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The Pharmacist’s News Source

Volume 41 • Number 6 • June 2014


Printer-friendly versions available online

in this issue UP FRONT


Hospitals tighten ESA use to reduce costs.



Are there cracks in the medical home model?



Improving adherence to evidence-based guidelines for cancer.


20 22

Maximizing the value of pharmacy techs with informatics expertise. Bringing sterile compounding in-house: lessons learned.


‘Megarule’ Eyed For 340B Clarity Las Vegas—If your hospital or pharmacy is involved in the federal 340B Drug Pricing Program, you’re probably spending a lot of time checking the Health Resources and Services Administration (HRSA) website. Sometime within the next six to eight weeks, the HRSA is expected to issue the highly anticipated “Megarule” or “Megareg,” which the agency says will clarify such notoriously murky matters as the definition of an eligible patient, compliance requirements for contract pharmacy arrangements, hospital eligibility criteria and eligibility of off-site facilities. 340B has long been a remarkably “unregulated” program. There have been guidelines, policy statements and frequently asked questions, but with the exception of last year’s Orphan Drug Exclusion Rule, none of the oversight of the program has risen to the level of a formal, Federal Register–published regulation. But in the wake of the Affordable Care Act’s (ACA) expansion of the program to include a much larger

W Ernie Anderson Jr., MS, RPh, on role of trust in creating highly performing teams. W Q&A: Marie ChisholmBurns, PharmD, on her most recent research award. W Bonnie Kirschenbaum, MS, RPh, assesses impact of ICD-10 code delay.


Medication Errors: A Year in Review, Part 2 See insert after page 12.

see 340B, page 6

At HOPA Annual Conference...

Gap in Herpes, VTE Prevention Seen in Myeloma New Orleans—Not all patients with multiple myeloma (MM) are receiving prophylaxis in accordance with the National Comprehensive Cancer Network guidelines, making them prone to higher rates of herpes zoster and venous thromboembolism, according to data presented at the 2014 Annual Conference of the Hematology/Oncology Pharmacy Association (HOPA).

see PREVENTION GAP, P page 14

Medical marijuana...

If Pot Is a Drug, Why Aren’t More Pharmacists Involved?

Tampa, Fla.—As more state legislatures consider joining the District of Columbia and the 22 states that have authorized medical marijuana, a new organization is seeking to position pharmacists as the professionals most qualified to help bring a more standardized and safer approach to cannabinoid therapy. The goal of the new organization, called the National Association of Cannabis Pharmacy (NACP), is “to create a unified voice for all stakeholders in cannabis-based med-

icine who believe that the science needs to be developed and the stigma needs to be removed from this modality,” James E. Smeeding, RPh, MBA, a board member of NACP, told Pharmacy Practice News. “We think pharmacists are the appropriate dispensers to help protect patients and make sure they get the best benefit and value from cannabis-based medicine.” NACP also aims to provide the means to track outcomes of patients taking medical

see MARIJUANA, page 4

Ambulatory Care Hits Prime Time Via New ASHP Recommendations Dallas—The American Society of HealthSystem Pharmacists (ASHP) has formally called for greater recognition and integration of ambulatory care pharmacists in the patient care process. At its inaugural summit on the growing subspecialty, the ASHP issued recommendations urging improved access to health care information technology (HIT) in the outpatient setting as well as greater collaboration and communication between pharmacists and other providers, administrators and payors. The timing of this call to action couldn’t

New Product Cutis sPharma introduces FIRST®- Vancomycin oral solution compounding kits. See page 15

have come at a better time, according to Ernest Anderson Jr., MS, RPh, a health care consultant in Brockton, Mass. Ambulatory pharmacy, he noted, is on the cusp of “significantly advancing our role in patient care, so I applaud the ASHP for focusing on this initiative.” Mr. Anderson added that “in the past, there was little financial incentive to include ambulatory care pharmacists on the health care team.” However, given the many studies showing that “we can reduce health

see AMBULATORY CARE, page 16

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Up Front 3

Pharmacy Practice News • June 2014



y implementing protocols that restrict the use of erythropoietinstimulating agents (ESAs), hospitals can successfully cut costs while maintaining an equivalent level of patient care, according to two recent studies. At St. John Hospital and Medical Center in Detroit, a policy that delayed ESA administration to certain patients decreased ESA purchases by more than $16,000 per month. “We wanted to [determine whether] having [such] a program in place would still benefit patients and potentially reduce costs,” said Michelle Dehoorne-Smith, PharmD, the manager of pharmacy patient care services at St. John Hospital. A similar measure at Banner Health, in Phoenix, saved $19,000 during a twomonth study period. ESAs have come under scrutiny because of their high costs and potential for harm. “Over the past eight years, perhaps more, we’ve noted that ESAs are associated with a lot of detrimental adverse effects,” said investigator Jeff Hurren, PharmD, a clinical specialist in drug information and policy at St. John Hospital. For example, a 2009 study of ESA use in patients with chronic kidney disease (CKD) or type 2 diabetes found that the likelihood of stroke was increased in patients who received darbepoetin (Aranesp, Amgen) (hazard ratio, 1.92; 95% confidence interval, 1.38-2.68) compared with placebo ((N Engl J Med d 361:2019-2032).

In 2011, the FDA released guidelines to help clinicians adopt more conservative ESA treatment for patients with CKD. The agency suggested that a patient with CKD who is not on dialysis should meet several criteria—a hemoglobin level of less than 10 g/dL and a high likelihood of red blood cell transfusion, with a risk for alloimmunization—before beginning ESA treatment. When administering ESA, the goal is to “provide the lowest dose possible that avoids transfusions,” Dr. Hurren said.

Delayed Dosing At St. John Hospital, modifications to the ESA policy included a switch from erythropoietin (Procrit, Janssen) to darbepoetin. Clinicians delayed ESA treatment until the seventh day after admission for some patient groups, although there was no delay for Jehovah’s Witnesses and other patients who could not receive transfusions. A retrospective study of 289 patients found that the new policy had no effect on transfusion rates or hemoglobin levels. The percentage of ESA doses administered on or after day 7 increased from 19% to 44% (P ( <0.001; Figure). This delay, Dr. Hurren said, helped ensure that the timing of administration did not result in double doses of ESA during care transitions. Given that the most frequent administration of darbepoetin is once weekly for non-dialysis patients, waiting until

day 7 “ensures you never double dose from the outpatient side,” said Robert Adamson, PharmD, the vice president of clinical pharmacy services at Barnabas Health, headquartered in Livingston, N.J. Oncology patients should receive darbepoetin once every three weeks, he added, and nephrology patients once every two weeks. Although waiting until day 7 “obviates the need for phone calls,” physicians risk giving patients such as these “more darbepoetin than they may need,” Dr. Adamson said. The approach that pharmacistss use at Barnabas Health is to ascertaiin when patients had last received darbepoetin. “This is a little more precise,” he noted.

Patients given ESA at day 7, %

Hospitals Tighten ESA Use To Reduce Costs 50


25 19




Figure. Effect of new policy to delay ESA administration.

Clinical Decision Support The Banner Health team implemented a clinical decision support system (CDSS) to restrict ESA orders for patients who had hemoglobin levels of greater than 11 g/dL. After the CDSS SS was in place, patients were significantly more likely to have iron studies (56% of patients after compared with 25% before; P<0.001), and administration of ESA decreased by 20%. Among patients with hemoglobin levels greater than 11 g/dL, ESA use dropped from 14% of patients to 0% ((P<0.001). Whichever approaches are used, to effectively enact a new ESA policy, it is

c critical to work with all mediccal staff to emphasize how the cchanges improve patient safetyy, Dr. Dehoorne-Smith said. If strategies t are seen primarily as efforts at cost reduction, she noted, they likely will not be so successful. —Ben Guarino The St. John Hospital and Banner Health studies were presented at the annual meeting of the American College of Clinical Pharmacy (abstracts 257 and 255, respectively).




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, Brockton, MA

Volume 41 • Number 6 • June 2014 •

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



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

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

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


David Bronstein, Editorial Director


Jeffrey Norenberg, PharmD, Albuquerque, NM

Indu Lew, PharmD, Livingston, NJ

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


Robert Ignoffo, PharmD, San Francisco, CA

s CT C. Michael White, PharmD, Storrs,

Sarah Tilyou, Senior Editor Kevin Horty, Don Pizzi, Adam Marcus, Cynthia Gordon, Paul Bufano, Contributing Editors

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


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

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4 Policy

Pharmacy Practice News • June 2014

Controlled Substances

MARIJUANA continued from page 1

marijuana and the metrics to convert those outcomes into real-world data that can be used to determine the safety and efficacy of products that are available or coming into the market, noted Mr. Smeeding, who announced the formation of NACP at the National Association of Specialty Pharmacy (NASP) 2014 Specialty Pharmacy Expo. Additionally, the association plans to offer educational products and an accreditation pathway, according to Mr. Smeeding, NASP’s executive director. In some states, pharmacists already are on board. In Connecticut, for example, new regulations require pharmacists’ oversight and staffing at six new stateapproved medical marijuana dispensaries. Nicholas Tamborrino, PharmD, is setting up a new ground-floor dispensing facility, called BluePoint Apothecary & Wellness, in a Branford, Conn., industrial park that is home to other medical offices. It is scheduled to open in August. Mr. Tamborrino recently worked at Yale-New Haven Health System, where he oversaw information technology training for the system’s five hospitals. BluePoint Apothecary is an independent venture that he owns and manages. He said he has hired another full-time pharmacist, Colleen Higgins, RPh, who specializes in alternative medicines, to help dispense cannabis-based compounds and counsel patients. “We’ll implement our own medication therapy management service based on patients’ medication history, condition and medical marijuana requirements,” Mr. Tamborrino said. BluePoint, he said, will be offering marijuana-containing products supplied by state growers approved by the Connecticut Department of Consumer Protection. “I’m trying to emphasize a medical office-type setting where patients get used to making appointments,” Mr. Tamborrino said. “This way I can set aside the appropriate time for each patient and make sure their medicine is in stock.” In Chicago, Joseph Friedman, RPh, a compounding pharmacist at Mark Drugs, is scouting surrounding communities to find an appropriate location for a medical marijuana dispensary. It will be one of 60 facilities scattered throughout Illinois that have been authorized to distribute limited amounts of physicianapproved medical marijuana to patients with cancer, HIV, multiple sclerosis and other serious illnesses, under a four-year pilot program that began in January. The search has encountered resistance in some communities. “We want to work with a municipality that wants to work with us,” Mr. Friedman said. “This is going to be very important as we submit our applications.”

In Colorado, a “makeshift sort of cleanroom” contains homegrown marijuana plants. Caregiver Max Sherwood extracts active cannabinoids from the plants’ flowers and then compounds them into tinctures for patients with HIV and other chronic conditions.

Regulatory Barriers The reluctance of financial institutions to deal with businesses that dispense a product that is illegal under federal law has been another challenge for medical marijuana dispensaries. Many have been forced to deal only in cash because banks won’t open business accounts for them. Mathew Sherwood, a licensed marijuana grower and patient caregiver in Colorado, said the cashonly status “has created a dangerous situation where you have a sought-after substance and large amounts of cash” on hand, inviting theft. Marijuana’s status as a federal Schedule I controlled substance also has had a dampening effect on the participation of many pharmacists, who are concerned about jeopardizing their licenses, said Lawrence J. Cohen, PharmD, BCPP, a professor of pharmacotherapy at the University of North Texas System College of Pharmacy, in Fort Worth. Still, Dr. Cohen said that he believes that with pharmacists’ unique knowledge, they could offer significant benefits to patients who require cannabinoid therapy. “I think we are in the best position and could contribute significantly in developing the materials to help people understand the risks and benefits” of medical marijuana, he said. Mr. Sherwood, who is not a pharmacist, agreed. He has spent the past eight years helping patients cope with severe conditions, ranging from multiple myeloma to HIV to relapsing-remitting multiple sclerosis. In a “makeshift sort of cleanroom” in his home, he said, he extracts active cannabinoid ingredients from the flowers of his homegrown marijuana plants (photos) and compounds them into tinctures using propylene glycol. The solution is then vaporized and inhaled through electronic cigarettes. “Dosages are not the same for all patients,” he noted, so

he has them start low and then titrate up to an effective dose. “I’ve seen it have unbelievable effects,” he said. “But I don’t feel like it should be my job. The skill set that I am using, the things I had to learn—these are things that are in a pharmacist’s wheelhouse.”

Movement Into Health Systems Although American Society of HealthSystem Pharmacists (ASHP) policy opposes “the procurement, storage, preparation or distribution of medical marijuana by licensed pharmacies or health care facilities for purposes other than research,” it encourages “continuing education that prepares pharmacists to respond to patient and clinician questions about the therapeutic and legal issues surrounding medical marijuana use.” Cynthia Reilly, RPh, the director of ASHP’s Medication Safety and Quality Division, noted that ASHP’s stance is based on “licensing implications that could result from the conflict between state and federal laws.” Ms. Reilly added that even if pharmacists are not involved in dispensing medical marijuana, they are “probably caring for patients who are using these products.” She said that ASHP has been providing education to its members because of the need for knowledge about how cannabis-based medicines can interact with other patient therapies. Health-system pharmacies in New York may find themselves involved in the delivery of medical marijuana therapy under a new plan to allow 20 hospitals around the state to make medical marijuana available to patients. At least 10 hospitals have expressed interest. “The day that was announced, we started getting requests from hospital pharmacists in New York about model rule policies and procedures,” Mr. Smeeding said. “Additionally, there is no surprise that by bringing [medical marijuana] into the hospital—which in many

ways becomes a hub for the community— it would be the pharmacy that ended up figuring out how to manage that forward. I think that is a challenge but also an opportunity.” Mr. Friedman said he has been working with a Chicago hospital that is interested in opening a medical marijuana dispensary but is concerned about jeopardizing its Medicare and Medicaid reimbursements. He noted that health systems in New York likely have similar concerns.

Where’s the Data? There is universal agreement that more medical marijuana research is needed. “About 500 different strains have been identified that have different effects, containing more than 100 cannabinoids,” Dr. Cohen said. “And they all don’t cause profound sedation, for example, or have any kind of euphoria effect. Some are very targeted and have a positive effect on nausea, reducing pain or inflammation.” Dr. Cohen said he hasn’t found any research that fully explains why specific strains of marijuana have such differing pharmacology. “And the reason why controlled research isn’t being done is because of the stigma—the view that this is an abusive substance and often a key ‘target’ of the ‘War on Drugs.’ I don’t believe that medical marijuana is always an abusive substance. Each patient’s medical conditions, health status and quality of life should be considered before discarding this as a truly viable treatment option for patients in need.” Mr. Sherwood noted that legislatively, medical marijuana is a “giant gray area, but, in my opinion, if somebody walked out of the Amazon [rainforest] with this plant right now, they would absolutely win an award. It would be something that every pharma company would be studying—pulling molecules apart and doing research on them.” —Bruce and Joan Buckley


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6 Policy

Drug Costs

Pharmacy Practice News • June 2014

Who Are 340B Hospitals?

340B continued from page 1

pool of covered entities that can receive discounts on covered outpatient drugs, the 340B program has mushroomed. The number of participants has also been spurred by a guidance that permits covered entities to use an unlimited number of contracted pharmacies to provide 340B drugs. “In the first year after the ACA was passed, there was a 161% increase in the number of contracted pharmacies under 340B,” said David Coury, PharmD, the vice president of business development at Acro Pharmaceutical Services (which has a 340B drug program), at the spring Armada Specialty Pharmacy Summit. “Within the past three years, there’s been an almost 300% increase. Now, nearly 14,000 pharmacies act as contract pharmacies for a 340B-covered entity, including more than 20% of total U.S. retail, mail and specialty pharmacies.” As of February 2014, he noted, 2,048 hospitals and health systems are participating as covered entities under 340B— approximately one-third of all hospitals in the country. Their 340B spending accounts for 62% of all hospital outpatient drug spending in the United States. That’s only likely to increase with the expansion of Medicaid as the ACA reaches full implementation. The Berkeley Research Group has estimated that by the end of this year, 342 additional hospitals will become eligible because of Medicaid expansion, representing an estimated $1.2 billion in additional 340B sales.

Scathing Reports This growing pool of 340B discount dollars has proved to be an incentive for program abuses. In February, the U.S. Department of Health and Human Services (HHS) Office of Inspector General issued a report finding significant problems with many 340B contract pharmacy arrangements. The report studied 30 covered entities—15 community health centers and 15 disproportionate share hospitals (DSHs)—which had arrangements with 199 unique contract pharmacies. Among the HHS’s findings: • There is a great deal of inconsistency about the definition of “eligible patient” in the contract arrangements between covered entities and pharmacies. • Eight of the 30 entities reviewed— or about 30%—did not offer the discounted 340B price to uninsured patients through their contract pharmacies. Although that is not, technically, required by HRSA for 340B participation, it appears obviously contrary to the intent of the program, critics contend. • Most of the covered entities do not conduct all of the oversight activities recommended by HRSA. • Many contract pharmacies struggle

About half are urban; half are rural.

864 (41.6%) are critical access hospitals (CAHs).

Located in 1,476 or 46% of all U.S. counties

Audit Prep 101


veryone’s hoping that the “Megarule” will make some of the gray areas of 340B compliance a little less hazy. But its issuance also may come with a potential downside, at least for some hospitals: more audits. So if you’re a covered entity or a contracted pharmacy, it’s time to consider what you can do to prepare for your 340B program coming under review. Douglas Wong, PharmD, the vice president of pharmacy practice at AmerisourceBergen’s Pharmacy Healthcare Solutions, offered a few key insights: 1. Break out the 340B dictionary. More specifically, have policies and procedures in place that clearly define “provider,” “patient” and “covered outpatient drug.” This can get complicated, Dr. Wong said. “It’s been stated that if a person is only coming to you for the purpose of getting a drug at a 340B discount, they don’t qualify as an eligible patient under the program. Consider, for example, a patient who comes to the hospital to get chemo, but a private physician is providing their follow-up. The definition of ‘patient’ says that the provider must be either contracted by, or employed by, the covered entity.” 2. Know about referral relationships. “Let’s say you have a medical practice that’s part of the covered entity, but doesn’t have a particular provider on site—such as a podiatrist,” he said. “The primary care doctor sends the patient to a podiatrist for an ingrown toenail, and he gives the patient a prescription for antibiotics. That could be considered eligible, because it’s a referral from the entity to a nonemployed provider that is not available within the entity.” 3. Check your OPA online data. Ensure that your information on the Office of Pharmacy Affairs (OPA) website is complete and accurate. “Auditors will compare the information you have listed with OPA with the information you have on site, such as the Medicare cost report and the chart of accounts listed in that cost report,” Dr. Wong said. “Locations outside the four walls of the covered entity have to be individually listed. Two hospitals, even if they’re under one Medicare provider number, have to identify a primary site. Any locations or departments outside of that primary site must be listed on the OPA website if you’re going to provide 340B drugs through those sites.” 4. Audit yourself. “Not only should you be commissioning third-party audits of your own, you should be doing self-audits, not just of contracted pharmacies, but the entire program,” Dr. Wong said. “For example, contract pharmacies that are using software to identify eligibility should be audited to confirm that those patients are, in fact, eligible.” 5. Be vigilant about double dipping. “In the eyes of the OPA, the entity has responsibility to make sure that state Medicaid requirements are met to ensure that duplicate discounts are prevented,” Dr. Wong said. “It’s up to the covered entity to reach out to the state—not the other way around—to determine if the state has specific requirements about modifiers on claims submitted that have already had a 340B discount. And no seeking rebates from the manufacturer on 340B drugs!” 6. Take advantage of Apexus’ 340B resources. They include its Apexus 340B university educational program (the next session is in July in Washington, DC), and its national call center, Apexus Answers. Find out more at Going forward, there will be much more emphasis on accountability and integrity for 340B, Dr. Wong predicted. “If you’re running a finely tuned program, there should not be any issues with an audit. The organizations that have not done any self-auditing are the ones who will be in trouble.” —G.S.

to prevent double discounting on 340B drugs through manufacturer’s rebates. These findings echo other recent indictments of the program’s effectiveness and oversight. An analysis of 2011

data conducted by Avalere and released this Spring ( found that one-fifth of 340B hospitals administer 80% of the total charity care provided by covered entities. For 45% of all

340B entities, charity care represented only 1% to 3.3% of their patient load. “A law like this was meant for charity,” said David Galardi, PharmD, the worldwide managing director of the consultancy Apogenics, in Dallas. “The intent was to improve indigent patient access to prescription drugs by helping covered entities purchase outpatient drugs at discounted prices, and to help entities stretch scarce federal resources as far as possible—enabling treatment with more comprehensive services. It wasn’t meant to fund hospital growth, but that’s how it’s being used.” Chris Hatwig, MS, RPh, the president of Apexus, Irving, Texas, which manages HRSA’s 340B Prime Vendor Program, argues that abuses of the program represent the exception rather than the rule. “Most entities with which we have worked are trying extremely hard to best serve their patients, many of whom are unable to pay for needed medications,” he said. “In my experience, as the former director of pharmacy at Parkland Health and Hospital System, a major safety net hospital serving north Texas, we provided medications to patients regardless of their ability to pay. When a hospital or clinic enrolls in the 340B program, it cannot be limited to using the program for only the uninsured— that is essentially an unworkable model. No organization is going to take on the cost burden of caring for this patient population and Medicaid patients at cost or less without some means of making up these losses or subsidized care with some insured patients to offset the losses.” It also has been argued that 340B is unintentionally driving up the cost of care, by incentivizing treatment in more costly hospital outpatient centers rather than infusion clinics or physicians’ offices. “Patients want to be treated in the most convenient location possible, and normally, without an economic incentive, physicians oblige them. But when you have these 340B incentives, patients miraculously move to settings that drive up enormous drug-related profit,” Dr. Galardi said.

Unintended Consequences These “unintended consequences” of 340B have been a double-edged sword for community oncology, said Ted Okon, executive director of the Community Oncology Alliance, Washington, D.C. “It’s an extremely important program, because more than ever—particularly in oncology—having a safety net is critical for patients in need.” But he argued that 340B incentives have helped to contribute to at least some of the recent spate of acquisitions of community oncology practices by hospitals and health systems, a trend that many have argued is driving up

Policy 7

Pharmacy Practice News • June 2014

Drug Costs pharmacy costs by shifting patients to more expensive sites of care. “The average oncologist, depending on the type of cancer they treat, uses anywhere from $2 million to $4 million in drugs per year,” he said. “If you take between 30% and 50% in discounts on that, you can see that it’s a very valuable revenue stream. No wonder there’s pressure on 340B hospitals to make these acquisitions.” But Mr. Hatwig said there are two sides to this coin. Declining government reimbursement “has resulted in patients being turned away by private oncologists. They tell patients to go to the local safety net hospital to get care, or the patients are required to do so as a last resource.” For uninsured or underinsured Americans, the private oncology practices may turn them away, “yet the safety net providers will still accept them,” he added. And without 340B, Mr. Hatwig said, safety net providers could not continue to do that. In a recent op-ed in Crain’s Chicago Business, Alan Channing, the president and CEO of Sinai Health System, Chicago, enumerated how 340B benefits his system. The program saves Sinai about $2 million a year, which in 2013, Mr. Channing wrote, helped the system to supply $930,000 in free and discounted medications to patients in need. The system also has used 340B savings to launch a specialty clinic for muscle spasm patients and to hire eight new disease management specialists who work with certain chronic disease patients on hospital-to-home transitions—a program that has lowered the group’s readmission rate by 45%. 340B also has proven to be a lifeline for small rural hospitals, noted Raymond Christensen, MD, a family practitioner at Mercy Hospital in Moose Lake, Minn., and the president of the National Rural Health Association. “It’s part of a complex array of programs that helps keep access in rural areas.” He cited, as examples, hospitals such as Cass County Memorial in Atlantic, Iowa, which gives patients in need a full year of outpatient medication for free, and supplies no-cost medication vouchers for emergency physicians to give to qualified patients. His own hospital has not participated in 340B in the past, Dr. Christensen said, but he plans to recommend to an incoming administrator that they explore the possibility.

chasing organization (GPO) as the most common violation for hospitals. Three types of covered entities—DSHs, children’s hospitals and freestanding cancer hospitals—are forbidden by statute from using a GPO for 340B-covered outpatient drugs. In 2012, the audit found, 42% of hospitals subject to the prohibition used a GPO in violation of the rule. Mr. Hatwig said the audit program, which began in 2012, is already significantly improving compliance among 340B-covered entities. He pointed to a May 9 memo to such entities from Kris-

ta Pedley, who directs HRSA’s Office of Pharmacy Affairs, about the audits. “The ‘sentinel effect’ of these audits has been remarkable,” she wrote. “We have seen many more covered entities prioritizing compliance, seeking technical assistance and taking steps to rectify violations.” “More audits on the way” hardly seems like the kind of headline to inspire more participation in a program. But Dr. Galardi said that going forward, non340B pharmacies will be at a significant disadvantage. “With the enormous cost pressures payors are under due to the

Drs. Coury and Christensen and Mr. Hatwig reported no relevant financial conflicts of interest. Dr. Galardi disclosed that he regularly consults with the pharmaceutical industry regarding 340B. His clients include manufacturers/sponsors, service organizations and specialty pharmacy/ distribution companies.

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Audit Expectations As of March, HRSA had audited 40 340B-covered entities, compared with 94 for all of 2013. Audits may speed up even more after the “Megarule” is issued—which Dr. Galardi also predicted will give drug manufacturers more audit authority. So far, the audit program—which began in 2012—has identified inappropriate use of a group pur-

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Indications and Usage NEXTERONE (amiodarone HCl) Premixed Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. NEXTERONE also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with NEXTERONE, patients may be transferred to oral amiodarone therapy. Use NEXTERONE for acute treatment until the patient’s ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but NEXTERONE may be safely administered for longer periods if necessary.

Important Risk Information NEXTERONE (amiodarone HCl) Premixed Injection is contraindicated in patients with: • Known hypersensitivity to any of the components of NEXTERONE, including iodine • Cardiogenic shock • Marked sinus bradycardia • Second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available • NEXTERONE should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias, who are thoroughly familiar with the risks and benefits fi of amiodarone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment. • Hypotension is the most common adverse reaction seen with intravenous amiodarone. In clinical trials, treatment-emergent, drug-related hypotension was reported in 16% (288/1836) of patients treated with intravenous amiodarone. Clinically significant fi hypotension during infusions was seen most often in the first several hours of treatment and appeared to be related to the rate of infusion. Monitor the initial rate of infusion closely and do not exceed the recommended rate. In some cases, hypotension may be refractory and result in a fatal outcome. Treat hypotension initially by slowing the infusion; additional standard therapy may be needed, including: vasopressors, positive inotropic agents and volume expansion. • In 4.9% (90/1836) of patients in clinical trials, drug-related bradycardia that was not dose-related occurred while patients were receiving intravenous amiodarone for life-threatening VT/VF. Treat bradycardia by slowing the infusion rate or discontinuing NEXTERONE. Treat patients with a known predisposition to bradycardia or AV block with NEXTERONE in a setting where a temporary pacemaker is available. • Elevations of blood hepatic enzyme values ALT, AST, GGT are commonly seen in patients with immediately life-threatening VT/VF. / In patients with life-threatening arrhythmias, the potential risk of hepatic injury should be weighed against the potential benefit of NEXTERONE therapy. Carefully monitor patients receiving NEXTERONE for evidence of progressive hepatic injury. In such cases, consider reducing the rate of administration or withdrawing NEXTERONE. • Like all antiarrhythmics, NEXTERONE may cause worsening of existing arrhythmias or precipitate a new arrhythmia. Monitor patients for QTc prolongation during infusion with NEXTERONE. Reserve the combination of amiodarone with other antiarrhythmic therapies that prolong the QTc to patients with life-threatening ventricular arrhythmias who are incompletely responsive to a single agent. • There have been postmarketing reports of acute-onset (days to weeks) pulmonary injury in patients treated with intravenous amiodarone. Findings included pulmonary infi filtrates and masses on X-ray, bronchospasm, wheezing, fever, dyspnea, cough, hemoptysis, and hypoxia. Some cases have progressed to respiratory failure or death. Two percent (2%) of patients were reported to have acute respiratory distress syndrome (ARDS) during clinical studies involving 48 hours of therapy. Pulmonary toxicity including pulmonary fifibrosis is a well-recognized complication of long-term amiodarone use. • Amiodarone inhibits peripheral conversion of thyroxine (T4) to triiodothyronine (T3) and may cause increased T4 levels, decreased T3 levels, and increased levels of inactive reverse T3 (rT3) in clinically euthyroid patients. Amiodarone can cause either hypothyroidism or hyperthyroidism. Evaluate thyroid function prior to treatment and periodically thereafter, particularly in elderly patients, and in any patient with a history of thyroid nodules, goiter, or other thyroid dysfunction. Because of the slow elimination of amiodarone and its metabolites, high plasma iodide levels, altered thyroid function, and abnormal thyroid function tests may persist for several weeks or even months following NEXTERONE withdrawal. • The most important adverse reactions were hypotension, asystole/cardiac arrest/pulseless electrical activity (PEA), cardiogenic shock, congestive heart failure, bradycardia, liver function test abnormalities, VT, and AV block. The most common adverse reactions leading to discontinuation of intravenous amiodarone therapy were hypotension (1.6%), asystole/cardiac arrest/PEA (1.2%), VT (1.1%), and cardiogenic shock (1%). • Drug Interactions • Since amiodarone is a substrate for CYP3A and CYP2C8, drugs/substances that inhibit these isoenzymes may decrease the metabolism and increase serum concentration of amiodarone. • Amiodarone inhibits p-glycoprotein and certain CYP450 enzymes, including CYP1A2, CYP2C9, CYP2D6, and CYP3A. This inhibition can result in unexpectedly high plasma levels of other drugs which are metabolized by those CYP450 enzymes or are substrates for p-glycoprotein. HMG-CoA reductase inhibitors that are CYP3A4 substrates in combination with amiodarone have been associated with reports of myopathy/rhabdomyolysis. Limit the dose of simvastatin in patients on amiodarone to 20 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required. • Some drugs/substances are known to accelerate the metabolism of amiodarone by stimulating the synthesis of CYP3A (enzyme induction). This may lead to low amiodarone serum levels and potential decrease in effi ficacy. Fluoroquinolones, macrolide antibiotics, and azoles are known to cause QTc prolongation. There have been reports of QTc prolongation, with or without TdP, in patients taking amiodarone when fluoroquinolones, macrolide antibiotics, or azoles were administered concomitantly. Please see brief summary of Full Prescribing Information on the following pages.

Baxter Healthcare Corporation Deerfield, IL 60015

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111932 07/13

NEXTERONE (amiodarone HCl) Premixed Injection for intravenous use Brief Summary of Prescribing Information. See PI for Full Prescribing Information. 1 INDICATIONS AND USAGE NEXTERONE is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. NEXTERONE also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with NEXTERONE, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2) in full prescribing information]. Use NEXTERONE for acute treatment until the patient’s ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but NEXTERONE may be safely administered for longer periods if necessary. 4 CONTRAINDICATIONS NEXTERONE is contraindicated in patients with: • Known hypersensitivity to any of the components of NEXTERONE Premixed Injection, including iodine. Hypersensitivity reactions may involve rash, angioedema, cutaneous/mucosal hemorrhage (bleeding), fever, arthralgias (joint pains), eosinophilia (abnormal blood counts), urticaria (hives), thrombotic thrombocytopenic purpura, or severe periarteritis (inflammation around blood vessels). • Cardiogenic shock. • Marked sinus bradycardia. • Second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available. 5 WARNINGS AND PRECAUTIONS NEXTERONE should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias, who are thoroughly familiar with the risks and benefits of amiodarone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment. 5.1 Hypotension Hypotension is the most common adverse reaction seen with intravenous amiodarone. In clinical trials, treatment-emergent, drug-related hypotension was reported as an adverse effect in 288 (16%) of 1836 patients treated with intravenous amiodarone. Clinically significant hypotension during infusions was seen most often in the first several hours of treatment and was not dose related, but appeared to be related to the rate of infusion. Hypotension necessitating alterations in intravenous amiodarone therapy was reported in 3% of patients, with permanent discontinuation required in less than 2% of patients. Treat hypotension initially by slowing the infusion; additional standard therapy may be needed, including the following: vasopressor drugs, positive inotropic agents, and volume expansion. Monitor the initial rate of infusion closely and do not exceed the recommended rate [see Dosage and Administration (2) in full prescribing information]. In some cases, hypotension may be refractory and result in a fatal outcome [see Adverse Reactions (6.2) in full prescribing information]. 5.2 Bradycardia and Atrio-ventricular Block In 90 (4.9%) of 1836 patients in clinical trials, drug-related bradycardia that was not dose-related occurred while they were receiving intravenous amiodarone for life-threatening VT/VF. Treat bradycardia by slowing the infusion rate or discontinuing NEXTERONE. In some patients, inserting a pacemaker is required. Despite such measures, bradycardia was progressive and terminal in 1 patient during the controlled trials. Treat patients with a known predisposition to bradycardia or AV block with NEXTERONE in a setting where a temporary pacemaker is available. 5.3 Liver Enzyme Elevations Elevations of blood hepatic enzyme values [alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT)] are commonly seen in patients with immediately life-threatening VT/VF. Interpreting elevated AST activity can be difficult because the values may be elevated in patients who have had recent myocardial infarction, congestive heart failure, or multiple electrical defibrillations. Approximately 54% of patients receiving intravenous amiodarone in clinical studies had baseline liver enzyme elevations, and 13% had clinically significant elevations. In 81% of patients with both baseline and on-therapy data available, the liver enzyme elevations either improved during therapy or remained at baseline levels. Baseline abnormalities in hepatic enzymes are not a contraindication to treatment. Acute, centrolobular confluent hepatocellular necrosis leading to hepatic coma, acute renal failure, and death has been associated with the administration of intravenous amiodarone at a much higher loading dose concentration and much faster rate of infusion than recommended [see Dosage and Administration (2) in full prescribing information]. In patients with life-threatening arrhythmias, the potential risk of hepatic injury should be weighed against the potential benefit of NEXTERONE therapy. Carefully monitor patients receiving NEXTERONE for evidence of progressive hepatic injury. In such cases, consider reducing the rate of administration or withdrawing NEXTERONE. 5.4 Proarrhythmia Like all antiarrhythmic agents, NEXTERONE may cause a worsening of existing arrhythmias or precipitate a new arrhythmia. Proarrhythmia, primarily torsade de pointes (TdP), has been associated with prolongation, by intravenous amiodarone, of the QTc interval to 500 ms or greater. Although QTc prolongation occurred frequently in patients receiving intravenous amiodarone, TdP or new-onset VF occurred infrequently (less than 2%). Monitor patients for QTc prolongation during infusion with NEXTERONE. Reserve the combination of amiodarone with other antiarrhythmic therapies that prolong the QTc to patients with life-threatening ventricular arrhythmias who are incompletely responsive to a single agent. Fluoroquinolones, macrolide antibiotics, and azoles are known to cause QTc prolongation. There have been reports of QTc prolongation, with or without TdP , in patients taking amiodarone when fluoroquinolones, macrolide antibiotics, or azoles were administered concomitantly [see Drug Interactions (7) in full prescribing information].

Amiodarone causes thyroid dysfunction in some patients, which may lead to potentially fatal breakthrough or exacerbated arrhythmias. 5.5 Pulmonary Disorders Early-onset Pulmonary Toxicity There have been postmarketing reports of acute-onset (days to weeks) pulmonary injury in patients treated with intravenous amiodarone. Findings have included pulmonary infiltrates and masses on X-ray, bronchospasm, wheezing, fever, dyspnea, cough, hemoptysis, and hypoxia. Some cases have progressed to respiratory failure or death. ARDS Two percent (2%) of patients were reported to have adult respiratory distress syndrome (ARDS) during clinical studies involving 48 hours of therapy. Pulmonary Fibrosis Only 1 of more than 1000 patients treated with intravenous amiodarone in clinical studies developed pulmonary fibrosis. In that patient, the condition was diagnosed 3 months after treatment with intravenous amiodarone, during which time the patient received oral amiodarone. Pulmonary toxicity is a well-recognized complication of long-term amiodarone use (see package insert for oral amiodarone). 5.6 Loss of Vision Cases of optic neuropathy and optic neuritis, usually resulting in visual impairment, have been reported in patients treated with oral amiodarone. In some cases, visual impairment has progressed to permanent blindness. Optic neuropathy and neuritis may occur at any time following initiation of therapy. A causal relationship to the drug has not been clearly established. Perform an ophthalmic examination if symptoms of visual impairment appear, such as changes in visual acuity and decreases in peripheral vision. Re-evaluate the necessity of amiodarone therapy if optic neuropathy or neuritis is suspected. Perform regular ophthalmic examination, including fundoscopy and slit-lamp examination, during administration of NEXTERONE. 5.7 Long-Term Use There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks. See package insert for oral amiodarone. 5.8 Thyroid Abnormalities Amiodarone inhibits peripheral conversion of thyroxine (T4) to triiodothyronine (T3) and may cause increased T4 levels, decreased T3 levels, and increased levels of inactive reverse T3 (rT3) in clinically euthyroid patients. Amiodarone is also a potential source of large amounts of inorganic iodine and can cause either hypothyroidism or hyperthyroidism. Evaluate thyroid function prior to treatment and periodically thereafter, particularly in elderly patients, and in any patient with a history of thyroid nodules, goiter, or other thyroid dysfunction. Because of the slow elimination of amiodarone and its metabolites, high plasma iodide levels, altered thyroid function, and abnormal thyroid function tests may persist for several weeks or even months following NEXTERONE withdrawal. There have been postmarketing reports of thyroid nodules/thyroid cancer in patients treated with amiodarone. In some instances hyperthyroidism was also present [see Adverse Reactions (6.2) in full prescribing information]. Hyperthyroidism and Thyrotoxicosis Hyperthyroidism occurs in about 2% of patients receiving amiodarone, but the incidence may be higher among patients with prior inadequate dietary iodine intake. Amiodarone-induced hyperthyroidism usually poses a greater hazard to the patient than hypothyroidism because of the possibility of thyrotoxicosis and arrhythmia breakthrough or aggravation, all of which may result in death. There have been reports of death associated with amiodarone-induced thyrotoxicosis. Consider the possibility of hyperthyroidism if any new signs of arrhythmia appear. Identify hyperthyroidism by relevant clinical signs and symptoms, subnormal serum levels of thyroid stimulating hormone (TSH), abnormally elevated serum free T4, and elevated or normal serum T3. Since arrhythmia breakthroughs may accompany amiodarone-induced hyperthyroidism, aggressive medical treatment is indicated, including, if possible, dose reduction or withdrawal of amiodarone. Amiodarone hyperthyroidism may be followed by a transient period of hypothyroidism. The institution of antithyroid drugs, Ƶ-adrenergic blockers or temporary corticosteroid therapy may be necessary. The action of antithyroid drugs may be especially delayed in amiodarone-induced thyrotoxicosis because of substantial quantities of preformed thyroid hormones stored in the gland. Radioactive iodine therapy is contraindicated because of the low radioiodine uptake associated with amiodarone-induced hyperthyroidism. When aggressive treatment of amiodarone-induced thyrotoxicosis has failed or amiodarone cannot be discontinued because it is the only drug effective against the resistant arrhythmia, surgical management may be an option. Experience with thyroidectomy as a treatment for amiodarone-induced thyrotoxicosis is limited, and this form of therapy could induce thyroid storm. Therefore, surgical and anesthetic management require careful planning. Neonatal Hypo- or Hyperthyroidism Amiodarone can cause fetal harm when administered to a pregnant woman. Although amiodarone use during pregnancy is uncommon, there have been a small number of published reports of congenital goiter/hypothyroidism and hyperthyroidism associated with oral administration. Inform the patient of the potential hazard to the fetus if NEXTERONE is administered during pregnancy or if the patient becomes pregnant while taking NEXTERONE. Hypothyroidism Hypothyroidism has been reported in 2% to 4% of patients in most series, but in 8% to 10% in some series. This condition may be identified by relevant clinical symptoms and particularly by elevated serum TSH levels. In some clinically hypothyroid amiodarone-treated patients, free thyroxine index values may be normal. Manage hypothyroidism by reducing the NEXTERONE dose and considering the need for thyroid hormone supplement. However, therapy must be individualized, and it may be necessary to discontinue oral amiodarone in some patients.

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

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

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

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

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

Thyroid: d thyroid nodules/thyroid cancer

6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a total of 1836 patients in controlled and uncontrolled clinical trials, 14% of patients received intravenous amiodarone for at least one week, 5% received it for at least 2 weeks, 2% received it for at least 3 weeks, and 1% received it for more than 3 weeks, without an increased incidence of severe adverse reactions. The mean duration of therapy in these studies was 5.6 days; median exposure was 3.7 days. The most important adverse reactions were hypotension, asystole/cardiac arrest/pulseless electrical activity (PEA), cardiogenic shock, congestive heart failure, bradycardia, liver function test abnormalities, VT, and AV block. Overall, treatment was discontinued for about 9% of the patients because of adverse reactions. The most common adverse reactions leading to discontinuation of intravenous amiodarone therapy were hypotension (1.6%), asystole/cardiac arrest/PEA (1.2%), VT (1.1%), and cardiogenic shock (1%). Table 4 lists the most common (incidence *2%) adverse reactions during intravenous amiodarone therapy considered at least possibly drug-related. These data were collected in clinical trials involving 1836 patients with life-threatening VT/VF. Data from all assigned treatment groups are pooled because none of the adverse reactions appeared to be dose-related. Table 4: ADVERSE REACTIONS IN PATIENTS RECEIVING INTRAVENOUS AMIODARONE IN CONTROLLED AND OPEN-LABEL STUDIES (> 2% INCIDENCE) Study Event

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

Controlled Studies (n=814)

Open-Label Studies (n=1022)

Total (n=1836)

Body as a whole

Body as a whole 13 (1.2%)

Body as a whole 37 (2.0%)

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

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

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

Other adverse reactions reported in less than 2% of patients receiving intravenous amiodarone in controlled and uncontrolled studies included the following: abnormal kidney function, atrial fibrillation, diarrhea, increased ALT, increased AST, lung edema, nodal arrhythmia, prolonged QT interval, respiratory disorder, shock, sinus bradycardia, Stevens-Johnson syndrome, thrombocytopenia, VF, and vomiting. 6.2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of amiodarone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body as a Whole: anaphylactic/anaphylactoid reaction (including shock), fever

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

Vascular: r vasculitis 7 DRUG INTERACTIONS Since amiodarone is a substrate for CYP3A and CYP2C8, drugs/substances that inhibit these isoenzymes may decrease the metabolism and increase serum concentration of amiodarone. Amiodarone inhibits p-glycoprotein and certain CYP450 enzymes, including CYP1A2, CYP2C9, CYP2D6, and CYP3A. This inhibition can result in unexpectedly high plasma levels of other drugs which are metabolized by those CYP450 enzymes or are substrates for p-glycoprotein. HMG-CoA reductase inhibitors that are CYP3A4 substrates in combination with amiodarone has been associated with reports of myopathy/rhabdomyolysis. Limit the dose of simvastatin in patients on amiodarone to 20 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required. Some drugs/substances are known to accelerate the metabolism of amiodarone by stimulating the synthesis of CYP3A (enzyme induction). This may lead to low amiodarone serum levels and potential decrease in efficacy. Fluoroquinolones, macrolide antibiotics, and azoles are known to cause QTc prolongation. There have been reports of QTc prolongation, with or without TdP, in patients taking amiodarone when fluoroquinolones, macrolide antibiotics, or azoles were administered concomitantly. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Category D Reproductive and teratology studies performed in rabbits and rats at doses of up to 100 mg/kg per day (about 1.4 times the maximum recommended human dose on a body surface area basis) revealed no evidence of embryotoxicity at 5 mg/kg and no teratogenicity was observed at any dosage in rabbits. Maternal toxicity and embryotoxicity were observed in rats in the 100 mg/kg group. Use NEXTERONE during pregnancy only if the potential benefit to the mother justifies the risk to the fetus. 8.2 Labor and Delivery It is not known whether the use of amiodarone during labor or delivery has any immediate or delayed adverse effects. 8.3 Nursing Mothers Amiodarone and one of its major metabolites, desethylamiodarone (DEA), are excreted in human milk, suggesting that breast-feeding could expose the nursing infant to a significant dose of the drug. 8.4 Pediatric Use The safety and effectiveness of amiodarone in pediatric patients have not been established; therefore, the use of amiodarone in pediatric patients is not recommended. 8.5 Geriatric Use Clinical studies of amiodarone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Carefully consider dose selection in an elderly patient. 10 OVERDOSAGE There have been cases, some fatal, of amiodarone overdose. Effects of an inadvertent overdose of intravenous amiodarone include hypotension, cardiogenic shock, bradycardia, AV block, and hepatotoxicity. Treat hypotension and cardiogenic shock by slowing the infusion rate or with standard therapy: vasopressor drugs, positive inotropic agents, and volume expansion. Bradycardia and AV block may require temporary pacing. Monitor hepatic enzyme concentrations closely. Amiodarone is not dialyzable.

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

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

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

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

111923 04/13

12 Policy

Pharmacy Practice News • June 2014

Health Care Reform Part 1 of a two-part series

Medical Home Model Shows Some Cracks P Table 1. Medical Homes Reduce Cost and Improve

atient-centered medical homes (PCMHs) may improve care and reduce costs only for the most complex and high-cost patients, two new studies suggest. For pharmacists, the findings beg two questions: Who are those patients and how can pharmacists working in PCMHs best serve them? “We spend lots of time and energy trying to meet the needs of all PCMH members, but the volume exceeds our resource capacity as pharmacists,” said Candice Garwood, PharmD, who is a clinical pharmacy specialist at the Rosa Parks Wellness Institute for Senior Health, a medical home that is part of the Detroit Medical Center, and was not involved in the research. “What these studies suggest is that we need to develop some way to estimate risk so that we can target those subgroups of patients who would benefit most from our services,” said Dr. Garwood, who is also a clinical associate professor at Wayne State University Eugene Applebaum College of Pharmacy and Health Sciences in Detroit.

Nearly a Dozen Measures Of Quality Assessed Running counter to some studies documenting positive PCMH outcomes (Table 1), the new studies indicate that a more focused approach is needed to make the PCMH strategy viable. In the first study, lead investigator Mark Friedberg, MD, who is a natural scientist at the RAND Corporation and clinical instructor in medicine in the Division of General Internal Medicine at Brigham and Women’s Hospital and Harvard Medical School, in Boston, and his colleagues analyzed data from 64,243 patients treated between June 2008 and June 2011 at 32 primary care practices that shifted to a PCMH model in 2008 (JAMA ( 2014;311:815-825). The PCMHs are part of the Southeastern Pennsylvania Chronic Care Initiative, which is one of the largest multipayor PCMH pilots in the country. Dr. Friedberg’s team documented 11 quality-measure outcomes for diabetes and asthma care and for preventive care, and also analyzed 11 measures of health care costs and utilization for inpatient, emergency department and ambulatory care. They compared these data with information from 55,959 patients treated over the same period at 29 matched primary care practices in Pennsylvania that did not adopt a PCMH model. All outcome measures were similar at study outset among the PCMHs and non-PCMH practices. Of the 22 measures, only nephropathy monitoring in patients with diabetes

Practice Organization

Health Information Technology

Quality Measures

Patient Experience

Quality Alaska Native Medical Center, Anchorage, AK • 50% fewer urgent care and emergency room visits • 53% fewer hospital admissions • 65% reduction in specialist utilization

Capital Health Plan, Tallahassee, FL • 40% fewer inpatient stays • 37% fewer emergency room visits • 18% lower health care claims costs

Geisinger Health System, Danville, PA • 25% fewer hospital admissions • 50% fewer hospital readmissions • 7% lower cumulative total spending

Group Health of Washington, Seattle, WA • 15% fewer inpatient stays • 15% fewer hospital readmissions • Estimated cost savings of $15 million (2009-2010) • 18%-65% improvements in medication management Source: Patient-Centered Primary Care Collaborative (

‘The next critical phase of PCMH development should focus on its strategic deployment for the care of high-utilization patients.’ —Thomas Schwenk, MD

Table 2. Quality and Utilization Outcomes in PCMHs Significantly better in PCMH setting • Nephropathy monitoring

No significant difference • HbA1c testing • HbA1c abnormal • LDL-C testing • LDL-C abnormal • Eye examinations • Asthma appropriate medication for pediatric patients • Breast cancer screening • Cervical cancer screening • Chlamydia screening • Colorectal cancer screening • All-cause hospitalization • Hospitalizations likely preventable by optimal ambulatory care • All-cause ED visits • Ambulatory care-sensitive ED visits • Primary care ambulatory visits • Specialist ambulatory care visits • Total costs of care • Two hospitalizations within one year, all causes • Three or more hospitalizations within one year, all causes • Two ED visits within one year, all causes • Three or more ED visits within one year, all causes ED, emergency department; Hb, hemoglobin; LDL-C, low-density lipoprotein cholesterol; PCMH, patient-centered medical home Source: JAMA 2014;311:815-825.

Family Medicine

was significantly better in the PCMHs, the investigators found (Table 2). Specifically, the baseline nephropathy monitoring rate for diabetes patients treated in PCMHs was 72.8%, and rose to 78% at the end of the first year after PCMH adoption ((P not significant). The monitoring rates increased to 81.1% at the end of the second year and remained steady at 82.7% at the end of the third year ((P<0.001).

Unselected Approach Won’t Work In an accompanying JAMA editorial, Thomas Schwenk, MD, University of Nevada School of Medicine, Pennington Medical Education in Reno, wrote that the study had done “a great service for advocates of the PCMH by effectively ending promotion of this care model as a generic, low-level, unselective approach to health care delivery for all” ((JAMA 2014;311:802-803). “The next critical phase of PCMH development should focus on its strategic deployment for the care of high-utilization patients,” Dr. Schwenk wrote. That conclusion seems to be supported by a separate analysis of 17 PCMHs in Pennsylvania, some of which were also included in the JAMA analysis ((Am J Manag Care 2014;20:e61-e71). Lead researcher Susannah Higgins, MS, who is a research scientist at Independence Blue Cross (IBC) in Philadelphia, and her colleagues used IBC claims data from 2009 to 2011 to compare utilization rates and costs for 6,940 PCMH patients and the same number of matched patients from 103 non-PCMH practices. In addition to studying the general patient population, they analyzed a subset of 654 PCMH patients and 734 non-PCMH patients who were the top 10% of health care users. They identified these patients by using a risk model incorporating age, gender and diagnoses. Similar to the JAMA study, Ms. Higgins’ group did not find significant differences in health care utilization and costs in the general population of PCMH and non-PCMH patients. However, in the high-cost subgroup, average monthly per-patient health care costs were $107 lower in the PCMH group than in the non-PCMH

Policy 13

Pharmacy Practice News • June 2014

Health Care Reform group at the end of year 1 ((P=0.04). The largest portion of the savings was related to a reduction in hospital admissions in PCMH patients, Ms. Higgins said. This, in turn, was likely a result of “overall better coordination of care of PCMH practices.” A spokesperson for IBC of Philadelphia, which sponsored the analysis, noted that most patients in the study had multiple chronic illnesses, including congestive heart failure, chronic obstructive pulmonary disease, diabetes and asthma. “These patients experience a disproportionately high number of hospital stays and costly health care services and are the patients for whom the PCMH model was designed to help most,” said the spokesperson, noting that IBC is analyzing correlations between specific PCMH features and quality, utilization and cost outcomes. “This research will help us understand which aspects of becoming a PCMH are most closely associated with success.”

A Study Weakness: ‘Nondescript’ PCMH Classifications That level of information would be critical in interpreting the findings, suggested Erika Smith, PharmD, BCPS, who is the clinical pharmacy manager at Froedtert & the Medical College of Wisconsin in Milwaukee, and an expert on PCMHs. “Simply stating that these were recognized medical homes, as the studies did, is a very nondescript classification,” said Dr. Smith, who was not involved in the research. “There can be significant differences in the processes and methods of different PCMHs, and it is hard to ascertain what interventions and processes were being utilized by the Pennsylvania PCMHs to improve patient care, and which of those were most successful.” Dr. Smith also said that a patient’s health care needs vary drastically based on health status, genetics “and luck,” and pharmacists need to take these factors into account to “stratify and layer care, resources, interventions and team members to support the specific patient most effectively and appropriately.” As for the type of care that pharmacists should provide in the PCMH context, Dr. Smith pointed to two schools of thought. The first is the pharmacist as “extender” of the primary care approach, which involves medication histories and reconciliation, medication education, and medication titration or management for common disease states such as hypertension and diabetes, Dr. Smith explained. “This approach potentially allows physicians to have more time with patients, performing complex clinical work,” she said. The second school of thought has pharmacists removing barriers to

adherence in the highest-risk patients by providing patient education, managing those receiving multiple medications, discontinuing unnecessary medications, addressing cost issues and collaborating with primary care providers and specialists. “This approach to high-risk patient management is holistic and takes into account a patient’s self-management skills as well as anything that can be done both from a medication and nonmedication perspective, to keep the patient well,” Dr. Smith said.

Reimbursement issues add to the challenge of adopting a universal approach to PCMH pharmacy care, she noted. “In many cases, we are still working to gain provider buy-in and prove our abilities, and our reimbursement options are severely limited. So, the processes of implementing, optimizing and measuring our services are not standardized. “As we are eventually challenged to standardize our processes and prove that pharmacists are a necessary part of the PCMH, we’ll need to hone in on

what specifically the pharmacist brings to the PCMH health care team.” —David Wild Drs. Garwood and Smith reported no relevant financial conflicts of interest. Ms. Higgins reported receiving funding for her study from Independence Blue Cross Philadelphia. Dr. Friedberg reported receiving study funding from the Commonwealth Fund and Aetna.

Part 2, July: Profiles of medical homes that have benefitted from pharmacist involvement.

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14 Clinical

Pharmacy Practice News • June 2014


PREVENTION GAP continued from page 1

In a study of patients with MM or mantle cell lymphoma (MCL) treated with proteasome inhibitors at the Karmanos Cancer Center, in Detroit, 29% of the 83 patients were not receiving antiviral prophylaxis for herpes zoster (poster 117). The National Comprehensive Cancer Network Guidelines (NCCN) recommend herpes zoster prophylaxis, without suggesting a specific dosing regimen, for patients treated with the proteasome inhibitors bortezomib (Velcade, Millennium) or carfilzomib (Kyprolis, Onyx). The guidelines list both acyclovir and valacyclovir as options to prevent herpes. The NCCN recommendation is based on evidence from several studies identifying a need for precautionary measures when these drugs are used. In one study, the prevalence of herpes zoster was 13% in patients with MM who were being treated with bortezomib ((J Clin Oncol 2008;26:4784-4790). In another report, the prevalence of herpes was 10.3% in patients with MCL or indolent B-cell lymphoma receiving chemotherapy, including bortezomib ((Leuk Lymphoma 2013;54:2185-2189).

Table. Risk Assessment Model for Managing VTE In MM Patients Treated With Immunomodulators Risk Factors

Recommended Action

Individual risk factors • Obesity (BMI ≥30 kg/m2) • Previous VTE • CVAD or pacemaker • Cardiac disease • Chronic renal disease (CrCl <30 mL/min) • Diabetes • Acute infection • Immobilization • Surgery • General surgery • Anesthesia • Trauma • Use of erythropoietin-stimulating agents • Blood-clotting disorders

No risk factor or one individual/MM risk factor Aspirin 81-325 mg once daily ≥2 individual/MM risk factors and/or receiving MM therapy LMWH (equivalent of enoxaparin 40 mg once daily) or full-dose warfarin (target INR 2-3)

MM-related risk factors • Diagnosis of myeloma • Hyperviscosity MM therapy Thalidomide or lenalidomide in combination with dexamethasone (≥480 mg/mo), doxorubicin, multiagent chemotherapy BMI, body mass index; CrCl, creatinine clearance; CVAD, central venous access device; INR, international normalized ratio; LMWH, low-molecular-weight heparin; MM, multiple myeloma; VTE, venous thromboembolism

Retrospective Chart Review In the Karmanos Cancer Center study, clinicians conducted a retrospective chart review of patients with MM or MCL receiving bortezomib or carfilzomib at the infusion center from January 2012 through July 2013. Among 83 patients, 71% received the recommended prophylaxis and 29% did not. The rate of herpes zoster was significantly higher in patients who did not receive prophylaxis (25% vs. 6.8%; P=0.03). “I was surprised that 29% of the study population was not receiving antivi-

ral prophylaxis,” said lead author of the study Che Min Chang, PharmD, an oncology pharmacy resident at Karmanos Cancer Center. “Our study shows opportunities for pharmacists to play a role in improving medication compliance. Hospitals can ensure higher

adherence to antiviral prophylaxis with patient education and medication reconciliation during clinic visits. Also, the addition of reminders into a paper or electronic chemotherapy order template may help physicians with ordering [of ] the medication.”

VTE Prevention In a second study presented at the HOPA meeting, investigators from University of Cincinnati Medical Center found that few patients with MM who are at increased risk for VTE are receiving the recommended prophylactic therapy to avoid this side effect (poster 7). Patients with MM have an increased incidence of VTE; the risk is heightened when patients are on immunomodulatory drugs. Studies have shown that when thromboprophylaxis is not used, VTE affects 26% to 75% of newly diagnosed and 11% to 15% of relapsed/refractory patients with MM ((Blood d 2006;108:403; N Engl J Med d 2007;357:2123-2132). The University of Cincinnati investigators retrospectively studied 62 patients with MM who were receiving immunomodulatory drugs at the medical center and found that 33.9% were given the recommended prophylactic VTE therapy, per the NCCN guidelines (Table). The investigators, led by Ruth Dede, PharmD, an oncology pharmacy resident at the medical center, also found that the risk for developing a VTE was more than double when patients did not receive the NCCN-recommended VTE preventive care. Among patients who received the NCCN-recommended prophylaxis, 4.8% developed a VTE, whereas among those who did not receive the appropriate prophylaxis, 12.2% developed a VTE. The small sample size prevented this difference from being statistically significant, but Dr. Dede said the study results should still spur changes at her institution. “I plan to present my findings to the physicians who care for these patients,” Dr. Dede said in an interview with Pharmacy Practice News. Moreover, “I hope to develop a best practice advisory [to incorporate] into the computer physician order entry system.”

Improving Adherence to Evidence-Based Guidelines for Cancer NEW ORLEANS—Various studies have demonstrated that many cancer patients do not receive therapy recommended in guidelines, such as those from the National Comprehensive Cancer Network. A new study reveals that implementation of an oncology prior authorization system through a Web-based portal can increase the use of evidence-based clinical pathway treatment plans by roughly 15%. “Providers and payors are both increasingly collaborating to improve outcomes and reduce costs and treatment variation. One of the solutions that has been successfully used is the adoption of clinical pathways,” said Barry Peterson, PharmD, BCOP, BCPS, an informatics/pharmacoeconomic specialist at New Century Health (NCH), Brea, Calif., who presented the study during the 2014 Hematology/Oncology Pharmacy Association (HOPA) annual conference. NCH implemented the chemotherapy prior authorization system at a midwestern oncology network that includes about 60,000 insured members. Using this system, physicians submit their chemotherapy treatment request through an online portal. If the

request doesn’t meet evidence-based guidelines, it is flagged for review by an NCH oncologist, who then calls the prescribing physician. The study compared treatment plan adherence to evidence-based clinical pathways and compendia recommendations before and after the initiation of the prior authorization system. Clinicians focused on compendium adherence rates for treatment of breast, colon, prostate and lung cancers, as well as lymphoma and multiple myeloma. The on-compendium rate was defined as the number of chemotherapy treatment requests reviewed that complied with Centers for Medicare & Medicaid Services–approved compendia, divided by the total chemotherapy requests reviewed. At baseline, the first quarter of 2011, the on-compendium rate was 82.6%. During the review period, the second quarter of 2011 to the fourth quarter of 2012, adherence jumped to 91.8% (P=0.021). “In quarter 4 of 2012, we had 118 chemotherapy requests, of which 115 met guideline-baseline therapy; so now, we are up to about 97.5%,” Dr. Peterson said.

Bruce A. Feinberg, DO, the vice president and the chief medical officer at Cardinal Health Specialty Solutions, in Dublin, Ohio, has more than 30 years working as a community oncologist and almost two decades working specifically with clinical pathways. He said many factors affect physician compliance with clinical pathways. “User-friendly technology— especially technology that removes or reduces administrative burdens, like prior authorization—is definitely one of those factors.” An array of additional factors contributes to compliance with guidelines, Dr. Feinberg said, noting that “the most significant factors that contribute to high rates of compliance, are respect for the physician– patient relationship, direct physician engagement in pathway design, true provider–payor collaboration that aligns incentives, compliance thresholds that permit autonomy and individualized patient care.” —K.O. Drs. Peterson and Feinberg reported no relevant financial conflicts of interest.

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Pharmacy Practice News • June 2014

Oncology More Aggressive Care Needed Jessica Poirier Duda, PharmD, BCOP, a clinical specialist pharmacist in hematology/oncology at the Arthur G. James Cancer Hospital & Richard J. Solove Research Institute at The Ohio State University, in Columbus, said she was not surprised by the results of either study because other investigators have documented poor adherence to guideline therapy. “Both studies confirm the need for appropriate supportive-care medications while patients are on specific chemotherapy agents, such as aspirin for immunomodulatory agents and acyclovir for proteasome inhibitors,” Dr. Duda commented. She added that the studies confirm the risks for certain significant adverse drug events when appropriate prophylaxis is not used. Beyond that, “there are two important take-away points,” Dr. Duda said. “One, there is still an important need for pharmacist interventions to make

‘I plan to present my findings to the physicians who care for these patients, and I hope to develop a best practice advisory to incorporate into the [CPOE] system.’ —Ruth Dede, PharmD sure patients are prescribed appropriate prophylaxis. There are many potential interventions to improve adherence, such as the development of chemotherapy treatment plans, medication reconciliation with chemotherapy, and nursing and

provider in-services. Second, we have a unique opportunity to educate patients on these supportive therapies, so they understand the importance of why they need to take the medications to improve adherence.” For example, she said, there

is a difference between telling patients they need to start acyclovir while on bortezomib, and explaining the risk for shingles with bortezomib and the importance of taking acyclovir as prescribed. Overall, Dr. Duda said, the studies underscore the importance of active involvement of pharmacists to ensure safe and appropriate delivery of chemotherapy. —Kate O’Rourke Drs. Chang, Dede and Duda reported no relevant financial conflicts of interest.



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utisPharma has announced the introduction of FIRST®Vancomycin oral solution compounding kits for the treatment of Clostridium difficile. The solution can be compounded in 60 seconds by adding a premeasured measured white grape–fllavored solution n to a bottle of preweighed vancomycin hydrochloride powder and shaking the components to achieve the desired admixture, the company noted in a press release. The first-line therapy for mild to moderate cases of C. difficile is metronidazole, and the second-line therapy for severe infections or treatment failure is oral vancomycin, according to CutisPharma. These antibiotics, however, are only commercially available in oral solid dosage forms. The FIRST® -Vancomycin oral solution compounding kit provides an alternative for patients who have difficulty swallowing and for those who require feeding tubes. Pharmacists frequently use lyophilized, sterile vancomycin hydrochloride powder for injection and sterile water for injection to compound an oral vancomycin solution. This process can take up to 20 minutes and the solution can be unpalatable for some patients, the company noted. The kits are available in two concentrations: a 25 mg/mL strength in 5and 10-ounce sizes, and a 50 mg/mL strength in 5-, 7- and 10-ounce sizes, “for multiple and flexible dosing,” CutisPharma stated. For more information, visit

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16 Operations & Management

Pharmacy Practice News • June 2014

Practice Models

AMBULATORY CARE continued from page 1

care costs, that situation has changed,” he said. He cited, as one example, the community-based drug therapy management programs for asthma, diabetes and other chronic illnesses targeted by the Asheville Project ((J Am Pharm Assoc 2003;43:173-184; J Am Pharm Assoc 2006; 46:133-147; and others). Many of the lessons learned in such programs are reflected in the ASHP’s new recommendations on ambulatory pharmacy. In this second installment of a four-part series, Pharmacy Practice News presents the second domain of the recommendations, with commentary by key stakeholders.

Domain 2.1: Access and Efficacy This section of the recommendations calls for providing pharmacists with increased access to patients’ medical records to facilitate better-coordinated team care, according to Kelly Epplen, PharmD, BCACP, an assistant professor of clinical pharmacy practice and administrative sciences at the University of Cincinnati’s James L. Winkle College of Pharmacy, in Ohio. “One of the most significant aspects of ambulatory care pharmacy is that we see patients along the continuum of care,” noted Dr. Epplen, who presented the recommendations at the ASHP summit. “And one of the most critical points along that continuum is the transition from one [clinical] setting to another.” For these handoffs to work as seamlessly as possible, access to patients’ electronic medical records (EMRs) “is essential,” Dr. Epplen stresssed. The EMRs, she explained, enable pharmacists to make optimal treatment decisions and document notes on their interventions “that can be made available to other members of the health care team, so that they too, can make accurate and informed clinical decisions.” Unfortunately, “at the moment, not all pharmacists—particularly those practicing in the community pharmacy setting— have the EMR access they need,” Dr. Epplen pointed out. And that’s a serious gap, she stressed, because “we cannot have comprehensive, seamless transitions of care without the interventions provided by community pharmacists.” Tim Brown, PharmD, BCACP, FASHP, the director of clinical pharmacotherapy in family medicine at Akron General Medical Center’s Center for Family Medicine, in Ohio, agreed that this section of the domain is critical to the growth of ambulatory pharmacy. But he stressed that significant roadblocks remain. “Until pharmacists receive provider status, we’ll be fighting a bit of an uphill battle to obtain EMR access for all,” said Dr. Brown, who was present at the sum-

‘It’s still a rarity that ambulatory care pharmacists work side-by-side with [office-based] physicians ... and this is largely because physicians do not understand that we do more than dispense medications.’ —Kelly Epplen, PharmD, BCACP

team,” he said. “The question is what are the specific roles that we will take on within the team in the future?” As for the question of accountability, “it is logical that as our clinical roles evolve and deepen, we will carry more responsibility and accountability for the outcomes of the care we provide,” he said, “whether it be controlling hemoglobin A1C levels or ensuring [that] patients are appropriately vaccinated.”

Domain 2.5: Patient Scoring System Needed mit. “The case is easier to make for community pharmacies aligned with health systems, since their pharmacists often work for the system. However, when you’re talking about community-based retail pharmacies with many locations in a single city, advocating for them to be able to access medical information for any patient who walks through their doors becomes more of a challenge.” Should that retail pharmacy expansion happen? “Yes, it has to,” Dr. Brown said. “But the question is how do we ensure portability of medical information while meeting HIPAA requirements for privacy?” That has to be solved quickly, he noted, “so that quality patient care can be provided across the care continuum.”

Domain 2.2: Collaboration Domain 2.2 emphasizes the need for ambulatory care pharmacists to collaborate with other members of the health care team, to foster “seamless” care transitions. According to Dr. Epplen, this section addresses a critical challenge: If pharmacists don’t advocate for themselves, other providers will step in and fill that gap in ambulatory care. Indeed, “many references that allude to the provision of care by non-physicians do not specifically identify pharmacists as practitioners eligible to provide these services [http://]. By excluding pharmacists, it is implied that we are ancillary, not integral, components of health care delivery. We need to change this.” Dr. Brown stressed that collaboration is indeed crucial, but not only between pharmacists and other care providers. “We should also be talking about pharmacist-to-pharmacist collaboration,” he said. “For example, when an intensive care patient transfers onto the floor, the ICU pharmacist needs to speak with the medical floor pharmacist, who then needs to communicate with the primary care pharmacist as that patient transitions back into the community. This type of collaboration strengthens the care we provide, but it also strengthens the bond between pharmacists.”

Domain 2.3: Data-Driven Care Using HIT to identify patients “for whom evidence-based, comprehensive

medication management is indicated” is at the core of domain 2.3. Using HIT in this way “can help us target our interventions to high-cost patients and help us reduce health care costs for all stakeholders,” Dr. Epplen said. “Most of us do not have the resources to see all of the patients who walk through our doors.” Once such patients are identified and pharmacists intervene and provide direct patient care, HIT then can be used to document the value of those interventions, Dr. Brown noted. But that won’t happen until the profession does a better job advocating for itself, he stressed. “We really have not made our needs known to health IT systems developers. Pharmacists need to stand up and say, ‘listen, we’re providing direct patient care and we need templates that allow us to document both the care we provide and the impact of that care.’ In my own physician office setting, for example, the [HIT] system did not initially include templates for documenting clinical pharmacy services, but we worked with the software developer to create our own templates.” However, using HIT only to document interventions won’t cut it in today’s risksharing health care models, Dr. Brown pointed out. “It also is needed for monitoring treatment goals and, thereby, demonstrating our impact on the quality and cost of care,” he said. “This is becoming an increasingly important point as we talk more and more about taking on responsibility for costs and being held accountable for the care that we provide.”

Domain 2.4: Accountability Domain 2.4 restates the importance of having ambulatory care pharmacists be “integral members of the health care team,” but with an important added layer of “accountability for the care of patients and populations.” In Dr. Epplen’s view, this recommendation again emphasizes that ambulatory care pharmacists should reject any practice model that makes them only ancillary team members. Until such marginalized models disappear, she noted, “obtaining provider status will continue to be a challenge.” Dr. Brown noted that some inroads in status already have been made. “In many settings, pharmacists are indeed accepted as integral members of the health care

This section states that “ASHP and ASHP Foundation, working with other key professional stakeholders, must develop and promote” tools for identifying patients who are most in need of comprehensive medication management. “This recommendation comes back to the question of providing care in the most efficient manner by targeting the highestcost patients—in this case, those with the highest risk of drug-related adverse events,” Dr. Epplen said. “To help us identify those patients, we indeed need [HIT], as well as a validated screening tool that can be used in any ambulatory care setting and for all patients. At the moment, no such tool is widely used or promoted.” The medication regimen complexity index (MRCI) has been proposed as such a tool ((J Am Med Inform Assoc 2013;20:499-505), she said, but she added that more data is needed to validate it before it is widely used.

Domain 2.6: Winning Hearts And Minds This section emphasizes the importance “of [increasing] public, regulatory, and health professional understanding of pharmacists’ roles and the value [pharmacists] bring as members of interprofessional health care teams.” To that end, Dr. Epplen said, “one of the biggest kudos we’ve received is from a publication issued by the Centers for Disease Control and Prevention [CDC], highlighting the contributions … that pharmacists bring to the table [].” Despite the CDC endorsement, however, “our roles continue to be poorly understood by physicians, physicians’ assistants, nurse practitioners and other providers and stakeholders,” she said. Indeed, “it’s still a rarity that ambulatory care pharmacists work side-by-side with physicians in the physician office setting, and this is largely because physicians do not understand that we do more than dispense medications. They need to understand [that] we also can have a significant impact on medication-related outcomes when we collaborate with them.” Dr. Epplen stressed that those outcomes aren’t just clinical. “A separate message that needs to be conveyed to payors and health systems administrators is that we can implement effective cost savings ini-

Operations & Management 17

Pharmacy Practice News • June 2014

Practice Models tiatives as well,” she stressed. “Although we can’t always generate direct revenue in accountable care organizations and patient-centered medical homes, for example, what we can do in those settings is help organizations meet institutionlevel quality benchmarks and, thereby, reduce the risk of penalties for not meeting those benchmarked outcomes.” Hitting those key benchmarks, she noted, can have a significant effect on a health system’s bottom line. One study has shown, for example, “a return on an investment of up to $12 for every dollar spent on our services [[J Am Pharm Assoc 2008;48:203-211],” she said. “On the other hand, the same level of accountability may mean sharing in the financial risk if benchmarks are not met.” In Dr. Brown’s view, “You can sum up [domain 2.6] in one word: marketing. We need to let other providers know what we do—and not just other providers, but also managed care providers, disease prevention organizations like the CDC and governmental organizations like CMS [Centers for Medicare & Medicaid Services]. The public also needs to see [our value] through all stages of the continuum, from the community through inpatient stays and across the lifespan.”

tinuing education programs for pharmacy technicians. So, pharmacy technicians are gaining respect for their professionalism.”

Domain 2.8: Goal Setting According to this section, “pharmacists who provide ambulatory care services must partner with patients, families and caregivers to set goals of therapy and promote accountability for self-management.” That is a laudable target, Dr. Epplen noted. “We need to empower patients to accept a share of the respon-

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This section underscores a reality of pharmacy practice: For ambulatory pharmacy to gain the time needed to provide patient-focused care, more dispensing and distributive functions need to be passed “to pharmacy technicians and other members of the health care team.” Dr. Epplen said staffing pressures are often at the heart of this practice reality. In many cases, “ambulatory care administrators are reluctant to pay for additional pharmacist staffing, even when more pharmacy resources are needed. So we need to work with technicians to help make optimal use of our limited time.” In cases where a pharmacy technician is not on staff, she added, “another option is to work with medical assistants and have them perform tasks like blood pressure checks or fingersticks, for example, so that we can see more patients, interpret those results and perform the other more specialized tasks [that] we’re trained to do.” Dr. Brown agreed that pharmacy technicians can be a linchpin in advancing the cause of ambulatory pharmacy. In fact, “it would be a huge oversight not to name them as integral members of the ambulatory health care team,” he stressed. “Not only is the value of pharmacy technicians growing, their profession is evolving as well.” In the past, he explained, technician training was often provided on the job. “Although this still occurs, now there is standardized testing and certification programs; and many hospitals have con-

18 Spotlight on Technology

Pharmacy Practice News • June 2014

Access to Patient Data Key to Success Dallas—Ambulatory care pharmacists need increased access to electronic medical records (EMRs) and health information exchange networks, according to presenters at the inaugural American Society of Health-System Pharmacists (ASHP) Ambulatory Care Conference and Summit. “Pharmacists need to have access to all information … across the care continuum, if we are to support safe, efficient and effective medication use,” said Kelly Epplen, PharmD, BCACP, an assistant professor in the Department of Clinical Pharmacy Practice and Administrative Sciences at the University of Cincinnati’s James L. Winkle College of Pharmacy, in Ohio.

Spotty EMR Connectivity Dr. Epplen, who spoke at the ASHP Conference and Summit, said that at the moment, pharmacists practicing in ambulatory care settings “absolutely do not” have the type of information tech-

nology (IT) infrastructure they need to provide optimal services. The sentiment was echoed by Mary Ann Kliethermes, BS, PharmD, the vice chair of ambulatory care and associate professor at the Chicago College of Pharmacy at Midwestern University, in Downers Grove, Ill. “While connectivity between pharmacists and other providers is very good in some practices, in others it is not,” said Dr. Kliethermes, who also spoke at the ASHP’s Conference and Summit. Dr. Kliethermes said that even pharmacists who do have access to EMRs might find the process of extracting the information they need to provide appropriate care and then generating a note at the end of a clinical encounter to be “very time-consuming.”

Quick Data Sharing The good news for those with EMR access is that the technology to enable more efficient sharing of patient information exists. Furthermore, such tech-

nology is being adopted increasingly, according to Rachelle “Shelly” Spiro, RPh, FASCP, the executive director of the Pharmacy Health Information Technology (HIT) Collaborative, a national nonprofit organization that advocates on behalf of the pharmacy profession’s IT needs. Ms. Spiro explained that a growing segment of health care providers, including pharmacists with EMR access, now can electronically update a patient’s clinical information and send data to other health care team members or to patients themselves. The ability to do this comes from electronic documents that employ clinical document architecture (CDA), Ms. Spiro said. “There are several structured document templates that use CDA, including discharge summaries, progress notes and care plans,” she explained. “Each structured document has the capability to incorporate standardized clinical terms from the EMR, such as information

on new health problems, medicationrelated information and allergies. After providers add their own patient encounter notes, the document’s programming code translates the notes into standardized terminology and shares it in a way that is similar to email exchange.” A growing number of health IT providers are adding CDA-sharing functionality into their systems, Ms. Spiro said. For example, commercial health care exchange vendors that have joined the nonprofit DirectTrust network ( collectively provide CDA-sharing capabilities to more than 4,000 health care organizations and 100,000 individuals (see a partial list of vendors, page 19). Ensuring that pharmacists can access and update EMRs and share patient information just as other providers do


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AMBULATORY CARE continued from page 17

sibility for their care.” This can be done, she noted, by giving patients education and medication adherence tools that help them develop self-care skills. She added that in many states, pharmacy practice acts require patients to provide their signatures on collaborative practice agreements. “Patients become more accountable and engaged when they put their signature on paper,” Dr. Epplen said. “But this is not a fail-safe approach, and we need to develop other ways of creating patient accountability.” Dr. Brown agreed that “at the center of the health care team are patients and their families who need to understand how important they are to the success of the care they receive. But to achieve this level of understanding, we need to remove potential obstacles. For example,

what are their learning abilities? Do they understand the care plan [that] we and their other providers have developed with them? Are they health care–literate? If they don’t fully understand and don’t buy in to what we’re recommending, their outcomes will be poorer. This will also affect the data we need to demonstrate that our interventions are leading to clinical and cost improvements. In other words, for pharmacists to be successful, we must engage our patients in their [own] care.”

Support From CMS The core concept behind the ambulatory care initiative—putting pharmacists at the head of medication management efforts—is not a new one, Dr. Brown noted. Nevertheless, new developments continue to push this agenda forward. “An important milestone that has helped, and will continue to help,

‘Pharmacists need to stand up [to health IT systems developers] and say, “listen, we’re providing direct patient care and we need templates that allow us to document both the care we provide and the impact of that care.”’ —Tim Brown, PharmD, BCACP, FASHP

pharmacists secure a place as important members of the health care team is the [CMS] requirement that Medicare Part D sponsors have an established medication therapy management (MTM) program [http://go.cms. gov/1fNeDBT],” he said. “Since we are the experts at providing MTM, many have used this document as an opportunity to propel their integration into the health care team, which of course assists our profession in moving forward along its evolutionary path.”

Additional Drivers Mr. Anderson cited several additional factors that are bringing ambulatory pharmacy front and center. He noted, for example, that an increasing number of providers are assuming financial risks and thus need more practitioners focused on improving patient outcomes. Other drivers, he noted, include

CMS’s policy of reducing reimbursements to facilities whose 30-day rehospitalization rates are deemed excessive. “There’s a host of other metrics that various entities are tracking to assess the quality of your ambulatory care services,” Mr. Anderson said. “So the time is right to make sure those services are top-notch, and this Summit surely will help in those efforts.” —David Wild Drs. Epplen and Brown reported no relevant financial conflicts of interest to disclose. Mr. Anderson reported serving on the board of MCS Carelink, a firm that provides software analytics and medication adherence tools for ambulatory care pharmacy.

Part 3, July: Tips for creating sustainable ambulatory care business models and a call for recognition of pharmacists as health care providers.

Spotlight on Technology 19

Pharmacy Practice News â&#x20AC;˘ June 2014

will require pharmacy management systems vendors to revamp their products, Ms. Spiro noted. â&#x20AC;&#x153;The pharmacy management systems used by most community pharmacies, including the large chains, are focused on the workflow of the dispensing process, but on the whole, we donâ&#x20AC;&#x2122;t have systems that manage the workflow of clinical processes,â&#x20AC;? she said. â&#x20AC;&#x153;However, as community care pharmacists, weâ&#x20AC;&#x2122;re going to need to be part of the exchange of clinical informationâ&#x20AC;&#x201D;and that includes collecting information, documenting our interventions, and exchanging our information with other providers or patients themselves.â&#x20AC;?

plans are not integrated into the usual workflow physicians follow when they use EMRs to guide patient care,â&#x20AC;? said Dr. Sachdev, who also spoke at the ASHPâ&#x20AC;&#x2122;s Ambulatory Care Conference and Summit. â&#x20AC;&#x153;At best, these progress notes are scanned in as PDFs and filed under a miscellaneous tab.â&#x20AC;? Pharmacist access to EMRs is absolutely necessary if they are to â&#x20AC;&#x153;document how our interventions affect clinical and cost outcomes and define and articulate a value proposition that justifies including us on health care teams,â&#x20AC;?

Dr. Sachdev said. â&#x20AC;&#x153;We need the outcomes data [in patientsâ&#x20AC;&#x2122; EMRs] to show that our services yield a positive return on investment.â&#x20AC;? Dr. Epplen agreed, adding that some health care stakeholders do not fully appreciate the role pharmacists can play in bettering patient outcomes and lowering health care resource utilization. However, she suggested, there is a Catch-22: Until other stakeholders place a higher value on ambulatory pharmacist care, some pharmacists practicing in these settings may contin-

ue to find themselves receiving spotty access to patient data. â&#x20AC;&#x153;We need funding to build and implement appropriate IT infrastructure in the pharmacy setting,â&#x20AC;? Dr. Epplen said, â&#x20AC;&#x153;but this will not occur unless ambulatory care pharmacists and ambulatory care pharmacy services are viewed as an essential component of care delivery.��&#x20AC;? â&#x20AC;&#x201D;David Wild None of the participants reported any relevant ďŹ nancial conďŹ&#x201A;icts of interest.

â&#x20AC;&#x2DC;Define and Articulateâ&#x20AC;&#x2122; Value The fluid nature of information sharing that CDAs are set to facilitate will improve pharmacist care and, in turn, patient outcomes, according to Gloria Sachdev, PharmD, a clinical assistant professor of primary care at Purdue Universityâ&#x20AC;&#x2122;s College of Pharmacy, in West Lafayette, Ind., and adjunct assistant professor at Indiana University School of Medicine, in Indianapolis. â&#x20AC;&#x153;Progress notes written by pharmacists who practice in community pharmacies in particular are often faxed to physicians and thus their assessments and

Selected Health IT Vendors That Support CDA Sharing â&#x20AC;˘ AthenaHealth, Inc. â&#x20AC;˘ Axesson â&#x20AC;˘ Care Accord â&#x20AC;˘ Cerner â&#x20AC;˘ Covisint Corporation â&#x20AC;˘ DataMotion Inc. â&#x20AC;˘ EMR Direct â&#x20AC;˘ Health Information Xchange of NY, Inc. â&#x20AC;˘ HealtheConnections RHIO of CNY â&#x20AC;˘ HealthUnity Corporation â&#x20AC;˘ ICA â&#x20AC;˘ Infomedtrix â&#x20AC;˘ Inpriva â&#x20AC;˘ IOD Incorporated â&#x20AC;˘ MaxMD â&#x20AC;˘ MedAllies â&#x20AC;˘ Medicity â&#x20AC;˘ MHIN â&#x20AC;˘ MRO Corporation â&#x20AC;˘ Orion Health â&#x20AC;˘ RelayHealth â&#x20AC;˘ San Diego Health Connect â&#x20AC;˘ Secure Exchange Solutions, Inc. â&#x20AC;˘ Surescripts â&#x20AC;˘ Updox

Rationale, Reversal, and Recovery Of Neuromuscular Blockade Part 2: Ongoing Challenges and Opportunities Case Study Dennis is a 68-year-old man undergoing open abdominal surgery (colectomy). Current Symptoms Â&#x2021;Dyspnea Vital Signs Â&#x2021;Height: 175 cm Â&#x2021;Weight: 85 kg 6LJQLÂżFDQW0HGLFDO+LVWRU\ Â&#x2021;Hypertension Â&#x2021;Congestive heart failure Â&#x2021;Obstructive sleep apnea &XUUHQW0HGLFDWLRQV Â&#x2021;Metoprolol 100 mg PO Â&#x2021;Ramipril 2.5 mg PO Laboratory Results Â&#x2021;Apnea hypopnea index: 26/h Â&#x2021;Left ventricular ejection fraction: 30%-35% Anesthesia is induced with sufentanil, propofol, and 0.6 mg/ kg rocuronium based on total body weight and maintained ZLWKGHVĂ&#x20AC;XUDQHLQDLUR[\JHQDQGVXIHQWDQLO6XUJLFDO FRQGLWLRQVDUHGLIÂżFXOWZLWKDODFNRIDEGRPLQDOZDOOPXVFOH relaxation and poor paralysis. An extra dose of rocuronium is administered for deeper neuromuscular block (NMB), and fewer than 2 train-of-four (TOF) responses are noted.

Global Education Group and Applied Clinical Education are pleased to introduce part 2 of a 3-part interactive CME series featuring challenging cases in NMB. Each activity presents a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit ZZZ&0(=RQHFRPQPEWRÂżQG out how your answers stack up against those of our multidisciplinary faculty panel. Access the activities on your desktop, laptop, or tablet to explore the issues surrounding safe, effective, NMB reversal via a unique multimedia learning experience and earn 1.0 AMA PRA Category 1 Credit.â&#x201E;˘ Complete the whole series and earn a total of 3.0 AMA PRA Category 1 Credits.â&#x201E;˘ This activityâ&#x20AC;&#x2122;s distinguished faculty

6RULQ-%UXOO0' Professor of Anesthesiology Mayo Clinic College of Medicine Jacksonville, Florida


Challenge Questions 1. What would you do if, at the end of the case, the TOF count is zero? 2. What would you do if, at the end of the case, the TOF count is 2?

Medical Director, Manager New Medical Center Nancy, France

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20 Spotlight on Technology

Pharmacy Practice News • June 2014

Maximizing the Value of a PT Informatics Specialist streamline billing processes.5 The PT informatics specialist was involved with the initial implementation of the ADCs at Magruder Hospital, including cabinet design, medication storage layout, programming preferences, and setting up security based on job description. The PT has since become the resource for all departments to troubleshoot any issues and ongoing maintenance of all ADCs, and is responsible for the addition or removal of medications from each cabinet, testing new functions, installing all upgrades, and training end users in pharmacy and nursing. Additionally, the PT runs reports analyzing narcotic usage and waste, helping to prevent diversion.

Kristy Malacos, MS, CPhT Pharmacy Administrator Magruder Hospital-Pharmacy Systems, Inc. Port Clinton, Ohio


agruder Hospital, a 25-bed critical access facility in Port Clinton, Ohio, was voted as one of the nation’s “most wired” hospitals in 2013.1 There were many lessons learned in achieving that level of automation, but one in particular resonated in the pharmacy department: the value of having a pharmacy technician (PT) who specializes in informatics working on all key aspects of medication management systems. The breadth of technology rollouts at Magruder Hospital was part of the reason a PT informatics specialist was needed. The technologies include an integrated electronic medical record (EMR) application from Cerner, a pharmacy information system, a formulary manager, an electronic medication administration record (eMAR), as well as computerized provider order entry (CPOE), bedside barcode scanning and Cerner’s RxStation automated dispensing cabinets (ADCs). Many hospitals have transitioned to paperless systems, but Magruder’s approach is a bit different than most: Its implementation and upkeep continues to be successful through the actions of the hospital’s PT informatics specialist.

An Evolving Position Technicians who specialize in this area focus on the acquisition, manipulation, analysis and storage of data within the pharmacy system. More specifically, they

focuse on daily electronic functions, such as CPOE, barcoding, formulary maintenance, and ADC implementation and troubleshooting. One of the key goals throughout this process is to ensure optimal patient outcomes related to medication use.2

Medication Safety Barcoding

Barcoding systems add an extra level of patient safety to the medication administration process and can reduce medication administration errors and drug-related adverse events if used in combination with an eMAR.3 At Magruder, the PT informatics specialist plays a key role in the success of this process by overseeing barcode implementation and maintenance. The technician works directly with nursing in the event of a scanning error to troubleshoot the problem and investigate any medications that cannot be scanned. Additionally, since the implementation of barcoding, reports have been created that show the percentage

An informatics specialist at Magruder Hospital adds a new product into the RxStation automated dispensing cabinet.

of medications scanned and what problems were encountered if scanning was not successful. The technician, with support from nursing administration, then communicates with each nurse directly to address specific issues and help improve the overall percentage of medications scanned. Barcode scanning was implemented at the end of 2012 at Magruder and the PT informatics specialist began analyzing scanning reports in January 2013. After launching an education campaign to retrain specific team members and to communicate the importance of scanning for patient safety, the average scanning rate reached 95% (the baseline rate was approximely 77%). As a result of this successful quality improvement effort, the nursing staff now understands the importance of communicating issues when scanning problems arise.

Formulary and Billing Drug Formulary Maintenance

The PT informatics specialist is responsible for adding any new drug into the formulary manager. This includes mapping the National Drug Code to the correct product, creating a description, adding pertinent dose and route information, building an order sentence, and updating all pricing information (including Current Procedural Terminology codes and billing factors). Billing Audits and Discrepancy Resolutions

Because he is directly involved in formulary and ADC maintenance, the PT informatics specialist is responsible for billing audits on a daily basis. He monitors all medication charges, investigates all discrepancies, and examines the charge on administration versus the charge on dispensing functions. This auditing is especially important for chemotherapy drugs, as well as for verifying correct charges for high-priced medications.

Medication Reconciliation

Medication reconciliation is the process of creating the most accurate list possible of a patient’s current medications, which is then reconciled against all new medications prescribed or administered during the patient’s hospital stay.4 With their informatics understanding, as well as knowledge of medications, the PT informatics specialist became an instrumental part of the medication reconciliation program at Magruder Hospital. The PT efficiently navigated through the electronic record to develop a system that worked within Cerner. As a result, the program has helped increase patient safety and physician satisfaction. Because errors are caught before discharge, patients are sent home with accurate medication lists. Automated Dispensing Cabinets

ADCs help improve inventory management, increase patient safety, and

Communication One of the most vital functions performed by the PT informatics specialist at Magruder is to liaise between many departments within the organization. The PT works directly with each nursing department, including surgery, oncology, ICU, medical/surgical, and emergency. Because of this relationship, the nursing staff has stated in meetings and on surveys that they feel comfortable openly discussing issues and providing useful feedback and suggestions for process improvement. In addition to nursing, the technician specialist works directly with the hospital’s finance department to resolve patient billing issues and helps to investigate any medication bills in question. Education is another important component of this position. The PT informatics specialist teaches the nursing staff to scan medications properly, document narcotic waste appropriately, and efficiently use

the ADCs. The PT is essentially an informal leader among all departments for troubleshooting anything medicationrelated that does not require clinical judgment by a pharmacist.

Fostering Collaboration The PT informatics specialist at Magruder Hospital is an essential part of the pharmacy team and a vital component for patient safety. He is located within the information technology (IT) department to allow effective collaboration between pharmacy and IT, which has been efficient and resourceful when issues arise. Additionally, the technician assists in daily duties in the pharmacy when needed, and can easily transition from technician duties to informatics assignments when required. Most training for this position occurs on the job, although some formal informatics educational programs exist. Pharmacists have the option of completing a residency or a master’s program in pharmacy informatics. For technicians, associate, bachelor’s, and master’s degrees are available in health informatics, with most programs offering an online option. Regardless of the level of integration of technology in a hospital, a PT informatics specialist can provide assistance in a multitude of areas. This position is imperative to an organization implementing an eMAR and/or ADCs, and if a system is already in place, the informatics specialist can help troubleshoot areas within nursing and other departments, thus minimizing workload on the IT department. The specialist also can help improve medication safety measures by assisting with barcoding and medication reconciliation, and provide auditing tools and reports, helping to prevent diversion, increase efficiency, and monitor trends in medication use.

References 1. HealthCare’s Most Wired. 2013 Most Wired winners. Accessed May 9, 2014. 2. Healthcare Information and Management Systems Society. What is pharmacy informatics? October 2006. https://www.himss. org/library/pharmacy-informatics/whatis?navItemNumber=17625. Accessed May 9, 2014. 3. Agency for Healthcare Research and Quality. AHRQ study shows using bar-code technology with eMAR reduces medication administration and transcription errors. May 2010. http:// Accessed February 2, 2014. 4. UW Health. Medication Reconciliation Policy. April 2007. files/PS_MedRec%20Policy%20Final.pdf. f Accessed May 9, 2014. 5. PP&P. Special PP&P buyer’s guide: automated dispensing cabinets. September 2006. http:// Accessed May 9, 2014.

22 Spotlight on Technology

Pharmacy Practice News • June 2014

Insourcing IV Sterile Compounding D

etermined to cement access to reliable and safe sources for crucial IV drug admixtures, a growing number of hospitals are bringing production of compounded sterile products (CSPs) in-house and turning their backs on external compounding pharmacies. Such far-reaching decisions reflect the lingering distrust of outsourced CSPs, according to several administrators from hospitals that have made this move. “People were really pulled up short by the events related to the New England Compounding Center [NECC],” said Eric Kastango, MBA, RPh, FASHP, the president and CEO of Clinical IQ and formerly a member of the United States Pharmacopeial Convention’s (USP) Compounding Expert Committee. “Warnings issued by the FDA to other compounding pharmacies have brought to light a lot of the ugly stuff that was going on.” That “ugly stuff ” included a wide range of manufacturing and quality control issues that resulted in a nationwide outbreak of severe meningitis cases caused by tainted steroid injections. To date, about 750 people have developed the infections; 64 have died, according to federal health officials. As a result of this massive breakdown in drug safety, Mr. Kastango noted, “hospitals are looking for strategies to become self-sufficient and vertically integrated, and to decrease reliance on these vendors.”

‘[Purchasing contaminated outsourced drugs] was much too real because it happened here, we didn’t just read about it. Something had to change.’ —Lorraine Lee, MHA, BS Pharm

as recommended by a group of physicians at the hospital, reduced demand for the drug by 30%. Help also came from nursing, which increased its use of closed systems that allow nurses to reconstitute IV drugs in patient care areas safely. Ideally, the second phase will be to divest all third-party CSPs, including total parenteral nutrition (TPN) products. The hospital is considering construction of a new 5,000- to 8,000-square-foot cleanroom at a cost upward of $1 million. Phase 3 would be construction of a centralized compounding service to supply all three of the system’s hospitals. Ms. Lee noted that insourcing changes the equation for beyond-use dating (BUD). One attraction of out-

‘You must have [hospital administration’s] total commitment that [insourcing] is the way the institution wants to go; it can’t be a partial effort.’ —Erasmo A. Mitrano, RPh, MS

A Wake-Up Call To Gain More Control For some hospitals the decision was, by necessity, sudden. In March 2013, Yale-New Haven Hospital, in Connecticut, received contaminated magnesium sulfate from a compounding pharmacy. No patients were harmed, but the incident was a wake-up call, according to Lorraine Lee, MHA, BS Pharm, the director of pharmacy. “It was much too real because it happened here, we didn’t just read about it,” Ms. Lee said. “Something had to change.” The hospital’s multiphase transition to insourcing—still a work in progress—began with cutting off the pharmacy responsible for the contaminated drugs. Producing enough CSPs internally then required a 260% increase in staff hours and far greater use of existing infrastructure. “The bulk of the CSP deficiencies were counteracted without the acquisition of additional equipment,” Ms. Lee said. Other adjustments included re-evaluating the use of previously outsourced CSPs. For example, tightening use restrictions for magnesium sulfate,

sourcing has been that compounding pharmacies offered extended BUD for the drugs they ship to the hospital, which potentially reduces wasted doses and allows hospitals to stock up on high-volume admixtures. But Ms. Lee became skeptical after her experience with contaminated products. “They tell you they can provide CSPs that have extended beyond-use dates [without compromising stability or sterility of the products] and they have the studies to back that up, but do they really? That’s a big red flag to me now,” she said. Hospitals that decide to do a higher percentage of sterile compounding inhouse must be ready to commit to the added time, training and testing neces-

Mass General’s Growing Menu Of Sterile Compounding Technology


athan Van Allen, PharmD, the pharmacy compounding manager at Massachusetts General Hospital, in Boston, offered additional details on the type of sterile compounding technologies in play at the facility. The systems are ones “we have either added to our operation, are in the midst of adding or investigating for the future,” he noted: • i.v. Station (Health Robotics). “These will be used for automated mixing and packaging either by mixing each individual dose separately or repackaging a premixed solution in a repeatable and controlled environment,” Dr. Van Allen said. • i.v. Soft (Health Robotics). This technology can be used for documenting and verifying the contents of compounded solutions. • Barcode scanning and point-of-service software. These programs allow for checking of ingredients before preparation and stepwise checks throughout the compounding process. • Mini-Bag Plus (Baxter). Proprietary system allowing for powdered vial to be attached to diluent bag on patient floor. • DoseEdge (Baxter). Dr. Van Allen and his colleagues are investigating this for documentation and verification of solutions. • Biological Safety Cabinets (Baker Co.). Preparation of sterile solutions for packaging, syringes for robotics automation, specialty preparations, etc. • Baxa Repeater Pump. Semi-automated syringe filler.

A pharmacy h technician t h i i programs a compounding robot to produce a batch of sterile intravenous medications in the Brigham and Women’s Hospital’s cleanroom.

sary to comply with USP standards for BUD, Ms. Lee stressed. “Operationally, it’s hard to manage and comes at a high cost, and that’s why hospital pharmacies typically don’t put beyond-use dates on the drugs they make,” she noted.

Mass General Pivots Quickly Massachusetts General Hospital (MGH), in Boston, decided to fast-track CSP insourcing after the FDA shut down Ameridose (a sister company of NECC) for multiple manufacturing violations in fall 2012. The company, which delivered about 68,000 doses to MGH monthly, had been the hospital’s primary CSP supplier, according to Erasmo A. Mitrano, RPh, MS, MGH’s associate chief of pharmacy. “We needed very quickly to change gears to take care of patients,” he said. In the year before the Ameridose closing, the hospital produced about 200,000 CSPs. The following year, insourced production reached 320,000—a 150% increase, according to Nathan Van Allen, PharmD, the pharmacy compounding manager. The hefty increase was made possible through increased staffing (including pharmacy students, overtime and outside agency help) and around-the-clock operation of compounding facilities. “We’re still using an additional 10 to 12 full time–equivalent staff positions than we were before,” Dr. Van Allen said, noting

Spotlight on Technology 23

Pharmacy Practice News • June 2014

that the added stress on the pharmacy staff has meant increased sensitivity to burnout and health problems. “We’re still in the middle of this; it hasn’t eased up,” added Mr. Mitrano. Just as at Yale-New Haven Hospital, the pharmacy leadership at MGH reached out to other services, particularly nursing and anesthesia, to help fill the vast shortfall. Systems such as Mini-Bag Plus (Baxter) allowed drugs to be reconstituted safely by nurses outside of a cleanroom. Anesthesia providers, who had been receiving 13,000 syringes monthly from Ameridose, began drawing up their own syringes in preparation for—and during—surgery. “That type of help had an enormous impact and took a lot of weight off our

shoulders,” Mr. Mitrano said. Making such a titanic transition— either under the gun or more deliberately—requires tremendous support from hospital administration, Mr. Mitrano stressed. “You must have their total commitment that this is the way the institution wants to go; it can’t be a partial effort,” he said. To keep up the momentum, the pharmacy is undergoing a build-out of its current facility and has acquired additional IV workstations and robotics, Mr. Mitrano noted. He predicted that automated production eventually will account for 75% of CSP preparation. “We’ll essentially have our own compounding facility within the hospital.” Self-sufficiency is getting closer, added

At Brigham and Women’s, A Suite Of Robots Lends a Helping Hand


he Pharmacy Department at Brigham and Women’s uses a variety of robotic technologies to assist in its transition toward bringing sterile compounding inhouse. Bill Churchill, MS, RPh, the hospital’s chief of pharmacy services, said the technologies have significantly boosted workplace efficiency and patient safety—and saved scarce health care dollars in the process. Until the latter part of 2013, three primary robotics systems Bill Churchill observes the IntelliFill were in use at Brigham and Womrobot sort syringes. en’s, Mr. Churchill noted: Health Robotics’ i.v. Station, which is used to compound batch-prepared drugs, as well as patient-specific IV bags and syringes; an Intellifill syringe robot, from Baxter, that prepares bulk batches of ready-to-use syringes (primarily for anesthesia and nursing staff); and Health Robotics’ CytoCare robot for preparing chemotherapy products. Since that time, “in our efforts to continually evaluate our technology, BWH has moved toward standardizing our robotic technology,” Mr. Churchill said. As a result, “we’ve moved away from the Intellifill and the CytoCare units, by bringing in two additional i.v. Station robots, and we are awaiting delivery of an i.v. Station Onco robot that will replace the CytoCare [unit].” He added that BWH also is using Aesynt’s i.v. Soft Assist system to streamline workflow related to manual compounding. “This basically helps us to supplement robotic production with manual processes as efficiently as possible,” Mr. Churchill explained. The gain in volume and efficiency that occurred as a result of these technologies has been significant, Mr. Churchill noted. The systems can aid in the preparation of more than 400,000 doses annually, all of which were previously done off-site and shipped to the hospital at significantly higher costs, he noted. Moreover, the robots have contributed to approximately $1.5 million in savings, Mr. Churchill said. The cost savings, he noted, were largely a result of shifting from higher-cost outsourced products to less expensively prepared products made at the hospital. “The calculation was a straightforward business analysis that was performed to get approval for the robotic devices, and then revalidated to prove ROI [return on investment] savings,” he said. Mr. Churchill stressed, however, that the importance of cost savings pales in comparison to the safety gains that occur as a result of increased automation. “IV medications that are prepared by humans are approximate—USP standards allow a range of plus or minus 10% of what the label amount says, but there can be much greater range of variability in the accuracy of preparation.” He added that the robots measure these medications not only by volume, but also by specific gravity, with an accuracy of plus or minus 5%. “That higher level of accuracy makes a difference for many patient populations, including elderly [patients], patients with renal or liver disease, as well as neonates and pediatric patients, to name a few.” —Steve Frandzel, David Bronstein

‘Bringing [sterile compounding] production inside and having control of our own environment with our own staff was a much better way for us to to go.’ —Bill Churchill, MS, RPh Dr. Van Allen. The hospital now produces about 90% of its CSPs; for now, it will continue to outsource TPN products.

BWH a Fan of ‘Re-Insourcing’ At Brigham and Women’s Hospital (BWH) in Boston, CSP supply lines were disrupted to a lesser extent than at other facilities during the IV compounding crisis, because the hospital had already begun the process of ramping up internal compounding of IV sterile products, according to Bill Churchill, MS, RPh, the chief of pharmacy services. Although quality and safety were major driving forces for “re-insourcing” (the term Mr. Churchill prefers for describing the hospital’s new direction), so were financial implications. The hospital projected, and realized, major savings (estimated at $1.5 million; sidebar) over the past few years, which it attributes to the strategic shift. “Bringing production inside and having control of our own environment with our own staff was a much better way for us to go,” Mr. Churchill said. The hospital also hired a microbiologist to work in the pharmacy department to coordinate all IV compounding quality assessment, including end-product testing, staff testing and facility testing, and to assure compliance with USP Chapter <797> standards. All CSP batches are tested and quarantined until they are confirmed sterile and stable. “Only after they pass muster with my microbiologist do they move into circulation for patients,” Mr. Churchill explained. BWH also invested in upgrading on-site cleanroom facilities. Once a new negative-pressure cleanroom is completed, the existing main cleanroom will be upgraded and renovated to further increase capacity. BWH also has purchased four IV compounding robots. A fifth one, dedicated to oncology, is expected in June. New workflow patterns and staff

responsibilities also emerged. The changes were heavily influenced by lean process redesign, a method for streamlining processes or systems by eliminating as much waste and unnecessary work as possible. Some pharmacy technicians, for example, have become automation experts, expanding their skill sets well beyond more traditional tasks, like drawing up syringes in a laminar flow hood. Additionally, the BWH pharmacy used to produce CSPs in batches to cover the following 18 hours of use, but that was not efficient. “Drug regimens change, orders get discontinued, doses get changed. A lot of the labor and materials expended for long batch runs were being wasted,” Mr. Churchill said. Now, the restructured workflow, supported by newer technology and greater staff expertise, allows batches to be produced every four hours. “That was a huge step forward for us.”

Centralized Compounding? The pharmacy now produces about 70% of the CSPs used at the hospital—up from about 40% two years ago. Going forward, Partners HealthCare, the umbrella system for both BWH and MGH, is contemplating the feasibility of a centralized compounding facility to supply all 13 of its hospitals. In the interim, the steps taken have been challenging and progress gradual. “It’s an ongoing process where you take things in bite sizes that you feel comfortable with,” Mr. Churchill said. “To make the change, operationalize that change, go back and re-evaluate it, then continue to evolve your process with the next change until you finally get it where you want it, takes time and patience. The process simply cannot be rushed.” —Steve Frandzel

More on the Web To read an expert’s take on the pros and cons of insourcing, “To Insource or Outsource? That Is the Question!”, visit You can access the article with your smartphone by scanning the adjacent 2D barcode.

Listen closely Plan ahead Do the right thing Deliver

You’re focused on patient care. We’re focused on you. We understand that drug production issues directly affect you and your patients. That’s why we’re working to rethink every step of our process, in partnership with you. Because while we’re changing how we work, we’re not changing who we are. We’re still ready to listen. Prepared to find solutions. Determined to be the supplier that delivers, every time. So you can deliver the best patient care, every day. See how we can deliver for you. Visit Hospira, Inc. 275 North Field Drive, Lake Forest, IL 60045 P14-0245-1-Mar., 14


Medication Errors: A Year in Review Partt 2 off a 2 2-Part P tS Series i

Horsham, Pennsylvania


he prevention of medication errors is an essential component of pharmaceutical care and

must be a core mission of every pharmacy. For medication error prevention efforts to be effective, they must become a priority.

The first step in setting up an error-reduction program is to establish a multidisciplinary team to improve medication use. The team must be given reasonable time and resources to assess medication safety and implement system-wide changes that make it difficult or impossible for practitioners to make mistakes that reach the patient. This multidisciplinary team should accept ownership of the medication-use process and enthusiastically embrace the opportunity

to improve medication safety. The goals of the team should include the following: • Promote a culture of safety to lower medication errors; • Increase detection and reporting of medication errors and potentially hazardous drug-use situations; • Explore and understand the root causes of medication errors; • Educate practitioners about the system-based Text continues on page 2



Computerized prescriber order entry (CPOE)—A fully integrated CPOE system includes the capability to build medication safety alerts (eg, look-alike names) and clinical decision rules. Additionally, the CPOE system should directly interface with the laboratory system and pharmacy, list drug– drug and drug–disease interactions, and offer clinical order-screening capability.


Bar-code–enabled point-of-care (BPOC) systems—These systems are designed to prevent medication errors at the point of medication administration. BPOC systems verify and record all medications administered to the patient through the use of a barcode scanner that matches the medication to the patient by scanning a bar code on the medication and a bar code on the patient’s wristband.


“Smart” infusion pumps—These infusion systems allow users to enter various drug infusion protocols into a drug library with predefined dose limits. If a dose is programmed outside of established limits or clinical parameters, the pump halts or sounds an alarm, informing the clinician that the dose is outside the recommended range. Some pumps can integrate patient monitoring and other patient parameters, such as age or clinical condition.



Automated dispensing cabinets (ADCs)—These are robust, point-of-use dispensing systems. ADCs should be integrated with the health care facility’s information system and directly interface with the pharmacy system. Additionally, ADCs must be able to use bar-coding technology for the restocking process to prevent medication errors.


“Robust” pharmacy order entry system— This order entry system is fully interfaced with a CPOE system. The pharmacy system must be able to produce medication safety alerts as well as directly interface with a health care facility’s information systems, such as the laboratory system. Additionally, this system must be used to generate a computerized medication administration record (MAR) to be used by the nursing staff while they administer medications.

P H A R M AC Y P R AC T I C E N E WS • J U N E 2 0 1 4


Table 1. Addressing Concerns Involving Infection Control Title

Problem/Discussion Point


Crosscontamination with insulin vials

• A nurse at a prison facility accidentally injected an inmate, who was positive for hepatitis C, with an empty insulin syringe before she realized it was not filled. She then used the same syringe and needle to draw insulin from a vial. • The vial was used later to prepare doses for other patients, and more than 70 additional patients were exposed to hepatitis C.

• Using 3-mL insulin vials would expose fewer patients if the vial becomes contaminated. • Where possible, preparation of patient-specific insulin doses by pharmacy would greatly reduce the risk for cross-contamination.

Multiple-dose pen devices

• Patients have been exposed to HIV, hepatitis B, and hepatitis C because insulin pens were reused for more than one patient after only changing the needle. • Studies show that contamination from retrograde blood flow into the pen after injection is possible. • Repeated warnings from the FDA, CDC, and ISMP have not succeeded in reducing these events.

• Risk associated with cross-contamination is best mitigated by not using insulin pens in hospitals. • The VA has prohibited use of multiple-dose pen devices in VA facilities, and the ISMP urges other hospitals to do the same.

Sterile compounding practices

• An ISMP survey revealed that up to 29% of pharmacy technicians reported that contamination of compounded sterile products occurred in their facility during the past year. • The survey revealed that only 50% of the staff pharmacists responding were confident that contamination had not occurred. • A report commissioned in Massachusetts on sterile compounding recommends stronger oversight and licensure of compounding pharmacies and calls for pharmacy boards to review compounding activities in hospitals and other locations, such as physician offices.

• Hospitals should use the Proceedings from the ISMP Sterile Preparation Compounding Safety Summit: Guidelines for Safe Preparation of Sterile Compounds as a resource to identify opportunities for improvements in sterile compounding practices in hospitals.

Transitioning from insulin pens to vials

• Staff accustomed to using insulin pens may lack knowledge about drawing insulin doses from a vial. • The U-100 designation on insulin vials has been misinterpreted to mean 100 units per vial, leading to overdoses. • The dose in units has been measured in mL by staff unfamiliar with the differences between an insulin syringe and other parenteral syringes, and there is a risk for these doses to be unlabeled. • Insulin vials often look alike, leading to mix-ups.

• Before transitioning from insulin pens, conduct a FMEA to proactively address problems that may arise, and reeducate staff regarding the processes associated with measuring doses, injection techniques and using insulin syringes. • Where possible, pharmacy should prepare, label, and dispense daily patient-specific basal insulin. • Rapid-acting insulin vials (3 mL preferred) should be dispensed and labeled for specific patients. • Provide insulin syringes in appropriate sizes (1, 0.5, 0.3 mL) to units where insulin may be administered and in hyperkalemia treatment kits.


CDC, Centers for Disease Control and Prevention; FMEA, failure mode and effects analysis; ISMP, Institute for Safe Medication Practices; V , Veterans VA, Vete a s Health ea t Administration d st at o

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causes of errors and their prevention; • Recommend methods to facilitate the implementation of organization-wide, system-based changes to prevent medication errors; • Respond to potentially hazardous situations before errors occur; and • Learn from errors occurring in other organizations through the ISMP Medication Safety Alert! and other published accounts of medication errors, and proactively take measures to prevent similar errors. Effective results depend on understanding the entire medication-use process through varied perspectives and disciplines. ISMP is a nonprofit organization that works closely



with health care practitioners and institutions, regulatory agencies, professional organizations, and the pharmaceutical industry to provide education about medication errors and their prevention. ISMP independently reviews medication errors that practitioners and patients have submitted voluntarily to the ISMP Medication Error Reporting Program. ISMP is an accessible resource for any pharmacist or organization interested in implementing the actions recommended herein. Among the many products and services that ISMP offers is the ISMP Medication Safety Alert!! Acute Care Edition, a biweekly newsletter that provides timely information related to error prevention. It identifies errors that have been reported by other organizations and offers

Table 2. Medical Devices and Other Discussion Items Title

Problem/Discussion Point



ADC alerts

• A nurse removed medications from an ADC and administered them to the patient before transferring the patient from one unit to another. • The nurse on the receiving unit removed medications from her unit’s ADC and gave the patient repeated doses without checking the patient’s MAR.

• Provide a pop-up, active alert on the ADC screen that notifies a nurse of a dose that has already been removed within a set timeframe. • Require the nurse to acknowledge the alert before allowing the medication to be removed again. • Always use the patient’s MAR/eMAR as the document to guide drug administration.


Demo-Dose products require caution

• The demo product, supplied by Pocket Nurse, was found by a pharmacy technician during routine inspection of a soon-to-be outdated cart that was still in service. • The demo product, and others like it, looks nearly identical to real prefilled emergency syringes (Abboject) from Hospira for good reason—they are sold for use during simulation training exercises. • Had this remained in the cart, it could have been injected during a code or at least could have delayed emergency treatment. • The distilled water contents in these demo syringes are not sterile, which could pose an infection risk if injected into a patient during the code.

• If your education department, simulation lab, or associated nursing school is using these or other demonstration products, they should be strictly limited to classroom use. • Instructors should account for each demonstration product at the end of the class to ensure that they do not travel outside the room and later reach a patient care area.


Evaluating independent double checks

• The value of a manual independent double check has been questioned by those who rarely find mistakes. • Its use has been a source of stress for busy staff and its overuse with high-alert drugs has been called to task given its status as a weak risk-reduction strategy, particularly if it is the only safeguard in place. • Inconsistent use, variability in its performance, and the superficial manner in which many checks are conducted has rendered this method less effective than anticipated. • However, studies have shown that independent double checks can detect up to 95% of errors; thus, carrying out a manual independent double check is worth the time and effort if done correctly.

• Manual double checks are most effective when conducted independently in a cognitive manner, and when used judiciously for selected high-risk tasks or high-alert medications. • Evaluate the procedures for which you require a double check, monitor compliance, assess how often the checks are conducted as designed, and then make the necessary revisions to promote effectiveness. • Avoid sole reliance on double checks as a safety strategy. Fewer double checks strategically placed at the most vulnerable points of the medication use process will be much more effective.

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recommendations to prevent those errors from occurring in the pharmacy. The information in the tables of this review summarizes many of the significant error-prevention strategies that were recommended in the ISMP Medication Safety Alert! Acute Care Edition during 2013. The errors presented in the tables are actual or potential errors reported to ISMP. Each table consists of 4 columns. The first column lists the medications, devices, or other problematic issues involved. The second column describes the specific error or problem involved. The third column contains ISMP’s recommendations to proactively address and prevent errors from occurring. The fourth column lists technology that may help prevent these errors. Technology can be a powerful tool

in the fight against medication errors but only when it is used appropriately within a well-designed medication-use system. The key summarizes the technology addressed in the tables, along with specific criteria that ISMP feels should be included.

Suggested Reading Cohen MR, ed. Medication Errors. 2nd ed. Washington, DC: American Pharmacists Association; 2007. Institute for Safe Medication Practices. ISMP Medication Safety Alert! Acute Care Edition newsletters 2013. default.asp. Accessed March 20, 2014. Institute for Safe Medication Practices website:



Table 2. Medical Devices and Other Discussion Items



Problem/Discussion Point


High-alert medication list bundled with risk reduction strategies

• Although many hospitals meet minimum Joint Commission requirements, some hospitals have neither a well-reasoned list of high-alert medications nor robust processes for managing the drugs on their list. • Instead, they appear to have a hastily devised list of high-alert medications, which may not be well known to clinicians, and rely on low-leverage risk-reduction strategies to prevent errors. • A list of high-alert medications is relatively useless unless it is up to date, known by all clinical staff, and accompanied by robust risk-reduction strategies more effective than awareness, manual double checks, staff education, and appeals to “be careful.”

• Periodically update your hospital-specific list of high-alert medications, and implement riskreduction strategies that address the underlying causes of errors, which have been identified through a literature search, information from the ISMP, analysis of internal reports, and FMEA. • Layer numerous risk-reduction strategies that affect as many steps of the medication process as feasible. • Bundle low-leverage risk-reduction strategies such as staff education and the use of reminders with high-leverage risk-reduction strategies such as forcing functions, maximizing access to information, limiting use, standardization, and simplification.

Infusion pumps

• A nurse needed to administer ciprofloxacin but could not find the drug in the smart pump’s library. • Fortunately, she did not simply override the dosechecking function and administer the drug. • Follow-up showed that the pump belonged to a different hospital and was brought into the facility during a patient transfer. • The two pumps looked identical, with the only difference being the respective organizations’ name displayed on the very top of the screen.

• Establish procedures outlining how to handle infusion pumps (and other equipment) during patient transfer. • Consider applying a large, auxiliary label with your hospital’s name on all pumps that are owned. • If rental pumps are used, they should arrive at the hospital with a blank library or have the library removed immediately by biomedical engineering, and the hospital-specific library should be loaded before use.

Saline flush administered via ON-Q C-bloc

• A laboratory technician who was attempting to collect blood from what she thought was a CVAD, instead administered a saline flush via yellowstriped extension tubing that was connected to an ON-Q C-bloc (I-Flow) continuous peripheral nerve block infusion. • The ON-Q system catheter was anchored to the front of the patient’s shoulder, not the back as usual. • The upper part of the gown obscured the ON-Q C-bloc system, but a blue connector was visible and thought to be attached to the CVAD. • Difficulty obtaining a blood return led to administration of the saline flush.

• Limit access to CVAD lines to those with professional training. • Promote a consistent process for tracing all catheters/lines from the access site to an infusion or capped access port before drawing blood, connecting tubing, or administering drugs or solutions. • Educate staff who might use or encounter ON-Q C-bloc or other new tubes, catheters, connectors, or drug delivery systems regarding proper use or access. • Affix labels to lines if the patient has more than one port of entry into the body. • Ensure that those drawing blood or accessing a drug delivery system understand that the intended use of yellow-striped tubing is for epidural use only. • Consider evaluating current delivery systems and mating devices to assess the overall risk for misconnected tubing.

Tuberculin syringes to measure U-500 insulin

• As use of U-500 insulin grows, so does the number of errors, mostly related to dosing confusion caused by not having a syringe with a U-500 scale. • Health care providers and patients rely on syringes meant for U-100 insulin to measure U-500 insulin doses. • This results in communicating the dose by the number of units that correspond to the U-100 syringe. • Another source of confusion is name similarity: HUMULIN R is the name for both U-100 insulin and U-500 insulin.

• Until U-500 syringes or pens are available, use tuberculin syringes to measure doses by volume using a dosing conversion chart. • Total doses should be expressed in both units and volume (eg, 200 units [0.4 mL]). • To minimize name confusion, ensure that the strength is listed with HUMULIN R insulin products during order entry. • Separate U-100 insulin and U-500 insulin vials.

ADC, automated dispensing cabinet; CVAD, central venous access device; eMAR, electronic medication administration record; FMEA, failure mode and effects analysis; ISMP, Institute for Safe Medication Practices; MAR, medication administration record





Table 3. ISMP’s 2014-2015 Targeted Medication Safety Best Practices for Hospitals Title

Problem/Discussion Point



“Glacial” acetic acid

• Patient harm has occurred when toxic chemicals have been misidentified as oral products, or when a very concentrated form of a chemical has been used erroneously in treating patients. • Of particular concern is glacial acetic acid. • Accidental topical application of “glacial” (greater than or equal to 99.5%) acetic acid has repeatedly resulted in serious patient harm, including severe pain and serious tissue damage, third-degree burns, and in one case, bilateral leg amputation. • Often in these cases, this item either was purchased accidentally or used in place of a much more diluted form of acetic acid, such as vinegar or a commercially available 0.25% acetic acid solution.

• The goal of this best practice is to prevent harm from the use of glacial acetic acid applied directly on patients. Eliminate glacial acetic acid from all areas of the hospital. • Remove and safely discard this product from all clinical areas of the hospital (including the pharmacy, clinics, and physician office practices), and replace it with vinegar (5% solution) or commercially available diluted acetic acid 0.25% (for irrigation) or 2% (for otic use). • Laboratory use excluded if the lab purchases the product directly from an external source.

Methotrexate dosing regimens

• Since early 1996, and as recently as 2013, fatal errors have been reported to the ISMP about the accidental daily dosing of oral methotrexate that was intended for weekly administration. • Prescribing errors occur when physicians, who are accustomed to prescribing many medications for daily administration, erroneously prescribe this medication for daily instead of weekly administration. • Dispensing errors occur in much the same way, when pharmacy technicians and pharmacists inadvertently select/approve daily instead of weekly administration during order entry or verification.

• The goal of this best practice is to prevent errors involving inadvertent daily dosing of oral methotrexate, both in the inpatient setting and after discharge. • Use a weekly dosage regimen default for oral methotrexate. • If weekly default is overridden to daily, require a hard stop verification of an appropriate oncologic indication. • Provide patient education by a pharmacist for all weekly oral methotrexate discharge orders. • Ensure that patients are given written drug information leaflets that contain clear instructions about the weekly dosing schedule. • Have patients repeat back the instructions to ensure that they understand the weekly dosing schedule and that the medication is not to be used “as needed” for symptom control.

Oral dosing devices

• The ISMP has received more than 50 reports of mix-ups between milliliter and household measures such as drops and teaspoonfuls, some leading to injuries requiring hospitalization. • Use of the apothecary system also has caused mix-ups between drams and milliliters and other non-metric measurements, such as ounces and tablespoons. • The ISMP first reported confusion in 2000 and has continued to receive reports of medication errors because of mix-ups between metric and non-metric units of measure.

• The goal of this best practice is to use liquid medication dosing devices (specifically oral syringes, cups, and droppers) that display volume using only the metric scale. • Purchase oral liquid dosing devices (oral syringes, cups, droppers) that display only the metric scale. • Additionally, if patients are taking an oral liquid medication after discharge, supply them with (or provide a prescription for) oral syringes, to enable them to measure oral liquid volumes in milliliters.

Oral liquid preparation

• The ISMP continues to receive reports of patients accidentally being given an oral liquid medication by IV, which on some occasions has been fatal. • This happens most often when an oral liquid is prepared extemporaneously or dispensed in a parenteral syringe that connects to vascular access lines. • Fatalities also have occurred when the contents of liquid-filled capsules (eg, niMODipine) were drawn for oral administration via a nasogastric or other tube with a parenteral syringe and then administered IV. • The oral syringe tip is designed to be incompatible with vascular lines to prevent it from being attached inadvertently.

• The goal of this best practice is to prevent the unintended administration of oral medications via the IV route. • Ensure that all oral liquids that are not available commercially as unit-dose products are dispensed by the pharmacy in an oral syringe. • Use only oral syringes that are marked “For oral use only.” • Ensure that oral syringes that are used cannot connect to any type of parenteral tubing used in the hospital. • Also, use of an auxiliary label “For oral use only” is recommended if it does not obstruct critical information because the print on the oral syringe is small.


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Table 3. ISMP’s 2014-2015 Targeted Medication Safety Best Practices for Hospitals continued Title

Problem/Discussion Point



Patient weight

• Official product labeling for medications provides weight-based dosing using only the metric system (eg, mg/kg). • Significant medication errors have occurred when the patient’s weight is documented in non-metric units of measure (eg, pounds) and it was confused with kilograms (or grams). • Numerous mistakes have been reported when practitioners convert weights from one measurement system to another, or weigh a patient in pounds but accidentally document the value as kilograms in the medical record, resulting in more than a twofold dosing error.

• The goal of this best practice is to standardize the measurement and communication of patient weight using only metric units of measure (grams [g] and kilograms [kg]). Measure and express patient weight in metric units only. • Ensure that scales used for weighing patients are set and measure only in metric units. • Replace current scales that measure in pounds with new scales that only measure weight in grams or kilograms. • If scales can measure in pounds and grams/ kilograms, modify the scale to lock out the ability to weigh in pounds. • Ensure that computer information systems and medication device screens (eg, infusion pumps), printouts, and preprinted order forms list or prompt for weight only in grams (for neonates) or kilograms. • Discontinue the documentation of patient weight in pounds in all locations, and instead document patient weight using only metric designations. • Use measured weight rather than a stated, historical, or estimated weight.


VinCRIStine in a minibag

• Results from the 2012 ISMP International Medication Safety Self Assessment for Oncology revealed that only 54% of US hospitals dispense vinCRIStine in a minibag of compatible solution to prevent accidental intrathecal administration. • To date, there are 120 published cases of accidental administration of vinCRIStine by the intrathecal route when the drug was dispensed in a syringe, and zero cases when it is dispensed in a minibag. • When vinca alkaloids are injected intrathecally, destruction of the central nervous system occurs. • Despite repeated warnings from national and international safety agencies, deaths from this kind of error continue to occur.

• The goal of this best practice is to ensure that vinca alkaloids are administered by the IV route only. Dispense IV vinca alkaloids in a minibag of a compatible solution, and never dispense and/or administer these drugs using a syringe. • Dilute the drug in a minibag that holds a volume that is too large for intrathecal administration (eg, 25 mL for pediatric patients and 50 mL for adult patients). • Prohibit IV vinca alkaloids in areas where intrathecal medications are administered and/or stored. • Confirm that any prescribed intrathecal medications have been administered before dispensing IV vinca alkaloids.


ISMP, Institute for Safe Medication Practices



June 2014