July 2014

The Pharmacist’s News Source

pharmacypracticenews.com

Volume 41 • Number 7 • July 2014

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in this issue UP FRONT

3

Heparin errors down to zero at Roanoke Memorial Hospital.

OPERATIONS & MGMT

4 6

Is your pharmacy viewed only as a cost center?

Lessons in paring a pharmacy drug budget.

POLICY

11

Bonnie K.’s 10-step plan for avoiding common billing errors.

CLINICAL

14 18 20

New report underscores dangers of marijuana.

FDA approves dalbavancin for skin infections.

Adding prevention to the C. difficile equation.

WEB EXCLUSIVE

pharmacypracticenews.com

W Navigating the BarcodeAssisted Medication Preparation Market, by Mark Neuenschwander and Jerry Fahrni.

Improved Coding, Informatics Fuel BMC Turnaround Boston—In fiscal year 2009, Boston Medical Center (BMC) was ranked in the bottom quartile of large academic hospitals in the University HealthSystem Consortium (UHC) on a key quality measure—the observed-toexpected mortality ratio. Today, the medical center is in the top quartile for this critical outcome.

BMC achieved the turnaround by employing a variety of quality improvement (QI) strategies, including using analytics to promote a culture of partnership and accountability, correcting ICD-9 diagnostic coding errors and improving several key aspects of patient care, with pharmacists playing an integral role in the process.

The turning point for BMC occurred in 2008, when it joined UHC, a network of hospitals that includes most of the nation’s leading academic medical centers. Each month, UHC members are required to send data that are standardized across all consortium hospitals. BMC learned that between

•

From the ASHP Meeting:

Technology Helps Lessen Risk of ‘Tight’ BG Control

Las Vegas—Walking the tightrope of “tight” blood glucose control has gotten significantly less risky at BJC HealthCare.

By combining sophisticated data processing with scorecards and other quality improvement (QI) tools, pharmacists and nurses at the St. Louis–based health system have helped slash the rate of severe hypoglycemia—a common side effect of the aggressive glucose treatment protocol—by nearly 60% and saved $7 million in related costs.

•

see TURNAROUND, page 22

see TIGHT CONTROL, page 16

Negative ALTTO Trial Shakes Up Breast Ca Research

ASHP Highlights Need for Strong Ambulatory Pharmacy Biz Models

Chicago—Negative results from the Phase III ALTTO trial have put the kibosh on using dual anti-HER2 therapy with lapatinib (Tykerb, GlaxoSmithKline) and trastuzumab (Herceptin, Genentech) in the adjuvant breast cancer setting. The study results have also undermined the use of smaller neoadjuvant breast cancer trials to identify therapies that will work in the adjuvant setting.

Dallas—The health care landscape is continuing its shift toward accountable care models that reward providers for delivering high-quality, costeffective care—a trend that can yield big dividends to ambulatory care pharmacists. But taking advantage of this opportunity requires a business savvy that the profession may not have—at least not yet.

To help fill that gap, the American Society of Health-System Pharmacists (ASHP) has focused the third domain of its new ambulatory care recommendations on the development

•

see SHAKE-UP, P page 15

New Product PharMEDium introduces patient safety-focused labeling system.

See pages 13 & 16

of sustainable business models that can help hospitals navigate this challenging transition. In this third installment of a four-part series, Pharmacy Practice News presents the key components of the business-focused domain, with commentary by key stakeholders.

Domain 3.1: Provider Status One of the most important determinants of success in ACOs and other new business models is for pharmacists to attain

•

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Up Front 3

Pharmacy Practice News • July 2014

Capsules

Heparin Errors Reduced Via Collaboration, Communication Las Vegas—After implementing a collaborative process to deal with an increase in heparin infusion errors averaging nearly one per month, a community teaching hospital has not recorded a single error causing harm since June 2012, according to a study presented at the American Society of Health-System Pharmacists Summer Meeting (poster 19-M).

Carilion Roanoke Memorial Hospital (CRMH), a 763-bed level 1 trauma center and regional referral center in Roanoke, Va., conducted a failure mode and effects analysis (FMEA) in 2011 to determine the causes of the heparin errors. The FMEA showed that a lack of knowledge regarding heparin therapy among staffers, poor communication between departments and inadequate comprehension of the proper heparin titration protocol were among the major obstacles to improving how the anticoagulant was being managed in the hospital.

Despite addressing these issues, the heparin error rate remained high, according to Victor DeLapp, PharmD, BCPS, a medication safety clinical specialist in the Department of Pharmacy Services at CRMH, and the primary

study author. Specifically, 17 errors with harm involving heparin infusions were reported from January 2011 to June 2012, which accounted for 7.8% of all heparin errors reported during this period, significantly exceeding the 3.1% rate of errors causing harm reported to the Joint Commission’s sentinel events database (http://bit.ly/1sBAylf ).

Not only can such errors put patients at increased risk, they also create a financial burden. Researchers in one study found that the cost of a severe bleeding episode from a heparin infusion is estimated at $11,189 initially, and $17,169 at six months for each case ((Am J Cardioll 2004;94:532-535).

“We learned that improvement was difficult because it involved a major commitment and a significant number of pharmacy hours,” Dr. DeLapp said. “The one thing about education is [that] you have to maintain that level of knowledge on a consistent basis, especially with new hires, and we probably didn’t do a great job with that. [Additionally,] it wasn’t just our hospital that was suffering; I spoke with several colleagues who were also having a hard

time dealing with similar problems.”

pital’s 28 adult inpatient units and the emergency department.

After hospital-wide implementation of this project, a medication use evaluation showed that appropriate heparin dose adjustments improved from 83.8% to 93.9% and electronic medication administration record documentation of heparin doses improved from 77.1% to 93.9%.

This project highlights the importance of communication between various departments and the significance of pharmacist involvement in the management of high-risk medications, Dr. DeLapp said. “Although there still are errors, they are more process-related, and people are more inclined to report them,” he noted. “Our approach is working, and it more than likely has applicability in other institutions. It’s safe to say that our collaboration probably resulted in lives being saved, because with these medications, you never know when you’re going to have a serious bleed.”

Sentinel Event Alert Helped Focus the Intervention To resolve the problem, a collaborative process was developed that included recommendations from the Joint Commission’s Sentinel Event Alert! on the use of anticoagulants (http://bit.ly/1sBAylfon), revised education for nurses and pharmacists, including detailed heparin protocol review, proactive monitoring of activated thromboplastin activation times, observing infusion pumps for every patient on heparin once daily and improved access to patient data. Focus also was placed on improving communication with the laboratory and phlebotomy staff, and improving documentation in the electronic medical record related to heparin infusions.

A pilot project was conducted on three nursing units with high use of heparin infusions. This process eventually was expanded to include nursing units with lower heparin infusion utilization to ensure that the process worked in both areas. The initiative ultimately was extended to the remainder of the hos-

—Paul Bufano The sources reported no relevant financial conflicts of interest.

WEB EXCLUSIVE: pharmacypracticenews.com Bonus ASCO and ASHP meeting coverage on opioid-induced constipation, heparin conversions, reducing the risk for falls and more.

EDITORIAL BOARD

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

Volume 41 • Number 7 • July 2014 • pharmacypracticenews.com

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

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EDITORIAL STAFF

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

CARDIOLOGY

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s CT C. Michael White, PharmD, Storrs,

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Ali McBride, PharmD, MS, BCPS, St. Louis, MO Sara S. Kim, PharmD, BCOP, New York, NY

James Prudden, Group Editorial Director Robin B. Weisberg, Manager, r Editorial Services Elizabeth Zhong, Associate Copy Chief

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4 Operations & Management

Pharmacy Practice News • July 2014

Finances Part 1 of a four-part series on repositioning hospital pharmacy

Rejecting the ‘Cost Center’ Approach I

n today’s health care economy, the last thing that you want to be is a “cost center.” But that’s exactly how most hospital pharmacies have been positioned for years. It doesn’t have to be that way, according to Mary Baxter, MBA, RPh, the vice president for performance and outcomes at Cardinal Health, which manages inpatient pharmacies for about 200 hospitals around the country.

“It is no longer enough to hold down costs and deliver the ‘Five Rights [of medication safety],’” she said. “You can’t just be a break-even or even a marginally profitable service department that fills orders, even if you do that well. The hospital pharmacy should be a strategic asset to the hospital system.”

With that in mind, Cardinal Health has created a new mantra for the hospital pharmacy that it calls the “Four F Framework”: • Find meaningful growth; • Fix inefficiencies; • Fulfill the quality care mission; and • Follow the patient.

“This is language that we came up with to talk to the C-suite in hospitals about how pharmacy can perform as a strategic asset, and support the hospital or health system’s agenda for responding and thriving during health care reform,” Ms. Baxter said.

None of the “Fs” requires an enormous amount of new knowledge or development of new tools, she stressed. But delivering on the strategic framework does require pharmacy leadership to be engaged beyond its own walls, participating in key hospital-wide committees and initiatives, Ms. Baxter emphasized.

In a series of four articles, Pharmacy Practice News will explore what Cardinal Health means by these “Four Fs” and how this strategic positioning is working for hospital pharmacies in practical terms.

Finding Meaningful Growth This component takes the traditional approach to pharmacy as a cost center— holding down drug spending—to a new level, and considers the pharmacy as a strategic source of new revenue. The idea behind finding meaningful growth, according to Ms. Baxter, is to look for every possible way that the hospital can reap the maximum benefit from programs that the pharmacy can participate in, including such initiatives as the Centers for Medicare & Medicaid Services’ Meaningful Use Incentive Program, which offers incentive payments to eligible hospitals that adopt, implement, upgrade or demonstrate mean-

‘Clinical pharmacists can deploy the electronic [health] record to uncover mistakes … and get the hospital appropriate reimbursement levels.’

—Mary Baxter, MBA, RPh ingful use of certified electronic health record (EHR) technology.

“A key reason for the meaningful use incentive plan is to get the technology in place so that all the caregivers who have influence on a patient’s outcome can work in the same direction for that patient,” Ms. Baxter said. And within pharmacy, that’s driven by computerized physician order entry (CPOE) technology, she noted.

Millions in Savings How much can a pharmacy actually realize in meaningful growth for their hospital through efforts like these? More than you might expect. IASIS Healthcare, a $2.8 billion health system with 20 acute care hospitals, worked with Cardinal to establish its CPOE system, which proved critical to meeting meaningful use criteria. So far, that investment has reaped more than $37 million in incentive payments: $32.2 million for 2011 to 2012, and $5.4 million in the first quarter of 2013, according to Tedd Adair, RN, BSN, IASIS’ vice president, clinical operations.

“Meaningful use is more than just CPOE, but CPOE is probably the Achilles heel of what almost everyone is dealing with,” Mr. Adair said. “It’s pretty easy to get a website set up and have patients download health information, but making sure that every order, for every medication, is entered into the computer every time so that you get drug–drug information, allergy information and other safety checks—that’s huge.”

As soon as a medication order is placed in a patient’s EHR, the information immediately appears on the other end for the pharmacist to review. Ultimately, when a nurse on the floor at 2 a.m. observes a change in a patient’s condition, she can call the on-call physician, who can immediately key in an order from home, Mr. Adair noted. “We’re still a ways to go from that, but with Cardinal’s help, our medication management system is as good as it can be,” he said.

Of course, some of the incentive payments for meaningful use help to offset the capital and operating expenses involved in bringing IASIS’ health information technology systems into compliance with meaningful use. “But it also creates an income stream that can be

used for additional projects that our hospitals are engaged in, such as buying new equipment and positioning budgets to afford merit or market adjustments,” Mr. Adair said. Assisting with meaningful use measures, specifically CPOE compliance, makes the pharmacy a significant asset to the hospital, he pointed out.

“IASIS was very good at using pharmacists to drive the CPOE usage so that the hospitals could attest that they were in fact meaningful users,” Ms. Baxter said. “Pharmacists, and the pharmacy in general, can do this at any hospital. They can work directly with the physicians to ensure that they are able to use a CPOE system, and that it’s easy. You have to commit to investing in the technology, and you have to make CPOE a goal. Once that happens, teams of pharmacists, nurses and physicians can get this done.”

Well-deployed EHR and CPOE systems also can allow clinical pharmacists to take on a detective role and save revenue for the hospital. “For example, let’s say that a very expensive antibiotic is being used to treat a patient whose DRG [diagnosis-related group] isn’t usually associated with that drug,” Ms. Baxter explained. “The pharmacist can dig deeper: Is the patient here for different reasons than they were initially coded for? Perhaps they came in for simple pneumonia, but their underlying issue is complications related to chronic lung disease. That should be coded to a different DRG. Clinical pharmacists can deploy the electronic record to uncover mistakes like this and get the hospital appropriate reimbursement levels.”

Retail Pharmacies Can Help Streamline Care Cardinal Health is employing another strategy to help hospitals achieve that first “F”: the opening of in-house retail pharmacies that serve both patients and hospital employees, like the one at Medical Center at Riverside Health System, the largest of six hospitals in the Riverside Health System, based in Newport News, Va. Patients can have their discharge prescriptions filled and brought to their rooms before they go home (instead of at an unaffiliated pharmacy elsewhere), leveraging existing pharmacy capabilities to add new revenue streams.

This approach also gives the hospital more influence over medication adherence, a major issue because 38% of hospital prescriptions are not filled after discharge. With medication nonadherence being a leading cause of hospital readmissions, in-house retail capabilities can position the pharmacy as a driver of key savings by helping the hospital or health system avoid readmission penalties.

“We as pharmacists have our language that we speak—the ‘Five Rights,’” Ms. Baxter said. “But in today’s health care environment, that’s not enough. We need to associate the work that can be done through pharmacy with the hospital or health system achieving its highest potential.”

Another Pharmacist’s Take To move away from the “cost center” role to a strategic asset position, the pharmacy must begin to focus less on medications that are expensive to the pharmacy, and more on medications that are expensive to the enterprise as a whole, commented Rob Adamson, PharmD, the vice president of clinical pharmacy services at Barnabas Health in Livingston, N.J. “Some medications that are inexpensive in pharmacy terms, when not deployed in the right way, may result in denied days and lead to major costs for the institution,” he explained.

In 2008, the pharmacy instituted a practice of converting patients from heparin to warfarin within 24 hours whenever possible. They’ve gone from an average convert time of four days to about 1.1. As a result, denied days from payors who previously balked at reimbursing for extended treatment regimens are now “pretty much nonexistent,” Dr. Adamson said. “Rate of conversion is still a metric we check.

During the first few years, we were able to cumulatively save about $4.5 million in denied days. The pharmacy realized nothing, but the system realized a lot.

Now they see us as having these cognitive services that can help the enterprise become more efficient.”

More recently, the Barnabas pharmacy team made a similar effort to improve conversion of IV steroids to oral steroids in patients with chronic obstructive pulmonary disease (COPD). “This has lowered the [hospital] length of stay for our COPD patients by almost one day, and gone from a disproportionately high length of stay for those patients to being in the 80th to 85th percentile,” Dr. Adamson said. “That gives you a tremendous improvement in negotiating power with insurance agencies.”

—Gina Shaw None of the sources had any relevant financial conflicts of interest to disclose.

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6 Operations & Management

Pharmacy Practice News • July 2014

Finances $1.3 million in savings achieved in one year

Lessons in Paring a Pharmacy Drug Budget D

rug purchasing analytics software can be an effective tool for identifying high-cost medications in a healthsystem, according to a new study.

Christy Norman, PharmD, the interim director of pharmacy at the Georgia Regents Health System in Augusta, used the software (McKesson Pharmacy Spend Trend Analytics) to identify 50 medications that accounted for the bulk of the system’s medication expenditures (poster 3-012). The analyses helped Dr. Norman and her colleagues to develop seven initiatives that led to a 7% reduction in drug spending.

“Many of the changes were simply formulary decisions that required P&T [pharmacy and therapeutics committee] approval and some re-education of pharmacists, nurses and physicians, along with ongoing evaluation of compliance,” Dr. Norman said.

The change that had the highest cost impact did require operational changes.

After evaluating the literature and comparing outcomes with a variety of kidney transplant induction agents, the team determined that using alemtuzumab (Campath, Genzyme) would be the most cost-effective treatment, when compared with the hospital’s traditional induction agent thymoglobulin. “Thymoglobulin is roughly $670 per vial and alemtuzumab is free from the manufacturer when used for induction,” Dr. Norman noted.

She added that cost-savings were also due to improved outcomes. “Monitoring of [those] outcomes is ongoing, but so far we have had a decrease in

Initiative

Annual Savings in Purchase Dollars, $

Transplant medication optimization

546,044

Antibiotic/antifungal initiatives: • Expansion of antimicrobial stewardship program • Carbapenem therapeutic interchanges • Targeted antimicrobial monitoring

478,289

Thrombin waste reduction

170,374

632-bed hospital’s pharmacy shave $1,302,774 off its drug spending over the one-year period. For example, the hospital switched from carbapenem to meropenem (Merrem, AstraZeneca) for certain infectious disease indications.

“Although carbapenem is available as a generic, because of contracts with our [group purchasing organization], we continued to purchase the branded product at a lower cost,” Dr. Norman said.

Optimization of anesthetic inhalation agents

57,732

Re-Education Needed

IVIG therapeutic interchange

50,335

Total annual savings

1,302,774

Other initiatives included re-educating physicians on the proper indications for use and dosing of IV immunoglobulin, expanding their antimicrobial stewardship program and targeting the efficient use of inhaled anesthetics. On the latter program, “we worked with Anesthesia on a ‘low-flow’ protocol and standardized the specific anesthetic gas used for most procedures done in our ORs.” Pharmacies considering revamping their own drug purchasing programs should gradually roll out initiatives, starting with those that have a high impact but require the least amount of effort, Dr. Norman recommended.

“For those initiatives that do require practice changes, identifying a physician to champion the change makes the transition much smoother,” she advised.

Table 1. Savings Summary of Initiatives

IVIG, intravenous immunoglobulin

‘For those initiatives that do require practice changes, identifying a physician to champion the change makes the transition much smoother.’

—Christy Norman, PharmD the number of acute rejection episodes since switching to Campath,” she said.

The change resulted in a $546,000 reduction in drug spending over a oneyear period, Dr. Norman said. But she stressed that the savings would not have accrued without staff training that helped make the switch a success. “The operating room [OR] staff was educated on preparing alemtuzumab and administering IV push in the OR immediately before surgery,” she explained. “This required additional training because

the hazardous medication had not been previously handled by the OR.” Another high-impact move was the decision to purchase thrombin in 5,000unit vials, rather than 20,000-unit vials.

Dr. Norman said significant amounts of unused thrombin in the 20,000-unit vials were being regularly discarded before the change. The switch to smaller vials reduced this waste as well as $170,000 of drug spending over the one-year period, Dr. Norman reported.

Several other initiatives helped the

—David Wild Dr. Norman reported no conflicts of interest.

She presented the data at the 2013 Midyear Clinical Meeting of the American Society of Health-System Pharmacists.

Pharmacists Play Key Role in Oncology Revenue Stream New Orleans—In April 2012, the University of Southern California (USC) Norris Comprehensive Cancer Center in Pasadena opened a hospital-based, outpatient oncology infusion center, where clinical pharmacists have been key in developing cost-savings and costavoidance initiatives. From formulary management alone, pharmacists have saved close to $550,000 in one year.

Much of the savings were made possible by the infusion center’s designation as a 1206D facility, according to Betty M. Chan, PharmD, BCOP, an assistant professor of clinical pharmacy at Norris. The designation, which is unique to the state of California, exempts hospital-based practices from drug-pricing regulations and other rules that affect physician-based clinics. As a result, facilities with the 1206D designation

Table. Drug Cost Analysis Data Drug

1206D Acquisition Cost, $

Non-1206D Acquisition Cost, $

Bevacizumab

607,834

659,526

Bortezomib

154,942

234,057

Docetaxel

66,015

141,461

incentives to develop outpatient infusion administration,” said Ali McBride, PharmD, the clinical coordinator of hematology/oncology at University of Arizona Cancer Center, in Tucson, who was not involved with the study. “This is a well-executed delivery of a system that has not been well documented. This can be a game changer in evaluating cost savings for California hospitals that are not 340B-based models.”

The Team in Action

benefit from improved reimbursement in the outpatient setting, Dr. Chan said. Other advantages include split billing, minimal staffing requirements

and shared medical resources between affiliated clinics and hospitals.

“The concept here is unique and provides a fresh view on evaluating cost

The new infusion center at the Norris Cancer Center has eight chairs and one bed, averaging 234 patients and 373 chemotherapy preparations per month.

Two full-time hem/onc physicians, six part-time physicians, one full-time pharmacist and one full-time pharmacy technician staff the center, according to Dr.

Operations & Management 7

Pharmacy Practice News • July 2014

Finances Chan, who described the initiative in a study her team presented at the annual meeting of the Hematology/Oncology Pharmacists Association (poster 110).

Pharmacists on the infusion team provide patient education on chemotherapy treatment–related toxicities, supportive care, symptom management and drug information resources, Dr. Chan pointed out. They also have played key roles in chemotherapy monitoring and assessment. Some of the biggest revenue stream enhancements, she said, have sprung from drug procurement and inventory control, medication use evaluation, continuous quality improvement projects and financial monitoring of daily utilization and purchases.

To document those economic benefits, Dr. Chan and her colleagues provided a retrospective review of financial data obtained from the center between September 2012 and September 2013.

The researchers obtained financial data based on purchasing history from McKesson Corporation and utilization history from the infusion center.

The annual savings on drug expenditures under 1206D acquisition was $354,466. The biggest savings came from bevacizumab (Avastin, Genentech), bortezomib (Velcade, Millennium) and docetaxel (Table). “The drug prices used in 1206D hospital-based clinic practice are individual contract prices [that] hospitals establish with the individual manufacturer and wholesaler,” Dr. Chan said. “The better pricing hospitals get compared with smaller private practice is likely due to patient volume and usage pattern. Manufacturers are more likely to decrease cost for the purchase of drugs for a larger hospital account than for small private practices.”

costs associated with hospitalizations.

These included the use of filgrastim (Neupogen, Amgen) or pegfilgrastim (Neulasta, Amgen) to avoid chemotherapy-induced neutropenia, the use of palonosetron (Aloxi, Eisai) and/or fosaprepitant (Emend, Merck) for refractory chemotherapy-induced emesis, and the use of Magic Mouth Wash (USC Daniel’s Solution) for mucositis.

As for future initiatives, on Jan. 1, 2014, the Norris Cancer Center and Hospital obtained 340B status as a freestanding cancer center, and pharmacists

will work to implement this 340B program to further reduce drug costs, Dr. Chan noted. Clinicians also will strive to develop a chemotherapy adherence program, expand investigational drug protocols and develop dose rounding and wastage protocols, she noted.

An ‘Out-of-the-Box’ Approach According to Dr. McBride, the pharmacy department had an “out-of-thebox” mentality that provided them with a focus to see the effects of pharmacy, not only on patient care, but also on cost sav-

ings and potential increased reimbursement streams in the outpatient setting.

“The 1206D price showed substantial cost savings,” Dr. McBride said. “This [initiative] provides a means to address revenue streams that were previously untapped. This merits further evaluation, as there may be long-term consequences of the 1206D designation that are yet unrealized.”

—Kate O’Rourke Drs. Chan and McBride reported no relevant financial conflicts of interest.

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Pharmacists were instrumental in several cost-containment initiatives. A formulary management switch from palonosetron (Aloxi, Eisai) to granisetron (Kytril, Roche) as the first-line 5-HT3 receptor antagonist of choice for moderately to highly emetogenic chemotherapy generated an annual cost savings of $518,450. Switching physicians’ request for ferric carboxymaltose (Injectafer, American Regent) to less-expensive alternatives such as ferumoxytol (Feraheme, AMAG) or iron sucrose (Venofer, Vifor) as the IV iron agent on formulary for use in irondeficiency anemia in chronic kidney disease also provided financial benefit.

The projected annual savings with a switch to ferumoxytol was $8,850. The projected annual cost savings with iron sucrose was $17,414.

Several measures spurred on by the pharmacist team helped avoid treatment delays, dose modifications and reduced

In today’s fast-paced pharm macy environment, every second counts and every preparation has to be right. ChemoLo ock can help with an intuitive and easy-to-use system that locks with a single motion n and an audible click, ensuring a safe and secure connection to minimize exposure to hazardous drugs and protect the patient preparation from contamination. ChemoLocck is also the first and only needlefree CSTD to receive FDA 510(k) clearance under thee ONB product code, keeping you and the drugs you mix safer while ensuring safe handling compliance.

For more information, call us at 800.824.7890 or visit go.icumed.com/chemolock-PPN

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800.824.7890 | www.icumed.com

8 Operations & Management

Pharmacy Practice News • July 2014

Finances

Rivaroxaban Beats Injectable on Cost-Effectiveness ivaroxaban was more cost-effective than other anticoagulants for inpatient use in two retrospective studies that included patients undergoing joint replacement as well as those with atrial fibrillation or venous thromboembolism. One expert predicted, however, that insurance issues and less expensive alternative agents might limit use of rivaroxaban when patients are discharged to the outpatient setting.

In the first study, rivaroxaban (Xarelto, Janssen) provided a safe and effective alternative to fondaparinux (Arixtra, GlaxoSmithKline) for prevention of venous thromboembolism (VTE) at a 128-bed inpatient rehabilitation facility. Because it is taken orally, rivaroxaban also was found to be less expensive, and easier to administer than the injectable fondaparinux.

“Anticoagulation costs make up a major portion of our drug expenses,” said lead researcher Nitika Agarwal, PharmD, the director of pharmacy at Marianjoy Rehabilitation Hospital, in Wheaton, Ill. “We were early adopters of fondaparinux, and it reduced our anticoagulant costs by 60% compared with enoxaparin. When rivaroxaban got approval in July 2011, we reviewed the drug for formulary approval, and had patients on it within three months.”

Dr. Agarwal and her colleagues collected data on 314 patients who had total knee arthroplasty or total hip arthroplasty, admitted to the hospital from January 2011 to December 2012. The patients received either fondaparinux 2.5 mg subcutaneously (primary agent used at the hospital until October 2011) or rivaroxaban 10 mg orally (primary agent used since November 2011) once daily for VTE prevention. Primary effectiveness outcomes were a composite of any deep venous thrombosis (DVT); nonfatal, symptomatic, objectively confirmed pulmonary embolism (PE); and all-cause mortality. Primary safety outcomes were any major or non-major bleeding events.

No VTE or PE events occurred among the 199 patients who took rivaroxaban,

whereas the rate of VTE or PE was 0.87% among the 115 patients who took fondaparinux. Major bleeding events occurred in 0.5% of patients prescribed rivaroxaban compared with 1.74% of those who received fondaparinux.

Minor bleeding events occurred in 1% of patients prescribed rivaroxaban compared with 1.74% of patients administered fondaparinux (Figure).

FCCP, BCPS, a clinical pharmacist in the Anticoagulation and Anemia Service at Kaiser Permanente in Aurora, Colo., told Pharmacy Practice News.

However, there’s a potential snag: “One barrier is drug coverage,” Dr. Clark said. “Even though it’s less expensive to the health plan, depending on the patients’ drug coverage, it could actually cost more.”

2.00 1.80

Rivaroxaban

1.60

Fondaparinux

1.74

1.74

1.40

Percent

R

1.20 1.00

0.87

0.80 0.60 0.40 0.20 0

1.0

0.5

0

VTE/PE

Major Bleeds

Minor Bleeds

Figure. Safety outcomes in patients undergoing anticoagulation therapy.

PE, pulmonary embolism; VTE, venous thromboembolism

A cost analysis revealed savings of approximately $13,000 for the period of thromboprophylaxis (average, 10 days) in the patients treated with rivaroxaban, which was 52% lower than the cost associated with fondaparinux.

Daily drug cost for rivaroxaban 10 mg was $6.39 per patient, and total drug cost was $11,994 for the study period (1,877 doses dispensed for 199 patients).

Daily drug cost for fondaparinux 2.5 mg was $13.20 per patient, and total cost was calculated to be $24,767 (1,877 doses that would have been dispensed for 199 patients).

Rivaroxaban is attractive because it is orally administered and affordable, and is expected to continue to replace injectables, Nathan Clark, PharmD,

Dr. Agarwal agreed. “But hopefully, the [Centers for Medicare & Medicaid Services] and health plans will adopt rivaroxaban in their formulary without any restrictions, like prior authorization, soon. In the meantime, we give a free 10-day supply coupon to patients, provided by the drug company, when they’re discharged.”

Shorter Length of Stay Underlies Cost Reductions The second study was a cost analysis model for inpatient anticoagulant treatment in the hospital setting. The investigators, led by Lynn Huynh, MPH, MBA, DrPH, from the health care consultancy Analysis Group, concluded that it was less expensive to treat patients with

rivaroxaban than with standard-of-care therapies, mainly because of the potential to shorten the hospital length of stay (LOS) associated with various approved indications.

The study evaluated 2,000 inpatients, including 492 patients with non-valvular atrial fibrillation, 186 with DVT, 208 with PE, 763 undergoing knee replacement and 351 undergoing hip replacement. The aim of the study was to project the cost estimates from the hospital perspective for the use of anticoagulants in these types of patients.

An overall potential saving of more than $1.7 million ($871 per patient) was observed for all patients who switched to rivaroxaban. The largest savings in hospital costs came from a reduction in the hospital LOS for patients with DVT and PE, which contributed to more than 85% of the potential savings. Cost savings ($41,052) also were observed for both knee and hip replacement surgeries, driven by differences in medication costs.

“What limits my enthusiasm for the study is that the main driver of cost savings is a shorter stay with DVT and PE patients,” Dr. Clark said. “A shorter hospital stay results in lower cost after DVT or PE, and this can be accomplished by using any number of drugs (rivaroxaban, fondaparinux or low-molecular-weight heparin [LMWH]). The costs of these drugs are not impressively different, roughly $15 per day for rivaroxaban versus $50 per day for fondaparinux or LMWH for initial DVT or PE treatment. Drug costs are not the primary driver of health care expense in this setting; it is the duration of hospitalization.”

—Dana Hawkins-Simons One of Dr. Huynh’s co-authors, Brahim Bookhart, is the director of health economics and outcomes research at Janssen Scientific Affairs. None of the other sources reported any relevant financial conflicts of interest. The studies were presented at the American Society of Health-System Pharmacists 2013 Midyear Clinical Meeting.

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Operations & Management 9

Pharmacy Practice News • July 2014

Finances

BUSINESS MODELS continued from page 1

health care provider status, according to Gloria Sachdev, PharmD, a clinical assistant professor of primary care pharmacy at Purdue University’s College of Pharmacy, in West Lafayette, Ind. Even in the current fee-for-service model, provider status is a requirement if pharmacists are to bill for those services, noted Dr. Sachdev, who led the development of the third domain of the ASHP’s four-part ambulatory care pharmacy practice recommendations and presented them at the group’s inaugural Ambulatory Care Conference and Summit.

‘No health care organization can financially sustain the $150,000 salary and benefits for a pharmacist without being clearly shown that their investment is yielding a return through cost savings or revenue generation.’

—Gloria Sachdev, PharmD

cists providing ambulatory care services should strive to “achieve a set of quality and cost measures...and demonstrate improvements in patient outcomes.”

In Dr. Sachev’s view, such metrics

need to be collected with an eye toward evolving health care models of payment.

“With ... patient-centered medical homes [PCMHs] and accountable care organizations [ACOs], demonstrating our eco-

WHEN YOU NEED THE POWER OF AN IV ANTIBIOTIC

nomic value means aligning pharmacy services and outcomes with organizational goals, which has been a challenge for some pharmacists,” she said. “In the meantime, no health care organization can financially sustain the $150,000 salary and benefits for a pharmacist without being clearly shown that their investment is yielding a return through cost savings or revenue generation.”

MTM and Readmissions An example of how clinical pharmacy

•

see BUSINESS MODEL, page 10

NOW APPROVED A WINNING APPROACH IN TREATING ABSSSI* WHEN MOVING BEYOND DAILY IV INFUSIONS TO A ONCE-A-WEEK INFUSION FOR TWO WEEKS Two-dose regimen of 1000 mg followed one week later by 500 mg *Acute bacterial skin and skin structure infections (ABSSSI)1 include cellulitis/erysipelas, wound infection, and major cutaneous abscess and have a lesion size of at least 75 cm2

The case for attaining provider status is supported by the growing body of evidence demonstrating the positive clinical impact of ambulatory pharmacy care, according to Toni Fera, PharmD, an independent hospital and pharmacy consultant located in Pittsburgh, who sat on the ASHP recommendations’ consensus panel but was not directly involved in developing this domain of the recommendations. “For example, it’s well documented that pharmacists can prevent adverse events, improve medication adherence and improve clinical outcomes, such as blood pressure and blood sugar control,” she said ((J Am Pharm Assoc 2006;46:133-147; Pharmacotherapy 2000;20:340S-344S).

“But without provider status, we largely haven’t been able to bill for many of the services that contribute to these improved outcomes.”

Such findings support the ASHP’s demand, stated in domain 3.1, that “pharmacists must be recognized as healthcare providers,” federally, stateby-state and by “other jurisdictions that have pharmacy practice acts as well as [by other payors].”

Domain 3.4: Quality and Cost Overcoming the provider status roadblock may require that pharmacists keep amassing evidence of their ability to improve patient outcomes and d save scarce health care dollars. Or, as stated in this section of the third domain, pharma-

For more information, visit www.dalvance.com INDICATION DALVANCE™ (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus).

IMPORTANT SAFETY INFORMATION Contraindications DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.

Warnings and Precautions Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE; exercise caution in patients with known hypersensitivity to glycopeptides.

Rapid intravenous infusion of glycopeptide antibacterial agents can cause reactions, including flushing of the upper body, urticaria, pruritus, and rash.

ALT elevations with DALVANCE treatment were reported in clinical trials.

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE. Evaluate if diarrhea occurs.

Adverse Reactions The most common adverse reactions in patients treated with DALVANCE were nausea (5.5%), headache (4.7%), and diarrhea (4.4%).

Use In Specific Populations In patients with renal impairment whose known creatinine clearance is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended two-dose regimen for DALVANCE is 750 mg followed one week later by 375 mg. No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and DALVANCE can be administered without regard to the timing of hemodialysis.

Please see DALVANCE Brief Summary of Full Prescribing Information on the adjacent page.

Reference: 1. Guidance for Industry. Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). October 2013. ©2014 Durata Therapeutics. All rights reserved.

Durata Therapeutics and Dalvance are registered trademarks of Durata Therapeutics Holding C.V. DAL-0073-US May 2014

10 Operations & Management

Pharmacy Practice News • July 2014

Finances

BUSINESS MODELS continued from page 9

services and cost-focused organizational goals can be aligned is by targeting hospital readmission rates through medication therapy management, Dr. Sachdev pointed out. She said the Centers for Medicare & Medicaid Services’ (CMS) Hospital Readmission Reduction Program penalizes hospitals that have high readmission rates for patients with acute myocardial infarction, pneumonia and heart failure. Thus,

gathering data on readmission rates of these groups before and after implementation of ambulatory pharmacist services would help establish a strong value proposition.

“That said, quality measures vary significantly among payors, so it is important to understand which measures your specific hospital system or provider group is aiming to achieve,” Dr. Sachdev added. For instance, a physician group may be focused on achieving CMS’s Physician Quality Reporting System (PQRS) measures, because these are publicly

DALVANCETM (dalbavancin) for injection, for intravenous use Brief Summary of Full Prescribing Information INDICATIONS AND USAGE: DALVANCE (dalbavancin) for injection is indicated for the treatment

of adult patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureuss (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosuss group (including S. anginosus, S. intermedius, S. constellatus). s Usage – To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial agents, DALVANCE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION: For treatment of adults with ABSSSI, the recommended

two-dose regimen of DALVANCE is 1000 mg followed one week later by 500 mg. DALVANCE should be administered over 30 minutes by intravenous infusion.

CONTAINDICATIONS: DALVANCE is contraindicated in patients with known hypersensitivity

to dalbavancin. No data are available on cross-reactivity between dalbavancin and other glycopeptides, including vancomycin.

WARNINGS AND PRECAUTIONS: Hypersensitivity Reactions–Serious hypersensitivity

(anaphylactic) and skin reactions have been reported in patients treated with DALVANCE. If an allergic reaction occurs, treatment with DALVANCE should be discontinued. Before using DALVANCE, inquire carefully about previous hypersensitivity reactions to glycopeptides, and due to the possibility of cross-sensitivity, exercise caution in patients with a history of glycopeptide allergy. Infusion-Related Reactions–DALVANCE is to be administered via intravenous infusion, using a total infusion time of 30 minutes to minimize the risk of infusion-related reactions. Rapid intravenous infusions of DALVANCE can cause reactions that resemble “RedMan Syndrome,” including flushing of the upper body, urticaria, pruritus, and/or rash. Stopping or slowing the infusion may result in cessation of these reactions. Hepatic Effects–In Phase 2 and 3 clinical trials, more DALVANCE- than comparator-treated subjects with normal baseline transaminase levels had post-baseline alanine aminotransferase (ALT) elevation greater than 3 times the upper limit of normal (ULN). Overall abnormalities in liver tests (ALT, AST, bilirubin) were reported with similar frequency in the DALVANCE and comparator arms. Clostridium difficile-Associated e Diarrhea –Clostridium difficile-associated diarrhea (CDAD) has been reported in users of nearly all systemic antibacterial agents, including DALVANCE, with severity ranging from mild diarrhea to fatal colitis. Treatment with antibacterial agents can alter the normal flora of the colon, and may permit overgrowth of C. difficile. C. difficilee 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 antibacterial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficilee should be discontinued, if possible. Appropriate measures such as fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. Development of Drug-Resistant Bacteria - Prescribing DALVANCE 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 clinical trials of DALVANCE cannot be compared directly to adverse reaction rates from clinical trials of another drug and may not reflect rates observed in practice. Adverse Reactions in Clinical Trials–Adverse reactions were evaluated for 1778 patients treated with DALVANCE and 1224 patients treated with comparator antibacterial agents in a total of seven Phase 2 and Phase 3 clinical trials. A causal relationship between study drug and adverse reactions was not always established. The median age of patients treated with DALVANCE was 47 years, ranging between 16 and 93 years old. Patients treated with DALVANCE were predominantly male (60%) and Caucasian (78%). Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation–Serious adverse reactions occurred in 109/1778 (6.1%) of patients treated with DALVANCE and in 80/1224 (6.5%) of patients treated with comparator. DALVANCE was discontinued due to an adverse reaction in 53/1778 (3%) of patients, and the comparator was discontinued due to an adverse reaction in 35/1224 (2.8%) of patients. Most Common Adverse Reactions–The most common adverse reactions in patients treated with DALVANCE were nausea (5.5%), headache (4.7%), and diarrhea (4.4%).

The median duration of adverse reactions was 4.0 days in both treatment groups.

Table 1. Selected Adverse Reactions in Phase 2/3 Trials Number (%) of Patients Dalbavancin Comparator (N = 1778) (N = 1224) Nausea 98 (5.5) 78 (6.4) Vomiting 50 (2.8) 37 (3) Diarrhea 79 (4.4) 72 (5.9) Headache 83 (4.7) 59 (4.8) Rash 48 (2.7) 30 (2.4) Pruritus 38 (2.1) 41 (3.3) Comparators included linezolid, cefazolin, cephalexin, and vancomycin

reported, or they may be targeting state Medicaid pediatric asthma measures, because those metrics affect reimbursement in a pay-for-performance model.

“Wherever possible, pharmacists should identify opportunities to close gaps in care and improve clinical, humanistic and economic outcomes,” she said.

Domain 3.3: Use IT to Measure Outcomes To document the value of those clinical services, having a strong, integrated

Initial U.S. Approval: May 2014 The following selected adverse reactions were reported at a rate of less than 2.0% in these clinical trials: Blood and lymphatic system disorders: anemia, hemorrhagic anemia, leucopenia, neutropenia, thrombocytopenia, petechiae, eosinophilia, thrombocytosis; Gastrointestinal disorders: gastrointestinal hemorrhage, melena, hematochezia, abdominal pain; General disorders and administration site conditions: infusion-related reactions; Hepatobiliary disorders: hepatotoxicity; Immune system disorders: anaphylactoid reaction; Infections and infestations: Clostridium difficilee colitis, oral candidiasis, vulvovaginal mycotic infection; Investigations: hepatic transaminases increased, blood alkaline phosphatase increased, international normalized ratio increased; Metabolism and nutrition disorders: hypoglycemia; Nervous system disorders: dizziness; Respiratory, thoracic and mediastinal disorders: bronchospasm; Skin and subcutaneous tissue disorders: urticaria; Vascular disorders: flushing, phlebitis, wound hemorrhage, spontaneous hematoma.

Alanine Aminotransferase (ALT) Elevations–Among patients with normal baseline ALT levels, more DALVANCE- than comparator-treated patients had post-baseline ALT elevations greater than 3 times the upper limit of normal (ULN), 12 (0.8%) vs. 2 (0.2%), respectively, including three subjects with post-baseline ALT values greater than 10 times ULN. Eight of 12 patients treated with DALVANCE and one comparator patient had underlying conditions which could affect liver enzymes, including chronic viral hepatitis and a history of alcohol abuse. In addition, one DALVANCE-treated subject in a Phase 1 trial had post-baseline ALT elevations greater than 20 times ULN. ALT elevations were reversible in all subjects. No comparator-treated subject with normal baseline transaminases had post-baseline ALT elevation greater than 10 times ULN. DRUG INTERACTIONS: Drug-Laboratory Test Interactions– Drug-laboratory test

interactions have not been reported. Drug-Drug Interactions – No clinical drug-drug interaction studies have been conducted with DALVANCE. There is minimal potential for drug-drug interactions between DALVANCE and cytochrome P450 (CYP450) substrates, inhibitors, or inducers.

USE IN SPECIFIC POPULATIONS: Pregnancy Category C.–There have been no adequate and well-controlled studies with dalbavancin in pregnant women. DALVANCE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. No evidence of embryo or fetal toxicity was found in the rat or rabbit at a dose of 15 mg/kg/day (1.2 and 0.7 times the human dose on an exposure basis, respectively). Delayed fetal maturation was observed in the rat at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis). In a rat prenatal and postnatal development study, increased embryo lethality and increased offspring deaths during the first week post-partum were observed at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis). Nursing Mothers– Dalbavancin is excreted in the milk of lactating rats. It is not known whether dalbavancin or its metabolite is excreted in human milk; therefore, caution should be exercised when DALVANCE is administered to a nursing woman. Pediatric Use–Safety and efficacy in pediatric patients have not been established. Geriatric Use–Of the 1778 patients treated with DALVANCE in Phase 2 and 3 clinical trials, 313 patients (17.7%) were 65 years of age or older. The efficacy and tolerability of DALVANCE were similar to comparator regardless of age. The pharmacokinetics of dalbavancin were not significantly altered with age; therefore, no dosage adjustment is necessary based on age alone. DALVANCE is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group. Renal Impairment–In patients with renal impairment whose known creatinine clearance is <30 mL/min and who are not receiving regularly scheduled renal dialysis, the recommended two-dose regimen for DALVANCE is 750 mg followed one week later by 375 mg. No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and DALVANCE can be administered without regard to the timing of dialysis.

Hepatic Impairment–No dosage adjustment of DALVANCE is recommended for patients with mild hepatic impairment (Child-Pugh Class A). Caution should be exercised when prescribing dalbavancin to patients with moderate or severe hepatic impairment (Child Pugh Class B or C) as no data are available to determine the appropriate dosing in these patients.

OVERDOSAGE: Specific information is not available on the treatment of overdose with DALVANCE, as dose-limiting toxicity has not been observed in clinical studies. In Phase 1 studies, healthy volunteers have been administered single doses of up to 1500 mg, and cumulative doses of up to 4500 mg over a period of up to 8 weeks, with no signs of toxicity nor laboratory results of clinical concern. Treatment of overdose with DALVANCE should consist of observation and general supportive measures. Although no information is available specifically regarding the use of hemodialysis to treat overdose, in a Phase 1 study in patients with renal impairment less than 6% of the recommended dalbavancin dose was removed.

Manufactured for: Durata Therapeutics U.S. Limited Chicago, IL 60606 US Patent Numbers: Available online at http://www.duratatherapeutics.com/products/product-patents DALVANCETM is a trademark of Durata Therapeutics Holding C.V. Please also see Full Prescribing Information at www.dalvance.com.

DAL-0067-US

information technology (IT) system in the pharmacy setting is critical, according to this section of the ASHP recommendations. Unfortunately, the “fragmented” nature of the current health IT infrastructure works against that goal, Dr. Fera said. She noted, for example, that some health care institutions use different IT systems in the outpatient and inpatient settings, which means that ambulatory care pharmacists—including community pharmacists—often don’t have access to patients’ medical records.

This access “is crucial because community pharmacists hold great potential to provide direct patient care,” she stressed.

“Health IT is so important on many fronts,” Dr. Fera added. “It allows us to document and follow up on our care, as well as to coordinate care with other providers. And on the back end, we can look at the data in a systematic manner to identify ways to continually improve our care and reduce costs for providers.”

Domains 3.2 and 3.5: What Is Your Value Proposition?

According to this section of the domain, once pharmacists have aligned their goals with broader organizational goals and gathered outcomes and cost data via IT systems, the value proposition needs to be “articulated and promoted for internal and external stakeholders.” As Dr. Sachdev told meeting attendees, this can be a challenge.

“We need to communicate in terms that are familiar to patients, health plan managers, hospitals, health systems and physician groups,” she explained.

“I work with self-insured employers, who are very interested and engaged in ambulatory care as a way of reducing the sometimes unsustainable financial resources they invest in the health and well-being of their employees, but outcomes like hemoglobin A1c mean little to them.”

Payors use terms such as costs per member per month, she said, “which isn’t terminology we typically use as pharmacists focusing on clinical outcomes.”

The business focus of the recommendations might present a challenge for ambulatory care pharmacists who have not necessarily had to generate “value equations” that demonstrate the impact of their services, but according to Dr. Fera, perhaps the most important part of the equation is already in place.

“There is a myriad of great ambulatory care services and programs, and each of these programs has a story to tell,” she said. “Our task is to bring these stories to broader stakeholder groups and highlight the achievements of pharmacists.”

—David Wild Drs. Sachdev and Fera reported no relevant financial conflicts of interest.

Policy 11

Pharmacy Practice News • July 2014

Reimbursement Matters

10 Steps To Getting Billing Right T

he failure of a single element in the cascade of events that comprise the revenue cycle is rarely the cause of a billing error. It’s more likely to be multiple underlying system failures and software snafus that lead to the mishap.

Our May 2014 column underscored this point, with details on end-to-end auditing and tips for understanding the revenue cycle with all of its complexities.

Will we always need to micromanage this process? Perhaps not; health care in the United States is moving away from fee-schedule manipulation and the constant need for vigilance and rebilling of denied services. Still, this is not the time to abandon the important goal of “getting it right.” Such efforts are critical because the rates of reimbursement we’re building now, based on our submissions to Medicare and other payors, will form the basis for future payments.

Our encouragement of readers’ questions on these reimbursement issues recently prompted Dusko Klipa, PharmD, BCPS, a newly minted director of pharmacy, to write a letter that exemplifies the confusion many are facing (see box below). Dr. Klipa is certainly not alone out there in trying to make sense of all this. If you find yourself in similar straits, Dear Ms. Kirschenbaum:

here are some strategies that can help your facility navigate these murky reimbursement waters.

1. The importance of copays. Medicare pays 80% of a drug’s cost and the patient pays 20%. Private payors set their own copay rates and most likely none are less than 20%; tiered programs may be considerably higher, especially for specialty medications. It is essential, therefore, that copays be collected and that

they be directed toward the drug/pharmacy component of the infusion center’s cost calculations. Don’t forget that there may be copay assistance programs for which your patients are eligible. Moreover, many Medicare patients have coinsurance to cover these copays and/or the portion of the drug cost that Medicare does not reimburse.

2. Medicare rates. Medicare bases its payment on average sales price (ASP),

“Reimbursement Matters” is a tool for maintaining your health system’s fiscal health.

Please email the author at bkirschen@aol.com with suggestions on reimbursement issues that you would like to see covered.

Bonnie Kirschenbaum, MS, FASHP

which is a calculated figure released by the Centers for Medicare & Medicaid Services (CMS) quarterly. Those

•

see 10 STEPS, page 12

Reform challenges taking you away from what you do best?

Turn to a name you know for proven solutions.

I

’ve recently started my new position as director of pharmacy and so I am in the process of carefully evaluating our resources and services. One thing that puzzles me is our outpatient infusion center. I have requested reimbursement numbers for patients in this care setting who have received various biologics— primarily rheumatology drugs such as Cimzia [certolizumab] and Remicade [infliximab]—and I quickly learned that we are losing money on these medications, even with Medicare and commercial payors. My limited experience with outpatient infusion centers tells me that these services should be profitable—that is, cost plus 6%.

I met with our finance department and their response was that it basically does not matter what we charge for these drugs, but what each payor is willing to pay us. My impression is that we are supposed to accept those rates, with the one benefit that it at least eliminates potential errors in our billing formula. They did find my analysis useful as they can now evaluate profitability of this service.

What am I missing? Any advice would be helpful. Thank you in advance and keep up the great work with your column.

Dusko Klipa, PharmD, BCPS St. Vincent’s Medical Center-Southside Jacksonville, Fla.

As the evolving healthcare landscape makes it more and more difficult to manage the business of caring for patients, turn to Walgreens for the operational expertise, systems support and talented professionals you need. Our industry-leading suite of programs includes: Onsite outpatient pharmacies—Offer immediate, economical onsite access to prescribed treatment. A Walgreens onsite outpatient pharmacy in Georgia helped the health system achieve a 26 percent relative improvement in a HCAHPS score related to communication on medication.1

Healthcare Clinic locations at select Walgreens— Evidence-based services from board-certified staff provide a lower-cost channel for nonemergent care to help optimize emergency department capacity by reducing wait times.†

WellTransitions®—Endorsed by the AHA, WellTransitions® program for medication adherence brings together pharmacists and hospital staff to improve patients’ transition of care from the hospital to the community and help reduce avoidable readmissions.

340B Complete®—A trustworthy solution with an impressive audit success rate and HFMA Peer Reviewed designation that offers unmatched access to Walgreens pharmacies, compliance-enabling administration support and opportunities for 340B drug cost savings.

The American Hospital Association (AHA) exclusively endorses WellTransitions® for leadership in assisting hospitals in reducing readmission rates and improving patients’ medication adherence after discharge. AHA Solutions awards exclusive endorsement to products and services that best support hospitals and healthcare organizations.

* HFMA staff and volunteers determined that this product has met specific criteria developed under the HFMA Peer Review Process. HFMA does not endorse or guarantee use of this product.

1. Stempniak M. Bedside delivery. An easier pill to swallow. Hospitals & Health Networks Web site. http://www.hhnmag.com/display/HHN-news-article. dhtml?dcrPath=/templatedata/HF_Common/NewsArticle/data/HHN/Magazine/2012/Aug/0812HHN_Inbox_bedside. Accessed Jan. 30, 2014. † Patient care services provided by Take Care Health Services, an independently owned professional corporation whose licensed healthcare professionals are not employed by or agents of Walgreen Co. or its subsidiaries, including Take Care Health Systems, LLC.

Find out how Walgreens can help your health system deliver better care a better way.

Visit WalgreensHealth.com/Business.

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12 Policy

Pharmacy Practice News • July 2014

Reimbursement Matters

10 STEPS continued from page 11

payments have nothing to do with what you pay for the drug; instead, they are calculated based on the price that drug manufacturers charge the wholesaler or other distributors, such as specialty pharmacies. Moreover, the resultant payment does not take into consideration any fees or markups or contracted rates involved when these entities sell the drug to you. So ASP will always be less than you pay for the drug. Each year, a percent rate is added on to ASP that is supposed to cover all these variables for you. Currently that rate is 6%. However, because sequestration—a process that automatically cuts items in the federal budget to satisfy spending targets—applies to these payments and will remain in place until 2025, 2% is deducted from ASP to give you ASP plus 4%.

3. Other payor rates. Each payor negotiates its payment rate with your facility. Are you a part of those discussions? For example, do you participate by providing your finance team with the minimum level of reimbursement that you will need just to break even?

Very few payors pay at a percentage of billed charges. Although such a basis for payment used to be in effect and facilities would just raise their prices when they needed income, this is no longer the general practice. Most payors pay a fixed amount and many base their payments on Medicare rates and ASP. Get a list of payor rates for the drugs used in your center for each of your major payors.

4. Billing units. Medicare, as well as most other payors, requires that you convert the dose of the drug given into billing units, which you then submit for billing. In other words, you are not paid for the entire vial of the product but only for the amount used for that patient. Yes, it is true that Medicare makes a provision for billing for waste, but most other payors do not. So it is essential to ensure that this billing-unit conversion is working correctly through all the steps between the drug being entered into the pharmacy computer system all the way through to the bill being released. There are lots of places this can go awry and leave you billing for only a fraction of what you should be. Amazingly, although this payment policy regarding billing units has been in place for almost 10 years, billingunit errors are one of the major errors reported by Medicare.

5. Correct codes. Coding is the language used to transmit information to the payor. It is essential that the correct Healthcare Common Procedure Coding System (HCPCS) code be used. Miscellaneous codes are used only until a HCPCS code is assigned to a medication, which most often actually occurs before

the FDA approves the drug. So be sure to clear miscellaneous codes from your Charge Description Master (CDM)— a comprehensive listing of items that could be billed to a patient, payor or health care provider. Also, make sure that the revenue cycle team or whoever handles the CDM actually is making the timely changes you are requesting and that the updates aren’t languishing for months before being acted on. Also, be vigilant regarding the move toward brand-specific HCPCS codes and make these changes rapidly when they occur.

For example, when Teva Oncology introduced Granix (TBO-filgrastim injection) to the market, not only did it get its own code (see box), but the one for Amgen’s Neupogen (filgrastim) changed as well.

There should always be a perfect match between the drug description, the billing units and the HCPCS code in your hospital’s pharmacy computer system, with a particular emphasis on the system’s CDM and Pharmacy Drug Master or drug dictionary.

If for some reason this process goes awry, remember that rebilling is permitted within a specific timeframe. If you have errors either in billing-unit calculation or are using the wrong HCPCS codes, rebill ASAP! 6. Drug administration fees. Each of the biologic, immunologic and chemotherapy agents given in the infusion center qualifies for the upper-level drug administration fees, a portion of which

should be transferred back to the pharmacy cost center. Are you using the correct drug administration CPT codes and is there perfect nursing documentation to support this?

7. Local and national coverage determinations (LCDs, NCDs) and prior authorizations. It is essential that all concerned understand which drugs have these coverage determinations, which are usually set either by Medicare Administrative Contractors (MACs) in your area or at the national level by CMS, and that your center has a set procedure for how to handle these binding payment decisions. The required documentation regarding compliance with these coverage determinations must be in the medical record before the drug order is written and especially before the drug is actually prepared and administered. If this step is not taken or documentation is missing, no payment will be made, and, unlike some other billing errors, this aspect of reimbursement cannot be remedied after the fact. Get the LCDs and NCDs from your MAC’s website and the prior authorization list from your payors. Work out a plan with the infusion center as to who is responsible for doing what, who’s documenting what and how this information is going to be transmitted to pharmacy. Equally important is ensuring that the documentation remains a permanent part of the record for auditing purposes.

8. Accepted compendia. Are you

aware of these invaluable resources?

They contain published clinical data that CMS and other payors will accept as the basis for establishing the “medical necessity” of the off-label use of a drug or biologic agent. Currently, CMS recognizes four drug compendia: 1) The American Hospital Formulary Service Drug Information, 2) The National Comprehensive Cancer Network Drugs & Biologics Compendium (NCCN Guidelines), 3) Thomson Micromedex’s DrugDex compendium and 4) Gold Standard/Elsevier’s Clinical Pharmacology.

Remember that you also can use these references as the basis for challenging a denied claim for payment. So having them on hand and being familiar with their contents is crucial to your efforts at maximizing reimbursement.

9. Payor status. Are you aware of whom the payor is when an order is transmitted/sent to the infusion center?

You can’t be an effective player in this if you don’t have the necessary data.

10. Get involved. One of the most important things that you can do is join lobbying efforts for a redefinition of ASP to more closely align it with actual cost. The hybrid of payment models will continue into the future, and pharmacy cannot afford to complacently sit by and wait for someone else to take action.

Please send your questions or comments to bkirschen@aol.com.

We encourage and appreciate your feedback!

■

Passing Along Pass-Through Status Changes

I

f you do a good job of trolling the CMS website for updates to its reimbursement policies and procedures, you’ll frequently come across important announcements that will have a major effect on your hospital’s bottom line if not adequately addressed. The pass-through status of drugs is a prime example: CMS makes changes in a drug’s pass-through status throughout the year as well as annually. Effective July 1, 2014, the products below were added (for more information on these updates, visit http://go.cms.gov/1mO6PwJ): HCPCS Code

Long Descriptor

APC

Status Indicator

C9022

Injection, elosulfase alfa, 1mg

1480

G

C9134

Factor XIII (antihemophilic factor, recombinant), Tretten, per 10 iu

1481

G

J1446

Injection, tbo-filgrastim, 5 micrograms

1447

G

Codes C d also l can change, h so iit’s essential i l that h these h are quickly i kl updated d d in i the h CDM C and d PDM. Note the h status indicator i di (SI) (S ) change to N for this morphine product, which means that Medicare no longer will pay for the drug.

New HCPCS Code

Long Descriptor

Q9970 Q9974

APC

Status Indicator

Old HCPCS Code

Injection, ferric carboxymaltose 1mg

9441

G

C9441

Injection, Morphine Sulfate, Preservative-Free for Epidural or Intrathecal Use, 10 mg

N/A

N

J2275

APC, ambulatory payment classification; CDM, Charge Description Master; G, payment by pass-through; HCPCS, Healthcare Common Procedure Coding System; N, bundled into other APCs; PDM, Pharmacy Drug Master

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14 Clinical

Pharmacy Practice News • July 2014

Controlled Substances

NIDA Study Cites Dangers of Marijuana Use in Teens E

ven the safest drugs carry risks, and medical marijuana is no exception.

Advocates of medicinal cannabis got a fresh reminder of that truth in a stark review article by scientists from the National Institute on Drug Abuse (NIDA). The report, published in The New England Journal of Medicine (2014;370:2219-2227), detailed some of the serious potential harms that marijuana can have on individuals who use it to get high—and by implication on those who use it for relief of serious pain conditions that traditional medicines have failed to alleviate.

They include not only the potential for addiction and cognitive damage— particularly for younger or heavier users—but also impaired motor coordination, altered judgment and even psychosis. Heavy marijuana smoking also increases the risk for chronic bronchitis and other pulmonary conditions, according to the report. And the potential dangers have grown in proportion with the steadily increasing amount of marijuana’s psychoactive component— delta-9-tetrahydrocannabinol (THC)— found in plants grown in the United States—from about 3% in the 1980s to 12% in 2012, according to the report.

“As policy shifts toward legalization of marijuana,” the authors noted, “it is reasonable and probably prudent to hypothesize that its use will increase and that, by extension, so will the number of persons for whom there will be negative health consequences.” (An accompanying sidebar describes the rise in emergency department visits at one major Colorado medical center after the state legalized recreational marijuana in 2013.)

Finding safe and effective ways to balance medical marijuana’s potential benefits and risks remains a key goal of researchers and providers in the growing number of states that have autho-

A Roadblock to Pharmacist Involvement

Where There’s Smoke Smoke, There’s F Fire ire

L

ike emergency departments (ED) in other Colorado hospitals, the ED at the University of Colorado Hospital in Denver experienced a spike in patient visits following last year’s state approval of recreational marijuana.

According to Andrew Monte, MD, an assistant professor of emergency medicine and medical toxicology, adverse reactions have ranged from exacerbations of psychiatric illness to chronic vomiting syndrome.

“We are also seeing an increase in the volume of burns due to the production of butane hash oil,” he said. “We had 11 patients admitted to our burn unit this year from making” this product. Butane, which is used to extract the oil from the marijuana plant, “is exceptionally flammable,” he said, “and so, unfortunately, it leads to explosions and burns.”

Children have been affected. “The last time I looked at the numbers,” Dr. Monte said, “there were nine children admitted to the pediatric ICU this year due to marijuana-related illness. Seven of those children were exposed to edibles. In comparison, last year there were only six patients all year.”

Dr. Monte expects the recent rise in marijuana-related ED visits to subside once people become more familiar with the use of the products. “We see increased health care visits with increased drug access,” he said. “This has been [the case] with new illicit drugs as well as new pharmaceuticals.”

—B.B., J.B.

rized its use. Colorado, for example, recently approved $9 million to fund five years of research on the therapeutic effects of marijuana and its components. California has spent $8.5 million on similar research.

Laura Borgelt, PharmD, BCPS, an associate professor at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, in Aurora, noted the importance of evaluating the potential benefits and risks of medical marijuana “so that we can determine

the patients that can benefit most while minimizing their risks. We need rigorous medical marijuana studies conducted to understand the most effective formulations and doses for particular conditions as well as the potential adverse effects and drug interactions that patients with these conditions may experience.”

Dr. Borgelt has been active in helping to establish guidelines for the packaging, labeling and testing, as well as the appropriate dosing, of medical marijuana sold in Colorado, where an estimated 100,000 people now use the products to relieve debilitating medical conditions.

GW Pharmaceuticals’ marijuana growing facility (left) and laboratory (above) are part of the company’s efforts to get a THC/CBD-containing drug to market (see sidebar, opposite).

The dearth of controlled research, along with marijuana’s federal status as a Schedule I controlled substance, have generally hampered pharmacists’ participation in the treatment of patients who have been unable to find relief from traditional therapies and might benefit from medicinal cannabis.

In New Mexico, for example, Ernest Dole, PharmD, BCPS, a certified pharmacist-clinician in a chronic pain clinic that is part of the University of New Mexico Hospitals, was cautious in telling Pharmacy Practice News how he interacts with patients with chronic pain who use marijuana to alleviate their symptoms.

Dr. Dole practices in a state where, for seven years, residents have been permitted to apply for a medical marijuana license that lets them purchase six ounces at a time to alleviate 16 conditions ranging from intractable chronic pain and nausea and vomiting to HIV/AIDS and Crohn’s disease.

Under a collaborative practice agreement, Dr. Dole sees about 12 to 15 patients a day in sessions lasting from 20 to 30 minutes. He discusses with them how their pain medications are working, and he makes adjustments based on what they report. For patients who use medical marijuana, he said he practices what he called “vigilant observation,” meaning that he neither recommends nor discourages its use.

“It is probably helping,” he said, “and there is probably less risk involved than with many other medications that we use. But there are so many unknowns.

Right now, you try to do the best that you can with the guiding principle being ‘first, do no harm.’”

Health-system policies generally discourage pharmacists from engaging in the management of medical marijuana, other than to note its use during medication reconciliation sessions and medication therapy sessions at outpatient clinics. F. Randy Vogenberg, PhD, RPh, a principal at the Institute for Integrated Healthcare, in Greenville, N.C., said state medical marijuana approval laws have created a dilemma for health systems not only because of legal and liability uncertainties but also because of the potential for adverse drug interactions that might lead to hospital readmissions, “which hospitals are trying to avoid right now.”

From a practice perspective, Dr. Vogenberg noted, hospital pharmacists need to be keenly aware of their own state laws on medical marijuana as well as their institutions’ specific policies and procedures, which in many cases, he added, “will supersede even state law—more stringent, as an example.”

Clinical 15

Pharmacy Practice News • July 2014

Oncology Table. Disease-Free Survival Rates in ALTTO Trial

SHAKE-UP continued from page 1

“This is a serious disappointment, not just for the investigators, but for the entire field [of breast cancer],” said George Sledge Jr., MD, a professor of medicine and the chief of the Division of Oncology, Stanford University Department of Medicine, in California. He was not involved with ALTTO but served as the discussant for the study (abstract LBA4) when it was presented at the recent annual meeting of the American Society of Clinical Oncology (ASCO).

Clinicians had high hopes for ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation), given that a year ago, researchers from the Phase III NeoALTTO trial reported that adding lapatinib to trastuzumab doubled pathologic complete response (pCR) in the setting of neoadjuvant treatment of patients with HER2-positive breast cancer. The ALTTO trial enrolled 8,381 women with HER2-positive, early-stage breast cancer. Patients underwent surgery and then received chemotherapy plus one year of treatment with either trastuzumab alone, lapatinib alone, trastuzumab followed by lapatinib, or concurrent trastuzumab and lapatinib.

The trial began in June 2007, and the lapatinib-alone arm was terminated early, in August 2011, due to futility.

At the ASCO meeting, investigator

Whatever the state laws and hospital policies may be, “pharmacists are in the best possible position to query patients in a nonjudgmental way about whether there is anything that they are using other than their prescription medications,” said Lawrence J. Cohen, PharmD, BCPP, a professor of pharmacotherapy at the University of North Texas System College of Pharmacy, in Fort Worth. “We can do that as part of a comprehensive medication history or medication reconciliation. We can probe even further: Are they using medical marijuana, recreational marijuana or any other substances that could have an impact on their medications or their health? It’s important to have that information.”

For one thing, Dr. Cohen noted, the use of marijuana can affect the hepatic metabolism of drugs such as warfarin (increasing free warfarin with an attendant increased risk of bleeding), ketoconazole, carbamazepine, and protease inhibitors (potentially reducing ritonavir and indinavir levels). “Think of how valuable it can be,” he said, “for a pharmacist to say to a patient who is stabilized on warfarin: ‘Marijuana displaces warfarin, meaning there will be more warfarin floating around in your bloodstream and you are higher risk for having bleeds.’”

Treatment

4.5-y DFS, %

Hazard Ratio

P Value

P Value Required For Significance

Trastuzumab

86

Concurrent lapatinib + trastuzumab

88

0.84

0.048

≤0.025

Trastuzumab followed by lapatinib

87

0.96

0.610

≤0.025

ALTTO,, Adjuvant j Lapatinib p And/Or / Trastuzumab Treatment Optimisation; p ; DFS,, disease-free survival

Martine Piccart-Gebhart, MD, PhD, an associate professor of oncology at Université Libre de Bruxelles and the head of the Department of Medicine at the Jules Bordet Institute in Brussels, Belgium, reported that patients treated with both HER2-targeted agents had no benefit related to disease-free survival at a median follow-up of 4.5 years (Table).

“It is difficult to mount any enthusiasm for combined blockade of HER2 in the adjuvant setting, at least with the combination used here,” Dr. Sledge said.

Drug R&D Takes a Hit The trial results also have broader implications for drug research. The FDA can grant accelerated approval for a medication based on a surrogate end point that is likely to predict improvements in overall and disease-free survival. Two years ago, an FDA draft guidance suggested that pCR could be used as a surrogate end point for neoadjuvant breast cancer therapies, based on studies

including a Cochrane analysis (Cochrane Database Syst Rev 2007;2:CD005002).

Allowing pCR to be used as an end point for approval would allow new drugs to get to patients years before the completion of large, cumbersome trials requiring thousands of patients.

“ALTTO requires us to rethink our approach to the development of new drugs for early-stage breast cancer,” Dr. Sledge said. “ALTTO represented a reasonable test of the hypothesis that improvements in pCR rates are associated with improved disease-free survival.

These hopes have now been dashed.”

A recently published meta-analysis of 12 breast cancer trials also has concluded that pCR rate does not predict event-free or overall survival (Lancet ( 2014 Feb 13. pii: S0140-6736[13]624228. Epub ahead of print].

In September 2013, pertuzumab (Perjeta, Genentech) became the first breast cancer drug to be granted accelerated approval by the FDA for a neo-

New THC/CBD-Containing Drugs on the Horizon

A

lthough marijuana itself is illegal under federal law, two products derived from extracts of the plant are slowly making their way to approval in the United States.

The FDA has granted fast-track approval status and orphan drug designation to Sativex, a combination of THC and cannabidiol (CBD), and Epidiolex, CBD alone.

Sativex, a metered-dose oromucosal spray, is in Phase III clinical trials for the relief of pain in patients with advanced cancer. It is already approved in 25 countries for the treatment of spasticity in patients with multiple sclerosis. Phase IIIII clinical trials of Epidiolex, an oral liquid formulation for the treatment of Dravet syndrome, a rare, treatment-resistant form of childhood epilepsy, are expected to begin in the second half of this year, followed by trials for the treatment of another rare, intractable form of pediatric epilepsy, Lennox-Gastaut syndrome.

GW Pharmaceuticals, the British biopharmaceutical company that created the two products, is in the early stages of developing other cannabinoid therapeutics, including potential treatments for glioma, ulcerative colitis and type 2 diabetes. “We’ve only just scratched the surface,” Mark Rogerson, a GW spokesman, said. “There is a huge potential there.”

Dr. Cohen noted that in Sativex, “CBD seems to modulate some of the psychoactive components of THC,” so it doesn’t produce “the kind of effect that people experience when they get high, but they still get improvement in physical symptoms like pain or nausea.”

—B.B., J.B.

Dr. Cohen mentioned other potential adverse effects of marijuana that pharmacists need to heed. “I work in behavioral health, so I think about the kinds of behavioral effects that can occur,” he said.

“What happens, for example, in a patient

with depression or anxiety or psychosis who uses medical marijuana? Will their symptoms be exacerbated? There are no controlled studies that have been done,” but pharmacists need to have a concern about patients who have preexisting

adjuvant treatment indication based on data showing an improvement in pCR. Dr. Sledge said the ALTTO trial raises the question of whether pertuzumab should have been approved for that indication on that basis.

Cindy L. O’Bryant, PharmD, BCOP, FCCP, an associate professor, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, in Aurora, Colo., agrees that using pCR as the basis for drug approvals may be flawed. “ALTTO reminds us that there is still work to be done to identify better surrogate endpoints for cancer trials that will allow for an earlier, reliable drug approval process and correlate more closely with survival outcomes,” she said. “This trial also brings to question the role of combined HER2 blockade and its importance in the biology of early stage breast cancer. Is this really a driver of disease progression?”

—Kate O’Rourke Dr. Sledge disclosed a consultancy/ advisory role with Genentech/Roche, Seattle Genetics and Symphogen, and honoraria from Genentech. Dr. PiccartGebhart disclosed relevant relationships with Amgen, Astellas Pharma, AstraZeneca, Bayer, Invivis, Lilly, MSD, Novartis, Pfizer, Roche/Genentech, Sanofi, Symphogen, Synthon and Verastem. Dr. O’Bryant had no relevant financial conflicts of interest to disclose.

behavioral conditions, he stressed.

That is also true for patients with cardiovascular and pulmonary conditions, Dr. Cohen said. “If somebody has a history of having had a myocardial infarction or arrhythmia,” he noted, “medical marijuana should be used with caution and should be monitored.”

Dr. Borgelt agreed that pharmacists are well positioned to help patients understand the risks and benefits of marijuana therapy. “We bring a unique perspective because we understand the pharmacology and the pharmacokinetics” as well as the interactions that might occur, she noted.

As a pharmacist who has worked with other professionals in Colorado to develop marijuana safety practices—like the use of child-resistant safety caps—Dr. Borgelt, who is also in clinical practice at the University of Colorado Health’s A.F. Williams Family Medicine Center in Denver, said she found it “really fascinating that different states are trying different approaches. I think that ultimately, we will probably end up finding out what works best in the medical model.”

—Bruce and Joan Buckley None of the sources reported any relevant financial conflicts of interest.

16 Clinical

Pharmacy Practice News • July 2014

Critical Care

TIGHT CONTROL continued from page 1

The campaign began following a larger call to action from BJC HealthCare’s CEO after 10,405 adverse drug events (ADEs) were identified at member hospitals over a one-year period. The directive was simple—eliminate all causes of preventable harm. The question was where to start?

The answer became evident when Paul Milligan, PharmD, working with the support of hospital executives, assembled a multidisciplinary QI team comprised of two epidemiologists, four pharmacists (including a data analyst and informaticist) and 17 nurses. The team’s first step was to automate a validated Institute for Healthcare Improvement ADE trigger tool that had primarily been used in paper-based chart reviews. After standard harm definitions were determined for each trigger, such as glucose levels between 15 and 39 mg/dL, the team integrated them into a Web-based alert. Once activated, the alert went to a pharmacist who determined if it was an actionable event on a case-by-case basis.

The systemwide analysis showed that from November 2009 to October 2010, 77% of the nearly 11,000 ADEs were attributable to hypoglycemia, with oversedation a distant second at 16%.

Although these numbers weren’t a surprise to the QI team, they were a shock to everyone else, Dr. Milligan said. In response, the team developed an automated hypoglycemia event identification tool where any glucose level meeting the inputted definition was considered an event. The next step was to raise awareness among caregivers at BJC because the high prevalence of abnormal blood glucose levels was still relatively unrecognized, he noted.

“For a while we didn’t do anything other than begin an open conversation about the condition, but our rates were slowly starting to decline anyway,” Dr. Milligan said. “We added severe hypoglycemia to our system quality scorecard, which is used to track multiple quality measures and has served as the roadmap to achieve clinical quality within BJC. We also encouraged nurses to enter hypoglycemia into the safety event selfreporting system, which furthered their involvement in assessing it.”

The team continued the process by developing a Hypoglycemia Event Analysis Tool, with the goal of discovering local causes of hypoglycemia that would guide future interventions. The automated system also became a way to share the standardized information with all of the hospitals and to create customized action plans.

By using the analytic tool, the team found that the majority of the problems with hypoglycemia were prescriber-

related. The top four systemwide causes were written up and sent as a letter to all physicians. Dr. Milligan offered further details on the incidence of these problem areas and the changes needed for improvement: Reduce home basal insulin (27%).

Prescribers, he noted, were urged to consider a 20% reduction of these insulin doses at admission. He explained that a person’s insulin intake is related to his or her calorie intake, so when diet changes in the hospital, the patient’s insulin dosage should change as well.

Review history of blood glucose levels daily (20%). Prescribers were urged to adjust basal insulin, especially bedtime dosing, as needed. Downward trends in morning glucose levels, he pointed out, often go unrecognized and can be a factor leading to severe hypoglycemia.

Consider the discontinuation of oral diabetic agents (8%). This should be done, Dr. Milligan noted, for most patients at admission. Because oral agents work for lengthy periods, physicians can struggle with maintaining their patients’ glucose levels for several days.

Stop sulfonylurea agents in highrisk patients (8%). These agents should be discontinued specifically in patients. who are 75 years of age or older, weigh less than 165 pounds, or who have diminished renal function, he said.

There were several lessons learned throughout the QI process, but one of the most crucial was the importance of collaboration. “One of our early prevention strategies included establishing a multidisciplinary hypoglycemia task force at every hospital,” Dr. Milligan said. “We realized that instead of [only pharmacists], we needed nurses at the bedside.

Also, we met monthly where we shared data between the hospitals and then proposed system policies.”

In addition to the clinical benefits noted, the effort also resulted in saving an estimated 8,100 inpatient days and $7 million in hospital costs as of December 2013, Dr. Milligan reported. Cost savings were estimated, he explained, by taking the count of prevented ADEs multiplied by an internal estimate of extra patient days and the hospital’s average hospital cost per patient-day.

Kudos From a BWH Pharmacist Paul Szumita, PharmD, BCPS, a clinical pharmacy practice manager at Brigham and Women’s Hospital in Boston, attributed the campaign’s success to its high level of collaboration and its strong focus on both clinical and educational aspects of care.

The clinical component has to be in place at the earliest phases of a patient’s treatment, Dr. Szumita said. He noted, for example, that “the home insulin regimen for a diabetic patient is almost never relevant when they arrive in the emer-

gency department. For insulin therapy we largely ignore what they are on and go forward with our own therapy.” That’s a risky oversight, “because home regimens are so basal-centric that when a patient has changes in nutritional status it can lead to trouble with hypoglycemia.”

As for the communication and education elements, the BJC initiative’s successful handling of those components is impressive “because they are probably the two hardest things to really nail down when establishing best practices,” Dr. Szumita said. “At first you educate everyone, but when new staff and residents come in, you have to do it all over again.

It’s a continuous process and it can be difficult when you can’t easily get everyone together. There has to be a system with clear standardization so everyone knows exactly what to do when a situation arises. Having the resources and leadership support for these efforts are key.”

A Physician Champion Leadership support in such efforts can come from multiple sources, but one particularly important “champion” to have onboard is a physician. One such champion was Garry Tobin, MD, the director of the Diabetes Center, Washington University, in St. Louis. Dr. Tobin showed his leadership skills by heading up a research project at Barnes-Jewish Hospital, which is a partner institution of Washington University and a member hospital of BJC. Dr. Tobin and his research team con-

ducted a prospective cohort study of hypoglycemia interventions in eight acute medicine floors at the hospital. The investigators wanted to see if a targeted intervention involving trained nurses using a hypoglycemia informatics alert would provide a greater reduction in severe hypoglycemia than usual patient care. They found that the interventions decreased severe hypoglycemia by 68% in high-risk patients. The interventions also resulted in changes in diabetes treatment in 50.8% of such patients, whereas physicians changed treatment in 22.9%.

Finally, the overall reduction of events during this study was 46%, including high- and low-risk patients.

Clare Blackburn, RN, CDE, who works in Washington University’s Division of Endocrinology, Metabolism and Lipid Research, gave kudos to Dr. Tobin for his willingness to invest time and energy into the hypoglycemia improvement project—as well as for his intervention methods. “The use of an informatics system to predict and prevent medication harm to patients is amazing,” Ms. Blackburn said. “However, clear guidelines for disease management, communication and collaboration, and the commitment of nurses, physicians and pharmacists involved in responding to the alert is the reason for [the program’s] success.”

—Paul Bufano None of the sources reported any relevant financial conflicts of interest.

NEW PRODUCT

PharMEDium Launches I.D. Your I.V. System

P

harMEDium Healthcare Corporation announced that it has launched the I.D. Your I.V.® solution, which includes “innovative, U.S.-patented labeling that helps clinicians easily and quickly confirm the identity of medications to improve administration accuracy and reduce the risk of errors,” the company noted in a press release.

I.D. Your I.V. “is more than just a redesigned label, but rather a patient-safety focused solution” that includes the PharMEDium compounded service, its clearVIEW™ overwrap bag, an all-inclusive barcode for better patient traceability, and an easy-to-read dual-labeled bag and IV tubing labels, the company noted. The labels—“a first of their kind,” according to the company—are removed from the back of the bag at the point of administration and folded around the tubing to offer clinicians an additional opportunity to reconfirm the correct medication is being delivered. “This solution is easily integrated into medication use workflows and fully supports the ‘5 rights’ of medication administration, so the right medication is delivered to the right patient with the right dosage using the right route at the right time,” the press release stated.

I.D. Your I.V. is based on input from more than 1,000 critical care nurses, nurse educators, clinical pharmacists and patient safety professionals who are responsible for IV therapy, PharMEDium noted. The company added that it began reaching out to its customers earlier this year to inform them of the enhancements and offering educational resources to clinicians to help communicate the changes around their organizations.

“This effort demonstrates PharMEDium’s decade-long understanding of the complex environment where multiple IV medications are used frequently,” said PharMEDium President Rich Kruzynski, RPh. He said the initiative also underscores “the company’s continued dedication to providing important tools to clinicians at the point of care.”

Q & A 17

Pharmacy Practice News • July 2014

Medi-Dose

The following advertorial is provided by Medi-Dose. It is designed to support the advertisement presented below.

MILT 4.0

Q: Is there a network version of MILT 4?

Q: MILT 3.0 has been the industry-leading solution for labeling and barcoding unit-dose medications for years. Why did you decide to create a new version of this program?

A: MILT 4 is sold as an unlimited individualsite license. You can install the program on as many computers as you need. It’s easy to share your database with all the computers in just a standard folder on the network—no server installation is required.

A: MILT 3.0 has been extremely well received by pharmacists in facilities of all kinds and sizes.

We would have continued to add features and enhancements indefinitely. But with 64-bit Windows becoming popular, the existing code had to be rewritten to support it. Rather than just reconfiguring MILT 3.0 for 64-bit, we chose to use the knowledge we gained working with so many pharmacists and rewrote the program to even better suit their specific needs.

Q: Can MILT 4 create advanced barcodes?

A: MILT 4 allows you to include up to seven pieces of information in a 1-D or 2-D barcode, and to include identifiers that distinguish each

piece of information. For example, you can create a barcode incorporating an NDC number, expiration date and lot number. If your barcode medication administration (BCMA) or point-ofcare (BPOC) systems can accommodate it, MILT 4 can generate it.

Q: What types of labels does MILT 4 support?

A: We have a complete line of thermal and laser labels designed specifically for pharmacy and nursing use. From moisture-resistant, tamper-evident labels for sealing solids in our blisters, to butterfly and flag shapes for syringes, to

labels small enough for unit-dose suppositories and large enough for IV bags, Medi-Dose/EPS and our MILT 4 software make it easy to label and barcode any medication.

Q: How can I try and order MILT 4?

A: A demo of MILT 4 can be downloaded directly from our website. Every feature is enabled in the demo program, providing you with an accurate evaluation of what MILT 4 can do. You can order the program by calling us at (800) 523-8966, or through our website at www.medidose.com.

®

Q: So the new version, MILT 4, requires 64-bit Windows?

A: No, MILT 4 works with either 64- or 32-bit Windows. Furthermore, it can even be installed on the same computer where MILT 3.0 is currently installed.

Q: How easy is it to move from MILT 3.0 to MILT 4?

A: MILT 4 lets you import all your users, log history and formulary information from MILT 3.0. All of the features of MILT 4.0 (both those from MILT 3.0 and the new ones we’ve added) have been arranged to best simulate the workflow in a pharmacy.

Q: Which enhancements will make the most difference for pharmacists and staff?

A: The faster printing, cleaner fonts and easier interface will be the most obvious improvements for existing users. One of the most asked-for features is the ability to have different date calculations associated with specific medications. MILT 4 will automatically calculate the appropriate beyond-use date each time someone opens that medication. Another requested feature is the ability to be prompted for specific data, like a lot number, each time a medication is selected. Both of these features allow pharmacists to guide their staff toward completing the packaging task correctly, but still allow for intervention when special occasions arise.

Software for Unit Dose Labeling

Unit Do se Bar Cod , ing, Pharma c Nursing y & Supply Experts !

• 64 Bit Compatible • Enhanced Printing, Fonts and Date Calculations • 1-D and 2-D Multi-Part Bar Codes • Include Tall Man Lettering, Shapes and Images • Scan Bottles to Import from Included NDC Database • Security Options to Ensure Your Work Flow • Group and Sort Your Formulary • Searchable Electronic Log • Easy Database Networking • Supports All Medi-Dose® and LiquiDose® Laser and Thermal Labels

M 4 is the newest version of Medi-Dose's industry MILT leeeading labeling and bar coding software. Every feature oof this custom-written program was specifically ddesigned to accommodate the needs of healthcare pprofessionals. With our large variety of laser and direct thermal labels, you can clearly identify and easily bar th code all medications.

Q: So pharmacists can configure MILT 4 to their specific requirements?

A: That’s right. The pharmacist can configure everything from the type of information to be collected, to the rules for how barcodes are created, to easily limiting or expanding the access that staff members have to features within the program, ensuring that those choices are enforced. Labels for each medication type can be customized, and packaging logs and reports can retrieve desired information about the work that has been done.

Download Demo at MediDose.com

•

800.523.8966

18 Clinical

Pharmacy Practice News • July 2014

Infectious Disease

FDA Approves Dalbavancin for Skin Infections T

he FDA has approved dalbavancin, a second-generation glycopeptide, for the treatment of gram-negative acute bacterial skin and skin structure infection (ABSSSI). The approval comes on the heels of two large trials that showed dalbavancin was as safe and effective as vancomycin in inducing a clinical response within 48 to 72 hours and in maintaining the response at the end of treatment.

Along with these findings, the drug’s weekly IV infusion dosing will make it an attractive ABSSSI treatment option, according to researchers and experts.

“The ease of use of dalbavancin in comparison with conventional daily treatment options potentially means that patients can be treated in the ambulatory setting and/or discharged earlier from [the] hospital to continue their recovery at home,” said Mark Wilcox, MD, a professor of medical microbiology at the University of Leeds in the United Kingdom, and the coordinating investigator of DISCOVER 2 (Dalbavancin for Infections of the Skin Compared to Vancomycin at an Early Response), one of two pivotal dalbavancin studies.

DISCOVER 1 and 2 were identical in design: randomized, double-blind, double-dummy noninferiority studies that included 1,312 adults in several countries with cellulitis, abscess or wound infection with an associated area of surface erythema measuring at least 75 cm2, accompanied by fever, leukocytosis and/ or increased immature neutrophil levels.

Dr. Wilcox and his colleagues randomized 659 of these patients to receive a 30-minute IV infusion of 1 g of dalbavancin (Dalvance, Durata Therapeutics), followed by a 500-mg IV infusion of the drug seven days later. In the control arm, 653 similar patients received 1 g of van-

Table. Cumulative Clinical Success Rates for Dalbavancin vs. Vancomycin/Linezolid Dalbavancin % (n/N)

Vancomycin/Linezolid % (n/N)

Clinical success at end of treatmenta

90.7 (517/570)

92.1 (502/545)

Clinical success at 28-day follow-upa

95.2 (495/520)

95.2 (477/501)

Outcome

Clinical success at end of treatment by infection typea Cellulitis

90.7 (294/324)

91.7 (276/301)

Major abscess

94 (125/133)

95.7 (133/139)

Traumatic wound/surgical site infection

86.7 (95/113)

88.6 (93/105)

Clinical success by pathogen typea Staphylococcus aureus

90.6 (173/191)

93.8 (166/177)

MRSA

89.2 (66/74)

96 (48/50)

MSSA

91.5 (107/117)

92.9 (117/126)

Streptococcus pyogenes

94.7 (18/19)

84.6 (11/13)

MRSA, methicillin-resistant S. aureus; MSSA, methicillin-sensitive S. aureus a

Analysis includes only clinically evaluable patients at end of treatment and follow-up.

Source: Wilcox HM, Poster 1339, Infectious Disease Week 2013. Data derived from DISCOVER 1 and 2.

comycin (15 mg/kg) IV every 12 hours for at least three days, after which time 551 switched to oral linezolid 600 mg every 12 hours for the duration of the 10to 14-day treatment period. Participants included both inpatients and outpatients.

According to a combined analysis of the two studies that was presented at Infectious Disease Week (IDWeek)

2013 (poster 1339), the dalbavancin and vancomycin/linezolid groups had similar rates of clinical success—defined as lesion spread cessation along with complete resolution of fever—at 48 to 72 hours after administration of the first drug dose (79.7% for dalbavancin vs.

79.8% for vancomycin/linezolid). Likewise, there were similar rates of clinical

Development of New Antibiotics Spurred by GAIN

W

ith its recent FDA approval, dalbavancin now joins a rarified group of novel antibiotics, some of which have benefited from the Generating Antibiotic Incentives Now (GAIN) Act, a federal law designed to expedite the approval and increase the commercial potential of new antibiotics.

“Through the GAIN statute, dalbavancin becomes among the first anti-infective agents to receive the QIDP [qualified infectious disease product] designation, which gives it a priority review and additional five years of data exclusivity,” said Paul Edick, CEO at Durata Therapeutics, dalbavancin’s Chicago-based manufacturer.

Along with the market incentives, the government trying to create the “large ABSSSI market” was another reason Durata chose to invest in developing an antibiotic, Mr. Edick said. Indeed, epidemiologic data gathered by Durata and presented at the Society of Hospital Medicine’s 2014 Annual Meeting in Las Vegas, showed that ABSSSIrelated hospital admissions in the United States rose by 17.3% between 2005 and 2011 (poster 3113). “[Additionally,] the dosing of Dalvance [dalbavancin] and the potential to administer care in an outpatient setting,

rather than the hospital, give it an advantage [over other current agents],” Mr. Edick added.

The GAIN Act is an important mechanism to boost research into novel antibiotics, said Christopher McCoy, PharmD, BCPS, the clinical pharmacy coordinator of antimicrobial stewardship, and the postgraduate year 2 residency program director for antimicrobial stewardship at Beth Israel Deaconess Medical Center, in Boston.

“Thus far, the GAIN Act has supported strong R&D [research and development] efforts at a number of companies, with an increase in the number of pipeline products for multidrug-resistant pathogens, but few have hit the approval stage,” Dr. McCoy said.

Other antibiotics that have benefited from the GAIN Act include two agents developed by Cubist Pharmaceuticals: Tedizolid phosphate (Sivextro) was recently submitted for fast-track approval for the treatment of ABSSSI, and in late April, a New Drug Application was submitted for ceftolozane/tazobactam for the treatment of complicated urinary tract infections and complicated intraabdominal infections.

—D.W.

success at the end of treatment in the dalbavancin and vancomycin/linezolid groups (90.7% vs. 92.1%, respectively).

There were no differences in treatment efficacy among vancomycin patients who switched to linezolid (Table).

In a secondary analysis of patients with methicillin-resistant Staphylococcus aureus, Dr. Wilcox’s team found that 89.2% achieved clinical success at the end of treatment compared with 96% of vancomycin/linezolid patients ( not significant).

(P A cumulative analysis of DISCOVER 1 and 2 safety data also presented at IDWeek 2013 (poster 1334) found that significantly fewer dalbavancin recipients than vancomycin/linezolid patients experienced more than one adverse event (AE; 44.9% vs. 46.8%, respectively; P=0.012), and there were also fewer treatment-related AEs with dalbavancin administration (23.7% vs. 26.4%, respectively; P=0.0004).

The most common treatment-related AEs were nausea (2.8% vs. 3.3%), diarrhea (2.5% vs. 3.7%), headache (1.5% vs. 1.6%), elevated γ-glutamyltransferase γ levels (1.1% vs. 1%), rash (1% vs. 1.1%), vomiting (1% and 0.9%) and pruritis (0.6% vs. 1.9%).

The trials’ findings are strengthened by the large study population and by a high proportion of patients with severe infections, “as determined by lesion size and signs of systemic response,” Dr. Wilcox said.

No Significant Safety ‘Red Flags’ “Dalbavancin seems to be comparable in efficacy to vancomycin, daptomycin, linezolid and ceftaroline, and from a safety perspective, there are no real red flags at this time,” said Debra Goff, PharmD, a specialty practice pharmacist in infectious diseases at Ohio State University Medical Center in Columbus, who was not involved in the research.

“We continue to see patients who are receiving vancomycin via outpatient parenteral antimicrobial therapy end up readmitted for a toxic vancomycin level and acute renal failure because they don’t get drug levels tested or don’t undergo serum creatinine monitoring,” Dr. Goff said. “It’s bothersome to see these patients readmitted within 30 days secondary to a preventable vancomycin-related adverse drug reaction.”

However, until dalbavancin is rolled out into widespread clinical use, it will carry some theoretical safety concerns, she noted. For example, there is the possibility of dalbavancin-associated liver injury, particularly in patients with preexisting liver disease, which means

•

see DALBAVANCIN, page 20

20 Clinical

Pharmacy Practice News • July 2014

Infectious Disease

Prioritize Prevention To Control C. difficile T

here is more to Clostridium difficile than just nausea and diarrhea; it is a highly contagious bacterium linked to 14,000 deaths in the United States annually, according to the Centers for Disease Control and Prevention.

With C. difficile now rivaling methicillin-resistant Staphylococcus aureus as the most common bacteria to cause health care–associated infections (HAIs), a team of experts has issued updated practice guidelines that encourage hospitals and other acute care settings to implement and prioritize prevention efforts.

The recommendations, which are part of the “Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals: 2014 Updates” ((Infect Control Hosp Epidemiol 2014;35:455-459), advise creating a multidisciplinary strategy that enlists a broad scope of hospital personnel, including leadership, physicians, pharmacists, and lab and environmental services staff.

The recommendations cite a wide range of tools for controlling HAIs, including promoting appropriate antimicrobial use and stewardship programs, treating infected patients in isolated rooms with proper contact precautions, requiring physicians to wash their hands with soap and water before every patient interaction, cleaning patient rooms and surfaces touched by doctors and patients, and creating reporting and alert systems to document and provide immediate notification of newly diagnosed patients.

Aggressive implementation of these basic measures and improvement of

DALBAVANCIN continued from page 18

recipients of this drug should be monitored for liver function, according to a poster (1334) presented at IDWeek 2013. Data from the poster showed that 0.5% of dalbavancin-treated patients had elevations in alanine aminotransferase greater than three times the upper limit of normal compared with 0.1% of control patients. The rates at the end of treatment were 0.4% and 0.3%, respectively.

Reduced Health Care Costs Health care utilization and costs could be lower with dalbavancin than with current ABSSSI treatments, according to Christopher McCoy, PharmD, BCPS, a clinical pharmacy coordinator of antimicrobial stewardship, and the postgraduate year 2 residency program director for antimicrobial stewardship at Beth Israel Deaconess Medical Center, in Boston.

antimicrobial prescribing could result in about a 30% reduction in C. difficile cases (Br J Clin Pharmacoll 2014;77:896-903; J Hosp Infectt 2013;84:227-234), noted Erik Dubberke, MD, MSPH, co-lead author of the practice guidelines and director of the Section of Transplant Infectious Diseases at the Washington University School of Medicine, in St. Louis.

“These decreases will occur primarily at the hospitals whose C. difficile infection (CDI) incidence is above the median,” Dr. Dubberke said. However, “more studies are needed to determine how to optimally reduce CDI incidence beyond this point, such as what to do with asymptomatic carriers and the potential impact of vaccines being developed.”

A Team Effort Due to a lack of definitive data, several additional strategies for reducing CDIs were not included in the new guidelines, the authors noted. These include using gowns and gloves by family members and other visitors, prescribing probiotics, using no-touch disinfection technology and restricting the use of gastric acid suppressants.

It is in part because of this lack of high-quality data on optimal prevention methods that rates of CDI have remained high for years, whereas other HAIs have declined, Dr. Dubberke said.

“For instance, catheter-associated bloodstream infections have the highest quality of data to support them” and have declined significantly in many hospitals, he noted ((PLoS One 2014;9:e93898), “but there are no C. difficile prevention

“The benefit of a once-weekly infusion means a reduced need for careful observation, including dedicated nursing time and no need for placement of a central catheter, which is required for other currently available therapies, such as daptomycin, vancomycin and ceftaroline,” said Dr. McCoy, who was not involved in the research on dalbavancin.

In addition to the potentially lower costs associated with administering dalbavancin, there are other reasons clinicians and administrators may choose the antibiotic over other ABSSSI treatments, Dr. McCoy said.

“There is the greatest potential for dalbavancin to displace the use of other drugs in patients lacking VNA [Visiting Nurse Association] service benefits, those managed by institutions offering outpatient infusion-site services and in those patients with a history of failure or intolerance to other agents,” he said.

“However, it remains to be seen whether

[efforts] that have that level of evidence.”

The same is true for surveillance data on C. difficile, Dr. Dubberke said. The National Healthcare Safety Network only started collecting data for CDIs a few years ago, he noted, and benchmark data on CDI incidence in the United States have not yet been published.

Because of these limitations, the updated HAI recommendations can serve as a roadmap for institutions that do not have an approach for addressing CDIs, commented Brian Potoski, PharmD, the associate director of the antibiotic management program at the University of Pittsburgh School of Pharmacy. “The resources aren’t there for some hospitals, so it can be difficult to collect all the data and then form a usable plan of action,” Dr. Potoski said. It thus “would be wise” for such institutions to base their CDI control efforts on the new guidelines, he said. “But sometimes it’s the simple things that are the most important. Look at hand hygiene, for example, because it can easily be tracked and implemented.

And because it’s not exclusive to C. difficile, you’ll get a lot of bang for your buck.”

In one study, he noted, hand hygiene measures reduced the incidence of several HAIs from 4.8 to 3.3 per 1,000 patientdays (BMJ Qual Saff 2012;21:1019-1026).

Can Robots Prevent CDIs? Advances in medical technology also offer hope for improved CDI prevention, including robots designed to kill off and prevent the transmission of pathogens by emitting ultraviolet (UV) light in hospital rooms, Dr. Potoski said. The

there is truly a pharmacoeconomic benefit of using this higher-cost agent, even when compared with the total costs of a full course of currently approved agents.”

Although the pricing for dalbavancin is unknown at the moment, Dr. McCoy said the approximate cost of a 10-day course of ceftaroline is $950, and the estimated cost of a 10-day treatment of daptomycin is roughly $3,000, depending on a patient’s weight.

Beyond the ABSSSI Indication Durata Therapeutics is pursuing additional indications for dalbavancin, including osteomyelitis, diabetic foot infections and pneumonia, Paul Edick, CEO of the Chicago-based company, wrote in an email. Moreover, Durata is conducting a Phase IIIb study examining the efficacy and safety of a single 1,500 mg dose of dalbavancin for ABSSSI. “It will definitely be interesting to see how the drug’s role will evolve,” said Kim Ly, PharmD, BCPS, a clinical

University of Pittsburgh Medical Center recently implemented such a device, but the frequency of where and when to use it optimally is still to be determined, he noted. What has been determined is the overall efficacy of the devices: one study showed that a mobile UV light unit significantly reduced C. difficile spores on contaminated surfaces in patient rooms ((Infect Control Hosp Epidemiol 2011;8:737-742).

Based on such data, “after a [UV-emitting robot] leaves an exposed area, you can be assured that the chance of transmission is significantly [reduced],” Dr. Potoski said. “Hospital administrators have to be willing to spend a little more now [on such technology] to save down the road and help cut back on readmissions and avoidable care.”

The compendium on HAIs is a result of a collaboration led by the Society for Healthcare Epidemiology of America, the Infectious Diseases Society of America, the American Hospital Association, and the Joint Commission, among others.

—Paul Bufano Dr. Dubberke reported that he has conducted research and/or has consulted for Sanofi Pasteur, Merck, Cubist, Microdermis and Rebiotix. Dr. Potoski had no relevant financial conflicts of interest to disclose.

pharmacy specialist in critical care and infectious diseases at Sunrise Children’s Hospital, in Las Vegas. “For conditions like endocarditis, osteomyelitis and septic arthritis, for which longer courses of antibiotics are needed, daily administration for four to eight weeks [as is done with other current treatments] can be a burden for patients,” said Dr. Ly, who was not involved in the research.

“A drug with a long half-life, like dalbavancin, where once-weekly administration is feasible, may be useful in situations like this,” Dr. Ly noted. “Of course, we won’t know if this is an option until further studies are conducted for these indications.”

—David Wild Drs. Ly and Goff reported no relevant financial conflicts of interest. Dr. Wilcox reported receiving research funding from Durata Therapeutics. Dr. McCoy reported consulting for Durata Therapeutics and conducting research for Forest Pharmaceuticals.

The McMahon Group Celebrates the Best of Its Outstanding Employees

2013

Once a year the McMahon Group takes time to look back at the previous year and acknowledge the extraordinary talents and persistence of its employees. The 43-year-old company publishes best-read medical newspapers and websites, creates custom media for medical industry firms and hospital systems and produces certified medical education platforms for clinicians.

Here is a review of the winners of the 2013 employee awards: MANAGEMENT/SUPPORT/IT/FINANCE/PRODUCTION

MANAGEMENT/SUPPORT/IT/FINANCE/PRODUCTION

Employees are asked to select two outstanding members from these diverse departments. The first winner was ROSA DIMICCO, whose challenging work in Finance includes overseeing accounts payable.

The second winner was YUMI VELIZ, who as part of the IT Department manages requests for IT assistance and maintains all servers and the infrastructure of the McMahon network.

MOST IMPROVED SALESPERSON OF THE YEAR

SALES ACHIEVEMENT AWARD OF THE YEAR

This award was given to MATTHEW SPOTO, whose work on Gastroenterology & Endoscopy News has brought in new clients and maintained steady relationships with existing clients, resulting in a record year.

DAVI A D KAPLAN, publication director of Pharmacy Practice Newss as well as Specialty Pharmacy Continuum, received this award for, among other accomplishments, spearheading new pharmacy publications.

ASSOCIATE/SENIOR/PROJECTS EDITOR OF THE YEAR

MANAGING EDITOR/COPY EDITOR OF THE YEAR

This award was given to Associate Projects Editor CARLOS PERKINS JR., whose job includes working closely with sponsoring companies to create great medical education programs that are delivered on time.

This year, Copy Editor ELIZABETH ZHONG won the award for her efforts in fine-tuning all the editorial material that is assigned to her. Her work helps ensure accuracy in all of our publications, medical education programs and sponsored custom media.

MAX GRAPHICS DESIGNER OF THE YEAR

SALESPERSON OF THE YEAR

Longtime staffer FRANK TAGARELLO T , who manages the Graphics Department, received the award for his inventive design work on such publications as Clinical Oncology News and Pharmacy Practice News and a variety of medical education projects.

For the eighth year in a row, RICHARD TUORTO, the senior group publication director of both Anesthesiology News and Pain Medicine News, won the award for bringing in the most revenue in the calendar year.

MCMAHON GROUP PERSON OF THE YEAR

PARTNERS’ AWARD

The winner of this year’s award was HYONG KWON, manager of the company’s IT development team, who oversaw innumerable projects, including updating our websites, creating tablet and digital versions of our publications, and managing the IT staff, to name just a few. There is a constant stream of IT requests that land on his desk and, somehow, Hyong is able to continually perfect our digital presence.

From time to time, CEO and Managing Partner Ray McMahon extends a special award to an individual whose efforts over many years have made a fundamental difference in the well-being of the company. This year that award went to his son, MATTHEW MCMAHON, whose position as the company’s general manager puts him front and center for major decisions involving policy, finance and overall governance.

22 Technology

Pharmacy Practice News • July 2014

Informatics

TURNAROUND October 2008 and September 2009, the median observed-to-expected mortality ratio of UHC teaching hospitals was 0.90 and BMC’s was 1.13. This ranked BMC 96th out of 105 hospitals, according to Stanley Hochberg, MD, the senior vice president for quality, safety and technology at BMC. Clinicians and statisticians at the hospital spent the next year analyzing data and developing a roadmap for improvement. Comparing rates of diagnoses between BMC and hospitals that were similar in size and setting, it was clear that diagnostic coding was a problem.

“We were not very good at carefully coding all comorbidities and complications,” Dr. Hochberg said. “This decreased our expected mortality and artificially worsened our mortality ratio.”

Additional data analysis revealed a variety of opportunities for improvements, according to Roshan Hussain, MPH, MBA, the director of analytics and public reporting at BMC. “We had system-level issues and opportunities related to specific areas and interventions,” said Mr. Hussain, who discussed the medical center’s success story at the recent Medical Informatics World Conference. “There were opportunities to … standardize ICU care, improve our rapid response teams and our care of sepsis patients, and better prevent VTE [venous thromboembolism] and PE [pulmonary embolism].”

ary team with a pharmacist present, the entire team came up with a new system to order and distribute the needed drugs,” Dr. Twitchell said.

The revised system included changing the way an automated drug dispensing cabinet (Pyxis, CareFusion) was stocked to ensure immediate access to sepsis medications. “The stocking changes centered around making the drugs needed for rapid treatment available at the bedside quickly and safely,” Dr. Twitchell said. “We specifically took the antibiotics that were on our order set and loaded them in Pyxis on the floors where inpatient sepsis is often identified. That way, once the drug was ordered, reviewed and approved, it was immediately available to the nursing staff to administer. We maintained the integrity of the medication safety process while reducing the time needed to get medications to the bedside significantly.”

In the five months after launching the QI initiative, the median time for delivering antibiotics to sepsis patients fell to 72 from 94 minutes, according to the BMC team. The sepsis bundle recommends a time frame of three hours.

“One hour is more aggressive than the minimum target, but truly important for improving survival,” Dr. Twitchell said.

He cited, as an example, a retrospective study which showed that every hour of delay past an initial recognition of fluid-refractory hypotension resulted in a 7.6% decrease in survival (Crit Care Med d 2006;34:1589-1596).

Sepsis Bundles

VTE, PE Prevention

Sepsis was chosen as one of the QI areas because the condition can be extremely difficult to manage, according to David Twitchell, PharmD, MBA. In particular, he noted, many hospitals fall short of complying with sepsis “bundles” of care that were developed as part of the Surviving Sepsis Campaign (SSC), a nationwide effort to reduce deaths from the bloodstream infection. In one seminal study, not complying with the bundles was associated with a more than twofold increase in hospital mortality (Crit Care 2005;9:R764-R770).

“We know these bundles are [critical to achieving] improved outcomes in sepsis,” Dr. Twitchell said. That is why he and his fellow pharmacists at BMC “addressed any aspect of medication therapy management that got in the way of meeting the [requirements of the] bundles.” The pharmacists determined, for example, that there was a delay in getting antibiotics and other needed medications to sepsis patients, and that physicians had too many drug options and were therefore picking suboptimal regimens to treat the condition. “By working in the interdisciplin-

For prevention of VTE and PE, pharmacists renewed their efforts to educate physicians about patients who might need prophylaxis, and in 2012, they made a formulary change. “We were using dalteparin [Fragmin, Eisai] as our in-patient low-molecular-weight heparin, and we switched to enoxaparin,” Dr. Twitchell said. “The switch came about because of anecdotes of patients leaving the hospital and not being able to afford dalteparin.” He explained that although the cost of enoxaparin is higher for BMC on the inpatient side, it is a generic formulation; thus, “the patient has little or no copay when they leave the hospital. So their overall cost burden is lessened, which we believe will improve access and adherence to medications, and is likely to reduce mortality and morbidity.”

The BMC roadmap to improved mortality was a success. In 2013, the observed-to-expected mortality ratio for BMC was 0.81, which ranked it 21 out of 121 medical centers. “In fiscal year 2013, we hit the top quartile and that is where we have maintained,” Mr. Hussain said.

As for the effects of these interven-

continued from page 1

‘Rapid sepsis recognition and order generation is key, and pharmacists must approve the orders and ensure ready drug availability at the bedside.”

—Judith Jacobi, PharmD

tions on a more narrow outcome— sepsis-related mortality—those data weren’t tracked as part of the current QI, Dr. Twitchell noted. But he acknowledged that it is an important end point, given that the main goal of the SSC was to bring about at least a 25% reduction in deaths from the often-fatal bloodstream infection.

Benchmarks Spurred Action Julie Cerese, RN, MSN, UHC’s senior vice president of performance improvement, gave kudos to BMC for making significant improvements to its overall mortality ratio. And while the degree of that improvement was surprising, she noted, it is not uncommon for medical centers to be spurred to action after they receive comparative benchmarking data from UHC. Such data “serve as a significant resource to help members positively impact performance,” Ms. Cerese said.

“Health care performance improvement is a complex and ongoing process, and we actively partner with and fully support all UHC members in the continuing quest to deliver efficient and effective patient care.”

Critical Care Pharmacist’s Take Sepsis is an important target for QI efforts, because mortality from the bloodstream infection remains higher than breast cancer, prostate cancer and AIDS combined, noted Judith Jacobi, PharmD, BCPS, a critical care pharmacist at Indiana University, in Indianapolis. Achieving the key items in the SSC bundles—especially early antimicrobial therapy—“is essential to maximizing survival,” Dr. Jacobi said. She added that there are many factors that delay initiation of broad-spectrum antibiotics beyond the target set forth in the SSC bundles, and the pharmacy “owns” many of those factors. It thus makes sense for pharmacists to spearhead efforts to boost compliance with that bundle component, she noted.

As for the specific efforts put forth

by BMC, Dr. Jacobi said that “many

groups have attempted to make mortality statistics look better by improving documentation. But the clinical process changes that also occurred [at BMC] suggest that this was more than a statistical improvement.” Significant components, she noted, “include using the multi-professional team as a coordinated workgroup and focusing their efforts on measurable activities.”

Dr. Jacobi stressed that an organized analysis of barriers and implementation of solutions, as done by the BMC team, is essential to improving sepsis management. “Rapid sepsis recognition and order generation is key, and pharmacists must approve the orders and ensure ready drug availability at the bedside,” she said. “Basic medication safety must not be abandoned.”

A further challenge, she noted, “is for nurses to feel the same imperative to administer [sepsis treatments], and not wait for radiology, procedures or other tasks to be completed first.”

Hospitals that are taking a hard look at their sepsis management protocols also should not forget about the technology side of the QI equation, Dr. Jacobi noted.

She cited, as an example, designing clinical decision support systems that can alert practitioners that risk factors for sepsis may be present, or to remind them to provide VTE prophylaxis. “Hopefully, the improved prophylaxis procedures at BMC will translate into VTE reduction, as has been demonstrated elsewhere, such as the University of New Mexico Health Sciences Center.”

Dr. Jacobi offered a final kudos to BMC for including leadership in their QI initiative. Although the strategies the medical center employed “were not unique,” she said, “it is always important to have administrative support for quality improvement programs, as well as a sustained effort to create and maintain those improvements.”

—Kate O’Rourke None of the sources reported any relevant financial conflicts of interest.

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1411925

086629

HurriCaine ONE Unit Dose Non-Aerosol Spray, Box of 25, 0.017 fl. oz. (0.5 mL) each

PRODUCT

If HurriCaine ONE is not yet available through your wholesaler, request it by name and NDC Number.

*Joint Commission Standard: MM.05.01.11, EP4

SPRAY KIT â&#x20AC;&#x201C; MULTIPLE USE 20% Benzocaine Oral Anesthetic t t t t t t

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1/2 SECOND SPRAY is all it takes!

ORDERING INFORMATION Spray â&#x20AC;&#x201C; 2 oz. spray can and 1 disposable extension tube NDC 0283-0679-02 Spray Kit â&#x20AC;&#x201C; 2 oz. spray can and 200 disposable extension tubes NDC 0283-0679-60 Extension tubes â&#x20AC;&#x201C; Box of 200 disposable extension tubes Product number 0283-1185-20

Extension Tubes

LLC

To request a free sample or for more information, call us at 1-800-238-8542 or 1-847-473-1100, M-F 8:00 a.m. â&#x20AC;&#x201C; 4:30 p.m. CST. www.beutlich.com HurriCaine ONE and HurriCaineÂŽ are registered trademarks of BeutlichÂŽ Pharmaceuticals, LLC. HOSH 667 0414

Because your patients have different needs… …Amgen supports a broad range of access programs INDEPENDENT CO-PAY FOUNDATIONS Amgen Assist can check the current funding status at different independent foundations for your office

MEDICARE

UNINSURED

COMMERCIALLY INSURED

THE SAFETY NET FOUNDATION The Safety Net Foundation provides products at no cost to eligible uninsured and underinsured patients THE NEULASTA/NEUPOGEN FIRST STEP™ PROGRAM The NEULASTA/NEUPOGEN FIRST STEP™ Program helps reduce out-of-pocket (OOP) costs for all eligible commercially insured patients.

Go to www.amgenfirststep.com for program eligibility and limitations

NEULASTA/NEUPOGEN NEULASTA FIRST STEP FIRST STEP PROGRAM PROGRAM ®

™

NEULASTA/NEUPOGEN FIRST STEP™ PROGRAM

*Please do not remove this sticker

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For more information regarding these programs, please call 1-888-4ASSIST or visit AmgenAssistOnline.com To enroll your patient into the Amgen FIRST STEP™ Co-pay Coupon Program call 1-888-65-STEP1 (1-888-657-8371) or visit amgenfirststep.com.

The NEULASTA/NEUPOGEN FIRST STEP™ Program MasterCard is issued by The Bancorp Bank pursuant to license by MasterCard International and this card may not be used everywhere Debit MasterCard is accepted. No cash or ATM access. MasterCard is a registered trademark of MasterCard International Incorporated. The Bancorp Bank; Member FDIC.

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