Wayne W. Wakeland

Abstract: A dramatic rise in the nonmedical of pharmaceutical opioids has presented the United States with a substantial public health problem. Nonmedical use of prescription pain relievers has become increasingly prevalent in the US over the last two decades, and diversion of medicines obtained by prescription is assumed to be a major source of supply for nonmedical opioid use. Policymakers striving to protect population health by ameliorating the adverse outcomes of nonmedical use of opioid analgesics could benefit from a systems-level model which reflects the complexity of the system and incorporates the full range of available data. To address this …

21st Century Healthcare - A New Scenario Needs New Rules Of The Game, Mian Atif Saeed

Mian Atif Saeed

We are witnessing a changing paradigm of healthcare sector in view increasing pressure on governments to provide free healthcare to citizens and increasing cost-consciousness of governments/payers to address this public issue. This changing paradigm in healthcare requirements requires a holistic review of the legislative framework in which industry operates. All stakeholders and all applicable regulatory and legal frameworks need to be appraised in order to address the requirements of 21st century healthcare. Drug development is very risky, costly and lengthy process and inventors and investor deserve financial gains for their efforts. Pharmaceutical industry requires the money to keep investing back …