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

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The Pharmacist’s News Source

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in this issue OPERATIONS & MGMT

Bundled interventions prevent drug-related hospital readmissions.

CLINICAL

Improving diabetes outcomes through patient education.

Using ideal body weight for sedating obese patients a prescription for failure.

The risks and benefits of epilepsy treatment.

Volume 39 9 • Number 12 • December 2012

40th ANNIVERSARY YEAR 1972–2012

Sandy Packed a Punch, But So Did Local Pharmacy Disaster Response H

ospitals and hospital pharmacies across New York and New Jersey prepared for the worst as the massive tropical storm named Sandy moved up the Atlantic Coast in late October, gathering force and threatening to take a sharp turn into one of the world’s most populous metropolitan areas. When the storm finally struck on Monday night, Oct. 29, the devastation exceeded even the gloomiest projections. More than 100 people lost their lives, countless homes were flooded or destroyed by the tidal surge and millions of others were plunged into darkness, many for weeks. Four Manhattan medical centers—NYU Langone, Bellevue, New York Downtown and Manhattan VA—were forced to close and evacuate more than 1,000 acute-care patients after rising East River tidal waters flooded lower floors and basements, disrupting back-up generator service and destroying many millions of dollars’ worth of medical equipment, medications and supplies. For NYU Langone alone the cost of restoration was put at $750 million to $1 billion. In New York’s outer boroughs, Sandy wreaked havoc on shoreline homes and medical facilities.

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Hurricane Sandy affected a huge swath of the East Coast, but some of the hardesthit areas were along the Jersey shore (inset).

see SANDY, Y page 9

POLICY

The first oral biologic agent approved for rheumatoid arthritis.

TECHNOLOGY

New hazardous-drug compounding system launched.

EDUCATIONAL REVIEW

Management of Warfarin Therapy

Is Fibrate-Statin Ban a Bad Idea? Hollywood, Fla.—In 2011, the FDA issued new dosing limits on simvastatin that included a contraindication for concomitant use of the fibrate gemfibrozil due to concerns about an increased risk for rhabdomyolysis. But the reaction of some health systems to ban the use of all statin-fibrate combinations has come with its own set of dangers, according to new data presented at the annual meeting of the American College of Clinical Pharmacy.

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see FIBRATES, page 15

Post-Discharge Outreach Emerges As a Key to Reduced Readmissions Hollywood, Fla.—To mitigate the longanticipated Medicare penaltiees for excessive hospital readmission ns that took effect in October, hos-pitals nationwide have struggled to shave their readmission rates and avoid potentially severe financial harm. Because medication-related factors aree thought to play a major role in readmissions, pharmacists havee seen an opening to contribute to the cause cause. Three studies presented at the American

College of Clinical Pharmacy annual meeting assessed the impact of those contribution ns. The initiatives studied focused on n resolving drug-related patient carre issues that often arise during tthe transition of care between iinpatient and outpatient settings. In one pilot study, researchers developed a protocol in which inpattient pharmacists continued their contact w with patients after discharge from a general m medicine unit, allowing them the

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Policy 3

Pharmacy Practice News • December 2012

Late-Breaker

Compounding Still a Cloudy Regulatory Landscape B

y the end of November, the toll had reached shocking dimensions. More than 500 people in 19 states had fallen sick with fungal meningitis or other infections linked to injections of contaminated methylprednisolone acetate made and widely distributed by the New England Compounding Center (NECC). Thirty-six of them had died, and up to 14,000 others remained at risk. The resulting public health crisis, which began in late September with a Centers for Disease Control and Prevention report of a single meningitis case in Tennessee, has resulted in the dismissals of two Massachusetts pharmacy board officials and instigated parallel U.S. Senate and House investigations into how such an outbreak could have occurred after long-standing FDA warnings about unsanitary conditions in NECC’s Framingham, Mass., facility. Legislation giving the FDA greater authority to regulate compounding activities, in concert with state boards of pharmacy, seems likely. The crisis also has galvanized feder-

al, state and private health authorities into re-examining how the high risk of compounding large quantities of specialty pharmaceuticals that do not have FDA approval and shipping them out of state—and indeed all compounded medications not prescribed for individual patients with special needs—might be minimized in the future. Hospitals and hospital pharmacies

authority over drug manufacturing. There is general agreement that NECC, under the guise of being a compounder, was ignoring the FDA and engaging in the manufacture of large quantities of unapproved pharmaceutical products for distribution to a diverse, multistate customer base, an endeavor that clearly is within the FDA’s scope. Many say the agency could have stepped in early to

‘We’re astonished that given [the FDA’s] long history of stated authority [over compounding] they’re now reversing themselves and saying they lack that authority. We believe that is really an attempt to dodge responsibility for their failures that contributed to the meningitis outbreak.’ —Michael A. Carome, MD have a huge stake in how the crisis shapes future federal and state policies. Although larger institutions meet most of their compounding needs in-house with clean rooms and other facilities that meet United States Pharmacopeia (USP) Chapter <797> sterility stan-

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dards, many also rely on outside companies to fill gaps in their own production capacity or to meet critical patient needs when drug shortages develop. Additionally, many smaller hospitals lack the financial resources to satisfy USP <797>’s exacting requirements for the preparation of high-risk infusions, and so depend on outside compounders to an even greater degree.

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Kasey Thompson, PharmD, the director of patient safety at the American Society of Health-System Pharmacists, said: “At ASHP this is a top issue for us, and we’re working very hard with Congress, the FDA and other stakeholders to help make sure that the right things happen in law, regulation or by other means to ensure that patients are protected.” At the heart of the issue is a thorny question: How much of the state pharmacy boards’ authority to regulate pharmacy compounding practice should be assumed by the FDA? In the case of NECC, the answer should have been easy. The FDA has clear

close down its operations. Michael A. Carome, MD, the deputy director of Public Citizen’s Health Research Group, told Pharmacy Practice News that his group believes that traditional compounding, where a physician writes a prescription to meet a patient’s unmet medical need, “fills an important niche in health care.” He added, however, that over the past two decades “many so-called compounding pharmacies have gone beyond that traditional niche and engaged in large-scale production of standardized versions of drugs and sold and distributed them widely throughout

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see COMPOUNDING, page 25

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 12 • December 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

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

David Bronstein, Editorial Director davidb@mcmahonmed.com

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

Elizabeth Zhong, Associate Copy Chief

Lawrence Cohen, PharmD, FASHP, FCCP, Fort Worth, Texas Larry Ereshefsky, PharmD, San Antonio, TX COMPLEMENTARY AND ALTERNATIVE MEDICINE

Ali McBride, PharmD, MS, BCPS, St. Louis, MO

Cathy Rosenbaum, PharmD, Cincinnati, OH

Sara S. Kim, PharmD, BCOP, New York, NY

CRITICAL CARE

PEDIATRICS

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4 Operations & Management

Pharmacy Practice News • December 2012

Medication Safety

Tackle Root Causes To Improve Patient Safety Chicago—Know your data, speak senior leadership’s language, and use proven methodologies to build a culture of safety that yields lasting change, L. Hayley Burgess, PharmD, urged pharmacy leaders at the American Society of Health-System Pharmacists annual leadership conference. Most adverse events are caused by a system failure, not individual recklessness or incompetence, said Dr. Burgess, the

director of medication safety and systems innovations for the Hospital Corporation of America, in Nashville, Tenn. As a result, pharmacists need to live and breathe failure mode effects analysis (FMEA) and root cause analysis (RCA), and become the champions and leaders of these methodologies in their facilities, she said. “If you are implementing a new technology and you are not doing an FMEA before it goes live, shame on you,

because you need to know the unintended consequences of what you do,” Dr. Burgess stressed. “If you are not looking for [those events,] you won’t find them until it’s too late.” FMEA “is also a great team builder. Everybody’s working toward a solution together. Collectively, we know a lot, and we can point out all the different needs and all the different spaces where we can hurt someone.”

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The barriers for pharmacists often are more cultural than informational, Dr. Burgess noted. “We have more information and more data than we know what to do with,” she said. But the ability to use that information to create meaningful change means aligning pharmacy’s goals with those of senior leadership.

Allen J. Vaida, PharmD, BSc, the executive vice president of the Institute for Safe Medication Practices (ISMP), commented in an interview that FMEA and RCA are both useful tools but added that pharmacy leaders need to make sure staff undergo training in their use, as well as other methodologies, such as Lean process improvement. By doing so, he noted, when RCAs and FMEAs are conducted, they are done appropriately and effectively. “Often we find [facilities] using the Lean methodology, but if they didn’t do a good RCA, they may be looking at the wrong process,” Dr. Vaida said. “When you get a group of individuals in an organization going through an event investigation and going through an RCA, they might not appreciate all of the other risks that they should be addressing,” unless some people have thorough training in the techniques. Dr. Burgess stressed the importance of asking physicians and nurses for feedback on what the pharmacy department can do better and where they believe the next harmful event could occur. “They will tell you, and then you need to act on it if you ask the question,” she said. Dr. Burgess also encouraged pharmacy leaders to tap the full range of safety improvement strategies. “We spend an awful lot of time on education and information, and it’s not that it’s not important,” she said. “But policies and procedures, checklists and double checks, standardization and protocols, automation and computerization, and forcing functions and constraints should all be part of the mix.” In every one of these key areas, “there is something you can do to prevent harm.” It is also important to know when it makes more sense to outsource certain services, Dr. Burgess noted. In short, “Don’t do things you don’t do very often and don’t do well,” she stressed. In the case of total parenteral nutrition, for example—a service that requires complex safety checks and workflows— “think about who else can do it and do it better,” she said. “If we’re smart about how we venture into [safety], we don’t have to own every piece of it. Own what you can manage and own what your expertise is.”

COMMITMENT IN ACTION.

Operations & Management 5

Pharmacy Practice News • December 2012

Medication Safety potential harmful events in the coming day. Other useful actions include walkarounds, team improvements based on FMEA and RCA, safety improvement contests, and team discussions of key events covered in the Quarterly Action Agenda and other publications of the ISMP (www.ismp.org/newsletters). “Share those on your director of pharmacy calls every month,” Dr. Burgess said. Choose one or two relevant items to discuss and “make it easy; make it actionable.” —Susan Birk

‘If you are implementing a new technology and you are not doing an FMEA before it goes live, shame on you, because you need to know the unintended consequences of what you do.’

—L. Hayley Burgess, PharmD

“If I don’t understand how the leaders of my company behave and what the culture is for RCA—if I don’t understand our mission and our values and drive toward that in all of my actions, and map back to what the expectation is in my company—I’m not going to have good outcomes,” she said. Unity with leadership—the sense that “we are in this together”—makes lasting improvement possible, Dr. Burgess said. “I know how my leadership responds when I pull the alarm and say something is wrong—that we have identified something that is going to hurt someone. They listen and they understand. If that’s not occurring in your organization, you need to understand why.” And don’t wait for leadership to show interest in you, she said. Take the reins. If administration has not already engaged you in a conversation about pharmacy’s future with health care reform, “then you need to be knocking on their door and telling them where you believe pharmacy’s role is. If you don’t, you will be left behind,” and you will have your role defined for you, rather than determining your department’s own destiny and advancing your practice. “Why is your program any more special than the 10 other people who are going to your leadership asking for money or time? They need to know the financial side. Know your elevator speech. Have your story ready.” According to Dr. Vaida, pharmacists can connect with leadership by using the ISMP Medication Safety Self-Assessment and other tools (www.ismp.org) to show how the organization can address Joint Commission standards or Centers for Medicare & Medicaid Services requirements. “You’ve got to be able to relay to leadership that what you are doing is not only going to improve care but is also going to decrease readmissions and decrease adverse events that may fall into those ‘never’ events that you may not get paid for,” Dr. Vaida said. “You have to have that full picture of the organization.”

that you can’t do it, but know the barriers that are ahead of you. Don’t set your people up to fail,” she said. Be clear about what you are asking your staff to do; create metrics, timelines and a dashboard so that everyone is on the same page; use a project management tracking tool to monitor

progress; and hold people accountable, she added. “If I believe it is important enough to ask them to do it, then I need to measure whether or not it was done. [Accountability] is not a bad thing.” Actions can include daily team briefings and huddles to review harmful events of the past 24 hours and discuss

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6 Operations & Management

Pharmacy Practice News • December 2012

Care Transitions

Bundled Interventions Help Keep Patients at Home Chicago—Health-system pharmacists have been busy testing ways to reduce preventable medication-related hospital readmissions in anticipation of the Medicare reimbursement penalties that began to hit noncompliant hospitals on Oct. 1 (the start of the 2013 program year). Ultimately, it will be bundles of coordinated interventions across multiple settings, rather than single standalone tactics that lead to workable solutions, said Kristine Gullickson, PharmD, FASHP, at the 2012 leadership conference of the American Society of HealthSystem Pharmacists (ASHP). At present, “the data are mixed” on how best to tackle one of health care’s most pressing issues, with some interventions showing little effect and others packing more of a wallop, Dr. Gullickson said during a session on care transitions. “We have a lot of work to do, and [pharmacists have] a lot of opportunity to get involved,” added Dr. Gullickson, the director of pharmacy at Abbott Northwestern Hospital, in Minneapolis. Outcomes data are needed within the profession to prove the value of transitions work, and it remains to be seen whether the data will support the additional pharmacy resources required to do this work well, she said. Dr. Gullickson cited an analysis of 43 studies that found no single intervention, implemented alone, to be regularly associated with a significant reduction in 30-day rehospitalizations. The study also found, however, that several categories of interventions together appeared to reduce readmissions. Those interventions included predischarge education and medication reconciliation; post-discharge phone calls and home visits; and a coach to help patients bridge transitions between care settings ((Ann Intern Med d 2011;155:520-528). A recent survey of 500 hospitals offers some clues on why some efforts to reduce readmissions come up short. The survey looked at 10 practices associated with reduced readmissions among patients with heart failure or acute myocardial infarction. Of the surveyed hospitals, 90% reported having written objectives on reducing readmissions, but only 49.3% partnered with community physicians and only 23.5% partnered with local hospitals to manage these patients. Furthermore, 46.4% of hospitals never involved pharmacists or pharmacy technicians in obtaining medication histories, and only 3.2% and 13.9% made contact with outside pharmacists or primary care providers, respectively, for medication reconciliation ((J Am Coll Cardioll 2012; 60:607-614). With an estimated 50% of patients who leave the hospital experiencing a

‘Don’t let the opportunity [to target hospital readmissions] slip by, because we know we can provide value.’ —Kristine Gullickson, PharmD medication-related issue, “we certainly have opportunities, not only in the hospital, but at discharge as well as when [patients are] at home,” Dr. Gullickson said during her presentation. In a follow-up interview, Dr. Gullickson noted that the current spotlight on readmissions gives health-system pharmacists an excellent opportunity to advance their practice by using their expertise to address an important problem and affect patient care. “Make sure your department is riding that wave,” she advised. “Don’t let the opportunity slip by, because we know we can provide value.” Start with a pilot project “and then expand from there,” she said.

Five Successful Interventions Although definitive solutions to the readmissions quagmire have yet to be teased out, trends are beginning to sur-

face, Dr. Gullickson noted. Of 11 programs in the Medicare Coordinated Care Demonstration, four reduced hospitalizations by 8% to 33% among high-risk patients. At least three of these programs used the following approaches: 1. frequent face-to-face contact with patients as a supplement to phone calls; 2.a designated communication hub for providers; 3. evidence-based patient education; 4.strong attention to medication management; and 5. timely, comprehensive transitional care following discharge ((Health Aff 2012;31:1156-1166). “It’s not just one thing that’s going to work … it’s a team approach” and a “package” of interventions with key components, such as a “discharge advocate” and follow up in the ambulatory setting, Dr. Gullickson said.

Research also is helping to identify which patients are most likely to need these interventions, she said. An analysis of adverse drug event (ADE) data revealed that four medications are implicated in 66% of emergency hospitalizations for ADEs: warfarin (33.3%), insulin (13.9%), oral antiplatelets (13.3%) and oral hypoglycemics (10.7%) ((N Engl J Med 2011;365:2002-2012). Such data are “important as we start to talk about risk stratification and which patients should we concentrate on,” Dr. Gullickson said. “Health systems can plan where to focus their efforts by looking at their own data.” That is where Abbott Northwestern Hospital began when it launched a pilot project to expand the hospital’s care transition efforts from heart failure, acute myocardial infarction and pneumonia to all conditions in 2011. The pilot focused on identifying patients at high risk for readmission based on hospital and emergency department use and other factors, and the development of a transitions care team consisting of a hospitalist, nurse manager, social worker, pharmacist and community pharmacy technician liaison, with a goal to reduce potentially preventable readmissions by 15% in the first year. A review of system-wide data revealed that 40% of patients returned to the hospital within seven days of discharge, which meant that the team needed to focus on preparing patients for those first critical days after leaving the hospital, Dr. Gullickson said. Not surprisingly, the data indicated that patients going to skilled nursing facilities (SNF) or home care settings were at greater risk for readmission. “We had to work really hard to develop what our plan was to get our patient through that bridge—that first three to five days—and then figure out what structure they had after that,” she said. Furthermore, an analysis of 180,000 system-wide discharges over two years showed that patients receiving more than 10 outpatient medications were five times more likely to be readmitted. These high-risk patients made up 9% of the inpatient population.

Focusing on High-Risk Patients The transition team’s intervention “package” for these high-risk patients included a medication history to identify discrepancies and problems; an assessment of the patient’s ability to manage medications; daily rounds by a pharmacy technician to resolve insurance and copay issues and ensure that patients had their discharge medications at discharge; progress notes with recommendations to providers; a standard process for handoff

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8 Operations & Management

Pharmacy Practice News • December 2012

Care Transitions

READMISSIONS continued from page 1

opportunity to solve medication problems both during and after hospitalization. “The inpatient pharmacist who took care of a hospitalized patient was the same one who followed up after discharge. I think that was the real key to the program’s success,” said lead co-author Kim Coley, PharmD, FCCP, a professor of pharmacy and therapeutics at the University of Pittsburgh School of Pharmacy. The pharmacists conducted medication reconciliation at admission and discharge, assessed patient access to medications and adherence to his or her regimen, provided patient education and called the patient within 72 hours of discharge to resolve any lingering issues. Because the protocol was standardized, every pharmacist in the study followed the same procedures throughout the transition process. The model also pushed pharmacists beyond their comfort zones, Dr. Coley noted. For instance, they spent more time in direct patient care activities and less time making rounds with the care team. “They liked this change, because they actually saw the impact their actions had on patients,” she said. Another novel aspect of the program was that inpatient pharmacists updated the outpatient medication list in the medical record. “That was a big change and something our hospital pharmacists had never done before,” said Dr. Coley. “It allowed everyone to be on the same page and improve continuity of care after a patient was discharged.” Overall, 220 patients participated in the study. Pharmacists resolved a mean of 3.5 medication discrepancies per patient at the time of hospital admission, and 7.9 discrepancies per patient when they compared the discharge medication list with the outpatient medical record. After discharge, the pharmacists reached 72% of eligible patients (n=112) via follow-up phone calls. The 30-day readmission rate among patients enrolled in the study was 11%, compared with 24% for a matched control group. Among patients on this unit, scores on the Hospital Consumer Assessment of Health Providers and Systems (HCAHPS) survey for how well

patients were taught about the uses and side effects of their medications rose from 22% and 27%, respectively, to 75%.

Complex-Return-Continuity System Eases Care Transitions In another pilot program, researchers implemented a system that they called complex-return-continuity (CRC), in which patients were booked for a posthospitalization appointment to see several clinicians in sequence. First, a patient met with a clinical pharmacist for medication reconciliation and a thorough assessment of their medication regimen, and to identify medication discrepancies, explained co-author Gretchen Tong, PharmD, CPP, a clinical instructor in the University of North Carolina Department of Family Medicine, in Chapel Hill. The pharmacist then consulted with the patient’s primary care provider (PCP) to relay pertinent findings and recommendations, after which the PCP met with the patient. “This way, the pharmacist can focus on medication therapy and allow the primary care provider to focus on the rest of the patient’s medical care,” Dr. Tong said. If needed, the patient met with a social worker to coordinate additional care and address issues such as community resource needs or financial barriers. Thirty-six patients were scheduled for the CRC visit and 28 attended. The hospital readmission rate for noshows was 27.3%, compared with 16.7% for patients who kept their appointments. According to survey results, most patients and providers perceived that patients had an improved understanding of their medications after the multidisciplinary visit. CRC appointments lasted about a third longer than typical, single-provider visits (90 vs. 67 minutes, on average), but patients reported that they did not perceive a difference. Dr. Tong acknowledged that the study’s small size prevented the researchers from making firm conclusions about the program’s long-term efficacy. “We have shown proof of concept by evaluating implementation and process measures,” she added. “We still need to evaluate clinical outcomes of this interdisciplinary approach, and

‘The pharmacist can focus on medication therapy and allow the primary care provider to focus on the rest of the patient’s medical care.’ —Gretchen Tong, PharmD, CPP

we’re in the process of designing a larger study to evaluate that.”

REACH Program Improves Medication Management A third study evaluated the Medication REACH program, which was implemented to increase pharmacist engagement during the hospital discharge process, and thereby improve medication management among high-risk patients with acute myocardial infarction (AMI), congestive heart failure (CHF) and hypertension. (The program takes its name from “validate medication Reconciliation; deliver patient-centered Education; resolve medication Access issues during transition; coordinate a comprehensive Counseling approach; Healthy, compliant patient at home.) Eighty-nine patients (17% with AMI, 48% with CHF and 82% with hypertension) were randomized to receive either traditional nurse-mediated or clinical pharmacist–mediated discharge counseling under REACH. Four clinical pharmacists were directly involved in medication reconciliation, patient education, resolving medication access issues and conducting medication counseling phone calls after discharge. During these phone calls, pharmacists reviewed medication regimens, resolved outstanding issues and underscored the importance of medication adherence. Patients in the intervention group (n=47) were less likely than those in the control group (n=42) to be readmitted to the hospital within 30 days (10.6%

vs. 21.4%, respectively). Clinical pharmacists made 59 medication management interventions, the most common being the initiation of a medication therapy (25%). The hospital considered the program a success, so they terminated the REACH study and opened the program to all patients who needed it, said coauthor Deborah Hauser, RPh, MHA, the network pharmacy director at Einstein Healthcare Network, in Philadelphia. “There are so many people who needed this type of intervention that the hospital wanted the study to end so that REACH could serve more patients,” she added. However, because the study was concluded prematurely, not enough data had been gathered to allow statistical analysis. The take-home message from these studies is that pharmacists are stepping up and asserting that these activities are within their scope of practice, commented Jeannell Mansur, RPh, PharmD, FASHP, a practice leader in medication safety with the Joint Commission. “They believe they can have a positive impact. It’s important to have pilot studies like these to test models and have pharmacists dedicated to them. It will be interesting to see how hospitals can find the resources for programs like these once they expand to cover many more patients. Staffing for pilot projects is always much simpler than when programs are rolled out on a larger scale.” —Steve Frandzel

If you missed any recent issues of Pharmacy Practice News, visit www.pharmacypracticenews.com.

Operations & Management 9

Pharmacy Practice News • December 2012

Disaster Preparedness

SANDY continued from page 1

Extensive flooding forced Coney Island Hospital, on Ocean Parkway in Brooklyn, to close and transfer patients elsewhere, including Maimonides Medical Center, in Brooklyn, which remained open throughout the crisis as a go-to facility for people affected by the storm. Maimonides also opened its doors to patients evacuated from NYU Langone, New York Downtown and Bellevue, as well as local nursing homes that lost power. Victor Cohen, PharmD, BCPS, GCP, the clinical pharmacy manager for the Department of Emergency Medicine at Maimonides, experienced Sandy’s power firsthand when the storm-driven tidal surge flooded his Bergen Beach neighborhood in the Mill Basin section of Brooklyn. Like his neighbors, he and his family hustled into their car to escape the rising water, but the car died in the middle of the street and they had to retreat to the highest floor in their house. “There was about two feet of water in the backyard with objects floating about,” he said. “Some water flooded the basement. We shut everything down. We were afraid of fire.” Fortunately, his house never lost power, but did need to have its gas line replaced on an emergency basis.

Maimonides Meets Surging Demand for Services In anticipation of the storm, Maimonides had ample medication supply on hand, according to director of pharmacy Fredrick Cassera, RPH, MBA. Thus, even the failure to receive the regular Tuesday shipment from AmerisourceBergen’s Pennsylvania distribution center never adversely affected patient care, even as more and more patients were being transported in from other facilities, Mr. Cassera said. By the next day, he noted, the wholesaler resumed shipments from its Boston warehouse. The patient surge did mean that more of the medical center’s pharmacy team of about 100 pharmacists and technicians had to be called into action compounding IV medications and parenteral nutrition solutions, Mr. Cassera said. A major drug recall from Ameridose during this critical period also contributed to citywide drug shortages and the need for stepped-up activity. “Our [USP Chapter] <797>-compliant IV room was on all four burners compounding IVs to get the production levels up,” he said. “We were very fortunate,” Mr. Cassera added. “We have a lot of dedicated staff that came in despite the conditions. Our administration made provision for alternate methods of transportation, like a car service, and they provided sleeping accommodations and meals. They really went into full mode to support us.”

The Brooklyn neighborhood (above and below) of Victor Cohen, PharmD, was hit hard by hurricane Sandy—as was his hospital, Maimonides Medical Center.

‘Some of the areas of our ED turned into virtual internal medicine floors, where we had to supply medications on a daily basis.’ —David Zimmerman, PharmD

The pharmacy also supplied discharge medications to patients from some closed hospitals as well as the medical center’s own patients who needed to have prescriptions filled or refilled. Maimonides gives all patients the option of receiving a supply of their discharge medications before leaving the hospital. “Approximately 20% of patients never fill their prescriptions,” Mr. Cassera said, “but by offering them that option at discharge, we feel very confident they are going home in a much safer environment.” In Maimonides’ crowded emergency department (ED), the number of boarded patients awaiting transfer to inpatient units began to mount as evacuees from other hospitals and nursing homes kept arriving, said David Zimmerman, PharmD, a postgraduate-year 2 emergency medicine resident, who oversees a resident pharmacist team staffing the satellite under the direction of Dr. Cohen. Dr. Zimmerman said the ED normally accommodates anywhere from 10 to 12 boarded patients a day. “During the hurricane,” he added, “the number of patients being boarded increased to 50 to 70.” Some remained in the ED as long as three days. “Some of the areas of our ED turned into virtual internal medicine floors, where we had to supply medications on a daily basis,” he said. The number of patients needing kidney dialysis also rose as local dialysis centers lost power. “It’s not uncommon for [the ED] to have one or two dialysis sessions a day,” Dr. Zimmerman said. “We were running dialysis sessions 24/7. We had to have nurses and technicians stay overnight to continue the sessions.” The ED also experienced a sharp rise in individuals seeking methadone because their regular clinics were closed. “There were anywhere from five to seven times more patients coming in for methadone than usual,” Dr. Zimmerman said. “We had to call and verify their dosage and contact their prescriber before we could give a dose.”

Putting Patients First At Barnabas Health New Jersey health care facilities also were severely tested by the storm, but most managed to remain in service and provide patient care as well as accommodate the inflow of local people affected by the storm. Barnabas Health’s six acute-care medical centers and one behavioral health acute care medical center all went on emergency generators, just as the storm cut off power to surrounding communities. Heavy medication ordering on Thursday and Friday by Barnabas pharmacies tracking the storm’s progress meant that none of the medical centers came close to

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10 Operations & Management

Pharmacy Practice News • December 2012

Disaster Preparedness

SANDY continued from page 9

medication shortages due to distribution interruptions, said Indu Lew, PharmD, the corporate vice president of education and research at Barnabas Health. “The directors of pharmacy ensured that we would minimally have a threeday supply of medications. The wholesalers called us on Sunday to make sure we would order before 5 p.m. in order to get deliveries even on Monday,” she said. “We have centralized parenteral nutrition processing, so we made sure we doubled up on our orders on Monday morning to cover Tuesday and Wednesday. And by Tuesday and Wednesday, we started getting [the required] deliveries.” Describing how the storm directly affected many of the health system’s staff, Dr. Lew noted that many staff members “lost their homes, everything they

in the wake of the storm had little effect on Barnabas physicians, nurses and licensed practitioners. Barnabas made special arrangements with certain stations that still had operating fuel pumps to provide gas to the medical centers’ essential staff. In Toms River, one station reserved a pump for employees at Barnabas’ nearby Community Medical Center.

NYU Langone Pharmacy Copes With Massive Shutdown Two weeks after the storm, NYU Langone was still at an early stage of recovery. Arash Dabestani, PharmD, the senior director of pharmacy, described some of the work that a core group of pharmacists was doing to prepare for the day when the huge medical center would return to full operation. Others among the 100-member staff of pharmacists were scattered

NYU Langone Hospital, in New York City, had to evacuate many of its acute-care patients to other city hospitals due to the effects of hurricane Sandy.

owned. It’s really tragic.” But she said the administration stepped in to help, allowing employees to give back vacation days and donate the dollar value to help people who were affected. “We have 20,000 employees,” she noted. “So if everyone gives a day, we can make a huge impact. Administration established programs for housing and transportation allowances, as well as provided meals in our cafeterias to employees and their families.” Intensive prior planning and constant communications during the storm and afterward helped to maintain business as usual even as communities all around were being devastated, Dr. Lew added. “The pharmacists, technicians and all of the staff really stepped up,” she said. “They stocked up and people worked double and triple shifts without complaint. They did a lot to make sure that patients were taken care of because they knew that what was happening was bigger than all of us.” The gasoline shortage crisis that hit

to different locations, including some to other pharmacies in the NYU complex and others to several hospitals needing help to manage the influx of NYU Langone patient evacuees.

but discarding medications that were damaged and securing our other stock,” Dr. Dabestani said. One of the chief concerns, he said, was to find a suitable location for the

‘People worked double and triple shifts without complaint. They did a lot to make sure that patients were taken care of because they knew that what was happening was bigger than all of us.’ —Indu Lew, PharmD Lights and telephone service had just been restored to the third-floor pharmacy earlier that day, but with the pharmacy system available on a read-only basis and no inpatients to service, the staff shifted attention to other tasks. “We’ve spent easily 75% of our time the last couple of weeks doing nothing

medical center’s investigational drug service. “We have many, many patients on research protocols who need to get their medications.” Fortunately, space was available in a newly constructed nearby NYU building. “This is a brand new pharmacy that has occupancy permits, but we haven’t moved in there yet,

Staff at Bellevue Hospital, in New York City, carry a baby down a stairwell during the hospital’s evacuation on Oct. 30, (Sheri Fink/ProPublica)

‘Our administration made provision for alternate methods of transportation, like a car service, and they provided sleeping accommodations and meals. They really went into full mode to support us.’ —Fredrick Cassera, RPh, MBA

‘Virtual Beds’ Aid in Disaster Response

aimonides Medical Center was able to handle the surge of patients from hospitals and nursing homes forced to close in part because of a “virtual bed” system that it has in place for just such emergencies. “When the need arises, as it did with Hurricane Irene, we have the ability to add beds to each patient area,” Mr. Cassera said. “Every medical/surgical unit has the potential to accommodate up to five additional beds.” The medical center also can activate virtual beds in larger areas that go unused during an emergency, such as the ambulatory surgery or endoscopy units. The virtual beds are part of Maimonides’ automated computer system, he said, so if they are activated, the additional medication demand can be handled easily by the automated cart-fill system and medication carousel. —B.B, J.B.

so we just moved them there for the time being.” Dr. Dabestani also has spent time training hospital staff for a switch to the Epic enterprise-wide management system. “Epic includes everything from patient billing and registration to medication profiles. This is a big deal, a very big deal. The goal-line date is still scheduled for Dec. 2, but the main hospital won’t be going live, so we’re going to use this downtime to make sure everybody is trained and tested.” Days after the storm had passed, Mr. Cassera said Maimonides Medical Center was “still in a surge mode,” with Coney Island and the other affected hospitals perhaps months away from reopening. “Many of my staff were also affected,” he said. “They’re dealing with this catastrophe on a personal level and yet maintaining their commitment to patients.” —Bruce and Joan Buckley

Q & A 11

Pharmacy Practice News • December 2012

Care Fusion The following advertorial is provided by CareFusion. It is designed to support the advertisement presented below.

CareFusion’s Continued Innovation on the Pyxis® 4000 Platform

Q: What is CareFusion? A: CareFusion is a global medical device company that delivers products and services that help measurably improve the medication safety and cost of health care. Used in more than 120 countries around the world, CareFusion solutions are among the most widely recognized brand names in the industry, including Pyxis MedStation® 4000 system.

risk for errors. Additionally, Pyxis Anesthesia system increases control over medication access with new advanced biometric scanning technology. To improve documentation accuracy, Pyxis Anesthesia system features a new software-forcing function that helps ensure the documentation of controlled substance waste. The added option of the Codonics™ Safe Label System™ SLS 500i™ streamlines the medication syringe labeling process. This labeling system addresses vial/ampoule swaps by scanning the drug container and asking for confirmation

before printing the label. It also addresses mislabeling/illegible labeling by providing full-color labels based on a site-specific pharmacy-developed formulary, and syringe swaps by enabling the scanning of labeled syringes to verify the contents pre-administration.

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A: For more information, visit carefusion.com/pyxis4000platform or email CareFusion Pyxis technologies at communications@carefusion.com. © 2012 CareFusion Corporation or one of its subsidiaries. All rights reserved. Pyxis, Pyxis MedStation, CUBIE, CareFusion and the CareFusion logo are trademarks or registered trademarks of CareFusion Corporation or one of its subsidiaries. Cerner Millenium is a registered trademark of Cerner Corporation or one of its subsidiaries. Codonics, Safe Label System and SLS 500i are registered trademarks of Codonics, Inc. or one of its subsidiaries.

Q: What is Pyxis MedStation 4000 system? A: Pyxis MedStation 4000 system, the cornerstone of the 4000 platform, is a leading automated dispensing system supporting decentralized medication management. By automating the medication management process throughout the hospital, the system streamlines medication distribution, improves nursing and pharmacy collaboration and workflow, helps support the Joint Commission and regulatory compliance efforts and interoperates with the hospital information system to provide information when and where needed.

Q: What are the new capabilities and technologies of Pyxis MedStation 4000 system? A: Pyxis MedStation® 4000 system electronic medical record interoperability with Cerner Millennium m® enables data sharing and centralizes clinical information between the two systems. This industry-first interoperability helps simplify the medication administration process, providing nursing and pharmacy the information needed to enhance medication safety and optimize workflow processes. Additionally, increasing choice and storage capacity of the CUBIE® system, the new full-height CUBIE pockets store larger medications such as prefilled syringes, vials and IV bags while leveraging the same demonstrated benefits of half-height CUBIE pockets. CUBIE pocket technology is secure and flexible, enabling pharmacy to reconfigure drawers and adjust pocket sizes to accommodate an ever-changing inventory due to drug shortages and formulary adjustments. Supporting the rapid initiation of medication orders, CUBIE system helps hospitals increase medication availability and predictability, reducing time to first dose. It can also help reduce loss of revenue on non-controlled medications due to inventory shrinkage and increases Pyxis MedStation system security and capacity with more line items and doses using full-height CUBIE pockets versus other drawer types.

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and optimize workflow, giving clinicians more time to focus on patients—that’s the CareFusion difference. Learn more at carefusion.com/PyxisCerner.

© 2012 CareFusion Corporation or one of its subsidiaries. All rights reserved. Pyxis, Pyxis MedStation, CareFusion and the CareFusion logo are trademarks or registered trademarks of CareFusion Corporation or one of its subsidiaries. Cerner and Cerner Millennium are trademarks or registered trademarks of Cerner Corporation or one of its subsidiaries. DI946

12 Operations & Management

Pharmacy Practice News • December 2012

Health Records

Meaningful Use, Part 2: Opportunity for Pharmacists?

harmacists play a key role in helping to advance safe and effective medication use as hospitals scramble to meet new Stage 2 requirements for the “meaningful use” of electronic health records by 2014, according to informatics and quality assurance pharmacists. The new requirements from the Centers for Medicare & Medicaid Services (CMS) are the latest phase in the government’s multiyear push to improve the

‘I see the move toward meeting these Stage 2 requirements as another great opportunity for pharmacy to get out and offer services and possibly expand the services they’re currently providing.’ —Benjamin Anderson, PharmD, MPH quality and efficiency of medical care by evolving to an all-digital national sys-

tem that aggregates accurate, up-to-date patient data across transitions of care.

BEYOND ABOVE-AND-BEYOND

Much of Stage 2 relates directly or indirectly to medication use, including new requirements for computerized provider order entry, clinical decision support, patient access to personal health records, medication order tracking, and compliance with 16 clinical quality measures (CQMs), including the provision of venous thromboembolism anticoagulation overlap therapy (sidebar, page 13). “I see the move toward meeting these Stage 2 requirements as another great opportunity for pharmacy to get out and offer services and possibly expand the services they’re currently providing,” said Benjamin Anderson, PharmD, MPH, an informatics pharmacist at HealthEast Care System in St. Paul, Minn. Those efforts, he noted, could be geared toward providing medication reconciliation for a substantial portion of the transitionsof-care opportunities that crop up when patients are admitted to the inpatient or emergency departments of eligible or critical-access hospitals. By doing so, Dr. Anderson noted, “pharmacists can help meet the clinical quality measures [CQM] that are part of the [Stage 2] goals.” The Stage 2 final rule requires that beginning in 2014, eligible hospitals and critical-access hospitals must report on 16 of 29 CQMs, selecting at least one in three of the six national quality strategy domains. Included in the 29 are measures relating to timeliness of emergency department care and to appropriate therapy for hemorrhagic and ischemic stroke, venous thromboembolism and acute myocardial infarction. Three other CQMs focus on appropriate antibiotic selection. A lot is at stake for health systems. In addition to the $20 billion in incentive payments that CMS already has begun to distribute to providers that have met Stage 1 requirements, there are the looming Medicare payment cuts for those that fail to begin meeting meaningful use measures by 2015. Dr. Anderson said HealthEast’s three acute care hospitals were well on their way to complying with Stage 2 measures. “Our leadership team took a very proactive role,” he said. “The goal was very much to stay at the front of deadlines for meeting Stage 1 and Stage 2. We’ve attested to Stage 1 and are putting the final upgrade into place that will allow us to finish our Stage 2 work.” One important new Stage 2 core objective calls for automatic medication tracking from order to administration using assistive technologies in conjunction with electronic medication administration records (eMARs). Anne M. Bobb, RPh, CPHIMS, the administrator of clinical quality excellence at Ann & Robert H. Lurie Children’s Hospital of Chicago, said that she believes the provision will have a

Operations & Management 13

Pharmacy Practice News • December 2012

Health Records tion. She noted that meeting the Stage 2 measure requiring 10% of medication orders to be tracked by an eMAR system with bedside bar coding or radiofrequency identification may be challenging for the more than half of U.S. hospitals that have not yet deployed bar-code medication administration technology.

A Core of Contention “significant impact” on hospitals. By “assistive technologies,” Ms. Bobb said, CMS was referring to point-of-care bar coding or radiofrequency identifica-

Software for Tracking VTE Overlap Therapy A Work in Progress? HOLLYWOOD, FLA—When it comes to evaluating complex medicationrelated patient data, computer software has a way to go before it can match the skills of clinical pharmacists. That is one conclusion that can be drawn from a study by pharmacist-researchers at Emory Healthcare in Atlanta. The researchers, led by Melissa M. Chesson, PharmD, BCPS, a clinical assistant professor at Mercer University College of Pharmacy and Health Sciences, assessed Emory’s ability to comply with the Centers for Medicare & Medicaid Services’ Stage 2 clinical quality measure (CQM) relating to venous thromboembolism (VTE) anticoagulation overlap therapy. That metric is one of 16 CQMs that hospitals are required to meet by 2015 in order to qualify for incentives under Stage 2 of Meaningful Use of electronic medical records (EMRs) program. It calls for 80% of patients with a confirmed VTE diagnosis to receive at least five days of overlap anticoagulation therapy consisting of a parenteral anticoagulant and warfarin and reach an international normalized ratio (INR) of at least 2 before ending the parenteral anticoagulant. To determine the health system’s potential performance, the researchers looked at EMRs of 111 patients diagnosed with VTE during six months leading up to Aug. 31, 2011. The compliance rate for the VTE metric was 72% (80 of 111), they reported at the annual meeting of the American College of Clinical Pharmacy (ACCP). Their secondary goal was to determine how well a new computer software tool could handle VTE compliance reporting. To that end, they looked at a subset of three months of EMR data captured through the end of the same study period, and matched their own manual data analysis against that of the software tool. The computer software did not perform nearly as well. The

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see VTE COMPLIANCE, page 14

Perhaps the most contentious new core objective focuses on patient access to medical records. It requires that more than half of patients discharged from hos-

pital emergency departments or inpatient settings be given online access to their medical records within 36 hours, and that more than 5% of them “view, download or transmit” their health information to a third party. Meeting the 5%-plus measure may be difficult for many hospitals. “Some hospitals haven’t even started down the path to a patient portal,” Ms. Bobb said. “Once you have one, you have to actively encourage patients to access and use it. And then on top of that, Stage 2 is forcing us to [ensure] that patients proactively mes-

sage their providers.” Rachelle “Shelly” Spiro, RPh, FASCP, the executive director of the Pharmacy e-Health Information Technology Collaborative, said that the effort to involve patients in managing their personal health records was just beginning. “There are real campaigns that are being pushed at the grassroots level,” she said, noting that Farzad Mostashari, MD, ScM, the national coordinator for health information technology, and his deputy, Judy Murphy, RN, “have taken this personally

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see MEANINGFUL, page 14

IN STOCK! Gris-PEG® (griseofulvin ultramicrosize)

Facts for Pharmacy - What Patients Should Know. Take Gris-PEG tablets whole or crushed in applesauce1,2 - For children2 or adults who may have difficulty swallowing, Gris-PEG may be crushed and sprinkled onto one tablespoon of applesauce. It must be swallowed immediately without chewing.

Do not stop taking medication early - Clinical relapse will occur if the medication is not continued until the infecting organism is eradicated. (refer to the Dosage and administration section of the full prescribing information). Dosing for Adults - Daily administration of 375 mg (as a single dose or in divided doses) will give a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis. For those fungal infections more difficult to eradicate, such as tinea pedis and tinea unguium, a divided dose of 750 mg is recommended. Dosing for Pediatrics - Approximately 3.3 mg per pound of body weight per day of ultramicrosize griseofulvin is an effective dose for most pediatric patients. On this basis, the following dosage schedule is suggested: Children weighing 35-60 pounds 125 mg to 187.5 mg daily. Pediatric patients weighing over 60 pounds 187.5 mg to 375 mg daily. Not indicated for use in children 2 years and younger Indication and Important Safety Information: Gris-PEG (griseofulvin ultramicrosize) is indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete’s foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber’s itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans,Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. Griseofulvin should not be prescribed to pregnant patients. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Safety and efficacy of griseofulvin for prophylaxis of fungal infections have not been established. Gris-PEG is contraindicated in patients Please see full prescribing information on adjacent page. Please visit www.grispeg.com/offers for patient sampling and patient co-pay assistance offer details. References: 1. Gris-PEG (griseofulvin ultramicrosize), [prescribing information]. Pedinol Pharmacal Inc., 2010 2. Not indicated for use in children 2 years and younger.

® A Division of Valeant Pharmaceuticals North America LLC

with porphyria or hepatocellular failure and in individuals with a history of hypersensitivity to griseofulvin. Since griseofulvin is derived from species of Penicillium, the possibility of cross sensitivity with penicillin exists; however, known penicillin-sensitive patients have been treated without difficulty. Since a photosensitivity reaction is occasionally associated with griseofulvin therapy, patients should be warned to avoid exposure to intense natural or artificial sunlight. There have been post-marketing reports of severe skin and hepatic adverse events associated with griseofulvin use. Patients should be monitored for hepatic adverse events. When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria, erythema multiforme-like drug reactions, and rarely, angioneurotic edema, and may necessitate withdrawal of therapy and appropriate counter measures. When an oral medication for a superficial fungal infection is warranted, we hope you consider Gris-PEG.

14 Operations & Management

Pharmacy Practice News â&#x20AC;˘ December 2012

Health Records VTE COMPLIANCE continued from page 13

researchersâ&#x20AC;&#x2122; paper analysis was able to detect a compliance rate of 72% (42 of 58) compared with 48% (12 of 25) for the software. The main reason the software tool lagged, Dr. Chesson said, was its inability to capture all of the complexities that go into determining antithrombotic therapy. For example, she said, a patient with a confirmed VTE might receive only three days of overlap

anticoagulation before surgery interrupts the therapy, which is then resumed for five days postsurgery. Or a patient may develop a bleed while on therapy, she added. â&#x20AC;&#x153;We can see that manually in the computer system,â&#x20AC;? she said, â&#x20AC;&#x153;but how will the software be able to document those events?â&#x20AC;? With more than two years to go before having to meet the 80% requirement, Emory Health Care and others who may be experiencing similar challenges have enough time to correct software deficiencies.

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But Dr. Chesson said the bar should be set even higher, adding that the compliance goal should be closer to 100%. â&#x20AC;&#x153;Yes, we need to meet these criteria,â&#x20AC;? she said, â&#x20AC;&#x153;but in the process these tools should be developed so that theyâ&#x20AC;&#x2122;re meaningful and useful to us, so we can create [treatment strategies] that help physicians and pharmacists to manage patient care appropriately and safely.â&#x20AC;?

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five-day VTE overlap therapy, William E. Dager, PharmD, a pharmacist specialist at the UC Davis Medical Center, in Sacramento, Calif., noted that it â&#x20AC;&#x153;has not been clearly definedâ&#x20AC;? as to what to do about patients whose INRs achieve 2 before five days of prophylaxis are completed, â&#x20AC;&#x153;because it has not been adequately studied.â&#x20AC;? The lack of clarity, Dr. Dager said, can â&#x20AC;&#x153;create a dilemmaâ&#x20AC;? for practitioners who are concerned about the potential for over-anticoagulating patients, â&#x20AC;&#x153;especially on days when they are outpatients, and there may not be close monitoring for a day or two, as far as whether they feel comfortable about completing the five days or not.â&#x20AC;? To overcome the uncertainty, he said, â&#x20AC;&#x153;clinicians need to carefully assess the risk for bleeding in thrombosisâ&#x20AC;? as well as patientsâ&#x20AC;&#x2122; â&#x20AC;&#x153;potential sensitivities to warfarin as they decide on the initial dosing structures.â&#x20AC;? Whatâ&#x20AC;&#x2122;s more, he said, â&#x20AC;&#x153;clearly from the day they initiate therapy,â&#x20AC;? clinicians need to have a plan to assure that five days of therapy will result in a successful outcome, whether a patient is on a care unit, in the outpatient setting or transitioning during that period. Clinicians also need to use informatics systems, he said, â&#x20AC;&#x153;to document clearly why they might decide to stop the parenteral anticoagulant agent before the five days is completed,â&#x20AC;? and the system they use needs to clearly provide â&#x20AC;&#x153;the means to document the rationale for making that decision.â&#x20AC;? Pharmacists, Dr. Dager added, â&#x20AC;&#x153;are going to become an increasingly key component in the initiation, transition and follow-up management in the outpatient setting for patients on dual therapies. They are a resource that can be tapped to facilitate this process so it can be successfully implemented and patients receive optimal care.â&#x20AC;? â&#x20AC;&#x201D;Bruce Buckley

MEANINGFUL continued from page 13

and are really trying to make sure that patients are engaged.â&#x20AC;? Ms. Spiro also said that the patient access was an important issue for hospital pharmacists, pointing out that â&#x20AC;&#x153;as patients leave the hospital, theyâ&#x20AC;&#x2122;re going to be asking for their medical records, and included in the medical record, as one of the most important pieces, is the medication record.â&#x20AC;? She added: â&#x20AC;&#x153;As pharmacists, we have this very important role in making sure that the active medication list that weâ&#x20AC;&#x2122;re putting out there upon discharge is accurate and something that patients can use.â&#x20AC;? â&#x20AC;&#x201D;Bruce Buckley

Clinical 15

Pharmacy Practice News • December 2012

Cardiology

FIBRATES continued from page 1

The most troubling unintended consequence is an increased risk for cardiovascular events in patients who are taken off fibrates, according to a retrospective study of patients treated at the Portland Veterans Affairs Medical Center (PVAMC). The percentage of patients with triglycerides greater than 240 mg/dL, high-density lipoprotein (HDL) less than 34 mg/dL and diabetes more than doubled (18% vs. 39%) following a universal mandate to discontinue fibrates in patients who had been given the drugs with statins, reported Harleen Singh, PharmD, BCPS, an associate professor in the Department of Pharmacy Practice at the Oregon Health & Sciences University College of Pharmacy, in Portland. An expert in cardiovascular medicine who was not affiliated with the study said the results should be seen as a warning not to apply fibrate-statin bans too aggressively. “I don’t think you can make a blanket statement for all patients,” said Robert DiDomenico, PharmD, a cardiovascular clinical pharmacist at the University of Illinois at Chicago (UIC) College of Pharmacy. “Some [patients] may have a real need to be on the fibrates to prevent the development of pancreatitis,” he said. Thus, issuing broad proscriptions without adequate investigation is “a little shortsighted.”

alternatives to replace the benefits they may have been deriving from fibrates, Dr. Singh reported. Prescribing rates for adjunctive therapies such as niacin or omega-3 fatty acids, for example, did not significantly change, she noted. The results suggest that patients such as those in the study may still benefit from statin–fibrate therapy in preventing major cardiovascular events, including nonfatal myocardial infarction and nonfatal strokes, Dr. Singh told Pharmacy Practice News. Those benefits already have been documented in a subgroup

analysis of the ACCORD trial ((N Engl J Med 2010;362:1563-1574), she noted. Dr. Singh added that more diligent follow-up efforts are needed, including more frequent monitoring of lipid levels, which typically is required in patients with high triglycerides. Dr. DiDomenico said that his own institution’s reaction to the FDA’s updated dosing guidelines on simvastatin may have been too broad. In response to the agency’s recommendations, he noted, clinical decision support on the electronic medical record at UIC no longer

allows physicians to coprescribe gemfibrozil and simvastatin. “What you are essentially telling the docs in training is that you should never put a patient on both of these drugs together, and in some patients, there definitely could be a benefit” to such combination therapy. —Susan Birk Dr. DiDomenico reported that he has served on Roche’s advisory board. Dr. Singh reported no relevant ﬁnancial conﬂicts of interest.

Policy’s Underpinnings PVAMC’s policy came out of a Veterans Health Administration recommendation, which discouraged “the use of any statin–fibrate combination because of the known risks and yet to be proven incremental benefit of these combinations beyond statin therapy alone” (National PBM Bulletin, June 9, 2011; www.pbm.va.gov). v To assess the impact of the PVAMC universal ban, Dr. Singh and her colleagues recorded lipid levels from the last test before discontinuation and the first test within eight to 20 weeks after. Of the 837 patients whose fibrates were discontinued, 398 have been screened to date and 348 met inclusion criteria. The majority had elevated triglycerides, 68% had diabetes, 32% had coronary artery disease, and 11% had a stroke before discontinuation. The 51% of patients who had followup lipid tests had a significant increase in mean triglycerides (248 mg/dL before, 376 mg/dL after; P=0.0011), a decrease in mean HDL (38 mg/dL before, 36 mg/dL after; P=0.0013) and an increase in mean total cholesterol (171 mg/dL before, 188 mg/dL after; P<0.05). Low-density lipoprotein levels did not change significantly. Part of the elevated cardiovascular risk may have been due to the fact that patients did not appear to be receiving

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16 Clinical

Pharmacy Practice News • December 2012

Ambulatory Care

Improving Diabetes Outcomes Through Patient Ed W

hether individualized or group-based, community- or hospitalcentered, pharmacist-run diabetes education programs can improve patient self-management, reducing diabetes’ effects and helping prevent serious complications, according to several reports presented at the American College of Clinical Pharmacy’s (ACCP) 2012 Virtual Poster Symposium. With the prevalence of diagnosed and undiagnosed diabetes mellitus pegged at 8.3% in 2010 by the Centers for Disease Control and Prevention (CDC) (Figure), and evidence suggesting that medical therapy is suboptimal in a majority of patients, efforts to ensure that patients know how to best manage their disease are more critical than ever. And although educational programs to achieve this end are available, according to one assessment, only 55% of patients with diabetes have accessed these resources (http://apps.nccd.cdc. gov/DDTSTRS/default.aspx). The magnitude of the public health challenge posed by diabetes is even great-

er in Alabama, where in 2010, Kristi Kelley, PharmD, helped to launch a pharmacistrun education program for patients with type 2 diabetes at Baptist Health Inc., in Birmingham. An estimated 11.7% of Alabama’s citizens reportedly carried a diagnosis of diabetes in 2011 (http://apps. nccd.cdc.gov/DDTSTRS/default.aspx), she said. When Dr. Kelley’s team created a collaborative, individualized education program at two of Baptist Health’s internal medicine resident clinics—the initial point of care for many of the health system’s patients with diabetes—they wanted to ensure patients had access to the program (poster 85). “At least one-third of the patients in our internal medicine clinics are uninsured and from an underserved population, which had made it challenging to refer to the hospital’s existing diabetes education programs, since they require payment,” explained Dr. Kelley, a clinical pharmacist in the hospital’s Continuity of Care Clinic and an associate clinical professor in the Department of Pharmacy Practice at Auburn Uni-

‘When the resources are available, these [pharmacist-run diabetes outreach] initiatives ultimately decrease the workload for physicians, improve outcomes and lower the overall cost to our health care system.’ —Molly Howard, PharmD 1,052,000

465,000

20-44

390,000

45-64

≥65

Age Group Figure. New cases of diagnosed diabetes in adults.a Source: 2007-2009 National Health Interview Survey estimates, projected to the year 2010. a

With children added, total number of U.S. population with diabetes is 25.8 million (8.3% of the U.S. population).

versity Harrison School of Pharmacy, in Auburn. Given the patient population, Dr. Kelley’s team offered one-onone sessions with a clinical or student pharmacist free of charge. A scarcity of resources meant the program had to be targeted for maximum efficacy, so she and her team asked clinic staff to refer only those patients who would most likely benefit from additional education. During sessions, patients received printed literature, counseling and a demonstration insulin injection to ensure their technique was correct. Educational content was tailored to each patient’s specific needs, with the most common topics being nutritional management and lifestyle modification, medication safety, ways of maximizing drug treatment efficacy, the role of blood glucose monitoring and the importance of preventing, detecting and treating acute disease complications. Some participants received more than one session if the pharmacist deemed it necessary or if the patient requested it. According to Dr. Kelley, 27% (47 of 172) of the internal medicine clinics’ patients with diabetes participated in at least one session during the 18-month study period following the program’s implementation. Among the 25 participants with available pre- and postintervention laboratory data, average hemoglobin A1c (HbA1cc) levels dropped from 9.4% prior to the intervention to 8.2% afterward. Noting that a 1% reduction in HbA1c is associated with an approximately 40% reduction in the incidence of microvascular complications, Dr. Kelley emphasized that the results are clinically meaningful ((Diabetes 1995;44:968-983). She said the multidisciplinary aspect of the program was critical to its success. Access to patient medical records allowed the pharmacist to contact the treating physician and recommend dose adjustments. For individuals who could not afford prescribed medications, the pharmacist worked with a social worker or resident to help obtain medications that were within their budget.

Although the initiative was linked to improved patient outcomes, Dr. Kelley suggested that staff have limited time to devote to work that is not reimbursed. “In a different setting such as a private physician’s office or a group practice, it potentially could be easier to bill,” she said.

Community Outreach In Burlington, N.C., Rachel Selinger, PharmD, a clinical pharmacy specialist at the University of North Carolina at Chapel Hill’s Campus Health Services, and her colleagues ran a diabetes patient education program in a community health clinic setting (poster 37). The initiative, which was implemented at the Charles Drew Community Health Center, where Dr. Selinger was the pharmacy manager at the time of the intervention, was part of the Patient Safety and Clinical Pharmacy Services Collaborative, a government-funded program aimed at improving outcomes and reducing adverse drug events (http://

www.hrsa.gov/publichealth/clinical/ patientsafety/index.htmll). Like the Alabama program, it also targeted higherrisk patients—specifically, those with little clinic contact and HbA1c levels above 9%. About 95% of the patients seen had type 2 diabetes, Dr. Selinger noted. Between September 2010 and August 2011, a case manager contacted 30 of these patients by phone and explained that their disease was not under control and that they were at risk for developing related complications. Those patients who were interested in better managing their disease subsequently met with a clinical pharmacist who reviewed optimal medication management strategies, provided medication adherence counseling and overall disease education, and worked with the patient’s physician or nurse practitioner to make dose adjustments if necessary. Molly Howard, a PharmD candidate at Creighton University’s School of Pharmacy and Health Professions,

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Clinical 19

Pharmacy Practice News • December 2012

Ambulatory Care

DIABETES

Table. Impact of Preventive Care In Diabetes Management

continued from page 16

in Omaha, Neb., and an intern at the Charles Drew Community Health Center when the program took place, presented the initiative’s outcomes at the ACCP Symposium. She said that after an average of three to four sessions, each lasting 15 to 30 minutes, HbA1c levels fell below 9% in roughly 40% of the participants. However, like the Auburn program, the N.C. initiative also came up against logistical and financial hurdles. “The time and resources required for programs like ours are difficult to sustain, with employees taking on additional tasks and with no organizational profit to warrant additional staffing,” Dr. Howard explained. “That being said, when the resources are available, these initiatives ultimately decrease the workload for physicians, improve outcomes and lower the overall cost to our health care system.” Indeed, the CDC has reported the benefits of various preventive care strategies in diabetes (Table).

Strength in Numbers A group-based approach outlined by Brittany Cogdill, PharmD, a clinical pharmacy specialist in ambulatory care at the Medical University of South Carolina’s College of Pharmacy, in Charleston, may be less time-intensive than individual education (abstract 8). Furthermore, it offers other unique advantages. “Group members benefit from receiving advice from others with diabetes, particularly when it comes to diet, instead of listening to health care professionals tell them what they should

Intervention

Complication Targeted

Risk Reduction

Comprehensive foot care programs

Amputations

45-85%

Laser screening for eye disease

Vision loss

50-60%

Hypertension screening and treatment a,b

Loss of proper kidney function

30-70%

Proteinuria (a risk factor for kidney disease)

35%

Cardiovascular disease (heart disease or stroke)

33-50%

Microvascular complications (eye, kidney, nerve diseases)

40%

Glucose controlc

Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers are the most effective antihypertensive agents for reducing declines in kidney function.

For every 10 mm Hg reduction in systolic blood pressure, the risk for any complication related to diabetes is reduced by 12%. Reducing diastolic blood pressure from 90 mm Hg to 80 mm Hg reduces the risk for major cardiovascular events by 50%.

Risk reduction based on a 1% drop in A1c (i.e, from 8% to 7%).

Source: CDC National Diabetes Fact Sheet, 2011 http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf

‘We know we can provide high-quality patient education and drug therapy management, and we need more demonstration projects like these to show other providers what we can bring to the table.’ —Brian Irons, PharmD do,” Dr. Cogdill said in an interview, noting that 85% of participants in a group program she and her colleagues implemented preferred this format over an individual approach. The program was offered free of charge to patients referred from the university’s affiliated hospital outpatient family med-

icine clinic. Individuals were initially contacted by phone by a pharmacist and invited to attend four 2.5-hour educational sessions—a total of 10 hours over a one-year period, she noted. Dr. Cogdill structured the group discussions on the American Diabetes Association’s Diabetes Conversation Maps

Insulin Medication Management: Small Changes, Big Results Jerry Meece, RPh, FACA, CDE Owner, director of clinical services Plaza Pharmacy and Wellness Center Co-author, American Association of Diabetes Educators’ most recent guidelines

ore than one-third of diabetes patients do not take their insulin as prescribed1 and one-fifth intentionally skip doses.2 Pharmacists can help address the issue of poor insulin adherence in two ways: 1. Educate patients about injection options. One reason patients skip doses or delay starting insulin is anxiety about needles. Many are not told about the availability of needles as short as 4 mm, which are less intimidating and more comfortable. Instead, they continue to use 12-mm needles. Recommending shorter needles also might improve injection site rotation, which about half of diabetes patients report not doing frequently enough,3 and which can cause lipohypertrophy and significantly affect insulin absorption.4 Longer needles require that patients pinch up skin and use two hands, whereas shorter needles can be injected with one hand and injection sites can be accessed more easily. Longer needles also may enter into the muscle, where insulin injection can lead to hypoglycemia. 2. Schedule appointments and follow-up visits. A scheduled initial appointment ensures that pharmacists have time

to prepare for counsel, give the patient their full attention and answer any questions. Follow-up appointments can be used to monitor treatment success and adherence as well as to identify possible errors due to poor recall of instructions or a new barrier to treatment and to observe a patient’s injection technique to make sure they are injecting correctly. Many pharmacists would say they do not have the time to schedule appointments and provide one-on-one education, but tasks like checking blood glucose, running a lipid panel or weighing the patient before they meet with the pharmacist, can be delegated to a technician in many cases, leaving the pharmacist with more time to review training and results. Taking the few extra minutes to check a patient’s treatment routine and ensure appropriate protocols are being followed can improve outcomes and position the pharmacy as a recognized center for diabetes care.

References 1. Global Attitudes of Patients and Physicians in Insulin Therapy (GAPP) Survey. Data on file. Novo Nordisk; 2010. 2. Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of insulin injection omission. Diabetes Care. 2010;33:240-245. 3. American Association of Diabetes Educators (2009). Strategies for Insulin Injection Therapy in Diabetes Self-Management White Paper. Retrieved from http://www.diabeteseducator.org/export/sites/aade/_resources/pdf/. 4. Vardar B, Kizilci S. Incidence of lipohypertrophy in diabetic patients and a study of influencing factors. Diabetes Res Clin Pract. 2007;77:231-236.

(http://www.healthyinteractions.com/ conversation-map-programs/conversation-map-experience/current-programs/ usdiabetes), which provide talking points around nutritional management, insulin treatment and blood glucose monitoring as well as information on the natural course of the disease, potential complications and gestational diabetes. Thirty-two patients with type 2 diabetes attended a single class and nine returned for more than one session over a one-year period. The intervention proved effective as evidenced by decreases in HbA1c. Among those with available laboratory data, average HbA1c dropped from 9.4% to 8.3% after group participation. Furthermore, systolic and diastolic blood pressure as well as low-density lipoprotein levels also decreased. Although the changes were not statistically significant, “the numbers “trended toward improved patient outcomes,” Dr. Cogdill said. The program did not involve a drug management component, but some patients may have had medication adjustments under their physicians’ care—a factor that Dr. Cogdill’s team did not account for when analyzing their outcomes.

Kudos on Effort, But Study Design Criticized Pharmacist-run programs will only be reimbursed if studies like these continue to be conducted, according to Brian Irons, PharmD, the division head of ambulatory care and an associate professor in the Department of Pharmacy Practice at the Texas Tech University Health Sciences Center’s School of Pharmacy, in Lubbock. “We know we can provide high-quality patient education and drug therapy management, and we need more demonstration projects like these to show other providers what we can bring to the table,” said Dr. Irons, who has previously developed and studied pharmacist-led educational programs but was not involved in the studies. Although the studies are encouraging, the conclusions are hampered by several significant design weaknesses, he said, and stronger studies on the topic need to be conducted. “The number of patients in each of the abstracts is small, there were no control groups, and there are many possible confounding variables that are difficult to account for,” he said. “Therefore, it’s not clear precisely to what extent the interventions and the pharmacist’s involvement actually contributed to improved outcomes and HbA1c reductions.” —David Wild Drs. Irons, Cogdill and Kelley and Ms. Howard reported no relevant ﬁnancial conﬂicts of interest.

20 Clinical

Pharmacy Practice News • December 2012

Critical Care

Procedural Sedation More Complicated in Obese Children

bese children who undergo procedural sedation are at an increased risk for adverse events including respiratory problems, a recent study has found. “If you are going to give procedural sedation to children, your risk for needing to provide airway repositioning, airway adjuncts and bag mask ventilation, and of running into airway complications, is higher if the child is obese,”

said Patricia Scherrer, MD, the medical director of sedation services at Children’s Hospitals and Clinics of Minnesota. Dr. Scherrer’s group presented its findings at the 2012 annual meeting of the Society for Critical Care Medicine (abstract 831). Peter Davis, MD, chief anesthesiologist at Children’s Hospital of Pittsburgh, said the study “goes along with the trend that being obese is detrimental to your

health.” Researchers have shown that obesity complicates anesthesia and procedural sedation in adults, but this is the first time a study demonstrated that obesity adversely affects procedural sedation in a pediatric population. “It hasn’t been documented in children before, but it is not a surprising finding,” Dr. Davis said. Dr. Scherrer and colleagues queried the database of the Pediatric Sedation Research Consortium (PSRC), a conglom-

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erate that has included between 28 and 35 institutions at any given time. Founded in 2001, the consortium prospectively enrolls and collects demographic and procedural information for all pediatric sedation procedures performed at centers in the PSRC. The database is housed at the Dartmouth Bioinformatics Service Center, in Lebanon, N.H. The investigators identified 28,792 patients in the PSRC whose body mass index (BMI) index could be calculated. They compared sedation-related outcomes, adverse events and required interventions for obese and non-obese patients. To be considered obese, patients had to fall in the 95th percentile or above in terms of BMI. Roughly three-fourths of the patients received propofol, either as a single agent or in combination with an analgesic. Other sedatives included chloral hydrate, dexmedetomidine (Precedex, Hospira), diazepam, etomidate, ketamine, methohexital (Brevital, JHP Pharmaceuticals), midazolam, pentobarbital and thiopental. Adverse events overall were more prevalent in obese patients (6.1% vs. 4.1%; P<0.001), with small increases in airway obstruction (2.1% vs. 1.1%; P<0.005), oxygen desaturation (1.3% vs. 0.7%; P<0.005), laryngospasm (0.4% vs. 0.2%; P<0.005), prolonged sedation/recovery events (0.35% vs. 0.13%; P<0.05) and sedation failures (0.39% vs. 0.2%; P<0.05).

Clinical 21

Pharmacy Practice News • December 2012

Critical Care ‘Administering a dose of midazolam based on ideal body weight—not accounting for the distribution into fat—could lead to sedation failure.’ —John Devlin, PharmD Although the relative increase for many of these complications was large, their absolute incidence was low. For example, the increase in laryngospasm doubled from 0.2% to 0.4%, but the complication occurred in only one of 250 of the children who were obese. According to Dr. Scherrer, however, “in terms of the overall number of pediatric patients who have received procedural sedation in the United States ... it ends up being a substantial number of patients.” In a multivariate logistic regression analysis, patients who were obese were more likely to have minor complications (odds ratio [OR], 1.28; 95% confidence interval [CI], 1.15-1.54) and moderate events (OR, 1.83; 95% CI, 1.51-2.21). No difference was identified for major adverse events. Airway interventions were more common in obese than in non-obese patients, including repositioning (40.5% vs. 34.3%), jaw thrust (22.1% vs. 17%), suctioning (16.3% vs. 13.2%), placement of an airway (15.8% vs. 12.1%) and bag/ valve/mask ventilation (4.2% vs. 3.4%) ( <0.01 for all). (P John Devlin, PharmD, an associate professor of pharmacy at Northeastern

University, in Boston, said it is important to consider whether the effect of obesity on the pharmacokinetic properties of the sedatives administered leads to the higher incidence of sedation failure and longer sedation recovery in obese patients.

“For example, a sedative like midazolam is distributed widely in fat, having a high volume of distribution. Therefore, administering a dose of midazolam based on ideal body weight—not accounting for the distribution into fat—could lead to sedation failure,” Dr. Devlin said. “Conversely, administering a dose of sedative with a lower volume of distribution, like dexmedetomidine, using an obese child’s actual body weight could lead to a longer period for sedation recovery.” Information on whether doctors used ideal, adjusted or actual body weight

when dosing patients would have been helpful in interpreting the study data, he said. Dr. Scherrer said the database does not collect this type of information. “What we can say to providers who offer procedural sedation for pediatric patients is that you have to think about this increased risk in obese patients,” Dr. Scherrer said. She added that her group did not find any correlation between specific medications that were used and the frequency of adverse events. —Kate O’Rourke

22 Clinical

Pharmacy Practice News • December 2012

Critical Care

Is Dexmedetomidine More Cost-Effective Than Propofol?

exmedetomidine is a more costeffective option than propofol for sedating mechanically ventilated patients after cardiovascular surgery, according to a single-institution, retrospective study. “Patients got off the ventilator quicker with dexmedetomidine,” said Matthew Wanat, PharmD, a clinical assistant professor at the University of Houston College of Pharmacy, and a clinical specialist at The Methodist Hospital in Houston.

Although dexmedetom midine (Precedex, Hospira) is increasingly popular with physicians, some administrators have pushed back against its use because of the higher up-front costs. Th he acquisition cost (average rage wholesale price) of one day of sedation for a 70-kg patient is $369.94 for

dexmedetomidine (0.5 mcg/kg d per hour) and $101.61 for propofol (35 mcg/kg per minute), according to Dr. Wanat, who led the study, which was presented at the American College of Clinical Pharmacy’s C viirtual poster session. The retrospective study included patients aged 18 years or older who underwent either coronary artery bypass

graft surgery and/or valve surgery at Methodist between January and June 2011. Of the 352 patients, 319 received propofol and 33 received dexmedetomidine as the primary sedation drug. The investigators analyzed factors including acquisition costs of the drugs, acquisition costs associated with the addition of a second agent for sedation, costs associated with mechanical ventilation and costs associated with delirium. The average cost of sedation per patient was $1,647 for dexmedetomidine and $1,831 for propofol. Dexmedetomidine reduced mechanical ventilation time and the need for a second sedative agent. There was no difference in delirium costs. “We are already using a lot of dexmedetomidine in ICUs. This study adds to our comfort level that dexmedetomidine is cost-effective,” said Marcia Buck, PharmD, a clinical pharmacy coordinator at the University of Virginia Children’s Hospital, in Charlottesville. “With the downsides of using propofol in terms of its toxicity profile, it is good to have this kind of data available.”

Study’s Shortcomings Hamper Concrete Conclusions John Devlin, PharmD, an associate professor in the Department of Pharmacy Practice at Northeastern University, and a scientist in the Division of Pulmonary, Critical Care and Sleep Medicine at Tufts Medical Center, in Boston, said it was hard to draw conclusions from this cost-analysis, given that clinical outcomes (e.g., duration of mechanical ventilation and delirium) were not based on data from a randomized controlled trial. “It is likely that underlying patient characteristics, with the potential to influence the clinical outcome—duration of mechanical ventilation—influenced the decision by clinicians to choose dexmedetomidine over propofol as the postsurgical sedative regimen,” commented Dr. Devlin. For example, he said, physicians at his institution generally avoid dexmedetomidine in cardiac surgery patients with underlying severe congestive heart failure and those who remain vasopressor-dependent after surgery. “Furthermore,” Dr. Devlin said, “there may be a bias to use dexmedetomidine in those patients who are expected to be extubated soon after surgery, given that dexmedetomidine does not influence respiratory drive and maintains greater patient arousability.” —Kate O’Rourke Drs. Wanat and Buck reported no relevant ﬁnancial conﬂicts of interest. Dr. Devlin has received research grants and honoraria from Hospira.

Clinical 23

Pharmacy Practice News • December 2012

Neurology

Weighing Risks and Beneﬁts in Epilepsy Rx Decisions Pharmacists should not discount antiepileptic agents due to toxicity

atients vary in their response to the various available epilepsy therapies, often requiring clinicians to weigh the risks of untreated disease with those for potential drug toxicities. Pharmacists should consider these constraints when consulting with epilepsy patients about their therapy, according to experts in the field of epilepsy. For example, pharmacists should respect—but not fear—the agent felbamate because, although it has some associated toxicity, it is an excellent drug for refractory epilepsy in patients over the age of 4 years, especially those with refractory Lennox-Gastaut syndrome (LGS), according to pediatric neurologist Mary L. Zupanc, MD. Calling felbamate “one of the best drugs we have available” for intractable epilepsy, Dr. Zupanc told Pharmacy Practice News that “doctors are increasingly using it, and pharmacists need to become familiar with this drug.” Some pharmacists have cautioned patients against taking felbamate, based on fears stemming from reports of aplastic anemia and liver toxicity after the drug received FDA approval in 1993. But these warnings to patients are misguided, said Dr. Zupanc, the director of the Comprehensive Epilepsy Program and the chief of the Division of Child Neurology at the Children’s Hospital of Orange County, in Orange, Calif. Dr. Zupanc said she was part of the investigational team for the drug and has used it extensively since 1987, before it was FDA-approved. The risks associated with felbamate must be weighed against the risks of inadequately controlled epilepsy, Dr. Zupanc stressed. Those risks include sudden unexplained death in epilepsy, progressive cognitive and motor decline and loss of independence, as well as depression, anxiety and suicide. Timothy E. Welty, PharmD, FCCP, BCPS, a professor and the chair of the Department of Clinical Sciences at the College of Pharmacy and Health Science of Drake University, in Des Moines, Iowa, agreed that pharmacists should be more circumspect in their criticism of a given antiepileptic drug (AED) because it might be appropriate for a particular patient despite its side-effect profile. Suggesting “a bit of caution,” he said, “Making broad statements about the appropriateness or safety of certain [epilepsy] drugs may not be needed. That’s especially true with a drug like felbamate, which requires a patient’s consent to be signed,” said Dr. Welty, whose practice is in neurology with a focus on epilepsy. Dr. Welty said he has seen similar overreaching in community pharmacy data-

bases for such medications as lamotrigine, which can cause an allergic rash. “Clearly there’s an increased risk for serious dermatologic reactions in children who take lamotrigine versus adults, but nowhere is it strictly contraindicated,” he said. Pharmacists should “try to understand that in treating patients with epilepsy drugs … especially when the patient is treated in an epilepsy center, a good amount of effort has been given to weighing the various options.” Concern about felbamate initially arose when 34 cases of aplastic anemia, 14 of them fatal, and 18 cases of liver toxicity, nine fatal, were reported among the 110,000 patients who were prescribed felbamate in the first year after its release. Virtually all cases occurred within six months of starting treatment; 68% were women, none were children under the age of 13 years, and all were on polytherapy.

cytopenia or autoimmune disorder and a positive antinuclear antibody titer. Of the 18 reported cases of liver toxicity, nine were adults and nine were children, 78% were females, and most patients were on polytherapy. The risk for liver toxicity with felbamate is estimated at between 1:6097 and 1:15,625, she said. Weekly or biweekly monitoring for side effects—including monitoring of complete blood count with differential, reticulocyte count and aspartate aminotransferase/alanine aminotransferase ratio—is recommended during the first three to six months of treatment. Properly monitored, felbamate plays an important role in helping many young patients who are severely disabled due to their epilepsy, particularly those with LGS, said Dr. Zupanc. “Felbamate wakes these kids up,” she said, noting that before felbamate came on the market, many of her patients with LGS were nonverbal

The components of a ketogenic meal, showing the breakdown of proteins, fats and carbohydrates, in grams.

As a result of those incidents, felbamate almost was removed from the market. But it has stayed on-label for children over the age of 4 years who have LGS and for patients with medically refractory epilepsy for whom the benefits of the drug outweigh the risks, due, in part, to advocacy efforts by the Child Neurology Society and parents who have seen the drug effectively control their children’s illness, she said. The estimated risk for aplastic anemia in patients taking felbamate is 27 to 209 per million, compared with two to six per million in the general population, she reported (Pediatr ( Neuroll 2010;46:396403). Major risk factors include female gender, postpubertal status, history of

and wheelchair-bound. After taking felbamate, she added, “a significant proportion of these patients became more alert and started verbalizing. Some of them even started walking.”

No Ideal Agent; Clinicians Must Choose the Best Option Dr. Zupanc reviewed the role of several other AEDs that clinicians have in their armamentarium. Some of them are not ideal, but in certain patients, they are the most viable option. For example, valproate is FDAapproved for both partial and generalized seizures, but it is relatively contraindicated in women of reproductive age. In adolescent girls, the drug may

increase the risk for polycystic ovarian syndrome (POS) and anovulatory cycles. (The risk for POS is approximately 56% in women with generalized epilepsy with exposure to valproate within the previous three years.) An international study indicated that babies born to women who had been taking valproate had a 10-point lower IQ than children in a control population. Despite these collective risks, Dr. Zupanc noted that for some women with epilepsy, valproate “is the only medication that controls their seizures, and so it is not a strict prohibition, it is just something that most clinicians are aware of. They will try to use other medications first.” Lamotrigine carries a black box warning for an allergic rash, but if it is titrated up slowly, the risk for an allergic rash is no greater than that for other AEDs, noted Dr. Zupanc. The risk for rash increases in the pediatric population, when the drug is coadministered with valproate or if it is titrated too rapidly. “If you add valproate to lamotrigine, you must cut the lamotrigine dose by over 50% because valproate inhibits the metabolism of lamotrigine,” she said ((Epilepsy Currr 2004;4:206-207). Most rashes occur within two to eight weeks of starting treatment. Lamotrigine also can lead to anxiety, obsessive-compulsive behavior, tics and sleep disturbance, said Dr. Zupanc. “The good news is that it does not affect cognitive function,” she added. Levetiracetam is used as adjunctive therapy for myoclonic seizures, generalized tonic-clonic seizures and partialonset seizures. “Parents like it because there are no drug interactions, it does not cause an allergic rash and it does not affect the bone marrow or liver,” Dr. Zupanc said. The most significant side effect is behavior disinhibition, which can be problematic in irritable patients or those with autism. Topiramate, which is indicated for use in children aged 2 years and older for adjunctive therapy in the treatment of partial seizures or generalized tonic-clonic seizures, can cause cognitive impairment and word-finding difficulties. “I’d use it with caution in someone who has a normal IQ,” she said. Thus in toddlers learning to speak or normal teenagers, topiramate probably is not the medication of choice; however, for a nonverbal, cognitively impaired child, it may be an appropriate option. Zonisamide, indicated for the control of partial seizures, is similar to topiramate, but “probably has less cognitive side effects,” said Dr. Zupanc. But she noted

•

see EPILEPSY, page 24

24 Clinical

Pharmacy Practice News • December 2012

Neurology

EPILEPSY continued from page 23

that both drugs “can cause oligohydrosis, and in southern California that can be a real problem.” Both drugs also can cause decreased appetite and weight loss. Dr. Zupanc stressed that surgery for epilepsy should not be viewed as a last resort. If an AED is not effective in controlling seizures, the chance of a second drug working is only 10%, and if an AED is not well tolerated due to side effects, the chance of another AED working is 40%. Patients should be evaluated at a tertiary care center for epilepsy surgery if two or three AEDs have failed, she said. Specifically, she noted, “If I have a baby who has a lesion and they’re failing their first antiepileptic medicine, I’ll be working them up for epilepsy surgery right away because the catastrophic effects of epilepsy on the developing brain are real, and the time to intervene with epilepsy surgery is when a patient is young. The developing brain is much more vulnerable to the catastrophic effects of epilepsy, and the brain has the greatest plasticity … when [patients are] young, so the time to intervene is right away.” Pharmacists can play a key role by regularly asking epilepsy patients whether they are having side effects from their medications and whether they are continuing to have seizures, said Dr. Welty. “If the answer to either question is yes,

the patient should get to an epilepsy center if they’re not already there,” he said. In some types of epilepsy, the data show that approximately 70% of patients who continue to have seizures on medications will become seizurefree with surgery, Dr. Welty noted. The current standard is to consider surgery after two or three medications have failed, but national data show that the time from a diagnosis of epilepsy to the recognition that the illness is refractory and that surgery may be warranted averages about 10 years for adults. “It’s taking too long, and pharmacists can play a very important role in identifying patients who would benefit from getting to an epilepsy center” where treatment options such as surgery or clinical trials are available, he said.

The Ketogenic Diet: Challenging but Effective The ketogenic diet, a high-fat, lowcarbohydrate diet that forces the body to burn fats rather than carbohydrates, inducing a state of ketosis, can be an effective treatment for epilepsy, but “the problem is that you have to weigh and measure every piece of food that comes across your mouth,” said Dr. Zupanc. The classic ketogenic diet consists of a 4:1 ratio by weight of fat to carbohydrate and proteins, so it requires highly motivated and organized families, she noted. In such patients, the diet can be very

successful, said Beth Zupec-Kania, RD, a consultant dietician with The Charlie Foundation, an organization established to raise awareness of the diet. According to a Blue Cross Blue Shield meta-analysis, 50% of patients who trial the diet experience a 50% or greater improvement in seizure control and 15% become seizure-free (Lefevre FV. Chicago: Blue Cross Blue Shield Association; 1998). Pharmacists can play an important role in supporting families whose children are on the ketogenic diet because medications are a key source of carbohydrates. Pharmacists can review medications for patients, recommend lowcarbohydrate alternatives and determine if certain medications can be crushed or dissolved without affecting the integrity of the active ingredients, she said. They can inform parents of the carbohydrate content of medications, so that carbohydrates in the diet can be adjusted accordingly, and they can compound carbohydrate-free medications and determine whether a compounded medication will lose its potency with time. Additionally, pharmacists can help establish protocols for dealing with patients on ketogenic diets who are admitted to their institutions. For example, Ms. Zupec-Kania noted that some hospitals have protocols in place that require patients on the ketogenic diet to be identified at admission and define protocols for “NPO [nothing-by-mouth]

status-ketogenic diet therapy,” with further instructions to obtain glucose every four hours and address as needed. Additional protocols delineating the use of supplements and medications provided by the family can be helpful as well. “We can prevent problems by having these protocols in place,” she said. Ms. Zupec-Kania has developed a comprehensive database for licensed health care professionals listing the carbohydrate content of various foods, vitamin and mineral supplements and brandname prescription medications called the KetoCalculator (www.ketocalculator. com). The nutrient content based on data from the USDA, food manufacturers, baby formula makers and pharmaceutical companies is reviewed and updated annually on the website. Ms. ZupecKania also has created a second database of over-the-counter products that can be downloaded from The Charlie Foundation’s website. —Susan Birk Based in part on presentations during the 2012 summer meeting of the American Society of Health-System Pharmacists. Dr. Zupanc is a consultant for Lunbeck and Questor. Ms. Zupec-Kania is the author of the KetoCalculator and a consultant for The Charlie Foundation. Dr. Welty is an investigator for the Equigen study of generic antiepileptic drug substitution funded by the FDA, the American Epilepsy Society and the Epilepsy Foundation.

OPERATIONS & MANAGEMENT

Care Transitions

INTERVENTIONS continued from page 6

to the next provider; and a transition conference with the patient, family and/or caregiver to set post-discharge goals and address risks and barriers that could lead to rehospitalization. Pharmacists attended these conferences only for the most complicated cases because patients and families said they were overwhelmed by the number of providers in the room, Dr. Gullickson said. Furthermore, “it takes 30 to 45 minutes a day for those conferences, and we don’t have the resources to commit our staff to attend all of those.” Inpatient pharmacists spent an average of 50 minutes and made an average of three drug therapy recommendations per patient, with an acceptance rate among providers of 68%. “The reason it wasn’t higher was that many of the interventions … didn’t need to be addressed right away in the hospital” and could be handled by the ambulatory physician, Dr. Gullickson said. The hospital was not able to track follow-up on those recommendations.

“That’s still a hole that we need to work through in our system,” she said. The hospital conducted similar pilots for heart failure and inpatient-to-SNF patients. The heart failure pilot compared a pharmacist review and education at discharge plus a follow-up phone call and a clinic visit with a pharmacist review at the clinic visit only. There were 13.6 interventions per patient in the transitions arm versus 6.9 in the clinic-only arm. In all, 69% of interventions in the clinic-only arm could have been addressed earlier with inpatient pharmacist involvement, reported Dr. Gullickson. Data for the SNF pilot are still pending.

At Sharp Memorial, Tracking From Admission to Discharge The Continuum of Care Network at Sharp Memorial Hospital, San Diego, one of eight organizations recognized by ASHP for pharmacist innovation in care transitions, focuses on heart failure patients but takes referrals from hospitalists, case managers, social workers and other team members for high-risk patients with all diseases. The program, a cooperative effort with

the Touro University-California College of Pharmacy, in Vallejo, involves a pharmacy postgraduate in work that extends beyond the boundaries of medication reconciliation, drug interactions and dosing, said Julie Truong, PharmD, a Continuum of Care resident pharmacist. Dr. Truong monitors patients on a daily basis from admission to discharge, looking at renal function, laboratory results, microbiology changes and other variables, and working closely with the entire care team to “anticipate discharge medications. It’s not just dropping in here and there, it’s really the entire process that I take responsibility for,” including making sure patients are able to pick up their medications at the community pharmacy. That comprehensive involvement “really broadens the pharmacist’s role,” she said. In the program’s first several months, resident pharmacist Andrea Backes, PharmD, focused on medication reconciliation at discharge and follow-up home visits five days post-discharge. Although discharge is where many medication problems eventually surface, “I noticed that a lot of problems

happen at the forefront—at the admissions side,” Dr. Truong said. She said that monitoring patients starting at admission helps to nip those problems in the bud. “Ideally we’d love to have [a pharmacist] who could work admissions, discharge and at home, but we had to ‘pick our battles,’ ” added Albert Rizos, PharmD, a system senior clinical pharmacy specialist at Touro. With Dr. Backes’ discharge and home-visit work and Dr. Truong’s current admissionthrough-discharge focus, “we’re getting extremely valuable data across all three,” and hopefully, those data ultimately will be used to demonstrate the value of these interventions and support the addition of pharmacy resources, he said. To date, the two residents have tracked interventions on 466 patients. The heart failure core measure compliance rate, which was in the 85th percentile at baseline, has risen to the 97th percentile with the pharmacist intervention, said Dr. Rizos. Outcomes data will be available next year. —Susan Birk

Policy 25

Pharmacy Practice News • December 2012

Late-Breaker

COMPOUNDING

The aim of the task force, he said, will be to consider and perhaps rewrite the state’s rules and requirements for compounding and manufacturing “both in our state and probably for products shipped in across our state lines.”

continued from page 3

the country in many cases, and that has crossed the line from that traditional compounding into drug manufacturing.” Dr. Carome said the FDA has the authority, under the federal Food, Drug and Cosmetic Act (FDAC), to regulate such manufacturing to ensure that drugs are safe and effective before approval and to make sure that companies continue to follow good manufacturing practices after approval. “We’re astonished,” he said, “that given that long history of stated authority they’re now reversing themselves and saying they lack that authority. We believe that is really an attempt to dodge responsibility for their failures that contributed to the meningitis outbreak.” The agency claims its authority is not so clear—a point made by the FDA Commissioner, Margaret Hamburg, MD, in testimony before the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP), which has jurisdiction over public health issues. Dr. Hamburg said that although the Food and Drug Administration Modernization Act of 1997 gave the agency the power to restrict the compounding of certain drugs and limit the quantity of compounded drugs shipped out of state, subsequent court challenges “have produced conflicting case law and amplified the perceived gaps and ambiguity associated with FDA’s authority over compounding pharmacies.” She added that the agency was looking “forward to working with Congress to address these issues.”

Where To Draw the Line On Regulatory Oversight? Wherever the fault in the current crisis, many believe that Congress needs to clarify the clouded boundary between the states’ long-established responsibility to inspect and license traditional pharmacies that compound preparations for individual patients and the FDA’s obligation to monitor the activities of larger compounding companies and step in when they cross the line into manufacturing. But where should the line be drawn? The ASHP’s Dr. Thompson called it “a regulatory gray area.” He said there was a “big difference” between the type of manufacturing done by companies like Pfizer, Merck and Amgen— and by the big generic companies as well—and “what is happening out there that looks like manufacturing in some compounding pharmacies.” Dr. Thompson was one of a handful of stakeholders who testified at the Senate HELP Committee’s mid-October hearing. He told committee mem-

NABP Issues National Plan of Action

bers that “once compounding activities advance along the continuum to manufacturing and the risk to patient safety and public health increases, there may be a need for a special category of FDA oversight that falls between compounding and manufacturing,” but does not require a new drug application or approval by the agency. He cited the example of a compounding pharmacy that sells to other organizations and not directly to patients. “They may need to be regulated by the FDA,” he said. “Doing so would allow hospitals, clinics and physician offices to purchase sufficient quantities of compounded product as is necessary to meet patient needs, while doing so under the assurance that they are making those purchases from appropriately regulated sources.”

Committee sent a letter to all 50 state boards of pharmacy seeking details concerning how they oversee the nation’s 5,000 to 7,500 pharmacies that specialize in compounding, more than 3,000 of which engage in sterile compounding, according to the International Academy of Compounding Pharmacists. Tom Van Hassel, RPh, MPA, the director of pharmacy at Yuma Medical Center in Yuma, Ariz., and the vice president of the Arizona State Board of Pharmacy, said he was planning to attend a Dec. 19 meeting of state pharmacy board executives in Washington, D.C., convened by the Senate HELP Committee. The Arizona board’s executive director, Hal Wand, RPh, MBA, also will attend, according to Mr. Van Hassel. Mr. Van Hassel said the Arizona board also has named a task force to

‘Once compounding activities advance along the continuum to manufacturing and the risk to patient safety and public health increases, there may be a need for a special category of FDA oversight that falls between compounding and manufacturing.’ —Kasey Thompson, PharmD Although boards of pharmacy are protective of their right to regulate compounding pharmacies within their state lines, many might be less apt to push back against perceived federal intrusion if the FDA were given a clear mandate to act collaboratively with them in regulating activities that they might not have the resources to carry out on their own, such as those of large compounding companies that ship product into and outside their state. In late November, the Senate HELP

determine its future course regarding the regulation of pharmacies that compound products for wider distribution. “The problem in our state and really every state is that there are no clear lines defining what is compounding and what is manufacturing,” he said. “It’s really difficult when you look at the whole gamut of compounding that goes on around the country. It’s hard for boards of pharmacy to know what they should be checking and what the FDA should be regulating.”

In response to the crisis, the National Association of Boards of Pharmacy (NABP) issued a national action plan designed to help individual states bolster their regulation of nontraditional compounding pharmacies like NECC. Carmen Catizone, MS, RPh, DPh, the executive director of NABP, told Pharmacy Practice News that “a number of states have asked us to represent them and coordinate their activities” relating to the Congressional inquiries and how the state boards might respond to the crisis. As an example, he said, “Iowa has contracted with us to inspect all 582 of their nonresident pharmacies. They are identifying how many of those are traditional sterile and nonsterile compounding pharmacies and how many are nontraditional (like NECC), which is the problem area that we’re going to focus on.” Dr. Catizone said NABP was sending Iowa’s list to all states and asking them to supplement the information by stating if the pharmacies exist, if they are compounding and if they are involved in nontraditional compounding activities—meaning the wider distribution of compounded products to multiple users, rather than in response to individual prescriptions. After the pharmacy list is fine-tuned, Dr. Catizone said NABP will “physically inspect all those pharmacies and update them in our database, creating profiles for new pharmacies that we find, and then make that information available [in special reports] that our public and the states can share.” He said NABP has the staff resources to carry out the inspections. “Last year we accredited 30,000 pharmacies for the CMS Durable Medical Equipment program, so we have field staff as well as in-house staff to review documents and special reports, policies, procedures, all those things. So we’re geared up, and it’s going to start in December.“ But additional support will be needed, he added, including training for inspectors and staff on the new requirements. “What’s going to have to happen,” he said, “is a public-private partnership with groups like NABP, where we actually do the inspections or assist the states in doing inspections and then the pharmacies pay fees to these private organizations for that work.” —Bruce and Joan Buckley

26 Policy

Pharmacy Practice News • December 2012

FDA Watch

New Oral Therapy Approved for Rheumatoid Arthritis

he FDA has approved tofacitinib (Xeljanz, Pfizer)—the first oral biologic agent for the treatment of rheumatoid arthritis (RA)—for use in patients with moderate to severe RA who have had inadequate response or intolerance to methotrexate. The drug may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). It should not be used with other biologic DMARDs or with potent immunosuppressant drugs, such as azathioprine and cyclosporine. Pfizer sought approval of two twicedaily doses for tofacitinib, 5 and 10 mg,

but only the 5-mg twicedaily dose was approved. The company plans to continue to evaluate the 10-mg dose for RA and also is studying the drug for other indications such as ulcerative colitis, psoriasis and Crohn’s disease. The FDA approved tofacitinib, a Janus kinase inhibitor, with a Risk Evaluation and Mitigation Strategy that requires dissemination of safety information, including details about the risks for serious infections, tuberculo-

sis, cancers and lymphoma. The agency also is requiring Pfizer to conduct postmarketing studies to evaluate tofacitinib’s potential longterm effects on heart disease, cancer and serious infections. Although as an oral therapy, tofacitinib has an advantage over injectable RA agents, such as adalimumab (Humira, Abbott), etanercept (Enbrel, Amgen) and infliximab (Remicade, Johnson & Johnson), an analysis from GlobalData indicates that Pfizer’s “high hopes” for this new drug “may not be fully real-

Omacetaxine Approved for CML

n Oct. 26, the FDA approved omacetaxine mepesuccinate (Synribo, Teva) for treatment of chronic myelogenous leukemia (CML). Omacetaxine is approved to treat adult patients who have chronic-phase (CP) or accelerated-phase (AP) CML and have exhibited resistance or intolerance to two or more tyrosine kinase inhibitors (TKIs). Omacetaxine received an accelerated approval based on response rate, rather than improvement in disease-related symptoms or increased survival, according to a press release from Teva. The drug’s effectiveness was evaluated in a combined cohort of patients whose

cancer progressed after prior treatment with two or more TKIs. All patients received omacetaxine. Among patients with CP-CML, 18% (14 of 76) achieved

a major cytogenetic response (MCyR), with a mean time to MCyR onset of 3.5 months and a median MCyR duration of 12.5 months. Among patients with

he FDA recently approved a labeling update for entecavir (Baraclude, Bristol-Myers Squibb) based on two studies of patients with hepatitis B virus (HBV) infection. The new labeling for the nucleoside analogue includes data on black patients with HBV infection as well as liver transplant recipients with the disease. HBV is of particular concern to the black community, with approximately 2 million individuals in the United States infected. Similarly, patients with end-stage liver disease and HBV require special attention, because these

AP-CML, 14% (five of 35) achieved a major hematologic response (MaHR), with a mean time to response onset of 2.3 months and a median MaHR duration of 4.7 months. Administered subcutaneously, omacetaxine is to be dosed twice daily for 14 consecutive days of a 28-day cycle at treatment induction, and twice daily for seven consecutive days of a 28-day cycle during maintenance therapy once a response is achieved. The most common side effects reported during clinical studies included thrombocytopenia, anemia, neutropenia, diarrhea, nausea, fatigue, injection site reactions and lymphopenia. —George Ochoa

FDA Approves Labeling Update for Entecavir

ized until safety and efficacy is proven to that of current biologics.” Based on their analysis and feedback from clinicians, Dina S. Rufo, MS, a therapy area analyst for GlobalData, predicted that tofacitinib “will play a third-line therapy role” until such time that comparable safety and efficacy is established. Tim Anderson, an analyst at Sanford Bernstein, further noted that “it is understandable why [new] patients might prefer an oral therapy versus one that requires needle-based delivery,” but he predicted that patients currently benefiting from other agents would be unlikely to switch. —Sarah Tilyou

patients may underggo liver transplantation as a trreatment option, but recurrence of HBV can damage the new livver. Entecavir is FDAapproved for adults witth chronic HBV infectio on with active viral repliication and either evidence of persistent elevations in alanine aminotransferase (ALT) or aspartate aminotransferase, orr histologically active disease. ease.

In thee first study on which the new labeling was based, investiigators assessed entecavir (0.5 mg once daily) in hepatitis h B e antigen ( HBeAg)-positive or negative, nucleosidenaive black (n=40) and Hispanic patients ((n=6) wit h c hro n i c HB BV infection. Thirtytwo patients (70%) achieved HBV DN NA levels less than 50 IU/mL att 48 weeks; 31 patients (67%) had normalization of ALT,

and 12 of 26 (46%) HBeAg-positive patients experienced HBeAg seroconversion. Because of low enrollment, the safety and efficacy of entecavir in Hispanic patients was not established.

Second Study In the second study, investigators assessed the safety and efficacy of entecavir (1 mg once daily) in 65 patients who had received a liver transplant for complications arising from chronic HBV infection. Of the 53 patients (82%) who completed the trial, all achieved HBV DNA levels less than 50 IU/mL at or after 72 weeks of treatment. —Staff

28 Technology

Pharmacy Practice News • December 2012

Automation

Robot Chemotherapy Prep Boosts Accuracy, Safety R

obotic antineoplastic preparation and adjuvant medication compounding improved medication preparation accuracy, reduced staff safety events and reduced overall costs but did not reduce the incidence of serious errors, during a recent observational study by researchers from two centers in Boston. Investigator Jeffrey M. Rothschild, MD, MPH, an associate professor of medicine at Brigham and Women’s Hospital and Harvard Medical School, said the study, the results of which were published online by the Journal of Oncology Practice on Sept. 25, was the first of its kind in the United States. The study was conducted to determine whether robotic antineoplastic and adjuvant medication compounding of bags and syringes could provide incremental safety and efficiency advantages compared with standard manual pharmacy preparation. The antineoplastic preparation process includes several stages that are vulnerable to opportunities for potentially harmful medication errors, including using the incorrect drug, dose, concentration or storage, said Dr. Rothschild. So these drugs have to be prepared with “great care because of their toxicity and narrow therapeutic window.” Intravenous formulations of antineoplastic agents present additional safety challenges. Dr. Rothschild and his co-investigators found that although the incidence of medication errors remained con-

Table. Medication Errors, Staff Safety Events With Robotic Versus Manual Antineoplastic Preparations Study Period

Robotic preparations (intervention period)

Serious Medication Errors, %

Staff Safety Events, %

0.7

5.1

0.7

2.9

Based on Seger AC, et al. J Oncol Pract. 2012 [ePub ahead of print]. doi:10.1200/JOP.2012.000600.

stant (0.7%; Table) during the baseline and robotic periods, robotic compounding improved the accuracy of prepared antineoplastic and adjuvant medications. From May 2009 when the study began at Brigham and Women’s and Dana-Farber Cancer Care Center, to April 2011 when it ended, medication accuracy rates improved from a failure rate of 12.5% in the manual preparation baseline period to a rate of 0.9% in the trial period with the robot ((P=0002). Using a ±5% variance, Dr. Rothschild said, that represented an accuracy improvement rate of 96%, which he called “impressive.” A secondary analysis using a ±10% variance measured eight failures, a 4.5% failure rate, in the baseline period compared with none in the intervention period. The percentage of observed staff safety events that had the potential to cause staff harm—such as spills/leaks,

closed-system transfer device failures, wrong technique and the failure to wear protective equipment—declined from 5.1% to 2.9% ((P=0.007). In addition to patient safety concerns, manual antineoplastic preparation, dispensing and waste disposal “create significant staff risks and consume significant staff time and costs,” Dr. Rothschild said. The many safety steps required include the correct matching of the order to the patient and the medication, drug transfers to both intermediate and final delivery containers and the careful disposal of waste. Additionally, the costs for the process done manually, including materials, equipment and labor, are quite high. Commenting on the study, Luci A. Power, MS, RPh, the senior pharmacy consultant for San Francisco, Calif.based Power Enterprises, described the findings as “very interesting, though

preliminary,” adding that this study of robotic technology supporting a cancer treatment center “definitely sets the stage for further research.” Although the percentage of spills and leaks, which accounted for 34 of the 73 staff safety events observed in the manual phase of the study, declined to 23 of the 28 events observed in the robotic phase, both Dr. Rothschild and Ms. Power noted that the decline could not be considered significant because the number of spill/ leak events measured were too low. Both said more studies are required to determine the benefits of robotic preparation in this area of staff safety.

Overall Costs Decreased During the trial, the mean costs for ancillary materials per preparation declined from $13.36 in the manual baseline period to $6.44 in the robotic intervention period. Dr. Rothschild explained that “by eliminating the pharmacy technician’s handling of open/exposed antineoplastic and adjuvant medications during robotic preparations, we were able to reduce ancillary costs associated with several components of the closed-system transfer device, particularly the vial and injection adapter components.” He further noted that “the savings for those components accounted for 60% of the overall costs of the closed-system components. When annualized for

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Technology 29

Pharmacy Practice News • December 2012

Automation the 16,500 antineoplastic bags/syringes that were prepared for the hospital in 2009, the savings in material costs would have been $115,500.” Although the pharmacy technician’s mean drug preparation time increased 160%, from four minutes, 12 seconds in the baseline period to 10 minutes, five seconds in the intervention period, the study showed that pharmacist’s mean drug preparation time decreased by 76%, dropping to 46 seconds in the intervention period from three minutes, 13 seconds in the baseline period. Dr. Rothschild attributed the decrease in the pharmacist’s time during the intervention period to “the quicker scanning process associated with the robotic software package. The pharmacist could scan the final administration container with all the product information displayed on a single screen, saving the time that pharmacists need to manually gather various verifying data, both in computer and written form.” The total mean drug preparation times for pharmacists and technicians together increased from seven minutes, 24 seconds in the baseline period to 10 minutes, 51 seconds in the intervention periods. Based on hourly salary and fringe benefit costs of $25.44 for technicians and $64.23 for staff pharmacists, mean total pharmacy labor costs per preparation dropped from $5.22 during the baseline period to $5.10 for the intervention period. During the intervention stage, the medications were prepared by the Brigham and Women’s Hospital pharmacy using a CytoCare Robot compounder made by Bolzano, Italy-based Health Robotics. After the trial, as a way to further increase accuracy in the future, the pharmacy installed Health Robotics’ i.v. SOFT gravimetric workflow software for manual preparations of antineoplastic drugs and adjuvant medication compounding and also re-educated its staff to improve accurate manual preparations, Dr. Rothschild noted. Although robotic compounding environments offer the potential for safer and more cost-effective antineoplastic and adjuvant medication preparation, they also could introduce unintended consequences including potential or actual harmful outcomes. Over the course of this study, Dr. Rothschild reported, there were 45 events of unintended consequence specifically attributable to the new technology (4.6%), including 41 mechanical and four software failure events. None of these events resulted in a final product, and they were not judged to be serious medication errors. They included 24 cases with no drug injected into the bag or syringe; four cases in which the internal checking system of the robot rejected the drug

‘The pharmacist could scan the final administration container with all the product information displayed on a single screen, saving the time [needed] to manually gather various verifying data ....’ —Jeffrey M. Rothschild, MD, MPH due to incorrect weight; three cases of bags, syringes or needles dropped or cracked before they were completed; three reconstitution shaker failures; two malfunctions of medication carousels;

five other mechanical failures; and four software failures that prevented the completion of drug preparation. Future additional studies, Dr. Rothschild and Ms. Power both said, are

needed to address the overall costs and benefits of using what Dr. Rothschild called “this expensive but potentially valuable alternative to manual preparations of antineoplastic and adjuvant medications and the clinical impact of the improved accuracy of preparations.” Ms. Power said that she believes that IV robots “will be major contributors to future IV compounding” and was “pleased that authors of this caliber are investigating robot use in compounding cancer treatments.” —Elizabeth Parks

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30 Technology

Pharmacy Practice News • December 2012

Automation

Diana System May Help Boost Compounding Safety I

n the wake of the fungal meningitis outbreak associated with contamination in a compounding pharmacy, ICU Medical is introducing the Diana Hazardous Drug Compounding System to help improve the safety and accuracy of the compounding process. First introduced in Europe and now being brought to the United States, Diana was originally developed to protect patients and clinicians from hazardous drug exposure during chemotherapy preparation, but it “may also keep the drugs themselves safe from exposure to outside contaminants,” according to the company. “Diana is a user-controlled sterile automated compounding system that utilizes ICU Medical’s microbiologically and mechanically closed components,” Robert Houde, RPh, ICU Medical’s Oncology Division director, told Pharmacy Practice News. “With the pharmacy technician using proper technique, Diana can ensure the drug product is sterile and safe for the patient.” Tom McCall, the San Clemente, Calif.-based company’s vice president of marketing, added, “The system is designed so that nothing gets in, and nothing gets out.” The microbiologically and mechani-

cally closed design of the Diana system is achieved through a series of needlefree components, including closed-vial access devices, male luers and connectors, according to a company press release. Throughout the automated compounding process, the components protect the drug from exposure to environmental contaminants and protect the user from exposure to the drug and accidental needlesticks. Additionally, the Diana system components “have all been tested extensively” and shown to “maintain sterility throughout the process,” said Mr. Houde. “While we aren’t saying that the system could prevent an incident like the meningitis outbreak, in light of calls for more control of compounding, the Diana

system is a tool that could improve the process and increase sterility, accuracy and safety,” said Mr. McCall. Asked how the Diana system differs from existing products, Mr. Houde answered, “Unlike other automated compounding technologies that require huge investments and do not fit within existing workflows, the Diana system fits inside an existing biologic safety cabinet and keeps pharmacists and technicians in control of the compounding process from beginning to end.” The Diana system has been used in Europe for more than a year. Birgit Tans, PharmD, the chief oncology pharmacist at University Hospitals Leuven, in Belgium, told Pharmacy Practice News that her institution has used it since May 2011.

“We use the Diana system to work faster and more accurately, with no risk for drug contamination thanks to the closedsystem components that are a part of the system,” Dr. Tans said. Regarding the system’s disadvantages, she added, “It would be great if there was a greater degree of traceability of the preparation by integrating a bar-code reader for the drug input, and a scale to double-check that we have added the right amount of drug to the patient container.” On the other hand, she noted that the system has the following advantages: “All of the fluid transfer connection points are completely closed with the Diana system. And they are the same components used in the ICU Medical ChemoClave system [a closed-system transfer device], so I know I can trust them.” The first U.S. Diana customer, OhioHealth in Columbus, planned to implement the system in November, Mr. Houde said, with official product rollout occurring at the American Society of Health-System Pharmacists Midyear Clinical Meeting in December. —George Ochoa Dr. Tans reported no relevant ﬁnancial conﬂicts of interest.

NEW PRODUCT

Medi-Dose®, Inc./EPS®, Inc. Announces New ORAL LiquiDose® Butterfly Labels

ncidents of patients being dispensed oral medication intravenously have been reported by various professional standards organizations. The incorrect labeling and inadvertent use of intravenous (IV) syringes for oral medications has often been cited as causes for these tragic mistakes. To minimize the potential for error when dispensing oral medication, EPS has released six new LiquiDose Butterfly Labels, all with a distinct ORAL imprint. Available in white, blue, red, green, yellow and orange, all EPS LiquiDose Butterfly labels can be printed with a regular laser printer. Their unique hourglass design provides practitioners ample area for medication identification without covering important markings on the item being labeled. The label’s ORAL imprint is strategically placed so as not to limit the space for necessary labeling information. When used with the company’s inexpensive MILT

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3.0 software, pharmacists and nurses can take advantage of all the formatting and reporting capabilities the program has to offer. Bar codes, graphics, special fonts, tall man lettering, shapes and logos can all be included on the labels. “Every hospital has unique requirements,” said Bob Braverman, director of marketing. “The new ORAL Butterfly labels help facilities call attention to information they believe vital in promoting safety and practitioner awareness, while reducing the potential for medication error.” These new ORAL-imprinted Butterfly labels have been designed to withstand rough use and storage in drawers or bins. The aggressive adhesive ensures that labels won’t be detached from their applied surfaces (syringes, ampules, etc.). For more information on the EPS LiquiDose Butterfly Labels and the company’s complete line of oral syringes and dispensers, please visit www.MediDose.com, call 800-523-8966 or email info@medidose.com.

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