PPN - January 2015

The Pharmacist’s News Source

pharmacypracticenews.com

Volume 42 • Number 1 • January 2015

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in this issue UP FRONT

3 4

Tips for building a proactive antibiotic stewardship program.

Genentech’s specialty pharmacy kerfuffle continues.

POLICY

6

340B drug discount program demands compliance; are you ready?

CLINICAL

12

Cancer drug prices put high cost of care in spotlight.

TECHNOLOGY

23

Kiosks, patient portals help boost medication reconciliation.

OPERATIONS & MGMT

28 30

Cognitive and emotional empathy can be keys to effective pharmacy leadership.

2015 CMS payment changes that all hospitals need to heed.

EDUCATIONAL REVIEW

Immune Globulins: Therapeutic, Pharmaceutical, Cost, and Administration Considerations See page 13.

ASHP Best Practices winner:

Discharge Care Slashes 30-Day Readmissions Anaheim, Calif.—In yet another illustration of how clinical pharmacists can reduce hospital utilization and costs, an outpatient clinic initiative by the University of North Carolina (UNC) has reduced 30-day hospital readmissions by 65% among at-risk internal medicine patients.

The researchers, whose project received a Best Practices Award at the American Society of HealthSystem Pharmacists (ASHP) 2014 Midyear Clinical Meeting, said the associated cost savings amount to an estimated $1.13 million annually.

“There are a multitude of transitions of care interventions described in the literature, but the UNC’s work is especially valuable and relevant,” commented Shannon Reidt, PharmD, MPH. “They used a standardized, consistent approach to their interventions, which likely improved their success in reducing readmissions, but

•

Cost savings, improved patient safety make compelling lli case ffor the h C C-suite i

see READMISSIONS, page 20

Nuclear Medicine: A Safety Gap In Your Hospital?

Anaheim, Calif.—Although the hospital pharmacy cannot order, stock or dispense radiopharmaceuticals, and they are not part of the department’s budget, pharmacy cannot ignore these drugs, according to two speakers at the American Society of Health-System Pharmacists 2014 Midyear Clinical Meeting.

Radiopharmaceutical use in the health system must comply with the Centers for Medicare & Medicaid

•

$1 Million Reasons To Invest in Robotics

Morris Eng, RPh, discusses safety checks built into his hospital’s IV robotic system, including weighing the bottle, checking the barcode and photographing the original medication.

P

harmacists often have a difficult time convincing the C-suite to purchase expensive technologies, but the investment can pay off in large savings, improved patient safety and more efficient use of pharmacy staff, according to Ruth E. Cassidy, PharmD, chief pharmacy officer and vice president of clinical services at SBH Health System in the Bronx, N.Y. “An institution has a certain amount of capital [to spend], and the board of trustees wants to know why it should invest in you [pharmacy],” Dr. Cassidy said. “I think directors of pharmacy struggle with [explaining] the return on investment.”

Even when the goal is to improve patient safety and care, SBH leadership wanted to understand how spending $1.5 million on one piece of equipment, such as the RIVA Robotic IV System (Intelligent Hospital Systems), would be advantageous, especially when the hospital was the first in the city to buy the robot. “The board of directors did this for patient safety and to bring us ahead of the curve, but if you talk with the financial guys, they still want to [see] that return [on investment].’”

Dr. Cassidy, who described the robotics rollout during a site visit with Pharmacy Practice News, noted that SBH saved $1 million on inventory as a result of the RIVA purchase. “That is just straight inventory, hard dollars—we took $1 million off the top.”

•

see RADIOPHARMACY, Y page 9

New Product Teva launches first generic Celebrex® Capsules in U.S. See page 8

Get the App

see ROBOTICS, page 24

Up Front 3

Pharmacy Practice News • January 2015

Practice Pearl

Taking a Proactive Approach to Antibiotic Stewardship Anaheim, Calif.—Don’t be sluggish about instituting an antibiotic stewardship program, Matthew J. Hoover, PharmD, BCPS, advised at the American Society of Health-System Pharmacists 2014 Midyear Clinical Meeting.

Optimizing the use of antimicrobials in an institution not only improves patient care and slows the development of drug resistance, but also decreases hospital costs. Dr. Hoover reported

the successful implementation strategy used at the Cleveland Clinic Marymount Hospital, which is a 315-bed, acute care community hospital in Garfield Heights, Ohio. The pharmacists used the mnemonic SLUGS to organize the program: • Selection • Length of therapy • Usage patterns • Gram stain • Service

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.

The Cleveland Clinic Health System formulary committee evaluated antimicrobials for inclusion, inclusion with restrictions or exclusion from the formulary. Site-specific modifications may be made to be more restrictive based on the populations at each hospital, explained Dr. Hoover, who is a pharmacy clinical specialist at Marymount and an assistant professor of pharmacy practice at the Northeast Ohio Medical

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-40188 January 2014 This brief summary is based on TBO-003 GRANIX full Prescribing Information.

University, in Rootstown. In addition, the committee members updated the hospital’s antibiogram to guide empiric antimicrobial selection.

The pharmacists addressed length of therapy, reviewing the time that patients were taking antimicrobials and contacting any physician who did not document the indication for the therapy after five days of treatment. Another component was evaluating usage patterns for the most frequently used antimicrobials and antifungals, and revising restrictions based on observed patterns, according to Dr. Hoover.

The pharmacists reviewed Gram stain results daily and made recommendations to continue the antimicrobial, change it or stop therapy based on the results.

They also provided services to the physicians and staff in the form of education about the new program, as well as choosing the most appropriate antibiotics using evidence-based guidelines. “It is essential to educate physicians and pharmacists on restriction and restriction changes, as well as to provide education on evidence-based antimicrobial practices,” he said.

“Reduction in antimicrobial costs has been sustained through October and is currently at a 24% reduction, equating to roughly $2.33 savings per adjusted patient-day. If the reduction is sustained through [December 2014], we expect to see an estimated overall cost savings of $230,000 for [the entire year],” he said.

Advice for ASP Start-Ups Dr. Hoover offered this advice to anyone starting a stewardship program.

“Don’t reinvent the wheel at your institution,” he said. “You do not need a complex initiative to start a stewardship program.”

Tried-and-true actions include restricting the use of specific antimicrobials; documenting dose, duration and indication for all prescriptions based on evidence and susceptibility; and educating prescribers and other staff about the evidence, Dr. Hoover noted, adding that the Centers for Disease Control and Prevention recommends choosing interventions tailored to the needs of the facility and available resources.

“Set yourself up for success by including key stakeholders,” he suggested, “educating the team and providing them with all the information they need to make evidence-based recommendations.”

—Marie Rosenthal

4 Up Front

Pharmacy Practice News • January 2015

Your Letters The following comments were posted at www.pharmacypracticenews.com about articles that appeared in recent issues.

costs to the patient, insurance companies and hospitals, as well as create further patient treatment delays. I personally do not see this as a safety issue from Genentech, but as a bid to raise their revenue and further add to the rising cost of medical treatment in our system.

More Consternation Over Genentech Distribution Model Re: “Genentech Doubles Down on Specialty Pharmacy Model,” November 2014.

M

y position in a four-physician oncology practice is that of patient advocate. I contact insurance companies to obtain prior authorization to treat cancer patients. I then assist patients in finding financial aid for their treatment. I have dealt extensively with insurance copay, pharmaceutical assistance (Novartis, Pfizer, Celgene, Genentech, etc.). I have also experienced through my patients and their families the higher costs and delays that are incurred by the specialty pharmacy distribution model.

With Genentech’s move to the specialty pharmacy model for all of their drugs, the question is not only pure cost but also availability. When our hospital is dealing with one distributor, we can maintain levels of drugs on hand and forecast the need for future shipments. I would question how quickly these specialty pharmacies can redistribute these drugs, since my past experience has been that it adds at least another 24 to 48 hours to our treatment time frame, and delays are rarely in the best interest of the patient.

The second point I must raise is one that has already been noted in the story: Hospitals order from recognized distributors within a safe supply chain.

There are safety checks already in place for avoiding counterfeit drugs and mishandling delicate, temperature- and moisture-sensitive drugs. I feel the move to the specialty model by Genentech is unwarranted from the larger model safety standpoint, but is guaranteed to increase

—Phyll... wrote on: 11/26/2014

Charlotte Arnold, Genentech representative, responds:

T

he reader does not appear to understand the change that Genentech made in the distribution of Avastin, Herceptin and Rituxan to hospitals.

We are working with the same distributors we were before to deliver these medicines to hospitals. We are now using their specialty distribution service instead of their wholesale service. A list of authorized distributors is available on our website (http://goo.gl/as2RNq).

We are not distributing these medicines through specialty “pharmacies,” which are separate entities from specialty “distributors.” Specialty pharmacies dispense medicines directly to patients once they’ve been prescribed by a doctor. Specialty distributors sell and deliver medicines to doctors’ offices, hospitals and specialty pharmacies.

Genentech’s goal is, and always will be, to get patients the medicines they need.

Specialty distributors have expertise in distributing specialty medicines, which require specific storage and handling. They also have fewer distribution centers,

which helps us better manage and track our supply, even in situations where we may have a constrained supply. This is a very real challenge.

Most hospitals were already purchasing other medicines from specialty distributors with no concern, including our medicines Perjeta, Kadcyla and Gazyva.

Community doctors have been purchasing all our infused cancer medicines this way since 2006. Now, all six of our infused cancer medicines are distributed the same way to all providers.

Patients continue to get their medicines and we are not aware of any appreciable delays. Specialty distributors provide next-day delivery as part of their standard service. They are well established in effectively distributing medicines for many manufacturers.

By consolidating all our infused cancer medicines into the same distribution channel, we have acknowledged there are efficiencies for us. However, we did not change the list price of these medicines as a result of this change and do not believe there should be any change in patients’ insurance or out-of-pocket responsibility. In the long term, we believe this is the best way to distribute our medicines safely and efficiently, and ensure patients continue to receive these lifesaving medicines when they need them.

We are disappointed to see the inaccurate characterization of our decision and the accusation that it will negatively affect cancer patients.

How is your hospital responding to this move by Genentech? Take the poll at pharmacypracticenews.com/ GenentechSurvey or scan the adjacent 2D barcode.

EDITORIAL BOARD

ART/PRODUCTION STAFF

ADMINISTRATION

Michele McMahon Velle, MAX Graphics/Creative Director

Robert Adamson, PharmD, Livingston, NJ

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

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

Volume 42 • Number 1 • January 2015 • pharmacypracticenews.com

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

INTERNAL MEDICINE

EDITORIAL STAFF

David S. Craig, PharmD, BCPS, Tampa, FL

Geoffrey C. Wall, PharmD, FCCP, BCPS, CGP, Des Moines, IA

Robert L. Barkin, MBA, PharmD, Chicago, IL

NUCLEAR PHARMACY

David Bronstein, Editorial Director davidb@mcmahonmed.com

BIOTECHNOLOGY

Jeffrey Norenberg, PharmD, Albuquerque, NM

Indu Lew, PharmD, Livingston, NJ

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

CARDIOLOGY

Robert Ignoffo, PharmD, San Francisco, CA

s CT C. Michael White, PharmD, Storrs,

Marie Rosenthal, MS, Senior Editor mrosenthal@mcmahonmed.com Kevin Horty, Don Pizzi, Adam Marcus, Contributing Editors

Philip E. Johnson, MS, RPh, FASHP, Tampa, FL

CNS/PSYCHIATRY

Cindy O’Bryant, PharmD, Aurora, CO

Charles F. Caley, PharmD, Storrs, CT Lawrence Cohen, PharmD, FASHP, FCCP, Fort Worth, Texas Larry Ereshefsky, PharmD, San Antonio, T Texas

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

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

COMPLEMENTARY AND ALTERNATIVE MEDICINE

ORGAN TRANSPLANT PHARMACY

Cathy Rosenbaum, PharmD, Cincinnati, OH

Eric Tichy, PharmD, BCPS, New Haven, CT

SALES

CRITICAL CARE

PEDIATRICS

Judi Jacobi, PharmD, FCCM, Indianapolis, IN

Gretchen Brummel, PharmD, BCPS, Hudson, OH

David Kaplan, Group Publication Director dkaplan@mcmahonmed.com

INFECTIOUS DISEASES

REIMBURSEMENT

Steven J. Martin, PharmD, BCPS, FCCM, Toledo, OH

Bonnie E. Kirschenbaum, MS, FASHP, Breckenridge, CO

David P. Nicolau, PharmD, Hartford, CT

TECHNOLOGY

Robert P. Rapp, PharmD, Lexington, KY

Thomas Van Hassel, RPh, Yuma, AZ

Craig Wilson, Classified Advertising g Sales cwilson@mcmahonmed.com

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6 Policy

Pharmacy Practice News • January 2015

Drug Pricing

340B Program Demands Compliance; Are You Ready?

More nonprofit institutions facing audits Orlando, Fla.—Given the complex requirements of the federal 340B Drug Pricing Program, chief pharmacy officers and other stakeholders need to dedicate resources to manage its complex components, according to Christopher A. Hatwig, the president of Apexus, the prime vendor for 340B participants.

Resources and Services Administration (HRSA), which administers the 340B program, has stepped up its oversight of the program, and conducting on-site audits is just one of the new “integrity initiatives” that it has implemented in the past few years. Audits were first initiated in fiscal year 2012, and the number of audits conducted continues to increase each year. The audits assess participants’ compliance with program guidance and ensure that products are not being diverted to ineligible patients.

As of September 2014, 236 audits had been performed, according to Sherry Pontell, the branch chief of performance and quality at HRSA. More are expected this year.

Any covered entity that fails to comply with 340B program rules may be required to refund the discounted monies to the manufacturers or be removed from the program, and they will be subject to a second audit the following year, according to Ms. Pontell.

Table 1. Coverage of Items Under 340B Program Covered

Not Covered

• Outpatient prescription drugs

• Vaccines

• OTC drugs with a prescription

• Inpatient drugs

• Clinic-administered drugs

• Drugs not directly reimbursed

• Biologics

• FDA does not require National Drug Code

• Insulin

• Orphan drugs O C, over-the-counter OTC, ove t e cou te

Table 2. 340B Program–Eligible Facilities Federal Grantees/Designees

Hospitals Subject to GPO Prohibition

• Federally qualified health centers

• Disproportionate share hospitals

• Federally qualified health center look-alikes

• Children’s hospitals • Freestanding cancer hospitals

• Title X family planning grantees • State AIDS drug assistance programs

Hospitals Subject to Orphan Drug Exclusion

• Ryan White Care Act grantees • Black lung clinics • Hemophilia treatment centers • Native Hawaiian health centers • Urban Indian organizations

• Critical access hospitals • Rural referral centers • Sole community hospitals • Freestanding cancer hospitals

• STD grantees • TB grantees GPO, group purchasing organization; STD, sexually transmitted transsmitted disease; TB, tuberculosis

The Prime Vendor “Health-system administrators need to actively engage the program,” said Mr. Hatwig, who updated pharmacists about 340B at the 2014 annual meeting of the National Association of Specialty Pharmacy (NASP).

Although 340B is a federal initiative, its scope extends “way beyond” any one department, Mr. Hatwig explained, and therefore, should not be the sole responsibility of the health-system pharmacy.

“If a hospital does not put the appropriate resources into 340B [compliance], it will get into trouble,” added Matt Johnson, the chief operating officer of ASD Healthcare/AmeriSourceBergen, who was part of a panel discussion on the topic at the meeting.

The concern is that if an institution is not compliant, it faces monetary sanctions, such as having to repay manufacturers for 340B discounts received over time. Worse yet, the facility could lose access to all 340B discounts for which it is eligible. Many safety-net organizations rely on their 340B program savings to remain viable.

More Audits Are Coming Audits should be on the mind of every 340B stakeholder. The Health

Apexus, which received a new prime vendor contract in September that will run until 2019, will continue to work with more than 25,000 safety-net provider locations, drug manufacturers, pharmacy wholesalers and other stakeholders to negotiate discounts on pharmaceuticals and offer support services to promote the program’s integrity, compliance and optimization, according to Mr. Hatwig. Participation in the Prime Vendor Program is voluntary, but more than 85% of all covered entities have enrolled. In addition to offering voluntary sub-340B discounts from manufacturers, Apexus can help institutions operate compliant pharmacy operations.

The program helps nonprofit institutions serve indigent patients by offering medications used for outpatient services at deep discounts, which will not be more than the post-rebate amount that Medicaid pays for drugs, according to Mr. Hatwig. That ceiling price is based on quarterly Medicaid metrics, which are calculated as the average manufacturer price (AMP) minus 23.1% plus an inflation penalty for branded products and AMP minus 13% for generic and over-the-counter drugs.

The program represents 2% to 3% of the more than $325 billion in annual pharmaceutical expenditures in the country, according to Mr. Hatwig.

The pricing changes quarterly, and this moving target is one reason to have a dedicated person within the pharmacy managing the program, he explained. Before the beginning of a new quarter, manufacturers upload prices to authorized wholesalers to be administered to the eligible hospitals and clinics. Manufacturers are responsible for capturing and reporting all sales to the retail class of trade during a given quarter to calculate a new AMP, unit rebate amount for Medicaid and 340B price. The calculations are performed and verified in the following quarter and then made available to Medicaid and the 340B covered entities in the next quarter. This explains the six-month (or two-quarter) lag in calculating and administering the ceiling pricing, Mr. Hatwig said.

These discounts enable eligible institutions to stretch scarce federal resources to provide comprehensive services to more eligible patients in support of the safety-net mission.

Pharmacy Contract Do’s and Don’ts Hospitals can contract with specialty pharmacies to improve patient access to care, Mr. Hatwig said, and he added that he is seeing a shift in the site of care for some patients, especially those needing oncology drugs. Many patients with cancer are now being treated in the hospital outpatient area or by specialty pharmacy instead of the practitioner’s office. Many factors have contributed to this shift in care, including declining reimbursements, the rise of accountable care organizations and the retirement of many private practice oncologists.

Eligible 340B entities can engage in contract pharmacy arrangements to provide care to patients, but they must understand that they are ultimately responsible for managing a compliant 340B pharmacy operation, Mr. Hatwig noted.

Some hospitals are required to comply with the group purchasing organization (GPO) prohibition to participate in the 340B program, which prevents them from accessing a GPO for the purchase of outpatient covered drugs

•

see 340B PROGRAM, page 8

Setting a New Standard Introducing Vazculep™ , the only FDA-approved Phenylephrine HCl Injection available in all 3 vial sizes.

INDICATIONS AND USAGE VAZCULEP™ (phenylephrine hydrochloride) Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Extravasation during intravenous administration may cause necrosis or sloughing of tissue Severe bradycardia and decreased cardiac output Allergic-type reactions: Sulfite Concomitant use with oxytocic drugs: Pressor effect of sympathomimetic pressor amines is potentiated ADVERSE REACTIONS Most common adverse reactions during treatment: nausea, vomiting, and headache.

To report SUSPECTED ADVERSE REACTIONS, contact ÉCLAT Pharmaceuticals at 1-877-622-2320 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the accompanying full prescribing information for complete safety information and dosage and administration instructions.

www.eclatpharma.com © 2014 ÉCLAT PHARMACEUTICALS, LLC

Vazculep™ (Phenylephrine HCl Injection) U The only FDA-approved Phenylephrine HCl Injection available in a complete range of 3 vial sizes – 1mL, 5mL and 10mL U Manufactured in a cGMP facility with a commitment to have adequate inventory in order to ensure an uninterrupted supply of product U Available with all leading wholesalers Vazculep™, Reach for the New Standard!

Vazculep Phenylephrine HCl Injection ™

www.vazculep.com

8 Policy

Pharmacy Practice News • January 2015

Drug Pricing

340B PROGRAM

BY THE NUMBERS

continued from page 6

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VAZCULEP safely and effectively. See full prescribing information for VAZCULEP. VAZCULEP (phenylephrine hydrochloride) Injection for intravenous use Initial U.S. Approval: 1954 INDICATIONS AND USAGE VAZCULEP (phenylephrine hydrochloride) Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

DOSAGE AND ADMINISTRATION VAZCULEP (phenylephrine hydrochloride) Injection, 10 mg/mL, is injected intravenously either as a bolus or in a dilute solution as a continuous infusion. Dilute before administration.

Dosing for treatment of hypotension during anesthesia • Bolus intravenous injection: 40 mcg to 100 mcg every 1-2 minutes as needed, not to exceed 200 mcg.

• Intravenous infusion: 10 mcg/min to 35 mcg/min, titrating to effect, not to exceed 200 mcg/min.

The dose should be adjusted according to the pressor response (i.e., titrate to effect).

DOSAGE FORMS AND STRENGTHS • Injection • 1 mL single use vials containing 10 mg phenylephrine hydrochloride (10 mg/mL) • 5 mL pharmacy bulk package vials containing 50 mg phenylephrine hydrochloride (10 mg/mL) • 10 mL pharmacy bulk package vials containing 100 mg phenylephrine hydrochloride (10 mg/mL)

while participating in the federal discount program.

Mr. Hatwig clarified that only certain medications qualify for 340B pricing, and the pricing on these medications cannot be used for inpatient services, nor can they be used for patients treated by the hospital or clinic who do not meet the definition of a patient under the program guidelines. The program is not restricted to uninsured patients.

With the exception of entities that decide to use non-340B drugs for Medicaid—called “carving out”—the hospital or clinic may use 340B purchased drugs for any eligible outpatient.

Duplicate discount generation, or causing both a 340B discount up front and a Medicaid rebate on the same transaction, is a prime concern for all 340B stakeholders. “Double dipping or duplicative discounts is the No. 1 concern for manufacturers,” Mr. Hatwig explained.

No manufacturer wants to be in the position of having to honor a 340B discount to an eligible 340B entity, when having to pay a rebate to a state Medicaid program on the same transaction. “The current work [of HRSA] is focused on

CONTRAINDICATIONS None

340B represents 2% to 3% of total U.S. pharmacy expenditures each year.

As of October 2014: • 28,306 registered sites • 14,236 non-hospital sites • 15,640 unique contract pharmacies • 17% of covered entity sites use contract pharmacies

driving program compliance,” explained J. Keith Hanchey, RPh, the managing director of health care at Navigant Consulting Inc., and a panel member during the 340B discussion.

State Medicaid programs are expanding and CMS expects them to seek rebates on all outpatient covered drugs.

Remaining compliant with both programs has become even more challenging for the hospitals and clinics, Mr. Hatwig said.

—Marie Rosenthal

NEW PRODUCT

WARNINGS AND PRECAUTIONS • Extravasation during intravenous administration may cause necrosis or sloughing of tissue • Severe bradycardia and decreased cardiac output • Allergic-type reactions: Sulfite • Concomitant use with oxytocic drugs: Pressor effect of sympathomimetic pressor amines is potentiated ADVERSE REACTIONS Most common adverse reactions during treatment: nausea, vomiting, and headache.

To report SUSPECTED ADVERSE REACTIONS, contact Éclat Pharmaceuticals at 1-877-622-2320 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS • Agonistic effects with monoamine oxidase inhibitors (MAOI), oxytocin and oxytocic drugs, tricyclic antidepressants, angiotensin and aldosterone, atropine, steroids, norepinephrine transporter inhibitors, ergot alkaloids • Antagonistic effects with Ơ-adrenergic antagonists, phosphodies terase Type 5 inhibitors, mixed Ơ- and ơ-receptor antagonists, calcium channel blockers, benzodiazepines and ACE inhibitors, centrally acting sympatholytic agents

Teva Launches First Generic Celebrex® Capsules in U.S.

T

eva Pharmaceutical Industries Ltd., announced the launch of the first FDA-approved generic equivalent to Celebrex® (Celecoxib) Capsules in the United States. Teva is offering 50, 100, 200 and 400 mg strengths of Celecoxib Capsules.

“Teva is pleased to be the first to launch generic Celebrex,” said Siggi Olafsson, president and CEO of Global Generic Medicines at Teva. “The addition of Celecoxib Capsules to our U.S. generics portfolio is further evidence of Teva’s commitment to bring affordable treatment solutions to patients.”

PHARMACY PRACTICE NEWS TWEETS!

USE IN SPECIFIC POPULATIONS • Pregnancy: Based on animal data, may cause fetal harm.

Revised: 7/2014

Follow us on Twitter @ PharmPracNews And send your Twitter handle to editor David Bronstein at davidb@mcmahonmed.com so we can follow you.

Policy 9

Pharmacy Practice News • January 2015

Medication Safety

RADIOPHARMACY continued from page 1

Services (CMS) conditions of participation (CoPs) for Medicare, the medication management standards established by the Joint Commission and other accrediting bodies, as well as the United States Pharmacopeia (USP) chapters <797> and <795>. These CoPs and standards require that hospitals handle radiopharmaceuticals using the same systems, controls and oversight as other medications to ensure safety and quality, according to Richard L. Green, RPh, BCNP, the director of the Radiopharmacy Practice, Quality and Regulatory Department team for Cardinal Health’s Nuclear Pharmacy Services business in Dublin, Ohio.

“Many institutions have failed to include radiopharmaceuticals in the hospital’s formulary process and the medication use protocols have not been reviewed by pharmacy staff,” Mr. Green told Pharmacy Practice News. Lack of compliance to Joint Commission standards can affect a hospital’s accreditation.

“Until recently, few people crossed that yellow [radioactive] sign,” added Patricia C. Kienle, RPh, MPA, FASHP, director of Accreditation and Medication Safety for Cardinal Health’s Innovative Delivery Solitions business. “But the Joint Commission and other accrediting bodies know they can go in there, and they will.”

cern for me,” Mr. Green said. “There’s no reason to use a knockoff. There are no shortages of radiopharmaceuticals.”

The first issue in closing some of these safety gaps is making sure that the nuclear pharmacy department is using FDA-approved medications and that these drugs are listed on the health system formulary, Mr. Green said. Additionally, the vendor should be vetted to make sure that it is also in compliance.

There are protocols for preparing, storing and using these products. “You need to be involved in every protocol in your

health system,” Ms. Kienle said. “There is a requirement, not a recommendation, that any protocol or standing order be approved by a medical staff committee, and pharmacy and nursing need to be involved in that process review and approve that protocol,” she said.

That doesn’t mean a pharmacist can just waltz in and take over, Mr. Greene said. As with any department, diplomacy is important, but once everyone understands the stakes, they can work to bolster compliance. “There is always the risk for a territorial dispute breaking out when

one department peeks its nose under the tent of another,” he said. “Once a mutual understanding ... occurs, then a pharmacy liaison can be assigned to the nuclear medicine department to bring about the necessary inclusion into the health system’s formulary, to ensure that drug use protocols are reviewed. Other issues, such as drug security, ancillary drug use, USP Chapter <797> compliance as well as any CII [Schedule II controlled] narcotic use will have to be addressed.”

—Marie Rosenthal

Leading the Specialty Pharmacy Industry With Innovative Programs and Services.

Out With the Old Traditionally, the medical director of the nuclear medicine department dictated policies and procedures, but a little more than 10 years ago, the Joint Commission ruled that pharmacy should have oversight of the radiopharmaceuticals and any compounding that goes on in that department, Ms. Kienle explained.

Then CMS and other accrediting bodies followed the Joint Commission’s lead.

There are 47 FDA-approved radiopharmaceuticals commercially available. They tend to have short half-lives of about six hours, which means they need to be delivered daily and prepared near the point of use for every patient every day. The hospital should have a policy allowing the courier to enter the nuclear department, deliver and store the drugs. However, some facilities do not use FDA-approved drugs, which have proven safety, efficacy, sterility and potency. “This is a big con-

Web Exclusive For a listing of the most common radiopharmaceuticals and more tips for ensuring their safe use, visit pharmacypracticenews.com/Radiosafety or scan the adjacent 2D barcode.

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NEW

NOW INTRODUCING

CONVENIENCE WITH FEWER VIALS

40 g VIAL

<

Avoid potential IG waste—With the widest range of vial sizes, dispense IG according to prescription 1 g 2.5 g 5 g 10 g 20 g 40 g Important Safety Information

Visit gamunex-c.com to learn more.

GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) is indicated for the treatment of primary humoral immunodeficiency disease (PIDD), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

Thrombosis may occur with immune globulin products, including GAMUNEX-C. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer GAMUNEX-C at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IVIG) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IVIG products containing sucrose. GAMUNEX-C does not contain sucrose. For patients at risk of renal dysfunction or failure, administer GAMUNEX-C at the minimum concentration available and the minimum infusion rate practicable.

GAMUNEX-C is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.

It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.

Severe hypersensitivity reactions may occur with IVIG products, including GAMUNEX-C. In case of hypersensitivity, discontinue GAMUNEX-C infusion immediately and institute appropriate treatment.

Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output in patients at risk of developing acute renal failure.

Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IVIG treatment, including GAMUNEX-C. There have been reports of noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]), hemolytic anemia, and aseptic meningitis in patients administered with IVIG, including GAMUNEX-C. The high-dose regimen (1g/kg x 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.

Because GAMUNEX-C is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, and, theoretically, the CreutzfeldtJakob disease (CJD) agent.

Do not administer GAMUNEX-C subcutaneously in patients with ITP because of the risk of hematoma formation.

Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure.

Assess renal function, including measurement of BUN and serum creatinine, before the initial infusion of GAMUNEX-C and at appropriate intervals thereafter.

Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies, because of the potentially increased risk of thrombosis.

If signs and/or symptoms of hemolysis are present after an infusion of GAMUNEX-C, perform appropriate laboratory testing for confirmation.

If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies and anti-HLA antibodies in both the product and patient’s serum.

After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation.

In clinical studies, the most common adverse reactions with GAMUNEX-C were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection-site reaction, nausea, pharyngitis, and urticaria with intravenous use (in PIDD) and infusion-site reactions, headache, fatigue, arthralgia and pyrexia with subcutaneous use (in PIDD); and headache, vomiting, fever, nausea, back pain, and rash (in ITP).

The most serious adverse reactions in clinical studies were pulmonary embolism (PE) in 1 subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in 1 subject (in PIDD), and myocarditis in 1 subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP). © 2014 Grifols Inc.

All rights reserved.

October 2014

GX239-1014

Please see brief summary of GAMUNEX-C full Prescribing Information on adjacent page.

GAMUNEXÂŽ-C

C ?6+8685:+/4+3/' =/:. 8+9;2:'4: ).'4-+9 /4 9+8;3 </9)59/:? '4* +2+):852?:+ /3('2'4)+9 3'? 5));8 /4 6':/+4:9 8+)+/</4- # :.+8'6?

Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified C !.853(59/9 .'9 5));88+* /4 6':/+4:9 8+)+/</4- # :.+8'6?

54/:58 6':/+4:9 =/:. 145=4 8/91 ,'):589 ,58 :.853(59/9 )549/*+8 HIGHLIGHTS OF PRESCRIBING INFORMATION ('9+2/4+ '99+993+4: 5, (255* </9)59/:? ,58 :.59+ ': 8/91 5, .?6+8 </9)59/:?

These highlights do not include all the information needed to use GAMUNEXÂŽ-C safely and effectively. See full prescribing C 9+6:/) +4/4-/:/9 ?4*853+ .'9 (++4 8+658:+* =/:. information for GAMUNEX-C. " $ '4* 5:.+8 # :8+':3+4:9 +96+)/'22? =/:. ./-. *59+9 58 8'6/* /4,;9/54 GAMUNEXÂŽ-C, [Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified] C +352?:/) '4+3/' )'4 *+<+256 9;(9+7;+4: :5 # :.+8'6? *;+ :5 +4.'4)+* 9+7;+9:8':/54 54/:58 6':/+4:9 ,58 .+352?9/9 '4* Initial U.S. Approval: 2003 .+352?:/) '4+3/' WARNING: THROMBOSIS, RENAL DYSFUNCTION C 54/:58 6':/+4:9 ,58 6;2354'8? '*<+89+ 8+'):/549 :8'49,;9/54 and ACUTE RENAL FAILURE 8+2':+* ');:+ 2;4- /40;8? %! & See full prescribing information for complete boxed warning.

C #52;3+ 5<+825'* E $3=:8-:>4> 8,y occur with immune globulin products, including GAMUNEX-C. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.

E := ;,?409?> at risk of thrombosis, administer GAMUNEX-C at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

E "09,7 /Csfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients.

E "09,7 /Csfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMUNEX-C does not contain sucrose.

E := ;,?409?> at risk of renal dysfunction or failure, administer GAMUNEX-C at the minimum concentration available and the minimum infusion rate practicable.

C " $ /9 3'*+ ,853 .;3'4 62'93' '4* 3'? )54:'/4 /4,+):/5;9 '-+4:9 + - </8;9+9 '4* :.+58+:/)'22? :.+ 8+;:@,+2*: '15( */9+'9+ '-+4: C " $ /9 45: '6685<+* ,58 9;();:'4+5;9 ;9+ /4 ! 6':/+4:9 ;+ :5 ' 65:+4:/'2 8/91 5, .+3':53' ,583':/54 *5 45: '*3/4/9:+8 " $ 9;();:'4+5;92? /4 6':/+4:9 =/:. !

C '99/<+ :8'49,+8 5, '4:/(5*/+9 3'? )54,5;4* 9+8525-/) :+9:/4- ----------------------------ADVERSE REACTIONS ---------------------------+8/5;9 '*<+89+ 8+'):/549 =./). 5));88+* /4 :.+ )2/4/)'2 :8/'29 =+8+ '4 +>')+8(':/54 5, ';:5/33;4+ 6;8+ 8+* )+22 '62'9/' /4 54+ 9;(0+): '4* 6;2354'8? +3(52/93 /4 54+ 9;(0+): =/:. ' ./9:58? 5, !.+ 359: )53354 '*<+89+ 8+'):/549 5(9+8<+* /4 âą&#x2013; 6':/+4:9 =+8+ PI 4tra<enous +'*').+ )5;-. /40+):/54 9/:+ 8+'):/54 4';9+' 6.'8?4-/:/9 '4* ;8:/)'8/' ;();:'4+5;9 4,;9/54 9/:+ 8+'):/549 .+'*').+ ,':/-;+ '8:.8'2-/' '4* 6?8+>/' ITP +'*').+ <53/:/4- ,+<+8 4';9+' (')1 6'/4 '4* 8'9.

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To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics Inc. at 1-800-520-2807 or FDA at 1-800-FDA-1088 or GAMUNEX-C is an immune globulin injection (human), 10% liquid www.fda.gov/medwatch. indicated for treatment of: ----------------------------DRUG INTERACTIONS ---------------------------C 8/3'8? ;358'2 33;45*+A)/+4)?

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---------------------USE IN SPECIFIC POPULATIONS ---------------------

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3036439/3036440-BS Revised: 7/2014

12 Clinical

Pharmacy Practice News • January 2015

Oncology

Battling the Financial Toxicity of Cancer Treatment Boston—At age 39, Chris was diagnosed with localized rectal cancer. He received treatment with capecitabine (Xeloda, Roche) and radiation, and initially responded well to therapy. Immediately before surgery, however, his doctor discovered the cancer had metastasized and began talking to him about further chemotherapy options, including continuing him on the capecitabine regimen. Chris flatly rejected this option.

“It wasn’t the physical toxicity that Chris was concerned about; it was the financial toxicity,” said Yousuf Zafar, MD, MHS, an associate professor of medicine at Duke Cancer Institute, in Durham, N.C. “Chris had a job and was insured, but he had no prescription drug coverage. For the five and a half weeks he was taking oral capecitabine, he was paying for all of it out of pocket. He never once mentioned to me his problem, and what is worse, I never asked him.”

As a result, Chris was in serious medical debt, a common outcome for cancer patients. The average amount that an insured cancer patient pays out of pocket per year is $4,800 (J ( Clin Oncol 2011:29;2821-2826). Fifty percent of Medicare beneficiaries with cancer spend more than 10% of their income on out-of-pocket health care costs; 28% spend more than 20% (Cancer 2013;119:1257-1265). “Our patients are paying a lot, probably more than we realize,” Dr. Zafar said, presenting some of the latest financial toxicity data at the American Society of Clinical Oncology Quality Care Symposium.

Drug prices are a common scapegoat for spiraling health care costs. According to Peter Bach, MD, from Memorial Sloan-Kettering Cancer Center, in New York, from the 1970s to the 1990s, the average cost of a month of chemotherapy was roughly $100. Today, the average price is $10,000 per month. Biologics, with their hefty price tags, are a huge factor. Just last month, Amgen’s new bispecific antibody leukemia drug, Blincyto (blinatumomab), hit the market with a price tag of $178,000, making it one of the world’s most expensive cancer medications.

In some cases, drugs have risen in price after entering the market. According to a recent investigation by Bloomberg News, between 2007 and 2014, the price of erlotinib 100 mg (Tarceva, Genentech) increased by 91% and the price of imatinib 400 mg (Gleevec, Novartis) increased by 158%. Dana Cooper, a Novartis spokesperson, explained that the company periodically adjusts the prices of its products to balance the cost of current products with the cost of developing new drugs. “The majority of CML [chronic myeloid leukemia]

patients pay less than $100 out of pocket per month for our CML treatments,” Ms. Cooper said. Susan Wilson, a spokesperson for Genentech, offered a similar comment, saying prices are occasionally adjusted so that the company can continue drug development.

Burden Falling on Patients As drug prices surge, patients are bearing a greater burden of the cost in the form of cost sharing. According to the 2013 Kaiser Family Foundation/Health Research and Educational Trust Survey of Employer-Sponsored Health Benefits, between 1999 and 2013, worker contributions to premiums have increased by 196%. Deductibles have almost doubled, with the average annual individual deductible in 2013 at $1,135.

In a recent survey of 174 individuals being treated for cancer, one-third of participants reported hardship as a result of their cancer costs, with 16% reporting difficulty paying for basic necessities and 19% reporting using up all or most of their savings (Oncologist 2014;19:414-420). A pivotal study by Ramsey et al found that cancer patients were 2.65 times more likely to go bankrupt than people without cancer ((Health Afff 2013;32:1143-1152).

Treatment adherence often is one of the first victims of financial toxicity.

One study ((J Clin Oncoll 2014;32:306-311) found that patients with higher copayments ($53 or more) were 70% more likely to discontinue therapy in the first six months of treatment. The authors also pointed out that the financial toxicity

of cancer treatments can reduce quality care by making patients spread out chemotherapy appointments, decline tests, delay care and replace prescriptions with over-the-counter medications.

A partial antidote to financial toxicity is to promote health care literacy. A 2014 survey showed that only 60% of U.S. citizens understood what a deductible was ((Proc Natl Acad Sci USA 2014;111:54975502). In another survey, roughly half of patients expressed interest in talking to doctors about cost, but only 19% had such a discussion ((J Clin Oncol 2013;31[suppl]; abstract 6506). Of those who discussed costs with their doctor, 57% reported that they felt the discussion helped decrease costs. Cost containment was achieved through various mechanisms: physician referrals to financial assistance (53%), clinicians advocating for patients with insurance companies (25%), a switch to a less expensive medication (19%), a decrease in tests (13%) and a decrease in doctor visits (6%).

“When I talk about financial toxicity with oncologists,” Dr. Zafar said, “I often am asked, ‘I have no idea how much these drugs cost, and even if I did, most of the time, I would not have an alternative treatment for my patients; so what do I do?”

Identifying Those at Risk Pointing patients to financial assistance is one solution, and identifying patients at risk for financial toxicity early is key. “Financial counselors and social workers have told us that it is much easier to help patients early than it is to actually dig them out of that

medical debt,” Dr. Zafar said. New tools to identify patients at risk for financial toxicity should help (see Web exclusive link). Once patients are identified as being at risk, they can be directed to resources such as company-run patient assistance programs.

Many companies, including Novartis and Genentech, have patient access programs, copay cards and other initiatives to help patients who are uninsured, underinsured or unable to afford their medicines. “We [Novartis] estimate that we provide support to approximately 35% of the CML patients taking one of our medicines, either through offering our CML medicines for free or providing copay support through our own copay card or through our financial support of charitable copay foundations,” Ms. Cooper said.

Genentech also provides similar programs. “The Genentech Access to Care Foundation, which provides free medicine to people without insurance, changed its eligibility criteria, with the goal of helping more people who may be struggling with high out-of-pocket costs,” Ms. Wilson said. The company also provides assistance with copays, such as an oncology copay card that helps people with commercial insurance so they will not pay more than $100 per copay, she explained.

Although these programs exist, it is clear that many patients don’t know about them. “Our studies have shown that patients are signed up for inappropriate, insufficient insurance plans.

They don’t know that patient assistance programs exist, and when they get to those programs, it might be too late,” Dr. Zafar said. “We have done a lot to describe this problem of financial toxicity, but now is the time to intervene. We need to start corralling our resources in health literacy, patient– physician communication and patient engagement in health system delivery, and start intervening on this problem of financial toxicity.”

—Kate O’Rourke Dr. Zafar has served as an unpaid consultant for Genentech and his spouse is employed

by GlaxoSmithKline.

Web Exclusive For a tool that can help you identify which patients are most at risk for financial toxicity from cancer drugs, scan the 2D barcode or go to pharmacypracticenews.com/cancercost.

Educational Review 13

Pharmacy Practice News • January 2015

Immune Globulins: Therapeutic, Pharmaceutical, Cost, and Administration Considerations JERRY SIEGEL, PHARMD, FASHP Clinical Associate Professor The Ohio State University College of Pharmacy Columbus, Ohio

F

or the past several years, the availability of immune globulin (Ig) products has been very good, so product shortages have not

played a major role in product choice. This allows clinicians to match the best product to the patient based on clinical condition and comorbidities.

New products have become available, providing more treatment options. There now are 5 Ig products indicated for subcutaneous (SQ) use in patients with primary immunodeficiency: Gammagard Liquid (Baxter), Gammaked (Kedrion), Gamunex-C (Grifols) come in 10% concentrations and can be administered intravenously or subcutaneously; Hizentra (CSL Behring) comes in a 20% concentration and can be administered subcutaneously. It should be noted that dosing adjustments are required for all SQ agents when converting from IV. Hyqvia (Baxter) is the newest SQ Ig product that became available in September 2014. While the IgG portion of the product is identical to Gammagard Liquid 10%, it is to be used in combination with recombinant human hyaluronidase (HY). This combination product allows for SQ administration of a large amount of Ig, equivalent in dose to that of IVIG, in one site and equivalent in coversion ratio on a 1:1 basis.

It is FDA-approved for primary immunodeficiency in adults. This is the first product of its type. In the chart it will look identical to Gammagard Liquid 10%, but will be distributed as a dual package with the 5 mL vial of HY. Instructions for administration are unique and specific to this product.

Two products, Gammaked and Gamunex-C, are approved for use in patients with chronic inflammatory demyelinating polyneuropathy (IV only).

Gammagard Liquid is approved to treat multifocal motor neuropathy.

A common question regarding Ig products relates to whether they are all the same. Although clinicians have considered all Ig products to have comparable efficacy, they are not pharmaceutically equivalent. It is imperative that Ig products not be interchanged without full consideration of the pharmaceutical differences.

The reasons for switching products may be clinical in nature and related to tolerability; they may be fiscal and based on contracting issues; or they may be due to product availability. It is best to consider product changes as if the patient is naive to Ig use, with increased monitoring and conservative infusion times.

Whereas Tables 1 to 5 may help facilitate these decisions, it is important to understand the clinical impact of changing products. Although all of the products contain primarily IgG, trace amounts of other Igs—IgA and IgM—as well as widely different stabilizing agents, may affect tolerability. The differences in salt, sugar, and overall osmolarity of these

products are particularly important when patients have various comorbidities, such as renal dysfunction, diabetes mellitus, vascular disease, or heart failure.

Differences between lyophilized and liquid products may result in changes in product concentration and infusion rate, as well as tolerability.

The tables in this review may be helpful for providing optimal care for patients receiving Ig products. They should be used as a general guide to help determine the product that is best suited for a particular patient population. Because there is variation from batch to batch, the exact numbers represent averages of selected batches; any one batch of any Ig product may have ranges outside these average numbers. When comparing administration rates, clinicians need to keep in mind that each patient has a maximum tolerated rate. This rate may be different for each Ig product. Ig must be administered slowly initially and titrated as tolerated. The rate also should be adjusted based on comorbidities. The infusion should be slowed or stopped if adverse events (AEs) become evident during the infusion.

(See the prescribing information for each agent for more information about AEs.)

KEY BEV

bovine enterovirus (RNA model)

BGMS blood glucose monitoring systems BPV

CF

complement fixation

CIDP

chronic inflammatory demyelinating polyneuropathy

CMV

chronic lymphocytic leukemia cytomegalovirus

D5W

dextrose 5% in water

EIA

enzyme immunoassay

EMCV encephalomyocarditis virus (RNA model) FDA

glucose dehydrogenasepyrroloquinolone quinone

GDO

glucose-dye-oxidoreductase

HAI

heterologous anti-immunoglobulin

HAV

hepatitis A virus

bovine papillomavirus

BVDV bovine viral diarrhea virus

CLL

GDHPQQ

Food and Drug Administration

HBV HCV

hepatitis B virus hepatitis C virus

HH

inhibition of hemolysis

HIV

human immunodeficiency virus

IFA

immunofluorescence assay

IgA

immune globulin A

IgG

immune globulin G

IgM

immune globulin M

IQPP

International Quality Plasma Program

ITP

idiopathic thrombocytopenic purpura

PEI

Paul Ehrlich Institute International Units

IU

international unit

PI

prescribing information

IVIG

intravenous immune globulin

PID

primary immunodeficiency

PPV

porcine parvovirus

PRV

pseudorabies virus

KD

Kawasaki disease

MEV

mouse encephalomyelitis virus

RIA

radioimmunoassay

MMN

multifocal motor neuropathy

RSS

reduced space symbology

RT

room temperature

SBV

Sindbis virus

SD

solvent detergent

SQ

subcutaneous

MMV

NA

mouse minute virus (model for non-lipid DNA virus) information not available

NaCl

sodium chloride

NDC

National Drug Code

NS

normal saline

NT

SV40 simian virus

PEG

TSE

transmissible spongiform encephalopathies

neutralization test

UIN

unique identifier number

polyethylene glycol

VZV

varicella zoster virus

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Table 1. Therapeutic Considerations FDAApproved Indications

pH (after reconstitution)

Halflife, db

Pathogen Inactivation/Removal

Plasmapheresis, US donors

30

Precipitation and removal of fraction III from resuspended fraction II+III, SD, 35 nm filtration

6.4-6.8

Plasmapheresis, US donors (>16,000)

23

pH 4.0/pepsin, nanofiltration, TSE removal

PID

<3.2 5.6±0.1 mcg/mLc,d (5%)c,d 5.5±0 (10%)c,d

US source IQPPcertified plasma from FDA-registered sites

4-week dosing: 32±5 (5%) 37±13 (10%)

Pasteurization (60°C, 10 h), SD, 20 nm nanofiltration, fraction I precipitation, fraction II+III incubation, PEG precipitation, acid treatment, TSE removal

Baxter Healthcare Corp Direct inquiries: (800) 423-2090 www.baxter.com

MMN, PID

37 mcg/mL

4.6-5.1

Plasma from FDAregistered sites

35

SD, low pH, nanofiltration

Gammagard S/D 5%

Baxter Healthcare Corp Direct inquiries: (800) 423-2090 www.baxter.com

CLL, ITP, KD, PID

<1 mcg/mLe

6.4-7.2

Plasmapheresis, 10,000 donors

37.7±15

SD

Gammaked 10%

Manufactured by Grifols Therapeutics Inc for Kedrion Biopharma Customer service/medical info: (855) 353-7466; www.gammaked. com; www.kedrion.com

CIDP, ITP, PIDf

47±13 4.0-4.5c,d mcg/mLc,d

US source IQPPcertified plasma from FDA-registered sites

35

Caprylate precipitation/depth filtration, caprylate incubation, depth filtration, column chromatography, low pH incubation, TSE removal

Gammaplex 5%

Bio Products Laboratory Customer service: (800) 843-7477 http://www.gammaplex.com

ITP, PID

<10 mcg/mL

U.S. source plasma from FDAregistered sites

4-week dosing: 41±14

SD, nanofiltration, terminal low pH incubation

Gamunex-C 10%

Grifols Therapeutics Inc Customer service: (800) 243-4153 Medical info: (800) 520-2807 www.gamunex-c.com

CIDP, ITP, PIDf

51±1.4 4.0-4.5c,d mcg/mLc,d

US source IQPP-certified plasma from FDAregistered sites

35

Caprylate precipitation/depth filtration, caprylate incubation, depth filtration, column chromatography, low pH incubation, TSE removal

Hizentra 20%

CSL Behring Customer service: (800) 683-1288 Medical info: (800) 504-5434 www.cslbehring.com www.hizentra.com

PID

≤50 mcg/mL

4.6-5.2

Plasmapheresis, US donors

NA

pH 4.0 incubation, nanofiltration, depth filtration, virus filtration, TSE reduction

Hyqvia (IgG 10% + HY 5%)

Baxter Healthcare Corp Direct inquiries: (800) 423-2090 www.baxter.com

PID

37 mcg/mL

4.6-5.1

Plasma from FDAregistered sites

35

SD, low pH, nanofiltration

Octagam 5%

Octapharma USA Customer service: (866) 766-4860 www.octapharma.com

PID

<200 mcg/mLg

5.1-6.0

US source and recovered plasma from FDA-registered sites

40

Cold ethanol, pH 4.0 incubation, SD

Octagam 10%

Octapharma USA Customer service: (866) 766-4860 www.octapharma.com

Chronic ITP 106 mcg/mL

4.5-5.0

US source and recovered plasma from FDAregistered sites

36-40

Cold ethanol, pH 4.0 incubation, SD

Privigen 10%

CSL Behring Customer service: (800) 683-1288 Medical info: (800) 504-5434 www.cslbehring.com; www.privigen.com

ITP, PID

4.6-5.0

Plasmapheresis, US donors (≥60,000)

36.6

pH 4.0 incubation, 20 nm virus filtration, depth filtration, TSE removal

IgA Content

Producta

Manufacturer

Bivigam 10%

Biotest Pharmaceuticals Medical info: (800) 458-4244 www.biotestpharma.com www.bivigam.com

PID

≤200 mcg/mL

4.0-4.6

Carimune NF

CSL Behring Customer service: (800) 683-1288 Medical info: (800) 504-5434 www.cslbehring.com

ITP, PID

1,0002,000 mcg/mL (6%)

Flebogamma 5% DIF Flebogamma 10% DIF

Instituto Grifols SA Barcelona, Spain Customer service: (888) GRIFOLS www.grifols.com

Gammagard Liquid 10%

Key on page 13. Footnotes on page 17.

≤25 mcg/mL

4.8-5.1

Plasma Source

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IgG Subclass,c %

Streptococcus pneumoniaec

HAVc

HBV (Surface Antibody)c

Herpes Simplex Type 1c

Type 1

Type 3

Haemophilus influenzae Type Bc

18.2 IU/mL

NA

NA

NA

NA

NA

NA

17 IU/mL

NA

Type 1: 0.99 x Ref (176)

2.8

3.6 IU/mL (NT)

313 (EIA)

180 (EIA)

1:60 (CF)

300 IU/mL (HAI)

1:512 (IFA); 1:2,560 (EIA)

1:348 (RIA)

1:64 (RIA)

1:128 (CF)

1:64 (NT)

2.7 (5%) 3.0 (10%)

2.2 (5%) 2.5 (10%)

7.0±1.0 IU/mL (5%); 13.7±1.4 IU/mL (10%)

NA

NA

15±1 mg/L (5%)

NA

30±6 PEI U/mL (5%); 36±7 IU/mL (10%)

21±4 IU/ mL (5%)

88.0±41.8 NA IU/g Ig (5%); 80.7±23.0 IU/g Ig (10%)

60.9 32.1

5

2.1

4.0 U/mL (NT)

NA

21.2 mcg/mL (EIA)

1:2,320 (EIA)

NA

68 PEI U/mL (EIA)

16.4 IU/mL (RIA)

≥0.20 IU/mL (EIA)

VZV: 32 U/mL (NT)

Type 1: 1:190 mIU/mL (NT)

67

25

5

3

2-5 IU/mL (NT); J5 lipid A 1:273

17.5 mcgAbN/ mL (EIA)

8.5 mcg/mL (EIA)

11 mcg/mL (EIA)

1,150 IU (HH)

37 PEI 1:267 mcg/mL (RIA) (EIA), 1:2,480 (NT)

820 mIU/mL (RIA)

1:1,000 (EIA)

1:305 (NT)

62.8

29.7

4.8

2.7

7±2 AU/mL

87.4±22.2 mcg/mL

26.1±7.7 mcg/mL

13.0±2.4 mcg/mL

16,846± 13,648 Todd U/mL

57 PEI U/mL

1:139

65±19 IU/g Ig

NA

1:22±0.35

64

30

5

1

2.2 IU/mL

2.3 mcg/mL

NA

791 mcg/mL

185 IU/mL

431 U/mL

20 IU/mL

4.7 IU/mL 5,129 AU/mL

NA

62.8

29.7

4.8

2.7

7±2 AU/mL

87.4±22.2 mcg/mL

26.1±7.7 mcg/mL

13.0±2.4 mcg/mL

16,846± 13,648 Todd U/mL

57 PEI U/mL

1:139

65±19 IU/g Ig

NA

1:22±0.35

68.7

26.6

2.7

2

≥2.5 IU/mL

NA

NA

NA

≥1,000 IU/mL

NA

NA

≥0.4 IU/mL

NA

NA

60.9 32.1

5

2.1

4.0 U/mL (NT)

NA

21.2 mcg/mL (EIA)

1:2,320 (EIA)

NA

68 PEI U/mL (EIA)

16.4 IU/mL (RIA)

≥0.20 IU/mL (EIA)

VZV: 32 U/mL (NT)

Type 1: 1:190 mIU/mL (NT)

65

30

3

2

5-30 IU/mL

NA

NA

NA

600800 IU/mL

33-40 IU/mL

21-25 IU/mL

51 IU/g

1:8,192

1:160-1:320 (NT)

65

30

3

2

67.8

28.7

2.3

1.2

4.9 (3.8-7.3) IU/mL

NA

NA

36.1 (26.4-45.0) IU/mL

1,746 (1,3102,010) IU/mL

76.4 (51.2-116.8) IU/mL

NA

5.3 (3.0-10.1) IU/mL

NA

NA

IgG1 IgG2

IgG3

IgG4

Diphtheria Toxinc

62.5

6

1.4

60.5 30.2

6.6

66.6 28.5 (5%) 27.9 (10%)

30.1

Streptolysin Oc

CMVc

Polio Type 2c

NA

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Table 2. Pharmaceutical Considerations

Producta

Method of Preparation h

Available Dosing Forms

Form

Gamma Globulin, %

Monomers, %

Bivigam 10%

Cohn-Oncley, cold ethanol fractionation, SD

IV

Liquid

≥96

100 monomers + dimers

Carimune NF

Kistler-Nitschmann,h pH 4.0 + trace pepsin, nanofiltration

IV

Lyophilized

≥96

92

Flebogamma 5% DIF Flebogamma 10% DIF

Cohn-Oncley,h ion-exchange chromatography, acid pH treatment, PEG precipitation, SD, pasteurization, dual nanofiltration (35+20 nm)

IV

Liquid

≥99c,d

>99.95 monomers + dimers (5%)c,d >99.89 monomers + dimers (10%)c,d

Gammagard Liquid 10%

Cohn-Oncley,h anion-exchange chromatography, SD, nanofiltration, ultrafiltration, low pH incubation

IV, SQ (SQ for PID only)

Liquid

≥98

≥95 monomers + dimers

Gammagard S/D 5%

Cohn-Oncley,h ultrafiltration, anion-exchange chromatography, SD

IV

Lyophilized

≥90

96.4

Gammaked 10%

Cold ethanol fractionation, anion-exchange chromatography, caprylate chromatography purified, low pH incubation

IV, SQ (SQ for PID only)

Liquid

100

100 monomers + dimersc,d

Gammaplex 5%

Cold ethanol fractionation, ion-exchange chromatography, SD, nanofiltration (20 nm), ultrafiltration, terminal low pH incubation

IV

Liquid

>99

≥99 monomers + dimers

Gamunex-C 10%

Cold ethanol fractionation, anion-exchange chromatography, caprylate chromatography purified, low pH incubation

IV, SQ (SQ for PID only)

Liquid

100

100 monomers + dimersc,d

Hizentra 20%

Cold ethanol fractionation, anion-exchange chromatography, octanoic acid fractionation, pH 4.0 incubation, depth filtration, nanofiltration (20 nm)

SQ

Liquid

≥98

≥90 monomers + dimers

Hyqvia (IgG 10% + HY 5%)

Cohn-Oncley,h anion-exchange chromatography, SD, nanofiltration, ultrafiltration, low pH incubation

SQ

Liquid

≥98

≥95 monomers + dimers

Octagam 5%

Cold ethanol fractionation, ultrafiltration, chromatography, SD, pH 4.0 incubation

IV

Liquid

≥96

≥90 monomers + dimers

Octagam 10%

Cold ethanol fractionation, ultrafiltration, chromatography, SD, pH 4.0 incubation

IV

Liquid

≥96

≥94 monomers + dimers

Privigen 10%

Cold ethanol fractionation, octanoic acid fractionation, anion-exchange chromatography, pH 4.0 incubation, depth filtration, nanofiltration (20 nm)

IV

Liquid

≥98

≥98 monomers + dimers

Key on page 13. Footnotes on page 17.

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IgM Content

Albumin

PEG

Sodium Content

Stabilizer

Osmolality/Osmolarity

2.3 mcg/mL

<0.5%

NA

100-140 mEq/L

Glycine

≤510 mOsm/kg

Trace

0

0

0% water, 0.9% NS

5% sucrose

In sterile water: 3%, 192 mOsm/kg; 6%, 384 mOsm/kg; 12%, 768 mOsm/kg In NS: 3%, 498 mOsm/kg; 6%, 690 mOsm/kg; 12%, 1,074 mOsm/kg

Trace

<2 mcg/mL (5%)c,d <5 mcg/mL (10%)c,d

Not detectable

Trace (<3.2 mEq/L)c,d

5% sorbitol (polyol)

326±5.1 mOsm/kg (5%)c,d 343±6.1 mOsm/kg (10%)c,d

Trace

NA

Not detectable

No sodium added

Glycine

240-300 mOsm/kg

Trace

<3 mg/mL

<2 mg/mL

0.85%

2% glucose, glycine

636 mOsm/L (5%), 1,250 mOsm/L (10%)i

Trace

<2 mcg/mLc,d

0

Trace (<7 mEq/L)c,d

Glycine

264±3 mOsm/kgc,d

<0.02 mcg/mLj

0j

0j

30-50 mEq/L

Sorbitol, glycine, and polysorbate 80

420-500 mOsm/kg, but not less than 240 mOsm/kg

Trace

<2 mcg/mLc,d

0

Trace (<7 mEq/L)c,d

Glycine

264±3 mOsm/kgc,d

Trace

≤2 mcg/mL

NA

Trace

Proline

380 mOsm/kg

Trace

NA

Not detectable

No sodium added

Glycine

240-300 mOsm/kg

≤0.1 mg/mL

0

0

≤30 mmol/L

10% Maltosek

310-380 mOsm/kg

<106 mcg/mL

0

0

≤30 mmol/L

Maltose (90 mg/mL)

310-380 mOsm/kg

3 mg/L

Trace

0

Trace

Proline

240-440 mOsm/kg

FOOTNOTES a

All agents are contraindicated for IgA deficiency with antibodies to IgA.

b

Varies with disease state, immune status, and age of the patient.

c

Average of sample lots.

d

Data on file at Grifols.

e

As of Dec. 2012, Baxter has discontinued Gammagard S/D 5%; the low IgA product will remain available for patients with known reactions to IgA or IgA deficiency with antibodies; all Gammagard S/D will be manufactured with IgA <1; special request only.

f

DO NOT USE Gammaked or Gamunex-C subcutaneously for ITP or CIDP.

g

With additional purification steps added

in 2010, current release lots contain <100 mcg/mL. Data on file at Octapharma. h

Cohn-Oncley is the original method of cold ethanol fractionation; Kistler-Nitschmann is the specific cold ethanol fractionation method used by the manufacturer (CSL Behring).

i

Limit infusion rate to <3.3 mg IgG/kg per minute (2 mL/kg/h) for 10% solutions.

j

Data on file at Bio Products Laboratory.

k

Maltose does not significantly affect serum glucose or insulin levels and can be safely administered to diabetic patients. Certain BGMS falsely interpret maltose, icodextrin, galactose, and xylose as glucose and can

l

provide falsely elevated glucose readings.

If insulin is administered as a result of these readings, hypoglycemia can occur. The BGMS that use test strips containing GDH-PQQ and GDO can provide these false readings. See PI for full details.

or stopping the infusion usually allows the symptoms to disappear promptly. p

Unless specific compatibility information is available, do not mix with other drugs or solutions.

Under appropriate storage conditions.

q

Patients at high risk for thromboembolic events include patients who are elderly, overweight, or immobilized; patients with a history of hypertension, cardiovascular disease, or thrombotic disorders; and those who are >65 or dehydrated.

r

Log reduction factor values obtained from those listed in the PI; most are available on respective websites.

s

Data on file at Octapharma.

m Must be used within 3 mo after removal from refrigerator to room temperature or less if expiration date is shorter. n

o

Some infusion rates were converted from those listed in the PI for consistency and reader convenience.

Certain severe adverse drug reactions may be related to the rate of infusion. Slowing

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Table 3. Cost Consideration Criteria Producta

Supply

Storagel

Distribution

Return Policy Warranty

Packaging or Labeling Enhancements

Bivigam 10%

5, 10 g

2°C-8°C, 24 mo; do not freeze

Wholesaler or direct

Shipping error; defective or damaged product; no out-of-date products

Tamper-evident seal, peel-off label with name, latex-free packaging, lot number, expiration date

Carimune NF

3, 6, 12 g

≤30°C, 24 mo

Wholesaler or direct

Shipping error; defective or damaged product; no out-of-date products

Tamper-evident seal, RSS barcode, peel-off label with lot number, expiration date

Flebogamma 5% DIF Flebogamma 10% DIF

2.5, 5, 10, 20 g (5%); 5, 10, 20 g (10%)

2°C-25°C, 24 mo; do not freeze

Wholesaler or direct

Shipping error; defective or damaged product; no out-of-date products

Tamper-evident seal with hologram, prior handling recognition, integral suspension band, laser-etched vials with UIN, barcode, peel-off label with product lot number

Gammagard Liquid 10%

1, 2.5, 5, 10, 20, 30 g

2°C-8°C, 36 mo; ≤25°C, 24 mo; do not freeze

Wholesaler or direct

No

Latex-free packaging, tamper-evident cap, RSS barcode, peel-off label with lot number, expiration date

Gammagard S/D 5%

2.5, 5, 10 g

≤25°C, 24 mo; do not freeze

Wholesaler or direct

No

Tamper-evident cap, peel-off label with lot number, expiration date

Gammaked 10%

1, 2.5, 5, 10, 20 g

2°C-8°C, 36 mo; ≤25°C, 6 mo; do not freeze

Wholesaler

Shipping error; defective or damaged product; no out-of-date products

Tamper-evident cap, laser-etched vials with UIN, NDC barcode, integral suspension band on larger vial sizes, peel-off label with product lot number, vial stopper not made with natural rubber latex

Gammaplex 5%

5, 10, 20 g

2°C-25°C, 24 mo; do not freeze

Wholesaler

Shipping error; defective or damaged product; no out-of-date products

Latex-free, single-use vial, tamper-evident cap, peeloff label with lot number, expiration date

Gamunex-C 10%

1, 2.5, 5, 10, 20 g

2°C-8°C, 36 mo; ≤25°C, 6 mo; do not freeze

Wholesaler or direct

Shipping error; defective or damaged product; no out-of-date products

Tamper-evident cap, laser-etched vials with UIN, NDC barcode, integral suspension band on larger vial sizes, peel-off label with product lot number, vial stopper not made with natural rubber latex

Hizentra 20%

1, 2, 4, 10 g

≤25°C, 30 mo

Wholesaler or direct

Shipping error; defective or damaged product; no out-of-date products

Latex-free packaging, single-use tamper-evident vials, peel-off label with lot number, expiration date

Hyqvia (IgG 10% + HY 5%)

2.5, 5, 10, 20, 30 g

2°C-8°C, 36 mo; do not freezem

Wholesaler or direct

NO

Latex-free packaging, tamper-evident cap, RSS bar code, peel-off label with lot number, expiration date.

Octagam 5%

1, 2.5, 5, 10, 25 g

2°C-25°C, 24 mo; do not freeze

Wholesaler or direct

Shipping error; defective or damaged product; no out-of-date products

Tamper-evident, latex-free packaging, peel-off label with lot number, expiration date

Octagam 10%

2, 5, 10, 20 g

2°C-8°C, 24 mo; ≤25°C, 6 mo; do not freeze

Wholesaler or direct

Shipping error; defective or damaged product; no out-of-date products

Tamper-evident, latex-free packaging, peel-off label with lot number, expiration date

Privigen 10%

5, 10, 20 g

≤25°C, 36 mo

Wholesaler or direct

Shipping error; defective or damaged product; no out-of-date products

Latex-free, single-use vial, tamper-evident seal, RSS barcode, peel-off label with lot number, expiration date

Table 4. IVIG Infusion Ratesn Initial Infusion Rate

Maintenance Infusion Rate

Maximum Infusion Rateo

Bivigam 10%

0.3 mL/kg/h for 10 min

Increase by 0.48 mL/ kg/h every 20 min if tolerated, up to 3.6 mL/kg/h

3.6 mL/kg/h

No filter required; for patients at risk for renal dysfunction or failure, administer at the minimum dose recommended and the minimum infusion rate practicableq

Carimune NF 3%-12%

0.48 mL/ kg/h

1-2 mL/kg/h

3 mL/kg/h

Reconstitution time is several minutes; no filter required; compatible with NaCl, D5W; increased risk for renal and thrombotic adverse effectsq

Flebogamma 5% DIF Flebogamma 10% DIF

0.6 mL/kg/h

Increase gradually as tolerated to 6 mL/kg/h (5%), 4.8 mL/kg/h (10%)

6 mL/kg/h (5%), 4.8 mL/ kg/h (10%)

No filter required; administer at the minimum infusion rate practical to patients >65 and those at risk for renal failure or thrombotic eventsq

Gammagard Liquid 10%

0.5 mL/kg/h for 30 min (PID)

Increase every 30 min if tolerated, up to 5 mL/kg/h (PID)

5 mL/kg/h (PID)

No filter required; patients at risk for renal dysfunction or thrombotic events should be gradually titrated up to a more conservative maximum rate <2 mL/kg/hq

IVIGa

Key on page 13. Footnotes on page 17.

Commentsp

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Table 4. IVIG Infusion Ratesn Initial Infusion Rate

Maintenance Infusion Rate

Maximum Infusion Rateo

Gammagard S/D 5%

0.5 mL/kg/h for 30 min

Increase gradually as tolerated to 4 mL/kg/h

4 mL/kg/h (5%)

Reconstitution time is <5 min at RT and >20 min if cold; 15-micron filter required and supplied with administration set; compatible with sterile water

Gammaked 10%

0.6 mL/kg/h, 1.2 mL/kg/h (CIDP)

Increase gradually as tolerated to 4.8 mL/kg/h

4.8 mL/kg/h

No filter required; do not dilute with NaCl, but NaCl flush is fine; incompatible with heparin (refer to full PI for details); administer at minimum infusion rate practical to patients >65 or at risk for renal or thrombotic eventsq

Gammaplex 5%

0.6 mL/kg/h, for 15 min

Increase gradually as tolerated every 15 min to 4.8 mL/kg/h

4.8 mL/kg/h

15- to 20-micron in-line filter recommended; ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue Gammaplex if renal function deteriorates; administer at minimum infusion rate practical to patients at risk for renal dysfunction or thrombotic eventsq

Gamunex-C 10%

0.6 mL/kg/h, 1.2 mL/kg/h (CIDP)

Increase gradually as tolerated to 4.8 mL/kg/h

4.8 mL/kg/h

No filter required; do not dilute with NaCl, but NaCl flush is fine; incompatible with heparin (refer to full PI for details); administer at minimum infusion rate practical to patients >65 or at risk for renal or thrombotic eventsq

Octagam 5%

0.6 mL/kg/h for 30 min

1.2 mL/kg/h for 30 min, then 2.4 mL/kg/h for 30 min, then as tolerated, up to maximum rate

<4.2 mL/kg/h

No filter required or supplied; if an in-line filter is used, the pore size should be 0.2-200 microns; for patients at risk for renal dysfunction or thrombotic events, administer at the minimum infusion rate practical, not to exceed 0.07 mL/kg/minq

Octagam 10%

0.01 mL/kg/ min for 30 min

Increase gradually as tolerated every 30 min to: 0.12 mL/kg/min

≤0.12 mL/kg/ min

No filter required or supplied; if an in-line filter is used, the pore size should be 0.2-200 microns; for patients at risk for renal dysfunction or thrombotic events, administer at the minimum infusion rate practical, not to exceed 0.03 mL/kg/minq

Privigen 10%

0.3 mL/kg/h

As tolerated, up to max- 2.4 mL/kg/h imum recommended rate (ITP), 4.8 mL/ kg/h (PID)

IVIGa

Commentsp

No filter required; administer at minimum infusion rate practical to patients at risk for renal dysfunction or thrombotic eventsq

Table 5. Log Reduction Factor Comparisonsr Enveloped Viruses HIV Producta

Models for HCV

Model for Large DNA

SBV

BVDV

PRV

Nonenveloped Virus

TSE (Prion)

Bivigam 10%

>9.62

>7.11

>11.79

>8.65

5.29 (MEV), 6.18 (BPV), 4.0 (PPV), 7.02 (SV40)

NA

Carimune NF

≥26

≥19

≥9

≥25

≥19 (BEV)

NA

Flebogamma 5% DIF, 10% DIF

≥25.11

≥6.49

≥21.28

≥27.78

≥15.04 (PPV), ≥19.25 (EMCV)

≥11.64

Gammagard Liquid 10%

>14.8

NA

>16.8

>16.9

>5.7 (HAV), >7.7 (EMCV), >5.1 (MMV)

NA

Gammagard S/D 5%

>15 (HIV-1) NA

>7.5

>9.3

>5.2 (HAV), >5.0 (EMCV), >5.3 (MMV)

NA

Gammaked 10%

≥14

NA

≥16.3

≥12.2

≥5.0 (HAV), 8.2 (PPV)

≥6.6

Gammaplex 5%

>12.9

>20.2

>11.7

NA

>5.9 (HAV), >7.5 (EMCV)

NA

Gamunex-C 10%

≥14

NA

≥16.3

≥12.2

≥5.0 (HAV)

≥6.6

Hizentra 20%

≥16.0

NA

≥11.8

≥17.7

≥9.6 (EMCV), ≥7.8 (MMV)

≥14.8

Hyqvia

>14.8

NA

≥16.8

>16.9

5.7 (HAV), >7.7 (EMCV), 5.1 (MMV)

NA

Octagam 5%

≥14.6

≥16.7

NA

≥16.1

≥9.5 (MEV), ≥7.7 (PPV)

≥6.7s

Octagam 10%

≥14.7

≥20.61

NA

≥18.22

≥20.20 (MEV), ≥6.53 (PPV)

NA

Privigen 10%

≥16.0

NA

≥11.8

≥17.7

≥9.6 (EMCV), ≥7.8 (MMV)

≥14.8

20 Clinical

Pharmacy Practice News • January 2015

Ambulatory Pharmacy

READMISSIONS continued from page 1

[this] also means that other institutions can adopt their model,” said Dr. Reidt, an ambulatory care clinical pharmacist at Hennepin County Medical Center in Minneapolis. Dr. Reidt was not involved in the project.

A Team Approach The research team included pharmacists, physicians, care managers, clinic support staff, management and quality improvement representatives at UNC’s internal medicine clinic, noted Jamie Cavanaugh, PharmD, an assistant professor of clinical education at the university’s Eshelman School of Pharmacy, in Chapel Hill.

Dr. Cavanaugh worked with the team to develop a standardized series of interventions, using a guide issued by the Institute for Healthcare Improvement on the prevention of avoidable rehospitalizations (available at http:// goo.gl/i5bF2q).

As part of the intervention they ultimately carved out, pharmacists provide medication management counseling, conduct medication reconciliation, identify barriers to care and available support services, and provide after-visit summaries, among other components.

Patient Education Educating patients about their medications is another important element of the visit, Dr. Cavanaugh said. “We use a teach-back technique, where we ask patients to repeat back to us what we’ve shared with them, so that we can correct any misunderstandings or gaps in knowledge,” she explained.

The 60-minute appointments also include a 20-minute meeting with an attending physician, who conducts physical examinations, diagnoses any new medical problems and reviews treatment goals with the patient. A social worker also participates in the appointment, when necessary.

“The central goal of the program is to provide follow-up care in the clinic within one week of discharge to those patients who are most unstable after discharge, so that we can preempt a possible decision to visit the hospital,” Dr. Cavanaugh said.

During a two-month pilot study of the initiative in 2012, the clinic’s care manager enrolled 52 recently discharged patients who were deemed to be at risk for 30-day readmission and invited them to attend an appointment at the internal medicine clinic.

Approximately one-fourth of the patients were considered to be at moderate to high risk for rehospitalization. “High risk” was defined as having three or more chronic disease states or

BEFORE VISIT • Review discharge summary

‘The central goal of the program is to provide follow-up care in the clinic within one week of discharge to those patients who are most unstable … so that we can preempt a possible decision to visit the hospital.’

• Contact primary care provider • Contact home health (as appropriate) • Review pending tests from discharge

—Jamie Cavanaugh, PharmD

• Start medication reconciliation • Identify patient goals for the visit • Gather patient reported factors contributing to admission or emergency department visit • Complete thorough medication review and education • Identify barriers to care

DURING THE VISIT • Complete medical interventions (appropriate to discharge conditions and chronic conditions) • Discuss goals of care • Update demographic information • Obtain social history • Order labs • Complete home health referral (as appropriate) • Review medication changes • Review self-management instructions using teach back • Provide visit summary

$1.1 Million in Savings Using the findings and Medicare data on average hospitalization costs, Dr. Cavanaugh said the intervention can prevent 102 hospitalizations annually, translating to an approximate $1.1 million in annual cost savings.

“After we demonstrated the success of the program, institution leadership asked pharmacy to implement similar initiatives [in other areas of specialty care], including ambulatory cardiology and clinics,” Dr. Cavanaugh noted. She said preliminary data from the family medicine clinic indicated that 30-day readmission rates among patients participating in the initiative were approximately 6.5%, compared with 20% among clinic patients receiving usual care. She also said her team has not formally studied the ongoing effect of the intervention at her internal medicine clinic, but data are monitored internally and indicate the intervention’s continued efficacy.

• Arrange follow-up

An Interprofessional Approach

AFTER THE VISIT • Complete referrals (as appropriate) • Complete documentation

three or more hospitalizations within the past year, as well as use of at least 10 medications. The most common diagnoses were hypertension, chronic obstructive pulmonary disease or asthma, diabetes, coronary artery disease and heart failure.

According to Dr. Cavanaugh, during the two-month period, 9% and 19% of patients who participated in the initia-

tive were readmitted to the hospital within 30 and 90 days of discharge, respectively. In contrast, 26% and 44% of 52 similar patients who were monitored during the same period and did not participate in the initiative were hospitalized within 30 and 90 days of discharge, respectively ((P<0.05 for intervention vs. usual care, for both 30 and 90 days).

Dr. Reidt believes the “comprehensive and interprofessional approach to managing care transitions” is key to the UNC program’s success. She pointed out that the approach considers a spectrum of variables that might affect a patient’s post-discharge care and outcomes. “For example, as part of the program, a care manager contacts the patient to assist with transportation to the clinic and to address any other barriers to them attending their appointment,” she said. “And, in addition to reviewing their medications, a clinical pharmacist practitioner assists patients with home health referrals.

“Other institutions can learn a lot from UNC’s experience,” Dr, Reidt said.

—David Wild Drs. Reidt and Cavanaugh reported no relevant financial conflicts of interest.

Proven efficacy in 3 FDA-approved indications

CIDP • PI • ITP

CIDP chronic inflammatory demyelinating polyneuropathy* PI primary immunodeficiency ITP idiopathic thrombocytopenic purpura

10% IGIV liquid solution • Sucrose-free • Ready-to-infuse • Subcutaneous dosing for PI indication •

GAMMAKED properties1:

Storage & Handling:

> > > > > >

> > > > >

No sugar Only trace amounts of sodium Close to physiologic osmolality Optimal pH Low infusion volume Trace amounts of IgA

Built-in hanger on 5 g, 10 g, 20 g vials Long 3-year shelf life; room temperature storage** Latex-free 5 color-coded package sizes with barcoding Peel-off labels to simplify recordkeeping ** Up to 6 months at any time during 36-month shelf life

* GAMMAKED is indicated for the treatment of CIDP to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.

WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE See full prescribing information for complete boxed warning.

Thrombosis may occur with immune globulin products, • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous including GAMMAKED. Risk factors may include: advanced (IGIV) products in predisposed patients. age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, • Renal dysfunction and acute renal failure occur more comindwelling vascular catheters, hyperviscosity, and cardiomonly with IGIV products containing sucrose. GAMMAKED vascular risk factors. Thrombosis may occur in the absence does not contain sucrose. of known risk factors.

• For patients at risk of renal dysfunction or failure, administer • For patients at risk of thrombosis, administer GAMMAKED GAMMAKED at the minimum concentration available and at the minimum dose and infusion rate practicable. Ensure the minimum infusion rate practicable. (Refer to section 5.2 adequate hydration in patients before administration. Moniof the Full Prescribing Information). tor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

•

References: 1. GAMMAKED [prescribing information]. 2013.

Please see next page for Brief Summary of GAMMAKED Product Information.

For Full Prescribing Information, please visit www.gammaked.com ©Kedrion Biopharma, Inc. All Rights Reserved. Printed in USA December 2014 GM-0080-01-2014

•

•

HIGHLIGHTS OF THE PRESCRIBING INFORMATION These highlights do not include all the information needed to use GAMMAKEDTM safely and effectively. See full prescribing information for GAMMAKED.

•

•

GAMMAKED, [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified] Initial U.S. Approval: 2003

WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE. See full prescribing information for complete boxed warning.

• Thrombosis may occur with immune globulin products, including GAMMAKED. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.

• For patients at risk of thrombosis, administer GAMMAKED at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

• Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients.

• Renal dysfunction and acute renal failure occur more commonly with IGIV products containing sucrose. GAMMAKED does not contain sucrose.

• For patients at risk of renal dysfunction or failure, administer GAMMAKED at the minimum concentration available and the minimum infusion rate practicable. (Refer to section 5.2 of the Full Prescribing Information).

•

• • •

•

•

- - - - - - - - - - - - - - - - - - - ADVERSE REACTIONS - - - - - - - - - - - - - - - - - Serious adverse reactions which occurred in the clinical trials were an exacerbation of autoimmune pure red cell aplasia in one subject and pulmonary embolism in one subject with a history of PE. The most common adverse reactions observed in ≥5% patients were: PI: Intravenous: Headache, cough, injection site reaction, nausea, pharyngitis and urticaria.

Subcutaneous: Infusion site reactions, headache, fatigue, arthralgia and pyrexia.

ITP: Headache, vomiting, fever, nausea, back pain and rash.

CIDP: Headache, fever, chills, hypertension, rash, nausea and asthenia.

To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics Inc. at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

- - - - - - - - - - - - - - - - - - - DRUG INTERACTIONS - - - - - - - - - - - - - - - - - -

- - - - - - - - - - - - - - - - - - INDICATIONS AND USAGE - - - - - - - - - - - - - - - - - GAMMAKED is an immune globulin injection (human) 10% liquid indicated for treatment of: • Primary Humoral Immunodeficiency (PI) • Idiopathic Thrombocytopenic Purpura (ITP) • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

- - - - - - - - - - - - - - - - - - - CONTRAINDICATIONS - - - - - - - - - - - - - - - - - - - • •

Anaphylactic or severe systemic reactions to human immunoglobulin IgA deficient patients with antibodies against IgA and a history of hypersensitivity

Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of developing acute renal failure.

Hyperproteinemia, with resultant changes in serum viscosity and electrolyte imbalances may occur in patients receiving IGIV therapy.

Thrombosis has occurred in patients receiving IGIV therapy. Monitor patients with known risk factors for thrombosis; consider baseline assessment of blood viscosity for those at risk of hyperviscosity.

Aseptic Meningitis Syndrome (AMS) has been reported with GAMMAKED and other IGIV treatments, especially with high doses or rapid infusion.

Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration. Monitor patients for hemolysis and hemolytic anemia.

Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).

Volume overload.

GAMMAKED is made from human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

GAMMAKED is not approved for subcutaneous use in ITP patients.

Due to a potential risk of hematoma formation, do not administer GAMMAKED subcutaneously in patients with ITP. Passive transfer of antibodies may confound serologic testing.

The passive transfer of antibodies may transiently interfere with the response to live viral vaccines, such as measles, mumps and rubella.

•

- - - - - - - - - - - - - - USE IN SPECIFIC POPULATIONS - - - - - - - - - - - - Pregnancy: No human or animal data. Use only if clearly needed.

• Geriatric: In patients over 65 years of age do not exceed the recommended dose, and infuse GAMMAKED at the minimum infusion rate practicable.

•

Visit www.gammaked.com for Full Prescribing Information

- - - - - - - - - - - - - - - - WARNINGS AND PRECAUTIONS -- - - - - - - - - - - - •

IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions.

Distributed by

Manufactured by Grifols Therapeutics Inc. Research Triangle Park, NC 27709 USA

400 Kelby Street, Fort Lee NJ 07024

Technology 23

Pharmacy Practice News • January 2015

Automation

Tech Tools Boost Success of Med Reconciliation Washington—Waiting-room kiosks, secure patient portals and regional health information exchanges are all technologies that the Veterans Health Administration (VA) has employed to boost the success of its medication reconciliation (MR) efforts at some of its hospitals.

In a panel presentation on innovative approaches to MR at the 2014 American Medical Informatics Association meeting, representatives from four VA medical centers presented the results of these pilot-project initiatives.

Computer Kiosk Approach The VA Portland Health Care System in Oregon has employed patient-centered technologies to improve medication history collection and discrepancy detection. “Medication reconciliation is only as strong as the medication history you collect,” said Blake Lesselroth, MD, the director of the Portland Patient Safety Center of Inquiry, a VA grant–funded organization that studies MR, and an associate professor of medicine and informatics at Oregon Health & Science University, also in Portland.

Borrowing an idea from airports, the hospital in 2007 set up a computer kiosk in outpatient waiting areas where patients could check in, swipe their patient identification card, and before seeing their provider, complete a medication history questionnaire. Dr. Lesselroth’s team saw this “as an opportunity to extend the meaningful time of the clinical encounter,” he said. “We can capture so much more valuable time in the waiting area that otherwise would not be available.” The kiosk questionnaire featured photos of medicines to improve patient recall and imported answers directly into the electronic medical record (EMR).

The kiosks were used for more than 100,000 clinical transactions.

Dr. Lesselroth’s team found that 85% of patients used it, completing sessions in about four minutes. The program helped detect an average of four medication discrepancies per patient.

Although patients with visual impairments or motor disabilities could not use the kiosks, in general, exit surveys showed that patients liked the process.

Specifically, 75% of surveyed patients said they thought the device was easy to use; 95% said the medical information was easy to understand; and 67% thought it improved their recall of medications. In the chemotherapy infusion suite, the kiosks helped providers identify about two medication discrepancies per patient, for drugs like anticonvulsants, anticoagulants and antiarrhythmics.

Inpatient clinical pharmacists at the VA Portland Health Care System in Oregon use a tablet-based approach to patient counseling and medication reconciliation.

The center has several strategies planned for the upcoming year, Dr. Lesselroth told Pharmacy Practice News, including working with the central VA office to improve on a computer tablet–based approach that proved to be a bit too time-consuming to use in early development; piloting MR technologies in an HIV primary care clinic; developing better strategies for inpatient implementation of the technologies; and conducting “usability” tests of the portable device with physicians, nurses and pharmacists to identify opportunities to improve workflow efficiency and technology value. For more information, see http://portlandpsci.wordpress.com.

EMR Fine-Tunes Process In Iowa City, Iowa, the VA Health Care System took part in a national study that sought to improve the MR process through a series of steps designed to boost the accuracy of medication histories obtained on admission. The quality improvement process also involved highlighting at discharge any changed, discontinued or new medications; educating the patient on discharge; and forwarding discharge medication lists to the next providers.

Peter Kaboli, MD, the chief of medicine for the VA and a professor of medicine at the University of Iowa Carver College of Medicine, in Iowa City, discussed lessons learned from an analysis of the initiative, known as MARQUIS. The project was assessed in a multicenter study funded by the Agency for Healthcare Research and Quality.

Within a group of six hospitals using four different EMR systems, project leaders identified physician and pharmacist mentors with quality improvement and medication safety experience, and local quality improvement teams, to work together to improve MR. The hospitals

participated in monthly calls, annual site visits and regular reviews of medication discrepancies found. Through a bundle of MR tools given to all hospitals, providers were taught how to take better medication histories, including accessing sources like patient medication lists and national sources like Surescripts, a network of pharmacies and hospitals that track prescription information.

The VA looked at all steps that happened before and after discharge, identifying problems with EMR documentation. Their seven-day delinquency rate for discharge summaries was 15%, and at the Sioux Falls VA, it was 35%. Additionally, patients were receiving as many as five medication lists at discharge. In a typical encounter, a physician would sign a final note with the medication list, and then if pharmacists corrected something during MR, they could not delete the old list and thus had to add another list. If the physician then realized some other MR issue arose, the only way to update was to add a third medication list, and so on. Nurses would cross out the old lists when handing patients their discharge instructions.

The VA also redesigned the discharge documentation process to work better within the confines of their EMR capabilities, and clarified roles so that nurses and pharmacists weren’t both doing MR. Now, the physician reviews medications, creates a final discharge medication list and signs the discharge instructions and summary. Then a pharmacist performs MR and discusses medication use with the patient. The pharmacist creates an addendum with medication instructions, any allergies and a list of all VA and non-VA medications. Finally, the nurse prints the discharge summary and instructions with a single medication list and gives it to the patient.

Delinquencies over seven days now average from zero to two per month, Dr. Kaboli said. These usually involve patients who die in the hospital because residents don’t realize that even deceased patients need a discharge summary. He and his team are working to revise the EMR for that.

“We’ve shown that we can implement medication reconciliation across relatively med rec–naive sites to improve processes of care and improve measurable potentially harmful discrepancies,” he said.

The VA version of MARQUIS is now being rolled out, he said. With a grant from the VA’s Office of Rural Health, they are hoping to implement it at additional sites.

The study’s free toolkit is available for downloading at www.hospitalmedicine.org/marquis.

In Boston, Focusing on Newly Discharged Patients The VA Boston Health Care System has focused its recent MR improvement efforts on promoting the safe use of medications prescribed to newly discharged patients. The VA’s quality improvement team decided to use secure patient portals as its preferred technology for accomplishing that goal, according to Steven Simon, MD, MPH, the section chief of general internal medicine for the VA and an associate professor of medicine at Boston’s Harvard Medical School.

Funded by the Center for Integration of Medicine and Innovative Technology (CIMIT) and the New England Veterans Engineering Resource Center, the VA piloted a program to test the patient portal approach, using secure messages for medication reminders. The VA designed a simple one-page document showing pictures of the medications and when to take them and had pharmacists email it to patients as a .pdf file through the hospital’s secure patient portal. Patients could open the file, print the document, fill out in marked spaces whether or not they were taking the medications as prescribed, and send it back.

Pharmacists could then review the document and express any concerns to the patient or physician by secure message or telephone, correct discrepancies and document them in the EMR, communicate with the primary care team if necessary, and send patients a final copy.

Sixty patients were recruited for the trial; 34 returned the document. The program identified 108 clinically significant medication discrepancies— approximately two per patient—and 23 potential adverse drug reactions. Of

•

see TECH TOOLS, page 27

24 Technology

Pharmacy Practice News • January 2015

Automation

ROBOTICS continued from page 1

A Welcome Upgrade When SBH’s board of directors decided to expand the Pharmacy Department, it was a welcomed upgrade, according to Morris Eng, RPh, who is the assistant director of pharmacy for finance, materials management and IT applications.

“We We were downstairs on the fifth floo or of the hospital paccked like

person could, explained Neils Erik Hansen, the president and CEO of Intelligent Hospital Systems. A self-contained glass housing with HEPA-filtered laminar airflow reduces the opportunity for contaminants to land on surfaces, while an ultraviolet light port disinfects each product. Photo and time-stamp product verification help ensure that the correct products at the correct dose are being compounded. RIVA’s USP Chapter compounde <797>–com mpliant technology processes ind dividual and batch doses, Mr. Hanseen added.

“The technician loads the raw medication in the vial, the syringes and the IV fluid bags, and fro om that point, everything is auto omated and taken care of

I’m going to have that drug there, and I am going to have the quantities that are needed for the number of patients that are on that floor.”

This perpetual inventory gives SBH greater control over the drug budget, according to Dr. Cassidy, which comes in handy because pharmacy drug spending typically increases every year—and in some years at a steeper than anticipated rate. “Because we monitored that inventory so closely, we actually reduced our inventory [spend] by $1 million,” she said.

When Dr. Cassidy reported the savings, the C-suite immediately wanted to

document significant “soft dollar” savings from the robotics initiative.

Other Tech Tools The IV robot isn’t the only pharmacy automation SBH rolled out to improve clinical care. The hospital also uses a database, Sentri-7, as a patient surveillance tool to detect potential medication errors early in the drug-ordering process and intervene as needed. For instance, the database tracks prothrombin time and international normalized ratio test results, which can be red flags for warfarin doses that are placing the patient at risk for excessive bleeds or clots. Blood cultures for infection, com mplete blood counts and other lab results also are

Photo os by MARIE ROSENTHAL

Inside the fully enclosed compounding chamber with HEPA-filtered laminar airflow, the RIVA robotic arm zips around picking up the medication in the bottle, taking steps, such as weighing it to assure it is correct, and extracts the specified amount into a syringe. After disinfecting the bag of IV fluid with high-intensity pulse-ultraviolet light, RIVA compounds the medication in the syringe with the IV fluid. RIVA can prepare up to 60 doses per hour.

sardines in a can,” he joked. The hospital moved the pharmacy to another floor and spent $10 million on the entire transformation.

“It was a big push by the board … to modernize, bringing our pharmacy into the state of the art, and RIVA was part of that process,” Mr. Eng said.

RIVA, a fully automated IV compounding system, puts a repeatable process in place that was previously done by an individual. The robot compounds medications and dispenses doses more safely, accurately and quickly than a

inside that box,” he said.

Additionally, the technology allows the pharmacy to track every drug, Dr. Cassidy explained. “From the time the physician orders and that order comes to pharmacy and the time it is administered to the patient, we know exactly what is happening with that drug because we track it every step of the way,” she said.

“If you happen to be on the fifth floor and you need this drug, I’m going to have that drug sitting there for the nurse when she needs it. If there is another patient on the fourth floor who needs another drug,

reduce pharmacy staff. But she pushed back and suggested that the pharmacists be redeployed to patient care areas. The goal of that strategy, she noted, was to improve several key clinical and financial outcomes, including a reduction in the hospital length of stay, 30-day readmissions and medical errors. Although data on those outcomes have not been compiled yet, Dr. Cassidy said she is confident she will eventually be able to

recorded in the database, along with any medications the patient is taking.

In the case of labs, “if [any values] go up a certain level, I intervene,” Dr.

•

see ROBOTICS, page 26

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26 Technology

Pharmacy Practice News â&#x20AC;˘ January 2015

Automation â&#x20AC;&#x2DC;An institution has a certain amount of capital [to spend], and the board of trustees wants to know why it should invest in you. Directors of pharmacy struggle with [explaining] the return on investment.â&#x20AC;&#x2122;

ROBOTICS continued from page 24

Cassidy said. â&#x20AC;&#x153;I make sure that I act and call the doctor and say, â&#x20AC;&#x2DC;We need you to decrease that dose.â&#x20AC;&#x2122;â&#x20AC;?

Robotic technology also can help streamline antibiotic stewardship efforts, she said. When the cultures come back, she can make antimicrobial recommendations based on the offending organism. â&#x20AC;&#x153;And it happens in real time. As soon as that culture hits the reporting mecha-

â&#x20AC;&#x201D;Ruth E. Cassidy, PharmD nism, I see it, so I can act [immediately]; Iâ&#x20AC;&#x2122;m not waiting three days,â&#x20AC;? she explained.

These types of interventions illustrate the value of retaining pharmacists and making them part of the patient

care team, Dr. Cassidy noted. â&#x20AC;&#x153;I donâ&#x20AC;&#x2122;t want to lose pharmacists,â&#x20AC;? she stressed. â&#x20AC;&#x153;I want to take them out of operations and put them up on the floors with the doctors where they are needed.â&#x20AC;?

This staffing strategy isnâ&#x20AC;&#x2122;t just good for the hospital and patients; itâ&#x20AC;&#x2122;s also good for the pharmacists, increasing their job satisfaction, Dr. Cassidy stressed. â&#x20AC;&#x153;Most pharmacists today go to school for six years and then do a two-year residency; they donâ&#x20AC;&#x2122;t want to [count pills] anymore,â&#x20AC;? she said. â&#x20AC;&#x153;They want to be talking to the doctors, and that is where you want them to make a difference and have [positive] outcomes.â&#x20AC;?

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The pharmacy technician collects the compounded IV bag, labeled and ready to be dispensed.

Dr. Cassidy admitted it could be difficult to translate that expertise into a financial benefit for the C-suite. However, if the collaboration between pharmacists, doctors and nurses does succeed in decreasing medication errors, hospital length of stay and 30-day readmissions, the hospital will see better reimbursements from Medicare, which can be evaluated and quantified, she pointed out.

Additionally, the pharmacy works closely with the manufacturers and the formulary committee to make sure that the most cost-effective options are being used by the hospital, according to Dr. Cassidy.

Automating the compounding process enabled Dr. Cassidy to redeploy her pharmacists, save money and improve patient careâ&#x20AC;&#x201D;three big wins for SBH and its patients. â&#x20AC;&#x201D;Marie Rosenthal

Technology 27

Pharmacy Practice News • January 2015

Automation

TECH TOOLS continued from page 23

the 60 patients recruited, nine were readmitted to the hospital within 30 days of discharge, the Boston VA’s average rate, and 90% of participants said they would use the document again.

The VA plans to launch a randomized controlled trial in 2015. “Our hope is that this is something patients will use and rely on,” Dr. Simon said.

But patient portals will not work for everyone, he said. Some patients have limited knowledge of computers and technology, or no access to computers.

Others fear they could lose in-person resources offered by the VA if they use more technology.

Those caveats aside, this continuityof-care approach to bolstering MR has great potential, Dr. Simon stressed.

“Medication safety is particularly important for [patients transitioning from the] hospital back at home,” he explained. In fact, MR should take place at every transition of care, he stressed: on admission, on discharge, during every outpatient visit and at every transition. But there is always some delay between hospital discharge and when a patient has a follow-up visit. Patients are discharged with a summary and new medications cleanly labeled but often return home to a stuffed medicine chest, and therefore may become confused, he pointed out.

Health Information Exchanges In the Bronx, the James J. Peters VA Medical Center is looking into how to use a regional health information exchange (RHIO), the Bronx RHIO, to improve MR, according to Kenneth Boockvar, MD, a professor of geriatrics and palliative medicine at the Icahn School of Medicine at Mount Sinai.

Nearly half (46%) of veterans use both VA and non-VA services, and “as providers and prescribers, we get frustrated that we don’t know about non-VA care unless hopefully a veteran tells us,” Dr. Boockvar said. Even then, he noted, there is often insufficient information on non–VA-prescribed medications.

His medical center has had a partnership with the Bronx RHIO, now funded by an innovation grant from the Centers for Medicare & Medicaid Services, since 2005. Through the RHIO, New York hospitals and other providers contribute patient data to a shared database if patients give consent. The Peters VA Medical Center set out to adapt its MR process to include info from the RHIO and test whether this adaptation enhanced care.

The VA team obtained consent from patients to pull their information from the Bronx RHIO. Then pharmacists conducted their standard MR with access to Bronx RHIO records. They documented

their findings and communicated with primary care teams if they found any risky discrepancies.

In a pilot study of 400 patients, about half had enhanced MR enabled by the RHIO. The RHIO contained information about non-VA inpatient medications for 23% of patients, about non-VA hospital discharge medications for 18%, and about

community pharmacy prescriptions for 19%. VA pharmacists identified an average of 1.2 discrepancies per patient, 32% with a potential for harm. For 5% of discrepancies, the RHIO was the only source to identify the discrepancy. Studies comparing these patients with those in a control group are still pending, Dr. Boockvar noted. The group identified some barriers to work through: Providers had to open the RHIO information separately from their own EMR, and some didn’t have passwords for the RHIO; some patients denied seeing non-VA providers for fear

of losing their VA services; and providers weren’t sure how to document RHIO information in their EMR. Nationally, the VA is working on a virtual lifetime electronic record to merge health information from VA and non-VA providers, noted Dr. Boockvar, who also is the associate director for research at the VA’s Geriatrics Research, Education, and Clinical Centers. Veterans can sign up at http://www.va.gov/vler.

—Karen Blum The authors reported no relevant financial conflicts of interest.

28 Operations & Management

Pharmacy Practice News • January 2015

Leadership in Action

Creating Value in Relationships

A

re you a people watcher? Do you have that uncanny ability to read body language, facial expressions and other indicators of a person’s energy and “vibe”? If not, it may be time to start cultivating these skills because, as a manager, they can help you engender high levels of trust in a relationship.

As emotional intelligence guru Daniel Goleman stated in his book, “Focus, The Hidden Driver of Excellence” (Harper-

Collins 2013), “everything we attend to in another person generates meaning at an unconscious level,” with what he called “our bottom-up circuitry” reading and registering those critical interpersonal signals.

Empathy and ‘Reading’ People All employees want to feel valued, respected and understood—it validates them and creates greater longevity of

employment. To engender those feelings, it may be helpful to view your interactions with staff based on what Goleman termed the “empathy triad,” which consists of the following: • Cognitive empathy is the ability to read the emotional signals of another, taking the other person’s perspective and comprehending their mental state without becoming emotionally involved. Goleman referred to these

“Leadership in Action” is authored by Ernest R. Anderson Jr., MS, RPh, of Brockton, Mass.

Mr. Anderson welcomes your input on leadership issues, at ernestanderson1130 @gmail.com

Ernest R. Anderson Jr., MS, RPh

as “top-down” mental operations.

• Emotional empathy involves feeling along with the other person, associating his or her emotions with our own.

We experience the other person’s joy or sorrow. This is the bottom-up brain circuitry that Goleman described in his book. These are spontaneous, automatic responses based on our own learned experiences.

• Empathetic compassion includes cognitive and emotional empathy but also a caring attitude that mobilizes us to help when needed. According to Goleman, this compassionate response also is bottom-up and is based on primal systems for caring located deep within the brain. Such responses are also combined with top-down circuitry that evaluates how much we value a person’s well-being.

To apply these values in relationships, you have to be self-aware, understanding your own thoughts and feelings. This is the first pillar of emotional intelligence, a concept that Goleman uses to explore the array of skills and characteristics that drive leadership performance. These relational circuitries of empathy are designed for face-to-face experiences and cannot be appreciated in electronic communications. In other words, email, texting or letters will not pick up these subtleties.

Emotional Empathy and Patients How does your understanding of emotional empathy affect both how you deal with employees and your connection with patients? We likely know from personal experience that our best interactions with physicians occur when they look us in the eye, nod as we explain our symptoms or pain and exhibit personal warmth toward us. However, if a physician or pharmacist interacts with a patient while staring at a computer screen or clipboard, that personal, empathetic connection is lost and the patient is likely to feel more like a number than an individual. This is the power of emotional empathy.

Showing empathetic concern for patients by reflecting back to them your understanding of how they must feel is powerful. Acknowledging their fear of a diagnosis, for example, and showing them that you understand their plight, increases the value of the caregiver–patient relationship and can increase patient compliance with instructions. This can be particularly helpful in fostering patient adherence to medication regimens.

Operations & Management 29

Pharmacy Practice News •January 2015

Leadership in Action

Granted, there are times when a professional must tune out emotions in order to maintain calm. Focusing on cognitive empathy helps attain that goal. In such cases, the prefrontal cortex tunes out the emotions. As a manager, this skill is critical to maintaining your cool when people around you are emotionally out of control. This is a learned ability that becomes all important when you need to act as a first responder during a crisis or disaster. It enables you to block out emotions, allowing pragmatic actions that bring order to chaos.

The challenge for caregivers is to maintain a cool focus while remaining open and responsive to a patient’s feelings, letting the patient know that you understand (emotional empathy) and care (empathetic compassion). Striking that balance requires self-awareness. If you are distressed, whether with a patient or in a managerial setting, it is important to identify where the stress is coming from.

Are you picking it up from other people?

Or are you transmitting those emotions and making a situation worse? If you, as the leader, are calm, you will be able to bring a sense of relaxation to a situation, which people can then mirror with their own behaviors and attitudes.

Improvement Requires Focus We’ve all heard it said that practice makes perfect. Athletes know, for example, that muscle memory is important and thus they will often repeat the key movements in their sport. Our minds really are no different; through a process known as “neuroplasticity,” our brains have the capacity to create new neuronal pathways in response to new stimuli.

There are several strategies for increasing the neuroplasticity of our brains.

Memorization and concentration on cerebral tasks can help, as can improving our ability to focus when our minds begin to drift. Daniel Friedland of “Super Smart Health” (http://supersmarthealth.com/ op/app) recommends that we focus on our breathing. When your mind wanders off the task at hand, focus on your breathing and then back on your task. Repeat this exercise every time your mind drifts off topic. When you bring your mind back to your breath and focus, the prefrontal cognitive control circuits take over. The more we practice this skill, the easier it gets and the less we wander or at least the quicker we get back in focus.

Positivity Matters Maintaining a positive attitude may sound like a hackneyed idea, but

according to Goleman, “positive emotions widen our span of attention; we’re free to take it all in. Indeed, in the grip of positivity, our perceptions shift.” Studies have shown that when we are upbeat, our left brain’s prefrontal cortex lights up with activity. Additionally, our dopamine levels increase with positive feelings and a striving toward goals with focus.

Think of the implications as you motivate your employees. Goleman quotes Marcial Losada, an organizational psychologist, who has deter-

mined that the most effective people have a positive/negative ratio of at least 2.9 good feelings to every negative moment. Too often, we focus on the negative traits that need to “get fixed” along with fear and guilt. It is better to start with a vision and dream, and then move to acquiring the necessary skills.

Give it a try: I wish you well as you strengthen your mind and boost your focus, empathy and compassion. You, your staffers and d your patients will prosper.

For more information visit Daniel Goleman’s website at http://goo.gl/q55iIF. ■

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30 Operations & Management

Pharmacy Practice News • January 2015

Reimbursement Matters

CMS Payments in 2015: A Few More Details P

ayment for the operating costs of acute care hospital inpatient stays under Medicare Part A (hospital insurance) by the Centers for Medicare & Medicaid Services (CMS) is based on prospectively set rates and is commonly referred to as the inpatient prospective payment system (IPPS).

The first thing to know about IPPS payments is that they function on a fiscal year (FY) basis beginning Oct. 1.

Under the IPPS, each case is categorized into a diagnosis-related group (DRG) with a payment weight assigned to it.

The payment weight is based on the average resources used to treat Medicare patients in that DRG and is adjusted for a wage index related to geography. Other variables can affect how a hospital’s IPPS payments are calculated.

For example, if the facility treats a high percentage of low-income patients, it receives the disproportionate share hospital adjustment, which results in a percentage increase in Medicare payments.

Approved teaching hospitals are also eligible for a percentage add-on payment for each case paid through IPPS. This add-on is known as indirect medical education adjustment. In general, IPPS payments are increased with an outlier payment to protect the hospital from large financial losses due to unusually expensive cases. (For more details on IPPS basics, visit http://goo.gl/TI7HZm.) Although reimbursement on a DRG basis is all-inclusive, there are a few opportunities for additional payments.

The new technology add-on payment policy, for example, provides additional payments for cases with high costs involving eligible new technologies while preserving some of the incentives under the average-based payment system. Responsibility for payment consideration falls to the manufacturer.

The deadline to submit (and for CMS to receive) an application for FY 2016 new technology add-on payments was Friday Nov. 21, 2014. This process is designed to identify and ensure adequate payment for new medical services and technologies under the IPPS. However, to receive special payment consideration, new technologies meeting this clinical definition must be demonstrated to be paid inadequately under the DRG system. Time is of the essence as well with an add-on payment lasting no less than two years and no more than three years from its approval date.

Two drugs lost IPPS new technology add-on payments for calendar year (CY) 2015, which began Oct. 1, 2014.

New technology add-on payments were discontinued for fidaxomicin (Dificid, Cubist) because it exceeded the timeframe limits for these payments, and for dalvabancin (Dalvance, Durata Thera-

peutics) because CMS determined that the technology did not meet the substantial clinical improvement criterion.

Three products will retain new technology payments because their threeyear anniversary dates will occur in the latter half of FY 2015. These include glucarpidase (Voraxaze, BTG International Inc.), prothrombin complex concentrate [Human] (Kcentra, CSL Behring) and the Zilver PTX drug-eluting peripheral stent.

Action step: Set up a mechanism for billing for these products when used in an inpatient setting for appropriate CMS patients with required documentation.

That will help ensur that the separately paid add-on revenue is actually paid.

Blood Clotting Factors Since 2005, CMS has been paying a furnishing fee for items and services associated with clotting factor. It is included in the published national payment limits for clotting factor billing codes. When the national payment limit for a clotting factor is not included on the Average Sales Price (ASP) Medicare Part B Drug Pricing File or the Not Otherwise Classified (NOC) Pricing File, the contractor must

make payment for the clotting factor as well as for the furnishing fee.

As with all drugs and biologics, CMS requires physicians and other providers to bill using the appropriate Healthcare Common Procedure Coding System (HCPCS) or Current Procedural Terminology (CPT) code and to accurately report the units of service. The units billed cannot exceed the maximum number of units per day based on the code descriptor; reporting instructions associated with the code; and/or other CMS local or national policy.

The CY 2015 Clotting Factor Furnishing Fee per unit effective Jan. 1 is increased to $0.197 per unit from $0.192 per unit in CY 2014.

Quarterly ASP File Updates ASP drug pricing data contain the payment amounts that will be used to pay for Part B-covered drugs. Each quarter, CMS publishes three sets of ASP updates as Excel tables. The January through March 2015 sets are now available and can be accessed at http:// goo.gl/EE62c6. Each of the three ASP sets serve a specific valuable purpose:

Short Description

HCPCS Code Dosage

Payment Limit

Products added effective Jan. 1, 2015 JO153

Adenosine inj 1 mg

1 MG

0.8417

J1071

Inj testosterone cypionate

1 MG

0.033

J1439

Inj ferric carboxymaltos 1 mg

1 MG

1.060

J2274

In morphine preservativ free

10 MG

9.276

J2704

Inj, propofol, 10 mg

10 MG

0.125

J3121

Inj testostero enanthate 1 mg

1 MG

0.055

J7200

Factor ix recombinan rixubis

1 IU

1.244

J7201

Factor ix fc fusion recomb

1 IU

2.821

J7327

Monovisc inj per dose

Per Dose

988.380

J7336

Capsaicin 8% patch

1 SQ CM

2.726

J9267

Paclitaxel injection

1 MG

0.161

J9301

Obinutuzumab inj

10 MG

54.241

Products subject to AMP-based reimbursement Jan 1 to March 31, 2015

a

Bonnie Kirschenbaum, MS, FASHP

January 2015 ASP Pricing File 12/09/2014: Sets the ASP or average manufacturer price (AMP) for the quarter and includes any changes such as newly added products, code changes, etc. The table is arranged by HCPCS code. Re-sort it alphabetically or use the Excel “find” function for ease of use. Your local Medicare Administrative Contractor (MAC) determines Part B payment limits for valid HCPCS codes that are not included in the quarterly ASP pricing file.

January 2015 NOC Pricing File 12/02/2014: This smaller list of products contains a few items that are reimbursable but doesn’t list HCPCS codes. These would need to be determined from the master all-inclusive HCPCS code set or obtained from your MAC. January 2015 ASP NDC-HCPCS Crosswalk 12/04/2014: The longest of the crosswalk file; lists product manufacturers and information on the NDC package size and number of billable units (as defined by the HCPCS code descriptor).

More OPPS Updates

Table. Products Newly Added or Subject To AMP-based Paymenta HCPCS Code

“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.

JO132

Acetylcysteine injection

100 MG

1.564

J2400

Chloroprocaine hcl injection

30 ML

16.733

J2675

Inj progesterone per 50 MG

50 MG

1.423

J3415

Pyridoxine hcl 100 mg

100 MG

7.270

J7507

Tacrolimus Imme Rel oral 1 mg

1 MG

1.042

J7626

Budesonide non-comp unit

0.5 MG

5.304

J9200

Floxuridine injection

500 MG

60.250

Effective Jan 1, 2015 through March 31, 2015. CMS requires input exactly as shown above.

AMP, average manufacturer price; ASP, average sales price; HCPCS, Healthcare Common Procedure Coding g System; y ; injj, injectable j

Additionally, through the Medicare Learning Network, CMS has released several important changes detailed in MM9014: January 2015 Update of the Hospital Outpatient Prospective Payment System (OPPS) that can be accessed at http://www.cms.gov/Outreach-andEducation/Medicare-Learning-NetworkMLN/MLNMattersArticles/Downloads/ MM9014.pdf. (Shortened URL: http://goo. gl/f9ZzxE). Future columns will discuss some of the implications of these updates.

More Resources 2015 ASP Drug Pricing Files: http://www.cms.gov/ apps/ama/license.asp?file=/ McrPartBDrugAvgSalesPrice/ downloads/2015-JanuaryASP-Pricing-File.zip (Shortened URL: http://goo. gl/Lr42bm) HCPCS 2015 Table of Drugs: http://www.cms. gov/Medicare/Coding/ HCPCSReleaseCodeSets/ Alpha-Numeric-HCPCSItems/2015-Table-of-Drugs-. html?DLPage=1&DLSort=0&D LSortDir=descending (Shortened URL: http://goo. gl/UAR4DI)

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