April 2011 digital edition of Pharmacy Practice News by McMahon Group

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The Pharmacist’s News Source Hematology/Oncology Pharmacy Edition

pharmacypracticenews.com

Volume 38 • Number 4 • April 2011

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Not Keeping Patients in this issue At Home Post-discharge Clinical Hem/Onc Pharmacy Looms as Big Cost Factor

ospitals with higher than expected 30-day risk-adjusted readmission rates for certain conditions will be hit with punishing Medicare payment penalties beginning Oct. 1, 2012. The losses could amount to millions of dollars per year for larger hospitals and health systems, according to Steve M. Riddle, BS Pharm, BCPS, FASHP, vice president of clinical affairs for Pharmacy OneSource. “It’s one of the most pressing issues facing hospitals probably in the next three to five years,” he said. Speaking at a Pharmacy OneSource webinar, “Locking the Revolving Door of Readmissions,” Mr. Riddle said CMS reimbursement reductions for hospitals failing to meet readmission targets will start at a cap of 1% of all Medicare Severity Diagnosis Related Group (MS-DRG) payments. The reductions will increase to 2% in fiscal 2014 and reach a plateau of 3% the following year. The focus initially will be on readmissions for

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see READMISSION, page 28

As Pain Rx Databases Gain Transparency, Are Pharmacists at Risk?

s prescription drug monitoring programs (PDMPs) proliferate and become more sophisticated, state legislators and other influential leaders are starting to delve into and address some of the related legal uncertainties. At issue: what precisely is the clinician’s role once details about a patient are retrieved? Can the clinician share that information with another clinician? What if the prescription for a controlled substance, once dispensed, leads the patient to harm him- or herself or someone else? The National Association of Boards of Pharmacy (NABP), which plans to launch a task force on PDMPs by midyear, will explore such legal issues as one of its primary charges, said Carmen Catizone, MS, RPh, DPh, the association’s executive director. It’s important that legal

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see PAIN RX, page 7

Study supports intermittent hormone therapy for prostate cancer.

Lack of standardization part of the problem

CDS Systems Still Can Miss Drug Interactions, Study Says

Critical Care Optimal glucose management in ICU still a challenge.

Operations & Mgmt

Practice Pearl Strategies for Chapter <797> compliance.

Leadership in Action The seven decisions of masterful leaders.

Technology

Automation New data underscore benefits of bar coding, CDS, smart pumps and more.

Opinion One tech expert’s take on ASHP’s new statement on bar coding.

Bar Coding Workarounds still the Achilles’ heel of BCMA.

ASHP Pearls Foster accountability and fix problems early when setting up bar coding programs.

Educational Review

Medication Errors: A Year in Review see insert after page

f you think your clinical decision support (CDS) software will alert you to every significant drug–drug interaction that comes through your system with each new prescription, think again. A new study from researchers at the University of Arizona has found that only 28% of pharmacies’ systems correctly identified eligible drug–drug interactions and noninteractions in a prescription order for a standardized fictitious patient (Am Med Inform Assoc 2011;18:32-37).

The findings suggest “that we have a fundamental problem with respect to the way that interactions are evaluated by drug knowledge databases, [and] how they’re assigned a level of severity within those databases,” said lead investigator Daniel Malone, RPh, PhD, professor of pharmacy at the University of Arizona Colleges of Pharmacy and Public Health, in Tucson. The CDS systems are also flawed, he

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see CDS System FLAWS, page 40

Elderly ICU Patients Often Given Inappropriate Drugs at Discharge San Diego—The prescribing of potentially inappropriate medications (PIMs) and actually inappropriate medications (AIMs) to the elderly is a very common practice and one that significantly increases after a hospital stay for critical illness, researchers said at the annual meeting of the Society of Critical Care Medicine. “We know from other studies that approximately 50% of the elderly are

discharged from the hospital with potentially inappropriate medications, but unfortunately we don’t know where these medications are started and if they are truly inappropriate,” said presenter Alessandro Morandi, MD, of the Center for Health Services Research, Vanderbilt Center for Quality Aging, at Vanderbilt University, in Nashville, Tenn. “We know from the literature that

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see INAPPROPRIATE RX, page 18

The Book Page ASHP’s PharmPrep Interactive Case-Based Board Review: Third Edition Diane B. Ginsburg See page

New Product Topotecan and Gemcitabine now available from APP Pharmaceuticals, Inc. See page

Sandoz now offers Enoxaparin Sodium for Injection.

WARNING: SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • Use of indwelling epidural catheters • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants • A history of traumatic or repeated epidural or spinal punctures • A history of spinal deformity or spinal surgery. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

Please see brief summary of full prescribing information including boxed warning on following page. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. www.us.sandoz.com a Novartis company

Available in 7 strengths in pre-filled syringes. ▲ 30 mg/0.3 mL pre-filled syringe; 40 mg/0.4 mL pre-filled syringe;

60 mg/0.6 mL pre-filled syringe; 80 mg/0.8 mL pre-filled syringe; 100 mg/1.0 mL pre-filled syringe; 120 mg/0.8 mL pre-filled syringe; 150 mg/1.0 mL pre-filled syringe

▲ Sandoz is a member of the Novartis family of companies — a name you can trust for quality and reliability

Choose the full potential of generics.

Enoxaparin Sodium Injection WARNING: SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • Use of indwelling epidural catheters • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants • A history of traumatic or repeated epidural or spinal punctures • A history of spinal deformity or spinal surgery. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis. - - - - - - RECENT MAJOR CHANGES - - - - - Boxed Warning, Warnings and Precautions (12/2009) - - - - - - INDICATIONS AND USAGE - - - - - Enoxaparin sodium injection is a low molecular weight heparin [LMWH] indicated for: • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness • Inpatient treatment of acute DVT with or without pulmonary embolism • Outpatient treatment of acute DVT without pulmonary embolism • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction [MI] • Treatment of acute ST-segment elevation myocardial infarction [STEMI] managed medically or with subsequent percutaneous coronary intervention [PCI] - - - - - - DOSAGE AND ADMINISTRATION - - - - - Indication

Standard Regimen

DVT prophylaxis in abdominal surgery

40 mg SC once daily up to 12 days

DVT prophylaxis in knee replacement surgery

30 mg SC every 12 hours up to 14 days

DVT prophylaxis in hip replacement surgery

30 mg SC every 12 hours or 40 mg SC once daily up to 14 days

DVT prophylaxis in medical patients

40 mg SC once daily up to 14 days

Inpatient treatment of acute DVT with or without pulmonary embolism

1 mg/kg SC every 12 hours or 1.5 mg/kg SC once daily (with warfarin) up to 17 days

Outpatient treatment of acute DVT without pulmonary embolism

1 mg/kg SC every 12 hours (with warfarin) up to 17 days

Unstable angina and non-Q-wave MI

1 mg/kg SC every 12 hours (with aspirin) 2 to 8 days

Acute STEMI in patients <75 years of age [For dosing in subsequent PCI, see Dosage and Administration]

30 mg single IV bolus plus a 1 mg/kg SC dose followed by 1 mg/kg SC every 12 hours at least 8 days (with aspirin)

Acute STEMI in patients ≥75 0.75 mg/kg SC every 12 hours (no years of age bolus) at least 8 days (with aspirin) • Adjust the dose for patients with severe renal impairment

- - - - - - DOSAGE FORMS AND STRENGTHS - - - - - 100 mg/mL concentration: Prefilled syringes: 30 mg/0.3 mL, 40 mg/0.4 mL Graduated prefilled syringes: 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/mL 150 mg/mL concentration: Graduated prefilled syringes: 120 mg/0.8 mL, 150 mg/mL - - - - - - CONTRAINDICATIONS - - - - - Active major bleeding Thrombocytopenia with a positive in vitro test for anti-platelet antibody in the presence of enoxaparin sodium Hypersensitivity to enoxaparin sodium Hypersensitivity to heparin or pork products - - - - - - WARNINGS AND PRECAUTIONS - - - - - Increased risk of hemorrhage: Use with caution in patients at risk Percutaneous coronary revascularization: Obtain hemostasis at the puncture site before sheath removal Concomitant medical conditions: Use with caution in patients with bleeding diathesis, uncontrolled arterial hypertension or history of recent gastrointestinal ulceration, diabetic retinopathy, renal dysfunction, or hemorrhage History of heparin-induced thrombocytopenia: Use with caution Thrombocytopenia: Monitor thrombocytopenia closely Interchangeability with other heparins: Do not exchange with heparin or other LMWHs Pregnant women with mechanical prosthetic heart valves and their fetuses, may be at increased risk and may need more frequent monitoring and dosage adjustment

- - - - - - ADVERSE REACTIONS - - - - - -

Most common adverse reactions (>1%) were bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea and nausea To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. - - - - - - DRUG INTERACTIONS - - - - - Discontinue agents which may enhance hemorrhage risk prior to initiation of enoxaparin sodium injection or conduct close clinical and laboratory monitoring - - - - - - USE IN SPECIFIC POPULATIONS - - - - - Severe renal impairment: Adjust dose for patients with creatinine clearance <30 mL/min Geriatric patients: Monitor for increased risk of bleeding Patients with mechanical heart valves: Not adequately studied Hepatic Impairment: Use with caution Low-weight patients: Observe for signs of bleeding

Manufactured by Baxter Pharmaceutical Solutions LLC for Sandoz Inc., Princeton, NJ 08540 Rev. July 2010

4 Up Front

Pharmacy Practice News • April 2011

Capsules

COPD Drug Approved

surf

APRIL 2011

watch

The five most-viewed articles last month on pharmacypracticenews.com: 1. Patient Transition Between Cancer Care Settings Lacking 2. ASHP Pearls Sessions Offer Pharmacists Wide Array of Practical Tips 3. VTE Prophylaxis Still a Mixed Bag 4. Empowering Students To Become Better Pharmacists 5. Educational Review: Management of Acute Coronary Syndromes Register for free at pharmacypracticenews.com to read these and other articles on the latest developments in hospital pharmacy.

heard here first

‘The fact that people find ways to disconnect

[from your BCMA system via workarounds] is not an argument against bar coding; it’s an argument for

stopping workarounds.’ See article, page 37

—Mark Neuenschwander

To Scan 2-D Bar Codes in PPN: 1. Download the FREE Microsoft Tag Reader application through your smartphone browser. 2. Open the Tag Reader and let it focus on the bar-code image to instantly access related materials and/or Web sites.

he FDA approved Forest Laboratories’ Daliresp for decreasing the frequency of exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis. Daliresp (roflumilast) is a selective phosphodiesterase 4 (PDE4) enzyme inhibitor and is the first in its class to be approved in the United States, according to an FDA press release. The safety and effectiveness of Daliresp was demonstrated in two Phase 3 clinical studies of more than 1,500 patients with severe COPD and chronic bronchitis. Patients given 500 mcg once daily experienced a 15% reduction in moderate or severe exacerbations in one trial and an 18% reduction in the other trial. Common side effects (≥2% incidence) included diarrhea, weight loss, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite, according to the drug’s prescribing information. A variety of mental health problems also have been associated with Daliresp and are noted in the warnings and precautions section of the product’s labeling. Overall, 5.9% of patients in controlled clinical trials treated with the drug reported psychiatric adverse reactions, versus 3.3% treated with placebo. The most common of those reactions were insomnia (2.4% vs. 1.0%), anxiety (1.4% vs. 0.9%) and depression (1.2% vs. 0.9%). Cases of suicide (one completed and two attempted) also have been reported. Labeling for Daliresp urges prescribers to advise patients and caregivers “to be alert for the emergence or worsening” of depression and the other documented psychiatric adverse reactions, and if such changes occur, to contact their health care provider. Using Daliresp in patients with a history of depression and/or suicidal thoughts thus should be done with an eye toward weighing the risks and benefits of the medication, according to the product labeling. That risk/benefit ratio was an issue for an FDA advisory committee that evaluated Daliresp for approval in April 2010. The committee voted 10-5 not to approve the drug, citing its “modest” increase in lung function and its link to potentially serious adverse effects. Asked to comment on why the FDA chose not to follow its own advisory committee’s recommendation, FDA spokeswoman Crystal Rice said that despite the 10-5 vote against approval, committee members expressed “considerable positive opinion regarding [Daliresp’s] safety and efficacy” during their deliberations. Ms. Rice added that the original proposed indication for Daliresp was for maintenance COPD therapy, rather than the more narrow, exacerbation-specific approved use. “This change was significant,” she said, because some committee members indicated that they would be more favorably disposed toward the more restrictive use. As for safety concerns, Ms. Rice stressed that Daliresp is prescribed with a Medication Guide that includes information on adverse effects. She also noted that the agency conducted “a comprehensive analysis” of suicidality data provided by Forest Labs. “Analysis of the suicidality data, the use of a Medication Guide and approval for the more narrowly defined COPD patient population … was felt to justify the potential risks of a new therapy for a disease for which there are no ideal treatments.” —David Bronstein

EDITORIAL BOARD

ART/PRODUCTION STAFF

Administration

Michele McMahon Velle, MAX Graphics/Creative Director

Robert Adamson, PharmD, Livingston, NJ

Frank Tagarello, Senior Art Director/Managing Director, MAX Graphics

Ernest R. Anderson Jr., MS, RPh, Boston, MA

Volume 38 • Number 4 • April 2011 • pharmacypracticenews.com

Anesthesiology/Pain Julie A. Golembiewski, PharmD, Chicago, IL Melvin E. Liter, MS, PharmD, FASHP, Lexington, KY

Internal Medicine

David S. Craig, PharmD, BCPS, Tampa, FL

Geoffrey C. Wall, PharmD, FCCP, BCPS, CGP, Des Moines, IA

Biotechnology

NUCLEAR PHARMACY

Indu Lew, PharmD, Livingston, NJ

Jeffrey Norenberg, PharmD, Albuquerque, NM Oncology

Cardiology C. Michael White, PharmD, Storrs, CT CNS/Psychiatry Charles F. Caley, PharmD, Storrs, CT Lawrence Cohen, PharmD, BCPP, FASHP, FCCP, Spokane, WA Larry Ereshefsky, PharmD, San Antonio, TX Complementary and Alternative Medicine Cathy Rosenbaum, PharmD, Cincinnati, OH Critical Care Judi Jacobi, PharmD, FCCM, Indianapolis, IN

Robert T. Dorr, PhD, RPh, Tucson, AZ Robert Ignoffo, PharmD, San Francisco, CA Philip E. Johnson, MS, RPh, FASHP, Tampa, FL Cindy O’Bryant, PharmD, Aurora, CO Ali McBride, PharmD, MS, BCPS, St. Louis, MO Pediatrics Gretchen Brummel, PharmD, BCPS, Hudson, OH Reimbursement Bonnie E. Kirschenbaum, MS, FASHP, Breckenridge, CO

Sarah Tilyou, Senior Editor smtilyou@mcmahonmed.com Kevin Horty, Don Pizzi, Adam Marcus, Cynthia Gordon, Kate O’Rourke, Contributing Editors James Prudden, Group Editorial Director Robin B. Weisberg, Manager, Editorial Services Elizabeth Zhong, Associate Copy Chief

SALES David Kaplan, Group Publication Director dkaplan@mcmahonmed.com Phil Redgate, Publication Director predgate@mcmahonmed.com

James O’Neill, Senior Systems Manager Dan Radebaugh, Director of Production and Technical Operations

McMAHON PUBLISHING Raymond E. McMahon, Publisher and CEO, Managing Partner Van Velle, President, Partner Matthew McMahon, General Manager, Partner Lauren Smith, Michael McMahon, Michele McMahon Velle, Rosanne C. McMahon, Partners

McMahon Publishing mcmahonmed.com Sales, Production and Editorial Offices: 545 West 45th Street, 8th Floor, New York, NY 10036. Telephone: (212) 957-5300.

Peggy McKinnon, PharmD, Detroit, MI

EDITORIAL STAFF

David P. Nicolau, PharmD, Hartford, CT Robert P. Rapp, PharmD, Lexington, KY

David Bronstein, Editorial Director davidb@mcmahonmed.com

David Nathanson, Account Manager dnathanson@mcmahonmed.com

Copyright © 2011 McMahon Publishing, New York, NY 10036. All rights reserved. Pharmacy Practice News (ISSN 0886-988x) is published monthly by McMahon Publishing. Periodicals postage paid at New York, NY, and at additional mailing offices. POSTMASTER: Send address changes to Pharmacy Practice News, Circulation Dept., 545 W. 45th St., 8th Floor, New York, NY 10036.

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Infectious Diseases Steven J. Martin, PharmD, BCPS, FCCM, Toledo, OH

A family-owned medical publishing and medical education company. McMahon publishes seven clinical newspapers and several annual or semiannual Special Editions.

Technology Thomas Van Hassel, RPh, Yuma, AZ

Nancy Parker, Executive Manager, Classified Advertising nparker@mcmahonmed.com

14 Molecules from A to Z

B A L A N C E Between perception and reality. Once thawed, Frozen Premix Medications are processed like any other refrigerated IV medication. Some think Frozen Premix Medications pose a challenge. But reality suggests increased efficiencies with minimal effort. Our unique, manufacturer-prepared, ready-to-use products fit right into your pharmacy process. Easily. Whether itâ&#x20AC;&#x2122;s storing or labeling, dispensing or recycling, the steps are familiar and already in place.

Warming up to Frozen Premix Medications really does make sense. Contact your Baxter pharmacy representative at 888-229-0001.

Baxter is a registered trademark of Baxter International Inc.

Medication Delivery

111349C 03/11

6 Up Front

Pharmacy Practice News • April 2011

in Brief

New Teaching Tool for Addiction Released

he National Institute on Drug Abuse (NIDA) recently released three new teaching resources on substance abuse and addiction that may help your physician colleagues cope with afflicted patients. The NIDAMED program offers physicians and other health care providers evidence-based tools to enable them to be the first line of defense against substance abuse

and addiction and to increase awareness of the likely impact of substance abuse on a patient’s overall health. The new teaching tools include: • an objective structured clinical examination from Boston University School of Medicine on opioid risk management, that covers how to initiate and manage long-term opioid therapy in patients with chronic pain, and how to discuss the risks and

benefits of opioids with patients; • a lecture presentation from the University of North Dakota School of Medicine & Health Sciences on how to talk to patients about sensitive subjects, including drug/alcohol use and abuse, intimate partner violence and sexual history/concerns; and • a methamphetamine lecture and a design for a clinical interclerkship for third-year medical students, developed by Creighton University, that introduces medical students to methamphetamine abuse and dependence, including its mechanism of action, short- and longterm effects and treatment. The NIDA curriculum resources are offered in multiple formats, including a Web module, an objective structured clinical examination, an interclerkship, problem- and case-based studies, lectures and a faculty workshop—all of which can be incorporated into existing medical school curricula. For more information, go to http:// www.drugabuse.gov/coe/cr-overview.htm.

—Staff

Volatile Agents Are Easy Target for Cost-Conscious Hospitals

Cost per Unit ($)

harmacists tasked with trying to rein in their budget for 1.6 volatile agents—which typically consume about 20% of 1.40 1.4 anesthesia drug expenses in a hospital—might want to take a page from a group in upstate New York. 1.2 1.03 When physician researchers at Albany Medical Center 1.0 0.83 realized how much they were spending on sevoflurane and 0.8 0.74 0.67 desflurane (Ultiva, Abbott), they wondered why the anesthe0.65 0.6 siology staff were eschewing isoflurane. Isoflurane is two to 0.46 0.4 five times cheaper, respectively, than the other two agents, 0.2 but Albany clinicians tended to use three times as much desflurane instead. 0.0 2008 January February March April May June The reason became clear immediately: Albany’s anesthesia Average 2009 2009 2009 2009 2009 2009 machines were equipped with only two vaporizers, for which sevoflurane and desflurane were typically the default drugs. Figure. Cost per billing unit of volatile The researchers decided to mount an additional bracket on agent before and after extra vaporizer the machines for isoflurane and watch what happened. was installed. After six months, the results were striking. Use of isoflurane nearly doubled, from 21% to 39% of the total volatile agents consumed. Meanwhile, use of sevoflurane fell from 20% of total consumption to 15% and desflurane consumption dropped from approximately 60% to 46%. The change produced dramatic savings. The cost per unit of anesthesia at Albany fell from an average of $1.40 per month in 2008 to as low as 46 cents per month after the shift, according to the researchers (Figure). The net savings during the six-month study period: a shade over $138,000. Whether the increase in isoflurane use had any effects on case turnover or discharge time from the postanesthesia care unit remains to be seen, said the researchers, who presented their findings at the annual meeting of the International Anesthesia Research Society (abstract S-151). —Adam Marcus

Topiramate Linked To Higher Incidence Of Cleft Palate, Lip

ew data suggest that the migraine headache drug topiramate increases the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, according to the FDA. Topiramate (Topamax, Ortho-McNeil Janssen) is approved to prevent

migraine headaches, but not to relieve the pain of migraines. “Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” said Russell Katz, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Alternative medications that have a lower risk [for] birth defects should be considered.” Data from the North American Antiepileptic Drug (AED) Pregnancy Registry

showed that infants exposed to topiramate during the first trimester of pregnancy experienced a 1.4% prevalence of oral clefts, compared with a prevalence of 0.38% to 0.55% in infants exposed to other AEDs. Based on the data, topiramate will have a stronger warning in its prescribing information (labeling). The pregnancy category will be changed to Pregnancy Category D. This means that there is positive evidence of human fetal risk based on human data, but the

Pooled Data May Be Shallow When It Comes to Disclosures

ooled analyses of randomized controlled drug trials rarely if ever specify whether the original research had ties to pharmaceutical companies with a stake in the findings. That’s the conclusion of a recent study that found that only two of 29 meta-analyses (7%) reported the funding sources of the 509 drug trials they covered and that none provided information about whether the authors of the pooled studies worked for or had received funding from industry. The researchers focused on metaanalyses published in 2009 in major journals with high-impact factors. They looked at trials of patented drugs in five clinical areas—oncology, cardiology, respiratory medicine, endocrinology and gastroenterology—known for strong sales of prescription medication. The study, published in the March 9 issue of JAMA, found that 219 of 318 (69%) trials in the meta-analyses that identified their funding sources had received support from pharmaceutical companies. Only about 25% of the 509 studies provided financial disclosures for the authors involved in the work. Of those that did so, 69% listed at least one author with a financial tie to the drug industry, according to the researchers. In seven cases, every study in the meta-analysis disclosed at least one potential conflict of interest—such as sponsorship by a drug maker or an author employed by the company whose drug product was being studied. One of those metaanalyses noted the sources of funding and none reported any of the financial ties or employment connections, the researchers said. “Without acknowledgment of [conflicts of interest] due to industry funding or author–industry financial ties” in the studies that meta-analy ses cover, “readers’ understanding and appraisal of the evidence from the meta-analysis may be compromised,” the authors wrote. (And yes, the authors of the JAMA study provided a lengthy disclosure statement at the end of their article.) —Adam Marcus

potential benefits of the drug in pregnant women may outweigh the risks in certain situations. The FDA previously designated the drug as Pregnancy Category C because of the lack of human data. The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information. —Staff

Pharmacy Practice News • April 2011

Policy 7

Pain Medicine 50

First of a Three-Part Series

2004

Part 1 (April): Legal issues

2006

Rate of Emergency Department Visits, %

Part 2 (May): Pain contracts Part 3 (June): Medical marijuana

PAIN RX continued from page 1

worries—driven in part by a high-profile Nevada case—don’t undercut the effectiveness of the databases for not only law enforcement, but also for clinicians who want to help patients, he said. “What responsibility does the pharmacist have when [he or she accesses] the data?” he asked. “And then what should the pharmacist do once that data is accessed? Those are questions that we have to look at further.” According to a legislative analysis conducted by the National Alliance for Model State Drug Laws in October 2010, at least 34 states had PDMPs in operation. An additional nine states had passed legislation to create their own programs. Meanwhile, identifying doctor shop pers who crisscross state lines is about to become easier. Officials at NABP are working with federal agencies and other groups to develop a broader database. Once established, authorized users will be able to check a patient’s use of controlled substances in participating states beyond their own (box, page 9). The state programs can differ from one another in various ways, including what type of controlled substances they track and how current the information is, according to experts interviewed. But there has been a move in recent years to encourage practitioners to check the databases more frequently, said Sherry Green, attorney and chief executive officer of the National Alliance for Model State Drug Laws, a nonprofit organization. As a result, there has been a heightened interest in related legal protections, she said. Ms. Green cited several states that either have already passed language in the last year to protect clinicians or are proposing bills during their current legislative sessions. “I think protections for people who are using the information and using the information appropriately are something that state decision makers are focused on,” Ms. Green said.

Revisiting State Protections One case that captured clinicians’ attention began seven years ago, when a Nevada driver high on controlled substances killed one man and injured another along the side of the freeway, Dr. Catizone said. Prior to the 2004 fatality, a state-controlled substances

2005

2007

2008

0 Fentanyl

Hydrocodone Hydromorphone

Methadone

Morphine

Oxycodone

Type of Opioid Analgesicb Figure. Emergency department visitsa for nonmedical use of selected opioid analgesics—United States, 2004-2008. a

Per 100,000 population; b Drug types include combination products (e.g., oxycodone and aspirin)

Source: Adapted from MMWR (2010;23:705-707).

task force had sent letters to pharmacies and physicians, warning that the woman had obtained a large quantity of controlled substances, about 4,500 hydrocodone pills, from 13 pharmacies during a one-year stretch. Family members of the victims sued not only the driver, but also those pharmacies that had been notified by the task force. In December 2009, the Nevada Supreme Court ruled in the case, Sanchez v. Wal-Mart Stores, that the pharmacies did not have a responsibility to unidentified third parties. But the ruling also included a strongly worded dissent, in which it was argued that there was a special relationship between the pharmacies and the patient, in which it could be argued that pharmacies had a duty to take measures to avoid forseeable harm. “We’ve been, like everyone else, watching the Supreme Court decision in Nevada,” Dr. Catizone said. “If trial

lawyers use those databases to try and mine that information to initiate lawsuits against pharmacists, then it’s going to put pharmacists in a whole different position, a much more defensive position, and that would be problematic.” In some sense, the clinical quandary may be more complex for hospital pharmacists if, when checking the database, they see a worrisome pattern of using controlled substances, said David Craig, PharmD, a pharmacist and pain management specialist at Moffitt Cancer Center in Tampa, Fla., who is familiar with the Nevada case. “They might be in a worse predicament if they discovered that information,” said Dr. Craig, who also is secretary of the American Pain Society. If the patient had an acute and immediate pain need, the detail in the database might not discourage Dr. Craig from dispensing. “I don’t know if it would necessarily influence my deci-

sion,” he said. “It’s obviously unethical to withhold appropriate medical treatment from somebody despite their background.” Nevada is one state that, during its current legislative session, is attempting to broaden immunity related to PDMPs. Under existing Nevada regulations, a pharmacist can only refuse to fill a prescription if it’s believed to be a fake or if it’s believed to risk medical harm to the patient, such as by causing an allergic reaction or drug interaction problem, said Larry Pinson, PharmD, executive secretary of the Nevada State Board of Pharmacy. Refusing to fill a prescription based on suspected doctor shopping currently falls into a gray area, he said. “It’s really an interesting question when a pharmacist is faced with filling what is a legal prescription, but then the

•

see PAIN RX, page 8

8 Policy

Pharmacy Practice News • April 2011

Pain Medicine

PAIN RX continued from page 7

pharmacist accesses the database and finds out that that patient has been to several doctors or several pharmacies,” he said. A bill, which as of press time had been proposed during the current legislative session, would provide civil and criminal immunity for Nevada clinicians who use the database and make related decisions, including whether or not to prescribe or to dispense a particular

m ed i ca t i on, Dr. Pinson said. It also would allow the exchange of information with other state PDMPs, such as through the computer portal being established by the NABP. Also in the last year, legislators who have passed laws to develop PDMPs in two different states—Delaware and South Dakota—have incorporated immunity provisions for clinicians into those

laws, Ms. Green said. “It suggests to me that it became a serious enough issue that they decided not to rely on their general state immunity laws, but put something specific in their PMP [prescription monitoring program] laws.” In the current legislative session, Virginia legislators also have proposed language that addresses a concern that sometimes arises in conversations with

clinicians, Ms. Green said. Can prescribing detail be shared with another clinician involved with that patient’s care without violating patient privacy? “It directly goes to the situation of what you do with this information once you have it,” she said. Sharing details with another clinician may not only guard against doctor shopping, but also could serve a clinical purpose, Ms. Green added. She described one scenario in which an elderly person doesn’t recall all of the medication that he’s taking. The Virginia bill, if it becomes law, would allow a pharmacist to notify another physician that the patient has already been prescribed an opioid medication.

Navigating Gray Areas

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The abuse of controlled substances remains a thorny and persistent clinical problem, according to a recent national analysis of drug-related emergency room visits. The analysis, published in the Morbidity and Mortality Weekly Report (2010;23:705-707), identified a 111% increase in nonmedical use of opioids from 2004 to 2008 (Figure, page 7). Nonmedical use was defined as taking a higher-than-recommended dose, using someone else’s prescription or documented abuse, among other categories. Attempted suicides and accidental consumption were excluded. The largest number of emergency department visits was recorded for oxycodone, hydrocodone and methadone. All three of these drugs showed a statistically significant increase during the fiveyear stretch, according to the analysis. For physicians working in pain management, the monitoring databases can be very helpful when they are striving to ease the pain of higher-risk patients, said Edward Michna, MD, JD, an anesthesiologist who specializes in palliative care and pain management at Brigham and Women’s Hospital, in Boston. Some patients may have a past history of abuse, but also a very real current pain problem, Dr. Michna noted. “So what we typically do is develop a treatment strategy to best address those risk factors,” he said. Checking the database can be combined with other measures, such as small prescriptions, weekly visits and regular urine testing, he added. However, there is at least one current drawback with the monitoring databases, Dr. Michna pointed out: the timeliness of the information can vary from state to state. Along with the timeliness of the data, a pharmacist also may have to weigh other mitigating factors, Dr. Catizone said. The pharmacist might note a worrisome pattern in the database, but a conversation with the patient’s doctor could sufficiently ease the pharmacist’s mind, he said. “There has to be some room there

Pharmacy Practice News • April 2011

Policy 9

Pain Medicine for the pharmacist to exercise professional judgment,” he said. “Not every decision is going to be black and white based simply on the data.” One scenario in which hospital pharmacists are more likely to check a state database is during the medication reconciliation process, said Tom Van Hassel, RPh, MBA, director of pharmacy at Yuma Regional Medical Center in Yuma, Ariz. Even if they do dispense the medication, pharmacists should note their concerns about potential excessive use in the patient’s record, as well as alert the prescriber, he said. In some states, the time lag in pharmacy reporting is slim. In Ohio, where the PMP began in 2006, the delay typically ranges from one to 10 days, said Danna Droz, RPh, JD, who is PMP administrator at the Ohio State Board of Pharmacy. With each passing year, the interest in the data increases, Ms. Droz said. In December 2010, there were 84,000 requests compared with 55,000 for December 2009. The bulk of the data requests, about 83%, come from prescribers, she said. Pharmacists comprise 15%; fewer than 2% involve law enforcement. “I have doctors tell me, ‘Using the PMP, it gives me my practice back,’ ” she said. “ ‘I can get that information and determine whether I’m dealing with someone who may be trying to scam me or bordering on abuse or if I’m dealing with a person who really did just fell off a ladder and hurt their back.’ ” Such peace of mind also benefits patients in pain, Ms. Droz added. “Those people don’t need to be painted with the broad brush of ‘Oh, I’m afraid that

you’re a drug abuser.’ ” Dr. Michna is looking forward to the day when prescribing information is routinely accessible in real time. But better data also might influence the legal landscape for clinicians practicing around the country, said the pain specialist and attorney, who stressed that he was expressing a personal opinion. “If the technology gets to the point where you have direct access to it [the information], then it’s going to become the standard of care that you have to check those databases prior to prescrib-

ing,” he said. “And failure to do so will be negligence per se.” Mr. Van Hassel stressed that all of these legal and policy issues surrounding pain are not just relevant to community pharmacies. “You may get that idea from the lawsuit, for example, which targeted Wal-Mart,” he said. “But don’t be mistaken: outpatient pharmacies are as liable as the corner drugstore when it comes to not paying heed to doctor-shopping, privacy issues and other aspects of pain management that can trip up unwary clinicians and administrators.”

The bottom line? “You must pay attention to high-risk patients,” he said. “We all know the signs of abuse, whether it be doctor shopping, erratic behavior, etc. You really just have to pay attention.” It also helps, Mr. Van Hassel said, to have protocols in place for dealing with problem patients. “If you don’t have staff education on this, and steps in place to address these challenges, you’re at risk for dire outcomes, not just for your department and hospital, but for the patients themselves.” —Charlotte Huff

Shopping Across State Lines

fficials at the NABP are working with federal agencies and other groups to build a linked database, to better flag doctor shopping and other worrisome prescription patterns across state borders. The system, dubbed PMP Interconnect, will provide a secure computer portal through which authorized users can check a patient’s usage of controlled substances in participating states. The data will be encrypted. NABP, which has contracted with Appriss, Inc., to develop and host PMP Interconnect, won’t store any information. A pilot project is slated for this spring, with plans for the full rollout by year’s end, according to Carmen Catizone, MS, RPh, DPh, the national association’s executive director. All states with prescription monitoring programs, including those in the works, will be invited to participate. —C.H.

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Pharmacy Practice News • April 2011

In Focus Patients receiving continuous hormone therapy

In prostate cancer patients with biochemical relapse...

Patients receiving intermittent hormone therapy

Study Supports Intermittent Hormone Therapy mittent therapy is just as effective as continuous androgen deprivation therapy. The potential savings with regard to medication costs are huge.” Patients randomized to intermittent hormone therapy had a median overall survival (OS) of 8.8 years compared with 9.1 years in patients receiving continuous therapy, a difference that was not statistically significant. Intermittent treatment reduced hormone exposure by 75% compared with continuous treatment. The trial met its predefined primary end point of noninferiority for intermittent versus continuous therapy in terms of overall survival. This comparability means that the vast majority of patients with localized prostate cancer can begin adjuvant hormone therapy with an intermittent regimen, according to the investigators. The study provided much-needed high-level data on one of the most controversial issues in the management of prostate cancer: how to respond to a rising PSA level after definitive treatment. No consensus has existed about the optimal therapeutic strategy for this clinical situation. The findings came from a randomized clinical trial involving 1,400 men with localized prostate cancer initially treated with curative radiation therapy. Subsequently, all of the patients had PSA recurrence more than a year after curative treatment, defined as a PSA level more than 3 ng/mL. The patients were randomized to continuous therapy or to an intermittent schedule of eight months on treatment, followed by a break until the patient’s PSA level exceeded 10 ng/mL. At that

point, patients in the intermittent arm received an additional eight months of hormone therapy, followed by another break in treatment. The median followup was 9.1 years. Patients in both arms continued treatment until progression to castration resistance, defined as a PSA level more than 10 ng/mL on three consecutive occasions at least one month apart despite hormone therapy. In the intermittent arm, men were switched to continuous therapy if their PSA value exceeded the 10-ng/mL threshold within two months of stopping treatment. The trial ended prematurely when a planned interim analysis showed the results had surpassed the threshold for noninferiority in terms of OS (hazard ratio [HR], 1.25; P=0.009). Patients in the intermittent arm were more likely to die of prostate cancer (122 vs. 97 deaths), whereas the continuous-therapy arm had more deaths from causes unrelated to prostate cancer (146 vs. 134). “The net effect was that the differences in deaths in the two arms canceled each other out, so that the total number of deaths did not differ significantly between the groups,” Dr. Klotz said. Patients in the intermittent arm received a median of two, eight-month cycles of androgen suppression (range, one to nine). Intermittent therapy was associated with a significant slowing of progression to castration resistance compared with continuous therapy (HR, 0.80; P=0.024). “One of the surprises in men in the intermittent arm was the time on ther-

Patients, %

Orlando, Fla.—When levels of prostate-specific antigen (PSA) begin to rise after definitive radiation therapy, most men with prostate cancer do just as well whether they receive intermittent or continuous administration of hormone therapy. This news comes from a large multicenter trial reported at the recent Genitourinary Cancers Symposium (abstract 3). “Intermittent androgen suppression should be the standard of care for most patients with PSA recurrence after initial treatment with radiation therapy or radical prostatectomy and subsequent radiation,” said Laurence Klotz, MD, chief of urology at Sunnybrook Health Sciences Center in Toronto, who presented the study. Asked to comment on the study, William D. Figg Sr., PharmD, senior scientist and head of the Clinical Pharmacology Program at the National Institutes of Health, in Bethesda, Md., said the results “are important, because they justify current clinical practice. For years we have felt intermittent hormonal therapy was equal to continuous and have incorporated that into clinical care. These data are the first large study to confirm this, in the setting of non-metastatic cancer.” Oliver Sartor, MD, professor of medicine and urology at Tulane University School of Medicine in New Orleans, who was not involved with the study, agreed that the findings have potentially huge clinical implications. The study, he noted, “reflects what a lot of us have been doing in the clinic with our patients on androgen deprivation therapy.” He added that the results “provide the proof that inter-

100

60 40 20 0

Figure. Incidence of hot flashes. apy,” said Dr. Klotz. “Earlier Phase II studies suggested that men spent about equal amounts of time on and off therapy. Instead, we found that men in the intermittent-therapy arm were on treatment only 27% of the time.” The incidence of hormone-related hot flashes was significantly lower with intermittent therapy than with continuous treatment (90% vs. 93%; P=0.02). Otherwise, the two treatment groups were similar with regard to adverse events, including sexual dysfunction, urinary frequency or urgency, fatigue, cardiac events and fractures. Dr. Klotz said the results show that intermittent androgen suppression is a “win-win situation. Not only do we have a therapy that appears to be better tolerated and just as effective [as continuous therapy], but it is also cost-saving.” Although Dr. Sartor agreed that intermittent therapy has advantages, it is not for every patient. Intermittent therapy requires greater compliance with care in terms of keeping clinic visits for serial PSA testing, he said. —Charles Bankhead

Clinical Index May Help Predict VTE Risk in Cancer Patients Orlando, Fla.—An index based on a handful of clinical factors showed promise for predicting cancer patients’ risk for recurrent venous thromboembolism (VTE), data from a retrospective chart review showed. Patients with a high clinical score had almost a fivefold greater incidence of VTE despite anticoagulation compared with patients who had a low score. The overall risk was similar among patients treated with low-molecular-weight heparin (LMWH) or a vitamin K antagonist (VKA), suggesting that the type of treatment did not affect risk. “Our goal is a prospective validation of this clinical prediction rule to assess its reproducibility and generalizability,” investigator Martha Louzada, MD, a hematologist at the University of West-

Table. Application of VTE Risk Score Score

Risk for VTE Recurrence, %

Risk Level

5.1

Low

9.8

Intermediate

≥1

15.8

High

VTE, venous thromboembolism

ern Ontario in London, Canada, said at a news briefing during the annual meeting of the American Society of Hematology (abstract 4209). “As better treatment becomes available,” Dr. Louzada added, “the quality of care can be improved by the ability to predict the risk of VTE recurrence in cancer patients and then treat them accordingly.”

200 of whom received VKAs and 343 of whom received a LMWH. Within six months after initiation of anticoagulation therapy, 55 patients (10.1%) had recurrent VTE. Dr. Louzada said the rate of VTE recurrence was 10.5% in heparin-treated patients and 9.5% in the patients who received VKAs.

Risk Factors Identified Current treatment guidelines recommend long-term prophylaxis with LMWH in all cancer patients with a history of VTE, noted Dr. Louzada. Whether patients can be stratified into high and low risk for VTE has remained unclear. To clarify the issue, she and her colleagues reviewed medical records of 543 cancer patients with treated VTE,

By multivariate analysis, the investigators identified five clinical factors associated with either higher or lower VTE risk: lung cancer (odds ratio [OR], 2.55), history of VTE (OR, 2.42), female sex (OR, 1.82), stage I cancer (OR, 0.75) and breast cancer (OR, 0.46). The investigators assigned a value of 1 to the three factors associated with increased VTE risk

•

see VTE RISK, page 30

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18 Clinical

Pharmacy Practice News • April 2011

Critical Care

INAPPROPRIATE RX

‘It is important to check before the patient is discharged [that] there is, in fact, an indication for any of the medications that are being prescribed.’

continued from page 1

potentially inappropriate medications are quite prevalent among seniors living in the community. About 60% have been found to have PIMs,” he said. “In this study, we found that after a critical illness, the proportion of patients with potentially inappropriate medications increased from 66% at preadmission to 85% at hospital discharge, and 60% were actually inappropriate. Importantly, half of these were newly

—Sandra Kane-Gill, PharmD

prescribed in the ICU.” In the hospital, elderly patients are often prescribed medications that may be considered potentially inappropriate but that can be appropriate for them in

a clinical context, Dr. Morandi said. “A classical example is the use of an antipsychotic drug to combat agitated delirium, which is very common in the ICU. These drugs should be stopped at discharge either from the ICU or the hos-

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pital once the symptoms are resolved.” Polypharmacy in the elderly is associated with worse cognitive function and adverse events, including an increased risk for falls, Dr. Morandi noted. It also increases health care costs. “We wanted to look specifically at this population because we suspected that they might have an increase in the number of inappropriate medications, especially because of their many transitions within the hospital,” he said. The Vanderbilt group prospectively studied 120 patients aged 60 years and older (median, 68; interquartile range, 66-74) who survived to discharge after septic shock, cardiogenic shock or respiratory failure. The patients’ median Acute Physiology and Chronic Health Evaluation (APACHE) II score was 27 and ranged from 20 to 32. The investigators collected information on the patients’ home medications, actual medications administered while in the ICU and the wards via their electronic medication administration record, and medications prescribed at discharge from the ICU and the hospital. They identified PIMs using the validated 2003 Beers criteria supplemented with additional drugs identified as PIMs in recent medication safety literature. Additionally, a panel consisting of a hospitalist, a geriatrician and a clinical pharmacist evaluated whether the PIMs prescribed at discharge also were AIMs, based on their indication, effectiveness, dosage and drug interactions. The study found that the proportion of patients receiving three or more PIMs increased from 16% before admission to 38% at hospital discharge. Of 104 patients who had at least one PIM at discharge, 59% also were deemed to have at least one AIM. Further analysis showed that the total number of PIMs in the cohort increased from 159 at preadmission to 253 at discharge. The median preadmission PIM was one (range, none to two), versus two (range, one to three) at hospital discharge (P<0.001).

ICU Often the Origin Of Problem

Opti

mize d for wide scr disp een lays

The study also found that 49% of the discharge PIMs and 58% of the discharge AIMs were initiated in the ICU. “The most common inappropriate drugs were the anticholinergic drugs, which can affect memory and cognitive function,” Dr. Morandi said. “They

•

see INAPPROPRIATE RX, page 20

Pharmacy Practice News • April 2011

Advertorial 19

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20 Clinical

Pharmacy Practice News • April 2011

Critical Care

Glucose Management in Critically Ill Patients Still a Problem San Diego—After a decade of trying to figure out the best way to manage blood sugars in the intensive care unit (ICU), some consensus is beginning to emerge, but there are still many more questions than answers. Much of the debate remains focused on tight glycemic control. Once thought to be the best strategy for improving glucose-related outcomes in critically ill patients, the practice has been questioned due to several negative studies published in the last few years. How tight the control should be, and whether hyperglycemia has the same effect on a patient with diabetes as on a patient without diabetes, are just two issues that have been raised by investigators and clinicians, according to Judith Jacobi, PharmD, critical care pharmacist at Indiana University Methodist Hospital, Indianapolis. Making the issue even more complex is the lack of accurate, dependable and straightforward ways of monitoring blood glucose levels in the ICU, Dr. Jacobi noted during a session on glucose management at the annual meeting of the Society of Critical Care Medicine. “Insulin has been around forever, but when the study by Grete Van den Berghe was published in 2001 in the New England Journal of Medicine [2001;345:1359-1367], it was a blockbuster,” Dr. Jacobi said. “We suddenly had to change the way we used insulin in critically ill patients because [the study documented] huge reductions in mortality and ICU complications. The impact of that has been a little bit insidious; it has caused us to pay more attention to elevated blood sugars and use insulin infusions much more frequently, but what we can’t agree on is what the optimal end point ought to be for a blood sugar range.” The Van den Berghe study demonstrated a very significant reduction in mortality of surgical ICU patients on mechanical ventilation with an insulin titrated to a very tight target of 80 to 110 mg/dL. But subsequent studies have shown that the glucose end point does not have to be as low as that, Dr. Jacobi said. “Clearly it is difficult to get the

INAPPROPRIATE RX continued from page 18

were the main culprits.” These data underline the importance of conducting an appropriate medication reconciliation at each transition of care during the hospital stay to avoid prescribing inappropriate medications and to increase patients’ safety. “In many hospitals, this step is not aggressively pursued.”

Another Critical Care Pharmacist’s Take

‘Getting an accurate blood sugar reading is quite a problem currently, and it’s kind of scary. But we just don’t have better alternatives.’

—Judi Jacobi, PharmD

blood glucose that low, and to do it safely. Initially, several professional organizations wrote guidelines that said that everybody in the ICU should have a blood sugar of 80 to 110 mg/dL but they’ve backed off, including the diabetes associations. Generally, most everyone suggests that the blood sugar should be kept less than 180 mg/dL, although it may still be that in some populations, lower is better.” Central to the debate about blood sugar levels is the question of which technology to use to obtain them. For a start, “we need a better monitoring system,” Dr. Jacobi said. “We use glucose meters in the ICU, partially because you need to get results right away. It can take forever to send a specimen to the lab. So we get rapid results with glucose meters but they are really not precise, especially at low blood sugars.” Finger-stick specimens can be difficult to obtain, especially from patients who are on vasopressors or who are edematous or have poor blood circulation in their hands. Glucose meters are especially inaccurate with fingerstick blood, Dr. Jacobi noted. In ICU patients, it is better to obtain blood from an artery or vein, and then use the glucose meter, she added. “It’s better to test blood that has been drawn, rather than finger-stick blood.”

Dr. Jacobi stressed that the blood sugar reading as assessed in the laboratory is the gold standard. “When you compare a specimen done with the glucose meter to a specimen done with the lab, the reading has to be within 15 mg/dL when the blood sugar is less than 75, according to monitoring standards. What that means is, if the meter says the blood sugar is as low as 70, it could really be as low as 55, which would obviously be important.” Although the literature is not consistent with regard to the dangers of low blood sugar, it is reasonable to believe that long periods of hypoglycemia could have adverse health effects, she added. “Getting an accurate blood sugar reading is quite a problem currently, and it’s kind of scary. But we just don’t have better alternatives. We are hoping that down the road we will have better devices,” Dr. Jacobi said. “Several companies are working on developing them. There was a device that has seen limited testing in the ICU that would be hooked up to the patient at the bedside and would automatically draw blood from an artery or vein, test it, and then return the extra. Other companies are testing implantable sensors for continuous intravascular measurement, or interstitial tissue measurement. I don’t know if they are moving toward FDA approval. I hope so.” Sandra Kane-Gill, PharmD, associate professor at the University of Pittsburgh School of Pharmacy, agreed that discharge from the ICU or hospital represents a good opportunity for medication reconciliation. “It is important to check before the patient is discharged [that] there is, in fact, an indication for any of the medications that are being prescribed,” Dr. Kane-Gill said. “There is literature suggesting that some drugs—for

John W. Devlin, PharmD, associate professor in the Northeastern University School of Pharmacy and a clinical pharmacist in the medical ICU at Tufts Medical Center in Boston, said that pharmacists have an important role to play in helping to find answers surrounding how glucose should be controlled in the critically ill. “In addition to the numerous excellent points that Dr. Jacobi makes surrounding glycemic control in the critically ill, the publication of Dr. Van den Berghe’s first study in 2001 should serve as an important reminder to the critical care community to be careful about changing practice based on the results of a singlecenter, randomized controlled trial,” he told Pharmacy Practice News. “What has transpired since 2001 has shown us that we should not adopt findings from a [randomized controlled trial] evaluating surgical patients [for] other critically ill populations, such as those admitted to a medical ICU. We have also learned the importance of obtaining a full understanding of the mechanisms of any condition or process such as hyperglycemia before implementing new strategies to reverse it—for example, tight glycemic control. We also have learned that efficacy and safety outcomes that are reported in a tightly controlled [randomized controlled trial] will not necessarily lead to the same benefits in a real-life ICU clinical practice.” Dr. Devlin added that critical care pharmacists could help further clinicians’ understanding of the strategies that should be used in the ICU for patients who are hyperglycemic by helping to conduct the research that hopefully will answer the many remaining questions in this area. “Given that pharmacists are key members of the ICU team, they are well positioned to translate findings from such research into everyday practice at not only the institutional ICU committee level but also at the ICU bedside.” —Fran Lowry example, those used for stress ulcer prophylaxis—are initiated in the ICU but not necessary after the ICU. But people sometimes forget to discontinue the medication.” Transitioning into the ICU, out of the ICU and out of the hospital “are points ... of care that provide a chance for us to be sure that all medications [that] patients are on are the correct ones.” —Fran Lowry

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22 Operations & Management

Pharmacy Practice News • April 2011

Practice Pearl USP <797> Monitoring Guidelines:

Standards for Pharmacy Practice Jessica Vargas

Vaiyapuri Subramaniam, PharmD, MS

Philip Coggins, RPh

PharmD Candidate Nova Southeastern University College of Pharmacy Fort Lauderdale, Florida

Associate Chief Consultant Pharmacy Benefits Management Services Department of Veterans Affairs Washington, DC Clinical Affiliate Professor Nova Southeastern University College of Pharmacy Fort Lauderdale, Florida University of Maryland School of Pharmacy Baltimore, Maryland

Pharmacist Program Manager Hunter Holmes McGuire VA Medical Center Richmond, Virginia

Christina Dang PharmD Candidate University of Maryland School of Pharmacy Baltimore, Maryland

lthough most pharmaceuticals are mass-produced to meet supply and demand needs, certain medications need to be custom-prepared when they are needed to meet requirements for light, temperature, chemical stability, sterility, etc. Sterility is essential for compounded medications intended for parenteral or sterile routes of administration to ensure medication safety. Safe compounding practices for sterile medications are important to prevent harm to patients from products that are contaminated, are the wrong strength, or are of poor quality. Pharmacists play a key role in developing and initiating safe medication practices to ensure that drug products indicated for sterile administration are prepared according to good compounding practices and that they meet standards of sterility, purity, quality, identity, and strength. They can set up and monitor compounding practices and develop competency checklists, such as that shown in the Table,1 to help ensure best practices for sterile compounding. A key development in ensuring safe compounding practices was the United States Pharmacopeia’s final release in 2008 of Chapter <797> (USP <797>) Pharmaceutical Compounding-Sterile Preparations, as a set of required standards for the compounding of sterile medications.1 It is considered an official minimum standard for compounding sterile medications and is enforceable by the FDA, state boards of pharmacy, and other regulatory agencies.2 As such, USP <797> mandates procedures and processes for sterile drug compounding of pharmaceuticals in a cleanroom environment and establishes the International Organization of Standards (ISO) requirements for acceptable cleanroom airborne particulate concentrations and assessment procedures. The maintenance of sterility and overall freedom from contamination of a compounded sterile preparation (CSP) depends on environmental quality control specifications, cleanroom monitoring and aseptic sterilization techniques, and appropriate personnel training. This review discusses the components of a program that hospitals need to establish to meet the USP <797> standards and

Mulraj P. Dhokai, PE Senior Mechanical Engineer Office of Construction and Facilities Management Department of Veterans Affairs Washington, DC

describes the role of pharmacists in ensuring that these standards are met.

Environmental Quality And Control Environmental conditions dictate the amount of exposure of the CSP to the immediate environment during processing. Therefore, it is important for conditions to ensure a certain level of quality and control. Total particle counts are designated according to each ISO classification. All certification records are to be maintained and reviewed by a supervising or designated employee to ensure that the controlled environment complies with requirements for air cleanliness, room pressures, and air changes per hour. Recertification should be done every 6 months, with environmental sampling under certain conditions, such as when new facilities are commissioned and certified, facilities are recertified, facilities and equipment are serviced, problems are identified with end products or staff techniques, and infections occur, with the source possibly linked to a CSP or inappropriate compounding practices. One way for hospitals to approach compliance with the USP <797> guideline is by renegotiating their current contract with the vendor to include biannual viable air monitoring, rather than purchasing a personal air sampler and conducting their own tests. Pressure differential is another important parameter that must be monitored and recorded at least during daily work shifts or by a continuous recording device. The pressure between ISO class 7 and the general pharmacy should not be less than 5 Pascal (Pa). Also, the airflow between the buffer area and ante area where low- and medium-risk CSPs are prepared should be maintained at a minimum velocity of 0.2 m per second. If the cleanroom has been constructed to prepare medium-risk products only but occasionally receives orders for high-risk sterile products, the hospital may want to consider formulary changes or searching for an outside vendor that has the capability to provide highrisk sterile products in a timely manner.

It is acceptable for institutions that prepare a low volume of hazardous sterile preparations (chemotherapy) without a negative pressure room to use a compounding aseptic containment isolator or biological safety cabinet along with a closed-system transfer device. These institutions must have 2 levels of containment to prepare hazardous product in a non-negative pressure area.

Cleanroom Monitoring and Aseptic Sterilization Techniques Proper cleaning procedures are essential for sterile compounding. The surfaces and air quality that can come in contact with the materials used to compound must be free of any pathogens or debris that can compromise the integrity of the final product. In an ISO class 5 area, cleaning and disinfecting before any compounding begins should be done with sterile water and nonshedding wipes (eg, composed of synthetic microfibers) and/or followed by wiping with residue-free disinfecting agents, such as sterile 70% isopropyl alcohol. The recommended frequency for cleaning the ISO class 5 area should be at the onset of each shift; before each batch, if there is a known surface contamination; after spills; and every 30 minutes following previous disinfection during ongoing compounding activities. In ISO class 7 buffer areas, ISO class 8 ante areas and segregated compounding areas, cleaning and disinfecting should be done daily. When necessary, clearing of dust and debris from storage sites for compounding supplies should be done with caution to preserve air quality. Other daily tasks include cleaning counters, work surfaces, and floors with cleaning and disinfecting agents and a nonshedding mop. Walls, ceilings, and storage shelving should be cleaned monthly according to American Society of Health-System Pharmacists (ASHP) recommendations.3 One way to ensure cleanliness and a sterile environment within a cleanroom is to request that environmental management services (EMS) assign staff trained in cleaning operating suites and other highly sensitive areas

to clean the IV cleanrooms. Also, creating log sheets for EMS staff to initial when they have completed their daily and monthly cleaning, in addition to pharmacy staff cleaning, will help keep track of these procedures.

Personnel Testing According to USP <797>, compounding personnel are responsible for maintaining quality control over the products they compound by practicing proper aseptic techniques and perfecting the skills necessary to ensure that CSPs are correctly identified, measured, diluted, mixed, purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed.1 Personnel who are to handle CSPs are required to undergo adequate training and pass written competency assessments and media-fill tests of aseptic manipulative skills. For initial training, it is recommended that personnel watch the ASHP video, “Quality Assurance for Pharmacy-Prepared Sterile Products,” and then undergo an assessment. For personnel who compound low- and medium-risk CSPs, testing must be done at least annually; for those who compound high-risk CSPs, testing should be semiannual. Maintaining appropriate cleanliness also is important for personnel. They must be able to demonstrate how to clean all internal components of the IV cleanroom hood using the proper technique and products. They also must demonstrate that they are able to correctly select appropriate syringe/needle sizes and be aware not to touch the syringe tip, plunger, or barrel. All items must be placed in the hood before compounding is started, and a distance of 6 inches must be kept from the edge to avoid any obstruction of air flow. CSP labeling requirements such as name and identification number, ingredient names, amounts, strengths, concentrations, expiration dates, administration regimens, auxiliary labels, and storage requirements all are basic guidelines personnel should be aware of when compounding. Garbing and gloving competency needs to be documented, assessed, and maintained. Evaluation involves visual observation. Proper technique involves removing all jewelry, wearing appropriate clean attire, and thoroughly washing hands and arms up to the elbows. For glove fingerprint sampling, sterile contact agar plates in which successful completion equals zero colony-forming units should be used to evaluate garbing and hand-washing techniques for all compounding risk levels. This should be done no less than 3 times prior to the worker initially being allowed to compound. After the initial assessment, it

PRINTER-FRIENDLY VERSION AT PHARMACYPRACTICENEWS.COM

Medication Errors: A Year in Review INSTITUTE FOR SAFE MEDICATION PRACTICES Horsham, Pennsylvania

he prevention of medication errors is an essential requirement for pharmaceutical care and must be a core mission of every pharmacy. For medication error

prevention efforts to be effective, they must become a priority.

The first step in setting up an error-reduction program is to establish a multidisciplinary team to improve medication use. The team must be given reasonable time and resources to assess medication safety and

implement changes at the system level that make it difficult or impossible for practitioners to make mistakes that reach the patient. This multidisciplinary team should accept ownership of the medication-use process and

KEY TO TABLES 1-4

Computerized Prescriber Order Entry (CPOE)—A fully integrated CPOE system includes the capability to build medication safety alerts (eg, lookalike names) and clinical decision rules. Additionally, the CPOE system should

directly interface with the laboratory system and pharmacy, list drug–drug and drug–disease interactions, and offer clinical order-screening capability.

Bar code–enabled point-of-care (BPOC) systems—These systems are designed to prevent medication errors at the point of medication administration. BPOC systems verify and record all medications administered to

the patient through the use of a bar-code scanner that matches the medication to the patient by scanning a bar code on the medication and a bar code on the patient’s wristband.

“Smart” infusion pumps—These infusion systems allow users to enter various drug infusion protocols into a drug library with predefined dose limits. If a dose is programmed outside of established limits or clinical parameters, the pump halts or sounds an alarm, informing the clinician

that the dose is outside the recommended range. Some pumps have the capability of integrating patient monitoring and other patient parameters, such as age or clinical condition.

Automated dispensing cabinets (ADCs)—These are robust, point-of-use dispensing systems. ADCs should be integrated with the health care facility’s information system and directly interface with the pharmacy system.

Additionally, ADCs must include the ability to use bar-coding technology for the restocking process to prevent medication errors.

system. Additionally, this system must be used to generate a computerized medication administration record (MAR) to be used by the nursing staff while administering medications.

“Robust” pharmacy order entry system—This order entry system is fully interfaced with a CPOE system. The pharmacy system must include the capability to produce medication safety alerts as well as directly interface with a health care facility’s information systems, such as the laboratory

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P H A R M AC Y P R AC T I C E N E WS

• APRIL 2011

Table 1. Safety Issues Related to Labeling, Packaging, and Nomenclature Title

Problem/Discussion Point

Recommendation

Technology

Ampicillin (Sandoz) and nafcillin (Sandoz)

• Ampicillin 2 g and nafcillin 2 g ADD-Vantage containers from Sandoz look nearly identical.

• If you use ADD-Vantage antibiotics in your facility, circle or highlight the drug name on the container to draw attention to it. • Consider purchasing one of these products from a different manufacturer.

2,4

Caffeine and sodium benzoate (American Regent)

• The label of this product prominently displays the strength of the caffeine component and states that each vial has 125 mg/mL of the caffeine moiety (250 mg caffeine total). • A physician ordered caffeine 500 mg IV, intending for the patient to receive 500 mg of caffeine and sodium benzoate, not 500 mg of the caffeine moeity. Basing the dose on the caffeine moiety, the nurse used 4 vials, so the patient actually received 1 g of caffeine and sodium benzoate, instead of the intended 500 mg.

• Alert staff that dosing confusion has been linked to the recently revised product label. • Prescribers should specify whether the dose is based on the combination of components or just the dose of the caffeine.

1,4,5

CATAPRES-TTS (cloNIDine, Boehringer Ingelheim) adhesive cover

• Catapres-TTS is packaged with an optional white, round adhesive cover to use over the patch in case it comes loose. • One patient at a long-term care facility did not receive cloNIDine for 2 weeks because only the cover was applied.

• Have pharmacy dispense each patch/cover pair in a plastic bag with a label reminder to apply the medication patch and adhesive cover. • Label the cover before application with the drug name and strength. • Leave a small edge of the medication patch uncovered to identify that the medication patch is underneath.

Cold storage solutions (ViaSpan)

• Cold storage solutions are available in plastic bags that resemble IV bags and contain a port that will accommodate IV tubing. • An organ procurement team left a liter bag of ViaSpan in a hospital where it was later returned to the hospital’s pharmacy with other IV solutions. • Inadvertent IV administration of organ preservation solutions would cause cardiac arrest because of the high potassium content.

• Alert operating room staff of the possibility for mix-ups between organ preservation solutions and IV containers. • Sequester the solutions away from other IV solutions. • Apply auxiliary warning labels to the outer wrap, noting that this concentrated electrolyte solution is to be used only for the storage or flushing of harvested organs.

2,3,4

Different ropivacaine lot numbers

• Ropivacaine in sodium chloride (PharMEDium) has been shipped in cartons containing CADD cassettes with multiple lot numbers and expiration dates. • In one instance, a pharmacy technician assigned the same expiration date to multiple cassettes while loading them in a dispensing cabinet.

• Educate pharmacy staff regarding the potential for products with different expiration dates to be shipped in the same carton. • ISMP has recommended to outsourcing companies that a more prominent auxiliary label be placed on the outer carton if products with differing expiration dates are shipped together.

enthusiastically embrace the opportunity to improve medication safety. The goals of the team should include the following: • Promoting a culture of safety to reduce medication errors; • Increasing detection and reporting of medication errors and potential hazardous drug-use situations; • Exploring and understanding the root causes of medication errors; • Educating practitioners about the system-based causes of errors and their prevention; • Responding to potentially hazardous situations before errors occur; • Recommending methods to facilitate the implementation of organization-wide, system-based changes to prevent medication errors; and

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• Learning from errors occurring in other organizations through the ISMP Medication Safety Alert! and other published accounts of medication errors, and proactively taking measures to prevent similar errors. Effective results depend on understanding the complex medication-use process as a whole through varied perspectives and disciplines. The Institute for Safe Medication Practices (ISMP) is a nonprofit organization that works closely with health care practitioners and institutions, regulatory agencies, professional organizations, and the pharmaceutical industry to provide education about medication errors and their prevention. ISMP independently reviews medication errors that practitioners and patients have voluntarily submitted to the ISMP Medication Error Reporting Text continues on page 8

Table 1. Safety Issues Related to Labeling, Packaging, and Nomenclature Title

Problem/Discussion Point

Recommendation

Technology

DIPRIVAN (propofol, APP Pharmaceuticals)

• The imported propofol product sold by APP Pharmaceuticals and manufactured by Fresenius Kabi only highlights the strength as 1%, making it difficult to determine the mg/mL strength. • Pharmacy-generated labels can easily cover the mg/mL strength, so the visible portion of the label reads “propofol 1%.” • In one case, propofol 5 mg (0.5 mL) was ordered for an agitated pediatric patient following extubation. The nurse accidently gave 5 mL (50 mg) of propofol because a pharmacy label covered the mg/mL strength.

• Pharmacy-applied labels should never obscure critical information on the manufacturer’s label. • Add an auxiliary label to draw attention to the mg/mL strength.

3,4,5

DTaP-Tdap

• Adult and pediatric products used to immunize patients against diphtheria, tetanus, and pertussis are easy to confuse because of their similar names and abbreviations (DTaP-Tdap). • The ISMP MERP database contains hundreds of cases of mix-ups of these products.

• Educate staff about the risk for confusion. • Separate the pediatric and adult formulations in storage areas. • Encourage prescribers to order the vaccines by brand name, not vaccine abbreviation. • Document the vaccine and lot number on the vaccine form/log just prior to administration (document administration after the vaccine has been given). • Ask parents or caregivers to assist with verification of the vaccine before it is administered.

1,2,4,5

LevETIRAcetam and levOCARNitine

• Two children received levETIRAcetam instead of levOCARNitine when a technician selected the wrong drug from an alphabetical pick-list during order entry. Neither child was harmed. • Both drugs have the same elixir strength and are dosed similarly in children.

• Use both brand and generic names, along with the indication, when prescribing these drugs. • Add these to your list of look-alike drug names and build software alerts to warn about confusion. • Change levOCARNitine to L-carnitine in drug databases, or take other measures to differentiate these drugs in pick-lists.

Misleading itraconazole packaging

• The itraconazole “100 mg” capsule strip pack actually contains two 100-mg capsules. • Staff may believe that the 2 capsules together equal 100 mg, which can lead to dosing errors.

• Label this product as itraconazole 200 mg (2 × 100 mg capsules). • If you supply unit-dose products to nursing homes or other outpatient settings, note this on the MAR or repackage the product.

Vasopressin and atropine

• The 1-mL vials of American Regent’s vasopressin injection (20 units/mL) and atropine sulfate injection (0.4 mg/mL) look very similar because the font style and color used on the labels and caps are nearly identical.

• Purchase one of the products from a different manufacturer to help distinguish between them. • At a minimum, the products should be stored in separate locations whenever possible.

2,3,4

Vecuronium and valproate sodium injection

• Two minibags were accidentally prepared with vecuronium instead of valproate sodium injection. • Both medication vials are nearly the same size with red caps and had been stocked close to each other in the pharmacy.

• Sequester neuromuscular blockers in a secure, lidded bin labeled “Paralytic Agent” in the pharmacy and any patient care locations where needed. • Apply a ShrinkSafe sleeve to the vials to warn about the drug’s paralytic nature. • Minimize the variety of neuromuscular blockers available in stock.

ISMP, Institute for Safe Medication Practices; MAR, medication administration record; MERP, Medication Errors Reporting Program

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Table 2. Safety Issues Associated With Order Communication Title

Problem/Discussion Point

Recommendation

Technology

Diltiazem “as directed”

• The rate of infusion for an IV diltiazem solution was unknown, so a pharmacist selected “UD” (ut dictum or “as directed”) from a drop-down list to populate the rate field. The nurse thought “UD” meant “unit dose” and ran the infusion at 125 mg/hour. The patient died after receiving the infusion.

• The Latin abbreviation “UD” should not be used because it is too easily confused with “unit dose.” • Consider requesting that your computer system vendor eliminate the ability to enter “UD” in the rate field. • Prescribers should provide complete orders; pharmacists and nurses should clarify incomplete orders.

1,2,3,5

DORIBAX (doripenem, Ortho-McNeilJanssen) and ZOVIRAX (acyclovir, GlaxoSmithKline)

• A unit secretary incorrectly interpreted a handwritten physician order for Doribax and entered “Zovirax 500 mg IV q8h.” The dose appeared to be appropriate for Zovirax, but the order was written by a pulmonologist; this seemed unusual to the pharmacist, prompting the pharmacist to clarify and correct the order transcription.

• Weigh the risk that unit secretaries might be entering medication orders. • Limit the prescribing of Doribax to infectious disease physicians. • Educate staff about the confusion between these 2 drug names.

1,5

Height versus weight

• While using an electronic prescribing system, a physician ordered 9 mg/kg of panitumumab (VECTIBIX, Amgen) IV every 3 wk for an adult patient, inadvertently entering the patient’s height (cm) as the weight, and the weight (kg) as the height. The patient received 650 mg more panitumumab than intended but was not harmed.

• Set protocol-based maximum doses in prescribing and pharmacy computer systems that require a reason for overriding an alert. • Monitor the electronic alert system to minimize the number of low-priority alerts, and test for inclusion of high-priority alerts. • Form an interdisciplinary team to identify how independent double-checks are conducted.

1,3,4,5

Meaning of “bi”

• The term “biweekly” usually means once every 2 wk, but it can also mean twice a week. • The word “bimonthly” usually means once every 2 mo, but it can also mean twice a month. • An order written for chlorambucil to be given “BIW” (intended meaning: biweekly or twice a week) was misinterpreted as twice daily.

• Avoid using the term “biweekly” (including the abbreviation BIW) and the term “bimonthly” when ordering medications. • Use terms such as “twice a week,” “every other week” (or “every 2 weeks”), or “every other month” (or “alternate months”).

1,5

PARoxetine and FLUoxetine

• An 8-year-old child with anxiety and depression incorrectly received PARoxetine 10 mg instead of FLUoxetine 10 mg when a telephoned prescription was misheard.

• Use both the brand and generic names when prescribing look-alike/sound-alike drugs. • Names on your look- and sound-alike list should be spelled back to the prescriber during read-back of a telephone or oral order. • Ensure that a process exists to educate professional staff about new medications before they are added to the formulary and prescribed.

1,5

Lack of standardized order sets in institutions

• Many organizations do not use standardized order sets or use poorly designed order sets.

• Use of standardized order sets minimizes incorrect or incomplete prescribing, standardizes patient care, and ensures clarity when communicating orders. • Use ISMP Guidelines for Standard Order Sets to ensure that the elements of safe order communication have been followed when designing paper-based or electronic order sets. • When developing an order set, gain consensus among all prescribers who treat the condition/ targeted patients regarding best clinical management so that a single order set can be created.

1, 2

Tall man lettering

• Drug names that appear to be very similar when handwritten and/or typewritten (eg, computer screens, typed labels) have a high potential of being confused, leading to drug prescribing, dispensing, and administration errors. • Difficulties with the use of tall man letters, which can help distinguish look-alike names, include inconsistent application in health settings and lack of standardization regarding which name pairs to include as well as which letters to present in uppercase.

• Highlighting a unique portion of a drug name by using “tall man” lettering draws attention to the dissimilarities of look-alike drug names. • Use the tall man lettering scheme provided in this list (http://www.ismp.org/Tools/ tallmanletters.pdf) to promote consistency.

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Scan for tallman letters tool. Instructions on page 8.

Table 2. Safety Issues Associated With Order Communication Title

Problem/Discussion Point

Recommendation

Technology

Wrong directions

• Space ran out on the first line of directions of an electronic prescription that printed in the pharmacy; the word “until” was split on the prescription so that the “l” appeared on another line. A technician mistook the letter l as the number 1, which altered the directions for duration of therapy from “7” to “17” days.

• Check your electronic systems to determine if words or numbers truncate/break onto different lines, potentially causing a problem on screens, labels, and MARs. • If you identify problems, alert your vendor and send examples to ISMP.

1,5

ISMP, Institute for Safe Medication Practices; MAR, medication administration record

Table 3. Problems Involving Drug Information, Patient Information, Staff Education, and Patient Education Title

Problem/Discussion Point

Recommendation

Technology

Accidental EpiPen (EPINEPHrine) self-injection

• A nurse unfamiliar with the new design of the EpiPen accidentally injected her thumb by pushing on the wrong end (orange tip) of the pen, presuming that it was similar to the NOVOLOG (insulin aspart) FLEXPEN (Novo Nordisk).

• Provide health care professionals and patients with instructions on the proper use of an EpiPen. • Incorporate a demonstration by the health care professional and/or patient to ensure understanding of the procedure.

Alarming infection control practices

• A recent online survey of 5,446 nurses revealed alarming lapses in basic infection control practices that place patients at risk for transmission of bloodborne disease: –Reuse of a syringe for another patient after only changing the needle –Reuse of single-use vials for multiple patients –Reentry into a multiple-dose vial with the same needle/syringe –Use of a common bag or bottle from which to prepare IV flush solutions or drug dilutions

• Enhance surveillance of proper technique and devote resources to ensure staff knowledge and skills associated with concepts of infection control and injection safety. • Use prefilled syringes or single-dose vials when possible to reduce the risk for contamination. • Provide inexpensive drugs in single-use containers and discard after first use. • Do not use bags or bottles of IV solutions as a communal supply of flushes for multiple patients.

Confusing DOCEtaxel and TAXOTERE concentrations

• TAXOTERE (Sanofi-aventis) now comes in a new 1-vial double concentration formulation, replacing the previous 2-vial (active drug and diluent) Taxotere packaging. • The new 1-vial concentration is 20 mg/mL compared with the previous 2-vial preparation, which was 10 mg/mL. • A forthcoming 1-vial generic DOCEtaxel product (Hospira) will be provided in a 10 mg/mL concentration, the same as the previous Taxotere formulation.

• Alert all pharmacy and oncology nursing staff to the new formulation in a double concentration and the forthcoming generic product that will be available in the prior concentration. • Update computer system databases and internal drug resources to ensure proper mixing. • If your computer system allows for order replication from past admissions, work with your IT department to intercept orders where medications have changed strengths.

EXALGO (HYDROmorphone extended-release, Mallinckrodt)

• Exalgo is indicated for opioid-tolerant patients requiring continuous opioid analgesia for an extended period of time. • Confusion between immediate- and extendedrelease products could result in a fatal overdose or poor efficacy.

• When prescribing Exalgo, include the proprietary name, and if the generic name is used, spell out “HYDROmorphone extended-release.” • If prescribing immediate-release HYDROmorphone, do not attach modifiers such as “IR.” • Before dispensing or administering Exalgo, verify that the patient is opioid-tolerant. • Counsel patients on how to properly take Exalgo, and encourage patients to read the medication guide included with the packaging.

Fibrin sealants

• Serious and fatal air or gas embolisms have occurred during or immediately after application of fibrin sealants using air- or gas-pressurized sprayers. • Risk is most significant when devices are used at a higher than recommended pressure or at a distance too close to the surface of the bleeding site.

• Educate surgical staff about this risk and proper use of the product. • Use the applicator, spray set, and pressure control device or regulator as noted in the labeling. • Use an air- or gas-pressure setting within the range recommended by the manufacturer. • Ensure that the distance between the spray head and the tissue is at or above the minimum recommended by the manufacturer.

2,5

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Table 3. Problems Involving Drug Information, Patient Information, Staff Education, and Patient Education (continued) Title

Problem/Discussion Point

Recommendation

Insulin errors

• In events reported to the Pennsylvania Patient Safety Authority involving insulin products, 52% were situations in which a patient received the wrong dose of insulin or had a dose of insulin omitted.

• To identify and monitor problems associated with insulin, the Pennsylvania Patient Safety Authority has posted a sample tool on its Web site: http://patientsafetyauthority.org/ EducationalTools/PatientSafetyTools/insulin/ Pages/home.aspx. • Consider using this tool to document facilityspecific process and outcome measures involving the use of insulin.

Technology

Scan for insulin safety tool. Instructions on page 8. Methylene blue

• Methylene blue is used as an antidote for drug-induced methemoglobinemia. • Accidental overdoses of methylene blue occur occasionally; the patient could turn blue, which can be mistaken for cyanosis. • Dosing errors are possible if the mg dose is accidentally prescribed as mL, or if the computer system lists the dose of methylene blue in mL.

• Ensure your computer system does not default to mL dosing for methylene blue. • Educate prescribers to order methylene blue only in mg. • Consider adding a maximum weight-based dose of 2.5 mg/kg to your pharmacy computer system for methylene blue to further protect against accidental overdoses.

1,5

niMODipine enteral administration

• When administering niMODipine through a feeding tube, the FDA recommends puncturing the capsule with an 18-gauge needle and extracting the liquid contents with a parenteral syringe labeled “Not for IV Use.” This may result in accidental IV administration, particularly if only the “…IV Use” portion of the label is read.

• Liquid niMODipine should be prepared ONLY in the pharmacy and be dispensed ONLY in an oral syringe labeled “WARNING: For Oral Use Only.” • Outsourcing the preparation of liquid niMODipine from a reliable compounding pharmacy is another option.

Syringe pullback

• Checks performed after manual IV admixture preparation often involve the “syringe pullback” method, which is less than ideal. • Two fatalities occurred because of IV admixture errors that were not detected during the checking process. • This type of error is based on the preparer’s memory of how much drug was added to the bag and proper placement of the syringe next to the used product in crowded spaces.

• Use commercially available or outsourced premixed products whenever possible. • When pharmacy admixture is required, employ an independent double-check process for high-alert medications. • Procure IV robotic preparation systems and commercially available workflow management systems.

SUPER GLUE (cyanoacrylate) and possibly other similar adhesive products

• A woman who had cataract surgery was reaching for her eye medications when she mistook Super Glue for eye ointment and glued her eye shut.

• Individuals using ophthalmics should be warned not to purchase Super Glue or other adhesives in a container that looks like an eye medication. • Store the glue far away from all medications and instruct patients to do the same. • In the event that eyelids are stuck together or bonded to the eyeball, wash the area thoroughly with warm water and apply a gauze patch. • The eye will open without further action within 1 to 4 days.

Wrong insulin concentration

• A new nurse in the emergency department helped a busy colleague by preparing an insulin infusion in a 5 units/mL concentration. The hospital’s standard concentration for insulin infusions was 1 unit/mL. Although the bag was properly labeled, the concentration was not reviewed during handoff to the receiving nurse, who started the infusion according to the hospital’s standard concentration.

• Pharmacies should prepare or outsource infusions that are not commercially available. • When 24-h pharmacy coverage is not an option, or if immediate use is warranted, up-to-date hospital-approved drug guidelines for IV admixtures prepared by nurses should be readily available. • Nurse-prepared infusions, especially with highalert drugs, should be independently checked after preparation and during handoffs.

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2,3

Table 4. Medical Devices and Other Discussion Items Title

Problem/Discussion Point

Recommendation

Technology

Accidental overdose with bolus of magnesium sulfate

• An obstetrician prescribed an IV magnesium sulfate bolus dose of 6 g over 30 min, followed by a continuous infusion of 2 g/hour for a patient in preterm labor. A nurse obtained a 20 g per 500 mL bag of magnesium sulfate and programmed the bolus to be delivered as a continuous infusion at 12 g/hour with no volume limit. The nurse forgot to return to the patient’s room in 30 min to reprogram the rate to 2 g/hour. The smart pump did not provide a hard stop to prevent the administration of an excessive dose of magnesium sulfate.

• Never infuse an IV magnesium sulfate bolus dose from the maintenance solution unless: –The bolus dose is delivered using the bolus-dose feature –Separate dose limits are operational for bolus and maintenance doses –Alerts are configured as a “hard stop” –A qualified nurse remains at the bedside during infusion of the bolus dose to monitor the patient for signs of magnesium toxicity.

2,3,5

Administration of IV Dakin’s solution

• A woman admitted to a hospital with burns on her arm had orders for topical wound irrigation with Dakin’s solution. An IV was started in the same arm and later capped but not removed because it was partially covered by the burn dressing. The nurse believed the capped IV was an irrigation catheter under the dressing and administered the Dakin’s solution via the capped IV catheter.

• Apply clearly visible labels on access lines that are covered with dressings or clothing. • Trace tubing and catheters to the point of origin to prevent misconnections. • Ask vendors to supply a setup for irrigations that won’t connect to an IV access port. • Prepare irrigations in the pharmacy in containers that are dissimilar to IV containers.

Baxa oral syringes

• Certain Baxa oral syringes make it difficult to measure doses. • Baxa’s 5-mL amber oral syringe marks 1/4 teaspoon at 1.2 mL instead of 1.25 mL. • Some numbers on Baxa’s 3- and 5-mL clear plastic oral syringes do not align with the correct calibration markings.

• Assess your supply of oral syringes and inform nurses accordingly. • Advise practitioners to measure doses in mL because of the misalignment of the teaspoonful markings. • Consider temporarily seeking inventory from another manufacturer.

Fatal heparin error

• Drug libraries and dose-checking capabilities on smart pumps often are not used. • In one case, a child died after receiving a large overdose of IV heparin because of an error in an infusion pump setting that was not detected during a verbal checking process; potentially beneficial features of the smart pump were not used.

• Identify and remove barriers to using smart pump technology to its full potential. • Examine internal errors associated with heparin and common risks to identify weaknesses in the way smart pumps are used.

Scan for tips on smarter use of smart pumps. Instructions on page 8. Infusion pump safety issues

• FDA has ordered Baxter to recall and destroy all Colleague pumps because the company did not address known safety issues within an acceptable timeframe. • Hospira Symbiq infusion pumps may not detect air in the line if a clinician programs the pump to infuse more volume than in the bag/bottle. • Unrestricted flow can occur with Symbiq if the cassette is removed before the cassette carriage is in the fully open position.

• Continue to use Baxter Colleague pumps while Baxter works with the FDA to develop a transition plan. • Visit the FDA’s Web site for strategies to mitigate risks with these pumps. • If using Hospira Symbiq pumps, review the safety steps outlined by the company with your frontline staff.

Intrathecal baclofen pump

• A patient was hospitalized after receiving a significant overdose of intrathecal baclofen. The patient’s physician had accidentally programmed a Medtronic SynchroMed II implantable pump to administer an extra dose every hour instead of every morning. • Medtronic had previously distributed a letter via its sales force to warn about programming errors and announce software modifications.

• Check that latest software updates are received for institutional pumps. • Do not rely on the updates alone to prevent errors. An independent double-check is one means to ensure accurate programming. • Advise emergency department staff to consider an error if patients with implantable pumps report a recent refill or programming change.

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Table 4. Medical Devices and Other Discussion Items

(continued)

Title

Problem/Discussion Point

Recommendation

IV tubing fits with nebulizer

• Albuterol inhalation solution was added to an IV bag with tubing that was fit into a nebulizer to provide continuous respiratory therapy. A nurse discovered that a patient’s IV medications had been infused into the IV tubing connected to the nebulizer.

• Only add inhalation solutions directly into a nebulizer cup as needed.

Ommaya reservoir

• An adult patient had been receiving IV vinCRIStine and intracerebroventricular methotrexate through an Ommaya reservoir. The patient inadvertently received vinCRIStine via the Ommaya reservoir and died.

• Dispense and administer vinCRIStine diluted in a minibag, and separate IV and spinal medication delivery times. • View the free FDA Patient Safety Video on this topic at www.accessdata. fda.gov/psn/transcript.cfm?show=68#7.

Technology

2,3,5

Scan for patient safety video. Instructions below.

Text continued from page 2

Program. ISMP is an accessible resource for any pharmacist or organization interested in implementing the actions recommended herein. Among the many products and services that ISMP offers is the ISMP Medication Safety Alert! Acute Care Edition, a biweekly newsletter that provides timely information related to error prevention. It identifies errors that have been reported by other organizations and offers recommendations to prevent those errors from occurring in the pharmacy. The information in Tables 1 to 4 of this review summarizes many of the significant error-prevention strategies that were recommended in the ISMP Medication Safety Alert! Acute Care Edition during 2010. The errors presented in the tables are actual or potential errors reported to ISMP. Each table consists of 4 columns. The first column lists the medications, devices, or other problematic issues

involved. The second column describes the specific error or problem involved. The third column addresses ISMP’s recommendations to proactively address and prevent errors from occurring. The fourth column lists technology that may help prevent these errors. Technology can be a powerful tool in the fight against medication errors but only when it is used appropriately within a well-designed medication-use system. The key summarizes the technology addressed in the tables, along with specific criteria that ISMP feels should be included.

Suggested Reading Cohen MR, ed. Medication Errors. 2nd ed. Washington, DC: American Pharmacists Association; 2007. Institute for Safe Medication Practices Web site: www.ismp.org. Institute for Safe Medication Practices. ISMP Medication Safety Alert! Acute Care Edition newsletter 2010. www.ismp.org/newsletters/ default.asp. Accessed March 28, 2011.

I N D E P E N D E N T LY D E V E L O P E D B Y M C M A H O N P U B L I S H I N G

Pharmacy Practice News • April 2011

Operations & Management 23

Practice Pearl should be performed again once a year for low- and medium-risk levels or semiannually for high-risk levels. Aseptic manipulation competency evaluation media-fill testing should be done during media-fill test procedures. Testing should reflect the most challenging/ stressful conditions that will be encountered during preparation. An initial media-fill test should be conducted and then additional testing should be done annually for low- and medium-risk levels, and semiannually for high-risk levels. Garbing, hand hygiene, environmental cleaning and disinfecting performed by compounding staff should be visually evaluated for competency and the results should be documented. Periodic surface sampling of defined ISO-classified areas

should be conducted at the completion of a compounding shift, and the results should be maintained and recorded in the pharmacy. Evaluations should be done during initial training of personnel, after completion of any media-fill test procedure, and when staff changes. One way to ensure that personnel training meets these standards is by designating a technician and a pharmacist to be accountable for tracking and monitoring all quality assurance recommendations associated with USP <797>, such as maintaining staff competency, performance improvement projects, and environmental quality assurance logs.

Conclusion Pharmacists are in a prime position

to ensure that USP <797> standards are adhered to for sterile drug compounding in health-system facilities. Their skills in pharmacotherapy help to ensure safe compounding practices to enforce the USP <797> environmental and competency standards required of pharmacy and hospital personnel. Pharmacist oversight of this area to ensure compliance and best standards of practice in sterile drug compounding, administration, and storage will promote patient safety.

2. Traynor K. JCAHO Offers Guidance, Timeline of USP 797 Compliance. 2004. http://www. ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=1684. Accessed January 26, 2011. 3. American Society of Health-System Pharmacists in collaboration with Baxter Healthcare Corporation. The ASHP Discussion Guide on USP Chapter 797 for Compounding Sterile Preparations. http://www.ashp.org/s_ashp/ docs/files/HACC_797guide.pdf. Accessed March 28, 2011. 4. Huynh T, Jalundhwala Y, Subramaniam V. Hazardous drugs—maintaining standards of safe pharmacy practice. Pharmacy Practice News. 2010;37(12):4-6.

References 1. The United States Pharmacopeial Convention. USP Chapter 797 Pharmaceutical Compounding – Sterile Preparations. In USP 31/NF 26;2008. Rockville, MD.

This article was written by the authors in their private capacity. No official support or endorsement by the VA is intended or should be inferred.

Table. Pharmacy Competency Checklists for Meeting USP <797> Standards for Sterile Compounding

Cleaning

Environmental Quality and Control

Standard Area Task/Test Total particle counts

Expectations (USP <797>; USP 33/NF 28; 2010)

Frequency (USP <797>; USP 33/NF 28; 2010)

• ISO class 5, 7, and 8 classified areas and any of the PECs • All certification records shall be maintained/reviewed by a supervising or designated employee

• Every 6 mo for recertifications and whenever any alteration/relocation is done to the environment/equipment

Pressure differential monitoring • Pressure from ISO class 7 to pharmacy shall be >5 Pa • Airflow between buffer and ante area where low- and medium-risk CSPs are prepared shall be a minimum velocity of 0.2 m/sec

• Recorded every shift (minimum at least daily) or by continuous recording device

Temperature and humidity monitoring

• Provide a temperature and relative humidity sensor in each buffer room to monitor these 2 environmental parameters

• Continuous monitoring • Temperature ≤68° F (20° C) • Relative humidity range between 30% and 60%

Viable air sampling with appropriate growth media

• Performed at locations prone to contamination, with impaction preferred for volumetric air collection

• Every 6 mo as part of the recertification of facilities/equipment

ISO class 5 primary engineering control (LAFW, BSC, CAI, CACI)

• Cleaning and disinfecting all areas before compounding using recommended disinfectants and materials

• At onset of each shift, before batches, after spills or surface contamination, every 30 min during compounding activities

Counters/work surfaces/floors

• Appropriate cleaning and disinfecting agents

• Daily

Personnel Testing

Walls/ceilings/storage shelving • Appropriate cleaning and disinfecting agents

• Monthly

Initial training/demonstration: didactic training, written test, observational skill assessment, and media-fill testing

• All personnel should view the ASHP video “Quality Assurance for Pharmacy-Prepared Sterile Products” and take assessment, demonstrate appropriate cleaning, manipulation and placement of materials and components within IV cleanroom hood, and be familiar with CSP labeling requirements

• Prior to being allowed to prepare CSPs and during regular interval assessments

Glove fingerprint sampling

• Sterile contact agar plates shall be used to evaluate competency of garbing and hand-washing techniques • Successful completion = zero CFU

• Complete 3 successful tests before compounding CSPs for human use, then: –Annually (low- and medium-risk CSPs) or –Semiannually (high-risk CSPs)

Garbing and gloving competency evaluation

• Observe performing appropriate hand hygiene and garbing procedures (remove all jewelry, wear appropriate attire, and cleanse hands/arms/elbows)

• Regular visual observation to be documented, maintained, and assessed

Aseptic manipulation competency evaluation media-fill testing

• Performed during media-fill test procedures that represent the most challenging/stressful conditions after successful completion of garbing and gloving competency • Maintain records of evaluation

• Before compounding sterile products, then: –Annually (low- and medium-risk CSPs) –Semiannually (high-risk CSPs)

Cleaning and disinfecting competency evaluation

• Visual observation shall be documented and maintained for long-term assessment

• Initial training on cleaning procedures • Changes in staff • Completion of any media-fill test procedure

Surface cleaning and disinfecting

• Surface sampling performed in all ISO classified areas

• Performed periodically (results as CFU/surface area unit)

ASHP, American Society of Health-System Pharmacists; BSC, biological safety cabinet; CACI, compounding aseptic containment isolator; CAI, compounding aseptic isolator; CFU, colony-forming units; CSP, compounded sterile preparation; ISO, International Organization of Standards; LAFW, laminar air-flow workbench; PECs, primary engineering controls Based on reference 1.

Date/Time Completed

24 Operations & Management

Pharmacy Practice News • April 2011

Leadership in Action

The Seven Decisions of Masterful Leaders I 3

n the decisions I make regarding leadership, I am keenly aware that I am always influencing others. That influence has the potential to be positive or negative. My goal is to lead in a positive way, to add something to the lives of those I mentor, work with and lead. It has been said that we will be known by the choices that we make in life. This is why I take my own choices quite seriously. I look for principles that I can follow. A principle is something that is always true and does not change. It’s similar to a law, such as the law of gravity. Whether we like it or not, it just is. We can defy it, but we can’t change it; it still works on us. Andy Andrews, in his book Mastering the Seven Decisions that Determine Personal Success (Nashville, TN: Thomas Nelson; 2008), has identified seven leadership principles that can help guide your decision making. As I have incorporated Mr. Andrews’ principles into my daily life, I have seen results. Mastering these seven decisions takes practice and consistency. It is not always easy, but it has enormous potential to make you successful. The Responsible Decision. The responsible decision says that we accept personal responsibility for all that we do. We do not blame others or our genetics, our history or our circumstances. Determinism has no place in our thinking. We are “responseable” (able to respond). Are you taking responsibility for what you do? One way to check yourself is to listen to your own language. Reactive people blame others for their circumstances and allow others to control them. I often tell the people I mentor not to be overtaken or controlled by the weaknesses of others. If you allow others to “make you mad,” all you’ve done is empower them. Make a decision to accept responsibility for your responses in all situations. This gives you the power and the upper hand. Be known as the calming force that looks at the facts and make a responsible decision, taking full ownership. This allows you to learn from your failures, grow and move forward. The Guided Decision. We recognize that we cannot possibly know everything we need to know to make perfect decisions. It’s often a good idea, therefore, to seek out wise counsel. Of course, wisdom goes beyond just knowledge. It is the application of that knowledge that makes one wise. So, who are your “go-to” people? I think of these people in my life as my personal board of directors. These are the individuals with whom I consult to gain insights, get input, bounce ideas around and gather information. Our system pharmacy

directors and clinical coordinators often are my board of directors, although they don’t know that. I consult their wisdom continuously. I have friends outside of pharmacy who also are a part of my board. Of course, I never pull all these people together into a room for a board meeting. But they truly are my personal consultants. Books and periodicals are other sources I use to help guide my decision making. In medicine, we use

evidence as our guide to making correct decisions. The Active Decision. The active decision says “I will be a person of action.” We often have heard of analysis paralysis, where we analyze so much and never make a decision. Successful people make decisions. We recognize that not all of our decisions will be 100% correct. We use the best wisdom we can garner to make informed decisions, but we move! I

“Leadership in Action” is authored by Ernest R. Anderson Jr., MS, RPh, System Vice President of Pharmacy, Steward Health Care System, Boston, Mass. Mr. Anderson welcomes your input on leadership issues, at ernest.anderson@ steward.org.

Ernest R. Anderson Jr., MS, RPh

think of the best leaders who I have seen in action. They are people who seek the counsel of those more knowledgeable, and set a course of action before they walk out of the room. Sometimes that action will be to gather more information

Step up to a range of insulin delivery options.

As part of Eli Lilly and Company’s ongoing commitment, we provide healthcare facilities with a choice of vial sizes. Humalog® (insulin lispro injection [rDNA origin]), Humulin® R U-100 (regular insulin human injection, USP [rDNA origin]), and Humulin® N (NPH human insulin [rDNA origin] isophane suspension) are available in a smaller vial size.* The smaller vials are designed to give healthcare facilities ﬂexibility when evaluating insulin storage and distribution (ﬂoor stock vs individual patient supply), in addition to the 10 mL vial and Humalog® KwikPen™. • Humalog Smaller Vial* NDC Number - 0002-7510-17 • Humulin R U-100 Smaller Vial* NDC Number - 0002-8215-17 • Humulin N Smaller Vial* NDC Number - 0002-8315-17 * Smaller vials contain 3 mL of insulin in a 5 mL vial.

Humalog Indication Humalog (insulin lispro injection [rDNA origin]) is for use in patients with diabetes mellitus for the control of hyperglycemia. Humalog should be used with longeracting insulin, except when used in combination with sulfonylureas in patients with type 2 diabetes.

HI69632

0211 PRINTED IN USA

Humalog Important Safety Information Contraindications Humalog is contraindicated during episodes of hypoglycemia and in patients sensitive to Humalog or one of its excipients. Warnings Humalog differs from regular human insulin by its rapid onset of action as well as a shorter duration of action. Therefore, when used as a mealtime insulin, Humalog should be given within 15 minutes before or immediately after a meal. Due to the short duration of action of Humalog, patients with type 1 diabetes also require a longer-acting insulin to maintain glucose control (except when using an insulin pump). Glucose monitoring is recommended for all patients with diabetes. The safety and effectiveness of Humalog in patients less than 3 years of age have not been established. There are no adequate and well-controlled clinical studies of the use of Humalog in pregnant or nursing women.

Pharmacy Practice News • April 2011

Operations & Management 25

Leadership in Action if necessary, but often it is with recommendations for action to the next level. Walk out of every encounter with an action plan. Clarify assignments, responsibilities and time lines. The Certain Decision. Once you have made the decision—stay resolute. Break through fear, judgment and second guessing. People can sense indecision. We need to exude passionate decisiveness. Think of those who you admire for their decisiveness. You want to be on their team. Now think of yourself as that decisive leader. People want

to be on your team. The Joyful Decision. We can choose to be happy, regardless of the circumstances. If you were hiring a new pharmacist and were interviewing two people of equal competency, but one was a positive, upbeat person and the other was the opposite, who would you choose? I’d choose the happy person. Successful people have made a decision to be joyful. Our countenance is a reflection of that decision. When I lecture, I consider it a success when I can get a laugh (or at least a smile).

The Compassionate Decision. Have you ever met one of those people who just “had it out” for another person? If so, chances are it was not pleasant. Are you one of these people? Harboring resentment only hurts the one who harbors it. Make an effort to not make decisions motivated by resentment or grudges. Choose to live at peace with others. Forgiveness is the compassionate decision that brings people together. The Persistent Decision. Most of us have encountered or even revered someone who had the tenacity to keep

Humalog Important Safety Information, continued

Warnings, continued Starting or changing insulin therapy should be done cautiously and only under medical supervision.

Other Side Effects, continued in action of Humalog, care should be taken in patients in whom hypoglycemia or hypokalemia may be clinically relevant (eg, those who are fasting, have autonomic neuropathy or renal impairment, are using potassiumlowering drugs, or taking drugs sensitive to serum potassium level).

Hypoglycemia Hypoglycemia is the most common adverse effect associated with insulins, including Humalog. Hypoglycemia can happen suddenly, and symptoms may be different for each person and may change from time to time. Severe hypoglycemia can cause seizures and may be life-threatening. Other Side Effects Other potential side effects associated with the use of insulins include: hypokalemia, weight gain, lipodystrophy, and hypersensitivity. Systemic allergy is less common, but may be life-threatening. Because of the difference

Please see adjacent pages for Brief Summary of full Prescribing Information for Humalog. Please see full user manual that accompanies the pen. Humalog® and Humalog® KwikPen™ are registered trademarks of Eli Lilly and Company and are available by prescription only. Humulin® is a registered trademark of Eli Lilly and Company.

going despite obstacles or failures. Are you one of them? We all can relate to having had failures or disappointments. How have you chosen to respond? Have you decided that this failure was a good learning experience, or a lesson in what not to do? Have you moved forward and persisted despite this setback? These seven principles can be highly effective in both your personal and professional lives. As I mentioned earlier, a framework can simplify and optimize decision making. This is one framework you can use to begin.

HUMALOG® INSULIN LISPRO INJECTION (rDNA ORIGIN) BRIEF SUMMARY: Consult package insert for complete prescribing information. INDICATIONS AND USAGE: Humalog is an insulin analog that is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Humalog has a more rapid onset and a shorter duration of action than regular human insulin. Therefore, in patients with type 1 diabetes, Humalog should be used in regimens that include a longer-acting insulin. However, in patients with type 2 diabetes, Humalog may be used without a longer-acting insulin when used in combination therapy with sulfonylurea agents. Humalog may be used in an external insulin pump, but should not be diluted or mixed with any other insulin when used in the pump. Humalog administration in insulin pumps has not been studied in patients with type 2 diabetes. CONTRAINDICATIONS: Humalog is contraindicated during episodes of hypoglycemia and in patients sensitive to Humalog or any of its excipients. WARNINGS: This human insulin analog differs from regular human insulin by its rapid onset of action as well as a shorter duration of activity. When used as a mealtime insulin, the dose of Humalog should be given within 15 minutes before or immediately after the meal. Because of the short duration of action of Humalog, patients with type 1 diabetes also require a longer-acting insulin to maintain glucose control (except when using an external insulin pump). External Insulin Pumps: When used in an external insulin pump, Humalog should not be diluted or mixed with any other insulin. Patients should carefully read and follow the external insulin pump manufacturer’s instructions and the “PATIENT INFORMATION” leaflet before using Humalog. Physicians should carefully evaluate information on external insulin pump use in the Humalog physician package insert and in the external insulin pump manufacturer’s instructions. If unexplained hyperglycemia or ketosis occurs during external insulin pump use, prompt identification and correction of the cause is necessary. The patient may require interim therapy with subcutaneous insulin injections (see PRECAUTIONS, For Patients Using External Insulin Pumps, and DOSAGE AND ADMINISTRATION). Hypoglycemia is the most common adverse effect associated with the use of insulins, including Humalog. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes and is particularly important for patients using an external insulin pump. Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (eg, regular, NPH, analog), species, or method of manufacture may result in the need for a change in dosage. PRECAUTIONS: General—Hypoglycemia and hypokalemia are among the potential clinical adverse effects associated with the use of all insulins. Because of differences in the action of Humalog and other insulins, care should be taken in patients in whom such potential side effects might be clinically relevant (eg, patients who are fasting, have autonomic neuropathy, or are using potassium-lowering drugs or patients taking drugs sensitive to serum potassium level). Lipodystrophy and hypersensitivity are among other potential clinical adverse effects associated with the use of all insulins. As with all insulin preparations, the time course of Humalog action may vary in different individuals or at different times in the same individual and is dependent on site of injection, blood supply, temperature, and physical activity. Adjustment of dosage of any insulin may be necessary if patients change their physical activity or their usual meal plan. Insulin requirements may be altered during illness, emotional disturbances, or other stress. Hypoglycemia—As with all insulin preparations, hypoglycemic reactions may be associated with the administration of Humalog. Rapid changes in serum glucose concentrations may induce symptoms of hypoglycemia in persons with diabetes, regardless of the glucose value. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control. Renal Impairment—The requirements for insulin may be reduced in patients with renal impairment. Hepatic Impairment—Although impaired hepatic function does not affect the absorption or disposition of Humalog, careful glucose monitoring and dose adjustments of insulin, including Humalog, may be necessary. Allergy—Local Allergy—As with any insulin therapy, patients may experience redness, swelling, or itching at the site of injection. These minor reactions usually resolve in a few days to a few weeks. In some instances, these reactions may be related to factors other than insulin, such as irritants in a skin cleansing agent or poor injection technique. Systemic Allergy—Less common, but potentially more serious, is generalized allergy to insulin, which may cause rash (including pruritus) over the whole body, shortness of breath, wheezing, reduction in blood pressure, rapid pulse, or sweating. Severe cases of generalized allergy, including anaphylactic reaction, may be life-

threatening. Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient. In Humalog-controlled clinical trials, pruritus (with or without rash) was seen in 17 patients receiving Humulin R® (N=2969) and 30 patients receiving Humalog (N=2944) (P=.053). Antibody Production—In large clinical trials, antibodies that cross-react with human insulin and insulin lispro were observed in both Humulin R- and Humalogtreatment groups. As expected, the largest increase in the antibody levels during the 12-month clinical trials was observed with patients new to insulin therapy. Usage of Humalog in External Insulin Pumps—The infusion set (reservoir syringe, tubing, and catheter), Disetronic® D-TRON®2,3 or D-TRONplus®2,3 cartridge adapter, and Humalog in the external insulin pump reservoir should be replaced and a new infusion site selected every 48 hours or less. Humalog in the external insulin pump should not be exposed to temperatures above 37°C (98.6°F). In the D-TRON®2,3 or D-TRONplus®2,3 pump, Humalog 3 mL cartridges may be used for up to 7 days. However, as with other external insulin pumps, the infusion set should be replaced and a new infusion site should be selected every 48 hours or less. When used in an external insulin pump, Humalog should not be diluted or mixed with any other insulin (see INDICATIONS AND USAGE, WARNINGS, PRECAUTIONS, For Patients Using External Insulin Pumps, Mixing of Insulins, DOSAGE AND ADMINISTRATION, and Storage). Information for Patients—Patients should be informed of the potential risks and advantages of Humalog and alternative therapies. Patients should also be informed about the importance of proper insulin storage, injection technique, timing of dosage, adherence to meal planning, regular physical activity, regular blood glucose monitoring, periodic hemoglobin A1C testing, recognition and management of hypoglycemia and hyperglycemia, and periodic assessment for diabetes complications. Patients should be advised to inform their physician if they are pregnant or intend to become pregnant. Refer patients to the “PATIENT INFORMATION” leaflet for timing of Humalog dosing (<_15 minutes before or immediately after a meal), storing insulin, and common adverse effects. For Patients Using Insulin Pen Delivery Devices: Before starting therapy, patients should read the “PATIENT INFORMATION” leaflet that accompanies the drug product and the User Manual that accompanies the delivery device. They should also reread these materials each time the prescription is renewed. Patients should be instructed on how to properly use the delivery device, prime the Pen to a stream of insulin, and properly dispose of needles. Patients should be advised not to share their Pens with others. For Patients Using External Insulin Pumps: Patients using an external infusion pump should be trained in intensive insulin therapy and in the function of their external insulin pump and pump accessories. Humalog was tested in the MiniMed®1 Models 506, 507, and 508 insulin pumps using MiniMed®1 Polyfin®1 infusion sets. Humalog was also tested in the Disetronic®2 H-TRONplus® V100 insulin pump (with plastic 3.15 mL insulin reservoir), and the Disetronic D-TRON®2,3 and D-TRONplus®2,3 insulin pumps (with Humalog 3 mL cartridges) using Disetronic Rapid®2 infusion sets. The infusion set (reservoir syringe, tubing, catheter), D-TRON ®2,3 or D-TRONplus®2,3 cartridge adapter, and Humalog in the external insulin pump reservoir should be replaced, and a new infusion site selected every 48 hours or less. Humalog in the external pump should not be exposed to temperatures above 37°C (98.6°F). A Humalog 3 mL cartridge used in the D-TRON®2,3 or D-TRONplus®2,3 pump should be discarded after 7 days, even if it still contains Humalog. Infusion sites that are erythematous, pruritic, or thickened should be reported to medical personnel, and a new site selected. Humalog should not be diluted or mixed with any other insulin when used in an external insulin pump. Laboratory Tests—As with all insulins, the therapeutic response to Humalog should be monitored by periodic blood glucose tests. Periodic measurement of hemoglobin A1C is recommended for the monitoring of long-term glycemic control. Drug Interactions—Insulin requirements may be increased by medications with hyperglycemic activity, such as corticosteroids, isoniazid, certain lipid-lowering drugs (eg, niacin), estrogens, oral contraceptives, phenothiazines, and thyroid replacement therapy (see CLINICAL PHARMACOLOGY). Insulin requirements may be decreased in the presence of drugs that increase insulin sensitivity or have hypoglycemic activity, such as oral antidiabetic agents, salicylates, sulfa antibiotics, certain antidepressants (monoamine oxidase inhibitors), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blocking agents, beta-adrenergic blockers, inhibitors of pancreatic function (eg, octreotide), and alcohol. Beta-adrenergic blockers may mask the symptoms of hypoglycemia in some patients. Mixing of Insulins—Care should be taken when mixing all insulins as a change in peak action may occur. The American Diabetes Association warns in its Position Statement on Insulin Administration, “On mixing, physiochemical changes in the mixture may occur (either immediately or over time). As a result, the physiological response to the insulin mixture may differ from that of the injection of the insulins separately.” Mixing Humalog with Humulin® N or Humulin® U does not decrease the absorption rate or the total bioavailability of Humalog.

Given alone or mixed with Humulin N, Humalog results in a more rapid absorption and glucose-lowering effect compared with regular human insulin. Pregnancy—Teratogenic Effects—Pregnancy Category B—Reproduction studies with insulin lispro have been performed in pregnant rats and rabbits at parenteral doses up to 4 and 0.3 times, respectively, the average human dose (40 units/day) based on body surface area. The results have revealed no evidence of impaired fertility or harm to the fetus due to Humalog. There are, however, no adequate and wellcontrolled studies with Humalog in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Although there are limited clinical studies of the use of Humalog in pregnancy, published studies with human insulins suggest that optimizing overall glycemic control, including postprandial control, before conception and during pregnancy improves fetal outcome. Although the fetal complications of maternal hyperglycemia have been well documented, fetal toxicity also has been reported with maternal hypoglycemia. Insulin requirements usually fall during the first trimester and increase during the second and third trimesters. Careful monitoring of the patient is required throughout pregnancy. During the perinatal period, careful monitoring of infants born to mothers with diabetes is warranted. Nursing Mothers—It is unknown whether Humalog is excreted in significant amounts in human milk. Many drugs, including human insulin, are excreted in human milk. For this reason, caution should be exercised when Humalog is administered to a nursing woman. Patients with diabetes who are lactating may require adjustments in Humalog dose, meal plan, or both. Pediatric Use—In a 9-month, crossover study of prepubescent children (n=60), aged 3 to 11 years, comparable glycemic control as measured by A1C was achieved regardless of treatment group: regular human insulin 30 minutes before meals 8.4%, Humalog immediately before meals 8.4%, and Humalog immediately after meals 8.5%. In an 8-month, crossover study of adolescents (n=463), aged 9 to 19 years, comparable glycemic control as measured by A1C was achieved regardless of treatment group: regular human insulin 30 to 45 minutes before meals 8.7% and Humalog immediately before meals 8.7%. The incidence of hypoglycemia was similar for all 3 treatment regimens. Adjustment of basal insulin may be required. To improve accuracy in dosing in pediatric patients, a diluent may be used. If the diluent is added directly to the Humalog vial, the shelf life may be reduced (see DOSAGE AND ADMINISTRATION). Geriatric Use—Of the total number of subjects (n=2834) in 8 clinical studies of Humalog, 12% (n=338) were 65 years of age or over. The majority of these were patients with type 2 diabetes. A1C values and hypoglycemia rates did not differ by age. Pharmacokinetic/pharmacodynamic studies to assess the effect of age on the onset of Humalog action have not been performed. ADVERSE REACTIONS: Clinical studies comparing Humalog with regular human insulin did not demonstrate a difference in frequency of adverse events between the 2 treatments. Adverse events commonly associated with human insulin therapy include the following: Body as a Whole—allergic reactions (see PRECAUTIONS). Skin and Appendages—injection site reaction, lipodystrophy, pruritus, rash. Other—hypoglycemia (see WARNINGS and PRECAUTIONS). OVERDOSAGE: Hypoglycemia may occur as a result of an excess of insulin relative to food intake, energy expenditure, or both. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. DOSAGE AND ADMINISTRATION: Humalog is intended for subcutaneous administration, including use in select external insulin pumps (see DOSAGE AND ADMINISTRATION, External Insulin Pumps). Dosage regimens of Humalog will vary among patients and should be determined by the healthcare provider familiar with the patient’s metabolic needs, eating habits, and other lifestyle variables. Pharmacokinetic and pharmacodynamic studies showed Humalog to be equipotent to regular human insulin (ie, one unit of Humalog has the same glucose-lowering effect as one unit of regular human insulin), but with more rapid activity. The quicker glucose-lowering effect of Humalog is related to the more rapid absorption rate from subcutaneous tissue. An adjustment of dose or schedule of basal insulin may be needed when a patient changes from other insulins to Humalog, particularly to prevent premeal hyperglycemia. When used as a mealtime insulin, Humalog should be given within 15 minutes before or immediately after a meal. Regular human insulin is best given 30 to 60 minutes before a meal. To achieve optimal glucose control, the amount of longeracting insulin being given may need to be adjusted when using Humalog. The rate of insulin absorption and consequently the onset of activity are known to be affected by the site of injection, exercise, and other variables. Humalog was absorbed at a consistently faster rate than regular human insulin in healthy male volunteers given 0.2 U/kg regular human insulin or Humalog at abdominal, deltoid, or

femoral sites, the 3 sites often used by patients with diabetes. When not mixed in the same syringe with other insulins, Humalog maintains its rapid onset of action and has less variability in its onset of action among injection sites compared with regular human insulin (see PRECAUTIONS). After abdominal administration, Humalog concentrations are higher than those following deltoid or thigh injections. Also, the duration of action of Humalog is slightly shorter following abdominal injection, compared with deltoid and femoral injections. As with all insulin preparations, the time course of action of Humalog may vary considerably in different individuals or within the same individual. Patients must be educated to use proper injection techniques. Humalog in a vial may be diluted with STERILE DILUENT for Humalog, Humulin N, Humulin R, Humulin 70/30, and Humulin® R U-500 to a concentration of 1:10 (equivalent to U-10) or 1:2 (equivalent to U-50). Diluted Humalog may remain in patient use for 28 days when stored at 5°C (41°F) and for 14 days when stored at 30°C (86°F). Do not dilute Humalog contained in a cartridge or Humalog used in an external insulin pump. Parenteral drug products should be inspected visually before use whenever the solution and the container permit. If the solution is cloudy, contains particulate matter, is thickened, or is discolored, the contents must not be injected. Humalog should not be used after its expiration date. The cartridge containing Humalog is not designed to allow any other insulin to be mixed in the cartridge or for the cartridge to be refilled with insulin. External Insulin Pumps—Humalog was tested in MiniMed®1 Models 506, 507, and 508 insulin pumps using MiniMed®1 Polyfin®1 infusion sets. Humalog was also tested in the Disetronic®2 H-TRONplus® V100 insulin pump (with plastic 3.15 mL insulin reservoir) and the Disetronic D-TRON®2,3 and D-TRONplus®2,3 pumps (with Humalog 3 mL cartridges) using Disetronic Rapid®2 infusion sets. Humalog should not be diluted or mixed with any other insulin when used in an external insulin pump. HOW SUPPLIED: Humalog (insulin lispro injection, USP [rDNA origin]) is available in the following package sizes (with each presentation containing 100 units insulin lispro per mL [U-100]): 10 mL vials NDC 0002-7510-01 (VL-7510) 3 mL vials NDC 0002-7510-17 (VL-7533) 5 x 3 mL cartridges3 NDC 0002-7516-59 (VL-7516) 5 x 3 mL prefilled insulin delivery devices (Pen) NDC 0002-8725-59 (HP-8725) 5 x 3 mL prefilled insulin delivery devices (Humalog® KwikPen™) NDC 0002-8799-59 (HP-8799) 1

MiniMed® and Polyfin® are registered trademarks of MiniMed, Inc. Disetronic®, H-TRONplus®, D-TRON®, and Rapid® are registered trademarks of Roche Diagnostics GMBH. 3 3 mL cartridge is for use in Eli Lilly and Company’s HumaPen ® MEMOIR™ and HumaPen ® LUXURA™ HD insulin delivery devices, Owen Mumford, Ltd.’s Autopen ® 3 mL insulin delivery device, and Disetronic D-TRON ® and D-TRONplus ® pumps. Autopen ® is a registered trademark of Owen Mumford, Ltd. HumaPen ®, HumaPen ® MEMOIR™ and HumaPen® LUXURA™ HD are trademarks of Eli Lilly and Company. Other product and company names may be the trademarks of their respective owners. 2

Storage —Unopened Humalog should be stored in a refrigerator (2° to 8°C [36° to 46°F]), but not in the freezer. Do not use Humalog if it has been frozen. Unrefrigerated (below 30°C [86°F]) vials, cartridges, Pens, and KwikPens must be used within 28 days or be discarded, even if they still contain Humalog. Protect from direct heat and light. Use in an External Insulin Pump—A Humalog 3 mL cartridge used in the D-TRON®2,3 or D-TRONplus®2,3 should be discarded after 7 days, even if it still contains Humalog. Infusion sets, D-TRON®2,3 and D-TRONplus®2,3 cartridge adapters, and Humalog in the external insulin pump reservoir should be discarded every 48 hours or less. Literature revised December 7, 2009 KwikPens manufactured by Eli Lilly and Company, Indianapolis, IN 46285, USA. Pens manufactured by Eli Lilly and Company, Indianapolis, IN 46285, USA or Lilly France, F-67640 Fegersheim, France. Vials manufactured by Eli Lilly and Company, Indianapolis, IN 46285, USA or Hospira, Inc., Lake Forest, IL 60045, USA or Lilly France, F-67640 Fegersheim, France. Cartridges manufactured by Lilly France, F-67640 Fegersheim, France for Eli Lilly and Company, Indianapolis, IN 46285, USA. www.humalog.com Copyright © 1996, 2008, Eli Lilly and Company. All rights reserved.

28 Policy

Pharmacy Practice News • April 2011

Reimbursement

READMISSION

Table. Opportunities for Pharmacy: Interventions for Preventing Readmissions

continued from page 1

heart failure, acute myocardial infarction and pneumonia. In 2014, chronic obstructive pulmonary disease (COPD) and a handful of vascular surgery procedures will be added, followed in 2015 by additional conditions. In seeking to reduce readmission rates, many hospitals face a difficult challenge, particularly smaller institutions with limited resources. Mr. Riddle cited a 2007 Medicare Payment Advisory Commission (MedPAC) report showing that 17.6% of patients admitted to the hospital were readmitted within 30 days of discharge at a cost of $12 billion. More than three out of four readmissions (75.6%) were potentially avoidable, he said. (To access the report, scan the 2-D bar code on this page.) Whether hospitals are penalized in 2013 will depend on their ability to meet readmission targets beginning October 2011. Even the smallest deviation above expected norms will result in reimbursement losses, Mr. Riddle said. He stressed that prior performance in one of these targeted measures will impact reimbursement across all CMS-reimbursed conditions. Additionally, “there will be no carrot for superior performance.” With the clock ticking, hospitals and health systems across the nation have been scrambling to get their 30-day risk-adjusted readmission rates in line with expectations before the Medicare tracking effort begins. For pharmacies, the challenge is how to channel their limited resources to achieve the greatest impact on readmissions. Mr. Riddle suggested that while there were many potential strategies for pharmacies to follow, the best approach might be to “stratify patients at the highest risk” for readmission and have pharmacists focus on them, perhaps choosing “one simple intervention” such as discharge follow-up phone calls to patients with complicated regimens to make sure they were taking medications correctly. Follow-up phone calls by a pharmacist were a key component of one comprehensive discharge planning initiative at Boston Medical Center that resulted in a 30% reduction in 30-day emergency department visits and rehospitalizations for 370 patients in the intervention group compared with those receiving standard care (n=368; Ann Intern Med 2009;150:178187). (For more study results, see “By the Numbers ...” on page 30). A nurse provided comprehensive discharge education to patients and made sure the care plan was transmitted to various stakeholders, while the pharmacist called patients two to four days after discharge to discuss the treatment plan, review medications and look for any problems. In addition to the reduction

Phase of Care Admission

Inpatient Stay

Discharge

Home

Service Perform Admission Assessment Determine factors in admission/readmission •Medication history •Medication reconciliation •Errors of omission •Adverse drug events (ADE) •Medication adherence •Medication access Determine post-hospital needs •Where will patient likely receive care? •Who are caregivers? •Barriers to care?

Care Optimization Provide effective teaching & enhanced learning •Identify barriers to learning •Medication management •Disease self-management •Medication adherence •Use “Teach Back” method •Provide tools Optimize the medication regimen •Initiate indicated medications •Discontinue unnecessary or unsafe medications •Simplify the medication regimen

Prepare for Transition in Care

Provide Appropriate Post-discharge Care

Medication regimen review •Medication reconciliation •Provide medication list and related information to: –Patient/caregiver –Physician/medical team –Pharmacy/pharmacist Verify appropriate post-discharge care plan •Match discharge followup to need (readmission risk stratification) •Ensure proper information is provided regarding contact information, action plan for care and symptom or ADE management

Contact patient/ caregiver •Live or virtual visit Patient status and medication review •Medication reconciliation •Medication adherence •ADE surveillance •Medication access •Medication management/ disease management Communicate to other providers any pertinent medical information or findings

FPO

Source: Steve M. Riddle, BS Pharm, FASHP

in hospital utilization, the interventions also resulted in cost savings of $149,995, or about $412 per patient versus those in the standard care group. At the webinar, Mr. Riddle also suggested looking closely at individual patient readmission rates. “Patients with a history of rehospitalizations have a greater chance of showing back up at your door,” he said. “It’s a good way for you to target patients that might be at the highest risk for rehospitalization.”

One Hospital Targets COPD That is the tack being taken at Yuma Regional Medical Center in Yuma, Ariz. Tom Van Hassel, RPh, MPA, Yuma’s director of pharmacy, said the pharmacy had examined the incidence of rehospitalizations for COPD and found that “a very small number of patients account for a high proportion of the readmissions.” With both money and staff short, he said the most “prudent” approach would be to identify those “frequent offenders” and spend more concentrated efforts on them. “If we can find out what works for them, we can make it available generally, trying to keep everyone from becoming repeat offenders.” Mr. Van Hassel said pharmacy, nursing and dietitians were still grappling with the best way to move forward. “Discharge education hasn’t been very effective. So we’re trying to determine what we can do on a proactive basis after patients go home. And who is

going to do that?” He said they were leaning toward a team approach, with a pharmacist, nurse or dietitian available for followup education, either by telephone or in organized classes, depending on individual patient needs. “The problem,” Mr. Van Hassel said, “is that no one is going to pay for it on the positive side. We’re just looking at not being penalized on the back end.” Medication reconciliation is another area where pharmacists have the potential for preventing adverse drug events and, consequently, readmissions. At Saint Barnabas Health Care System (SBHCS) in New Jersey, pharmacists are being used selectively in the discharge reconciliation process, for patients taking seven or more medications. “We have 9,000 nurses in the system and 120 pharmacists,” said Robert T. Adamson, PharmD, corporate vice president of clinical pharmacy services at SBHCS, a 10-hospital system based in West Orange. “That’s why we only do the most complicated cases.” The one area where the impact of pharmacist interventions is being measured, Dr. Adamson said, is in the transplant population. “A pharmacist does all of the transplant medications because obviously that is very delicate,” he said. “She calls patients a week after discharge to make sure they don’t get readmitted.” The program has been under way for less than six months, he said, so the evi-

dence of averted readScan for missions is still unclear. MedPAC Report; Instructions, He added, however, page 4 that “anecdotally, [the transplant team says] they are not seeing patients come in as often for rejections.”

More Med Reconciliation Efforts Steward Health Care System, in Massachusetts, is taking a more global approach, seeking to improve the medication reconciliation process and foster more accurate and efficient communication of medication data across transitions of care. The system is also looking for ways to use pharmacists more strategically in the medication reconciliation process for patients at higher risk for readmission. “One of the big areas of opportunity for reducing readmissions has to do with medications,” said Ernest R. Anderson Jr., MS, FASHP, system vice president of pharmacy at the six-hospital health system, with headquarters in Boston. “That’s why as pharmacists we’re interested in how well we do with the whole medication reconciliation process, passing information about a patient’s meds all the way through the system.” Mr. Anderson said the reconciliation process often is not done well in many places, and patients end up back in the hospital with adverse events because they took a medication found in the home medicine cabinet that’s in the same

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30 Policy

Pharmacy Practice News • April 2011

Reimbursement

READMISSION continued from page 28

therapeutic class as a drug prescribed at the hospital. Mr. Anderson said that part of the answer to improving medication reconciliation lies in designing better computerized systems to capture and transfer complete and accurate medication data electronically from hospitals to primary care providers and community pharmacies and then back again to hospitals if patients are readmitted. “We’re moving in the right direction, but it is still at an elementary stage,” he said. Mr. Riddle noted that “hospitals are getting busier and busier and we’ve got a lot of work to do, but targeting readmissions is going to be critical for us to fit in over the next few years to really drive health care forward.” —Bruce Buckley

Due Diligence at Steward Health Care

ike other hospital networks, Steward Health Care System has been analyzing its readmission rates to determine if it has any vulnerability to Medicare payment reductions. Without disclosing the findings, Erika Sundrud, MA, assistant director of performance improvement, said, “As with any hospital in the nation, there are opportunities to improve here.” She added that the reason for improving was not just potential reimbursement losses, but because “it is actually better patient care to keep these folks out of the hospital.” One solution that pharmacy would like to implement is involvement of pharmacists at an earlier stage in a patient’s hospital stay to fix any medication discrepancies well before discharge. Ms. Sundrud said Steward was piloting programs that include pharmacists on morning medical-surgical floor rounds at two hospitals. “That’s the time when you can catch any medication errors or problems,” she said. “We’re hoping that has some impact on the discharge scenario as well.” Pharmacy also would like to add a pharmacist and perhaps a technician or two to the emergency department (ED), which accounts for 50% of hospitalizations, and is trying to justify the additional full-time equivalents (FTEs) by examining “the cost of adverse events that result from not doing medication reconciliation at the front end,” said Ernest R. Anderson Jr., MS, FASHP, system vice president of pharmacy at Steward. “Ideally, we would have pharmacists working on the discharge end,” Mr. Anderson said. Such efforts, he noted, would not be focused on every patient, but instead would be reserved for those “more likely to get into trouble if they don’t take their medications correctly,” such as patients going home after a hospitalization for heart failure or acute myocardial infarction. Patients on complicated drug regimens also would be targeted. Mr. Anderson said pharmacy was trying to justify spending for additional FTEs by weighing it against the cost of potential adverse events. “It’s not easy to get finance folks to buy off on what the value is of reducing adverse events during an inpatient length of stay.” He added, “We’re trying to educate the finance folks that we need to look at the literature, at studies showing where those costs were incurred and what was their total value. “We need to take an evidence-based approach to cost savings,” he said, “just as with therapy.” —B.B.

By the Numbers: Impact of Pharmacists

he impact of pharmacists’ interventions on post-discharge hospital utilization has been documented in a handful of trials in addition to the Boston Medical Center study cited in the main article. For example, at Huddersfield Royal Infirmary, Huddersfield, United Kingdom, 43 elderly patients on complex medication regimens who received comprehensive counseling from a clinical pharmacist 24 hours before discharge, along with standard discharge medication and information discharge summaries (MIDS) and a medicine reminder card, were significantly less likely to be rehospitalized than 40 control group patients, who were given only MIDS and medicine reminder cards (5 vs. 19 readmissions at visit 1; 3 vs. 14 at visit 2; P<0.05). The positive results for the intervention group also included significantly better medication adherence (48% of patients adherent vs. 16% at visit 1; 70% vs. 16% at visit 2; P<0.001) and fewer general practitioner visits (19 vs. 27 at visit 1; 24 vs. 32 at visit 2; P<0.05). Those results held steady at two to three weeks and again at nine weeks during scheduled home visits by a research pharmacist (Br J Clin Pharmacol 2002;54:657-664). At the University of California, San Francisco, pharmacist-researchers evaluated the impact of two-day post-discharge phone calls by a pharmacist on patient satisfaction and clinical outcomes. During the calls, which averaged 10 minutes, pharmacists asked patients if they had questions about their medications and whether

they had experienced any adverse events. In 15 cases, pharmacists were able to identify and resolve medication problems. Two weeks after discharge, researchers mailed satisfaction questionnaires to patients and reviewed hospital records. They found patient satisfaction with medication care instructions was significantly higher in the intervention group than in the control group (86% vs. 61%, respectively; P=0.007). Additionally, there were significantly fewer emergency department visits within 30 days for the intervention group compared with the control group (11 vs. 27, respectively; P=0.005). Although there were also fewer rehospitalizations in the intervention group, the study lacked sufficient power to show significance (Am J Med 2001;111:26s-30s). In another trial, researchers at the Queen Elizabeth Hospital/University of Adelaide, South Australia, evaluated the effect of one-week post-discharge home visits by a nurse–pharmacist team on mortality rates and unplanned readmissions for patients with heart failure. The goals of the team were to optimize medication management and identify early clinical deterioration. At six months post-discharge, the intervention group had significantly fewer unplanned readmissions than patients who did not receive home visits (36 vs. 63, respectively; P=0.03), as well as fewer days of hospitalization (261 vs. 452, respectively; P=0.05) There also were fewer out-of-hospital deaths (Arch Intern Med 1998;158:1067-1072). —B.B.

Clinical

HemOnc in Focus

VTE RISK continued from page 10

(lung cancer, history of VTE and female sex); they assigned a value of –1 to stage I disease and –2 to breast cancer. Patients with breast cancer “can still have a high VTE risk because the majority of [such] patients are female and being female is a high-risk predictor,” said Dr. Louzada. “However, breast cancer predicts low risk, so an individual patient’s risk will depend on the stage of malignancy and history of venous thrombosis.” Application of the scoring system to the 543 patients showed that a score of 0 or lower was associated with a six-month recurrent VTE incidence of 4.5% (considered low risk; 48% of the population)

versus 19.7% for a score of 1 or higher. To validate the scoring system, investigators applied the risk-stratification system (sex, tumor site, disease stage and history of VTE) to 819 cancer patients in two randomized clinical trials comparing LMWH and VKAs for VTE treatment. Overall, 10.5% of the patients had a qualifying thrombotic event within six months after starting anticoagulation. Patients with a score less than 0 (19% of patients) had a low (5.1%) risk for VTE recurrence, increasing to intermediate (9.8%) risk for patients with a score of 0 (42% of patients), and high (15.8%) risk among patients with a score of 1 or higher (38% of patients). “The results of this preliminary validation dataset suggest the reproduc-

ibility of our model,” said Dr. Louzada. “The three-risk category score is less discriminatory than our original model, suggesting an advantage to classifying patients’ tumor stage as TNM stage I, versus stage II, III and IV.” “Our model appears to differentiate risk for recurrence and should be utilized in treatment trials,” she added. “The trials might evaluate novel treatment strategies in high-risk patients, since heparin alone does not seem to be enough, [as well as] the less costly strategy of LMWH followed by oral anticoagulants in the low-risk population to [see] whether vitamin K antagonists can be as safe and effective as long-term LMWH.” The retrospective nature of the analyses limits their applicability to clinical

practice, said Eric Sadler, MD, PhD, a hematologist at Washington University in St. Louis and moderator of the news briefing. Given such limitations, a more practical approach is needed, noted Ann K. Wittkowsky, PharmD, FASHP, director, anticoagulation services, University of Washington Medical Center, in Seattle. “It is important for clinicians to recognize the inherent risk of thromboembolism in patients with cancer,” she stressed, “and to provide appropriate VTE prophylaxis and long-term treatment according to current guidelines from the American College of Chest Physicians and the National Cancer Care Alliance.” —Charles Bankhead

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32 Technology

Pharmacy Practice News • April 2011

Automation

Technology Research Roundup at ASHP Midyear Anaheim, Calif.—Technology is transforming today’s pharmacy. From programmable smart pumps to bar-code systems that resemble a FedEx driver’s utopia, new high-tech tools aim to reduce errors, improve efficiency and maximize patient safety. But how are they being incorporated at the institutional and clinical levels, and what effect are they really having? This roundup looks at four recent technology-related

abstracts presented at the annual Midyear Clinical Meeting of the American Society of Health-System Pharmacists.

Bar-coding Boom The pharmacy at Children’s Hospital in Boston verifies approximately 2,500 orders and dispenses more than 7,200 medication doses daily. With volumes like those, it’s little wonder that when Children’s decided to implement bar-

coding technology, it took a “soup to nuts” approach. Pharmacy Medication Tracking tracks the life cycle of a medication order from order placement to delivery. “We were inspired by the Children’s Hospital of Philadelphia, which has a system that mirrors FedEx,” said Peter Lutz, PharmD, associate director of pharmacy. “Several vendors have a similar system, but they only track the order once it leaves the pharmacy. We want-

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ed that system on steroids—so that we could track orders from the time they were placed through to when they were administered to the patient, with safety alerts built in. That’s where we wanted to go after something novel.” With the new bar-code system, the order and delivery process is as follows: • The provider places an order. • The pharmacist verifies and assigns a product to the order. • The technician—who must sign into the system with an individual PIN— scans a prelabeled delivery container, the order(s) and each medication item. • The technician changes the order’s status to “ready for pharmacist verification” on an interactive computer touch screen and physically forwards the bag with the filled medications in a bin to the pharmacist. • The pharmacist manually reviews all contents of the bin, and, if they are correct, places the order in the delivery bag and presses “verify.” If incorrect, the pharmacist presses “incomplete” to return the order. • The hospital courier picks up the verified bag, scans it to record departure, and delivers it to the appropriate destination, where it is scanned again (against a destination bar code on the patient’s room or other location). “There are a number of built-in safety checks in the system,” Dr. Lutz said. For example, the system checks an ordered medication against the assigned medication; allows only one patient per bag; and does not allow cancelled, suspended and modified orders to be scanned into a bag. “We project that we prevented 5,000 potential medication errors from going out the pharmacy door in the first six months,” he said. “That’s because the system won’t let you proceed if an order has been modified or discontinued between the time it was placed and the time it was filled at the pharmacy bench. In the old world, we would have dispensed the order with no idea if it had been discontinued or changed to another dose.” There also is a live interface with the hospital’s patient information system, so if a patient is transferred to a different nursing unit after the order leaves the pharmacy, the pharmacy courier’s scanner will alert them to the move when they scan the bar code at their destination. “This was a trick I didn’t think they could pull off, but they did,” Dr. Lutz said.

Surviving a Vendor Implosion

At Boston Medical Center (BMC), the pediatric satellite pharmacy also took the “in-house” route to designing its bar-coding technology system, after its first vendor, for which BMC was the beta test site, “went down the drain”

Pharmacy Practice News • April 2011

Technology 33

Automation in 2009. “When we knew they were in trouble, I took over the project,” said Sanjay Abraham, PhD, pharmacy operations manager. “The problem with the old software is that the system was based on a one-dimensional, linear bar code. You can keep scanning the same item, and it doesn’t check for an expiration date or lot number.” The system that Dr. Abraham and his team developed is two-dimensional, incorporating lot number and expiration date along with the prescription number or medication ID. “Every order, whether it’s patient-specific or something we make in the pharmacy, gets a bar code that has all this information.” This system reduces the number of entries that have to be made by the technician and decreases software processing time, Dr. Abraham said. “It helps the technician and the pharmacist know that the product is valid. On the operations side, we found that we could maintain or redirect FTEs [full-time equivalents] based on volume.” The bar-code system is integrated with the hospital’s Sunrise clinical manager electronic health record and computerized order entry system and with its GE-Centricity pharmacy system. “There’s nothing written on paper now; it’s all electronic,” he noted. “The label is generated when the pharmacist verifies the physician’s order electronically. Then the label is scanned to pull the information into the bar-coding system. The information on each component is scanned, telling the technician what to add to each bag, and then at the end of the process, it’s pulled into the pharmacist’s queue. Products that require dilutions have the same process, only in this case, the technician generates the labels for the dilutions, which also must be scanned before the final product is also scanned. The pharmacist then verifies the order with the product in front of him or her. Products that have not been used can be recycled, and the system automatically checks with the new order whether the recycled product is valid.” As of October 2010, virtually every single order in the pediatric setting (except NF and custom drips not in the library) comes through the bar-coding system. New products arriving from the manufacturer also are scanned to ensure that they are in the pharmacy’s bar-code library. “I don’t allow anyone to skip a step,” says Dr. Abraham. As a result, he reported at the Midyear, adverse drug events have dropped by approximately 44% in the pediatric setting.

Impressed With Bar-coding Implementation John Poikonen, PharmD, director of clinical informatics at the UMass Memorial Health Care, in Worcester,

‘We project that we prevented 5,000 potential medication errors from going out the pharmacy door in the first six months.’ —Peter Lutz, PharmD and writer of the popular RxInformatics blog, praised Drs. Lutz and Abraham for taking bar-code technology into pharmacy operations and management. “The literature is saturated with bar-code technology around meds administration, but this is different,” Dr. Poikonen said.

“It’s a more emerging technology. It’s the next wave of pharmacy applications, if you will. We’ve unit-dosed things to the nth degree, and now you’re moving to the next level of control and understanding the distribution of things.” Dr. Poikonen found an even more inno-

vative abstract from Oregon Health & Science University (OHSU), where pharmacists developed a clinical scoring tool to assist with patient prioritization. “We have pharmacists running around verifying orders all day long,” he said. “If I’m being deluged by multiple orders and inputs, I need to focus my attention first to the most important things. One way to focus one’s efforts would be to rank orders in some level of priority.” The prioritization tool wasn’t the original goal of the project, according

•

see TECH ROUNDUP, page 39

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34 Technology

Pharmacy Practice News • April 2011

Opinion

A Marathon or Another Mount Everest? Experts assess ASHP statement on bar-code verification during inventory, preparation and dispensing of medications Jamie Kelly President Entropy Research San Diego, California

n its March 2011 issue, the American Journal of Health-System Pharmacy (68:422-425) included a report encouraging the “prudent use of bar-code scanning in inventory management, dose preparation and packaging and dispensing of medications” as a means of enhancing patient safety and quality of care. The report, issued by the American Society of Health-System Pharmacists (ASHP), noted that the potential benefits of the technology include increased accuracy in core pharmacy functions, safeguards against improperly prepared admixtures, checks to intercept expired or recalled medications, and the provision of digital records for every transaction within the pharmacy. The report points out that not every medication error is associated with computerized prescriber order entry (CPOE) or bar code medication administration (BCMA), nor can these technologies prevent every medication error in the medication use process, although most studies on the use of medication safety technology to date have focused on the ordering and administration phases. This focus is changing, suggests ASHP, as hospitals demonstrate that the use of pharmacy-based bar-code scanning can “significantly reduce opportunities for medication errors and reduce the occurrence of potential adverse drug reactions.” Intuitively, it is easy to see how a medication that is properly packaged, labeled and stocked will have fewer failure points, or looked at in another way, that a lapse in any one of these processes will increase the chances that an error will reach the patient. Although the statement calls attention to the importance and cost-effectiveness of a pharmacy-based scanning system, suggesting that medication bar coding “may be considered a prerequisite for BCMA success,” ASHP does not ignore the enormity and complexity of adopting such a system. A number of caveats are described, including the need for hospitals to understand the resources and planning required. “Any program of pharmacy-based bar-code scanning should be accompanied by appropriate training, policies, and procedures to promote and optimize safe use of the system,” the group wrote. ASHP

recognizes that optimal use also would require regular audits of staff compliance and system effectiveness. ASHP’s case for bar-code scanning presents a widely embraced ideal—scan during inventory, preparation and dispensing, and you will see improvements in patient safety and quality of care. Verification scanning when loading or returning medications to the dispensing cabinets is an obvious and plausible objective.

Bar-Coding Veterans’ View But as ASHP pointed out, challenges remain. To get a fuller sense of those challenges, I recently interviewed several experts on bar coding. In response to ASHP’s recommendation that hospitals scan during retrieval of medications to “mitigate the hazards of erroneous medication stocking,” Richard Malone, PharmD, BCPS, MHA, program director of investigational drug service for Vanderbilt University Medical Center, in Nashville, Tenn., questioned the value of assuming a definite cost for an uncertain gain. “It would add to the nurse’s workload and might not add any significant safety benefit,” he said. “Additionally, the automatic dispensing cabinets used on most hospital nursing units are configured for scanning upon stocking by a pharmacy technician rather than during drug removal by a nurse.” Furthermore, a hospital undertaking pharmacy scanning will need to know what to expect in practice, starting with the gaps between the statement’s recommendations and what is currently

feasible. Dr. Malone voiced concern about the current level of compatibility between clinical information systems (CIS), bar-code scanners and manufacturers’ bar codes available to pharmacies around the country. “The ability of CIS to capture lot numbers and expiration dates as well as provide reports on the disposition of these products as they work their way through a hospital or health care system is limited at best. I would dare say the technology is nonexistent in most facilities.” While the technology’s potential is evident, pharmacy practice has some catching up to do. Stuart Levine, PharmD, informatics specialist at the Institute for Safe Medication Practices warned that although ASHP and the body of accumulating literature on the topic support bar coding every individual dose, “some of the technologies such as carousels and automated dispensing cabinets are usually set up as a sampling methodology and not 100% bar coding of each dose.” The ASHP statement proposes that pharmacy-based bar-code scanning is a technology that all hospitals and health systems ought to implement, whether as a prerequisite for or in tandem with BCMA initiatives that extend verification safeguards to the point of care. Yet, the organization clearly concedes that hospitals need to have a realistic picture of the time, resources and commitment required. Throughout the statement, terms such as proper, appropriate or prudent qualify the planning, deployment and practice it endorses,

ASHP’s case for bar-code scanning presents a widely embraced ideal—scan during inventory, preparation and dispensing, and you will see improvements in patient safety and the quality of care.

acknowledging that bar-code verification can be a tortuous journey and not a singular destination. Many clinical experts such as Dr. Malone and Mr. Levine agree and encourage their peers to educate themselves and understand the limitations of current systems and practices, many of which will be specific to their own facilities.

The Challenge for Pharmacy Leaders Mark Neuenschwander, president of The Neuenschwander Company and cofounder of The unSUMMIT for Bedside Barcoding, said that he considers the statement, hammered out on ASHP’s anvil over years of meetings, sound theory. According to Mr. Neuenschwander, the challenge is for pharmacy leaders to put theory into practice. “Our experience with The unSUMMIT for Bedside Barcoding has proven that there are plenty of pharmacists who have already traveled a long distance in the right direction,” he said. “Fortunately, they are more than eager to share their stories about making a safer route for medications from pharmacy, into the hands of nurses and, ultimately, to patients at the point of care.” We rely on ASHP and other thought leaders to encourage hospital pharmacy to push the envelope of medication safety practices. The statement on bar-code verification extends our gaze to a higher plane, but for those of us down in the weeds, the ideals may feel like pie in the sky. So my suggestion is to take the statement for what it is—a clear and thoughtful map toward a safer medication distribution system. Achieving this goal is more analogous to running a marathon than climbing Mount Everest. No amount of fitness can ensure a spot on the world’s highest peak because any number of uncontrollable events may end your ascent. But with proper training and commitment, you can tackle a 26.2-mile run. Likewise, with realistic expectations and the proper education, strategy and leadership, hospitals can achieve bar code verification during inventory, preparation and dispensing of medications. Jamie Kelly is the president of Entropy Research, Inc, a marketing firm serving health care information technology vendors, medical device manufacturers and the life science industry. A longtime advocate for patient safety improvement through prudent technology adoption, Ms. Kelly is the co-founder of the annual unSUMMIT for Bedside Barcoding educational conference (www.unsummit.com). She can be contacted at jkelly@entropyresearch.net.

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Indication and important limitations • SAMSCA is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure, cirrhosis, and Syndrome of Inappropriate Antidiuretic Hormone (SIADH) • Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with SAMSCA. It has not been established that raising serum sodium with SAMSCA provides a symptomatic benefit to patients

Important safety information SAMSCA should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely. Too rapid correction of hyponatremia (e.g., >12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction may be advisable. Contraindications: Urgent need to raise serum sodium acutely, inability of the patient to sense or appropriately respond to thirst, hypovolemic hyponatremia, concomitant use of strong CYP 3A inhibitors, anuric patients. • Subjects with SIADH or very low baseline serum sodium concentrations may be at greater risk for too-rapid correction of serum sodium. In patients receiving SAMSCA who develop too rapid a rise in serum sodium or develop neurologic sequelae, discontinue or interrupt treatment with SAMSCA and consider administration of hypotonic fluid. Fluid restriction should generally be avoided during the first 24 hours • Dehydration and hypovolemia can occur, especially in potentially volume-depleted patients receiving diuretics or those who are fluid restricted. In patients who develop medically significant signs or symptoms of hypovolemia, discontinuation is recommended • Gastrointestinal bleeding in patients with cirrhosis: Use in cirrhotic patients only when the need to treat outweighs this risk • Avoid use with: CYP 3A inhibitors and CYP 3A inducers. Reduced dose of SAMSCA may be needed if used with P-gp inhibitors • Co-administration with hypertonic saline is not recommended • Monitor serum potassium in patients with levels >5 mEq/L and in those receiving drugs known to increase serum potassium Commonly observed adverse reactions: (SAMSCA vs placebo) thirst (16% vs 5%), dry mouth (13% vs 4%), asthenia (9% vs 4%), constipation (7% vs 2%), pollakiuria or polyuria (11% vs 3%) and hyperglycemia (6% vs 1%). Reference: 1. Market Rx 2010.

For more information about SAMSCA, visit samsca.com or call 1-877-726-7220.

Please see Brief Summary of FULL PRESCRIBING INFORMATION, including Boxed WARNING, on the following page. Manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan. Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850. US Patent Nos: 5,258,510 and 5,753,677. Samsca is a registered trademark of Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan.

February 2011

0711A-2015B

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Pharmacy Practice News • April 2011

Technology 37

Bar Coding

Workarounds a Persistent Challenge With BCMA Systems Y

Scanning Outside the Room And Other System Subversions The workaround issue was clearly in effect during one six-hour observation period, when the investigators documented 121 instances of medication administration involving 468 different workarounds (an average of 3.8 workarounds per administration). In all of those workarounds, nurses scanned medications outside of the patient’s room—a major cause of potential drug errors, because the nurse cannot verify that the right drug is actually being administered to the right patient, according to co-investigator Christopher R. Fortier, PharmD, manager, pharmacy support services at MUSC. Additional workarounds included scanning the patient’s wristband bar code when it was not attached to the patient (90.1%), confirming the administration before administration actually occurred (82.6%), scanning medications for more than one patient at a time (46.3%) and scanning a bar code once the dosage unit had been separated from its package (23.1%)(Figure). The high-alert medication warnings were typically issued by the BCMA system’s electronic medication administration record (eMAR) component. The most common alert message triggered was incorrect dosage (65%), followed by drug administration too late (29%), administration too early (4%) and no drug order or schedules found (2%). (The too-early or too-late alerts were generated for medications that were administered 30 minutes before or 30 minutes after the scheduled administration time.) Many of the workarounds observed in the study involved drug order entry

rather than bar code scanning, Dr. Fortier noted. And in some cases, nurses weren’t the only ones at fault: pharmacists were also seen engaging in possible order entry workarounds that had the potential to “compromise the safety features of the BCMA and eMAR system,” he and his co-investigators reported. Specific pharmacy workarounds observed during the study included duplicate orders, lack of medication order verification, and incorrectly timed medications resulting in administration too early/too late errors for the nursing staff. However, “no actual drug errors were reported” in relation to the pharmacist workarounds, the team noted. Dr. Fortier stressed that such errors “are not a bar-code issue; these are order-entry concerns. But on the patient care unit, the errors can create a potential workaround which could lead to a medication administration error.” Overall, the results of the study showed that the BCMA system was doing what it was designed for—“to alert clinicians of potential errors,” he said. However, “although you can perfectly implement the technology, if people are not following proper procedures, you are not going to see the full benefit of the system. The human factor [can] introduce new errors that the system cannot prevent.”

Lessons Learned, Fixes Implemented With the results of the study in hand, Dr. Fortier went back to staffers, shared the results and developed potential fixes. For example, “we created nurs-

ing reports that are sent monthly to nurse managers to determine whether patient wristbands were being scanned properly or whether medications were being administered before scanning or whether nurses were overriding alerts.” The nursing staff also addressed the problems head-on, he noted. “Nurse managers now conduct random monthly observational audits to determine whether nurses are following the proper procedures.” To eliminate errors caused by workarounds, MUSC put a “hard stop” into the bar-coding software. As a result, “nurses now have to stop and document why they’ve done an override.” To address the issue of some of the alerts being generated by incorrectly entered orders, MUSC began an ongoing educational program with its pharmacists, including classes reviewing the eMAR and nurse medication administration process, simulating what a nurse experiences when an order profiled by pharmacy comes up in the system. MUSC also created automated pop-up messages within the pharmacy information system to remind pharmacists about specific order requirements that could cause nursing alerts if entered incorrectly. “These involve some of the more common order-entry oversights that were taking place,” Dr. Fortier said. “The messaging system reminds them that when dealing with a specific drug, dose or drug regimen, they need, for example, to time it appropriately so nurses don’t get an alert message.” MUSC also began educating and retraining nurses so they could better understand why it was important to

comply with the BCMA processes, and why, if an override was necessary, its justification should be documented.

Continuing Education The workaround problems that the study documented are not uncommon. A study in the Journal of the American Medical Informatics Association (2008;15:408-423) identified 15 types of workarounds, including such behaviors as nurses temporarily affixing patient ID bar codes to computer carts, scanners, doorjambs or their belt-rings as well as carrying several patients’ pre-scanned medications on carts. Several factors were identified as potential causes of the workarounds, including unreadable medication bar codes, malfunctioning scanners, unreadable or missing patient ID wristbands, non–bar-coded medications, failing batteries, uncertain wireless connectivity and emergencies. Consequences of the workarounds included administration of wrong medications, doses, times and formulations, the authors reported. When the JAMIA study was published, some individuals interpreted the results “as evidence that verifiable bar coding does not work,” said Mark Neuenschwander, co-founder of The unSUMMIT for Bedside Barcoding and president and founder of The Neuenschwander Company, a pharmacy technology consultancy company. “But I contacted the authors, and I can tell you that they don’t support that conclusion at all, and neither do I.”

•

see BCMA SYSTEMS, page 38

100

90.1

Frequency (%)

et another study has found that workarounds by nurses—and in some cases, pharmacists—can shortcircuit even the best-intentioned bar code medication administration (BCMA) system. The study, an 11-month effort by researchers at the Medical University of South Carolina (MUSC), in Charleston, found that the 709-bed hospital’s BCMA system did succeed in warning clinicians to the potential for high-alert medication errors. Indeed, such alerts accounted for 55% of the total warnings issued by the BCMA system. However, due to workarounds and other system limitations, “it is not possible to state with certainty whether these [alerts] were errors that actually reached the patient or justified clinician overrides,” the investigators reported (Ann Pharmacother 2011 Feb 1 [Epub ahead of print]).

82.6

Omitted step Unauthorized step Incorrect sequence

60 46.3

40 23.1

14.9 9.9

Failure to scan medication

Failure to scan Scanning medication patient bar code outside of the patient’s room

Scanning the bar code after the dosage unit has been separated from its package

Scanning patient bar code that is not attached to patient

Scanning medications for more than one patient at a time

Figure. Nursing workarounds observed with BCMA system.

Confirming administration before administration occurs

38 Technology

Pharmacy Practice News • April 2011

Bar Coding

BCMA SYSTEMS continued from page 37

M r. Ne u e n s c hwan d er st res s ed , however, that the JAMIA and MUSC studies and others like them “are very important and very helpful.” But he cautioned that such research should never be interpreted as reasons for not doing bar coding. “People work around bar coding just like people work around seat belts. The fact that people find ways to disconnect is not an argument against bar coding;

it’s an argument for stopping workarounds.” Mr. Neuenschwander added that education, training and enforcement can be a very effective hedge against workarounds and can significantly boost compliance. The stakes for such efforts are quite high, he noted. “There are many studies that show that when you use bar coding [properly], you reduce medication errors and adverse drug events, which in turn can save lives. If you are careless with it, however, it costs lives and safety and careers.’ ”

The Evidence for Bar Coding Just as there are mounting studies documenting the pitfalls of bar code implementation, there also are studies showing the technology’s benefits. According to a study published in The New England Journal of Medicine (2010;362:1698-1707), the rate of potential adverse drug events (other than those associated with timing errors) fell from 3.1% without the use of a bar-code eMAR to 1.6% with its use, representing a 50.8% relative reduction. Transcription errors

occurred at a rate of 6.1% on units that did not use the bar-code eMAR, but were completely eliminated on units that did use the technology. As far as the technology’s impact on in-hospital mortality, Mr. Neuenschwander noted that “it is very difficult to document saved lives.” However, based on the NEJM study and others like it, “preventing adverse drug events is clearly [achievable].” Dr. Fortier said that MUSC is now working on a follow-up study to determine if the solutions they put in place are reducing the number of workarounds. Although those data currently are being analyzed, there have been “significant improvements across the board.” As a result, he concluded, “both nurses and pharmacy have a better understanding of the impact BCMA can have in preventing medication administration errors.” —Liz Parks

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Pharmacy Practice News • April 2011

Technology 39

Automation

TECH ROUNDUP continued from page 33

to Kat Miller, PharmD, now an operations manager for the inpatient pharmacy at United Hospital in St. Paul, Minn., who was assigned a pharmacy scoring project during her residency at OHSU. “Originally, we wanted to score patients so that we could see if we could decrease their length of stay. But that wasn’t what the pharmacists wanted. They wanted to identify the people who had the most clinical issues that they needed to prioritize in their patient load for the day. “They wanted to increase points for the patients they could have the most clinical impact on,” Dr. Miller said. “So we picked out a few key things—for example, certain medications that we know require therapeutic monitoring, and differences in lab values for some of those medications. The higher the score, the pharmacist that morning will focus on what she can do to impact those patients. Those with a lower score and less acute issues could be addressed by the evening pharmacist.” During the tool’s pilot phase, 62 patients were assessed both by a pharmacist individually and by the scoring tool. More than two-thirds (68%) of the patients’ acuity scores were ranked the same by the clinical scoring tool and the pharmacist. “We found that the tool worked very well for certain populations, such as our oncology patients,” Dr. Miller said. “It allowed the oncology group to readily identify those patients who were in for inpatient chemotherapy versus those who were a readmit with an infection or some other complication. But for pediatric patients, we discovered that some of the lab parameters were not the same and we needed to make adjustments. For example, a creatinine level greater than 1.5 is bad in an adult, but meaningless in a pediatric patient. And in the NICU [neonatal intensive care unit], they wanted us to get more in depth so that the tool could separate out the babies who needed a little more help as opposed to just the feeders and growers.”

Combating ‘Alert Fatigue’ Smart infusion pumps have been a boon to many hospitals, but they also have their drawbacks. One is the issue of “alert fatigue.” Smart pumps sound an alarm to alert the nurse when she is programming a dose that’s over or under standard limits—alarms that are frequently found to be a nuisance, and overridden quickly without making the standard checks required (the Five Rights of Medication Administration). Mercy Health System in St. Louis, analyzed its programming data from December 2008 through February

2010, and identified six medications for which the most common nursing response to their frequent dosing alarms was to override them in two seconds or less. Pharmacists reviewed the drugs and determined that dosing limit changes in the drug library would still be safe and reduce nuisance alerts—allowing nurses to pay closer attention to more significant alerts. In the month after the changes were

made, nuisance alerts decreased by 65%. “This study points out why the concept of alerts is still in its infancy,” Dr. Poikonen said. “People pound their chests about the wonderful things clinical decision support programs do for patients, but in actuality, nurses override them and people do workarounds, it costs time, and is it really useful? If your system has an abundance of overrides, either the process needs to

ERROR PREVENTION

change, or the software does. I think it’s often a little bit of both.” Mercy’s experience with smart pumps and nuisance alerts points to a broader problem in pharmacy technology, Dr. Poikonen concluded. “It’s a concept I’ve seen over and over: implement and then forget. With immature products, like all the technology we’ve just talked about, if you don’t continue to focus on whether they’re doing what you’ve intended them to do, you create more errors rather than fixing them.” —Gina Shaw

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40 Technology

Pharmacy Practice News • April 2011

Clinical Decision Support

CDS SYSTEM FLAWS continued from page 1

noted, “by the way in which software vendors incorporate those database rating systems into the pharmacy dispensing software programs, and how the organizations that install the software modify their alert levels.” Dr. Malone and his co-investigators visited 64 pharmacies across Arizona and provided them with the fictitious patient’s orders, which consisted of 18 different medications that posed 13

clinically significant drug–drug interactions. Of the 64 pharmacies, 18 correctly identified eligible interactions and noninteractions. The median sensitivity to detect wellestablished interactions was 0.85 (range, 0.23-1.0); median specificity was 1.0 (range, 0.83-1.0); median positive predictive value was 1.0 (range, 0.88-1.0); and median negative predictive value was 0.75 (range, 0.38-1.0). This finding isn’t exactly news, Dr. Malone said. In 2006, his team reported the results of a similar, smaller study

done in Tucson, in the Journal of Managed Care Pharmacy (2006;12:383-389). Both community and hospital pharmacies were studied, and although community pharmacies did better, both types missed a significant number of interactions. The median sensitivity and median specificity for community pharmacies were 0.88 (range, 0.81-0.94) and 0.91 (range, 0.67-1.00), respectively. For hospital pharmacies, the median sensitivity and median specificity were 0.38 (range, 0.15-0.94) and 0.95 (range, 0.81-0.95), respectively.

Looked at another way, of the eight computerized CDS systems evaluated in the study, all performed with a sensitivity of at least 0.81, “meaning that, in the worst-case scenario, they would miss approximately one out of every five clinically important [drug-drug interactions],” the authors wrote. Dr. Malone added that “we haven’t really seen much of an improvement in these systems over time.” One of the confounding issues, he noted, is that what one drug knowledge database vendor considers a very significant interaction might be labeled only a moderately important interaction by another vendor. “The evidence for drug interactions is fairly limited, and usually based on case reports,” he said. “Occasionally you will see prospective pharmacokinetic studies, but rarely do you see a thorough, systematic evaluation of interactions in the same fashion we’re used to seeing for drug approvals—probably because it would be unethical.” In October 2009, Dr. Malone chaired a meeting, held at the headquarters of U.S. Pharmacopeia in Rockville, Md., bringing stakeholders together to discuss this problem and other issues around the appropriate integration of drug information into CDS systems. The group’s recommendations—soon to be published in a white paper—suggest standardizing the evaluation of drug interactions and call for the funding of research to provide better evidence to support drug interactions and their integration into CDS systems. “What would be very beneficial would be to have an expert group determine specific drug interactions that need to be reported in every system,” said Bruce Chaffee, PharmD, clinical pharmacist, informatics and outcomes, and clinical associate professor, College of Pharmacy, University of Michigan Health System, Ann Arbor. “Then it would be incumbent on the content providers and software vendors to make sure that they’re included, and institutions to make sure they properly work in their systems.” Part of the problem, Dr. Chaffee added, is that there are literally thousands of drug–drug interactions, many of which may become a nuisance to experienced prescribing physicians—especially in a hospital setting. “In our institution, we’re trying to squeeze down the number of alerts,” he said. “In a hospital system, you’re more likely to mitigate the risk by monitoring for the occurrence of problems. You can give two drugs in concert while monitoring for significant clinical changes, such as increased blood levels. This can be more problematic for an ambulatory patient, who would have to go in and get levels drawn.”

•

see CDS SYSTEM FLAWS, page 43

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42 Technology

Pharmacy Practice News • April 2011

ASHP Pearls

Presenters Share Bar-coding Wisdom and Lessons Learned Anaheim, Calif.—Bar-coding issues were well represented during the Pearls sessions at the American Society of Health-System Pharmacists (ASHP) 2010 Midyear Clinical Meeting. The following highlights some presentations meant to help pharmacists improve bar-coding systems at their institutions.

Fostering Accountability Can Help Trim Bar-code Override Rates

A bar-code system override is a breach of established safety systems that can result in patient harm, according to Kathryn Montanya, PharmD, MS, director of pharmacy services at Forsyth Medical Center, a Novant Health facility in Winston-Salem, N.C. Dr. Montanya offered tactics pharmacists can use to partner with nurses to help decrease bar-code medication administration (BCMA) overrides in a presentation at the Safety and Quality Pearls session during the ASHP meeting. “One of the first steps in the process of assessing and addressing overrides in your facility is to determine how frequently they’re happening,” said Dr. Montanya. “This can be surprisingly difficult, depending on the system you have.” When determining the rate of overrides, it is important to look closely at the data, she said. “When we approached this for our system, it was stunning how complicated and confusing some of the data and reports that were coming from our bar-coding system were. So a lot of time went into just decoding that for nursing and finding ways for them to access and understand the information.”

She noted that it also is important to look at unit-specific rates as well as overall rates because there can be large variation across units. At her institution, they found an average override rate of 6%, but some units had rates upward of 20%. Once the rate is established, she said, a target needs to be set for improvement. That depends, in part, on the culture and atmosphere for change at an institution. One approach is to start with the current average and try to bring outliers to at least that level. The causes of the overrides have to be identified to start the process for change. All users of the system should be involved

in the process, noted Dr. Montanya. This includes nurses, pharmacists, patient registration staff, information technology staff and quality improvement personnel, whose presence helps to “establish overrides as a priority in your organization.” Dr. Montanya noted that a culture of accountability is crucial to the success of efforts to reduce BCMA overrides. She provided the example of a nurse leader who told her staff that if they were going to override a BCMA alert, she wanted a page or a voice mail explaining why there was an override. “Their overrides averaged 0%,” said Dr. Montanya. In that setting, the nurses became fully accountable and overrides became unacceptable. To get to that point, however, the system has to be up to snuff. Hardware issues, such as low batteries, insufficient numbers of scanners, bad wireless connectivity, etc, and bar-code issues, such as unreadable bar codes, bar codes not in the system, missing bar codes, etc, need to be resolved first. On the pharmacy side, processes need to be in synch to ensure the successful linking of bar codes throughout the various hospital systems. “This is where your department needs to step in and be consistent,” stressed Dr. Montanya. She suggested that some members of the pharmacy staff should be specialized to be able to handle technical questions about the system, but she cautioned that the staff should not be too specialized because nurses will need to be able to get help with the system “whenever they need it.” Her “worst nightmare” is to hear that a nurse would call the pharmacy with a question about a drug that would not scan properly “and the pharmacist would say, ‘just override it.’ As far as establishing accountability the way that nurse leader did, we really had to just say that was not acceptable.” Responsibilities for pharmacy include providing resources for staff, such as barcode handbooks delineating the protocols and processes involved in assessing a bar code that will not scan, and evaluating reports to identify drugs for which BCMA overrides are occurring, so that any system errors can be rectified. “We saw dramatic improvements as a result of nursing creating accountability, leaders addressing system problems and pharmacy focusing on bar-code service,” said Dr. Montanya. “The average overrides in targeted units dropped dramatically with implementation of these tactics.” For example, she said

one unit averaged 7% for medication overrides before the improvement process and now averages 1%. “In medication safety,” she said, “there are so few things that we can really measure, watch decrease and get a really satisfying response out of it, and this is one of them.” [For more coverage of BCMA workarounds, see article, page 37.]

West Virginia System Irons Out Bar-code Kinks Through Validation Pharmacists at West Virginia University Healthcare, in Morgantown, ran into some issues with both commercial bar codes and pharmacy-generated bar codes when they conducted a validation process for their new bar-code medication administration (BCMA) system. In the informatics pearls session, Kelly Duarte, PharmD, clinical specialist, informatics, noted that there were several problems that arose with respect to the manufacturer bar codes. One issue was that some products did not have any bar codes on them. She noted that in some cases, the products were creams or lotions, many of which did not need to be under pharmacy’s purview. Other products had multiple bar codes, creating confusion. For example, sometimes the bar code on the outer packaging is not the same as the individual unit-dose bar code. To resolve these issues, Dr. Duarte said, “some products were removed from pharmacy inventory and sent to materials management; other products, such as unit-dose nebulized medications, had to be individually tagged by the pharmacy with a custom bar code that was built in our system. Some items that had multiple bar codes, such as IV fluid bags and inhalers, just took nurses getting used to what they should scan.” For products such as vaccines, which have one bar code on the outer box and another on the vial, Dr. Duarte said that it is particularly “important to validate the bar code the nurse will be scanning. Some of the individual vials’ bar codes had to be manually entered in our system,” she said, explaining that “manufacturers sometimes only submit the outer

package bar code to the databases that we use to import data into our system.” They did not have as many problems with their own patient order label bar codes, said Dr. Duarte, but “we ran into a few.” For example, on labels of drugs with especially long names, text often would run into the bar code and distort it. “Even if the text touched the bar code, it would not work,” she said. “So, it may look OK to the untrained eye, but it will not scan.” Also, there were cases where pharmacists would sign on the bar code or they would wrap and bend the bar-code labels on small products. “We had to retrain our pharmacists and technicians not to sign on the bar code and not to fold the bar code when they were labeling small syringes,” noted Dr. Duarte. “We designed our labels using a small two-dimensional bar code instead of a long linear one and placed it away from where initials would be signed.” P h a rmacists a l s o had to re me mb e r th at under the new system, they could not substitute one product for another, even if the products would be considered therapeutically equivalent. This presented issues for various products, particularly when manufacturers were switched or there were shortages of certain products. “The department has had to become more vigilant about matching the product ordered to what is dispensed,” Dr. Duarte said. “If the pharmacy changes from a tablet to a capsule, now they let the build team know.” For products such as multivitamins, for which “we really can’t stick with one product, we have built them a ‘custom record,’ with a custom NDC and bar code. This product then is packaged with the custom bar code.” Dr. Duarte summarized her basic rules to help pharmacists facilitate the transition to BCMA at their institutions. “You need to scan what the nurse will scan … verify that the bar code scans and [finds] the correct product … that you have built out, verify the dose scanned is correct, verify that the product scanned is on your formulary [and] continue to scan all your inventory coming in.”

Resolve Bar-code Problems First To Reduce eMAR Problems Later To address concerns about drugs that were not scanning properly before they embarked on a full rollout of their electronic medical records (eMAR) system,

Pharmacy Practice News • April 2011

Technology 43

Clinical Decision Support pharmacists at Massachusetts General Hospital (MGH), in Boston, undertook a full assessment of their automated dispensing cabinets (ADCs), uncovering and resolving problem medications. In a presentation at the Informatics pearls session, Ron Imperiali, RPh, associate chief of pharmacy, informatics at MGH, noted that they worked with two types of bar codes—those generated in the pharmacy and those provided with the product by the manufacturers. “I thought going into this that the problem would be with the pharmacy labels,” said Mr. Imperiali. That wasn’t the case. “Those bar codes have just about everything that you need for the nurse to successfully scan,” he said. “It turned out that it was the commercial bar codes that had the problems.” The pharmacists at MGH evaluated one-month usage for every ADC in the hospital. They tested medications that were dispensed at least five times per month and ended up with 750 line items. They ran those drugs through the computerized prescriber order entry (CPOE) system, verified them in the pharmacy system, and sent them to the eMAR system. “What we saw surprised us,” said Mr. Imperiali. “Results for one of our cabinets showed a 79% success rate for scanning. We knew that that was not going to be appropriate and that we needed to do something about it.” The main issues they uncovered were scans that showed over- or underdosing of a drug. “This was usually due to the units of measure not matching between the physician order entry system and the pharmacy system.” Another problem was products that did not have any bar code. The solutions to these problems were relatively easy, noted Mr. Imperiali. For products that did not have a bar code, they added one, and for the over- and underdosing problems, they changed the units on the bar code or on the pharmacy and CPOE systems so that everything matched. They initially ended up with a list of problem drugs that they could not fix before the rollout. They created a “noscan list,” and nurses were told not to scan these items. Since then, they have implemented a new bar-code service that uses national drug code numbers, which addresses the drugs in the no-scan list. Mr. Imperiali had some suggestions for those implementing new bar-coding systems. “Before going live with a bar-code medication administration system, be sure to test as many of the different bar codes for medications that the nurse will administer as possible,” he said. “Be sure to do it early enough so there is enough time to come up with a plan for those that do not scan.” —Sarah Tilyou

CDS SYSTEM FLAWS continued from page 40

If you’d like to test your own institution’s CDS system against Dr. Malone’s fictional patient, he’s developed an evaluation tool that includes most of the drug– drug interactions used in the new study. It’s slated to appear in an upcoming issue of the Journal of the American Pharmacists Association (by summer 2011). “There won’t be a one-size-fits-all solution to this issue,” he said. “Blindly taking a CDS [software] product off the

shelf and saying ‘Turn it on,’ won’t work. It will require focused efforts on the part of drug knowledge database vendors, software vendors, and the scientific community to integrate this information into meaningful CDS system, so that it makes sense when we get the interactions and they’re relevant to the patient.” Steve Sklar, PharmD, clinical manager of drug interaction and allergy databases for Wolters Kluwer’s Medi-Span drug information database, commented, “We as vendors need to set good editorial policy and conduct good critical literature

evaluation to make sure that we’ve done all we can on the data side to see that our hits are as precise as possible.” Dr. Sklar said that he sees end-user customization capabilities as the future of such databases. “They’ll allow the end user to say, ‘I’m aware of this interaction and I don’t want to see it again on this particular patient.’ Customization layers will take the global data that we’ve filtered, and allow the user at the patient level to fine-tune it even further.” —Gina Shaw

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