February 2014

The Pharmacist’s News Source

pharmacypracticenews.com

Volume 41 • Number 2 • February 2014

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in this issue UP FRONT

3

ISMP webinar: more data needed to guide biosimilars adoption.

OPERATIONS & MGMT

New Feature!

4

Student’s Corner: Capturing medication discrepancies with post-discharge phone calls.

CLINICAL

22 24

New FDA guidelines boost safety of drug labeling.

Practice Pearl: Pharmacy residents show worth in managing geriatric clinic.

POLICY

26

It’s time to stop fighting specialty pharmacy.

EDUCATIONAL REVIEW

REMS for Long-Acting Opioids Visit pharmacy practicenews.com

Medical Homes Get Spruce-Ups From Pharmacists Orlando, Fla.—Although a growing number of hospital pharmacies are adding medication reconciliation to their list of services, two new studies show that repeating the process in ambulatory pharmacy clinics and providing other transitional care programs can reduce 30-day readmissions and the utilization of urgent-care resources.

Both research efforts garnered 15th Annual Best Practices Awards in Health-System Pharmacy, which were presented at the American Society of Health-System Pharmacists (ASHP) 2013 Midyear Clinical Meeting.

The first study, by investigators at the Eastside Adult Internal Medicine Clinic, a patient-centered medical home (PCMH) that is part of Denver Health Medical Center, focused on the use of pharmacist-conducted telephone follow-up post-discharge.

Sarah Anderson, PharmD, a clinical pharmacy specialist at at PCMH, said the strategy served as an important

•

see RECONCILIATION, page 10

ASHP’s Top Tips For Safer Insulin Treatment Plans Orlando, Fla.—The American Society of Health-System Pharmacists (ASHP) Foundation has issued 10 clinical recommendations it believes can substantially reduce the incidence of in-hospital insulin-related adverse events (AEs) if implemented.

The strategies, which target errors during all stages of insulin use, “have several strong advantages,” said Joshua Neumiller, PharmD, CDE, an

•

Part 1 of a 2-part series

Bright Ideas for Boosting Savings—and d Patient Care Orlando, Fla.—Cost-saving strategies were front and center at the American Society of Health-System Pharmacists (ASHP) 2013 Midyear Clinical Meeting. Ranging from a simple yet highly effective metered dose inhaler switch to a revamping of a hospital’s medication reconciliation n program, the initiatives saved scarcce health care dollars, maintained d or improved patient care and streaamlined pharmacy operations.

In this, the first of a two opart series, Pharmacy Practicce News details the initiativees and offers lessons learned for fo health systems facing simil ilar fiscal challenges.

more than $1 million annum ally may ma seem like a tal all order, but tthat is precisely what was accomplished by a team of clinicians, respiratory therapists and pharmacists at Ascension Health, a national network of non onprofit hospitals based in St.. Louis (poster 5-051).

Royy Guharoy, PharmD, MBA A, who is the chief pharmaccy officer and vice presiden nt at Ascension Health, said d this multidisciplinary gro oup set out to find a product that addressed the shortcomings off using metered dose inhalers (MDIs) s) to administer ipratropium/ albuterol iin ventilated patients. “Drug

Switch to Nebulizer A High-Impact Move e Implementing a syste tem-wide change that requires litttle investment, is seamless in execution and has the potentiall to save sav

•

see COST SAVINGS, page 6

Breaking Down the Barriers To Entry on Critical Care Team Orlando, Fla.—Emergency department (ED) pharmacists do more than simply review orders, as evidenced by a large body of data presented at the American Society of Health-System Pharmacists 2013 Midyear Clinical Meeting. Whether providing antibiotic stewardship recommendations, titrating drips during code and trauma responses or optimizing sedation levels in patients undergoing rapid-sequence intubation, the sophisticated scope of services provided by this growing pharmacy subspecialty was well on display at the meeting.

Collecting Data Helps Make the Case It took a while for ED staff at WakeMed Health and Hospitals in Raleigh, N.C., to realize that a pharmacist can contribute to the department’s operations. “There was definitely difficulty involved with integrating new, unfamiliar pharmacy services into a department that had been traditionally run by physicians and nurses,” said Ryan Owenby, PharmD, who

•

see INSULIN TIPS, page 18

see BARRIERS, page 13

New Product FDA approves Olysio for hepatitis therapy.

See page 12

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Up Front 3

Pharmacy Practice News • February 2014

Drug Development

Trials, Data Needed To Guide Biosimilar Adoption E

ffectively integrating biosimilar drugs into the U.S. market will require careful collaboration between manufacturers and regulators, according to clinicians who spoke during a recent web conference hosted by the Institute for Safe Medication Practices (ISMP).

For a number of blockbuster biologic drugs, the road ahead leads to the so-called patent cliff. Several drugs will lose their market protection within the next decade, including adalimumab in 2016 (Humira, Abbott) and trastuzumab in 2019 (Herceptin, Genentech). At the same time, the market for biologics is booming, with worldwide sales climbing from $46 billion in 2002 to $169 billion in 2012, an IMS Health report estimated.

As the demand for biologics continues to grow, physicians, regulators and patients are looking to biosimilars, the off-patent compounds that are comparable to biologics— although not identical copies— to help rein in costs.

“We definitely need biosimilars as a strategy to reduce our health care costs,” said Edward Li, PharmD, an associate professor in the Department of Pharmacy Practice at the University of New England, in Portland, Maine, who spoke during the ISMP seminar.

The pathways to approval for biosimilars and generic drugs run parallel, although there are a few important distinctions. Under the Biologics Price Competition and Innovation (BPCI) Act, part of the Affordable Care Act, a manufacturer can apply for a shortened approval process through the FDA. Previously, in 1984, the U.S. Drug Price Competition and Patent Term Restoration Act had paved the way for a standard method of approving nonbranded medication through an Abbreviated New Drug Application. At that time, however, Congress excluded biologic drugs from the abbreviated pathway, citing the difficulty of manufacturing these compounds.

“When you consider small molecule drugs,” Dr. Li said during the ISMP conference, “those are relatively simple [to produce] compared to a biologic manufacturing process.”

Big—but Not Easy Part of the challenge arises from the extreme disparity in size of the compounds. With a sequence of 165 amino acids, epoetin, for example, has a molecular mass of about 30,000 Da, hundreds of times larger than inorganic compounds such as the chemotherapy agent cisplatin. And unlike the chemical production of a small molecule compound, creating a large biologic drug requires living cells. “It’s not quite like synthesizing something in a test tube,” said Leonard Zwelling, MD, MBA, a clinical

oncologist and professor of medicine and pharmacology at the University of Texas MD Anderson Cancer Center in Houston, who was not involved with the ISMP web seminar.

Because biosimilars are the product of living systems, it will be impossible for other manufacturers to perfectly match the structure of a brand-name biologic.

Although a biosimilar could have the majority of the same chemical constituents as a reference drug, post-translational modifications such as protein folding or other biological quirks of a cell line may affect a biosimilar agent’s efficacy.

Dr. Li noted that the complexity of producing biosimilars would keep the costs of these drugs higher than the price of traditional generic pharmaceuticals. “But we are going to see some savings compared to the reference product,” he said during the web conference.

“Hopefully, that will increase access to expensive therapies.”

John Mbagwu, PharmD, a clinical pharmacist for the medical consulting group Optum, told Pharmacy Practice News that, on the high end, estimates for the manufacture of a biosimilar would be about $250 million. Although this is a fraction of the average $1.2 billion cost of bringing a new drug to market, manufacturing is not the only expense that the biosimilar approval process will incur. Compared with a generic drug, a biosimilar requires more rigorous safety and efficacy data to earn approval.

Ensuring Biosimilar Safety Approval for generic drugs must show bioequivalence in form, safety and route of administration, and the agents are not required by the FDA to undergo comparative clinical trials. Biosimilars, on the other had, must demonstrate that they are “highly similar” (Figure). To guide manufacturers looking to bring biosimilars to market, the FDA has released three draft recommendations. In a 2012 draft guidance, the agency said that approval of a biosimilar must be based on “data derived from analytical studies, animal studies and a clinical study or studies,” under the BPCI Act. Because biologic drugs are manufactured in cells derived from hamsters, rabbits and other organisms, they pose varying risks for immunogenicity. A patient’s immune system may produce antibodies that neutralize the biologic, or develop antibodies that trigger antibody-mediated disease or other adverse reactions. Dr. Li cited an increase in the number of cases of pure red cell aplasia linked to biologic erythropoietin products in the 1990s.

“The whole point of this abbreviated biosimilar [approval] pathway is [to allow] the FDA [to] prospectively

Figure. Biosimilar development approach.

Adapted from Clin Pharmacol Therr 2012;91:409-417; http://1.usa.gov/L62id7

review these agents, so we don’t have immunogenicity issues in the future,” Dr. Li said. To that end, the FDA has recommended comparative parallel studies in its guidances.

But the requirement for clinical data increases the projected costs of biosimilars. Although generic drugs can be purchased at cost reductions of up to 80% of the price of branded versions, a 2011 review reported that estimates for biosimilars prices would be 15% to 30% less than the reference drug (Clinicoecon Outcomes Res 2011;3:29-36).

In June, the chief executive officer of Celltrion announced that the biosimilar version of infliximab, Remsima, would be more than 30% cheaper than Johnson & Johnson’s Remicade. Celltrion is seeking approval for Remsima in Europe, where more than a dozen biosimilars have been approved by the European Medicines Agency. In the European Union, biosimilars saved an estimated $2.6 billion (1.9 billion euros) in 2009, according to the European Generic Medicines Association.

Overcoming Prescriber Skepticism When biosimilars become available in the United States, a large body of clinical data will be needed to help overcome another hurdle—prescribers’ skepticism. Biosimilars of infliximab, such as Remsima, have been studied in patients with rheumatoid arthritis and may rely on “indication extrapolation” to be approved and/or used for inflammatory bowel disease and other indications. A 2013 study conducted by the

market research firm BioTrends found that about 70% of the 90 gastroenterologists surveyed would not prescribe a biosimilar that had only been tested in patients with rheumatoid arthritis.

Additional clinical data will also enable certain biosimilars to be labeled interchangeable, a term that has already come under fire in the United States. Under a provision of the BPCI, biosimilars deemed interchangeable by the FDA can be substituted without a pharmacist notifying the prescribing physician.

A bill passed by California’s state Senate would have voided that provision, requiring pharmacists to notify prescribers which biosimilar drug they had dispensed. Responding to calls from the Generic Pharmaceutical Association and other critics, Gov. Edmund G. Brown vetoed the bill. In a letter to the state Senate, Mr. Brown pointed out that the FDA has not yet determined the standards for interchangeability, writing, “to require physician notification at this point strikes me as premature.”

The question to ask becomes not when will biosimilars become available in the United States, Dr. Zwelling said, but when will doctors prescribe them?

“Until I see a trial in which the biosimilar and the [reference] drug are compared head to head, in real patients with real cancer,” he said, “I wouldn’t prescribe it, and I wouldn’t let my mother take it.”

—Ben Guarino Dr. Zwelling reported no relevant financial disclosures. Dr. Li has served on advisory boards for Amgen and Hospira.

4 Operations & Management

Student’s Corner

Pharmacy Practice News • February 2014

Editor’s note: This new section will provide a platform for preceptors and student pharmacists to share research, opinions, and practical tips to help them usher the profession of pharmacy into the future.

We welcome your feedback and ideas. Please send them to smtilyou@mcmahonmed.com.

Capturing Medication Discrepancies With Post-Discharge Phone Calls Jennifer Miao

1%

PharmD Candidate 2014

3% 9%

Hanlin Li PharmD Candidate 2014

1%

Tran H. Tran, PharmD, BCPS

Patients unable to be reached Patients without discrepancy

4%

Wrong dose or frequency

3%

32%

Missing prescriptions

Assistant Clinical Professor

Duplicate medication

9%

Additional medications not in chart

St. John’s University Queens, New York

Still on discontinued medications Cost-prohibitive medications

38%

I

n its 2011 National Patient Safety Goals, the Joint Commission states that health care providers need to “maintain and communicate accurate patient medication information.”1 Medication reconciliation can help ensure that the medications taken by a patient are accurately reflected in the medication list found in the patient’s electronic health record. Numerous studies demonstrate that pharmacists can play a critical role in identifying and reconciling medications to minimize discrepancies.2-6 We conducted a study to describe medication discrepancies that pharmacy students caught during phone calls to patients conducted within 72 hours of discharge from the hospitalist service at a large academic hospital. Patients discharged to nursing home, prisons, or shelters were excluded. We asked patients to describe the name, dose, and frequency of medications they were currently taking. Patients’ responses were compared with discharge medication lists from electronic health record (EHR) systems. Discrepancies were documented and discussed with the pharmacist

Unsure of medications

Figure. Medication discrepancies captured during post-discharge phone calls. and medical team to identify the cause(s) of the discrepancies. Dispensing pharmacy information was collected and updated in the patients’ charts to aid future communication between hospital staff and outpatient pharmacists.

The students called 71 patients discharged from the hospitalist service over 34 days. After making up to 3 attempts per patient (average 1.48), they reached 48 patients (67.6%). Of those reached, nearly 40% (n=21) had a drug discrepancy. The figure indicates the frequency with which each type of discrepancy occurred.

Overall, medication discrepancies occurred frequently following hospital discharge. The reasons for discrepancies varied greatly and were sometimes intentional. Post-discharge phone calls

gave students the opportunity to reiterate the importance of medication adherence, clarify side effects, and relay patient-reported adverse effects back to the medical team. Students also confirmed clinic appointments and identified patients in need of additional counseling or follow-up. The students reported that they faced a few obstacles during some of the phone calls, such as language barriers, inconsistency of patient information in EHRs, and missing pharmacy information.

In future studies, initiating pharmacy student involvement early in the medication reconciliation process (ie, time of admission) should be considered. Earlier access to accurate patient information will streamline medication reconciliation and facilitate counseling during dis-

EDITORIAL BOARD

Volume 41 • Number 2 • February 2014 • pharmacypracticenews.com

Julie A. Golembiewski, PharmD, Chicago, IL

Indu Lew, PharmD, Livingston, NJ

INTERNAL MEDICINE Geoffrey C. Wall, PharmD, FCCP, BCPS, CGP, Des Moines, IA NUCLEAR PHARMACY Jeffrey Norenberg, PharmD, Albuquerque, NM

CARDIOLOGY

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

C. Michael White, PharmD, Storrs, s CT

Robert Ignoffo, PharmD, San Francisco, CA

CNS/PSYCHIATRY

EDITORIAL STAFF

3. Koehler BE, Richter KM, Youngblood L, et al.

Reduction of 30-day postdischarge hospital readmission or emergency department (ED) visit rates in high-risk elderly medical patients through delivery of a targeted care bundle. J Hosp Med. 2009;4(4):211-218.

4. Jack BW, Chetty VK, Anthony D, et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial.

Ann Intern Med. 2009;150(3):178-187.

5. Schnipper JL, Kirwin JL, Cotugno MC, et al.

Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006;166(5):565-571.

6. Wong JD, Bajcar JM. Medication reconciliation at hospital discharge: evaluating discrepancies.

Ann Pharmacother. 2008;42(10):1373-1379.

This research was presented at the 2013 annual meeting of the American College of Clinical Pharmacists (abstract 383).

Column continues on page 8

Marty Barbieri, Production Manager Brandy Wilson, Circulation Coordinator

Sarah Tilyou, Senior Editor smtilyou@mcmahonmed.com

Van Velle, President, Partner

Ben Guarino, Staff Writer

Philip E. Johnson, MS, RPh, FASHP, Tampa, FL Cindy O’Bryant, PharmD, Aurora, CO

James Prudden, Group Editorial Director

Lawrence Cohen, PharmD, FASHP, FCCP, Fort Worth, Texas

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

Robin B. Weisberg, Manager, r Editorial Services

Larry Ereshefsky, PharmD, San Antonio, T Texas

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

COMPLEMENTARY AND ALTERNATIVE MEDICINE

ORGAN TRANSPLANT PHARMACY Eric Tichy, PharmD, BCPS, New Haven, CT PEDIATRICS Gretchen Brummel, PharmD, BCPS, Hudson, OH

Dan Radebaugh, Director of Production and Technical Operations

McMAHON PUBLISHING

Charles F. Caley, PharmD, Storrs, CT

CRITICAL CARE

2. Bedell SE, Jabbour S, Goldberg R, et al. Discrepancies in the use of medications: their extent and predictors in an outpatient practice. Arch Intern Med. 2000;160(14):2129-2134.

David Bronstein, Editorial Director davidb@mcmahonmed.com

Kevin Horty, Don Pizzi, Adam Marcus, Cynthia Gordon, Contributing Editors

Cathy Rosenbaum, PharmD, Cincinnati, OH

1. The Joint Commission. National patient safety goals effective July 1, 2011. Ambulatory Health Care Accreditation Program. NPSG.01.01.01. http://www.jointcommission.org/assets/1/6/ NPSG_EPs_Scoring_AHC_20110707.pdf.

Accessed January 13, 2014.

James O’Neill, Senior Systems Manager

ANESTHESIOLOGY/PAIN

BIOTECHNOLOGY

References

Frank Tagarello, Senior Art Director/Managing / Director, r MAX Graphics

ADMINISTRATION Robert Adamson, PharmD, Livingston, NJ Ernest R. Anderson Jr., MS, RPh, Boston, MA

Melvin E. Liter, MS, PharmD, FASHP, Lexington, KY David S. Craig, PharmD, BCPS, Tampa, FL Robert L. Barkin, MBA, PharmD, Chicago, IL

charge. Our study found that pharmacy students can have a positive impact on patient care by performing post-discharge phone calls to detect medication discrepancies on an internal medicine service. Integrating pharmacy students in this process provides them with an opportunity to apply their skills and more actively participate in patient care.

Elizabeth Zhong, Associate Copy Chief

SALES David Kaplan, Group Publication Director dkaplan@mcmahonmed.com

Raymond E. McMahon, Publisher and CEO, Managing Partner Matthew McMahon, General Manager, Partner Lauren McMahon Smith, Michael McMahon, Michele McMahon Velle, Rosanne C. McMahon, Partners

MCMAHON PUBLISHING MCMAHONMED.COM Sales, Production and Editorial Offices: 545 West 45th Street, 8th Floor, New York, NY 10036.

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TECHNOLOGY Thomas Van Hassel, RPh, Yuma, AZ

ART/PRODUCTION STAFF

Robert P. Rapp, PharmD, Lexington, KY

Michele McMahon Velle, MAX Graphics/Creative Directo

Copyright © 2014 McMahon Publishing, New York, NY 10036. All rights reserved. Pharmacy Practice News (ISSN 0886-988x) is published monthly by McMahon Publishing. Periodicals postage paid at New York, NY, and at additional mailing offices. POSTMASTER: Send address changes to Pharmacy Practice News, Circulation Dept., 545 W. 45th St., 8th Floor, New York, NY 10036.

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Judi Jacobi, PharmD, FCCM, Indianapolis, IN INFECTIOUS DISEASES Steven J. Martin, PharmD, BCPS, FCCM, Toledo, OH David P. Nicolau, PharmD, Hartford, CT

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6 Operations & Management

Pharmacy Practice News • February 2014

Finance

COST SAVINGS

45

continued from page 1

40

1. Adverse drug reaction 2. Contraindication

33

35

Event, n

penetration with MDIs can vary depending on the individual respiratory therapist’s technique,” Dr. Guharoy explained. “And because MDIs add air pressure, they can disrupt ventilator settings and require respiratory therapist monitoring.”

There is also significant waste associated with MDIs, he said, noting his health system spends $2.4 million annually on MDIs. After reviewing alternative products, pharmacists at St John Providence System, an Ascension hospital in Detroit, switched from MDIs to a multiuse nebulizer (Aeroneb Pro, Aerogen). The switch had profound effects, Dr. Guharoy said at the ASHP meeting. “The average cost on a per-patient basis dropped from $191 with MDIs to $46 with the nebulizer,” he noted.

KEY

40

3. Drug-disease interaction 4. Drug-drug interaction

30

5. Error – administration

25

6. Error – dispensing

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7. Omission of drug orders

20

8. Polypharmacy

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9. Labs requested

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10

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11. Therapeutic (IV to oral)

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10. Therapeutic duplication

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13. Untreated diagnosis 14. Wrong dose

0

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2.

3.

4.

5.

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7.

8.

9.

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11.

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13.

14.

15.

15. Wrong frequency

Figure 1. Frequency of errors detected during admission medication reconciliation and hospital stay.

30

28

KEY 1. Omission of drug allergy

25

2. Contraindications 3. Discontinued drugs in profile 4. Drug-drug-disease interaction

Event, n

20 15

14

7. Extraneous orders 8. Dispensing/ordering errors 9. Inaccurate discharge instructions

5

5

Because the new nebulizers are not replaced as often as MDIs and do not add to ventilator airflow, respiratory therapists spend less time managing the new devices. “We expect to save between $870,000 and $1.7 million based on a 50% to 100% [Ascension Health] system-wide conversion to the new nebulizers,” Dr. Guharoy said.

Although they have not measured the clinical effects of the switch, Dr. Guharoy said nebulized administration is associated with “much better lung penetration and better therapeutic outcomes.”

Reaping Rewards Via Pharmacist Rounding Mate Soric, PharmD, a clinical internal medicine pharmacist at the University Hospitals Geauga Medical Center, a community hospital in Chardon, Ohio, hopes the financial effects of a pharmacy inpatient rounding service he helped establish in 2011 will nudge other community hospitals to add pharmacists to their own rounds (poster 5-169).

“We’ve achieved savings in inpatient drug expenditures that more than justify the position,” said Dr. Soric, who is also an assistant professor in the Department of Pharmacy Practice at Northeast Ohio Medical University in Rootstown.

6. Omission of medication orders

11

10

10

Aeroneb Pro (Aerogen).

5. Duplicate instructions for same drug

15

1

1

1.

2.

1

5

2

3

1

10. Not alerting medication changes

5

11. Polypharmacy

2

13. Unnecessary medication orders

0

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12. Therapeutic duplication

5.

6.

7.

8.

9.

10.

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13.

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14. Incorrect dosing 15. Incorrect frequency

Figure 2. Discharge medication discrepancies.

The researcher collected data from 1,049 patients examined between Jan. 1 and Dec. 31, 2011, by an internal or family medicine physician team that included a clinical pharmacist as well as pharmacy residents and students.

The 1,656 interventions performed by the group included issuing recommendations for drug therapy optimization, such as adding a medication to a treatment regimen according to published guidelines (32.6%), advising caregivers on techniques to prevent adverse events (AE) (19.3%), providing drug information to patients and other providers (19.1%) and adjusting drug dosages (13.2%). Additionally, they made cost-savings recommendations (8.5%), such as switching from more expensive IV formulations to oral formulations (8.5%), and ordered laboratory tests that physicians had not overloooked, in order to monitor the safety and efficacy of a therapy (7.4%), Dr. Soric noted.

The average total per-patient drug expenditure in this group was $285, significantly lower than the average $412 for 1,959 patients in a control group seen during the same period by

internal or family medicine rounding teams without a pharmacist ((P=0.01), he reported.

Some of the more striking savings occurred in patients with pneumonia, Dr. Soric noted. Drug costs in the patients seen by a pharmacist during rounds equaled $320 vs. $503 when no pharmacist was present on the rounding team ( =0.0006), he said, adding that “the (P impact here was mostly due to antimicrobial stewardship–style interventions.”

Dr. Soric emphasized the methodologic strength of the cost–benefit analysis, noting that most studies “look at potential cost avoidance based on estimated cost savings per intervention. We instead looked directly at medication expenditures in patients seen or not seen by pharmacists during rounds,” he said. “And since there were no differences in the severity of illness or lengths of hospital stay between the groups, the cost impact is likely attributable to the presence of the pharmacist.”

Med Reconciliation a Safety Net Sumana Alex, PharmD, BCPS, a clinical pharmacy specialist at the Veterans

Affairs Medical Center in Washington, D.C., shared her own experience conducting daily rounds with one of the VA’s six internal medicine teams between August and October 2102 (poster 3-076).

Dr. Alex’s duties included monitoring inpatient drug therapy, interviewing patients upon admission to obtain their medication history, counseling patients at discharge, conducting medication reconciliations at admission and discharge, and following up with high-risk patients after discharge. Over a threemonth study period, she reviewed 160 admissions, 145 discharges and conducted 179 inpatient interventions.

The errors she detected during admission medication reconciliation and during inpatient hospital stays included 40 cases of wrong doses, 33 cases of diagnoses not receiving drug treatment and 21 unintentional drug omissions (Figure 1). She also identified 104 medication discrepancies at the time of discharge, 89 of which she was able to resolve before patients actually left the hospital (Figure 2).

“A review team of one pharmacist

Operations & Management 7

Pharmacy Practice News • February 2014

Finance

$327,231 $2.7 million

Market share discounts Patient assistance programs Inventory management refinements

Figure 3. Distribution of $3.8 million in spending cuts at a 969bed academic medical center pharmacy. and two hospitalists deemed that 28% of the mistakes I identified would have potentially been harmful if not for my interventions,” she noted. Potential mistakes that were averted included administration of contraindicated drugs, or drugs that had been assigned incorrect doses, frequencies or routes of administration. Dr. Alex said 91% of her recommendations were accepted by physicians.

The researchers also documented $186,121 in costs attributable to 11 significant drug-related AEs that occurred in the study patients either before or during admission. As a result of pharmacist interventions in these and other events, the hospital saved an estimated $169,070 that would have been spent on the AErelated treatments, Dr. Alex noted.

The interventions also led to an estimated $9,714 in savings directly attributable to medication changes. “These direct, medication-related savings would have been three times higher in private hospitals, but the VA obtains drugs at a lower acquisition cost,” she said.

Turning Budget Cuts Into Process Improvements The $3.8 million in spending that Cindy Jeter, CPhT, CPP, BGS, helped a 969-bed academic medical center pharmacy cut after being hit with a 10% budget reduction is only a partial testament to the success of her approach (poster 3-006). “Most importantly, the pharmacy met its goal by trimming its drug spend, not by eliminating staff,” said Ms. Jeter, a supply chain management consultant with McKesson Health Systems’ Pharmacy Optimization Team in Springdale, Ark. The achievement, at the Thomas Jefferson University Hospital, in Philadel-

Off Hours a Potential Revenue Generator Until March 2013, off-hour medication orders were managed differently among Summa Health System’s seven hospitals: Some of the facilities relied on two Summa hospitals that had offhour pharmacists; one contracted with a for-profit vendor; and two had their own pharmacists review orders the following morning (poster 3-008).

“The situation was costly and left the door open to medication errors,”

160

said Kenneth Komorny, PharmD, who is the system director of pharmacy for four of Summa’s hospitals, which are located in Akron, Ohio.

The situation also promp pted Dr. Komorny and Summa’s other pharmacy directors to p pitch the idea of a centralized, inhouse remote order-processsing center to hospital leadershiip.

“Once we got approval,, we needed to create the sysstem from scratch,” he recalled. “T This meant hiring a site manager to create the hardware and software infrastructure, to train n each of the pharmacy systems, to o develop policies and procedurees and to devise a standard workflow w.”

Between March 4 and Maay 31, 2013, during which time all five o of the Summa hospitals without off-hour pharmacists were gradually brought ught online, the newly formed service enabled participants to process 35,883 orders, field 952 phone calls and conduct 290 clinical interventions.

Although no objective tool was used to document the clinical impact of those interventions, facilities reported a lowered incidence of medication errors during the evening and night shifts, Dr. Komorny reported. The reduction was attributable to several factors, including faster time to verification, fewer overrides at the automated dispensing machine (Figure 4) and the availability of the pharmacist for questions, the researchers found.

Moreover, nursing satisfaction improved at all facilities based on nursing comments, with some facilities reporting “vast improvement,” Dr. Komorny said. Pharmacy staff satisfaction also improved due to lower workload regarding other facilities, he noted.

146

There was one additional benefit: pharmacists at the non–24-hour facilities no longer were required to spend the first one to two hours of their shift verifying orders from the overnight period. As a result, “pharmacists can spend more time on clinical issues and improving patient care,” he said.

As for cost savings, the service generated an estimated $14,398 in revenue from per-order processing fees during the three-month period, with the added bonus of being provided “at the least possible cost” to Summa’s hospitals, Dr. Komorny said.

“The one Summa joint venture affiliate that had been using a for-profit service reduced its costs by more than 60% by converting to our internal service,” which was totally home-grown, he added. “Our plan now is to generate further revenue for Summa by offering the service at a marked-up but affordable, price-competitive rate to nonSumma hospitals.”

—David Wild

140 Drs. Guharoy, Soric, Alex and Komorny reported no relevant financial conflicts of interest.

120

Event, n

$734,325

phia, was the result of several initiatives, Ms. Jeter explained. Pharmacy staff now ensures that all eligible individuals are enrolled in patient assistance programs, for example. That effort helped the pharmacy recoup $734,325 worth of medications and devices from manufacturers over a oneyear period (Figure 3).

Capturing more of the vendor market share also helped the pharmacy negotiate larger discounts, she said, and contributed to a further $327,231 shave off its one-year drug spend.

With Ms. Jeter’s help, pharmacy has also refined its inventory management approach, applying stricter criteria for use of nonformulary items and ordering and dispensing drugs on short supply only through the pharmacy storeroom, in order to reduce waste, for example.

These measures and the broader initiative have diminished the value of the pharmacy’s inventory by $2.7 million compared with the six months before the project, Ms. Jeter said.

“The pharmacy now has an additional 8.2% budget reduction to deal with for the coming year,” Ms. Jeter said, “but through our collaborative\ training and development of policies and procedures, staff will be able to maintain the progress they made and accomplish additional successes.”

100 82

80 50

60

52

52

A Sneak Peak at Part 2 • Probiotics slash incidence, severity and cost of C. difficileassociated diarrhea.

40 20 0 January

February

March

April

May

Figure 4. Profile overrides at the ADC (Pyxis) for a Summa Health System facility after adding off-hour processing of medication orders.

• Antimicrobial stewardship programs can benefit even smaller hospitals.

• Linezolid reduces cost of VRE bacteremia therapy.

• Pharmacists help stem overuse of high-cost antimicrobials.

8 Operations & Management

Pharmacy Practice News • February 2014

Student’s Corner Column continued from page 4

Tips for Teaching Students Patient-Based Documentation Skills Angela O. Shogbon, PharmD, BCPS Clinical Assistant Professor

Lisa M. Lundquist, PharmD, BCPS

Table. Students’ Confidence and Knowledge In Writing SOAPE Notes

Clinical Associate Professor

Pre-Test

Post-Test

a

2.62 ± 0.49

3.58 ± 0.36

a

85.2 ± 19.3

99.0 ± 4.6

Kathryn M. Momary, PharmD, BCPS Associate Professor

Knowledge scores, %

Mercer University Atlanta, Georgia a

T

he Accreditation Council for Pharmacy Education considers professional communication involving effective written and verbal skills and documentation of pharmacist recommendations to be essential for pharmacist development.1 Effective documentation of pharmacotherapy recommendations enables pharmacists to keep other health care providers informed of important clinical recommendations and serves to document the services pharmacists provide.2 The SOAPE note format is one such method of written communication that involves the documentation of pharmacotherapy notes in the following sections: Subjective, Objective, Assessment, Plan, Education. Appropriate formal training, practice, and feedback to students regarding effective patient-based documentation skills is essential to their

P Value <0.001

Numbers are expressed as mean ± SD. SOAPE, Subjective, Objective, Assessment, Plan, Education

preparation for pharmacy practice.3 Students become exposed to pharmacotherapy note documentation in experiential rotations, but introduction earlier in the pharmacy curriculum may help to better prepare students to write pharmacotherapy notes.

We conducted a research study to evaluate the effectiveness of using a structured approach to patient-based pharmacotherapy notes, specifically the SOAPE note format, to improve students’ knowledge and confidence in patient-based documentation skills in a therapeutics course.

For 3 consecutive years, we incorporated 5 weekly patient-case discussion sessions into the cardiovascular/ renal therapeutics course for student pharmacists in their second profes-

sional year. Each week, students participated in small group discussions on a patient case they completed before the session, using the SOAPE note format. Then, students completed a second in-class patient case in small groups during the SOAPE session, and submitted a SOAPE note for a grade. A SOAPE note approach to patient cases also was incorporated into all lectures throughout the course. A pre-test and a post-test assessing students’ confidence and knowledge in preparation of SOAPE notes were administered at the beginning and end of the course, respectively.

Perception of confidence was ranked on a 4-point Likert scale ranging from 1 ((strongly disagreee) to 4 (strongly agreee).

In all, 373 students (88.4%) completed both the pre- and post-test. Students

displayed increased levels of confidence and knowledge in writing SOAPE notes by the end of the course (Table). Student performance on the written SOAPE notes also significantly improved between the first and last sessions, despite cumulative content material of topics assessed.

These findings may be the result of students’ continued exposure to writing SOAPE notes throughout the course, both during traditional classroom time and during the weekly SOAPE sessions.

A structured approach to patient-based pharmacotherapy notes may enhance students’ understanding and confidence to perform this vital task in other courses, on experiential rotations, and in clinical practice.

References 1. Accreditation Council for Pharmacy Education (ACPE). Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree. https://www.acpe-accredit.org/standards/default.asp. Accessed January 15, 2014.

2. MacKinnon GE 3rd. Documentation: a value proposition for pharmacy education and the pharmacy profession. Am J Pharm Educ.

2007;71(4):73.

3. Prosser TR, Burke JM, Hobson EH. Teaching pharmacy students to write in the medical record. Am J Pharm Educ. 1997;61(2):136-140.

Using PharmD Students To Improve Inpatient Immunization Core Measures Charlene A. Hope, PharmD, BCPS, CPPS, CPHQ Clinical Pharmacy Manager Norwegian American Hospital Chicago, Illinois

M

ore than 50,000 adults in the United States die annually as a result of vaccine-preventable diseases and their associated complications. To address this, the Centers for Medicare & Medicaid Services (CMS) established inpatient adult immunizations (IMM) as core measures.

To meet the requirements of these core measures, Norwegian American Hospital assembled an interdisciplinary team to participate in the American Society of Health-System Pharmacists Mentored Adult Immunization Impact Program.

The team’s goals were to improve vaccine rates hospital-wide, with a primary

focus on the acute care, women’s health, and behavioral medicine nursing units.

An innovative component of the program was the incorporation of pharmacy students into the IMM service.

As part of the initiative, Advance Pharmacy Practice Experience students were assigned to a medical-surgical unit and were involved in screening and educating patients about the importance of immunizations. For patients who expressed interest in receiving vaccination, students also administered vaccines. All students were required to have completed the American Pharmacists Association’s Pharmacy-based Immunization Delivery Training Program before participating in the program.

Pharmacy students also were responsible for preparing the immunization and documenting administration in the

electronic health record. Students communicated and worked closely with nursing staff throughout the process.

The team conducted an intervention phase, during which they devised project objectives and implemented specific tactics via a Plan-Do-Study-Act (PDSA) cycle. They collected data from the medical-surgical nursing unit and compared it with the data from the telemetry unit, which had received all other interventions except involvement of the pharmacy students. The PDSA cycle that evaluated the student-run 10-day pilot service resulted in a 12% increase in completed documentation and a 25% decrease in missed opportunities to administer vaccines before patient discharge.

A combination of strategies, including the student-run service, has resulted in an overall improvement in inpa-

tient immunization compliance. The 2 CMS IMM core measures demonstrated an average increase in the core measure compliance rate of 24% from the first quarter of 2012 (before student involvement) to the first quarter of 2013 (with student involvement).

The student service pilot program was very successful. Students had the time to dedicate to screening, education, and administration of vaccines. Advantages of the service include increased interactions between the nursing staff and the pharmacy department, and, most importantly, the attainment of this essential core measure.

This research was presented at the American Society of Health-System Pharmacists 2013 Midyear Clinical Meeting (abstract 3-088).

Attention Students and Preceptors!

Pharmacy Practice News is seeking suggestions from readers for our new Student’s Corner section. All submissions will be considered for publication.

Please send them to Sarah Tilyou at smtilyou@mcmahonmed.com.

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10 Operations & Management

Pharmacy Practice News • February 2014

Finance

RECONCILIATION continued from page 1

“safety net” for patients.

“Our ambulatory-based program has reduced the incidence of medicationrelated problems and directs individuals who are registered with our PCMH to follow up with their primary care physician [PCP], rather than going to the emergency room,” Dr. Anderson explained.

As part of a multidisciplinary transitional care team at her PCMH, Dr. Anderson is notified regularly of any of the clinic’s patients who are discharged into the community from the health system’s hospital. The Denver Health Medical Center has an integrated electronic health record (EHR) system, which Dr. Anderson and her colleagues use to review each patient’s course of hospital treatment, compare the pre- and posthospitalization medication regimens and determine whether the patient has a follow-up appointment scheduled with his or her PCMH-based PCP. All of these patients receive a phone call within four days of hospital discharge and are asked which medications they have at home and which they are taking. Patients receive medication-use education, and they can discuss their discharge instructions as well as any drug-related questions.

If they do not have a follow-up PCP appointment scheduled, Dr. Anderson’s team helps arrange one. The content of each call is documented in the patient’s EHR so that both hospital staff and the PCP know of any drugrelated issues or other concerns.

Between July 1, 2010 and June 30, 2011, when the program was piloted, Dr. Anderson and a fellow clinical pharmacy specialist tried to contact 470 patients after discharge, successfully reaching 207 individuals.

“Many of those who were not reachable were Medicaid patients who may not have had a phone, for example,” Dr. Anderson explained, noting her team attempts three phone calls before deeming an individual unreachable. “Unfortunately, we do not have the resources to verify a correct address and send someone to the patient’s home if they can’t be reached by phone.”

She said 11% of contacted patients required at least one pharmacist intervention, such as medication or nonmedication counseling, scheduling of an anticoagulation clinic follow-up appointment, or help picking up or refilling their medication.

Those patients successfully contacted were more likely to attend a PCP follow-up appointment at the medical home (66.2% vs. 44.5% for contacted vs. not contacted; P<0.01) and were less likely to be readmitted to hospital within 30 days of discharge (10.6% vs.

19.8%; P<0.01), she found. With a threeday hospital stay costing an estimated $10,000 to $15,000 based on Medicare reimbursement, the averted readmissions during the 12-month pilot period amounted to a savings of $300,000 to $450,000, Dr. Anderson said. Health systems that serve a larger population of insured individuals are likely to achieve greater savings, she noted.

“In light of the success of our intervention, we’ve added resources and we now have nine slots per week for postdischarge visits with a clinical pharmacy specialist,” Dr. Anderson said. “At the same time, our health system has hired non-pharmacist patient navigators who conduct the initial phone calls and triage patients to us as needed.”

Hae Mi Choe, PharmD, who is the director of Innovative Ambulatory Pharmacy Practices at University of Michigan Health System in Ann Arbor, and who was not involved in Dr. Anderson’s program, said the findings demonstrate the marked benefits of having pharmacist-led transitional care in the ambulatory setting.

“We need more efforts like Dr. Anderson’s in order to demonstrate the impact of these interventions and to strengthen the financial and clinical case for pharmacist-led transitional care programs based in the ambulatory environment,” said Dr. Choe, who is also a clinical associate professor of pharmacy in the College of Pharmacy at the University of Michigan in Ann Arbor.

Figure. Clinic care transitions process at Rosa Parks Wellness Institute for Senior Health.

MRP, medication-related problems

‘In light of the success of our intervention, we’ve added resources and we now have nine slots per week for post-discharge visits with a clinical pharmacy specialist.’

—Sarah Anderson, PharmD

At Rosa Parks, More Medical Home Benefits A similar phone-based, pharmacistguided intervention implemented at the Rosa Parks Wellness Institute for Senior Health, which is a medical home that is part of the Detroit Medical Center, resulted in improved patient safety and lower health care utilization.

Candice Garwood, PharmD, a clinical pharmacy specialist at Rosa Parks who helped create the program and whose work also was recognized by the ASHP with a Best Practices award, said her PCMH patients receive medication reconciliation at the time of hospital discharge. But that process is not perfect, she stressed: there can be “confusion, medication duplication and other medication-related problems after patients have arrived at home.”

“As a PCMH, we receive our patients back into the community after discharge and care for them going forward,” explained Dr. Garwood, who is also a clinical associate professor at Wayne State University Eugene Applebaum College of Pharmacy and Health Sciences, in Detroit. “So, when we call them after a few days of being at home, we are in a good position to help them integrate their hospital discharge med-

ications into their real-world supply of medications.”

During a seven-month pilot of her institution’s phone-based intervention (Figure), she and a team of pharmacy residents and pharmacy students attempted to contact 178 patients and conducted medication reconciliations in 93 of them. In most cases where medication reconciliation was not conducted, there was no answer or the patient’s phone number was incorrect.

However, nearly 18% of patients who were contacted declined involvement in the program, Dr. Garwood said, noting that her team is trying to create processes that will allow them to connect with more individuals.

Among those patients who had medication reconciliations done, Dr. Garwood and her colleagues uncovered

an average of three (±2) drug-related issues per patient, warranting interventions ranging from patient education (37.1% of calls) to immediate medication changes (6.3%).

“Since we have a collaborative practice agreement with the primary care doctor at our medical home responsible for these patients, we can address some drug-related issues that we catch,” she said. For example, in patients who are taking two statins unnecessarily, she can discontinue one of the prescriptions.

Similar to Dr. Anderson’s intervention, Dr. Garwood’s program has led to positive outcomes, although an analysis showed they were not statistically significant. She found that in the group who received medication reconciliation, the rates of 30-day readmission

•

see RECONCILIATION, page 12

Take a bite out of G-CSF acquisition costs* GRANIX is another option in short-acting G-CSF therapy TM

GRANIX™ is an option for hospitals and payers to consider when determining health system budgets » FDA approved through the rigorous BLA† process » Teva’s short-acting G-CSF was first introduced in Europe in 2008 and is available in 42 countries‡1 » GRANIX J Code: J 1446-Injection, tbo-filgrastim, 5 micrograms, effective January 1, 2014 †Biologics License Application. ‡As of February 2014. *Based on wholesale acquisition cost (WAC) of all short-acting G-CSF products as of November 11, 2013. WAC represents published catalogue or list prices and may not represent actual transactional prices. Please contact your supplier for actual prices.

Indication

» GRANIX is a leukocyte growth factor indicated for reduction in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Important Safety Information » Splenic rupture: Splenic rupture, including fatal cases, can occur following the administration of human granulocyte colonystimulating factors (hG-CSFs). Discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture in patients who report upper abdominal or shoulder pain after receiving GRANIX. » Acute respiratory distress syndrome (ARDS): ARDS can occur in patients receiving hG-CSFs. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS. » Allergic reactions: Serious allergic reactions, including anaphylaxis, can occur in patients receiving hG-CSFs. Reactions can occur on initial exposure. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim. » Use in patients with sickle cell disease: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disease receiving hG-CSFs. Consider the potential risks and benefits prior to the administration of GRANIX in patients with sickle cell disease. Discontinue GRANIX in patients undergoing a sickle cell crisis. » Potential for tumor growth stimulatory effects on malignant cells: The granulocyte colony-stimulating factor (G-CSF) receptor, through which GRANIX acts, has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded. » Most common treatment-emergent adverse reaction: The most common treatment-emergent adverse reaction that occurred in patients treated with GRANIX at the recommended dose with an incidence of at least 1% or greater and two times more frequent than in the placebo group was bone pain.

Please see brief summary of Full Prescribing Information on adjacent page.

For more information, visit GRANIXhcp.com.

Reference: 1. Data on file. Teva Pharmaceuticals: Filgrastim MA Approvals Worldwide. February 2014.

©2014 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. GRANIX is a trademark of Teva Pharmaceutical Industries Ltd. All rights reserved. GRX-40178 February 2014.

12 Operations & Management

Pharmacy Practice News • February 2014

Finance

RECONCILIATION continued from page 10

and acute care utilization were 20% and 21%, respectively, compared with 27% and 35%, respectively, among patients who did not receive medication reconciliation ((P=NS for both).

In the group of patients who did visit the hospital after discharge, individuals who received medication reconciliation returned after an average of 52 days, compared with 38 days among those who did not undergo medication

‘Getting the infrastructure and funding in place to support the additional pharmacist time required for these programs is challenging, so making use of students and residents is one way to implement a program like this.’

—Hae Mi Choe, PharmD reconciliation ((P=NS).

Dr. Choe commented that an important aspect of Dr. Garwood’s program was the utilization of pharmacy stu-

BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR GRANIX™ (tbo-filgrastim) Injection, for subcutaneous use SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE GRANIX is indicated to reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

4 CONTRAINDICATIONS None.

5 WARNINGS AND PRECAUTIONS 5.1 Splenic Rupture Splenic rupture, including fatal cases, can occur following administration of human granulocyte colony-stimulating factors. In patients who report upper abdominal or shoulder pain after receiving GRANIX, discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture.

5.2 Acute Respiratory Distress Syndrome (ARDS) Acute respiratory distress syndrome (ARDS) can occur in patients receiving human granulocyte colony-stimulating factors. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS. 5.3 Allergic Reactions Serious allergic reactions including anaphylaxis can occur in patients receiving human granulocyte colony-stimulating factors. Reactions can occur on initial exposure. The administration of antihistamines‚ steroids‚ bronchodilators‚ and/or epinephrine may reduce the severity of the reactions. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim.

5.4 Use in Patients with Sickle Cell Disease Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disease receiving human granulocyte colony-stimulating factors. Consider the potential risks and benefits prior to the administration of human granulocyte colony-stimulating factors in patients with sickle cell disease.

Discontinue GRANIX in patients undergoing a sickle cell crisis.

5.5 Potential for Tumor Growth Stimulatory Effects on Malignant Cells The granulocyte colony-stimulating factor (G-CSF) receptor through which GRANIX acts has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded.

6 ADVERSE REACTIONS The following potential serious adverse reactions are discussed in greater detail in other sections of the labeling: UÊ -« i VÊ,Õ«ÌÕÀiÊQsee Warnings and Precautions (5.1)] UÊ VÕÌiÊ,ië À>Ì ÀÞÊ ÃÌÀiÃÃÊ-Þ `À iÊQsee Warnings and Precautions (5.2)] UÊ -iÀ ÕÃÊ iÀ} VÊ,i>VÌ ÃÊQsee Warnings and Precautions (5.3)] UÊ 1ÃiÊ Ê*>Ì i ÌÃÊÜ Ì Ê- V iÊ i Ê Ãi>ÃiÊQsee Warnings and Precautions (5.4)] UÊ * Ìi Ì > Êv ÀÊ/Õ ÀÊ À ÜÌ Ê-Ì Õ >Ì ÀÞÊ vviVÌÃÊ Ê > } > ÌÊ i ÃÊQsee Warnings and Precautions (5.5)] The most common treatment-emergent adverse reaction that occurred at an incidence of at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group was bone pain.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

GRANIX clinical trials safety data are based upon the results of three randomized clinical trials in patients receiving myeloablative chemotherapy for breast cancer (N=348), lung cancer (N=240) and non-Hodgkin’s lymphoma (N=92). In the breast cancer study, 99% of patients were female, the median age was 50 years, and 86% of patients were Caucasian. In the lung cancer study, 80% of patients were male, the median age was 58 years, and 95% of patients were Caucasian. In the non-Hodgkin’s lymphoma study, 52% of patients were male, the median age was 55 years, and 88% of patients were Caucasian. In all three studies a placebo (Cycle 1 of the breast cancer study only) or a non-US-approved filgrastim product were used as controls. Both GRANIX and the non-US-approved filgrastim product were administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy for at least five days and continued to a maximum of 14 days or until an ANC of *10,000 x 106/L after nadir was reached.

dents and pharmacy residents. “Getting the infrastructure and funding in place to support the additional pharmacist time required for these pro-

Bone pain was the most frequent treatment-emergent adverse reaction that occurred in at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group. The overall incidence of bone pain in Cycle 1 of treatment was 3.4% (3.4% GRANIX, 1.4% placebo, 7.5% non-US-approved filgrastim product).

Leukocytosis In clinical studies, leukocytosis (WBC counts > 100,000 x 106/L) was observed in less than 1% patients with non-myeloid malignancies receiving GRANIX. No complications attributable to leukocytosis were reported in clinical studies.

6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The incidence of antibody development in patients receiving GRANIX has not been adequately determined.

7 DRUG INTERACTIONS No formal drug interaction studies between GRANIX and other drugs have been performed.

Drugs which may potentiate the release of neutrophils‚ such as lithium‚ should be used with caution.

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone-imaging results.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of GRANIX in pregnant women. In an embryofetal developmental study, treatment of pregnant rabbits with tbo-filgrastim resulted in adverse embryofetal findings, including increased spontaneous abortion and fetal malformations at a maternally toxic dose. GRANIX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In the embryofetal developmental study, pregnant rabbits were administered subcutaneous doses of tbo-filgrastim during the period of organogenesis at 1, 10 and 100 mcg/kg/day. Increased abortions were evident in rabbits treated with tbo-filgrastim at 100 mcg/kg/day. This dose was maternally toxic as demonstrated by reduced body weight. Other embryofetal findings at this dose level consisted of post-implantation loss‚ decrease in mean live litter size and fetal weight, and fetal malformations such as malformed hindlimbs and cleft palate. The dose of 100 mcg/kg/day corresponds to a systemic exposure (AUC0-24) of approximately 50-90 times the exposures observed in patients treated with the clinical tbo-filgrastim dose of 5 mcg/kg/day.

8.3 Nursing Mothers It is not known whether tbo-filgrastim is secreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GRANIX is administered to a nursing woman. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates.

8.4 Pediatric Use The safety and effectiveness of GRANIX in pediatric patients have not been established.

8.5 Geriatric Use Among 677 cancer patients enrolled in clinical trials of GRANIX, a total of 111 patients were 65 years of age and older. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients.

8.6 Renal Impairment The safety and efficacy of GRANIX have not been studied in patients with moderate or severe renal impairment. No dose adjustment is recommended for patients with mild renal impairment.

8.7 Hepatic Impairment The safety and efficacy of GRANIX have not been studied in patients with hepatic impairment.

10 OVERDOSAGE No case of overdose has been reported. ©2013 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved.

GRANIX is a trademark of Teva Pharmaceutical Industries Ltd. Manufactured by: Distributed by: Sicor Biotech UAB Teva Pharmaceuticals USA, Inc. Vilnius, Lithuania North Wales, PA 19454 U.S. License No. 1803 Product of Israel GRX-40189 January 2014 This brief summary is based on TBO-003 GRANIX full Prescribing Information.

grams is challenging, so making use of students and residents is one way to implement a program like this.”

More Positive Outcomes Toni Fera, BS, PharmD, a consultant with the Pittsburgh Regional Health Initiative, has implemented a care transition pharmacist role in two community hospitals and reported similar, positive results at the ASHP 2013 Summer Meeting, in Minneapolis. Patients discharged from the Monongahela Valley Hospital who were contacted by a pharmacist were 48% less likely to require an acute care visit within 30 days of discharge, compared with patients not contacted by a pharmacist.

“The pharmacist role in the ambulatory setting will continue to evolve,” Dr. Fera told Pharmacy Practice News.

“The evidence clearly demonstrates the value of medication management in the ambulatory setting by reducing hospital admissions and readmissions.”

—David Wild None of the participants reported relevant conflicts of interest.

New Product

FDA Approves Olysio For Hepatitis C Therapy

T

he FDA has approved a new protease inhibitor to treat adult patients with chronic hepatitis C virus (HCV) genotype 1 infection. Janssen Therapeutics’ Olysio (simeprevir) is approved for use in combination with pegylated interferon (IFN)-alfa and ribavirin for treatment-naive patients as well as patients for whom previous HCV antiviral therapies were ineffective.

In its approval, the FDA cited safety and efficacy data from more than 2,000 patients in several placebo-controlled clinical trials. All patients in the studies received IFN and ribavirin in combination with simeprevir or a placebo. Up to 80% of patients who were treated with simeprevir achieved sustained virologic response (SVR) compared with 37% to 50% of patients given placebo.

Itching, nausea and skin rash were the most common adverse effects of treatment with simeprevir in clinical studies. The FDA also reported that some study participants who received simeprevir had severe photosensitivity reactions that required hospitalization. Women who are pregnant or planning to become pregnant should avoid taking simeprevir, as it is associated with birth defects and fetal mortality.

For more information, visit www.olysio.com.

—Based on press releases from the FDA and Janssen Therapeutics

Clinical 13

Pharmacy Practice News • February 2014

Emergency Medicine

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KEY 100

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

Code stroke Trauma alert Trauma one Code STEMI Code blue Resuscitated code Pediatric trauma code OB trauma code Vancomycin management Heparin protocol management Anticoagulant management Other protocol management Aminoglycoside management High-dose solumedrol protocol Integrilin protocol Fosphenytoin management Provide drug information – nurse Provide drug information – ED practitioner Provide drug information – admitting physician/practitioner 20. Initiation of needed lab draws 21. Provide drug information – patient/ family member

98

Interventions, n

90

80

76 67 58

60 40

38

36 29 23

21

20 11

20 16 10

6

5

4

1

1

13.

14.

15.

16.

3

1

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Figure 1. Top three intervention categories.

continued from page 1

was an ED pharmacist at WakeMed and is now a clinical pharmacy specialist in emergency medicine at the Durham VA Medical Center in Durham, N.C. The professional tension he felt with other WakeMed ED staff spurred Dr. Owenby and a colleague to develop an electronic worksheet so that he and the eight other pharmacists added to the ED in 2012 could document their clinical services (poster 5-068). The worksheet is structured as a series of drop-down menus, beginning with broad categories of interventions such as code responses, and narrowing down to more detailed interventions—differentiating code stroke responses from code trauma responses, for example.

Between January and June 2013, he and the other ED pharmacists documented 866 interventions. The information showed the most common steps taken were code responses (42.6%), followed by drug information interventions (14.9%), protocol or consult management during a patient’s ED stay (13%) and admission medication order interventions (10.4%). A wide range of subinterventions was nested within these categories (Figure 1).

Dr. Owenby said he used the data to assemble intervention-specific “job descriptions.” For example, the collected information revealed that during code trauma responses, two of the most common pharmacist interventions were managing rapid-sequence intubation kits and obtaining medications that were needed STAT from the automated dispensing machines located just outside the trauma bay.

Delineating pharmacists’ duties is one way the worksheet has helped Dr. Owenby and his team integrate into the ED, he said. “Trauma response teams in

particular are very well-oiled machines,” he noted. “So, in those situations, being part of a very regimented structure and having everyone know what you are responsible for is critical.”

Saving Time and Money Like Dr. Owenby, Patrick Ryan, PharmD, who is an ED pharmacist at the 234-bed Melrose-Wakefield Hospital, a Hallmark Health System hospital located in Melrose, Mass., also found he needed to clarify what skills he could offer in the ED (poster 5-071).

“Emergency room docs at my hospital didn’t seem to know what the value of a pharmacist in the ED could be,” said Dr. Ryan, who was hired for the position in July 2012.

Although he primarily meant to conduct medication reconciliations—and has been doing so for roughly one-third of the ED patients who present during his shifts—Dr. Ryan’s supervisors gave him free rein to intervene wherever he

$63,648 on annualized basis.

Suffice it to say, ED staff are now far clearer than they had been before about the usefulness of Dr. Ryan’s skills.

“Now they think my work is invaluable,” he said.

saw a need for his skills. Their green light allowed him to expand his services to include everything from providing antibiotic stewardship recommendations to titrating drips during code and trauma responses to verifying that supposed drug allergies were not, in fact, adverse drug reactions.

Taking on those duties has reduced some of the workload for ED nurses.

“The chief nursing officer has received numerous emails and calls from staff and they’ve all been very positive,” he said.

Although Dr. Ryan has not studied the actual clinical effects of his interventions, he has used clinical surveillance software (Sentri7; Pharmacy OneSource) to estimate the financial effects of the 1,783 interventions he conducted between September 2012 and May 2013. By preventing adverse events and making sure medications were not used unnecessarily, he helped save or avoid an estimated $47,736 in treatment costs during that nine-month period, or

Safer N-Acetylcysteine Rx For Acetaminophen Toxicity ED pharmacists are in a good position to address the high rate of IV N-acetylcysteine (IV N-AC) infusion errors in patients with acute acetaminophen toxicity, according to findings from a single-center retrospective study conducted by Nadia Awad, PharmD (poster 3-066), who is a clinical assistant professor of emergency medicine at the Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey in Piscataway.

In the study, Dr. Awad and several colleagues reviewed medical records from 93 patients who had received IV

•

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Interruption in the infusion for more than 30 minutes Deviation in rate of infusion of third dose by at least 10% Deviation in rate of infusion of second dose by at least 10% Deviation in loading dose by at least 10% Failure to order loading, second or third dose Deviation in rate of infusion of loading dose by at least 10% Deviation in rate of infusion of second dose by at least 10% Deviation in rate of infusion of third dose by at least 10% Continuation beyond 21 hours with no clinical evidence

Figure 2. Types of administration errors associated with IV N-acetylcysteine infusion in the treatment of acetaminophen toxicity.

Indications and Usage NEXTERONE (amiodarone HCl) Premixed Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. NEXTERONE also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with NEXTERONE, patients may be transferred to oral amiodarone therapy.

Use NEXTERONE for acute treatment until the patient’s ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but NEXTERONE may be safely administered for longer periods if necessary.

Important Risk Information NEXTERONE (amiodarone HCl) Premixed Injection is contraindicated in patients with: • Known hypersensitivity to any of the components of NEXTERONE, including iodine • Cardiogenic shock • Marked sinus bradycardia • Second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available • NEXTERONE should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias, who are thoroughly familiar with the risks and benefits fi of amiodarone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment.

• Hypotension is the most common adverse reaction seen with intravenous amiodarone. In clinical trials, treatment-emergent, drug-related hypotension was reported in 16% (288/1836) of patients treated with intravenous amiodarone. Clinically significant fi hypotension during infusions was seen most often in the first several hours of treatment and appeared to be related to the rate of infusion. Monitor the initial rate of infusion closely and do not exceed the recommended rate. In some cases, hypotension may be refractory and result in a fatal outcome. Treat hypotension initially by slowing the infusion; additional standard therapy may be needed, including: vasopressors, positive inotropic agents and volume expansion.

• In 4.9% (90/1836) of patients in clinical trials, drug-related bradycardia that was not dose-related occurred while patients were receiving intravenous amiodarone for life-threatening VT/VF. Treat bradycardia by slowing the infusion rate or discontinuing NEXTERONE. Treat patients with a known predisposition to bradycardia or AV block with NEXTERONE in a setting where a temporary pacemaker is available.

• Elevations of blood hepatic enzyme values ALT, AST, GGT are commonly seen in patients with immediately life-threatening VT/VF. / In patients with life-threatening arrhythmias, the potential risk of hepatic injury should be weighed against the potential benefit of NEXTERONE therapy. Carefully monitor patients receiving NEXTERONE for evidence of progressive hepatic injury. In such cases, consider reducing the rate of administration or withdrawing NEXTERONE. • Like all antiarrhythmics, NEXTERONE may cause worsening of existing arrhythmias or precipitate a new arrhythmia. Monitor patients for QTc prolongation during infusion with NEXTERONE. Reserve the combination of amiodarone with other antiarrhythmic therapies that prolong the QTc to patients with life-threatening ventricular arrhythmias who are incompletely responsive to a single agent.

• There have been postmarketing reports of acute-onset (days to weeks) pulmonary injury in patients treated with intravenous amiodarone. Findings included pulmonary infi filtrates and masses on X-ray, bronchospasm, wheezing, fever, dyspnea, cough, hemoptysis, and hypoxia. Some cases have progressed to respiratory failure or death. Two percent (2%) of patients were reported to have acute respiratory distress syndrome (ARDS) during clinical studies involving 48 hours of therapy. Pulmonary toxicity including pulmonary fifibrosis is a well-recognized complication of long-term amiodarone use.

• Amiodarone inhibits peripheral conversion of thyroxine (T4) to triiodothyronine (T3) and may cause increased T4 levels, decreased T3 levels, and increased levels of inactive reverse T3 (rT3) in clinically euthyroid patients. Amiodarone can cause either hypothyroidism or hyperthyroidism. Evaluate thyroid function prior to treatment and periodically thereafter, particularly in elderly patients, and in any patient with a history of thyroid nodules, goiter, or other thyroid dysfunction. Because of the slow elimination of amiodarone and its metabolites, high plasma iodide levels, altered thyroid function, and abnormal thyroid function tests may persist for several weeks or even months following NEXTERONE withdrawal.

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

• Drug Interactions • Since amiodarone is a substrate for CYP3A and CYP2C8, drugs/substances that inhibit these isoenzymes may decrease the metabolism and increase serum concentration of amiodarone.

• Amiodarone inhibits p-glycoprotein and certain CYP450 enzymes, including CYP1A2, CYP2C9, CYP2D6, and CYP3A. This inhibition can result in unexpectedly high plasma levels of other drugs which are metabolized by those CYP450 enzymes or are substrates for p-glycoprotein. HMG-CoA reductase inhibitors that are CYP3A4 substrates in combination with amiodarone have been associated with reports of myopathy/rhabdomyolysis. Limit the dose of simvastatin in patients on amiodarone to 20 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required.

• Some drugs/substances are known to accelerate the metabolism of amiodarone by stimulating the synthesis of CYP3A (enzyme induction). This may lead to low amiodarone serum levels and potential decrease in effi ficacy. Fluoroquinolones, macrolide antibiotics, and azoles are known to cause QTc prolongation. There have been reports of QTc prolongation, with or without TdP, in patients taking amiodarone when fluoroquinolones, macrolide antibiotics, or azoles were administered concomitantly.

Please see brief summary of Full Prescribing Information on the following pages.

Baxter Healthcare Corporation Deerfield, IL 60015

Drug Delivery.

Nexterone (amiodarone HCl)

For the way you pharmacy.

Premixed Injection It’s About Time.

Two-year shelf life Extended stability for greater convenience.

No admixing Helps minimize errors due to compounding.

Ready to use Because every second counts.

It’s the only cGMP manufacturer-prepared, premixed amiodarone on the market. Find out how Nexterone (amiodarone HCl) can help you.

Contact your Baxter representative to place an order at 888.229.0001. For more information on how Nexterone (amiodarone HCl) can enhance patient care, visit nexterone.com.

DESCRIPTION

PRODUCT CODE

STRENGTH/ VOLUME

CONCENTRATION

NDC #

PACK FACTOR (cartons/case)

2G3451

150 mg/100 mL

1.5 mg/mL

43066-150-10

12

2G3450

360 mg/200 mL

1.8 mg/mL

43066-360-20

10

NEXTERONE (amiodarone HCl) Premixed Injection

Baxter, Galaxy, Nexterone and the Sphere Graphic are trademarks of Baxter International Inc.

111932 07/13

NEXTERONE (amiodarone HCl) Premixed Injection for intravenous use Brief Summary of Prescribing Information. See PI for Full Prescribing Information.

1 INDICATIONS AND USAGE NEXTERONE is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. NEXTERONE also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with NEXTERONE, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2) in full prescribing information].

Use NEXTERONE for acute treatment until the patient’s ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but NEXTERONE may be safely administered for longer periods if necessary.

4 CONTRAINDICATIONS NEXTERONE is contraindicated in patients with: • Known hypersensitivity to any of the components of NEXTERONE Premixed Injection, including iodine. Hypersensitivity reactions may involve rash, angioedema, cutaneous/mucosal hemorrhage (bleeding), fever, arthralgias (joint pains), eosinophilia (abnormal blood counts), urticaria (hives), thrombotic thrombocytopenic purpura, or severe periarteritis (inflammation around blood vessels).

• Cardiogenic shock.

• Marked sinus bradycardia.

• Second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available.

5 WARNINGS AND PRECAUTIONS NEXTERONE should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias, who are thoroughly familiar with the risks and benefits of amiodarone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment.

5.1 Hypotension Hypotension is the most common adverse reaction seen with intravenous amiodarone. In clinical trials, treatment-emergent, drug-related hypotension was reported as an adverse effect in 288 (16%) of 1836 patients treated with intravenous amiodarone. Clinically significant hypotension during infusions was seen most often in the first several hours of treatment and was not dose related, but appeared to be related to the rate of infusion. Hypotension necessitating alterations in intravenous amiodarone therapy was reported in 3% of patients, with permanent discontinuation required in less than 2% of patients.

Treat hypotension initially by slowing the infusion; additional standard therapy may be needed, including the following: vasopressor drugs, positive inotropic agents, and volume expansion. Monitor the initial rate of infusion closely and do not exceed the recommended rate [see Dosage and Administration (2) in full prescribing information].

In some cases, hypotension may be refractory and result in a fatal outcome [see Adverse Reactions (6.2) in full prescribing information].

5.2 Bradycardia and Atrio-ventricular Block In 90 (4.9%) of 1836 patients in clinical trials, drug-related bradycardia that was not dose-related occurred while they were receiving intravenous amiodarone for life-threatening VT/VF. Treat bradycardia by slowing the infusion rate or discontinuing NEXTERONE. In some patients, inserting a pacemaker is required. Despite such measures, bradycardia was progressive and terminal in 1 patient during the controlled trials. Treat patients with a known predisposition to bradycardia or AV block with NEXTERONE in a setting where a temporary pacemaker is available.

5.3 Liver Enzyme Elevations Elevations of blood hepatic enzyme values [alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT)] are commonly seen in patients with immediately life-threatening VT/VF. Interpreting elevated AST activity can be difficult because the values may be elevated in patients who have had recent myocardial infarction, congestive heart failure, or multiple electrical defibrillations. Approximately 54% of patients receiving intravenous amiodarone in clinical studies had baseline liver enzyme elevations, and 13% had clinically significant elevations. In 81% of patients with both baseline and on-therapy data available, the liver enzyme elevations either improved during therapy or remained at baseline levels. Baseline abnormalities in hepatic enzymes are not a contraindication to treatment.

Acute, centrolobular confluent hepatocellular necrosis leading to hepatic coma, acute renal failure, and death has been associated with the administration of intravenous amiodarone at a much higher loading dose concentration and much faster rate of infusion than recommended [see Dosage and Administration (2) in full prescribing information].

In patients with life-threatening arrhythmias, the potential risk of hepatic injury should be weighed against the potential benefit of NEXTERONE therapy. Carefully monitor patients receiving NEXTERONE for evidence of progressive hepatic injury. In such cases, consider reducing the rate of administration or withdrawing NEXTERONE. 5.4 Proarrhythmia Like all antiarrhythmic agents, NEXTERONE may cause a worsening of existing arrhythmias or precipitate a new arrhythmia. Proarrhythmia, primarily torsade de pointes (TdP), has been associated with prolongation, by intravenous amiodarone, of the QTc interval to 500 ms or greater. Although QTc prolongation occurred frequently in patients receiving intravenous amiodarone, TdP or new-onset VF occurred infrequently (less than 2%). Monitor patients for QTc prolongation during infusion with NEXTERONE. Reserve the combination of amiodarone with other antiarrhythmic therapies that prolong the QTc to patients with life-threatening ventricular arrhythmias who are incompletely responsive to a single agent.

Fluoroquinolones, macrolide antibiotics, and azoles are known to cause QTc prolongation. There have been reports of QTc prolongation, with or without TdP , in patients taking amiodarone when fluoroquinolones, macrolide antibiotics, or azoles were administered concomitantly [see Drug Interactions (7) in full prescribing information].

Amiodarone causes thyroid dysfunction in some patients, which may lead to potentially fatal breakthrough or exacerbated arrhythmias.

5.5 Pulmonary Disorders Early-onset Pulmonary Toxicity There have been postmarketing reports of acute-onset (days to weeks) pulmonary injury in patients treated with intravenous amiodarone. Findings have included pulmonary infiltrates and masses on X-ray, bronchospasm, wheezing, fever, dyspnea, cough, hemoptysis, and hypoxia. Some cases have progressed to respiratory failure or death.

ARDS Two percent (2%) of patients were reported to have adult respiratory distress syndrome (ARDS) during clinical studies involving 48 hours of therapy.

Pulmonary Fibrosis Only 1 of more than 1000 patients treated with intravenous amiodarone in clinical studies developed pulmonary fibrosis. In that patient, the condition was diagnosed 3 months after treatment with intravenous amiodarone, during which time the patient received oral amiodarone. Pulmonary toxicity is a well-recognized complication of long-term amiodarone use (see package insert for oral amiodarone).

5.6 Loss of Vision Cases of optic neuropathy and optic neuritis, usually resulting in visual impairment, have been reported in patients treated with oral amiodarone. In some cases, visual impairment has progressed to permanent blindness. Optic neuropathy and neuritis may occur at any time following initiation of therapy. A causal relationship to the drug has not been clearly established. Perform an ophthalmic examination if symptoms of visual impairment appear, such as changes in visual acuity and decreases in peripheral vision. Re-evaluate the necessity of amiodarone therapy if optic neuropathy or neuritis is suspected. Perform regular ophthalmic examination, including fundoscopy and slit-lamp examination, during administration of NEXTERONE. 5.7 Long-Term Use There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks. See package insert for oral amiodarone.

5.8 Thyroid Abnormalities Amiodarone inhibits peripheral conversion of thyroxine (T4) to triiodothyronine (T3) and may cause increased T4 levels, decreased T3 levels, and increased levels of inactive reverse T3 (rT3) in clinically euthyroid patients. Amiodarone is also a potential source of large amounts of inorganic iodine and can cause either hypothyroidism or hyperthyroidism. Evaluate thyroid function prior to treatment and periodically thereafter, particularly in elderly patients, and in any patient with a history of thyroid nodules, goiter, or other thyroid dysfunction. Because of the slow elimination of amiodarone and its metabolites, high plasma iodide levels, altered thyroid function, and abnormal thyroid function tests may persist for several weeks or even months following NEXTERONE withdrawal.

There have been postmarketing reports of thyroid nodules/thyroid cancer in patients treated with amiodarone. In some instances hyperthyroidism was also present [see Adverse Reactions (6.2) in full prescribing information].

Hyperthyroidism and Thyrotoxicosis Hyperthyroidism occurs in about 2% of patients receiving amiodarone, but the incidence may be higher among patients with prior inadequate dietary iodine intake. Amiodarone-induced hyperthyroidism usually poses a greater hazard to the patient than hypothyroidism because of the possibility of thyrotoxicosis and arrhythmia breakthrough or aggravation, all of which may result in death. There have been reports of death associated with amiodarone-induced thyrotoxicosis. Consider the possibility of hyperthyroidism if any new signs of arrhythmia appear.

Identify hyperthyroidism by relevant clinical signs and symptoms, subnormal serum levels of thyroid stimulating hormone (TSH), abnormally elevated serum free T4, and elevated or normal serum T3.

Since arrhythmia breakthroughs may accompany amiodarone-induced hyperthyroidism, aggressive medical treatment is indicated, including, if possible, dose reduction or withdrawal of amiodarone.

Amiodarone hyperthyroidism may be followed by a transient period of hypothyroidism.

The institution of antithyroid drugs, Ƶ-adrenergic blockers or temporary corticosteroid therapy may be necessary. The action of antithyroid drugs may be especially delayed in amiodarone-induced thyrotoxicosis because of substantial quantities of preformed thyroid hormones stored in the gland.

Radioactive iodine therapy is contraindicated because of the low radioiodine uptake associated with amiodarone-induced hyperthyroidism.

When aggressive treatment of amiodarone-induced thyrotoxicosis has failed or amiodarone cannot be discontinued because it is the only drug effective against the resistant arrhythmia, surgical management may be an option. Experience with thyroidectomy as a treatment for amiodarone-induced thyrotoxicosis is limited, and this form of therapy could induce thyroid storm. Therefore, surgical and anesthetic management require careful planning.

Neonatal Hypo- or Hyperthyroidism Amiodarone can cause fetal harm when administered to a pregnant woman. Although amiodarone use during pregnancy is uncommon, there have been a small number of published reports of congenital goiter/hypothyroidism and hyperthyroidism associated with oral administration. Inform the patient of the potential hazard to the fetus if NEXTERONE is administered during pregnancy or if the patient becomes pregnant while taking NEXTERONE. Hypothyroidism Hypothyroidism has been reported in 2% to 4% of patients in most series, but in 8% to 10% in some series. This condition may be identified by relevant clinical symptoms and particularly by elevated serum TSH levels. In some clinically hypothyroid amiodarone-treated patients, free thyroxine index values may be normal. Manage hypothyroidism by reducing the NEXTERONE dose and considering the need for thyroid hormone supplement. However, therapy must be individualized, and it may be necessary to discontinue oral amiodarone in some patients.

5.9 Surgery Perform close perioperative monitoring in patients undergoing general anesthesia who are on amiodarone therapy as they may be more sensitive to the myocardial depressant and conduction defects of halogenated inhalational anesthetics.

Nervous System: hallucination, confusional state, disorientation, and delirium, pseudotumor cerebri

5.10 Corneal Refractive Laser Surgery Advise patients that most manufacturers of corneal refractive laser surgery devices contraindicate corneal refractive laser surgery in patients taking amiodarone.

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

5.11 Electrolyte Disturbances Correct hypokalemia or hypomagnesemia whenever possible before initiating treatment with NEXTERONE, as these disorders can exaggerate the degree of QTc prolongation and increase the potential for TdP. Give special attention to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhea or in patients receiving concomitant diuretics.

Thyroid: d thyroid nodules/thyroid cancer

6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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

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

Table 4 lists the most common (incidence *2%) adverse reactions during intravenous amiodarone therapy considered at least possibly drug-related. These data were collected in clinical trials involving 1836 patients with life-threatening VT/VF. Data from all assigned treatment groups are pooled because none of the adverse reactions appeared to be dose-related.

Table 4: ADVERSE REACTIONS IN PATIENTS RECEIVING INTRAVENOUS AMIODARONE IN CONTROLLED AND OPEN-LABEL STUDIES (> 2% INCIDENCE) Study Event

Body as a whole Fever Cardiovascular System Bradycardia Congestive heart failure Heart arrest Hypotension Ventricular tachycardia Digestive System Liver function tests normal Nausea

Controlled Studies (n=814)

Open-Label Studies (n=1022)

Total (n=1836)

Body as a whole

Body as a whole 13 (1.2%)

Body as a whole 37 (2.0%)

24 (2.9%) Cardiovascular 49 (6.0%) 18 (2.2%) 29 (3.5%) 165 (20.2%) 15 (1.8%) Digestive System 35 (4.2%) 29 (3.5%)

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

Cardiovascular 90 (4.9%) 39 (2.1%) 55 (2.9%) 288 (15.6%) 45 (2.4%) Digestive System 64 (3.4%) 72 (3.9%)

Other adverse reactions reported in less than 2% of patients receiving intravenous amiodarone in controlled and uncontrolled studies included the following: abnormal kidney function, atrial fibrillation, diarrhea, increased ALT, increased AST, lung edema, nodal arrhythmia, prolonged QT interval, respiratory disorder, shock, sinus bradycardia, Stevens-Johnson syndrome, thrombocytopenia, VF, and vomiting.

6.2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of amiodarone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: anaphylactic/anaphylactoid reaction (including shock), fever

Pancreatic: pancreatitis Renal:l renal impairment, renal insufficiency, acute renal failure

Vascular: r vasculitis 7 DRUG INTERACTIONS Since amiodarone is a substrate for CYP3A and CYP2C8, drugs/substances that inhibit these isoenzymes may decrease the metabolism and increase serum concentration of amiodarone.

Amiodarone inhibits p-glycoprotein and certain CYP450 enzymes, including CYP1A2, CYP2C9, CYP2D6, and CYP3A. This inhibition can result in unexpectedly high plasma levels of other drugs which are metabolized by those CYP450 enzymes or are substrates for p-glycoprotein.

HMG-CoA reductase inhibitors that are CYP3A4 substrates in combination with amiodarone has been associated with reports of myopathy/rhabdomyolysis.

Limit the dose of simvastatin in patients on amiodarone to 20 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required.

Some drugs/substances are known to accelerate the metabolism of amiodarone by stimulating the synthesis of CYP3A (enzyme induction). This may lead to low amiodarone serum levels and potential decrease in efficacy.

Fluoroquinolones, macrolide antibiotics, and azoles are known to cause QTc prolongation. There have been reports of QTc prolongation, with or without TdP, in patients taking amiodarone when fluoroquinolones, macrolide antibiotics, or azoles were administered concomitantly.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Category D Reproductive and teratology studies performed in rabbits and rats at doses of up to 100 mg/kg per day (about 1.4 times the maximum recommended human dose on a body surface area basis) revealed no evidence of embryotoxicity at 5 mg/kg and no teratogenicity was observed at any dosage in rabbits.

Maternal toxicity and embryotoxicity were observed in rats in the 100 mg/kg group.

Use NEXTERONE during pregnancy only if the potential benefit to the mother justifies the risk to the fetus.

8.2 Labor and Delivery It is not known whether the use of amiodarone during labor or delivery has any immediate or delayed adverse effects.

8.3 Nursing Mothers Amiodarone and one of its major metabolites, desethylamiodarone (DEA), are excreted in human milk, suggesting that breast-feeding could expose the nursing infant to a significant dose of the drug.

8.4 Pediatric Use The safety and effectiveness of amiodarone in pediatric patients have not been established; therefore, the use of amiodarone in pediatric patients is not recommended.

8.5 Geriatric Use Clinical studies of amiodarone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Carefully consider dose selection in an elderly patient.

10 OVERDOSAGE There have been cases, some fatal, of amiodarone overdose. Effects of an inadvertent overdose of intravenous amiodarone include hypotension, cardiogenic shock, bradycardia, AV block, and hepatotoxicity.

Treat hypotension and cardiogenic shock by slowing the infusion rate or with standard therapy: vasopressor drugs, positive inotropic agents, and volume expansion. Bradycardia and AV block may require temporary pacing. Monitor hepatic enzyme concentrations closely. Amiodarone is not dialyzable.

Baxter Healthcare Corporation Deerfield, IL 60015 Baxter, Galaxy, Nexterone and the Sphere Graphic are trademarks of Baxter International Inc.

Cardiovascular: r hypotension (sometimes fatal), sinus arrest Dermatologic: toxic epidermal necrolysis (sometimes fatal), exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, skin cancer, pruritus, angioedema

Sourced from: 07-19-68-241 Rev. January 2012

Endocrine: syndrome of inappropriate antidiuretic hormone secretion (SIADH) Hematologic: pancytopenia, neutropenia, hemolytic anemia, aplastic anemia, thrombocytopenia, agranulocytosis, granuloma Hepatic: hepatitis, cholestatic hepatitis, cirrhosis Injection Site Reactions: pain, erythema, edema, pigment changes, venous thrombosis, phlebitis, thrombophlebitis, cellulitis, necrosis, and skin sloughing Musculoskeletal:l myopathy, muscle weakness, rhabdomyolysis

111923 04/13

18 Clinical

Pharmacy Practice News • February 2014

Diabetes

INSULIN TIPS continued from page 1

assistant professor in the Department of Pharmacotherapy at Washington State University’s College of Pharmacy in Spokane. “One thing is that they [the recommendations] stress the need for standardized, evidence-based, protocoldriven order sets for insulin use and they also recommend transitioning from reactive to proactive glycemic management approaches,” commented Dr. Neumiller, who was not involved in developing the recommendations.

Other organizations have published safe insulin-use guidelines ((J Clin Endocrinol Metab 2012;97:16-38; ACE/ADA Task Force consensus statement Endocr Pract 2006;12[suppl 3]:4-13). Nevertheless, insulin-related AEs remain unacceptably high, according to Daniel Cobaugh, PharmD, lead author of the recommendations and vice president of the ASHP Research and Education Foundation, in Bethesda, Md. To develop these new recommendations, the ASHP Foundation commissioned the Institute for Safe Medication Practices (ISMP) to review the published literature and the ISMP National Medication Error Reporting Program to identify in-hospital insulinuse errors. Based on the findings, Dr. Cobaugh and his colleagues generated a 60-item survey, which they disseminated to a 21-member panel asked to rank the three highest-priority errors they thought should be addressed (Table).

Dr. Cobaugh said the broadly representative panel—including pharmacists, physicians, nurses and consumer advocacy groups—will help drive adoption of the recommendations. “This is the first time an interprofessional panel has issued insulin safety use recommendations,” he stressed.

The 10 recommendations were developed from the panel’s input and include the following:

Prescribing • In both computerized prescriber order entry systems and paper medical record systems, replace the use of free-text insulin orders with evidencebased, protocol-driven order sets for specific insulin uses. The sets should include guidance for glucose monitoring and decision support, and should take into consideration a patient’s nutritional status (see the American Association of Clinical Endocrinologists’ Diabetes Resource Center for

Highest-Priority Insulin Errors* • Incorrect dosage/irrational orders • Nomenclature-related errors • Incorrect transcription of verbal or telephone orders • Transcription of incorrect dose • Failure to double-check insulin products before administration • Confusion with look-alike containers • Unsecure storage in patient care and pharmacy areas • Administration of incorrect doses • Incorrect use of insulin pens • Failure to match insulin to nutritional status or intake • Failure to appropriately monitor for insulin effects and adjust dose accordingly * List not in order of priority Source: ASHP

sample order sets at http://inpatient. aace.com/protocols-and-order-sets).

• Eliminate routine administration of sliding-scale insulin doses as a primary treatment strategy for hyperglycemia.

Storing and Dispensing • Store only U-100 concentration insulin, and ensure the insulin and administration devices kept in patient care areas are securely stored. There have been cases in which U-500 insulin was inadvertently used instead of U-100 insulin, leading to a fivefold increase in insulin concentrations and severe hypoglycemia ((Am J Health Syst Pharm 2011;68:63-68).

Additionally, there have been reports of insulin being confused with other medications such as heparin (see, e.g., Pennsylvania Patient Safety Authority Pa Patient Saf Advis 2010;7:9-17).

• Develop hospital-wide standard concentrations for insulin infusions. “There can be confusion and errors if concentrations are not standardized,” Dr. Cobaugh explained.

Administering • Because insulin infusions prepared by clinicians potentially can be diluted to incorrect or nonstandard concentrations, leading to medication errors, limit preparation of bolus and infusion insulin to the pharmacy.

• Develop policies and procedures and provide staff education to ensure

i insulin pens aare not reused in multiple patients.

Pens have been found to contain blo ood cells and tisssue following a sin ngle use, and thereefore present an in nfection risk if reussed in another patieent. Both the FDA and th he ISMP have warned of this risk (see “Information for healthcare professio onals: risk of transmission o of blood-borne pathogens from m shared use of insulin penss” at www.fda. gov and the IS SMP’s “Reuse of insulin pen for multiple patients risks transmission of bloodborne disease” at www.ismp.org).

Monitoring • Ensure insulin use is linked to a patient’s nutritional status and coordinate meal delivery, point-of-care glucose testing and insulin administration in a standardized fashion.

• Educate patients and their caregivers to request rapid-acting insulin at the beginning of a meal, because administering rapid-acting insulin along with meals decreases the risk for insulinrelated hypoglycemia.

• In patients with variable nutritional intake, delay administration of prandial insulin until meals are completed.

• Develop protocol-driven and evidence-based order sets for insulin use and blood glucose monitoring for use specifically during enteral (EN) and parenteral nutrition (PN) interruptions (see J Hosp Med 2009;4:3-15 for EN- and PN-specific order sets).

Evaluating • Prospectively document hypoglycemia and hyperglycemia rates. Monitor insulin use, coordinated insulin administration, glucose testing and nutritional delivery. The Surgical Care Improvement Project (http://www. jointcommission.org/surgical_care_ improvement_project) and the Partnership for Patients (partnershipforpatients.cms.gov) are two collaborations that provide national quality measure outcomes for comparison.

• Provide real-time, hospital-wide glu-

cose reports to health care teams to ensure appropriate surveillance and management of patients with unexpected hypoglycemia (blood glucose ≤40 mg/dL) and hyperglycemia (blood glucose ≥180 mg/dL).

Planning • Provide standardized education, including competency assessments, to all hospital-based health professionals responsible for insulin use.

Gregory A. Maynard, MD, MSc, who co-authored the recommendations and presented them at the ASHP 2013 Midyear Clinical Meeting, said the recommendations include a heavy emphasis on physician insulin prescribing as well as nursing care. “We found some of the most common causes of insulin-related errors were inappropriate prescribing, failure to adjust insulin dosing in response to unexpected nutrition interruption and mismatch between carbohydrate intake and insulin intake,” said Dr. Maynard, who is the director of the Center for Innovation and Improvement Science at the University of California, San Diego.

He added that caregivers also need to improve how and when they assess initial insulin events.

“We don’t do a good enough job at looking at why hypoglycemia occurs, and this doesn’t allow us to deter recurrences,” Dr. Maynard said.

Scott Mathis, PharmD, the director of pharmacy at Monmouth Medical Center in Long Branch, N.J., applauded the guidelines for being “more focused on safety than previous guidelines.

“They use an objective and structured approach based on tracking and trending of actual adverse events,” said Dr. Mathis, who was not involved in the development of the recommendations.

“One thing I like is that they allow use of insulin pens in hospital,” he said.

“In my experience, having nurses draw up doses from vials in syringes leads to a large potential for errors, especially 10-fold dosing errors due to incorrect volume being drawn up.”

The recommendations were also published in the ASHP journal earlier in 2013 ((Am J Health Syst Pharm 2013;70:1404-1413).

—David Wild Dr. Cobaugh reported receiving funding from Sanofi for the development of the recommendations. Drs. Maynard, Mathis and Neumiller reported no relevant conflicts of interest.

Follow us on Twitter @PharmPracNews

Clinical 19

Pharmacy Practice News • February 2014

Transplant Medicine

Steroid Withdrawal Effective in Two Patient Populations lbuquerque, N.M.—Two groups of investigators successfully withdrew corticosteroids from different patient populations, according to studies presented at the 2013 annual meeting of the American College of Clinical Pharmacy. The first study evaluated long-term effects of steroid withdrawal following kidney transplantation, and the other looked at the efficacy of certolizumab pegol (Cimzia, UCB Pharma) as a steroid-sparing agent in patients with Crohn’s disease.

“Steroids are inexpensive, and they’re effective for quick disease management,” said Eric M. Tichy, PharmD, BCPS, FCCP, a senior clinical pharmacy specialist at Yale-New Haven Hospital, New Haven, Conn., who was not involved in either study. Nevertheless, he said, “Steroids cause a myriad of side effects, including cardiovascular disease and diabetes,” so pharmacists “should help make sure that patients are on the lowest effective dose” or are tapered off completely, if possible.

In the kidney transplant study (abstract 182), Kimi Ueda, PharmD, BCPS, and colleagues analyzed prospective data from the four-year MORE (Mycophenolic Acid Observational REnal Transplant) study. They identified 363 patients who underwent corticosteroid withdrawal by month 3 post-transplant, and compared them with 509 patients who continued to receive corticosteroids. At four years’ post-transplant, biopsy-proven acute rejection and patient survival were similar, but graft survival was higher among those who stopped steroid therapy than among those who continued it (96.9% vs.

93.7%; P=0.03). Adverse events (mainly leukopenia and neutropenia) were higher in the corticosteroid-withdrawal group (64.2% vs. 34.2%; P<0.01).

A

Safety and Efficacy 2) trial ((N Engl J Med d 2007;357:239-250). In this trial, 668 adults with active Crohn’s disease who responded to an open-label loading dose of certolizumab pegol were given continuous therapy with certolizumab pegol, at a dosage of 400 mg, or placebo every four weeks for 24 weeks. Among the patients taking corticosteroids at baseline who responded to the loading dose of certolizumab pegol, 45 began a corticosteroid

taper with certolizumab pegol therapy.

Of these, 31% (14 of 45) were in corticosteroid-free clinical remission at week 26.

Lead author Tanna Hassig, PharmD, BCPS, a clinical pharmacy specialist at the Medical University of South Carolina, in Charleston, noted the important role of pharmacists in minimizing exposure to corticosteroids. “The hospital pharmacist has to see how long the patient has been on steroids, look at the patient’s entire

medication regimen, and understand what is the long-term plan.”

—George Ochoa Drs. Hassig and Tichy reported no relevant financial conflicts of interest. Some of Dr. Hassig’s co-authors are employees of UCB Pharma. Dr. Ueda reported being on the speakers’ bureau for Novartis and receiving grant support from Bristol-Myers Squibb.

Some of Dr. Ueda’s co-authors are employees of Novartis.

Differentiated packaging – Your “Best Supporting Actors” in helping to reduce the risk of medication errors

A Real-World Study Dr. Ueda, a transplant pharmacist at California Pacific Medical Center, in San Francisco, said this study is important for several reasons. “It is a multicenter, observational [trial] where patients are treated according to clinical practice rather than a specific research protocol. It’s also large— more than 800 patients—and prospective.

From the data gathered, we can get an idea of what’s really going on.”

Dr. Ueda said they found “no difference in long-term complications such as osteoporosis, cardiovascular disease risk and new-onset diabetes after transplantation,” but Dr. Tichy said that perhaps the four-year study period was “not enough time to see a difference.”

The other study (abstract 238) analyzed data from the 26-week, randomized controlled PRECiSE 2 (Pegylated Antibody Fragment Evaluation in Crohn’s Disease:

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20 Clinical

Pharmacy Practice News • February 2014

Emergency Medicine

BARRIERS

‘Trauma response teams in particular are very well-oiled machines. So, in those situations, being part of a very regimented structure and having everyone know what [ED pharmacists] are responsible for is critical.’

continued from page 13

N-AC at Robert Wood Johnson University Hospital in New Brunswick, N.J., between 2006 and 2012. The patients were between ages 21 and 89 years at the time of treatment, and more than 90% (86 of 93) had presented with acetaminophen toxicity and 71% (66 of 93) had ingested the medication along with other substances.

According to Dr. Awad, physicians made 79 infusion errors in 52.7% (49

—Ryan Owenby, PharmD of 93) of the patients (Figure 2, page 13). The most common errors Dr. Awad found were infusion interruptions, which lasted a mean of 7.5 hours.

“The complexity of this protocol makes it prone to dosing- and infusionrelated errors,” said Dr. Awad, noting

that the protocol begins with an infusion of 150 mg/kg N-AC for one hour, followed by 50 mg/kg for four hours and 100 mg/kg for 16 hours.

Errors did not affect the efficacy of IV N-AC in reversing hepatoxicity or coagulopathy but in a subgroup of 32

Rationale, Reversal, and Recovery of Neuromuscular Blockade Part 1: Framing the Issues Case Study Harold is a 74-year-old man undergoing a video-assisted right upper lobectomy for stage I non-small cell lung cancer.

Current Symptoms • Dyspnea • Coughing with hemoptysis • Chest pain Vital Signs • Height: 177.8 cm (70”) • Weight: 65 kg (143 lb) Signi¿cant Medical History • Hypertension • Chronic obstructive pulmonary disease (moderate) Current Medications • Metoprolol succinate ER 50 mg/d • Tiotropium bromide inhalation powder Laboratory Results • 2-cm lesion in right upper lobe revealed on chest computed tomography (CT) scan; malignancy con¿rmed with needle biopsy • No abnormal bronchopulmonary or mediastinal lymph nodes; brain CT, isotopic bone scan, abdominal ultrasonography negative for distant metastases • Forced expiratory volume in the ¿rst second: 43.6% of predicted value (1.44 L) • Carbon monoxide diffusing capacity: 71.7% of predicted values (20.19 mL/min/mmHg) • Cardiac ultrasonography: normal pulmonary artery pressure (22 mm Hg) At induction, Harold receives propofol 1.5 mg/kg and rocuronium 0.6 mg/kg. During the procedure, movement of the diaphragm interferes with surgery.

This activity is jointly sponsored by Global Education Group and Applied Clinical Education.

Supported by an educational grant from Merck.

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Each activity will present a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit www.CMEZone.com/nmb1 to ¿nd out how your answers stack up against those of our multidisciplinary faculty panel.

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patients whose hospital length of stay exceeded one week, 72% (23 of 32) had errors in administration of their IV N-AC infusions. “The effect was particularly strong in those patients who had the infusion beyond the recommended 21-hour period,” Dr. Awad said.

Ensuring physicians, toxicologists and others involved in the care of patients receiving IV N-AC understand the regimen protocol and the nowdocumented effect of interrupting it could help minimize errors, Dr. Awad noted, adding that Robert Wood Johnson University Hospital is also considering changes to how N-AC solution is prepared. “They currently prepare each dose in separate bags, but there are a number of studies that have found that preparing the entire dose in a single bag and programming the pump to deliver the correct dose at the correct rate can prevent these types of errors from occurring.”

Improved Rapid-Sequence Intubation Patients undergoing rapid-sequence intubation (RSI) are more likely to receive sedation if a pharmacist is present during intubation, University of California, San Francisco (UCSF) researchers reported (poster 3-069).

Lead investigator Zlatan Coralic, PharmD, BCPS, an emergency medicine clinical pharmacist at UCSF, reviewed medical records from 499 patients who underwent RSI at the university’s ED between 2008 and 2012 and found many were not receiving appropriate sedation and analgesia. Specifically, 55.7% (278 of 499) did not receive post-RSI analgesia and 25.7% (128 of 499) were not given sedatives during their stay in the ED. “Intubation hurts and analgesia and sedation need to be administered,” Dr. Coralic emphasized. “There are very few instances where these should not be administered.”

Further analyses revealed two interesting sets of findings: 60.8% and 28.3% of a subset of patients given rocuronium for RSI did not receive analgesia and sedation, respectively, compared with 48.6% and 15.6% of those administered succinylcholine ((P≤0.004 for both).

“There may be a false sense that patients are sedated with rocuronium,” Dr. Coralic said. “It is a much longer- acting paralytic than succinylcholine but it is just that—a paralytic. It does not provide any analgesia or sedation.” In contrast, the effect of succinylcholine diminishes after five to 10 minutes, “unmasking a

Clinical 21

Pharmacy Practice News • February 2014

Emergency Medicine patient’s agitation and prompting providers to administer analgesia and sedation much sooner than with rocuronium.”

On average, succinylcholine recipients received analgesia and sedatives 20 minutes sooner than rocuronium patients, he found.

Further analyses showed that only 19% of rocuronium recipients were left unsedated when an ED pharmacist was present during RSI compared with 35% who were unsedated when a pharmacist was not present ((P=0.01).

“I think that pharmacists are aware of rocuronium’s pharmacokinetics and its duration of action and they prompt providers to order analgesia and sedation,” Dr. Coralic said. He added that pharmacist attendance did not correlate with analgesia use in rocuronium recipients or with both analgesia and sedation in succinylcholine recipients.

Although his was a single-center study, the findings are not unique to UCSF, Dr. Coralic said. A retrospective analysis of data from more than 1 million patients included in the National Hospital Ambulatory Medical Care Survey found that fewer than half of ED patients who underwent RSI received appropriate sedation ((Am J Emerg Med 2013;31:222-226).

“There is plenty of room for improvement in every emergency department,” he said.

Boosting Accuracy Of Medication Reconciliation ED pharmacists at Little Company of Mary Hospital in Evergreen Park, Ill., improved the accuracy of admissiontime medication lists so profoundly that the effects were felt all the way to the time of discharge (poster 5-024).

According to Richard Mioni, PharmD, BCPS, who is a clinical pharmacist at the hospital, as the number of accurate admission medication lists rose from 32.3% when gathered by nurses to 94.2% when pharmacists conducted reconciliations, the number of accurate discharge medication lists increased from 16.7% to 33.7%.

The findings are based on an analysis conducted by his pharmacy’s clinical coordinator, Dr. Mioni said.

She compared medical records and nurse-collected medication lists for 31 ED admissions seen during a single day in August 2011, before the ED’s pharmacist-run medication reconciliation program was implemented in September 2012. The coordinator also looked at 40 patients’ medical records from a single day during that inaugural month. Twelve of those patients had both nurse-obtained medication histories and pharmacist medication reconciliations, and 28 only had nurses obtain their drug histories. Finally, she compared medical records from 104

ED admissions that took place over several days in August 2013 with the same patients’ pharmacist-conducted admission medication reconciliations.

“We used charts as the benchmark since they are the only legal documents we have showing whether physicians made any corrections to the medication histories and reconciliations,” Dr. Mioni said.

The findings showed the average number of errors per patient medication history, including incorrect, incomplete or omitted information, dropped from

2.94 in August 2011, when nurses were obtaining histories, to 0.07 in August 2013, when pharmacists were conducting reconciliations.

Errors in discharge medication lists also decreased over the same period, from 4.2 to 2.06 per patient.

“Our plan is to include a pharmacist on discharge to further improve the accuracy of those medication reconciliations,” Dr Mioni said.

The researcher did not study possible associations between medication list inaccuracies and adverse events, but

said, “We know that the rate of errors prior to pharmacists coming into the ED impacted in-hospital quality measures, and we have survey results from physicians, nurses and pharmacists that indicate dissatisfaction with the medication history process at that time.”

—David Wild

None of the participants reported relevant financial conflicts of interest.

22 Clinical

Pharmacy Practice News • February 2014

Medication Safety

Better Package Design Helps Prevent Drug Errors

E

fforts by manufacturers to improve the way they label and package drugs—prompted by new guidelines issued by the FDA just over a year ago— have been largely successful, according to the Institute for Safe Medication Practices (ISMP). The recommendations have made many companies prioritize the information on labels, avoid too similar designs among different products and standardize ways to indi-

‘I believe we have the safest drug product labeling and packaging around the world.’

—Michael R. Cohen, RPh, MS, ScD cate drug strengths.

“Poor design of container labels and carton labeling can obscure critical safety information,” said Irene Z. Chan, PharmD, BCPS, a safety evalu-

ator in the FDA’s Division of Medication Error Prevention and Analysis, during a Dec. 19 conference hosted online by the ISMP. Problematic names, labels and pack-

aging contribute to 33% of all medication errors—including a proportionate number of fatalities—out of the annual total of 400,000 errors in the United States, according to a 2006 estimate by the Institute of Medicine.

To address this problem, the FDA issued a series of guidelines to drug manufacturers, beginning in December 2012.

They describe ways to properly design drug products, cartons and container labels. The final recommendation, to be released this year, will address naming conventions for proprietary drugs.

Manufacturers’ recent steps to improve labeling safety have a long precedent, according to Michael R. Cohen, RPh, MS, ScD (hon.), FASHP, the president of the ISMP. “We feel pretty proud of the progress that’s been made over the last 20 years,” Dr. Cohen said during the Web conference. He attributed much of this progress to clinicians and patients who have reported problems to the ISMP and the FDA’s MedWatch.

“I believe we have the safest drug product labeling and packaging around the world,” he stressed.

What Hospitals Can Do There are several proactive steps that health systems can take to decrease errors related to drug labels, according to Kelly J. Besco, PharmD, a medication safety coordinator at OhioHealth in Columbus, Ohio, who was not involved with the ISMP conference. Various barcoding technologies, for example, can “ensure you’re putting the right drug in the right location on an inpatient care unit, or ensure you are giving the correct medication by scanning the drug against a patient’s ID band prior to administration,” she told Pharmacy Practice News.

A cost-benefit analysis of the bar code system at Brigham and Women’s Hospital in Boston found an annual reduction of 517 adverse drug events, saving $2.2 million per year ((Arch Intern Med 2007;167:788-794).

Such interventions, however, aren’t always sufficient to overcome poorly constructed containers or imprecise labels, Dr. Chan noted. “What we’ve found is that product design features that predispose end users to errors can often withstand interventions,” she said, including those efforts “focused on product labeling or education of health care providers or patients.”

That’s why the FDA has chosen to focus on the source of the problem— manufacturers with poorly designed labels—rather than on end users. Medication packaging and labels need to reflect the variety of factors that can influence an end user’s behaviors, Dr.

Clinical 23

Pharmacy Practice News • February 2014

Medication safety Chan said. If manufacturers do not anticipate multiple environments of use, from hospital pharmacies to local drugstores, the lack of foresight can compound poor design problems, she noted.

systems, such as a prefilled syringe.

“There can be so many distractions on a label: corporate logos, different colors, highly stylized graphics,” Dr. Cohen told Pharmacy Practice News.

Companies need to be willing to “work with front-line practitioners to test their products prior to marketing,” so pharmacists have a chance to evaluate how well these products are packaged.

Effects of Poor Labeling Such faulty packaging has led to a variety of problems, including people ingesting topical Benadryl sold in drugstores. The container’s shape seemed to indicate it was intended for oral use, Dr. Besco said, and the description “Topical Analgesic” was written in “very, very small” letters on the original labels. “This was the most important piece of information for the consumer to acknowledge prior to taking the medication, and could have prevented the errors from occurring.”

In May 2010, the FDA reported that ingesting Benadryl Extra Strength Itch Stopping Gel caused cases of hallucinations and unconsciousness; in response, Benadryl maker Johnson & Johnson added a sticker with “For Skin Use Only” in large type on the cap.

In a clinical environment, improper type size also can cause harm. Dr. Chan cited the example of a vial of heparin that, with a quick glance at the large bold number on the label, appeared to contain 1,000 units. In actuality, the bold number listed the units per milliliter, and the full 30-mL vial totaled 30,000 units of heparin. “We have run into problems where people see concentration per milliliter and that doesn’t represent the whole content of vial,” Dr. Chan said. “That has led to overdoses.”

Indeed, several high-profile cases of heparin overdoses—some fatal—have occurred in recent years due to such confusion. The FDA responded by recommending that manufacturers follow the guidelines laid out in U.S. Pharmacopeial Convention Chapter <1>. The USP chapter stipulates that small-volume parenteral product labels should state the quantity of a drug per total volume before listing the per milliliter concentration (see photo). Several heparin vial manufacturers have revised their labeling to comply with that directive ((Pharmacy Practice News, July 2013; http://bit.ly/1dzevxE).

What’s in a Name?

Labeling-related medication safety issues also can arise when clinicians have difficulty discerning between drug names or packaging. In the event that one drug is mistaken for another, Dr. Besco said, OhioHealth’s medication safety team will partner with pharmacy purchasers to determine if an alternative manufacturer offers the drug in a more distinctive container.

Otherwise, the purchasers will try to obtain the drugs in different delivery

—Ben Guarino Old (left) and new versions of heparin injection label. Both vials hold the same exact amount of medication.

Source: NAN Alert, June 10, 2013.

ERROR PREVENTION

No sources reported relevant financial conflicts of interest.

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PATIENT SAFETY

24 Clinical

Pharmacy Practice News • February 2014

Practice Pearl

Pharmacy Residents Show Worth in Geriatric Clinic Cassandra White, PharmD Assistant Professor of Pharmacy Practice Husson University School of Pharmacy Bangor, Maine Clinical Pharmacy Specialist VA Maine Healthcare System Augusta, Maine

Alisa Hughes-Stricklett, PharmD, BCPS Clinical Pharmacy Specialist VA Maine Healthcare System Augusta, Maine

P

harmacists are acutely aware of the problems associated with polypharmacy, especially in the geriatric population. Defined as administration of more medicines than are clinically indicated, polypharmacy increases vulnerability to adverse drug events and negative health outcomes.1 There is no consensus on how many prescriptions constitute polypharmacy, but common cut-points include 5, 6, or 9 prescriptions. As the number of prescriptions increases, the risk for pharmacologic interactions between drugs and disease states escalates, as does the risk for patient administration errors. This is especially true in the geriatric population with multiple chronic disease states, changes in drug metabolism and excretion, increased fall risk, and potential harm from medication misadventures.2 Clinical pharmacists regularly review medication profiles for patients in nursing homes to address these con-

cerns, but geriatric patients living in the community have the same need for clinical pharmacy cognitive services. A pharmacy resident geriatric clinic was developed at the VA Maine Healthcare System, under the direction of a clinical pharmacist preceptor, to extend these clinical services to ambulatory geriatric patients. The postgraduate year 1 pharmacy resident, a fully licensed pharmacist, was able to fill a void in clinical services that was due to staffing constraints and provided a unique service to patients and medical providers in the VA Maine Healthcare System. The goal of the clinic was to improve patient safety. This was accomplished by evaluating the appropriateness of therapy, decreasing polypharmacy, and helping patients better understand their medications.

Before the clinical pharmacy visit, the pharmacy resident conducted a thorough chart review with medication history and drafted a chart note based on that review (Figure 1). A template guided the pharmacy resident to assess active and expired medications, patient adherence, labs, and renal function. The reviews also incorporated principles from consultant pharmacy, including assessment of appropriate drug, dose, indication, therapeutic targets, excessive duration, duplicate therapy, complexity, formulary agents, fall risk, and interactions.

The resident discussed observations and recommendations based on the review with the preceptor before the clinic visit to ensure quality and consistency. This

S: Patient (name), a (age) year old (sex) was seen in the Geriatric Clinic on (date) for a medication review. _____________________________________________________________ PCP: _______________________________________________________________________________________ Prior medical history (problem list): ________________________________________________________ Allergies: __________________________________________________________________________________ O: Vitals, Height, Weight, and Latest Lab Results: _____________________________________________________________________________________________ Active medication list: _____________________________________________________________________ A/P: All active and recently expired medications were reviewed

• Nurse calls patient the day before

• Pharmacist interviews patient

• Patient checks into the clinic

• Pharmacist reconciles medications

• Nurse conducts their session • Nurse hands off patient to pharmacist

• Pharmacist reviews recommendations and discusses them with physician

• Physician meets patient after consultation with pharmacist • Physician implements recommendations and confirms them with patient

Figure 2. Flow of geriatric clinic.

Supplements Antihypertensive agents Gastrointestinal agents Hypoglycemic agents Antilipemic agents Topical agents Genitourinary agents Antidepressants Antiplatelet agents Othera

a

Other (in descending order): cholinesterase inhibitors, analgesic agents, benzodiazepines, bisphosphonates, pulmonary agents, anticonvulsants, antiinflammatory agents, ophthalmic agents, antianginal agents, antibiotics, antihistamines, antiparkinson agents, antipsychotics, antirheumatics, expectorants, otic agents, and thyroid therapy

Recently EXPIRED medications: ____________________________________________________________ I. Medications that may contribute to the patient’s risk for falls: _____________________________________________________________________________________________

Figure 3. Recommendations by therapeutic class.

II. Additional criteria for review Adverse drug interactions noted with current medications/problems: _____________________________________________________________________________________________ Medical condition without medication treatment: ___________________________________________ Duplicate therapy: _________________________________________________________________________ Renal/hepatic/other dose adjustments: ____________________________________________________ Meds/supplements identified for possible discontinuation: _____________________________________________________________________________________________ _ III. Medical history was reviewed for drug indications, unnecessary drugs, medication monitoring, and dose appropriateness.

Pharmacist’s recommended plan of care: __________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________

Figure 1. Geriatric clinic note template.

provided an enhanced learning experience for the pharmacy resident and high-quality clinical pharmacy services for the patient and provider. After documentation of medication reconciliation during the patient visit, the drafted note was permanently placed in the patient’s electronic medical record.

Coordinating with the clinic nurse and medical provider allowed the pharmacy visit to be incorporated into the patient’s regularly scheduled geriatric primary care appointment (Figure 2). Patients met individually with the nurse, phar-

macist, and provider, in that order. The registered nurse called patients the day before to confirm their appointments and instructed them to bring all of their medications, including prescription and over-the-counter drugs. On the day of clinic, the nurse conducted the initial work-up and assessed vital signs. Next, the patient was seen in the pharmacist’s office, where the resident examined each medication with the patient, taking time to counsel and answer questions. The pharmacy resident also discussed recommendations with the patient that would

Clinical 25

Pharmacy Practice News • February 2014

Practice Pearl

Table. Benefits of a Pharmacy Resident Geriatric Clinic Provides the opportunity for a PGY1 pharmacy resident to review a patient’s profile, meet with the patient, and communicate recommendations within a multidisciplinary team Offers clinical pharmacy services to a patient population at higher risk for adverse events associated with polypharmacy

agents (Figure 3). Subsequent visits did not produce as many recommendations as the initial appointment but ensured that the patient understood any changes made previously.

The resident geriatric clinic model offered clinical pharmacy services to ambulatory geriatric patients, a population at higher risk for adverse events associated with polypharmacy. This model provided a unique opportunity for the pharmacy resident to improve skills with medication profile review, patient counseling, and interdisciplin-

ary teamwork. This 3-way communication with the patient, pharmacist, and physician achieved immediate results.

It included the patient in the plan determined by the pharmacist and physician and preserved the central patient–physician relationship. The clinic yielded an overall reduction in prescribed medications, but more importantly, it improved patient safety by reducing fall-risk medications, individualizing therapy, and addressing adherence problems (Table).

Keys to success of the clinic were physical location within proximity of the

nurse and physician, a willing physician, the ability to pre-review the patient profile and prepare a note, and a readily available medication and health history.

References 1. Haque R. ARMOR: a tool to evaluate polypharmacy in elderly persons. Ann Long-Term Care. 2009;17(6):26-30.

2. Hajjar ER, Hanlon JT. Polypharmacy and other forms of suboptimal drug use in older patients. In: Hutchinson LC, Sleeper RB, eds.

Fundamentals of Geriatric Pharmacotherapy: An Evidence-Based Approach. Bethesda, MD: American Society of Health-System Pharmacists; 2010:109-120.

Achieves instant results via 3-way communication with the pharmacist, provider, and patient Reduces the total number of medications Individualizes therapy Ensures appropriate medication monitoring Addresses drug adherence and compliance issues Aids conversion of medications to formulary-preferred agents

REMEDIES Risk Evaluation and Mitigation Strategies: an Employer-Driven CME Initiative for Efficacy and Safety

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Complete Parts 1 and 2 to meet et the requirements of the FDA Blue Blueprint print fo forr Prescriber er Education fo for Extended-Release and Long Long-Acting -Acting Opioid Ana Analges Analgesics lgesics ics

Decreases the amount of fall-risk medications prescribed Acknowledges that patients were without previous clinical pharmacy support due to staffing limitations

Navigating g Opioid RE REMS MS

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be conveyed to the provider. The pharmacist relayed the recommendations, along with an annotated medication list with a paper copy of the review, to the provider before the provider saw the patient. If the physician accepted the recommendations, he or she would implement the changes and review them with the patient during their time together.

At the conclusion of the visit, the patient received an updated medication list.

The pharmacy resident clinic was held one-half day per week. The pharmacy resident collected data on the initial patient visit to the clinic for the first 5 months of the program (64 patients).

During that time, the overall number of prescriptions dropped from 800 to 667 and the average number of prescriptions per patient decreased from 12.5 to 10.4. Of the 150 recommendations the resident made, 90% were accepted, 43 of which involved a medication associated with an increased risk for falls. When analyzed by the type of recommendation, 41% decreased regimen complexity, 28.3% were based on therapeutic drug monitoring, 24.1% were obsolete orders, and 6.6% involved formulary-preferred agents. The most common therapeutic classes affected were dietary supplements, antihypertensive agents, gastrointestinal agents, hypoglycemic drugs, and antilipemic

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26 Policy

Pharmacy Practice News • February 2014

Reimbursement Matters

It’s Time To Stop Fighting Specialty Pharmacy T

200

Sales (US $Bn)

he surge in spending for specialty pharmaceuticals can no longer be ignored. No matter how uncomfortable some health systems may be with brown bagging and other so-called “hassles” associated with these products, it is time to address this juggernaut. Not convinced? Consider this: Specialty medicines are on pace to be the biggest driver of branded drug spending in developed markets, with a projected 30% increase in spending over the next five years, according to the latest industry figures.

Are you ready to benefit from this market trend? Or are you going to continue to fight change and defend your culture simply because “that’s the way we do it here”? Your decision on this important practice challenge will have a major effect—good or bad—on your hospital’s bottom line in coming years.

Unfortunately, not all health systems are being receptive to that message. At the recent Midyear Clinical Meeting of the American Society of Health-System Pharmacists, in Orlando, I was most disappointed in the attitudes and foot dragging I saw on the topic of specialty pharmacy. The most common complaint I heard was “changing anything would make it unsafe for my patients.”

I understand the concern for patient

150

100

148

153

169

180

193

50

0

2012

2013

2014

2015

2016

2017

Figure. Specialty spending between 2012 and 2017.

Source: IMS Health Institute for Healthcare Informatics

care. But it is important to remember that they are not only your patients; you share them with lots of other providers in a variety of care settings. So yes, I agree 100% that you need to be patientcentric—but don’t be pharmacy-centric, where you only cling to modes of practice that you like or are familiar with.

Two Scenarios Granted, there are legitimate concerns about disconnects in the proper use and monitoring of specialty medications as the patient moves from site to site. But

Ensuring the Safe Use of Specialty Medications

1. Establish an SP policy with defined steps and a limited scope to ensure optimal outcomes.

2. Incorporate the policy into your hospital’s CPOE, eMAR, CDM and pharmacy computer systems.

3. Vet the SP providers that are supplying medications to your patients.

4. Determine mechanisms for identifying the specialty medications coming into your system.

5. Provide secure, inventoried storage; refrigeration may be needed (see below).

CDM, Charge Description Master; CPOE, computerized prescriber order entry system; eMAR, electronic medication administration record; SP; specialty pharmacy

Web Exclusive: Taking the Next Step

I

160

f your health-system chooses to work with, rather than reject, patients who come in with specialty medications, the next step eventually may be to gain access to specialty pharmacy contracts. When that occurs, one of the first considerations is to guarantee the safe storage and provision of the drugs not only during a patient’s hospital stay but also on an outpatient basis as well.

Since 2007, the University of Illinois Hospital and Health Sciences System has been storing and shipping specialty medications. For a detailed account of their strategies, access the online version of this article at www.pharmacypracticenews.com.

as a health system–based caregiver, you either can help improve this process by being actively engaged in it, or you can stonewall it when the patient needs to be admitted to your facility. To illustrate that point, let’s look at two scenarios, one patient-centric and one not, involving a patient on an oral specialty medication supplied by a specialty pharmacy.

Scenario 1. A patient with a chronic condition being treated with an expensive oral specialty drug requires admission for an unrelated reason. Upon medication reconciliation at admission, you determine that this drug is on the list of medications taken at home. Your facility does not have a relationship with a specialty pharmacy distributor and prohibits the use of any medications from home— known as “brown bagging”—regardless of the circumstances or the drug.

You notify the admitting physician that the patient will not be allowed to continue therapy because you cannot purchase the drug and you won’t allow the patient to take her own drug, which already has been purchased and paid for. The admitting physician does not understand your recalcitrant stand and takes the matter to the C-suite. You are asked for an explanation. You agree to make arrangements to purchase the product (if at all possible) and notify the C-suite of the substantial financial consequence because the product will not be billable. The physician rethinks the relationship with your hospital and uses other facilities when similar situations arise.

Scenario 2. The same patient presents to your facility and is admitted. At medication reconciliation, you meet with the patient and family and share with them the hospital policy on the use of medications from home. This policy has recently moved away from the traditional ban on all brown-bag drugs to a more inclusive policy that addresses specialty medications that must be continued during admission. It clearly defines the very limited number of specialty drugs

“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

that will be allowed during a patient’s hospital stay, and outlines the safety precautions that the facility takes to ensure identification of the prescription medication and storage requirements.

It also details the safe return of the remaining medication upon discharge and includes this in discharge medication reconciliation planning. The admitting physician is impressed with the progressive thinking at this facility and the willingness of its departments to be functional players in the ever-changing world of health care delivery.

Which scenario best describes your setting? Don’t overthink and overcomplicate the issue; just put a plan into place!

More Reasons Not To Fight As noted, I realize you may encounter resistance to the idea of embracing patients who come to your facility with a specialty drug in hand. But I have to again stress how much you are swimming upstream by ignoring this market force. Let’s take a deeper look into the explosive growth of specialty pharmaceuticals. Sales of the medications in developed markets rose to $153 billion in 2013, according to the IMS Institute for Healthcare Informatics report, “The Global Use of Medicines: Outlook through 2017” (tinyurl.com/ lnvorg6). The increase is expected to continue in coming years, hitting $160 billion in 2014, $169 billion in 2015, $180 billion in 2016, and $193 billion in 2017 (Figure).

These drugs also cut across nearly all major chronic disease states, including oncology; asthma; chronic obstructive pulmonary disease; cystic fibrosis; HIV and other viral diseases, including hepatitis C; rheumatoid arthritis; and conditions treated with immunostimulants, immunosuppressants and interferons. So if you’re hoping that your health system’s unique patient demographics will insulate you from this trend, think again. In fact, I would posit that treatment of these chronic conditions with convenient oral or self-administered drugs—a hallmark of specialty pharmaceuticals—whenever possible is key to ensuring the highest possible quality of life for patients. ■

Best practices in automation, automation informatics and patient safety Don’t miss our debut issue, mailing in the Summer of 2014 Each annual installment of PTR will include: Practice Profiles Innovative health systems share tips on automation, CPOE and other key pharmacy technology rollouts.

The Safety Connection Bar coding, smart IV infusion pumps and other other hi-tech approaches to ensuring safe medication use.

ROI by the Numbers Want to add technology but can’t convince the c-suite that it’s cost cost-effective? Our return on investment case studies can help.

Informatics Clinical decision support software and other methods for tapping into crucial diagnostic information at the point of care.

These are just a few of the topics and features on tap for our first issue. Interested in contributing?

Send an email with your article ideas to davidb@mcmahonmed.com

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