Pharmacy Practice News - June 2010 - Digital Edition by McMahon Group

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Millions in savings reported

Targeting Drug Wastage Slashes Chemotherapy Cost New Orleans—Strategies that resulted in significant cost savings, including a novel way to extend the beyond-use dating of chemotherapy medications, the judicious use of elastomeric pumps and having pharmacists supervise IV compounding to reduce drug wastage, were presented at the sixth annual meeting of the Hematology/Oncology Pharmacy Association. Ryan A. Forrey, PharmD, assistant director in the Department of Pharmacy at the Arthur G. James Cancer Hospital, Columbus, Ohio, demonstrated how he and his team were able to use an automated compounding device to extend beyond-use dating of chemotherapy agents from single-dose vials. In doing so, they were able to decrease pharmaceutical wastage while complying with United States Pharmacopeia (USP) Chapter <797> recommendations for sterile compounding. “The ultimate goal is to save money,” Dr. Forrey said in an interview. “After USP <797> went into place, its latest revisions stated that you could only use a single-

•

see COST SAVINGS, page 12

New Orleans—Boston researchers have developed a bar code–based syringe-labeling system they believe has the potential to significantly improve patient safety and workflow in the operating room. A pair of studies by the investigators revealed that the technology not only provides full compliance with requirements of both the Joint Commission and the American Society of Anesthesiologists (ASA), it also improves the efficiency of the clinicians who use the device. And it passed muster with at least one pharmacist who specializes in medication safety in the operating suite. The system, a bar code–driven method of printing full Joint Commission-compliant drug labels at the time that the OR clinician draws up the syringe, “certainly makes sense, and it’s something that we would consider for the medications that we cannot prepare in the pharmacy department beforehand,” said Meagan Rushe, PharmD, manager of the Shock Trauma and OR

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see SYRINGE LABELS, page 34

Volume me 37 • Number 6 • June 2010

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McMahon Publishing

in this issue Up Front

ASHP Late-Breaker Pharmacists boost quality of post-anesthesia care.

Audits reveal high rate of HIV prescribing errors.

Daily Feedback Can Help Fix Drug Order-Entry Errors Multistep action plan cut medication mishaps by 72%

Operations & Mgmt

Finance Saint Barnabas just says no to payment claims denials.

Policy

Research Tangled bureaucracy of NCI trials may imperil innovation.

Clinical

Hem/Onc Pharmacy Improving the costeffectiveness of antinausea medications.

Formulary Focus

Automated Syringe Labels May Boost OR Drug Safety

rin

GPO-wide echinocandin switch saves $4 million.

Pharmacy Heritage The amazing Charles Rice and Bellevue Hospital.

Tampa, Fla.—Progress in reducing medication order-entry errors took off slowly at first at Bloomington Hospital in Bloomington, Ind., after the Pharmacy Department launched an error-avoidance initiative in February 2009. As the months went by, however, the error rate kept falling, and by the time the full impact of the pharmacy’s actions took hold, it had been cut by 72%. At less than 0.5%, the rate of order-entry errors had not been that high to begin with, according to Stephen L. Speth, RPh, MS, pharmacy manager at the 317-bed community hospital, who presented the data at the American Society of Health-System Pharmacists Summer Meeting this month. However, the high volume of orders—an average of 2,500 per day—resulted in “an unacceptable number of errors.”

•

see ORDER ENTRY, page 22

Technology

unSummit 2010 Ten years of bar coding triggers turnaround at VA.

Educational Review

Diagnosis and Treatment of Mycosis Fungoides and Sézary Syndrome See www.pharmacypracticenews.com

QI Project Shows a Less-Is-More Strategy Works in ICU Sedation

lighter touch with sedation in critically ill patients can translate into a host of benefits, according to the results of a new quality improvement (QI) project. The effort, by a multidisciplinary team at Baltimore’s Johns Hopkins University, involved reducing the medication dosages in their medical intensive care unit (MICU). As a result of the QI program, patients experi-

enced significantly less delirium and an increased ability to be mobilized and undergo rehabilitation therapy. The improved outcomes “were certainly encouraging,” said lead author Dale M. Needham, MD, PhD, associate professor of medicine. “Another key payoff, however, was reduced length of stay [LOS], which we documented not only in the intensive care

•

see ICU SEDATION, page 18

New Products American Health Packaging adds metformin, other SKUs to its growing line of unitdose medications. See page

Pharmacy’s Most Dispensed Name… now appearing on our tablets and capsules

We know you trust our products. On average, pharmacists fill 1 out of every 6 prescriptions with a Teva product*. We want patients to share your trust and confidence in Teva. That’s why, over the next few months, you’ll begin to see tablets and capsules imprinted with the Teva name. In some cases, this new Teva imprint will replace the company identifier code. Ultimately, all our capsules and most of our tablets will proudly bear the Teva name. Patients will come to know us better, making your job a little easier every time you confidently dispense quality Teva products.

*data on file, Teva Pharmaceuticals

888 TEVA USA • www.tevausa.com

8618

Up Front 3

Pharmacy Practice News • June 2010

Capsules FDA Watch

surf

Tarceva Approved for Maintenance Therapy in Lung Cancer

JUNE 2010

watch

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

AMA Seeks Limits to Pharmacists’ Scope of Practice Concern Revving Up Over REMS REMS for Opioids: A Review and Critique Millions of Elderly Given Inappropriate Drugs in ED Aggressive Steps Urged for Managing Toxicities During Chemotherapy

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

heard here

‘We tend to think patients with cancer comply with oral regimens because they fear

dying from their disease. But that’s just not always the case.’

first

See article, page 21

—Niesha Griffith, MS, RPh, FASHP

MCMAHONMEDICALBOOKS.COM

The Book Page

Managing Anticoagulation Patients in the Hospital: The Inpatient Anticoagulation Service Michael Gulseth See page

he FDA has approved erlotinib (Tarceva, Genentech) for maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. The approval was based on a randomized doubleblind, placebo-controlled, multinational trial of 889 patients with locally advanced or metastatic NSCLC whose disease did not progress during first-line platinum-based chemotherapy. Patients were randomized (1:1) to receive either erlotinib (150 mg) or placebo orally once daily until disease progression or unacceptable toxicity. The primary end point was whether adding erlotinib to platinum-based chemotherapy improved progression-free survival (PFS) when compared with placebo in either all patients or in patients with endothelial growth factor receptor (EGFR) immunohistochemistry (IHC)-positive tumors. Overall survival (OS) was a secondary end point in the trial but was designated as the regulatory end point for approval of this indication. Patient demographics and disease characteristics were balanced between the two groups. Approximately 70% of patients’ tumors were EGFR-positive. The hazard ratio for PFS was 0.71 (95% confidence interval [CI], 0.62-0.82; P<0.0001). The hazard ratio for OS was 0.81 (95% CI, 0.70-0.95; P=0.0088). The PFS and OS hazard ratios in patients with EGFR IHC-positive tumors were 0.69 (95% CI, 0.58-0.82) and 0.77 (95% CI, 0.64-0.93), respectively. The PFS and OS hazard ratios in patients with IHCnegative tumors were 0.77 (95% CI, 0.51-1.14) and 0.91 (95% CI, 0.59-1.38), respectively. Following disease progression, a greater proportion of patients in the placebo group (57%) received second-line treatment for NSCLC compared with the erlotinib group (47%). Of the 259 patients in the placebo group who received second-line treatment, 37 (14%) received either erlotinib or gefitinib (Iressa, AstraZeneca) at first progression, 80 (31%) received docetaxel, and 37 (14%) received pemetrexed (Alimta, Lilly). In total, 59% of patients in the placebo group who received treatment at the time of tumor progression received FDA-approved second-line NSCLC drugs. The safety results for patients treated with erlotinib were consistent with the known safety profile previously described in product labeling. The most common (>20%) adverse reactions in patients receiving erlotinib were rash-like events and diarrhea. This approval is erlotinib’s second indication in locally advanced or metastatic NSCLC. Erlotinib was originally approved in November 2004 for the treatment of patients with locally advanced or metastatic NSCL after failure of at least one prior chemotherapy regimen. —Staff

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Volume 37 • Number 6 • June 2010 • pharmacypracticenews.com

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4 Up Front

Pharmacy Practice News • June 2010

ASHP Late-Breaker

Pharmacists Speed Drug Delivery in Post-Anesthesia Care Units Presence cuts delivery time for stat medications by 60% Tampa, Fla.—Stationing a pharmacist in the post-anesthesia care unit (PACU) has been a boon to nurses and patients at Rex Healthcare, a 432-bed community hospital in Raleigh, N.C., by decreasing delivery time for stat medications by 60%. “It goes a long way toward improving patient care and the overall environment when the pharmacist is right there, in the middle of the action,” said Emmeline Igboekwe, PharmD, a pharmacist with Rex Healthcare, who presented the results of a four-month study on the strategy in a poster session at the American Society of Health-System Pharmacists’ Summer Meeting.

Moving Up From the Basement Before 2008, the central pharmacy at Rex Healthcare provided pharmacy services to the PACU. Orders would arrive in the PACU but then need to be faxed down to the pharmacy—a situation that wasn’t working so well, said Dr. Igboekwe. “The nonstandard meds, like epidurals, weren’t stored in the PACU. The pharmacist downstairs would have to pick up the fax and enter the order. If there were issues with any of the medications, the order wasn’t complete or there was any need for clarification, it took extra time to get the meds up to the patients [postsurgery],” she said. In fact, in 2007, the average length of time for stat drug delivery was

48.25 minutes, with waits as long as 133 minutes. “You could understand why nurses were frustrated with that,” Dr. Igboekwe said. “Imagine patients waiting that long for pain meds. Nurses were speaking up about it, and the whole rapport between nurses and the pharmacy was less than ideal.” At the time, Rex Healthcare had begun decentralizing pharmacy services, so that pharmacists could rotate through clinical care teams in different departments. After discussions between the PACU and pharmacy leadership, it was determined that this decentralized approach could address the drug delivery problems post-anesthesia. As a result, now pharmacist and nurse workstations exist side by side, with a computer and mobile

Table. Stat Drug Audit—Before and After Pharmacy Decentralization Before PACU RPh 1/07–4/07

After PACU RPh 4/09–6/09

Average drug delivery time (min)

48.25

18.9

Range of drug delivery time (min)

13–133

3–55

% of drug delivered in <25 min

87.5

PACU, post-anesthesia care unit

gets to the floor, the medications already are there. Sometimes the drugs are delivered before the label is printed out.” As a result of the new process, the average wait for stat drug delivery is now 18.9 minutes, with 87.5% of stat drugs delivered within 25 minutes (see

‘It’s very helpful to get out of the basement and be where the patients are; that’s where it matters most.’ —Emmeline Igboekwe, PharmD phone in the pharmacist’s area to aid in communication. Perhaps most importantly, there’s no longer any fax machine in the loop, because orders are handed directly to the pharmacist. “The pharmacist knows what’s available then and there, and can call down and give the pharmacy a heads-up to get the meds ready and sent up. They can say, ‘We need this now,’ before the order is even entered into the computer,” Dr. Igboekwe said. “By the time the patient

Before PACU Pharmacist

Table). Not only has that increase in delivery speed improved patient care and outcomes, nurse satisfaction with pharmacy services is “off the charts,” Dr. Igboekwe said. During followup, nurses completed a survey that assessed how they felt about pharmacists and pharmacy services before and after decentralization to the PACU. The survey results indicated improved satisfaction in several key areas (see Figure). For example, 100% of the nurses rated the timeliness of drug delivery

After PACU Pharmacist

Nurse Satisfaction, %

100

Knowledge of RPh in answering medication-related questions

Helpfulness and courtesy shown during interactions

Timeliness in responding to issues and concerns

Turnaround time on PACU medication orders

Commitment to assuring quality and safety of orders

Ease of order clarification by RPh

Figure. Nurse satisfaction with PACU pharmacist services.a PACU, post-anesthesia care unit a

Overall rating of pharmacy services

as “excellent,” whereas 20% of nurses selected that response to rate timeliness before the new process. Likewise, 100% of nurses responded with a rating of “excellent” for commitment to quality and safety (previously 40%), overall satisfaction with pharmacy services (previously 20%) and ease of order clarification (previously 18%). “It’s very helpful to get out of the basement and be where the patients are; that’s where it matters most,” Dr. Igboekwe said. “It’s also better for morale when you know the nurses by name and they know you by name.”

‘Presence Is Huge’ Asked to comment on the poster, Julie Golembiewski, PharmD, clinical assistant professor of pharmacy practice at the University of Illinois at Chicago College of Pharmacy, offered kudos to the Rex Healthcare team for increasing the profile of pharmacists in the care of patients in the PACU. “Presence is huge,” Dr. Golembiewski said. “People are more likely to ask you a question if you’re right there and they see you, instead of picking up the phone and calling. That improves patient care and can result in earlier and more timely interventions.” Dr. Golembiewski, who has published extensively in the area of OR pharmacy, sees several advantages to having a pharmacist in the PACU, particularly at larger hospitals that have higher numbers of inpatients. “In a smaller hospital where there’s a lot of outpatient procedures, it’s mostly a matter of making sure patients understand how to take their meds when they leave, so it’s not much of an issue,” she said. “However, with inpatients, that’s a different story. A lot of the bigger hospitals struggle with timing. I can see how delays happen and where it would be much easier to start everything in the PACU, especially for pain meds and the first dose of antibiotics, where timing is important.”

Online survey, May 2009.

—Terri D’Arrigo

6 Up Front

Pharmacy Practice News • June 2010

ASHP Late-Breaker

Audits Reveal High Rate of ARV Prescribing Errors Tampa, Fla.—A volunteer team of pharmacists and physicians at St. John’s University in Queens, New York, used a twice-weekly audit system to detect an approximately 28% rate of medication errors in a high-risk population of inpatients taking antiretroviral (ARV) medications, according to an abstract presented at the 2010 meeting of the American Society of Health-System Pharmacists. Between March and September 2009, the team reviewed a total of 600 records

for patients on ARV medications, and found 173 potential errors for which they made corrective recommendations. Dosing errors comprised 35% of the total; drug–drug interactions, 32%; and missing medications, 17%. The collaborative care team made medication changes in 58% of cases, based on the reviewers’ recommendations; in most other cases, the patients involved had already been discharged from the hospital. “This is a very difficult population

to manage,” said lead author Tomasz Jodlowski, PharmD, assistant clinical professor of pharmacy at St. John’s University. “There are a lot of drugdrug interactions, and a lot of comorbid conditions and polysubstance abuse issues in these patients. They are typically on a lot of medications, and polypharmacy increases the likelihood of adverse consequences.” The effects of medication errors, particularly drug–drug interactions,

Immune Globulin Intravenous (Human) Flebogamma® 5% DIF For intravenous use only Rx only

BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE Flebogamma® 5% DIF is indicated for replacement therapy in primary (inherited) humoral immunodeficiency disorders. DOSAGE AND ADMINISTRATION The usual dose of Flebogamma® 5% DIF for replacement therapy in primary humoral immunodeficiency diseases is 300 to 600 mg/kg body weight administered every 3 to 4 weeks. An in-line filter with a pore size of 15 to 20 microns is recommended for the infusion. Antibacterial filters (0.2 micron) may also be used. Discard unused contents and administration devices after use. The infusion of Flebogamma® 5% DIF should be initiated at a rate of 0.01 mL/kg body weight/minute (0.5 mg/kg/minute). If, during the first 30 minutes, the patient does not experience any discomfort, the rate may be gradually increased to a maximum of 0.10 mL/kg/minute (5 mg/kg/minute). For patients judged to be at risk for developing renal dysfunction or considered to be at increased risk of thombotic/thromboembolic events, it may be prudent to limit the infusion rate to a maximum rate less than 0.06 mL/kg body weight/minute (3 mg/ kg/minute). Reduction in dose, concentration, and/or rate of infusion in patients at risk of acute renal failure, which includes patients over 65, has been proposed in the literature in order to reduce the risk of acute renal failure. CONTRAINDICATIONS Flebogamma® 5% DIF should not be administered to individuals with a history of severe or anaphylactic reactions to blood or blood-derived products. Patients with severe selective IgA deficiency (IgA < 0.05 g/L) may develop anti-IgA antibodies that can result in a severe anaphylactic reaction. Anaphylaxis can occur using Flebogamma® 5% DIF even though it contains low amounts of IgA (typically < 50 μg/mL). Such patients should only receive intravenous immune globulin with utmost caution and in a setting where supportive care is available for treating life-threatening reactions. If patients are known to be intolerant to any component of Flebogamma® 5% DIF, such as sorbitol (i.e., intolerance to fructose), they should not receive the product. WARNINGS Immune Globulin Intravenous (Human) (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Flebogamma® 5% DIF does not contain sucrose. See PRECAUTIONS and DOSAGE AND ADMINISTRATION sections for important information intended to reduce the risk of acute renal failure. Flebogamma® 5% DIF is made from human plasma. As with all plasma derived products, the risk of transmission of infectious agents, including viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated. The risk that such products will transmit an infectious agent has been greatly 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. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Biologicals at 888-GRIFOLS (888-474-3657). All patients, but especially individuals receiving Flebogamma® 5% DIF for the first time or being restarted on the product after a treatment hiatus of more than 8 weeks, may be at risk for the development of inflammatory reactions characterized by fever, chills, nausea, and vomiting. Careful monitoring of recipients and adherence to recommendations may reduce the risk of these types of events. Appropriate supportive care, including immediate access to epinephrine injection, should be available for the management of acute anaphylactic reactions.

could range from therapeutic failure of certain drugs to serious toxicity. “One of the biggest issues is the combination of protease inhibitors with statins,” Dr. Jodlowski said. “Protease inhibitors can act to increase the levels of certain statins, leading to toxicities as severe as rhabdomyolysis.” Another classic interaction of ARV

PRECAUTIONS General: Any vial that has been entered should be used promptly. Partially used vials should be discarded and not saved for future use because the solution contains no preservative. Do not use if turbid. Solution that has been frozen should not be used. Ensure that patients are not volume-depleted before the initiation of the infusion of IGIV. Renal Function: Periodic monitoring of renal function and urine output is particularly important in patients judged to have a potential increased risk for developing acute renal failure. Renal function, including measurement of blood urea nitrogen (BUN)/serum creatinine, should be assessed before the initial infusion of Flebogamma® 5% DIF and again at appropriate intervals thereafter. If renal function deteriorates, discontinuation of the product should be considered. For patients judged to be at risk for developing renal dysfunction, it may be prudent to reduce the amount of product infused per unit time by infusing Flebogamma® 5% DIF at a maximum rate less than 0.06 mL/kg (3 mg/kg) body weight/minute. Aseptic Meningitis Syndrome: An aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. The syndrome usually begins within several hours to 2 days following IGIV treatment. It is characterized by symptoms and signs including severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, and nausea and vomiting. Cerebrospinal fluid (CSF) studies are frequently positive with pleocytosis up to several thousand cells per cubic milliliter, predominantly from the granulocytic series, and with elevated protein levels up to several hundred mg/dL. Patients exhibiting such symptoms and signs should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis. AMS may occur more frequently in association with high-dose (e.g., > 1.0 g/kg body weight) and/or rapid-infusion IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae. Hemolysis: Immune Globulin Intravenous (Human) (IGIV) products can contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration [See ADVERSE REACTIONS]. IGIV recipients should be monitored for clinical signs and symptoms of hemolysis [See PRECAUTIONS: Laboratory Tests]. Thrombotic Events: Thrombotic events have been reported in association with IGIV (See ADVERSE REACTIONS). Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. Baseline assessment of blood viscosity should be considered in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies [See PRECAUTIONS: Laboratory Tests]. Transfusion-Related Acute Lung Injury (TRALI): There have been reports of non-cardiogenic pulmonary edema [Transfusion-Related Acute Lung Injury (TRALI)] in patients administered IGIV. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever and typically occurs within 1 to 6 hours after transfusion. Patients with TRALI may be managed by using oxygen therapy with adequate ventilatory support. IGIV recipients should be monitored for pulmonary adverse reactions. If TRALI is suspected, appropriate tests should be performed for the presence of antineutrophil antibodies in both the product and patient serum [See PRECAUTIONS: Laboratory Tests]. Information For Patients: Patients should be instructed to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath (which may suggest kidney damage) to their physicians. It is recommended that the lot number of the vials used be recorded when Flebogamma® 5% DIF is administered. Laboratory Tests: Renal function, including measurement of blood urea nitrogen (BUN)/serum creatinine, should be assessed before the initial infusion of Flebogamma® 5% DIF in patients judged to have a potential increased risk for developing acute renal failure and again at appropriate intervals thereafter.

Up Front 7

Pharmacy Practice News • June 2010

ASHP Late-Breaker medications is that between atazanavir and the heartburn drug esomeprazole. “Everybody’s on the ‘purple pill,’ and if the combinations aren’t used appropriately, it can decrease absorption and lead to therapeutic failures,” Dr. Jodlowski said.

‘With a 28% risk for dosing errors and drug interactions, if a patient gets [an ARV] drug on Friday, can they wait over the weekend for the next review? That could be somewhat problematic.’

—Betty Dong, PharmD

A Pharmacist Offers Caveats The rapid pace of introduction of new ARV drugs in recent years adds to the potential for medication errors, noted Betty Dong, PharmD, professor of clinical pharmacy at the University of California, San Francisco who specializes in HIV

care and is involved with the National HIV/AIDS Clinicians’ Consultation Center. “Within the last two years, there has been a wealth of new ARV drugs introduced. All of them have very complicated

Following infusion of Flebogamma® 5% DIF, there may be a transitory rise of various antibody titers that may result in misleading positive results in serological testing. Baseline assessment of blood viscosity should be considered in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. If TRALI is suspected, appropriate tests should be performed for the presence of antineutrophil antibodies in both the product and patient serum. Pregnancy Category C: Animal reproduction studies have not been performed with Flebogamma® 5% DIF. It is also not known whether Flebogamma® 5% DIF can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Flebogamma® 5% DIF should be given to a pregnant woman only if clearly needed. Drug Interactions: Antibodies in Flebogamma® 5% DIF may interfere with the response to live viral vaccines, such as measles, mumps, and rubella. Physicians should be informed of recent therapy with Immune Globulin Intravenous (Human) so that administration of live viral vaccines, if indicated, can be appropriately delayed 3 or more months from the time of IGIV administration. Pediatric Use: The above mentioned clinical trial with Flebogamma® 5% DIF enrolled only a very limited number of children (0) and adolescents (3) with primary humoral immune deficiency, a number insufficient to fully characterize and establish the efficacy and safety in pediatric patients. Geriatric Use: Subjects over 65 are at increased risk of renal failure with IGIV treatment. For these subjects, and for any other subjects at risk of renal failure, the infusion rate of Flebogamma® 5% DIF should be limited to < 0.06 mL/kg/min (3 mg/kg/min). Adverse Reactions Increases of creatinine and blood urea nitrogen (BUN) have been observed as soon as 1 to 2 days following infusion of IGIV. Progression to oliguria and anuria requiring dialysis has been observed, although some patients have improved spontaneously following cessation of treatment. Types of severe renal adverse reactions that have been seen following IGIV therapy include: acute renal failure, acute tubular necrosis, proximal tubular nephropathy, and osmotic nephrosis. Certain severe adverse reactions may be related to the rate of infusion. The recommended infusion rate [See DOSAGE AND ADMINISTRATION] must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Adverse reactions may occur more frequently when a high infusion rate is used, the treatment is the initial exposure to immunoglobulin, the immunoglobulin product has been changed to that of a different manufacturer, or there has been a long interval (more than 8 weeks) since the previous infusion. Slowing or stopping an infusion usually results in the prompt disappearance of symptoms. Post-Marketing: The following adverse reactions have been identified and reported during the postapproval use of IGIV products. Respiratory

Cardiovascular Neurological Integumentary Hematologic General/Body as a Whole Musculoskeletal Gastrointestinal

Apnea, Acute Respiratory Distress Syndrome (ARDS), Transfusion-Related Acute Lung Injury (TRALI), cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm Cardiac arrest, thromboembolism, vascular collapse, hypotension Coma, loss of consciousness, seizures, tremor Stevens-Johnson Syndrome, epidermolysis, erythema multiformae, bullous dermatitis Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs) test Pyrexia, rigors Back pain Hepatic dysfunction, abdominal pain

Because post-marketing reporting of these reactions is voluntary and the at-risk populations are of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to exposure to the product. Such is also the case with literature reports authored independently. Adverse events were reported in a study of 46 individuals with primary humoral immunodeficiency diseases receiving infusions every 3 to 4 weeks of 300 to 600 mg/kg body weight. Forty-three (94%) subjects experienced at least 1 adverse event

dosing and interaction profiles. If you haven’t kept up with the literature, they can be very challenging.” Dr. Dong practices most frequently at San Francisco General Hospital, where

irrespective of the relationship with the product, and these subjects reported a total of 595 adverse events. None of the 46 subjects who participated in this study discontinued the study prematurely due to an adverse experience related to the study drug. One subject had treatment-emergent bronchiectasis, mild, ongoing, after infusion #10; and one subject had recurrent moderate leukopenia after the 7th and 12th infusions. No adverse events occurred with an incidence of > 2% on a per infusion basis. Table 1. Adverse Events Occurring with an Incidence of > 15% Adverse Event

Number of AEs

Combined Bronchitis Cough and productive cough Diarrhea NOSa Headache NOS and sinus headache Nasal congestion Injection site reaction NOS Pyrexia Arthralgia Sinusitis NOS Pharyngitis Upper respiratory tract infection Wheezing and asthma aggravated

19 10 14 46 11 13 27 11 38 9 24 24

Number of Subjects with AEs 14 10 9 16 7 7 17 7 20 8 15 10

Percent of Subjects with AEs 30 22 20 35 15 15 37 15 44 17 33 22

a. NOS = not otherwise specified The total number of AEs (regardless of attribution) reported whose onset was within 72 hours after the end of an infusion of Flebogamma® 5% DIF was 216. There were a total of 709 infusions, resulting in a rate of 0.305 (95% confidence interval 0.225 to 0.412) temporally associated AEs per infusion. There were 144 infusions (20.1%, 1-sided 95% upper bound confidence interval = 24.4%) associated with 1 or more AEs that began within 72 hours after the completion of an infusion. Table 2. Summary of Infusions with Mild, Moderate, and Severe TreatmentRelated Adverse Events Severity of AE Mild Moderate Severe

No. Infusions 58 25 1

Adjusted % a with AE 7.9 3.6 0.1

Confidence Intervalb 10.4 4.9 0.3

a specialized ARV order sheet is always reviewed by an HIV-knowledgeable pharmacist, specifically looking for issues such as drug–drug interactions before orders are filled. “This is something that should be going on automatically wherever you have patients on ARVs, but I suspect at more than a few institutions, it’s not.” Dr. Dong praised St. John’s University for introducing the ARV drug audits, but said that the abstract results suggest that medication orders need to be reviewed even more frequently. “They have a fair number of patients on HIV therapy,” she said. “It’s great to audit the medications twice a week, but their findings underscore that the potential for problems is quite high. With a 28% risk for dosing errors and drug interactions, if a patient gets [an ARV] on Friday, can they wait over the weekend for the next review? That could be somewhat problematic.”

Patient Transfers Can Be Trouble Spot With the limited resources and a volunteer team, Dr. Jodlowski said, his institution found that daily review wasn’t feasible. “But everyone in the hospital is continuously evaluated,” he said. “One thing that we’ve found with medication reconciliation is that as people transfer within the continuum of care and have different providers, things can get changed. This continuous evaluation allows us to see that change. For example, if someone’s kidney function has deteriorated or improved, drugs can be added and subtracted often. There are a lot of variables that happen in hospitals, and this process ensures that we can see how things are changing.” —Gina Shaw

a. Adjusted % = average of the % of infusions with a treatment-related adverse event for each individual subject. b. The 95% upper bound for the adjusted % of infusions for which at least 1 treatmentrelated adverse event was reported was derived by using the t-statistic. The number and percent of subjects with treatment-emergent rises in AST or ALT are in Table 3. Table 3. Number (%) of Subjects with Treatment-Emergent Rises in AST or ALT (N = 46) Laboratory Test AST ALT

Assessment Criteria Above 3x the ULNa Above 3x the ULN

n 3 1

% 6.5 2.2

a. ULN = upper limit of normal. None of these subjects had a concomitant treatment-emergent rise in total bilirubin. Reported adverse reactions with Flebogamma® 5% DIF and other IGIV products include: headache, chills, fever, shaking, fatigue, malaise, anxiety, back pain, muscle cramps, abdominal cramps, blood pressure changes, chest tightness, palpitations, tachycardia, nausea, vomiting, cutaneous reactions, wheezing, rash, arthralgia, and edema, often beginning within 60 minutes of the start of the infusion. Rarely, Immune Globulin Intravenous (Human) can induce a severe fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with IGIV. In the case of shock, the current standard medical treatment for shock should be implemented. Manufactured by INSTITUTO GRIFOLS, S.A. Barcelona - Spain U.S. License No. 1181 Distributed by GRIFOLS BIOLOGICALS INC. Los Angeles - CA 90032 Phone: 888-GRIFOLS (888-474-3657)

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8 Operations & Management

Pharmacy Practice News • June 2010

Finance

Saint Barnabas Just Says No to Claims Denials Editor’s Note: In April 2009, the Saint Barnabas Health Care System employed a pharmacy clinical financial analyst to manage insurance claims denials and other reimbursement challenges faced by the health system. The following article—the first in a two-part series—details the knowledge and skills that such a pharmacist should have to manage a large number of denied claims and, in the process, recover millions of dollars in lost revenue. The next article will discuss how to calculate return on investment and other economic benefits, and offer tips on selling the program to reluctant administrators.

n these trying economic times, it is not unusual to see health care facilities implement various cost-containment strategies to maintain or enhance their financial landscape. Most institutions have used formulary restrictions and/or therapeutic interchanges to reduce medication expenditures, while some have even been forced to cut back on clinicians and other hospital personnel. Unbeknownst to many health care administrators, managing claims denials can be another effective way for hospitals to save millions of dollars each year, without compromising patient care or reducing staff. Health care providers recently have begun to recognize the potential for effective claims management to improve their cash flow and bottom line by reducing unnecessary denials and increasing reimbursement rates. For instance, one facility in Mississippi recently developed a claims management program that cut its denial rate in half; this translated into thousands of dollars worth of additional monthly revenue that otherwise would have been lost.1 Similar results can be expected at other institutions across the country, because health care experts believe that as many as 90% of claim denials may be prevented through improved verification, authorization and clinical documentation.2 Our decision to hire a pharmacy clinical financial analyst to manage claims denials within the Saint Barnabas Health Care System (SBHCS) was sparked by a medication-related reimbursement issue identified at SBHCS’ central business office. Traditionally, the SBHCS facilities have used darbepoetin alfa (Aranesp, Amgen) for the treatment of anemia associated with myelodysplastic syndrome (MDS), as recommended in the National Comprehensive Cancer Network clinical practice guidelines.3 However, we had incidentally discovered that the fiscal intermediary for New Jersey no longer reimbursed the SBHCS for MDS patients treated with this medication. This was no trivial matter, as the health system has historically spent more than $1 million annually on this product alone. Thus, we created a reconciliation packet contain-

ing literature analyses, internal medication use evaluations of darbepoetin alfa in MDS and letters of support from physicians. This initiative successfully reversed nearly $400,000 worth of claims denials. Realizing that we could affect a significant number of denials by hiring a full-time employee to manage these types of reimbursement issues, SBHCS brought pharmacy clinical financial analyst Ellen Fan, RPh, on board in April 2009.

For instance, denials often result from process breakdowns due to inadequate interdepartmental communication or failure to learn from previously denied claims.1 The clinical financial analyst must take the initiative to fix this process and educate everyone involved. Simply refiling a denied claim is not a solution, because the claim will continue to be denied; instead, the root cause of the problem must be identified and understood, and an improved claims management process must be put into place to address future issues.4

Saint Barnabas Health Care System West Orange, New Jersey

work at SBHCS, where she handles and resolves reimbursement issues on a regular basis. Her contracting knowledge has enabled her to identify carve-out opportunities where SBHCS was able to maximize reimbursement and make

The majority of claims denials are due to operational issues such as incomplete documentation, inappropriate billing units, a lack of contractual agreements or inaccurate coding of patient- or disease-related information.

Dual Skill Set Is Crucial When searching for a pharmacist for this position, it is important to select someone who is well versed in both the clinical and financial arenas. Some claims denials are due to clinical issues (i.e., product/service deemed unnecessary by the payer, drug–diagnosis mismatch) that require the pharmacist to gather appropriate clinical information for appeal to fiscal intermediaries or other third-party payers to allow these medications to be reimbursed. The majority of claims denials, however, are due to operational issues such as incomplete documentation, inappropriate billing units, a lack of contractual agreements or inaccurate coding of patient- or disease-related information.1 A pharmacist who has worked for an insurance company or previously has dealt with claims denials will be better equipped to handle these types of challenges. Likewise, experience working as a managed care pharmacist or pharmacy benefits manager (PBM) (i.e., third-party administrator responsible for processing and paying prescription drug claims) can help prepare an individual for this role. Additionally, the clinical financial analyst should be proficient in project management, because resolving reimbursement issues often requires considerable change and may involve several hospital personnel, particularly when dealing with multiple departments and facilities within a health system.

Shilpa Amara, PharmD* Indu Lew, PharmD* Robert T. Adamson, PharmD* Drew Misuro, RPh, MBA* Ellen Fan, RPh*

Finally, this pharmacist should have a good working knowledge of contracts because hospitals contract with various insurance companies, and must abide by the rules of these agreements. The pharmacist also may be asked to work with payers during contract renegotiations to remove administrative and procedural obstacles that tend to generate large numbers of denials.4

An Ideal Fit Based on those criteria, Ms. Fan was considered an ideal fit for the role of SBHCS pharmacy clinical financial analyst. In the past, she worked for the PBM National Prescription Administrators (now Express Scripts), where she learned the ins and outs of claims denials as related to formulary issues. She also was employed by several pharmaceutical companies (i.e., Pfizer, Bradley, and Forest), where she learned how drug manufacturers work with payers to market their products. Additionally, Ms. Fan’s previous experiences in managed care contracting allowed her to attain valuable contract-related expertise. All of the skills she acquired from these positions have proven useful for her

recommendations for additional drugrelated contract amendments. “To qualify for this position, you definitely have to enjoy analyzing data,” Ms. Fan said. “You also have to be very detail-oriented, to ensure that denials are appropriately resolved. Follow-through is vital, because all process changes must be audited to maintain results.” In her role at SBHCS, Ms. Fan has the unique opportunity to work on both the financial and operational sides of the health system. She coordinates and supports institutional efforts to maximize reimbursement for drug therapy and pharmacy-related services. Her position is part of an interdepartmental partnership effort that requires interaction with billing, collections, pharmacy information technology (IT), pharmacy directors, charge integrity, managed care, compliance, oncology nursing leadership, hospital outpatient clinics, patient accounts and site directors/liaisons. Specifically, she works with charge integrity, as well as with the individual facilities’ pharmacy and IT departments, to determine that all administered medications appear appropriately on the patient bill with correct coding and billing units, and to develop a process to audit and monitor high-priced

•

see CLAIMS DENIALS, page 10

10 Operations & Mgmt

Pharmacy Practice News • June 2010

Finance

CLAIMS DENIALS continued from page 8

or high-volume outpatient medications. She also analyzes and reviews drug and drug-related billing denials for medical necessity or any other coding denial reason. Using her project management skills, she then collaborates with hospital outpatient departments and cancer centers to obtain appropriate documentation and clinical information for appeals processing.

An Invaluable Resource Furthermore, Ms. Fan scans the U.S. government’s Federal Register for reimbursement policy updates and checks with local carriers for hospital reimbursement coding changes. She also serves as a resource by disseminating information on drug-related issues with Medicare (National Coverage Determination/Local Coverage Determination), Medicaid or insurance-based reimbursement to appropriate individuals. Prior to the introduction of Ms. Fan’s position, the central business office and the SBHCS facilities were separate entities that conversed only in the face of a problem. By bridging the gap between these sectors, Ms. Fan fosters proactive communication between two areas that had a tacit linkage at best. This provides the health system with a tremendous advantage, because managing claims denials often requires a two-pronged approach. Not only must we aggressively resolve the denials that come in on the back end, but we must also institute process changes on the front end—and this may only be accomplished by promoting cross-departmental communication and cooperation to identify and resolve the issues at hand.5 Between May and December 2009, Ms. Fan was able to recover $1.2 million in total revenue from managing/resolving claims denials. Not surprisingly, Ms. Fan found that most denials at our institutions involve injectable medications; they occur primarily in the hematology and oncology areas because accurate codes and appropriate diagnosis and

billing units are required for these products. These are particular areas of concern, due to the high dollars spent on these medications versus decreasing payments received; in fact, Ms. Fan was able to recover approximately $12,500 on leuprolide alone, over a two-month period. Thus, these may be areas worth investigating in other institutions as well. Employing a pharmacy clinical financial analyst to manage claims denials can generate significant cost savings for health care facilities because many claims for medications are unnecessarily denied. In selecting a candidate for this role, it is important to choose someone who has both clinical and financial/ payment-related knowledge, because denials may be due to both clinical and operational issues. Additionally, the position requires excellent managerial skills because large processes may need to be repaired and resolved to prevent future denials; the pharmacist also should be able to facilitate communication between various departments within the health system, so that the system may reap the full benefits of this position.

References 1. Hodges J. Effective claims denial management enhances revenue. Healthcare Financial Management. 2002;56:40-50. 2. Minich-Pourshadi K. Denials bleed you: four ideas to fix it. HealthLeaders Media. http:// www.healthleadersmedia.com/content/FIN245417/Denials-Bleed-You-Four-Ideas-to-FixIt. Accessed February 18, 2010. 3. Myelodysplastic Syndromes. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. V.2.2010. http://www. nccn.org/professionals/physician_gls/PDF/ mds.pdf. Accessed February 18, 2010. 4. Cathey R. 5 ways to reduce claims denials. Healthcare Financial Management. 2003;57:44-48. 5. Crane AB. Taking the offensive against claims denials. H&HN Hosp Health Netw. 2007;81:46-50. * Dr. Amara, Medical Communications Specialist; Dr. Lew, Corporate Vice President of Education and Research; Dr. Adamson, Corporate Vice President of Clinical Pharmacy; Mr. Misuro, Corporate Vice President of Pharmacy Operations; Ms. Fan, Pharmacy Clinical Financial Analyst.

What’s Your Financial Success Story?

Do you have a program that has boosted reimbursement or in some other way improved finances at your hospital? If so, please send us details and we’ll help you get your results published. Contact

ppneditor@mcmahonmed.com

Policy 11

Pharmacy Practice News • June 2010

Clinical Trials

IOM Report Predicts Troubled Future for Cancer Research C ancer research in the United States faces a bleak future unless sweeping changes are made to the current clinical trials system, according to a new report from the Institute of Medicine (IOM). The nation’s largest network of clinical trials is hamstrung by a tangled bureaucracy, inadequate financial support and insufficient innovation, according to the 295-page report, “A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program.”

unlikely to accrue enough patients to answer the question you started with,” Dr. Mendelsohn said. “It’s a huge waste of time, effort and resources, and it’s unfair to patients who signed a consent form thinking they would be contributing to medical knowledge.” Committee member and researcher Michael Carducci, MD, knows firsthand the aggravation of shepherding trials from initial application to subject enrollment. One of his proposals for a

trial of a first-line prostate cancer treatment has yet to get out of the group’s steering committee, despite having what he describes as a reasonable target and multiple groups within the program willing to participate. “I’m frustrated with this one example, but I also know people who have been trying to get their studies through since 2006 and just got the concept approved,” said Dr. Carducci, AEGON Professor in Prostate Cancer Research at the Johns

Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore. “Now they have to get them up and running so that the original question remains relevant.” The report also blames inadequate NCI funding for the system’s stagnation. Many clinical investigators and providers shoulder up to half the cost of their work, said Dr. Mendelsohn, and almost all investigators seek supplemental funding from other sources, such as

•

see TRIAL TROUBLE, page 17

‘Very good data show that if you don’t get a trial started within two years, it’s unlikely to accrue enough patients to answer the question you started with.’ —John Mendelsohn, MD Plethora of Problems The stakes could not be higher, in the view of John Mendelsohn, MD, president of the University of Texas M.D. Anderson Cancer Center, Houston, and chair of the 17-member committee responsible for the findings. “If the clinical trials system does not improve its efficiency and effectiveness, the introduction of new treatments for cancer will be delayed and patient lives will be lost unnecessarily,” wrote Dr. Mendelsohn in the introduction. The National Cancer Institute (NCI)– sponsored Clinical Trials Cooperative Group Program comprises 10 groups that involve more than 3,100 institutions and 14,000 investigators who enroll more than 25,000 patients in trials each year. One prominent flaw identified in the IOM report is the convoluted system for designing, reviewing and initiating clinical trials—researchers must navigate a maze of oversight and overlapping reviews. Often, proposals are redrafted and recycled multiple times as they bounce between academic institutions, federal agencies, institutional review boards and industry. Proposals may linger for years, and many trials die on the vine. The average interval between trial application and launch stands at more than two years. Delays of that magnitude disrupt patient enrollment and frequently lead to the abandonment of trials. In fact, only 60% of NCI–sponsored Phase III clinical trials reach completion. “Very good data show that if you don’t get a trial started within two years, it’s

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Hem/Onc Pharmacy

Pharmacy Practice News • June 2010

In Focus

COST SAVINGS

continued from page 1

dose vial for six hours if it was kept inside the hood. When we evaluated our waste using the six-hour rule, we [estimated that it was] about $1.1 million dollars in 2008.” The researchers used the Gri-fill System 3.0 automated compounding device (Grifols USA) to save any remaining drug over 5 mL from selected singledose vials after six hours of use. Two outpatient pharmacies were selected to participate in the study, based on volume and specific pharmaceuticals commonly used, and four drugs—cetuximab (Erbitux, Bristol-Myers Squibb), gemcitabine (Gemzar, Eli Lilly), oxaliplatin (Eloxatin, Sanofi-aventis) and rituximab (Rituxan, Genentech)—were studied. The amount of drug saved for later use in dose compounding was recorded. “The aim was to take the contents of a vial, pass it through the compounding device which has a filter that ensures sterility, and then use the remainder of that vial on subsequent days, instead of throwing it away,” Dr. Forrey explained. The investigators found that medication that normally would have been wasted was able to be saved and used at a later date. For the four medications, the amount of money saved over a one-year period at the two pharmacies was $111,532, or approximately 10% of the total waste estimated in 2008. The average savings per vial was $233.20 for rituximab, $255.55 for cetuximab, $211.50 for gemcitabine and $535.90 for oxaliplatin. “The system more than paid for itself,” said Dr. Forrey. “The return on investment was seven months, just for using it to save the remainder of a limited number of chemotherapy agents. If the Gri-fill was also used for compounding, efficiency and workflow gains might have also been realized.”

Elastomeric Versus Electronic Medication Pumps In another study, Anna Palafox, PharmD, and her colleagues at Evanston Hospital in Evanston, Ill., compared elastomeric and electronic medication pumps for continuous-infusion chemotherapy in their outpatient cancer center and found that the elastomeric infusion pumps were more cost-effective. Their use also improved workflow efficiency and increased customer (i.e., patient) loyalty and safety, Dr. Palafox said. “Much chemotherapy is being delivered in an ambulatory care center rather than in a hospitalized setting and these ambulatory medication delivery systems allow for continuous infusion, eliminating the need for a hospital stay,” she

Percentage

18 15

Disease progression

Symptomatic toxicity

Patient Wrong order or Treatment “no show” chemotherapy delay ordered because too early of patient preference

Dose adjustment

Abnormal laboratory result

Other

Figure. Reasons for chemotherapy wastage.

‘The [automated compounding] system more than paid for itself. The return on investment was seven months, just for using it to save the remainder of a limited number of chemotherapy agents.’

—Ryan A. Forrey, PharmD

said. “There are several types of ambulatory pumps available, and we wanted to evaluate them for efficiency, customer loyalty, economic outcomes and safety.” The researchers evaluated two elastomeric pumps (the Baxter Infusor and the Grifols Dosi-fuser) and one electronic pump (the CADD Legacy) for continuous infusion of 5-fluorouracil (5-FU) over 48 hours. To evaluate efficiency, Dr. Palafox and her team looked at the time it took for the pharmacist and technician to prepare the pumps. For the electronic pump, the technician took 20 minutes to draw up solutions, inject solutions into the bag, remove air bubbles and prime the tubing. The pharmacist took 60 minutes for order verification, pump calculations, patient counseling, pump calibration, pump programming and pump cleaning. The time to prepare the elastomeric pump was shorter for both the technician and the pharmacist. The technician time was 10 minutes to draw up solutions, inject solution into the pump and to prime the tubing. The pharmacist time was 20 minutes for order verification, pump calculations and patient counseling. “Obviously, from a time perspective, the elastomeric was the better choice,” Dr. Palafox commented. The elastomeric pumps were also less expensive. There was a $20,000 annual cost savings with the elastomeric devices due to decreased equipment costs. The maximum savings were seen with the Dosi-fuser. The more efficient workflow and significant reduction in

time and resources with the elastomeric pumps resulted in an additional annual cost savings of $29,572.50. “Medicare reimburses for the electronic pumps but not for the elastomeric pumps, yet costs were still lower with the elastomeric pumps,” Dr. Palafox said. Patients preferred the elastomeric pump over the electronic pump because they felt it was lighter, more convenient, quieter and more discreet. The pharmacy preferred the elastomeric pump because, in addition to requiring less time to prepare than the electronic pump, it required less storage space and less documentation because it does not need tracking, batteries, calibration or maintenance. Of the two pumps, pharmacy preferred the Dosi-fuser because only one size pump is required for most patients’ doses, Dr. Palafox said. Oncology staff also preferred the elastomeric device because it came with simpler patient education materials and was also associated with fewer afterhour calls, she added. In addition, the elastomeric pumps had fewer malfunctions. The electronic pumps had 17 malfunctioning events that occurred after hours, and required intervention by the pharmacist or the physician. “This resulted in patient anxiety, inconvenience, and loss of trust regarding integrity of the infusion,” Dr. Palafox said. Electronic pumps could also be accidentally disconnected from the administration set, causing medication to freeflow into the patient. They also require

the use of an anti-siphon valve, she said. “For patients on FOLFOX [leucovorin, 5-fluorouracil (5-FU) and oxaliplatin] or FOLFIRI [5-FU, folinic acid and irinotecan], given over 48 hours, the elastomeric pump is exactly what we are geared toward. So for those infusions, it is perfect,” Dr. Palafox said. “Our pump evaluation project resulted in a decision to change to the elastomeric pumps. However, if we have a different duration of infusion, such as continuous infusion for 96 hours, we can’t use elastomeric pumps. In this case, the electronic pumps are more beneficial. But in general, we are now using the elastomeric pumps.”

Hem/Onc Pharmacist A Great Investment In a third study, having a hem/onc pharmacist oversee the preparation of chemotherapy drugs significantly reduced the amount of chemotherapy wastage and resulted in considerable cost savings as well as reductions in chemotherapy errors. Sarah M. Ussery, PharmD, a hematology/oncology advanced practice specialist at Veterans Affairs North Texas Health Care System (VANTHCS), Dallas, decided to provide oversight in the monitoring of the chemotherapy preparation shortly after joining this institution. “When we started this project, we had significant chemotherapy wastage occurring that we didn’t even know about because there wasn’t a dedicated hem/onc pharmacist overseeing the

Hem/Onc Pharmacy 13

Pharmacy Practice News • June 2010

In Focus preparation of chemotherapy drugs,” Dr. Ussery told Pharmacy Practice News. The practice at VANTHCS was to mix chemotherapy in a batch-type format, before the patient arrived at the facility, which wasted a lot of chemotherapy drugs along with a half-million dollars annually. “Chemo was coming back because patients had a dose change, or they couldn’t get their chemo because their blood counts were too low or they weren’t doing well, or there were a lot of toxicities that were stopping them from getting their chemo, and so these drugs were going to waste,” she said. Dr. Ussery and her colleagues implemented a monitoring and management program with a view to minimizing chemotherapy wastage and optimizing cost savings for the VANTHCS pharmacy department. They documented chemotherapy wastage on a wastage monitoring log over a two-month period in 2005 and again in 2007. The log captured the date of wastage, the drug name and dose wasted, and the reason for wastage. In 2006, the hospital implemented a chemotherapy management program that delayed the preparation of expensive chemotherapies with agents such as bevacizumab (Avastin, Genentech/ Roche) and rituximab. In 2008, additional expensive chemotherapies such as gemcitabine and oxaliplatin were added to the delayed-preparation list, and chemotherapy wastage was recorded for another two-month period. The study found that a total of 143 chemotherapy doses of bevacizumab, docetaxel, gemcitabine, oxaliplatin and rituximab were wasted over two months in 2005. For that period, the total cost of the unused medications was approximately $90,000, extrapolated to more than $500,000 annually. The most common reason for wastage was disease progression, which occurred in 23% of cases. (Other reasons are shown in the Figure.) Drug wastage over two months was monitored again in 2007. This time, the monitoring identified 61 wasted chemotherapy doses, and the chemotherapy drugs were similar to those drugs wasted in 2005. The total cost of wastage was about $42,000, extrapolated to $250,000 annually. Faced with these results, the system agreed to approve one full-time hematology/oncology clinical pharmacy specialist to oversee chemotherapy ordering and preparation. As a result, when wastage was next measured over a twomonth period in 2008, the total cost was $15, or about $90 annually. “I was hired to review the orders and to make sure everything looked good before we mixed the chemo, and that the patient was good to go. I was only in the posi-

tion for six months, and it resulted in just two doses of 5-FU being wasted,” Dr. Ussery said in an interview. Before this, the problem of drug wastage was under the radar, she said. “Nobody knew that it was a problem. The hem/onc department didn’t know it was a problem because they’re not in the pharmacy day to day. We had one chemotherapy technician, and in order to keep up with everything, she had to do a lot of chemo mixing in the morning, before the patient showed up. She didn’t even realize how expensive these drugs are. When we built a table

with the drug cost for each vial, this helped with the understanding that certain therapies must be kept on hold until we know for sure that the patient is going to receive [the] therapy.” Hematology/oncology pharmacists can identify problems because of their intimate knowledge of and links to chemotherapy ordering, Dr. Ussery said. In fact, institutions could benefit by having a hem/onc pharmacy specialist come in just to review the process. “You’d be amazed at the things you could find.” Commenting on these studies for Pharmacy Practice News, Luci Power, MS,

RPh, senior pharmacy consultant at Power Enterprises, San Francisco, said that strategies that reduce the wasting of hazardous drugs are needed both for financial considerations and to eliminate as much toxic waste as possible, which has its own financial implications. “Reduction of hazardous waste by any means is a laudable goal,” she said, “to reduce the actual cost of therapy, reduce the related cost of special disposal and to be environmentally conscious in improving the ‘green’ part of chemotherapy.” —Fran Lowry

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Hem/Onc Pharmacy

Pharmacy Practice News • June 2010

In Focus

Ondansetron and Palonosetron: A Tale of Two Antiemetics New Orleans—Heavier pretreatment with corticosteroids, along with a nod toward palonosetron as the preferred agent, were among the strategies that improved the cost-effectiveness of antiemetic therapy in two studies presented at the sixth annual meeting of the Hematology/Oncology Pharmacy Association (HOPA). Reporting the results of a retrospective, unblinded study, investigators from Brigham and Women’s Hospital, in Boston, said that palonosetron (Aloxi, Eisai) was associated with a trend toward fewer hospital readmissions due to chemotherapy-induced nausea and vomiting (CINV) compared with ondansetron in patients receiving intraperitoneal cisplatin for gynecologic cancers. But they also found that the duration of ondansetron therapy was suboptimal, and concluded that their findings require further exploration in prospective, randomized trials. In another study, investigators from Massachusetts General Hospital (MGH) in Boston quantified and characterized palonosetron use with a view to developing cost-effective guidelines. In doing so, they found that only half of the patients in their retrospective analysis received adequate corticosteroids before palonosetron was initiated. They concluded that antiemesis management could be improved by educating caregivers about the optimum use of corticosteroids.

Impact on Hospital Readmissions In the Brigham and Women’s study, researchers reviewed all intraperitoneal cisplatin administrations for gynecologic cancers for two time periods: January to June 2006, and October 2007 to June 2008. They noted and compared the occurrence of CINVrelated hospital readmissions, emergency department visits and outpatient encounters occurring within seven days after administration of cisplatin with ondansetron or with palonosetron. They defined CINV-related resource use as events associated with dehydration, hypovolemia, nausea/vomiting, hypokalemia, constipation, shortness of breath or syncope/collapse. “When ondansetron went generic, the difference in cost between the two drugs became substantial. Because of the lack of ... data identifying palonosetron as superior, it was mandated that ondansetron should be the front-line agent for all patients at our institution, so from that point we became an ondansetron hospital,” said Anne McDonnell, PharmD, a clinical pharmacy specialist at Brigham and Women’s. “After imple-

mentation, anecdotal reports from a lot of our clinicians were indicating that there was a higher incidence of healthcare resource use in patients who were receiving ondansetron compared with patients receiving palonosetron as their front-line therapy.”

the big picture and health care-related costs, palonosetron may prevent rehospitalizations, but of course further trials are necessary. As this was a retrospective, unblended study, the results are more hypothesis-generating,” she told Pharmacy Practice News.

‘It is unlikely that physicians in our institution will be willing to switch back now to ondansetron in patients receiving IV cisplatin therapy based on their clinical experience.’ —Anne McDonnell, PharmD There were 19 patients in the ondansetron arm and 34 patients in the palonosetron arm. The mean age for both was 59 years and the majority of patients had ovarian cancer. Ondansetron was used in 39 cisplatin administrations, and palonosetron in 89 cisplatin administrations. The average length of hospital stay was approximately two days. Palonosetron was always administered as a single-day therapy, whereas one, two and three days of ondansetron were administered in 25%, 61% and 14% of cycles, respectively. The study found that two patients (5.1%) on ondansetron were hospitalized for CINV compared with none of the patients on palonosetron (P=0.09). There were no significant differences in CINV-related emergency department visits or outpatient encounters between the two groups. “These findings need to be confirmed in a prospective randomized trial that compares outcomes with single-dose palonosetron versus multiple-dose ondansetron in this patient population,” Dr. McDonnell said. “However, it is unlikely that physicians in our institution will be willing to switch back now to ondansetron in patients receiving IV cisplatin therapy based on their clinical experience.” Dr. McDonnell said these data are important for pharmacists because there have been no head-to-head studies demonstrating superiority in the intraperitoneal cisplatin population for either of these agents. “When looking at drug costs alone, ondansetron may be a preferred agent. However, if you look at

Palonosetron Spike Examined Gayle Blouin, PharmD, from MGH, reported the results of a retrospective analysis of palonosetron use that was conducted at her center over a threemonth period. “The National Comprehensive Cancer Network [NCCN] recommends palonosetron to prevent CINV that is associated with moderately emetogenic and highly emetogenic chemotherapy,” Dr. Blouin said. “In 2009, our center observed a 50% increase in the use of palonosetron. We were curious about where it was being used, so we decided to study this further and to quantify and characterize its use.” The investigators’ retrospective analysis examined the antiemetic regimen employed in both the acute and delayed setting prior to initiating palonosetron. Data were collected from electronic medical records, pharmacy records and drug utilization reports. Dr. Blouin and her team found that palonosetron was being used most of the time as recommended by the NCCN. The most common chemotherapy regimens identified contained carboplatin, cisplatin or doxorubicin-cyclophosphamide. In all, 59 patients received palonosetron for a total of 149 doses. Palonosetron use by diagnosis was as follows: breast cancer, 28%; gynecologic cancer, 10%; pancreatic cancer, 10%; colorectal cancer, 8%; lung cancer, 8%; head and neck cancer, 7%; lymphoma, 7%; other (esophageal, glioblastoma, adrenal, sarcoma, gastric), 22%. Palonosetron was administered in cycle 1 in 31% (n=18) of patients and

initiated concurrently with aprepitant (Emend, Merck) in 78% (n=14) of patients. It was initiated after cycle 1 in 69% (n=41) of patients and used in combination with aprepitant in 68% (n=28) of these patients. Of note, however, only 50% of patients were adequately managed on corticosteroids, receiving them before palonosetron was initiated. “This was a big revelation, and something we can actually wrap our arms around and change with some teaching programs, which we have already started,” Dr. Blouin told Pharmacy Practice News. Based on these findings, the drug formulary at MGH now has restrictions on the use of palonosetron, she added. “It is available for patients who are refractory or intolerant to optimal doses of ondansetron and a corticosteroid. Our pharmacists are actually contacting the clinician when we see orders for palonosetron to verify that the patients are refractory.” Palonosetron is expensive, and therefore it is important to use it appropriately and judiciously, she added. “We want it to be available for the patients who need it but certainly not make it a free-for-all for use in all of the regimens that were using it. We’re in an environment now where we have to look carefully at what we are using. Unfortunately, we’re going to see a lot more projects looking at cost and how we can be more cautious about what we are using.” Asked for her comments, Dayna McCauley, PharmD, BCOP, a clinical specialist in gynecologic oncology practice at Stony Brook University Hospital, Stony Brook, N.Y., said that the dose of intraperitoneal cisplatin used in the study reported by Dr. McDonnell was 100 mg/m2, and that this, rather than the antiemetic therapy that was used, might have been responsible for the increased use of hospital resources. “This dose and regimen, as reported by Armstrong et al in 2006, was associated with significant toxicity, including nausea, vomiting and dehydration,” noted Dr. McCauley. “In fact, in this original paper, only 40% of patients were able to complete six cycles of therapy. However, moving forward, the Gynecologic Oncology Group is using a dose of 75 mg/m2 IP [intraperitoneal] for cisplatin in its current up-front ovary trial. Reducing the dose to 75 mg/m2 will go further to reduce toxicity than altering the antiemetic regimen per se.” —Fran Lowry Drs. McDonnell, Blouin and McCauley have reported no relevant financial relationships.

Hem/Onc Pharmacy 17

Pharmacy Practice News • June 2010

In Focus

Meta-Analysis Links TKIs to Arterial Thromboembolic Events T

he oral tyrosine kinase inhibitors (TKIs) are associated with a significantly increased risk for arterial thromboembolic events, according to a new meta-analysis reported in the Journal of Clinical Oncology (2010;28:2280-2285). “Clinicians should be aware of the possibility of increased [thromboembolic events], especially in higher-risk patients,” according to lead author Toni Choueiri, MD, director of the Lank Center for Genitourinary Oncology, Dana-Farber/ Brigham and Women’s Cancer Center, in Boston, and his colleagues. “Adverse effects of [vascular endothelial growth factor] TKIs warrant careful, continued surveillance and prompt reporting.” The meta-analysis, evaluating 10,255 patients with a variety of cancers, showed an increase in the relative risk (RR) for arterial thromboembolic events with the TKIs sunitinib (Sutent, Pfizer) and sorafenib (Nexavar, Bayer/Onyx) compared with placebo. In the analysis of three studies available to calculate the risk, there were 22 events in 989 patients treated with sorafenib or

sunitinib and six events in 868 control patients, yielding an RR of 3.03 for the patients treated with the TKIs (95% confidence interval [CI], 1.25-7.37; P=0.015). Of 9,387 patients included in the incidence analysis, 122 experienced a sorafenib- or sunitinib-related arterial thromboembolic event (RR, 1.4%; 95% CI, 1.2%-1.6%; P=0.159). The incidences of arterial thromboembolic events with sunitinib and sorafenib were not statistically different, at 1.3% (95% CI, 1.0%1.6%) for sunitinib and 1.7% (95% CI, 1.1%-2.4%) for sorafenib (P=0.35). The study analyzed 10 Phase II and III trials and expanded-access programs published between January 1966 and July 2009 and also included abstracts presented at meetings of the American Society of Clinical Oncology and the European Society of Medical Oncology held between 2004 and 2009. Of these trials, six involved renal cell carcinoma and the other four, hepatocellular cancer, GI stromal tumor, non-small cell lung cancer and neuroendocrine tumor. The trials included patients with ade-

quate organ, coagulation and hematologic function. They generally excluded patients with uncontrolled hypertension or a recent (within the past 12 months) history of clinically significant cardiovascular or cerebrovascular events or disease. The dosages used were sunitinib 50 mg orally once daily on a four weeks on/two weeks off schedule and sorafenib 400 mg orally twice daily, which are the FDA-approved doses for clinical trials. The most commonly reported event was cardiac ischemia or infarction in seven trials, followed by cerebral ischemia in three trials. Two studies reported both cardiac and cerebral ischemia. In previous work, Dr. Choueiri and his colleagues showed that these targeted agents also were associated with a significantly increased risk for bleeding (Lancet Oncol 2009;10:967-974). In that meta-analysis of 6,779 cancer patients, the incidence of all grades of bleeding events associated with sunitinib and sorafenib was 16.7% (95% CI, 12.7%21.5%), and the incidence of high-grade events was 2.4% (95% CI, 1.6%-3.9%).

The RR for bleeding events of any grade was 2.0 (95% CI, 1.14-3.49; P=0.015). In an interview with Pharmacy Practice News, Dr. Choueiri speculated that the qualities that make sunitinib and sorafenib so effective against cancer also make them potentially cardiotoxic. “These drugs inhibit tumor angiogenesis and this has translated into major therapeutic advances, but they also interfere with endothelial cell regulation, which is essential for hemostatic balance. Inhibiting vascular endothelial growth factor with these drugs can disrupt this hemostatic balance, which can be tipped toward thrombosis or bleeding.” Patients taking these drugs need frequent and careful monitoring, especially if they are elderly or have a history of thromboembolic events, Dr. Choueiri added. “We should not stop using these drugs, but we have to exercise caution, especially in a predisposed population. The most important thing is to be aware that these adverse events can occur.” —Fran Lowry

POLICY

Clinical Trials

TRIAL TROUBLE continued from page 11

drug companies. Furthermore, academic centers don’t adequately value cooperative group trials when evaluating faculty accomplishments, which discourage participation by potential researchers.

Fixing the System The committee laid out four broad goals—and supporting recommendations—for the system to regain its footing (see sidebar). To improve system efficiency, the committee advises consolidating back-office functions, committees and even cooperative groups themselves; streamlining review and oversight processes; increasing collaboration among various participants; and standardizing data collection and analysis. It also endorsed an NCI working-group recommendation of a target timeline for Phase III trials of 300 days from protocol submission to final approval. The target timeline is 200 days for Phase II trials. “What’s needed is a great deal more working together and harmonizing,” said David Dilts, PhD, director of clinical research at the Knight Cancer Institute and professor of health care management at the Oregon Health & Science University, Portland. Dr. Dilts, an operations management expert, considers the problem from the perspective of a systems engineer. “There is a significant

amount of redundancy in the system that could be removed to dramatically streamline it without sacrificing safety or efficacy,” he said. For example, not all proposals need to pass through com-

pletely different sets of scientific reviews and institutional review boards. Other recommendations include instituting better processes for selecting trials most likely to succeed; incorporat-

Summary of the Committee’s Goals And Recommendations Goal I. Improve the speed and efficiency of the design, launch and conduct of clinical trials 1. Review and consolidate some front-office operationsa of the Cooperative Groups on the basis of peer review. 2. Consolidate back-office operations of the Cooperative Groups and improve processes.b 3. Streamline and harmonize government oversight. 4. Improve collaboration among stakeholders.

Goal II. Incorporate innovative science and trial design into cancer clinical trials 5. Support and use biorepositories. 6. Develop and evaluate novel trial designs. 7. Develop standards for new technologies.

Goal III. Improve the means of prioritization, selection, support and completion of cancer clinical trials 8. Reevaluate the role of NCI in the clinical trials system. 9. Increase the accrual volume, diversity and speed of clinical trials. 10. Increase funding for the Cooperative Group Program.

Goal IV. Incentivize the participation of patients and physicians in clinical trials 11. Support clinical investigators. 12. Cover the cost of patient care in clinical trials. a

Front-office operations refer primarily to the Cooperative Group scientific committees and statistical offices, which are responsible for activities such as trial design, prioritization and data analysis.

Back-office operations refer to administrative structures and activities that include such things as data collection and management, data queries and reviews, patient registration, audit functions, case report form processing, image storage and retrieval, drug distribution, credentialing of sites, funding and reimbursement for patient accrual.

ing more scientific innovation, such as identifying biomarkers that can predict therapeutic response (thus decreasing the number of patients a trial requires); centralizing operations such as data collection, data auditing and drug distribution; increasing NCI funding; and increasing recognition and rewards from academic centers for clinical investigators. “The NIH [National Institutes of Health] and NCI should place comparable value on clinical research as it does on lab research,” Dr. Mendelsohn said. “That means covering the costs adequately.” Academic centers can help by honoring clinical investigators to the same degree they do lab researchers in terms of protected time, tenure and salary support. Much of the report’s contents have been discussed in the past, said Dr. Mendelsohn. “Now we have to put it all together in a way that everyone can look at and say, ‘Wow, there’s something that really needs to be changed.’ There are many stakeholders, including patients, clinical investigators, government agencies like the NCI and FDA, pharmaceutical companies and payers. Each one is trying to achieve a common goal of translating scientific discoveries into new treatments that will benefit cancer patients, and each one will have to do some giving in order to make this system efficient and more powerful.” —Steve Frandzel

18 Clinical

Pharmacy Practice News • June 2010

Critical Care

ICU SEDATION

‘It appears that we have a win–win situation—improved patient outcomes with reduced [length of stay], not to mention the ability to handle more critically ill patients.’

continued from page 1

by 2.1 days (95% confidence interval [CI], 0.4-3.8), while hospital LOS was reduced by 3.1 days (95% CI, 0.3-5.9). Compared with the same four-month period in the prior year, this represented a 30% reduction in MICU LOS and an 18% reduction in hospital LOS, the investigators reported. The reduction “has permitted our MICU to admit 20% more patients during the four-month quality improvement period compared with the prior year,” Dr. Needham said. “Thus, it appears that we have a win–win situation—improved patient outcomes with reduced LOS, not to mention the ability to handle more critically ill patients.”

How It Was Done To achieve these benefits, additional physical and occupational therapists were added to a team that included the full complement of attending physicians, nurses, respiratory therapists and the MICU pharmacist. The pharmacy clinical specialist, Annette M. Rowden, PharmD, said the project resulted in an overhaul of medication protocols. As part of this formalized change, Dr. Rowden said, the team used a new sedation scale and assessed patients for delirium using a tool known as CAMICU (Confusion Assessment Method for the ICU). “We made this part of

100

60 50 40

The Johns Hopkins project is one of several efforts that seek to improve ICU patient outcomes by reducing oversedation. For example, a “wake-up-andbreathe” protocol, in which patients are periodically assessed for their readiness to be weaned off sedatives and mechanical ventilation, reduced LOS and also enhanced cognition (Lancet 2008;371:126-134). Further evidence of the weaning strategy’s efficacy, including reduced mortality, was presented at the 2009 annual meeting of the Society of Critical Care Medicine. John W. Devlin, PharmD, associate professor, Department of Pharmacy Practice, Northeastern University in Boston, said it’s not surprising that reducing sedation and improving ventilator weaning has become a relatively common area of research. “This is a common clinical challenge in critical care,” he said. “ICU clinicians frequently struggle when attempting to incorporate each of these interventions into their daily practice.” As for the Johns Hopkins QI project, Dr. Devlin said it is “noteworthy, because it demonstrates that a multidisciplinary ICU team, using a structured quality improvement process, was able to protocolize sedation practices to reduce both deep sedation and delirium and boost early mobility.”

daily practice, as part of our efforts to develop strategies to improve nighttime sleep. It has been exciting and gratifying to be part of this ongoing quality improvement process.” Dr. Needham said that having a pharmacist involved in the project was a critical element to its success. “Our MICU pharmacist was key in providing input and support for a change in sedation,” he said. “She is one of the very few clinicians in our academic ICU who is there every day, five days per week, and can appreciate changes in practice when nursing or physician staff change.” In addition to underscoring the value of pharmacy, Dr. Needham said, the project yielded valuable lessons about how to optimally care for MICU patients. “We learned that critically ill patients can be safely and comfortably awake and mobile in the ICU, actively receiving rehabilitation therapy (including sometimes walking), despite requiring moderate levels of support from both mechanical ventilation and vasopressors,” he said. “It’s really made a difference in the quality of care we can deliver in this setting.” The QI project also shed light on the amount of pain medications needed by MICU patients. “The average pain score was 0.6 (on a 0 to 10 scale) both before and after our quality improvement proj-

Pre-QI

—Ted Agres

Post–QI

60 47 40

25 20

24 20

Figure. Impact of MICU quality improvement project. MICU, medical intensive care unit; QI, quality improvement. Mean daily sedative doses.

0 Benzodiazepine use

Growing Area of Interest

—Dale M. Needham, MD, PhD

Milligramsa

Percentage of MICU Days

unit, but in the hospital overall.” The project, conducted by a team of physicians, pharmacists and other caregivers, included 57 patients with acute respiratory failure who were admitted to the 16-bed MICU at Johns Hopkins from February to August 2007 (Arch Phys Med Rehabil 2010;91:536-542). All patients required mechanical ventilation for four or more days and were cognitively intact and without neuromuscular disease prior to admission. In contrast to patients in the preQI group (n=27), the 30 patients in the QI arm had benzodiazepine usage drop from 50% to 25% of MICU days (P=0.002), with the median midazolamequivalent dose dropping from 47 to 15 mg per day (P=0.09; see Figure). Median morphine-equivalent doses dropped from 71 to 24 mg per day (P=0.01), the investigators reported. “With this change, patients could be wider awake,” Dr. Needham said, as evidenced by a significant increase in the proportion of MICU days during which patients were alert: 21% of days pre-QI versus 66% post-QI. Delirium also improved significantly: the sedation side effect was present in 21% of MICU days pre-QI versus 53% post-QI (P=0.003). This change enabled caregivers to provide more rehabilitation treatments per patient (a median of one session in the pre-QI group vs. seven in the QI group; P<0.001), resulting in a higher level of functional mobility (treatments involving sitting or greater mobility, 56% vs. 78%; P=0.03), he noted. All of those benefits had an impact on patient stays: MICU LOS was reduced

ect, despite the fact that we had markedly decreased the amount of benzodiazepines and narcotic doses given to the patients,” Dr. Needham said. “This strongly suggests that patients were getting more pain medication than what they really needed before we started this QI project.”

Midazolam

Morphine

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20 Clinical

Pharmacy Practice News • June 2010

Critical Care

Digital Handoff Smooths Flow Between OR and ICU W

hen a patient in a cardiothoracic operating room is about to be sent to the intensive care unit, a nurse places a call to let the ICU know of the impending arrival. Sometimes this call is made hours in advance, and the unit might still have to scramble to find an available bed and put together the care team.

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At NewYork-Presbyterian Hospital/ Columbia University Medical Center, in New York City, a new system is allowing smooth electronic transfer of patient information from OR to ICU, and early reports show dramatic improvements in workflow. “Communication is a major cause of medical errors,” said Sumeet Goswami, MD, assistant professor of anesthesiology at Columbia, who has evaluated the system. “Instead of somebody reporting from memory and losing pieces of information at every step, we ensure that that doesn’t happen.” Dr. Goswami and colleagues recently conducted a study for which much of the patient information was collected electronically and was made accessible on a secure Web site to both the OR and ICU teams. They presented their findings at the 2010 Society for Critical Care Medicine annual congress in Miami Beach, Fla. (abstract 756). The electronic system provides the progress of surgery cases in the OR, allowing an ICU to plan ahead and have a bed ready for the incoming patient. The record also contains information including past medical history, allergies, whether the intubation was easy or difficult, as well as data on infusions, blood products and urine output. One measure of the efficacy of the electronic system was the time between skin closure and the patient’s departure from the OR. In one analysis, Dr. Goswami’s group assessed 104 patients processed under traditional methods and 160 patients who came through using the electronic system. Time from closure to departure was 39 minutes and 26 minutes, respectively (P<0.0004), the researchers said. After a six-week break, two more groups of patients were transferred using traditional (n=313) and electronic (n=232) methods. Again, the electronic system resulted in significantly less time between wound closure and transfer to the ICU (37 vs. 26 minutes, respectively; P<0.004). “It wasn’t so much whether we can group information and send it back and forth; it was, can we change the flow?” said Desmond Jordan, MD, associate professor of anesthesiology at Columbia and a co-author of the study. “It’s not just the information, it’s the interchange of information that becomes incredibly important.” The system also can automatically page ICU interns when a certain phase of the OR case occurs, alerting them to the progress of the patient. Lauren Wilcox, a computer science researcher at Columbia who was not involved in the study but who has worked

with Dr. Goswami, said that the previous, inefficient method of phone call transfers of information needs replacing. “You would have a lot riding on one ICU nurse to prepare for a patient,”

Dr. Goswami said that studying improvements in medical outcomes with the electronic system has not yet been attempted but would be worthwhile. Any improvements in outcome

‘Communication is a major cause of medical errors. Instead of somebody reporting from memory and losing pieces of information at every step, we ensure that that doesn’t happen.’ —Sumeet Goswami, MD

Ms. Wilcox said. “And if that nurse was attending to a patient and wasn’t available, you might be holding on the phone for 20 minutes, or calling back repeatedly. That is incredibly inefficient in an ICU or OR setting.”

Patient Care Also Improved Allowing information transfer between the departments electronically could improve not only workflow but also patient care, Ms. Wilcox said. “With the previous method, if you have a patient who isn’t assigned a care team yet or isn’t assigned a bed yet, the team would need to do that on the spot, and that might result in delayed therapy. Everyone on the care team is interrupted, and must hurry to get meds, drips and ventilator equipment set up for the new patient. Having the patient information delivered electronically allows clinicians to fit the preparations into their workflow, and the patient can experience a smoother transition to the ICU.”

would most likely involve a reduction in medical errors, he said. “Improved communication can reduce medical errors. When a patient comes in, a lot of the data is the same, but we hope the quality of the data will be better.” Dr. Jordan agreed, but noted that an error does not necessarily imply a worse outcome for the patient, given the checks and safety measures at hospitals. “Still, that is the next leg of the study,” he said. Ms. Wilcox said the new system is a “cutting-edge” program that has few analogs elsewhere in hospital systems. Information transfer between hospital departments and units remains an area with much room for innovation. “I hope to see more applications designed to support patient handoff,” she said. “Physician handoff and patient transfer between units are critical points of care that could be better supported by technology.” —Dave Levitan

2010

SPRING/SUMMER

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Outpatient Pharmacy Automation

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Medication Management Systems

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SPRING/SUMMER

BARCODE PACKAGING SYSTEMS 7

IV AUTOMATED DEVICES 10

MEDICAL PACKAGING INC.

BAXA CORPORATION

Pharmacy Accessory Label Printer (PALP)

DiscPac™ Self-Righting Luer Tip Caps

Address: 470 Route 31, P.O. Box 500, Ringoes, NJ 08551 Phone: (800) 257-5282 Fax: (609) 466-3775 E-mail: medpak@medpak.com Web Site: www.medpak.com

Address: 9540 South Maroon Circle, Suite 400, Englewood, CO 80112 Phone: (800) 567-BAXA (2292) Fax: (800) 494-BAXA (2292) E-mail: info@baxa.com Web Site: www.baxa.com Product Description: DiscPac™ Self-Righting Luer Tip Caps secure easily to any size Luer syringe. Available in 12 colors, the caps are packaged individually or in convenient DiscPacs of 25 and 100. They are latex-free—no natural-rubber latex components and made of non-DEHP material that withstands freezing. DiscPacs may be closed and stored in the hood for later use. Available on group purchasing organization contracts. Visit www.baxa.com for order numbers.

Product Description: The Pharmacy Accessory Label Printer (PALP) completes the solution for a pharmacist’s ancillary barcoding and labeling needs. Ampoules, vials, syringes and other parenteral medications can be quickly labeled and barcoded with Medical Packaging Inc.’s freezer-grade, pressure-sensitive labels.

BARCODING SYSTEMS 8

IV AUTOMATED DEVICES 11

B. BRAUN MEDICAL, INC.

BAXA CORPORATION

Pinnacle® TPN Management System

ExactaMix™ 2400 Compounder (EM2400)

Address: 824 12th Avenue, Bethlehem, PA 18018 Phone: (610) 691-5400 Fax: (610) 691-2202 E-mail: ryan.mcginley@bbraun.com Web Site: www.bbraunusa.com

Address: 9540 South Maroon Circle, Suite 400, Englewood, CO 80112 Phone: (800) 567-BAXA (2292) Fax: (800) 494-BAXA (2292) E-mail: info@baxa.com Web Site: www.baxa.com

Product Description: The Pinnacle® TPN Management System streamlines the total parenteral nutrition process for improved safety and efficiency. Pinnacle TPN uses barcode verification and barcoded patient prescriptions to help reduce medication errors. Also, the Windows® browser–based total parenteral nutrition calculating software includes Trissels™ Ca/P Check software and provides flexibility for single-, multiple- and network-user access and Internet capability.

Product Description: The EM2400 streamlines multisource mixing applications—improving productivity and reducing labor costs. It features barcode veriﬁcation, a closed system with no sterility breaks, accurate delivery with a secondary check, easy setup, high-speed delivery, air occlusion detection, and an electronic Y-site for high-use ingredients and lockout for incompatible ingredients. Disposables are available on group purchasing organization contracts.

BARCODING SYSTEMS 9

IV AUTOMATED DEVICES 12

CAREFUSION

BAXA CORPORATION

Pyxis PARx® System

IntelliFill™ I.V.

Address: 3750 Torrey View Court, San Diego, CA 92130 Phone: (858) 617-2000 Fax: (858) 617-2900 E-mail: communications@carefusion.com Web Site: www.carefusion.com Product Description: The Pyxis PARx® system provides a complete chain of custody on medications during the medication replenishment process. The technology automates the reﬁll process to help ensure the right medication is getting to the right Pyxis MedStation® unit.

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Address: 9540 South Maroon Circle, Suite 400, Englewood, CO 80112 Phone: (800) 567-BAXA (2292) Fax: (800) 494-BAXA (2292) E-mail: info@baxa.com Web Site: www.baxa.com Product Description: With IntelliFill™ I.V., each dose is individually labeled, barcoded, scanned and matched to order. It captures source images for review and verification. IntelliFill™ I.V. also provides high-speed automation and on-demand reconstitution and filling. It saves significant costs in medication acquisition.

COMING DECEMBER 2010

Generate product awareness and attract new customers! Circulation Breakdown Hospital Pharmacy Directors/Chiefs ....................................... 8,453 Formulary Directors .....................................................................2,093 Staff Pharmacists ....................................................................... 26,700 Clinical Pharmacists ...................................................................... 3,831 Other ................................................................................................... 824

Bonus Circulation Chief Information Officers .......................................................... 3,722 Purchasing Directors/Materials Management ........................ 5,134

TOTAL ................................................................................. 50,757 The Pharmacy Practice News Buyer’s Guide has been completely redesigned to increase the depth and breadth of products listed. The new guide will feature any device, from Luer locks to barcode systems—used by hospital pharmacists in every practice area and specialty.

The Buyer’s Guide is always available online at

PharmacyPracticeNews.com

pharmacypracticenews.com Don’t miss these key features of our Web site: BUYER’S GUIDE—DIGITAL EDITION Click here to access the digital version of the 2010 Spring/Summer Buyer’s Guide.

DEPARTMENTS This tab features topic-specific coverage of clinical news, technology, policy and pharmacy operations and management.

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ABOUT US Visit this tab to learn more about the editorial mission of Pharmacy Practice News.

SPRING/SUMMER

IV AUTOMATED DEVICES 13

OTHER 16

BAXA CORPORATION

RapidFill™ Automated Syringe Filler

DoseEdge™ Pharmacy Workﬂow Manager

Address: 9540 South Maroon Circle, Suite 400, Englewood, CO 80112 Phone: (800) 567-BAXA (2292) Fax: (800) 494-BAXA (2292) E-mail: info@baxa.com Web Site: www.baxa.com/rapidﬁll

Address: 9540 South Maroon Circle, Suite 400, Englewood, CO 80112 Phone: (800) 567-BAXA (2292) Fax: (800) 494-BAXA (2292) E-mail: info@baxa.com Web Site: www.baxa.com/doseedge

Product Description: The RapidFill™ Automated Syringe Filler reduces costs from premade syringes. RapidFill automates filling, capping, labeling and barcoding of sterile batch syringes—800/hour. It is designed to fit in the hood and colored labels are available. Disposables are available on group purchasing organization contracts. Visit www.baxa.com/rapidfill for more information.

Product Description: DoseEdge™ Pharmacy Workflow Manager is the first and only completely integrated system for managing IV and oral dose preparation. DoseEdge provides real-time status of incoming and in-process doses, barcode drug verification, dose tracking and automatic dose calculation. It offers a best practices approach for pharmacy workflow and remote inspection of pharmacy preparation steps. Also available: DoseEdge TPN for managing the parenteral nutrition compounding process, including manual additions. Visit www.baxa.com/doseedge for more information.

Outpatient Pharmacy Automation

OTHER 14

CAREFUSION

ROBOTIC DISPENSING SYSTEMS

Pyxis® Connect System

HEALTH CARE LOGISTICS

Address: 3750 Torrey View Court, San Diego, CA 92130 Phone: (858) 617-2000 Fax: (858) 617-2900 E-mail: communications@carefusion.com Web Site: www.carefusion.com

Medium Clear Bin for Omnicell® Shelf Zones Address: P.O. Box 25, Circleville, Ohio 43113 Phone: (800) 848-1633 Fax: (800) 447-2923 E-mail: hcl@healthcarelogistics.com Web Site: www.healthcarelogistics.com

Product Description: The Pyxis® Connect medication order management system provides a unique solution to enhance communication and efficiency between pharmacy and nursing departments. Pharmacists can use the system from the central pharmacy, nursing floor, remote office or other location for decentralized order entry and provide coverage for satellite hospitals and third shifts.

Product Description: These durable plastic bins optimize space in Omnicell® shelf zones; there is no need to modify bins already present or remove a shelf to achieve desired storage results. Each bin has an angled front edge, label holder and hand grip to make supply retrieval, identiﬁcation and maneuverability virtually effortless. Small and large sizes also are available.

Information Systems

Medication Management Systems DRUG DELIVERY SYSTEMS

LAB MONITORING SOFTWARE 18

COOPER-ATKINS CORPORATION

BAXTER HEALTHCARE

Temp Trak Temperature Monitoring System

Sigma Spectrum Infusion System

Address: 33 Reeds Gap Road, Middlefield, CT 06455 Phone: (860) 347-2256 ext. 162 Fax: (860) 347-5135 E-mail: healthcare@cooper-atkins.com Web Site: www.cooper-atkins.com Product Description: Temp Trak is a real-time, 24/7 monitoring system that combines an automated collection of temperature data with real-time notification alerts that can be customized to specific pharmacy requirements. It is a wireless system that monitors temperatures from –200°C to 450°C.

Address: 25212 West IL Route 120 WG1-1N, Round Lake, IL 60073 Phone: (847) 270-5772 Fax: None E-mail: jo_ann_fujii@baxter.com Web Site: www.baxter.com Product Description: The Sigma Spectrum Infusion System is a Generation 2 Infusion System that redeﬁnes smart pump technology by making patient safety a top priority with features that go beyond dose error reduction software (DERS) to support the goal of reducing potential medication errors. Spectrum pumps are manufactured by Sigma and distributed exclusively by Baxter Healthcare Corporation.ORAL &

ENTERAL DEV ICES

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SPRING/SUMMER

ORAL & ENTERAL DEVICES 19

IV PROTECTIVE DEVICES 22

BAXA CORPORATION

HEALTH CARE LOGISTICS

ExactaMed® Oral Dispensers

Lock-to-Pole IV Lock Box With Key Lock

Address: 9540 South Maroon Circle, Suite 400, Englewood, CO 80112 Phone: (800) 567-BAXA (2292) Fax: (800) 494-BAXA (2292) E-mail: info@baxa.com Web Site: www.baxa.com

Address: P.O. Box 25, Circleville, Ohio 43113 Phone: (800) 848-1633 Fax: (800) 447-2923 E-mail: hcl@healthcarelogistics.com Web Site: www.healthcarelogistics.com Product Description: This locking IV box protects controlled substance infusions from tampering and diversion and locks to the pole to prevent the entire box from being stolen. Clear PETg (glycolised polyester) construction provides durability for everyday use and keeps contents visible. The box is available with standard key or keyless digital lock. It accommodates bag sizes up to 1,000 mL.

Product Description: ExactaMed® includes market-leading dispensers and accessories for accurate and safe ﬁlling and delivery of oral medication. Unique tip design, gray piston and blue printing provide clear differentiation from IV syringes. They are the only complete range of dispensers—from 0.5 to 60 mL—that ensures precise delivery as low as 0.01 mL. Also available: specialty dispensers for enteral, vaginal and topical medications. Available on group purchasing organization contracts. Visit www.baxa.com for order numbers.

PCA DEVICES 20

FLUID DISPENSING SYSTEMS 23

BAXTER HEALTHCARE CORPORATION

BAXA CORPORATION

Ipump Pain Management System

Repeater™ Pump

Address: 25212 West Route 120, Round Lake, IL 60073 Phone: (847) 270-2655 Fax: (847) 270-5272 E-mail: susan_gorin@baxter.com Web Site: www.baxter.com

Address: 9540 South Maroon Circle, Suite 400, Englewood, CO 80112 Phone: (800) 567-BAXA (2292) Fax: (800) 494-BAXA (2292) E-mail: info@baxa.com Web Site: www.baxa.com

Product Description: The Ipump Pain Management System provides simplicity, safety and security with the versatility to meet many acute pain management needs. The ﬂexible Ipump system is designed to help each patient become ambulatory as quickly as possible. The system is programmable for epidural, IV or subcutaneous delivery. It delivers continuous, basal + PCA, or PCA infusions.

Product Description: Tired of reconstituting, pooling and then filling syringes, dispensers and elastomeric devices? The Repeater Pump automates fluid transfer needs with high flow rates, variable speeds and delivery accuracy as low as 0.2 mL. Disposables available on group purchasing organization contracts. Visit www.baxa.com for order numbers.

IV Devices

OTHER 24

IV PROTECTIVE DEVICES 21

BAXA CORPORATION Tamper-Evident Luer Lock Tip Caps Address: 9540 South Maroon Circle, Suite 400, Englewood, CO 80112 Phone: (800) 567-BAXA (2292) Fax: (800) 494-BAXA (2292) E-mail: info@baxa.com Web Site: www.baxa.com Product Description: Tamper-Evident Luer Lock Tip Caps are latex-free—no natural-rubber latex components—and made of non-DEHP materials. A three-part cap requires the user to break off the outer sleeve to dispense medication. A red ring remains, indicating the outer sleeve has been tampered with. The caps are sold in sterile packs of 10 for convenient use. Available on group purchasing organization contracts. Visit www.baxa.com for order numbers.

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BAXA CORPORATION ExactaMix™ EVA Containers Address: 9540 South Maroon Circle, Suite 400, Englewood, CO 80112 Phone: (800) 567-BAXA (2292) Fax: (800) 494-BAXA (2292) E-mail: info@baxa.com Web Site: www.baxa.com Product Description: ExactaMix™ EVA Containers offer better bag clarity for ease of visual inspection, attached bag clamp for convenient closure and covered addition port to keep the area protected until used. New lay-ﬂat tube material minimizes the risk of particulates in the bag. EVA construction provides cleaner disposal for incineration. Manufacturing in North America reduces shipping time. Available on group purchasing organization contracts. Visit www.baxa.com for order numbers.

SPRING/SUMMER

OTHER 25

BAXA CORPORATION RapidFillâ&#x201E;˘ Connectors Address: 9540 South Maroon Circle, Suite 400, Englewood, CO 80112 Phone: (800) 567-BAXA (2292) Fax: (800) 494-BAXA (2292) E-mail: info@baxa.com Web Site: www.baxa.com Product Description: RapidFill Connectors enable connections of male Luer syringes, tube sets, repeating syringes, bag ports and other containers. They are available with caps, allowing intermittent ďŹ lls and capped storage. The connectors are latex-freeâ&#x20AC;&#x201D;no natural-rubber latex componentsâ&#x20AC;&#x201D;and made of non-DEHP materials. Available 50 per case. Available on group purchasing organization contracts. Visit www.baxa.com for order numbers.

in Your Inbox

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OTHER 26

BAXA CORPORATION SuporÂŽ Syringe Filters Address: 9540 South Maroon Circle, Suite 400, Englewood, CO 80112 Phone: (800) 567-BAXA (2292) Fax: (800) 494-BAXA (2292) E-mail: info@baxa.com Web Site: www.baxa.com Product Description: SuporÂŽ sterile syringe ďŹ lters assure quality control during sterile drug preparation. The ďŹ lters feature double-Luer design for secure attachment and rapid ďŹ ltration and high throughput, with low protein binding and broad drug compatibility. They allow for fast and effective ďŹ ltration. Available on group purchasing organization contracts. Visit www.baxa.com for order numbers.

OTHER 27

BAXA CORPORATION TwoFerâ&#x201E;˘ Needles Address: 9540 South Maroon Circle, Suite 400, Englewood, CO 80112 Phone: (800) 567-BAXA (2292) Fax: (800) 494-BAXA (2292) E-mail: info@baxa.com Web Site: www.baxa.com Product Description: TwoFerâ&#x201E;˘ dual-purpose Luer-lock needles allow for vented and non-vented vial additions and withdrawals. Huber points minimize the risk for coring. Reconstitution and ďŹ&#x201A;uid transfer applications can be performed without changing needles. Available on group purchasing organization contracts. Visit www.baxa.com for order numbers.

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

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Clinical 21

Pharmacy Practice News • June 2010

Compliance

Oral Cancer Meds Pose Challenges O

ncology outpatients, organ transplant patients and the elderly with multiple ailments are among the many patient populations who have complex medication regimens and who could benefit from extra education and compliance aids that help them stay on a proper treatment course, health-system pharmacists told Pharmacy Practice News. Many of these compliance aids are of the high-tech variety, such as electronic pill-bottle caps that audibly remind patients to take their medications. But even decidedly low-tech approaches can work, such as simple drug calendars that patients can take with them at discharge. But whatever is used, one thing is clear: Clinicians cannot make the mistake of assuming patients will take their medications simply because they are very ill.

The Arthur G. James Cancer Hospital “We tend to think patients with cancer comply with oral regimens because they fear dying from their disease,” said Niesha Griffith, MS, RPh, FASHP, director of pharmacy and the hematology/oncology residency program at The Arthur G. James Cancer Hospital at Ohio State University in Columbus (known as “The James”). “But that’s just not always the case.” Ms. Griffith stressed, however, that noncompliance may not be the only problem to contend with in this patient population. “What concerns me more, at least potentially, is inappropriate use [of medications] due to lack of education. One of our medical directors said he is concerned that some patients might think ‘if one pill is good, two is better.’ We don’t know yet if this [fear] is wellfounded, but we think it is a possibility.” She said she empathizes with cancer patients, and senses that they “are overwhelmed to begin with,” so the more education the better. The pharmacists at The James round with physicians, nurses and nurse practitioners at the four outpatient clinics, which handle 94,000 patient visits per year and are growing. Her staff estimates spending anywhere from 30 to 60 minutes educating each oral chemotherapy patient when medication is first prescribed. Although the specifics of those counseling sessions can vary, “Compliance and patient safety are always very closely tied together. Patients need to understand the toxicities, the specific adverse reactions to watch for and actions to take, such as calling their physician.” Clinics at The James continue to collect data on the use of oral chemotherapy agents in an effort to continually improve management of patients on the medications. This is a crucial process, Ms.

Griffith said, because the number of oral medications coming onto the market is projected to increase significantly. Before qualifying a patient to take oral chemotherapy, the staff must assess the patient’s “readiness to self-administer a dangerous medication,” she said. “Do they [patients] clearly verbalize understanding of the directions for use? Can they swallow a pill? Is there a caregiver on hand to assist?” added Ms. Griffith, who chaired an oral chemotherapy task force at The James. The group’s primary focus, she said, was patient education, patient safety and adherence to the prescribed drug regimen. Medication calendars are the most popular aids among the oral chemotherapy patients. They list the specific medication, dose, number of pills and time of day for each dose—a key adherence tool, given the fact that some medications are given a week or two on, then a week or two off, and then on again. Also, Walgreens, which fulfills the clinics’ pharmacy operations onsite, has an adherence system that tracks refill dates. The adherence challenge grows more complicated as dosing changes. “We may use different combinations of doses as we grow more familiar with the agents and begin to use them in various types of cancer—yet manufacturers often don’t supply different strengths, so patients then need to take different numbers of pills to get the right dose,” Ms. Griffith said. “We’d welcome anything that could improve safety and eliminate confusion.”

Meridian Health At Meridian Health, an operator of four hospitals in Ocean and Monmouth counties in New Jersey, its two outpatient pharmacies and a satellite comprise a closed-network pharmacy for employees. This is a younger demographic than the typical market for medication compliance aids, said Bob Schenk Jr., RPh,

CCP, manager, Meridian an Ambulatory Pharmacy cy Services, and clinical cal pharmacist specialist, ist, Meridian Pharmamacology Institute. Yet he points to several dozen patients who spent about $20 each out of pocket this past year to buy a compliance aid, the GlowCap SOLO, which glows and plays a tune as a medication reminder. The device helps patients stay on their regimens and refill their scripts, added Mr. Schenk. “They invested and they have the mindset that it’s important.” Meridian sees revenue opportunities in expanding outpatient compliance, with its March 2010 launch of a five-tier service plan it calls MediSuite. For fees as high as $184.99 per month, it provides up to six audio and visual reminders daily, plus online reporting and tracking that alerts caregivers to missed doses and pending refills and a nurse visit to assist patients in getting back on a proper medication plan. “Insurers, pharmaceutical manufacturers and health systems all have vested interests in greater compliance,” said Mr. Schenk. “As health care reform becomes enacted, there will be greater emphasis on paying for outcomes rather than services. If a person is discharged from a hospital and then readmitted [due to noncompliance] soon [thereafter], the hospital will face the prospect of receiving less reimbursement or none at all for the initial stay.”

Going Wireless With AT&T Noting that the GlowCaps used at Meridian actually are an earlier version of what Vitality Inc., Cambridge, Mass., currently offers, CEO David Rose told Pharmacy Practice News of a new wireless partnership with AT&T, and a new business model that pays pharmacies and

Research Shows Compliance Benefits, Challenges

he cost of noncompliance is high and very well documented in the literature. A 2005 study in the online journal BioMedSearch.com, for example, showed that the least-compliant diabetes patients have a 30% risk for hospitalization, compared with 13% for the most compliant, and that every dollar spent on medications taken saved $7 in medical costs. The study, by Medco Health Solutions, Inc., also estimated that adherence to medication therapy averages only 50% to 65% for common chronic conditions such as hypertension and diabetes. The researchers estimated that noncompliance may cost the U.S. health care system as much as $300 billion annually. More recently, a 2010 study by investigators at Brigham and Women’s Hospital and Massachusetts General Hospital, Boston, found that 28% of electronic prescriptions for new medications are not filled. The study, based on an analysis of 195,930 e-scripts, was published online in the Journal of General Internal Medicine (DOI 10.1007/s11606-010-1253-9). —A.H.

The GlowCap SOLO electronic T pill bottle lights up and plays a tune as a medication reminder.

makes the caps free for patients. m In the AT&T wireless system, a nightlight contains the “guts” of a minini iPhone and acts as a hub for as many as 12 different GlowCaps in a person’s home. Each cap emits sound and flashes a different color in sync with the nightlight when a specific medication is due to be taken; reminder phone calls or text messages (to patients and caregivers) get more urgent as time passes. Reminder calls ask, “Are you planning to take your medication? If not, tell us why. Are there side effects? Do you believe you don’t need them? Do you want to talk with a pharmacist? Are you out of medication?” In the home, the initial reminder works 94% of the time, and a secondary reminder another 5% of the time, according to Mr. Rose. “For the first time, we can use minute-by-minute adherence data to motivate healthy behavior,” he said. At the GlowCaps call center, operators know every detail of a prescription that hasn’t been taken because of a process that starts in the pharmacy: Express Scripts, a pharmacy benefits management (PBM) company based in St. Louis, which distributes GlowCaps for Vitality, instructs pharmacists to scan the bar-code label on the vial and then to scan the cap itself. The PBM plans a summer trial of the GlowCaps on drugs for cholesterol, diabetes, high blood pressure and heart failure, the Wall Street Journal reports. “PBMs believe employers will pay for the caps because they will reduce care costs,” Mr. Rose said. “And programs we run for pharmaceutical manufacturers [because they sell more drugs] allow us to pay the pharmacy enough to double the pharmacy’s margin on the dispensing fees, about $2 or $3 for every branded medication prescription.” Beyond the alerts, Vitality sends weekly compliance reports to patients and nonprofessional caregivers (usually family members), as well as a monthly report it encourages patients to share with their physician, transplant nurse, pharmacist or other key practitioner who could intervene if necessary. (Two other sources of high-tech compliance aids: epill.com, a site that offers organizer pillboxes, timers and watches; and PatientCompliance.net, a site offering watches, alarms, timers, organizers, fall-prevention devices and medication-alert jewelry.) As for Ms. Griffith’s point about complex regimens for patients on oral chemotherapy, Mr. Rose said GlowCaps can be programmed remotely to accommodate changes in the numbers of pills, dosing frequency, and “on–regimen” or “off–regimen” weeks. —Al Heller

22 Clinical

Pharmacy Practice News • June 2010

Medication Safety Error Feedback

ORDER ENTRY continued from page 1

So a decision was made to develop a two-pronged error-prevention strategy consisting of daily feedback to pharmacists committing errors and a failure mode and effects analysis (FMEA) to determine the causes, and develop a long-term action plan. Neither was easy. The first hurdle was to find a way to capture the error data being bounced back to pharmacy as a result of nursing’s bar-code confirmation process in a form that Mr. Speth could use to educate pharmacists and initiate practice changes. Before changes were instituted, he said, error messages, once clicked on, simply disappeared and could not be retrieved for tracking or research purposes. That black hole was resolved, he said, when an in-house programmer developed a “capture mechanism” capable of recording errors on a spreadsheet file. Implementing a feedback mechanism resulted in an almost immediate drop in daily order-entry errors, from an average of 8.6 before the start of the program to 6.8 per month after initiation. Even more challenging was the FMEA, which took six months to complete. “It was a very laborious process,” Mr. Speth said, but it resulted in a seven-point action plan that drove down the error rate even more. “Even the awareness that we were doing a FMEA resulted in improvement,” he added, with the number of errors falling to 4.8 per day in March 2009. During the six-month FMEA process, the daily average dropped to 4.2 and then to 2.4 after the first five of seven action steps had been implemented. The current number is 2.1. “I was very pleased because each step that we did resulted in an improvement,” Mr. Speth said. “It’s encouraging to see that we have been able to sustain that over time.” The action plan’s seven steps ranged from developing best practices for medication order review and entry to incorporating a double-check to verify order accuracy (accompanying box). Five steps have been completed, and the sixth— reducing distractions and interruptions— was in progress when Mr. Speth spoke to Pharmacy Practice News. The seventh step—a double-check by another pharmacist—might not be carried out, according to Mr. Speth. “We decided that it was impractical to have another pharmacist do that,” he said, “and since nursing does the confirmation step in their system, that serves as a double-check.” During the FMEA, pharmacy learned that nurses intercepted most orderentry errors before the error could reach a patient, Mr. Speth said, adding that only “a very small percentage—

Average Number per Day

10 9

New Rxcomm Live Review

8.6 FMEA Begun

8 6.8

7 6

Duplicate Reminder

5.1

4.8

PACWAD Competency

FMEA Actions 4.5

4.2

4.4

4.2

3.3

2.9

2.6

2.4

2.7 2.2

2.1

1 0

Jan 2009

Feb March April

May

June

July

Aug

Sept

Oct

Nov

Dec

Jan Feb March April 2010

Month/Year

Figure. Number of pharmacist order entry errors per day. FMEA, failure mode and effects analysis; PACWAD, patient identification, allergies, creatinine clearance, weight, age and drug profile

‘[The Bloomington study] should be validated at other facilities. If it were, I would predict that these seven steps would become best practices.’

—John Poikonen, PharmD

less than 5%—reached the patient, but resulted in no harm.” However, he said, “even though we knew that the nursing confirm step was in place, there was concern because [that step] is only as effective as the nurse who is doing it.”

Hybrid Practice Model Bloomington Hospital’s 18-member pharmacy staff operates on a hybrid practice model, with five clinical pharmacists assigned to nursing units and three pharmacists fulfilling orders in the central pharmacy on day shift. “One thing that struck me was the high degree of variability in order-entry practice from pharmacist to pharmacist,” Mr. Speth said. “We kind of assume that if you graduate from pharmacy school, you know how to enter orders. But when we looked at that, we saw there was no consistency. That is when we designed our best practice for reviewing and entering orders.” It included memory devices to prevent the skipping of steps needed to ensure accuracy: the acronym PACWAD for patient identification, allergies, crea-

tinine clearance, weight, age and drug profile, and DDRFCT—“We couldn’t come up with a good acronym”—for drug, dose, route, frequency, comments, and times (start and stop). “We even developed diagrams showing that this is the path your eyes should follow when doing a review,” Mr. Speth said. Surveys done before and after the action plan was put into place showed that the best practices were mostly being followed. The proportion of pharmacists performing PACWAD increased from 49% to 87% and the proportion of those performing DDRFCT and duplicate search doubled, from 39% to 79%. Mr. Speth also was pleased with a statistical chart showing less variability in the error rate as time went on, with fewer spikes in the day-to-day percentage of errors to orders—a measure of quality. “If we have a big day now, it is three or four errors,” he said. Mr. Speth said Bloomington’s bestpractice model was relevant for hospitals that had not yet developed a computerized provider order-entry (CPOE)

Bloomington Hospital Pharmacy’s Seven-Step Action Plan 1. Design and implement best practice for medication order review. 2. Design and implement best practice for medication order entry. 3. Optimize prebuilt protocols in the pharmacy computer system. 4. Reduce the number of nuisance alerts in the pharmacy computer system. 5. Filter pharmacist work assignments in the pharmacy computer system. 6. Reduce distractions and interruptions during order entry.

system. (Nationwide, 17% of hospitals had CPOE systems in place in 2009, according to a New England Journal of Medicine study [2009;360:1628-1638]). “That means that there is still a whole lot of opportunity for error on the pharmacist’s part,” he said. He added that although Bloomington’s pharmacy department carried out a FMEA “because we really wanted to investigate what the causes of the errors were and to try to figure out how to solve them, I think a hospital could be successful without that step if they were able to capture the data and give timely feedback.”

Part of the Best-Practices Canon? “This is a very nice study,” said John Poikonen, PharmD, director of clinical informatics at UMass Memorial Health Care, in Worcester, who added that it reminded him of another study carried out by the Collaborative Alliance for Nursing Outcomes, which showed the value of implementing six best practices of medication administration. (The study appeared in the Dec. 2009 issue of The Joint Commission Journal on Quality and Patient Safety.) He said the Bloomington study “should be validated at other facilities. If it were, I would predict that these seven steps would become best practices.” Dr. Poikonen also noted that “while most state pharmacy practice acts and the Joint Commission mandate that pharmacists review all pharmacy orders, I am not convinced that this is the best use of pharmacists’ time. In a new pharmacy practice model, patients might be better served if pharmacists concentrated on high-risk medication orders. Clinical decision support, if built properly, might be able to automatically verify low-risk orders. Decreasing the pure volume of medication orders might also have a large effect on error rates.”

7. Incorporate a double-check to verify accuracy of order entry.

—Bruce and Joan Buckley

Expanded broad-spectrum coverage1* is on your side

*TYGACIL does not cover Pseudomonas aeruginosa.

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

Important Safety Information • TYGACIL is contraindicated in patients with known hypersensitivity to tigecycline • Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening. TYGACIL should be administered with caution in patients with known hypersensitivity to tetracycline-class antibiotics • Isolated cases of significant hepatic dysfunction and hepatic failure have been reported in patients being treated with tigecycline. Some of these patients were receiving multiple concomitant medications. Patients who develop abnormal liver function tests during tigecycline therapy should be monitored for evidence of worsening hepatic function. Adverse events may occur after the drug has been discontinued • The safety and efficacy of TYGACIL in patients with hospital-acquired pneumonia have not been established • TYGACIL may cause fetal harm when administered to a pregnant woman • The use of TYGACIL during tooth development may cause permanent discoloration of the teeth. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated • Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis • Monotherapy should be used with caution in patients with clinically apparent intestinal perforation • TYGACIL is structurally similar to tetracycline-class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL • To reduce the development of drug-resistant bacteria and maintain the effectiveness of TYGACIL and other antibacterial drugs, TYGACIL should be used only to treat infections proven or strongly suspected to be caused by susceptible bacteria. As with other antibacterial drugs, use of TYGACIL may result in overgrowth of non-susceptible organisms, including fungi • The most common adverse reactions (incidence >5%) are nausea, vomiting, diarrhea, abdominal pain, headache, and increased SGPT • In a pooled analysis of all Phase 3 and 4 studies that included a comparator, the risk difference of all-cause mortality was 1.0% (95% CI 0.2, 1.8) between TYGACIL (3.9%) and comparator-treated patients (2.9%). No significant differences were observed between treatments by infection type and, in general, deaths were the result of worsening or complications of infection or underlying comorbidities. The cause of the imbalance has not been established • Prothrombin time or other suitable anticoagulant test should be monitored if TYGACIL is administered with warfarin • Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective • The safety and effectiveness of TYGACIL in patients below age 18 and lactating women have not been established Please see brief summary of Prescribing Information on adjacent page. Reference: 1. TYGACIL® (tigecycline) Prescribing Information, Wyeth Pharmaceuticals Inc.

Expanded broad-spectrum coverage

24 Clinical

Pain Medicine

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

TYGACIL (N=2514)

Comparatorsa (N=2307)

6 3 3 6 8

4 3 2 7 5

12 2 26 18

11 2 13 9

4 3 2 3 4 5 4 5

3 2 1 1 3 3 5 5

Vancomycin/Aztreonam, Imipenem/Cilastatin, Levoﬂoxacin, Linezolid. LFT abnormalities in TYGACIL-treated patients were reported more frequently in the post therapy period than those in comparator-treated patients, which occurred more often on therapy. In all Phase 3 and 4 studies that included a comparator, death occurred in 3.9% (147/3788) of patients receiving TYGACIL and 2.9% (105/3646) of patients receiving comparator drugs. In a pooled analysis of these studies, the risk difference of all-cause mortality was 1.0% (95% CI 0.2, 1.8) between TYGACIL and comparator treated patients. No signiﬁcant differences were observed between treatments by infection type (see Table 2). The cause of the imbalance has not been established. Generally, deaths were the result of worsening or complications of infection or underlying co-morbidities. Table 2. Patients with Adverse Events with Outcome of Death by Infection Type

TYGACIL Infection Type cSSSI cIAI CAP HAP Non-VAPa VAPa RP DFI

Comparator

n/N

Risk Difference* % (95% CI)

12/834 40/1382 12/424 65/467 40/336 25/131 11/128 7/553

1.4 2.9 2.8 13.9 11.9 19.1 8.6 1.3

6/813 27/1393 11/422 56/467 42/345 14/122 2/43 3/508

0.7 1.9 2.6 12.0 12.2 11.5 4.7 0.6

0.7 (-0.5, 1.9) 1.0 (-0.3, 2.2) 0.2 (-2.3, 2.7) 1.9 (-2.6, 6.4) -0.3 (-5.4, 4.9) 7.6 (-2.0, 16.9) 3.9 (-9.1, 11.6) 0.7 (-0.8, 2.2)

CAP = Community-acquired pneumonia; cIAI = Complicated intra-abdominal infections; cSSSI = Complicated skin and skin structure infections; HAP = Hospital-acquired pneumonia; VAP = Ventilator-associated pneumonia; RP = Resistant pathogens; DFI = Diabetic foot infections. * The difference between the percentage of patients who died in TYGACIL and comparator treatment groups. a These are subgroups of the HAP population. Note: The studies include 300, 305, 900 (cSSSI), 301, 306, 315, 316, 400 (cIAI), 308 and 313 (CAP), 311 (HAP), 307 [Resistant gram-positive pathogen study in patients with MRSA or Vancomycin-Resistant Enterococcus (VRE)], and 319 (DFI with and without osteomyelitis). In comparative clinical studies, infection-related serious adverse events were more frequently reported for subjects treated with TYGACIL (7%) versus comparators (6%). Serious adverse events of sepsis/septic shock were more frequently reported for subjects treated with TYGACIL (2%) versus comparators (1%). Due to baseline differences between treatment groups in this subset of patients, the relationship of this outcome to treatment cannot be established [see WARNINGS AND PRECAUTIONS]. The most common treatment-emergent adverse reactions were nausea and vomiting which generally occurred during the first 1 – 2 days of therapy. The majority of cases of nausea and vomiting associated with TYGACIL and comparators were either mild or moderate in severity. In patients treated with TYGACIL, nausea incidence was 26% (17% mild, 8% moderate, 1% severe) and vomiting incidence was 18% (11% mild, 6% moderate, 1% severe). In patients treated for complicated skin and skin structure infections (cSSSI), nausea incidence was 35% for TYGACIL and 9% for vancomycin/aztreonam; vomiting incidence was 20% for TYGACIL and 4% for vancomycin/aztreonam. In patients treated for complicated intra-abdominal infections (cIAI), nausea incidence was 25% for TYGACIL and 21% for imipenem/cilastatin; vomiting incidence was 20% for TYGACIL and 15% for imipenem/cilastatin. In patients treated for community-acquired bacterial pneumonia (CABP), nausea incidence was 24% for TYGACIL and 8% for levofloxacin; vomiting incidence was 16% for TYGACIL and 6% for levofloxacin. Discontinuation from tigecycline was most frequently associated with nausea (1%) and vomiting (1%). For comparators, discontinuation was most frequently associated with nausea (<1%). The following adverse reactions were reported infrequently (<2%) in patients receiving TYGACIL in clinical studies: Body as a Whole: injection site inflammation, injection site pain, injection site reaction, septic shock, allergic reaction, chills, injection site edema, injection site phlebitis Cardiovascular System: thrombophlebitis Digestive System: anorexia, jaundice, abnormal stools Metabolic/Nutritional System: increased creatinine, hypocalcemia, hypoglycemia, hyponatremia Special Senses: taste perversion Hemic and Lymphatic System: partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased international normalized ratio (INR), thrombocytopenia Skin and Appendages: pruritus Urogenital System: vaginal moniliasis, vaginitis, leukorrhea Post-Marketing Experience The following adverse reactions have been identified during postapproval use of TYGACIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure. Anaphylaxis/anaphylactoid reactions, acute pancreatitis, hepatic cholestasis, and jaundice. DRUG INTERACTIONS Warfarin Prothrombin time or other suitable anticoagulation test should be monitored if tigecycline is administered with warfarin [see CLINICAL PHARMACOLOGY (12.3) in full Prescribing Information]. Oral Contraceptives Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective. USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects—Pregnancy Category D [see WARNINGS AND PRECAUTIONS] Tigecycline was not teratogenic in the rat or rabbit. In preclinical safety studies, 14C-labeled tigecycline crossed the placenta and was found in fetal tissues, including fetal bony structures. The administration of tigecycline was associated with slight reductions in fetal weights and an increased incidence of minor skeletal anomalies (delays in bone ossification) at exposures of 5 times and 1 times the human daily dose based on AUC in rats and rabbits, respectively (28 mcg·hr/mL and 6 mcg·hr/mL at 12 and 4 mg/kg/day). An increased incidence of fetal loss was observed at maternotoxic doses in the rabbits with exposure equivalent to human dose. There are no adequate and well-controlled studies of tigecycline in pregnant women. TYGACIL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Results from animal studies using 14C-labeled tigecycline indicate that tigecycline is excreted readily via the milk of lactating rats. Consistent with the limited oral bioavailability of tigecycline, there is little or no systemic exposure to tigecycline in nursing pups as a result of exposure via maternal milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TYGACIL is administered to a nursing woman [see WARNINGS AND PRECAUTIONS]. Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 years have not been established. Because of effects on tooth development, use in patients under 8 years of age is not recommended [see WARNINGS AND PRECAUTIONS]. Geriatric Use Of the total number of subjects who received TYGACIL in Phase 3 clinical studies (n=2514), 664 were 65 and over, while 288 were 75 and over. No unexpected overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity to adverse events of some older individuals cannot be ruled out. No significant difference in tigecycline exposure was observed between healthy elderly subjects and younger subjects following a single 100 mg dose of tigecycline [see CLINICAL PHARMACOLOGY (12.3) in full Prescribing Information]. Hepatic Impairment No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B). In patients with severe hepatic impairment (Child Pugh C), the initial dose of tigecycline should be 100 mg followed by a reduced maintenance dose of 25 mg every 12 hours. Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response [see CLINICAL PHARMACOLOGY (12.3) and DOSAGE AND ADMINISTRATION (2.2) in full Prescribing Information]. OVERDOSAGE No specific information is available on the treatment of overdosage with tigecycline. Intravenous administration of TYGACIL at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting. In single-dose intravenous toxicity studies conducted with tigecycline in mice, the estimated median lethal dose (LD50) was 124 mg/kg in males and 98 mg/kg in females. In rats, the estimated LD50 was 106 mg/kg for both sexes. Tigecycline is not removed in significant quantities by hemodialysis. This Brief Summary is based on TYGACIL direction circular W10521C013 ET01, revised 09/09.

Intrathecal Pump Beats Opioids for End-Stage Ca Pain

mplanted intrathecal therapy costs less than long-acting opioids for patients with end-stage cancer pain over the last year of life, according to a retrospective analysis presented at the 2009 fall meeting of the American Society of Regional Anesthesia and Pain Medicine in San Antonio (abstract ID 2). Although intrathecal (IT) therapy for pain dates back at least five decades, experts say the approach is still widely underused in pain management for cancer patients, primarily because of concerns about significant up-front costs. “I think it’s underused and used way too late in the [treatment] algorithm,” said Tim Deer, MD, clinical professor of anesthesiology and pain medicine at West Virginia University, in Morgantown. Previous research by Dr. Deer and others shows that IT therapy has some advantages over opioids from a quality-of-life (QoL) perspective for patients with terminal cancer pain (J Clin Oncol 2002;20:4040-4049). When used for palliative care, patients report less fatigue and somnolence with IT pumps, as well as better overall QoL, said Dr. Deer. “Not only is it better for them, but it’s also better for their caregivers,” he said. “Systemic opioid therapy for these patients requires such huge doses, that yes, you can create a patient who has dramatically reduced pain, but they are so mentally clouded ... that they can’t communicate with their families in their final months of life,” said senior author Robert Hurley, MD, chief of pain medicine at the University of Florida in Gainesville. Despite the QoL benefits of IT therapy for cancer pain, cost and reimbursement issues have hindered widespread use. In a survey Dr. Deer published in Pain Medicine in 2009 (10:304-309), more than 90% of respondents who used IT therapy in their practices (n=87) reported that “reimbursement rates for filling, refilling and programming patient pumps are not adequate to cover practice costs.” Dr. Deer said that “some physicians don’t offer the therapy because they just can’t afford to. Patient access has been reduced in the past few years secondary to cuts in reimbursement, and it’s unfortunate because in many cases it would greatly enhance the patient’s life.” Last year, Dr. Hurley and a colleague, Meredith Adams, MD, a fellow in pain medicine at Johns Hopkins University in Baltimore, informally surveyed fellows and attending physicians at several major academic institutions, asking them how long it takes for the cost of opioids for palliative cancer pain to cross-over, or equal, the high up-front

Clinical 25

Pharmacy Practice News • June 2010

Pain Medicine cost of IT pumps. There was wide variability in the responses, Dr. Hurley said; however, ultimately most physicians settled on three months. When asked why, many said they were trained that way, based primarily on old data on the costs of IT therapy. “The big problem was the way people were quoting [old] literature,” Dr. Hurley said. “Even though it’s old baseline data, it also was being entirely misrepresented in people’s recollections.”

Current Study To compare the costs of IT and systemic opioid therapies, Drs. Hurley and Adams retrospectively collected 2009 reimbursement data from the Centers for Medicare & Medicaid Services on IT pumps for the last year of life in patients with metastatic cancer. This included costs of professional and facility fees, medication and pump reprogramming. They then developed four therapeutic models based on national standards of practice, which varied in expense based on the type of pretherapeutic trial (e.g., outpatient vs. inpatient trial) and whether hydromorphone or ziconotide (Prialt, Elan) was used in the IT pump. The least expensive model—a “singleshot,” outpatient trial followed by IT hydromorphone—averaged $36,000. The most expensive—an inpatient trial followed by IT ziconotide—cost approximately $66,000. According to published research, the total health care costs in the last year of life for patients with metastatic cancer on long-acting opioids ranged from $76,446 to $90,935, depending on the type of opioid used (Manag Care Interface 2004;17:28-34). The overall cost of long-acting opioids comes not only from the cost of drugs, Dr. Hurley said, but also from hospital readmissions. Many patients with terminal cancer are readmitted to hospitals with a primary diagnosis of refractory pain, which for end-of-life cancer patients usually means admission to an intermediate care or intensive care unit. “That is where the cross-over point becomes very clear,” Dr. Hurley said. “If you have multiple admissions throughout a year, you will very rapidly pay for intrathecal care, provided it keeps patients from getting admitted.” He added that only prospective studies will be able to address questions about hospital admissions for patients with IT pumps, but at his institution and at John Hopkins, IT pumps have been shown to prevent cancer patients from being readmitted with a primary diagnosis of pain. Dr. Hurley said this cost study is only the first of several that he hopes will provide clear data on when to initiate IT therapy. “The No. 1 barrier has been cost, and this is why we have gone after this,” he said.

not all hospitals or clinics fit that mold.” As for clinical considerations, IT therapy “does effectively treat pain and can improve a patient’s QoL,” she said. But for some patients, “the thought of needles and wearing a pump around does not fit into their lifestyle.” Dr. O’Bryant also had some caveats about the issue of mental confusion. “Not all patients who are on high-dose LOAs become mentally altered, and in

Cindy L. O’Bryant, PharmD, BCOP, associate professor, University of Colorado Denver, Aurora, agreed that more cost data are needed, especially because the economics of cancer therapy can vary between practice settings. “If you’re in a closed system, for example, IT therapy upfront may be a better option, because you’re in a position to actually benefit from downstream savings from reduced LOS,” she said. “But

fact, there are some patients who are quite functional on these medications,” she said. “Mental cloudiness is patientdependent and can be seen at low doses as well. The bigger issue here is the cost of oral meds and the inconvenience of taking so much of the oral drug.” Bottom line? “A patient’s pain management has to be individualized and may require a combination of dosing forms for the best outcomes. Each therapy will have its up- and down-sides, so close personal management is best.” —Gabriel Miller

PREVNAR 13™ NOW RECOMMENDED BY ACIP*1

THE CPT® CODE IS 90670† Prevnar 13™ provides coverage against 13 serotypes, including 19A, which is the leading cause of invasive pneumococcal disease in children less than 5 years of age in the United States2,3 • The ACIP recommends Prevnar 13™ for routine vaccination of children 2 months through 59 months of age1 For the full ACIP recommendation, please visit www.cdc.gov/mmwr. *Advisory Committee on Immunization Practices. †

CPT is a registered trademark of the American Medical Association (AMA).

INDICATION FOR PREVNAR 13™

• Prevnar 13™ is a vaccine approved for use in children 6 weeks through 5 years of age (prior to the 6th birthday) • Prevnar 13™ is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F IMPORTANT SAFETY INFORMATION FOR PREVNAR 13™

• Severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 13™, Prevnar ® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), or any diphtheria toxoid–containing vaccine is a contraindication to the use of Prevnar 13™ • Prevnar 13™ does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes • Immunocompromised children or children with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response to active immunization • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Prevnar 13™, to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination • The most commonly reported serious adverse events were bronchiolitis (0.9%, 1.1%), gastroenteritis (0.9%, 0.9%), and pneumonia (0.9%, 0.5%) for Prevnar 13™ and Prevnar®, respectively • The most commonly reported solicited adverse reactions (≥20%) in US clinical trials with Prevnar 13™ were redness, swelling and tenderness at the injection site, fever, decreased appetite, irritability, increased sleep, and decreased sleep Please see Brief Summary of Prescribing Information on reverse side. For more information about Prevnar 13 ™, please visit www.prevnar13hcp.com, or call 1-800-666-7248. References: 1. Centers for Disease Control and Prevention. Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children — Advisory Committee on Immunization Practices (ACIP), 2010. MMWR. 2010;59:258-261. 2. Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals Inc. 3. Hicks LA, Harrison LH, Flannery B, et al; for Active Bacterial Core Surveillance Program of the Emerging Infections Program Network. Incidence of pneumococcal disease due to non–pneumococcal conjugate vaccine (PCV7) serotypes in the United States during the era of widespread PCV7 vaccination, 1998–2004. J Infect Dis. 2007;196:1346-1354.

NOW Manufactured by Wyeth Pharmaceuticals Inc. 266704-01

April 2010

26 Pharmacy Heritage

Pharmacy Practice News • June 2010

The Amazing Charles Rice and Bellevue Hospital N

o one knew where he really came from or where he trained. Even after his death in 1901, his origins remained open to debate. Charles Rice arrived at Bellevue Hospital as a patient in 1865 and lived on the grounds of the large complex until his death almost 36 years later. In the intervening years, he oversaw the largest pharmacy operation in America and led both the reformation of the United States Pharmacopeia (USP) and the creation of the National Formulary (NF).

A Drug Service Pioneer

Only a few public hospitals existed in the United States until well after the Civil War, and even fewer had professionally trained pharmacists on staff. Consequently, hospital-trained physicians in America had little understanding of or appreciation for pharmacists and pharmacy, unlike those who trained in many European hospitals. In 1904, Martin Wilbert, a hospital pharmacist and historian, wrote, “How woefully deficient and

unsatisfactory the drug service in many of our hospitals must be becomes evident when we realize that in this great country, with hundreds of institutions, we have had but one solitary instance of a hospital pharmacist who has become widely known through his professional and scientific work. I refer to Charles Rice of Bellevue Hospital, New York.” Bellevue Hospital traced its beginnings to a six-bed infirmary, established in 1736 in New York City’s almshouse.

267625-03

Dennis B. Worthen, PhD

Dennis B. Worthen, PhD, the author of “Pharmacy Heritage,” is the Lloyd Scholar at the Lloyd Library and Museum in Cincinnati. He can be reached at dbworthen@ lloydlibrary.org

Serving at times as a jail as well as a pest-house for patients infected with communicable diseases, by the beginning of the Civil War, Bellevue Hospital had established its own medical college. In 1867, Bellevue opened one of the very first outpatient departments—the Bureau of Medical and Surgical Relief for the Out of Door Poor. Rice, who had begun working in the hospital’s drug department, was named the outpatient facility’s first director. In 1885, he was named chemist and superintendent of the General Drug Department and later, chemist of the Department of Public Charities and Corrections. By this time, Rice had assumed responsibility not only for Bellevue Hospital but for all of the medical institutions of the city and county: eight hospitals, four branches of the New York City Lunatic Asylum, the almshouse and workhouse, the penitentiary, the Tombs prison, four district prisons containing approximately 17,000 prisoners, and four large dispensaries treating 60,000 patients annually. The earliest centralized formulary of the municipal hospitals of New York was issued in 1868. Entitled Formulae of Mixtures, Pills and Other Preparations at Bellevue & Charity Hospitals, the 14-page pocket-sized book had no authorship attribution, although it is likely that Rice was involved; the five subsequent editions identified Rice as the author. The 59 formulae of the first edition included expectorants, laxatives and tonics. Separate instructions included the handling of poisons and rules regarding the quantity of medicines to be prescribed and sent to the floor: • No mixture, the dose of which is a teaspoonful, shall be ordered or sent in larger quantities than 2 oz. • No mixture, the dose of which is a tablespoonful, shall be ordered or sent in larger quantities than 4 oz. • If the bulk of a mixture above 2 oz. or 4 oz. respectively consists of water, it may be supplied in reasonable quantities. • All other medicines shall be prescribed or sent only in quantities sufficient to last 24 hours. Charles Rice reportedly began each day by testing the milk that was delivered to all of the city hospitals before

Pharmacy Heritage 27

Pharmacy Practice News • June 2010

Charles Rice spent his life at Bellevue as a pharmacist ensuring that the right medicine was available for patients for both the hospital and the nation.

Suggested Reading Anderson L, Higby GJ. The spirit of voluntarism: a legacy of commitment and contribution. The United States Pharmacopoeia 1820-1995. Rockville, MD: United States Pharmacopoeial Convention; 1995.

A page from the earliest centralized formulary, published in 1868 and likely authored by Charles Rice while he was at Bellevue Hospital.

Worthen DB. Charles Rice (1841-1901): Creator of the Modern Scientific Pharmacopoeia and Father of the National Formulary. J Am Pharm Assoc. 2004;44:521-523.

Charles Rice’s analytical laboratory at Bellevue Hospital, circa 1890.

going to his office. Once at work, he continued those efforts by being responsible for food products that were purchased for use at Bellevue. But as a pharmacist, he really shone by personally overseeing the requisitions for medical and surgical supplies prepared by pharmacists—not only at Bellevue but at other institutions in the system. His efforts to work for the public good were noteworthy at a time when it was said his was the only department that had not suffered through the influence of political intrigue at one time or another.

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Expert on Drug Adulteration Rice’s work at Bellevue and his personal friendship with Edward Robinson Squibb made him familiar with the problems and extent of pharmaceutical product adulteration. In 1880, he was named the chair of the USP Committee of Revision, a post he filled until his death in 1901. As chair, Rice quickly moved to organize an expanded and widely dispersed committee to “address the needs of professional practice, mass manufacturing and developing regulations against drug adulteration.” He advocated the incorporation of average doses into product monographs to provide useful information to the compounder. Rice also had an interest in providing pharmacists with tested formulas that the pharmacist could compound rather than depend on mass-produced products. He led the New York effort to prepare a formulary composed of unofficial formulas; many had been deleted from the previous issue of USP. This effort led to the first publication of the NF in 1888. Rice’s efforts in the development of modern compendial works on the identification and production of standardized medicines were formalized when the USP and NF were established as the official standards under the 1906 Pure Food and Drug Act, legislation that mandated the federal inspection of meat products and forbade the manufacture, sale or transportation of adulterated food products and dangerous patent medicines.

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28 Clinical

Pharmacy Practice News • June 2010

Cardiology

Genetic Warfarin Test Reduces Hospitalizations Atlanta—Genotyping patients taking warfarin to determine their sensitivity to the drug resulted in a 30% reduction in all-cause hospitalizations and hospitalizations for bleeding and thromboemboli, according to research presented at the American College of Cardiology (ACC) 2010 Scientific Sessions. “Genetic testing is a tool clinicians can use to more accurately predict the best warfarin dose early on,” said Robert S. Epstein, MD, chief medical officer and president of Medco Research Institute, Franklin Lakes, N.J. “Patients may get to a stable dose more quickly, and therefore have a lower risk of negative outcomes.” Dr. Epstein led the Medco-Mayo Warfarin Effectiveness Study (MMWES), which he said was the first national, prospective, comparative effectiveness study to evaluate the role of genetic testing in helping physicians determine the optimum dose of warfarin and to monitor intensity during the early, crucial, dose adjustment phase of treatment. “Warfarin exhibits large, interindividual dosing requirements, and [that variation] is a leading cause of morbidity and mortality,” Dr. Epstein explained. “It can take weeks or months of repeated blood tests and dose adjustments to determine the right dose for each patient. During that time, patients are at high risk for either thromboembolism from too little warfarin or dangerous bleeding from too much warfarin.” For the study, Dr. Epstein and his team recruited 896 men and women, aged 40 to 75 years, who were being placed on warfarin for the first time. All participants were members of a prescription benefits plan managed by Medco Health Solutions, and came from 49 states and a variety of practice settings. Shortly after starting warfarin therapy, patients gave a blood or buccal swab sample that was analyzed for expression of two genes, CYP2C9, which influences warfarin’s pharmacokinetics, and VKORC1, which influences the drug’s pharmacodynamics. These two genes account for approximately 33% of the variation in warfarin dosing. All samples were analyzed at Mayo Clinic in Rochester, Minn.

Detailed Patient Reports Compared with historical controls who did not undergo genetic testing, patients who had genetic testing were 31% less likely to be hospitalized for any cause during the first six months of warfarin therapy (adjusted hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.58-0.82; P<0.001). They were

also 28% less likely to be hospitalized for bleeding or thromboembolism (HR, 0.72; 95% CI, 0.53-0.97; P=0.029). When the researchers looked at physician response, they found that more than 75% of physicians agreed to have

and you can get a return back within 24 hours,” Dr. Epstein told Pharmacy Practice News. “Rather than wait through trial and error and measure the [international normalized ratio] test over time, this can give you a quick read on

‘It’s a very simple test to administer. The sample can be obtained with a cotton-tipped applicator that can be sent through the mail to a laboratory, and you can get a return back within 24 hours.’ —Robert S. Epstein, MD

warfarin genotyping tests on the market, and major laboratories are able to interpret them. However, although genotyping is readily available, “it is not readily reimbursed by all payers—at least not yet,” he said. “Once we continue to show results such as these, I expect that this will change.” The tests cost between $200 and $400, depending on the lab. Dr. Epstein said it is well worth it. “If you can avoid one or two hospitalizations per hundred patients, you’ve more than paid for the test on a population level. Plus, you only need to take the test once. This is your genetics; your genes don’t change.”

Results Are Exciting, But …

‘The CYP2C9 and VKORC1 genes affect only 33% of the warfarin variability. This test may give practitioners a false sense of security when monitoring patients on warfarin, resulting in decreased monitoring and increased risk of bleeding.’ —Kelly Nystrom, PharmD

Kelly Nystrom, PharmD, assistant professor of pharmacy practice at Creighton University, Omaha, Neb., offered a more cautious view about the utility of genomic testing for warfarin sensitivity. She told Pharmacy Practice News: “While I think the results of Dr. Epstein’s trial are exciting, the article he refers to … states that pharmacogenetic testing would not be cost-effective unless three criteria were met: prevention of more than 32% of major bleeding events, availability of results within 24 hours and cost of less than $200. I don’t think there are many sites currently that could meet all three criteria.” Dr. Nystrom added, “We must also remember that the CYP2C9 and VKORC1 genes affect only 33% of the warfarin variability. This test may give practitioners a false sense of security when monitoring patients on warfarin, resulting in decreased monitoring and increased risk of bleeding.” —Fran Lowry

their patients tested. “We looked at the next prescription filled at the pharmacy within three weeks of the laboratory report and found that about 50% of the patients returned for a refill of their prescription,” Dr. Epstein said. “The doctor paid attention to the genotype, reordered the warfarin, and the dose went up or down according to what the genetics implied.” He added that the findings of his study are in line with results from a meta-analysis of three clinical trials of warfarin genotyping published in 2009, that showed a 32% decrease in major bleeding (relative risk, 0.68; 95% CI, 0.22-2.06) with genotyping compared with no genotyping (Ann Intern Med 2009;150:73-83). “It’s a very simple test to administer. The sample can be obtained with a cotton-tipped applicator that can be sent through the mail to a laboratory,

what those patients’ requirements are at the time you start therapy.”

Pharmacists Can Help Despite these advantages, less than 2% of doctors nationwide are actually using the test. This means an opportunity for pharmacists to inform them about the need for the test, he said. “Pharmacists are in a great position to educate physicians, because they really don’t know. But pharmacists would understand this very well,” Dr. Epstein noted. “They have a background in pharmacokinetics and pharmacodynamics and they are right there, receiving the prescription at the first dose, so they can pick up the phone and remind physicians about the test.” Dr. Epstein added, “It’s a good opportunity to counsel people about an important new technology.” There are at least four FDA-approved

The study was supported by Medco Research Institute and Mayo Clinic Center for Individualized Therapy. Dr. Epstein and Dr. Nystrom have reported no relevant financial relationships.

What’s Your View? =?6;A

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Should genetic testing for warfarin sensitivity become the standard of care? Are other pharmacogenetic tests undervalued and underused?

Send replies to

ppneditor@mcmahonmed.com

Clinical 29

Pharmacy Practice News • June 2010

Cardiology

Targeting Peri-op Blood Pressure Pays Off C areful control of blood pressure during cardiac surgery pays off in significantly lower hospitalization costs for the patient, according to a study presented at the 2010 annual meeting of the Society of Cardiovascular Anesthesiologists, in New Orleans (abstract 6). If blood pressure rises too high or falls too low during any major surgery, the outcomes often are less than optimal. Several serious complications, including stroke, myocardial infarction or renal disease, can arise and result in more money spent on treatments and prolonged lengths of stay. “At the end of the day, tight blood pressure control saves money,” said lead author Alan Multz, MD, chairman of medicine at Nassau University Medical Center in East Meadow, N.Y. Although the link between perioperative control of blood pressure and patient outcomes has been studied in detail, there is less data on its relationship with cost—a particularly important variable in light of the poor state of the U.S. economy and the notorious economics of the nation’s health care system. To tease out the connection, Dr. Multz’s team collected blood pressure and clinical outcome data from 1,512 patients who underwent coronary artery bypass grafting, valve replacement or valve repair surgery as part of the ECLIPSE (Evaluation of CLevidipine In the Perioperative Treatment of Hypertension Assessing Safety Events) trials. Then they matched their resulting complications and lengths of stay to cost data obtained from a database of inpatient discharges at Massachusetts General Hospital (MGH), in Boston. To quantify how “tight” blood pressure was controlled, the researchers measured deviations of systolic blood pressure from what is considered normal: 75 to 135 mm Hg during surgery and 85 to 145 mm Hg before or after surgery. Both magnitude (in mm Hg) and duration (in minutes) of these excursions were captured as the area under the curve (AUC) and normalized per hour. For example, an average of 0 mm Hg per minute per

hour meant that a patient’s blood pressure always stayed within the normal range. “The area under the curve is not standard in clinical practice,” Dr. Multz said. “However, it is a good way—in our opinion—to look at the quality of blood pressure control.” After adjusting for potential confounding factors, such as age, preoperative heart rate and duration of surgery, the researchers found that a perioperative AUC below 10 mm Hg per minute per hour was associated with 7.2% lower costs (P=0.018) compared with an AUC above 10. A reduction in the AUC from above to below 10 mm Hg per minute per hour translated into an average savings of $3,493. Overall, the mean costs were $46,883 for ECLIPSE patients with an AUC below this threshold, and $52,407 for those whose values fell above it. Previous analyses of the ECLIPSE trials have shown an association between precise blood pressure control and improved clinical outcomes. “We feel that one of the medications that was studied in the ECLIPSE trial, clevidipine [Cleviprex, The Medicines Company], really accomplishes tight blood pressure control quickly, and limits some of the variability in the area under the curve that you see with other things like nitroglycerin or sodium nitroprusside,” Dr. Multz said. The Medicines Company funded the ECLIPSE trials and also supported the latest study. Dr. Multz also has received consulting fees from the company.

In addition, ECLIPSE was not designed to analyze hospitalization expenses. “These secondary analyses related to outcomes and associated costs are fascinating, but they should be considered hypothesis-generating, since the original study design and methods were geared toward measuring the efficacy of a newer antihypertensive agent,” said David Reich, MD, chairman of anesthesiology at Mount Sinai Medical Center in New York City. Furthermore, not everyone agrees that AUC is a useful measure of blood pressure control. “While AUC was clearly associated with adverse events in this investigation and the ECLIPSE trial, there may be other and perhaps more valid and reliable approaches to summarizing departures from [blood pressure] normality,” Dr. Reich said. No distinctions could be made between hypotension and hypertension, for example, because both could produce an identical AUC. Dr. Reich suggested that deviation from normal of mean arterial pressure is potentially a better measure for these types of analyses than systolic blood pressure, because it is less affected by monitoring artifacts, such as dampened arterial line tracings. With certain study design modifications, Dr. Reich said, future work based on the researchers’ “thought-provoking” data should shed new light on whether intraoperative blood pressure control yields “meaningful [improvements in] patient outcomes following cardiac surgery and high-risk noncardiac surgery.”

Study Limitations

Pharmacist’s Perspective

Aside from the potential conflict of interest, a few other limitations of the research exist. The information on complications and lengths of stay was based on retrospective data and matched to only one year of cost data extracted from the MGH database. The matching was necessary to compare similar cohorts of patients, he said. “We are looking into expanding our analysis prospectively to see if we reach the same conclusions,” Dr. Multz added.

Asked to comment on the study, C. Michael White, PharmD, professor of pharmacy, University of Connecticut, and director, UCONN/Hartford Hospital Evidence-Based Practice Center, said that the reported AUC methodology used by the investigators “is a reasonable measure of blood pressure control over time. This study shows that patients who have the ability to maintain normal blood pressure control after major surgery have fewer hospital costs.”

Reducing blood pressure AUC to below 10 mm Hg per hour yielded an average savings of $3,493. But Dr. White had some caveats for clinicians who are tempted to push hard when applying the findings in clinical practice. “What I worry about is that people will jump the gun and try to force tight blood pressure control on patients, which is not what this study assessed,” he said. “Remember the tight glucose control fiasco, where we knew that people who underwent aggressive therapy did better than those without tight control, but when we tried to force people to maintain tighter control with rigorous insulin regimens, we did not receive the expected benefits. This is likely because there are big confounders in these retrospective trials that cannot be matched for or teased out, and those with tighter glucose control were not the same as those with poor control. “I fear the same is true for blood pressure control, where things like atrial fibrillation can cause blood pressure to go down and a myocardial infarction can cause blood pressure to increase or decrease depending on the type of infarction and its time-course. It may be these comorbidities or complications that cause blood pressure instability, not that blood pressure instability was causing these events.” —Lynne Peeples

In Brief Dexilant PPI (Formerly Kapidex) Now Available in Pharmacies

akeda Pharmaceutical’s newly named dexlansoprazole proton pump inhibitor (PPI) is now available in pharmacies across the United States. The PPI, formerly called Kapidex, is now called Dexilant, according to a press release from the company. After receiving reports of dispensing errors under the name Kapidex, Takeda, in coordination with the FDA, decided

that changing dexlansoprazole’s trade name to Dexilant would be the best way to minimize future errors. The formulation, indication and approved dosages of Dexilant remain the same as that of Kapidex, which was originally approved by the FDA in January 2009. Dexilant is a once-daily, oral medication indicated for the treatment of heartburn associated with symptomatic nonerosive gastroesophageal reflux disease, the healing of erosive esophagitis (EE) and the maintenance of healed EE.

The drug is a PPI designed to provide two separate releases of medication. For full prescribing information, visit www.dexilant.com. Individuals and health care professionals who have questions about the name change should contact Takeda at (877) TAKEDA-7. Errors involving Dexilant or any other products should be reported to the FDA MedWatch program online at www.fda.gov/medwatch. —Staff

30 Clinical

Pharmacy Practice News • June 2010

Formulary Focus

GPO-Level Echinocandin Switch Yields Savings Gita Wasan Patel, RPh, PharmD, BCPS Clinical Pharmacy Coordinator The Medical Center of Plano Plano, Texas

John Theobald, PharmD Director, Clinical Pharmacy Services HealthTrust Purchasing Group Brentwood, Tennessee

ealthTrust Purchasing Group (HPG) supports nearly 1,400 notfor-profit and for-profit acute care facilities, as well as ambulatory surgery centers, physician practices and alternate care sites. With an annual purchasing volume of more than $17 billion, including approximately $3.5 billion in pharmaceuticals, HealthTrust is committed to obtaining the best price for clinically recommended products, ensuring their timely delivery and continuously evaluating and improving its services to the patients, physicians and clinicians it serves. Echinocandins are a novel class of antifungal agents that have increased in use over the past several years based on new clinical practice guidelines for the treatment of candidemia issued by the Infectious Diseases Society of America (CID 2009;48:503-535). Since 2007, HPG had seen an increase in the use of these products, with an annual spend of approximately $20 million. HPG evaluated the echinocandin class throughout 2008 and made the decision, based on clinical merit, to pursue micafungin (Mycamine, Astellas Pharma Inc.) as the echinocandin of choice for the entire

in September 2008, members received best pricing on micafungin. Data collected included market share of caspofungin, anidulafungin and micafungin pre- and postconversion and the cost

group purchasing organization (GPO). An implementation toolkit was authored to assist hospitals with the conversion process. A thorough literature search was performed on all three agents in the echinocandin class. The toolkit consisted of a comparison of the agents as it pertained to indications, therapeutic uses, pharmacokinetics, dosing, adverse events and drug interactions. A review of the 2009 updated candidemia guidelines provided the framework for the appropriate use of these agents. The toolkit also provided an abridged document that could be submitted to hospitals’ Pharmacy and Therapeutics Committee for approval and a memo that could be disseminated to medical, nursing and pharmacy staff for education. Multiple webcasts were offered to discuss the clinical data and answer any questions the members had. A GPO–vendor relationship with Astellas Pharma Inc. provided dual support for implementation. HPG provided three levels of support to the membership: Implementation Toolkit/ CE Webcast, clinical pharmacy consult service and physician liaison support. Also, monthly conference calls to corporate member pharmacy leadership occurred to ensure health systems and facility pull-through. There was a ninemonth ramp-up period to convert sites from caspofungin (Cancidas, Merck & Co.) and anidulafungin (Eraxis, Pfizer) to micafungin, with a 75% market share requirement for best pricing based on equivalent milligram utilization. During the ramp-up period, which began

•

see ECHINOCANDINS, page 32

Conversion programs:

A Model for Your Hospital? Robert R. Rapp, PharmD, FCCP Professor of Pharmacy University of Kentucky College of Pharmacy Lexington, Kentucky

his switch program is something that many hospitals are now implementing because the echinocandins are viewed by most Pharmacy & Therapeutics committees to be clinically equivalent. Five years ago, there may have been some debate about that. But with the publication of a study by Pappas et al (Clin Infect Dis 2007;45:883-893), which was first reported at the 2007 ICAAC annual meeting, we had the evidence needed to establish that micafungin was noninferior to caspofungin for the treatment of candidemia. The study included adult patients with candidemia and other forms of invasive candidiasis randomly divided into three treatment groups: micafungin 100 mg daily (n=191), micafungin 150 mg daily (n=199) and caspofungin 70 mg followed by 50 mg daily (n=188). Clinical and mycologic success ranged between 71.4% and 76.4% among the three groups—a statistically nonsignificant difference. As soon as that study was published, we declared these drugs absolutely interchangeable, and ever since that time we’ve been a micafungin hospital because the drug was available at the best price—and it is effective. Is there room for other approaches? You can split hairs and cite the fact that caspofungin has the rescue indication for aspergillosis. But most of the use of echinocandins is for candida, so consequently we rely on micafungin, and most hospitals that I know of have done the same thing. Still, this article is very useful, because it outlines the rationale for conversion to micafungin, and details an effective approach for partnering with a GPO to maximize the impact of the therapeutic switch program. The only caveat I would offer is that pharmacists sometimes focus too much on the cost of antibiotics rather than the whole patient. It’s important to remember that antibiotics account for only 2% of the overall cost of care for many seriously ill patients; the remaining 98% of the clinical picture should not be ignored.

UTILIZATIONa

COST SAVINGS

Caspofungin

Anidulafungin

Micafungin

Combined

7% 10%

80%

90%

$, Millions

10%

savings yielded from the conversion. Prior to the conversion, the echinocandin utilization (based on milligram equivalents) was caspofungin,

15 10 5 0

2007 Preconversion: September 2008

Postconversion: August 2009

Figure. Impact of echinocandin conversion program. a

Market share based on milligram % equivalents

2008 Annual Echinocandin Spending

2009

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32 Clinical

Pharmacy Practice News • June 2010

Formulary Focus

Alvimopan Helps Reduce Length of Stay, Cost of Care Postoperative ileus drug promotes GI recovery following bowel resection

harmacist-led studies at two hospital systems found that the use of alvimopan (Entereg, Adolor/GSK) in patients undergoing partial bowel resections reduced their average hospital length of stay (LOS) by at least one day, resulting in considerable total cost savings for the hospitals. At Moses Cone Health System in Greensboro, N.C., pharmacists evaluating the findings of a six-month study reported that the average LOS for 51 patients treated with alvimopan was 1.2 days less than for a similar group of control patients who were not administered the drug. For laparoscopic patients, the reduction averaged 0.9 days, according to the investigators. In another, smaller study, pharmacists at St. Joseph’s Medical Center in Stockton, Calif., found that use of alvimopan “resulted in an approximately 20-hour earlier restoration of bowel function” and an LOS reduction of 2.5 days compared with patients who did not receive the drug, according to William P. Yee, PharmD, clinical information coordinator for the medical center. Although the study involved only six patients, Dr. Yee called the findings “promising,” and said “the data seem to be holding up” since the early results were tabulated for a poster that was presented at the American Society of Health-System Pharmacists Midyear Clinical Meeting in December 2009. Alvimopan is an oral µ-opioid receptor antagonist approved for accelerating gastrointestinal (GI) recovery in adult patients receiving IV opioid therapy following partial large or small bowel resection with primary anastomosis. It acts peripherally to block the effects of opioids on GI motility and

ECHINOCANDINS continued from page 30

80%; anidulafungin, 10%; micafungin, 10%. The market share one year after the switch program began was caspofungin, 7%; anidulafungin, 3%; micafungin, 90%. The cost savings during eight months of the initial ramp-up period was approximately $4 million,

Coming in the August issue: “A Sepsis Story,” by 2009 ASHP Best Practice Award winners Gita Wasan Patel, PharmD, and Nicki Roderman, MSN. Read about how a community hospital successfully tackled the issue of sepsis bundles.

secretion without reversing their central analgesic effect. More than 80,000 patients undergo open bowel resections in the United States each year, spending an average of 15.9 days in the hospital at a mean cost of just under $83,000 per procedure, according to the Agency for Healthcare Research and Quality (AHRQ). The average LOS for laparoscopic bowel resections is much smaller, according to the AHRQ (http://www.ahrq.gov/data/ hcup/factbk7/factbk7d.htm).

Formulary Concerns Linda W. Benares, PharmD, who led the Moses Cone study, told Pharmacy Practice News, “Alvimopan was a very new drug when a request was made by our surgeon group to add it to the formulary. Because ecause it was a fairly expensive ve medication, we wanted d to see if we could mimic the [0.88day reduction in]] length of stay” reported in n the original clinical trials.. When the pharmacy harmacy team looked at total costs for the alvimopan-treated group, they found an average per-patient saving of $1,042 for those undergoing ing open procedures res and $338 for those ose receiving laparososcopies, according ng to Dr. Benares, s, who was a firsttyear resident att the time of the study. She has

with an extrapolated annualized cost savings of approximately $6 million. The cost savings calculations did not account for the Wholesale Acquisition Cost (WAC) pricing that other products would defer to once taken off contract, but is based on actual contract pricing of these agents at baseline.

A Repeatable Success From a facility standpoint, similar economic results have been appreciated by HealthTrust member facilities. The Medical Center of Plano (TMCP) is a 437-bed facility that is part of Hospital Corporation of America and uses HPG as its GPO. TMCP made the conversion from caspofungin to micafungin in January 2009, and subsequently began tracking patients postconversion. The

since moved on to Parkland Health and Hospital System in Dallas, for a secondyear residency in ambulatory care. The team arrived at the savings by comparing the retrospective average daily cost per patient of bowel resections at Moses Cone for open cases ($1,357) and laparoscopies ($938) with the average daily per-patient costs in the study group. The latter included a $61 per-dose cost of alvimopan. The multihospital Moses Cone Health System averages 500 bowel resections per year, but Dr. Benares said, “Only a small portion would be eligible based the prescribing criteria that we implemented at the hospital.” The criteria ruled out patients unable to take oral medication preoperatively because of preexisting bowel obstruction or acute abdowhose nasogastric tubes men or whos could not be removed one day surgery. Also excluded were after surgery end-stage renal patients with w disease or overt hepatic failure. o Of the 51 5 alvimopan-treated patients in i the study group, 28 (55%) underwent open procedures procedur and the remainder laparoscopies. Eighlap teen (35%) were being treated treat for colon cancer, 15 (29%) for colon pol(2 yps, 11 (22%) for diverticular ticula disease and the rest for other conditions. tions Patients enrolled in the t open-label study received one dose of rec alvimopan 12 mg prealv operatively and two op doses per day for up do to t seven days following i surgery.

When the positive alvimopan data were presented to the Pharmacy and Therapeutics Committee, Dr. Benares said the drug was approved for long-term inclusion in the health system’s formulary. Erin R. Fox, PharmD, manager of the Drug Information Service at University of Utah Hospitals & Clinics, Salt Lake City, said, “These data highlight the important role clinical pharmacists have in evaluating appropriate medication use for patients. For a drug like alvimopan, the pharmacy department may have a difficult time justifying the additional cost of the medication without data demonstrating a shorter length of stay.” Clinical pharmacists, Dr. Fox noted, “can play a key role in developing guidelines to ensure appropriate use, evaluating patient candidates for treatment to ensure guidelines are met, and following up on data to demonstrate decreased length of stay and overall decreased costs to the organization. The pharmacy budget may increase, but overall the organization benefits.” Dr. Fox added that pharmacists handle another potentially challenging aspect of alvimopan therapy: managing the Risk Evaluation and Mitigation Strategy (REMS) associated with the drug. When the FDA approved alvimopan, she explained, the agency required hospitals using the drug to adopt a REMS to ensure that the benefits of the medication continue to outweigh the risks. “Hospitals have to receive special certification, distribute educational materials to health care professionals and monitor the drug’s effectiveness regularly,” she said. “That can be a fairly arduous task, and we should be able to help.”

conversion was quick and simple, fully supported by HPG’s implementation toolkit. After discussions with and approval from the main infectious disease physicians at the facility, TMCP’s Pharmacy and Therapeutics Committee approved an automatic interchange. Pharmacists were able to change all caspofungin orders to micafungin 100 mg daily unless aspergillosis was suspected, in which case a 150-mg daily dose was used. From January 2009 to March 2010, approximately 90 patients at TMCP were treated with micafungin. The predominant indications were candidemia and Candida present in the sputum/ bronchial washings, and the dose most frequently administered was 100 mg daily. Only two patients received the

150-mg daily dose, one for refractory aspergillosis and the other for highly resistant esophageal candidiasis. TMCP saved more than $11,000 in 2009 based on the contract pricing for both agents. That savings is more substantial now that caspofungin is available at the WAC versus the contract price. HPG was able to navigate an extremely successful GPO-wide conversion to micafungin as the primary echinocandin. This initiative was successful from an economic and clinical standpoint due to the multilayered support provided by HPG to its membership and the partnership with Astellas, both of which helped to ensure that appropriate information was disseminated at a grassroots level. ■

—Bruce and Joan Buckley

34 Technology

Pharmacy Practice News â&#x20AC;˘ June 2010

Bar Coding

SYRINGE LABELS continued from page 1

Pharmacy satellites at the University of Maryland Medical Center (UMMC), in Baltimore. Dr. Rushe stressed that preparing doses in the pharmacy â&#x20AC;&#x153;is always the best way to ensure safety.â&#x20AC;?

Not a Lone Struggle Wilton C. Levine, MD, clinical director of anesthesia, critical care and pain medicine at Massachusetts General Hospital (MGH), who led the research, said that the bar codeâ&#x20AC;&#x201C;based syringe-labeling

project â&#x20AC;&#x153;started about three years ago as an internal compliance project and very quickly became a patient safety project. We suspected we had difficulty meeting all the regulatory compliance for properly labeling syringes, and we knew from talking to our colleagues around the country that we were not the only ones who struggled with this.â&#x20AC;? Dr. Levine and his colleagues set out to create a simple, user-friendly system that could quickly and easily generate a label meeting all of the regulatory compliance requirements of the Joint Commission.

The result is the SmartLabel a artLabel system, which producess Joint Commission- and ASAA compliant syringe labels bels on demand at the point n nt of care. â&#x20AC;&#x153;When you use this new bar-coding system, you take a vial of medication that a at you want to draw up into a syringe and scan it,â&#x20AC;? ,â&#x20AC;? said coinvestigator Karen Nanji, MD, a resident at MGH. â&#x20AC;&#x153;A few seconds later, it prints a label with the name of the medication, the concentration, the date and time

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it was drawn up, expiration information and the name of in the th he person who drew it up.â&#x20AC;? The system produces an audiT readout of the drug name and ble rrea concentration where appropriate, conce ent as welll aas any alerts if the vial has expired. all â&#x20AC;&#x153;And al ll of that happens as youâ&#x20AC;&#x2122;re drawing up tthe medication,â&#x20AC;? Dr. Nanji said. â&#x20AC;&#x153;So by tthe time itâ&#x20AC;&#x2122;s in the syringe, the label is ready to go. This is where the time-saving comes in, because you donâ&#x20AC;&#x2122;t have to manually write all the information after youâ&#x20AC;&#x2122;ve drawn up the drug.â&#x20AC;? In the first of two studies presented at the 2009 annual meeting of the ASA (abstract A609), the researchers evaluated physiciansâ&#x20AC;&#x2122; baseline compliance with labeling requirements over a one-month period. Syringes were assessed for a variety of elements, including drug name, concentration, preparation date and time and clinician initials. SmartLabel was then installed in five operating rooms. The study found that of the 1,090 syringes evaluated as part of the baseline study, 497 (45.6%) were prefilled by the pharmacy or a third-party vendor, whereas 593 (54.4%) were prepared by the clinician. Of those prepared by clinicians, only 269 met Joint Commission requirements for proper labeling. Failure took many forms: 257 labels carried only the drug name; 35 had the drug name and concentration but no expiration date; and 32 syringes had no label at all (Figure, page 36). After the labeling system was implemented, the researchers evaluated 340 labels, 139 of which (41%) were prefilled. Of the remaining 201 (59%) prepared by clinicians, 100% were fully compliant with both Joint Commission and ASA requirements.

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In a second study (abstract A612), the investigators observed and timed 64 clinicians during preparation of three medicationsâ&#x20AC;&#x201D;succinylcholine, propofol and atropineâ&#x20AC;&#x201D;using the SmartLabel system and conventional, manual-entry techniques. At the conclusion of the study, participants also completed a survey about their experiences. Preparation times were shorter using the SmartLabel system (129.9 vs. 138.6 seconds; P=0.01). This difference persisted for all three drugs: propofol, 50 versus 56.6 seconds; succinylcholine, 43.7 versus 44.6 seconds; and atropine, 38.2 versus 41.4 seconds. Twenty errors were found in the 192 syringes prepared using the conventional method (10.4% error rate). These errors included incorrect time or date and wrong concentration of the drug. No errors were found using the SmartLabel system.

â&#x20AC;˘

see SYRINGE LABELS, page 36

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36 Technology

Pharmacy Practice News • June 2010

unSummit 2010

Ten Years of Bar Coding Fosters Turnaround at VA puterized data searches and identifying problems and deficits. The inforp mation can’t get misplaced. Hurricanes or floods don’t Hurr destroy it, as we learned dest with Katrina. We were up wit and running the next day an because every site could b pull up the information for our patients iin New Orleans. Those patients were then sent p to their local pharmacies if tthey needed medicaThere was a problem with tions. The

Atlanta—Ten years ago, the hospitals that made up the Veterans Affairs (VA) health care system in the United States were considered by many to be the worst in the world. Now, VA is credited with running some of the best health care systems in the nation. What happened to trigger the turnaround? According to Ronald Schneider, RPh, MHA, pharmacist consultant to the Department of Veterans Affairs, it was technology—specifically bar-code medication administration (BCMA). “When I started in the VA 22 years ago, we were not the best health care in the world. We were pretty bad. People didn’t want to come to us. We have changed that. We are now considered the best health care system in the world,” he said, referring to a book called “The Best Care Anywhere” by Phillip Longman, which touts VA’s use of information technology and bar coding to streamline and enhance patient care. “We didn’t pay this guy to write this. We were stunned when he wrote it, but we were very happy,” said Dr. Schneider, who detailed VA’s transformation from the worst health care system to the best at the unSUMMIT 2010 meeting here. The integrated approach that has turned VA from second rate to a leader in efficiency and quality is called VistA, which stands for Veterans Health Information Systems and Technology

Architecture. It is used throughout VA in all of its health care settings, g , including inpatient, outpatpatient and long-term care. “It’s an integrated system,” Dr. Schneider explained. “All our systems talk to each other. We don’t buy a system for billing, we don’t buy a system for pharmacy. It’s t’s all homegrown and everyerything is available everywhere here throughout VA.” The lynchpin of VistA is

its Computerized Patient Record System (CPRS), an electronic health record that contains data on all VA patients. Its advantages are numerous, Dr. Schneider said. “Every VA health care system has CPRS. It can call up any patient record anywhere. Diagnostic images are part of the record, and it simplifies data retrieval, enabling com-

mailing stuff out to them because their homes were destroyed, but we allowed them to walk into a CVS or Walgreens and get their medications on us. The pharmacies refilled and billed us.” The ability to do extensive data searches has resulted in discoveries of important clinical findings, he noted. For example, a cardiologist noticed that

SYRINGE LABELS

(some serious) or are more likely to generate regulatory issues,” she said. “So, no doubt, automation of the labeling process has its benefits.” At UMMC, Dr. Rushe said, “we’re striving to lower the [percentage of medications prepared by the OR staff ] by enhancing our ability to stock premixed syringes in the OR.” The limiting factor, to date, has been automated drug cabinets (ADCs) that need to be retrofitted to accommodate the larger size of the premixed syringes. “The ADCs we currently have in our OR suites can handle some prefilled syringes, but the space is insufficient to meet the anesthesiologists’ needs. We’re adding drawers with new reconfigurations that can stock more premixed syringes.” Two new drugs—ephedrine and phenylephrine—are currently being added, Dr. Rushe said. Other premixed medications that may be stocked include rocuronium, succinylcholine, fentanyl and methadone. The cart reconfiguration effort yields multiple benefits, Dr. Rushe noted. “The most obvious is that the medications are prepared in the pharmacy department in compliance with USP Chapter <797> sterile compounding regulations,” she said.

“Bottom line, pharmacy-based preparation of sterile products for the OR decreases the risk for contamination and reduces the potential for error.” Dr. Rushe pointed to another benefit: “When a premixed syringe is removed from the ADC anesthesia cart, its bar code can be scanned for charge capture, thus maximizing drug reimbursement.” And once UMMC connects the ADC system to the electronic anesthesia record the facility is planning to roll out, she said, “we’ll have an effective tool for identifying drug diversion.”

continued from page 34

As Dr. Nanji told Pharmacy Practice News, clinicians readily accepted the automated labeling system. “We found that 86% perceived it to be faster,” she said. “A full 95% thought it fit well into the workflow, 97% thought it was userfriendly and easy to use, while 98% thought it improved patient safety. That kind of satisfaction data says a lot about how easy it is to implement as a system, because one of the biggest barriers to implementing new technology is physician resistance due to the technology not fitting well into their workflow.” Yet as with any type of technology, there is room for error. “The power could go out, or the machine could run out of ink or labels,” Dr. Levine said. “All machines have failure modes, but we accept them as part of the proposition.”

Premixed Meds Crucial Dr. Rushe said the fact that about half of the medications used in MGH ORs were drawn by OR staff makes sense, because a similar percentage occurs at UMMC. “The drawn medications are those that are more prone to error

‘We have added a bar-code quality clause and our suppliers have to give us bar codes that pass verification. We’ve kicked people off of VA contracts because they do not pass verification.’ —Ronald Schneider, RPh, MHA

blood pressure readings were going up in the winter. He then did a data search throughout the entire VA and found a cyclic trend to blood pressure—it does indeed rise in the winter and go down in the summer. The finding was presented by VA’s Ross Fletcher, MD at the American Heart Association’s 2007 Scientific Sessions and has since been replicated in other studies. “We can identify all kinds of problems and when you have millions of pieces of data, it’s very easy to try to correct some things,” Dr. Schneider commented. “We don’t have paper charts on our floors. We have everything we need to know about patients on laptops.”

Early Adopters of BCMA A second lynchpin of VA’s quality improvement efforts is BCMA. VA was one of the first health-care organizations to develop BCMA technology, which was piloted by field staff at the Topeka VA Medical Center in Kansas in 1994. In 1999, it was rolled out to 60,000 beds at all 172 VAs, and in 2003, 100% of all VA inpatient wards were using BCMA to document medication administration. Currently, 678,000 medications are scanned each day in VA hospitals, and 1.3 billion medications have been scanned since the inception of BCMA at VA. “If used correctly, BCMA eliminates

•

see VA TURNAROUND, page 38

A) No labeling elements

B) Name only

Can We Talk? An additional medication safety initiative at UMMC takes a lower-tech approach: a committee of nurses, pharmacists, nurse anesthetists and anesthesiologists that meets once a month to discuss issues that could impact the quality of OR care. “We call it our OR Medication Process Improvement Committee,” Dr. Rushe said, “and it’s impressive how constructive communication across the care team improves the identification of safe medication practices.” —Michael Vlessides, David Bronstein

C) Propofol without expiration

D) Joint Commission–compliant

Figure. Examples of noncompliant and compliant labels.

PATIENT SAFETY GUIDELINES AND HEALTH CARE COSTS W

38 Technology

Pharmacy Practice News • June 2010

Drug Compliance

VA TURNAROUND continued from page 36

errors at the point of administration, although the error rate will increase at the beginning,” Dr. Schneider noted. “Your error rate is going to go up at the start because there are all kinds of things that you are going to find out now that you never knew before. You won’t give medication to the wrong patient, but your variance will go up.” The use of BCMA has also permitted accurate documentation of resource needs. “Now we have the data to prove that we need more nursing staff. Before BCMA, if your nurses were having trouble delivering or administering medications to patients, there really was no way to accurately document it. But now we have the statistics to prove that we are only able to pass so many medications within the appointed time. So BCMA can do some good things for you,” he said. An adjunct to BCMA, Positive Patient Identification for lab specimen collection, also is planned. Overseeing the use of VA’s bar-code technology system is the Barcode Resource Office (BCRO), which was

first chartered in June 2003 as the BCMA Joint Program Office. The mission of the BCRO is to centralize and streamline communication channels between field and upper management, establish and maintain best-practice models, test and monitor software and hardware, and maintain equipment performance standards. “We have a point of contact in every one of our VA hospitals, so we know exactly who to go to and they know exactly who to go to,” said Dr. Schneider. “We test and monitor everything, which is something we did not do when we started BCMA.” Every year, the BCRO tests wristbands “to see if they really work.” It also has developed a bar-code verification process and in October 2004, established bar-code verification labs. As of December 2006, all scanners, bar-code printers, and bar code print media must meet minimum standards of the BCRO to be approved for purchase. “When we started, we did not have any contractual standards for bar-code quality. Putting a bar code on your product might meet the government regulation, but it could be the worst bar code in the world and wouldn’t

scan. Now we have added a bar-code quality clause and our suppliers have to give us bar codes that pass verification. We’ve kicked people off of VA contracts because they do not pass verification,” said Dr. Schneider.

software and vendor wristbands is beneficial to the entire health care industry, which has a positive impact on all of us,” Dr. Fahrni said in an interview with Pharmacy Practice News. He added that he was also impressed

‘[VA’s] continuous efforts to test and evaluate bar-coding hardware, software and vendor wristbands is beneficial to the entire health care industry, which has a positive impact on all of us.’

—Jerry Fahrni, PharmD

An Impressive Achievement Jerry Fahrni, PharmD, information technology pharmacist at Kaweah Delta Health Care District, Visalia, Calif. was impressed by Dr. Schneider’s presentation and VA’s programs. “The VA clearly takes BCMA/BPOC [bar-code point of care] seriously and has developed various systems for automated collection of bad bar-code scans, which they track and submit to the FDA for correction. Their continuous efforts to test and evaluate bar-coding hardware,

by the “amazing effort” VA has put into creating a single, well-integrated database in which all bar-coding information is housed. “The data is stored in a centralized repository where it is readily accessible for viewing and reporting via a simple Web interface. It’s refreshing to see someone developing a robust data collection system instead of creating silos that no one can get into.” —Fran Lowry

NEXT ISSUE

SPOTLIGHT on TECHNOLOGY Don’t miss our special Spotlight On section in the July issue, featuring the following pharmacy technology coverage: Q&A with Dennis Tribble, PharmD, FASHP, past chairman of the pharmacy informatics and technology section for the American Society of Health-System Pharmacists. Dr. Tribble discusses the importance of adding the “human element” to any technology rollout, and sees computerized decision support systems and interoperability as two pharmacy hot spots in particular need of “the human element.”

Pro/Con: Are remote telepharmacy systems the best method for providing 24/7 access to pharmacist review of drug orders?

Meeting Coverage: More news from unSUMMIT 2010, including reports on the best methods for training bedside barcoding practitioners and an update on whether radio frequency identification (RFID) technology is ready for prime time.

Safer Smart Pumps. In the wake of a major pump recall, what is being done to ensure the safety of the devices?

Clinical and Pharmacoeconomic Evaluation of Thrombin-Containing Products in the Hospital Setting

Online: www.appliedcme.com/thrombins E-mail:

thrombins@appliedcme.com

Phone:

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(815) 377-2470

Mail:

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Chair

July 24, 2010 The Westin New York at Times Square 270 West 43rd Street • New York, NY 8:00 AM - 8:30 AM 8:30 AM - 11:45 AM

Breakfast, Registration, Welcome Lectures, Case Studies, Q&A

For complete activity information and to register, visit www.appliedcme.com/thrombins.

Paul M. Ness, MD Director, Transfusion Medicine Professor, Pathology, Medicine & Oncology The Johns Hopkins University School of Medicine Baltimore, Maryland

Faculty

Mark A. Malesker, PharmD Professor of Pharmacy Practice and Medicine Creighton University School of Pharmacy and Health Professions Omaha, Nebraska

William D. Spotnitz, MD, MBA Director, Surgical Therapeutic Advancement Center Professor of Surgery University of Virginia School of Medicine Charlottesville, Virginia

Learning Objectives At the completion of this activity, participants should be better able to: 1. Analyze the clinical and economic effects of bleeding in the surgical setting, especially as they pertain to the management of acquired postoperative coagulopathy. 2. Describe key mechanisms that may underlie the development of acquired postoperative coagulopathy. 3. Assess relevant risks and beneﬁts of topical thrombins for achieving hemostasis. 4. Devise an inventory of considerations (eg, active components, clinical proﬁles, and pharmacoeconomic impact) by which topical thrombins should be evaluated, acquired, and used in the hospital setting.

Target Audience Surgeons and pharmacists

Accreditation Statements

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

Supported by an educational grant from ZymoGenetics

Physician: This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of AKH Inc. and Applied Clinical Education. AKH Inc. is accredited by the ACCME to provide continuing medical education for physicians. AKH Inc. designates this educational activity for a maximum of 3 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity. Pharmacy: AKH Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. AKH Inc. approves this application-based activity for 3 contact hours (0.3 CEUs). UAN 0077-9999-10-025-L01-P