Pharmacy Practice News - September 2009 - Digital Edition by McMahon Group

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Volume 36 • Number 9 • September 2009 ❃

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In Cancer-Related Anemia, in this issue Up Front Pharmacists Get the Nod In Brief For Best Patient Outcomes Physician-managed patients fared worse in new study Miami—A retrospective analysis of 100 patients receiving darbepoetin alfa at an anemia clinic found that those who were managed by pharmacists were more likely to achieve target hemoglobin levels and had more frequent laboratory monitoring of their iron levels than patients who were seen by physicians. In addition, treatment guidelines were more closely adhered to in patients receiving pharmacist care than in the physician-managed patients, according to a study presented in a poster at the 5th Annual Conference of the Hematology/Oncology Pharmacy Association. The results indicate that pharmacists have an important role to play in managing patients in supportive care clinics, said Jamie Poust, PharmD, of the University of Colorado Cancer Center, Aurora, who led the study. “These data show that having a pharmacist be

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FDA issues alert on potentially deadly blood glucose test errors.

Your Letters Kudos for columnist extolling life balance.

Clinical

Clotting Disorders New options for treating fibrinogen deficiency.

Operations & Mgmt

Going Green Tips for making hospitals more environmentally friendly.

Leadership in Action Ernie Anderson Jr., MS, RPh, continues to explore his life portfolio.

see ANEMIA CLINIC, page 18

Policy

Raising the Quality Bar: A Primer on Safe Practices From Nat’l Quality Forum

t least one message in the National Quality Forum’s new Safe Practices for Better Health Care—2009 Update seems clear: Pharmacists and pharmacy leaders have a key role to play in helping to improve health-system safety. Many of the 34 safe practices detailed in the NQF update directly depend on pharmacists’ evidencebased interventions as “medication safety officers”— the term Michael R. Cohen, MS, ScD, RPh, FASHP, president of the Institute for Safe Medication Practices (ISMP) and member of the NQF consensus committee that devised the update, used to describe their role. Most of the practices rely on pharmacists acting as interdisciplinary team members. “I’ve even counted it up,” said Hayley Burgess, PharmD, BCPP, director of performance improvement measures, standards and practices at the Texas Medical Institute of Technology (TMIT), in

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see NQF REPORT, page 16

Infectious Disease Experts debate best strategies for antibiotic stewardship programs.

Educational Review Compatibility of Commonly Used IV Drugs Insert after page

The Book Page Compliance for Coding, Billing & Reimbursement, 2nd Edition See page

Improving the Safety of IV Drug Delivery

Heart Failure Outreach Yields Benefits, But Challenges Cited

n Australian study has shown that when pharmacists collaborate with primary care physicians and make house calls to help heart-failure (HF) patients manage their disease, the rate of rehospitalizations is nearly halved. The study, by researchers at the Department of Veterans’ Affairs (VA) in Canberra, follows earlier trials down under that document the value of HF home visits by pharmacists. But do the results have any relevance to how the profession can help manage the disease in the United States? Sean Jeffery, PharmD, CGP, a geriatric specialist working with the VA Connecticut Healthcare System Department of Pharmacy, in West Haven, works closely with physicians and other caregivers and does make house calls when HF patients show signs of disease exacerbation. His efforts are part of the VA’s home-based primary care program. “But most hospitals can’t send pharmacists into the field—there just isn’t an economic model that makes it feasible outside of the VA,” he said. There is, however, a rich body of evidence showing that a related approach— inpatient counseling by pharmacists, coupled with outpatient follow-up via e-mails, telephone calls and other forms of electronic monitoring—can achieve similar results. Still, cost and staffing pressures hinder widespread adoption.

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see HF PROGRAMS, page 22

Global initiative debuts in U.S. on Nov. 5

Awareness Effort Seeks Better Nutrition in Hospitalized Patients

o address the inertia that often characterizes how U.S. hospitals deal with malnutrition in their patients, organizers are bringing the successful European and Asian nutritionDay program to American hospitals. The goal: to document and improve patient nourishment and related outcomes and reduce costs. For 30 years, it has been well docu-

mented that 55% to 65% of hospitalized patients are malnourished or at risk for malnourishment, according to Gail Gewirtz, MS, RD, national project coordinator/president of nutritionDay in the United States. This malnutrition contributes to poor healing, increased morbidity and mortality and increased costs.

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see OUTREACH, page 5

New Products Helixate FS approved for hemophilia A in children.

S&S Technology announces the launch of their Pharmacy Carousels System (PCS). See page

CareFusion Corp.— a new name for an established medical technology company. See page

Expanding our portfolio in 2009 All Teva Unit Dose products contain the following on every cell: • Scannable Bar Code • Product Description • NDC #

• Lot # • Expiration Date • Product Source

19 Hughes • Irvine, California 92618 • 800.729.9991 • www.tevausa.com

8341 A

Up Front 3

Pharmacy Practice News • September 2009

Capsules In Brief

surf

FDA Issues Warning on Glucose Test Strips

watch

SEPTEMBER 2009

The five most-viewed articles last month on pharmacypracticenews.com: 1. Recruiting, Retaining Pharmacists May Hinge on Depth of Offerings 2. Pharmacist-led Program for Smoking Cessation Can Double Quit Rates 3. Hospitals May Be Letting Crucial Drug Pricing Tool Rust 4. Strong Medication Reconciliation Effort Lowers ADE Readmissions 5. CPOE in Ambulatory Setting Comes With Growing Pains Register for free at pharmacypracticenews.com to read these and other articles on the latest developments in hospital pharmacy.

heard here first

‘[Hospitals] need to … play a part in healing the ecosystem. We need to have buildings that restore, that regenerate.’’ —Robin Guenther

See article, page 20

fter years of warnings from clinicians that falsely elevated blood glucose test results can occur in certain patients using glucose dehydrogenase-pyrroloquinolone quinone (GDH-PQQ) test strips, the FDA issued a public health notification warning health care facilities not to use the strips. “This is an action that should probably have been taken years ago,” said Jerry Siegel, PharmD, senior director of pharmacy at The Ohio State University Medical Center, in Columbus. “This problem has been known for nearly a decade.” Dr. Siegel presented a study on some monitors and test strips involved in the false-positive readings at the 2008 American Society of Health-System Pharmacists Summer Meeting, in Seattle. [For details, see www. pharmacypracticenews.com/fwd/11283.htm] According to the FDA, GDH-PQQ-based glucose monitoring is prone to errors because the technique measures a patient’s blood glucose value using a methodology that cannot distinguish between glucose and non-glucose sugars. “When these non-glucose sugars are present in the blood, using a GDH-PQQ glucose test strip will produce an elevated glucose result which may suggest the need for clinical action,” the FDA noted. “This can lead to inappropriate dosing and administration of insulin, potentially resulting in hypoglycemia, coma or death.” Dr. Siegel stressed that the potential for false-positive readings is significant when using GDH-PQQ-based glucose monitoring, given the large number of medications and foods a patient could be taking that contain non-glucose sugars. He said drugs containing maltose and icodextrin are the non-glucose sugars of most concern, but that there is a potential for false readings with xylose- and galactose-containing compounds as well. For hospitals that still stock GDH-PQQ glucose test strips, the FDA urged that they not be used in patients who are receiving the following “interfering prodducts” that contain non-glucose sugars: • Extraneal (icodextrin) peritoneal dialysis solution • Some immunoglobulins, including Octagam 5%, WinRho SDF Liquid, Vaccinia Immune Globulin Intravenous (Human) and HepaGam B • Orencia (abatacept) • Adept adhesion reduction solution (4% icodextrin) • Bexxar radioimmunotherapy agent • Any product containing, or metabolized to, maltose, galactose or xylose. The FDA also suggested several workflow tweaks that could help prevent problems with these test strips, such as adding drug interaction alerts in computerized prescriber order entry systems, patient profiles and charts. The agency’s alert followed a 2008 report on the potential for maltose-containing immunoglobulin products to trigger falsely elevated blood glucose readings (www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm155099.htm). The Institute for Safe Medication Practices also has issued alerts on the topic (www.ismp.org). —David Bronstein

EDITORIAL BOARD

Dan Radebaugh, Director of Production and Technical Operations

ADMINISTRATION Robert Adamson, PharmD, Livingston, NJ Ernest R. Anderson Jr., MS, RPh, Boston, MA

Mark Neufeld, Production Manager

ANESTHESIOLOGY/PAIN

Volume 36 • Number 9 • September 2009 • pharmacypracticenews.com

Robert Barkin, PharmD, Chicago, IL Julie A. Golembiewski, PharmD, Chicago, IL Melvin E. Liter, MS, PharmD, FASHP, Lexington, KY BIOTECHNOLOGY Indu Lew, PharmD, Livingston, NJ CARDIOLOGY

James Prudden, Group Editorial Director

Susan Goodin, PharmD, BCOP, New Brunswick, NJ

Elizabeth Zhong, Associate Copy Chief

Van Velle, President, Partner

Robert Ignoffo, PharmD, San Francisco, CA

Brian Dunleavy, Editorial Director, Promotional Medical Education

Thomas Ciriacks, Vice President, Medical Education

Philip E. Johnson, MS, RPh, FASHP, Tampa, FL

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

PEDIATRICS Gretchen Brummel, PharmD, Hershey, PA REIMBURSEMENT Bonnie E. Kirschenbaum, MS, FASHP, Breckenridge, CO TECHNOLOGY Susanne E. Larrabee, RPh, Petoskey, MI

CRITICAL CARE

Thomas Van Hassel, RPh, Yuma, AZ

John W. Devlin, PharmD, BCPS, FCCM, Boston, MA Judi Jacobi, PharmD, FCCM, Indianapolis, IN Lynda Welage, PharmD, FCCM, Ann Arbor, MI

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Steven J. Martin, PharmD, BCPS, FCCM, Toledo, OH Peggy McKinnon, PharmD, Detroit, MI David P. Nicolau, PharmD, Hartford, CT Robert P. Rapp, PharmD, Lexington, KY

Sarah Tilyou, Senior Editor smtilyou@mcmahonmed.com

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4 Up Front

Pharmacy Practice News • September 2009

Your Letters

Kudos for Surviving Crisis Mode Ernie Anderson’s July Leadership in Action column (“Life Portfolio—The Work Continues, But at a New A Shared Struggle Venue,” page 13), in which he detailed the reasons why he has left the Lahey Clinic for greener pastures ’ve been following your series in Pharmacy Practice News for some in Boston, resonated with many readers. Here is a sampling of the feedback we received.

How To Measure Life Balance

Global Self-Assessment: The Wheel of Life Romance

very much enjoyed Ernie Anderson’s life portfolio article in the July 2009 edition of Pharmacy Practice News. I have not yet read the book that seems to have had such a great impact on Mr. Anderson, but I plan to. I expect it will be a useful resource for my own efforts to help people strike an effective balance in their personal and professional lives. I have coordinated many leadership development conferences for students, residents and practitioners over the years through the Texas Society of Health-System Pharmacists and the Texas Pharmacy Association. One of the many tools I use to assist with self-assessment is a balance wheel I designed based on some models I have encountered (Figure). It’s a helpful tool for making you look at what is important in life and which areas you may be neglecting. Thanks to Mr. Anderson for sharing his experience and informing others of [Corbett’s] book. I’ll pick up a copy soon.

Kevin Purcell, MD, PharmD, MHA Healthcare Leaders 2B/Pediatric Research 4U Corpus Christi, Texas

Career Move Seen As Logical Next Step

have enjoyed your columns for the past several years and often wondered where you found the time to reflect and develop your professional group as much as you did. I wonder about that even more, now that you admit you spent as much as 14 hours a day away from family and operated in crisis mode much of the time. Kudos to you for being able to do so for so long. As a former director of pharmacy who faced many of the same challenges you did, your last article resonated with me. I am glad you took the next step; it was a logical one and fitting since you apparently did not reach a burnout stage. Making a rational choice rather than one forced on you allows you to move forward without excess baggage. I chose to return to practice rather than pursue another leadership position and find it a much more rewarding experience that has afforded the balance I could not attain as a pharmacy director. I hope you are able to provide the leadership to your new [staff] so that they can emulate your style and reflect from time to time rather than operate in crisis mode. Having a thinker like you at the executive table can be a catalyst in the development of pharmacy prac-

Fun, Relaxation, and Hobbies

Family

3 2 2

2 Health and Fitness

Career and Professional Growth and Development

1 3

2 1

1 2

2 3

Home and Living Environment

Friends and Social Activities

3 3

Money and Financial Planning

Spirituality and Personal Growth and Development

Neighbors and Community Involvement

What is your satisfaction level in each area? 1–Not satisfied; 2–Somewhat satisfied; 3–Very satisfied

For each pie-shaped area of the wheel of life, start at the center of the wheel and shade in sections until you reach your level of satisfaction. After you are done, identify all areas that you need to work on. Then set goals in each of those areas so that you can eventually shade in your entire wheel and roll more smoothly, evenly and successfully along your journey in life. You can’t travel too far with a flat tire!

Henry Lubinski, RPh, MS Monmouth Medical Center Long Branch, N.J.

Grassroots Support

just read your article, detailing your reasons—both professional and personal—for seeking a new position. Congratulations on a great read! I do hope you run for the ASHP Board and eventually president. I think you’d be excellent and I would support you wholeheartedly.

Philip W. Rioux, RPh, FASCP Director of Pharmacy Central Maine Medical Center Lewiston, Maine

Inspired To Strap On the Skis enjoyed your latest article, “Life Portfolio….” You have articulated the challenges I face daily. I was intrigued by how you opened with the slalom water-skiing course. It reminded me that I haven’t skied in several years and I owe it to myself to strap on my vintage O’Brien skis and just do it. I have ample opportunity to go skiing as I live on Lake

Mark Sullivan, PharmD, MBA, BCPS Director, VUH Pharmacy Operations Vanderbilt University Hospital Nashville, Tenn.

tice. I look forward to reading how you face these new challenges.

1 2

time and just wanted to thank you for your piece in the current edition. Many of us in the late 40 to early 50 age range are struggling with similar issues, having reached a certain point in our careers, and wondering how “fighting fires” became job No. 1. I intend to find a copy of David Corbett’s book [“Portfolio Life: The New Path to Work, Purpose and Passion After 50”; Jossey-Bass, November 2006] this weekend, thanks to your recommendation. Please keep writing!

Quinsigamond and have ready access to a boat and miles of flat water. The overused excuse that the hospital and other obligations always take precedence over my life’s balance needs to be addressed. Thank you for your openness.

A Muse for Looming Retirement

r. Anderson’s life changes and thoughts are a good look at “the man in the mirror.” His application of [Stephen] Covey’s “Seven Habits” with [David] Corbett’s “Portfolio Life: The New Path to Work, Purpose and Passion After 50” [Jossey-Bass, November 2006] have enabled him to clearly define his five- to 10-year life goals. What a great example for the 20-, 30- and 40-somethings to see and follow. Mr. Anderson has been and will continue to be an inspiration to me, and will surely help me follow through on defining my goals and aspirations as I approach retirement in seven to 10 years.

Steve Gerardi, MS, RPh Kaiser Permanente Napa, Calif.

Denis Brown, RPh, FASCP Director of Pharmacy—Memorial Campus Worcester, Mass.

A Master’s Class In Life Planning

would like to use your article, “Life Portfolio—The Work Continues, But at a New Venue” in a master’s in hospital pharmacy course that I teach during spring semester. You really put it out there in this article and I am curious to see what reaction you get. More power to you, and I hope you now can run for the ASHP Board of Directors. Your story sounds very similar to that of [ASHP past president] Kevin Colgan’s departure from his director of pharmacy position, so perhaps this will lead more pharmacy directors to rethink the personal and professional goals they want to achieve in their positions.

Stephen C. Dedrick, MS Director of Continuing Education UNC Eshelman School of Pharmacy Chapel Hill, N.C.

Tell Us Your Story: Winner Gets Corbett’s “Portfolio Life”—on an Amazon Kindle!

o you have a compelling story to tell about a recent life or career change? Share it with us, and if your entry is chosen by our board of experts as the winning essay, you’ll win a free copy of David Corbett’s “Portfolio Life: The New Path to Work, Purpose and Passion After 50,” loaded onto a free Amazon Kindle! Entries should be no longer than 800 words and sent to ppneditor@mcmahonmed.com. Good luck!

Clinical 5

Pharmacy Practice News • September 2009

Events

OUTREACH continued from page 1

But, she told Pharmacy Practice News, too many facilities have argued that “it’s not happening at their hospital or they need outcome data to justify nourishing their patients.” This attitude has stymied efforts to address the problem but ultimately led to the creative approach taken as part of nutritionDay. The approach, which has been implemented over the past five years in more than 30 countries, will be initiated in the United States on Nov. 5 and annually thereafter. The program allows hospitals and specific patient-care areas to self-assess how well they are addressing malnutrition. Specific specialty areas within a participating center (e.g., intensive care unit, pediatrics) will conduct one-day mini nutritional assessments of 15 to 20 patients within the given unit. Thirty days later, each patient will be reassessed, providing progressive outcome information for review and analysis. The information gleaned will provide a snapshot for facilities and will allow them to correlate status on nutrition day with 30-day outcomes, Ms. Gewirtz said. Each facility or unit will receive a report comparing its own results and the collective data from all units of the same specialty type. The specialty areas within a facility can compare themselves with similar areas at other institutions. In addition, facilities eventually will be able to track their year-to-year trends, she noted. No special knowledge is needed to conduct the assessment. The program provides single-sheet questionnaires that make data collection quick and easy and provide practical information. All documents as well as sample reports are available on the Web site, www. nutritionday.org. Ms. Gewirtz noted that “these audits already have been shown to significantly impact nourishment practices and patient outcomes” in Europe.

A Useful Benchmarking Tool Jay Mirtallo, MS, RPh, specialty practice pharmacist in surgery/nutrition support at The Ohio State University Medical Center, in Columbus, gave nutritionDay kudos for shining a light on an under-recognized aspect of patient care. In Europe, he said, the outreach program “has been a very useful tool for benchmarking and bringing social and government awareness” to this issue. But in the United States, he said, “we’re kind of behind the eight ball,” although the need is there. Mr. Mirtallo is part of a group comprising representatives from the American Society for Parenteral and Enteral Nutrition (ASPEN), the European Society for Clinical Nutrition and Metabolism

(ESPEN) and other organizations working to define disease-related malnutrition. Citing some of the data from the previous nutritionDay studies conducted in Europe, Mr. Mirtallo said that patients who are malnourished have a sixfold increase in mortality. He also described a nutritionDay study that was presented at the 2008 ESPEN meeting investigating the relationship of body mass index (BMI) and nutritional intake with mortality in German and Austrian nursing home residents. The residents’ BMI and their nutritional intake were evaluated on nutritionDay and out-

comes were evaluated at six months. The outcome data from 1,492 residents showed that a lower BMI value on nutritionDay correlated with a higher mortality (21.6% for BMI <20 kg/m², 16.8% for BMI 20-22 kg/m2, 10.4% for BMI ≥22 kg/m2; P<0.0001). In addition, 8.7% of those who had eaten their entire lunch had died, compared with 18% of those who had eaten half their lunch, 25% of those who had one-fourth of their lunch and 42% of those who had eaten none of their lunch (P<0.0001). Another study published online on July 15 in Clinical Nutrition (doi:10.1016/j.

clnu.2009.05.013) showed that decreased food intake also is a risk factor for mortality in hospitalized patients. In this study, participating centers in Europe and Israel studied 16,290 adult hospitalized patients on nutritionDay 2006 to assess the effect of food intake and nutritional factors on in-hospital mortality within 30 days. The investigators found that more than half of the patients did not eat the whole meal provided by the hospital. Furthermore, decreased food intake on nutritionDay or during the previous week was

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see OUTREACH, page 15

Gelfoam + Human Thrombin In one kit. ®

Gelfoam Plus...

• Provides cost savings compared to items purchased separately1 • Offers additional savings opportunities with inclusion in the Baxter Value Incentive Program • Allows easy management of thrombin use • Helps consolidate inventory of multiple products And FLOSEAL [Hemostatic Matrix] are part of a complete hemostasis product line from Baxter. For more information please contact your local Baxter BioSurgery Representative or call 1-800-423-2090.

www.baxterbiosurgery.com GELFOAM PLUS Hemostasis Kit Indications GELFOAM PLUS is intended as a hemostatic device for surgical procedures when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is either ineffective or impractical. Thrombin (Human) used without the Gelfoam Sterile Sponge is not indicated for hemostasis. Important Safety Information GELFOAM PLUS should not be used in closure of skin incisions, because it may interfere with the healing of the skin edges. GELFOAM PLUS should not be placed intravascularly, because of the risk of embolization. GELFOAM PLUS is not recommended for use other than an adjunct for hemostasis. GELFOAM PLUS contains thrombin, which is made from human plasma. It may carry the risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. While packing a cavity for hemostasis is sometimes surgically indicated, GELFOAM PLUS should not be used in this manner unless excess product not needed to maintain hemostasis is removed. Whenever possible, GELFOAM PLUS should be removed after use in laminectomy procedures and from foramina in bone, once hemostasis is achieved. This is because GELFOAM Plus may swell to its original size on absorbing ﬂuids, and produce nerve damage by pressure within conﬁned bony spaces. GELFOAM PLUS is not recommended in the presence of infection. There have been reports of fever associated with the use of Gelfoam Sterile Sponge, without demonstrable infection.

FLOSEAL [Hemostatic Matrix] Indications FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. Important Safety Information FLOSEAL must not be injected into blood vessels, or allowed to enter blood vessels. Do not apply in the absence of active bleeding. Extensive intravascular clotting and even death may result. Do not use FLOSEAL in the closure of skin incisions because it may interfere with the healing of the skin edges. Do not use FLOSEAL in patients with known allergies to materials of bovine origin. FLOSEAL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The maximum swell volume of approximately 20% is achieved within about 10 minutes. Excess FLOSEAL (material not incorporated in the hemostatic clot) should be removed from the site of application using gentle irrigation. RX only: For safe and proper use of these devices, please refer to full device Instructions For Use. 1. 2006 IMS Hemostat and Sealant Revenue, Unit, and ASP Sales Data. Baxter, FLOSEAL and ADVANCING SURGERY,ENHANCING LIFE are trademarks of Baxter International Inc. Gelfoam is a registered trademark of Pharmacia & Upjohn Company LLC., used under license. BS1889 4/2008

6 Clinical

Pharmacy Practice News • September 2009

In Brief positive pressure ventilation may be used to improve ventilatory status.

Dulcet Strains, Decorous Rest F or some people, music can be a shot in the arm. For others, it can help ease the pain from one. Indian pediatricians have found that soothing music is nearly as effective as a local anesthetic cream at preventing pain associated with venipuncture. Researchers at Seth GS Medical College and KEM Hospital, in Mumbai, studied 150 children, aged 5 to 12, who were randomized into three groups: 50 received topical applications of eutectic mixture of local anesthetic (EMLA); 50 received a placebo cream with no active ingredients; and 50 received no cream but underwent vein puncture while classical Indian instrumental music was piped into the room. Compared with children in the placebo group, those treated with EMLA and those who heard music reported significantly less pain when the cannula was inserted, as well as one and five minutes later, according to the researchers. The investigators used a visual analog scale (VAS) to assess patient discomfort. They also relied on ratings of pain from the children and their parents, as well as their own impressions and those of independent observers. Although the anesthetic cream appeared to be somewhat more effective than music, the difference was not consistent

More Leadership On Drug Safety Urged

he Joint Commission has issued a Sentinel Event Alert urging health care leaders to step up their efforts at preventing medication errors by adopting the “zero-defect” approach used in other high-risk industries such as aviation and nuclear energy. “Health care leaders are directly responsible for establishing a culture of safety,” said Mark R. Chassin, MD, the group’s president, in a news release. “This Alert provides leaders with concrete strategies for demonstrating a commitment to safety and to improving patient outcomes.” The Joint Commission urged leaders to take a collaborative approach to medication safety—one that involves health care trustees, executives and physician leaders. “In safe organizations, safety is rooted in the culture and the system, rather than in the behavior of individuals,” the group noted. The Joint Commission suggested that the governing body, chief executive officer, senior managers and medical staff leaders at health care organizations take a series of 14 specific steps to improve patient safety, including the following: • Define and establish an organizationwide safety culture that includes a code of conduct for all employees. • Institute an organization-wide policy of transparency that sheds light on all adverse events and patient safety issues. • Make the organization’s overall safety performance a key, measurable part of the evaluation of the CEO and all leadership. • Ensure that caregivers involved in adverse events that result in unintentional patient harm receive attention that is just, respectful, compassionate, supportive and timely. • Create and communicate a policy that defines behaviors that are to be referred for disciplinary action and a timeframe for that action to take place.

• Add a human element to safety improvement by having patients communicate their experiences and perceptions to leadership. • Reward and recognize staff whose efforts contribute to safety. The Joint Commission also urged health care organizations to use the Leadership section of the group’s accreditation standards to improve patient safety. The standards offer guidance on a number of patient safety initiatives, including the use of reporting systems for adverse events and near misses and the design of processes to support safety. —David Bronstein

ASA Issues Guidance On Neuraxial Opioids

—Rose Fox

across all time points or between raters. “The difference between VAS scores with [EMLA] and music is not always significant,” they wrote. “Hence, the choice between EMLA and music could be dictated by logistical factors.” The researchers reported their findings in the Indian Journal of Pediatrics (April 23, Epub ahead of print). What sounds good to children also appeals to adults. In an unrelated study, Swedish surgeons found that soothing music was more effective than chemical sedation at easing preoperative anxiety. The study, which included nearly 330 adult patients scheduled for elective surgery, showed that patients who listened to relaxing tunes reported larger drops in anxiety—based on the State Trait Anxiety Inventory—than did those given oral midazolam (0.05-0.1 mg/kg; P<0.001). “Higher effectiveness and absence of apparent adverse effects makes preoperative relaxing music a useful alternative to midazolam for premedication,” the authors wrote. The findings were published April 14 in the online edition of Acta Anaesthesiologica Scandinavia. —Adam Marcus

n response to increasing reports of respiratory depression related to neuraxial opioid administration, the American Society of Anesthesiologists has released new practice guidelines for the treatment of patients receiving epidural or spinal administration of opioids in inpatient or ambulatory settings. But some elements of the guidelines may significantly increase the burden on hospital staff and could lead to higher costs of treatment, experts said.

Published in Anesthesiology (2009;110:218-230), the guidelines specify methods by which the risk for respiratory depression may be assessed and mitigated. The document calls for a directed history and physical examination that looks for evidence of sleep apnea and evaluates airway, heart and lung function. The guidelines also strongly advise using “the lowest efficacious dose of neuraxial opioids” and to exercise caution and increase monitoring when concurrently administering neuraxial and parenteral opioids. In addition to lowering the likelihood of respiratory depression, these steps also may reduce the risk for or severity of other adverse outcomes such as cardiac arrest, brain damage and death, according to the task force. The guidelines emphasize the importance of monitoring patients during and immediately after the administration of opioids. Recommendations include two hours of continuous monitoring after a single injection of neuraxial lipophilic opioids to evaluations every one to four hours in the 48 hours following the administration of sustained- or extended-release epidural morphine. Supplemental oxygen should be available for patients receiving neuraxial opioids, and noninvasive

Shingles Pain Eased Via Controlled-Release Oxycodone: Study

ontrolled-release oxycodone is a safe and effective treatment for relieving the acute pain caused by herpes zoster (HZ), according to a recent study. CR-oxycodone also was found to show promise in preventing postherpetic neuralgia, which develops in a substantial percentage of patients with HZ infection (shingles). The randomized, placebo-controlled trial incorporated aggressive titration schedules of oxycodone and gabapentin with famciclovir to treat patients with acute pain from HZ. Researchers recruited 87 patients (at least 50 years old) with HZ, in whom a rash had appeared within the previous six days. Pain reductions of at least 30% and 50% were considered clinically important endpoints. Administration of up to 120 mg per day of CR-oxycodone significantly reduced mean pain levels on days 1 through 8 (P=0.01) and days 1 through 14 (P=0.02). Its effects, however, were negligible over the full 28-day study period. This result is explained by the natural progression of HZ infections in which pain tends to diminish within two or three weeks after the rash appears. Gabapentin showed little pain relief compared with the placebo, with a minor benefit demonstrated in the first week only (P=0.13). This finding may be a result of the study’s small sample size, the low drug doses (≤1,800 mg/d) or because patients in the early stages of shingles experience nociceptive pain, whereas gabapentin is a first-line drug for neuropathic pain. Adverse effects (or fear of them) led to seven discontinuations (24%) in the CR-oxycodone group; constipation was the most common side effect. In the gabapentin group, four patients (14%) discontinued treatment as a result of adverse effects, again mainly attributed to constipation. The initiation of routine laxative therapy at the beginning of treatment would likely increase the tolerability of both drugs. The findings were published in Pain (2009;142:209-217). —Seth Kandel

FDA Panel Supports Automated Sedation System

n FDA advisory panel has recommended that the agency approve a controversial device that provides computer-aided propofol sedation for colonoscopy and other office-based gastrointestinal procedures. The panel voted 8 to 2 in favor of the device, called Sedasys, provided the FDA restricts its use to patients under the age of 70. Panelists also expressed concern that some patients experienced general anesthesia while on the machine and called for more research on its safety and efficacy. Developed by Ethicon Endo-Surgery, a division of John-

son & Johnson, Sedasys combines a drug delivery system with sensors to monitor heart rate, blood pressure, oxygen saturation and other patient data. The machine is designed to be used by a team of nurses and physicians, although not necessarily anesthesiologists, for patients requiring light or moderate sedation. In submissions to the FDA, the company estimated that anesthetists participate in about 25% of all endoscopies. In a company-funded trial involving 1,000 patients, patients treated with Sedasys emerged from sedation faster than those given conventional care—2.7 versus 6.3 minutes, on average.

PATIENT SAFETY GUIDELINES AND HEALTH CARE COSTS W

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Improving the Safety of IV Drug Delivery and recommendations from this confer- rules regarding never events, medication ence were published in the January 2009 safety and error summaries, infection American Journal of Health-System Phar- control considerations, and a review of macy (66:185-192).4,5 parenteral nutrition (PN) standardization. Corporate Vice President The conference followed the Nation- Conference participants also reviewed Baylor Health Care System al Institutes of Health consensus devel- available drug delivery systems, which Dallas, Texas opment process and included a multidis- were defined as “the means by which ciplinary consensus panel, in addition to medications are prepared, processed, and an expert audience representing urban delivered to health care personnel and the In 2000, Bates et al published a con- and rural hospitals, major health systems, patient or other caregiver for IV adminsensus document with the goal of help- pediatric hospitals, home health care istration.”5 These include manufacturer ing health systems balance cost, quality, practices, and several national regulatory ready-to-use (RTU) products, outsourced IV products, POC-activated products, traefficiency, and safety of IV drug delivery and policy agencies. systems in relation to the medication-use The conference opened with presenta- ditional pharmacy-compounded items, process as a whole.1 The expert panel tions on regulatory and professional stan- and admixtures prepared by a caregiver concluded that manufacturer-prepared, dards associated with IV delivery, CMS at the point of care. point-of-care (POC)–activated, and pharmacy-based IV admixture programs were superior to other types of products for Table 1. Elements for Consideration of IV Delivery Systems IV drug delivery (IV push, volume control chambers, and augmented IV push Domain Definition systems). Although no significant changes to the Applicability The degree to which the delivery system meets the available products for IV delivery have needs of patients without adaptation. This should been made over the past 9 years, a numinclude meeting the needs of special patient populaber of regulatory, policy, and technolotions such as pediatrics, neonates, or fluid-restricted gy issues have significantly affected the patients. preparation and delivery of IV admixtures Ease of use The extent to which various end users can procure, in the United States. United States Pharprepare, and administer the medication in the safest macopeia (USP) Chapter <797>, the Joint manner. This should also take into consideration the Commission standards on medication number of steps required, complexity, and availability management, the Centers for Medicare of personnel for procurement, preparation, delivery, & Medicaid Services (CMS) rule on hosand administration. pital-acquired conditions, bedside barcode scanning, and the greater accepRegulatory compliance The degree to which all applicable regulatory and tance of smart infusion pump technology accreditation requirements are met, including Joint are examples of these changes. Commission standards, state pharmacy and public All of these issues occur in the backhealth regulations, and USP Chapter <797> standards. drop of a long overdue, nationwide focus on patient safety. IV admixture errors are Cost The total expense associated with medication procureof particular concern, because the risk ment, storage, preparation, and delivery to the point of associated with these therapies often care. Compounding equipment, labor, education, and is much greater due to the immediate training costs also should be taken into consideration. onset of systemic effects, low therapeutic index of many IV medications, and difSafety The potential and actual risk for harm to health care ficulty reversing pharmacologic effects personnel and patients, including errors and adverse after IV administration.2 Furthermore, IV drug events (eg, administration of wrong medication, errors continue to occur in part because infections, phlebitis). of issues associated with product labeling, Implementation The resources and requirements for procurement, mix-ups, drug familiarity, and inattentionpreparation, delivery, administration, and monitoring of al blindness.3 the medication. This includes staff orientation, training, So how can pharmacists practicing in and competency assurance across all appropriate dishealth systems today begin to address ciplines and departments for safe and effective product safety issues associated with IV drug delivery systems? Answering this question use. was the purpose of the Second ConsenUSP, United States Pharmacopeia sus Development Conference on the SafeAdapted from reference 5. ty of Intravenous Drug Delivery Systems, held Aug. 7-9, 2008. The proceedings

Michael Sanborn, MS, FASHP

PHARMACY PRACTICE NEWS • SEPTEMBER 2009

Conference Findings Each of these 5 delivery systems has its advantages and disadvantages. Therefore, the outcomes of the conference included several key requisites that can be helpful for pharmacists in various health-system settings. First was a summary of elements to consider when selecting specific IV delivery systems for use throughout the organization: applicability, ease of use, regulatory compliance, cost, safety, and implementation (Table 1). Each of these domains will have institution-specific relevance and priority. As an example, if a hospital has not yet standardized a majority of IV drug concentrations, then this important task could affect the ease of use and possibly the applicability domains within the organization. To move the facility toward a greater use of premixed RTU products, the hospital would have to consider the time and effort associated with implementing concentration standards, as well as the concentrations that are available for purchase. The group also concluded that although the use of premixed PN is not common practice in hospitals, increased use of these products would likely reduce patient risk. This conclusion came about partly because of the obvious reductions in potential for compounding errors, infection risk, and prescribing errors through the use of a standardized, RTU PN product. Debate continues over standardized versus customized PN formulations and whether or not standardized PN products may improve patient safety.4 Once the domains were established, all conference participants ranked each of the available delivery systems within each domain. Before this scoring exercise, participants were asked to consider each domain as having equal weight. With the understanding that individual practice sites would possibly rank items differently, the results overall were interesting. Manufacturer RTU products scored the best overall, with the highest scores in the areas of ease of use, regulatory compliance, safety, and implementation.5 This score implies that facilities should strive to incorporate RTU products whenever possible to improve performance in each of these domains. Outsourced RTU and POC-activated products also scored well, especially

Supported by

in the areas of safety, ease of use, and regulatory compliance. Outsourced products also scored high in the applicability domain, because many of the available products from outsource manufacturers are developed to fit an area of need in which a manufacturer RTU is not available. Importantly, participants were told to assume that the outsource vendor had been vetted completely by the facility and met all regulatory requirements. This process is essential before choosing any outsource partner.5 Products compounded in the pharmacy scored fourth overall. Regulatory compliance, cost, implementation, and ease of use earned relatively low scores, primarily because of participants’ perceptions that complete compliance with USP Chapter <797> requirements has not been implemented at most facilities. (This perception has been supported in the literature.6) Pharmacy-compounded items scored the highest overall in applicability, which confirms the flexibility and capabilities of IV admixture areas to compound virtually any type of item based on patient need. It was not surprising that bedside compounding ranked at the bottom of the list. Safety and regulatory compliance were significant detractors, especially in light of the Joint Commission’s efforts to provide medications in their most RTU form. However, it was noted that these products, when used immediately, are generally exempt from USP <797> requirements.

The Scoring Matrix as a Tool Physicians, nurses, and pharmacists— as well as others who use IV products— might score items differently within each domain. One strength of the scoring matrix and domain definitions format is that it can be used as a tool for organizations to evaluate their own performance and practices related to IV drug delivery systems. A blank copy of the grid (Table 2) can be distributed to different disciplines for scoring (eg, at a Pharmacy and Therapeutics Committee or Nursing/Pharmacy meetings). The resulting scores and differences from one practitioner to another can provide valuable insight to the overall effectiveness of the admixture service. Nurses or physicians may rank one type of product considerably higher or lower than pharmacists.

It also may be necessary to evaluate some IV products independently. Because of the inherent risk associated with IV chemotherapy products, a separate assessment for these admixtures should be conducted. Also, the IV push route should be limited to use only when required by the medication or the patient’s condition.5 Other high-risk products also may warrant independent consideration. Using this process to develop an objective, multidisciplinary evaluation of IV delivery for the facility across the key domains can identify opportunities to improve pharmacy services. It is likely that multiple situations exist in which a lowerranked IV delivery system can be changed to alternatives that are more desirable. Implementing these changes can improve overall patient safety, service, efficiency, and regulatory compliance.

Additional Considerations Some additional areas of consideration were identified but were beyond the scope of the conference. For instance, national standards should be developed for outsourced IV vendors. The American Society of Health-System Pharmacists recently drafted guidelines for outsourcing sterile compounding, and publication of the final version is expected soon.5 Another recommendation included the development of national standards

for rates of IV medication administration that are available at the point of administration, preferably on the medication label. Standards for interface technology between automated dispensing cabinets, smart infusion pumps, and bedside bar-code scanning systems also were suggested.5 Also, as medication delivery systems and technology continue to increase in complexity, a new, specialized role for pharmacists may evolve. The addition of a “medication systems pharmacist” who can evaluate and improve all aspects of medication delivery throughout an organization was discussed. There are other areas to consider when evaluating and improving IV medication delivery. Moving from lower- to higherranked systems, while reducing the number of disparate delivery types, should be a goal. Reducing IV admixture waste, increasing staff competence, and standardizing administration procedures also must be addressed. Finally, special consideration for distinct patient care areas (eg, the emergency department, procedure areas, operating rooms, ambulatory infusion centers, etc) is worthwhile.

improve the safety of drug delivery in the United States. Pharmacists in a variety of practice settings can use the resulting decision matrix as a means to improve IV admixture services.

References 1.

Bates DW, Cousins DD, Flynn E, Gosbee JW, Richason L, Schneider PJ. Consensus development conference statement on the safety of intravenous drug delivery systems: balancing safety and cost. Hosp Pharm. 2000;35(2):150-155.

Proceedings of a summit on preventing patient harm and death from i.v. medication errors. Am J Health-Syst Pharm. 2008;65:2367-2379.

Inattentional blindness: what captures your attention? ISMP Medication Safety Alert! February 26, 2009;14(4).

Sanborn M, Gabay M, Moody ML. The safety of intravenous drug delivery systems—update to the 1999 Consensus Development Conference. Hosp Pharm. 2009;44:159-164.

Sanborn MS, Moody ML, Harder KA, et al. Second Consensus Development Conference on the Safety of Intravenous Drug Delivery Systems—2008. Am J Health-Syst Pharm. 2009;66:185-192.

Candy TA, Schneider PJ, Pedersen CA. Impact of United States Pharmacopeia chapter 797: results of a national survey. Am J Health-Syst Pharm. 2006;63(14):1336-1343.

Conclusion The focus of the Consensus Conference on IV Drug Delivery Systems was to develop practical guidance on ways to

Table 2. Facility-Specific Scoring Grida Manufacturer Outsourced RTU RTU

PPOCActivated

Pharmacy Compounded

Non–Pharmacy Compounded at POC

Applicability Ease of use Regulatory compliance Cost Safety Implementation TOTAL SCORE POC, point-of-care; RTU, ready to use a

Scoring should be based on a Likert scale ranging from 1 (very weak) to 7 (very strong). Adapted from reference 5.

PHARMACY PRACTICE NEWS • SEPTEMBER 2009

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Clinical 11

Pharmacy Practice News • September 2009

Clotting disorders

Current Concepts in the Management of

Congenital Fibrinogen Deficiency JERRY SIEGEL, PHARMD, FASHP Senior Director of Pharmaceutical Services The Ohio State University Medical Center Columbus, Ohio

27-year-old woman undergoes a routine cholecystectomy. Her past medical history reveals that she has had anemia most likely

associated with her unusually heavy menstrual flow and that she takes an iron supplement for this condition.

She also has had 2 spontaneous abortions at 24 and 25 years of age. The surgeon reassures the patient that the cholecystectomy is routine, with very little chance of complication. Shortly after the surgery begins, a large amount of blood pours from the open wound and the patient’s blood pressure drops drastically. The surgeon orders multiple units of packed red blood cells and cryoprecipitate. The patient is stabilized and transferred to the surgical intensive care unit (ICU). Because of the bleeding event, laboratory tests are ordered to define her coagulation status. Her fibrinogen level is found to be 75 mg/dL and she is diagnosed with hypofibrinogenemia, a type of congenital fibrinogen deficiency.

Definition and Etiology Congenital fibrinogen deficiencies are rare, potentially life-threatening bleeding disorders that affect approximately 1 per 1 million persons, with an estimated prevalence of 300 patients in the United States.1 These disorders occur equally in men and women who have diminished or dysfunctional concentrations of fibrinogen (also called Factor I), a plasma glycoprotein needed for blood clotting. Fibrinogen levels in plasma determine the potential clotting ability and activity in the body. There are three types of congenital fibrinogen deficiencies: afibrinogenemia, hypofibrinogenemia, and dysfibrinogenemia, all of which are inherited in an autosomal manner. Afibrinogenemia is the complete absence of plasma fibrinogen; hypofibrinogenemia occurs when fibrinogen levels are significantly below normal; dysfibrinogenemia presents when fibrinogen antigen levels are normal, but fibrinogen function is strikingly impaired due to one or more genetic mutations. A combination of both low fibrinogen levels and impaired fibrinogen function is known as hypodysfibrinogenemia and occurs only occasionally. Fibrinogen deficiencies also may be acquired from defective synthesis linked to liver disease; as an outcome of disseminated intravascular coagulation; and as a

result of abruptio placenta, a pregnancy disorder in which the placenta prematurely detaches from the wall of the uterus. The lack of fibrinogen leads to impaired aggregation of platelets at the site of injury, making bleeding worse. Similarly, abnormal and dysfunctional fibrinogen may result in a poorly formed or unstable clot, leading to a bleeding tendency. To determine fibrinogen levels and confirm a diagnosis, blood coagulation testing should be done. Deficiencies may be indicated by absent or delayed clot formation in the following clotting tests: prothrombin time (PT), partial thromboplastin time (PTT), and thrombin time (TT). These 3 blood tests measure the time required for the patient’s blood to clot. Each one assesses different clotting factors and the tests are often conducted simultaneously to ensure proper diagnosis.

Symptoms Congenital fibrinogen deficiencies may manifest at an early age and can vary in severity.2 Symptoms of congenital fibrinogen deficiencies include moderate to severe bleeding following injury or surgery3; bleeding of the umbilical cord at birth and from the site of the umbilical stump in a newborn; spontaneous bleeding; and bone, joint, or tissue hemorrhage.3 Postpartum hemorrhage, menorrhagia, abruptio placenta and spontaneous abortions also have been observed in women with these deficiencies.2,4 The most common causes of death in afibrinogenemic patients are associated with bleeding and are attributed to postoperative bleeding and intracranial hemorrhage.4 In one evaluation, intracranial bleeding caused one-third of the deaths in the patients studied.5 Some patients with hypofibrinogenemia and dysfibrinogenemia do not experience symptoms; however, this does not preclude the possibility of profuse bleeding if they are hemostatically challenged, such as during surgery or following trauma. Patients with dysfibrinogenemia also are at risk for thrombosis.

Patient Case Study 2 A 62-year-old man comes to the emergency department complaining of epistaxis and prolonged bleeding after “nicking” himself shaving. His medical history reveals that he underwent an orthotic liver transplant five years ago. He is on a maintenance regimen of immunosuppressive drugs, including cyclosporine and prednisone. His laboratory blood work shows a platelet count of less than 5,000/mcL, a white blood cell count of 10,000/mcL, and a hemoglobin level of 12 g/dL. His chief complaints are of nosebleeds and a throbbing headache. Because of his age and thrombocytopenia, the concern is that he has acute thrombocytopenic purpura despite no previous history. To treat this condition, 1 g/kg of IV immunoglobulin (IVIG) is administered. The patient is admitted to the ICU and the infusion is given without complications over 6 hours. The platelet count rises to 50,000, 24 hours post-infusion. The patient’s headache has increased in severity and he is still showing signs of intermittent epistaxis. A second course of IVIG is ordered, but before infusion the patient becomes confused, his right pupil dilates, and he loses consciousness. The patient is taken immediately for a computed tomography scan that reveals a cerebral hemorrhage. At this time the platelet count is more than 75,000. Cryoprecipitate is ordered for this patient, who has a blood type of AB Rh-negative. He is prepared for surgery to relieve the pressure caused by the cerebral bleeding. Fresh-frozen plasma (FFP) is ordered from the blood bank. What is happening with this patient? Does he have idiopathic thrombocytopenic purpura (ITP)? If not, what other conditions could cause these symptoms, and what other tests could or should have been performed? What is the significance of his medical history?

Treatment Until recently, treatment for patients with congenital and acquired fibrinogen deficiencies in the United States has been limited to infusions

•

see FIBRINOGEN, page 13

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Compatibility of

Commonly Used Intravenous Drugs LISA CAYO, PHARMD Clinical Pharmacy Coordinator Garden City Hospital Garden City, Michigan

he number of available IV medications continues to expand. In addition, many institutions

have observed an increase in patient acuity, as well as a rise in the number of medications administered to each patient. These factors have resulted in a seemingly endless number of possible combinations of IV medications and, along with these combinations, potential incompatibilities.

A chance of incompatibility exists whenever one or more medications are combined or added to an IV fluid. It is important to recognize that compatibility is not just a function of the drugs themselves, but also is dependent upon a variety of factors, including concentration, temperature, storage vehicle, infusion solution, order of mixing, and administration technique. Compatibility differences have been reported for different brands of the same drug. The table on the following pages provides

compatibility information for dozens of commonly used drugs. The purpose of this chart is to provide data in an organized, concise format so that compatibility information can be accessed quickly and conveniently. A clear and concise compatibility chart can be a useful tool in helping health care professionals deliver safe, high-quality IV therapy to patients. Obviously, all conditions that may affect compatibility cannot be included in such a format; however, the importance of these factors should not be overlooked. Text continues on page 6.

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

P H A R M AC Y P R AC T I C E N E WS â&#x20AC;˘ S E P T E M B E R 2 0 0 9

Amiodarone

Ampicillin

Ampicillin-sulbactam

Argatroban

Azithromycin

Aztreonam

Bivalirudin

Bumetanide

Calcium gluconate

Cefazolin

Cefepime

Cefotaxime

Cefotetan

Ceftazidime

Ceftizoxime

Ceftriaxone

Ciprofloxacin

Clindamycin

Dexamethasone

Dextrose 5% in water

Diazepam

Diltiazem

Diphenhydramine

Dobutamine

Dolasetron

Dopamine

Doripenem

Doxycycline

Enalaprilat

Epinephrine

Eptifibatide

Esmolol

Esomeprazole

Famotidine

Fentanyl

Fluconazole

Furosemide

Gatifloxacin

Gentamicin

Acyclovir

(continued)

Amikacin

Acyclovir

Table. Compatibility of Selected IV Drugs

C I

Amikacin

Amiodarone

Ampicillin

Ampicillin-sulbactam

Argatroban

Azithromycin

Aztreonam

Bivalirudin

Bumetanide

Calcium gluconate

Cefazolin

Cefepime

Cefotaxime

Cefotetan

Ceftazidime

Ceftizoxime

Ceftriaxone

Ciprofloxacin

Clindamycin

Dexamethasone

D5W

Diazepam

Diltiazem

Diphenhydramine

Dobutamine

Dolasetron

Dopamine

Doripenem

Doxycycline

Enalaprilat

Epinephrine

Eptifibatide

Esmolol

Esomeprazole

Famotidine

Fentanyl

Fluconazole

Furosemide

Gatifloxacin

Testing was performed with ethylenediaminetetra-acetic acid (EDTA)-containing formulation.

KEY A = Physically compatible for at least 2 hours C = Physically compatible

I = Incompatible N = Information on compatibility is not available or conflicting

E = Physically compatible for at least 2 minutes G = Physically compatible in glass bottle only H = Physically compatible for at least 1 hour

R = Physically compatible for 24 hours under refrigeration S = Physically compatible in 0.9% sodium chloride

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

Granisetron

Heparin

Hydrocortisone Sod. Succ.

Hydromorphone

Imipenem-cilastatin

Insulin, regular

Labetalol

Levofloxacin

Linezolid

Lorazepam

Magnesium sulfate

Mannitol

Meropenem

Methylprednisolone sod. Succ.

Metoclopramide

Metronidazole

Midazolam

Morphine sulfate

Nafcillin

Nitroglycerin

Nitroprusside

Norepinephrine

Ondansetron

Pantoprazolea

Penicillin G Potassium

Phenylephrine

Phenytoin

Piperacillin-tazobactam

Potassium chloride

Prochlorperazine

Propofol

Ringerâ&#x20AC;&#x2122;s, lactated

Sodium bicarbonate

Sodium chloride 0.9%

Ticarcillin-clavulanate

Tigecycline

Tobramycin

TMP-SMX

Vancomycin

Vasopressin

Acyclovir

Amikacin

Amiodarone

Ampicillin

Ampicillin-sulbactam

Argatroban

Azithromycin

Aztreonam

Bivalirudin

Bumetanide

Calcium gluconate

Cefazolin

Cefepime

Cefotaxime

Cefotetan

Ceftazidime

Ceftizoxime

Ceftriaxone

Ciprofloxacin

Clindamycin

Dexamethasone

D5W

Diazepam

Diltiazem

Diphenhydramine

Dobutamine

Dolasetron

Dopamine

Doripenem

Doxycycline

Enalaprilat

Epinephrine

Eptifibatide

Esmolol

Esomeprazole

Famotidine

Fentanyl

Fluconazole

Furosemide

Gatifloxacin

Table continues on page 4.

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

P H A R M AC Y P R AC T I C E N E WS â&#x20AC;˘ S E P T E M B E R 2 0 0 9

Amiodarone

Ampicillin

Ampicillin-sulbactam

Argatroban

Azithromycin

Aztreonam

Bivalirudin

Bumetanide

Calcium gluconate

Cefazolin

Cefepime

Cefotaxime

Cefotetan

Ceftazidime

Ceftizoxime

Ceftriaxone

Ciprofloxacin

Clindamycin

Dexamethasone

Dextrose 5% in water

Diazepam

Diltiazem

Diphenhydramine

Dobutamine

Dolasetron

Dopamine

Doripenem

Doxycycline

Enalaprilat

Epinephrine

Eptifibatide

Esmolol

Esomeprazole

Famotidine

Fentanyl

Fluconazole

Furosemide

Gatifloxacin

Gentamicin

Granisetron

Heparin

Hydrocortisone

Hydromorphone

Imipenem-cilastatin

Insulin, regular

Labetalol

Levofloxacin

Linezolid

Lorazepam

Magnesium sulfate

Mannitol

Meropenem

Methylprednisolone

Metoclopramide

Metronidazole

Midazolam

Morphine sulfate

Nafcillin

Nitroglycerin

Nitroprusside

Norepinephrine

Ondansetron

Pantoprazole

Penicillin G

Phenylephrine

Phenytoin

I N

Piperacillan-tazobactam I

Gentamicin

Amikacin

(continued)

Acyclovir

Table. Compatibility of Selected IV Drugs

Potassium chloride

Prochlorperazine

Propofol

Ringerâ&#x20AC;&#x2122;s, lactated

Sodium bicarbonate

Sodium chloride 0.9%

Ticarcillin-clavulanate

Tigecycline

Tobramycin

TMP-SMX

Vancomycin

Vasopressin

Testing was performed with ethylenediaminetetra-acetic acid (EDTA)-containing formulation.

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

Vasopressin

Vancomycin

TMP-SMX

Tobramycin

Tigecycline

Ticarcillin-clavulanate

Sodium chloride 0.9%

Sodium bicarbonate

Ringer’s, lactated

Propofol

Prochlorperazine

Potassium chloride

Piperacillin-tazobactam

Phenytoin

Phenylephrine

Penicillin G Potassium

Pantoprazolea

Ondansetron

Norepinephrine

Nitroprusside

Nitroglycerin

Nafcillin

Morphine sulfate

Midazolam

Metronidazole

Metoclopramide

Methylprednisolone sod. Succ.

Meropenem

Mannitol

Magnesium sulfate

Lorazepam

Linezolid

Levofloxacin

Labetalol

Insulin, regular

Imipenem-cilastatin

Hydromorphone

Hydrocortisone Sod. Succ.

Heparin

Granisetron C

Gentamicin

Granisetron

Heparin

Hydrocortisone

Hydromorphone

Imipenem-cilastatin

Insulin, regular

Labetalol

Levofloxacin

Linezolid

Lorazepam

Magnesium sulfate

C C

Mannitol

Meropenem

Methylprednisolone

Metoclopramide

Metronidazole

Midazolam

Morphine sulfate

Nafcillin

Nitroglycerin

Nitroprusside

Norepinephrine

Ondansetron

Pantoprazolea

Penicillin G

Phenylephrine

Phenytoin

Piperacillin-tazobactam

Potassium chloride

Prochlorperazine

Propofol

Ringer’s, lactated

Sodium bicarbonate

Sodium chloride 0.9%

Ticarcillin-clavulanate

Tigecycline

Tobramycin

TMP-SMX

Vancomycin

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

Vasopressin

P H A R M AC Y P R AC T I C E N E WS • S E P T E M B E R 2 0 0 9

Three types of incompatibilities are commonly discussed: physical, chemical, and therapeutic. Physical incompatibilities are the most easily detected and are evidenced by visible changes such as particulate formation, haze, precipitation, color change, or gas evolution. Chemical incompatibilities are those that result in decomposition of a drug. Loss of potency of greater than 10% over the defined testing period is considered chemical incompatibility. Most chemical incompatibilities can be detected only with a suitable analytic method. Therapeutic incompatibilities, in which a drug combination results in undesirable antagonistic or synergistic pharmacologic activity, are beyond the scope of most compatibility references. Despite the differing nature of compatibilities, the type of incompatibility or compatibility is not specified in this chart. A designation of compatible indicates that the combination evaluated appears to be

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

compatible based on the tests performed, whether these tests measured physical, chemical, or both types of compatibility. While it is not possible to predict all incompatibilities that may arise, it is hoped that their occurrence may be minimized. Continuing research to add to the existing body of knowledge of IV compatibilities is vital.

Suggested Readings Brammer MK, Chan P, Heatherly K, et al. Am J Health-Syst Pharm. 2008;65:1261-1265. Data on file, Sanofi-Aventis. Data on file, Wyeth Pharmaceuticals. DRUGDEX速 System (Intranet database). Version 5.1. Greenwood Village, CO: Thomson Healthcare. Trissel LA, ed. Handbook on Injectable Drugs. 15th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2009.

PRINTER-FRIENDLY VERSION AT PHARMACYPRACTICENEWS.COM

Patient Guide to

Intravenous Medication Safety

n increasing number of intravenous (IV) medications are available and are being given to patients. This growth has resulted in a seemingly endless number of possible combinations of IV medications, and, along with these combinations, potentially dangerous interactions. Whenever IV medications are combined or added to an IV fluid, there is a chance that the medications are not compatible. There are also risks of other problems with IV medications, including infection, allergic reactions, solids forming in the IV solution, and incorrect medications or doses given.

Questions To Ask Asking questions (or having a family member or friend ask for you if you are unable to do so yourself) will help ensure you get the correct IV medications in the hospital. Ask: • What drugs am I being given?

Hospital Safeguards Hospitals have systems in place to avoid IV medication errors. These may include: • A chart for the health care team to check to make sure that the IV drugs given to a patient are compatible and will not interact in an unsafe way. • Doctor and pharmacist checks of patient records to make sure that patients have the right prescription for their age, gender, weight, medical conditions, and allergies.

• What does the medicine do?

• Pharmacy and health insurance company computer systems that automatically perform safety checks.

• How often do I need it?

• Computerized drug-ordering systems.

• How long will I receive medicine intravenously?

• Devices built into medical equipment to help stop mistakes.

• Can all my medicines be given together in one IV bag?

• ID bracelets and tracking systems to make sure the right patient gets the right drug. • Handheld personal digital assistant (PDA) devices for physicians, with software that checks for potentially harmful drug interactions.

• Have you checked my ID bracelet? (This should be done every time medication is given, to prevent you from getting someone else’s medication.)

Additional Tips for Patients • In the hospital, make sure that everyone knows your medical and medication history, including allergies and previous bad reactions to drugs.

FOR MORE INFORMATION The Food and Drug Administration

www.fda.gov/medwatch/how.htm Institute for Safe Medication Practices

UPDATED 0909

www.ismp.org

• When you are given IV fluids, read the bag to find out what is in it. Ask the nurse how long it should take for the liquid to run out, and tell a member of the health care team if it is dripping too quickly or too slowly. • Tell your nurse if you don’t feel well after receiving IV medication. Ask for help immediately if you think you are having a side effect or reaction.

From the office of Directions/comments

in Your Inbox Pharmacy Practice News is now available as an E-newsletter.

Get the latest news delivered directly to your computer and PDA. The new interactive format has embedded Web Site links that give you instant access to additional information, unique searching features and printing capabilities. Each installment contains brief summaries of the most important articles from the current monthâ&#x20AC;&#x2122;s issue, as well as breaking news ahead of print.

Clinical 13

Pharmacy Practice News • September 2009

Clotting Disorders

FIBRINOGEN continued from page 11

infection have reduced the risk for infection, there is still a theoretical risk for virus transmission associated with transfusion of either plasma or cryoprecipitate due to the lack of virus inactivation/elimination steps.17 In many countries, use of cryoprecipitate or FFP is steadily declining because of the limitations of these therapies and the introduction of safer and more effective products.23

New Therapy In January 2009, the FDA approved human fibrinogen concentrate

(HFC), marketed as RiaSTAP (CSL Behring), for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. HFC is not indicated for the treatment of dysfibrinogenemia.24 HFC has demonstrated safety and has been shown to raise fibrinogen levels based on a Phase II, prospective, open-label pharmacokinetic and safety study that showed an improvement in maximum clot firmness, which is a laboratory measure of the structural

•

see FIBRINOGEN, page 14

Expanded broad-spectrum coverage1*† is on your side

d ow te N ica BP d A in or C f

of cryoprecipitate, FFP or otherwise prepared plasma. Both cryoprecipitate and FFP are indicated to restore fibrinogen levels, thus promoting blood clotting. Cryoprecipitate is usually dosed at 10 units and can rapidly raise the concentration of fibrinogen.6 FFP treats both single and multiple coagulation factor deficiencies, but it should be used only to replace single, inherited clotting factor deficiencies for which no virus-safe fractionated product is available.7 The amount of therapy dosed and the duration of that treatment depend on the target of replacement therapy, the patient’s bleeding history, or the operative procedure.8 Accurate dosing is an important factor in the safety and efficacy of fibrinogen replacement therapy. However, when either plasma or cryoprecipitate is used, exact fibrinogen replacement dosing cannot be determined because neither the fibrinogen content nor the volume is accurately measured during the manufacturing process.9 To maintain target fibrinogen levels, large amounts and multiple units of FFP must be used.10 The few clinical studies conducted on FFP have indicated that large plasma infusion volumes can increase the risk for transfusion-associated circulatory overload (TACO).11 This condition, triggered by a rapid transfusion of a large volume of blood, can result in such adverse events as dyspnea, orthopnea, peripheral edema, and rapid increase in blood pressure, and occurs in approximately 1 in 100 to 1 in 10,000 transfusions.12 In addition, repeated infusions of large amounts of cryoprecipitate to maintain a fibrinogen level more than 100 mg/dL for 5 to 7 days or longer periods have been associated with increased risk for thromboembolic complications.13 Cryoprecipitate is prepared from plasma that is thawed under controlled conditions at 4°C, the temperature at which certain plasma proteins precipitate.14 The thawing and pooling, as well as the ABO blood type matching that needs to be conducted with cryoprecipitate and plasma treatments, take between 1 and 2 hours to complete and can significantly delay treatment with replacement therapy.7 If large volumes of ABO-incompatible plasma or cryoprecipitate are administered, intravascular hemolysis can occur.15 In addition to the lack of evidence supporting the safety and efficacy of both FFP and cryoprecipitate, the presence of unwanted and unnecessary proteins in these therapies has

been shown to cause allergic reactions such as itching, hives and rash in 20% to 30% of treated patients.16-21 The use of FFP and cryoprecipitate also leads to increased costs for the health care system because of the blood typing and increased administration and monitoring time required. The Medical and Scientific Advisory Council of the National Hemophilia Foundation has emphasized the importance of virally safe blood factor concentrates.22 Although strict donor selection and sensitive testing of each donation to detect evidence for viral

* The clinical signiﬁcance of in vitro activity is unknown. † TYGACIL does not cover Pseudomonas aeruginosa.

TYGACIL is indicated for the treatment of adults with: • Complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis • Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros • Community-acquired bacterial pneumonia caused by Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus inﬂuenzae (beta-lactamase negative isolates), and Legionella pneumophila

Important Safety Information • To reduce the development of drug-resistant bacteria and maintain the effectiveness of TYGACIL and other antibacterial drugs, TYGACIL should be used only to treat infections proven or strongly suspected to be caused by susceptible bacteria • Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening. TYGACIL should be administered with caution in patients with known hypersensitivity to tetracycline-class antibiotics • TYGACIL is contraindicated in patients with known hypersensitivity to tigecycline • TYGACIL is structurally similar to tetracycline-class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL • The safety and efficacy of TYGACIL in patients with hospital-acquired pneumonia have not been established • In clinical trials, the most common treatment-emergent adverse events in patients treated with TYGACIL were nausea (26%) and vomiting (18%) • TYGACIL may cause fetal harm when administered to a pregnant woman. The safety and effectiveness of TYGACIL in patients below age 18 and lactating women have not been established • Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis • Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective. Prothrombin time or other suitable anticoagulant test should be monitored if TYGACIL is administered with warfarin • The use of TYGACIL during tooth development may cause permanent discoloration of the teeth. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated • Monotherapy should be used with caution in patients with clinically apparent intestinal perforation • Isolated cases of significant hepatic dysfunction and hepatic failure have been reported in patients being treated with tigecycline. Some of these patients were receiving multiple concomitant medications. Patients who develop abnormal liver function tests during tigecycline therapy should be monitored for evidence of worsening hepatic function. Adverse events may occur after the drug has been discontinued • In patients with severe hepatic impairment (Child Pugh C), the initial dose of TYGACIL should be 100 mg followed by 25 mg every 12 hours. Patients should be treated with caution and monitored for treatment response • The following drugs should not be administered simultaneously through the same Y-site as TYGACIL: amphotericin B and diazepam Please see brief summary of Prescribing Information on adjacent page. Reference: 1. TYGACIL® (tigecycline) Prescribing Information, Wyeth Pharmaceuticals Inc. © 2009, Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101

May 2009

247820-01

Expanded broad-spectrum coverage

14 Clinical

Pharmacy Practice News • September 2009

Clotting Disorders

FIBRINOGEN continued from page 13

integrity of the clot, reflecting the underlying effectiveness of the fibrinogen present to form a fibrin clot. The active component in HFC, fibrinogen, has been in clinical use for decades in Europe and has been shown to provide convenient and safe replacement therapy to patients with congenital fibrinogen deficiencies. Fibrinogen concentrates are the preferred treatment in many countries because of the demonstrated and

potential advantages compared with cryoprecipitate and plasma in terms of safety, efficacy, access to timely intervention, and precise dosing.25 Compared with FFP, HFC directly targets and corrects the underlying deficiency. The overall volume of infusion is reduced, thus decreasing the risk for volume overload in the patient.26 Also, HFC is a purified fibrinogen concentrate that undergoes virus inactivation and removal for safety assurance. Because there is no exposure to extraneous blood proteins with HFC use, it also comes with

TYGACIL® (tigecycline) Brief Summary See package insert for full Prescribing Information. For further product information and current package insert, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. INDICATIONS AND USAGE TYGACIL is indicated for the treatment of adults with complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillinsusceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis. TYGACIL is indicated for the treatment of adults with complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros. TYGACIL is indicated for the treatment of adults with community-acquired pneumonia infections caused by Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates), and Legionella pneumophila. CONTRAINDICATIONS TYGACIL is contraindicated for use in patients who have known hypersensitivity to tigecycline. WARNINGS AND PRECAUTIONS Anaphylaxis/Anaphylactoid Reactions Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including TYGACIL, and may be life-threatening. TYGACIL is structurally similar to tetracycline-class antibiotics and should be administered with caution in patients with known hypersensitivity to tetracycline-class antibiotics. Hepatic Effects Increases in total bilirubin concentration, prothrombin time and transaminases have been seen in patients treated with tigecycline. Isolated cases of significant hepatic dysfunction and hepatic failure have been reported in patients being treated with tigecycline. Some of these patients were receiving multiple concomitant medications. Patients who develop abnormal liver function tests during tigecycline therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing tigecycline therapy. Adverse events may occur after the drug has been discontinued. Mortality Imbalance and Lower Cure Rates in Ventilator-Associated Pneumonia A study of patients with hospital acquired pneumonia failed to demonstrate the efficacy of TYGACIL. In this study, patients were randomized to receive TYGACIL (100 mg initially, then 50 mg every 12 hours) or a comparator. In addition, patients were allowed to receive specified adjunctive therapies. The sub-group of patients with ventilator-associated pneumonia who received TYGACIL had lower cure rates (47.9% versus 70.1% for the clinically evaluable population) and greater mortality (25/131 [19.1%] versus 14/122 [11.5%]) than the comparator. Use During Pregnancy TYGACIL may cause fetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking tigecycline, the patient should be apprised of the potential hazard to the fetus. Results of animal studies indicate that tigecycline crosses the placenta and is found in fetal tissues. Decreased fetal weights in rats and rabbits (with associated delays in ossification) and fetal loss in rabbits have been observed with tigecycline [see USE IN SPECIFIC POPULATIONS]. Tooth Development The use of TYGACIL during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Results of studies in rats with TYGACIL have shown bone discoloration. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. Clostridium difficile Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. Patients With Intestinal Perforation Caution should be exercised when considering TYGACIL monotherapy in patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation. In cIAI studies (n=1642), 6 patients treated with TYGACIL and 2 patients treated with imipenem/cilastatin presented with intestinal perforations and developed sepsis/ septic shock. The 6 patients treated with TYGACIL had higher APACHE II scores (median = 13) versus the 2 patients treated with imipenem/cilastatin (APACHE II scores = 4 and 6). Due to differences in baseline APACHE II scores between treatment groups and small overall numbers, the relationship of this outcome to treatment cannot be established. Tetracycline-Class Effects TYGACIL is structurally similar to tetracycline-class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL. Superinfection As with other antibacterial drugs, use of TYGACIL may result in overgrowth of non-susceptible organisms, including fungi. Patients should be carefully monitored during therapy. If superinfection occurs, appropriate measures should be taken. Development of Drug-Resistant Bacteria Prescribing TYGACIL in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, 2514 patients were treated with TYGACIL. TYGACIL was discontinued due to adverse reactions in 7% of patients compared to 6% for all comparators. Table 1 shows the incidence of treatment-emergent adverse reactions through test of cure reported in 2% of patients in these trials. Table 1. Incidence (%) of Adverse Reactions Through Test of Cure Reported in 2% of Patients Treated in Clinical Studies Body System Adverse Reactions Body as a Whole Abdominal pain Abscess Asthenia Headache Infection Cardiovascular System Phlebitis Digestive System Diarrhea Dyspepsia Nausea Vomiting Hemic and Lymphatic System Anemia Metabolic and Nutritional Alkaline Phosphatase Increased Amylase Increased Bilirubinemia BUN Increased Healing Abnormal Hypoproteinemia SGOT Increasedb SGPT Increasedb Nervous System Dizziness Skin and Appendages Rash

TYGACIL (N=2514)

Comparatorsa (N=2307)

6 3 3 6 8

4 3 2 7 5

12 2 26 18

11 2 13 9

4 3 2 3 4 5 4 5

3 2 1 1 3 3 5 5

a reduced risk for virus transmission to the recipient.

Conclusion Fibrinogen deficiency is a very rare disorder that could easily be missed in diagnosis. The historical lack of specific treatment has led to a generalized approach to this coagulopathy with blood product transfusions. Recognition of fibrinogen deficiency is important to correct therapeutic decision analysis. The administration of blood products for the treatment of any condition will always have a

Vancomycin/Aztreonam, Imipenem/Cilastatin, Levoﬂoxacin, Linezolid. LFT abnormalities in TYGACIL-treated patients were reported more frequently in the post therapy period than those in comparator-treated patients, which occurred more often on therapy. In Phase 3 double-blind studies that included a comparator and employed a 1:1 randomization, death occurred in 4.7% (107/2274) of patients receiving TYGACIL and 3.8% (85/2264) of patients receiving comparator drugs. In a pooled analysis of these studies, the risk difference of all-cause mortality was 1.0% (95% CI -0.3, 2.2) between TYGACIL and comparator treated patients. No signiﬁcant differences were observed between treatments by infection type (see Table 2). Generally, deaths represented complications of the underlying disease or progression of disease. A causal relationship to TYGACIL has not been established. Table 2. Patients with Adverse Events with Outcome of Death by Infection Type

theoretical risk for viral or prion transmission. These products should be administered strictly in accordance with prescribing information. Transfusion reactions are common and may include immune complex, complement activation, kinin release or even volume-related adverse events. The ability to provide specific, targeted therapies is vital to the successful treatment of any patients with clotting factor disorders. Continuing education for prescribers and pharmacists in the arena of hemophilic factor deficiencies is essential for the safe treatment and care of this specialized population of patients.

TYGACIL Infection Type cSSSI cIAI CAP HAP Non-VAPa VAPa

n/N

Comparator %

Risk Difference* % (95%CI)

6/566 24/817 12/424 65/467 40/336 25/131

1.1 2.9 2.8 13.9 11.9 19.1

1/550 17/825 11/422 56/467 42/345 14/122

0.2 2.1 2.6 12.0 12.2 11.5

0.9 (-0.3, 2.2) 0.9 (-0.8, 2.6) 0.2 (-2.3, 2.7) 1.9 (-2.6, 6.4) -0.3 (-5.4, 4.9) 7.6 (-2.0, 16.9)

CAP = Community-acquired pneumonia; cIAI = Complicated intra-abdominal infections; cSSSI=Complicated skin and skin structure infections; HAP = Hospital-acquired pneumonia; VAP=Ventilator-associated pneumonia. * The difference between the percentage of patients who died in TYGACIL and comparator treatment groups. a These are subgroups of the HAP population. Note: The Phase 3 Studies include 300 and 305 (cSSSI), 301 and 306 (cIAI), 308 and 313 (CAP), and 311 (HAP). In comparative clinical studies, infection-related serious adverse events were more frequently reported for subjects treated with TYGACIL (7%) versus comparators (6%). Serious adverse events of sepsis/septic shock were more frequently reported for subjects treated with TYGACIL (2%) versus comparators (1%). Due to baseline differences between treatment groups in this subset of patients, the relationship of this outcome to treatment cannot be established [see WARNINGS AND PRECAUTIONS]. The most common treatment-emergent adverse reactions were nausea and vomiting which generally occurred during the first 1 – 2 days of therapy. The majority of cases of nausea and vomiting associated with TYGACIL and comparators were either mild or moderate in severity. In patients treated with TYGACIL, nausea incidence was 26% (17% mild, 8% moderate, 1% severe) and vomiting incidence was 18% (11% mild, 6% moderate, 1% severe). In patients treated for complicated skin and skin structure infections (cSSSI), nausea incidence was 35% for TYGACIL and 9% for vancomycin/aztreonam; vomiting incidence was 20% for TYGACIL and 4% for vancomycin/aztreonam. In patients treated for complicated intra-abdominal infections (cIAI), nausea incidence was 25% for TYGACIL and 21% for imipenem/cilastatin; vomiting incidence was 20% for TYGACIL and 15% for imipenem/cilastatin. In patients treated for community-acquired bacterial pneumonia (CABP), nausea incidence was 24% for TYGACIL and 8% for levofloxacin; vomiting incidence was 16% for TYGACIL and 6% for levofloxacin. Discontinuation from tigecycline was most frequently associated with nausea (1%) and vomiting (1%). For comparators, discontinuation was most frequently associated with nausea (<1%). The following adverse reactions were reported infrequently (<2%) in patients receiving TYGACIL in clinical studies: Body as a Whole: injection site inflammation, injection site pain, injection site reaction, septic shock, allergic reaction, chills, injection site edema, injection site phlebitis Cardiovascular System: thrombophlebitis Digestive System: anorexia, jaundice, abnormal stools Metabolic/Nutritional System: increased creatinine, hypocalcemia, hypoglycemia, hyponatremia Special Senses: taste perversion Hemic and Lymphatic System: partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased international normalized ratio (INR), thrombocytopenia Skin and Appendages: pruritus Urogenital System: vaginal moniliasis, vaginitis, leukorrhea Post-Marketing Experience The following adverse reactions have been identified during postapproval use of TYGACIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure. Anaphylaxis/anaphylactoid reactions, acute pancreatitis, hepatic cholestasis, and jaundice. DRUG INTERACTIONS Warfarin Prothrombin time or other suitable anticoagulation test should be monitored if tigecycline is administered with warfarin [see CLINICAL PHARMACOLOGY (12.3) in full Prescribing Information]. Oral Contraceptives Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective. USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects—Pregnancy Category D [see WARNINGS AND PRECAUTIONS] Tigecycline was not teratogenic in the rat or rabbit. In preclinical safety studies, 14C-labeled tigecycline crossed the placenta and was found in fetal tissues, including fetal bony structures. The administration of tigecycline was associated with slight reductions in fetal weights and an increased incidence of minor skeletal anomalies (delays in bone ossification) at exposures of 5 times and 1 times the human daily dose based on AUC in rats and rabbits, respectively (28 mcg·hr/mL and 6 mcg·hr/mL at 12 and 4 mg/kg/day). An increased incidence of fetal loss was observed at maternotoxic doses in the rabbits with exposure equivalent to human dose. There are no adequate and well-controlled studies of tigecycline in pregnant women. TYGACIL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Results from animal studies using 14C-labeled tigecycline indicate that tigecycline is excreted readily via the milk of lactating rats. Consistent with the limited oral bioavailability of tigecycline, there is little or no systemic exposure to tigecycline in nursing pups as a result of exposure via maternal milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TYGACIL is administered to a nursing woman [see WARNINGS AND PRECAUTIONS]. Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 years have not been established. Because of effects on tooth development, use in patients under 8 years of age is not recommended [see WARNINGS AND PRECAUTIONS]. Geriatric Use Of the total number of subjects who received TYGACIL in Phase 3 clinical studies (n=2514), 664 were 65 and over, while 288 were 75 and over. No unexpected overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity to adverse events of some older individuals cannot be ruled out. No significant difference in tigecycline exposure was observed between healthy elderly subjects and younger subjects following a single 100 mg dose of tigecycline [see CLINICAL PHARMACOLOGY (12.3) in full Prescribing Information]. Hepatic Impairment No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B). In patients with severe hepatic impairment (Child Pugh C), the initial dose of tigecycline should be 100 mg followed by a reduced maintenance dose of 25 mg every 12 hours. Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response [see CLINICAL PHARMACOLOGY (12.3) and DOSAGE AND ADMINISTRATION (2.2) in full Prescribing Information]. OVERDOSAGE No specific information is available on the treatment of overdosage with tigecycline. Intravenous administration of TYGACIL at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting. In single-dose intravenous toxicity studies conducted with tigecycline in mice, the estimated median lethal dose (LD50) was 124 mg/kg in males and 98 mg/kg in females. In rats, the estimated LD50 was 106 mg/kg for both sexes. Tigecycline is not removed in significant quantities by hemodialysis. This Brief Summary is based on TYGACIL direction circular W10521C009 ET01, revised 03/09.

Acknowledgment is given to Kristin Inman Brower, PharmD, clinical pharmacist at The Ohio State University Medical Center, for her assistance with this manuscript. Dr. Brower has no commercial interests to disclose. Dr. Siegel has received consulting fees from CSL Behring.

References 1.

Mannucci PM, Duga S, Peyvandi F. Recessively inherited coagulation disorders. Blood. 2004; 104(5):1243-1252.

2. Al-Mondhiry H, Ehmann WC. Congenital afibrinogenemia. Am J Hematol. 1994;(46):343-347. 3. Lak M, Keilhani M, Elahi F, Peyvandi F, Mannucci PM. Bleeding and thrombosis in 55 patients with inherited afibrinogenemia. Br J Haematol. 1999; 107(1): 204-206. 4. Martinez J. Congenital dysfibrinogenemia. Curr Opin Hematol. 1997;4(5):357-365. 5. Henselmans JM, Meijer K, Haaxma R, Hew J, van der Meer J. Recurrent spontaneous intracerebral hemorrhage in a congenitally afibrinogenemic patient: diagnostic pitfalls and therapeutic options. Stroke. 1999;30(11): 2479-2482. 6. Ketchum L, Hess JR, Hiippala S. Indications for early fresh frozen plasma, cryoprecipitate and platelet transfusion for trauma. J Trauma. 2006;60(6 suppl):S551-S558. 7. British Committee for Standards in Haematology, Blood Transfusion Task Force. Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant. Br J Haematol. 2004;166:11-28. 8. Bolton-Maggs PH, Perry DJ, Chalmers EA, et al. The rare coagulation disorders— review with guidelines for management from the United Kingdom Haemophilia Centre Doctors’ Organisation. Haemophilia. 2004;10(5):593-628. 9. Peyvandi F, Haertel S, Knaub S, Mannucci PM. Incidence of bleeding symptoms in 100 patients with inherited afibrinogenemia or hypofibrinogenemia. J Thromb Haemost. 2006;4(7):1634-1637. 10. Stanworth S. The Evidence-Based Use of FFP and Cryoprecipitate for Abnormalities of Coagulation Tests and Clinical Coagulopathy. Hematology: American Society of Hematology Education Program Book. 2007;179-186. 11. Popovosky MA. Transfusion and lung injury. Transfus Clin Biol. 2001; 8(3):272-277. 12. Fiebig EW, Busch MP. Infectious complications of blood transfusion. In: Vengelen-Tyer V, ed. American Association of Blood Banks Technical Manual. Bethesda, MD: AABB Press, 1999: 577-600.

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Clotting Disorders 13. Roque H, Stephenson C, Lee MJ, et al. Pregnancy-related thrombosis in a woman with congenital afibrinogenemia: a report of two successful pregnancies. Am J Hematol. 2004; 76(3):267-270. 14. Thompson HW, Touris S, Giambartolomei S, Nuss R. Treatment of congenital afibrinogenemia with cryoprecipitate collected through a plasmapheresis program using dedicated donors. J Clin Apheresis. 1998;13:143–145. 15. Lopez-Plaza I. Cryoprecipitate component characteristics: its uses and complications. The Institute for Transfusion Medicine (1995). http://itxm.org/tmu1995/tmu3-95. htm. Accessed April 22, 2009.

16. Acharya SS, Coughlin A, Dimichele DM, North American Rare Bleeding Disorder Study Group. Rare Bleeding Disorder Registry: deficiencies of factors II, V, VII, X, XIII, fibrinogen and dysfibrinogenemias. J Thromb Haemost. 2004; 2(2):248-256.

20. Sonntag J, Stiller B, Walka MM, Maier RF. Anaphylatoxins in fresh-frozen plasma. Transfusion. 1997;37(8):798-803.

17. Consensus conference. Fresh-frozen plasma: indications and risks. JAMA. 1985;253(4):551-553.

22. MASAC Recommendation #187: MASAC recommendations concerning the treatment of hemophilia and other bleeding disorders. Revised November 2008. http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF. aspx?menuid=57&contentid=693. Accessed April 22, 2009.

18. McVerry BA, Machin SJ. Incidence of alloimmunization and allergic reactions to cryoprecipitate in haemophilia. Vox Sanguinis. 1979;36(2):77-80. 19. Silberstein LE, Kruskall MS, Stehling LC, et al. Strategies for the review of transfusion practices. JAMA. 1989; 262(14):1993-1997.

21. Wolff G. Fresh frozen plasma: effects and side effects. Bibl Haematol. 1980; 46:189-206.

23. Santagostino E, Mannucci PM, Bianchi Bonomi A. Guidelines on replacement therapy for haemophilia and inherited coagulation disorders in Italy. Haemophilia. 2000;6(1):1-10.

24. United States Food and Drug Administration. Product approval Information. http:// www.fda.gov/cber/products/riastap.htm. Accessed April 22, 2009.

25. Lauzon C. Rare bleeding disorders. Presented at: International Congress of the World Federation of Haemophilia; June 1-5, 2008; Istanbul, Turkey.

26. Danés AF, Cuenca LG, Bueno SR, Mendarte Barrenechea L, Ronsano JB. Efficacy and tolerability of human fibrinogen concentrate administration to patients with acquired fibrinogen deficiency and active or in high-risk severe bleeding. Vox Sanguinis. 2008;94(3):221-226.

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associated with an increased mortality risk, even after adjustment for various patient and disease-related factors. The adjusted hazard ratio for death was 2.10 (1.53-2.89) among those who had eaten a fourth of the meal on nutritionDay and 3.02 (2.11-4.32) when none of the meal was eaten. Mr. Mirtallo said health professionals often argue that “ ‘these patients are sick, that’s why they have increased mortality.’ But there is probably a percentage of those patients—it might be 10%, it might be 70%—who would improve if you paid more attention to nutrition.”

A D V E R T I S E M E N T

Postoperative complications: The pharmacist’s role in prevention

Another Supporter James Abberton, RPh, director of pharmacy services at Long Island Jewish Medical Center in New Hyde Park, N.Y., which is participating in nutritionDay this year, said that when a patient in poor nutrition is hospitalized, “how do we assure that they are properly nourished during their hospital stay and after they are discharged? This is a significant challenge.” Likening nutritionDay to “nutrition reconciliation,” he said, the program will help address that challenge and “bridge the gap from the inpatient to the outpatient setting.” Rafael Barrera, MD, consulting physician for nutritionDay in the United States, and critical care and nutrition specialist at Long Island Jewish Medical Center, predicted that “the scope and currency of information collected on nutritionDay in the U.S., coupled with advanced capabilities to share and compare insights from this data, promises to advance efforts to improve nutrition practices and patient outcomes many-fold.” nutritionDay is supported by organizations including ASPEN, ESPEN and the American Dietetic Association. The nutritionDay team is seeking participation from U.S. hospitals. To register for the program, send an e-mail to nutritiondayus@ymail.com. —Sarah Tilyou

An under-recognized complication, immune-mediated coagulopathy (IMC) can result in: • Significant utilization of blood and blood products • Costly studies and consultations • Reoperations for actively bleeding patients • Extended hospital stays Learn how to reduce the risk of this type of complication in July’s supplement to Pharmacotherapy, “The Pharmacist’s Role in the Prevention of Immune-mediated Coagulopathy.” • Developed from a 2008 ASHP Midyear Meeting continuing education n symposium, topics include: “Achieving hemostasis in the surgical field” — Bradley Boucher, PharmD, and Oren Traub, MD, PhD “Topical thrombins: benefits and risks” — Christopher Lomax, PharmD, and Oren Traub, MD, PhD “Immune-mediated coagulopathy: a case study” — Joseph Naoum, MD “Thrombin products: economic impact of immune-mediated coagulopathies and practical formulary considerations” — Stacy Voils, PharmD • Available to all concerned professionals in print or online at www.pharmacotherapy.org

16 Operations & Management

Pharmacy Practice News • September 2009

Quality Improvement

NQF REPORT continued from page 1

Austin. “Pharmacists with their expertise fit very nicely into the majority of the safe practices. Pharmacists clearly are medication experts, but they are well trained beyond that to implement sustainable, reliable change within organizations.” Working with Charles R. Denham, MD, chairman of TMIT and co-chair of the NQF Safe Practices Consensus Committee, Dr. Burgess has collaborated with pharmacy and other organizations to create the third and latest rendition of the detailed safe-practices roadmap first issued in 2003. Beginning next year, the NQF report will be updated annually. The newest version has changed significantly since the last report in 2006. It contains seven new practices designed to avoid costly, hospital-associated adverse events, ranging from multidrug-resistant organism infections to serious patient falls. (See accompanying box for full list.) Other earlier practices have been substantially revised or consolidated, and two—evidence-based referrals and perioperative myocardial infarction/ischemia prevention—have been retired because they are covered effectively by other organizations’ safety programs. For health care organizations, the NQF safe practices have cost, as well as quality, implications. A federal law requires government agencies to use standards endorsed by voluntary consensus standard-setting organizations such as NQF in their performance evaluations. In October, the Centers for Medicare & Medicaid Services (CMS) began cutting payments to organizations for safety breeches related to the NQF’s 2006 update of Serious Reportable Events in Healthcare—those “never events” deemed preventable by good care. If the NQF safe practices seem similar to those of other organizations, it is because they represent the collective input of many health care stakeholder groups including the Joint Commission, the American Society for Health-System Pharmacists (ASHP) and the ISMP. According to Mary Andrawis, PharmD, MPH, director, Clinical Guidelines and Quality Improvement at ASHP, the health-system pharmacists’ group worked closely with Drs. Cohen and Burgess and others in helping to revise the safe practices. Although Drs. Andrawis and Cohen said all 34 safe practices were important, they particularly emphasized No. 18 in interviews with Pharmacy Practice News. That practice urges pharmacy leaders to take “an active

role on the administrative leadership team that reflects their authority and accountability for medication management systems performance across the organization.” Both pharmacists participated in a recent TMIT webinar on medication safety, in which the importance of pharmacy leadership in the hospital environment received special attention. (See sidebar below on TMIT’s webinar series.) “The reason I talk so much about pharmacy leadership in safe practices,” Dr. Andrawis said, “is because it represents an opportunity to put that missing piece of the puzzle back into the system, which is getting the pharmacist involved in care so that we can get better outcomes for the patient, prevent medication errors and reduce costs.” Dr. Cohen noted that pharmacy leaders “recognize that pharmacists are the ones who follow the safety literature, and they are in the best position to bring medication safety issues to the attention of the rest of the medical staff and professional staff and to oversee activities taking place within the organization.” He added: “One of the primary rea-

sons that doctors, nurses, the hospital leadership want pharmacists there is to assure that patients receive medications as safely as possible, and this document supports that in so many ways.”

Fall Prevention One of the “never events” described in NQF’s 2006 serious reportable events update concerns patient deaths or serious disabilities attributed to falls. Safe practice No. 33 in the new update calls on practitioners to reduce fallrelated injuries by “implementing evidence-based intervention practices.” Oklahoma City’s Mercy Health Center is among the hospitals that rely on pharmacists to flag the charts of patients taking medications that increase the likelihood of falls, particularly for older people. Burl Beasley, BS Pharm, MPH, medication safety coordinator at Mercy, has led studies showing the benefit of a pharmacydeveloped tool in reducing fall-related injuries. In a comment on the new safety practice, Mr. Beasley noted that “pharmacists are an important part of the health care team when it comes to falls preven-

‘Pharmacists with their expertise fit very nicely into the majority of the safe practices. [They] clearly are medication experts, but ... are well trained beyond that to implement sustainable, reliable change within organizations.’ —Hayley Burgess, PharmD, BCPP

Seven Habits For Better Health 1. Care of the caregiver 2. Multidrug-resistant organism prevention 3. Catheter-associated urinary tract infection prevention 4. Organ donation 5. Glycemic control 6. Fall prevention 7. Pediatric imaging

tion. Pharmacist review of medication profiles can impact patient care by suggesting alternative treatments without the side effects that may lead to falls.” At Mercy, he said, pharmacists’ routine review of medication profiles, with the modification, discontinuation or interchange of medications, has helped reduce the rate of patient falls by 36% from 2005 to 2007. “With a typical fall costing approximately $22,000,1 we estimated a savings of $220,000 per year due to pharmacist intervention alone,” Mr. Beasley said. He added that the results had shown that “regular pharmacist review of medication profiles can reduce fall rates in the acute care setting. This can then translate into cost savings in the form of prevented falls.” Another new NQF safe practice zeroes in on the importance of glycemic control. It urges practitioners to “take action to improve glycemic control by implementing evidence-based intervention practices that prevent hypoglycemia and optimize the care of patients with hyperglycemia and diabetes.”

Focus on Glycemic Control

Free Webinar on NQF Update

MIT and NQF are co-hosting a free webinar educational series based on the new NQF safe practices update. Pharmacists and other health care professionals can sign up to listen in on one or more of the webinars by going to SafetyLeaders.org. They also can download previous sessions, including transcripts and slides. Dr. Burgess said that more than 1,000 lines have been made available for the webinars. “The hospitals that [TMIT] works with will often have 20 or 30 people gathered, so the reach of these webinars is huge,” she said. “And we know that many pharmacists aren’t traveling because of budget restrictions, so what a great way to join and get free education. “I’ve found that pharmacists often don’t know about the Safe Practices for Better Healthcare, and they don’t know about the resources like these free webinars,” she added. Cynthia Reilly, RPh, director, Practice Development Division at ASHP, said, “one of the things that we are really happy about is this series of webinars. NQF and TMIT fully appreciated that it isn’t enough to publish these safe practices; they’re doing webinars to make sure we get the message out to clinicians so that we can actually make change.” http://www.safetyleaders.org/pages/idPage.jsp?ID=4935

—B.B., J.B.

Gita Wasan Patel, PharmD, clinical pharmacy coordinator of the Medical Center of Plano in Texas, said it was important that glycemic control “has come to the forefront when it comes to quality of care because acute hyperglycemia in the hospitalized patient has pretty much been an afterthought in most practitioners’ minds up until recently.” In the past, she noted that if a patient were admitted with pneumonia, the physician would worry about the lung infection, not about blood sugar levels running in the 200s. Now, with studies showing the deleterious effect of acute hyperglycemia not only in people with diabetes but also in all hospitalized patients, the issue is drawing increased attention among quality experts. “The crux of why I’m happy that this has come into play with the National Quality Forum is that it is forcing practitioners to be more cognizant of

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Pharmacy Practice News • September 2009

Quality improvement blood-sugar issues in the hospitalized patient,” she said. At the 440-bed Medical Center of Plano, the 25 staff pharmacists play a key role in glycemic control as well as in other clinical issues that the NQF focused on in its safe practices update, including anticoagulation therapy and appropriate antibiotic treatment. “We have about 50 different clinical algorithms that pharmacists are implementing on any given day,” Dr. Patel said. “We don’t have clinical specialists. All pharmacists are expected to understand the algorithms and be able

to implement them.” Referring to safety practice No. 18 on pharmacy leadership, Dr. Patel noted that Plano’s pharmacist staff had gained increased autonomy over the years because of the administration’s willingness to allow innovation. “It’s been kind of like a circle,” she said. “They give us a little bit of autonomy. We run with it and do a good job. Then when we propose a new algorithm, they have confidence in us and we just go from there.” In eight years, she said, pharmacists have gone from basic therapeu-

tic interchanges to pharmacodynamic antibiotic dosing to algorithms for sepsis and glycemic control to anticoagulation management. “In the end,” she added, “the winners are the patients because they get optimized, tailored care and greater safety.” The ISMP’s Dr. Cohen believes that passage of health care reform legislation ultimately may provide momentum for wide adoption of the NQF safe practices. “I can see a point up ahead where we actually have legislation that facilitates health care coverage for everyone,” he said, “and I

can’t imagine that we wouldn’t have a national patient safety office, similar to what we’ve seen in the United Kingdom, that would make sure that organizations implement safe practices like these.” —Bruce and Joan Buckley

Reference 1. Haumschild MJ, Karfonta TL, Haumschild MS, et al. Clinical and economic outcomes of a fall-focused pharmaceutical intervention program. Am J Health-Syst Pharm. 2003;60:1029-1032.

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In Focus

ANEMIA CLINIC continued from page 1

part of therapy can make a difference. We can take these results and look to apply them in managing other conditions, such as nausea and vomiting, bisphosphonate use and other supportive care issues.” Dr. Poust and her colleagues reviewed the electronic medical records of 50 patients receiving the erythropoiesisstimulating agent (ESA) darbepoetin alfa (Aranesp, Amgen) through the pharmacy-managed anemia clinic, and 50 patients who were managed solely by

‘A pharmacist’s time is not cheap by any means, so from an institutional standpoint, being able to get reimbursed for the services that we were providing was important.’ —Jamie Poust, PharmD

physicians. The review was conducted between March 2006 and March 2007. The characteristics of the patients were somewhat different in the two

groups. Patients in the pharmacist-managed group had more metastatic disease and also had lower baseline hemoglobin levels compared with the physician-

managed patients. The average baseline hemoglobin in the pharmacist- and physician-managed groups was 9.2 and 10.6 g/dL, respectively. The analysis revealed that 67% of the patients achieved target hemoglobin in the pharmacist group compared with 55% of the patients in the physician group, a difference that was not statistically significant (P=0.226). Iron studies were done in 90% of the pharmacist group, but were never done in the patients who were managed by physicians. In the group managed by physicians, only one patient received

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Pharmacy Practice News • September 2009

In Focus iron supplementation. “Iron studies must be done prior to initiation of ESA treatment and treated accordingly to maximize ESA effect,” said Dr. Poust.

Guideline Adherence Also Suboptimal Another outcome that was assessed was adherence to guidelines. The guideline protocol consisted of baseline, six-week and 12-week hemoglobin assessments and appropriate dose modifications based on these assessments. Here, too, the pharmacist-managed patients fared better than those managed by physicians:

Adherence to guidelines was 87% in the pharmacist-managed group compared with 17% (P=0.0001) in the physicianmanaged group. “A lot of the adherence issues that I noticed came from a lack of dose titration and hemoglobin evaluation,” Dr. Poust said. “Physicians would put patients on the drug and leave them on that dose indefinitely, or if the patient’s hemoglobin dropped they’d give them another dose instead of doing appropriate dose escalation.” The physicians also ignored the recommendation to hold darbepoetin alfa

therapy once hemoglobin levels rose to more than 12 g/dL. “There were situations where it was greater than 12 g/ dL and it was still given in the physician group,” she said. “The 12 g/dL was chosen in our institutional algorithm because the risks for complications— venous thromboembolism, cardiovascular, etc.—are greater at a hemoglobin in excess of 12 g/d, without much therapeutic benefit. This is a controversial topic and not everyone agrees with it. However, it was adopted in our institutional algorithm.” Added Dr. Poust, “this study was

designed to evaluate compliance with the algorithm, not whether the choice of 12 g/dL was ‘correct or incorrect.’ The data with increased mortality with hemoglobin levels greater than 12 came out after this study was conducted.”

Pharmacy Billed for Services Importantly, the pharmacy department was allowed to bill for its management services. “We were generating income, and this was one of the first times in our institution that a pharmacist was able to bill for services. This was a good thing for everyone. A pharmacist’s time is not cheap by any means, so from an institutional standpoint, being able to get reimbursed for the services that we were providing was extremely important,” Dr. Poust said. She added that she was not surprised that pharmacists did better than physicians in managing cancer patients’ anemia. “We had a pharmacist who was completely dedicated to this service and could focus solely on managing these patients. When a physician has 40 patients in the clinic, is writing chemotherapy orders, doing pain management and trying to call the oncology floor to admit a patient, they’ve got so much on their plate and I honestly don’t think they have the time that they would like to focus on anemia management. Our physicians who referred patients to our clinic loved the service because they didn’t have to worry about managing any of this. We had a lot of good buy-in from the physicians.” Asked to comment on the study, Renee Freitag, PharmD, a clinical oncology pharmacist from Providence Regional Cancer Partnership in Everett, Wash., said the results were “exciting and encouraging.” She added, “It is nice to see pharmacists branching out into other clinical areas, helping to extend the physician’s time and getting paid for our services. I think the trend in pharmacist-provided anemia management is the very near future of clinical oncology pharmacy.” —Fran Lowry

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20 Operations & Management

Pharmacy Practice News • September 2009

Going Green

Clinicians, Heal Thy Planet Eco movement eyes ‘regenerative’ hospitals Chicago—As vendors scurried around the Hyatt Regency in preparation for the start of CleanMed 2009, a collection of noted architects, engineers, designers and health care professionals huddled in a subterranean room of the hotel. Gail Vittori, co-coordinator of the Green Guide for Health Care, stood and addressed the audience. “This is about health care as the intersection between the environment and the human experience,” Ms. Vittori announced. The workshop, Designing the Regenerative Hospital: An Imperative for the 21st Century, will serve as the blueprint for the new Green Guide for Health Care. The guide (available at www.gghc. org) offers a toolkit of environmentally sustainable practices for hospitals and health care facilities. It was launched in 2003, when a collection of leaders concerned with green health care decided to create a document to assist the greening of American medicine. Now they have a new target—“regenerative” hospitals. “We need to restore and play a part in healing the ecosystem. We need to have buildings that restore, that regenerate,” said Robin Guenther, co-coordinator of the guide. “There is a perfect alliance between the idea of regenerative buildings and health care; the missions of healing connect.” But the call goes beyond fields of native plantings. According to workshop presenters, regenerative hospitals would not only help the environment, but could improve recovery times, increase profits, reduce nursing turnover, assist in recruitment and put natural foods onto the menus of hospital cafeterias. But to become a reality, regenerative hospitals will require change, cautioned Kim E. Shinn, director of sustainable design at TLC Engineering for Architecture in Nashville, Tenn. “And people would rather speak in public than change.”

See No Evil Hospitals are huge consumers of water and energy, sprawling campuses of impervious surfaces, producers of copious amounts of waste. They often comprise scores of buildings devoid of natural air flow, natural light and natural materials. In short, they’re ecological nightmares. For decades, hospital administrators haven’t particularly worried about this. “They held an understanding and belief that ‘health care is about saving lives, not the environment. We support it, but it’s not our problem,’ ” said Jerry Smith, director of health care and

sustainable initiatives at MSI Design in Columbus, Ohio. “That attitude is changing.” Mr. Shinn went further. “If you look at the income statement for a hospital, the utility costs are fractional. They are very minor when compared to labor costs and litigation, insurance and risk management. If a director of facilities management says, ‘Hey, Mr. CFO, if you give me $1 million, I can save us $250,000 in a year on utilities,’ the CFO will say, ‘Where do I get $1 million, and will that get me more patients? Will it improve reimbursement? Will it help me attract docs?’ ”

Surprising Benefits According to Kumkum M. Dilwali, senior director of the Green Guide for Health Care, for at least some of these questions the answer may be yes. In March, Rick Fedrizzi, founder and chief executive officer of the U.S. Green Building Council, designated Dell Children’s Medical Center of Central Texas, in Austin, as the world’s first Leadership in Energy and Environmental Design (LEED) Platinum hospital. Constructed on the brownfield site of a former municipal airport, the facility—part of Seton Health System— incorporates a wide range of sustainable practices. The building was designed

to maximize access to daylight, which reduces energy use. It includes six courtyards with natural plantings that use less water and give patients and staff access to natural settings. The medical center has a natural gas–fired power plant from which it gets its energy. But something else happened after Dell Children’s opened, Ms. Dilwali said. When the Seton Health System compared staff turnover and recruitment at the new hospital to its old facility, “their retention was much higher.” Ms. Guenther said staffing benefits have been seen at green hospitals across the United States and Canada. When a green-certified hospital opened in Ontario, it received applications from nurses across the country. When a survey on staff happiness was conducted at Oregon’s Providence Newberg Medical Center, “the results were off the charts,” she said. If hospital operators ask why they should go green, they should “pick up the phone and talk to any of the owners of the first 43 LEED-certified hospitals and have a conversation about what it’s meant to their image in the community, what it’s meant to their ability to attract qualified staff and the response of their staff,” Ms. Guenther said. “They aren’t doing this once and saying, ‘that was fun but I wouldn’t

do that again’; they’re moving forward faster with their other projects.” Given the premium on most “green” consumer products, ecologically friendly hospitals might seem to cost more to build than conventional facilities. But that’s not necessarily the case. Alan R. Bell, director of design and construction for Seton Network Facilities, said the 500,000-sq ft Dell cost $130 million, or $260 per square foot. In current dollars, the project would cost $318 per square foot—well within the range of what hospital buildings now cost without environmentally kind details. “I’ve talked to some of my contractor friends, and they said that for a ‘normal’ hospital, right now, it would be between $310 and $325 per square foot,” Mr. Bell said. The last three years have seen a monumental shift toward construction vendors and suppliers with green products, he added. This, in turn, has driven down the cost of many products. “It gives them a competitive advantage,” he said. “If you can get green carpet or a regular carpet, and they’re the same cost, you’ll get green carpet.”

Culturing Change Increasing access to daylight is not the only thing that hospitals are doing to reduce their energy consumption and lighten their ecological tread

Hospitals are huge consumers of water and energy, sprawling campuses of impervious surfaces, producers of copious amounts of waste.

Hospital Eco Facts

ospitals are notorious consumers of energy, sucking power for heat, lights, hot water, laundry and other aspects of daily operation. All that adds up to an average of 27.5 kWh of electricity, and another 110 cu ft of natural gas—or $3.71 per square foot in 2005 prices, according to the Healthcare Environmental Resource Center, an information clearinghouse. But energy diets can help. A 150,000-sq ft hospital that slashes its power use by 20% can save more than $111,000 per year on its energy bill. In addition to reducing demand for resources, some hospitals have begun tackling the power problem from the other end of the plug: generation. The Veterans Affairs hospital in Ann Arbor, Mich., is one of a handful of facilities to mount a turbine on its roof in an effort to produce at least some of its annual energy needs, which amount to about 22 million kWh. Hospital administrators also plan to install solar panels to complement the 16-ft tall turbine, and to reap savings from more efficient air conditioning systems and other technologies. A consortium of Pennsylvania hospitals recently announced that it would begin buying roughly one-third of its electricity directly from a major wind farm in Bucks County. The deal could save the individual institutions millions of dollars over the coming decade. —Staff

Operations & Management 21

Pharmacy Practice News • September 2009

Going Green

Code Green: A Hospital Lightens Its Environmental Impact about this,” she continued. “I think most people feel there’s very little they can do that makes a difference in our world. But this is something that makes you feel like you’re playing a part.”

Jacksonville, Fla.—If Nicole Webel, MD, and her colleagues at Seattle Children’s Hospital have their way, operating room personnel across the country will soon be touting the three S’s (sort, separate and share the message) as a way to help save lives—and the environment. “We recycle at home, and then come to work, where we don’t,” said Dr. Webel, acting assistant professor of anesthesiology at Seattle Children’s. “So, I saw it as a conflict of values. Of course the hospital environment is different, and there are all kinds of rules that apply differently than in the home environment. But I wanted to challenge that assumption and see if there was any kind of difference that we could make.” Dr. Webel created a committee representing all areas of the perioperative environment, including pre- and postoperative nurses, a surgeon, a scrub technician, a circulating nurse and an OR manager. Staff members from environmental services and the hospital’s sourcing department also participated. After several brainstorming sessions, the group identified a handful of areas where OR personnel could decrease the amount of waste being created and separate it into correct areas for disposal. The three S’s were born. “We first asked ourselves if we were sourcing our products in an environmentally friendly way,” Dr. Webel told Pharmacy Practice News. “As an example, we found that all of our surgical packs were arriving with Betadine [Purdue Pharma] trays, which were piling up in the bin for donation to developing countries. The bin was overflowing to the point where we were just throwing them away.” The solution to that problem was simple. “We went back to our sourcing people and asked them to eliminate the trays from our packs.” New bins were created for the OR to allow for separation of recyclable materials when cases were started; a separate recycling bin also was added. “We don’t

recycle any items that have touched the patient,” said Dr. Webel, who reported on the program at Pediatric Anesthesiology 2009 (abstract 9-9), a joint meeting sponsored by the Society for Pediatric Anesthesia and the American Academy of Pediatrics. “We’re very careful not to have any contaminated items go into the recycling bin.” Although surgical suites may be the biggest waste creators in the hospital, Dr. Webel and her colleagues did not stop there. Recycling bins were added to all perioperative areas where regular trash bins were located; composting stations were introduced to preand postoperative areas, as well as employee lounge areas, for coffee grounds, paper towels and certain food items, such as fruits and vegetables.

An important part of the environmental equation is reprocessing surgical instruments, which diverts them from landfills. Drug disposal was altered to prevent contamination of groundwater. Of the many institutional challenges, the most daunting may well have been changing the perspectives of the staff. “There were a few naysayers who argued that it was going to take too much time and be too much work,” Dr. Webel said. Those attitudes turned around in just a few weeks. “Now, there’s quite a bit of excitement

recycling and reprocessing efforts are projected to range from $50,000 to $100,000 in the first year, not to mention drastic reductions in waste creation. “Our neurosurgery rooms have almost no trash coming out anymore and our cardiac rooms have reduced their trash by over 50%,” Dr. Webel said. Garbage production in the anesthesia lounge has been reduced by 60%. Composting areas are getting significant traffic. Perhaps most important, OR turnover time has not been adversely affected as a result of these efforts.

And if Dr. Webel thought her undertaking would stop at her institution, she was mistaken. Once she and her colleagues realized that many recyclable packaging items were not marked with the universal recycling symbol, she took the matter up with the manufacturers themselves. As with any new undertaking, there is more work to be done—a challenge Dr. Webel embraces. “We’re working on adding light and temperature sensors to the operating rooms, so the lights turn off and the temperature changes when nobody’s in there,” she said. “There are a lot more things we can look at with our green-colored glasses.” Daniel Bainbridge, MD, assistant professor of anesthesia at The University of Western Ontario, in London, said he has witnessed a steady change in environmental attitude during his years at the London Health Sciences Centre, although he questioned its motive. “Our hospital has a lights-out initiative, with posters reminding people to shut off lights when not in rooms, more driven by cost reductions for the hospital than any real green initiative.” The ORs have also created a recycling program to reduce waste. “There are many initiatives driven by producers as well,” Dr. Bainbridge noted. “I can remember 10 years ago having plastic packaging for all syringes, which was made of the same material as the syringe itself. Today, they are packaged in paper and thin plastic, a dramatic reduction.” Yet for every initiative such as these, there are many yet to be undertaken, such as the effect of volatile agents on the environment. “Most are pollutants which destroy ozone and or add to greenhouse gases,” Dr. Bainbridge pointed out. “However, there is at least one company trying to capture this waste, recycle it, and selling it back to the hospital at a reduced cost. However, anything not recycled is unfortunately vented into the atmosphere.” —Michael Vlessides

(see article, above). Steps can be taken to reduce waste by adopting reusable products or even starting a composting program. Some hospital landscaping incorporates fruit trees and vegetable gardens to produce natural foods for their cafeterias. Mr. Shinn cited a hospital in Florida that captures condensate from its air conditioning system to be used in its cooling tower. But challenges remain. “We knew this was about market transformation, about culture change,” Mr. Smith explained. “Before sustain-

able design came along, before the Green Guide, before anything, it was just ‘this is the way we do business.’ To change the culture of a health care institution or to transform the way we design and deliver architecture, is huge.”

on board, there is the local municipality that will be impacted by their design decisions,” Ms. Dilwali said. “You have to fight it with science,” Mr. Shinn suggested. “A doctor is a scientist, a nurse has scientific training. If you can show them that a practice has no infection control compromises, then you have a chance.” Advocates admit that the hospital that creates more energy than it uses, that creates more clean water than it pollutes, that heals the planet as well as people, and that is truly restorative

remains a goal, not a reality. But work on the new guide is moving forward: Volunteer committees are being formed to write the new toolkit. Clinicians are welcome to contact the Green Guide if they are interested in assisting. Ms. Guenther added that clinicians can also change their own hospitals. “If you are an anesthesiologist and can’t stand the waste in your operating suite, join your hospital’s green team. If you don’t have one, create one. You can make a difference.” —David Jakubiak

Attractive ECO-nomics The researchers have yet to perform a rigorous cost-savings analysis of the project. However, Dr. Webel said that simply separating regular waste from hazardous medical waste saved Seattle Children’s $20,000 in the first six months. “All of our anesthesia carts had a red bag in the waste container, but nothing we were putting in that bag was hazardous. So we were able to incur a terrific cost savings simply by changing bags.” The anticipated cost reductions from

‘We’re working on adding light and temperature sensors to the operating rooms, so the lights turn off and the temperature changes when nobody’s in there. There are a lot more things we can look at with our green-colored glasses.’ —Nicole Webel, MD

‘Fight It With Science’ Some hospitals, municipalities and patients have questions about the safety of sustainable design. One area where this has been true is infection control. “There are the regulatory systems—it’s not only getting the hospital leadership

22 Operations & Management

Pharmacy Practice News • September 2009

Practice Models

HF PROGRAMS continued from page 1

One recent U.S trial to document the efficacy of pharmacist HF care was conducted at Wishard Health Services in Indianapolis. In the National Institutes of Health-funded study, low-income patients with HF were randomly assigned to a pharmacist intervention group (n=122) and a “usual care” group (n=192) that did not see a pharmacist targeting HF. The most marked effect was observed in emergency department visits and hospital readmissions—both occurred 19.4% less frequently (incidence rate ratio, 0.82; 95% confidence interval [CI], 0.73-0.93) in patients seen by pharmacists (Ann Intern Med 2007;146:714-725). The pharmacist interventions started with a baseline medication history, “where we asked patients to list all of the prescription and OTC drugs and supplements they were taking,” said James Young, PharmD, a study co-author and clinical pharmacist at Wishard. “Because the patients often had poor health literacy, we also took pains to educate them about the basics of their disease and the adverse health effects of not complying with their drug regimens. We also gave them an easy-to-follow timeline that helped them remember when to take their meds.” To assess medication adherence—the other major endpoint of the study—the researchers used electronic prescription container lids that recorded the time and date of each opening and closing of the drug vial. The data showed that medication adherence was 67.9% and 78.8% in the usual care and intervention groups, respectively (95% CI, 5.0%-16.7%). “Unfortunately, the improvements we documented in both primary endpoints dissipated three months after the study was completed,” Dr. Young said. “Out of sight, out of mind, I guess.”

that the results weren’t deemed compelling enough for Wishard to continue the pharmacist interventions. “It’s not as though our study was the only one to show benefit,” he added. “Multiple trials have been done over the last decade documenting the value of both inpatient and outpatient HF pharmacist care.” Indeed, a recent review of the literature by Koshman et al (Arch Intern Med 2008;168:687-694) found 12 randomized controlled trials of pharmacist interventions in HF, with the majority showing improved patient outcomes. Given those results—especially the significant reduc-

tions in all-cause mortality seen in several trials—“the incorporation of pharmacists into HF care teams should be strongly considered,” the researchers concluded. What has to happen to make that recommendation a reality? “We need a fundamental change in practice,” Dr. Murray said. “I understand the reluctance to change our dispensing-based approach to pharmacy. And in the case of heart failure, you really need some specialized training and education to do this well. But isn’t that what we all went to pharmacy school for—to treat patients and improve outcomes?”

Early Adopters Comment Wendy Gattis Stough, PharmD, the lead author of a seminal study that was the first to document the value of having clinical pharmacists on the HF care team, agreed there is much inertia to overcome in order for this practice model to spread. “But the data certainly are there; we showed that our profession can make a huge impact,” Dr. Stough said, referring to the PHARM (Pharmacist in Heart Failure Assessment Recommendation and Monitoring) study (Arch Intern Med 1999:159;1939-1945). In the study, which included 181 patients, pharmacists provided medication evalu-

The risks associated with cattle thrombin may stay with patients long after surgery

Patients with antibodies to cattle thrombin products should not be re-exposed due to the risk of developing postsurgical immune-mediated coagulopathy.2 In a recent clinical trial, 1 in 6 surgical patients with likely prior exposure to cattle thrombin had antibodies to cattle thrombin.3 Minimize these risks with RECOTHROM RECOTHROM, the only recombinant human thrombin, is 100% free of cattle plasma and as effective as cattle thrombin.4,5 In a phase 3 study of RECOTHROM compared to cattle thrombin, adverse events were reported with similar frequency in both treatment groups, and no reported adverse events were considered causally related to antibody formation in either group. Limited data (n=6) exist regarding re-exposure to RECOTHROM.

No Staying Power? One might expect that the falloff seen by Dr. Young and his colleagues would be a powerful argument for restarting the program once the study grant ended. But administrators chose a different course— to first fill other, more established outpatient pharmacy positions. In fact, “only recently have we been able to fill the last [such] position at our facility,” he said. Still, “administrators were impressed by the findings, and the HF program continues to be evaluated.” The cost-savings associated with the program are part of its allure, Dr. Young added. Indeed, “as more patients received the HF intervention, the development costs became negligible and the overall cost savings per patient approached $3,000.” Michael D. Murray, PharmD, MPH, principal investigator and lead author of the Annals study, said it is “unfortunate”

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Indication: RECOTHROM Thrombin, topical (Recombinant) is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. Important Safety Information: For topical use only—do not inject directly into the circulatory system. Potential risk of thrombosis if absorbed systemically. Do not use for the treatment of massive or brisk arterial bleeding or in patients with known

hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins. No speci¾c adverse events have been established as adverse reactions causally related to RECOTHROM administration. In a clinical study comparing RECOTHROM to bovine thrombin, adverse events were reported with similar frequency in both treatment groups. The most common event was incision site complication. Limited data (n=6) are available on repeat exposure to RECOTHROM.

Operations & Management 23

Pharmacy Practice News • September 2009

Practice Models ation, therapeutic recommendations to the attending physician, patient education and follow-up telemonitoring. The endpoint of combined all-cause mortality and HF events was significantly lower in the intervention group than in the controls (four vs. 16 cases; P=0.005). Ed Rainville, PharmMS, a clinical pharmacist at Saint Francis Medical Center in Peoria, Ill., also authored an early article on pharmacist HF interventions—specifically, medication therapy management and telephone follow-up after discharge. Although the study (Am J Health-Syst Pharm 1999;56:1339-1342) was small—34

patients equally divided between pharmacist intervention and control groups— “the results were impressive,” Dr. Rainville said. During the year of postdischarge monitoring, 10 (58.8%) of the control patients were readmitted with HF, compared with only four (23.5%) of the intervention patients (P<0.05). But again, the HF program sputtered soon after study’s end. “It came down to the realities of hospital economics,” Mr. Rainville said. “It’s great if your interventions save health care dollars by keeping HF patients out of the hospital. But the insurers get the bulk of those savings—

Please see Brief Summary of full Prescribing Information on next page. References: 1. Ness P, Creer M, Rodgers GM, et al; the Recognition, Evaluation and Treatment of Acquired Coagulopathy Consensus (RETACC) Panel. Building an immune-mediated coagulopathy consensus: early recognition and evaluation to enhance post-surgical patient safety. Patient Saf Surg. 2009;3(1):8. 2. Thrombin-JMI [package insert]. Bristol, TN: King Pharmaceuticals, Inc.; 2007. 3. Singla NK, Ballard JL, Moneta G, Randleman CD Jr, Renkens KL, Alexander WA. A phase 3b, open-label, single-group immunogenicity and safety study of topical recombinant thrombin in surgical hemostasis. J Am Coll Surg. 2009;209(1):68-74. 4. Chapman WC, Singla N, Genyk Y, et al. A phase 3, randomized, double-blind comparative study of the ef¾cacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg. 2007;205(2):256-265. 5. RECOTHROM [package insert]. Seattle, WA: ZymoGenetics, Inc.; 2009. RECOTHROM is a registered trademark of ZymoGenetics, Inc. ©2009 ZymoGenetics, Inc. All rights reserved. RT264-00, July 2009

the hospital actually loses money when you reduce hospital readmissions. Isn’t this the debate we’re now having about health care reform? How do you calculate cost savings, from the point of view of the provider or society as a whole?” UNC’s Dr. Murray suggested a way to defray at least some of an HF pharmacist’s costs—by characterizing the outreach as medication therapy management (MTM) services and thus reimbursable by CMS. [For details on the MTM provision, see www.pharmacypracticenews. com/fwd/10700.htm.) Tracy DeWald, PharmD, BCPS, a clinical

To learn more, call 1-888-784-7662 or visit www.RECOTHROM.com

pharmacist in the Duke University Heart Center, in Durham, who has continued some of the work Dr. Stough described in the PHARM study, said she doubts such payments would be enough to kick-start other, similar programs. “I just don’t think the funding options available, even with MTM payments, are sufficient to cover a pharmacist’s salary, particularly in this economic environment—we’re not even filling provider positions at this time.” Those pressures are part of the reason why Dr. DeWald can only spend one day per week in Duke’s outpatient HF clinic.

•

see HF PROGRAMS, page 24

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION

24 Operations & Mgmt.

Pharmacy Practice News • September 2009

RECOTHROM Thrombin, topical (Recombinant) Rx Only The following is a brief summary of the full prescribing information for RECOTHROM Thrombin, topical (Recombinant).

Practice Models

HF PROGRAMS continued from page 23

INDICATIONS AND USAGE RECOTHROM Thrombin, topical (Recombinant), is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP. DOSAGE AND ADMINISTRATION For topical use only. DO NOT INJECT.

with absorbable gelatin sponge. The amount required depends upon the area of tissue to be treated. DOSAGE FORMS AND STRENGTHS

CONTRAINDICATIONS Do not inject directly into the circulatory system. Do not use for the treatment of massive or brisk arterial bleeding. any components of RECOTHROM, or hamster proteins. WARNINGS AND PRECAUTIONS Potential risk of thrombosis if absorbed systemically. potential for allergic reaction. ADVERSE REACTIONS

RECOTHROM to bovine thrombin,1 adverse events were reported with similar frequency in the two treatment groups, and the most common events reported were incision site complication, procedural pain, and nausea.

human thrombin. Antibodies against bovine thrombin product were not tested either group did not lead to any adverse events such as excessive bleeding.

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REFERENCES 1

“My primary clinical effort is in the acutecare inpatient setting,” she said. “But I can get a lot done on that one clinic day, using a few basic strategies [sidebar].” Dr. DeWald added that this dual approach to managing HF “works really well. As an outpatient pharmacist, I can help assess the changes we made in the inpatient setting, and similarly when patients are admitted to the hospital I have more insight into their longterm management and what may have contributed to the hospitalization. This underscores the benefits of establishing a strong continuity of care.” But what if even one day of outpatient

pharmacy services for HF is beyond a hospital’s resources? “You can still help patients via inpatient care,” Dr. Stough said. “Our OPTIMIZE-HF study [Am Heart J 2008;156:662-673] showed that when pharmacists help ensure that proper inpatient HF drug therapy, such as ACE inhibitors and beta-blockers, is provided, mortality and rehospitalizations are significantly reduced 60 to 90 days after discharge.” In an ideal world, Dr. Stough added, “both inpatient and outpatient components would be doable. But you already have pharmacists in the hospital—they’re a built-in resource you can tap into and reap at least some of the benefits we’ve seen in the published HF trials.” —David Bronstein

Tips for Taming Heart Failure

he statistics of heart failure (HF) are sobering: within one year after an initial hospitalization, up to 50% of patients will be rehospitalized and up to 40% will die from their disease, according to published reports.1 Several factors contribute to this bleak prognosis, including complex drug regimens, the advanced age of the patients and patient difficulty understanding the nature of their disease. Fortunately, pharmacists can help on all counts, according to several experts interviewed by Pharmacy Practice News. Herein are just a few of their strategies—both inpatient and outpatient—for improving HF outcomes: Don’t accept polypharmacy. It is not unusual for older patients with HF to be taking upward of 15 medications to manage their diseases, according to Sean Jeffery, PharmD. To aid such patients, “it’s not always as simple as helping them organize their meds into daily pillboxes,” he said. “We’ll certainly help them do that, but a much better initial strategy is to focus on the appropriateness of each medication. In many cases, you’ll be able to reduce their pill burden in the process.” Tracy DeWald, PharmD, said she also takes that strategy, adding that duplication of therapy—metoprolol tartrate and metoprolol succinate, for example—is a common cause of “pill bloat” that pharmacists can resolve. Quiz the patient. When Dr. DeWald first sees patients at Duke’s HF clinic, “I have them bring in all of their medication vials and take them out one by one. Then I ask them questions to get a baseline of how much—or little—they understand about their drug regimens.” Their answers, she said, “really help you target your patient counseling efforts.” Challenge the hypertension fallacy. Patients with HF often suffer from low blood pressure as a result of systolic dysfunction. “They know their blood pressure is low, so when they go to their retail pharmacy for a refill of their ACE [angiotensin-converting enzyme] inhibitors or beta-blockers and the pharmacist tells them the drugs are for high blood pressure, there’s a disconnect and they often stop taking the drugs,” Dr. DeWald said. “It’s a common misconception, so take pains to explain how the drugs actually improve their overall cardiac function.” Tailor your patient counseling. The amount and level of information shared with patients has to be very individualized, said Wendy Gattis Stout, PharmD. For example, “some people can understand specific information on how to avoid drug interactions. But that may be overwhelming for others,” she said. “But regardless of how much information you provide, one message should be made clear to all HF patients: don’t start any new drug regimen without first contacting you or someone else on your HF care team.” Engage the family. This is another effective strategy for taking some of the pressure off the patient with HF. “Actually, it’s probably one of the single most effective interventions you can do—getting the family involved (a son or daughter or spouse) and making sure they have an accurate list of medications that Mom or Dad is taking, and what those meds are for,” said Sean Jeffery, PharmD. “It can make a huge difference.” Don’t go it alone. At least one study has shown that when pharmacists are part of a multidisciplinary HF care team, key outcomes such as adherence rates and rehospitalizations are improved far more than when pharmacists go it alone.1 “I can’t emphasize this enough,” said Dr. DeWald. “We don’t have the staff at Duke, nor do most other hospitals, to manage HF patients as inpatients or outpatients without the help of nurse practitioners, physician assistants, nurses and cardiologists. It truly has to be a team effort.” —D.B.

Reference 1. Koshman SL, Charrois TL, Simpson SH, McAlister FA, Tsuyuki RT. Pharmacist care of patients with heart failure: a systematic review of randomized trials. Arch Intern Med. 2008;168(7):687-694.

Operations & Management 25

Pharmacy Practice News • September 2009

Leadership in Action

Pharmacist, Lead Thyself W

ho says that nothing good can come from television? CBS’s “Crime Scene Investigation” (CSI) has been asking a most provocative question for several years in its opening song by The Who: “Who Are You?” I often ask this question of myself. In June of this year, I was honored to give the keynote address to the Hematology/Oncology Pharmacy Association at its annual meeting in Miami. I began the session with this same song and asked the audience the same personal question several times during the presentation. If you have been following this column, you may have been considering your “Life Plan.” But the life-plan question can easily be substituted by asking yourself who you really are. There is a saying that “being precedes doing.” Oftentimes, our work defines who we are. I am a pharmacist and a pharmacy administrator. While that is admirable, I suggest to you that we all look deeper than our careers for self-definition. In his book “Portfolio Life: The New Path to Work, Purpose and Passion after 50, ”1 David Corbett asks the question: “What is our passion, our energy, our purpose and our calling?” This goes beyond our work (I would hope). In the sports world, athletes are taught to visualize their performance—to see it in their mind’s eye before actually getting onto the field or the court. I recently read “Golf’s Sacred Journey: Seven Days at the Links of Utopia,”2 by David L. Cook. In this excellent book, the author describes a frustrated golfer who encounters Johnny, the master teacher at the eponymous course. Johnny teaches principles in a very unorthodox fashion. For example, to master the golf swing, he puts our frustrated golfer in a shaky canoe and sends him down a river, fly fishing. Through this experience, Johnny teaches him the importance of balance, rhythm, patience and freedom. Whether swinging a golf club, fly fishing from a canoe or in life, these four elements are essential. To assess where you are, I encouraged you in previous articles to write out the five components of your life plan and put five goals under each of the five components. If you have done that exercise, you should see a mixed balance of these five most important areas of your life. When you are balancing them properly, you have established a certain rhythm to your life. We need patience first—with ourselves and then with others. If we have the elements of balance, rhythm and patience, then we will have a sense of freedom that comes from being in control. When we are out of control, the

result is a sense of guilt. Your life plan is a reflection of your answer to the question, “Who Are You?”

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

Ernest R. Anderson Jr., MS, RPh

Prescriptions for Awareness In the last segment, I suggested that you look beyond your public and private life aspects and consider your inner life. In his book “The Seven Habits of Highly Effective People,”3 Stephen Covey tells a great story of a middle-aged professional who visits his doctor complaining of a general sense of malaise and a lack of motivation. The doctor gets a commitment that the gentleman will explicitly follow the directions on four prescriptions, each of which is to be opened at a secluded destination at prespecified times of the day.

little perplexed, but soon he reminisces to his childhood, his family and friends, and considers the root of his values and core beliefs that have made him the person he is today. This proved quite exhilarating. At 3 p.m., he opens the next prescription: “Examine Your Motives.” As he thinks deeply about how he relates to people and the person he is today, he concludes that many changes are in order, because he is actually quite selfish. At this point, he makes a pact with himself that he is going to change—particularly

Defining your passion, energy and purpose can go a long way toward ensuring a fulfilling, well-balanced life, both personally and professionally. The gentleman selects the oceanfront to complete the exercise. At 9 a.m., he reads the first prescription: “Listen Carefully.” At first, he views this whole idea as ludicrous; however, as he quiets himself down to actually listen, he gets into his inner life and really listens not only to the sounds around him, such as the sea gulls, the ocean waves and even the sand crabs digging in the sand, but he slows down enough to listen to his inner self. He enjoys this time so much that he almost doesn’t want to go on to the next prescription. At 12 noon, he opens the next prescription which contains three words: “Try Reaching Back.” At first, he is a

in his relationships with others. Finally, at 6 p.m., he opens the last prescription, which reads “Write Your Troubles in the Sand.” He takes a broken seashell and writes his troubles in the sand at the high-water mark and watches as the waves of the rising tide come in and wash them away—a truly deep exercise. How is your own balance in life? What is your passion, energy, purpose and calling? By writing a life plan or a personal mission statement that is a true reflection of who you are and where you want to go, following and achieving your goals provides great satisfaction. If you are having trouble getting started, I

encourage you to examine your own life story just as our patient did at the beach when he was “reaching back.” As David Corbett states, “Writing your own life story can be daunting. It doesn’t have to be long; it only has to be true.” Examine the allocation of time in each of the five components of your life plan. Re-adjust as necessary to find the right balance.

Relationships Hold Key to Happiness As I have reflected back over my life, my greatest satisfaction has come from the meaningful relationships that I have made with others, both in the professional world of pharmacy and in my more private world of family and friends. Reaching my mid-50s has caused me to reflect on my past and on my future, to evaluate what is important and how I want to continue to influence people through encouragement. I often speak with people about their sphere of influence. By reaching out to people with genuine interest in their development, I have formed strong bonds. This interest is both personal and professional. As I have written in my column, my philosophy is to be a “servant leader.” As I serve people, I am leading them to be successful in their lives. This is my passion, my purpose and my calling. I am energized when I see others become successful in their endeavors. I view this column as a way to serve its readers: to encourage and, hopefully, relate a few nuggets of truth that will help each reader. Based on the e-mails and personal responses I get from readers [see page 4], I sense I am helping some to see things in a new light. In my last article, I told you I would keep you posted on my new job, which came about through my evaluation of my personal life plan. While there are many challenges at any new position (people to meet, systems to understand, schedules to establish), the greatest lesson that I am learning is the power of encouragement. The job is still very new and I have a lot to learn. Fortunately, I have a boss who is very encouraging. We are on the same page. Encouragement is the birthplace of motivation. I am energized by this encouragement. I recommend that you also consider whom you can encourage and motivate toward success.

References 1. Corbett D. Portfolio Life: The New Path to Work, Purpose and Passion After 50. New York, NY: John Wiley & Sons, Inc.; 2007. 2. Cook DL. Golf ’s Sacred Journey: Seven Days at the Links of Utopia. Utopia, Texas: Sacred Journey Stories; 2006. 3. Covey SR. The Seven Habits of Highly Effective People. New York, NY: Fireside/Simon & Schuster; 1989.

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WARNING: INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM SODIUM serum sodium can be monitored closely oo 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

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IMPORTANT SAFETY INFORMATION FOR SAMSCA™ (tolvaptan) 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. SAMSCA is contraindicated in the following conditions: 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 Too Rapid Correction of Serum Sodium Can Cause Serious Neurologic Sequelae – During initiation and after titration monitor patients to assess serum sodium concentrations and neurologic status. Subjects with serum sodium. In patients receiving SAMSCA who develop too rapid a rise in serum sodium, discontinue or interrupt treatment with SAMSCA and consider administration of hypotonic fluid. Fluid restriction during the should generally be avoided. Gastrointestinal Bleeding in Patients with Cirrhosis – Used only when the need to treat outweighs this risk Dehydration and Hypovolemia – In patients who develop medically significant signs or symptoms of hypovolemia, discontinuation is recommended. Dehydration and hypovolemia can occur, especially in Co-administration with Hypertonic Saline – Not recommended CYP 3A Inhibitors – Do not use with strong inhibitors of CYP 3A; avoid concomitant use with moderate CYP 3A inhibitors CYP 3A Inducers SAMSCA may need to be increased P-gp Inhibitors Hyperkalemia or Drugs that Increase Serum Potassium – Monitor serum potassium levels in patients levels Pregnancy and Nursing Mothers – SAMSCA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from SAMSCA, a decision should be made to discontinue nursing or SAMSCA, taking into consideration the importance of SAMSCA to the mother. Commonly observed adverse reactions – (incidence ≥ and hyperglycemia (6% vs 1%)

Please see Brief Summary of FULL PRESCRIBING INFORMATION, including Boxed WARNING, on the following pages.

Reference: 1. Schrier RW, Gross P, Gheorghiade M, et al; SALT Investigators. Tolvaptan, a selective oral vasopressin V2 for hyponatremia. N Engl J Med

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27 Proven Marketing Strategies To Boost Your Practice Profits

Lonnie Hirsch; Stewart Gandolf

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You'll find all the physical therapy marketing secrets you need to know packed onto these eight fast-paced, information-rich CDs. This comprehensive CD series contains hundreds of ideas, techniques and secrets gleaned from our experience consulting for more than 3,000 private practices. You will hear valuable information to help you increase your physical therapy practice profits, enhance your reputation, attract your favorite cases and differentiate yourself from your competition.

Beyond Pain

Compliance for Coding, Billing & Reimbursement

Thomas Moshiri, MD

A detailed and intensive review of the core knowledge needed to pass the pain boards. Containing the essential information you must know and condensing complex subjects into easy-to-understand topics. No other book contains all the information you need in an easy-to-understand manner in one single location.

Duane C. Abbey

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Ethical Issues in Chronic Pain Management Michael E. Schatman

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Michael Reiman, CFS, RFC, DIA; Max Adams, Esq, LUTCF, CRFA

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Christopher R. Jarvis, MBA; David B. Mandell, JD, MBA; Jason M. O’Dell, CWP; Claudio A. DeVellis, JD, CPA

For Doctors Only teaches doctors how to efficiently practice so they can get more out of a medical practice. More specifically, For Doctors Only will help doctors protect their personal and practice assets from lawsuits, taxes and bad investments while showing them the secrets to building wealth through the leverage of people, assets and effort.

Rehabilitation and Palliation of Cancer Patients

The Art and Politics of Science

Wealth Protection MD

Herrmann Delbrück

To improve quality of life for cancer patients has been the endeavour of the author for the past 25 years in rehabilitation and palliation. To maintain quality of life is an important challenge not only for health aftercare service, but also in palliative and terminal situations.

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The Art and Politics of Science is a glimpse into the world of high-stakes, big-budget science narrated by a man intimately acquainted with its everyday applications—an education for people in all walks of life from a scientist whose own research and professional commitments helped to shape our scientific age.

Christopher R. Jarvis, MBA; David B. Mandell, JD, MBA; Celia R. Clark, JD, LLM; Glenn M. Terrones, Esq.

This book teaches doctors how to protect their personal and practice assets from lawsuits, taxes, bad investments, bankruptcy and divorce by combining the expertise of a financial planner, asset protection attorney and estate planning attorney. This comprehensive guide explains domestic and offshore asset protection, tax-saving vehicles, captive insurance companies and more. PPN0909

30 Policy

Pharmacy Practice News • September 2009

Cost Savings

Survey: GPOs Save U.S. Hospitals Billions Annually G

roup purchasing organizations save U.S. hospitals $36 billion each year in supply costs, plus another $2 billion or so in reduced staffing required for purchasing activities, a new survey has found. Of the nation’s estimated 5,000 hospitals, 429 participated in the survey, which was conducted by the consulting company Health Care Sector Advances, Inc., and funded by the Health Industry Group Purchasing Association (HIGPA), which represents 16 group purchasing organizations (GPOs). GPOs have been around for decades yet remain invisible to the public, said Eugene S. Schneller, PhD, a professor at Arizona State University in Phoenix, and owner of Health Care Sector Advances, in an April teleconference. “GPOs are key players in health care reform. They literally save the country tens of billions of dollars annually through the power of aggregated purchasing volume and negotiated discounts with manufacturers, distributors and vendors.” The average U.S. hospital would need to employ a minimum of nine additional people in order to provide the services that a GPO provides, Dr. Schneller added.

Supply and Labor Cost Savings The survey was sent to purchasing directors at 28 hospital systems—ranging from groups of two to 100 hospitals—located throughout the United States. On average, the hospitals had 380 beds and more than 20,000 admissions per year. The analysis did not look at capital equipment, but rather focused on key products used by hospitals and regu-

larly purchased through GPOs: inpatient pharmaceuticals, general medical items, orthopedic implants, cardiology implants and other clinical products.

prices are an important benchmark for negotiating prices for expensive physician-preference items such as cardiology and orthopedic implants,

The average U.S. hospital would need to employ a minimum of nine additional people in order to provide the services that a GPO provides. Non-labor costs for U.S. hospitals are estimated at $310 billion per year, according to 2007 data from the Centers for Medicare & Medicaid Services. The survey respondents purchased 72.8% of their goods through GPOs, saving an average of 18.7%. That suggests an annual national savings of $42.2 billion. However, because 20% of nonlabor hospital products typically are not offered by GPOs, said Dr. Schneller, the report estimates that using GPOs results in a national cost savings of $36 billion, broken down as follows: • $8.5 billion on general medical products, such as bandages, gauze, physiotherapy supplies, needles, syringes, and paper for electrocardiogram machines; • $6.8 billion on inpatient pharmaceuticals, IV solutions and contrast media; • $1.9 billion on cardiology implants, including pacemakers, stents and valves; • $840 million on orthopedic implants; and • $17.96 billion on other clinical products, such as anesthesiology, radiology and laboratory supplies; housekeeping products; and office materials. The report also highlighted that GPO

Dr. Schneller said. Todd Ebert, president and chief executive officer of Amerinet, Inc., a St. Louis-based GPO with customers in all 50 states, said the survey results confirm the added value of group purchasing. “In the current economic conditions, there is not a health care provider that is not looking for ways to reduce costs and improve quality of patient care,” he said. “The bottom line is, GPOs are an important way to keep prices down, allowing our customers to provide more of the best quality care.” Alan Yordy, president and chief executive officer of PeaceHealth, a health care system of seven hospitals serving Washington, Oregon and Alaska, added that his health care system obtains three main benefits from GPOs. “First, as a small system, there is simply no amount of staffing we could provide to do the work of contracting or data gathering that a GPO provides,” Mr. Yordy said. “Second, the GPO helps us connect with other health care providers across the country,” to benefit from lower prices for combined higher spending volumes. “Lastly, and this is really a new area for many GPOs, there is now an increased focus on patient safety initiatives,” such

as using unique patient identifiers for all implantable products. Curtis Rooney, president of HIGPA, added that the report highlights the added value that GPOs bring. “By saving hospitals and other providers money on nearly everything they buy—from surgical supplies and medical equipment and pharmaceuticals to food—GPOs enable hospitals to buy more equipment and hire more doctors and nurses.” Todd Nelson, MBA, technical director of the Healthcare Financial Management Association, agreed that GPOs provide access to lower prices and more favorable contract terms with suppliers based on economies of scale. However, Mr. Nelson said, when a hospital joins a GPO, its choice of suppliers for some items may be limited, or it may be forced to switch to a new supplier or renegotiate an existing supplier agreement. A hospital might also choose to contact a regional supplier directly when its GPO does not have an agreement with that supplier.

Senators Seek Transparency Those supplier-purchaser relationships are far too secretive and might hide business practices that actually inflate health care costs, according to a group of U.S. senators. In mid-August, the legislators sent letters to the seven largest GPOs asking for more details on their contracting and negotiating polices. The effort was made because the U.S. government foots the bill for a large portion of GPO purchases, through Medicare payments. With health care reform efforts heating up, GPOs may be asked to play a role in paring more costs from the system. —Marlene Busko

Oversight

Nearly Half of Hospitals Flunk Reporting Rule for Problem Docs

housands of U.S. hospitals may be shirking their responsibility to report cases of wrongdoing by physicians to a national data bank, a new report has found. Nearly half of U.S. hospitals have reported no instances of disciplinary action against their physicians, despite a 17-year-old law requiring them to make disclosures, according to the report by the advocacy group Public Citizen. Public Citizen claims that hospitals use loopholes to evade the spirit of the reporting law, which mandates that any doctor who has had his or her admitting privileges revoked or restricted for at least 30 days be entered into the National Practitioner Data Bank. The group said hospitals are plagued by “lax peer review, including a culture

among doctors of not wanting to ‘snitch’ on colleagues.” Hospital administrators also impose light penalties on transgressors, keeping sanctions under the threshold that would trigger a report or offering leaves of absence instead of suspensions, Public Citizen said. Before launching the database, federal health officials projected that hospitals would submit 5,000 reports of privilege actions each year. “However, the average number of hospital reports per year has been 650,” Public Citizen said in a letter to Kathleen Sebelius, secretary of the Department of Health and Human Services. “As of December 2007, there was a total of only 11,221 such reports.” “It is impossible to justify the fact that thousands of hospitals, which collectively

have granted admitting privileges to hundreds of thousands of doctors, have not reported a single discipline case in 17 years,” said Sidney Wolfe, MD, acting president of Public Citizen, in a statement. “Our report shows there is an urgent need for the Obama administration to step in and hold hospital administrators accountable, as well as ensure that hospital medical staffs hold their own physicians accountable for patient safety.” Failure to report disciplinary action against physicians prevents state medical boards from learning about such cases, creating the potential for harm to patients, the group said. Public Citizen has called for changes to the Health Care Quality Improvement Act of 1986, including imposing fines on

hospitals that fail to report disciplinary actions against doctors. The group also would like the government to make compliance with the reporting law a component of hospital accreditation and Medicare program participation. Elizabeth Lietz, a spokeswoman for the American Hospital Association, dismissed the Public Citizen report. “Hospitals, physicians and caregivers all work together to provide patients the right care in the right place at the right time and take seriously their responsibility for patient care,” Ms. Lietz said. “The premise that the number of reports received by the National Practitioner Data Bank correlates to jeopardized patient care is inaccurate.” —Adam Marcus

BRIEF SUMMARY: For full prescribing information, see package insert.

VOLUVEN

Skin and subcutaneous tissue disorders (Common, >1 to <10%, dose dependent): Prolonged administration of high dosages of hydroxyethyl starch may cause pruritus (itching) which is an undesirable effect observed with all hydroxyethyl starches.

For administration by intravenous infusion. Initial U.S. Approval: 2007

Investigations (Common, >1% to <10%, dose dependent): The concentration of serum amylase can rise during administration of hydroxyethyl starch and can confound the diagnosis of pancreatitis. At high doses the dilutional effects may result in decreased levels of coagulation factors and other plasma proteins and in a decrease of hematocrit. [see Interference with Laboratory Tests (5.3)]

To report SUSPECTED ADVERSE REACTIONS, contact Hospira Inc. at 1-800-441-4100 or electronically at ProductComplaintsPP@ hospira.com or FDA at 1-800-FDA-1088 or electronically at www.fda.gov/medwatch.

6.2 Adverse Reactions in Clinical Trials Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug may not reflect the rates observed in practice.

(6% HYDROXYETHYL STARCH 130/0.4 IN 0.9% SODIUM

CHLORIDE INJECTION)

INDICATIONS AND USAGE

Voluven® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is indicated for the treatment and prophylaxis of hypovolemia. It is not a substitute for red blood cells or coagulation factors in plasma. 4

CONTRAINDICATIONS

The use of Voluven® is contraindicated in the following conditions: •

known hypersensitivity to hydroxyethyl starch [see General Warnings and Precautions (5.1)]

•

fluid overload (hyperhydration) and especially in cases of pulmonary edema and congestive heart failure

•

renal failure with oliguria or anuria not related to hypovolemia

•

patients receiving dialysis treatment

•

severe hypernatremia or severe hyperchloremia

•

intracranial bleeding.

WARNINGS AND PRECAUTIONS

5.1 General Warnings and Precautions Anaphylactoid reactions (mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary edema) have been reported with solutions containing hydroxyethyl starch. If a hypersensitivity reaction occurs, administration of the drug should be discontinued immediately and the appropriate treatment and supportive measures should be undertaken until symptoms have resolved. [see Adverse Reactions (6)] Fluid status and rate of infusion should be assessed regularly during treatment, especially in patients with cardiac insufficiency or severe kidney dysfunction. In cases of severe dehydration, a crystalloid solution should be given first. Generally, sufficient fluid should be administered in order to avoid dehydration. Caution should be observed before administering Voluven® to patients with severe liver disease or severe bleeding disorders (e.g., severe cases of von Willebrand´s disease). 5.2 Monitoring: Laboratory Tests Clinical evaluation and periodic laboratory determinations are necessary to monitor fluid balance, electrolyte concentrations, kidney function, acid-base balance, and coagulation parameters during prolonged parenteral therapy or whenever the patient’s condition warrants such evaluation. 5.3 Interference with Laboratory Tests Elevated serum amylase levels may be observed temporarily following administration of the product and can interfere with the diagnosis of pancreatitis. At high dosages the dilutional effects may result in decreased levels of coagulation factors and other plasma proteins and a decrease in hematocrit. 6

ADVERSE REACTIONS

6.1 Overall Adverse Reaction Profile From the accumulated clinical development experience, expected adverse reactions after administration of Voluven® occurring in less than 10% of patients are as follows:

Immune system disorders (Rare, >0.01% to <0.1%): Products containing hydroxyethyl starch may lead to anaphylactoid reactions (hypersensitivity, mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary edema). In the event of an intolerance reaction, the infusion should be discontinued immediately and the appropriate emergency medical treatment initiated. [see General Warnings and Precautions (5.1)]

Voluven®,

During clinical development, 471 patients were exposed to and a total of 768 patients received the hydroxyethyl starch 130/0.4 drug substance contained in Voluven® at different concentrations (2%, 4%, 6%, or 10%) and at cumulative doses of several mL up to 66 L1). The mean duration of treatment with hydroxyethyl starch 130/0.4 was 3.9 ± 3.3 days, mean cumulative doses were 3338 ± 3695 mL, and the longest follow-up period was 90 days. In the US trial, 100 patients undergoing elective orthopedic surgery were treated either with Voluven® (N=49) or hetastarch (6% hydroxyethyl starch in 0.9% sodium chloride injection) (N=51) for intraoperative volume replacement. Mean infusion volumes were 1613 ± 778 mL for Voluven® and 1584 ± 958 mL for hetastarch.

Adverse reactions observed in at least 1% of patients: In the US trial comparing Voluven® with hetastarch, a possible relationship to Voluven® was reported in five cases in a total of three patients (aPTT elevated, PT prolonged, wound hemorrhage, anemia, pruritus). A possible relationship to hetastarch was reported in five patients (three cases of coagulopathy; two cases of pruritus). The three coagulopathy cases in the hetastarch group were serious and occurred in patients receiving more than the labeled ceiling dose (20 mL/kg), whereas no serious coagulopathy occurred in the Voluven® group. 6.3 Postmarketing Experience The following adverse reactions have been identified during the postapproval use of Voluven® and other types of hydroxyethyl starch solutions. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

8.4 Pediatric Use In one trial, children including newborns to infants (<2 years) undergoing elective surgery were randomized to receive Voluven® (N=41) or 5% albumin (N=41). The mean dose of Voluven® administered was 16 ± 9 mL/kg3). Voluven® may be given to premature infants and newborns only after a careful risk/benefit evaluation. The safety and efficacy of Voluven® have not been established in the age group of 2 to 12 years. Use of Voluven® in children >12 years is supported by evidence from adequate and well-controlled studies of Voluven® in adults and by data from children <2 years old. Dosage in children should be adapted to individual patient colloid needs, taking into account underlying disease, hemodynamics and hydration status. [see Pediatric Dose (2.2)] 8.5 Geriatric Use Of the total number of subjects in clinical studies of Voluven® (N= 471), 32% were 65 years old and older while 7% were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 8.6 Renal impairment Voluven® is mainly excreted by the kidneys, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Volume status, infusion rate, and urine output should be closely monitored. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. [see Pharmacokinetics (12.3)] 10 OVERDOSAGE As with all plasma volume substitutes, overdosage can lead to overloading of the circulatory system (e.g. pulmonary edema). In this case, the infusion should be stopped immediately and if necessary, a diuretic should be administered. [see General Warnings and Precautions (5.1)] 15 REFERENCES 1)

Neff TA, Doelberg M, Jungheinrich C, et al. Repetitive large-dose infusion of the novel hydroxyethyl starch HES 130/0.4 in patients with severe head injury. Anest Analg 2003; 96 (5): 1453–9

Kozek-Langenecker S. Effects of hydroxyethyl starch solutions on hemostasis. Anesthesiology 2005; 103 (3): 654-60

The safety profile from postmarketing experience of Voluven® is not different from the profile obtained from clinical trials performed using the product.

Lochbühler H, Galli C, Hagemann H. Hydroxyethyl starch HES 130/0.4 in paediatric surgery: results of an explorative, controlled, multicenter safety study. Crit Care 2003; 7 (Suppl 1):, P107

Based on spontaneous reporting of hypersensitivity reactions, urticaria, bronchospasm, or hypotension were the most frequently reported serious adverse drug reactions for patients treated with Voluven®.

Jungheinrich C, Neff T. Pharmacokinetics of hydroxyethyl starch. Clin Pharmacokinetik 2005; 44 (7): 681-699

Jungheinrich C, Scharpf R, Wargenau M, et al. The pharmacokinetics and tolerability of an intravenous infusion of the new hydroxyethyl starch 130/0.4 (6%, 500 mL) in mild-to-severe renal impairment. Anesth Analg 2002; 95 (3): 544 – 51

Leuschner J, Opitz J, Winkler A, Scharpf R, Bepperling F. Tissue storage of 14C-labeled hydroxyethyl starch (HES) 130/0.4 and HES 200/0.5 after repeated intravenous administration to rats. Drugs R D 2003; 4 (6): 331-8

Gandhi SD, Weiskopf RB, Jungheinrich C et al. Volume replacement therapy during major orthopedic surgery using Voluven® (hydroxyethyl starch 130/0.4) or hetastarch. Anesthesiology 2007; 106:1120-1127

With the administration of hydroxyethyl starch solutions, disturbances of blood coagulation can occur depending on the dosage2). 8

USE IN SPECIAL POPULATIONS

8.1 Pregnancy Pregnancy Category C. Voluven® has been shown to cause embryocidal or other adverse effects in rats and rabbits when given in doses 1.7 times the human dose. There are no adequate and wellcontrolled studies in pregnant women. Voluven® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The type of hydroxyethyl starch present in Voluven® had no teratogenic properties in rats or rabbits. At 5 g/kg of body weight per day, administered as a bolus injection, fetal retardations and embryolethal effects were observed in rats and rabbits, respectively. In rats, a bolus injection of this dose during pregnancy and lactation reduced body weight of offspring and induced developmental delays. All adverse effects were seen exclusively at maternal toxic doses due to fluid overload. [see Toxicology (13.2.1)] Fertility studies on directly exposed animals have not been conducted.

16 HOW SUPPLIED/STORAGE AND HANDLING Voluven® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) for intravenous infusion is supplied in the following primary container and carton sizes: Polyolefin bag (freeflex®) with overwrap: 500 mL Carton of 15 x 500 mL NDC 0409-1029-01 Store at 15° to 25°C (59° to 77°F). Do not freeze.

8.2 Labor and Delivery Information on the use of Voluven® during labor or delivery is unknown.

Manufactured by: Fresenius Kabi Norge AS, P.O. Box 430, NO-1753 Halden, Norway

8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Voluven® is administered to a nursing woman.

Distributed by: Hospira, Inc. 275 North Field Drive Lake Forest, Illinois 60045 USA Made in Norway Reference EN-1597

Policy 33

Pharmacy Practice News â&#x20AC;˘ Month 2008

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Financial Health

Economic Crisis Impacts Oncology Practices Dr. McDonald is a Clinical Pharmacist in Oncology Outpatient Services at Norton Cancer InstituteLouisville Oncology Pharmacy Services in Louisville, Kentucky. She is the winner of a writing contest in our sister publication, Clinical Oncology News.

or years, oncology practices have struggled with increasing overhead costs and decreasing reimbursement rates, but the current economic crisis has created new challenges that impact the quality of patient care and the financial health of oncology practices. As more patients face an uncertain financial future, practices are forced to take on new roles and responsibilities in patient care.

Overall Struggles Today, an increasing number of patients cannot meet their co-pay or deductible obligations, and they are slow or delinquent in paying for services rendered. Under financial strain and out of fear that they may incur additional medical expenses, some patients are not contacting their doctorâ&#x20AC;&#x2122;s office to report side effects associated with chemotherapy, or such reporting may be at a minimum. Some patients also are downplaying the severity of symptoms when talking with doctors, out of concern about the financial obligation of a hospital admission. Without the complete clinical picture of the patientâ&#x20AC;&#x2122;s status, oncologists may be making inappropriate treatment decisions. In addition, large co-pay obligations may be stopping some patients from filling prescriptions, which can interfere with treatment. For example, treatment may be delayed because a patient refuses to fill an antiemetic prescription due to co-pay responsibilities; without the drug, the patient then may suffer from severe nausea. Under tight financial conditions, it is not surprising that co-pay foundations and drug assistance programs are critical contacts in most oncology practices. Foundations, however, may take weeks to grant approvals or run out of funds because of the large number of applicants. Patients are often overwhelmed navigating the complicated system of health care reimbursement and require intensive assistance from office staff to submit applications. Addressing patientsâ&#x20AC;&#x2122; economic challenges increases staff workloads and, unfortunately, patient care sometimes suffers. Many clinicians

now find themselves spending just as much time resolving financial obstacles as dealing with clinical matters. As patients struggle to gain financial assistance, therapy may be delayed. Oncology clinicians are faced with difficult decisions regarding treatments as patients await financial assistance.

Oral Agents and the Transfusion Setting In recent years, a new challenge has emerged on the horizon: reimbursement of oral chemotherapy regimens. Outpatient prescription benefits have shifted from the traditional two copay brand versus generic to a multitiered system. It is very common for oral oncolytics to be covered under the specialty tier of a patientâ&#x20AC;&#x2122;s pharmacy benefit plan. Many plans have implemented 25% co-pay for specialty medications, and patients with Medicare Part D plans often find themselves in the â&#x20AC;&#x153;donut holeâ&#x20AC;? with the first fill of a specialty medication. Patients are not financially prepared to meet copay or deductible obligations and may choose to delay therapy. Patients also are more likely to adapt behaviors to reduce medication expenses such as skipping pills or decreasing doses to extend their medication supply. The infusion setting is another area that is witnessing increasing problems. Oncology practices devote endless hours completing prior authorizations, appealing denials to insurance companies and finding support for the underinsured. An increasing number of patients may find themselves without health benefits because of the loss of a job that provided health insurance or the loss of a job that renders them unable to pay premiums for their independent policy. As a result of the expense of oncology agents, other patients are finding that they have exceeded their maximum lifetime benefit in their health plan. These patients are likely to have their therapy interrupted, as they attempt to find an alternate method of coverage. Patients face many barriers when undergoing chemotherapy. Financial pressure affects the treatment options available to patients, therapeutic outcomes and the revenue stream into oncology practices. As the number of patients facing job loss and additional financial pressure continues to grow, clinicians must respond to the economic pressures that affect patients and the practice. â&#x20AC;&#x201D;Kelly Anne McDonald, PharmD, MBA

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34 Policy

Pharmacy Practice News • September 2009

Medication Safety

SAMHSA, FDA Initiate Public Outreach Campaign Looking for a safer use of methadone

n an effort to reduce the amount of poisonings related to unsafe use of methadone, the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) and the FDA have initiated a public outreach campaign, “Follow Directions: How to Use Methadone Safely.” Methadone, a long-used treatment for patients addicted to heroin and other opiates, increasingly is being prescribed for patients suffering from chronic pain. However, the availability of methadone, combined with a lack of knowledge among patients about the drug’s unique characteristics, has contributed to an increase in methadonerelated poisonings and death. Whereas patients treated for addiction receive their methadone in a tightly regulated clinic environment, those receiving the drug for pain management often are sent home with prescriptions for large amounts and with an inadequate understanding of the new medication. The new campaign, which includes a brochure, a poster and a fact sheet, advises patients to provide physicians with their complete medical history; take their medication exactly as prescribed; never give away any of the methadone; and contact their physician immediately if they experience any side effects. “We realize that a much larger number of individuals are being given methadone prescriptions for pain,” said H. Westley Clark, MD, JD, director of SAMHSA’s Center for Substance Abuse Treatment. “They are more likely to misuse the methadone depending on their situation and their understanding of it.” For example, he emphasized that methadone, when combined with alco-

very unforgiving in terms of respiratory depression, especially in people who are naïve to the medication. And I think that’s where we’re getting into some trouble, because teenagers and college students are getting into the drug without understanding it and dying.”

Need for Research: Critical Gaps

‘With the pain medications, fairly large amounts are being prescribed and then kids and teenagers can get access to these drugs.’

—Frederick W. Burgess, MD

hol or other pain medications, can lead to respiratory depression and death.

Diversion There was an increase in methadone prescriptions for pain management in 2006 from approximately 531,000 to 4.1 million. This increase has been accompanied by a surge in diversion of the drug. “With the pain medications, fairly large amounts are being prescribed and then kids and teenagers can get access to these drugs,” said Frederick W. Burgess, MD, clinical associate professor of surgery, Brown University, and chief of anesthesiology, Providence VA Medical Center, both in Rhode Island. “Methadone is one of the preferred drugs for treating cancer

patients … so a prescription for 100 tablets is in the house, the kids get into some of it, nobody really notices it’s missing and it gets out into the community.” According to the National Survey on Drug Use and Health, deaths caused by accidental drug poisoning increased by 68% between 1999 and 2004, and the majority of these deaths were associated with opioids. “Kids and teenagers can get access to these drugs, but they really don’t understand them at all,” said Dr. Burgess. “They think of them the same way they would oxycodone or hydrocodone—short-acting drugs that can get you high briefly—but methadone is a very slow-onset drug, a very long-lasting drug, and it seems to be

Dr. Clark is hopeful that the new public outreach campaign will not only promote safer use of methadone, but also will open the door for increased research in opioids for treatment of chronic noncancer pain. He cited a review published in the Journal of Pain (2009;10:147-159) that addresses critical research gaps in opioid treatment for chronic noncancer pain. According to the review, there is a serious shortage of studies on long-term use of opioids, particularly methadone. “These gaps in research for medications for chronic noncancer pain are casting a cloud on the pain community,” said Dr. Clark. “Practitioners must work on a case-by-case basis; their judgment is undermined and called into question by diversion.” The new campaign hopefully will lead the public, as well as the pain community, in the right direction by promoting the correct use of methadone. “Methadone is safe when used properly,” Dr. Clark emphasized. Ideally, the government and pain community can work together to promote knowledge of the unique qualities of methadone, and future studies will yield more information on its role as a treatment for chronic noncancer pain. —Laura Tendler

Industry News

Carefusion’s Focus: Medical Devices Supporting Patient Care and Safety S

AN DIEGO, CA—The biggest medical company you’ve never heard of is ready to lose its anonymity. Although CareFusion Corporation is brand new, it already employs more than 15,000 people globally who do business in 120 different countries. Its mature product lines and newer offerings are focused on improving patient care and safety. Jim Mazzola, senior vice president of marketing and communication, explained, “The parent company, Cardinal Health, is primarily a North American distribution business, while CareFusion is primarily a global medical device business. We determined that these very different businesses would both be better positioned in their respective markets if they were separate and could therefore invest independently to grow.” CareFusion’s product lines already are well known and widely used in hospitals

worldwide. “They run the gamut from surgical instruments, to ventilators, to IV infusion pumps,” Mr. Mazzola explained. One example is Pyxis, “an automated dispensing and patient identification system that secures pharmaceuticals on the nursing floor, cutting down the time it takes to deliver drugs to where they are needed—at the patient’s bedside.” The system greatly reduces the possibility of medication errors, an important consideration given the extent of annual adverse drug events among hospitalized patients. Alaris is CareFusion’s line of infusion pumps. Among its many innovations, “Alaris introduced ‘guardrails safety software,’ which allows hospitals to set parameters for medication infusions. If a nurse accidently enters a value that is above or below the recommended dosage—for example, 2.0 is entered as 20.0—it will stop the infusion.”

CareFusion also markets AVEA and Pulmonetic Systems, a line of ventilation and respiratory products, and will shortly introduce a full-function ventilator that weighs only 9 lb. The EnVe Palmtop Ventilator, or PTV, is an advance in patient care and safety because it allows the patient to be moved without having to be switched from a bedside ventilator to a transport ventilator. Studies have found that changing ventilators increases the risk for ventilator-associated pneumonia.

Diversified Line of Products CareFusion, whose international headquarters is located here, also markets the V. Mueller line of surgical instruments; monitoring and diagnostic products for neurology; products for interventional medicine; ChloraPrep, which helps reduce surgical

site and bloodstream infections; and MedMined, an infection surveillance software service that oversees the threat of hospitalacquired infections and helps hospitals refine their practices to avoid them. CareFusion has plans to introduce nearly 40 new products in the next 18 months. “Some of our new offerings will connect existing products, such as Pyxis and MedMined, to further enhance safety and help hospitals measurably improve the care they deliver.” “We are in business in many parts of the world,” Mr. Mazzola said. “Although these markets can be very different, many of the challenges hospitals face are really the same. Adaptation and sensitivity to these local markets come into play, but patient safety and improving patient care are important everywhere.” —Staff

Policy 35

Pharmacy Practice News • September 2009

Infectious Disease Antimicrobial stewardship programs:

Keys to Getting Them Right Rosemont, Ill.—The increasing recognition that giving inappropriate antimicrobial therapy is a medication error, combined with the Centers for Medicare & Medicaid Services decision to cut reimbursement for preventable hospital-acquired infections, has put increased impetus on the development of antimicrobial stewardship programs at hospitals throughout the country. Infectious disease pharmacists debated the best approaches such programs can take to optimize antimicrobial therapy during a session at the American Society of Health-System Pharmacists Summer Meeting. One of the “keys to success is getting the right people to the table,” said Robert Owens, PharmD, co-director of the Antimicrobial Stewardship Program at Maine Medical Center, in Portland. This includes infectious disease physicians and pharmacists as well as representatives from the microbiology department, Pharmacy & Therapeutics Committee, medical information systems, epidemiology and administration. Another key to success is implementing the right type of program. During the session, Dr. Owens and other speakers debated the merits of active versus passive antimicrobial stewardship programs. Passive programs incorporate elements such as formulary restrictions, preauthorization, automatic stop orders, antimicrobial order forms and usage guidelines. Active programs incorporate some of the elements of a passive program but, more importantly, include a formal prospective interventional program. The Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) guidelines for developing an institutional antimicrobial stewardship program (Clinical Infect Dis 2007;44:159-177) state that both types of programs together should be considered a “foundation” for developing these infectious disease pharmacy intervention strategies. Calling the IDSA/SHEA guidelines “pretty much the bible” in this arena, speaker Marc H. Scheetz, PharmD, MSc, infectious disease pharmacist at Northwestern Memorial Hospital in Chicago, agreed that ideally a program would incorporate both passive and active elements. However, if he had to choose one approach over another, he would recommend a prospective interventional program. Inappropriate antimicrobial regimens lead to antibiotic resistance, increased costs and preventable adverse drug events. “We have to focus

on all of these things, and I believe that prospective audit and feedback is the most effective manner” to do this, Dr. Scheetz said. “The preponderance of data really is here for prospective audit and feedback.” Referring to studies that evaluated passive versus active programs (Infect Control Hosp Epidemiol 2003;24:699-706; Clin Infect Dis 1999;29:1189-1196), he said “programs

that use active management perform much better, even for cost.” In fact, he said, such programs often “pay for themselves.”

Strict Policies = Adversarial Relationships For his part, Dr. Owens offered anoth-

er reason to avoid strict restriction policies. “We don’t know” whether restriction decreases resistance, but “we do know that it creates an adversarial relationship with prescribers.” On the other hand, speaker Hannah R. Palmer, PharmD, raised some of the

•

see STEWARDSHIP, page 37

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Policy 37

Pharmacy Practice News • September 2009

Infectious Disease

STEWARDSHIP continued from page 35

challenges that go with a prospective intervention program. One of her biggest concerns with the prospective programs is the time delay that can occur before a patient gets appropriate therapy. Referring to data on patients with septic shock from the surviving sepsis guidelines (Crit Care Med 2008; doi: 10.1097/01.CCM.0000298158.12101.41), Dr. Palmer, infectious disease clinical coordinator at St. Luke’s Episcopal Hospital, in Houston, said, “every hour of inappropriate therapy increases mortality; why would you want to wait?” Additionally, she said, prospective intervention programs are by nature voluntary for prescribers. “No matter how sweet I am about it, they don’t have to accept what I suggest. It is their choice, and that can be dangerous.” Lastly, she said, unlike a restriction program which is set in place and can be referred to, prospective order and feedback “is a daily battle.”

‘There are ways that prescribers game the system, but if you are in the trenches giving them a tap on the shoulder, it really makes a difference.’ —Robert Owens, PharmD

them a tap on the shoulder, it really makes a difference.” The most common intervention Dr. Owens makes is dose optimization, followed by discontinuing redundant therapy, making IV-to-oral switches

and streamlining therapy. When the program was started in 2001, they focused primarily on dose optimization and discontinuing redundant therapy. “Because we focused, we made major differences. Then we added oth-

er things later.” The underlying driver for improving antimicrobial stewardship programs, according to Dr. Owens, will be the recognition that this is a patient safety issue. Decisions that are made now about how to properly treat infections will have implications for the coming decades, he predicted. The wrong choices will lead to increasing resistance, morbidity and mortality. “We have reached a point where we cannot afford to not act.” —Sarah Tilyou

Active Program in Maine Maine Medical Center’s stewardship approach includes just such a prospective intervention program, with identification, communication and follow-up components. In the identification component, the infectious disease pharmacists get a daily report that lists the patients receiving antibiotics and includes information on dose, route, allergies, diet and blood cultures. Dr. Owens said having this report ahead of time allows him to meet the patients on the floor armed with that background information and make better treatment recommendations. Through the second component of their prospective audit and feedback program, the communication component, Dr. Owens and the other infectious disease pharmacists recommend changes in therapy in a report sent to prescribers. Through the final, or follow-up, component of the program, prescribers accept or reject those recommended interventions. If the interventions are rejected, the reasons and prescribers are tracked to allow pharmacy to follow up with administration, department heads, etc, when necessary. Although the acceptance rate for their interventions is generally over 95%, Dr. Owens acknowledged that Dr. Palmer was correct in saying that prospective programs require an ongoing process communicating with prescribers and educating them about optimal antimicrobial choices. “You have to continue to educate, and continue and continue. Education is the cornerstone of everything you do.” He added, “There are ways that prescribers game the system, but if you are in the trenches giving

Color-coded labels make it easier to select the correct product for dispensing.

“Tall man lettering” aids in distinguishing similar product names.

Safety Every Step of the Way Unit dose products are meant to ensure patient safety. Scanning at the bedside reduces countless medication administration errors each year. Other measures can also be taken to complement the accuracy the bar code provides. In addition to being bar coded to the dose level, our packages are created to aid the pharmacist to select the correct product for dispensing. Color-coded labels within a product family and differentiating the strengths on the label make it much easier to select the correct product. In addition, we use “tall man lettering” to ease in distinguishing very similar product names. From the pharmacy to the patient bedside, American Health Packaging takes care to support health care providers to ensure the safety of their patients every step of the way. 800.707.4621 americanhealthpackaging.com

38 Policy

Pharmacy Practice News • September 2009

Drug Approvals

Onsolis Comes With First Opioid REMS—and Some Rancor T

he approval of a new opioid pain reliever for the treatment of some patients with breakthrough cancer pain may seem on the surface as simply a step forward in pain pharmacotherapy. The FDA’s approval of the pain drug Onsolis, however, is replete with backstory and the potential for ongoing controversy, as the agent is the first in the opioid drug class to come with a Risk Evaluation and Mitigation Strategy (REMS), an FDAmandated plan for minimizing the risks of taking a drug. The Onsolis REMS—and most likely the risk plans for all opioids for which they will be required—will include a restricted distribution program under which prescribers, pharmacies and patients would have to register in order to prescribe, dispense and receive Onsolis, respectively. The drug will be delivered directly to the patient’s home and is restricted in physician offices and hospitals in order to reduce the risk for diversion. This, and several other aspects of the REMS, have come under fire by groups like the American Pain Society (APS), which feels that many of the recommendations it made regarding the REMS during its development process were ignored by the FDA. Empowered by the Food and Drug Administration Amendments Act of 2007 to require drugs to carry REMS, the FDA first acknowledged it would ask 24 manufacturers of long-acting and extended-release opioids to develop such risk management plans for their products in February 2009. Each of these agents is formulated with one of the following active ingredients: fentanyl, hydromorphone, methadone, morphine, oxycodone or oxymorphone. Onsolis (fentanyl buccal soluble film, Meda AB, BioDelivery Sciences) is indicated for the management of breakthrough pain in adult patients with cancer (aged ш18 years) already taking and tolerant of opioids for their chronic cancer pain. The focus of a clinical trial program involving more than 300 patients and 90,000 administered doses, Onsolis is slated for launch in the fourth quarter of 2009.

Safety Concerns Cited Onsolis is a short-acting agent but was required to include a REMS because of safety concerns with fentanyl products. An opioid analgesic, fentanyl is a Schedule II controlled substance with substantial potential for misuse and abuse. Onsolis’ label will carry a boxed warning, stating that it should not be used to treat migraines, dental pain or postoperative pain, or by patients taking opioids on an intermittent basis. The required labeling will stress that, given substantial differences between the pharmacokinetic pro-

file of Onsolis and other fentanyl products that affect the degree of drug absorption, Onsolis should not be substituted by or for any other fentanyl products. “Onsolis can provide strong pain relief to patients who are opioid tolerant. But for patients who are not opioid tolerant, it can lead to overdose, sudden serious breathing difficulties and death,” said Bob Rappaport, MD, director, Division of Anesthesia, Analgesia and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research (CDER). “For this reason, Onsolis should be prescribed only under the safeguards provided by the FDA-required REMS and by health care professionals knowledgeable about Onsolis and the use of potent opioid medications.”

Pharmacy Training Program The Onsolis FOCUS (Full Ongoing Commitment to User Safety) Program will include a prescriber/pharmacy training program, educational materials and patient counseling calls to make sure they understand how to properly use the drug. The hot button component of FOCUS, however, is the restricted redistribution program.

“The REMS for Onsolis was specifically tailored to that drug and should not be viewed as a model REMS for long-acting and extended-release opioid products,” said Douglas Throckmorton, MD, deputy director of CDER. “Developing the comprehensive REMS for these other products is a complex undertaking. We will take the time necessary to review all of the public comments and will proceed in a deliberate manner toward the mutual goals of patient access and patient protection.” “The chief concern for oral membrane fentanyl products is the fact that patients need to be opioid tolerant,” said Dr. Finn. “That’s not the concern for long-acting products. There are different safety concerns for the two products, so they have to be different kinds of REMS.”

APS Frustration “The FDA has held a series of meetings with stakeholders, including a large public meeting, and also solicited written public comments to hear more about how to develop this REMS,” said the FDA in a statement announcing the Onsolis approval. In a July 24 letter from society president Charles E. Inturrisi,

Cognitive impairments due to cancer-related pain may make REMS-mandated patient counseling problematic. “There is a restricted distribution program that FDA has required but we don’t see that being in any way an obstacle to the proper patients receiving the product,” said Andrew Finn, MD, executive vice president of product development for BioDelivery Sciences, in a July 17 teleconference. “The product will be delivered to a courier service, and that’s the way it will be delivered to the patient directly. We think that’s a positive.” “We don’t see it [the REMS] affecting the long-term sales of this product,” agreed BioDelivery Sciences CEO Mark Sirgo in the same teleconference. “We actually think this educational process will drive usage, and do it in an appropriate way in making sure the product gets to appropriate patients.” The FDA was quick to point out that the REMS for Onsolis was not a “one-sizefits-all” plan for all opioids, given that the product is a short-acting medication.

PhD, to Dr. Rappaport, the APS acknowledged the opportunity to present their recommendations to the agency, but added that it was “surprised and disappointed” that the Onsolis REMS was “in stark contrast to many of the stakeholder suggestions made.” “We [the APS] are concerned with the well-documented issues of misuse, abuse and overdose deaths—particularly in the youth—but we advocate for a rational approach that will minimize secondary, unintended consequences such as restriction of access to proper pain care,” APS Public Policy Committee co-leader Edward Michna, MD, said in an interview. “Of concern, in particular, are the already underserved communities.” One of the APS’s concerns is that REMS will not be required of all opioids. “We do want to emphasize again our belief that opiate-induced dangers and the REMS to address them share many

features across the opiate drug class— regardless of their route of administration, onset of action and potency,” the APS president wrote in the letter. If the REMS does not cover all opioids, “you will probably drive prescribing to the uncovered class,” said Dr. Michna. Among the issues described in the APS letter regarding the “stringent and complicated” Onsolis REMS: Registry requirements. “The attempted reassurance in the announcement that after patient, prescriber and dispenser are all found to be registered the drug should be delivered within five business days may give small comfort to the cancer patient without intravenous access in need of rapid analgesia (from, for example, dressing changes) several times a day,” wrote the APS, “particularly if the patient happens to be located in a place where distribution is restricted, like a hospital. Restricted distribution. “Not allowing hospital and institutional pharmacies to stock these medications for immediate use … denies patients and prescribers access to medications that may for these clinical situations be the best alternative,” according to the APS. Patient education. While medication guides are “worthwhile educational efforts,” they are not an adequate replacement for a knowledgeable pharmacist or clinician, according to the APS. “Many patients suffering from cancer-related pain are cognitively impaired, particularly at the end of life, which makes counseling and education of a patient, let alone a counseling call, difficult or impossible.”

More Dialogue Needed The APS urged the FDA to once again be open to stakeholder input, especially from pain and palliative care groups, to ensure the “unintended consequences” of implementing a REMS are reduced. “It would indeed be tragic if the very patients that these products were developed and approved for were denied access to their specific therapeutic qualities,” the letter concluded. Making it clear that he was speaking as an individual and not on behalf of the APS, Dr. Michna said he believes the REMS will limit access to Onsolis. “I have spoken to many physicians about this and no one is going to be certified for this medication,” he said. Actiq (transmucosal fentanyl citrate, Cephalon) and Fentora (fentanyl buccal tablet, Cephalon), two other fentanylbased products that recently have been approved by the FDA, also will include REMS, both of which are purported to be similar in nature to the Onsolis risk management plan. —Donald M. Pizzi

Pharmacy Practice News • September 2009

New Products/Industry news S&S Puts Stamp on Drug Carousel Technology

&S Technology announced the launch of its Pharmacy Carousels System (PCS). Designed to be a “drop in” product, the PCSCV10 immediately improves patient care and safety while at the same time reducing the cost and burden of manually filling doctor’s orders for patients, according to the company. Some of the features of S&S Technology’s PCS-CV10 include: • Software controls that interface with most pharmacy systems in use today; • The capability of storing 240 individual drug items; • Visual cues to indicate exact location of each and every drug; • Remote access to reports and controls; • Bar code, magnetic badge, RFID option for charting and billing; and • ICLS (Individual Controlled Locking System) for drawer access. For more information, the company can be contacted via e-mail at jbeegle@radx.com, via phone at (281) 815-1300 or on the Web at www.medcart.com.

Helixate FS for Hemophilia Prophylaxis in Children

SL Behring announced that Helixate FS, Antihemophilic Factor (Recombinant), has been approved by the FDA for routine prophylaxis in children with hemophilia A who are 16 years old or younger and do not have pre-existing joint damage. This new indication was granted by the FDA after determining Helixate FS is safe and effective for routine prophylaxis, which can reduce the frequency of bleeding episodes and the risk for joint damage in children with hemophilia A. “Bleeding into joints, including the ankles, elbows and knees, is a concern for children with hemophilia A and their treatment providers,” said Jerry S. Powell, MD, director of the Hemophilia Treatment Center at the University of California, Davis. “The FDA’s approval of Helixate FS ... will help our patient population effectively manage their condition.”

For more information about Helixate FS, please visit www.HelixateFS.com or call CSL Behring Consumer Affairs at 1-888-508-6978.

CareFusion Launches Jazz Festival Series

areFusion created the CareFusion Jazz Festival Series to support the launch of this new company and recognize individuals and organizations working to improve patient care. The new medical technology company combines its proven technologies with information to help measurably improve the delivery of patient care. The Jazz Festival Series comprises some of the largest and oldest jazz festivals in the

world, attracting both big-name and upand-coming artists. “There is a clear connection between jazz and medicine that provides the perfect opportunity to launch our new brand, raise funds for and awareness of patient safety and help support and preserve the arts,” said David Schlotterbeck, CEO of CareFusion. “Both jazz and the practice of medicine embrace innovation, performance and change. Jazz is also used to teach listening skills to medical students and resonates with our customers.” (The connection between jazz and medicine is also made at mcmahonjazzmedicine.com, a sister publication of this newsmagazine, which celebrates the improvisational

nature of creative art and the practice of medicine.) The CareFusion Jazz Festival Series schedule includes: • George Wein’s CareFusion Jazz Festival 55 (Newport, R.I.), Aug. 7–9, 2009, completed • Chicago Jazz Festival presented by CareFusion, Sept. 4–6, 2009, completed • CareFusion Presents Dizzy’s Den at the Monterey Jazz Festival, Sept. 18–20, 2009 • CareFusion Manly Jazz Festival

BRIEF SUMMARY OF PRESCRIBING INFORMATION TM

RiaSTAP , Fibrinogen Concentrate (Human) For Intravenous Use, Lyophilized Powder for Reconstitution Before prescribing, please consult full prescribing information, a summary of which follows. Some text refers to full prescribing information. 1 INDICATIONS AND USAGE RiaSTAP™, Fibrinogen Concentrate (Human) is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. RiaSTAP is not indicated for dysfibrinogenemia. 4 CONTRAINDICATIONS RiaSTAP is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis to RiaSTAP or its components. 5 WARNINGS AND PRECAUTIONS 5.1 Allergic Reactions Allergic reactions may occur. If symptoms of allergic or early signs of hypersensitivity reactions (including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis) occur, immediately discontinue administration (see Patient Counseling Information [17.1]). The treatment required depends on the nature and severity of the reaction. 5.2 Thrombosis Thrombosis may occur spontaneously in patients with congenital fibrinogen deficiency with or without the use of fibrinogen replacement therapy.1 Thromboembolic events have been reported in patients treated with RiaSTAP. Weigh the benefits of RiaSTAP administration versus the risk of thrombosis. Patients receiving RiaSTAP should be monitored for signs and symptoms of thrombosis. (see Patient Counseling Information [17.2]) 5.3 Transmissible Infectious Agents RiaSTAP is made from human plasma. Products made from human plasma may contain infectious agents (e.g., viruses and theoretically the Creutzfeldt-Jakob disease agent [CJD]) that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by a process demonstrated to inactivate and/or remove certain viruses during manufacturing. (see Description [11]). Despite these measures, such products may still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products (see Patient Counseling Information [17.3]). All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CSL Behring at 1-866-915-6958. 6 ADVERSE REACTIONS The most serious adverse reactions that have been reported in clinical studies or through postmarketing surveillance following RiaSTAP treatment are allergic-anaphylactic reactions and thromboembolic episodes, including myocardial infarction, pulmonary embolism, deep vein thrombosis, and arterial thrombosis. The most common adverse reactions that have been reported in clinical studies or through postmarketing surveillance following RiaSTAP treatment are allergic reactions and generalized reactions such as chills, fever, nausea, and vomiting.

(Australia), Oct. 3–5, 2009 • CareFusion Jazz Festival Paris, Oct. 16–24, 2009 • CareFusion New York Jazz Festival, June 2010 (exact dates TBD) As part of the Festival Series, CareFusion will broadcast the performances of select festival artists live to hospitals. Caregivers and administrators from hospitals across the United States, Europe and Australia will also be invited to special VIP events at the festivals to raise funds and awareness for a new health care safety campaign named ‘Rhythm of Care,’ which brings together organizations and people from health care to promote best practices.

6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical studies and may not reflect the rates observed in practice. The most common adverse reactions observed in more than one subject in clinical studies (frequency >1%) were fever and headache. 6.2 Postmarketing Experience Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure. Adverse reactions reported in patients receiving RiaSTAP for treatment of fibrinogen deficiency include allergic-anaphylactic reactions (including rash, dyspnea, etc.), general reactions such as chills, fever, nausea, vomiting and thromboembolic complications such as myocardial infarction, pulmonary embolism, and deep vein thrombosis. The following adverse reactions, identified by system organ class, have shown a possible causal relationship with RiaSTAP.

(see Warnings and Precautions, Thrombosis [5.2]) 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with RiaSTAP. It is not known whether RiaSTAP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RiaSTAP should be used during pregnancy only if clearly needed. 8.2 Labor and Delivery RiaSTAP has not been studied for use during labor and delivery. 8.3 Nursing Mothers RiaSTAP has not been studied in nursing mothers with congenital fibrinogen deficiency. 8.4 Pediatric Use RiaSTAP studies have included subjects below the age of 16 years. In the pharmacokinetic study (see Pharmacokinetics [12.3]), 2 children (8 and 11 years), 3 adolescents (12, 14 and 16 years), were studied. Subjects less than 16 years of age (n = 4) had shorter half-life this study limits statistical interpretation. 8.5 Geriatric Use The safety and efficacy of RiaSTAP in the geriatric population has not been studied. There were an insufficient number of subjects in this age group to determine whether they respond differently from younger subjects. Reference: 1.Peyvandi F, Haertal S, Knaub S, et al. Incidence of bleeding symptoms in 100 patients with inherited afibrinogenemia or hypofibrinogenemia. J Thromb Haemost CSL Behring GmbH US License No. 1765

CSL Behring LLC Kankakee, IL 60901 USA Based on January 2009 version

THE FIRST AND ONLY FIBRINOGEN CONCENTRATE NOW WITHIN YOUR REACH

Important Safety Information RiaSTAP™, Fibrinogen Concentrate (Human), is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. RiaSTAP™ is not indicated for dysfibrinogenemia. RiaSTAP™ was approved using maximum clot firmness (MCF) as a surrogate marker likely to predict clinical benefit. Thus, the hemostatic efficacy of RiaSTAP™ in acute bleeding episodes has not been established. A post-marketing study is being conducted to verify clinical endpoints.

FINALLY—the access and convenience you’ve been waiting for Concentrated lyophilized protein that is easily reconstituted in minutes Labeled ﬁbrinogen content to assist with coagulation management

RiaSTAP™ is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to RiaSTAP™ or its components.

Demonstrated ability to effectively raise ﬁbrinogen levels to within target levels

Monitor patients for early signs of allergic or hypersensitivity reactions and if necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving RiaSTAP™; weigh the beneﬁts of administration versus the risks of thrombosis.

Concentrated ﬁbrinogen allows for low infusion volume1 and quick administration

RiaSTAP™ is made from pooled human plasma. Products made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The most serious adverse reactions that have been reported in subjects in clinical studies who received RiaSTAP™ are thromboembolic episodes, including myocardial infarction and pulmonary embolism, and allergic-anaphylactic reactions. The most common adverse reactions observed are allergic reactions, including chills, fever, nausea, and vomiting. Monitor patients for early signs of allergic or hypersensitivity reactions and if necessary, discontinue administration. Please see brief summary of prescribing information on next page.

Virus inactivation/removal reduces risk of exposure to infectious agents Easily stored and accessed when needed, due to room temperature storage and 30-month shelf life

For more information, visit www.riastap.com. New

Reference: 1. Mannucci PM, Duga S, Peyvandi F. Recessively inherited coagulation disorders. Blood. 2004;104:1243–1252. RiaSTAP is a trademark of CSL Behring GmbH. © 2009 CSL Behring LLC, 1020 First Avenue, PO Box 61501 King of Prussia, PA 19406-0901 www.CSLBehring-US.com Printed in USA IO#RIA-007T 3/2009

Strengthens clots. Supports hemostasis.