The October 2012 Digital Edition of Pharmacy Practice News by McMahon Group

C OTL ct io H N IGH n be OL T O gi N ns on O G pa Y ge

The Pharmacist’s News Source

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in this issue UP FRONT

The power of observation in sterile compounding.

POLICY

New drugs for multiple sclerosis, cystic fibrosis, and more.

OPERATIONS & MGMT

ECRI study: drug administration a danger spot in acute care setting.

Right and wrong words in the peacemaking process: Ernie Anderson Jr.

CLINICAL

Making pharmacogenomics a practical reality.

TECHNOLOGY

Clean rooms, hoods and outsourcing: striking the right balance for safety.

EDUCATIONAL REVIEW

Compatibility Of Commonly Used IV Drugs See insert after page 16.

Volumee 39 • Number 10 • October 2012

40th ANNIVERSARY YEAR 1972–2012

Initiative Boosts Compliance With Electrolyte Therapy Baltimore—A new software-based protocol for standardizing electrolyte replacement therapy (ERT) across multiple sites and types of care has yielded major improvements in speed and accuracy, according to a task force of health professionals at Sentara Obici Hospital, in Suffolk, Va. With the new system in place, nine of every 10 patients who are candidates for ERT now get the infusions in a timely manner, with the ingredients well matched to the metabolic needs of the patients—a rarity before the system was implemented, the team reported in a poster presented at the 2012 Summer Meeting of the American Society of Health-System Pharmacists. The protocol was designed and developed in-house by a cross-disciplinary team of physicians, nurses, pharmacists and information technology professionals, according to task force member Olubukola Fakunle-Adeyemi, PharmD. Introduced a

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see ELECTROLYTES, page 27

Shift to Electronic Tools Boosts Event Detection Baltimore—Health systems are using a variety of electronic trigger tools and other software-based solutions to boost the reporting and detection of medication events, in many cases before the mishaps reach patients. At St. Jude Children’s Research Hospital, in Memphis, the multipronged strategy has led to a 20% increase in event reporting and has had a significant impact on the

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see TRIGGERS, page 25

Price Gouging: A Black Mark On Gray-Ma G

ray-market distributors are taaking advantage of long-term critical drug shortages to demand exorbitaant payments from hospital pharmacies that run out of options for obtainiing lifesaving treatments from regular wholesalers, according to a recent C Congressional report. Investigators who compiled the report found numerous instances in which short-supply medication ns changed hands multiple times across a chain of buyiing and selling, with each transaction adding a fat marrkup until the products reached hospital pharmacies at prices at least 30 times higher than typical contract amounts. Several pharmacy directors from m top health systems say that in the months since the rreport was issued, they have continued to feel the stiing of steep price hikes. “Just last week, I paid abou ut 10 times what it used to cost me for propofol,” said Tom Van Hassel, RPh, MPA, of Yum ma Regional Medical Center, in Yum ma, Ariz. “If I am truly out, I really havee no choice; I have to buy whatever I can. It doesn’t matter if it’s $27 a bottle o or $300 a bottle. I can’t close my hosspital surgery down because I don’t have a crucial induction agent.”

•

see GRAY MARKET, T page 10

Sticker shock: one wholesaler charged $600 for a vial of fluorou uracil—a markup of 8,471% over the original $7 price.

Layered Learning Plugs Students Into Real-World Pharmacy Svces

hree years ago, the Esshelman School of Pharmacy at the University of North Carolina at Chapel Hill (UNC) unfurrled its layered learning practice m model (LLPM). Since that time, the program’s focus and conten nt have been steadily refined with one primary goal in mind: to improve the learning experience of pharmacy students and residents, while simultaneously adapting patient care practices to keep pace with the rapid changes in health care.

““We wanted to turn the maany needs that faced us into posiitive outcomes,” said Rowell Dan niels, PharmD, MS, director of p pharmacy for UNC Hospitaals and Clinics and executiive associate dean for pharmacy clinical practice at the m School of Pharmacy. “At the S same time, we wanted to increase the quality of experiences in the pharmacy school, so we sought to elevate the level of pharmacy practice in the hospital while providing an

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The Book Page Drug Discovery and Development: Technology in Transition: Second Edition

see LEARNING, page 19

New Product

Raymond G Hill

Pﬁzer Injectables announces availability of methotrexate injection, USP.

See page 29.

See page 18.

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Up Front 3

Pharmacy Practice News • October 2012

Capsules

surf

CDC Updates Guidelines for HBV-Infected Health Care Providers

OCTOBER 2012

watch

The five most-viewed articles last month on pharmacypracticenews.com: 1. Pharmacists Applaud Chemo Guidelines for Obese Patients 2. Tales of Success in Boosting HCAHPS Scores 3. Med Management Standards From JC Still a Challenge 4. Automation Shines Light on ‘Black Hole’ of OR Drugs 5. Vancomycin Plus Piperacillin-Tazo May Trigger Acute Kidney Injury Register for free at pharmacypracticenews.com to read these and other articles on the latest developments in hospital pharmacy.

heard here

‘Students and residents have

much more exposure to patients from a counseling perspective under [the layered learning] model,

first

and they’re much more involved in the discharge process.’ —Larry Buie, PharmD, BCPS, BCOP

See article, page 1

he Centers for Disease Control and Prevention (CDC) has issued revised guidelines for managing health care providers and medical students who are infected with hepatitis B virus (HBV) to reduce the risk for transmission to patients. The new guidelines (MMWR Recomm Rep 2012;61:1-12) echo the 1991 CDC recommendations (MMWR Recomm Rep 1991;40:1-9) that HBV infection should not disqualify infected individuals from practicing surgery, dentistry or medicine, but they also update the recommendations in several key ways. Most notably, the CDC no longer advocates that providers or students with HBV inform patients of their HBV status, because disclosing this information “might actually be counterproductive to public health.” “In general, I think these recommendations are a first step toward preventing discrimination against HBV-infected health care workers while still protecting patient safety,” said Robert S. Brown Jr., MD, MPH, Frank Cardile Professor of Medicine, chief, Center for Liver Disease and Transplantation, Columbia University College of Physicians and Surgeons, NewYork-Presbyterian Hospital/ Columbia University Medical Center, in New York City. “It is clear that HBV-infected health care providers should not be restricted in their ability to practice medicine and surgery, and this is now clearly stated,” said Dr. Brown, who was not involved in creating the new guidelines. The new guidelines discuss advances in the management of chronic HBV infection, notably that HBV DNA serum levels should be used to monitor infectivity instead of hepatitis B e-antigen status. They also recommend a threshold serum HBV DNA value of less than 1,000 IU/mL as safe for practice. Three main situations in which health care providers would pose a risk to patients are addressed in the guidelines: • Providers with an infectious virus circulating in the bloodstream; • Providers with an injury (a puncture wound) or a condition that permits exposure to infectious fluids; and • Providers whose infectious fluid comes into direct contact with a patient’s wound or exposed tissue. Most HBV-infected health care workers do not meet these criteria and pose no risk to patients, but those who might meet the criteria (notably providers performing exposure-prone procedures) should be monitored by an expert review panel, according to the report. This expert panel would evaluate the provider’s HBV status, assess practices and adherence to recommended surgical and dental techniques, and would investigate providers for suspected and documented breaches resulting in patient exposure, the report noted. The panel also would reinforce the practice of standard precautions, including double gloving, regular glove changes and avoiding the use of blunt surgical needles. Based on these guidelines, the authors encourage institutions to develop their own policies for identifying and managing HBV-infected health care providers and students. Although Dr. Brown praised the overall thrust of the new guidelines, he said that the local expert panel component might be problematic. “I am concerned that the creation of [the] panels may lead to variability across facilities and ongoing discrimination in some institutions [that] is not based on data or clear risk to the patients.” To view the recommendations, visit www.cdc.gov/mmwr/preview/mmwrhtml/rr6103a1.htm. —Victoria Stern Dr. Brown reported no relevant ﬁnancial conﬂicts of interest.

EDITORIAL BOARD

ART/PRODUCTION STAFF

ADMINISTRATION

Michele McMahon Velle, MAX Graphics/Creative Director

Robert Adamson, PharmD, Livingston, NJ

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

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

Volume 39 • Number 10 • October 2012 • pharmacypracticenews.com

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

INTERNAL MEDICINE

EDITORIAL STAFF

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

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Robert L. Barkin, MBA, PharmD, Chicago, IL

NUCLEAR PHARMACY

BIOTECHNOLOGY Jeffrey Norenberg, PharmD, Albuquerque, NM

Indu Lew, PharmD, Livingston, NJ

Sarah Tilyou, Senior Editor smtilyou@mcmahonmed.com

CARDIOLOGY

ONCOLOGY

C. Michael White, PharmD, Storrs, s CT

Robert T. Dorr, PhD, RPh, Tucson, AZ

Kevin Horty, Don Pizzi, Adam Marcus, Cynthia Gordon, Contributing Editors

CNS/PSYCHIATRY

Robert Ignoffo, PharmD, San Francisco, CA

James Prudden, Group Editorial Director

Charles F. Caley, PharmD, Storrs, CT

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

Robin B. Weisberg, Manager, r Editorial Services

Cindy O’Bryant, PharmD, Aurora, CO

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Lawrence Cohen, PharmD, BCPP, FASHP, FCCP, Spokane, WA Larry Ereshefsky, PharmD, San Antonio, TX COMPLEMENTARY AND ALTERNATIVE MEDICINE

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CRITICAL CARE

PEDIATRICS

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4 Up Front

Pharmacy Practice News â&#x20AC;˘ October 2012

Commentary More on Amanita Mushroom Toxicity To the Editor:

e: â&#x20AC;&#x153;Milk Thistle Extract Takes the Sting Out of Amanita Mushroom Toxicityâ&#x20AC;? (August, page 1): The cluster of four amatoxin poisoning cases described in the article, which were treated at Medstar Georgetown University Hospital (MGUH), in Washington, DC, has created a great deal of interest, first because potentially fatal amatoxin poisonings are quite rare in the United States and second because the patients were treated with Legalon SIL, a concentrated derivative of milk thistle. The use of IV silibinin has been available via clinical trial in this country since early 2010.

From the

However, the mushrooms pictured with your article are not any of the approximately seven to eight species of Amanita that contain amatoxins. The photographs used depict Amanita muscaria, which contains toxins that produce bizarre symptoms in both humans and animals1 but have no lasting effects and do not affect the liver or kidneys. Hence, IV silibinin would not be used to treat those poisonings. The amatoxin-containing Amanita species, especially A. phalloides, are responsible, worldwide, for 90% to 95% of all fatalities caused by mushrooms. A few mushrooms in other genera (e.g., some species of Galerina and

Lepiota, and Conocybe filaris, also contain amatoxins but are less likely to be consumed because they are small and less attractive). Galerinas could be collected by those seeking hallucinogenics. There were at least a couple of fatalities a number of years ago due to this confusion. It is difficult to be sure how effective IV silibinin is in helping patients to recover from amatoxin poisonings, but since it seems to have no negative side effects and is provided free of charge by the manufacturer, Madaus GmbH, Cologne, Germany, for use in the clinical trial, it is definitely recommended. The mortality rate in untreated amatoxin poisonings is approximately 50%, but with timely (within 36 hours) and aggressive supportive care, especially

Web

Gabapentin May Be a Potent Weed Killer (June 2012)

h my goodness... â&#x20AC;&#x153;Potent weed killerâ&#x20AC;? is an understatement. Side effects of gabapentin include, but are not limited to, severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips or tongue; unusual hoarseness); difficult or painful urination; fever; memory problems; new or worsening mental or mood changes (e.g., depression, agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, suicidality; exaggerated feeling of well-being); red, swollen, blistered or peeling skin; severe headache or dizziness; the list goes on. Obviously, the dangerous side effects of gabapentin are not worth the risk for a person who simply wants to quit using marijuana, especially since withdrawal from weed, in most cases, will only cause agitation and restlessness for a few days. Thus, for any â&#x20AC;&#x153;responsibleâ&#x20AC;? physician whose patient said, â&#x20AC;&#x153;Hey doc, I need to get off the marijuana, what about gabapentin?â&#x20AC;? the only ethical response would be to say something along the lines of â&#x20AC;&#x153;Marijuana is kidâ&#x20AC;&#x2122;s stuffâ&#x20AC;&#x201D;grow up and quit using it, it is that simple.â&#x20AC;? Otherwise, whatâ&#x20AC;&#x2122;s nextâ&#x20AC;&#x201D;shall we prescribe Desoxyn [methamphetamine hydrochloride] to treat people who want to quit coffee? Insanity.

chas_...

rehydration with electrolytes, that rate drops to about 10%. In more than the past 100 years in the United States, deaths from amatoxins have averaged fewer than 1.5 per year. In Europe, where there are far more of these poisonings, IV silibinin has been used for approximately 20 years. But still there is not enough data to prove the effectiveness of the substance. Todd Mitchell, MD, MPH, from Dominican Hospital, in Santa Cruz, Calif., the principal investigator for clinical trials of Legalon SIL in the United States, states that timely, aggressive rehydration is critical in caring for these patients, because once the kidneys are affected (due to the severe vomiting and diarrhea seen in amatoxin poisonings), little can be done (personal communication). Biliary drainage, used in two of the MGUH cases, is difficult to perform and increases the risk for infection, according to Dr. Mitchell. The late Thomas Duffy, MD, of Walnut Creek, Calif., proposed this treatment for amatoxin poisonings many years ago, but [he] qualified that it would require an expert and experienced physician in the field to carry it out (personal communication). To my knowledge, high-dose penicillin is no longer recommended.

Marilyn Shaw Mycology consultant to Rocky Mountain Poison & Drug Center Denver, CO Toxicology Committee, North American Mycological Association

References

Vancomycin Plus Piperacillin-Tazo May Trigger Acute Kidney Injury (June 2012)

epsis causes acute kidney injury as well. Patients treated with two antibiotics, as was the case in the study highlighted in this article, are usually more ill than those treated with one antibiotic and thus are more likely to develop pre-renal failure or infection-related glomerulonephritis. Was there adjustment for baseline SOFA [Sequential Organ Failure Assessment] or APACHE II [Acute Physiology and Chronic Health Evaluation II] scores? Piperacillin has been on the market for 25 to 30 years, piperacillin/tazobactam for about 20. But now suddenly these meds are causing renal failure that no one noticed before? I am [as] yet unconvinced.

bruce...

1. Beug M, Shaw M. Animal poisoning by Amanita pantherina and Amanita muscaria: a commentary. McIlvainea: Journal of American Amateur Mycology. 2009;18:37-39.

Seeking More Advice On Resolving Conflict In the Workplace To the Editor:

agree with Bruce (previous comment): Sick people develop kidney injury. Sick people are on more than one antibiotic. End of story! This research unfortunately promulgates the same nonsense that vancomycin causes renal injury. It does not. There are no prospective randomized trials of 10 to 15 mg/L vs. 15 to 20 mg/L regimens demonstrating greater renal injury. But sick patients with acute kidney injury accumulate more vancomycin; thus, from a retrospective analysis they appear to correlate (but definitely there is no evidence of causation). If you look back on why all of a sudden we have such an intensive interest in vancomycin-associated nephrotoxicity (either alone or in combo with piperacillin/tazobactam), you will realize the investigators are often supported by the manufacturers of linezolid or daptomycin!

raria... Editorâ&#x20AC;&#x2122;s note: As was stated in the published article, the investigators who were quoted reported no relevant ďŹ nancial conďŹ&#x201A;icts of interest.

thoroughly enjoy reading the â&#x20AC;&#x153;Leadership in Actionâ&#x20AC;? columns by Ernie Anderson in Pharmacy Practice News. I have served as a staff pharmacist and clinical coordinator for about 19 years in small hospital pharmacies. I am by nature nonconfrontational and usually attempt to resolve conflict through nonconfrontational means. However, as Mr. Anderson eloquently stated in his June column (â&#x20AC;&#x153;Conflict: The Destroyer or the Opportunity?â&#x20AC;?), this isnâ&#x20AC;&#x2122;t always possible. I have just accepted the position of director of advanced experiential education at a small pharmacy school. I have traditionally shied away from mega-leadership positions but see

â&#x20AC;˘

see ADVICE, page 6

6 Up Front

Pharmacy Practice News • October 2012

Commentary

ADVICE continued from page 4

myself as being placed in increasingly more and more such positions/situations. I wanted to solicit your opinion on how I might most effectively prepare for such a major change. I envision this transition necessitating the keen ability to effectively communicate and deliberate with many, many intelligent and often strong-willed professionals. I desire the ability, strength and wisdom to effectively and fairly manage such an opportunity. Any resources or advice that might assist me to this end would be greatly appreciated. Keep up the good work—you are indeed making a difference.

work to ensure that it is being done in the manner we have defined. At Virginia Mason Medical Center, we have taken the practice of observation one step further and have placed four cameras in our clean room. This allows the area manager to discreetly observe at any time the sterile compounding procedures being performed. This avoids the Hawthorne effect, a phenomenon in which a group of workers changes their performance—sometimes negatively—in response to being observed. This strategy also allows us to capture video of best practices or those individual practices that need to be improved. If

a nonstandard procedure is observed, a clip can be downloaded and shared with the individual employee or to the larger team for educational purposes. This is just one of the many lean and/ or technology solutions we have implemented in our clean room. For example, using lean concepts we designed the clean room with pass-through systems that allow staffers to access products and supplies without leaving the clean room. We also have put in place systems to minimize batch production and move it closer to one-piece-flow. Most recently, we began a process to design a system to introduce bar-code scanning to

mistake-proof the preparation process. We look forward to sharing these efforts in more detail with your readers. And thanks again for the continued quality of the materials you put out in your journal.

Roger Woolf, PharmD Administrative Director Pharmaceutical Services Virginia Mason Medical Center Seattle, WA

Editor’s note: look for a Practice Pearl on Virginia Mason’s approach to sterile compounding in an upcoming issue.

Brian Dial, PharmD Wingate University School of Pharmacy Wingate, NC

Mr. Anderson responds:

irst, thanks for the positive feedback. I am always pleased when I get feedback like yours; it encourages me to continue these articles. Regarding your question: a couple of books that come to mind are by Ken Blanchard. The first is the classic “The One Minute Manager” [William Morrow; 1982] and the second is “Servant Leader” [Thomas Nelson; 2003]. I think the key for you in the question you pose is that of accountability. It is important that everyone understands the expectations you have for their performance. When expectations are clearly delineated and understood, then there often is not a need for confrontation. If everyone is on the same page at the beginning and knows what the deliverables are, then there should be no surprises. However, if there is the need to confront then your goal should be to reiterate what everyone agreed to at the beginning. I wish you the best in this new role— accept it as a challenge to stretch and build your character.

Observation a Powerful Tool for Ensuring Safe Sterile Compounding To the Editor:

can honestly say that your journal is one of the few I flip though cover to cover each month; there is always something applicable to my practice. In the June issue, George Ochoa wrote an article on sterile compounding (“Abide by Guidelines To Prevent Infections in Sterile Compounding,” page 6), and Eric Kastango’s comments on observation as a quality improvement tool caught my eye. Mr. Kastango cited a lean process improvement concept known as “going to gemba,” which is a Japanese term for going to the workplace and seeing what is done in an effort to visually audit whether people are following proper procedures. I have been a student of lean management techniques for the past 10 years and cannot overemphasize the importance of observing our day-to-day

INDICATION: Venofer ® (iron sucrose injection, USP) is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). IMPORTANT SAFETY INFORMATION: • Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been lifethreatening and fatal, have been reported in patients receiving Venofer ® (iron sucrose injection, USP). Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer ® immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer ® administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Venofer® when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. • Venofer ® may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer ®. Hypotension following administration of Venofer ® may be related to rate of administration and total dose delivered. Leading anemia management.™

Up Front 7

Pharmacy Practice News • October 2012

What’s Your View?

• Off Offer insights i i h that h are not widely id l known, k understood d d or published. • Explain why the pearl should be implemented on a widespread basis.

e welcome contributions from readers, so here are guidelines for submitting your views in a variety of formats: Letter to the Editor Send your comments, questions and criticisms regarding articles in Pharmacy Practice News to the editor at davidb@mcmahonmed.com, with “Letter to the Editor” in the subject line. Practice Pearls Practice Pearls focus on a clinical or operational problem at your institution, with tips (“tricks of the trade”) on how to manage the problem via an innovative system or strategy. Be sure to:

Readers whose Practice Pearls are accepted for publication will be paid a $100 honorarium. Send Pearls to smtilyou@ mcmahonmed.com, with “Practice Pearl” in the subject line. Pharmacy Profiles Do you have an inspiring or transformative tale to tell about yourself or a pharmacist colleague? If so, send details to davidb@mcmahonmed.com, with “Profile” in the subject line. Forms Bank If you have a clinical form that has improved the efficiency and quality of your hospital, send it in; we’ll help you share it with our readers. Here’s Here s what we need:

• A sample l off your clinical li i l fform, preferably f bl sent as a Microsoft Word document. • A 500-word article describing why the clinical form was developed at your institution. • Outcomes data showing the beneficial impact of the form is always a plus. • Your full name, title and academic or practice affiliation. Contributions should be sent to davidb@ mcmahonmed.com, with “Forms Bank” in the subject line. For more detailed submission guidelines, visit http://www.pharmacypracticenews. com/Contact.aspx?t=3#advboard or click on the QR code at right to access the g guidelines with y your smartphone. p

The science behind the molecule behind the formulation... The efficacy behind the safety behind the trust A distinctive hydrogel core...a long history of clinical excellence... over 260 million units*1 prescribed...and counting

There’s CORE Experience in every drop ™

Millions prescribed. Millions treated.

• Venofer ® is contraindicated in patients with known hypersensitivity to Venofer ®. Do not administer to patients with evidence of iron overload. • In efficacy studies in non-dialysis dependent-CKD patients (N=139), the most frequent adverse events ( 5%) whether or not related to Venofer® administration, were nausea (8.6%), taste disturbance (7.9%), peripheral edema (7.2%), diarrhea (7.2%), dizziness (6.5%), hypertension (6.5%), infusion site pain or burning (5.8%), dyspnea (5.8%), and vomiting (5.0%). • In multi-dose efficacy studies in hemodialysis dependent-CKD patients (N=231), the most frequent adverse events (>5%) whether or not related to Venofer® administration, were hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%), hypertension (6.5%), chest pain (6.1%), and diarrhea (5.2%). In the study of peritoneal dialysis-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer ®, reported by 5% of these patients were infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract, pharyngitis) (16.0%), diarrhea (8.0%), vomiting (8.0%), hypertension (8.0%), peripheral edema (5.3%), and nausea (5.3%). *100 mg vials and ampules worldwide from 1992 to February 2011. Reference: 1. Data on file. American Regent, Inc. Shirley, NY.

Please see brief Prescribing Information on adjacent page.

8 Policy

Pharmacy Practice News • October 2012

FDA Watch

FDA Approves Teriflunomide for Multiple Sclerosis

n Sept. 12, the FDA approved teriflunomide (Aubagio, Genzyme), a once-daily tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS). “In a clinical trial, the relapse rate for patients using Aubagio was about 30% lower than the rate for those taking a placebo,” Russell Katz, MD, the director of the Division of Neurology Products in the FDA’s Center for Drug Evalua-

tion and Research, said in a statement. “Multiple sclerosis can impair movement, sensation and thinking, so it is important to have a variety of treatment options available to patients.” According to Genzyme press releases, Phase III studies of teriflunomide included the TEMSO (Teriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis)

(Table 1. Continued)

BRIEF SUMMARY OF PRESCRIBING INFORMATION

Adverse Reactions (Preferred Term)

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Venofer safely and effectively. See full prescribing information for Venofer. Initial U.S. Approval: 2000 RECENT MAJOR CHANGES Warnings and Precautions 6/2011 INDICATIONS AND USAGE Venofer is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). DOSAGE AND ADMINISTRATION Administer Venofer intravenously either by slow injection or by infusion. CKD patients on hemodialysis: 100 mg undiluted slow intravenous injection over 2 to 5 minutes or as an infusion of 100 mg, diluted in a maximum of 100 mL of 0.9% NaCl, over a period of at least 15 minutes. CKD patients not on dialysis: 200 mg undiluted slow IV injection over 2 to 5 minutes. • CKD patients receiving peritoneal dialysis: infuse 300 mg over 1.5 hours given on two occasions 14 days apart followed by a single infusion 14 days later of 400 mg given over 2.5 hours. Dilute each Venofer dose in a maximum volume of 250 mL of 0.9% NaCl. DOSAGE FORMS AND STRENGTHS • 10 mL single use vial / 200 mg elemental iron (20 mg/mL) • 5 mL single use vial / 100 mg elemental iron (20 mg/mL) • 2.5 mL single use vial / 50 mg elemental iron (20 mg/mL) CONTRAINDICATIONS • Known hypersensitivity to Venofer WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Venofer administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Venofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. • Hypotension:Venofer may cause hypotension. Monitor for signs and symptoms of hypotension during and following each administration of Venofer. • Iron Overload: Regularly monitor hematologic responses during Venofer therapy. Do not administer Venofer to patients with iron overload. ADVERSE REACTIONS • The most common adverse reactions (≥ 2%) following the administration of Venofer are diarrhea, nausea, vomiting, headache, dizziness,hypotension,pruritus,pain in extremity,arthralgia,back pain,muscle cramp,injection site reactions,chest pain,and peripheral edema. To report SUSPECTED ADVERSE REACTIONS, contact American Regent, Inc. at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION 2 DOSAGE AND ADMINISTRATION Venofer must only be administered intravenously either by slow injection or by infusion. The dosage of Venofer is expressed in terms of mg of elemental iron. Each mL contains 20 mg of elemental iron. The usual total treatment course of Venofer is 1000 mg. Venofer treatment may be repeated if iron deficiency reoccurs. 2.1 Adult Patients with CKD on dialysis Administer Venofer 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session.Venofer should be administered early during the dialysis session. 2.2 Adult Patients CKD not on dialysis Administer Venofer 200 mg undiluted as a slow IV injection undiluted over 2 to 5 minutes on 5 different occasions over a 14 day period. There is limited experience with administration of an infusion of 500 mg of Venofer, diluted in a maximum of 250 mL of 0.9% NaCl, over a period of 3.5 to 4 hours on day 1 and day 14. 2.3 Adult Patients with CKD receiving peritoneal dialysis Administer Venofer in 3 divided doses, given by slow intravenous infusion, within a 28 day period: 2 infusions each of 300 mg overr 1.5 hours 14 days apart followed by one 400 mg infusion over 2.5 hours 14 days later. Dilute Venofer in a maximum of 250 mL of 0.9% NaCl. 5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Venofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Most reactions associated with intravenous iron preparations occur within 30 minutes of the completion of the infusion. 5.2 Hypotension Venofer may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer. Hypotension following administration of Venofer may be related to the rate of administration and/or total dose administered. 5.3 Iron Overload Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients receiving Venofer require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Do not administer Venofer to patients with evidence of iron overload. Transferrin saturation values increase rapidly after intravenous administration of iron sucrose; do not perform serum iron measurements for at least 48 hours after intravenous dosing. 6 ADVERSE REACTIONS Venofer injection may cause serious hypersensitivity reactions and hypotension. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in practice. 6.1 Adverse Reactions in Clinical Studies The frequency of adverse reactions associated with the use of Venofer has been documented in six clinical trials involving 231 patients with HDD-CKD, 139 patients with NDD-CKD and 75 patients with PDD-CKD. Treatment-emergent adverse events reported by ≥ 2% of treated patients in the six clinical trials for which the rate for Venofer exceeds the rate for comparator are listed by indication in Table 1. Patients with HDD-CKD received 100 mg doses at 10 consecutive dialysis sessions until a cumulative dose of 1000 mg was administered. Patients with NDD-CKD received either 5 doses of 200 mg over 2 weeks or 2 doses of 500 mg separated by fourteen days, and patients with PDD-CKD received 2 doses of 300 mg followed by a dose of 400 mg over a period of 4 weeks. Table 1. Treatment-Emergent Adverse Reactions Reported in ≥ 2% of Study Populations and for which the Rate for Venofer Exceeds the Rate for Comparator Adverse Reactions (Preferred Term) Subjects with any adverse reaction Ear and Labyrinth Disorders Ear Pain Eye Disorders Conjunctivitis Gastrointestinal Disorders Abdominal pain Diarrhea Dysgeusia Nausea Vomiting

HDD-CKD Venofer (N=231) %

NDD-CKD Venofer Oral Iron (N=139) (N=139) % %

Venofer (N=75) %

PDD-CKD EPO* Only (N=46) %

78.8

76.3

73.4

72.0

65.2

2.2

0.7

0.4

2.7

2.9 10.1 0 12.2 8.6

4.0 8.0 0 5.3 8.0

6.5 4.3 0 4.3 2.2

3.5 5.2 0.9 14.7 9.1

1.4 7.2 7.9 8.6 5.0

trials. In the primary end point of the TOWER study, which included 1,169 patients with relapsing forms of MS, patients who received a 14-mg dose of teriflunomide had a 36.3% reduction in annualized relapse rate compared with placebo ((P<0.0001). With respect to the main secondary end point, the teriflunomide group had a 31.5% reduction in the risk for 12-week sustained accumulation of disability compared with the place-

General Disorders and Administration Site Conditions Asthenia Chest pain Feeling abnormal Infusion site painor burning Injection site extravasation Peripheral edema Pyrexia Infections and Infestations Nasopharyngitis, Sinusitis, Upper respiratory tract infections, Pharyngitis Injury, Poisoning and Procedural Complications Graft complication Metabolism and Nutrition Disorders Fluid overload Gout Hyperglycemia Hypoglycemia Musculoskeletal and Connective Tissue Disorders Arthralgia Back pain Muscle cramp Myalgia Pain in extremity Nervous System Disorders Dizziness Headache Respiratory, Thoracic and Mediastinal Disorders Cough Dyspnea Nasal congestion Skin and Subcutaneous Tissue Disorders Pruritus Vascular Disorders Hypertension Hypotension

HDD-CKD Venofer (N=231) %

NDD-CKD Venofer Oral Iron (N=139) (N=139) % %

Venofer (N=75) %

PDD-CKD EPO* Only (N=46) %

2.2 6.1 3.0 0 0 2.6 3.0

0.7 1.4 0 5.8 2.2 7.2 0.7

2.2 0 0 0 0 5.0 0.7

2.7 2.7 0 0 0 5.3 1.3

0 0 0 0 0 10.9 0

2.6

2.2

4.3

16.0

4.3

9.5

1.4

3.0 0 0 0.4

1.4 2.9 2.9 0.7

0.7 1.4 0 0.7

1.3 0 0 4.0

0 0 2.2 0

3.5 2.2 29.4 0 5.6

1.4 2.2 0.7 3.6 4.3

2.2 3.6 0.7 0 0

4.0 1.3 2.7 1.3 2.7

4.3 4.3 0 0 6.5

6.5 12.6

6.5 2.9

1.4 0.7

1.3 4.0

4.3 0

3.0 3.5 0

2.2 5.8 1.4

0.7 1.4 2.2

1.3 1.3 1.3

0 2.2 0

3.9

2.2

4.3

2.7

6.5 39.4

6.5 2.2

4.3 0.7

8.0 2.7

6.5 2.2

*EPO=ERYTHROPOIETIN 6.2 Adverse Reactions from Post-Marketing Spontaneous Reports In the post-marketing safety studies in 1,051 treated patients with HDD-CKD, the adverse reactions reported by > 1% were: cardiac failure congestive, sepsis and dysgeusia. The following additional adverse reactions have been identified with the use of Venofer from postmarketing spontaneous reports: Anaphylactic-type reactions, shock, loss of consciousness, collapse, bronchospasm, dyspnea, convulsions, light-headedness, confusion, angioedema, swelling of the joints, hyperhidrosis, back pain, bradycardia, and chromaturia. 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. Symptoms associated with Venofer total dosage or infusing too rapidly included hypotension, dyspnea, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema, and cardiovascular collapse. Symptoms may respond to IV fluids, hydrocortisone, and/or antihistamines. Slowing the infusion rate may alleviate symptoms. 7 DRUG INTERACTIONS Drug interactions involving Venofer have not been studied. However, Venofer may reduce the absorption of concomitantly administered oral iron preparations. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Venofer should be used during pregnancy only if clearly needed. 8.3 Nursing Mothers It is not known whether iron sucrose is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Venofer is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness of Venofer in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of Venofer did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Greater sensitivity of some older individuals cannot be ruled out. In general, dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 10 OVERDOSAGE No data are available regarding overdosage of Venofer in humans. excessive dosages of Venofer may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. do not administer Venofer to patients with iron overload. 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How supplied Venofer is supplied sterile in 10 mL, 5 mL, and 2.5 mL single use vials. Each 10 mL vial contains 200 mg elemental iron, each 5 mL vial contains 100 mg elemental iron, and each 2.5 mL vial contains 50 mg elemental iron (20 mg/mL). 16.2 Stability and storage Contains no preservatives. Store in original carton at 25°C (77°F). Excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Do not freeze. Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion. 17 PATIENT COUNSELING INFORMATION Prior to Venofer administration: • Question patients regarding any prior history of reactions to parenteral iron products. • Advise patients of the risks associated with Venofer • Advise patients to report any symptoms of hypersensitivity that may develop during and following Venofer administration, such as rash, itching, dizziness, light-headedness, swelling, and breathing problems.

AMERICAN REGENT, INC. SHIRLEY, NY 11967 Venofer is manufactured under license from Vifor (International) Inc., Switzerland.

IN2340BS, Rev. 6/2011

bo group (P ( =0.0442). The results were consistent with those observed in the TEMSO study, according to Genzyme. The most common side effects of teriflunomide in clinical trials include diarrhea, abnormal liver tests, nausea and hair loss, according to an FDA press release. A boxed warning on the drug notes the risk for liver problems, including death, and a risk for birth defects. Physicians should perform blood tests to check liver function prior to and periodically during treatment. Also included in the boxed warning is an alert stating that the drug may cause fetal harm; teriflunomide is labeled as Pregnancy Category X. “The approval of our first MS therapy represents an important milestone for Genzyme and underscores our commitment to long-term leadership and partnership in the MS community,” Genzyme president and CEO David Meeker, MD, said in a statement. —George Ochoa

Panel: Tobramycin OK for Infections In Cystic Fibrosis

he FDA Anti-Infective Drugs Advisory Committee has recommended the use of tobramycin inhalation powder (TIP) for the management of patients with cystic fibrosis whose lungs contain the bacterium Pseudomonas aeruginosa.

During their Sept 5 meeting, the committee voted 13 to 1 that there was adequate evidence of safety and efficacy to support this use, according to the FDA and a press release from manufacturer Novartis. “FDA will carefully consider the committee’s recommendations as we continue to evaluate the application,” the FDA wrote in an email. TIP is an inhaled formulation consisting of dry powder in capsules delivered via an inhaler, potentially reducing administration time compared with the

Policy 9

Pharmacy Practice News • October 2012

FDA Watch nebulized product tobramycin inhalation solution (TOBI, Novartis), according to the press release. Three Phase III clinical trials were presented at the advisory committee meeting. Two were double-blind trials comparing TIP with placebo, and the third was an open-label trial comparing TIP with TOBI. All three trials used the proposed TIP dosage of 112 mg twice daily in a 28-days-on, 28-days-off treatment cycle. Compared with placebo, patients treated with TIP in one of the placebocontrolled trials (N=61) experienced relative improvements in lung function, as measured by forced expiratory volume in 1 second (FEV1 %). The other placebo-controlled trial (N=62), however, failed to show similar improvements. In the open-label trial (N=517), TIP showed comparable efficacy to TOBI 300 mg, and also was associated with a reduction in administration time of about 70%, cutting about 13 hours per treatment cycle. TIP and TOBI are similar in safety profile, aside from local effects due to powder inhalation, Novartis reported. The FDA noted that in the open-label trial, there were more discontinuations in the TIP arm than the TOBI arm, and a greater proportion of the discontinuations were attributed to adverse events (13% TIP vs. 8.1% TOBI). TIP is intended for use in patients with cystic fibrosis aged 6 years and older, whose lung function is within the range for FEV1 between 25% and 80% of predicted. —George Ochoa

New Sublingual Doses of Suboxone Film Approved

eckitt Benckiser Pharmaceuticals Inc., announced FDA approval of the 4- and 12-mg doses of Suboxone (buprenorphine and naloxone) sublingual film. Suboxone sublingual film is indicated for maintenance treatment of opioid dependence. The individually wrapped, unit-dose packaging of Suboxone sublingual film in more dosage choices is intended to provide health care professionals with more flexible, customizable treatment options and potentially reduce the risk for children accessing inappropriately stored medication, according to the manufacturer. Suboxone sublingual film is an office-based treatment that allows patients to be discreetly treated for opioid dependence in the privacy of a physician’s office. Because Suboxone sublingual film is approved for at-home use, people liv-

ing with opioid dependence can continue their daily lives while under a physician’s care similar to other chronic diseases, such as diabetes, asthma or hypertension. Treatment with Suboxone sublingual film is best delivered in conjunction with counseling and psychosocial support. The new 4- and 12-mg dosage strengths of Suboxone sublingual film will be available later this year. As part of the FDA requirements to ensure the benefits of treatment with Suboxone sublingual film outweigh potential risks—particularly risks for accidental overdose, misuse and abuse—the company has implemented a Risk Evaluation and Mitigation Strategy program. —PPN Staff

Linzess Approved To Treat IBS and Chronic Constipation

he FDA recently approved Linzess (linaclotide), a new drug to treat constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC) in adults who do not respond to standard treatments. Linaclotide, the active ingredient in Linzess, is a first-in-class, guanylate cyclase-C (GC-C) agonist that acts selectively within the intestine to accelerate gastrointestinal transit and reduce abdominal pain, according to the two companies co-marketing the drug, Forest Laboratories, Inc., and Ironwood Pharmaceuticals, Inc.

testinal disorders,” according to Victoria Kusiak, MD, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition.” The efficacy of Linzess for the management of IBS-C was established in two, double-blind, Phase III studies. More than 1,600 patients were randomly assigned to take Linzess 290 mcg or placebo for at least 12 weeks. Those taking the medication reported less abdominal pain and an increased number of complete spontaneous bowel movements than those on placebo, the study showed. Two additional double-blind, Phase III clinical studies were undertaken to evaluate Linzess as a treatment for CIC. More than 1,200 patients were randomly assigned to three groups, the first taking a daily dose of Linzess 290 mcg, the second a daily dose of Linzess 145 mcg and the third a placebo for a 12-week period. Patients taking Linzess reported having more complete, spontaneous bowel movements than those on placebo, according to results of these studies. The FDA has approved a recommended daily dose of 290 mcg of Linzess for

patients with IBS-C and 145 mcg for patients with CIC, as the studies did not show that the higher dose is more effective for patients with CIC.

Adverse Events Detailed In the IBS-C clinical trials, the most common adverse events (AEs) in patients taking Linzess and placebo were diarrhea (20% vs. 3%), abdominal pain (7% vs. 5%), flatulence (4% vs. 2%), abdominal distention (2% vs. 1%), headache (4% vs. 3%) and viral gastroenteritis (3% vs. 1%). AEs reported in the CIC clinical trials for Linzess versus placebo were diarrhea (16% vs. 5%), abdominal pain (7% vs. 6%), flatulence (6% vs. 5%), abdominal distention (3% vs. 2%), upper respiratory tract infection (5% vs. 4%) and sinusitis (3% vs. 2%). Linzess is approved with a boxed warning that it should not be given to pediatric patients aged 6 through 17 years. It is contraindicated in pediatric patients up to 6 years of age and also in patients with known or suspected mechanical gastrointestinal obstruction. The manufacturers expect to launch Linzess before the end of 2012. —Maureen Sullivan

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10 Policy

Pharmacy Practice News • October 2012

Drug Shortages

GRAY MARKET continued from page 1

Mr. Van Hassel said he buys most pharmaceuticals direct from the hospital’s primary wholesaler under a group purchasing organization contract. However, he noted, if an essential product is not available from his regular source, as in the recent propofol shortage, he will turn to alternate suppliers. “There are some bad apples that are in business purely looking for short products,” he said. “They don’t sell a legitimate line of products. They really only deal in hard-to-find pharmaceuticals.” Mr. Van Hassel does do repeat business with selected secondary suppliers. “It’s not that they’re all bad. That’s the hard part of this. The good ones get lumped in with the bad ones.”

‘No law says [a drug] can’t pass through several hands, but if there are an excessive number of wholesalers touching the product, we’ll shy away from it.’ —David Mayhaus, MS, PharmD The Good and the Bad The Congressional report, Shining Light on the “Grey Market,” acknowledged that duality. Although it focused a harsh light on the practices of a group of pharmacies and distributors operating “outside of authorized distribution networks,” it also told how the mainstream drug distribution system, including the legitimate secondary market, works to ensure safe passage of medications from manufacturers to patients.

‘Instead of [gray-market] suppliers, we use internal systems and regional relationships to manage specific shortages.’ —Roger Woolf, PharmD

pipeline for cytarabine drieed up and hospital inventoryy became perilously low. Cin-cinnati Children’s Hospi-tal had little choice. “Afterr careful consideration [and] due diligence,” he said, the hospital “did in fact purchase this drug from altern native wholesalers. Because of th his purchase, we did not run out of thiis important drug and all the patients recceived all the appropriate doses.” Dr. Mayhaus told Pharmacy Practice News that the price paid fo or the essential leukemia therapy was “ggreater than 35 times” the hospital’s regular contract amount. And these are not isolated cases; similarly steeep markups continue to hit his pharm macy budget “and remain a real challenge,” ge ” he said. said

How High Is Too High?

Most of the report, however, was devoted to the bad actors. One scenario described a 25-vial shipment off fluorouracil with an original $7 per-vial wholesaler price that was ultimatelyy sold, after six separate transactions, to a California regional medical center at $600 per vial, a markup of 8,471%. At a July Congressional hearingg on the report, David Mayhaus, MS, PharmD, chief pharmacy director at Cincinnati Children’s Hospital Medical Center, in Ohio, told senators and others in attendance that his hospital sometimes had to pay alternative wholesalers many times the normal contract price to obtain a critical drug in short supply. He cited one instance when the usual

Dr. Mayhaus, who sits on the pharmacy executive committee of the Children’s Hospital Association, said hospitals generally were not opposed to paying somewhat higher prices for products they were unable to obtain from regular sources. “We know these secondary wholesalers are not buying it for prices that our big wholesalers pay,” he said, but he questioned why prices were “30, 40, 50 times more than our acquisition costs.” In response to the report’s critical findings, Patricia Earl, a consultant to the National Coalition of Pharmaceutical Distributors, told hearing attendees, “I cannot emphasize enough the value that small or secondary pharmaceutical distributors bring to the health care system.” She said there were “thousands of small distributors that work with hospitals across the nation. To remain competitive they must comply with laws, follow pedigree and handling regulations to the letter and still offer an economical price point that allows for only a modest profit margin. If they do anything else, they run the risk of permanently losing a customer.” Most hospitals have strict policies about acquiring drugs outside normal channels. Some make it a rule not to buy in the gray market. Others will do so only as a last resort, and then only after scrupulous pedigree checking. Multiple transactions for a single drug almost always raise a red flag and lead a hospital to forego the purchase.

“No No law says [a drug] can can’tt pass through several hands, but if there are an excessive number of wholesalers touching the product, we’ll shy away from it,” Dr. Mayhaus told Pharmacy Practice News. He said Cincinnati Children’s Hospital does use “a small group of secondary wholesalers,” but only ones licensed by the Ohio Board of Pharmacy. The pharmacy board, he noted, “has a process to vet the legitimacy” of out-of-state wholesalers. “So if Joe’s Wholesaler contacts me and they’re not listed on the Ohio Board of Pharmacy Web site, we will not use them,” he said.

A Combined Coping Strategy Roger Woolf, PharmD, administrative director at Virginia Mason Medical Center in Seattle, said his hospital “does not consider purchasing pharmaceutical products outside the traditional distribution channels,” meaning its primary wholesaler or direct from a manufacturer. “Instead of alternate suppliers,” he said, referring to the gray market, “we use internal systems and regional relationships to manage specific shortages. This means working with our providers on the demand side of medication use and extensive communication with our wholesaler to manage product flows and obtain alternative dosage forms or therapeutic alternatives.” One lesson learned in recent years, Dr. Woolf said, “has been that different wholesalers have access to different drug supplies. This means that the

•

see GRAY MARKET, page 12

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12 Policy

Pharmacy Practice News • October 2012

Drug Shortages

GRAY MARKET

‘If I have no propofol, I have to buy whatever I can. It doesn’t matter if it’s $27 a bottle or $300 a bottle. I can’t close my hospital surgery down because I don’t have [the drug].’

continued from page 10

historical approach of having a single wholesaler for all drug purchases is probably not the optimal arrangement. This has led us to look at having more than one wholesaler agreement and in our case using regional care delivery arrangements with partner organizations to improve our overall access to product. This places a greater burden on us to ensure product custody, in that we have to understand

—Tom Van Hassel, RPh, MPA

our regional partners’ standards for drug control as well as our own.” Because drug distribution laws vary from state to state, one solution to the gray-market problem might be a feder-

al law governing the sale and shipment of drugs across state lines. Mr. Van Hassel, who currently serves as vice president of the Arizona Board of Pharmacy, said that such legislation may help. But

another option—certification—should also be part of any solution to ensuring supply-chain safety. “One of the things we’re concerned about, and every other pharmacy board in the country is concerned about, is how do we control the drugs that come into our state to make sure they’re of the highest quality,” he said. “There is no way without having all wholesalers board-certified.” He pointed to the National Associ ati o n o f Bo ard s o f Phar macy ’s Verified-Accredited Wholesale Distributor (VAWD) program as a potential model for a nationally required certification process. “We need to be able to require that you are a VAWD-certified wholesaler,” he said, “and if you’re not certified and not following pedigrees, then you cannot sell those products.” Multiple sales of the same product also have to be barred, he said. “We need to stop all these inter-wholesaler sales. We can’t allow product to be sold six and eight and 10 times before it gets to the end user. The only way that can be done is on a national level.” —Bruce Buckley

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Operations & Management 13

Pharmacy Practice News • October 2012

Medication Safety

Administration Errors Are Danger Spot in Acute Care Setting

edication errors occur most often during the medication administration phase, according to the results of a survey that aims to make health care facilities aware of patterns and trends in medication errors and to make recommendations for improvement. Eighty health care facilities, including acute care, pediatric and long-term care centers, submitted 695 medication events to the survey, which was conducted by the Emergency Care Research Institute (ECRI Institute PSO Deep Dive: Medication Safety, 2011). The facilities were asked to submit at least 10 medication events over a fiveweek period (April 15, 2011 to May 20, 2012). Acute care centers submitted the majority of events. More than 90% of medical events reported were classified as “incidents,” meaning errors that actually reached the patient, whether or not harm was done. About half of the events affected patients between the ages of 18 and 84 years, according to the results of the survey. Almost 70% of errors took place in the administration phase, followed by errors in dispensing (approximately 16%), prescribing (8.5%) and monitoring (7.8%). “The sheer number of drugs administered in health care facilities increases the likelihood that medication errors will occur if risk reduction systems are not in place,” the study authors noted. Additionally, the report identified that of the 320 events categorized as administration-only errors, almost 40% involved IV drug regimens, compared with oral administration (18%) and subcutaneous injection (7.8%). The report makes recommendations for safe IV practices that focus on improving systems rather than the more common current practice of focusing on human performance. For example, facilities should aim to have a uniform set of “smart” programmable IV infusion pumps with a dose error-reduction system that alerts staff if programmed doses do not match hospital protocol for each drug. Additionally, the range of concentrations available for a given infusion should be limited; standardized dosing methods established; and in the case of high-alert medications, staff should double-check drug dose and concentration. Furthermore, the ECRI report suggests that pharmacies should be solely authorized to prepare IV solutions, with the nurse’s role limited to emergency cases. Barbara Rebold, RN, MS, the director of operations for ECRI Institute PSO (Patient Safety Organization), offered a rationale for the group’s strategy for improving the safe use of IV medications. Human factors, engineering and clinical patient safety research “tells us that

we cannot eliminate human error,” she wrote. Thus, “we need to focus on [system improvements that can foster] event prevention.” By designing better systems, she added, “we allow the barriers to more effectively and efficiently prevent or lessen harm caused by adverse events.”

Low Response an Issue These findings are not surprising, according to Allen Vaida, PharmD, the

executive vice president of the Institute for Safe Medication Practices. “So many patients are receiving IV medications in an acute care setting, and because many of these medications [are administered using] a variety of doses and timings, there is more of a chance for error to occur,” he told Pharmacy Practice News. What was surprising, Mr. Vaida noted, was the relatively small numbers of events submitted by the survey respon-

dents. “Several hundred hospitals [participated] over a five-week period, but less than 700 errors [were] reported— you’d expect the number of errors to be way higher,” he said. “Overall, it’s hard to get a lot from this report. The recommendations are fine but they’re highlevel. You could make these recommendations without any of this data.” —Maureen Sullivan

14 Operations & Management

Pharmacy Practice News • October 2012

Leadership in Action

Words: A Friend or a Foe Communication starts with listening

ave you ever entered into a conversation with great intentions of resolving an issue by getting your point across only to come away muttering to yourself, “Well, that didn’t go quite as I intended.”? All too often I have had that experience and resolved to prepare better and lead with a question, especially if the

SELENIUM INJECTION (AS SELENIOUS ACID)

conversation is with someone I don’t know well. Words are so simple. We use them constantly. Yet, words are very powerful and can mean the difference between a successful conversation and a harmful one. We continue our series on peacemaking based on Ken Sande’s book “The Peace Maker” (Third Edition, Baker

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BRIEF SUMMARY DESCRIPTION: Selenium Injection is a sterile, nonpyrogenic solution for use as an additive to solutions for Total Parenteral Nutrition (TPN). INDICATIONS AND USAGE Selenium Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of selenium in TPN solutions helps to maintain plasma selenium levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms. CONTRAINDICATIONS Selenium Injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis. WARNINGS Selenium Injection can be toxic if given in excessive amounts. Supplementation of TPN solution with selenium should be immediately discontinued if toxicity symptoms are observed. Frequent determination of plasma selenium levels during TPN support and close medical supervision is recommended. Selenium Injection is a hypotonic solution and should be administered in admixtures only. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. PRECAUTIONS As selenium is eliminated in urine and feces, selenium supplements may be adjusted, reduced or omitted in renal dysfunction and/or gastrointestinal malfunction. In patients receiving blood transfusions, contribution from such transfusions should also be considered. Frequent selenium plasma level determinations are suggested as a guideline. In animals, selenium has been reported to enhance the action of Vitamin E and decrease the toxicity of mercury, cadmium and arsenic. Pregnancy: Teratogenic effectss. Pregnancy Category C: Selenium at high dose levels (15-30 mcg/egg) has been reported to have adverse embryological effects among chickens. There are however, no adequate and wellcontrolled studies in pregnant women. Selenium Injection should be used during pregnancy only if potential benefit justifies the potential risk to the fetus. Presence of selenium in placenta and umbilical cord blood has been reported in humans.

Books; 2004). When you approach someone with a question, instead of letting the hammer come down on them, you show grace and a willingness to understand. People often make assumptions. We think we know why someone acted in a particular way or failed to act in a particular way. The reality is we need to learn the story behind the person’s action or inaction. As a leader, if you come down with the hammer, you will put people on the defensive and they often become unresponsive to problem solving. When you lead with a question, in contrast, it

ADVERSE REACTIONS The amount of selenium present in Selenium Injection is small. Symptoms of toxicity from selenium are unlikely to occur at the recommended dosage level. OVERDOSAGE Chronic toxicity in humans resulting from exposure to selenium in industrial environments, intake of foods grown in seleniferous soils, use of selenium-contaminated water, and application of cosmetics containing selenium has been reported in literature. Toxicity symptoms include hair loss, weakened nails, dermatitis, dental defects, gastrointestinal disorders, nervousness, mental depression, metallic taste, vomiting, and garlic odor of breath and sweat. Acute poisoning due to ingestion of large amounts of selenium compounds has resulted in death with histopathological changes including fulminating peripheral vascular collapse, internal vascular congestion, diffusely hemorrhagic, congested and edematous lungs, brick-red color gastric mucosa. The death was preceded by coma. No effective antidote to selenium poisoning in humans is known. Animal studies have shown casein and linseed oil in feeds, reduced glutathione, arsenic, magnesium sulfate, and bromobenzene to afford limited protection. DOSAGE AND ADMINISTRATION Selenium Injection provides 40 mcg selenium/mL. For metabolically stable adults receiving TPN, the suggested additive dosage level is 20 to 40 mcg selenium/day. For pediatric patients, the suggested additive dosage level is 3 mcg/kg/day. Aseptic addition of Selenium Injection to the TPN solution under laminar ﬂow hood is recommended. Selenium is physically compatible with the electrolytes and other trace elements usually present in amino-acid/dextrose solution used for TPN. Frequent monitoring of plasma selenium levels is suggested as a guideline for subsequent administration. The normal whole blood range for selenium is approximately 10 to 37 mcg/100 mL. Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). HOW SUPPLIED: Selenium Injection 65.4 mcg (equivalent to elemental selenium 40 mcg/mL). NDC 0517-6510-25 10 mL Single Dose Vial Packaged in boxes of 25

AR159 Iss. Date 8/2012

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

Ernest R. Anderson Jr., MS, RPh

tells the other person that you are interested in him or her and want to learn the root cause of a conflict or issue. Such an approach becomes an opportunity for opening dialogue via effective listening, so that you can then correct the person’s behavior, if necessary, in a way that helps rather than harms. You also may need to ask clarifying questions to understand fully or you may want to reflect back your understanding of what you are hearing. If you determine that you need to correct someone, you may want to start the correction with a statement such as, “In listening to you I sense that you want to do well at this job. My responsibility is to help you be successful. So let’s talk about how you can improve.” If you can ask leading questions to steer someone in the right direction to the proper conclusions, then you’ve been successful. If that does not work, then there may be the direct method of just laying it out. You are holding people accountable because you are concerned about their success in their jobs, so conveying that goal while still taking a sterner approach can be a path to success. There also may be times when, as a leader, you are at fault and the source of a conflict, which comes out in the conversation. In those times, you may need to humbly admit to your shortcomings. In many cases it is a combination of partial fault of both parties. This takes you listening for the truth in what the other is saying. By admitting your fault, you open up the opportunity for dialogue to fully reach a deep understanding. Find those areas that you both have in common before moving on to the areas where matters need to be resolved. As a manager, it is important to keep your emotions in check, not become defensive and show a controlled response.

How We Speak Matters Another element in communication is the ability to speak to others in a clear, constructive and persuasive manner. Remember that communication is more than words, however. The other party quickly perceives our attitudes. If we can show patience and gentleness to others, their receptivity to our correction will be increased. Our tone of speech also is important. As a leader, if we come alongside to help someone and correct him or her, it is far better than if we come from above. Choosing the right time and place is important. Make sure you have enough time for

Operations & Management 15

Pharmacy Practice News • October 2012

Leadership in Action

When To Get Others Involved Sande recommends a stepwise approach to conflict resolution: Step 1: Overlook minor offenses. There are some issues that are just not worth fighting over. Step 2: Speak to someone in private when there is a conflict. By going to this person you are seeking to resolve the issue and restore the relationship. The discussion above has been largely centered on this step. Step 3: Have someone else go with you if you have been unsuccessful in confronting an individual when trying to resolve a matter. As a manager, you might have to resort to asking Human Resources to become involved in a situation. If it is a peer relationship then this is a bit of a different circumstance.

When you lead with a question, it tells the other person that you are interested in them and want to learn the root cause of a conflict or issue. to both parties. Hopefully by bringing greater understanding to a situation, the parties can resolve differences. If there still is no resolution, the mediator may need to take the role as an arbitrator and determine the outcome of a dispute. It is best if the mediator is agreed on by both

IMIPENEM.

The purp pose of bringing someone aalong when there has been n no resolution is to act as the intermediary. This individual listens to both sides of an issue and helps to provide clarity and understanding

MEROPENEM.

the conversation and do o so in person and in private. Corrective conversations are not done well through email or letter un nless it is the invitation to do so in p person. The following are a few additional tips for handling these types of confrontational conversation ns: Use a story or analogy y to get a point across. You want to appeal to the values and heart off the other person to capture his or her h attention. You also need to com mmunicate clearly. Planning your words ords care carefully can help get the conversation started in the right direction. If you are partially at fault for an issue that has arisen, state so at the beginning and further state that your desire is to resolve any conflict so you can move forward. Use “I” statements rather than “you” statements. For example, “I feel that you are not pulling your weight” is received a bit differently from “you are not pulling your weight.” The former opens conversation, the latter makes the other person defensive. Be objective when possible. For example, you may state, “You have been late for work five times in the past three weeks,” which is very different from “you are always late for work.” Ask for feedback. This is a great check to see if your intent really is being understood. Getting agreement on understanding and developing an action plan going forward provides great clarity and avoids future conflicts regarding a given issue. You also may need to suggest solutions to help the other person solve the issue that has caused a conflict, whether that conflict is with yourself or with the other person. Sande quotes a mediator, Ron Kraybill: “Effective confrontation is like a graceful dance from supportiveness to assertiveness and back again.” I find a lot of truth in this statement from my own experiences.

individuals. As a leader, you may sometimes take on either of these two roles in a dispute, whether in your department or perhaps outside of your department.

The Bottom Line In all cases, resolving conflict aims at restoration and personal growth and improvement of those involved. Conflict is a part of life and is manifested as long as there are human beings interacting. Resolving conflict restores communication and peace. Unresolved conflict results in strife and resentment.

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16 Clinical

Pharmacy Practice News • October 2012

Practice Pearl Revamped reporting and data mining help improve dispensing accuracy

Changes in Workﬂow Help Address Near-Miss Errors Laura Haynes, PharmD, BCPS Clinical Pharmacy Specialist, Medication Safety Department of Pharmacy Hospital of the University of Pennsylvania Philadelphia, Pennsylvania

A Sharpened Focus On Near-Miss Events Prior to initiation of the current system in early 2011, there was no focused resource to review reported nearmiss events. Staff discussed anecdotal reports of events within the department and implemented a reactive approach, making changes to the standard of practice by trial and error. Discussion of reported near-miss events occurred at daily huddles as seen fit by the management team. The pharmacy management team realized that this process was not useful based on a lack of interest and devoted time from staff, as well as a lack of standardized reporting to make event tracking and trends

Figure 1. Example of near-miss documentation. available for review. To revamp our process, we formed an internal near-miss committee in April 2011 within the Pharmacy Department. Pharmacists, interns, technicians, and members of the management team were included in this committee to discuss all facets of the Pharmacy Department’s dispensing model. The committee implemented a tracking system for, and collected data on, near-miss events. An example of the data form is included as Figure 1. The medication involved and the type of near-miss event are important pieces of information to include on this simple paper documentation form. In order for data to be tracked effectively, only one type of near miss is chosen for each event. The “other” category is considered the catch-all category including, but not limited to, expired medications, medications missing from the robot manual pick, or lack of correct accessory labels (eg, Do Not Refrigerate or Protect from Light). All of the paper documents are input

into a master document and then reported to the committee and all pharmacy staff. Initially, data were reported at weekly intervals. This later was lengthened to monthly intervals. During these monthly meetings, committee members have thoughtful discussions about changes that could be implemented within the Pharmacy Department to address near-miss events. All suggestions and changes to the pharmacy policies are evaluated by the pharmacy management team and then put into operation. Figure 2 provides an example of a report presented to the staff at a monthly meeting. The report shows the cumulative types of near misses reported since initiation of the tracking form.

Focus on Potassium Chloride During one meeting at which a review of near-miss events was held, it was noted that a high number of events were being reported for IV potassium chloride and it was suggested that a double tech-check process should be

450

Cumulative Number Of Near Misses

edication event reporting is a completely voluntary process at many institutions and is used frequently to document the specifics of medication events. The current process for reporting medication events at the Hospital of the University of Pennsylvania, part of the University of Pennsylvania Health System, is through an internal electronic database. Once an event occurs, the health care provider who was involved in or aware of the event completes a report, and alerts are assigned to involved departments for review and follow-up. This event report requires documentation of multiple pieces of information—the medication and step in the medication management process involved, as well as specific details about the event. This system is very helpful for identifying trends in reporting and event categories as well. The Medication Safety Committee reviews these events and event trends as a standing item at monthly meetings. Based on the desire to optimize the medication dispensing model at the institution, the Pharmacy Department wanted to get a better handle on the kinds of “near misses” that were occurring and being caught in the pharmacy dispensing areas prior to delivery to the patient care units. Pharmacy wanted to track and provide simpler documentation for near-miss events that occurred in the pharmacy using the electronic system already in place for event reporting.

400 350 300

implemented for all IV potassium chloride bags dispensed from the pharmacy. Because it can cause serious patient harm if used improperly, IV potassium is considered to be a high-alert medication at most institutions, including the Hospital of the University of Pennsylvania, and is included in the Institute for Safe Medication Practices’ high-alert medication list. Additionally, IV potassium chloride is available in multiple premade strengths and concentrations to provide adequate options for potassium supplementation in a variety of patients, which can lead to confusion and possibly errors. The double techcheck process for IV potassium chloride was implemented housewide at the Hospital of the University of Pennsylvania during the day and evening shifts, and weekly auditing of all orders with regard to compliance now is documented and reviewed. The hospital’s tracking and data evaluation since April 2011 showed more than 1,100 near-miss events reported; potassium chloride ranked in the top 10 most common medications associated with near-miss events. Since implementation of the double tech-check IV potassium chloride process in November 2011, fewer events have been reported (Figure 3). Auditing of the process over 2 one-week periods has provided insight into the compliance rate (Figure 4) and units associated with events. Responsibility for the changes to the dispensing process falls primarily to staff champions on the committee. Additionally, the first-line staff’s buyin has had a positive effect on attitude and demeanor related to error/event reporting. The limitations of this type of reporting are that, not unlike the institution’s electronic system, it is a voluntary system. Staff levels during different shifts could result in compliance differences as well as differences in the degree of reporting. The activities of the dispensing areas differ and could lead to variations in reporting. Space challenges within the dispensing areas and other work areas also could limit the amount and frequency of reports.

250

Conclusion

200 150 100 50 0

Wrong Diluent

Wrong Dose

Wrong Drug

Wrong Formulation

Wrong Patient

Other

Figure 2. Types of near misses (data tabulated from April 2011 to May 2012).

Near-miss reporting is helpful for investigating medication events before they reach patients, and an interdisciplinary committee is best equipped to achieve buy-in to facilitate change. The change to the potassium chloride dispensing process did not completely eliminate potassium events, but it did help to improve the reporting process and has generated a tool within the

Clinical 17

Pharmacy Practice News • October 2012

Genetics

Making Pharmacogenomics a Practical Reality O

nce regarded as futuristic, pharmacogenomics testing has become an everyday reality at Vanderbilt University Medical Center, in Nashville, Tenn., where the screening is used routinely to detect genetic variants that can adversely affect drug metabolism and compromise patient safety.

Muscle toxicity caused by statins, excessive clotting in patients receiving warfarin and toxic reactions to chemotherapy are among the adverse drug events that are being avoided in certain patients as a result of the pharmacogenomics initiative, according to Leslie R. Mackowiak, RPh, MS, the university’s

‘This science is evolving—not just ordering a test, but interpreting the test result with action items to ensure drug efficacy and safety.’

‘If we tell a prescriber we have this problem with a patient’s genetic variants, we also want to [suggest] a therapeutic alternative. … That’s really where a lot of our work has been done.’

—Grace M. Kuo, PharmD

—Leslie R. Mackowiak, RPh, MS

Simvastatin was added to the PREDICT testing protocol because patients with certain polymorphisms have markedly increased systemic exposure to the statin.

director of clinical informatics. The key to the success of the program, she noted, is being able to add the results of the tests and the recommended therapeutic interventions into clinical decision support software that is used throughout the hospital and available to clinicians at the patient’s bedside. “We recognize the vast information barrage that we have, and so we work hard to put good information in front of our clinicians,” Ms. Mackowiak said during a recent webinar sponsored by Wolters Kluwer Health, a clinical surveillance software provider. “All of the

new information on proteomics and genetics is great, but our goal was to make sure that it didn’t exist in a silo— rather, it had to be an integral part of the decisions our clinicians make when they are choosing a patient’s drug therapy.”

Choosing The Right Genetic Test for the Right Patient Drawing on her experience with Vanderbilt’s Pharmacogenomic Resource for Enhanced Decisions in Care and Treatment (PREDICT) initiative, Ms. Mackowiak explained what is involved in

•

see PGx, page 18

Compliance, %

80 4 Implementation of process change

70 60 50 40 30 20 10

Ma y2 01 2

Ap r2 01 2

Ma r2 01 2

Fe b2 01 2

Ja n2 01 2

De c2 01 1

No v2 01 1

Oc t2 01 1

Se p2 01 1

Au g2 01 1

Ju l2 01 1

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Ma y2 01 1

0 Ap r2 01 1

Number of Reported Events

Practice Pearl

Figure 3. IV potassium chloride events reported by month.

Pharmacy Department to identify areas of improvement. Further review of these data, as well as comparison with the overall hospital reporting system, is in the works.

The review of near-miss monthly reports and trend data has been extremely rewarding because it gives first-line staff an opportunity to express opinions and ideas for change. Educa-

Dispensing Area #1

Dispensing Area #2

Figure 4. Compliance rates for new IV potassium chloride dispensing process.

tion of all staff about change as well as auditing for adherence to new and old policies is crucial to the survival of new

initiatives. The culture of safety with reporting and discussion of events has greatly improved the whole department’s attitude regarding events, types of errors, and a no-blame, just culture. Overall, the near-miss reporting system within the Pharmacy Department at the Hospital of the University of Pennsylvania has engaged front-line staff and empowered all levels of the pharmacy team to optimize and continuously improve the medication dispensing process. I would like to personally thank Richard Demers and Melissa Hibbs, as well as the Near-Miss Committee and Department of Pharmacy at the Hospital of the University of Pennsylvania. Without their desire and input to make a difference, as well as their diligence in reporting, this initiative would not have been possible. Presented as a management case study at the 2012 ASHP Summer Meeting.

18 Clinical

Pharmacy Practice News • October 2012

Genetics

PGx continued from page 17

putting pharmacogenomics into practice. The first step is to have systems in place for identifying patients who are likely to receive medications during hospitalization, and then to perform preemptive genetic testing accordingly. “There’s not time in post-catheterization when you need your anticoagulant drug to really figure it out,” she said. When a clear picture emerges on the likely tests needed, the PREDICT process begins to unfold in multiple steps that include patient involvement; processing a patient blood sample in the laboratory, with DNA extracted and an assay performed; conversion of the raw data to a “fact” about drug-genome interaction that can be used in computerized clinical decision support; and the health care provider’s use of the information to optimize patient management. Drug-genome interactions are incorporated into the patient’s electronic health record. “This is part of how we do business now,” Ms. Mackowiak said. The genetic tests are integrated with the hospital’s inpatient computerized physician order entry (CPOE) system. In the case of clopidogrel—one of the first PREDICT drug protocols—the physician is prompted if the patient

has been tested for cytochrome enzyme CYP2C19 variants and has a *2/*2 genotype that predisposes the patient to be a poor metabolizer of the drug. If the defect is detected, prasugrel (Effient, Eli Lilly) is recommended as an alternative agent, but other options are presented. Clinical decision support also is available in the outpatient CPOE system, although without all the functionality of the inpatient system. Ms. Mackowiak noted that expert panels and the hospital’s Pharmacy and Therapeutics Committee helped determine the therapeutic recommendations that were built into the genetic testing components of the CDS system. “If we tell a prescriber we have this problem with a patient’s genetic variants, we also want to [suggest] a therapeutic alternative. … That’s really where a lot of our work has been done,” she said.

Avoiding Problems With Simvastatin The PREDICT initiative has been steadily evolving and now includes pharmacogenomic applications for several additional drugs. Simvastatin, for example, was added to the PREDICT testing protocol because patients with the single nucleotide polymorphism (SNP) rs4149056 affecting the SLC01B1 gene have markedly increased systemic

Accessing Pharmacogenomics Information via the Web

harmacists seeking more information on pharmacogenomics can make an effective start by accessing a USCD Skaggs School of Pharmacy and Pharmaceutical Sciences Web site that links to a wide range of educational materials (http:// pharmacogenomics.ucsd.edu/home.aspx). One of the main links is to the Pharmacogenomics Education Program: Bridging the Gap between Science e and Practice (PharmGenEd), an evidence-based educattion program designed for pharmacists and physicians, pharmacy and medical students, and other health care professionals. Developed with support from the Centers for Disease Control and Prevention, the program disseminates content in a variety of formats, including Web-based or live continuing education modules, evidence-based pubcasts and videocasts, and review articles in print. Users also can subscribe to regular updates via the PharmGenEd news feed.

exposure to the statin and thus are more likely to experience muscle toxicity than patients who do not have the genetic defect (N ( Engl J Med d 2008;359:789799). This problem is especially acute in patients who are prescribed high-dose regimens—typically at 80 mg per day. Genetic testing also is done in patients who are candidates for warfarin and azathioprine, and protocols are in the works for tacrolimus, tamoxifen and abacavir. “It still takes a lot of work to do every single drug,” Ms. Mackowiak said. In the case of simvastatin, there was “lots of conversation about just the warnings and how to state the warnings. … [They were] wordsmithed considerably to make sure we were telling the clinicians the right thing” (Figure).

The Future Of Pharmacogenomics In many hospitals besides Vanderbilt, progress in implementing pharmacogenomics continues to be slow, in part because most hospitals aren’t equipped to perform the genetic testing and thus have to outsource, which can be an expensive proposition and can sometimes delay care, according to Grace M. Kuo, PharmD, an associate professor of clinical pharmacy at the University of California, San Diego (USCD) Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla. Without ready access to testing, it’s not surprising that there remains “a huge gap between [pharmacogenomics] evidence and practice,” said Dr. Kuo, who also is the director of the Pharmacogenomics Education Program: Bridging the Gap between Science and Practice (PharmGenEd). (See box.) Other barriers involve general attitudes toward the science of genetic testing, Dr. Kuo noted. “Some pharmacists and physicians are waiting until ‘prime time’ to gain pharmacogenomics knowledge,” she said. As for patients, “many laypeople think genomics is cloning,” so that has led to some resistance. However, “when they learn that pharmacogenomics can help prevent toxicity and predict optimal drug response, most have no concerns.” A lack of consistent and clear guidance on pharmacogenomic testing also tends

to inhibit widespread uptake, according to Dr. Kuo. She pointed out, for example, that in 2010, the FDA ordered a black box label for clopidogrel regarding the role of CYP2C19 gene variants in the drug’s metabolism and efficacy, but did not offer methods indicating how to incorporate the data into clinical decision-making practices. Payment also can be a hindrance. If the data from pharmacogenomics testing become part of a patient-specific drug therapy intervention, according to online background material on PREDICT, only about $30 can be collected for each case. “Unfortunately that’s far less than the cost of the test,” Ms. Mackowiak said. She added that “we are currently working on reimbursement. We started this as a pilot and Vanderbilt has been doing the testing for free to the patients.” Dr. Kuo described several key factors that will affect the adoption of pharmacogenomic testing in hospitals. She said that although education on the discipline is not lacking at the provider level, “we still need more clinical protocols based on evidence.” However, that may be a moving target, because “this science is evolving—not just ordering a test, but interpreting the test result with action items to ensure drug efficacy and safety.” Additionally, the technology component is crucial, Dr. Kuo stressed, with further efforts needed to interface pharmacogenomics information with electronic medical records. Why make the effort to iron out the wrinkles of pharmacogenomics? Put simply, “it can help guide [the clinician] to the optimal drug therapy,” Dr. Kuo said. “We want our patients to get the best drug therapy in the safest way possible—that’s always been the most compelling reason for pursuing this.” Ms. Mackowiak made a similar point. “At Vanderbilt, our vision with PREDICT has always been clear: With this technology, we are more confident than ever that we can give the right drug to the right patient.” —George Ochoa Ms. Mackowiak and Dr. Kuo reported no relevant ﬁnancial conﬂicts of interest.

New Product

Pfizer Injectables Adds Methotrexate Injection, USP

fizer Injectables, part of Pfizer Inc.’s Established Products Business Unit, announced the addition of methotrexate injection, USP to the company’s growing portfolio of generic oncology products. Methotrexate is indicated for certain types of neoplastic diseases, a severe recalcitrant disabling type of psoriasis that is not adequately responsive to other forms of therapy and certain types of active rheumatoid arthritis (RA) in adults and children. For a complete listing of indications and safety information including Boxed Warning, please see the full

prescribing information available at pfizerinjectables.com. This is the first time Pfizer has secured rights for methotrexate in the United States, according to the company. In March 2012, the FDA approved the abbreviated new drug application (ANDA) for methotrexate injection in the following presentations: 50 mg/2 mL (25 mg/mL)

single-dose vials, 100 mg/4 mL (25 mg/mL) single-dose vials, 200 mg/8 mL (25 mg/mL) single-dose vials, 250 mg/10 mL (25 mg/mL) single-dose vials, and 1 g/40 mL (25 mg/mL) single-dose vials. “U.S. drug shortages remain an ongoing issue and serious threat to public health. We have been placing our priority on making available quality products from reliable supply sources, because every day counts for patients who are waiting,” said James Hageman, vice president of Pfizer Injectables. “With the introduction of methotrexate injection, USP, we are helping to address drug shortages for patients and their caregivers.”

Operations & Management 19

Pharmacy Practice News • October 2012

Education

LEARNING continued from page 1

advanced experience for students and residents. That’s how we arrived at the layered learning practice model.” In essence, the LLPM mirrors some of the basic aspects of the medical model applied to physician training. For instance, students and residents may gather medical histories, conduct patient discharge consultations and medication counseling and advise patients about specific treatments, such as anticoagulation therapy, explained Dr. Daniels. He emphasized that students and residents are matched to clinical responsibilities based on their education and skill levels and professional maturity. All activities are supervised by experienced attending pharmacists, many of whom have completed at least one year of residency training and have years of practice behind them. “We’re not just throwing learners out there independently,” Dr. Daniels said. “There’s a thoughtful approach for having residents and students follow a “see one, do one, teach one” process. Early on, it’s similar—although not identical—to the medical model. For example, students learn about our hospital’s systems and the medications we use. Progressively, they become more proficient in our clinical practice model, and they must earn increasing levels of responsibility.” He noted that LLPM has been implemented sporadically in clinical rotations; the verdict on whether it becomes a fixture in the curriculum depends on several factors. “The challenge is to make sure we don’t harm patient care,” Dr. Daniels said. “Secondly, if we’re going to establish this as a standard, we must apply it consistently across the hospital so our learners get meaningful exposure regardless of what area they’re rotating to.” The LLPM contrasts appreciably with the typical pharmacy student’s experience, during which they shadow their instructors and observe at a distance. “We are giving students direct ownership of their work,” Dr. Daniels said. “They’re responsible for speaking up on rounds. At discharge they’re responsible for helping patients transition in a safe way out of the acute-care environment. They’re responsible for thinking three steps ahead: Are these medications going to be high-cost? Are there prior authorization concerns? How do we set up patients to be successful? I’m trying to think about how I can elevate practice so it meets the hospital’s needs while also providing an advanced experience for our learners—both students and residents.”

Focusing on the Patient Larry Buie, PharmD, BCPS, BCOP, a hematology/oncology clinical specialist and an attending pharmacist for the LLPM, praised the new program for its

emphasis on patient care. “Students and residents have much more exposure to patients from a counseling perspective under this model, and they’re much more involved in the discharge process,”

Dr. Buie said. “By moving from passive to active learning models, students and residents can apply their knowledge directly related to the patients they care for in the hospital.”

The greatest educational benefits for learners is the depth of knowledge they can attain from the active learning environment provided by the LLPM, added Jill Bates, PharmD, MS, BCOP, also a hematology/oncology clinical specialist and an attending pharmacist for the LLPM. “I’ve observed that learning under the LLP model produces a change in behavior,” she said, “whereas the traditional model facilitates an assumed change in thought that may or may not be coupled with a behavior change.”

•

see LEARNING, page 20

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20 Operations & Management

Pharmacy Practice News • October 2012

Education Pre-LLP launch Post-LLP launch

continued from page 19

Early on, however, many students were not enamored of the new approach to their education; they voiced their irritation in surveys submitted during and after their rotations, according to Lindsey Poppe, PharmD, MS, BCPS, pharmacy clinical manager of the oncology service line at UNC Hospitals. Confused expectations were at the root of the discontent, Dr. Poppe noted. “At first, we didn’t sit down with them and explain

Data collected by the hospital also links the LLPM to improved patient care. In one example, when LLP was not in effect, pharmacists conducted medication reconciliation and medication adjustments for 45% and 22% of bone marrow transplant patients, respectively. During the LLPM pilot rotations, those functions were completed 100% and 40% of the time, respectively. In addition, discharge counseling was virtually never conducted for hematology/oncology patients before the LLP launch; post-implementation, the rate jumped to 78%.

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the [curriculum] changes, so they were caught off guard,” she said. In response, the attending pharmacists revamped the orientation process so that students and residents knew what to expect during the rotation—and what was expected of them. “The key for student satisfaction was to explain the new model up front,” which primed them for a learning process that was more active than what they were accustomed to, Dr. Poppe added. Since the changes, she said, overall satisfaction with the LLPM rotation has been much higher than with the traditional rotation.

m in istratio n

In November 2010, a couple of years after Dr. Daniels initiated LLP, the Pharmacy Practice Model Initiative (PPMI) summit convened and established a new vision for pharmacy practice in hospitals. Dr. Daniels said he used some of the recommendations to further shape the LLPM at Eshelman. “In some ways, the summit confirmed a lot of our thoughts and beliefs,” Dr. Daniels said. “But in addition, the PPMI raised issues we had not thought about, such as augmented use of pharmacy technicians and technology. As a profession, we aren’t leveraging those to the fullest. There’s been a lot of learning from the PPMI reflected in our program.” He also took to heart a sentiment of the PPMI summit that pharmacy must conform to a changing health care environment or be changed by it. “We’re seeing a larger acknowledgment that pharmacy, as a profession, has to organize itself in a way that is meaningful to health care leadership, not just independent practice. I think the LLP model is one step toward that objective.” Not only does UNC’s initiative enhance direct patient care, it also gives students access to learning opportunities that test them and make the best use of their abilities, commented David Chen, RPh, MBA, director of Pharmacy Practice Sections and Section of Pharmacy Practice Managers for the American Society of Health-System Pharmacists. “It’s quite impressive what they’ve done.” Added Mr. Chen, “The [LLPM] will increase pharmacy students’ and residents’ exposure to new and expanded roles and maximize their clinical knowledge and patient care skills. It really hits multiple facets of what we’re trying to do to change pharmacy practice. It allows you to take care of more patients more directly every day. That’s something considered very important to the future of health-system pharmacy.” —Steve Frandzel

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21 Spotlight on Technology

Pharmacy Practice News • October 2012

Formulary Management

can’t do it all or all at one time. Know4Go ensures we take the opportunities with the maximum benefit. benefit ” The program has improved staff collaboration and reduced confusion between contrary evidence and opinions, Dr. Martin said. In addition, “when we put a decision on the table, if we say no, it’s not that the decision is permanently no, it’s just not right at this time, so that has made things more comfortable.”

Interest Piqued Several hospitals have approached Dr. Martin about using Know4Go. Know4Go She has started working on a new version of the program that could be adopted by other facilities. She also has been using Know4Go to evaluate whether the hospital should adopt other health technologies. John Poikonen, PharmD, director of clinical informatics at the University of Massachusetts Memorial Medical Cen-

ter in Worcester, called the technology “pretty cool and interesting” but said the process for evaluation would have to be made evident to stakeholders because “sometimes there is an overreliance on local opinion and culture over medical evidence.” Added Dr. Poikonen, “I’m excited to see this in the public domain or as an open-source product for people to use and adapt.” —Karen Blum

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Buenos Aires—A computerized decision-making tool that considers evidence-based evidence based medicine plus factors like social, legal and ethical concerns is helping one Canadian hospital make decisions about which perioperative drugs to stock in their formulary. The program, called Know4Go, was designed about four years ago by Janet Martin, PharmD, who has a master’s in health technologies assessment, at London Health Sciences Centre University Hospital, affiliated with the University of Western Ontario. Know4Go incorporates a mathematical formula calculating the impact not only of evidence-based medicine but also of factors she calls SLEEPERs—the social, legal, environmental, ethical, political, entrepreneurial, research and stickiness/reversibility issues that often are to blame when someone or something goes against evidencebased medicine when making formulary decisions. The analytical tool is designed as a graph, with budget impact (the cost of a new drug or device per patient in their setting) along the y axis and the benefit impact (the number of eligible patients divided by the number needed to treat to prevent a bad outcome) along the x axis. The results help make apparent whether formulary decisions should be a ‘go’ or a ‘no-go’ relative to the next best alternative. In a recent study, Dr. Martin and colleagues identified high-stakes perioperative drugs for review based on their likely clinical, economic and risk impact. They used Know4Go to calculate the benefit index based on local patient characteristics and number likely to be helped or harmed; estimate local budget impact; perform a SLEEPERs assessment; and make informed decisions. Dr. Martin and her colleagues have used the program to evaluate more than $6 million of drug therapies at their hospital, according to an abstract presented at the recent World Congress of Anaesthesiologists meeting. The program helped them reverse a trend from rising drug costs in the two years before Know4Go was implemented to a steep decline after implementation, with an estimated savings of $1.1 million both from preventing the uptake of some expensive drugs and from eliminating orders of medications that were no longer helpful. “Once something is in practice, it’s much harder to take it out instead of preventing it in the first place,” Dr. Martin told Pharmacy Practice News. “When making decisions, we have to make trade-offs and decide what we’re going to do and not do, recognizing we

22 Spotlight on Technology

Pharmacy Practice News • October 2012

Mobile Devices

martphones and tablets and other mobile computing information technologies (IT) have “the the potential” potential to enhance medication care in hospitals, according to San Diego-based health care technology consultant Mike Wisz, MBA.

In a July webinar sponsored by the unSUMMIT, an organization that creates educational events focused on bar barcode point-of-care (BPOC) technology, Mr. Wisz offered guidance for hospitals going through “the decision process of figuring out which mobile computer

‘Mobile devices, whether smartphones or tablets, are increasingly the prism through which patients, families and clinicians view and manage aspects of their health. That trend is going to accelerate, and it will affect the IT world within hospitals.’ —Mike Wisz, MBA

options to deploy for acute care in their unique settings and how to build a team to make that happen. happen ” “Mobile devices, whether smartphones or tablets,” he said, “are increasingly the prism through which patients, families and clinicians view and manage aspects of their health. That trend is going to accelerate, and it will affect the IT world within hospitals.” Through a convergence of technologies, such as those that enable remote patient monitoring, telehealth, online medical collaborations, cloud computing and coordinated patient care, the worldwide mobile health market is projected to grow to $23 billion by 2017, he said, citing statistics from PricewaterhouseCoopers (Table 1)). “At that point,” he said, “$23 billion wiill be a pretty healthy fraction of the overall health IT (HIT) market.” As early as 2013, according to estimates by Pricewaterhouse, the mobile HIT market will generrate worldwide sales of $4.5 billion. Already there is a great deal of “very good health and medical care software—some 13,000 apps—on the market for iOS and Android mobile devices,” according to Mr. Wisz. Noting that these apps “are more user-friendly than HIT/electronic health record apps,” he said that sets up a need for pharmacists and nurses to bring their own stateof-the-art mobile devices with clinical applications to their hospitals (Table 2). He noted that some pharmacists are starting to do this, “taking their personal iPads to work, using them to look up drug information, such as calculators, to look at images of pills

Table 1. Worldwide Estimated Sales for Mobile Health Market Year

Estimated Sales, $ billions

2013

4.5

2014

6.9

2015

10.2

2016

15.4

2017

23.0

Source: PricewaterhouseCoopers funded by the GSM Association

and sometimes to deal with pharmacy shortages.”

A Convergence Of Devices Urged Hospital pharmacists use mobile devices in other clinical situations, such as when they are “in the pharmacy to perform medication check-ins to facilitate BPOC and for medication repackaging routines,” said webinar moderator Charles J. Still, MBA. He stressed, however, that the pharmacists “should use the same types of devices that nurses use on the floor to avoid scenarios

•

see HEALTH IT, page 24

Tips for Choosing Mobile Devices for Health Systems

n his unSUMMIT webinar on trends for integrating mobile computing devices with health care apps to Barcode Point of Care (BPOC) systems, Mike Wisz, MBA, offered guidance on how best to evaluate and deploy the various mobile options now on the market. The choices he discussed included Workstations On Wheels (WOWs), in-room solutions (such as arm mounts and wall cabinets) and mobile computing devices including smartphones and tablets. (See related story, this page.) Based on his observations as a mobile health technology and medication management consultant with 20 years experience with a variety of hospitals and health systems, Mr. Wisz considers understanding workflow to be the first step in making decisions about which of these options are the best choice for a particular need. “Process and workflow are important, especially with bar coding. There are a lot of things going on, including how the process impacts nurses’ productivity.” WOWs are “the most popular option right now,” he noted, but “in-room options are getting better and they are becoming more popular, so there is a trend to using more in-room options, driven by new construction that often includes a computer in every room or even by every bed. Some leading vendors are recommending larger screen requirements, as large as 22 inches, to look at all the detailed information that is available through the software applications. Mobile deployments including smartphones and tablets as well as handheld computers, he said, “have always been dependent on the software that a hospital is using for its BPOC application. Most vendors support both handheld and mobile applications, as well as full screens. But, generally, BPOC applications from most

vendors work best on a full screen.” But the medication distribution process, he said, also can determine the choice of which type of system to deploy. “If a hospital is going to store and manage medications near the bedside, that sets up a nice opportunity to use WOWs as your computer device. It cuts down the hunting-and-gathering time because the medication is right there in the cart.” The choice between in-room and mobile WOWs and handheld devices, he said, has always been “a trade-off over the years,” between such things as screen size versus portability and considerations like battery life and size. The industry has been looking to tablets as a compromise solution because they are portable and they have larger screens than handhelds and smartphones. Tablets offer significant promise, but they haven’t yet worked as well as their promise would lead you to think.” Considerations in deploying WOWs, he said, include the availability and depth of wireless coverage, shorter battery life, space consideration because they tend to “get in the way” and their weight and mobility. However, he noted that WOWs are “increasingly getting better, lighter and easier to wheel. And a lot of hospitals are changing their medication distribution model, by storing medications closer to patients’ rooms allowing nurses to spend more time at the bedside.” To make the most informed choices, said Mr. Wisz, hospitals “will need to draw together an interdisciplinary team to focus on such details as where the medications are being prepped as well as stored, etc.” —L.P.

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24 Spotlight on Technology

Pharmacy Practice News • October 2012

Mobile Devices

HEALTH IT continued from page 22

where a bar code reads OK in the pharmacy but is unreadable by a nurse at the bedside using a less capable scanner. scanner” Mr. Wisz predicted that there would be opportunities “for pharmacy to do more work with mobile devices in the future, particularly for decentralized pharmacists throughout the hospital because the convenience of mobile would seem to be a natural fit for tasks oriented around reading but nott order

Table 2. How Hospitals Are Responding To the Mobile Device Trends Trend

Respondents, %

Support a BYOD policy

85a

Planning to expand or refresh their Wi-Fi networks this year

Supporting EMR apps on mobile devices

Using desktop virtualization solutions

BYOD, bring your own mobile device; EMR, electronic medical record a

Most support “only Internet” access as guest; less than 10% allow full access to the network for work tasks from own devices. Source: Aruba Networks, Inc., 2012 Healthcare Mobility Trends Survey

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review,” or inputting data. The scanning of medications as they are dispensed— an additional bar-coding safety check— “also could be done on mobile devices like iPad and Android tablets,” he said. Pharmacy specialists can use tablets to help document that an intervention helped to improve health and the value that a pharmacist contributes to enhanced health care. “I haven’t talked to a lot of folks who are actually doing that,” Mr. Wisz told Pharmacy Practice News. “But I think we will see more of that over the next few years.” Reviewing the results of the Aruba Networks, Inc., 2012 Healthcare Mobility Trends Survey during the webinar, Mr. Wisz noted that half of all hospitals are planning to expand or refresh their Wi-Fi networks this year; 66% are supporting electronic medical record applications on mobile devices and 58% are using desktop virtualization solutions, such as those from Citrix (a Santa Clara, Calif.-based provider of cloud, networking and virtualization technologies). In a related evolution, he said, smartphones are evolving into medical device platforms, “as an increasingly wide array of accessories can be added to the phone, taking advantage of capabilities such as the camera, which can be adapted to perform eye exams, for example.” A variety of sensor technologies are being developed around these platforms, for use both by health care professionals as well as consumers, Mr. Wisz noted. “Smartphones also are being used,” he said, “to view a wide variety of images, including image types used within radiology, pathology and cardiology.” In hospitals, he added, smartphones also are being adopted to transmit voice alarms and text messages, “using consumer-grade usability to improve communications, coordination and care.” In evaluating tablets like the iPad, Mr. Wisz focused on their “promise,” which he said, “will increasingly affect medical computing over the next few years. However, they are not ready for prime time in the acute care environment. Perhaps the most significant drawback of iPads for BPOC,” he noted, “is that the applications have not been redesigned from the ground up to work effectively” with these tablets. “Tablets are also limited with respect to data entry; they are difficult to disinfect; they are fragile and have a short battery life (10 hours); they can’t multitask and they have no bar-code reader.” He added, however, “that we are seeing a lot of enthusiasm in health care for tablets, and physicians—especially affiliated physicians—are driving IT departments to be able to support tablets. And I think you are going to see iPad and Android tablets more widely used in the future.” —Liz Parks

Spotlight on Technology 25

Medication Safety

TRIGGERS continued from page 1

quality and consistency of patient care, James Hoffman, PharmD, MS, the medication outcomes and safety officer at the hospital, noted during a workshop on the topic held at the American Society of Health-System Pharmacists’ 2012 Summer Meeting. The effort at St. Jude relies heavily on the hospital’s information sciences resources, which includes an electronic, voluntary event reporting system that staffers use to manually input patient safety events. The system was designed to “offer all kinds of ways to mine data and to leverage the information that’s collected to improve patient safety and quality of care,” Dr. Hoffman said. The system allows for much more rapid event entry than the hospital’s previous system, he noted. “In developing the software, we set a goal that entering a report should only take two minutes,” Dr. Hoffman said. “Because St. Jude developed the software, it has been a longterm process, but this effort has paid off. We structured the software so data can be easily retrieved and analyzed and ultimately used to improve patient care.” That streamlining was an important part of the reason why event reporting has increased since the program was implemented in 2009, Dr. Hoffman noted. But there was another, equally important contributor: creating a culture that emphasizes the positive impact that event reporting can have on patient safety. The multi-pronged approach to event reporting in use at St. Jude also is crucial, Dr. Hoffman stressed. “The key is to make use of multiple event detection methods, since each identifies different events,” he said. Those occurrences, he noted, include adverse drug events, where a patient is harmed by a medication; near-miss events, where errors occur but do not reach the patient; and no-harm events (an error that reaches a patient without causing any injury). Electronic trigger tools can be a very effective component of a combined event detection strategy and are increasingly part of the mix at St. Jude. The triggers pull data from the hospital’s electronic health record (EHR), based on a library of triggers that are known to cause events, such as the administration of naloxone and other antidotes. Trigger tools can capture an abundance of data once the system is set up, Dr. Hoffman noted. In fact, “triggers through an EHR are an exciting tool for catching errors that can be used further as hospitals continue to implement EHRs,” he said. “But voluntary event reporting through a well-designed electronic system, such as the one we

have in place, also should be part of your overall strategy.” Although voluntary reporting has drawbacks—compliance rates are usually low, ranging from only 0.04% to 6% (Am J Health Syst Pharm 2002;59:4362002;59:436 446)—“it still yields qualitatively rich information, is low-cost and enables health care providers to be directly involved in the reporting process,” Dr. Hoffman said.

An Advocate of Trigger Tools Trigger tools are at the core of an ini-

tiative at Children’s National Medical Center in Washington, D.C. During the ASHP session, David Stockwell, MD, MBA, medical director of the center’s pediatric intensive care unit (PICU), shared results from an analysis of his institution’s hypoglycemia trigger data to illustrate the value of this detection method. For hypoglycemia trigger criteria, they turned to previously published laboratory cut-off values and events ( (Pediatrics 2011;127:e1035-e1041). Dr. Stockwell said hypoglycemia triggers have captured 1,254 events,

including 198 confirmed ADEs, since being implemented in 2007. Strikingly, none had been reported voluntarily, he noted. An analysis of the data showing the majority of ADEs occurred in the neonatal intensive care unit (NICU) in insulin recipients allowed his team to focus interventions on that environment, he explained. “We knew about the potential for hypoglycemia with insulin use in the NICU, but what we found with the information from the electronic

•

see TRIGGERS, page 26

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26 Spotlight on Technology

Pharmacy Practice News • October 2012

Medication Safety

TRIGGERS continued from page 25

triggers was alarming,” Dr. Stockwell told Pharmacy Practice News. “So, based on our findings findings, we reassessed our treatment protocols, presented what we found in our analysis as well as the revised protocols to NICU physicians and nurses, and have since noticed fewer preventable events and improved adherence to protocol. A subsequent review of trigger trends led us to change the protocol again

and to further home in on dextrose and amphotericin infusions, which we found were associated with the most frequent ADEs.”

Global Triggers In contrast to location- or eventspecific triggers such as hypoglycemia triggers, which facilitate pinpointed interventions, a broader picture of the incidence of ADEs at the institutional level can be obtained by creating global triggers that incorporate multiple modules of triggers, David Clas-

sen, MD, the chief medical information officer at Pascal Metrics in Washington, D.C., and an expert on patient safety and IT, told workshop attendees. Global modules can include triggers for critical care and emergency depart department admissions, medication-related ADEs, emergent surgical procedures, and labor and delivery complications, said Dr. Classen. However, he noted that although triggers are the most robust method for identifying ADEs, the abundance of harvested data needs to be reviewed

and corroborated with information from patient charts to confirm that flagged events in fact represent ADEs. “If you query the use of Narcan, for example, it’s not immediately clear whether the drug has been adminis administered for opioid overdose or to prevent constipation,” echoed Dr. Stockwell. In sifting through the collected data, Dr. Classen suggested limiting trigger reviews to 20-minute blocks every two weeks and selecting 10 records at random. The triggers and related medical records should be analyzed by two independent mid-level reviewers and confirmed by a physician. “Follow the recommended sequence for review and don’t read the entire medical record,” Dr. Classen advised. “And remember that a trigger does not necessarily represent an adverse event. Most importantly, be consistent.”

Take It Slow For institutions thinking of implementing a trigger system, Dr. Stockwell’s own advice was not to be overly ambitious at the initial stages. “The challenge can become burdensome and you may end up not setting the system up at all,” he cautioned. “Instead, use high-impact triggers that are more likely to capture true ADEs, demonstrate the value of the system, and then expand the number of triggers from there.” For clinics and centers that find the cost of a sophisticated electronic trigger system prohibitive, ADEs can still be tracked using information on hand, commented Craig Pedersen, RPh, PhD, a consultant on medication use systems and safety in Monroe, Wash., and co-author of several ASHP surveys of hospital-based pharmacy practice. “Even smaller facilities have the ability to access data from automated dispensing cabinets and pharmacy information systems to look for use of specific trigger medications such as phytonidione, diphenhydramine, naloxone, flumazenil, antiemetics and antidiarrheals,” said Dr. Pedersen, who was not involved in the workshop. “Furthermore, hospital pharmacy departments can and should work with their laboratory departments to get predefined out-of-range laboratory values communicated to the pharmacy. All these data are valuable and can be used by pharmacists to prospectively monitor patient response to drug therapy and to detect adverse drug events.” —David Wild Drs. Hoffman, Stockwell and Pedersen reported no relevant conﬂicts of interest; Pascal Metrics, where Dr. Classen is chief medical information ofﬁcer, provides services in the area of adverse event detection.

Spotlight on Technology 27

Medication Safety

ELECTROLYTES continued from page 1

little over a year ago, the new system was implemented throughout the hospital, in contrast to the previous system, pital system which at one point included three different ERT protocols, depending on the level of care under which patients were placed: critical care, step-down electrolyte replacement or medical/ surgical. Each level of care addressed different electrolyte deficiencies and gave different replacement options—a setup that was not working for patients or caregivers, Dr. Fakunle-Adeyemi noted. The issue came to a head in 2010 when an audit under the old system found that, of 14 patients in need of ERT, none received the correct potassium replacement and no follow-up labs were ordered. “The existing protocols were complex and we saw an opportunity for improvement,” said Lee Knill, RN, one of the primary authors of the new protocol. “Of all the possible ERT choices listed on the medication administration record, nursing staff had no way of knowing which choice to select for a particular lab reading,” Ms. Knill explained. They also were required to get authorization from the attending physician each time electrolyte levels fell within a critical level range. “They would have to remember to order follow-up labs,” she added, pointing to the system’s lack of automatic prompts for further action, a shortcoming exacerbated during shift change. In March 2011, the new, single protocol was piloted to enhance the hospital’s electronic medical administration record (eMAR) system, which it maintains for each patient. The initiative was developed to address the lack of nurses’ autonomy in selecting the appropriate ERT, and also to address the overarching problem of physicians, pharmacists and nurses not being able to communicate effectively. The new protocol streamlines the process for administering ERT regardless of a patient’s level of care. It allows physicians to create “implement” orders for the entire ERT protocol or for each individual electrolyte, and it specifically lists the critical value replacement parameters (Figure). In a departure from the old system, ERT requirements are now entered on the eMAR as “scheduled” medications instead of “PRN” or “as needed,” giving nursing staff and pharmacists clear instructions on the levels and timing of doses, the criteria for administering and repeating them and when to order follow-up labs. One month after implementation, a follow-up audit of 18 patients showed that there still was some room for improvement: of 30 scenarios requir-

‘Do [this] with eyes wide open, and realize that you may have to draw on more staff resources to pull it off.” —Todd W. Canada, PharmD

that, “although very encouraging, perhaps was to be expected, because this new system is so much easier for both the physician to order and the bedside nurse to use,” Dr. Fakunle-Adeyemi said. Physicians still must be alerted if a patient shows critical-value electrolyte levels, she added, but nurses now have the autonomy to act within the parameters set out by the new system. However, it is not mandatory for a physician to order the protocol for each and every patient. “That’s the only way a protocol will work,” Dr. Fakunle-Adeyemi said. “You have to stay on it and hammer it home through education, education, and even more education.”

Kudos for the New Initiative ERT protocols standardize the way electrolytes are ordered and administered—something that most physicians do randomly, according to Todd Canada, PharmD, BCNSP, a nutrition specialist at the University of Texas MD Anderson Cancer Center, in Houston. Such a lack of standardization can negatively affect patient safety, Dr. Canada said. He cited, as an example, studies showing that heart surgery patients on diuretics who did not receive appropriate potassium-containing ERT had an elevated risk for cardiac arrhythmias ((JAMA 1999;281:2203-2210; J Am Coll Cardioll 2004;44:938-939).

The main electrolytes in body fluid: Na+, sodium ion; Cl–, chloride ion; Mg2+, magnesium ion; Ca2+, calcium ion; K+, potassium ion

“Most clinicians have received little other than ‘on-the-job’ training during their residencies about how important it is to replace an electrolyte abnormality, [or] the urgency and the appropriate way to order it for patient safety,” he said. “So programs such as the one in place at Sentara Obici are sorely needed.” Dr. Canada stressed, however, that hospitals should be ready for a potential increase in workload if they succeed in revamping their ERT protocols and boost compliance with ERT. “Remember, 5% to 15% of hospitalized patients have at least one electrolyte abnormality upon admission, and this number is even higher in critically ill patients,” he said. “So it is quite possible that by improving your system for identifying viable candidates for ERT, you soon will be replacing electrolytes in patients who previously were missed by your clinical staff. That means increased workload for your pharmacists and nurses.” Dr. Canada added that boosting compliance with ERT also may exacerbate electrolyte shortages, “which will require prioritizing the most appropriate patients to receive the available supply.” Are those challenges reason to shy away from ERT process improvement? “Absolutely not,” Dr. Canada said. “Rather, do it with eyes wide open, and realize that you may have to draw on more staff resources to pull it off.”

Figure. Electronic protocol tool for enhancing compliance with electrolyte therapy.

ing potassium replacement, 22 followed protocol (73.3%) but only five (17%) had labs drawn correctly. As a result, the development team added several enhancements, such as changing follow-up labs to daily instead of four hours after the last dose (except for lab draws associated with critical values). The most recent audit (AprilMay 2012) showed that those efforts have paid off: of 51 opportunities for ERT, 48 followed protocol (94%). Of 48 opportunities for lab follow-ups, 47 (98%) were drawn correctly. Overall compliance with the protocol continues to exceed 90%—a result

‘The only way a protocol will work [is]...to stay on it and hammer it home through education, education and even more education.’ —Olubukola Fakunle-Adeyemi, PharmD

—Maureen Sullivan

28 Spotlight on Technology

Pharmacy Practice News • October 2012

Sterile Compounding

ospitals can provide sterile-compounding services and meet United States Pharmacopeia (USP) Chapter <797> standards in several ways: outsource the services; build in-house clean rooms (with or without hoods or benches); or take a hybrid approach. For Yuma Regional Medical Center, in Yuma, Ariz., mixing and matching different technologies made the most sense when it built a state-of-the art, nearly $1 million clean-room complex that opened in late-2010, according to director of pharmacy Tom Van Hassel, RPh, MPA. There were many lessons learned along the way, Mr. Van Hassel said in an interview with Pharmacy Practice News. But one is paramount for hospitals that are committed to going the clean-room route, he stressed: “Do it to your best ability, or else don’t do it all, and instead outsource with a reputable, vetted sterile-compounding vendor.” Why the need for such fierce commitment to the clean-room process? “Being in the middle is the worst place,” Mr. Van Hassel said. “Limping along is where the highest risk is for not having expertise and allowing errors to get through. Once you commit, set policies and train staff. That’s the most important part. Otherwise, a clean room isn’t a clean room.”

The Setup at Yuma Yuma, a 369-bed facility, took a multidisciplinary approach to building its clean room, with Arcola engineering the complex and Grifols designing the system to optimize space based on workflow. The process took about a year until launch, Mr. Van Hassel noted. The clean room is equipped with Baker hoods and cabinets, and uses an HVAC system armed with 21 HEPA filters within the sealed, controlled space. The setup also includes an automatic hand-washing and sanitizer station, built-in eyewash for safety, pass-through windows, speakers in the walls, hands-free sinks and stainless steel surfaces for easy cleaning. The pharmacy staff disinfects the room every day. “These are superior physical working conditions, which makes it easier for us to comply with USP <797> standards,” Mr. Van Hassel said. The 24 x 40-foot space has discrete work zones that support workflow and ease access to supplies for the compounding pharmacy technicians, he added. Specifically, the ISO7 clean room has three ISO5 isolator hoods; a chemotherapy biosafety room has two biological safety cabinets; and an anteroom for quick preparations has one hood. There also is a storage area and space to dress, gown, glove and wash. And the supervising pharmacists have

access to electronic medical records, which yields several benefits, including better order prioritization. prioritization A wide range of admixtures come out of these clean rooms—from simple IV piggybacks of antibiotics or electrolytes and flush bags of saline and heparin in different sizes, to cardiac agents such as phenylephrine and norepinephrine, and chemotherapy solutions.

Benefits Detailed Yuma’s expansion of its sterile compounding services has yielded numerous benefits, Mr. Van Hassel noted. The sterile compounding center—a former set of conference rooms—has enabled pharmacy to deliver medications four times a day instead of once a day, as done previously, when Yuma mostly outsourced. And it has been saving at a five-figure monthly clip. Over the past 10 months, he said, direct savings have been $6 per preparation compared with outsourced purchases. This adds up quickly to average savings of $13,000 per month, because the pharmacy at Yuma batchprepares between 2,000 and 2,500 IV bags monthly. The facility also “reduces medication waste significantly because we’ve standardized all concentrations to maximize reuse,” he said. Despite these benefits, Mr. Van Hassel estimated that only 10% of hospitals in the United States perform sterile compounding within their own clean-room

Tom Van Hassel, RPh, MPA, director of pharmacy at Yuma Regional Medical Center, in Yuma, Ariz., compounding a sterile preparation in the facility’s new $1 million clean room.

The “Bootie Butler” allows pharmacists working in the clean room to put on shoe covers without stooping or bending. It about five seconds for both shoes. (Bootiebutler.com)

facilities. Why the slow uptake? One likely reason is the high cost of the build-out, he noted. Juan Miguel Cana, a general manager in the hospital division at Los Angeles-based Grifols USA, a company with clean-room design and construction experience, said that clean rooms cost between $400 and $1,200 per square foot, depending on the scope of work. Those costs can add up quickly,

Mr. Van Hassel acknowledged. Thus, adequate hospital size should be the first consideration in deciding on clean rooms as an option. The volume threshold, he noted, should be “about 100 or more beds, unless the patient mix already warrants a lot of critical drips and compounding.” For smaller hospitals or those facing

•

see CLEAN ROOM, page 30

Commissioning and Certifying Clean Rooms

ospitals should commission their clean rooms before going live, even though USP Chapter <797> doesn’t mandate it, urged Ryan A. Forrey, PharmD, MS, the associate director of pharmacy and infusion services at Ohio State University James Cancer Hospital and Solove Research Institute, in Columbus. “Kick the tires, or you don’t know it will be up to correct clean-room standards. For example, duct work could leak and you might not be able to maintain ISO pressure differentials,” said Dr. Forrey, who has some experience in this area. He oversees five sterile preparation areas for chemotherapy compounding in the main hospital, and he has designed four such areas for the new, adjacent James Cancer Hospital on the campus. “Your clean room may meet standards on day 1 but will start to fail if it hasn’t been designed and constructed properly. Head off any issues you may have later as filters get loaded. Most pharmacies don’t think or know about commissioning and don’t do it.” Dr. Forrey said he requires every new space to be commissioned, adding that it should cost about $4 per square foot to go through testing rigors. Smaller spaces can expect to pay a higher rate because of setup and travel costs. USP Chapter <797> does mandate that clean rooms be certified every six months, and that documentation be on hand in case of an audit by the Joint Commission or a state board of pharmacy. At about $1 per square foot, plus a fee for each hood and cabinet, OSU pays more than $10,000 annually to certify seven sterile-compounding spaces, according to Dr. Forrey. His tips for passing both: • Hire a consultant during the design phase to ensure that engineers have designed the space to meet USP Chapter <797> standards. Have the consultant follow up during construction to make sure that what is designed is actually being built. OSU uses Specialty Operations Solutions, Warwick, R.I. • Build commissioning costs into the project budget, and build leeway into the construction timeline to resolve any issues the consultant may identify. • Interview several certification companies. Make sure they know about pharmacy clean rooms, USP Chapter <797> requirements and the equipment in place. • Reach out to colleagues for referrals to reputable firms. One referred by Yuma Regional Medical Center is CSI Testing, Plymouth, Minn. • Be prepared for a time commitment: Certification could take several hours, depending on room size, so plan to come in early on test days. • Establish standard operating procedures on system maintenance. Make sure the facilities staff knows how to maintain systems in between the six-month tests. For instance, OSU changes its filters monthly in the air handlers on the roof and restricts access to this area. Also, one engineer is the go-to expert on USP Chapter <797> and clean-room activities. —A.H.

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30 Spotlight on Technology

Pharmacy Practice News • October 2012

Sterile Compounding

CLEAN ROOM

Resources

continued from page 28

budget pressures, a more economical solution might be the outsourcing option, Mr option Mr. Van Hassel noted noted. But even those costs can start to get burdensome if your volume begins to grow beyond a certain point, according to Ryan A. Forrey, PharmD, MS, an associate director of pharmacy and infusion services at The Ohio State University (OSU) James Cancer Hospital and Solove Research Institute, in Columbus. Mr. Van Hassel said that if the longterm costs of outsourcing are a concern and the expense of adding a clean room seems too high, adding glove boxes may be a middle-of-the road solution for hospitals. Glove boxes, he noted, are special hoods that are entirely selfcontained “and by definition meet the standards of an anteroom buffer area and clean room in one closed cabinet space, but at a far lower cost.” Glove boxes (also known as compounding aseptic isolators) cost $12,500 to $17,200 each; horizontal laminar flow hoods for chemotherapy cost $4,200 to $7,500; and biologic safety cabinets cost $4,500 to $13,500, according to industry sources.

Clean rooms Pharmacy Cleanroom Solutions, Inc.: (866) 777-4797 Triad Design & Equipment: (800) 966-1979 Grifols USA: (888) 474-3657 Misterium modular system, Phocus Rx remote validation system, Cleanroom Connect carousels

Hoods, Benches, Cabinets Germfree: (800) 888-5357 VersaFlow, LFGI RadioPharmacy Isolator A pass-through box prevents contaminants from entering Yuma Regional Medical Center’s clean room from the nonsterile outer area.

sales manager in the pharmacy sales division at Germfree, a supplier of hoods and cabinets based in Ormond Beach, Fla. “Pharmacists have to come up with creative ways to save money because the cost of compounding sterile products is very high.” USP <797> enforcement also

makes “equipment cost a factor to think about before getting into it,” he added. For many hospitals, a mix of sterilecompounding technologies makes the most sense, according to Mr. Cana. “Primary engineering controls (such as cabinets, isolators and workbenches) locat-

Balancing Cost and Safety Mr. Cana agreed that for many hospitals, cost is an important consideration. But he stressed that patient safety also should be part of the calculus for comparing sterile-compounding solutions. “Health care organizations need to give first priority to address medication errors with the most potential for patient harm,” Mr. Cana said. He noted that IV medication errors pose the greatest risk for harm, with up to 79% of harmful or fatal parenteral errors linked to the IV route of administration, according to MEDMARX data cited in a 2008 report (sidebar). A well-executed clean room, he suggested, can lower the risk from contaminated IV solutions and reduce hospital readmissions for infections caused by those tainted formulations. Given all of these factors, Mr. Cana said, “pharmacy directors are looking at clean rooms as strategic assets.” If building a clean room is ultimately the strategy that your hospital chooses, Mr. Cana offered a few tips to ensure a smooth rollout. “Review in great detail the processes you want to perform, make sure the environment facilitates best workflow practice, and look ahead to extra space for future growth,” he said. “Don’t design the room to [current activity levels] today because compounding activities [will grow] year to year.” Such growth may be anticipated, but health reform “is having an impact on who is getting into and out of sterile compounding,” said Terrance Stubbs, a