September 2011 - Digital Edition by McMahon Group

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Volume 38 • Number 9 • September 2011

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in this issue Pharmacists Phone Clinical Home for MTM Service Cardiology Strategy yields care and cost benefits, but challenges remain

telephone-based medication therapy management (MTM) program directed by pharmacists in Texas successfully lowered drug costs and resolved medical issues for participating Medicare Part D beneficiaries, according to reviews of the program. A sample of 60 Medicare Part D beneficiaries who received a pharmacist-provided telephone MTM consultation through the program, administered by the Scott & White Health Plan, had nearly twice as many medication and health-related problems resolved than did individuals in a control group who did not opt in to the program. Total Part D drug costs decreased by $588 for the intervention group

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see MTM SERVICES, page 42

Pop-up e-Reminders At Point of Care May Boost HCAHPS Scores Louisville, Ky.—A large health system is using bar code–enabled pop-up boxes on computer screens at the point of care to remind more nurses to educate patients about the potential side effects of medication therapy. The strategy, in place at the Hospital Corporation of America (HCA), has had a positive effect on how patients perceive the care they receive—an outcome that the health system hopes will translate to improved Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores. That, in turn, can mean higher consumer ratings and, ultimately, more revenue for the hospital, according to Noel C. Hodges, RPh, MBA, division director, HCA Central Atlantic Supply Chain, in Richmond, Va. “HCAHPS is a national survey to standardize

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see HCAHPS, page 38

Strategy slashes readmission rates for stroke.

Hem/Onc Pharmacy PARP inhibitors double progression-free survival in relapsed ovarian cancer.

Technology Rollouts Increase Efficiency at Christiana System E-prescribing, clinical decision support help ease workflow pressures, improve drug safety

IVIG FAQ

Infusions may ease Clostridium difficile infections.

Technology

Social Networking At ASHP Summer Meeting, Twitter birds came home to roost.

Operations & Mgmt

Practice Pearl Medication disposal dos and don’ts.

Leadership in Action Knowing when to speak, when to listen and other mentoring “nuggets.”

Policy

A Christiana Care physician enters her first CPOE orders, with assistance from a go-live support team member.

he lightning speed of a newly launched computerized prescriber order entry (CPOE) system backed by robust clinical decision support led to a sharp reduction in pharmacy workload at Delaware’s Christiana Care Health System, according to Terri Corbo, PharmD, BCPS, FASHP, vice president of pharmacy services.

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Joint Commission Pilot project underscores pharmacy’s role in discharge MTM.

Practice Pearl Preparing staff for field surveys.

Educational Review

Compatibility of Commonly Used Intravenous Drugs insert after page

see CHRISTIANA CPOE, page 22

Pharmacists and Anesthesiologists Partner To Improve OR Outcomes Denver—By teaming up with pharmacists, anesthesiologists can enhance their capacity to protect patient safety and their hospital’s bottom line. That was the common conclusion of two posters presented at the American Society for Health-System Pharmacists Summer Meeting— one proposing a new tool to track the

use, and waste, of anesthetic agents and another comparing the effectiveness of two popular inhaled anesthetics.

Safety Through Standardization Michael Chappell, RPh, operations supervisor at Methodist Dallas Medical Center,

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see COLLABORATION, page 8

New Product Pfizer Injectables Introduces Heparin Sodium Injection, USP. See page 44.

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Pharmacy Practice News • September 2011

Up Front 3

Clinical Controversies

Approval of Depot Naltrexone for Opioid Dependence Faulted S

ome addiction experts are questioning the wisdom of the FDA’s October 2010 approval of depot naltrexone (Vivitrol, Alkermes) to treat opioid dependence, asserting that data on the agent’s safety are insufficient. In a commentary published in The Lancet (2011;377:1468-1470), critics argued that the risk for opioid overdose with oral naltrexone may be significant and that it was not adequately

investigated in trials of the injectable form of the drug, one of which was reported in the same issue of The Lancet (2011;377:1506-1513). “This medication is a potentially powerful addition to the treatment armament, but the pivotal clinical trial on which the approval was based failed to carefully evaluate the risk for overdose, known to be many times higher in oral naltrexone users than in patients on

methadone or buprenorphine,” according to lead author Daniel Wolfe, MPH, director of the International Harm Reduction Development Program, Open Society Foundations, New York City. In the commentary, Mr. Wolfe and his co-authors conceded that the newly published findings were impressive, showing that 126 patients receiving depot naltrexone remained abstinent for a median of 90% of the six-month dou-

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ble-blinded treatment period, compared with 35% among 124 subjects receiving placebo therapy. Mr. Wolfe noted, however, that the safety results failed to include data from 59 naltrexone recipients who did not complete the study. “It may or may not be that these patients went on to fatally overdose,” Dr. Wolfe said. “The investigators didn’t ask, so it’s impossible to know.”

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see NALTREXONE, page 4

4 Up Front

Pharmacy Practice News • September 2011

Clinical Controversies

NALTREXONE continued from page 3

Mr. Wolfe noted the overdose rate reported in the recent Lancet trial contrasts with previous trials of opioid dependence treatments, which have consistently shown multiple deaths among both treatment and placebo groups (Lancet 2003;361:662-668). He discussed an Australian literature review of opioid agonist and antagonist addiction treatments that showed individuals receiving oral naltrexone

were three times more likely than those receiving agonists to experience opioid overdoses (Addiction 2004;99:450-460). The FDA also examined data from an earlier study in which 436 patients with either alcohol or opioid dependence received depot or oral naltrexone for up to one year (www.clinicalstudyresults. org/documents/company-study_3856_0. pdf ). Investigators reported three opioid overdoses, but those results also did not include data from 286 non-completers. Mr. Wolfe called the findings “similarly vague.”

‘The pivotal clinical trial on which the approval was based failed to carefully evaluate the risk for overdose.’ Daniel Wolfe, MPH, et al.

Before approving the drug, the FDA advisory committee also considered postmarketing reports of opioid over-

COMING SOON

Bridging the gap between the hospital and post-discharge care

In This Issue Technology Watch

Patient telemonitoring helps hospitals maintain seamless post-discharge care.

Cindy Kuzendorf, PharmD discusses the rewards of preceptoring the nation’s only ASHPaccredited home infusion residency program.

Business Case Study

TPN Regimens In Hospital Causing Problems at Home

For Aralast, Limiting Distribution Helps Boost Drug Safety

Overfeeding triggers risky electrolyte imbalances post-discharge

Registries, monitoring plan help ensure optimal outcomes

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Q&A

Volume 1 • Number 1 • November 2011

Fight or switch? One health-system’s strategy for becoming a specialty pharmacy contractor.

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see TPN REGIMENS, page 3

Clinical Controversies

Continuous vs. intermittent IV antibiotic dosing: why the disconnect between hospital and home?

Educational Review

Compatibility of Commonly Used Intravenous Drugs

see ARALAST, page 1

Coding Consult POLICY WATCH

Joint Commission Eyes Stronger Oversight Of Specialty Pharmacy

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see COMMISSION, page 1

Top 10 Coding Mistakes—And How To Fix Them

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New Products Ipilimumab (Yervoy, BMS) approved for metastatic or unresectable melanoma.

Scriptpro announces new enhancements to its remote telepharmacy system.

See page 50.

A new quarterly publication from the editors and publisher of Pharmacy Practice News. Each issue will provide essential clinical and business information for stakeholders in specialty pharmacies, home infusion providers, insurers and managed care organizations. Our goal: to help foster high-quality, cost-effective treatment across the entire patient-care continuum.

dose and deaths among depot naltrexone users. Nineteen fatalities, including four opioid overdoses, have been reported to the manufacturer since the drug was approved to treat alcohol dependence in 2006. Mr. Wolfe and his colleagues, however, said they found what they suspected to be additional deaths in depot naltrexone recipients in the FDA’s Adverse Event Reporting System (AERS), some of which were due to “unknown causes” (personal communication; May 17, 2011). He stated that because postmarketing reports are voluntary, they tend to underestimate the incidence of adverse events; thus, the risk for overdose and death in opioid-dependent patients given depot naltrexone actually may be higher than recorded in the study data or the AERS database reports. “Families of those who have died of a drug overdose may be particularly reluctant to report the cause of death,” he added. “And since most of the estimated 45,000 patients who have received depot naltrexone since its approval nearly six years ago have presumably been alcohol-dependent, it’s possible the risk for death may be higher in opioid-dependent patients.” Mr. Wolfe acknowledged that depot naltrexone may prove to be safer than the oral form, given that the risk for opioid overdose is highest when naltrexone is discontinued abruptly. Extended release of the drug could help reduce the risk related to medication discontinuation. Representatives at Alkermes declined to comment on Mr. Wolfe’s article. A press officer at the FDA also chose not to comment on the issues raised by the study, but provided this brief statement: “The U.S. FDA Psychiatry Drugs Advisory Committee … agreed that the safety data were adequate,” and “11 of 13 voting members agreed that the data were sufficient to conclude that the drug is effective in the patient population that was studied.” The FDA’s response did not satisfy Mr. Wolfe and his colleagues, who demanded that “the FDA should justify why it has lowered the scientific, regulatory and ethical standards in approving depot naltrexone for treatment of opioid dependence.” —David Wild Mr. Wolfe reported no relevant conflicts of interest.

Pharmacy Practice News • September 2011

Up Front 5

Capsules

Breakthrough Pain a Persistent Problem

surf

SEPTEMBER 2011

watch

The five most-viewed articles last month on pharmacypracticenews.com: 1. CMS 30-Minute Rule on Drug Administration Seen as Risk to Patients 2. Concerns Emerge Over Ipilimumab Pricing and Restricted Distribution 3. A Call to Action on Sterile Compounding Gains Traction 4. Each Member of the BCMA Team Should Be a Key Player in Patient Safety 5. Reducing ‘Alert Fatigue’ Helps Avoid Dangerous Distractions Register for free at pharmacypracticenews.com to read these and other articles on the latest developments in hospital pharmacy.

heard here first

‘The technologies related to the medical home are going to grow tremendously and pharmacy has the opportunity to be a great leader.’

See article, page 24

—Christopher Fortier, PharmD

To Scan 2-D Bar Codes in PPN: 1.

Download the FREE Microsoft Tag Reader application through your smartphone browser.

Open the Tag Reader and let it focus on the bar-code image to instantly access related materials and/or Web sites.

recent survey of commercially insured patients with chronic pain found that the vast majority experienced breakthrough pain (BTP) that significantly affected their quality of life, ability to function and productivity. According to lead author Arvind Narayana, MD, MBA, the survey results highlight the need for pain practitioners to adopt a “consistent, systematic approach” to the diagnosis, assessment and treatment of BTP. The National Breakthrough Pain Survey questioned 905 members from 14 geographically dispersed U.S. health plans identified by the HealthCore Integrated Research Database. All of the patients surveyed suffered from and received treatment for chronic cancer and noncancer pain. The survey found that an overwhelming majority of these chronic pain patients, nearly 80%, also experienced BTP, defined as a transitory exacerbation of pain that occurs in patients receiving long-term opioid therapy for persistent pain conditions. As a result of their BTP, these patients missed nearly twice as many workdays over the course of a year as the non-BTP sufferers surveyed. BTP was unpredictable, with most patients reporting multiple occurrences per day. Survey respondents reported an average of two BTP incidents per day, and each incident lasted an average of 30 to 45 minutes. The respondents noted that BTP significantly interfered with work, school, family and/or social activities, and BTP sufferers surveyed were not able to perform their job function for nearly twice as many days as those without BTP. “BTP predicts clinically significant reductions in quality of life, functioning and productivity compared with patients who had controlled persistent pain and no BTP. These differences were similar for the cancer and the noncancer groups,” Dr. Narayana concluded. “[The results show that] interventions to treat BTP must assess not only differences in pain intensity and pain relief over time, but days of missed work and social [activities] as well,” said Mellar P. Davis, MD, FCCP, professor of medicine at the Cleveland Clinic Lerner School of Medicine and Case Western Reserve University, both in Cleveland, who was not involved in the study. “Interventions must also include a cost-utility analysis, and [treatment options] that are expensive may be economically advantageous if absenteeism is reduced and social roles regained.” —Brian P. Dunleavy

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Volume 38 • Number 9 • September 2011 • pharmacypracticenews.com

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Internal Medicine

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6 Clinical

Pharmacy Practice News • September 2011

Neurology

Bridging the Stroke Gap Between Hospital and Home

Gaps in education/interventions (n=262) Discharge medication discrepancies (n=122) Dosing/other prescription errors (n=5) Duplications (n=3)

Figure 1. Post-discharge medication-related issues in stroke patients (N=392).

at Forsyth Medical Center in Win- pharmacists at the new Stroke Bridge ston-Salem, N.C., sought to bridge this Clinic saw 72 patients. They identified gap for patients who have had strokes 122 discharge medication discrepanand complicated transient ischemic cies, five dosing or other prescripattacks (TIAs)—a population that may tion errors, three duplications and be especially at risk for poor out- 262 gaps in education or interventions comes. A separate study previously (Figure 1). found that nearly two-thirds of MediThe pharmacists’ interventions ap- care beneficiaries discharged after peared to pay off. Based on a comparison ischemic stroke died or were rehospi- of data from January to September 2010, talized within one year (doi: 10.1161/ the team noted that the Stroke Bridge STROKEAHA.110.601831). Clinic had cut the 30-day readmission “It can be six weeks before patients rate by nearly a factor of 3: from 59 of are able to see a specialist or primary 788 (7.5%) to two of 72 (2.8%). However, care physician, and all kinds of things the difference did not reach statistical can happen after a stroke,” said Dr. significance (Figure 2). Bruner, a pharmacy resident at ForsythGaps in education/ The strategy also could be applied to interventions (n=262) and lead researcher on the poster. “It’sDischarge other acute care health issues, such as medication (n=122) and myocardial infarction, so important to have the medicationsdiscrepancies pneumonia squared away early and make sure thatDosing/other suggested Dr. Bruner. prescription errors (n=5) you have all your home health needsDuplications (n=3) Impact on Readmissions set up.” Kathleen Baldwin, PharmD, clinical This is in a hospital’s best interest too. If after various events, includ- pharmacy practitioner for neurology at ing a heart attack, a patient returns Baptist Medical Center in Jacksonville, within 30 days for the same indica- Fla., praised the team’s effort—partion, the center would not receive ticularly for this specific population. Medicare or Medicaid reimbursement. “What they do may influence whether Although such restrictions have not [patients] come back to the hospital or been extended to strokes, 30-day read- not,” she said. Stroke patients often leave the hospimissions continue to be under great tal cognitively impaired, which could scrutiny at Forsyth. So Dr. Bruner and her colleagues affect their ability to comply with implemented a one-time visit between the medications prescribed at disseven and 10 days after discharge, at charge, added Dr. Baldwin. Furtherwhich time the stroke/TIA patient, more, some patients may be too embarpharmacist and other providers could rassed to reveal that they don’t have address any issues that have arisen, insurance, leaving them unable to such as medication reconciliation and afford the medications. Dr. Baldwin and her team are develadherence, as well as secondary prevention strategies including smoking oping a project with a “similar spin,” she said. Rather than waiting a week or and hypertension. Between Oct. 20 and Dec. 29, 2010, so to see the patients, they plan to hold

30-Day Readmissions, %

Denver—Hospital readmission rates are under increasing scrutiny these days, and with good reason. An estimated one in five hospitalized Medicare patients is readmitted within 30 days, at a cost of $17 billion a year, according to a 2009 study published in The New England Journal of Medicine (doi:10.1056/NEJMsa0803563). What’s more, in half of these cases, the patient had not seen a doctor between hospital stays. In their poster (9-T) at the American Society of Health-System Pharmacists Summer Meeting, Laura Bruner, PharmD, and her colleagues

7.5

6 4 2.8

2 0

Jan. 2010

Sept. 2010

Figure 2. Impact of pharmacist interventions on stroke patients.

‘It can be six weeks before patients are able to see a specialist or primary care physician, and all kinds of things can happen after a stroke.’ —Laura Bruner, PharmD the clinic before a patient goes home. The project is in the design phase, with implementation planned for the fall. “I’m surprised that they are waiting so long post-discharge,” said Dr. Baldwin, noting the common scenario of a patient without insurance getting sent home with a free seven-day supply of clopidogrel (Plavix, Sanofi-aventis). “If they wait 10 days to see them, it could be too late.” Instead, she suggested that by meeting patients before they go home, the team could rethink the treatment plan and, if necessary, “replace a $200 drug with something on the $4 Walmart list. While a generic statin such as pravachol will never be studied the way Lipitor has, we feel it is better to provide patients with a statin they can afford rather than no statin at all.” She added, “There are many resources out there if you look for them, such as copay reducer coupons for Lipitor and other medications for patients with insurance but high copays.” —Lynne Peeples Drs. Bruner and Baldwin reported no relevant conflicts of interest.

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8 Clinical

Pharmacy Practice News • September 2011

Medication Safety

COLLABORATION continued from page 1

had recognized the challenges in distribution, personnel accountability and patient safety with controlled substances—particularly in the fast-paced operating room (OR). With such a wide range of different anesthesia kits and reports, it was “difficult to reconcile what anesthesiologists said they were using with what they actually used,” he said.

‘We’re spending an awful lot of money [on desflurane], but we’re not getting any benefit.’ —Eric L. Chernin, RPh So Mr. Chappell and his pharmacy colleagues decided to collaborate with the center’s anesthesiology and surgery departments to create a universal kit that would cover 95% of their surgery patients. Inside were various dosages of fentanyl, hydromorphone, midazolam and morphine. “We put everything in one place,” said Mr. Chappell, lead researcher (poster 3-M), noting that anesthesia providers, pharmacists and pharmacy technicians each had clear responsibilities. “The kits

would come back to us from the provider along with the anesthesia record,” he added, “so pharmacists could look at them and see what they used, what they put on the record and then reconcile any waste.” Technicians would then validate and refill the kits’ contents. The team analyzed billing and financial data from two months before and after the kits were implemented in June 2010. Sure enough, they found that medication tracking became much more accurate with the introduction of the kits. The rate of discrepancies dropped from 6.8% during week 1 to 2.7% at week 13 (Figure). Mr. Chappell’s team linked most of the discrepancies to drug waste procedures, such as the mislabeling of waste syringes or lack of documentation. Total medication charges for both inpatient and outpatient anesthesia, however, remained similar between the pre- and post-periods: $250.78 and $253.24, respectively. One year after the kits’ implementation, the team has no intention of slowing down the effort. Mr. Chappell suggested that they might even create more specialized kits; for example, kits for minor cases don’t need all the pieces included in the original. Asked to comment, Tricia Meyer, MS, PharmD, assistant professor of anesthesiology at the Texas A&M College of Medicine, in College Station, said the Methodist Dallas Medical Center findings demonstrate that pharmacists in the OR “can take a lead as medication safety experts, whether officially or unofficially.” Dr. Meyer suggested that pharmacists also can promote medication safety by preparing IV medication kits to be used after hours, complete with admixture instructions, IV bag, labels and filter needles, as well as by placing a bulletin board outside of the OR pharmacy with current information on drugs, dosing charts for pediatric dosages, drug shortage updates and information on black box warnings.

Is Pricier Always Better? Inhaled anesthetic agents also contribute significantly to the overall cost and safety of anesthesia, each differing to some degree in their potency, minimum alveolar concentration, lipid solubility, induction characteristics and recovery time.

We Want Your Pearls Do you have an interesting practice pearl you’d like to share? If so, send it to smtilyou @mcmahonmed.com. Pearls should: • Focus on a clinical or operational problem at your institution, with tips (“tricks of the trade”) on how to manage the problem via an innovative system or strategy

Two of the newest agents, desflurane (Suprane, Baxter) and sevoflurane, are prized for their low solubility and, therefore, more rapid recovery time compared with older inhaled anesthetics, such as isoflurane. Due to its particularly low solubility, some anesthesiologists suggested that desflurane could nudge out sevoflurane in effectiveness. However, it also costs significantly more: $19.61 per minimal alveolar concentration (MAC) hour compared with $5.76. (MAC hour is a measure of the amount of anesthetic gas needed to prevent movement in response to a surgical incision.) “If this rapid recovery allows for the

Rate of Discrepancies, %

10 8 6.8

6 4 2.7

2 0

Week 1

Week 13

Figure. Anesthesia medication discrepancies, pre- and postimplementation.

Research findings demonstrate that pharmacists in the OR ‘can take a lead as the medication safety expert, whether officially or unofficially.’ —Tricia Meyer, MS, PharmD completion of additional surgical cases by decreasing operating suite turnover time, or reduction in personnel overtime expenses, then it could yield a cost savings,” said Eric L. Chernin, RPh, pharmaceutical care specialist in OR pharmacy at Sarasota Memorial Hospital, in Florida. Sarasota Memorial used both agents, with desflurane limited to patients undergoing bariatric surgery and using one of two available desflurane vaporizers, until anesthesiologists began a push to turn rooms over faster and lobbied to use the more expensive agent. They argued that the recovery characteristics of desflurane would indeed lead to much shorter room turnovers, and desflurane vaporizers were subsequently placed in every OR suite. Mr. Chernin and his colleagues responded by conducting a retrospective review to determine if the agent sped up emergence time from general anesthesia and improved overall efficiency of the OR. After reviewing 100 charts in both September 2009 and September 2010—matching the surgeon, procedure and agents whenever possible—preliminary results suggested that there was no clinically significant difference in emergence times

•O ffer insights that are not widely known, understood or published •E xplain why the pearl should be implemented won a widespread basis •N ot exceed 1,000 words Readers whose Practice Pearls are accepted for publication will be paid a $100 honorarium.

between the two inhaled anesthetics. The finding remained even after analyzing differences in emergence times and differences in surgical procedure duration. Mr. Chernin questioned whether the switch to desflurane was worthwhile. “We’re spending an awful lot of money, but we’re not getting any benefit,” he said. “A couple of minutes here or there are meaningless. You can’t capture those minutes from a financial perspective. You’re not going to do an extra case in that room that day or send recovery personal home early.” Still, he noted that there are some patients, such as those who have a bad airway or need to be awoken and recover reflexes as quickly as possible, for which the pricier anesthetic might make sense. “But it doesn’t pay to use it exclusively in this setting.” Dr. Meyer said the poster “is a solid example of how operating room pharmacists can play a pivotal role in the evaluation of drugs used in the OR through collaboration with anesthesiologists.” —Lynne Peeples Dr. Meyer, Mr. Chappell and Mr. Chernin reported no relevant conflicts of interest.

Pharmacy Practice News • September 2011

Clinical 9

Medication Safety

A Plan for Reporting Accidents Waiting To Happen A

new system that encourages every clinician to report situations that put patients at risk appears to be doing just that. Within 24 months, the new program based at Johns Hopkins Hospital, in Baltimore, distributed 27 so-called “Good Catch Awards” to clinicians who reported potentially dangerous situations that resulted in changes that were potentially lifesaving, including a national recall of improperly labeled drugs that had caused look-alike medication errors. The concept of the program is based on the idea that one person is rarely at fault; rather, it is a faulty system, said Justin Hamrick, MD, third-year anesthesia resident in the Department of Anesthesiology and Critical Care Medicine at the institution. As a result, raising concerns becomes part of protecting every person in that system and not blaming any individual. “It’s rare that it’s a particular person [who is] a problem; it’s usually the system that’s the problem,” Dr. Hamrick said. Since the hospital implemented the Good Catch Award program, the number of electronic reports submitted to the Patient Safety Network has increased considerably, he said, although he has not yet formally tracked the difference. Approximately 5% to 10% of the incidents reported were considered to have caused harm to patients. The rest were what the researchers called “near misses,” in which patients were not actually harmed. “Most of the incidents were

related to unsafe conditions that [could] have caused harm but didn’t reach the patient,” Dr. Hamrick said. These incidents often are not reported because the risk is less obvious, but it still exists, he said. “These are the incidents we wanted to capture, before a patient was actually [injured].”

‘It’s rare that it’s a particular person [who is] a problem; it’s usually the system that’s the problem.’ —Justin Hamrick, MD Dr. Hamrick and his colleagues presented details of the program at the 2011 annual meeting of the International Anesthesia Research Society (S-120), including examples of errors that were caught and rectified as a result of the new program. For instance, one clinician reported a situation in which a patient almost received an incorrect medication. An assumption that the prescriber may have been at fault was proved false when a closer look revealed that the vial did not have a proper warning label from the manufacturer, causing an antibiotic to resemble a paralytic drug. This investigation led to a recall of the paralytic by the FDA.

It is one thing to let clinicians know that the Good Catch program is not about assigning blame for mistakes; getting them to believe it is another issue, Dr. Hamrick said. To convince people that the objective is to identify problems in the system—not individuals—the team spent time explaining to nurses, residents and doctors why errors almost always are systems problems (e.g., the positioning of equipment during a procedure). One report caused the safety committee to realize that a machine used in the operating room (OR) contained troublesome buttons, so that pressing one button would trigger the one next to it, causing the machine to be set incorrectly. This led to a voluntary report to the FDA, and permission was obtained to have the machine modified to prevent the problem from recurring. An incident that involved insulin administered in the OR revealed to investigators that those who prepared insulin in the OR sidestepped the safety checks that take place when insulin is prepared by the pharmacy. This triggered formation of a new policy that stated that only the pharmacy could make up orders of insulin. When clinicians win a Good Catch Award, they receive public recognition with explanations of their “good catches” on wall boards within the surgical suite, Dr. Hamrick said. The system, not yet implemented hospital-wide, remains

part of the perioperative safety team of the Weinberg OR suite at the Johns Hopkins Hospital. The new system is a definite improvement over systems that exist at many other hospitals—which often isn’t much, according to Robert Stoelting, MD, president of the Anesthesia Patient Safety Foundation. He said in some ways the Good Catch program resembles systems in place at airlines and nuclear power plants, where everyone on the team is considered responsible for reporting any safety issues. “The ‘good catch’ concept I certainly support. It’s a good step to supporting a safety environment in a health care facility.” The next step, Dr. Stoelting said, would be to install a national database where every hospital must report all errors and so-called near misses, so that everyone can learn from each other. “I don’t see [the Good Catch program] as really solving the problem of knowing the number of adverse events on a national level,” Dr. Stoelting said. Currently, he said, voluntary registries for particular types of incidents, such as postoperative blindness, do not capture all mishaps and, therefore, miss many opportunities for improvement. —Alison McCook

FDA Downplays Risk for Esophageal Cancer From Bisphosphonates

n a statement released on July 21, the FDA declared that there is no clear link between bisphosphonate use and increased risk for esophageal cancer (www.fda.gov/drugs/drugsafety/ ucm263320.htm). The agency concluded that the benefits of using bisphosphonates outweigh the potential risks and that there is no need to screen for esophageal cancer in asymptomatic patients who receive these drugs. Prateek Sharma, MD, professor in the Division of Gastroenterology and Hepatology, University of Kansas School of Medicine, Kansas City, agreed with the FDA’s statement that the benefits of bisphosphonate therapy offset the risks. “Concerns that patients might develop esophageal cancer should not be a criterion for not initiating therapy with bisphosphonates,” he said. “Those who need it should be started on this treatment.” The FDA’s review included one case series and four epidemiologic studies, two of which analyzed the same British database but yielded conflicting results.

In the first analysis of the British General Practice Research Database, Chris Cardwell, PhD, from the Centre for Public Health, Queen’s University Belfast, United Kingdom, and researchers at the National Institutes of Health in Bethesda, Md., compared the incidence of esophageal cancer in nearly 42,000 patients receiving bisphosphonates to a similar number of control subjects not receiving the drugs and found no difference in the incidence of esophageal cancer after adjusting for potentially confounding variables (JAMA 2010;304:657-663). A second analysis of the same database conducted by Jane Green, PhD, clinical epidemiologist at the Cancer Epidemiology Unit at the University of Oxford, England, compared a subset of individu-

als diagnosed with esophageal cancer to matched controls without the disease (BMJ 2010;341:c4444). Unlike Dr. Cardwell, Dr. Green’s team found that individuals were 1.93 times more likely to have esophageal cancer if they had filled 10 or more bisphosphonate prescriptions than if they had not used drugs from this class. Findings from a large Danish cohort study, which included only patients with fractures, yielded even more divergent results. The study showed that fracture patients using bisphosphonates were 65% less likely than fracture patients not receiving these drugs to have esophageal cancer (N Engl J Med 2009;360:1789-1790). In a fourth longitudinal study presented at the Third Joint Meeting of the European Calci-

fied Tissue Society and the International Bone and Mineral Society, researchers found no difference in risk for esophageal cancer among long-term alendronate users, compared with those not using bisphosphonates (abstract OC29). The FDA addressed the contradicting findings, saying that “differences in methodologies in these studies may account for the discrepant findings. Also, since these studies are observational rather than randomized, they are subject to bias and confounding.” The statement emphasized that patients should be instructed to follow directions of bisphosphonate use and to sit upright for 30 to 60 minutes after taking the medication. Doing so should minimize the risk for esophagitis and other esophagus-related adverse events that have been shown to increase the risk for esophageal cancer. —David Wild Dr. Sharma has nothing to disclose.

Hem/Onc Pharmacy In Focus

Mixed News on PARP Inhibitors Presented at ASCO and requires monthly infusions. “Who wants to be coming in and getting cytotoxic chemotherapy once a month?” Dr. Goff asked. “Ovarian cancer is often a chronic disease, so we need to find agents that keep the disease from growing and are relatively nontoxic. Olaparib looks like it could be one of those agents.” The news from a Phase III trial of a different PARP inhibitor, iniparib, in metastatic triple-negative breast cancer (TNBC), was not nearly so encouraging. Despite promising results in the Phase II setting reported earlier this year (N Engl J Med 2011;364:205-214), a Phase III trial showed the drug yielded only a onemonth improvement in PFS that was not statistically significant (abstract 1007). (The study was supported by BiPar Sciences, now owned by Sanofi-aventis.) The trial involved 519 women, each treated with two or fewer regimens for metastatic disease. All patients received gemcitabine and carboplatin and were randomized to iniparib or placebo. Patients in the iniparib arm had a median PFS of 5.1 months, compared with 4.1 months in the placebo group (P=0.027). Median OS was 11.8 months in patients on iniparib and 11.1 months in the placebo arm (P=0.28). “These results were definitely disappointing,” said Julie Gralow, MD, director of breast medical oncology at the University of Washington and the Seattle Cancer Care Alliance. “This shows you why we do Phase III trials.” But the results do not necessarily mean that PARP inhibitors don’t work in TNBC. “We can say that iniparib doesn’t work in this particular setting,” said Alex Adjei, MD, PhD, professor and chair of the Department of Medicine and senior vice president for clinical research at Roswell Park Cancer Institute, in Buffalo, N.Y. “There are two Placebo Olaparib

8.4

PFS, mo

Chicago—The results of several new trials of different PARP inhibitor drugs for treatment of ovarian cancer and breast cancer were reported at the recent annual meeting of the American Society for Clinical Oncology. In some cases, experts called the results “exciting,” and in others, “disappointing.” By far the most encouraging results came from a Phase II, randomized, placebo-controlled study of AstraZeneca’s olaparib in 265 women with relapsed, platinum-sensitive serous ovarian cancer with and without BRCA1/2 mutations (abstract 5003). Patients were randomized to the investigational oral poly (ADP-ribose) polymerase (PARP) inhibitor or placebo. Patients receiving olaparib almost doubled their progression-free survival (PFS): 8.4 months compared with 4.3 months in those taking placebo. This translated to a 65% reduction in the hazard ratio (HR, 0.35; P<0.00001). Although adverse events were more common with the PARP inhibitor—nausea being the most common—overall tolerability was good, according to lead investigator Jonathan Ledermann, MD, consultant in medical oncology at University College London Hospitals, and professor of medical oncology at University College London. Barbara Goff, MD, director of gynecologic oncology at the University of Washington and the Seattle Cancer Care Alliance, was delighted by the results. “What was exciting to me is that the women in this study didn’t necessarily have BRCA mutations. They had highgrade serous tumors and were platinum-sensitive—two things that we have thought would signal response to PARP inhibitors,” she said. Dr. Goff noted that there has long been a need for a targeted agent to use as maintenance therapy in patients with recurrent ovarian cancer. “Most women with advanced-stage ovarian cancer are going to recur, so to have agents that can keep people from progressing and developing symptoms is important,” she said. “Until recently, all we’ve had is bevacizumab [Avastin, Genentech], but it’s expensive, and there are significant toxicities. These results open up an oral alternative as a maintenance therapy that is relatively nontoxic.” (Bevacizumab is not approved yet for ovarian cancer, but some doctors have been using it off label.) Some studies have examined the use of paclitaxel as a maintenance therapy for ovarian cancer, and it has been found to improve PFS but not overall survival (OS). And paclitaxel, too, is associated with significant toxicities— including hair loss and neuropathy—

6 4.3

4 2 0

Figure. PFS in patients with platinum-sensitive ovarian cancer. PFS, progression-free survival

A pathologic specimen of ovarian carcinoma and model of PARP1.

‘The olaparib data, this single-agent maintenance trial, really opens up the field. … This is major, exciting news.’ —Ursula Matulonis, MD issues that may be playing a part here. First, the really promising data with the PARP inhibitors that we have had was really in patients with BRCA1/2 mutations. In this trial, they tried to broaden this idea a little bit into triple-negative, and said that these cancers are sort of like BRCA1 cancers, but that’s not necessarily so.” Some TNBC patients may be similar to BRCA1 patients, whereas others may not have the DNA deficiencies associated with the PARP inhibitor response, Dr. Adjei noted. In her talk, lead investigator of the study, Joyce O’Shaughnessy, MD, Celebrating Women Chair in Breast Cancer Research, Baylor Sammons Cancer Center, and co-chair, Breast Cancer Research, US Oncology, both in Dallas, also pointed out that iniparib might not be a true PARP inhibitor. Indeed, as Robert Nagourney, MD, medical and laboratory director at Rational Therapeutics, in Long Beach, Calif., pointed out in his blog, a full dose of a true PARP inhibitor combined with carboplatin and gemcitabine would likely yield intolerable toxicities. The Phase I results, in retrospect, provide a clue to this, noted Dr. Adjei. “This is a drug where the single-agent Phase I study was really benign. There were virtually no toxicities. To reach their highest tolerable dose, they had to use pharmacokinetics because there were so few toxicities. That’s very unusual.” Dr. Gralow agreed. “We need to separate iniparib out from the other drugs that are true PARP inhibitors,” he said. “Iniparib definitely has inhibition of DNA repair, a minor part of which is PARP. We didn’t understand that even a

couple of years ago. We have to be careful about what we say this drug does.” More work needs to be done in TNBC to determine if there is a population of patients who will respond to a PARP inhibitor that has true PARP inhibition at physiologic doses. “Is there a subpopulation in triple-negative that will have single-agent responses? Or do you have to augment their activity with either chemo or other targeted therapies aimed at other pathways besides DNA repair?” asked Ursula Matulonis, MD, director and program leader of medical gynecologic oncology at DanaFarber Cancer Institute, in Boston. “All this is still unknown.” Dr. Gralow drew parallels with the groundbreaking targeted breast cancer agent trastuzumab (Herceptin, Genentech). “If you look at the modeling, if we’d tested trastuzumab in the general breast cancer population, even though 20% to 25% of women with breast cancer express HER2, it never would have shown a benefit.” According to Dr. Matulonis, the olaparib results in ovarian cancer should be getting much more attention. “To date, the ability of a true PARP inhibitor to shrink tumors and kill cancer cells has been shown predominantly in germline BRCA carriers,” she said. “The olaparib data, this single-agent maintenance trial, really opens up the field to say that we can use these drugs not only in women with BRCA mutations, but in those with high-grade serous mutations regardless of if they have the [BRCA] mutations as well. This is major, exciting news.” —Gina Shaw

Hem/Onc Pharmacy 11

Pharmacy Practice News • September 2011

In Focus

Heightened Risk for Lymphomas Found in Celiac Patients Sixfold increased risk should be taken seriously, expert advises Chicago—Columbia Medical Center’s celiac specialists are asking gastroenterologists to screen their patients with celiac disease carefully for lymphoma, after new research showed individuals with the disease have a sixfold increased risk for developing any kind of lymphoma, and even greater odds for developing non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. “Patients with celiac disease are usually not taken seriously, but they are actually at increased risk for lymphoma and should be followed closely,” said senior author Peter H.R. Green, MD, professor of clinical medicine and director of the Celiac Disease Center at Columbia University, New York City. Other studies have shown a link between lymphoma and celiac disease. In 2009, an analysis of data from a Swedish cancer registry, including more than 60,000 patients with lymphoma, found a fivefold risk for non-Hodgkin’s lymphoma in patients with celiac disease (Gastroenterology 2009;136:91-98). Last year, a U.S. study showed celiac disease is associated with an increased risk for both B- and T-cell lymphomas (Clin Gastroenterol Hepatol 2010;8:10421047). In a group of 63 patients with both lymphomas and celiac disease, investigators found that patients with B-cell lymphomas had a better prognosis than patients with T-cell lymphomas; those with B-cell lymphomas outlived those with T-cell lymphomas by an average of 96.6 months (P=0.02). To confirm the association between celiac disease and different lymphoma types, Dr. Green and his colleagues retrospectively analyzed the charts of all patients treated at Columbia University’s Disease Celiac Center between 1981 and 2010. Of the 1,285 adults with biopsy-confirmed celiac disease, 40 also were diagnosed with a lymphoproliferative disorder (LPD). Overall, the risk that celiac sufferers will develop any LPD was 6.5 times greater than the general population (standardized incidence ratio [SIR], 6.5; 95% confidence interval [CI], 4.68.6). Their overall risk for non-Hodgkin’s lymphoma was almost four times that of the general population (SIR, 3.9; 95% CI, 2.4-5.8), accounting for 82.5% of the LPDs in the study. Five patients developed chronic lymphocytic leukemia (SIR, 4.9; 95% CI, 1.8-9.5). For certain subtypes of non-Hodgkin’s lymphoma, the SIRs were extremely high. Celiac sufferers had a 32.2-fold higher incidence of mantle cell B-cell lymphoma, a 37.1-fold great-

er incidence of marginal zone lymphoma and a 22.4 times higher incidence of of non–enteropathy-associated T-cell lymphomas (non-EATLs). Although T-cell cancers usually represent 10% to 15% of non-Hodgkin’s lymphomas, in the celiac study 17 of 33 cases (51.5%) were T-cell–based. Twelve of these

•

see LYMPHOMAS, page 12

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Hem/Onc Pharmacy In Focus

LYMPHOMAS continued from page 11

were EATLs and five were other T-cell lymphomas. For EATLs, investigators could not calculate the SIR because there were no data in the Surveillance Epidemiology and End Results database for these lymphomas. However, crude calculations suggest that the SIR for EATL in celiac disease patients would be high. The study cohort had an overall rate of 0.93%. Other studies have reported an estimated annual incidence of EATL at about 0.5 to 1 per 1 million people in Western countries (Blood 2010;115:3664-3670). The risk for EATL is “infinitely high compared with the normal population,” said Dr. Green. The study also picked up several pre-

viously unknown associations between celiac disease and lymphomas. Individuals who developed an LPD and celiac disease were a mean age of 58

study has important limitations. The prevalence of LPD may be overestimated because investigators used data from a large referral center. On the

‘Patients with celiac disease are usually not taken seriously, but they are actually at increased risk for lymphoma and should be followed closely.’

—Peter H.R. Green, MD

years when they were diagnosed with celiac, which was 15 years older than the rest of the study cohort. Celiac and LPD sufferers also had higher rates of diarrhea (60% vs. 40%; P=0.016), abdominal pain (18% vs. 6%; P=0.0048) and weight loss (13% vs. 4%; P=0.028). The investigators noted that the

other hand, the figures may underestimate prevalence because many patients came to the clinic only once or were lost to follow-up. Experts stress that it is important to keep the LPD risk for celiac sufferers in perspective. Although celiac patients do have increased rates of

these cancers, these cancers are still rare. “The total incidence of LPD in the study was 3.1% and the overall U.S. lifetime risk for LPD is 2.1%. It’s only slightly higher than the general population,” said Daniel Leffler, MD, director of clinical research at the Celiac Center at Beth Israel Deaconess Medical Center, Boston. Additionally, the mechanism behind this association between LPDs and celiac disease is not clear. Most chronic autoimmune disorders increase LPD risk likely because of chronic immune stimulation or proliferation, which increases the risk for mutations and chromosomal abnormalities over time. According to Dr. Leffler, “These are the precursors to malignancy.” —Christina Frangou

CLINICAL

IVIG FAQ

The Role of Immunoglobulins in C. difficile Infections Jerry Siegel, PharmD, FASHP Clinical Associate Professor The Ohio State University College of Pharmacy Columbus, Ohio

Q: What is the role of immunoglobulins in the treatment of Clostridium difficile infection (CDI)? A: CDI is the most common nosocomial infection resulting in health care–associated diarrhea. The occurrence rate ranges from four to six per 1,000 admissions and up to 22.5 cases per 1,000 admissions in endemic areas.1 This rate has been increasing over the past 10 years, and a new epidemic strain has been associated with a high rate of morbidity and mortality. Recurrent or chronic CDI occurs in about 30% of patients treated with conventional therapies such as oral metronidazole.1 Oral vancomycin is given in severe cases, but it is not always effective. Other antibiotics, such as rifampin and rifaximin (Xifaxan, Salix), and probiotics also have been used to treat CDI. A prospective study of 271 hospitalized patients who had low serum immunoglobulin G (IgG) levels showed they were 48 times more likely to get CDI than patients who did not have low IgG levels.2 Considering this risk factor, the use of immunoglobulin therapy may be warranted. However, the only controlled study conducted to date did not indicate that intravenous immunoglobulin (IVIG) showed a benefit over standard therapy.1 In this study, IVIG was only

used in patients with severe CDI. Historically, immunoglobulin therapy has been more effective at preventing rather than treating infections. This leads to the question of whether immunoglobulin therapy potentially is effective because it boosts the immune system or has neutralizing antibodies to the C. difficile toxins. Although all of the commercially available immunoglobulin products contain antibodies to the C. difficile toxin A, antitoxin titers vary considerably among the different products. It is not known if this is clinically relevant because it is not known how much immunoglobulin actually reaches the colon when it is given intravenously. This is an issue with vancomycin treatment of CDI. Vancomycin is only effective against CDI when it is given orally, not when it is given intravenously, and it may be the same for immunoglobulins. This raises the question of whether the oral route would be a viable way to use immunoglobulins to treat CDI. In the 1980s, clinicians used oral immunoglobulin to treat hemorrhagic gastroenteritis in patients receiving allogeneic bone marrow transplants.3 The immunoglobulin was detected intact in the feces of these patients as long as the patients were on

high-dose H2 antagonists. In a recent animal study, an oral immunoglobulin was developed in eggs that had neutralizing antibodies to both A and B toxins.4 Only one study using oral immunoglobulin has been published thus far.5 This study was prematurely terminated due to discontinuation of the product by the manufacturer. The limited results showed that the protein whey version of immunoglobulin was as effective as metronidazole. Studies to determine the role of both IV and oral immunoglobulin for the prevention and treatment of chronic and recurrent CDI clearly are needed. Because the majority of the literature on the use of immunoglobulins in CDI are case reports, it is difficult to make specific recommendations regarding dose or frequency, or even the best time to initiate therapy. The majority of the cases were patients who had failed metronidazole and/or vancomycin. The most frequently prescribed dose was 400 mg/kg given once or repeated in 21 days if necessary. The cases reported in the literature showed impressive results in intractable cases.6 It is not known how often this therapy has been used without success. Considering the high cost of immunoglobulin products, the

therapy often is given as a last resort and in severely ill patients for whom it may be least likely to be effective; thus, it is unknown whether it would be more effective if given at an earlier stage. Further study is necessary to determine the appropriate algorithm for use. Finally, it may be worthwhile to consider the use of immunoglobulin by rectal administration. This method can ensure that the immunoglobulin reaches the colon intact and is not broken down by the stomach or small intestine, as can occur if it is given orally, or does not cross into the colon, as can occur if it is given intravenously.

References 1. O’Horo J, Safdar N. The role of immunoglobulin for the treatment of Clostridium difficile infection: a systematic review. Int J Infect Dis. 2009;13(6):663-667. 2. Kyne L, Warny M, Qamar A, Kelly CP. Asymptomatic carriage of Clostridium difficile and serum levels of IgG antibody against toxin A. N Engl J Med. 2000;342(6):390-397. 3. Tutschka PJ. The use of immunoglobulin in bone marrow transplantation. J Clin Immunol. 1990;10(6 suppl):88S-92S. 4. Kink JA, Williams JA. Antibodies to recombinant Clostridium difficile toxins A and B are an effective treatment and prevent relapse of C. difficile-associated disease in a hamster model of infection. Infect Immun. 1998;66(5):2018-2025. 5. Young KW, Munro IC, Taylor SL, Velkamp P, van Dissel JT. The safety of whey protein concentrate derived from the milk of cows immunized against Clostridium difficile. Regul Toxicol Pharmacol. 2007;47(3):317-326. 6. Beales IL. Intravenous immunoglobulin for recurrent Clostridium difficile diarrhea. Gut. 2002;51(3):456.

Optimizing the Selection and Use of Topical Hemostats November 12, 2011 Omni Parker House 60 School Street • Boston, MA 7:30 AM - 8:30 AM 8:30 AM – 11:45 AM

Breakfast, Registration Lectures, Case Studies, Q&A

Online: www.mededpre-reg.com/topicalhemostats Email: topicalhemostats@appliedcme.com Phone: (212) 624-0571 Fax: (815) 377-2470 Mail: Applied Clinical Education 545 West 45th Street New York, NY 10036

Chair Cataldo Doria, MD, PhD, FACS Nicoletti Family Professor of Transplant Surgery Associate Professor of Surgery Director, Division of Transplantation Jefferson Medical College Thomas Jefferson University Hospital Philadelphia, Pennsulvania

Faculty Danial E. Baker, PharmD

Bradley A. Boucher, PharmD

Professor of Pharmacy Associate Dean for Clinical Programs Director, Drug Information Center College of Pharmacy Washington State University Spokane, Washington

Professor, Vice-Chair for Institutional Programs Department of Clinical Pharmacy Associate Professor Department of Neurosurgery University of Tennessee Health Science Center Nashville, Tennessee

Learning Objectives

Jointly sponsored by AKH Inc., Advancing Knowledge in Healthcare and Applied Clinical Education

At the completion of this activity, participants should be better able to: 1. Appraise the clinical and economic effects of excessive intraoperative or postoperative bleeding and common preoperative strategies for minimizing bleeding events. 2. Describe key clinical factors that influence the selection and use of topical hemostats as adjuncts for achieving surgical hemostasis. 3. Delineate clinical characteristics and pharmacoeconomic (direct and nonmedication costs) considerations by which topical hemostats should be evaluated, acquired, and used in hospitals. 4. Develop a plan for reconciling cautionary guidance and clinical best practices with regard to the selection and use of the full range of topical hemostats.

Target Audience Surgeons and pharmacists

Criteria for Success Brought to you by

To obtain credit for this activity, participants should listen to the presentation, complete the activity evaluation and submit the form to an ACE staff member upon departure. For questions regarding this CME/CE activity please email service@ akhealthcare.com.

Accreditation Statements

Supported by an educational grant from A Bristol-Myers Squibb Company

For complete activity information and to register, visit

www.mededpre-reg.com/topicalhemostats

Physicians: This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of AKH Inc. Advancing Knowledge in Healthcare and Applied Clinical Education. AKH Inc. is accredited by the ACCME to provide continuing medical education for physicians. AKH Inc. designates this live activity for a maximum of 3 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity. Pharmacists: AKH Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. AKH Inc. approves this application-based activity for 3 contact hours (0.3 CEUs). UAN 0077-9999-11-038-L04. Initial release date: November 12, 2011.

20 Clinical

Pharmacy Practice News • September 2011

Critical Care

Palliation Lacking in Long-Stay ICU Patients A

mid the hustle of the intensive care unit, assembling an interdisciplinary team meeting to clarify the treatment goals of patients and their families and ensuring these goals are being met can seem like a daunting task. Rebecca Aslakson, MD, an intensivist and palliative care anesthesiologist at The Johns Hopkins Hospital, in Baltimore, said doing so is not only possible, it’s a requisite for good care.

“To be sure, assembling the various stakeholders and care providers is defi-

nitely time-intensive,” said Dr. Aslakson, assistant professor of anesthesiol-

COMING SOON

Bridging the gap between the hospital and post-discharge care

In This Issue Technology Watch

Patient telemonitoring helps hospitals maintain seamless post-discharge care.

Cindy Kuzendorf, PharmD discusses the rewards of preceptoring the nation’s only ASHPaccredited home infusion residency program.

Business Case Study

TPN Regimens In Hospital Causing Problems at Home

For Aralast, Limiting Distribution Helps Boost Drug Safety

Overfeeding triggers risky electrolyte imbalances post-discharge

Registries, monitoring plan help ensure optimal outcomes

Q&A

Volume 1 • Number 1 • November 2011

Fight or switch? One health-system’s strategy for becoming a specialty pharmacy contractor.

•

see TPN REGIMENS, page 3

Clinical Controversies

Continuous vs. intermittent IV antibiotic dosing: why the disconnect between hospital and home?

Educational Review

Compatibility of Commonly Used Intravenous Drugs

see ARALAST, page 1

Coding Consult POLICY WATCH

Joint Commission Eyes Stronger Oversight Of Specialty Pharmacy

•

see COMMISSION, page 1

Top 10 Coding Mistakes—And How To Fix Them

New Products Ipilimumab (Yervoy, BMS) approved for metastatic or unresectable melanoma. See page 50.

Scriptpro announces new enhancements to its remote telepharmacy system. See page 50.

ogy and critical care medicine. “But it is part of our responsibility to consult with patients and their families, since they are the experts on what their priorities are. We need to work as best we can to provide care according to reasonable priorities and goals, recognizing a patient’s prognosis and balancing his or her goals with what is realistic.” Indeed, understanding a patient’s treatment goals can help determine the most effective course of care and save precious intensive care unit (ICU) resources, Dr. Aslakson added. “We once had a surgical ICU [SICU] patient stay six months before we sat down and proactively communicated with the family about palliative care,” she said. By the end of his ICU stay the patient had incurred $3 million in hospital bills, she said. “In talking about palliative care, we found out the patient had made it clear to his family that his greatest fear was to waste away in pain in a hospital or nursing home,” she said. “Evidently, this patient’s suffering and the enormous financial costs associated with his care were tragically unnecessary.” So-called “family meetings” at the Johns Hopkins SICU follow a palliative care model, Dr. Aslakson explained. Their purpose is to understand what patients envisioned their care would look like (sidebar). Although palliative care is commonly perceived as being specifically for terminally ill patients, Dr. Aslakson emphasized this is not the case. “A palliative approach is about providing true holistic care for those enduring the greatest amount of pain and suffering,” said Dr. Aslakson, whose group presented the findings at the 2011 annual meeting of the Society of Critical Care Medicine (abstract 741). “This includes aggressive symptom management, clarification of mutual care goals and focused attention on the psychosocial needs of patients and their families.” Members of the critical care team can play a role by asking patients and their family members about the patients’ values and determining the possibility of meeting those values given the treatment options, Dr. Aslakson said. However beneficial and cost-effective these meetings can be, they are difficult to coordinate in an open or semi-open ICU setting. Nursing, surgery, anesthesiology, medicine and social work staff must agree both with each other and the patient’s family about a time and place to meet. Selecting patients most likely to benefit from these meetings is equally challenging, Dr. Aslakson said. As a starting point, she and her colleagues chose those whose SICU stay exceeded one week, positing that their SICU stays

Pharmacy Practice News • September 2011

Clinical 21

Critical Care Palliative Care Goals And Principles • Prevent and relieve suffering, regardless of the stage of the disease or the need for other therapies • Enhance quality of life for patients and families, optimizing function, helping with decision making and providing opportunities for personal growth • Manage pain and other distressing symptoms

‘We tend to focus on hard data and numbers. Good communication, which is an important part of critical care, consequently does not receive the attention it deserves.’ —Daniel Brown, MD, PhD of multidisciplinary critical care practice at Mayo Medical School, in Rochester, Minn., praised the Johns Hopkins team for sharing its structured approach

for gathering critical care providers, patients and their families. “We tend to focus on hard data and numbers. Good communication, which

is an important part of critical care, consequently does not receive the attention it deserves,” Dr. Brown said. “This aspect of care becomes all the more necessary in longer stay patients, because expectations and prognoses change and exchanging a unified and complete set of information with patients and their families [is] essential. The investigators here have put forth an approach that reduces the risk for treatment concerns slipping through the cracks.” —David Wild

• Incorporate psychosocial and spiritual care with consideration of patient/family needs, preferences, values, beliefs and culture • Ensure treatment is comprehensive and patientcentered with a focus on the central role of the family unit in decision making • Guide and assist the patient and family in making decisions that enable them to work toward their goals • Incorporate the expertise of various providers to assess and treat the complex needs of seriously ill patients and their families • Leadership, collaboration, coordination and communication are key elements for effective integration of these disciplines and services Adapted from the National Consensus Project for Quality Palliative Care. Clinical practice guidelines for quality palliative care. 2nd ed. Pittsburgh, PA: National Consensus Project for Quality Palliative Care; 2009:80.

would continue well beyond this time and that they would be a high-mortality segment of the SICU population. Between May and November 2009, the researchers assessed the feasibility of convening these meetings with 25 patients and families who met the seven-day threshold. They successfully held meetings with 15 (60%) of the 25 patients, with early death or patient transfer the most common reasons for not doing so. As the investigators suspected, these patients remained in the hospital for extended periods—a mean of 53 days, 41 days of which, on average, were spent in the SICU. Moreover, 44% died during their SICU stay. The cost of care for the patients amounted to a mean $165,648. Although the study did not look at the effects of interdisciplinary meetings on the course of treatment, Dr. Aslakson insisted that simply demonstrating the feasibility of holding them was a useful finding in itself. Daniel Brown, MD, PhD, associate professor of anesthesiology and director

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22 Technology

Pharmacy Practice News • September 2011

Informatics

CHRISTIANA CPOE continued from page 1

The launch not only led to greater pharmacy efficiency at the 1,154-bed health system, it also gave a boost to medication safety. In the months following the 2009 implementation, Dr. Corbo said staff pharmacists found they had more time for reviewing the appropriateness of prescriber orders and making interventions. The efficiency gains, she said, enabled pharmacy to “repurpose” 1.5 staff pharmacist shifts per day and one technician shift per day into a new medication safety role in the emergency department (ED). “We had a fourth-floor satellite pharmacy that we were able to close,” Dr. Corbo told participants in a recent Institute for Safe Medication Practices [ISMP] webinar, “and the benefit was that we moved that pharmacist and technician into admission histories down in our ED. We considered that a win as we drove to meet more patient needs.” A reduction in staffing costs was an added benefit. While Christiana Care’s full-time equivalent (FTE) pharmacy staff level remained unchanged, the health system was able to cancel a contract for a remote pharmacist orderentry service that helped fill in when the pharmacy “was struggling under a paper system,” Dr. Corbo said. Today, some 2.5 years after Christiana Care’s smaller Wilmington Hospital went live in January 2009, followed two months later by the 913-bed Christiana Care Hospital in Newark, Del., 95% of prescriber orders are transmitted via CPOE, Dr. Corbo said. Only a handful of services—oncology, women’s and children’s among them—still lack the technology. “Over time, they will be rolled out,” she told Pharmacy Practice News. Dr. Corbo and Christina Michalek, BS, RPh, FASHP, medication safety specialist at ISMP, teamed up during the 90-minute webinar to explore some of “the expected and unexpected results of CPOE implementation.” Their overall message was that although CPOE deployment has multiple ongoing challenges, its safety advantages continue to materialize long after the system goes live. “We have yet to tap the full benefit of our system,” Dr. Corbo said. Nationwide, CPOE adoption has been uneven. Often it is the last piece of safety-enhancing technology that hospitals put in place, after automated dispensing cabinets, electronic medical record systems, IV smart pumps and point-ofcare bar coding. The latest rollout data available, from the American Society of Health-System Pharmacists’ 2010 Survey of Pharmacy Practice (Am J Health Syst Pharm

A Christiana Care nurse walks through the steps of bar code point of care medication administration as a CPOE go-live support team member stands ready to offer assistance.

Flipping the Switch To Improve Outcomes

erri Corbo, PharmD, told webinar participants that the CPOE system benefits became apparent almost from the moment the switch was flipped. “We quickly learned to appreciate the legibility, the speed at which we received orders and our ability to process them,” she said. Moreover, order clarification requests from pharmacists were immediately visible to prescribers and nurses and “often before we could make the page or get hold of the physician, that physician had already gone in and make a change, depending on how well we had expressed what our concern was.” Other key improvements, she said, included an immediate reduction in manual formulary conversions and many more instances of weights and allergies being documented “because we had built that into the required system design.” —B.B.

‘You’re going to have to put multiple pharmacy staff on the same portion of the [CPOE] build to make sure that a human error doesn’t get through.’ —Terri Corbo, PharmD, BCPS, FASHP 2010;68:669-688), show a national CPOE adoption rate of just over 16%, although the rate for hospitals with at least 600 beds is almost 57%. Both percentages are likely to have increased in the past year, but the goal of universal adoption is probable only in larger hospitals and health systems.

Barriers to Adoption A major barrier to more rapid CPOE implementation is the complex and costly requirements of developing and deploying a system, including clinical decision support, that meets individual hospital needs. At Christiana Care,

Dr. Corbo said, the development phase “took at least two years.” One of the chief lessons that the Christiana Care team learned during the process of building the system, she said, was that human error was an everpresent risk. “CPOE is high-volume, complex work that involves multiple details for every single medication order that you’re going to prebuild for your system,” she said. The Christiana Care team developed approximately 210 medical and surgical order sets by the time the system was ready to go live. “Human error is inevitable,” she added. “The key message is that multiple

sets of eyes should review the clinical content. You’re going to have to put multiple pharmacy staff on the same portion of the [CPOE] build to make sure that a human error doesn’t get through.” One “downside” to developing decision support, Dr. Corbo said, was that “some end users believe the system is designed to catch everything. The answer is not to design a system that catches everything because it is just not possible. But it’s important that pharmacy is aware of that. You need those redundant safety checks.” Ms. Michalek agreed that the potential for error remained a threat even after going live. “There will be errors that are not easily caught,” she said. “When a prescriber selects a wrong patient or a wrong medication, it might not be very visible to the pharmacist who is verifying the order.” Some errors are easier to catch, she noted—for example, if an adult dose is ordered for a pediatric patient—but others may not be so readily detected. “Prescribers are going to expect all errors to be caught,” Ms. Michalek said. “We know that’s not going to happen, so you really need to keep them in the loop as to what clinical decision support is active in the system.” Additionally, she said, no matter what computer system is used for CPOE, missed doses and extra doses are going to occur. “The big lesson is that pharmacists and nurses need to manage the electronic medication administration record by looking” for those hard-to-spot errors. Physicians, she added, “have never typically looked for those errors when modifying an existing order. You can have a patient receive two doses of the same medication within a few hours if a physician doesn’t time that correctly. And if a physician orders a once-daily dose and it’s beyond the dose for today, that patient might not receive the dose until tomorrow, if somebody doesn’t pick up on that.”

‘Clicking’ Errors Targeted Dr. Corbo described how the CPOE team came up with a solution that helped reduce the risk for a physician unintentionally clicking on the wrong medication and having it added to a patient’s order list without the physician noticing. To prevent that, Dr. Corbo said, “we went back and made sure than any medication that had only one order sentence now had a minimum of two. Then … an active decision has to be made by the prescriber. For most meds it was easy to come up with at least two sentences for dosing.”

•

see CHRISTIANA CPOE, page 25

COMING SOON

Bridging the gap between the hospital and post-discharge care

In This Issue Technology Watch

Patient telemonitoring helps hospitals maintain seamless post-discharge care.

Cindy Kuzendorf, PharmD discusses the rewards of preceptoring the nation’s only ASHPaccredited home infusion residency program.

Business Case Study

TPN Regimens In Hospital Causing Problems at Home

For Aralast, Limiting Distribution Helps Boost Drug Safety

Overfeeding triggers risky electrolyte imbalances post-discharge

Registries, monitoring plan help ensure optimal outcomes

Q&A

Volume 1 • Number 1 • November 2011

Fight or switch? One health-system’s strategy for becoming a specialty pharmacy contractor.

•

Clinical Controversies

Continuous vs. intermittent IV antibiotic dosing: why the disconnect between hospital and home?

Educational Review

Compatibility of Commonly Used Intravenous Drugs

see ARALAST, page 1

see TPN REGIMENS, page 3

Coding Consult POLICY WATCH

Joint Commission Eyes Stronger Oversight Of Specialty Pharmacy

•

see COMMISSION, page 1

Top 10 Coding Mistakes—And How To Fix Them

New Products Ipilimumab (Yervoy, BMS) approved for metastatic or unresectable melanoma. See page 50.

Scriptpro announces new enhancements to its remote telepharmacy system. See page 50.

24 Technology

Pharmacy Practice News • September 2011

Social Networking

Leveraging Pharmacy Practice via Technology Denver—Tweets from attendees of a session at the American Society of HealthSystem Pharmacists (ASHP) Summer Meeting quickly stacked up as Christopher Fortier, PharmD, opened discussion on the critical role of automation and technology in leveraging pharmacy practice.

JFahrni: Conference note taking on an iPad during informatics session. Poetic. #ashpsm “We need to get the pharmacist out from behind a desktop computer in the hospital basement and out onto the floor, providing direct patient care,” said Dr. Fortier, manager of Pharmacy Support and Operating Room Services at the

simple piece of advice as he handed off the microphone: “GIT R DUN.”

The Do’s of Documentation Robert T. Adamson, PharmD, corporate vice president of clinical pharmacy systems at Saint Barnabas Health Care System in West Orange, N.J., followed up by delving deeper into the importance of documentation and describing how the latest technology could be harnessed to improve accuracy and efficiency across the medication-use process. “We should be documenting all the things that we do,” said Dr. Adamson. Undoubtedly, few would disagree with that statement; however, the best way to document remains an open question. Dr. Adamson suggested that pharmacy has evolved beyond paper-based manual records, cumbersome spreadsheet data-

‘We need to get the pharmacist out from behind a desktop computer in the hospital basement and out onto the floor, providing direct patient care.’ —Christopher Fortier, PharmD Medical University of South Carolina, in Charleston, and chair of the session. Advancing medication-use technologies, he suggested, has the power to make pharmacy more interoperable, patientcentered, analytical, automated, remote and mobile. In turn, he suggested, pharmacy can change clinical practice model. “Patients are becoming much more responsible for their own care—taking their own blood pressure at home—and those results being remotely downloaded into an electronic health record, for example,” said Dr. Fortier. “The technologies related to the medical home are going to grow tremendously and pharmacy has an opportunity to be a great leader.” Also quickly evolving is the quantity of data and automation available to “improve efficiencies” and “get pharmacists out of the distribution process and into the clinical arena,” he added. One example is giving pharmacists handheld tablets so they can apply “clinical surveillance technologies to monitor patients on the floor.” The conclusions of the ASHP/ASHP Foundation Pharmacy Practice Model Initiative (PPMI) Summit held in Dallas in November 2010 reinforced these concepts, with the consensus statement including 14 goals related to technology—from the use of electronic medical records to automated robotics. Applying these recommendations as a guide, while acknowledging the rising challenges and barriers such as increased pressure to cut costs, Dr. Fortier gave one

bases and small-screened PDAs (personal digital assistants). Today’s modern pharmacy computer systems, intranet and Internet commercial products and tablets “make the most sense,” he said. Bill G. Felkey, MS, professor emeritus of pharmacy care systems at Auburn University, in Auburn, Ala., who was not involved in the ASHP presentation, also recognized the key role of mobile devices. “Mobile information appliances offer the greatest opportunity for decision support using the best science possible in the practice of pharmacy and in the health care management decisions for patients,” said Mr. Felkey. Pointing to the wide range of software available for pharmacy, he quipped, “There is an app for that!” Of course, because there still is a generation that struggles with adjusting to the world of emails and cell phones, adoption of new technologies by pharmacy’s veterans could present significant challenges. “It’s hard to tell someone who’s been working for 30 or 40 years to learn new things,” Dr. Adamson said. “You should track what they do and give some honest feedback.” This should be done oneon-one, he noted, and in such a way that the pharmacist can understand why and how a few changes could improve his or her care of patients. But it’s not only pharmacists who need to be involved in

any integration. Dr. Adamson also pointed to the need for consensus throughout a hospital before implementing any of these options. “Hospital leadership and IT [information technology] also need to be on board,” he stressed.

New Tools of the Trade William W. Churchill, MS, RPh, chief of service in the Department of Pharmacy at Brigham and Women’s Hospital, in Boston, agreed that the first step in implementing new technologies is to get everyone on the same page. “Departments need to sit down and create a vision of what it will encompass—what technology, where should it fit in and who should use it,” Mr. Churchill said. At Brigham and Women’s, he added, most of the new technology has been “home-grown.” For example, the hospital implemented bar code medication administration (BCMA) in 2003. Thanks in part to the hard stop whenever a nurse doesn’t give the right dose of the right drug to the right patient at the right time, the tool has led to about a 50% reduction in potential adverse drug events: 3.1% to 1.6%. Mr. Churchill and his colleagues reported these results in The New England Journal of Medicine in 2010 (doi: 10.1056/NEJMsa0907115). “When nurses aren’t efficient, neither are pharmacists,” he added. What’s more, the devices are saving the hospital money. The institution broke even by the end of the

first year and reaped a net benefit of $3.3 million over the first five years—facts that easily got the audience’s attention.

MeganPharmD: Wow, Churchill says bar-code technology in the pharmacy at Brigham & Women’s paid for itself in reduced med errors in one year! #ashpsm Bar-code verification is the last crucial link in a closed-loop medication-use process that also includes computerized provider order entry (CPOE) and electronic medication administration records (eMAR). “It’s simple; it’s not rocket science,” Mr. Churchill said. Yet nearly half of U.S. hospitals don’t have bar-code verification systems. “That needs to be fixed, and quickly,” he added. Technological improvements need not end there. Mr. Churchill also recommended the use of robotic technology in both inpatient and outpatient pharmacies. At Brigham and Women’s, this addition resulted in no job losses and at least $1 million in savings. “Technology can never replace the critical thinking of clinicians, but it can free up clinician time for other responsibilities such as direct patient care,” he said. “Clinical pharmacists are vitally important in assuring success with medication safety technology.”

PRINTER-FRIENDLY VERSION AT PHARMACYPRACTICENEWS.COM

Compatibility of

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

he number of available IV medications continues to expand. Many institutions have observed an

increase in patient acuity and a rise in the number of medications administered to each patient. This increases the likelihood that multiple IV medications will need to be administered concurrently.

These factors contribute to the escalating complexity of IV drug administration and have resulted in an ever-increasing number of possible incompatibilities. The potential for serious and life-threatening adverse drug events exists when incompatible medications are infused together. Therefore, it is important to verify drug compatibility prior to coadministration. A clear and concise compatibility chart can be a useful tool in helping to deliver safe, high-quality IV therapy to patients. A chance of incompatibility exists whenever any

medication is combined or added to an IV fluid. It is important to recognize that compatibility is not just a function of the drugs themselves, but also can be dependent on a variety of factors including the concentration, temperature, storage vehicle, infusion solution, order of mixing, and administration technique. Compatibility differences even have been reported for different brands of the same drug. Three types of incompatibilities are commonly discussed: physical, chemical, and therapeutic. Physical Text continues on page 6

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

P H A R M AC Y P R AC T I C E N E WS â&#x20AC;˘ S E P T E M B E R 2 0 1 1

Amiodarone

Ampicillin

Ampicillin-sulbactam

Anidulafungin

Argatroban

Azithromycin

Aztreonam

Bivalirudin

Bumetanide

Calcium gluconate

Caspofungin

Cefazolin

Cefepime

Cefotaxime

Cefoxitin

Ceftaroline

Ceftazidime

Ceftizoxime

Ceftriaxone

Ciprofloxacin

Clindamycin

Daptomycin

Dexamethasone

Dextrose 5% in water

Diazepam

Diltiazem

Diphenhydramine

Dobutamine

Dopamine

Doripenem

Doxycycline

Enalaprilat

Epinephrine

Eptifibatide

Esmolol

Esomeprazole

Famotidine

Fentanyl

Fluconazole

Furosemide

Gentamicin

Acyclovir

(continued)

Amikacin

Acyclovir

Table. Compatibility of Selected IV Drugs

Amikacin

Amiodarone

Ampicillin

Ampicillin-sulbactam

Anidulafungin

Argatroban

Azithromycin

Aztreonam

Bivalirudin

Bumetanide

Calcium gluconate

Caspofungin

Cefazolin

Cefepime

Cefotaxime

Cefoxitin

Ceftaroline

Ceftazidime

Ceftizoxime

Ceftriaxone

Ciprofloxacin

Clindamycin

Daptomycin

Dexamethasone

D5W

Diazepam

Diltiazem

Diphenhydramine

Dobutamine

Dopamine

Doripenem

Doxycycline

Enalaprilat

Epinephrine

Eptifibatide

Esmolol

Esomeprazole

Famotidine

Fentanyl

Protect from light. Testing was performed with ethylenediaminetetra-acetic acid (EDTA)-free formulation.

KEY A = Physically compatible for at least 2 hours

H = Physically compatible for at least 1 hour

C = Physically compatible

I = Incompatible

D = Physically compatible in dextrose 5% in water

N = Information on compatibility is not available or not adequate

E = Physically compatible for at least 5 minutes

R = Physically compatible for 24 hours under refrigeration

G = Physically compatible in glass bottle only

S = Physically compatible in 0.9% sodium chloride

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

Granisetron

Heparin

Hydrocortisone Sod. Succ.

Hydromorphone

Imipenem-cilastatin

Insulin, regular

Labetalol

Levofloxacin

Linezolid

Lorazepam

Magnesium sulfate

Mannitol

Meropenem

Methylprednisolone sod. Succ.

Metoclopramide

Metronidazole

Micafungin

Midazolam

Morphine sulfate

Nafcillin

Nitroglycerin

Nitroprussidea

Norepinephrine

Ondansetron

Palonosetron

Pantoprazoleb

Penicillin G Potassium

Phenylephrine

Phenytoin

Piperacillin-tazobactam

Potassium chloride

Prochlorperazine

Propofol

Ringerâ&#x20AC;&#x2122;s, lactated

Sodium bicarbonate

Sodium chloride 0.9%

Tacrolimus

Tigecycline

Tobramycin

TMP-SMX

Vancomycin

Vasopressin

Voriconazole

Acyclovir

Amikacin

Amiodarone

Ampicillin

Ampicillin-sulbactam

Anidulafungin

Argatroban

Azithromycin

Aztreonam

Bivalirudin

Bumetanide

Calcium gluconate

Caspofungin

Cefazolin

Cefepime

Cefotaxime

Cefoxitin

Ceftaroline

Ceftazidime

Ceftizoxime

Ceftriaxone

Ciprofloxacin

Clindamycin

Daptomycin

Dexamethasone

D5W

Diazepam

Diltiazem

Diphenhydramine

Dobutamine

Dopamine

Doripenem

Doxycycline

Enalaprilat

Epinephrine

Eptifibatide

Esmolol

Esomeprazole

Famotidine

Fentanyl Table continues on page 4

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

Ampicillin-sulbactam

Anidulafungin

Argatroban

Azithromycin

Aztreonam

Bivalirudin

Bumetanide

Calcium gluconate

Caspofungin

Cefazolin

Cefepime

Cefotaxime

Cefoxitin

Ceftaroline

Ceftazidime

Ceftizoxime

Ceftriaxone

Ciprofloxacin

Clindamycin

Daptomycin

Dexamethasone

Dextrose 5% in water

Diazepam

Diltiazem

Diphenhydramine

Dobutamine

Dopamine

Doripenem

Doxycycline

Enalaprilat

Epinephrine

Eptifibatide

Esmolol

Esomeprazole

Famotidine

Fentanyl

Gentamicin

Granisetron

Heparin

Hydrocortisone

Hydromorphone

Imipenem-cilastatin

Insulin, regular

Labetalol

Levofloxacin

Linezolid

Lorazepam

Magnesium sulfate

Mannitol

Meropenem

Methylprednisolone

Metoclopramide

Metronidazole

Micafungin

Midazolam

Morphine sulfate

Nafcillin

Nitroglycerin

Nitroprusside

Norepinephrine

Ondansetron

Palonosetron

Pantoprazole

Penicillin G

Phenylephrine

Phenytoin

Piperacillan-tazobactam I

Gentamicin

Ampicillin

Furosemide

Amiodarone

Furosemide

Fluconazole

Amikacin

Fluconazole

(continued)

Acyclovir

Table. Compatibility of Selected IV Drugs

C N

Potassium chloride

Prochlorperazine

Propofol

Ringerâ&#x20AC;&#x2122;s, lactated

Sodium bicarbonate

Sodium chloride 0.9%

Tacrolimus

Tigecycline

Tobramycin

TMP-SMX

Vancomycin

Vasopressin

Voriconazole

Protect from light. Testing was performed with ethylenediaminetetra-acetic acid (EDTA)-free formulation.

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

Granisetron

Heparin

Hydrocortisone Sod. Succ.

Hydromorphone

Imipenem-cilastatin

Insulin, regular

Labetalol

Levofloxacin

Linezolid

Lorazepam

Magnesium sulfate

Mannitol

Meropenem

Methylprednisolone sod. Succ.

Metoclopramide

Metronidazole

Micafungin

Midazolam

Morphine sulfate

Nafcillin

Nitroglycerin

Nitroprussidea

Norepinephrine

Ondansetron

Palonosetron

Pantoprazoleb

Penicillin G Potassium

Phenylephrine

Phenytoin

Piperacillin-tazobactam

Potassium chloride

Prochlorperazine

Propofol

Ringerâ&#x20AC;&#x2122;s, lactated

Sodium bicarbonate

Sodium chloride 0.9%

Tacrolimus

Tigecycline

Tobramycin

TMP-SMX

Vancomycin

Vasopressin

Voriconazole

Fluconazole

Furosemide

Gentamicin

Granisetron

Heparin

Hydrocortisone

Hydromorphone

Imipenem-cilastatin

Insulin, regular

Labetalol

Levofloxacin

Linezolid

Lorazepam

Magnesium sulfate

Mannitol

Meropenem

Methylprednisolone

Metoclopramide

Metronidazole

Micafungin

Midazolam

Morphine sulfate

Nafcillin

Nitroglycerin

Nitroprussidea

Norepinephrine

Ondansetron

Palonosetron

Pantoprazoleb

Penicillin G

Phenylephrine

Phenytoin

Piperacillin-tazobactam

Potassium chloride

Prochlorperazine

Propofol

Ringerâ&#x20AC;&#x2122;s, lactated

Sodium bicarbonate

Sodium chloride 0.9%

Tacrolimus

Tigecycline

Tobramycin

TMP-SMX

Vancomycin

Vasopressin

C C

Voriconazole

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

Text continued from page 1

incompatibilities are the most easily detected and are evidenced by visible changes, such as particulate formation, haze, precipitation, color change, and gas evolution. Chemical incompatibilities are those that result in decomposition of a drug. Loss of potency of greater than 10% over the defined testing period is considered chemical incompatibility. Most chemical incompatibilities can be detected only with a suitable analytic method. Therapeutic incompatibilities in which a drug combination results in undesirable antagonistic or synergistic pharmacologic activity are beyond the scope of most compatibility references. The purpose of this chart is to provide data in an organized, concise format from which compatibility information can be accessed quickly and conveniently. Although there are differing types of incompatibilities, the type of incompatibility or compatibility is not specified in this chart. A designation of â&#x20AC;&#x153;compatibleâ&#x20AC;? indicates that the combination evaluated appears to be compatible based on the tests performed, whether these tests measured physical, chemical, or both types of compatibility. All conditions that may affect compatibility cannot be included in such a format and it is not possible to predict all incompatibilities that may arise, but it is hoped that the information provided may

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

help clinicians minimize their occurrence. Continuing research adding to the existing body of knowledge on IV compatibilities is vital.

Suggested Reading Bertsche T, Mayer Y, Stahl R, Hoppe-Tichy T, Encke J, Haefeli WE. Prevention of intravenous drug incompatibilities in an intensive care unit. Am J Health Syst Pharm. 2008;65(19):1834-1840. Canann D, Tyler LS, Barker B, Condie C. Visual compatibility of IV medications routinely used in bone marrow transplant recipients. Am J Health Syst Pharm. 2009;66(8):727-729. Condie CK, Tyler LS, Barker B, Canann DM. Visual compatibility of caspofungin acetate with commonly used drugs during simulated Y-site delivery. Am J Health Syst Pharm. 2008;65(5):454-457. Data on file. Wyeth Pharmaceuticals. DRUGDEXÂŽ System (Internet database). Greenwood Village, CO: Thomson Reuters (Healthcare) Inc. Nemec K, Kopelent-Frank H, Greif R. Standardization of infusion solutions to reduce the risk of incompatibility. Am J Health Syst Pharm. 2008;65(17):1648-1654. Trissel LA, ed. Handbook on Injectable Drugs. 16th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2011.

Dr. Cayo reports no relevant conflicts of interest.

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Pharmacy Practice News • September 2011

Technology 25

Social Networking Still, as much as technology can improve practice, there are always risks. “With great connectivity comes great need for security and confidentiality,” noted Mr. Felkey. “Every measure should be taken to secure the protected health information being transferred around the health system electronically.” The answer, Mr. Churchill suggested, is for a multidisciplinary team to tap into the ever-growing supply of data and evaluate the risks, minimize the costs and produce a business plan that’s beneficial for both the patients and the hospital. He compared the ideal end product to the tracking system at FedEx, which uses geodatabase technology to document a delivery from start to finish.

FortiPharm: Churchill: we need FedEx-like tracking within all our pharmacies. #ashpsm

Just Do Something In May 2011, Lancaster General Health, in Lancaster, Pa., implement-

ed a new, integrated pharmacy information system. But the integration of technologies at Lancaster started years ago, explained Rich Paoletti, MBA, BS Pharm, vice president of Lancaster General. BCMA and eMAR came about in 2004, smart pumps in 2006 and infusion device interoperability a couple years later. Mr. Paoletti focused his portion of the session on infusion devices, which he suggested could improve clinical decision support at the point of care while employing a library of medications customized to meet an organization’s needs and calculating weightbased infusion rates. Unfortunately, such infusion integration has been far from perfect to date. In April 2010, the FDA launched the Infusion Pump Improvement Initiative after noticing a growing number of pump-related adverse events, patient deaths and device recalls. The agency highlighted the need to eliminate software defects, and user interface and mechanical or electrical failures, among dangerously common problems. Pharmacists should be front and

center in this effort, leading integration of these devices with electronic medical records, according to Mr. Paoletti. However, they face stiff challenges: Intellectual property rights, collaboration between vendors, and current technologies may all limit implementation of such changes. And both eMAR and BCMA are necessary prerequisites. Mr. Paoletti also emphasized the need for standardization throughout, including education, rigorous review and testing, and the engagement of nurses, physicians and pharmacists. “The more we sweat in training, the less we bleed in war,” said Mr. Paoletti, quoting the U.S. Navy Seal Team Six. Still, the ultimate strategy, he told the ASHP attendees, is to not be paralyzed by what can seem like an overwhelming challenge. “Just start doing something,” he recommended. “You do have to create a vision, but you also need to start somewhere.” The smart pump was one of his hospital’s “somethings.” And it proved successful—significantly simplifying the process and reducing the time involved

in infusions by nearly 25%. Reported heparin events also dropped by 60%. This outcome, too, impressed the attendees of the session, as several “tweeted up” some of the striking statistics.

JFahrni: Lancaster General went from a 17-step pump programming process to 7 steps with smart pump integration and barcode technology. #ashpsm “The practice of pharmacy is not only supported by technology, but increasingly is driven by it,” said Mr. Felkey. “Over 90% of patients have a cell phone or a smartphone within three feet of them 24/7. Think of the possibilities.” —Lynne Peeples Drs. Fortier and Adamson, and Messrs. Churchill, Felkey and Paoletti, reported no relevant conflicts of interest.

Informatics

CHRISTIANA CPOE continued from page 22

Ms. Michalek warned that CPOE would not fix existing problems in a faulty medication use process. “You really need to address what is currently not fitting into that ideal process before you implement. You’re not going to be able to gain the full benefits of CPOE if you try to lay it on top of existing poor habits or bad practices.” That is why Dr. Corbo said the Christiana Care development team put so much emphasis on creating a viable “build strategy” before launching the new technology. “It’s hard to be nimble once you’re live and go back and reset the standard for where you’re headed. So we had a foundation of clinical ownership and leadership, we standardized

where possible, and we leveraged decision support where most critical. This is not just about go-live. You’re constantly tweaking, [learning] and building for new needs of the population.” (Pharmacy Practice News reported in January 2011 on Christiana Care’s fiveyear campaign to standardize injectable hydromorphone dosing, an effort that eventually encompassed its CPOE system. The health system’s success story won an ISMP 2010 Cheers Award. (To access article, scan the 2-D barcode on this page or visit www.pharmacypracticenews.com/christiana*). John Poikonen, PharmD, clinical informatics director at the University of Massachusetts Memorial Health Care, Worchester, said that it was “really exciting that CPOE is crossing the chasm of early adopters, where best

pharmacy practices are beginning to emerge. We are starting to see that it is about the entire medication use process and not just all about physician

adoption. Chronicling the success and failures, as was done here, is so important for others to stand on our shoulders and do even better.” Scan for Cheers Award story; Prior to impleInstructions, p. 5 menting the CPOE system, Christiana Care had implemented an electronic medical record along with bar code point of care medication administration. Now, Christiana reports that these three technologies together provide enhanced safety in the prescribing, dispensing and administration of medications throughout the health system. —Bruce Buckley

In Brief

No More Whitelisting for Pharma on Facebook

reedom to comment on pharmaceutical company Facebook pages is now possible following a policy change by the popular social media Web site. Facebook recently sent an email to pharmaceutical companies informing them they can no longer regulate their pages through the practice of “whitelisting.” In the past, pharmaceutical companies

had the authority to whitelist, or disable comments, on original content, thus allowing the company to be the only content contributor to the page. Facebook generally allows individuals who have been “friended” by personal page creators to post comments or comment on the existing content. Before Facebook’s decree, pharma companies would simply submit a request to a Facebook representative to disable a comment. Now, any new pharma page created can no longer

use the feature. With Facebook’s approval, however, branded pages that deal exclusively with a prescription drug may be able to continue the whitelisting practice, according to the letter. Facebook said the new policy is more in line with its mission to provide an open, two-way dialogue between businesses and consumers. However, Facebook acknowledged that the changes may prompt companies “to re-evaluate [their] strategy and presence on Facebook.” —Kevin Enright

PREMIXED AMIODARONE. Indications and Usage NEXTERONE (amiodarone HCl) Premixed Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. NEXTERONE also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. Use NEXTERONE for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but NEXTERONE may be safely administered for longer periods if necessary.

Important Risk Information NEXTERONE (amiodarone HCl) Premixed Injection is contraindicated in patients with: • Known hypersensitivity to any of the components of NEXTERONE, including iodine • Cardiogenic shock • Marked sinus bradycardia • Second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available • NEXTERONE should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias, who are thoroughly familiar with the risks and benefits of amiodarone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment. • Hypotension is the most common adverse reaction seen with intravenous amiodarone. In clinical trials, treatment-emergent, drug-related hypotension was reported in 16% (288/1836) of patients treated with intravenous amiodarone. Monitor the initial rate of infusion closely and do not exceed the recommended rate. In some cases, hypotension may be refractory and result in a fatal outcome. Treat hypotension initially by slowing the infusion; additional standard therapy may be needed, including: vasopressors, positive inotropic agents and volume expansion. • In 4.9% (90/1836) of patients in clinical trials, drug-related bradycardia that was not dose-related occurred while patients were receiving intravenous amiodarone for life-threatening VT/VF. Treat bradycardia by slowing the infusion rate or discontinuing NEXTERONE. Treat patients with a known predisposition to bradycardia or AV block with NEXTERONE in a setting where a temporary pacemaker is available. • Like all antiarrhythmics, NEXTERONE may cause worsening of existing arrhythmias or precipitate a new arrhythmia. • The most common adverse reactions leading to discontinuation (1-2%) of intravenous amiodarone therapy are hypotension, asystole/cardiac arrest/pulseless electrical activity, VT, and cardiogenic shock. • Other important adverse reactions are torsade de pointes (TdP), congestive heart failure, liver function test abnormalities, pulmonary disorders, and thyroid abnormalities. • Drug Interactions: Since amiodarone is a substrate for CYP3A and CYP2C8, drugs/substances that inhibit these isoenzymes may decrease the metabolism and increase serum concentration of amiodarone. Amiodarone inhibits p-glycoprotein and certain CYP450 enzymes, including CYP1A2, CYP2C9, CYP2D6, and CYP3A. This inhibition can result in unexpectedly high plasma levels of other drugs which are metabolized by those CYP450 enzymes or are substrates for p-glycoprotein. Fluoroquinolones, macrolide antibiotics, and azoles are known to cause QTc prolongation. There have been reports of QTc prolongation, with or without TdP, in patients taking amiodarone when fluoroquinolones, macrolide antibiotics, or azoles were administered concomitantly. Please see brief summary of Full Prescribing Information on the following pages.

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NEXTERONE (amiodarone HCl) Premixed Injection for intravenous use Brief Summary of Prescribing Information. See PI for Full Prescribing Information. 1 INDICATIONS AND USAGE NEXTERONE is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. NEXTERONE also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with NEXTERONE, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2) in full prescribing information]. Use NEXTERONE for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but NEXTERONE may be safely administered for longer periods if necessary. 4 CONTRAINDICATIONS NEXTERONE is contraindicated in patients with: • Known hypersensitivity to any of the components of NEXTERONE Premixed Injection, including iodine. Hypersensitivity reactions may involve rash, angioedema, cutaneous/mucosal hemorrhage (bleeding), fever, arthralgias (joint pains), eosinophilia (abnormal blood counts), urticaria (hives), thrombotic thrombocytopenic purpura, or severe periarteritis (inflammation around blood vessels). • Cardiogenic shock. • Marked sinus bradycardia. • Second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available. 5 WARNINGS AND PRECAUTIONS NEXTERONE should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias, who are thoroughly familiar with the risks and benefits of amiodarone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment. 5.1 Hypotension Hypotension is the most common adverse reaction seen with intravenous amiodarone. In clinical trials, treatment-emergent, drug-related hypotension was reported as an adverse effect in 288 (16%) of 1836 patients treated with intravenous amiodarone. Clinically significant hypotension during infusions was seen most often in the first several hours of treatment and was not dose related, but appeared to be related to the rate of infusion. Hypotension necessitating alterations in intravenous amiodarone therapy was reported in 3% of patients, with permanent discontinuation required in less than 2% of patients. Treat hypotension initially by slowing the infusion; additional standard therapy may be needed, including the following: vasopressor drugs, positive inotropic agents, and volume expansion. Monitor the initial rate of infusion closely and do not exceed the recommended rate [see Dosage and Administration (2) in full prescribing information]. In some cases, hypotension may be refractory and result in a fatal outcome [see Adverse Reactions (6.2) in full prescribing information]. 5.2 Bradycardia and Atrio-ventricular Block In 90 (4.9%) of 1836 patients in clinical trials, drug-related bradycardia that was not dose-related occurred while they were receiving intravenous amiodarone for life-threatening VT/VF. Treat bradycardia by slowing the infusion rate or discontinuing NEXTERONE. In some patients, inserting a pacemaker is required. Despite such measures, bradycardia was progressive and terminal in 1 patient during the controlled trials. Treat patients with a known predisposition to bradycardia or AV block with NEXTERONE in a setting where a temporary pacemaker is available. 5.3 Liver Enzyme Elevations Elevations of blood hepatic enzyme values [alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT)] are commonly seen in patients with immediately life-threatening VT/VF. Interpreting elevated AST activity can be difficult because the values may be elevated in patients who have had recent myocardial infarction, congestive heart failure, or multiple electrical defibrillations. Approximately 54% of patients receiving intravenous amiodarone in clinical studies had baseline liver enzyme elevations, and 13% had clinically significant elevations. In 81% of patients with both baseline and on-therapy data available, the liver enzyme elevations either improved during therapy or remained at baseline levels. Baseline abnormalities in hepatic enzymes are not a contraindication to treatment. Acute, centrolobular confluent hepatocellular necrosis leading to hepatic coma, acute renal failure, and death has been associated with the administration of intravenous amiodarone at a much higher loading dose concentration and much faster rate of infusion than recommended [see Dosage and Administration (2) in full prescribing information]. In patients with life-threatening arrhythmias, the potential risk of hepatic injury should be weighed against the potential benefit of NEXTERONE therapy. Carefully monitor patients receiving NEXTERONE for evidence of progressive hepatic injury. In such cases, consider reducing the rate of administration or withdrawing NEXTERONE.

5.4 Proarrhythmia Like all antiarrhythmic agents, NEXTERONE may cause a worsening of existing arrhythmias or precipitate a new arrhythmia. Proarrhythmia, primarily torsade de pointes (TdP), has been associated with prolongation, by intravenous amiodarone, of the QTc interval to 500 ms or greater. Although QTc prolongation occurred frequently in patients receiving intravenous amiodarone, TdP or new-onset VF occurred infrequently (less than 2%). Monitor patients for QTc prolongation during infusion with NEXTERONE. Reserve the combination of amiodarone with other antiarrhythmic therapies that prolong the QTc to patients with life-threatening ventricular arrhythmias who are incompletely responsive to a single agent. Fluoroquinolones, macrolide antibiotics, and azoles are known to cause QTc prolongation. There have been reports of QTc prolongation, with or without TdP, in patients taking amiodarone when fluoroquinolones, macrolide antibiotics, or azoles were administered concomitantly [see Drug Interactions (7) in full prescribing information]. Amiodarone causes thyroid dysfunction in some patients, which may lead to potentially fatal breakthrough or exacerbated arrhythmias. 5.5 Pulmonary Disorders Early-onset Pulmonary Toxicity There have been postmarketing reports of acute-onset (days to weeks) pulmonary injury in patients treated with intravenous amiodarone. Findings have included pulmonary infiltrates and masses on X-ray, bronchospasm, wheezing, fever, dyspnea, cough, hemoptysis, and hypoxia. Some cases have progressed to respiratory failure or death. ARDS Two percent (2%) of patients were reported to have adult respiratory distress syndrome (ARDS) during clinical studies involving 48 hours of therapy. Pulmonary Fibrosis Only 1 of more than 1000 patients treated with intravenous amiodarone in clinical studies developed pulmonary fibrosis. In that patient, the condition was diagnosed 3 months after treatment with intravenous amiodarone, during which time the patient received oral amiodarone. Pulmonary toxicity is a well-recognized complication of long-term amiodarone use (see package insert for oral amiodarone). 5.6 Loss of Vision Cases of optic neuropathy and optic neuritis, usually resulting in visual impairment, have been reported in patients treated with oral amiodarone. In some cases, visual impairment has progressed to permanent blindness. Optic neuropathy and neuritis may occur at any time following initiation of therapy. A causal relationship to the drug has not been clearly established. Perform an ophthalmic examination if symptoms of visual impairment appear, such as changes in visual acuity and decreases in peripheral vision. Re-evaluate the necessity of amiodarone therapy if optic neuropathy or neuritis is suspected. Perform regular ophthalmic examination, including fundoscopy and slit-lamp examination, during administration of NEXTERONE. 5.7 Long-Term Use There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks. See package insert for oral amiodarone. 5.8 Thyroid Abnormalities Amiodarone inhibits peripheral conversion of thyroxine (T4) to triiodothyronine (T3) and may cause increased T4 levels, decreased T3 levels, and increased levels of inactive reverse T3 (rT3) in clinically euthyroid patients. Amiodarone is also a potential source of large amounts of inorganic iodine and can cause either hypothyroidism or hyperthyroidism. Evaluate thyroid function prior to treatment and periodically thereafter, particularly in elderly patients, and in any patient with a history of thyroid nodules, goiter, or other thyroid dysfunction. Because of the slow elimination of amiodarone and its metabolites, high plasma iodide levels, altered thyroid function, and abnormal thyroid function tests may persist for several weeks or even months following NEXTERONE withdrawal. There have been postmarketing reports of thyroid nodules/thyroid cancer in patients treated with amiodarone. In some instances hyperthyroidism was also present [see Adverse Reactions (6.2) in full prescribing information]. Hyperthyroidism and Thyrotoxicosis Hyperthyroidism occurs in about 2% of patients receiving amiodarone, but the incidence may be higher among patients with prior inadequate dietary iodine intake. Amiodarone-induced hyperthyroidism usually poses a greater hazard to the patient than hypothyroidism because of the possibility of thyrotoxicosis and arrhythmia breakthrough or aggravation, all of which may result in death. There have been reports of death associated with amiodarone-induced thyrotoxicosis. Consider the possibility of hyperthyroidism if any new signs of arrhythmia appear.

Identify hyperthyroidism by relevant clinical signs and symptoms, subnormal serum levels of thyroid stimulating hormone (TSH), abnormally elevated serum free T4, and elevated or normal serum T3. Since arrhythmia breakthroughs may accompany amiodarone-induced hyperthyroidism, aggressive medical treatment is indicated, including, if possible, dose reduction or withdrawal of amiodarone. Amiodarone hyperthyroidism may be followed by a transient period of hypothyroidism.

Table 4 lists the most common (incidence â&#x2030;Ľ2%) adverse reactions during intravenous amiodarone therapy considered at least possibly drug-related. These data were collected in clinical trials involving 1836 patients with life-threatening VT/VF. Data from all assigned treatment groups are pooled because none of the adverse reactions appeared to be dose-related. Table 4: ADVERSE REACTIONS IN PATIENTS RECEIVING INTRAVENOUS AMIODARONE IN

The institution of antithyroid drugs, Î˛-adrenergic blockers or temporary corticosteroid therapy may be necessary. The action of antithyroid drugs may be especially delayed in amiodarone-induced thyrotoxicosis because of substantial quantities of preformed thyroid hormones stored in the gland. Radioactive iodine therapy is contraindicated because of the low radioiodine uptake associated with amiodarone-induced hyperthyroidism. When aggressive treatment of amiodarone-induced thyrotoxicosis has failed or amiodarone cannot be discontinued because it is the only drug effective against the resistant arrhythmia, surgical management may be an option. Experience with thyroidectomy as a treatment for amiodarone-induced thyrotoxicosis is limited, and this form of therapy could induce thyroid storm. Therefore, surgical and anesthetic management require careful planning. Neonatal Hypo- or Hyperthyroidism Amiodarone can cause fetal harm when administered to a pregnant woman. Although amiodarone use during pregnancy is uncommon, there have been a small number of published reports of congenital goiter/hypothyroidism and hyperthyroidism associated with oral administration. Inform the patient of the potential hazard to the fetus if NEXTERONE is administered during pregnancy or if the patient becomes pregnant while taking NEXTERONE. Hypothyroidism Hypothyroidism has been reported in 2% to 4% of patients in most series, but in 8% to 10% in some series. This condition may be identified by relevant clinical symptoms and particularly by elevated serum TSH levels. In some clinically hypothyroid amiodarone-treated patients, free thyroxine index values may be normal. Manage hypothyroidism by reducing the NEXTERONE dose and considering the need for thyroid hormone supplement. However, therapy must be individualized, and it may be necessary to discontinue oral amiodarone in some patients. 5.9 Surgery Perform close perioperative monitoring in patients undergoing general anesthesia who are on amiodarone therapy as they may be more sensitive to the myocardial depressant and conduction defects of halogenated inhalational anesthetics. 5.10 Corneal Refractive Laser Surgery Advise patients that most manufacturers of corneal refractive laser surgery devices contraindicate corneal refractive laser surgery in patients taking amiodarone. 5.11 Electrolyte Disturbances Correct hypokalemia or hypomagnesemia whenever possible before initiating treatment with NEXTERONE, as these disorders can exaggerate the degree of QTc prolongation and increase the potential for TdP. Give special attention to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhea or in patients receiving concomitant diuretics. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

CONTROLLED AND OPEN-LABEL STUDIES (> 2% INCIDENCE) Study Event

Controlled Studies (n=814)

Open-Label Studies (n=1022)

Total (n=1836)

Body as a whole Fever

Body as a whole 24 (2.9%)

Body as a whole 13 (1.2%)

Body as a whole 37 (2.0%)

Cardiovascular System Bradycardia Congestive heart failure Heart arrest Hypotension Ventricular tachycardia

Cardiovascular 49 (6.0%) 18 (2.2%) 29 (3.5%) 165 (20.2%) 15 (1.8%) Digestive System 35 (4.2%) 29 (3.5%)

Cardiovascular 41 (4.0%) 21 (2.0%) 26 (2.5%) 123 (12.0%) 30 (2.9%) Digestive System 29 (2.8%) 43 (4.2%)

Cardiovascular 90 (4.9%) 39 (2.1%) 55 (2.9%) 288 (15.6%) 45 (2.4%)

Digestive System Liver function tests normal Nausea

Digestive System 64 (3.4%) 72 (3.9%)

Other adverse reactions reported in less than 2% of patients receiving intravenous amiodarone in controlled and uncontrolled studies included the following: abnormal kidney function, atrial fibrillation, diarrhea, increased ALT, increased AST, lung edema, nodal arrhythmia, prolonged QT interval, respiratory disorder, shock, sinus bradycardia, Stevens-Johnson syndrome, thrombocytopenia, VF, and vomiting. 6.2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of amiodarone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body as a Whole: anaphylactic/anaphylactoid reaction (including shock), fever Cardiovascular: hypotension (sometimes fatal), sinus arrest Dermatologic: toxic epidermal necrolysis (sometimes fatal), exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, skin cancer, pruritus, angioedema Endocrine: syndrome of inappropriate antidiuretic hormone secretion (SIADH) Hematologic: pancytopenia, neutropenia, hemolytic anemia, aplastic anemia, thrombocytopenia, agranulocytosis, granuloma Hepatic: hepatitis, cholestatic hepatitis, cirrhosis Injection Site Reactions: pain, erythema, edema, pigment changes, venous thrombosis, phlebitis, thrombophlebitis, cellulitis, necrosis, and skin sloughing Musculoskeletal: myopathy, muscle weakness, rhabdomyolysis Nervous System: hallucination, confusional state, disorientation, and delirium, pseudotumor cerebri Pancreatic: pancreatitis

In a total of 1836 patients in controlled and uncontrolled clinical trials, 14% of patients received intravenous amiodarone for at least one week, 5% received it for at least 2 weeks, 2% received it for at least 3 weeks, and 1% received it for more than 3 weeks, without an increased incidence of severe adverse reactions. The mean duration of therapy in these studies was 5.6 days; median exposure was 3.7 days.

Renal: renal impairment, renal insufficiency, acute renal failure

The most important adverse reactions were hypotension, asystole/cardiac arrest/pulseless electrical activity (PEA), cardiogenic shock, congestive heart failure, bradycardia, liver function test abnormalities, VT, and AV block. Overall, treatment was discontinued for about 9% of the patients because of adverse reactions. The most common adverse reactions leading to discontinuation of intravenous amiodarone therapy were hypotension (1.6%), asystole/cardiac arrest/PEA (1.2%), VT (1.1%), and cardiogenic shock (1%).

Vascular: vasculitis

Respiratory: bronchospasm, possibly fatal respiratory disorders (including distress, failure, arrest and ARDS), bronchiolitis obliterans organizing pneumonia (possibly fatal), dyspnea, cough, hemoptysis, wheezing, hypoxia, pulmonary infiltrates and /or mass, pleuritis Thyroid: thyroid nodules/thyroid cancer

Baxter Healthcare Corporation Deerfield, IL 60015 Baxter, Galaxy and the Sphere Graphic are registered trademarks of Baxter International Inc. NEXTERONE is a registered trademark of Prism Pharmaceuticals, Inc.

Sourced from: 07-19-65-459 Rev. November 2010

30 Operations & Management

Pharmacy Practice News • September 2011

Practice Pearl Waste management strategies every pharmacist should know

Tips for Disposal of Unused and Expired Medications Jessica Chasler PharmD candidate University of Maryland School of Pharmacy Baltimore, Maryland

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

edication disposal is a hot topic in pharmacy today, and it is rapidly gaining the attention of more and more professionals and consumers alike. Pharmacists have the potential to be on the forefront of this movement, but it is essential that their knowledge of proper medication disposal is current, complete, and accurate. Only about 20% of pharmacists report learning about medication disposal in pharmacy school.1 This article is designed to provide a background into the importance and significance of proper medication disposal, describe the correct way to dispose of unwanted medications, and provide pharmacists with examples of existing medication disposal programs. It also contains a list of resources that can be used to further expand and supplement pharmacists’ knowledge of this subject.

Pharmaceutical Waste In the Environment In a series of investigations performed by the US Environmental Protection Agency (EPA), multiple pharmaceutical products were detected as contaminants in various ecosystems. Compared with what is known about the effects of pesticides, little is known about the overall impact of pharmaceutical waste on the environment. Although pharmaceuticals tend to be present in relatively low levels, and the results of short-term exposure seem to be minimal, the results of longterm exposure to these low levels of pharmaceutical waste remain unknown. This uncertainty is compounded by the fact that research in this area tends to focus on acute effects of pharmaceutical waste, whereas the more subtle and chronic effects of such exposure have yet to be investigated thoroughly. Although more than 100 individual pharmaceutical and personal care products have been identified in various environments that have been studied, the presence of certain drug classes in particular is cause for elevated concern. Antimicrobials, as

well as natural and synthetic steroids, which have the potential for substantial effects on the endocrine systems of exposed organisms, are among the drugs that fall into this category, along with selective serotonin reuptake inhibitors, which have been shown to affect spawning and other behaviors in shellfish, and calcium channel blockers, which can inhibit sperm activity in some aquatic organisms.2 Not only does pharmaceutical waste pose an environmental risk, it potentially poses a public health risk as well. According to an Associated Press article published in 2008, both prescription and over-the-counter drugs were detected in the drinking water of at least 41 million Americans.3 Many water treatment systems are unable to remove all pharmaceutical products from tap water, and testing for the presence of pharmaceutical products in drinking water is not a regular practice because it is not required by the federal government. As with contamination of the environment with drug products, levels of drug contamination in tap water were considerably low, but there remains much speculation as to what risk is associated with long-term, chronic exposure to these drug products.3 Most medications found in water sources originate from human waste; the body only absorbs a fraction of a medication taken orally, and the rest is generally excreted unchanged and subsequently flushed into the sewer system. This makes it even more important to refrain from flushing unused medicines or washing them down the drain because this practice increases the pharmaceutical burden on the waste stream and waterways.3

Current Medication Disposal Practices It was previously believed that the best way to prevent accidental consumption of prescription medications was to dispose of any unused or expired medications in the toilet or down the drain, as opposed to discarding them in the trash, where animals or humans would be more likely to encounter them. However, as awareness of the possible ecological and public health effects of medication flushing spread, recommendations for medication disposal practices began to shift.4 The White House Office of National Drug Control Policy (ONDCP) released an official guidance in 2007 (updated in 2009) for proper medication disposal that advises people NOT to flush their medications down the toilet or wash them down the drain and provides explicit directions

for how to dispose of medications safely in the trash as solid wastes.5 It is unclear, however, how well these recommended disposal practices have been communicated to the general public. A study performed in 2006, in which 301 patients were surveyed in an outpatient setting, found that 53.8% of patients reported flushing their unused medications down the toilet, while 35.2% reported disposing of medications by rinsing them down the sink.6 A similar study completed in 2010 found that 74.2% of patients still disposed of medications via an inappropriate method, although the proportion of patients flushing their medications (27.2%) was substantially lower than in the earlier study. A significant portion of the patients surveyed disposed of medications inappropriately in the trash, either reporting that they threw their medications directly into the trash (17.7%) or dumped the medication from the bottle directly into the trash (16.9%).7 Although it appears practices may have shifted over time, there is still a knowledge deficit when it comes to the appropriate methods for medication disposal. Although the disposal of hazardous pharmaceutical waste generated by health care facilities is regulated by the Resource Conservation and Recovery Act (RCRA), no such regulation governs the disposal of household hazardous wastes, which includes unused medications. Therefore, it is crucial for frontline health care professionals, and, in particular, pharmacists—who already counsel and field medication-related questions—to educate their patients on the importance of proper medication disposal and the correct way to dispose of medications, and to encourage patients to be proactive with this process. Evidence shows that this effort by pharmacists can have a substantial impact on patient behaviors. Studies have shown that educating patients on medication disposal can inspire them to change the

way they dispose of their medications. One study found that previous counseling by a health care provider on how to properly dispose of medications, as well as having more recent pharmacy visits, was highly associated with returning medications to a pharmacy, as opposed to disposing of them in the toilet or sink.6 When pharmacy students were used as community educators during one pharmacy’s medication disposal event, a survey following the education session revealed that 80.1% of patients were motivated to change their disposal practices. Participants also reported an increased knowledge of the environmental problems associated with medication waste following the session.7

Proper Drug Disposal As discussed previously, a large number of pharmaceutical products are already present in the environment and in various water sources. Although it is unclear the extent to which these contaminants will ultimately impact the environment and human health, it is important to limit the amount of pharmaceutical waste that is inappropriately introduced into these areas. Proper disposal of drugs also can mitigate drug diversion, the misuse and abuse of prescription products, and the accidental ingestion of harmful substances by children or animals. Removing unwanted medications from the home reduces the risk for unintentional consumption of the wrong medication, an issue that has proven to be a significant one; in 2007 alone, there were more than 23,000 cases of accidental exposure to another person’s medicine reported to poison centers across the United States.8 To control the quantity of pharmaceutical products released into the environment, it is recommended that patients do not flush their unwanted medications. There are, however, certain exceptions to the “no-flush” rule, and the FDA’s Web site contains a list of drugs for which the FDA does rec-

Pharmacy Practice News • September 2011

Operations & Management 31

Practice Pearl Table. Medication Disposal Resources for Pharmacists and Patients Resource

What They Provide

Where You Can Find Them

State and local governments

Agencies at the state and local levels are able to provide regulations for drug take-back programs, locations of controlled substance takeback collection boxes established by police departments or local drug enforcement agency field offices, waste management household hazardous waste programs, or other programs established by the state, city, or county. State boards of pharmacy also may have regulations that dictate what a pharmacist is allowed to do with respect to medication take-back programs.

http://www.justice.gov/dea/agency/domestic.htm (DEA field office locations)

SMARxT Disposal

http://www.smarxtdisposal.net/index.html This public awareness campaign is the result of a partnership between the US Fish and Wildlife Service, the American Pharmacists Association, and the Pharmaceutical Research and Manufacturers of America. The Web site provides instructions for the proper disposal of medications; links to safe disposal resources, including campaign materials; news about pharmaceuticals in the environment; and answers to common questions about medication disposal.

Dispose My Meds

This online resource was created by the National Community Pharmacists Association, along with various other partners. The Web site contains a tool that will locate independent pharmacies with medication take-back programs within a certain zip code, city, or state. Dispose My Meds also has information about the safety and environmental risks associated with improper medication disposal, and a media center with links to news articles, videos, and audio related to proper medication disposal.

http://disposemymeds.org/

The Drug Take-Back Network

A joint effort by the Product Stewardship Institute and King Pharmaceuticals, this Web site contains links to local resources and events, as well as suggestions and tips for planning a take-back event. It also provides descriptions and advice from successful take-back programs, along with resources for pharmacies and organizations to adapt for their own events, such as waste inventory spreadsheets.

http://www.takebacknetwork.com/index.html

No Drugs Down the Drain

Developed by the California Pharmacists Association, this Web site contains a link to search waste collection agencies that will accept unwanted medications across the United States, as well as more detailed instructions for California residents. It also contains information about the importance of safe drug disposal, with links to several other helpful medication disposal sites.

http://nodrugsdownthedrain.org/

Private companies

Private companies, such as Waste Management and Sharps, Inc, will provide mail-back disposal services for a fee. Patients must be advised to verify what types of medications and devices are accepted through these programs. Sharps, Inc also provides a take-away service for pharmacies that are interested in collecting patients’ unused medications on-site.

http://www.wm.com/products-and-services/residential-curbside-pickup/ household-hazardous-waste.jsp (Waste Management)

ommend flushing. Most of these drugs are narcotics or controlled substances, which are especially dangerous if accidentally ingested by children and pets. Pharmacists should be particularly mindful of medications for which proper disposal is imperative. These medications are commonly used in the outpatient setting, and are also P-listed hazardous waste under RCRA, indicating that they pose a greater risk for harm than other drugs. Although RCRA does not extend to a patient’s home medications, the same hazards exist with these

medications if they are inappropriately released into the environment from the home. These drugs include warfarin, nicotine (in all forms), nitroglycerin, and phentermine. The best method for medication disposal is incineration because, even with proper disposal in the trash, pharmaceutical waste may eventually leak into the ground. However, incineration requires the collection of unwanted medicines by a third party. Community drug takeback programs or household hazardous waste collection events collect unused

http://www.sharpsinc.com/ unused-medications.htm (Sharps, Inc)

prescription drugs and arrange for them to be safely destroyed. If a take-back program is unavailable, there are recommendations for disposing of medications in household trash designed to maximize the safety of this method. The ONDCP recommends removing prescription medications from their original containers and mixing them with an undesirable substance, such as kitty litter, coffee grounds, or sawdust inside of a sealable container (a plastic bag or empty margarine container are recommended). All personal

information should be removed from the container label of the original prescription bottles, including the prescription number; then the sealed container with the drug mixture and the empty bottles should be disposed of in the trash.5 The American Pharmacists Association recommends that unwanted medications be crushed or dissolved with water prior to mixing with the undesirable substance.9 Alternative recommendations published by state governments and health care organizations suggest that medica-

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32 Operations & Management

Pharmacy Practice News â&#x20AC;˘ September 2011

Practice Pearl

DISPOSAL continued from page 31

tions be disposed of in their original containers. This ensures that if they are accidentally ingested, the contents can be readily identified. Personal information on the medication bottles still should be removed, and water or soda should be added to tablets and capsules to dissolve them. Again, medications should be mixed with kitty litter, coffee grounds, or a similar unappealing substance. The lid of the medication bottle should be shut and sealed with duct tape or packing tape. Then, the medication bottle(s) should be placed inside a container that is not see-through, which then should be taped shut. This container should be disposed of in the trash.10 Liquid medicines should be mixed with salt, flour, charcoal, or a nontoxic powdered spice, such as turmeric or mustard, to give the mixture an unappealing smell and texture. Medicines that come in blister packs should be wrapped in multiple layers of duct or opaque tape, and then placed inside an opaque container for sealing. Most importantly, medications should NEVER be concealed with food products because this could lead to inadvertent consumption by animals.10

Medication Disposal Programs Several programs across the United States have been established to help patients dispose of their unused and expired medications. These programs range from local efforts organized by a single pharmacy, to statewide initiatives designed to reduce prescription medication misuse and abuse. In 2007, the state of Maine implemented a statewide prescription mail-back program authorized to handle both noncontrolled and controlled prescription medications. The program was enacted through the state legislature with help from an EPA Aging Initiative grant. The program began by targeting older adults, and eventually phased in all adult populations. Maineâ&#x20AC;&#x2122;s drug take-back program distributes postage-paid disposal kits to participating pharmacies and several other locations throughout the state. Contained within the kit are a postagepaid envelope, an instruction packet, and a survey. Unused medications are placed inside the envelope and returned to the Maine Drug Enforcement Agency, where they are destroyed.11 As of April 2010, the Maine take-back program had received 3,925 envelopes and disposed of more than 2,300 pounds of unwanted medications. About 17% of the returned medications were scheduled drugs (CII-CIV). The survey provided important information about the reasons users of the service possessed the unused medications. These included statements such as the following: the medications

belonged to a deceased relative (19.6%), the physician told the patient to stop taking the medicine or gave the patient a new prescription (27.3%), or the patient had a negative reaction or allergy to the medication (11.9%).11 Individual pharmacies also have been getting involved on a smaller scale by organizing drug take-back events in coordination with local police or drug enforcement authorities. It is important to note that pharmacies cannot take possession of unwanted controlled substances, and, therefore, for an event to be success-

ful, local law enforcement must involved early in the planning process.12 It also is essential to verify if there are any state board of pharmacy regulations for pharmacist-operated medication take-back events, controlled substance laws, public safety laws concerning law enforcement possessing noncriminal evidence, and privacy laws that could impact the way an event is run within a particular state.13 When planning a medication take-back event, there are other important considerations as well. It is vital to establish a secure place to store the collected

medications during the event to ensure they will not accidentally get mixed in with inventory if the event is held in a pharmacy. Other steps in planning an event include arranging adequate staff to greet, direct, and counsel patients, as well as collect, identify, and log medications; arranging for hazardous waste hauling or disposal; determining what will and will not be collected (eg, whether or not nonprescription items, sharps, thermometers will be collected); arranging for equipment and supplies such as tables and chairs, hazardous waste con-

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Operations & Management 33

Practice Pearl tainers, drug references for identifying opportunities for pharmacists and File Slug medications, computers for logging what pharmacy organizations to Current file: ppn enews ad.indd 1St ProoF layout aPProved Final oK ProoF coordi1: 1/28 initialS and date initialS andand date involve rev 1: 1/29them is collected; arranging for advertising; nate with students rev 2: 1/30 Full name of project maX sign-off and planning how data will be collected. in community outreach projects. Durrev 3 1/30 Senior editor Before the medication take-back event ing one such student-aidedrevtake-back 4 Style chges fr. prev. Copy editor rev 5reported takes place, it is important to establish event, the majority of patients rev 6 revision # Proof 1 Sales what the responsibilities of each person that pharmacy students were rev 7 a good layout date/time September 2, 2011 8:26 am Production 8 involved will be, and to ensure that cor- resource for information onrev safe medi9 editorial date/time Creative does using rect procedures for handling (eg, wearing cation disposal.7 Not only rev trim Size taBloid 63p X 78p CommentS: gloves) and packing the collected medi- students help accommodate the issue Color Specs 4C cations are understood and are followed of staffing a take-back event, but getFile Path ppn enews ad.indd ting them involved helps to impart on the day of the event.13 Medication disposal education and important drug disposal knowledge to take-back events also are excellent the next generation of pharmacists.

Conclusion StatuS and HiStory

AsuPdrug PiCKed From: experts and some of the most aPPlied to: accessible health care practitioners, pharad layout eXPt’d: macists are in an excellent position to ad layout reCeived: educate patients on drug disposal. Pharedit layout eXPt’d: macists can help patients locate mediedit layout reCeived: cation take-back services in their area, to: david and/or From: Frank plan their own event. Counseling patients on the correct ways to dispose of their medications can make a difference in their beliefs and behaviors. By getting involved in promoting safe medication disposal, pharmacists can make a difference regarding an issue that affects both

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

public health and the environment.

References 1. Jarvis C, Seed S, Silva M, Sullivan K. Educational campaign for proper medication disposal. J Am Pharm Assoc. 2009;49(1):65-68. 2. United States Environmental Protection Agency. Pharmaceuticals and Personal Care Products (PPCPs). http://www.epa.gov/ppcp/. Accessed July 26, 2011. 3. Donn J, Mendoza M, Pritchard J, Associated Press. Drugs found in drinking water. USA Today. September 12, 2008. http://www.usatoday.com/news/nation/2008-03-10-drugs-tapwater_N.htm. Accessed July 26, 2011.

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34 Operations & Management

Pharmacy Practice News • September 2011

Practice Pearl

DISPOSAL continued from page 33

4. Glassmeyer ST, Hinchey EK, Boehme SE, et al. Disposal practices for unwanted residential medications in the United States. Environ Int. 2009;35(3):566-572. 5. Office of National Drug Control Policy. Proper disposal of prescription drugs. https://www. ncjrs.gov/ondcppubs/publications/pdf/prescrip_disposal.pdf. Accessed July 26, 2011. 6. Seehusen DA, Edwards J. Patient practices and beliefs concerning disposal of medications. J Am Board Fam Med. 2006;19(6):542-547. 7. Abrons J, Vadala T, Miller S, Cerulli J. Encour-

aging safe medication disposal through student pharmacist intervention. J Am Pharm Assoc. 2010;50(2):169-173. 8. Bronstein AC, Spyker DA, Cantilena LR Jr, Green JL, Rumack BH, Heard SE. 2007 annual report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 25th annual report. Clin Toxicol (Phila). 2008;46(10):927-1057. 9. American Pharmacists Association. APhA provides guidance on proper medication disposal: use with respect and discard with care. http://www.pharmacist.com/AM/Template. cfm?Section=News_Releases2&template=/ CM/ContentDisplay.cfm&ContentID=12267. Accessed July 26, 2011.

10. Connecticut Department of Environmental Protection. How to dispose of prescription medicines and over-the-counter (OTC) products. http://www.ct.gov/dep/lib/dep/p2/individual/consumerpharmdisposalfactsheet.pdf. Accessed July 26, 2011. 11. Kaye L, Crittenden J, Gressitt S. Executive summary: reducing prescription drug misuse through the use of a citizen mail-back program in Maine. http://www.epa.gov/aging/RXreport-Exe-Sum/. Accessed July 26, 2011. 12. Johnson MG. Tools based on experiences of a community pharmacy providing destruction services for unwanted medications. J Am Pharm Assoc. 2010;50(3):388-393.

13. Rubinstein L. Holding an unwanted medication collection for community pharmacies: a quick guide. http://www.nerc.org/documents/ unwanted_medication_collection_quick_ guide_11_08.pdf. Accessed July 26, 2011.

This article was written by the authors in their private capacity and the views expressed do not necessarily reflect those of the VA or University of Maryland. No official support or endorsement by the VA or the University of Maryland is intended or should be inferred. The authors report no relevant conflicts of interest.

COMING SOON

Bridging the gap between the hospital and post-discharge care

In This Issue Technology Watch

Patient telemonitoring helps hospitals maintain seamless post-discharge care.

Cindy Kuzendorf, PharmD discusses the rewards of preceptoring the nation’s only ASHPaccredited home infusion residency program.

Business Case Study

TPN Regimens In Hospital Causing Problems at Home

For Aralast, Limiting Distribution Helps Boost Drug Safety

Overfeeding triggers risky electrolyte imbalances post-discharge

Registries, monitoring plan help ensure optimal outcomes

Q&A

Volume 1 • Number 1 • November 2011

Fight or switch? One health-system’s strategy for becoming a specialty pharmacy contractor.

•

see TPN REGIMENS, page 3

Clinical Controversies

Continuous vs. intermittent IV antibiotic dosing: why the disconnect between hospital and home?

Educational Review

Compatibility of Commonly Used Intravenous Drugs

see ARALAST, page 1

Coding Consult POLICY WATCH

Joint Commission Eyes Stronger Oversight Of Specialty Pharmacy

•

see COMMISSION, page 1

Top 10 Coding Mistakes—And How To Fix Them

New Products Ipilimumab (Yervoy, BMS) approved for metastatic or unresectable melanoma.

Scriptpro announces new enhancements to its remote telepharmacy system.

See page 50.

Pharmacy Practice News • September 2011

Operations & Management 35

Upcoming

Coming Soon:

Scheduled topics include:

Leading Change in the New Health Care Landscape This bimonthly column by Sharon Murphy Enright, BSPharm, MBA, will outline practical strategies for meeting the constant challenge of change in health-system pharmacy practice.

• How to create the will for change among your staff so they become partners in achieving major process improvement. •U sing clinical microsystems to focus on the most important improvement factor—the patient and family members. •H ow a leading health system built an alignment for change that is a driving force for a new practice model. •F inding pharmacy the sweet spot in accountable care organizations/medical homes.

Be sure to look for the debut column in November

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36 Operations & Management

Pharmacy Practice News • September 2011

Leadership in Action

Leadership in Pharmacy: More Nuggets of Wisdom T ‘As leaders, we need to be aware that our attitudes toward the

his month, we continue the seriesFile Slug ppn enews ad.indd 1St ProoF layout aPProved Final oK ProoF 1: 1/28 of my favorite leadership “nuggets” initialS and date initialS and date rev 1: 1/29 rev 2: 1/30 Full name the of projectbook Leadership Gold, by John maX sign-off from rev 3 1/30 Senior editor unexpected have a big Maxwell (Nashville, TN: Thomas Nelson revinfluence 4 Style chges fr. prev. Copy editor rev 5 Publishers; 2008). Let’s see how they rev 6 revision # Proof 1 apply to the profession of pharmacy. Sales rev 7 layout date/time September 2, 2011 8:26 am Production rev 8 veterans would be great leaders. rev 9 editorial date/time Creative Is Experience a Good Teacher? So who is more likely to learn from trim Size taBloid 63p X 78p CommentS: Is experience a good teacher? I guess life’s experiences? Who is mostly likely Color Specs 4C that example, if experience to use their life’s lessons to help them File Pathdepends. For ppn enews ad.indd were a universally good teacher, all become great leaders? Current file:

StatuS and HiStory

PiCKed uP From: aPPlied to:

ad layout eXPt’d:

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The older I get, the more keenly I watch other leaders to see what I can learn from them. I appreciate the variety of viewpoints in any group setting. I have also learned to ask clarifying questions

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

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

Ernest R. Anderson Jr., MS, RPh

that I intuit may be on the minds of others. Sometimes I even ask leading questions (to which I already know the answers) when I suspect that others do not fully understand the topic of conversation. I seek to learn throughout all of my experiences. Here are some suggestions to help you stay on the path of lifelong learning.

Ask Yourself at the End Of Every Day ... “What new thing did I learn today?” This forces you to review the day and reflect on it. Sometimes you may realize that you learned a new fact; other times you may learn a lesson on how to better deal with people. A recent example in my own life was establishing a better attitude toward consultants in the workplace. Most of us view outside consultants and analysts with skepticism. However, I recently met with a great pharmacistconsultant from a national hospital consulting firm, and we agreed that we would work together. I made a decision to treat this individual as my ally and not as an adversary. I shared my vision of the profession of pharmacy with him and found that he felt much the same way. After a two-and-a-half hour conversation, we agreed to educate non-pharmacy consultants—as well as our own corporate administrators—with the goal of prompting our pharmacy departments to achieve the tenets of the American Society of Health-System Pharmacists’ pharmacy practice model initiative (PPMI). “How do I handle the unexpected?” It is likely that you are in a leadership position because you are a good planner. As leaders, we need to be aware that our attitudes toward the unexpected have a big influence on our learning. For example, if we view interruptions as “nuisances,” we probably won’t learn much. However, if these experiences are viewed as an opportunity to think quickly on our feet, draw on our skills and show our flexibility and ingenuity, we may surprise ourselves with the outcome. I find that the most frequent interruptions are caused by people in need of my help and expertise. Since I love to teach, learning how to deal with people in a constructive way exhilarates me. When someone walks out of my office ready to

Pharmacy Practice News • September 2011

Operations & Management 37

Leadership in Action

conquer the world, I also feel inspired. At that point, I usually realize that the interruption was well worth my time.

The last point is that many people think that to succeed, they must

keep their success strategies to themselves (to avoid competition on

their upward journeys). However, this type of thinking is not compatible with success. The reality is, sharing successes with others improves our relationships, shows our orientation as servant-leaders, engenders cooperation and often leads to great respect from others. “Horizontal” relationships with others can actually power our vertical climbs up the ladder. It is through these connections that we truly advance ourselves. Power plays may proffer short-term gains, but those gains are rarely sustained over the long term.

Know When To Speak And When To Listen As I think back over the years, I remember times when I spoke too much and listened too little. I thought I knew it all. The reality is that I didn’t know what I didn’t know. That’s a dangerous place to be. Slowly, I came to understand the wisdom in silence (and I started learning a lot that I had missed).

Anti-Infective Therapy You Can Take to The Bank

Experience Can Be The Best Teacher Experience is a great teacher—but only when we pay attention. The best learners reflect on what went right and what went wrong in various situations. That said, it is sometimes difficult to distinguish between the two. As Maxwell says: “Often the young man knows the rules, but the old man knows the exceptions.” The admonishment here is that the old man has gained wisdom through life’s experiences.

What About Success? We often hear that we should be climbing the “ladder of success.” As you consider this, also ask yourself these three questions: 1. Is the ladder against the right wall? 2. Have I stepped on anyone else’s head as I climbed? 3. Should I keep my methods of success a secret? We are fortunate, since there are many ladders to climb within pharmacy. My advice to young pharmacists is to explore all of their options. This way, they can be sure to prop their ladders against the proper pharmacy wall. Likewise, I have seen people who climb over other people on their way up the ladder, only to find that they have ruined not only their relationships with those they’ve trampled, but also with observers. There is no success where you have lost the respect of others with whom you work or who you manage. You may end up gaining a position of authority, but sacrificing the power that should accompany it, due to your lack of respect for others. This can kill even the most promising careers. It is critical to earn the respect of those you lead.

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38 Policy

Pharmacy Practice News • September 2011

Bar Coding

HCAHPS continued from page 1

the amount of information that is publicly reported on a patient’s perception of their hospital care. The results are publicly reported on the Internet and anyone can look at the scores for every hospital in the country,” Mr. Hodges explained at the unSUMMIT for Bedside Barcoding annual meeting. “As a consumer of health care, you can decide, based on the criteria that are important to you, where you want to go. For instance, if you are going to have surgery, you probably don’t want to go to a hospital that doesn’t do a good job with pain management.” The Centers for Medicare & Medicaid Services (CMS) implemented the HCAHPS survey in October 2006 and the first public reporting of HCAHPS results occurred in March 2008. For Mr. Hodges and his colleagues, the initial HCAHPS results at their hospitals were sobering. They had decided to focus on nursing communication because scores in that part of the HCAHPS domain are the most influential in terms of overall patient satisfaction. “We thought our nurses were doing a good job educating our patients about new medications and side effects and adverse events, but when the scores came out, we found that we were not doing a very good job at all,” he recalled. “What we thought we were communicating, and the education we had gone through, just wasn’t resonating with the patients.”

Back to the Drawing Board After investigating, they found that patients were not recognizing that the nurse was teaching them about side effects because the term “side effect” was not used. They also realized that new nurses may not be familiar with potential side effects and that the nurse might not be able to return to the patient’s bedside with the promised medication information. Those realizations prompted Mr. Hodges and his team to provide a way for the nurse, at the point of care, to deliver the information to the patient with the help of specific cues in the form of a pop-up box that appears each time he or she is set to administer a new medication. “The nurses are pivotal to this aspect of HCAHPS, which mandates educating patients about new medications. We realized that in order to make sure patients remember that their nurses have asked them the mandated questions, the questions have to be asked in a way that the patients can remember,” Mr. Hodges said. The important three questions asked by HCAHPS are: 1. During the hospital stay, were you

‘I was so taken with this idea, that I took the paper and emailed it to one of our pharmacists who is in charge of our IT department and asked if it would be possible for us to have a pop-up like that.’

—Ernest R. Anderson Jr., MS, RPh

idea, that I took the paper and emailed it to one of our pharmacists who is in charge of our IT [information technology] department and asked if it would be possible for us to have a pop-up like that,” he said. “If IT tells me that we can, I would be very interested in doing this. We measure HCAHPS all the time, so anything that helps us do better, I’m for it.” Mr. Anderson added that he thought scripting for nurses “is a wonderful idea. There can be hundreds of nurses in any given hospital and I’m sure that not all of them are going to know all of the side effects of the medications they are giving to patients, so having pharmacy give them this crucial information is a no-brainer.” Steward Health Care is very much aware of the importance of HCAHPS scores. “The scores are highlighted at every frontline management meeting so they are incredibly important,” Mr Anderson said. “In fact we post our scores for all of our four HCAHPS measures on our Web site. You can click on them and see how we do compared with the other hospitals in that same geographic area. So we are really highlighting HCAHPS and anything we can do to improve them, we will do.”

Another Fan

given any medicine that you had not taken before? 2. Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? 3. Before giving you any new medicine, how often did hospital staff describe possible side effects in a way you could understand? To help the nurses ask the right questions, Mr. Hodges designed a pop-up box that appears on the computer screen each time they scan a medication at the patient’s bedside. The pop-up box alerts the nurse about a new medication. It contains the drug classification and lists two common side effects. The box also scripts the dialogue for the nurse (e.g., “Did you educate the patient on side effects [Yes] [No]?”) The box also provides automatic documentation that the patient has been educated if this has been done at the point of care. If the nurse is unable to educate or provide information, the pop-up box remains until the education is provided either to the patient, the family or a significant other. The pharmacy department defined a new drug as any drug given for the first time in the hospital, even if the patient used the same drug at home.

Pharmacy also determined the common side effects associated with each class of drug. “Before, the nurse had to figure out what is a new medication. We eliminated that. Then the nurse had to know the side effects, and we added that information. Since our nurses are all scanning at the bedside, that information is right there,” Mr. Hodges said. Since the new system has been in place, the percentage of patients who said they were “always” told about new medications and side effects has risen by about 9% and continues to trend upward, Mr. Hodges said. “We’re not trending as well as we would like, but we are showing improvement, which is what we want to do. We want to improve our patient care and educate our patients on their medications so having a way to do this is a good thing.”

‘A Great Idea’ Ernest R. Anderson Jr., MS, RPh, system vice president of pharmacy at Steward Health Care, a large integrated health care system that comprises eight hospitals based in Boston, told Pharmacy Practice News that he approved of this approach. “I was so taken with this

Another fan of the pop-up box to guide nurses at the point of care is Peggy Malovrh, PharmD, clinical coordinator at Sparrow Health System in Lansing, Mich. “Mr. Hodges makes excellent points in his article. The nurse is with the patient at the time of medication administration and is in the best position to educate the patient. The computer screen pop-up box is a wonderful tool to promote patient education,” she told Pharmacy Practice News. “Obviously, the pharmacist is also an excellent resource for the patient. The value of a pharmacist providing medication education is really apparent when dealing with complex drug regimens, high-alert agents and patients with a history of nonadherence,” Dr. Malovrh added. “The pharmacist also plays an important role in providing nurses with the drug information they need to educate the patient, or making sure they can use electronic resources efficiently,” she continued. “In our institution, we are using the ‘teach-back’ method. After providing verbal and written instructions, the patient then restates what they have learned. This helps to assure the patient has a clear understanding of the information provided.” —Fran Lowry Mr. Hodges, Mr. Anderson and Dr. Malovrh reported no relevant conflicts of interest.

HAZARDOUS

PHARMACEUTICAL WASTE. Is your facility at risk?

Hospital pharmacies throughout the United States purchase well over 4 billion hazardous materials each year, generating more than 84,000 tons of hazardous pharmaceutical waste.1 The EPA has stepped up enforcements to ensure that pharmaceutical waste is managed safely from the moment it is generated and finally disposed.2 Pharmacists are responsible for the “cradle to grave” management of pharmaceuticals. CareFusion now offers Pyxis EcoStation™ system, a proprietary, automated waste management system that helps hospitals identify, classify, sort and segregate pharmaceutical waste, while providing pharmaceutical waste records to facilitate tracking and regulatory controls of more than 180,000 National Drug Codes. To learn how CareFusion can help your hospital measurably improve pharmaceutical waste management, register for one of our upcoming educational webinars at www.seeuthere.com/PyxisEcoStationWebinar or contact us at communications@carefusion.com.

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1 Fein, Adam J. Pembroke Consulting, Inc. 2010-11 Economic Report on Retail and Specialty Pharmacies, December 2010. 2 Accessed from http://www.epa.gov/oecaerth/civil/rcra/rcraenfstatreq.html. © 2011 CareFusion Corporation or one of its subsidiaries. All rights reserved. EcoStation and Pyxis are trademarks or registered trademarks of CareFusion Corporation or one of its subsidiaries. DI3093 (0911)

40 Policy

Pharmacy Practice News • September 2011

Joint Commission

How to prepare your staff for a Joint Commission Survey; page 44

Pharmacist’s Key Role in Discharge Medication Reconciliation Denver—A patient’s medication list often evolves significantly between hospital admission, transfers among internal departments and discharge—drugs are started and stopped; doses and frequencies are changed. Pharmacists, however, can play a significant role in sorting out such messes and thereby potentially preventing costly readmissions, suggests a poster (48-M) presented at the American Society of Health-System Pharmacists Summer Meeting. In fact, the pilot project found that a pharmacist detected errors on at least two of every three discharge medication lists. “It is very important for the pharmacist to be involved in admission and discharge medication reconciliation,” said Lori Curtis, PharmD, a clinical pharmacy specialist at Indiana University Health-University Hospital in Indianapolis and an author on the poster. “We are the ones who have the eyes to identify these problems.” For a six-month period in 2008 and 2009, the hepatology service at the hospital had an average readmission rate of 26.5%.

tions and high-cost medications that could prevent patient adherence. In the end, among 1,594 medications prescribed to 141 patients between October 2009 and March 2010, the researchers identified 194 problems on 97 (69%) discharge medication lists. The most common issues included medication omissions and dosing errors. A lack of patient-friendly language also appeared to be a barrier to proper adherence to medications. The team also found that this review was not time-intensive. Most often it required less than 10 minutes—the average time it took Dr. Curtis. “I think that’s because I was a member of the team,” she noted. “I was rounding and taking care of problems during the admission and throughout the course of inpatient treatment.” However, to the team’s surprise, readmission rates did not budge. Dr. Curtis pointed to some potential limitations of the preliminary study, including frequently incomplete admission medication histories and a lack of electronic medical records at the time

‘[Transfers of care] are all critical, vulnerable moments for patients, when they are going from one health care setting to another. During these periods, patients are at a high risk for medication discrepancies and adverse drug events.’ —Olavo Fernandes, PharmD A multidisciplinary group including upper hospital administration was formed to combat the hospital’s overall high number of readmissions. The team chose to target the hepatology service for the pilot because it accounted for the greatest rate of readmissions. As one of the solutions, the team began to require clinical pharmacists to review discharge medications for patients discharged from the hepatology service, comparing the list against drugs taken at admission and while in the hospital. The pharmacist would then identify and assess a range of issues, including duplications, omissions, dosing errors, patient-friendly language, drug interac-

of the project. Furthermore, her team only looked at patients in one particular unit, and only when Dr. Curtis was in the hospital. Olavo Fernandes, PharmD, assistant professor of pharmacy at the University of Toronto, said that the study would have needed more patients to appropriately detect a true effect of this intervention on readmissions. Pharmacist involvement with discharge reconciliation, he noted, should make a positive impact on readmissions, but a larger study may be required to know for sure. “Pharmacists can play a meaningful role,” added Dr. Fernandes. “Working with the patient and their families and

‘If we can detect errors prior to a patient going home and counsel the patient, then we are doing our duty as pharmacists.’ —Lori Curtis, PharmD other health care professionals, they can help ensure that the admission medication history is aligned with what is going on at home and document a clear medication plan for patients at discharge.”

A Joint Commission Concern The Joint Commission has long agreed on the importance of reconciling medication lists. Based on evidence that medication discrepancies can affect patient outcomes, the commission introduced medication reconciliation as No. 8 on its list of National Patient Safety Goals in 2005. Shortly after, accredited organizations were required to implement and communicate complete medication lists within and between facilities and homes. Although the commission does not have any current data on the rates of compliance with this goal—it has not been counted in the accreditation process since 2009—Bret Coons, spokesperson for the commission, noted that it had been “among the top requirements cited in the survey process.” Dr. Fernandes emphasized the importance of reconciliation at admission and internal transfer within the hospital, as well as at discharge. “These are all critical, vulnerable moments for patients, when they are

Coming this Fall in our Special Edition …

going from one health care setting to another,” he said. “During these periods, patients are at a high risk for medication discrepancies and adverse drug events.” In addition to the medications that are changed over the course of a patient’s hospital stay, Dr. Fernandes suggested the importance of providing clarity to patients and community clinicians about the preadmission medications that are “not to be changed.” For example, an orthopedic surgeon is probably not going to alter the patient’s oncology and cardiology medications. That certainly doesn’t mean the patient should not continue taking these drugs, but there can be authentic confusion about whether these medications should be continued after discharge. Not only can pharmacists help ensure that the correct medications go home with a patient, they “should be taking this one step further and counseling patients,” Dr. Curtis said. “If we can detect errors prior to a patient going home and counsel the patient, then we are doing our duty as pharmacists.” —Lynne Peeples Drs. Curtis and Fernandes, as well as Bret Coons, reported no relevant conflicts of interest.

Optimizing the Selection and Use of Topical Hemostats November 12, 2011 Omni Parker House 60 School Street • Boston, MA 7:30 AM - 8:30 AM 8:30 AM – 11:45 AM

Breakfast, Registration Lectures, Case Studies, Q&A

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Faculty Danial E. Baker, PharmD

Bradley A. Boucher, PharmD

Professor of Pharmacy Associate Dean for Clinical Programs Director, Drug Information Center College of Pharmacy Washington State University Spokane, Washington

Professor, Vice-Chair for Institutional Programs Department of Clinical Pharmacy Associate Professor Department of Neurosurgery University of Tennessee Health Science Center Nashville, Tennessee

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42 Policy

Pharmacy Practice News • September 2011

Patient Education

MTM SERVICES continued from page 1

and increased by $207 for the control group. There were no differences in medication adherence between the two groups. These results were presented this spring at the International Society for Pharmacoeconomics and Outcomes Research’s annual meeting, in Baltimore, where lead author Leticia R. Moczygemba, PharmD, PhD, assistant professor of pharmacotherapy and outcomes science at the School of Pharmacy at Virginia Commonwealth University in Richmond, received a Best New Investigator Podium Research Presentation Award. Dr. Moczygemba worked with Evelyn R. Gabrillo, PharmD, the Scott & White MTM coordinator, to help the plan evaluate its MTM program, including recruiting patients and collecting and analyzing the data. Her efforts, a follow-up study to her doctoral dissertation, were supported by a junior investigator research grant from the American Society of Health-System Pharmacists Research and Education Foundation.

Focus on Chronic Disease The program, which began in 2007, was aimed at plan members taking at least two medications, who had at least two chronic diseases and Part D medication costs of at least $1,000 per quarter, regardless of where they obtained their medications. Eligible beneficiaries were mailed a brochure about the program inviting them to call and participate. Of 1,999 eligible Medicare beneficiaries, 123 (6%) received a Scott & White pharmacist-directed MTM consultation. The plan followed the guidelines recommended by the American Pharmacists Association and the National Association of Chain Drug Stores Foundation, including a comprehensive medication therapy review (MTR), which identified any medication-related symptoms or difficulties. Following the consult, pharma-

‘We are not recommending telephone as the preferred method, but the way Scott & White structured their program was very beneficial to the patients.’ —Jamie C. Barner, PhD

Health System/Health Alliance Plan (HFHS/HAP), according to Vanita Pindolia, PharmD, vice president of ambulatory clinical pharmacy programs at HFHS. Between 2006 and 2010, 2,894

cists mailed patients a personal medication record and a medication action plan summarizing their problems and providing instructions on how to take their medications. Pharmacists also intervened with providers or referred patients to additional providers if necessary, and documented and followed up on all consults within three months. Dr. Moczygemba said that although she was pleased with the overall results, further data evaluation is needed to assess how to increase enrollment in the program and to determine why medication adherence was not higher in the intervention group. It could be that some patients opted to go outside the plan to purchase $4 generic medications from chain stores, so future studies that measure adherence should consider this in the study design, she noted. “Almost 100% of plans are using telephone as one mode of MTM delivery,” Dr. Moczygemba said. “I do think you can do it in a quality manner.” In a patient satisfaction survey mailed to participants, the overall mean satisfaction score on a 5-point scale was 4, according to results published last year in the journal Research in Social & Administrative Pharmacy (2010;6:143-154). “We are not recommending telephone as the preferred method, but the way Scott & White structured their program was very beneficial to the patients,” some of whom had mobility or transportation issues, said Jamie C. Barner, PhD, professor of pharmacy administration at the University of Texas at Austin College

of Pharmacy, and senior investigator of the study. “The goals of the program aligned with CMS’ [Centers for Medicare & Medicaid Services’] goals for MTM, which include optimizing treatment outcomes through improved medication use among eligible Part D beneficiaries.” Dr. Barner added, “This was comprehensive MTM.” Phone calls lasted an average of 60 to 75 minutes, she said, and in addition to medication review, pharmacists asked patients about receiving preventive health screenings, such as diabetic eye exams and colonoscopies.

Hello, Detroit Telephone MTM also is working well for Detroit’s Henry Ford

Part D plan participants (24%) enrolled in their program. In patient surveys between 2006 and 2009, 91% of respondents reported that the service was convenient, and 87% reported that their drug costs had been reduced. Although MTM there initially was set up to meet CMS requirements, specific employer groups within the health plan and multidisciplinary clinics within the health system soon expressed interest in the service. As a result, Dr. Pindolia and colleagues have launched additional telephone MTM programs for these entities. They are in the process of starting an additional program for hospital readmission avoidance. MTM is conducted by ambulatory clinical pharmacists within HFHS, all

Pharmacy Practice News • September 2011

Policy 43

Patient Education of whom have been trained by Dr. Pindolia in telephonic delivery of MTM. Each case, on average, takes 90 minutes, including time with the patient, time with the physician, researching any problems and documentation. The pharmacy team works on Health Alliance Plan (HAP; an HMO in Michigan that is part of HFHS) and additional HFHS insurers. Pharmacists conducting MTM integrate patients’ personal health care goals, Dr. Pindolia said. For example, an 85-year-old patient with diabetes may have very different goals from a 65-year-old patient with the same disease. When working with physicians to modify patients’ medications, she said, integrated health-system physicians accept the pharmacists’ recommendations 80% of the time, and health plan–contracted community physicians accept their recommendations about two-thirds of the time. They have achieved positive clinical outcomes and demonstrated cost savings. The program is portrayed so positively in the community that they have received calls from more than 50 patients per year who were not insured by HAP (which also is a subsidiary of the HFHS) but who heard of the program through family or friends. For them, pharmacists performed a simple 20-minute assessment, she said.

gle with how to adjust taking medications to their lifestyle. Telephone MTM could be an option for those who can understand the directions by phone, she said.

MTM Reimbursement Still Problematic  Some challenges remain with reimbursement, pharmacists say. At Henry Ford Hospital, Part D MTM services are covered by an administrative fee submitted by the plan. For other HFHS divisions, Dr. Pindolia said she develops business cases and has physi-

cian groups, health plans or employer groups sign off for payment of services. The UIMC program was largely unreimbursed for MTM services, Dr. Kliethermes said, although they did bring additional business to the outpatient pharmacy by encouraging patients to get all of their medications filled there. She said, however, “Most of the Medicare patients we saw had prescription drug plans that had internal programs and that did not give us an option for billing or payment for MTM.” —Karen Blum

Suggested Reading Moczygemba LR, et al. Patient satisfaction with a pharmacist-provided telephone medication therapy management program. Res Social Adm Pharm. 2010;6:143-154. Moczygemba LR, et al. Development and implementation of a telephone medication therapy management program for Medicare beneficiaries. Am J Health Syst Pharm. 2008;65:1655-1660. Pindolia VK, et al. Mitigation of medication mishaps via medication therapy management. Ann Pharmacother. 2009;43:611-620. Kliethermes MA, et al. Model for medication therapy management in a university clinic. Am J Health Syst Pharm. 2008;65:844-856.

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A Phone Call Not Always the Answer Still, telephone MTM programs are not ideal for every population, according to Mary Ann Kliethermes, PharmD, associate professor and vice chair of ambulatory care for Midwestern University’s Chicago College of Pharmacy in Downers Grove, Ill. From 2001 to 2008, she directed a referral-based MTM clinic at the University of Illinois Medical Center (UIMC) at Chicago, where many of her 150 patients did not have sustained access to telephones or had poor cognition and would not have been good candidates for telephone consultations. At UIMC, patients taking multiple long-term medications were scheduled for monthly, face-to-face visits with pharmacists, who timed the refills of the medications to coincide with these visits. Pharmacists would do medication review, fill pill boxes for patients and provide patients with a medication list describing the pills’ appearance and when best to take them. Psychiatric patients and some other patients were scheduled weekly, to improve medication adherence. At Midwestern, Dr. Kliethermes is establishing MTM programs for patients in the Chicago suburbs who have access to computers and are overall more knowledgeable about their health but still strug-

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44 Policy

Pharmacy Practice News • September 2011

Practice Pearl

Preparing Staff for the Joint Commission Survey Daniel Shifrin, RPh, MS Adjunct Faculty Union County College Union, New Jersey

t is crucial to prepare one’s staff for a Joint Commission survey. Staff members should feel confident and comfortable with the survey process because a major portion of the survey’s success depends on their responses. Department managers can implement a 4-part plan to prepare staff members for a Joint Commission survey. In the first part of the plan, it is the manager’s duty to explain the Joint Commission process to staff members. This includes describing the tracer method, in which a patient or process is followed throughout the facility. The manager should discuss the pro-

cedure surveyors use to question staff members using this method. It is just as important to know how to answer the question, as it is to know the right answer. Staff members should be taught to really listen to the question. They should answer only the question asked, and then stop, without rambling or volunteering more information than needed to answer the question. A manager also needs to empower his or her staff. He or she should make staff members responsible for addressing and maintaining certain aspects of the department. Examples of such tasks may include labeling and separating the lookalike/sound-alike medications or devising a performance improvement project.

100

Responses, %

80 68

60 48

40 20 0 Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Figure. Percentage of correct mock survey responses.

By doing so, staff members will become more integrally involved in the Joint Commission survey. In the second part of the plan, staff members should be taught how to respond to the surveyor’s questions by using whatever resources are necessary. The staff should be encouraged to “show” the answer, rather than simply “telling” the answer. For instance, a surveyor might ask a staff member how he or she handles high-risk medications. Instead of simply answering the question, the staff member should bring the surveyor to the refrigerator and show him or her the high-risk labeled vials of insulin and how they are separated into bins. The same “show-and-tell” process also should be used for all questions regarding per96 formance improvement. It is much easier to discuss key points of a performance improvement project when standing directly in front of an explanatory poster. The third part of the plan features a question-andanswer game used to quiz Nov staff members. Questions may relate to who the safety officer is, or to unaccept-

able abbreviations, for example. Correct responses by staff members in these types of games improve over time. In the final part of the plan, non-pharmacy personnel are invited to conduct mock surveys to test pharmacy staff. At first, the surveys are announced and conducted in groups, allowing staff members to answer questions together. Eventually, a more challenging format is introduced in which hospital executives appear unannounced in the department. Their role is to ask questions of staff members, as well as to intimidate them. With repetition, staff members become less frightened by these mock surveyors and more comfortable with the process. This practice provides staff members with the confidence needed for the actual Joint Commission survey. During an in-house study conducted at JFK Medical Center in Edison, New Jersey, the percentage of correct responses on mock surveys increased from 48% to 96% over an 8-month period, showing the value of such a program (Figure). By developing a plan to educate staff members, pharmacy staff will become more receptive to and familiar with the questioning process and better prepared for the Joint Commission survey. Mr. Shifrin has more than 25 years of experience as a manager/director of pharmacy at several health systems in New Jersey.

New Products/Indications Lialda Gains Approval for Maintenance Of Remission in Ulcerative Colitis

Pfizer Injectables Introduces Heparin Sodium Injection, USP

For more information about Lialda, visit www.lialda.com.

For more information about Pfizer Injectables’ heparin sodium injection, including full prescribing information, please visit http://pfizerinjectables.com. To report an adverse event or to speak to a member of Pfizer Medical Information, please call (800) 438-1985.

he FDA has approved Lialda (mesalamine) Delayed Release Tablets, manufactured by Shire, for maintenance of remission of ulcerative colitis (UC). Lialda was approved by the FDA in 2007 for induction of remission in patients with active, mild to moderate UC. The FDA’s new approval is based on positive safety and efficacy results from a sixmonth, randomized double-blind study. The study investigators assessed the drug’s maintenance using a modified Ulcerative Colitis Disease Activity Index; success was considered a subscore of less than or equal to 1. Of 343 patients receiving Lialda 2.4 g per day administered once daily, 83.7% maintained disease remission at month 6, compared with 81.5% of 336 patients who received the standard mesalamine delayed-release 1.6 g per day, administered as 0.8 g twice daily. The most common side effects reported with Lialda included UC-like symptoms, headache, gas, abnormal liver function test results and abdominal pain. Some patients experienced inflammation of the pancreas, leading to treatment discontinuation. If patients are allergic to sulfasalazine, they also may be allergic to Lialda or drugs that contain or are converted to mesalamine. Some patients taking Lialda or mesalamine-containing products have reported heart-related allergic reactions, such as inflammation of the heart muscle and of the lining of the heart. Products that contain mesalamine have been associated with a condition that may be difficult to distinguish from a flare-up of UC, which includes cramping, stomachache, bloody diarrhea, fever, headache and rash. Mesalamine may increase the risk for kidney problems when used with nonsteroidal antiinflammatory drugs, as well as increase risk for blood disorders when used with azathioprine and 6-mercaptopurine. Mesalamine also may enhance a patient’s risk for liver failure. Patients are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/Safety/MedWatch or via telephone at (800) FDA-1088.

—Based on a press release from Shire

fizer Injectables, part of Pfizer Inc.’s Established Products Business Unit, announced the introduction of its FDA-approved heparin sodium injection, USP for the U.S. market. Pfizer Injectables’ heparin sodium injection is available in glass vials available as 1,000 units/mL preservative-free in 2-mL single-dose vials; 1,000 units/mL in 10-mL multidose vials; 5,000 units/ mL in 1-mL multidose vials; 5,000 units/mL in 10-mL multidose vials; and 10,000 units/mL in 1-mL multidose vials. In addition, the packaging for Pfizer Injectables’ heparin sodium injection is color-coded and has prominent dosage strength information and preservativefree indications on vial labels and cartons. A “NOT FOR LOCK FLUSH” warning is also applied to the plastic flip-tops, aluminum overseals and unit-of-use labels. This packaging is designed to help differentiate among the five different product potencies and help reduce dosing errors. A Data Matrix 2D label coding provides lot, NDC number and expiration-date tracking. Furthermore, Pfizer Injectables’ production of crude heparin begins with raw materials supplied by facilities in Iowa and Toronto. The active pharmaceutical ingredient is processed and purified at the Pfizer Ohio plant, the purified heparin sodium is manufactured and packaged at the Pfizer Michigan facility and the product is shipped from Pfizer’s logistics center in Tennessee. “Pfizer Injectables offers unique packaging inclusive of label colors matching strength and cap, data matrix bar codes and clear dosage strength information,” James Hageman, vice president of Pfizer Injectables, noted in a company press release. “Our priority is the safety of all patients who take Pfizer medicines. “We are also proud of our investments in the local economies in Franklin, Ohio; Kalamazoo, Michigan; and Memphis, Tennessee by adding our heparin sodium injection to our growing portfolio of injectables,” Mr. Hageman added.

—Based on a press release from Pfizer

COMING SOON

Bridging the gap between the hospital and post-discharge care

In This Issue Technology Watch

Patient telemonitoring helps hospitals maintain seamless post-discharge care.

Cindy Kuzendorf, PharmD discusses the rewards of preceptoring the nation’s only ASHPaccredited home infusion residency program.

Business Case Study

TPN Regimens In Hospital Causing Problems at Home

For Aralast, Limiting Distribution Helps Boost Drug Safety

Overfeeding triggers risky electrolyte imbalances post-discharge

Registries, monitoring plan help ensure optimal outcomes

Q&A

Volume 1 • Number 1 • November 2011

Fight or switch? One health-system’s strategy for becoming a specialty pharmacy contractor.

•

Clinical Controversies

Continuous vs. intermittent IV antibiotic dosing: why the disconnect between hospital and home?

Educational Review

Compatibility of Commonly Used Intravenous Drugs

see ARALAST, page 1

see TPN REGIMENS, page 3

Coding Consult POLICY WATCH

Joint Commission Eyes Stronger Oversight Of Specialty Pharmacy

•

see COMMISSION, page 1

Top 10 Coding Mistakes—And How To Fix Them

New Products Ipilimumab (Yervoy, BMS) approved for metastatic or unresectable melanoma. See page 50.

Scriptpro announces new enhancements to its remote telepharmacy system. See page 50.

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of physicians surveyed (N=57) would recommend SAMSCA to a colleague 1 In this same survey (patient cases; N=150), physicians were satisﬁed or very satisﬁed with SAMSCA 90% of the time1

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

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

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

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

February 2011

0711A-2015C