February 2011 digital edition of Pharmacy Practice News by McMahon Group

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The Pharmacist’s News Source

pharmacypracticenews.com

Volume 38 • Number 2 • February 2011

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McMahon Publishing

Tough Love Approach in this issue Front Seeks Better Pyxis Use Up Capsules By Anesthesiologists By the numbers at SCCM Annual Congress

[Editor’s note: see clarification notice for this article on page 38.] Anaheim, Calif.—Medicine is often all about outcomes; whatever management strategy yields the greatest impact on a patient’s health usually is embraced, even if a few eggs are broken in the process. But at St. Joseph’s Regional Medical Center, a 650-bed, Level II trauma hospital in Paterson, N.J., the pharmacy department’s policy of fining anesthesiologists $100 for each medication discrepancy arising from the improper use of automated dispensing cabinets (ADCs) is testing that end-justifies-the-means argument to its limit. The $100 fine is levied for each discrepancy that goes unresolved for more than 72 hours. Hospital administrators also are notified, and in one more turn of the screw, a Drug Enforce-

•

see PYXIS INFRACTIONS, page 38

Critical Care Congress

Practice Pearls How to ban smoking in the workplace.

Clinical

Cardiology Controversy still stirring over use of beta-blockers in noncardiac surgery.

Practice Pearls More tips from ASHP Midyear Clinical Meeting.

Operations & Mgmt

Education Empowering students to become better pharmacists.

Leadership in Action

VTE Prophylaxis Still a Mixed Bag Most patients treated, but only a few get guidelines-recommended regimens San Diego—Prophylaxis against venous thromboembolism (VTE) is inappropriate in the vast majority of critical care patients, despite readily available guidelines for VTE prevention from the American College of Chest Physicians (ACCP), researchers said at the 2011 annual meeting of the Society of Critical Care Medicine. In the VTE START (Venous Thromboembolism Study to Assess the Rate of Thromboprophylaxis) trial, the largest evaluation of VTE prophylaxis in critical care patients to date, only 12.5% of nearly

•

see VTE PROPHYLAXIS, page 18

❃

Digging deeper into Accountability Leadership.

Technology

Patient Transition Between Cancer Care Settings Lacking Medication reconciliation, postdischarge follow-up among pitfalls cited in new ACCC practice survey

any h ospitals als and on co l og ogy group practices ces are failing to effectively manage cancer patients’ transition from inpatient hospital care to the outpatient setting, according to a new report by the Association of Community Cancer Centers (ACCC). Practices are falling short in their efforts to adequately coordinate medical services, maintain complete medical records and nd obtain essential case information during the complex process. According to the report, about half of the oncology groups surveyed designate staff to manage postdischarge transitions, yet few have implemented specific transition policies or checklists. At hospitals, oncology-specific transi-

tion policies are largely nonexistent; few monitor readmissions or follow up discharged patients. And despite having computerized prescriber order entry (CPOE) systems, most oncology groups perform fewer than half of the 11 medication

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see TRANSITION, page 8

Part 2 in a Series: ASHP Pearls

Automation A savvy solution for enhancing drug delivery.

Educational Reviews

Management of Acute Coronary Syndromes see page

Sessions Offer Pharmacists Wide Array of Practical Tips Anaheim, Calif.—Our continuing coverage of the multisession pearls presentations held during the ASHP Midyear Meeting includes a caution about chemotherapy interactions, tips on automating international normalized ratio ordering, and a rationale for keeping succinylcholine as the drug of choice for rapid sequence intubation.

Certain Oral Chemotherapy Agents Pose Drug Interaction Risks A subset of oral tyrosine kinase inhibitors (TKIs) has the potential for significant drug interactions with some commonly used medications, according to a

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see TKI INTERACTION, page 20

The Book Page The APhA Complete Review for Pharmacy American Pharmacists Association

See page

New Product CutisPharma launches new prescription mouthwash kits for compounding. See page

Sandoz now offers Enoxaparin Sodium for Injection.

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

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

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

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

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

Choose the full potential of generics.

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

- - - - - - RECENT MAJOR CHANGES - - - - - Boxed Warning, Warnings and Precautions (12/2009) - - - - - - INDICATIONS AND USAGE - - - - - Enoxaparin sodium injection is a low molecular weight heparin [LMWH] indicated for: • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness • Inpatient treatment of acute DVT with or without pulmonary embolism • Outpatient treatment of acute DVT without pulmonary embolism • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction [MI] • Treatment of acute ST-segment elevation myocardial infarction [STEMI] managed medically or with subsequent percutaneous coronary intervention [PCI]

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

- - - - - - ADVERSE REACTIONS - - - - - Most common adverse reactions (>1%) were bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea and nausea To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. - - - - - - DRUG INTERACTIONS - - - - - Discontinue agents which may enhance hemorrhage risk prior to initiation of enoxaparin sodium injection or conduct close clinical and laboratory monitoring

- - - - - - DOSAGE AND ADMINISTRATION - - - - - Indication

Standard Regimen

DVT prophylaxis in abdominal surgery

40 mg SC once daily up to 12 days

DVT prophylaxis in knee replacement surgery

30 mg SC every 12 hours up to 14 days

DVT prophylaxis in hip replacement surgery

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

DVT prophylaxis in medical patients

40 mg SC once daily up to 14 days

Inpatient treatment of acute DVT with or without pulmonary embolism

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

Outpatient treatment of acute DVT without pulmonary embolism

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

Unstable angina and non-Q-wave MI

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

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

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

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

- - - - - - USE IN SPECIFIC POPULATIONS - - - - - Severe renal impairment: Adjust dose for patients with creatinine clearance <30 mL/min Geriatric patients: Monitor for increased risk of bleeding Patients with mechanical heart valves: Not adequately studied Hepatic Impairment: Use with caution Low-weight patients: Observe for signs of bleeding

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

4 Up Front

Pharmacy Practice News • February 2011

Capsules

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FEBRUARY 2011

watch

10|

The five most-viewed articles last month on pharmacypracticenews.com: 1. 2. 3. 4. 5.

AMA Seeks Limits to Pharmacists’ Scope of Practice Optimal Vancomycin Use Elusive Despite New Rx Guidelines Going Wireless With Medication Tracking FDA Cracks Down on Manufacturers of Dietary Supplements BCMA Lessons Learned

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Register for free at pharmacypracticenews.com to read these and other articles on the latest developments in hospital pharmacy.

heard here first

‘Most [pharmacy] schools are struggling to place students in any experiential sites, let alone ones that have been trained, tested, and proven to deliver

$37,118.96|

high-quality experiences.’

From the Society of Critical Care Medicine’s 2011 annual meeting, in San Diego. (Additional coverage, page 1.)

The hours saved in achieving optimal anticoagulation when a postoperative, weight-based, unfractionated heparin dosing protocol was used in artificial heart valve recipients versus conventional dosing protocols. Bleeding episodes and other key outcomes also were improved (abstract 768). The percentage-point increase in the incidence of hypoglycemia when critically ill patients are given bolus doses of insulin to start their infusion therapy compared with intermittent infusions alone (23.8% vs. 2.8%, P<0.001) (abstract 50). The additional cost of managing surgical intensive care unit (ICU) patients who have ventilator-associated pneumonia and severe vitamin D deficiency versus patients without the deficiency ($68,862.52 vs. $31,743.56; P=0.001). The findings point to the importance of adequate vitamin D levels in proper immune function, according to the investigators (abstract 205). —David Bronstein

—Steven J. Martin, PharmD, BCPS, FCCP, FCCM

See article, page 26

CORRECTION

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

he educational review, “Managing Intravenous Iron in the Oncology Setting,” which appeared in our November 2010 issue, has been updated to address two errors. The update now states that: • The molecular weight of ferumoxytol (Feraheme) is 750,000 Da. • Both low-molecular weight and high-molecular weight iron dextran products carry black box warnings on their labeling. In addition, a section detailing the incidence of infusion-related reactions with low-molecular weight and high-molecular weight iron dextran products has been revised, based on new cited references. The updated manuscript can be accessed at www.pharmacypracticenews.com.

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Volume 38 • Number 2 • February 2011 • pharmacypracticenews.com

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6 Up Front

Pharmacy Practice News â&#x20AC;˘ February 2011

Practice Pearls

Large Health Care System Bans Smoking in the Workplace T Antonia Carbone, PharmD

Pharmacy Practice Resident Kimball Medical Center Saint Barnabas Health Care System Livingston, New Jersey

Shilpa Amara, PharmD Medical Communications Specialist Livingston Services at Saint Barnabas Health Care System Livingston, New Jersey

he implementation of smoke-free initiatives in the workplace has been proven to reduce tobacco use, improve health, and reduce expenditures. As a result, the southern and northern facilities in the Saint Barnabas Health Care System (SBHCS) enacted a smoke-free policy in November 2008, and November 2009, respectively. This discussion describes the goals and requirements of this initiative, its implementation process, and its impact on patients and employees in SBHCS.

Accounting for 5.4 million deaths each year, tobacco use is a major public health concern. An estimated 46 million people (or 20.6% of all

adults) in the United States currently smoke cigarettes, and tobacco use has been shown to result in death in up to 50% of its users.

Additionally, smoking significantly increases the risk for developing cardiovascular disease, stroke, and chronic obstructive lung disease. It also is associated with several types of malignancies, which is not surprising, given that tobacco contains more than 50 cancer-causing agents; some of these chemical components include arsenic, ammonia, cadmium, carbon monoxide, methane, and butane, which may be found in poison, household cleaners, batteries, exhaust gas, sewer gas, and lighters, respectively.1-4

Figure. Pharmacy order entry screen for nicotine patch. In view of these health risks, the World Health Organization (WHO) has developed a treaty that sheds light on the global tobacco epidemic and the importance of smokefree environments.5 According to this report, enacting a smoke-free policy in the workplace may help to decrease tobacco-related morbidity and mortality. Indeed, research indicates that tobacco users working in a smoke-free facility would smoke 2 to 4 fewer cigarettes per day, and that the introduction of such a policy might even prove to be a stepping stone for permanent smoking cessation.6 Furthermore, implementation of a smoke-free policy may beget an 80% to 90% reduction in exposure to secondhand smoke,7 which is responsible for 50,000 deaths each year, in the United States alone.8 In fact, data suggest that exposure to secondhand smoke may be even more detrimental to oneâ&#x20AC;&#x2122;s health than direct exposure through smoking.9 In addition to its health-related benefits, the economic advantages

Up Front 7

Pharmacy Practice News • February 2011

Practice Pearls of implementing a smoke-free policy in the workplace should not be overlooked. Cigarette smoking is estimated to be responsible for $193 billion in annual health-related economic losses in the United States ($96 billion in direct medical costs and approximately $97 billion in lost productivity), and the emergence of smoke-free work environments may help to reduce these expenditures.7 Smoke-free policies have been shown to discourage smoking, reduce cigarette consumption, and increase the likelihood of cessation, and as a result, workplaces across the country have begun to enact such policies. One cohort study was conducted to assess the impact of smoke-free workplace policies on smoking cessation behaviors; results revealed that people who worked in environments that changed to or maintained smoke-free policies between 1993 and 2001 were nearly twice as likely to have stopped smoking by 2001 as people whose work sites did not implement these policies.10 In light of these findings, SBHCS, which contains facilities located throughout New Jersey, has decided to ban the use of tobacco on all of its campuses. Table 1 highlights the top 10 reasons underlying this initiative.11 According to the smokefree program at SBHCS, cigarette smoking is prohibited among all employees, patients, and visitors, both indoors and outdoors, on any property belonging to or operated by the health system. The southern facilities first went smoke-free on Nov. 20, 2008, the 32nd anniversary of the Great American Smokeout, while the northern facilities followed suit one year later, on Nov. 19, 2009. It was SBHCS’s hope that the smoke-free work environment would result in health-related benefits for both smokers and nonsmokers, and ensure a healthy environment for employees, patients, and their families. SBHCS also anticipated an increase in productivity among employees, as well as a reduction in hospital expenditures.

Key Steps Detailed Successful implementation of the smoke-free program at SBHCS required several key steps. Once commitment to this initiative was declared, the health system assigned responsibility and authority to the Institute for Prevention, an organization that promotes wellness through a wide variety of individualized programs designed to meet the needs of society. With the help of the Institute for Prevention, an executive

task force was created to ement a smoke-free implement sultation plan, and to consultation e creation of work guide ups within individgroups ual facilities. Addial l y, S B H CS t i o nal eloped a timedeveloped line for implementation, as well as promotional and educational materials designed to inform employees, patients, and the community about the program’s goals and

requirements. Following its execution, SBHCS monitored compliance to enforce the policy.11 As per the SBHCS smoke-free initiative, all patients are permitted to request nicotine replacement therapy (ie, patches, gum, lozenges) to provide comfort while hospitalized. Nicotine patches also are provided to employees at a discounted rate, and they could apply to receive up to 80% reimbursement upon completion of therapy. Additionally, a Tobacco Dependence Treatment Program, funded by a grant from the New Jersey Department of Health and Service Office of

‘It was a smooth transition, because there was a lot of information distributed in the building prior to implementation, and because all patients at this facility are provided with nicotine replacement therapy to help manage cravings.’ —Mark Mierzwa, PharmD

Table 1. Top 10 Reasons To Go Smoke-Free11 1.

It is the right thing to do

To further denormalize tobacco use in the community

To better support tobacco dependence treatment programs/ Joint Commission and QIO Tobacco Measures

To protect workers and patients from secondhand smoke

To reduce potential liability

To eliminate secondhand smoke coming in through windows, doors, and ventilation systems

To match policies to mission

To reduce smoking among workforce

To show community leadership on the No. 1 preventable cause of death and disease

10. To enhance public image QIO, Quality Improvement Organization

Epidemiology, is o offered to employee ees and to the public lic; this program is de designed to help its members cope w with the transition, Scan for more an and ideally, to help th them quit smok- smoking cessation success stories. in ing altogether. ParInstructions, p. 4 tic ticipants receive in individual tobacco as assessments, after which they work w with a treatment specialist to develop a treatment plan that best suits th their needs. Although its long-term health and ec economic benefits cannot yet be as assessed, the smoke-free initiative has been well received by patients and hospital staff. Mark Mierzwa, PharmD, assistant director of pharmacy at Saint Barnabas Behavioral Health, describes how patients at this facility, many of whom are regular smokers, handled the change. “It was a smooth transition,” Dr. Mierzwa said, “because there was a lot of information distributed in the building prior to implementation, and because all patients at this facility are provided with nicotine replacement therapy to help manage cravings.” Specifically, as per the Pharmacy and Therapeutics Committee protocol, pharmacists at the Behavioral Health Center now have the ability to order nicotine patches for patients; the pharmacy order entry screen is depicted in Figure 1, page 6. Upon admission, the nursing staff asks patients whether they smoke, and if so, how many cigarettes they smoke per day; a list is generated and prints in the pharmacy on a daily basis. “The list indicates how many cigarettes each patient smokes per day, which allows the pharmacist to order the appropriate dose of the nicotine patch,” said Megan Maroney, PharmD, pharmacy practice resident at Behavioral Health. Patients who smoke more than 10 cigarettes per day receive a 21-mg per 24-hour patch for up to 6 weeks; those who smoke less than 10 cigarettes per day receive a 14-mg per 24-hour patch for up to 6 weeks. Patients are then switched to a lower dose for 2 weeks; they receive either a 14-mg per 24-hour or 7-mg per 24-hour patch, depending on the number of cigarettes initially smoked per day. The patch is always ordered, although patients have the option to decide whether or not they would like to use one. “Some patients say ‘the patch does nothing for me,’ or ‘it makes me more

•

see SMOKING BAN, page 42

Hem/Onc Pharmacy

Pharmacy Practice News • February 2011

In Focus

TRANSITION continued from page 1

reconciliation activities queried. Among organizations with transition programs in place, few measure or analyze their processes for quality improvement. But the report, Transitions Between Care Settings, identified some high notes, pointing out “substantial progress in recent years,” such as the growing use of electronic health records (EHR) and improvements in at least some aspects of medication reconciliation. More than 60% of oncology groups surveyed take proactive steps to ensure they know when a patient is admitted to the hospital by a physician at another practice. A similar percentage routinely arranges postdischarge office appointments. The report also cited “exemplary patient care transition activities,” illustrated through nine case examples. According to George Kovach, MD, president of Iowa Cancer Specialists, a community practice in Davenport, the study is an attempt to codify and rank the problems in order of priority, then open up avenues to address them. Dr. Kovach also is a member of the ACCC advisory committee. The findings were based on survey responses from 108 ACCC member hospitals and 41 ACCC member oncology practices.

Cancer Maze “This resonates for us in a big way,” said Mark Krasna, MD, medical director of the Cancer Institute at St. Joseph’s Catholic Medical Center in Baltimore. “Every time a care-setting transition

occurs, there is the potential challenge fo r m i s communication, delayed treatment and potentially a bad outcome because of incorrect treatment.” “Cancer care is so multifaceted and requires such a wide swath of the medical continuum, that a strong glue is needed to hold all of the parts together,” said Alan Weinstein, MD, medical director of the Fox Chase Virtua Cancer Program in Mount Holly, N.J., and chair of the ACCC Guidelines Committee. “Disseminating information to the clinicians along the many spokes of care is so difficult.” The intricacies of cancer care also mean that during inpatient–outpatient transitions, the risks to patients are particularly high, given the increased potential for gaps or interruptions in complex and time-sensitive treatment regimens. “For the patient’s sake,” the ACCP report stated, “communication processes should be formalized to ensure that discharge summaries, medication lists, and other information are available to oncologists and care teams in a timely fashion.” Unfortunately, that process doesn’t happen regularly enough. Simply obtaining hospital discharge information can be exasperating, Dr. Kovach said. Sometimes he doesn’t learn about a patient’s hospitalization until long after the patient has been discharged. During one examination, he found a long scar

•

see TRANSITION, page 10

ACCC Survey: Key Hospital Findings • About 85% of responding hospitals have a function (or team) assigned to manage the oncology patient’s transition between care settings. However, only 55% of hospitals reported having a written policy managing the general patient’s transition, and just 3% have a policy that relates specifically to the oncology patient’s transition. • Most hospitals (93%) have a usual (or formal) process for contacting the oncologist’s office when a patient is admitted for oncology-related treatments, but far fewer (66%) have procedures in place for making contact when the patient is admitted with cancer as a secondary diagnosis. • After discharge, hospitals are not very likely to communicate with oncology patients to confirm that follow-up appointments have been scheduled or met (only 18% do so), or to check in (through a clinician phone call) on how patients are doing more generally (33%; see Figure on page 10). In the openended responses, a few hospitals mentioned that registered nurses or social workers make home visits to patients following discharge. • Among 16 specific transition activities queried in the survey, no single hospital used more than 13 of those activities. Only 17 hospitals (23%) used half or more of the transition activities. This suggests that most hospitals (77%) likely have room for improvement in managing the patient transition. • Respondents indicated that their computerized prescriber order entry (CPOE) systems are likely to offer a reconciled drug listing (60%), be accessible by community oncologists (63%), have an e-prescription capability (63%), and include chemotherapy drugs. However, the home drug inputs to the systems may not be complete. Only 12% of hospitals can access a prescription database for home drugs, and only 38% follow up with pharmacies when they suspect the list is not complete. • Among 13 medical reconciliation practices identified through the survey questions, no hospital reported using all of the activities, although five hospitals use 11 of the activities and almost 70% of the hospitals use seven or more of the activities.

Medication Reconciliation May Get Easier, But Successes Already Seen

t’s not surprising that medication reconciliation was one of the core patient-transition activities assessed in the ACCC survey. The practice of maintaining accurate drug lists as patients move among various care settings and providers can have a major impact on the quality of care. It also can be a major compliance challenge for hospitals. The last year that the Joint Commission surveyed hospitals for medication reconciliation compliance was in 2008, Scan for MATCH before the rule was suspended due to concerns that its medication recrequirements were too onerous. Approximately 20% of onciliation toolkit. surveyed hospitals failed to meet the demands of the rule, Instructions, p. 4 according to a Joint Commission representative. A new, toned-down version of the rule will take effect this July, and will likely help hospitals boost compliance. Fortunately, a growing number of hospitals already have made strides with the regulation. At Northwestern Memorial Hospital in Chicago, a critical factor for enhanced medication reconciliation has been ensuring that each patient’s medication record is complete and accurate at the time of hospital admission, said Kristine Gleason, RPh, clinical quality leader. “We’ve put a great deal of attention on the admission process, because if you can’t get a good medication history at that time, the discrepancies propagate through the patient’s stay and beyond their discharge,” Ms. Gleason said. Northwestern is also “entirely wired,” through its electronic health records (EHR) system, which has streamlined information flow and helped to keep patient information current. Oncology presents its own set of challenges, she added, because drug regimens are often cyclic and the drugs themselves highly toxic. In addition, medication management of comorbidities is likely to take a back seat during cancer treatment. It’s important, Ms. Gleason said, that all of a patient’s medical conditions continue to be managed properly so that unnecessary complications, and resulting hospital readmissions, are cut to a minimum. Consistent medication reconciliation processes, she said, help achieve that objective. Northwestern also has adopted the Medication at Transitions and Clinical Handoffs (MATCH) medication reconciliation toolkit (developed by the Agency for Healthcare Research and Quality). MATCH is designed to identify patient risk factors that are frequently responsible for inaccurate medication reconciliation, including limited English proficiency and low health literacy, complex medication histories or impaired mental status. Its goal is to measurably decrease the number of discrepant medication orders and associated potential and actual patient harm. MATCH can be applied to inpatient and outpatient settings, and to electronic or paper-based medical records systems. (For more information about MATCH, visit http://www.nmh.org/nm/for+physicians+match or scan the 2-D bar code below). Medication reconciliation compliance at Northwestern runs at 95% or higher, Ms. Gleason said. “We’ve made it an ‘always practice,’ meaning it should be completed for every patient. And while our compliance rate is very high, I can’t say for sure what the quality of those interactions are. We’re looking at ways to measure that.” That level of consistency is also a precept at the Cancer Center of Holy Family Memorial Hospital in Manitowoc, Wis. “We expect medication reconciliation to be done every time a patient walks through the door,” said Joy Singer, RN, director of cancer services at the cancer center. The ACCC report cited as “exemplary” the patient transition practices (particularly medication reconciliation) at the cancer center. According to Ms. Singer, system-wide EHRs allow physician notes and medication lists to be accessed easily throughout the network, which includes Holy Family network hospitals, physician practices, pharmacies, and home care and hospice agencies. The EHR also prompts for medication reconciliation—a feature that has boosted compliance rates. The hospital also emphasizes face-to-face reporting at patient handoffs between treatment areas. It’s not enough just to make a phone call or a verbal report, Ms. Singer explained, because the staff member you speak with on the phone may not be the person who physically receives the patient. The admission staff instructs patients to bring all the medications they are taking at home to the hospital or to their first appointment at the Cancer Care Center. A comparison is made between what patients say they’re taking and information on the network’s list. The list is automatically revised whenever a medication change is made. Primary care physicians for hospitalized patients receive a computer-generated message informing them when a patient is discharged and whether a follow-up appointment or lab tests are necessary. “This allows those of us on the outpatient side to make sure there is follow-through,” she said. Discharged patients who receive follow-up care outside of the hospital’s network get a printout detailing their current drug therapy. It is just such a situation—when patients leave the care of an integrated health system—where care transitions can most easily falter. “Even if we nail the processes down within our own four walls,” said Ms. Gleason, “we have to be sure to ease the transition to the next provider, even if that provider is outside of our system.” —Steve Frandzel

Built on data

Hem/Onc Pharmacy

Pharmacy Practice News • February 2011

In Focus

TRANSITION continued from page 8

down the patient’s sternum from open heart surgery months earlier—news that never reached his office. “You often have to dig for information that should have been transmitted to you as part of routine procedures,” he noted. Integrated, multidisciplinary oncology facilities, such as the Helen F. Graham Cancer Center in Newark, Del., have some advantages when it comes to managing the transition, because all of their oncology services are under

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one roof, not geographically or institutionally fragmented, said Nicholas J. Petrelli, MD, medical director of the center. “But we still need to improve the links between the various areas of care, and we still have patients who get lost in the cancer maze.”

Technology Gap EHRs have begun to improve care coordination within facilities, but they have yet to truly repair the existing communication discontinuities among caregivers, because the many systems in use cannot exchange data.

CSL Behring BRIEF SUMMARY OF PRESCRIBING INFORMATION

Some viruses, such as Parvovirus B19 virus (B19V) or hepatitis A (HAV), are particularly difﬁcult to remove or inactivate. B19V may most seriously affect pregnant women and immune-compromised individuals.

Humate-P® Antihemophilic Factor/von Willebrand Factor Complex (Human)

Although the overwhelming number of B19V and HAV cases are community acquired, reports of these infections have been associated with the use of some plasma-derived products. Therefore, physicians should be alert to the potential symptoms of B19V and HAV infections (see Patient Counseling Information [17.1]). Symptoms of B19V may include low-grade fever, rash, arthralgias, and transient symmetric, nondestructive arthritis. Diagnosis is often established by measuring B19V-speciﬁc IgM and IgG antibodies. Symptoms of HAV include low-grade fever, anorexia, nausea, vomiting, fatigue, and jaundice. A diagnosis may be established by measuring speciﬁc IgM antibodies.

Before prescribing, please consult full prescribing information, a brief summary of which follows. Some text and references refer to full prescribing information. 1 INDICATIONS AND USAGE 1.1 Hemophilia A Humate-P, Antihemophilic Factor/von Willebrand Factor Complex (Human), is indicated for treatment and prevention of bleeding in adults with hemophilia A (classical hemophilia). 1.2 Von Willebrand Disease (VWD) Humate-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for: (1) treatment of spontaneous and trauma-induced bleeding episodes, and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD as well as patients with mild to moderate VWD where use of desmopressin (DDAVP) is known or suspected to be inadequate. Controlled clinical trials to evaluate the safety and efﬁcacy of prophylactic dosing with Humate-P to prevent spontaneous bleeding have not been conducted in VWD subjects (see Clinical Studies [14]). 3 DOSAGE FORMS AND STRENGTHS Humate-P is a sterile, lyophilized powder for intravenous administration. Each vial of Humate-P contains the labeled amount of VWF:RCo and FVIII activity expressed in International Units (IU). The average ratio of VWF:RCo to FVIII is 2.4:1. Approximate potencies are shown below; check each carton/vial for the actual potency prior to reconstitution: VWF:RCo/vial 600 IU 1200 IU 2400 IU

FVIII/vial 250 IU 500 IU 1000 IU

Diluent 5 mL 10 mL 15 mL

IU = International Units.

4 CONTRAINDICATIONS Humate-P is contraindicated in individuals who have had an anaphylactic or severe systemic reaction to antihemophilic factor or von Willebrand factor preparations. 5 WARNINGS AND PRECAUTIONS 5.1 Thromboembolic Events (VWD Patients) Thromboembolic events have been reported in VWD patients receiving Antihemophilic Factor/von Willebrand Factor Complex replacement therapy, especially in the setting of known risk factors for thrombosis.3,4 Early reports indicate a higher incidence may occur in females. Endogenous high levels of FVIII have also been associated with thrombosis, but no causal relationship has been established. Exercise caution and consider antithrombotic measures in all at-risk VWD patients who are receiving coagulation factor replacement therapy. 5.2 Monitoring for Intravascular Hemolysis Humate-P contains blood group isoagglutinins (anti-A and anti-B). When doses are very large or need to be repeated frequently (for example, when inhibitors are present or when pre- and post-surgical care is involved), monitor patients of blood groups A, B, and AB for signs of intravascular hemolysis and decreasing hematocrit values and treat appropriately. 5.3 Monitoring VWF:RCo and FVIII Levels Monitor the VWF:RCo and FVIII levels of VWD patients receiving Humate-P using standard coagulation tests, especially in cases of surgery. It is advisable to monitor trough VWF:RCo and FVIII:C levels at least once a day in order to adjust the dosage of Humate-P as needed to avoid excessive accumulation of coagulation factors (see Dosage and Administration [2.2, 2.3]). 5.4 Transmission of Infectious Agents Humate-P is made from human plasma. Products made from human plasma may contain infectious agents (e.g., viruses and theoretically, the Creutzfeldt-Jakob disease [CJD] agent) that can cause disease (see Description [11] and Patient Counseling Information [17.1]). The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses during manufacturing (see Description [11.1] for virus reduction measures). Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Thus the risk of transmission of infectious agents cannot be eliminated completely. Report all infections thought by a physician possibly to have been transmitted by this product to CSL Behring Pharmacovigilance at 1-866-915-6958 or FDA at 1-800FDA-1088 or www.fda.gov/medwatch.

Physicians should strongly consider administration of hepatitis A and hepatitis B vaccines to individuals receiving plasma derivatives. Potential risks and benefits of vaccination should be weighed by the physician and discussed with the patient. 6 ADVERSE REACTIONS The most serious adverse reaction observed in patients receiving Humate-P is anaphylaxis. Thromboembolic events have also been observed in patients receiving Humate-P for the treatment of VWD (see Warnings and Precautions [5.1]). Reports of thromboembolic events in VWD patients with other thrombotic risk factors receiving coagulation factor replacement therapy have been obtained from spontaneous reports, published literature, and a European clinical study. In some cases, inhibitors to coagulation factors may occur. However, no inhibitor formation was observed in any of the clinical studies. In patients receiving Humate-P in clinical studies for treatment of VWD, the most commonly reported adverse reactions observed by >5% of subjects are allergic-anaphylactic reactions (including urticaria, chest tightness, rash, pruritus, and edema. For patients undergoing surgery, the most common adverse reactions are postoperative wound and injection-site bleeding, and epistaxis. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice. Treatment of Bleeding Episodes in VWD Allergic symptoms, including allergic reaction, urticaria, chest tightness, rash, pruritus, and edema, were reported in 6 of 97 (6%) subjects in a Canadian retrospective study (see Clinical Studies [14.1]). Four of 97 (4%) subjects experienced seven adverse events that were considered to have a possible or probable relationship to Humate-P. These included chills, phlebitis, vasodilation, paresthesia, pruritus, rash, and urticaria. All were mild in intensity with the exception of a moderate case of pruritus. In a prospective, open-label safety and efficacy study of Humate-P in VWD subjects with serious life- or limb-threatening bleeding or undergoing emergency surgery, seven of 71 (10%) subjects experienced nine adverse reactions. These were one occurrence each of mild vasodilation and mild pruritis; two occurrences of mild paresthesia; and one occurrence each of moderate peripheral edema and extremity pain and severe pseudothrombocytopenia (platelet clumping with a false low reading). Humate-P was discontinued in the subject who experienced the peripheral edema and extremity pain. Prevention of Excessive Bleeding During and After Surgery in VWD Among the 63 VWD subjects who received Humate-P for prevention of excessive bleeding during and after surgery, including one subject who underwent colonoscopy without the planned polypectomy, the most common adverse events were postoperative hemorrhage (35 events in 19 subjects with five subjects experiencing bleeding at up to three different sites), postoperative nausea (15 subjects), and postoperative pain (11 subjects). Table 5 presents the postoperative hemorrhagic adverse events. Table 5: Hemorrhagic Adverse Events in 63 Surgical Subjects Adverse Event

Wound/injection site bleeding Epistaxis Cerebral hemorrhage/ subdural hematoma Gastrointestinal bleeding Menorrhagia Groin bleed

Surgical Procedure Category

Number of Subjects/ Events

Major Minor Oral Major Minor

8/11 2/2 2/6 4/4 1/1

Major

1/2

Major

1/3

Major Oral

1/1 1/1

Onset* Severity (Number of (Number of Events) Events) On Post Mild Mod Severe 7 4 9 – 2 2 – 1 1 – – 6 3 3 – 2 2 3 1 – 1 – 1 – – 2† 3‡ 1 –

–

– 1

1 –

– –

Hem/Onc Pharmacy 11

Pharmacy Practice News • February 2011

In Focus “There’s a huge information technology gap between hospitals, outpatient offices, physicians and patients,” Dr. Weinstein said. “Until everyone begins using electronic records that are transportable, verifiable and instantaneous, we’re not going to have what we want, which is for the next set of caregivers to receive a patient’s complete history.” Medication reconciliation has fared better and is a relative bright spot within transition activities. According to the ACCC report, nearly 80% of the oncology groups conduct medication reconciliation, and about 75% have CPOE systems.

Adverse Event Ear bleed Hemoptysis Hematuria Shoulder bleed * † ‡ §

Surgical Procedure Category Major Major Major Major

Number of Subjects/ Events 1/1 1/1 1/1 1/1

Onset* (Number of Events) 1 – 1 – 1 – 1 –

‘Every time a care-setting transition occurs, there is the potential challenge for miscommunication, delayed treatment and potentially a bad outcome because of incorrect treatment.’ —Mark Krasna, MD A main reason why medication reconciliation outpaces EHRs has much to do with the prescription drug claims process itself, explained Ernest Anderson Jr., MS, RPh, system vice president of pharmacy, Caritas Christi Health Care, Brighton, Mass. Because all prescriptions are adjudicated through a centralized claims processor, the information trav-

1 1 1 1

Severity (Number of Events) – – – – – – – –

On = on-therapy; onset while receiving Humate-P or within 1 day of completing Humate-P administration. Post = post-therapy; onset at least one day after completing Humate-P administration. Reported as serious adverse events following intracranial surgery. Two of these events were reported as serious adverse events following gastrojejunal bypass. Reported as a serious adverse event requiring hysterectomy following hysteroscopy and dilation and curettage.

Table 6 lists the non-hemorrhagic adverse events reported in at least two subjects, regardless of causality, and the adverse events that were possibly related to Humate-P. Pulmonary embolus considered possibly related to Humate-P occurred in one elderly subject who underwent bilateral knee replacement. Table 6: Non-Hemorrhagic and Possibly Related Adverse Events in 63 Surgical Subjects

Body System

Body as a whole

Cardiovascular

Digestive Hemic and lymphatic system Metabolic/ nutritional Nervous Skin and appendages Urogenital * †

Adverse Event (AE)

Pain Fever Abdominal pain Infection Surgery Back pain Facial edema Chest pain Pulmonary embolus† Thrombophlebitis† Nausea Constipation Vomiting Sore throat Anemia / decreased hemoglobin

Number of Subjects With an AE Possibly Related to Humate-P – – – – – – – –

Number of Subjects With an AE Regardless of Causality* 11 4 3 3 3 2 2 3

1 1 – 1 –

1 15 7 3 2

–

Increased SGPT

Dizziness Headache Increased sweating Insomnia Pruritus Rash Urinary retention Urinary tract infection

1 1 – – – 1 –

5 4 3 2 3 1 4

–

Events occurring in two or more subjects. Events occurring in separate subjects.

Eight subjects experienced 10 postoperative serious adverse events: one with subdural hematoma and intracerebral bleeding following intracranial surgery related to an underlying cerebrovascular abnormality; one with two occurrences of gastrointestinal bleeding following gastrojejunal bypass; and one each with sepsis, facial edema, infection, menorrhagia requiring hysterectomy following hysteroscopy and dilation and curettage, pyelonephritis, and pulmonary embolus. 6.2 Postmarketing Experience The following adverse reactions have been identiﬁed during postapproval use of Humate-P. Because these reactions are reported voluntarily from a

els through a common conduit. “You can retrieve that information and have a record of all, or most, of the medications a patient has been receiving,” Mr. Anderson said. “When a patient goes to the next site of care, someone can pull up that information.” [Although IT can certainly help ease medication reconciliation compliance,

population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Humate-P exposure. Adverse reactions reported in patients receiving Humate-P for treatment of VWD or hemophilia A are allergic-anaphylactic reactions (including urticaria, chest tightness, rash, pruritus, edema, and shock), development of inhibitors to FVIII, and hemolysis. Additional adverse reactions reported for VWD are thromboembolic complications, chills and fever, and hypervolemia. 7 DRUG INTERACTIONS None reported. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Humate-P. It is also not known whether Humate-P can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Humate-P should be given to a pregnant woman only if clearly needed. 8.2 Labor and Delivery It is not known whether Humate-P can cause harm to the mother or the fetus when administered during labor and delivery. Humate-P should be given during labor and delivery only if clearly needed. 8.3 Nursing Mothers It is not know whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Humate-P is administered to a nursing woman. 8.4 Pediatric Use Hemophilia A Adequate and well-controlled studies with long-term evaluation of joint damage have not been done in pediatric subjects. Joint damage may result from suboptimal treatment of hemarthroses. VWD The safety and effectiveness of Humate-P for the treatment of VWD was demonstrated in 26 pediatric subjects, including infants, children, and adolescents, but have not been evaluated in neonates. The safety of Humate-P for the prevention of excessive bleeding during and after surgery was demonstrated in eight pediatric subjects (ages 3 to 15) with VWD. Of the 34 pediatric subjects studied for either treatment of bleeding episodes in VWD or prevention of excessive bleeding during and after surgery, four were infants (1 month to under 2 years of age), 23 were children (2 through 12 years), and seven were adolescents (13 through 15 years). As in adults, pediatric patients should be dosed based on body weight (kg) (see Dosage and Administration [2.2, 2.3]). 8.5 Geriatric Use Clinical studies of Humate-P did not include sufﬁcient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. As for all patients, dosing for geriatric patients should be appropriate to their overall situation. 15 REFERENCES 3. Mannucci, PM. Venous Thromboembolism in Von Willebrand Disease. Thromb Haemostas. 2002;88:378-379. 4. Markis M, Colvin B, Gupta V, Shields ML, Smith MP. Venous thrombosis following the use of intermediate purity FVIII concentrate to treat patients with von Willebrand’s disease. Thromb Haemostas. 2002;88:387-388.

Manufactured by: CSL Behring GmbH 35041 Marburg, Germany US License No. 1765

Distributed by: CSL Behring LLC Kankakee, IL 60901 USA

Based on January 2010 revision.

Mix2Vial is a trademark of West Pharmaceuticals Services, Inc.

hospitals may well be getting their biggest boost from the Joint Commission, which recently released a less stringent version of the National Patient Safety Goal (NPSG). The new rule, now reclassified as Goal No. 3, takes effect July 1, 2011. For profiles of successful medication reconciliation programs, see sidebar, page 8.]

Who Is Running the Show? According to the ACCC report, some hospitals and group practices have figured out ways to actually handle patient transitions quite well. One particularly effective technique is to employ patient navigators. Often RNs or social workers, the navigators track and monitor a patient’s cancer treatment and keep clinicians in the information loop. At a time when patients face a daunting maze of disconnected activities, navigators can coordinate patient care, educate patients, refer patients and families to needed psychosocial services and link patients and families to appropriate financial and community resources. “Our team is centered around patient navigators,” Dr. Petrelli said. “They know about every one of our patients who is admitted to the hospital, then follow them through discharge and beyond.” Iowa Cancer Specialists and St. Joseph’s in Baltimore also have patient navigators on staff. As yet, there are no incentives built into reimbursement structures to make transition efforts financially attractive. That may change as some transition activities become widely recognized as best practices by influential medical groups. Down the road, accountable care organizations (ACOs) may lead to better information sharing within and among health care organizations, and as a result a higher quality of care and smoother patient transitions. Under the ACO model, various components of health care are consolidated, and providers are held jointly accountable for the health of their patients. “With an ACO, you would ideally have a continuum of data that follows a patient when they move between inpatient and outpatient settings,” said Ali McBride, PharmD, MS. oncology clinical pharmacy resident, H. Lee Moffitt Cancer Center, Tampa, Fla. ACOs are largely conceptual, with only a smattering of pilot programs across the nation. But, he added, “There’s definitel y a move me n t toward this new model of health Scan to access ACCC care.” survey summary. —Steve Frandzel

Instructions, p. 4.

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Hem/Onc Pharmacy

Pharmacy Practice News • February 2011

In Focus

More Bad News for Bevacizumab Meta-analysis underscores drug’s link to congestive heart failure, but study design criticized

evacizumab (Avastin, Genentech) is associated with an increased risk for high-grade congestive heart failure (CHF) in women with breast cancer, according to a new study in the Journal of Clinical Oncology. The study, a meta-analysis of five randomized controlled trials (RCTs) led by Toni K. Choueiri, MD, assistant professor of medicine at Harvard Medical School, Boston, comes on the heels of the FDA’s announcement in December that it was revoking bevacizumab’s indication for metastatic breast cancer (MBC) because of a plethora of toxicities, including bowel perforation, as well as a lack of improved survival benefit. But the impact of the meta-analysis, published online Jan. 4 (doi:10.1200/ JCO.2010.32.9060), may be tempered by the fact that several experts have criticized its design and questioned its clinical significance. (On the regulatory front, Genentech announced in January that it was asking for a formal hearing before the FDA so that the company could present its case for why bevacizumab’s breast cancer indication should not be revoked. Under agency regulations, interested parties can request such hearings before the FDA can rescind a previously approved indication.)

Researchers Cast Wide Net Aiming to shed more light on whether bevacizumab could be cardiotoxic in the setting of advanced breast cancer, Dr. Choueiri and his team reviewed PubMed citations from January 1966 to March 2010. They also searched abstracts presented at the American Society of Clinical Oncology (ASCO) and the San Antonio Breast Cancer Symposium (SABCS) meetings for relevant clinical trials. Their original search yielded 60 bevacizumab studies, including 49 abstracts from PubMed and 11 from ASCO or SABCS meetings. Eventually, they selected five Phase III multicenter RCTs, comprising 3,784 patients with MBC, for their meta-analysis. The selected trials were a study by Miller et al (J Clin Oncol 2005;23:792799), along with E2100, AVADO (AVastin plus Docetaxel), RIBBON-1 and RIBBON-2 (Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of Chemotherapy With or Without Bevacizumab for First-Line Treatment of HER2-Negative Locally-Recurrent or Metastatic Breast Cancer). In all of these trials, patients with uncontrolled hypertension, clinically significant CHF, cerebrovascular disease or peripheral vascular disease and unstable angina or

recent history of myocardial infarction were excluded. All of the trials allowed the inclusion of patients with a history of prior anthracycline therapy, and one trial included patients on concomitant anthracycline treatment. Two of the trials included patients with HER2-positive disease who had received prior treatment with trastuzumab (Herceptin, Genentech). The analysis showed nearly a fivefold increase in the risk for CHF in bevacizumab-treated patients compared with controls. Of the 2,365 patients who received bevacizumab, 36 had high-grade CHF, for an overall incidence rate of 1.6% (95% confidence interval [CI], 1.0%-2.6%). Among the 1,418 patients who did not receive treatment with bevacizumab, four had high-grade CHF events, for an incidence rate of 0.4% (95% CI, 0.2%-1.0%). In an accompanying editorial (doi: 10.1200/JCO.2010.31.9129), Nitin Verma, MD, and Sandra M. Swain, MD, from the Washington Cancer Institute, Washington Hospital Center, Washington, D.C., criticized the study, saying the results should be viewed with extreme caution. “Performing a meta-analysis with retrospectively collected heart-failure data adds little to our current body of evidence,” they wrote. “On the basis of the limitations of the study, we still lack convincing evidence that bevacizumab is associated with an increased risk of significant heart failure.” None of the trials included stringent cardiac monitoring, and cardiac events were recorded only when they were clin-

ically significant. And, depending on the study, anywhere from 50% to 100% of the patients had received prior anthracycline, which is well known to be cardiotoxic, further muddying the waters, the editorialists point out.

Hem/Onc Pharmacist’s Take Asked to comment on the meta-analysis, Myke Green, PharmD, BCOP, oncology clinical coordinator at University Medical Center/Arizona Cancer Center, in Tucson, said the study brings to light the fact that cardiac-related issues are fairly common in the breast cancer population. “This study needs to be sorted out in more detail about the contributory effects from other therapies,” he said. “Given the fact this is a meta-analysis, it has some inherent challenges. It is also retrospective, so it is difficult to really zero in on why the patients allocated to bevacizumab had a higher incidence compared with those who were not.”

Payments for Avastin Seem Safe

ecent concerns that insurers may cite the FDA’s decision to rescind bevacizumab’s indication for advanced breast cancer as a reason not to pay for the targeted agent seem to have eased. The payment question first surfaced in early January, when one regional Medicare contractor announced that it would not pay for the targeted agent to treat advanced breast cancer. The rationale? The treatment would constitute off-label use. Shortly thereafter, the contractor, Palmetto GBA, reversed that position, citing Genentech’s request for a formal hearing to review the FDA’s actions. Palmetto GBA sets payment policy for South Carolina, Ohio, West Virginia, California, Nevada and Hawaii. Given that broad swath of coverage, it’s not surprising that the initial announcement to cut off reimbursement triggered widespread concern among patient advocacy groups. But at least one pharmacy administrator with expertise in reimbursement issues said that there is no strong basis for denying bevacizumab claims. “Payers routinely cover off-label use of cancer drugs—especially if that treatment is supported in the NCCN’s [National Comprehensive Cancer Network] drug compendium,” said Phil Johnson, MS, RPh, pharmacy advocacy director, Moffitt Cancer Center and Research Institute, in Tampa, Fla. “As far as I know, the drug is still listed as an appropriate, level 2A therapy for advanced breast cancer.” In early February, Bill McGivney, PhD, the NCCN’s CEO, told Pharmacy Practice News that the level 2A recommendation still stands. Based on that recommendation, several major private insurers, including WellPoint, UnitedHealth Group and Aetna Inc., announced that they would continue to pay for the drug. Ali McBride, PharmD, MS, BCPS, of Barnes-Jewish Hospital, in St. Louis, added that although there had been some initial concern that states were going to pull bevacizumab from their Medicare and Medicaid formularies, “they’ve now put that decision on hold, awaiting further details on the situation.” —David Bronstein

Dr. Green said that patients with MBC who are placed on bevacizumab need to be monitored closely. “I would want to know if they had anthracyclines or chest irradiation or both, and I would obtain an ejection fraction and then follow them closely with a MUGA [multigated acquisition] scan or an echocardiogram more frequently than we would perhaps ordinarily do to stay on top of the situation.” With all its limitations, the study does underscore that patients with breast cancer who are put on bevacizumab need to be closely watched, he said. “Even if they are not currently receiving anthracyclines or chest x-rays, we should not just close the book on evaluating their cardiac status simply because they’re not actively on either therapy. And perhaps that is the mechanism of bevacizumab—that it unmasks something that is just below the surface that was brought about by other factors.” Alternatively, bevacizumab itself may have a direct mechanism for causing cardiotoxicity, with the vascular endothelial growth factor (VEGF) pathway the prime culprit. Mice lacking the VEGF gene have thinned myocardial walls and depressed basal contractile function. Mesenchymal stem cells that overexpress VEGF may have a protective effect on the myocardium. Such observations, according to background information in the JCO study, “implicate a critical role for VEGF in coordinated tissue growth and angiogenesis in the heart and suggest that blocking this pathway may lead to a disruption in cardiac remodeling and consequently induce heart failure.” At press-time, yet more bad news for bevacizumab surfaced: a meta-analysis in the Journal of the American Medical Association found that the targeted agent caused nearly 50% more fatal adverse events compared with control groups (2011;305:487-494). Scan for more —Fran Lowry

Avastin news. instructions, p. 4.

Clinical 15

Pharmacy Practice News • February 2011

Cardiology Commentary

POISE-D for Change Controversy dogs use of β-blockers in noncardiac surgery New York—More than two years after the publication of the POISE trial suggested that use of β-blockers in patients undergoing noncardiac surgery might be more harmful than helpful, the therapy remains contentious. The study indicated a substantial risk for stroke with perioperative β-blockers in the largest such cohort ever studied, but some experts point out methodological flaws and increasingly consider that study damaging to patients. “The POISE [Perioperative Ischemic Evaluation] study clearly has serious and irreversible flaws in design, execution and safety oversight,” said Dennis T. Mangano, MD, PhD, founder of the nonprofit Ischemia Research and Education Foundation. “It’s clear that they got the beneficial effects of metoprolol [the β-blocker used in POISE], but they got serious complications. The trial should have been stopped one-third of the way through. The doses should have been changed, the design should have been different.” Dr. Mangano, one of the most vocal critics of POISE and a strong supporter of the use of β-blockers in the noncardiac perioperative setting, spoke about the issues at the 2010 PostGraduate Assembly in Anesthesiology. He later spoke of his concerns regarding the Patient scheduled for surgery with: Coronary artery disease

Peripheral vascular disease

Two Risk Factors: • • • •

Age greater than 60 years Hypertension Diabetes Cholesterol above 240 mg/dL • Smoking

Aortic stenosis Congestive heart failure Unstable angina New-onset angina Change in anginal pattern Angina without medical therapy Intra-coronary stent on platelet inhibitor

Refer to cardiology

POISE study and the impact it has had on clinical practice, where it continues to play an influential role in guidelines and shape the overall discussion of the topic.

Overdose? Primary among the study’s problems, according to Dr. Mangano, was the dose of metoprolol given. The 8,351 patients in the study received either a placebo (n=4,177) or 200 mg of metoprolol per day beginning two to four hours prior to surgery and continuing for 30 days (n=4,174). Dr. Mangano said 200 mg is a far higher dose than should be given to most patients, although the study’s principal investigator pointed out that the 200 mg is half the maximum daily therapeutic dose. During the 30-day follow-up period, fewer patients given β-blockers reached the primary composite end point of cardiovascular death, nonfatal myocardial infarction (MI) and nonfatal cardiac arrest (244 vs. 290 patients; hazard ratio [HR], 0.84; P=0.0399). Metoprolol also reduced the incidence of MI overall, with an HR of 0.73 (P=0.0017) compared with the placebo group. The problematic result, however,

β-Blockers • Atenolol 25 mg PO QD to start, if heart rate greater than 60 and systolic blood pressure greater than 120 mm Hg. Titrate dose to effect. • Atenolol or metoprolol IV on day of surgery. Atenolol or metoprolol IV post-op until taking PO then. • Atenolol 100 mg PO QD for at least a week post-op (hold for heart rate less than 55 or systolic blood pressure less than 100 mm Hg). • If known CAD or PVD continue indefinitely.

β-blocker

tudies conducted before POISE [Perioperative Ischemic Evaluation study] were very small and powered to look at the benefits of β-blockers, but not the drugs’ harms. So it is not surprising that those previous studies did not find any impact on patients. I agree that the overly aggressive dosing in POISE was especially problematic, and may have contributed to the negative results. But that dosing really was not out of line with what was being done clinically. The biggest issue with the POISE trial is that the investigators even aggressively dosed heart failure (HF) patients with β-blockers, a known bad idea for 20 years. However, I worry that people are trying to say that an earlier trial, by Mangano et al (N Engl J Med 1996;335:1713-1721), proved that β-blockade was beneficial to patients. I strongly disagree with that assessment for several reasons. First, people in that earlier study did not have to be β-blocker–naïve, and 18% and 8% of patients randomized to atenolol and placebo, respectively, were on chronic β-blockers. That is critical, because β-blocker withdrawal is such an important risk factor for negative cardiac effects. That factor alone could have overemphasized the benefits. Second, although not statistically significant (but underpowered), more people in the atenolol group received chronic β-blockers after the study protocol ended than those initially randomized to placebo. Remember that atenolol did not have an acute beneficial effect. Finally, in the republication of the results two years later [Anesthesiology 1998;88:7-17], the authors reported that in-hospital stroke occurred in 4% of atenolol patients and 1% of placebo patients (P=0.21). This is consistent with the impact seen in POISE; the difference here is lack of power. If I were to devise a trial to answer these questions regarding β-blocker efficacy, I would do the following: • Initiate the drugs several days in advance of the surgery and then titrate to some effect (based on heart rate, PR interval and blood pressure). Starting β-blockers immediately before surgery sounds hokey and dangerous. • Avoid CYP2D6 inhibitors or build in reduced maximum dosages in patients receiving carvedilol or metoprolol. (CYP2D6 inhibitors can lead to accentuated β-blocker concentrations and unpredictably lower heart rate and blood pressure.) • Exclude HF patients from the trial. This is critical, because it is well known that aggressive β-blockade in HF is associated with poor hemodynamic response. • Only study higher cardiovascular risk surgeries (vascular surgery, preexisting, known cardiac disease, etc.). People get too caught up in relative risks and this leads them astray. If there is a one-in-a-million chance of cardiac problems, then reducing the risk by 50% doesn’t really change anything. It is in this population where rare adverse events easily can outpace the benefits. • Genotype test for adrenoceptor β-1 and β-2 polymorphisms. In a previous noncardiac surgery study, the effects of therapy were suggested to be different based on the genetic profile, and this needs to be explored.

‘The [researchers] conclude that β-blockers are dangerous and shouldn’t be used. Their conclusion is medically irresponsible and inappropriate. That’s the wrong conclusion. And that conclusion has harmed patients.’

—Arthur Wallace, MD, PhD

If Unable to Take β-blockers

If patient has a specific contraindication (asthma not COPD) to β-blockers: • Clonidine 0.2 mg • Clonidine 0.2 mg PO tablet night PO table morning before surgery of surgery. • Clonidine TTS#2 Patch (0.2 mg/ 24 h) night before surgery

• Hold for systolic blood pressure less than 120 mm Hg.

Proceed with surgery

Figure. General guidelines for the adoption of perioperative anti-Ischemic prophylaxis. Arthur Wallace, MD, PhD, and his colleagues at the University of California, San Francisco, offer the following “basic rules” for setting up a β-blocker protocol to reduce cardiac risk in perioperative patients. Chart reprinted with permission.

C. Michael White, PharmD, professor of pharmacy, University of Connecticut, Storrs, and director, UCONN/Hartford Hospital Evidence-Based Practice Center, in Hartford, Conn., offered the following comments on the ongoing debate over the POISE trial results.

was stroke incidence: 41 patients in the metoprolol group experienced a stroke, compared with 19 in the placebo group, for an HR of 2.17 (P=0.0053). In addition, more deaths occurred in the metoprolol group (HR, 1.33; P=0.0317). The POISE results were published in Lancet in 2008 (371:1839-1847). “I think that there is no doubt that there is a benefit to giving perioperative β-blockers: If you give them you prevent MIs,” said Philip J. Devereaux, MD, assistant professor of clinical epidemiology and biostatistics at McMaster University in Ontario, and the principal investigator on POISE. “At the same time, I think it is cavalier to look past the risks associated with perioperative β-blockers.”

Dr. Devereaux said he agreed that the dose of metoprolol in the study was too high—in a sense. “People are 100% right. … The dose of β-blockers in POISE was too high for the benefit that we saw. It’s not worth it for the risk that we saw.” The question, he said, is whether a lower dose would give the same benefits while avoiding the risk. “I would put forward that no one has ever shown that,” Dr. Devereaux said. Previous studies revealed the potential signal of higher risk for stroke, but only POISE had the patient population to reach statistical significance, he noted. Dr. Mangano said that the dosing in

•

see POISE-D, page 16

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Pharmacy Practice News • February 2011

Cardiology

POISE-D continued from page 15

the POISE study also suffered from a lack of titration and variation; patients younger and older with varying degrees of sickness received the same dose. Yet, although patients with heart failure generally take no more than 25 mg of metoprolol to start, they received an initial dose of 200 mg in POISE. Arthur Wallace, MD, PhD, professor of anesthesia and perioperative medicine at the University of California, San Francisco, agreed that the dosing issues with POISE confound the conclusions on use of β-blockers in the study population. “If you had done a study where you had the wrong dose, you would conclude there is a therapeutic index for all drugs, and we clearly gave too much drug,” said Dr. Wallace, who has helped establish perioperative β-blocker programs in more than 150 hospitals. “They [the POISE authors] don’t conclude that. They conclude that β-blockers are dangerous and shouldn’t be used. Their conclusion is medically irresponsible and inappropriate. That’s the wrong conclusion. And that conclusion has harmed patients.” For his part, Dr. Devereaux argued that thorough titration of dosing in the millions of surgical patients is unrealistic, practically speaking, and that POISE’s counter-to-current practice results make it difficult for some experts to accept.

John E. Ellis, MD, adjunct professor in anesthesia and critical care at the University of Pennsylvania School of Medicine, in Philadelphia, said the size of the POISE study makes it impossible to ignore. “The importance of POISE is that a lot of trials beforehand focused only on cardiac events, and POISE focused on everything,” he told Pharmacy Practice News. “And POISE suggested that you reduce cardiac events but you increase stroke. That’s important to know. So if you’re trading benefit in one organ system for damage in another, that’s a problem.”

However, Dr. Ellis said he agreed with some of the methodological concerns. “They gave too much drug,” he said. In addition, he noted that subsequent large trials in the Netherlands have not shown a risk for stroke with β-blockade begun and titrated in advance of surgery. “We’re naïve if we think we can have answers with just a couple of hundred patients,” Dr. Devereaux said. Proving that a lower dose would work as effectively and safely would require a large, blinded and randomized trial. Experts agree that such a trial would be very costly and is unlikely to be conducted

in the near future. Daniel Sessler, MD, professor and chair of the Department of Outcomes Research at the Cleveland Clinic in Ohio, agreed that overlooking POISE in favor of much smaller studies is dangerous. “Suppose there had been no benefit,” Dr. Sessler said. “The same people who now complain that the dose was too high would say that the dose was too low. There might be a dose that is both effective and safe. But you can’t just assume that such a dose exists. Until there is a randomized trial large enough to evaluate safety—one with many thousands of

Step up to a range of insulin delivery options.

‘Startling’ Result “We have this result that has startled a lot of people. And the problem is that there have been experts in the area recommending β-blockers for 15 years prior to us doing POISE, and they clearly don’t like the results of POISE,” he said. “And neither do the POISE investigators. We wish we had hit a homerun and showed no risk, but that’s not the reality.” Prior to POISE, the joint guidelines from the American Heart Association and the American College of Cardiology (AHA/ACC) for perioperative use of β-blocker were based on small studies that did not adequately demonstrate a safe profile for the drugs, Dr. Devereaux said. Two of the most important of those studies, one by Dr. Mangano and colleagues published in 1996, had 200 patients (N Engl J Med 1996;335:17131721) and 112 patients (N Engl J Med 1999;341:1789-1794). Both showed significant benefit with the β-blockers atenolol and bisoprolol, respectively. Dr. Wallace said the latter study stopped at 112 patients only because the therapy’s success made it unethical to withhold β-blockers from some patients. As Dr. Devereaux pointed out, Dr. Mangano’s atenolol study also targeted 50% of the maximum daily therapeutic dose.

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

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

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

Clinical 17

Pharmacy Practice News • February 2011

Cardiology patients—clinicians should be very careful with perioperative β-blockers.” Dr. Wallace and his colleagues recently published an epidemiologic study in Anesthesiology (2010;113:794-805) of 38,779 operations performed at the San Francisco Veterans Administration Medical Center. They found significant reductions in 30-day and one-year mortality rates with the use of perioperative β-blockers. A pilot study suggested that starting a β-blocker more than two weeks prior to surgery could reduce the risks for cardiac complications and death substantially

(Pharmacy Practice News, December 2010; access via 2-D bar code at right). For the moment, the AHA/ACC guidelines continue to recommend that patients already on β-blockers—a group excluded in the POISE study—continue taking the medication over the perioperative period. But recommendations are tempered for patients undergoing noncardiac surgery who have not been taking β-blockers. A class IIa recommendation deems it “reasonable” to give β-blockers “titrated to heart rate and blood pressure” in patients with high cardiac risk undergoing “inter-

mediate-risk surgery.” The recommendations were updated after the POISE data were published, reflecting the uncertainty generated by the large study’s results. “It was very destructive to a pretty clear, obvious, well-thought-out field of anesthesia that had a fundamental improvement of care,” Dr. Wallace said. Dr. Wallace went further, calling emphatically for a retraction of the POISE paper. “The average doctor doesn’t go through and look at this study in bitter detail.” Dr. Mangano agreed that the overriding

Humalog Important Safety Information, continued

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

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

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

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

effect among clinicians is most likely confusion at this point. Based on impressions from anecdote, Dr. Ellis said that POISE has led clinicians to pull back on the Scan for more beta blocker controversy. use of β-blockers periop- Instructions, p. 4 eratively. Is that justified? “I’m not sure,” he said. “I look at it like this in 2011: β-blockers are good for the heart, and they may be bad for the brain, particularly if you give too much. But there will continue to be controversy.” —Dave Levitan

18 Clinical

Pharmacy Practice News • February 2011

Critical Care

VTE PROPHYLAXIS

‘There is still one-fourth of individuals who did not get any [type of VTE prophylaxis] and so we have to keep on reaching out to educate their caregivers. But for the most part, patients are getting treated. Now we just have to make sure we do it right.’

continued from page 1

23,000 patients who were assessed were found have received the appropriate type, dose and duration of prophylaxis, said Paul P. Dobesh, PharmD, FCCP, BCPS, associate professor of pharmacy practice at the University of Nebraska Medical Center, Omaha. “The risk for venous thromboembolism can vary widely in critical care patients, but most patients have several risk factors,” Dr. Dobesh said. “The ACCP guidelines suggest that most crit-

—Paul P. Dobesh, PharmD, FCCP, BCPS

HUMALOG® INSULIN LISPRO INJECTION (rDNA ORIGIN) BRIEF SUMMARY: Consult package insert for complete prescribing information. INDICATIONS AND USAGE: Humalog is an insulin analog that is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Humalog has a more rapid onset and a shorter duration of action than regular human insulin. Therefore, in patients with type 1 diabetes, Humalog should be used in regimens that include a longer-acting insulin. However, in patients with type 2 diabetes, Humalog may be used without a longer-acting insulin when used in combination therapy with sulfonylurea agents. Humalog may be used in an external insulin pump, but should not be diluted or mixed with any other insulin when used in the pump. Humalog administration in insulin pumps has not been studied in patients with type 2 diabetes. CONTRAINDICATIONS: Humalog is contraindicated during episodes of hypoglycemia and in patients sensitive to Humalog or any of its excipients. WARNINGS: This human insulin analog differs from regular human insulin by its rapid onset of action as well as a shorter duration of activity. When used as a mealtime insulin, the dose of Humalog should be given within 15 minutes before or immediately after the meal. Because of the short duration of action of Humalog, patients with type 1 diabetes also require a longer-acting insulin to maintain glucose control (except when using an external insulin pump). External Insulin Pumps: When used in an external insulin pump, Humalog should not be diluted or mixed with any other insulin. Patients should carefully read and follow the external insulin pump manufacturer’s instructions and the “PATIENT INFORMATION” leaflet before using Humalog. Physicians should carefully evaluate information on external insulin pump use in the Humalog physician package insert and in the external insulin pump manufacturer’s instructions. If unexplained hyperglycemia or ketosis occurs during external insulin pump use, prompt identification and correction of the cause is necessary. The patient may require interim therapy with subcutaneous insulin injections (see PRECAUTIONS, For Patients Using External Insulin Pumps, and DOSAGE AND ADMINISTRATION). Hypoglycemia is the most common adverse effect associated with the use of insulins, including Humalog. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes and is particularly important for patients using an external insulin pump. Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (eg, regular, NPH, analog), species, or method of manufacture may result in the need for a change in dosage. PRECAUTIONS: General—Hypoglycemia and hypokalemia are among the potential clinical adverse effects associated with the use of all insulins. Because of differences in the action of Humalog and other insulins, care should be taken in patients in whom such potential side effects might be clinically relevant (eg, patients who are fasting, have autonomic neuropathy, or are using potassium-lowering drugs or patients taking drugs sensitive to serum potassium level). Lipodystrophy and hypersensitivity are among other potential clinical adverse effects associated with the use of all insulins. As with all insulin preparations, the time course of Humalog action may vary in different individuals or at different times in the same individual and is dependent on site of injection, blood supply, temperature, and physical activity. Adjustment of dosage of any insulin may be necessary if patients change their physical activity or their usual meal plan. Insulin requirements may be altered during illness, emotional disturbances, or other stress. Hypoglycemia—As with all insulin preparations, hypoglycemic reactions may be associated with the administration of Humalog. Rapid changes in serum glucose concentrations may induce symptoms of hypoglycemia in persons with diabetes, regardless of the glucose value. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control. Renal Impairment—The requirements for insulin may be reduced in patients with renal impairment. Hepatic Impairment—Although impaired hepatic function does not affect the absorption or disposition of Humalog, careful glucose monitoring and dose adjustments of insulin, including Humalog, may be necessary. Allergy—Local Allergy—As with any insulin therapy, patients may experience redness, swelling, or itching at the site of injection. These minor reactions usually resolve in a few days to a few weeks. In some instances, these reactions may be related to factors other than insulin, such as irritants in a skin cleansing agent or poor injection technique. Systemic Allergy—Less common, but potentially more serious, is generalized allergy to insulin, which may cause rash (including pruritus) over the whole body, shortness of breath, wheezing, reduction in blood pressure, rapid pulse, or sweating. Severe cases of generalized allergy, including anaphylactic reaction, may be life-threatening. Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient. In Humalog-controlled clinical trials, pruritus (with or without rash) was seen in 17 patients receiving Humulin R® (N=2969) and 30 patients receiving Humalog (N=2944) (P=.053). Antibody Production—In large clinical trials, antibodies that cross-react with human insulin and insulin lispro were observed in both Humulin R- and Humalog-treatment groups. As expected, the largest increase in the antibody levels during the 12-month clinical trials was observed with patients new to insulin therapy. Usage of Humalog in External Insulin Pumps—The infusion set (reservoir syringe, tubing, and catheter), Disetronic® D-TRON®2,3 or D-TRONplus®2,3 cartridge adapter, and Humalog in the external insulin pump reservoir should be replaced and a new infusion site selected every 48 hours or less. Humalog in the external insulin pump should not be exposed to temperatures above 37°C (98.6°F). In the D-TRON ®2,3 or D-TRONplus ®2,3 pump, Humalog 3 mL cartridges may be used for up to 7 days. However, as with other external insulin pumps, the infusion set should be replaced and a new infusion site should be selected every 48 hours or less. When used in an external insulin pump, Humalog should not be diluted or mixed with any other insulin (see INDICATIONS AND USAGE, WARNINGS, PRECAUTIONS, For Patients Using External Insulin Pumps, Mixing of Insulins, DOSAGE AND ADMINISTRATION, and Storage). Information for Patients—Patients should be informed of the potential risks and advantages of Humalog and alternative therapies. Patients should also be informed about the importance of proper insulin storage, injection technique, timing of dosage, adherence to meal planning, regular physical activity, regular blood glucose monitoring, periodic hemoglobin A1C testing, recognition and management of hypoglycemia and hyperglycemia, and periodic assessment for diabetes complications. Patients should be advised to inform their physician if they are pregnant or intend to become pregnant. Refer patients to the “PATIENT INFORMATION” leaflet for timing of Humalog dosing (< _15 minutes before or immediately after a meal), storing insulin, and common adverse effects. For Patients Using Insulin Pen Delivery Devices: Before starting therapy, patients should read the “PATIENT INFORMATION” leaflet that accompanies the drug product and the User Manual that accompanies the delivery device. They should also reread these materials each time the prescription is renewed. Patients should be instructed on how to properly use the delivery device, prime the Pen to a stream of insulin, and properly dispose of needles. Patients should be advised not to share their Pens with others. For Patients Using External Insulin Pumps: Patients using an external infusion pump should be trained in intensive insulin therapy and in the function of their external insulin pump and pump accessories. Humalog was tested in the MiniMed®1 Models 506, 507, and 508 insulin pumps using MiniMed®1 Polyfin®1 infusion sets. Humalog was also tested in the Disetronic ®2 H-TRONplus ® V100 insulin pump (with plastic 3.15 mL insulin reservoir), and the Disetronic D-TRON ®2,3 and D-TRONplus ®2,3 insulin pumps (with Humalog 3 mL cartridges) using Disetronic Rapid®2 infusion sets. The infusion set (reservoir syringe, tubing, catheter), D-TRON®2,3 or D-TRONplus ®2,3 cartridge adapter, and Humalog in the external insulin pump reservoir should be replaced, and a new infusion site selected every 48 hours or less. Humalog in the external pump should not be exposed to temperatures above 37°C (98.6°F). A Humalog 3 mL cartridge used in the D-TRON ®2,3 or D-TRONplus ®2,3 pump should be discarded after 7 days, even if it still contains Humalog. Infusion sites that are erythematous, pruritic, or thickened should be reported to medical personnel, and a new site selected. Humalog should not be diluted or mixed with any other insulin when used in an external insulin pump. Laboratory Tests—As with all insulins, the therapeutic response to Humalog should be monitored by periodic blood glucose tests. Periodic measurement of hemoglobin A1C is recommended for the monitoring of long-term glycemic control. Drug Interactions—Insulin requirements may be increased by medications with hyperglycemic activity, such as corticosteroids, isoniazid, certain lipid-lowering drugs (eg, niacin), estrogens, oral contraceptives, phenothiazines, and thyroid replacement therapy (see CLINICAL PHARMACOLOGY). Insulin requirements may be decreased in the presence of drugs that increase insulin sensitivity or have hypoglycemic activity, such as oral antidiabetic agents, salicylates, sulfa antibiotics, certain antidepressants (monoamine oxidase inhibitors), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blocking agents, beta-adrenergic blockers, inhibitors of pancreatic function (eg, octreotide), and alcohol. Beta-adrenergic blockers may mask the symptoms of hypoglycemia in some patients. Mixing of Insulins—Care should be taken when mixing all insulins as a change in peak action may occur. The American Diabetes Association warns in its Position Statement on Insulin Administration, “On mixing, physiochemical changes in the mixture may occur (either immediately or over time). As a result, the physiological response to the insulin mixture may differ from that of the injection of the insulins separately.” Mixing Humalog with Humulin® N or Humulin® U does not decrease the absorption rate or the total bioavailability of Humalog. Given alone or mixed with Humulin N, Humalog results in a more rapid absorption and glucose-lowering effect compared with regular human insulin. Pregnancy—Teratogenic Effects—Pregnancy Category B—Reproduction studies with insulin lispro have been performed in pregnant rats and rabbits at parenteral doses up to 4 and 0.3 times, respectively, the average human dose (40 units/day) based on body surface area. The results have revealed no evidence of impaired fertility or harm to the fetus due to Humalog. There are, however, no adequate and well-controlled studies with Humalog in pregnant women. Because

animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Although there are limited clinical studies of the use of Humalog in pregnancy, published studies with human insulins suggest that optimizing overall glycemic control, including postprandial control, before conception and during pregnancy improves fetal outcome. Although the fetal complications of maternal hyperglycemia have been well documented, fetal toxicity also has been reported with maternal hypoglycemia. Insulin requirements usually fall during the first trimester and increase during the second and third trimesters. Careful monitoring of the patient is required throughout pregnancy. During the perinatal period, careful monitoring of infants born to mothers with diabetes is warranted. Nursing Mothers—It is unknown whether Humalog is excreted in significant amounts in human milk. Many drugs, including human insulin, are excreted in human milk. For this reason, caution should be exercised when Humalog is administered to a nursing woman. Patients with diabetes who are lactating may require adjustments in Humalog dose, meal plan, or both. Pediatric Use—In a 9-month, crossover study of prepubescent children (n=60), aged 3 to 11 years, comparable glycemic control as measured by A1C was achieved regardless of treatment group: regular human insulin 30 minutes before meals 8.4%, Humalog immediately before meals 8.4%, and Humalog immediately after meals 8.5%. In an 8-month, crossover study of adolescents (n=463), aged 9 to 19 years, comparable glycemic control as measured by A1C was achieved regardless of treatment group: regular human insulin 30 to 45 minutes before meals 8.7% and Humalog immediately before meals 8.7%. The incidence of hypoglycemia was similar for all 3 treatment regimens. Adjustment of basal insulin may be required. To improve accuracy in dosing in pediatric patients, a diluent may be used. If the diluent is added directly to the Humalog vial, the shelf life may be reduced (see DOSAGE AND ADMINISTRATION). Geriatric Use—Of the total number of subjects (n=2834) in 8 clinical studies of Humalog, 12% (n=338) were 65 years of age or over. The majority of these were patients with type 2 diabetes. A1C values and hypoglycemia rates did not differ by age. Pharmacokinetic/pharmacodynamic studies to assess the effect of age on the onset of Humalog action have not been performed. ADVERSE REACTIONS: Clinical studies comparing Humalog with regular human insulin did not demonstrate a difference in frequency of adverse events between the 2 treatments. Adverse events commonly associated with human insulin therapy include the following: Body as a Whole—allergic reactions (see PRECAUTIONS). Skin and Appendages—injection site reaction, lipodystrophy, pruritus, rash. Other—hypoglycemia (see WARNINGS and PRECAUTIONS). OVERDOSAGE: Hypoglycemia may occur as a result of an excess of insulin relative to food intake, energy expenditure, or both. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. DOSAGE AND ADMINISTRATION: Humalog is intended for subcutaneous administration, including use in select external insulin pumps (see DOSAGE AND ADMINISTRATION, External Insulin Pumps). Dosage regimens of Humalog will vary among patients and should be determined by the healthcare provider familiar with the patient’s metabolic needs, eating habits, and other lifestyle variables. Pharmacokinetic and pharmacodynamic studies showed Humalog to be equipotent to regular human insulin (ie, one unit of Humalog has the same glucose-lowering effect as one unit of regular human insulin), but with more rapid activity. The quicker glucose-lowering effect of Humalog is related to the more rapid absorption rate from subcutaneous tissue. An adjustment of dose or schedule of basal insulin may be needed when a patient changes from other insulins to Humalog, particularly to prevent premeal hyperglycemia. When used as a mealtime insulin, Humalog should be given within 15 minutes before or immediately after a meal. Regular human insulin is best given 30 to 60 minutes before a meal. To achieve optimal glucose control, the amount of longer-acting insulin being given may need to be adjusted when using Humalog. The rate of insulin absorption and consequently the onset of activity are known to be affected by the site of injection, exercise, and other variables. Humalog was absorbed at a consistently faster rate than regular human insulin in healthy male volunteers given 0.2 U/kg regular human insulin or Humalog at abdominal, deltoid, or femoral sites, the 3 sites often used by patients with diabetes. When not mixed in the same syringe with other insulins, Humalog maintains its rapid onset of action and has less variability in its onset of action among injection sites compared with regular human insulin (see PRECAUTIONS). After abdominal administration, Humalog concentrations are higher than those following deltoid or thigh injections. Also, the duration of action of Humalog is slightly shorter following abdominal injection, compared with deltoid and femoral injections. As with all insulin preparations, the time course of action of Humalog may vary considerably in different individuals or within the same individual. Patients must be educated to use proper injection techniques. Humalog in a vial may be diluted with STERILE DILUENT for Humalog, Humulin N, Humulin R, Humulin 70/30, and Humulin® R U-500 to a concentration of 1:10 (equivalent to U-10) or 1:2 (equivalent to U-50). Diluted Humalog may remain in patient use for 28 days when stored at 5°C (41°F) and for 14 days when stored at 30°C (86°F). Do not dilute Humalog contained in a cartridge or Humalog used in an external insulin pump. Parenteral drug products should be inspected visually before use whenever the solution and the container permit. If the solution is cloudy, contains particulate matter, is thickened, or is discolored, the contents must not be injected. Humalog should not be used after its expiration date. The cartridge containing Humalog is not designed to allow any other insulin to be mixed in the cartridge or for the cartridge to be refilled with insulin. External Insulin Pumps—Humalog was tested in MiniMed®1 Models 506, 507, and 508 insulin pumps using MiniMed®1 Polyfin®1 infusion sets. Humalog was also tested in the Disetronic ®2 H-TRONplus ® V100 insulin pump (with plastic 3.15 mL insulin reservoir) and the Disetronic D-TRON ®2,3 and D-TRONplus ®2,3 pumps (with Humalog 3 mL cartridges) using Disetronic Rapid®2 infusion sets. Humalog should not be diluted or mixed with any other insulin when used in an external insulin pump. HOW SUPPLIED: Humalog (insulin lispro injection, USP [rDNA origin]) is available in the following package sizes (with each presentation containing 100 units insulin lispro per mL [U-100]): 10 mL vials NDC 0002-7510-01 (VL-7510) 3 mL vials NDC 0002-7510-17 (VL-7533) NDC 0002-7516-59 (VL-7516) 5 x 3 mL cartridges 3 5 x 3 mL prefilled insulin delivery devices (Pen) NDC 0002-8725-59 (HP-8725) 5 x 3 mL prefilled insulin delivery devices (Humalog® KwikPen™ ) NDC 0002-8799-59 (HP-8799)

1 2 3

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

ical care patients will require VTE prophylaxis, but while the ACCP provides recommendations on the appropriate type, dose and duration of VTE prophylaxis, the frequency of hospital compliance with these guidelines in critical care patients [had been] unknown.” Dr. Dobesh and his colleagues reviewed discharge and billing records for 22,801 critical care patients admitted to 16 acute care hospitals from January 2005 to December 2006. “We were hoping to get a nationwide perspective but as it turned out, all of our hospitals were from the Midwest and the Southwest,” he told Pharmacy Practice News. All patients were at least 18 years of age, had inpatient stays of at least two days’ duration and no contraindication to VTE prophylaxis. The patients had multiple risk factors for VTE, with the most common being surgery (47.5%), followed by heart or respiratory failure (45.3%), acute medical illness (36%) and a central venous catheter (11.9%). The investigators identified the recommended type (mechanical or pharmacologic), dose and duration of VTE prophylaxis according to the ACCP guidelines and compared this with the regimen that was actually received in VTE START. They found that 73.5% of the patients received some type of VTE prophylaxis, but only 12.5% received the appropriate prophylaxis in terms of type, dose and duration. The most common reason for inappropriate prophylaxis was incorrect type selected, in 34.2% of critical care patients. The next most common reason was inappropriate dose, in 12.8% of patients, followed by inappropriate duration in 3.8%. Additionally, 10.2% of patients were found to have had both inappropriate dosing and duration.

Glass Half Full Storage —Unopened Humalog should be stored in a refrigerator (2° to 8°C [36° to 46°F]), but not in the freezer. Do not use Humalog if it has been frozen. Unrefrigerated (below 30°C [86°F]) 12 vials, cartridges, Pens, and KwikPens must be used within 28 days or be discarded, even if they still contain Humalog. Protect from direct heat and light. Use in an External Insulin Pump—A Humalog 3mL cartridge used in the D-TRON®2,3 or D-TRONplus®2,3 should be discarded after 7 days, even if it still contains Humalog. Infusion sets, D-TRON ®2,3 and D-TRONplus ®2,3 cartridge adapters, and Humalog in the external insulin pump reservoir should be discarded every 48 hours or less. Literature revised December 7, 2009 KwikPens manufactured by Eli Lilly and Company, Indianapolis, IN 46285, USA. Pens manufactured by Eli Lilly and Company, Indianapolis, IN 46285, USA or Lilly France, F-67640 Fegersheim, France. Vials manufactured by Eli Lilly and Company, Indianapolis, IN 46285, USA or Hospira, Inc., Lake Forest, IL 60045, USA or Lilly France, F-67640 Fegersheim, France. Cartridges manufactured by Lilly France, F-67640 Fegersheim, France for Eli Lilly and Company, Indianapolis, IN 46285, USA. www.humalog.com Copyright © 1996, 2008, Eli Lilly and Company. All rights reserved.

The fact that such a small percentage of critical care patients actually received the right VTE prophylaxis according to ACCP recommendations does not particularly disappoint Dr. Dobesh. Looking at the results from a “glass half full” perspective, he said that his study shows that most critical

Clinical 19

Pharmacy Practice News • February 2011

Critical Care assessment and prevention to address many of the deficiencies identified in the VTE START study.” There also are policy implications of not providing adequate VTE prophylaxis. “From a regulatory perspective, the testing of performance measures is going into place this year,” Dr. Kiser added. “The performance measures will follow the National Quality Forum documents for VTE prophylaxis. In a few years, the best performers will be given the best [reimbursement], so there will also be financial incentives for institutions to improve VTE risk

care patients are indeed getting some kind of prophylaxis. “What I take away from these results is that 74% of critical care patients are being given some kind of VTE prophylaxis, so clinicians taking care of them know that such prophylaxis is necessary,” he said. Thus, “people out there are realizing the need for prophylaxis and perhaps that hurdle of getting that fact recognized is almost over. “Of course there is still one-fourth of individuals who did not get anything and so we have to keep on reaching out to educate their caregivers. But for the most part, patients are getting treated. Now we just have to make sure we do it right.” This study highlights some important issues, said Ty H. Kiser, PharmD, BCPS, assistant professor, Department of Clinical Pharmacy, University of Colorado, Aurora. “Looking at the study results, it is clear that we have significant room for improvement in both appropriate assessments of VTE risk and appropriate VTE prevention,” he told Pharmacy Practice News. “For ICU patients, a challenge is to get prophylaxis initiated, and to do so when it is feasible and safe for the patient. A question is, can we develop a strategy to assess risk not only on admission but also at transfer out of the ICU if prophylaxis was not warranted or feasible while the patient is critically ill? This has significant implications for health systems.” A plan must be established to continually assess and provide appropriate VTE prophylaxis for each individual patient, Dr. Kiser stressed. “A global approach using a three-tier risk assessment score, or an opt-out approach, is what most institutions are using, but this provides only a starting point in the process. ICU health care practitioners see significant heterogeneity in our patient population, so therefore we have to develop strategies for individual, patient-centered VTE risk

assessment and prevention.” Pamela L. Smithburger, PharmD, BCPS, assistant professor of pharmacy and therapeutics at the University of Pittsburgh School of Pharmacy, weighed in, calling the study “welldesigned” and on an important topic. “The results reconfirm the importance of vigilance in monitoring and reviewing patients’ VTE prophylaxis on a daily basis for appropriate choice, dose and duration of prophylaxis.” The study was sponsored by Sanofiaventis. —Fran Lowry

20 Clinical

Pharmacy Practice News • February 2011

Practice Pearls Table. Potentially Significant TKI Interactions

TKI INTERACTION

Type of Interaction

Drugs Involved

Inhibitors of CYP3A4 can lead to increased dasatinib, imatinib and nilotinib exposure

Ketoconazole, levothyroxine, voriconazole, amiodarone

Inhibitors of CYP3A4 and Pgp can increase plasma and intracellular imatinib (and likely dasatinib) concentrations

Verapamil, erythromycin/clarithromycin, cyclosporine, fluconazole/ketoconazole, pantoprazole

Inducers of CYP3A4 can decrease dasatinib, imatinib and nilotinib exposure

Rifampin, phenytoin, St. John’s wort

continued from page 1

presentation during the clinical pearls session. Kamakshi Rao, PharmD, reviewed the TKIs dasatinib (Sprycel, Bristol-Myers Squibb), imatinib (Gleevec, Novartis) and nilotinib (Tasigna, Novartis)—the mainstay of treatment for chronic myelogenous leukemia—and reported that minor pharmacokinetic differences between these agents “can really change their drug interaction potential.” Dr. Rao, clinical pharmacy specialist

Haouala A, Widmer N, Duchosal MA, Montemurro M, Buclin T, Decosterd LA. Drug interactions with the tyrosine kinase inhibitors imatinib, dasatinib, and nilotinib. Blood. 2010. [Epub ahead of print]. doi:10.1182/blood-2010-07-294330.

in hematology oncology, at the University of North Carolina Hospitals and Clinics in Chapel Hill, noted that all

three agents “use the cytochrome P450 3A4 pathway as their major metabolic pathway, but imatinib also uses some

ancillary P450 isoenzymes as well.” She added, however, that there are differences between these agents with respect to their substrate, inducer and inhibitor potentials that influence how these drugs interact with other agents. All three of these TKIs have some important interactions that can lead to either underexposure or overexposure to the chemotherapeutic agent (Table). In addition to the interactions listed in the table, Dr. Rao discussed some specific clinical concerns. For example, in patients receiving calcium channel blockers coadministered with TKIs, the blood pressure–lowering effect of calcium channel blockers may be increased. “Blood pressures should be monitored carefully [and] changing blood pressure therapy may be necessary,” particularly with dasatinib (Sprycel, Otsuka), noted Dr. Rao. Statins also have been shown to interact with TKIs (Haouala et al. Blood 2010 [Epub ahead of print]; doi:10.1182/ blood-2010-07-294330). “When comparing statin therapy, pravastatin has the least interaction potential and should be considered over other statins,” she suggested. Another clinical consideration is that dasatinib and nilotinib have been associated with prolongation of the QTc interval (Haouala et al. Blood 2010 [Epub ahead of print]; doi:10.1182/blood2010-07-294330). Dr. Rao recommended “strict monitoring” and serial electrocardiograms in patients taking dasatinib or nilotinib who are also receiving digoxin, quinolones or other medications known to prolong the QTc interval. Drug interactions such as these are likely to increase, according to Dr. Rao, because oral drugs represent a tremendous growth area in oncology, with over one-fourth of oncology drugs in the pipeline being oral formulations. Additionally, patients receiving oral chemotherapy agents often are cared for in non-oncology areas, making it even more important for pharmacists to identify these potential interactions and educate nurses and others caring for these patients to be aware of them. “As the world of oncology continues to grow,” said Dr. Rao, “pharmacists are going to have to play key roles in identifying and managing potential drug interactions.”

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Pharmacy Practice News • February 2011

Practice Pearls Succinylcholine Should Stay the Primary Choice for Intubation Succinylcholine has advantages over newer agents, and despite its side effects should remain the drug of choice for rapid sequence intubation, according to Nicole Acquisto, PharmD, BCPS, emergency medicine clinical pharmacy specialist at the University of Rochester Medical Center in Rochester, NY. “Succinylcholine has generally been used first-line,” noted Dr. Acquisto during the emergency medicine pearls session at the ASHP meeting. “We like it because it has a quick onset of action (about 30 to 60 seconds) and a short duration of action (only about five to 10 minutes).” This compares favorably with onsets of one to three minutes and durations of 30 to 60 minutes for nondepolarizing agents such as rocuronium, vecuronium, atracurium and cisatracurium (Nimbex, Abbott). However, succinylcholine has side effects, including muscle fasciculations—which can lead to increased intracranial or intraocular pressure and post-paralysis pain. Other undesireable effects include hyperkalemia, bradycardia, myalgias and malignant hyperthermia. Dr. Acquisto presented data from two meta-analyses that compared succinylcholine with rocuronium. (Karcioglu O et al. Intl J Clin Pract 2006;60:16381646; Perry JJ et al. Cochrane Database Syst Rev. 2008;Apr 16[2]:CD002788). The Karcioglu review of 16 randomized controlled trials encompassing 1,362 patients found that compared with rocuronium, succinylcholine resulted in a 17% (95% confidence interval [CI], 13%-22%) higher frequency of excellent intubating conditions and a 5.1% (95% CI, –7.3% to –2.9%) lower frequency of unacceptable intubating conditions. Perry et al reviewed 37 studies encompassing 2,690 patients and also found that succinylcholine resulted in more frequent excellent intubating conditions compared with rocuronium (relative risk, 0.86; 95% CI, 0.8-0.92). Beyond these data indicating that succinylcholine results in superior intubating conditions, Dr. Acquisto mentioned several drawbacks of the nondepolarizing agents. She noted that with these longer-acting agents, clinicians are unable to re-examine the patient for 30 to 60 minutes unless a reversal agent is used. “In someone with a neurologic injury, this is definitely a problem.” Additionally, she said, when the longeracting agents are used, “if the attempt to esablish an airway is unsuccessful, you may have to support ventilation for up to 60 minutes, or longer depending

on the patient, the specific neuromuscular blocking agent used, and the dose administered.”

Automating INR Orders Improves Efficiency and Safety Pharmacists and information technology experts at a Delaware health system automated the ordering of baseline international normalized ratios (INRs) for patients prescribed warfarin within their health system, reducing errors, increasing efficiency and making it easier to meet national patient safety goals. In a presentation during the informatics pearls session, Dean A. Bennett, RPh, medication safety specialist at Christiana Care Health System in Newark, described how the health system’s existing manual INR ordering process (Figure 1) was prone to error, and caused delays and friction between pharmacists and nurses. Mr. Bennett said this manual approach was “highly

prone to a lot of problems,” with many of the steps contributing to delays. Even after a prescriber alert was set up on Christiana’s computerized prescriber order entry (CPOE) systems, pharmacists still were receiving 15% of warfarin orders without an accompanying INR result for the pharmacist to review before dispensing. To address these problems, Mr. Bennett and his colleagues applied clinical decision support (CDS) using the Cerner Discern Rules Engine. Now, when an order for warfarin is entered into the CPOE system, the system goes through a series of steps, explained Mr. Bennett. “Automatically, a custom code looks to see if there is an INR result and/or an INR order. If an INR result is not posted, it automatically suppresses dispensing, and if an INR has not been ordered, it orders one, and then it monitors to see when that INR returns,” he said. “When that INR returns, an INR result order is created in the system and routed to the pharmacist work order queue.” The CDS process map for the new

YES

system is shown in Figure 2. CDS was added for all the steps in the top tier, eliminating many of the manual steps for pharmacists, such as searching for the initial result and suppressing dispensing, Mr. Bennett said. Additionally, the new process frees up the nurses as well, he said. “The nurses are no longer stuck as a ‘middleman’ in the process.” By applying these CDS steps to the ordering process, Mr. Bennett said, “we’ve been able to … lean our process a little bit by removing a number of steps that are no longer necessary.” He noted that such “processes that are prone to human error and provide little or no value when performed manually may be ideal candidates for intelligent automation.” —Sarah Tilyou. Coming soon: Look for pearls on maintaining patency in peripheral catheters in pediatric patients, allopurinol for treating gout and angina, improving safe use of automated pumps, and more.

YES

Figure 1. The manual system.

The boxes outlined in red were prone to delays.

YES

Figure 2. The automated system.

The boxes outlined in yellow were processes that previously were performed by pharmacists but are now automated; the boxes in blue are the nurse-performed processes that are now automated.

INR, international normalized ratio

Flebogamma 10%DIF 速

Immune Globulin Intravenous (Human)

26 Operations & Management

Pharmacy Practice News • February 2011

Education

Empowering Students To Become Better Pharmacists Caitlin M. White PharmD Candidate 2011

Tuong K. Diep PharmD Candidate 2011

Lillian O. Kang, PharmD Assistant Professor of Pharmacy Practice Wegmans School of Pharmacy St. John Fisher College Rochester, New York

mpowerment is a word that does not often cross most pharmacy students’ minds, but it really should be part of their daily learning. By fostering students’ confidence in their understanding of concepts and their ability to fulfill the responsibilities of a pharmacist, pharmacy professors can empower their students. Empowerment also features a selfmotivation component. Pharmacy students are intrinsically motivated to become pharmacists when they enter pharmacy school. They have a desire to help patients and to learn how they can play a role in patients’ health. Professors can further empower their students by guiding them and cultivating these motivations. What is most important is for professors and students to realize that empowerment is not just a word; it represents actions that allow students to become emboldened to be better pharmacists.

Meaningful Assignments Pharmacy education starts out very structured. Learning a topic begins with preparatory work, often reading

clinical cases. A reading guide consisting of several questions focusing on the basic concepts within the reading can be a helpful learning tool. Answering these questions in the guide can prepare the students for the lecture and allow them to focus on the main points of the subject at hand so that the details can be filled in during the lecture. This may empower students to participate in discussions in class because they already have a basic understanding of the materials and can ask questions about parts that were not fully understood during the reading.

Learning Process Often, professors enter the classroom, open a PowerPoint file, and proceed with the lesson, moving from slide to slide without integrating preparatory assignments, to which students devoted their time. The information is simply “fed” to students, causing them to disengage and eventually memorize the information, often without comprehending the fundamental concepts. Grades play a major role in encouraging this memorization. Students cannot successfully complete any class without attaining a minimum grade. Grades serve as short-term motivators by inducing pressure to study. However, such an approach

Because grading is a necessary evil, improvement can be achieved by changing the process of teaching and incorporating interactive elements. assignments, designed to help students gain background knowledge prior to class sessions. It is important to ensure that these assignments are meaningful in building the student’s knowledge and enhancing his or her ability to apply that knowledge to clinical situations. Students require guidance, learning objectives, and prompting questions to understand new materials. Learning can be enhanced by requiring the students to perform several tasks—providing written responses to questions, discussing materials, and applying the subject matter to

to studying results only in shortterm memory gains, unless it is also applied to a practical situation. Concentrating on achieving a certain grade increases stress and hinders the learning experience. In our current system, it seems impossible to eliminate this form of evaluation because grading is the main standard applied in the field of pharmacy to license pharmacists and offers an easy way to assess students’ learning on an individual basis. Because grading is a necessary evil, improvement can be achieved by changing the process of teach-

ing and incorporating interactive elements. Interacting with fellow students and receiving feedback is part of learning through ‘doing,’ which supports the development of critical thinking skills. Peer learn-

ing is extremely valuable, especially because professors have difficulty connecting with all students in a lecture hall. Within groups, students can help build their knowledge because

•

see STUDENTS, page 36

Pharmacy Education: The Status Quo Has To Go Steven J. Martin, PharmD, BCPS, FCCP, FCCM Professor and Chair, Department of Pharmacy Practice College of Pharmacy, The University of Toledo, Toledo, Ohio

n their article, “Empowering Students To Become Better Pharmacists,” White et al. present concerns regarding contemporary pharmacist education with which most academic pharmacists would agree. Most instructors want to empower their students to take responsibility for their pharmacy education and to actively seek to become outstanding pharmacists, not just outstanding students. I also recognize the current emphasis on grades mentioned by White et al; grades themselves do seem to be the driving force in the educational process for many students. Additionally, the authors point out the legitimate need for meaningful assignments that integrate foundational material into the practice of pharmacy and its emphasis on patient care. They rightly suggest that a process of content dissemination disengaged from the actual practice component is unhelpful in the development of quality practitioners. However, academic pharmacy is a changing field, and there are many forces that impact these and other aspects of the educational process. None seems more challenging than the competing interests of producing more pharmacists, while reducing educational resources. The number of new schools of pharmacy has escalated over the past decade, and it seems that a new school begins the process of accreditation every few months. Each of these schools requires high-quality administrators, professors and instructors, experiential sites and preceptors, and an adequate infrastructure to succeed in educating competent pharmacists. Beyond the growth of new schools, existing schools have been in the expansion business, creating satellite campuses and growing enrollment such that class sizes of 100 or more are the norm. One must ask, do we have enough well-qualified administrators, professors, instructors, experiential sites, and preceptors to accomplish this massive expansion of academic pharmacy? Do we have a process in the profession to train pharmacists to be educators? Do we have the right number of educators to train the vast number of pharmacy students currently in school? With the requirement to prepare students at the doctoral level, has there also been a requirement to expand the instructional infrastructure to meet not only the output requirements but also the quality requirements for well-prepared practitioners? I think not. I think we have a woefully inadequate infrastructure for the approximately 40,000 current pharmacy students. Doctoral-level education is difficult when class sizes exceed 100 students. The interaction between professor and students is largely one-way when the student-to-faculty ratio in the classroom is greater than 100 to 1. Professors have a difficult time getting to know each student in their classroom, when they may teach one or more courses to each class year in the program (ie, P1s, P2s, P3s). This inadequacy of instructional infrastructure also is evident in experiential education. Most schools are struggling to place students in any experiential sites, let alone ones that have been trained, tested, and proven to deliver highquality experiences. Preceptors at these experiential sites commonly know little about the school’s curriculum, the pedagogy of the program, or the competencies required by the accrediting body. Students recognize this problem, and this would be an ideal opportunity for them to take responsibility for their own education, through the empowerment suggested by White et al. However, this is not the type of learners our American education system has created. Instead, we have created very bright and very capable learners who follow rules, follow direction, and in general, follow. I have no succinct, magical formula for improving this condition. I believe we must either reduce the number of pharmacists being produced or expand the resources available to produce them. Neither option is likely to get much traction in today’s economic times. The profession will continue to move forward; our current process is not broken but rather, worn and weathered. The determination, dedication, and passion of the members of the academic pharmacy community will continue to make possible the impossible. However, unlike the authors, I believe there is no option but to reform the educational process for pharmacists. The status quo simply cannot be maintained.

A Sight for Sore Eyes

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FOR MORE INFORMATION, CALL 1-866-625-1618 OR VISIT www.SagentPharma.com. HEPARIN Sodium Injection, USP with PreventIV Measures Packaging and Labeling SM

28 Clinical

Pharmacy Practice News â&#x20AC;˘ February 2011

Educational Review

Delineating Potential Roles for Pharmacists in the

Management of Acute Coronary Syndromes

ROBERT LEE PAGE II, PHARMD, MSPH, FCCP, FASHP, FAHA, FASCP, BCPS, CGP Associate Professor Clinical Pharmacy and Physical Medicine Clinical Specialist, Division of Cardiology University of Colorado Schools of Pharmacy and Medicine Aurora, Colorado

cute coronary syndrome (ACS) is an umbrella term that includes unstable angina (UA) and acute myocardial infarction (AMI), both ST segment elevation myocardial infarction (STEMI) and non-ST segment

Scan for PDF of this review. Instructions, p. 4

elevation myocardial infarction (NSTEMI).1,2 ACS originates from the erosion or rupture of an unstable plaque within the coronary artery, which sets off a cascade resulting in the formation of an occlusive or nonocclusive thrombus.3

Despite advances in medical interventions such as percutaneous intervention (PCI) and pharmacotherapy, cardiovascular disease still results in significant morbidity and mortality in the United States. According to the American Heart Association (AHA), ACS accounts for more than 733,000 hospital discharges (approximately 80% of these cases are either UA or NSTEMI, and about 20% are STEMI).4 One-third of patients with STEMI die within 24 hours of onset of ischemia, and 15% of those with UA/NSTEMI either die or experience a reinfarction within 30 days of hospitalization.5 Financially, ACS is exorbitantly expensive, costing Americans more than $150 billion annually.5 Based on the findings from a multiemployer

claims analysis for the time period 2001 to 2002, the mean length of hospitalization for a patient with ACS was 4.6 days, with a cost of approximately $23,000 per capita.6 The analysis also showed that nearly 20% of patients with ACS are rehospitalized within 1 year and approximately 60% of the costs related to ACS are due to rehospitalization. Although these statistics appear dismal, mortality from ACS appears to be decreasing, which can be attributed in part to application of evidenced based pharmacotherapies.7,8 Based on data from the CRUSADE National Quality Improvement Initiative, which tracks guideline adherence, facilitates process improvement, and improves health outcomes for

patients with ACS, adherence to evidenced based guidelines remains imperfect, and significant variation in quality of care exists among hospitals nationwide.9 From the standpoint of pharmacotherapy, the CRUSADE data suggest that care gaps exist for all major treatments but are most notable for use of glycoprotein (GP) IIB/IIIA inhibitors, clopidogrel, and lipid-lowering therapy. For every 10% increase in the overall composite guideline adherence at a hospital, there exists a 10% reduction in the overall risk for death at that hospital (adjusted odds ratio [OR], 0.90; 95% confidence interval (CI), 0.84-0.97; P<0.001).10 Data from the GRACE (Global Registry of Acute Coronary Events) study also

Clinical 29

Pharmacy Practice News • February 2011

Educational Review demonstrate that increased use of guideline-recommended pharmacotherapies in patients with ACS is associated with fewer adverse cardiac events and deaths.11 With this in mind, pharmacists within inpatient settings are uniquely positioned to impact the care of patients with ACS. With access to a patient’s complete medical record and medication regimen, pharmacists can recommend pharmacotherapies based on risk stratification, evaluate and document whether a patient has received guideline-based pharmacotherapies, and provide patientspecific discharge counseling.

Table 1. Risk Evaluation Using the TIMI Risk Score TIMI Risk Scorea NSTEMI Risk Factor Age ≥65 y

≥3 risk factors for CAD

Prior history of CADc

Aspirin use in past 7 d

≥2 anginal events in past 24 h

ST-segment deviation ≥0.5 mm

Elevation of cardiac markersd

TIMI Risk Score: Using Risk To Your Advantage Immediately on admission, patients with ACS should be evaluated and stratified with respect to risk for death and reinfarction, based on presenting signs and symptoms, past medical history, and echocardiogram (ECG) and cardiac biomarker changes. The first risk stratification method, introduced by Killip et al in 1967, was found to be a useful, convenient tool for early risk stratification for patients with STEMI.12 Higher Killip class was found to be associated with increased in-hospital and 1-year mortality (Table 1). Since that time, many risk stratification tools have been developed and validated, such as the Platelet glycoprotein IIb/ IIIa in Unstable angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) risk score and the GRACE risk score.13 However, the most commonly used method for risk stratification has been the Thrombolysis in Myocardial Infarction (TIMI) risk score, which was introduced in 2000 and can be used to stratify risk in patients with either STEMI or UA/ NSTEMI.14,15 The TIMI risk score is a means of integrating all of a patient’s clinical factors and markers into a comprehensive risk stratification tool. Table 1 summarizes the TIMI risk score,16 and electronic versions for STEMI and UA/NSTEMI also are available at http://www.mdcalc.com/ timi-risk-score-for-uanstemi and http://www.mdcalc.com/timi-riskscore-for-stemi. For patients with STEMI, the higher the risk score, the greater the 30-day mortality rate. For UA/NSTEMI, TIMI scores of 5 to 7, 3 to 4, and 0 to 2 reflect a high, medium, and low risk for death, MI, or need for urgent coronary artery revascularization, respectively. A low-risk patient with negative cardiac biomarkers may undergo a noninvasive stress test or be discharged from the emergency department (ED) with further diagnostic

No. of Points

Case Study: Applying TIMI Scores

STEMI Risk Factor

No. of Points

Age 65–74 y

Age ≥75 y

SBP <100 mm Hg

Heart rate >100 beats/min

Killip class II–IV (see box)

Weight <67 kg

History of HTN, diabetes, or angina

Time to reperfusion therapy >4 h

Anterior ST segment elevation or left bundle branch block

Killip Class

In-hospital and 1-y Mortality, %

Class

Symptoms

No heart failure

Mild heart failure, rales, S3, congestion on chest radiograph

III

Pulmonary edema

Cardiogenic shock

TIMI risk score data from references 14 and 15. A risk score is calculated by adding the total number of risk factors. Total points for STEMI are 0 to 14, in which risk scores of 0, 2, 4, 6, 7, and >8 correspond to a 30-day mortality rate of 0.8%, 2.2%, 7.3%, 16%, 23%, and 36%, respectively. Total points for NSTEMI are 0 to 7, in which scores of 0 or 1, 3, 5, and 7 correspond to a 3%, 5%, 12%, and 19% risk for death or repeat MI at 14 days, respectively.

Risk factors include smoking, diabetes, HTN, family history of CAD, and hypercholesterolemia.

Defined as a prior coronary stenosis ≥50%; history of previous MI, PCI, or CABG; or chronic stable angina pectoris associated with a positive exercise tolerance test or pharmacologically induced nuclear imaging or echocardiographic changes (positive nuclear imaging or echocardiographic changes required if female).

Either troponin I or T or CK-MB.

Killip class data from reference 12.

CABG, coronary artery bypass graft; CAD, coronary artery disease; CK-MB, creatine kinasemyocardial band; HTN, hypertension; MI, myocardial infarction; NSTEMI, non–ST segment elevation myocardial infarction; PCI, percutaneous coronary intervention; SBP, systolic blood pressure; STEMI, ST-segment elevation myocardial infarction; TIMI, thrombolysis in myocardial infarction Modified from reference 16.

testing scheduled for the near future. Moderate- to high-risk patients often are admitted to a coronary intensive care unit or cardiac step-down floor. Patients at high or moderate risk who have positive cardiac biomarkers should receive early coronary angiography within 12 to 24 hours of admission and possible revascularization if a coronary artery thrombosis or stenosis is detected. Moderate-risk patients with negative biomarkers may receive angiography with revascularization or undergo a noninvasive stress evaluation.

For example, suppose a 67-yearold man presented to the ED with chest tightness and shortness of breath. He gave a history of similar symptoms that lasted 20 minutes the prior day. He was given aspirin, intranasal oxygen, atorvastatin (Lipitor, Pfizer), metoprolol, and IV nitroglycerin; at that time, his blood pressure was 100/60 mm Hg, and his heart rate was 88 beats/minute. His ECG continued to show ST segment depression in the anterior leads and he had negative cardiac biomarkers. His past medical history was significant for coronary artery disease (CAD), hyperlipidemia, diabetes, and hypertension, and he smoked one pack of cigarettes daily. Based on his presentation, this patient was diagnosed with UA. Using the TIMI Risk Score for UA/NSTEMI, he had a risk score of 5 based on his age (1 point); at least 3 risk factors for CAD (1 point), prior CAD history (1 point), and ST segment deviation (1 point). Based on this TIMI risk score, this patient was at high risk for death and AMI, and had a high need for urgent coronary artery revascularization. Additionally, this patient would have received an invasive rather than a conservative approach to management, meaning that he would have proceeded directly to angiography and PCI. Particularly for patients with UA/NSTEMI, the TIMI risk score can help direct treatment. For example, the 2007 American College of Cardiology (ACC)/AHA guidelines recommend beginning anticoagulant therapy for all patients (without contraindications) as soon as possible after presentation.17 The guidelines recommend 4 options: unfractionated heparin (UFH), enoxaparin, fondaparinux (Arixtra, GlaxoSmithKline), and bivalirudin (Angiomax, The Medicines Co; approved only for patients managed according to an invasive strategy such as PCI). In the TIMI-11B trial, compared with UFH (70 U/kg bolus, followed by 15 continued on following page

30 Clinical

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Educational Review continued from previous page

U/kg per hour for 3-8 days), enoxaparin (30 mg IV bolus followed by 1 mg/kg subcutaneously twice daily for 8 days) reduced the composite end point of death, MI, or need for urgent revascularization at 8 days (P=0.048)

and 43 days (P=0.048).18 Based on subanalyses of this study, the benefit of enoxaparin appears to be greatest for high-risk subgroups, such as those with ST segment deviation, elevated troponins, and a high TIMI risk score (eg, ≥5).14,18,19

In patients with UA/NSTEMI, several large trials have demonstrated that the GP IIB/IIIA inhibitors are of benefit for patients considered high risk, those undergoing PCI, or both.20,21 Patients who obtain the greatest advantage from these agents are

those who have elevated troponins, diabetes, ST segment changes, recurrent angina, or a TIMI risk score of 4 or higher at presentation.22-26 The 2007 ACC/AHA guidelines recommend that for patients with UA/NSTEMI who will be treated with an invasive

Table 2. 2008 ACC/AHA ACS Performance Measures Quality Performance Measure

Measure Description

Aspirin at arrival

AMI patients who receive aspirin within 24 h before or after hospital arrival.

Aspirin prescribed at discharge

AMI patients who are prescribed aspirin at hospital discharge.

Statin at discharge

AMI patients who are prescribed a statin at hospital discharge.

β-blocker prescribed at discharge

AMI patients who are prescribed a β-blocker at hospital discharge without contraindications.

Evaluate left ventricular systolic functiona

AMI patients with documentation that LVSF was evaluated during hospitalization or is planned after discharge.

ACE inhibitor or ARB for LVSD

AMI patients with LVSD, defined as an ejection fraction of 40% or less, who are prescribed an ACE inhibitor or ARB at hospital discharge.

Time to fibrinolytic therapy

AMI patients with STEMI or LBBB on the ECG should receive fibrinolytic therapy within 30 min of arrival at the hospital.

Time to PCI

AMI patients with STEMI or LBBB on the ECG should receive primary PCI within 90 min of arrival at the hospital.

Reperfusion therapy

AMI patients with STEMI or LBBB on ECG performed closest to arrival receiving either fibrinolysis or primary PCI or who are transferred to another facility for primary PCI.

Time from ED arrival at STEMI referral facility to ED discharge from STEMI referral facility in patients transferred for primary PCIa

In centers where PCI is not available on-site, patients may be transferred to another facility for treatment. Because delayed PCI may not be as beneficial as timely fibrinolysis, opting for transfer for PCI rather than fibrinolysis requires that transfer be performed in a timely manner.

Time from ED arrival at STEMI referral facility to primary PCI at STEMI receiving facility among transferred patientsa

Smoking cessation advice/counseling

AMI patients with a history of smoking cigarettes who are given smoking cessation advice or counseling during the hospital stay.

Cardiac rehabilitation patient referral from an inpatient setting

All patients hospitalized with a primary diagnosis of AMI referred to an early outpatient cardiac rehabilitation program.

Test Measure

Measure Description

LDL cholesterol assessmenta

AMI patients with documentation of LDL cholesterol concentration in the hospital record or documentation that the LDL cholesterol testing was conducted during the hospitalization or is planned after discharge.

Excessive initial heparin dosea

AMI patients who receive excessive dosing of UFH initially.

Excessive initial LMWH dose

AMI patients who receive excessive subcutaneous dosing of a LMWH initially.

Excessive initial GP IIB/IIIA dosea

AMI patients who receive excessive dosing of abciximab (ReoPro, Lilly), eptifibatide (Integrilin, Schering), or tirofiban (Aggrastat, Iroko) initially.

Clopidogrel prescribed at discharge for medically treated AMI patientsa

Medically treated AMI patients who are prescribed clopidogrel (Plavix, Bristol-Myers Squibb), prasugrel (Effient, Lilly), or ticlopidine at hospital discharge.

Presence of an anticoagulation dosing protocol for ACSa

Presence of a protocol or other clinical aid (eg, nomogram, electronic order entry) in the hospital record of AMI patients that addresses dosing of anticoagulant therapy and parenteral antiplatelet agents (ie, UFH, LMWH, GP IIB/IIIA inhibitors)

Presence of an anticoagulant medication error tracking systema

Evidence of a tracking system for identifying dosing errors in anticoagulation therapy in the hospital record of AMI patients.

ACC, American College of Cardiology; ACE, angiotensin-converting enzyme; ACS, acute coronary syndrome; AHA, American Heart Association; AMI, acute myocardial infarction; ARB, angiotensin receptor blocker; ECG, eclectrocardiogram; ED, emergency department; LBBB, left bundle branch block; LDL, low-density lipoprotein; LMWH, low-molecular-weight heparin; LVSD, left ventricular systolic dysfunction; NSTEMI, non-ST segment elevation myocardial infarction; PCI, percutaneous coronary intervention; STEMI, ST segment elevation myocardial infarction; UFH, unfractionated heparin a

New measure

Adapted from reference 29.

Clinical 31

Pharmacy Practice News • February 2011

Educational Review initial strategy, either a GP IIB/IIIA inhibitor—abciximab (ReoPro, Lilly), eptifibatide (Integrilin, Schering), or tirofiban (Aggrastat, Iroko)—or clopidogrel (Plavix, Bristol-Myers Squibb) should be added to aspirin and anticoagulant therapy before diagnostic angiography is performed. The guidelines also state that considering use of both a GP IIB/IIIA inhibitor and clopidogrel is reasonable. Based on our patient case and his TIMI risk score, this patient would be a candidate for enoxaparin and a GP IIB/IIIA inhibitor, as long as he does not have contraindications to either therapy.

and angiotensin-converting enzyme inhibitor therapy, as well as smoking cessation programs.29 For a hospital to receive credit for meeting these performance measures, it must document each measure as being met or document why the measure was not met in the patient’s chart. Inpatient pharmacists can play a critical role in quality improvement within their health systems by participating on protocol/guideline writing committees, anticoagulation subcommittees, and medication safety committees; assisting with design of

computer order-entry sets; and facilitating and documenting implementation of these performance measures.

Providing Counseling: Targeting the ‘Smoking’ Gun It is not surprising that smoking is associated with at least a 1.5- to 3-fold increased relative risk for MI due to its effects on coronary perfusion, myocardial oxygen demand, and thrombosis.30-33 Recent data have suggested that smoking cessation after an AMI may be associated with as much as a 50% reduction in mortality after 1

to 3 years.33-35 Mortality reduction is apparent within a few months and diminishes with time, with the risk for reinfarction approaching that of nonsmokers by 3 years of cessation.31 As mentioned above, smoking cessation has been identified as an important performance measure for ACS, and the US Public Health Service guidelines highlight the importance of initiating smoking cessation treatments in hospitalized patients. However, many patients do not receive optimal smoking cessation counseling continued on following page

Performance Measures: Applying and Documenting Evidence-based Guidelines Since around 2000, there has been an enhanced acknowledgment that implementation of the ACC/AHA guideline recommendations for ACS can result in lower patient morbidity and mortality. These cardiovascular metrics, also referred to as quality core measures, evaluate the quality of care provided to patients with ACS and focus only on the strongest recommendations from the ACC/AHA guidelines. Performance measures are a subset of these core measures and are intended to be publicly reported to allow consumers to make more informed choices, are compared between institutions, and are used by third-party payers in pay-for-performance considerations.27 For example, Medicare uses these performance measures when comparing hospitals. 28 Test measures, also known as candidate measures, are quality Scan for measures that do performance not meet the crimeasures; teria for a perforinstructions, page 4. mance measure but can be used by hospitals for quality improvement programs. As seen in Table 2, the STEMI and UA/NSTEMI performance measures were revised by the ACC/AHA in 2008.27 These are endorsed by multiple organizations such as the Leapfrog Group, the National Quality Forum, the Joint Commission, the Agency for Healthcare Research and Quality (AHRQ), and the American Public Health Association to ensure effective, timely, safe, efficient, and patient-centered medical care. The majority of these performance measures revolve around providing appropriate drug therapy, such as antiplatelet, β-blocker, statin,

*Betamethasone 6 mg/mL as 3 mg/mL Betamethasone Sodium Phosphate and 3 mg/mL Betamethasone Acetate† Celestone® and Soluspan® are registered trademarks of Schering Corp. The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.

Important Safety Information: As with any potent corticosteroid, adverse events have been associated with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, including fluid and electrolyte disturbances, as well as adverse reactions involving the following systems: allergic reactions, cardiovascular, dermatologic, endocrine, gastrointestinal, metabolic, musculoskeletal, neurological/psychiatric, and ophthalmic. Corticosteroids may also affect immune response. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy. Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP should not be administered intravenously or used in systemic fungal infections. Vaccination administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids and to seek medical advice at once should they develop fever or other signs of infections. Persons who are on corticosteroids should be warned to avoid exposure to chicken pox or measles and to seek medical advice without delay if exposed. Please see next page for brief summary of full prescribing information

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32 Clinical

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while they are in the hospital, which results in a missed opportunity for an intervention.36 In many hospitals, nurses or respiratory therapists may provide smoking counseling; however, pharmacists are well trained to provide this type of counseling. Beginning on the day of admission, inpatient pharmacists can obtain from the patient a complete history of tobacco use; discuss reasons/motivation to quit; elucidate triggers for tobacco use; highlight concerns about

when it comes to the management of patients with ACS. Through their involvement with risk stratification and pharmacotherapy implementation, evaluation and Scan for AHRQ documentation of persmoking formance core measures, resource; and provision of cominstructions, page 4. prehensive smoking cesConclusion: Taking sation counseling at the bedside, It to the Next Level pharmacists can expand their curWithin inpatient health systems, rent roles and help improve the pharmacists are the unsung heroes care of patients with ACS. weight gain, withdrawal and relapse; set a quit date; refer patients for counseling support; and provide pharmacologic assistance. The AHRQ publishes an excellent resource for clinicians involved with smoking cessation at all levels of the care continuum.37

References 1.

Kushner FG, Hand M, Smith SC Jr, et al. 2009 focused updates: ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and ACC/AHA/SCAI guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2009;54(23):2205-2241.

2. Antman EM, Hand M, Armstrong PW, et al. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2008;51(2):210-247. 3. Antman EM, Anbe DT, Armstrong PW, et al. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction--executive summary. A report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2004;44(3):671-719. 4. American Heart Association. Heart Disease and Stroke Statistics At A Glance 2010. http://www. americanheart.org/downloadable/ heart/1265665152970DS-3241%20 HeartStrokeUpdate_2010.pdf. Accessed December 15, 2010. 5. Kolansky DM. Acute coronary syndromes: morbidity, mortality, and pharmacoeconomic burden. Am J Manag Care. 2009;15(2 suppl):S36-S41. 6. Menzin J, Wygant G, Hauch O, et al. Oneyear costs of ischemic heart disease among patients with acute coronary syndromes: findings from a multi-employer claims database. Curr Med Res Opin. 2008;24(2):461-468. 7. Krumholz HM, Wang Y, Chen J, et al. Reduction in acute myocardial infarction mortality in the United States: riskstandardized mortality rates from 19952006. JAMA. 2009;302(7):767-773. 8. Yeh RW, Sidney S, Chandra M, et al. Population trends in the incidence and outcomes of acute myocardial infarction. N Engl J Med. 2010;362(23):2155-2165. 9. Peterson ED, Bynum DZ, Roe MT. Lessons learned from the CRUSADE National Quality Improvement Initiative. Curr Cardiol Rep. 2008;10(4):285-290. 10. Peterson ED, Roe MT, Mulgund J, et al. Association between hospital process performance and outcomes among patients with acute coronary syndromes. JAMA. 2006;295(16):1912-1920. 11. Fox KA, Steg PG, Eagle KA, et al. Decline in rates of death and heart failure in acute coronary syndromes, 1999-2006. JAMA. 2007;297(17):1892-1900. 12. Killip T 3rd, Kimball JT. Treatment of myocardial infarction in a coronary care unit. A two year experience with 250 patients. Am J Cardiol. 1967;20(4):457-464. 13. Yan AT, Yan RT, Tan M, et al. Risk scores for risk stratification in acute coronary syndromes: useful but simpler is not necessarily better. Eur Heart J. 2007;28(9):1072-1078. 14. Antman EM, Cohen M, Bernink PJ, et al. The TIMI risk score for unstable angina/non-ST elevation MI: A method for prognostication and therapeutic decision making. JAMA. 2000;284(7):835-842. 15. Morrow DA, Antman EM, Parsons L, et al. Application of the TIMI risk score for

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Educational Review ST-elevation MI in the National Registry of Myocardial Infarction 3. JAMA. 2001;286(11):1356-1359. 16. Page RL 2nd, Nappi JM. In: Koda-Kimble MA, Young LY, Aldredge BK, Corelli RL, Guglielmo BJ, Kradjan WA, Williams BR, eds. Applied Therapeutics-The Clinical Use of Drugs: Wolters Kluwer; 2009. 17. Anderson JL, Adams CD, Antman EM, et al. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-Elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2007;50(7):e1-e157. 18. Antman EM, McCabe CH, Gurfinkel EP, et al. Enoxaparin prevents death and cardiac ischemic events in unstable angina/non-Qwave myocardial infarction. Results of the thrombolysis in myocardial infarction (TIMI) 11B trial. Circulation. 1999;100(15):1593-1601. 19. Morrow DA, Antman EM, Tanasijevic M, et al. Cardiac troponin I for stratification of early outcomes and the efficacy of enoxaparin in unstable angina: a TIMI-11B substudy. J Am Coll Cardiol. 2000;36(6):1812-1817. 20. Boersma E, Harrington RA, Moliterno DJ, et al. Platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: a meta-analysis of all major randomised clinical trials. Lancet. 2002;359(9302):189-198. 21. Levine GN, Berger PB, Cohen DJ, et al. Newer pharmacotherapy in patients undergoing percutaneous coronary interventions: a guide for pharmacists and other health care professionals. Pharmacotherapy. 2006;26(11):1537-1556. 22. PRISM-PLUS Study Investigators. Inhibition of the platelet glycoprotein IIb/IIIa receptor with tirofiban in unstable angina and nonQ-wave myocardial infarction. Platelet Receptor Inhibition in Ischemic Syndrome Management in Patients Limited by Unstable Signs and Symptoms. N Engl J Med. 1998;338(21):1488-1497.

28. US Department of Health and Human Services. Hospital compare. http://www. hospitalcompare.hhs.gov. Accessed January 13, 2011. 29. Krumholz HM, Anderson JL, Bachelder BL, et al. ACC/AHA 2008 performance measures for adults with ST-elevation and non-ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. Circulation. 2008;118(24):2596-2648. 30. Ginn MB, Cox G, Heath J, et al. Evidencebased approach to an inpatient tobacco cessation protocol. AACN. 2008;19(3): 266-278. 31. Prescott E, Hippe M, Schnohr P, et al. Smoking and risk of myocardial infarction

in women and men: longitudinal population study. BMJ. 1998;316(7137):1043-1047.

left ventricular dysfunction. Am J Cardiol. 2010;106(7):911-916.

32. Van Spall HG, Chong A, Tu JV. Inpatient smoking-cessation counseling and allcause mortality in patients with acute myocardial infarction. Am Heart J. 2007;154(2):213-220.

35. Gerber Y, Rosen LJ, Goldbourt U, et al. Smoking status and long-term survival after first acute myocardial infarction: a population-based cohort study. J Am Coll Cardiol. 2009;54(25):2382-2387.

33. Wilson K, Gibson N, Willan A, Cook D. Effect of smoking cessation on mortality after myocardial infarction: meta-analysis of cohort studies. Arch Intern Med. 2000;160(7):939-944.

36. Thorndike AN, Rigotti NA, Stafford RS, Singer DE. National patterns in the treatment of smokers by physicians. JAMA. 1998;279(8):604-608. 37. Fiore MC, Jaen CR, Baker TB, et al. Treating tobacco dependence: 2008 update. In: AHCPR Supported Guide and Guidelines. Rockville, MD: Agency for Health Care Policy and Research. http://www.ncbi.nlm. nih.gov/books/NBK12193/.

34. Shah AM, Pfeffer MA, Hartley LH, et al. Risk of all-cause mortality, recurrent myocardial infarction, and heart failure hospitalization associated with smoking status following myocardial infarction with

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24. Heeschen C, Hamm CW, Goldmann B, et al. Troponin concentrations for stratification of patients with acute coronary syndromes in relation to therapeutic efficacy of tirofiban. PRISM Study Investigators. Platelet Receptor Inhibition in Ischemic Syndrome Management. Lancet. 1999;354(9192):1757-1762. 25. Morrow DA, Antman EM, Snapinn SM, et al. An integrated clinical approach to predicting the benefit of tirofiban in nonST elevation acute coronary syndromes. Application of the TIMI Risk Score for UA/NSTEMI in PRISM-PLUS. Eur Heart J. 2002;23(3):223-229. 26. Theroux P, Alexander J Jr, Pharand C, et al. Glycoprotein IIb/IIIa receptor blockade improves outcomes in diabetic patients presenting with unstable angina/ non-ST-elevation myocardial infarction: results from the Platelet Receptor Inhibition in Ischemic Syndrome Management in Patients Limited by Unstable Signs and Symptoms (PRISM-PLUS) study. Circulation. 2000;102(20):2466-2472. 27. Spinler SA. Evolution of Antithrombotic Therapy Used in Acute Coronary Syndromes. In: Dunsworth TS, Richardson MM, JWM C, eds. Pharmacotherapy SelfAssessment Program, Book 1. 7th ed. Lenexa, KS: American College of Clinical Pharmacy; 2010.

Proven technologies. Measurable results. That’s CareFusion. Hospital and health system pharmacists are being asked to become more efficient and increase accuracy while reducing drug budgets and waste. Many hospitals have purchased central pharmacy inventory management software to help achieve these results, freeing pharmacists to focus on clinical outcomes.1 By implementing central pharmacy inventory management software across your health system—from receipt to point of use—you will be enabled to reduce on-hand inventory, centralize distribution and package sharing, and reduce waste.

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1 Pericak C and Maher B Profiles of Multi-Site and Multi-Location Pharmacy Services at Hospitals. The Advisory Board Original Inquiry Brief, July 2010. © 2011 CareFusion Corporation or one of its subsidiaries. All rights reserved. Pyxis is a trademark or registered trademark of CareFusion Corporation or one of its subsidiaries. PHACTS is a trademark or registered trademark of PHACTS, LLC or one of its subsidiaries. DI2481 (0211)

34 Operations & Management

Pharmacy Practice News • February 2011

Leadership in Action

Accountability Leadership: A Deeper Look “People are always blaming their circumstances for what they are. I don’t believe in circumstances. The people who get on in this world are the people who get up and look for the circumstances they want, and if they can’t find them, they make them.” —George Bernard Shaw Last month in this column, we began to explore the principles introduced by the acronym “LEAD,” as used by author Gerry Kraines in his book, “Accountability Leadership” (Pompton Plains, NJ:

Career Press; 2001). This month, we go even more deeply into the meaning behind each term. everage. This concept acknowledges that moving up in an organization

requires a proportional increase in complexity. As you promote staffers to positions of greater responsibility, ask yourself if they have the mental capacity to fulfill their job requirements. As leaders, we are responsible for placing the right people in the right positions. It is critical to ascertain what Kraines calls the “force of logic” in your prospective employees. This “force” represents the ability of a prospective employee to apply logic to problems that need to be solved.

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

Ernest R. Anderson Jr., MS, RPh

There are multiple levels of logic. The first level is a volley of possible solutions. The next level of thinking is that of deduction, as in “if ‘a,’ then ‘b,’ if ‘b,’ then ‘c.’ ” The third level of logic is an even deeper level of if/then thinking. It requires going down a logical decision tree, based on each answer in a series. Pharmacists perform this kind of thinking in the clinical assessment of patients and drug interactions. The fourth level of the force of logic requires a parallel array of decision trees. In this level, a certain line of reasoning makes sense under a particular set of circumstances, while a different line of reasoning makes sense under a different set of circumstances. Determining the interrelationship between these multiple scenarios requires this fourth level of thinking. Kraines identifies four different orders of complexity in organizations that correspond to each level of logic. The lowest of these levels is charged with implementing clearly defined processes that are defined a level or two above them in the hierarchy. Above the processdefining level are strategic functions and asset-enhancing systems created within the context of the economy, politics, technology and society. According to the author, there must be a balance between creativity and accountability. Imbalance, he asserts, can create anarchy or autocracy. Managers who can think at least a level above themselves in the corporate hierarchy are necessary to achieve this balance. Leverage is about understanding and the managerial system of complexity and judgment, he writes. ngaging commitment. To engage the commitment of others, managers need to be dedicated listeners who show genuine interest in their staffs and who know how to deliver maximum benefit to the organization (patients) by leveraging their contributions. This leads to greater satisfaction of the employees, creating loyalty and commitment. “In solid psychological contracts, work provides people with meaning and purpose, the challenge and stimulation of purposeful activities, the support of others working on those activities, the potential of successes, and the reward of working well with others,” the author writes. As managers, we need to be aware of these implicit psychological contracts that exist and be cognizant of the employee’s expectations, which are often unspoken. Under no circumstances should an

Operations & Management 35

Pharmacy Practice News â&#x20AC;˘ February 2011

Leadership in Action employee commit to a target that he or she thinks is impossible to attain. People gain value through mature, constructive working relationships with others at work. As a manager, you can set a constructive context that does not tolerate or support pettiness. People also want recognition for their successes. As managers, we need to look for the opportunities to praise the successes of individuals and groups (and never take credit for the success of our groups). ligning judgment. Organizational alignment is imperative to optimize successful organizational performance. Employees must understand the context and translation of complexity in which we are asking them to apply their creative skills and abilities. If we expect our employees to use their judgment, we need to give them the context at our level and one level above us or we set them up to fail. When we ask for input from our employees, we get better solutions, broader involvement and commitment. eveloping capabilities. Our responsibility as managers and leaders is to develop the full poten-

tial that our employees may not even realize exists within them. Our role is to assess the leadership potential in othersâ&#x20AC;&#x201D;honestly recognizing their cognitive levels and corresponding ability to solve complex problems. We need to encourage creativity on â&#x20AC;&#x153;relative accountabilitiesâ&#x20AC;? while the individual delivers on their â&#x20AC;&#x153;fixed accountabilities.â&#x20AC;? We are responsible for assessment and for the coaching of those with potential to operate at higher levels. As we look at potential employees to coach, Kraines suggests we ask the following questions:

â&#x20AC;&#x2DC;Our responsibility as managers and leaders is to develop the full potential that our employees may not even realize exists within them.â&#x20AC;&#x2122; â&#x20AC;˘ Does the employee possess the raw ability to handle the complexity of their role? â&#x20AC;˘ Is the employee knowledgeable and

skilled to master the actual work of the role? â&#x20AC;˘ Does the employee value the work of the role to fully apply his or her capabilities to succeed in meeting the roleâ&#x20AC;&#x2122;s accountabilities? Do they have the desire? â&#x20AC;˘ Is the employee mature enough to handle the stresses, uncertainties, tough decisions and strained working relationships that are inevitable in any managerâ&#x20AC;&#x2122;s role? On a personal level, I find the coaching role and the subsequent development of the employee to be exhilarating.

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Reprints of Pharmacy Practice News articles are available in minimum quantities of 500. Reprints can be ordered in black & white or 4-color versions and printed on 80-lb. glossy stock. Standard turnaround time is 4 weeks.

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36 Operations & Management

Pharmacy Practice News • February 2011

Education

STUDENTS continued from page 26

they are given the opportunity to process what they have read, make sense of concepts, and discuss pertinent ideas. Furthermore, this method of learning provides another avenue to grade students besides quizzes and examinations. Grading can be based on these verbal and written assignments, diving into the depth of a patient case and patient-specific therapeutic choices, which parallels real-life decisions much better than multiple-choice or true/false questions. Although this may increase the workload and time that the faculty would be required to spend on the topic, this initial commitment may obviate the need for substantial reteaching during advanced pharmacy practice experiences (APPEs) because students might be able to recall more information.

Case-based Learning and the Real World Another growing area of pharmacy education programs is case-based learning, which involves a small group of students meeting about a patient case. The groups reach a conclusion concerning patient therapy after researching the patient’s disease state(s) and considering all therapeutic options. Having such diverse case-based learning, in which disease states are consistently incorporated in subsequent patient cases, can help develop students’ analytical skills and better prepare them for APPEs. Students should be allowed to make mistakes at this level so they can learn from them. Rather than

associating case-based learning with a single right answer, emphasis should be placed on multiple reasonable therapeutic options. Furthermore, students need to be provided with appropriate settings in which to present evidence-based recommendations to their peers. Requiring that students make a brief presentation after researching diseases and therapeutic options may be a beneficial way to enhance the process of acquiring and analyzing information. The more students can gain experience verbalizing their thoughts in a classroom setting, the easier the transition will be to the “real world” setting. Developing sufficient fundamental knowledge as well as the ability to apply it to patients with different clinical presentations will help students achieve their goal of appropriately tailoring medication therapies.

Student and Professor Relationships Student–professor relationships may start in the classroom, but should not end there. Instead, these bonds need to be enhanced outside of the classroom by periodic informal meetings at a convenient time for both the student and the professor. It may be most beneficial for a student to form a true mentorship with 1 or 2 professors. Close relationships with 1 to 2 professors permit ample time and occasion to connect professionally with one another. In the current system, students’ underlying motivations to become great pharmacists are put aside while the focus is shifted to ordinal grades. It is essential for professors to build these strong, nurturing rela-

tionships with their students to show them that the world of pharmacy is not simply based on grades. Professors should act as role models and lead by example, showing students how to appropriately engage in discussion with fellow health care providers. Professors can ensure that students stay on track with their initial goals as well as aid them in forming new professional goals. When students seek further opportunities, professors can serve as networking facilitators, bringing contacts to students to assist them on their professional journey to success. This is yet another way in which professors can gauge how well they have prepared the students for their future endeavors.

Conclusion Students have the fundamental knowledge, but need direction in applying the concepts effectively. Meaningful assignments can initiate the learning process of elemental

New Product

knowledge, which can be further molded during case-based learning. Through professors and peers, students can be empowered and motivated to meet these challenges. As patient care is shifting to a team-based approach, education needs to follow through the encouragement of students to advocate for their own learning in working with their peers in the construction of their knowledge. Students need to be shown how to become autonomous and embark on their own ways of becoming pharmacists. Education between professors and students is a two-way street, so let us hope that neither one passes by the other without taking a moment to learn from each other. Let us decide together if pharmacy education merits change or should maintain the status quo.

The authors have no conflicts of interest/ financial disclosures to report.

We Want Your Pearls

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Benadryl, hydrocortisone, nystatin, and tetracycline. The kits are made for one patient and include pre-weighed powders and a pre-measured suspension. With FIRST®—Mouthwash Kits, the pharmacist needs only to add the powders to the liquid suspension, shake, and then dispense to the patient. “By launching FIRST®—Duke’s and FIRST®—Mary’s, [clinicians] now have

four of the more commonly prescribed magic mouthwash prescriptions available in a kit,” said Dr. Indu Muni, founder, chairman and CEO of CutisPharma, Inc. “The company now offers an expanded line of Magic Mouthwash formulations for patients, physicians and pharmacists.” FIRST®—products save dispensing time and can be compounded by the pharmacist while the patient waits, increasing customer satisfaction. Using FIRST®—Mouthwash kits, the pharmacist can compound a prescription faster than those prepared in the conventional way. A single NDC number assigned for the entire kit facilitates the third-party reimbursement process and reduces audit-related adjustments. For more information, call James Nagle at 781-935-8141 x120.

Do you have an interesting practice pearl you’d like to share? If so, send it to ppneditor@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 • Offer insights that are not widely known, understood or published • Explain why the pearl should be implemented on a widespread basis • Not exceed 1,000 words

Readers whose Practice Pearls are accepted for publication will be paid a $100 honorarium.

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38 Technology

Pharmacy Practice News • February 2011

Automation

continued from page 1

ment Administration (DEA)report is filed for any discrepancies that remain unresolved for more than two weeks, according to Mitch G. Sobel, RPh, MAS, corporate director of pharmacy services at St. Joseph’s Healthcare System and the program’s creator. The aggressive policy paid dividends almost immediately: From the prelaunch period of January to April 2010, anesthesiologists accessing ADCs racked up an average of 45 unresolved controlled substances discrepancies per day. After issuance of the fine and DEA report plan, unresolved discrepancies dropped to an average of three per day—a 94% decrease (Figure), Mr. Sobel reported during a poster session at the Midyear Clinical Meeting of the American Society of Health-System Pharmacists (ASHP). What’s more, during the first two months of the program, no one was required to pay any fines or be reported for noncompliance. (If levied, the fines were to be paid to the St. Joseph’s Foundation as a charitable contribution.) One might think the punitive policy was triggered by a concern over drug diversion. “But that wasn’t really the case,” Mr. Sobel said. “The real driver here was patient safety.” Anesthesiologists, he explained, were often taking out multiple vials from ADC drawers, with the good intention of using only one and then returning the “justin-case” vials after the case was done. Thus, when the Pyxis machine prompted them to input the number of drug vials removed, they’d key in “1” and not “2.” “The problem is that the anesthesiologists often failed to return those vials,” Mr. Sobel said. “The vials ended up on top of the Pyxis cabinets, in clinicians’ pockets—in a lot of places that made oversight of their safe use impossible. It really put patients at risk.” In such cases, he added, operating room (OR) and Pyxis pharmacy technicians had to “clean up” after the anesthesiologists and record the medication discrepancy. Then the technicians had to try to get the clinicians to fill out an unresolved medication discrepancy report. “That’s not easy in our hospital,” Mr. Sobel said. “Most of our anesthesiologists are a contracted group. So they’d be here for a few days and then move on to another facility. That made it incredibly hard to track them down.”

Not the First Option Mr. Sobel stressed that the fines and DEA reports were not the first steps that the pharmacy department took to ensure proper use of ADCs. “We spent months and months educating anesthesiologists how to use the Pyxis machines correctly,” he said. “Our tech-

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fter this article went to press, it was determined that it misstated the policy for encouraging proper use of automated dispensing machines by anesthesiologists at St. Joseph’s Regional Medical Center. According to officials at St. Josephs, the policy was presented to hospital administrators but was neither implemented nor communicated to the department of anesthesiology.

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Figure. Average anesthesia ADC controlled substances discrepancies per day (2010). nicians instructed them repeatedly on this, stressing that, by law and hospital policy, you have to handle your controlled substances appropriately; that you must do the required reports to keep the medication counts accurate, so that you don’t stock out; and also so that you maintain the security and safety of these high-risk medications.” Mr. Sobel also reached out to hospital administration as well as the chair of the anesthesiology department to stress the importance—and benefits— of complying with the ADC rules. Those outreach efforts were done with an appreciation of the fact that the anesthesiologists had been using a manual process for recording medication use for years. “They were used to having an open-the-drawer, grab-whatyou-need, close-the-door approach, and then at the end of the case, they could easily reconcile whatever they used or didn’t use on a very familiar, paper-based system,” Mr. Sobel said. “But that’s just not how a Pyxis-based ADC system works: clinicians have to log in, log out and document in real time what they are doing. It’s an ondemand type of culture shift that we realized was very difficult.”

‘Enough Is Enough’ But how long was the pharmacy department willing to wait for the anesthesiologists to get on board with the new requirements of the electronic system— two months? Four months? After about five months, Mr. Sobel decided that “enough was enough; we really had to take a stand and say, ‘we’ve provided you with plenty of education and the opportunity to comply. We’ve talked individually and we’ve had repeated meetings, but it’s just not working.’” The real tipping point came when Mr. Sobel realized that the relationship between his pharmacy technicians and anesthesiologists “was turning into, if not an adversarial relationship, a very strained one,” he said. “I just could not let that continue.” That’s when Mr. Sobel approached administrators at the health system with his proposal to levy fines and issue DEA reports on noncompliant physicians. “I explained the legal and regulatory implications: that if this continued, the

pharmacist in charge was liable for DEA fines, as was the hospital and the anesthesiologists. But again, that was not my only—or even primary—message. What I really stressed was that we were not only protecting ourselves, we were also protecting our patients. Because if you don’t have drugs lying around unaccounted for, you don’t have discrepancies and your patient care will be that much better and safer.” Could a less confrontational solution have been attempted? “You have to realize that we took our time with this and exhausted a lot of other less draconian measures without success. If you keep blowing through stop signs and you get caught, you pay a fine. These anesthesiologists were going through stop signs and not taking the medication discrepancies seriously. So we really had no choice.” Plus, it’s hard to argue with the results, Mr. Sobel stressed. “Our goal was to get our medication resolutions down to three days and our discrepancies down to a manageable level. And that’s exactly where we ended up.” At times, the results were even more impressive. “I just checked with my staff, and for the last 48 hours, we had no unresolved medication discrepancies,” he said during the poster session. “That’s the third time we’ve gone two days without a discrepancy since I started this program. That, to me, is incredible, and underscores the fact that we struck just the right tone and intent with these interventions.”

Anesthesiologist Has Concerns Such a sentiment makes sense from pharmacy’s point of view. But what about anesthesiologists who could be on the receiving end of the monetary fines and DEA reports? Robert E. Johnstone, MD, vice president for professional affairs, American Society of Anesthesiologists, said he had some concerns about the punitive nature of the St. Joseph’s approach. “I’d like to have seen more systemsthinking here, where an attempt was made to implement positive rewards before fines and punishment,” Dr. Johnstone said. “This pharmacy [department] seems to want to maximize its service above all the other critical aspects of care delivery. What if the Blood Bank

fined clinicians for not completing transfusion slips, or the infectious disease service for inadequate hand-washing, or the medical records department for not complying with a billing rule? It just creates a negative place to work—one where the institution or patient may suffer.” Dr. Johnstone added that the professed goal of the St. Joseph’s initiative— to improve patient safety—implies that there is a lack of commitment to that goal among anesthesiologists. “I would submit that anesthesiologists are in fact focused on patients and their safety,” he said. “They direct perioperative care in hospitals and will help improve systems when constructively engaged.”

ASHP Section Facilitator’s Take Peggy Bickham, PharmD, networking facilitator for the OR/Anesthesiology Inpatient Care Practitioners Section of ASHP, said she understood such concerns. “I’m not sure how well this would go over at my hospital,” she said. “I might have difficulty getting buy-in for this.” But she acknowledged that improper ADC use by anesthesiologists and the medication discrepancies that it can cause is a common problem. In fact, it is one that came up repeatedly during the OR/Anesthesiology networking session at the recent Midyear Clinical Meeting. “Making the switch from manual to electronic drug stocking and tracking systems in the OR is no easy task, and several of our members expressed frustration with the process,” she said. As for how to best change the behavior of recidivist anesthesiologists, “At the end of the day, if your repeated attempts to educate and instill proper procedures fail, as they appear to have done at St. Joseph’s, I don’t think you have any other choice but to take a stronger approach.” Dr. Bickham said her only lingering concern would be the long-term effect that such an approach has had on the relationship between the hospital’s anesthesiology and pharmacy departments. “I understand that this was done, in part, to prevent that relationship from becoming adversarial,” she said. “But one could argue that levying monetary fines and issuing DEA reports is a curious method for accomplishing that goal.” Still, you can’t deny the outcome: A 94% drop in unresolved medication discrepancies “is very impressive,” Dr. Bickham said. “It’s something I’d certainly be proud of.” —David Bronstein

40 Technology

Pharmacy Practice News • February 2011

Automation

Omnicell’s Savvy Solution for Enhancing Drug Delivery A ‘Over the last 10 to 15 years, I have brought a lot of automation medication usually makes several stops after leaving the hospital pharmacist’s hands and before getting injected or swallowed—hopefully into, or by, the intended patient. The new Savvy Mobile Medication System from Omnicell, Inc., aims to streamline this drug delivery process and close off the last loophole through which medicine is often lost: the journey from the automated dispensing cabinet (ADC) to the patient. “We wanted to take the traditional mobile cart, which is basically just a computer on wheels, a step further,” said Len Hom, product marketing manager of Mobile Medication Solutions at Omnicell. “By integrating it within our product line, Savvy is able to share information that will ultimately benefit pharmacy from a workflow perspective and, most importantly, from a patient safety standpoint.” The system, demonstrated in December at the American Society for HealthSystem Pharmacists (ASHP) Midyear Clinical Meeting and Exhibition in Anaheim, Calif., connects wirelessly to Omnicell ADCs. This allows nurses to

use Savvy to verify and remotely issue medications from the cabinet for multiple patients at one time. Once a nurse arrives at the cabinet, each patient’s medications are already selected and can be immediately dispensed and placed into one of the 12 locking drawers, automatically assigned to individual patients using the Omnicell software application. They can then wheel the loaded-up Savvy securely to each bedside—without the typical time-intensive trips back to the cabinet between patients—and follow a “guiding light” to the appropriate patient’s drawer, which is designed to unlock independently of the others. Two easily replaceable batteries keep Savvy operating up to 18 hours. Savvy also can be used to access electronic medical records, among other hospital applications, and will take advantage of new bedside-point-of care and bar-coding systems. For example, nurses can scan both the patient and the medication prior to administration to ensure that “the right medication and the right dose are administered to the right patient

and a lot of new features to this hospital. But I think this is the only time that nurses are saying that pharmacy has done something for them.’

—Qazi Halim, RPh

at the right time,” noted Mr. Hom. “And within that process, the system records administration of all the medications,” he added. This is what Mr. Hom calls closedloop medication accountability: The Savvy system can create a report of what medication was removed from the cabinet versus what was given to patients. The end result, touts Savvy’s makers and some early users, is reduced medication errors and diversion, as well as increased efficiency. Savvy is expected to become generally available in the second quarter of 2011.

A Mobile Nurse Server? “On the surface, it appears to be a highly sophisticated ‘mobile nurse server,’” said Mark H. Siska, RPh,

MBA/TM and past chair of ASHP’s Section of Informatics & Technology. “You are using the ADC as a distribution center for the multipatient nurse server.” He noted that the Savvy technology is uniquely targeted to improve one of the many subprocesses within medication use that is known to be a root cause for error: the bundling of medications at the time of administration. Although Mr. Siska has yet to use the system himself, Qazi Halim, RPh, director of pharmacy services at Brookdale Hospital Medical Center in, New York City, has been testing Savvy in one pilot unit of his center since October. “Other units are now asking when they will have this system extended to them,” he said.

•

see DELIVERY, page 42

PandoraVIA 2.0 Introduced at ASHP

ust two months after Omnicell, Inc., announced its acquisition of Pandora Data Systems, a leading developer of pharmacy analytics software, the expanded company unveiled its first product upgrade. PandoraVIA 2.0, on display in December at the American Society for Health-System Pharmacists meeting in Anaheim, Calif., aims to provide a more user-friendly interface than its predecessor, while offering additional capabilities to help hospitals control drug diversion, manage their inventory and monitor patient safety. “If you looked at it, you’d see a dashboard look and feel; however, the underlying analytic algorithms are Scan for more still the same,” said Kristin Russel, PandoraVIA’s director PandoraVIA with Omnicell. “For example, while the prior version also coverage. offered anomalous usage reports, users would have to Instructions, p. 4 know precisely where to click to get to the information they wanted,” added Ms. Russel. “Now, they don’t have to look across every cabinet or dig all the way down into the data.” Directly on the home page, a set of customizable widgets displays trends. Users can then get a deeper sense of the numbers behind their narcotics inventory, for example, by intuitively clicking on any of the data points and drilling as far down as the level of an individual. Of course, if they don’t want that information so readily available, the homepage can be reconfigured. “Essentially, we’re taking a business intelligence approach to the same information,” Ms. Russel said. “Users don’t have to draw as many of their own conclusions. The software helps them draw the same conclusions, just at a higher level.” There are also some new additions within the software enhancement. These include virtualization—the software is VMware ready and certified—as well as an inventory management tool that allows users to look from the desktop into various medication cabinets and adjust par levels as needed. The software even has the capability of reporting what goes in and out of Savvy, the company’s new mobile medication system. Meanwhile, for nurses, PandoraVIA 2.0 includes an added patient safety report, helping them to analyze intervals between medication administrations. “Now we have something new for diversion control, inventory management and nursing,” Ms. Russel noted. “But many of the features our Pandora users have appreciated are still intact, including our interoperability.” —L.P.

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42 Technology

Pharmacy Practice News • February 2011

Automation

DELIVERY continued from page 40

Before Savvy came along, according to Mr. Halim, some nurses would use a cart after pulling medications from the cabinet, whereas others would not. The Savvy cart has changed that. “Now, the nurses are spending less time with the cabinet,” he said. “They do all their homework with the medication cart. Then they go to the cabinet, take their medication and transport it in the cart.” Not only does it save them time but it may also help them avoid interruptions while ordering medications, which can also lead to errors. The nurses seem to be pleased with the new addition. “Over the last 10 to 15 years, I have brought a lot of automation and a lot of new features to this hospital. But I think this is the only time that nurses are saying that pharmacy has done something for them,” said Mr. Halim. “We’re hearing less complaints. And if the nurses are happy, the pharmacists are happy.” Mr. Halim also highlighted his careerlong challenge of dealing with missing-

‘Implementing [the Savvy system in] an integrated approach with the customer’s electronic medical records and automated dispensing cabinets could certainly create opportunities for greater safety and efficiency.’

—Mark H. Siska, RPh, MBA/TM

dose scenarios. “I think with this system, that is happening less,” he noted.

Medication Tracking to the Point of Care But if a gap does appear between what was pulled from a cabinet and what was administered, pharmacists also may be better able to track it down. Ultimately, Savvy aims to bring medication tracking to the point of care, allowing pharmacy to see beyond just what is happening at the cabinet and know when the medication is delivered at the patient bedside via an integrated pointof-care system. “Maybe a nurse dispensed 10 mg of morphine for a particular patient but only administered 5 mg,” added Mr. Hom. “The discrepancy of that extra 5 mg could be for viable reasons. But with the information readily available through our systems that can talk to

each other, pharmacists are able to quickly and easily investigate.” Mr. Hom recalled how pharmacists at the recent demonstration keyed in on the idea of having a report at their fingertips where they could spot such inconsistencies. As they know, the responsibility for keeping track of the whereabouts of all medications that go in and out of the central pharmacy rests on their shoulders. Pharmacists are also accountable for ensuring that the hospital meets the Institute for Safe Medication Practices (ISMP) recommendations. “Savvy can give pharmacists peace of mind, as it meets, and even exceeds, these guidelines,” noted Mr. Hom. For example, according to the ISMP guidelines surrounding the safe use of ADCs, if a clinician pulls multiple patients’ medications from the cabinet then they need to put those medications

in a mobile cart that is labeled with patient-specific drawers and that can be locked if unattended. The Savvy mobile cart is designed to do both. “This technology should be relatively seamless to the pharmacy practice and the drug delivery system,” Mr. Siska said. However, as with any new technology in today’s environment, he added, it must be assessed within the context of the organization’s ideal vision and strategy for an information technologyenabled medication use process. “By itself, Savvy would be of limited value,” noted Mr. Siska. “But implementing [the Savvy system in] an integrated approach with the customer’s electronic medical records and automated dispensing cabinets could certainly create opportunities for greater safety and efficiency.” Mr. Halim pointed to one more potential benefit of Savvy: the indirect impact it may have on a patient’s perception of their medical care. “When you roll in that state-of-the-art cart with computer and begin administering medication to a patient,” he said, “I think they think something good is happening.” —Lynne Peeples

UP FRONT

Practice Pearls

SMOKING BAN continued from page 7

anxious.’ Others say, ‘I know that once I get the patch I will be calmer and have less anxiety,’” Dr. Maroney explained.

‘Nothing To Fear’ “People are fearful of the quitsmoking campaign, but there is nothing to fear, as long as information is distributed and patients are provided with nicotine patches,” Dr. Mierzwa said. In fact, implementation of the smoke-free program (and availability of the nicotine patch) was actually expected to reduce anxiety among psychiatric patients at the Behavioral Health Center. “Prior to the enactment of the smoke-free policy, 6 smoke breaks were in place. Those who smoked regularly did not feel that 6 smoke breaks were enough, and subsequently experienced anxiety. Since patients were provided with nicotine patches after enactment of the smoke-free policy, it was anticipated that their anxiety would decrease because cravings would diminish,” explained Dr. Mierzwa. As such, a study was conducted to determine whether implementa-

tion of the smoke-free policy would impact use of anti-anxiety medications among psychiatric patients at the Saint Barnabas Behavioral Health Center. The study compared the use of “as-needed” anti-anxiety medications 6 months before and after enactment of the smoke-free policy; 199 patients were evaluated in the 6 months prior to its implementation, and 208 were evaluated after the facility went smoke-free. Overall, results demonstrated no change in the use of anti-anxiety medications following implementation of the policy, but a reduction was seen in the use of these medications in individual cases. Additionally, “Some patients didn’t even realize they could ask for an anti-anxiety medication on an asneeded basis, and others said they would rather not take medications if possible,” noted Dr. Maroney. Thus, assessment of anti-anxiety medication use alone may not have been a reliable indicator of patients’ anxiety, which is likely to have decreased following implementation of the smoke-free initiative. Enactment of a smoke-free policy in the workplace may contribute to a reduction in the number of people who experience morbidity and mor-

tality as a result of tobacco use.5 The incidence of lung cancer and coronary artery disease may diminish as smokers are forced to decrease tobacco use, and nonsmokers would be less likely to be exposed to secondhand smoke. The decision to prohibit smoking in the workplace has consistently shown positive results, and is recommended for all health care facilities.10

References 1. Tobacco Key Facts. World Health Organization. http://www.who.int/topics/tobacco/ facts/en/index.html. Accessed June 9, 2010. 2. National Toxicology Program. Report on carcinogens, 11th ed. Research Triangle Park, NC: US Department of Health and Human Services, Public Health Service; 2005.

United States, 2000–2004. Centers for Disease Control and Prevention (CDC). MMWR Morb Mortal Wkly Rep. 2008;57:1226–1228. 8. Haw SJ, Gruer L. Changes in exposure of adult nonsmokers to secondhand smoke after implementation of smoke-free legislation in Scotland: national cross sectional survey. Br Med J. 2007;335:549. 9. Schick S, Glantz S. Philip Morris toxicological experiments with fresh sidestream smoke: more toxic than mainstream smoke. Tobacco Control. 2005;14:396–404. 10. Bauer JE, et al. A longitudinal assessment of the impact of smoke-free worksite policies on tobacco use. Am J Public Health. 2005;95:1024–1029. 11. Connie Greene. Taking Action: Implementing a Smoke/Tobacco Free Campus. http://www. instituteforprevention.com/downloads/takeaction.pdf. Accessed June 10, 2010.

3. Respiratory health effects of passive smoking. Environmental Protection Agency. Washington, DC, United States; 1992. Table 3-1. 4. Smoking and Tobacco Use. Centers for Disease Control and Prevention. http://www.cdc.gov/ tobacco/data_statistics/fact_sheets/health_ effects/effects_cig_smoking/index.htm. 5. WHO Report on the Global Tobacco Epidemic: Implementing Smoke Free Environments, 2009. World Health Organization. Accessed June 9, 2010. Available at: http://www.who.int/ tobacco/mpower/en/. 6. Pierce JP, León M. Effectiveness of smoke-free policies. Lancet Oncol. 2008;9:614–615. 7.

Smoking-attributable mortality, years of potential life lost, and productivity losses—

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