THE INDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTSAnesthesiologyNews.com • M a r c h 2 0 1 3 • Volume 39 Number 3

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‘The Merciful Magic of Ether’—Anesthetics in the Civil War

The United States is observing a sesquicenten-nial remembrance of the Civil War, the bloodi-est conflict the nation has ever experienced. In

battle after battle from the spring of 1861 until April 1865, Americans fought and killed one another for rea-sons still debated today. The conflict claimed the lives of some 620,000 soldiers (and possibly many more) and left hundreds of thousands wounded.

In an article published in 1988, surgeon F. Wil-liam Blaisdell identified eight medical advances that occurred during the Civil War years. These develop-ments involved recordkeeping, management of mass casualties in a timely fashion—the standardization of the ambulance corps being a critical example—design

of hospitals, sanitation and hygiene, female nurses, and the vast experience with management, surgery and anesthesia gained by numerous physicians.

The source of much of our knowledge about medical

In Operating Room,

A Switch to Prefilled

Syringes Pays OffSan Juan, Puerto Rico—Incorporating standardized, ready-to-use (RTU) anesthetics in the operating rooms helped one hospital in St. Louis significantly increaseproper labeling of medicines and reduce medication waste.

Researchers from Barnes-Jewish- Hospital say their medication intervention, presented at the Society of

Critical Care Medicine’s annual congress, more than ompliance and nearly tion waste.

meet a medication paradigm established

ng a consensus confer-ce convened in 2010

by the Anesthesia

Near-Miss Data ShowSi f

Washington—Although nearlhough nearly 15% of hospital-based anesthesia occurs outside theid hoperating room, clinicians have little data on rates of morbidity and mortality in theselocations.

But the evidence that does exist points to a cause for concern. A new study by California

non–archers shows that near misses in nresemay be onng room anesthesia (NORA) mayoperatin

en that adversethe rise, a significant worry given the rise, that adversea significant worry given ththe riseare associated with a events in these locations are as

verity of injury and are more likely to higher severity of injuryresult in death than those occurring in oper-lating rooms (Curr Opin Anaesthesiol 2006; l19:436-442).

“My clinical experience suggested that provi-sion of anesthesia outside the operating room

Visit u

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annu

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see Civil War page 46

see near miss page 36see prefilled page 30

INSIDE08 | COMMENTARYWhen it comes to hospital care, it’s not howyou look.

16 | TECHNOLOGY2013 on track for more interoperability standards.

32 | PRNWhat’s in your stomach? Hospital food goes gourmet.

42 | PAIN MEDICINEThe great divide in global access to pain relief.

VivaSight from ETView,see pages 20 & 25.

Rusch EZ-Blocker Endobronchial Blockerfrom Teleflex,see page 32.

Transdermal PCA in Acute Postoperative Pain Management, see insert at page 24.

NEW PRODUCT FEATURED PRODUCT SPECIAL REPORT

14 |Perioperative Patient Monitoring: Case Studies In Cardiac Surgery (Part 2 of a 3-Part Series)

Critical Care Medicine s annuadoubled labeling co

eliminated medicatTo better

safety pdurin

encKe

vin

King

Anesthesiologists—You Can Now Qualify for the Medicare EHR Incentive Payment with

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4 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

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March 2013

ADVISORY BOARD

JEFFREY L. APFELBAUM, MD, Chicago, IL

PAUL G. BARASH, MD, New Haven, CT

CHRISTOPHER W. BRYAN-BROWN, MD, Bronx, NY

KEITH CANDIOTTI, MD, Miami, FL

PETER J. DAVIS, MD, Pittsburgh, PA

D. JOHN DOYLE, MD, PHD, Cleveland, OH

LEE A. FLEISHER, MD, Philadelphia, PA

ELIZABETH A.M. FROST, MD, New York, NY

CLIFFORD GEVIRTZ, MD, New York, NY

JULIAN M. GOLDMAN, MD, Boston, MA

CHRISTOPHER M. GRANDE, MD, MPH, Baltimore, MD

ADMIR HADZIC, MD, PHD, New York, NY

ZEEV N. KAIN, MD, Irvine, CA

ALAN KAYE, PHD, MD, New Orleans, LA

ROBERT S. LAGASSE, MD, New Haven, CT

ALEX MACARIO, MD, MBA, Stanford, CA

PETER J. PAPADAKOS, MD, Rochester, NY

LINDA S. POLLEY, MD, Ann Arbor, MI

MICHAEL F. ROIZEN, MD, Cleveland, OH

JOAN E. SPIEGEL, MD, Boston, MA

SUSAN T. VERGHESE, MD, Washington, DC

EUGENE R. VISCUSI, MD, Philadelphia, PA

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PAUL F. WHITE, PHD, MD, Los Altos, CA

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MCMAHON PUBLISHING

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SEE ARTICLE ON PAGE 10.

No matter the setting, inpatient

facility or outpatient, company model

deals, and management fee deals,

raise hugely significant

compliance concerns: jail, fines,

civil penalties and debarment.

The five most-viewed articles last month onAnesthesiologyNews.com

1. Systemic Strategies for Reducing Blood Loss in Surgery(Educational Review)

2. Registry Sheds Light on Poor Outcomes of Nerve Blocks

3. To Do Less Harm, Know What You Don’t Know

4. Lidocaine + Propofol = Less Injection Pain

5. Meta-Analysis: IV Analgesic Reduces PONV When Given Early

Register for free @ AnesthesiologyNews.comto read these and other articles.

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What’ll It Cost? For Anesthetics, Residents Don’t Seem To Know

Anesthesia residents fail to reduce their drug expenditures in cardiac surgery cases despite

education aimed explicitly at control-ling those costs, a new study suggests.

The news might not be quite so bad, however. The researchers who con-ducted the study said trends in health care reform, particular a generally heightened awareness of the cost of care, might have diluted the effect of the intervention.

“Even though this particular study hasn’t documented decreases yet, we are going to keep working on it. We need to educate the next generation[of clinicians] to be as cost-consciousas possible,” said David Broussard, MD, system vice chair for anesthe-siology at Ochsner Health Systemin New Orleans, who led the study. Dr. Broussard reported his group’s findings at the American Society of Anesthesiologists 2013 annual Confer-ence on Practice Management (abstractPM03).

The New Orleans researchers aren’tthe first to find that anesthesiology residents might be budgetarily chal-lenged. In a 2007 study, a group atStony Brook University, in New York, showed that residents vastly overesti-mated costs for commonly used med-ications such as opioids, antiemetics and induction and reversal agents—by as much as 10-fold. On the other hand, they were in good company: so did nurse anesthetists and faculty members.

In the latest study, Ochsner anesthe-sia residents about to enter their car-diac rotations were given a 20-minuteeducational session on the costs of the drugs used in 77 cases performed by residents the previous year. Traineesalso received a printout of the drugs used in the cases, and their costs to the hospital system.

Before the intervention, drug costs per patient averaged $193.50. Thatfigure rose to $259.30 in 16 compari-son cases performed after the training, a statistically insignificant difference, according to the researchers.

Roughly 30% of the total drug costs in these cardiac cases was attributable to a single agent, nicardipine (Cardene, Cornerstone Therapeutics), which isused to lower blood pressure to preventexcessive bleeding and which has nogeneric equivalent, Dr. Broussard said.

Although the educational interven-tion did not lead to lower drug costs, Dr. Broussard said he is not convinced it had no value. Rather, he said, its effects may have been masked by other trends in health care.

“We’ve had globally increased atten-tion to the costs of care, and folks in the operating room are much more dil-igent in documenting every drug we’re using,” he told Anesthesiology News.

“Maybe in the past we used a drug but didn’t document it from a charge standpoint.”

In follow-up work, he has noted that residents have recorded using more muscle relaxants per hour of sur-gery than those in the baseline group from 2011. That, he said, reflects the increased attention of clinicians to keeping track of medications they administer during surgery.

What’s more, Dr. Broussard added,the study tracked Ochsner’s contrac-tual drug prices, which fluctuate over time and could have confounded the results. “We haven’t given up on this effort,” he said.

One step his department has taken is to require that residents request permission from the senior staff to administer the most expensive drugs.Although that might strike some as restrictive, so far the policy has met with enthusiasm, Dr. Broussard said.

“All of our residents have expressed an interest in participating in heath care reform.”

Roy Soto, MD, professor of anesthe-siology at the Oakland University Wil-liam Beaumont School of Medicine, in Oakland, Mich., and a co-authorof the 2007 study on drug costs, said that if residents have a block when it comes to absorbing information about the price of anesthetics, it’s not simply stubbornness.

“Residents are smart enough to real-ize that if you use more expensive med-ications, recovery is enhanced” in some cases, Dr. Soto said. “If you use a more expensive antin ausea medication [for example] but the patient goes home more quickly, that’s better for the hos-pital. On the front end, the pharma-cist is not going to see that. There’s so much focus on cost, but that focus is siloed.”

—Adam Marcus

6 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

IN BRIEF

Improve Practice Communication andMobility with MMPact® Practice Point.Q. How does MMPact Practice Point improve practice

communication?

A. It is an open forum that allows voting consensus, goal setting, scheduling and staff announcements. Answers to questions can be posted in an expedient manner, all authorized staff members can review and provide commentary, and emailing has never been easier with links to various contacts and groups all in one place.

Q. How does the MMPact Practice Point virtual library fea-

ture add value?

A. Physicians can access corporate documents—health insurance, long-term disability, retirement, etc.—contracts, board meeting minutes, and news and announcements in a secure manner without the burden of provisioning server and storage capacity. Additionally, practice leaders can authorize access to important documents at any time, from their desktop, laptop or mobile device.

Q. Why are mobile technologies so important for anesthesia

practices?

A. Many companies are headed in this direction. In fact, MMPact Practice Point was built using Microsoft SharePoint technology, which is used by 78% of For-tune 500 companies. It showcases recent financial and operational data for groups, as well as scheduling and announcements—all in one location. Mak-ing this information available in a mobile platform enables anesthesiologists and group leaders to make decisions in a more timely manner than ever before. They have the flexibility to attend to the needs of their practice whenever and wherever they want.

Q. What is meant by the “real-time capability” that MMPact

Practice Point offers?

A. Real-time capability means that charges and deposits for the practice are posted daily and consistently, or from an individual standpoint, physicians can conduct expense reimbursements with the click of a button. Offering anesthe-siologists on-demand access to information is increasingly critical—especially highly granular information broken down by physician, location, provider and/or CPT® code, which enables physicians to be more agile in their decision making.

Q. How can practices track performance indicators within

the software?

A. Dashboards can reveal whether a physician is only running charges on the last five days of every month, or whether there is a coding lag. The MMPact Practice Point Dashboard provides topical, day-to-day, key performance indi-cators against which physicians and leaders can benchmark. This data offers some comfort that the group is on track, at any point in time.

Q. How can practices use MMPact Practice Point to bench-

mark their productivity against other practices?

A. Data points to benchmark include productivity levels, charges, reimburse-ments and units, and anesthesia practices should compare these measure-ments with their own performance in the previous year. Nationwide billing providers such as Medical Management Professionals, Inc. (MMP) have access to the data from an array of practices, which can be de-identified and matched against the characteristics of a given group to yield useful information.

Q. How does MMPact Practice Point benefit physicians on an

individual basis?

A. Physicians have the ability to customize their MMPact Practice Point home page to suit their individual needs. Tabs can be set up for easy navigation to dif-ferent areas within the application, which may include corporate documents, practice scoreboard, board meetings or coding regulations, as examples. Per-sonal income, benefits information, CEU tracking, licenses and DEAs can be viewed per a secure login page that is specific to each individual.

The following advertorial has been provided by MMP, and isdesigned to support the advertisement presented to the right.

MCAN2250.indd 1 12/8/12 2:27 PM

It’s Not How You Look: A Cautionary Tale From the Ward“You look mah-velous!You know, my father used to say to me,‘Nando, don’t be a schnook.It’s not how you feel—it’s how you look!’”

—Billy Crystal

The shaking chills rattled me out of a deep sleep. If only I could raise the temperature in my

spaceship. My eyes opened—it was 2

a.m., and I was home in bed, not on a medical mission to Alpha Centauri. I pulled the covers higher, to no avail. By morning I was achy, weak and febrile, and spent the next 24 hours in bed barely able to eat or drink. The next day, my right leg was red and swollen and my doctor, who is almost always avail-able, was out of town, so it was off to the emergency room. It was my birthday

and I was as sick as I have ever felt.As she took my vital signs, the effi-

cient triage nurse got my basic infor-mation and chatted. “But you must have forgotten to list your β-blocker.Your blood pressure is 110/60 and pulse 62,” she said. I proudly explained that those numbers were typical for me. I was as healthy as a horse and my only medication is a baby aspirin.

I heard the same comments, moreor less, from the emergency physician and nurses as they asculted, thumped, prodded, drew blood and placed an IV catheter. “And,” each said, “you look great—15 years younger.” Despite feeling very ill, I sucked it up. Look-ing back, I don’t think I made it clearenough that I felt lousy and had taken little by mouth in more than a day.

It took a few hours to get admit-ted to the best room in the house: pri-vate, top floor, corner with views of the park. My afternoon nurse and techni-cian introduced themselves, hooked up my catheter to a pump and admin-istered my first dose of antibiotic. My vital signs remained similar to those during triage. And of course, “Doctor, you look so young. If there is anything we can do, just ask.” Everyone was so nice and complimentary.

I poked at dinner but couldn’t eat, and managed only a few sips of gin-ger ale. The night shift arrived and told me how the night would progress and, naturally, how great I looked. Itoccurred to me that hours had passed since I had gone to the bathroom—many more than usual. It took min-utes to get out of bed; everything hurt. I passed a few drops of urine and, feel-ing dizzy and hot, stumbled back to bed. I glanced at the IV bag: only 300 cc had been infused since I was admit-ted. But for those few sips, I was NPO for 36 hours. My fluid deficit had to be four or five liters.

“Nurse,” I called. “I am dehydrated. I need fluid, lots of fluid—stat!”

My nurse said he would call the cov-ering physician and turned to walk out.

8 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

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But I begged, “Take my vital signs,” and to humor me, he did. My blood pressure was 155/87,my pulse was 95 and my temper-ature read 101.6 F. “So, you havehigh blood pressure?” “No, no,”I tried to explain. “These num-bers are misleading; I’m hyper-dynamic.” He quickly received approvalby phone to bolus me one liter over a few hours, after which I would receive more as needed.

As the saline trickled in and I unhap-pily contemplated my options, the light bulb went on. I paged the on-callanesthesiologist and, like the cavalry riding over the hill, he soon appeared carrying two liters of Ringers and a blood pump. He closed the door, pulled the curtain and quickly infused the life-giving fluid.g

As my cerebral perfusion improved, I began to wonder how this issue had been missed and what would have happened had I not self-ff diagnosedand been aggressively, although unof-ficially, treated. I imagine that my next vital signs would have been even more abnormal. The staff would have increased my IVs, although not nearly as much, and I would have improved—eventually, but not as fast. Had I more comorbidities, the outcome might not have been quite so good.

Of equal interest, I thought I had wonderful care and attention from all the staff. What was missing? An answer arrived three weeks later in the form of a four-page questionnaire which was similar, if far more detailed, to the one sent following a hotel stay or automobile oil service: Was I treated with respect by nurses, aides and dietary? Check. Was the bathroom clean? Check. Was my pain treated? Check. Was the food hot? Check.

Although these aspects of a hospital stay certainly are important, are they critical? Does the quest for perfect cus-tomer satisfaction equate to the deliv-ery of excellent medical care? There is evidence out there suggesting that the two do not necessarily correlate but like the No Child Left Behind pro-gram in public education, the hospital is teaching to the test.

Then, there is nursing time devotedto the electronic medical record—the one we are assured will bring health care to new and unimaginably improved heights. Aggravating the nursing short-age, this represents a further loss of face time with the patient and may result in the nurse missing subtle (or not so sub-tle) changes in the patient’s condition.

Lastly, where were the doctors? My physician returned from vacation and

saw me the following morning. He devotedtime and effort to my illness and cured mebut where was thatcrew of interns and res-idents, the hardwork-ing slightly disheveled

physicians in training who used to round on us sick folk looking for just such issues as I had? Gone, baby, gone. When I asked him, my doc simply said, “Welcome to the 21st century.”

On Dec. 16, the day of my admis-sion, no less an authority than the New York Times gave its imprimatur to the way things are and will be: “There is plenty of evidence,” an editorial in the paper declared, “that well-trainedhealth workers can provide routineservice that is every bit as good or bet-ter than what patients will receive froma doctor” (italics mine). The piecewent on to glorify the abilities of vari-ous providers, including patients them-selves, as superior to those of MDs.

How long before hospitalized patients will have to bring their own bandages, medicines and toilet paper? The 21st century, indeed!

I was discharged after two days of IV antibiotics. As my wheelchair went past the front desk, I caught a reflec-tion of my sad and aging face.

—Steven Kron, MD

Dr. Kron, an anesthesiologist in Southington, Conn., is a frequent contributor to Anesthesiology News.

M A R C H 2 0 1 3 A n e s t h e s i o l o g y N e w s . c o m I 9

COMMENTARY

Steven S. Kron, MD

Some people just look at the surface.

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3M is a trademark of 3M Company, used under license in Canada. SPOTON, BAIR HUGGER and BAIR PAWS are trademarks

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Two’s Company, Three’s a Crowd: Company Model Deals in the Hospital Setting

As readers of Anesthesiology Newsundoubtedly are aware, for the past four decades, the predomi-

nant relationship between anesthesiol-ogists and hospitals has been through anesthesia groups, which more often than not hold an exclusive contract for

all anesthesia services at the hospital.And whether or not there’s a group,

and whether or not there is an exclu-sive contract, the relationship betweenanesthesiologists and hospitals has predominantly been direct, with no middleman.

My previous articles addressing the so-called “company model” situation [see www.anesthesiologynews.com] reveal that those anesthesia compa-nies are essentially middlemen between anesthesiologists and ambulatory sur-gery centers (ASCs), as well as in the

economic relationship between anes-thesiologists and payers.

Despite the regulatory uncertainty of the company model, including an unfavorable advisory opinion from the Office of Inspector General (OIG) of Medicare, as discussed below, themodel in the ASC context appears to be gaining steam. As if that were not troubling enough for anesthesiologists,what if company model structuresjump the barrier between outpatient and inpatient facilities and were to beinstituted within hospitals?

You don’t need to wonder—it’salready starting to happen.

The Company Model Business Model

Let’s begin with a quick primer on the company model in the ASC setting so that we have a basic level of under-standing, before discussing the model’sleap to the hospital domain.

In its most direct form, the company model involves the formation, by thesurgeon-owners of an ASC, of an anes-thesia services company to provide all of the anesthesia services for the center. Before the formation of the company, all anesthesia services were provided by anesthesiologists either for their sep-arate accounts or for the account of their anesthesia group. After the for-mation of the company, anesthesiolo-gists are employed or subcontracted, with a significant share of the anesthe-sia fee being redirected to the company model’s owners, the surgeons.

1 0 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

COMMENTARY

Mark F. Weiss, JD

Enhanced HumblesLapWrap®p Positioning Pad

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Key Compliance IssuesThe federal anti-kickback statute

(AKS) prohibits the offer of, demand for, payment of, or acceptance of any remuneration for referrals of Medicare or Medicaid patients. There are excep-tions, most notably regulatory “safe har-bors,” that describe certain arrangementsnot subject to the AKS because they are unlikely to result in fraud or abuse.

Broad OIG GuidanceThe OIG of the U.S. Department

of Health and Human Services, the agency charged with regulating and enforcing the AKS, has issued two fraud alerts applicable to the analysis of company model deals: its 1989 SpecialFraud Alert on Joint Venture Arrange-ments, which was republished in 1994, and a 2003 Special Advisory Bulletin on Contractual Joint Ventures.

Note that the term “joint venture,”as used by the OIG in the alerts, isnot limited to the creation of a legalentity; rather, it covers any arrange-ment, whether contractual or involving a new legal entity, between parties in a position to refer business and those providing items or services for whichMedicare or Medicaid pays.

The OIG has made clear that com-pliance with both the form and the substance of a safe harbor is requiredin order for it to provide protection.The OIG demands that if one under-lying intention is to obtain a benefitfor the referral of patients, the safe har-bor would be unavailable and the AKS would be violated.

Although each alert is illustrative of the regulatory posture of the OIG, the 2003 Special Advisory Bulletin is partic-ularly on point in connection with ana-lyzing company model structures. In it, the OIG focuses on arrangements in which a health care provider in an initialline of business (for example, a surgeon) expands into a related business (such asanesthesiology) by contracting with an existing provider of the item or service (anesthesiologists or nurse anesthetists)to provide the new item or service to the owner’s existing patient population.

The 2003 bulletin lists some of the common elements of these problem-atic structures in general—neither of the alerts are anesthesia- or any other specialty-specific. In the points thatfollow, I have substituted words suchas “surgeon” and “anesthesiologist,” allin brackets, for the broader terms used by the OIG.• The surgeon expands into [an anes-

thesia business] that is dependent on direct or indirect referrals from, or on other business generated by, the

owner’s existing business [such as the surgeon’s practice or ASC].

• The surgeon does not operate the[anesthesia] business—the [anes-thesiologist] does—and does not commit substantial funds or human resources to it.

• Absent participation in the joint venture, the [anesthesiologist] would be a competitor [of the surgeon’s anesthesia company], providing ser-vices, billing and collecting [for theanesthesiologist’s own benefit].

• The [surgeon] and the [anesthesiol-ogist] share in the economic benefit of the [surgeon’s] new [anesthesia] business.

• The aggregate payments to the [sur-geon] vary based on the [surgeon’s]referrals to the new [anesthesia] business.

2012 Advisory Opinion 12-06The OIG’s first pronouncement

directly on the propriety of the com-pany model came in June 2012, when

it issued Advisory Opinion 12-06.The anesthesia group requesting the

opinion presented two alternative pro-posed scenarios, one a management fee deal and the other a company model structure.

In the proposed company model structure, the surgeons, or their ASC, would set up an anesthesia company tohold the exclusive anesthesia contract at the ASC. The anesthesia company would engage the anesthesia group at a

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COMMENTARY

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negotiated rate as an independent con-tractor to provide the actual anesthesia care and certain related services. Theanesthesia company would retain any profit.

In its Opinion 12-06, the OIGstated that there was no safe harboravailable in respect of the distributions that the surgeons would receive from their anesthesia company. The ASC safe harbor does not apply to protectdistributions of anesthesia profits.

Even if the safe harbor for paymentto employees applied, or if the safeharbor for personal services contracts applied, those safe harbors would pro-tect payments to the anesthesiologists. But they would not apply to the com-pany model profits that would be dis-tributed to the surgeons, and such remuneration would be prohibitedunder the AKS if one purpose of theremuneration is to generate or rewardreferrals for anesthesia services.

Because the failure to qualify for a safe harbor does not automatically render an arrangement a violation of the AKS, the OIG then turned to an

analysis pursuant to the 2003 Special Advisory Bulletin and found that the physician-owners of the proposed com-pany model entity would be in almost the exact same position as the suspect joint venture described in the bulletin: that is, in a position to receive indi-rectly what they cannot legally receive directly—a share of the anesthesiolo-gists’ fees in return for referrals.

Therefore, the OIG stated that the proposed company model venture could potentially generate prohibited remuneration under the AKS, and the OIG potentially could impose admin-istrative sanctions on the requestor.

Leaping, Perhaps Without Looking

Despite the fact that company model deals in the ASC setting are, to say the least, problematic, we are begin-ning to see related models appearing inthe hospital context.

One category of these arrange-ments is almost exactly analogous to the company model, but with an addi-tional compliance twist. The hos-pital, generally in the context of a renewal of an anesthesiology group’s

exclusive contract, grants a carve-out,either immediate or contingent (in other words, an option) in favor of a referring physician, “Dr. X” or his group. Dr. X is permitted, pursuant tothe terms of the carve-out, to use an entity to engage his own anesthesiol-ogists. Sometimes, the existing anes-thesia group is given a right of first negotiation to allow it to try to come to terms with Dr. X to provide those anesthesiologists.

This scheme places Dr. X in the position of being able to engage his own anesthesiologists at a wholesale rate, thus being able to profit from the difference between wholesale and retail, whether that anesthesia coverage ends up coming from newly recruited anesthesiologists or from the existing anesthesia group itself pursuant to the right of first negotiation.

A second category involves a carve-out as well, but with a slightly different twist. Here, the hospital attracts a new referring physician, “Dr. Y,” often in the context of a new service line. As a part of Dr. Y’s willingness to relocate, she requires that she be able to bring along her own anesthesiologists, with whom

she has worked for years and who are intimately familiar with her proceduresand the way she works. Although much harder to discover without loose lips on either Dr. Y’s part (not very likely) or on the part of Dr. Y’s anesthesiologists (more likely after a glass or two of wine),it is sometimes the case that those anes-thesiologists are engaged directly or indirectly by Dr. Y.

Of course, either of those arrange-ments, the first more demonstrably so, is the functional equivalent of a com-pany model deal imported to the hos-pital setting.

Note that there is an additional, extremely serious compliance issue pre-sented here: Is the hospital’s award of

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COMMENTARY

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the carve-out to Dr. X or Dr. Y itself a kickback to induce him or her to con-tinue to refer, as in Dr. X’s case, or tobegin to refer, as in Dr. Y’s case? That is, is the contractual right in favor of either of those physicians, enabling him or her to profit from anesthesia services, itself remuneration in viola-tion of the AKS?

The answer, of course, turns on the facts, but sometimes rules of thumb like “where there’s smoke, there’s fire” turn out to be very handy.

As hinted at in connection with theDr. Y example, it’s common for the arrangement between the hospital andthe referring physician to be dressed up in terms of quality: There is a need, after all, the documents argue, for Dr.X to have a dedicated, small group of anesthesiologists aligned with him toachieve the world’s highest quality, say, left nostril surgery, to patients.

But of course, a pig in a skirt is still a pig.

As a bonus, there is a related non-company model,y kickback-suspiciousmodel that must be mentioned.

In addition to addressing a company model arrangement, Advisory Opinion 12-06 dealt with a second proposed arrangement, one in which the ASC would charge the anesthesia provider a so-called “management fee.”

In similar fashion, we are seeing hospitals requiring that anesthesia groups obtain “services” from the hos-pital’s related management company as a condition of their exclusive con-tract. Although the fee in this contextis not a duplication of what the facil-ity already is being reimbursed for by payers (which was an issue in Advisory Opinion 12-06), query what the anes-thesiologists are really paying for.

ConclusionAs the economics of health care

become more acute, it is likely that more in the position to refer will attempt, legally or illegally, to profit from those referrals.

The company model in the ASC setting is simply one variant of this attempt.

Although the issue is contentious from the anesthesiologist’s viewpoint, and although Advisory Opinion 12-06denied regulatory approval to one such deal, the issue is far from settled as more and more referring physicians and facilities are attempting to plan around the opinion.

At the same time, the aggressiveness previously confined to the outpatient setting is beginning to take hold in the hospital context.

And unfortunately, anesthesiologists under pressure—often combined with an unwillingness to invest in fighting off the overture—sometimes give in rather than challenge.

No matter the setting, inpatientfacility or outpatient, company model deals, and management fee deals, raise hugely significant compliance con-cerns: jail, fines, civil penalties and debarment.

—Mark F. Weiss, JD

Mark F. Weiss is an attorney who specializes in the business and legal issues affecting physicians and physician groups on a national basis. He holds an appointment as clinical assistant professor of anesthesiology at USC’s Keck School of Medicine and practices with Advisory Law Group, a firm with offices in Los Angeles and Santa Barbara, Calif., representing clients across the country. He offers complimentary educational materials for our readers at advisorylawgroup.com. Mr. Weiss can be reached by email at markweiss@advisorylawgroup.com or at (310) 843-2800.

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COMMENTARY

14 ANESTHESIOLOGY NEWS • MARCH 2013

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Part 2 of a 3-Part Series

Perioperative Patient Monitoring: Case Studies in Cardiac SurgeryIntroduction

Although complications are a signif-

icant risk factor following any surgical

procedure, there are particular neurologic

complications often related to cardiac sur-

gery, including embolic stroke and transient

ischemic attacks, that are associated with

high postoperative mortality.1 As with other

types of surgery, the development of these

neurologic complications may be linked to

a patient’s preexisting comorbid condition,

such as peripheral vascular disease, con-

gestive heart failure, or a history of myocar-

dial infarction.2 Patients at risk for embolic

events may be screened using ultrasonog-

raphy to determine the presence of aortic

plaque near the sites for cannulation, cross-

clamping, and saphenous vein grafting to

avoid embolization. However, the etiology

of serious neurologic complications also

may be related to a second factor: hypoper-

fusion occurring within the perioperative

period.2 This factor is of particular concern

during cardiopulmonary bypass (CPB) when

there is non-pulsatile blood flow and typi-

cally lower mean arterial blood pressure.

Neurologic complications are more com-

mon among patients undergoing surgery

with CPB, especially when the surgery is

complex, involves aortic valve replacement,

or consists of surgery on multiple valves.1

Studies have shown an increased incidence

of adverse perioperative outcomes includ-

ing neuropsychological dysfunction,3,4

prolonged hospital length of stay (LOS),4

and major organ morbidity and mortality5

when patients experience intraoperative

cerebral oxygen desaturation regardless of

the type of surgery or whether the proce-

dure is performed “on-pump” or “off-pump.”

Low preoperative regional cerebral oxygen

saturation (rSO2) values also may be related

to adverse outcomes.5-7

Regional Oxygen Saturation Assessment Using Cerebral Oximetry

Clinicians increasingly are employing

cutaneous determination of rSO2 using real-

time cerebral oximetry as a tool for reduc-

ing risk for perfusion-related complications.

Technologies, such as the INVOS™ Cerebral/

Somatic Oximeter, complement ultrasonog-

raphy and hemodynamic monitoring by pro-

viding data that reflect the balance between

oxygen delivery and consumption within

the cerebral microcirculation. Because cere-

bral tissue (with its limited oxygen reserve)

is sensitive to changes in oxygen delivery

and consumption, rSO2 monitoring also may

serve as an index of perfusion and decreased

oxygen delivery to other major organs.8

Real-time rSO2 monitoring provides crit-

ical information that guides clinicians to

make adjustments of intraoperative parame-

ters beyond traditional vital signs (heart rate,

blood pressure [BP], central venous pres-

sure, and pulse oximetry). Clinical judgment

employs this real-time data to optimize the

delivery and consumption of oxygen within

the sampled brain tissue, thereby potentially

averting permanent cerebral injury. The rSO2

data provide a more robust determination

of optimal fluid administration, inotropic

support, and hematologic transfusion. Oxy-

gen saturation is helpful particularly during

surgeries that employ CPB, which dissociates

the autonomic nervous system and tradi-

tional vital signs (eg, low BP and tachycardia

as an indicator of potential hypoperfusion/

Case Study 1: 73-Year-Old Man Undergoing Aortic Valve Replacement and Repair of an

Aortic Aneurysm

T he patient presented for an aortic valve replacement for valve insufficiency and repair of an aortic aneurysm involving

the ascending aorta. His American Society of Anesthesiologists classification was 4 (patient with severe systemic disease). Anes-thetic induction primarily consisted of fentanyl supplemented with midazolam; anesthesia was maintained with isoflurane and fentanyl; midazolam was administered to maintain BIS (bispectral index) values less than 60.

Regional cerebral oxygen saturation (rSO2) monitoring using the INVOS system revealed baseline values of 67 and 68, and an interventional threshold of 54 (20% below baseline). The rSO2

values exhibited variability during placement of monitoring catheters with the left hemisphere exhibiting lower rSO2 thanthe right hemisphere, a trend thatpersisted throughout most of thesurgery. The values from both cere-bral hemispheres increased afterinduction of anesthesia and with1.0 fraction of inspired oxygen. TherSO2 values decreased markedlyafter the institution of cardiopul-monary bypass (CPB), which waspresumably related to anemia fromhemodilution (hematocrit 25% andpartial carbon dioxide alveolar pres-sure [PaCO2] 32.6 mm Hg). Physio-logic parameters were adjusted whenever possible to increase rSO2

above the interventional thresh-old: The CPB sweep was adjustedto raise PaCO2 toward a mainte-nance level greater than 40 mmHg. The patient then was cooled to16°C in anticipation of deep hypo-thermic circulatory arrest (DHCA).These adjustments increased rSO2

above the interventional threshold.The rSO2 values decreased bilat-erally during DHCA, with rSO2 onthe left side breaching the inter-ventional threshold. Reinstitutionof circulation with CPB restored

rSO2 values, but they declined again during rewarming. Hemo-dynamic, respiratory, hematologic, and anesthetic parame-ters were adjusted to optimize the delivery and consumption of oxygen within the sampled brain tissue, and rSO2 increased (Figure). The patient awoke several hours following surgery with no apparent neurocognitive deficits. This case illustrates the utility of cerebral oximetry monitoring during a cardiac surgical procedure that is typically associated with significant physiologic and hemodynamic changes.

The Western Pennsylvania and Forbes Regional Hospitals use a systematic process that maintains or increases rSO2

values based on the most likely etiology. For example, decreases in rSO2 that occur before CPB are assessed in terms of hemody-namic perfusion. Cardiac function is evaluated using trans-esophageal echocardiography and by measuring cardiac output with thermodilution. Therapy for improving tissue oxygenation then is directed at increasing systemic vascular resistance or cardiac contractility, depending on the assessment of ventricu-lar function. If decreased rSO2 occurs during CPB, increasing pump flow and/or systemic vascular resistance generally resolves the reduction in rSO2 values.

0

10

20

30

40

50

60

70

80

90

7:1

0:2

6

7:1

9:5

0

7:2

9:1

4

7:3

8:3

9

7:4

8:0

5

7:5

7:3

0

8:0

6:5

5

8:1

6:2

0

8:2

5:4

5

8:3

5:1

0

8:4

4:3

6

8:5

4:0

0

9:0

3:4

0

9:1

3:1

1

9:2

2:3

6

9:3

2:0

1

9:4

1:2

7

9:5

0:5

2

10

:00

:18

10

:09

:44

10

:19

:10

10

:28

:36

10

:38

:02

10

:47

:28

10

:56

:53

11:0

6:1

9

11:1

5:4

5

11:2

5:1

0

11:3

4:3

5

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4:0

1

11:5

3:2

7

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:02

:53

12

:12

:18

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:21

:44

12

:31

:10

12

:40

:35

12

:50

:01

rSO

2

BLUE is LEFT Cerebral GREEN is RIGHT Cerebral

Baselines: Right = 68

Left = 67

0854: On CPB, cool to

16 degrees centigrade

1001: Off CPB

On Circ Arrest

1014: On CPB,

Off Circ Arrest

1022: Rewarm to

25 degrees centigrade

pCO2 Hct

0736 49.5 36

0825 38.9 37

0905 32.6 25

0935 39.2 27

1006 40.2 29

1025 42.0 29

Interventional Threshold = 54

Critical Threshold = 50

0740: Induction of

general anesthesia

Figure. Clinical values for case patient 1: Arch repair of aortic aneurysm/aortic valve replacement.

CPB, cardiopulmonary bypass; Hct, hematocrit; pCO2, carbon dioxide partial pressure; rSO2, regional cerebral oxygen saturation

Courtesy of Christopher A. Troianos, MD.

Christopher A. Troianos, MD

Professor and Chair of AnesthesiologyThe Western Pennsylvania and Forbes Regional HospitalsWest Penn Allegheny Health SystemPittsburgh, Pennsylvania

ANESTHESIOLOGY NEWS • MARCH 2013 15

Supported by

BB

12

34

Case Study 2: 86-Year-Old Man With Stanford Type A Aortic Dissection

T he patient was transferred from a local hospital where he pre-sented with chest pain. His American Society of Anesthesi-

ologists classification was 4E (emergency patient with severe systemic disease); his weight was 80 kg. Computed tomography angiography of the chest revealed Stanford type A dissection of the aorta, and he was scheduled for repair of the dissection. Afterbeing transferred to the operating room, a bilateral radial arte-rial catheter, 3.9-mm introducer, and pulmonary artery catheter were placed under sedation. In addition to the standard moni-tors, sensors for the BIS Brain Function Monitoring System and the INVOS Cerebral Oximeter were placed before induction, andbaseline readings were recorded. After an uneventful induc-tion and intubation, anesthesia was maintained with isoflurane, fentanyl, midazolam, and a muscle relaxant. Femoral–femoral bypass was initiated and surgical exposure was obtained using a midline sternotomy. Hypothermic circulatory arrest was initiatedper protocol with administration of a standard pharmaceutical

regimen (agents added to the perfusion pump 3 minutes prior to arrest: methylprednisolone 1,000 mg, sodium bicarbonate 50 mEq/mL, mannitol 25 g, magnesium sulfate 2 g; agents given 2-3 minutes prior to arrest: furosemide 20 mg and midazolam 5 mg). Propofol 2 to 5 mg/kg was given to achieve a BIS reading near 0, and circulatory arrest was initiated. Cerebral protection was achieved by allowing perfusion to the brain via the innomi-nate artery in addition to hypothermia and achievement of a flat line electroencephalogram (EEG), with a BIS reading close to 0.

The pulsatile circulation to the brain was restored after 7 min-utes, 31 seconds, which was confirmed by examination of the cerebral saturation. An aortic cross clamp was applied and the diseased aorta was replaced with a tube graft. Because the aortic dissection had involved the right coronary artery ostia, the right coronary artery was bypassed with a saphenous vein graft. Hemo-stasis was achieved and heparin was reversed with protamine. The patient’s chest was closed, and he was transferred to the ICU with extubation of his trachea on postoperative day 1. The BIS monitor allowed the clinician to gauge the depth of anesthesia, and was used as an EEG monitor during circulatory arrest to main-tain the cerebral electrical activity as close to 0 as possible.

Once circulatory arrest was no longer required, the clinician allowed the BIS value to rise. BIS values were maintained within a range of 20 to 50 in order to act as an additional guide for depth of anesthesia and level of consciousness. Cerebral perfusion also was monitored using the INVOS system. Blood pressure, blood gas management, and hemoglobin concentration were adjusted as needed to maintain adequate cerebral perfusion, using cere-bral oximetry as a gauge. Cerebral saturation was maintained at 20% of the baseline value except during the circulatory arrest. The BIS monitoring system was an effective tool available to the anes-thesiologist, allowing for the maintenance of anesthetic depth and simultaneous monitoring of EEG to keep readings as close to flat line as possible during circulatory arrest.

Disclosures: Dr. Goldberg reported that he is a consultant for and on the speakers’ bureau of Cadence Pharmaceuticals, Inc. Drs. Muntazar and Troianos reported no relevant financial conflicts of interest.

Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Covidien, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature.

Copyright © 2013, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

hypo-oxygenation, and hypertension and

tachycardia as an indicator of inadequate

sedation/analgesia).

Murkin et al evaluated 200 patients under-

going coronary artery bypass using CPB.

Patients were randomized into 2 groups: a

control group in which the INVOS system

was used to obtain baseline rSO2 levels, but

clinicians did not have access to the INVOS

system data during surgery, or an interven-

tion group in which cerebral oximetry was

used actively to drive a management pro-

tocol that was designed to keep rSO2 values

at or above 75% of the baseline threshold.6

The authors found that fewer patients in the

intervention group (n=1) suffered a stroke

compared with patients in the control group

(n=4). Following a secondary analysis, the

authors found that patients in the interven-

tion group (n=3) experienced significantly

reduced rates of prolonged ventilation (>48

hours), sternal infection, renal failure, reop-

eration, and death compared with the con-

trol group (n=11).6 Furthermore, use of the

INVOS system with an intervention protocol

was associated with a shorter duration of

cerebral desaturation, shorter hospital LOS,

and decreased major organ morbidity com-

pared with the control method. A limitation

of this study was that cerebral oximetry was

not continued to the ICU. The authors noted

that interventions guided by the INVOS

system intraoperatively could have been

continued in the ICU setting.6

Evaluating Depth of AnesthesiaAnd Level of Consciousness

One potential therapeutic intervention

for improving the rSO2 levels obtained using

cerebral oximetry is to administer anesthetic

agents that reduce cerebral metabolism. This

intervention improves rSO2 levels because

rSO2 values represent a mix of arterial and

venous vascular oximetric sampling in an

approximately 1:3 ratio, respectively, and

therefore primarily reflect venous sampling

as opposed to the arterial sampling of a pulse

oximeter. Reduced oxygen consumption

increases venous oxygen saturation, thereby

increasing rSO2. However, near-infrared spec-

troscopy cannot replace a more specific indi-

cator of anesthetic depth, such as use of a

BIS™ (bispectral index) monitor. Studies have

demonstrated that a BIS value between 40

and 60 (on a scale of 0 to 100) reflects appro-

priate surgical anesthetic depth, and corre-

sponds to decreased cerebral metabolic rate

and a low probability of consciousness.9

Kertai et al investigated the associa-

tion between clinical variables, anesthetics,

cumulative duration of low BIS values, and

intermediate-term mortality in 460 patients

who underwent emergency cardiac sur-

gery, coronary artery bypass, or surgery of

the thoracic aorta. The cumulative duration

of a low BIS value (<45) was independently

associated with intermediate-term mortal-

ity, a hazard ratio of 1.29 per hour, or 29%

increased risk for death for every cumulative

hour a BIS value less than 45 was recorded.10

Similarly, Leslie et al reported that BIS values

less than 40 for more than 5 minutes dur-

ing cardiac surgery were associated with a

hazard ratio of 1.41 for mortality compared

with other BIS values.11 Patients above BIS

values of 40 showed improved survival and

reduced morbidity.11

Use of this technology during cardiac sur-

gery has led to investigations using BIS in

other postoperative settings (eg, postanes-

thesia care unit, ICU) when patients require

ongoing mechanical ventilation and seda-

tion. Solanki et al reported that a closed-

loop anesthesia delivery system using BIS to

direct propofol infusion after open heart sur-

gery resulted in patients spending a greater

proportion of time within the sedation tar-

get range compared with manual adjust-

ments of propofol infusions.12

ConclusionThese case studies highlight various fac-

tors that affect regional cerebral oxygen-

ation and anesthesia depth and alert the

clinician to avert potential misalignment

between cerebral oxygen delivery and con-

sumption. The INVOS Cerebral/Somatic

Oximeter and BIS Brain Function Monitoring

System can guide appropriate use of hemo-

dynamic- and anesthetic-based interven-

tions in patients undergoing cardiac surgery

and thereby optimize short- and long-term

outcomes. Further studies to determine the

utility of these systems in the postoperative

period would be beneficial.

References

1. Baranowska K, Juszczyk G, Dmitruk I, et al. Risk

factors of neurological complications in cardiac

surgery. Kardiol Pol. 2012;70(8):811-818.

2. Wanamaker KM, Moraca RJ, Nitzberg D, Magovern

GJ Jr. Contemporary incidence and risk factors for

carotid artery disease in patients referred for coronary

artery bypass surgery. J Cardiothorac Surg. 2012;7:78.

3. Yao FS, Tseng CC, Ho CY, Levin SK, Illner P. Cerebral

oxygen desaturation is associated with early postop-

erative neuropsychological dysfunction in patients

undergoing cardiac surgery. J Cardiothorac Vasc

Anesth. 2004;18(5):552-558.

4. Slater JP, Guarino T, Stack J, et al. Cerebral oxygen

desaturation predicts cognitive decline and longer

hospital stay after cardiac surgery. Ann Thorac Surg.

2009;87(1):36-44; discussion 44-45.

5. Fischer GW, Lin HM, Krol M, et al. Noninvasive cerebral

oxygenation may predict outcome in patients under-

going aortic arch surgery. J Thorac Cardiovasc Surg.

2011;141(3):815-821.

6. Murkin JM, Adams SJ, Novick RJ, et al. Monitoring

brain oxygen saturation during coronary bypass sur-

gery: a randomized, prospective study. Anesth Analg.

2007;104(1):51-58.

7. Heringlake M, Garbers C, Käbler JH, et al. Preoperative

cerebral oxygen saturation and clinical outcomes in

cardiac surgery. Anesthesiology. 2011; 114(1): 58-69.

8. Murkin JM. Cerebral oximetry: monitoring the brain

as the index organ. Anesthesiology. 2011; 114(1): 12-13.

9. Bowdle TA. Depth of anesthesia monitoring.

Anesthesiol Clin. 2006;24(4):793-822.

10. Kertai MD, Pal N, Palanca BJ, et al; The B-Unaware

Study Group. Association of perioperative risk

factors and cumulative duration of low bispectral

index with intermediate-term mortality after car-

diac surgery in the B-Unaware Trial. Anesthesiology.

2010;112(5):1116-1127.

11. Leslie K, Myles PS, Forbes A, Chan MT. The effect of

bispectral index monitoring on long-term survival in

the B-aware trial. Anesth Analg. 2010;110(3):816-822.

12. Solanki A, Puri GD, Mathew PJ. Bispectral index-con-

trolled postoperative sedation in cardiac surgery

patients: a comparative trial between closed loop and

manual administration of propofol. Eur J Anaesthesiol.

2010;27(8):708-713.

Michael E. Goldberg, MD

Professor and Chair, Department of AnesthesiologyAssociate Dean for Academic AffairsCooper Medical School of Rowan UniversityChief, Department of Anesthesiology, Cooper University HospitalCamden, New Jersey

Muhammad Muntazar, MD

Associate Professor of AnesthesiologyCooper Medical School of Rowan UniversityHead, Division of Cardiothoracic AnesthesiaCooper University HospitalCamden, New Jersey

Medical Device Interoperable Standards To Grow in 2013But experts fear more standards could sow confusion, not communication

When Mindray engineers designed the “A series” of all-in-one anesthesia sys-

tems, they included the latest open stan-dards for devices to communicate with each other including HL7, IEEE and 11073.

In an era of proprietary interfaces

that can prevent medical devices inhospitals from interacting, Mindray,based in China, figured that giving itsnew systems tested and known interop-erability standards might be trailblaz-ing or at least act as a conversationstarter for hospital procurement.

It wasn’t.

“We’re at the point where there really is no excuse in general for not building devices that comply with interoperabil-ity standards,” said Ken Fuchs, senior principal architect of enterprise systems for Mindray North America, in Mah-wah, N.J. “But the reality, at least from my perspective, is that customers really

don’t care at this point.”Most agree that hospital medical

devices need interoperability standards, much like Wi-Fi and Bluetooth for computer networking. But moving from a competing barrage of proprietary and open-sourced interoperability standards dto a clear set of guidelines may be years away, experts say.

In 2013, a new industry push toward interoperability standards will come from collaboration between the Associ-ation for the Advancement of Medical Instrumentation (AAMI), a trade orga-nization, and safety standards specialists Underwriters Laboratories (UL).

“There are many existing interop-erability standards and implementa-tion profiles, but these often do not offer the clarity or specificity needed to enable complete interoperability and uniformity of medical device sys-tems,” Mary Logan, AAMI president, wrote in an email. “The new AAMI/UL project will not supplant or replace this existing body of standards, but will attempt to map them into a larger framework that not only enables true interoperability across systems, but also allows important aspects such as risk management, reliability and security to be adequately addressed.”

The collaboration was announced in October and applications for the interoperability standards committee will be accepted in early 2013.

The collaboration will have a public review period at a later date, Ms. Loganadded.

When discussing the device with anesthesiologists, most tell Mr. Fuchsthey do not care about the standards, much like Internet surfers do not fret about Wi-Fi consortia.

“That’s interesting,” Mr. Fuchsrecalled most anesthesiologists telling him. “But I’m all about how I use the device, not what goes out the other end.”

Plenty of Justification—And Obstacles

The complicated standoff involves budget-strapped hospitals that cannot afford infrastructure overhauls, clini-cians who may not be vocal about hav-ing their equipment interact, companies that want to protect their technologies, a lack of procurement incentives and federal regulations that may inadver-tently slow developers.

Hospitals likely will find the money from waste in redundant administrative

1 6 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

TECHNOLOGY

roles and procedures, said Venkat Rajan, a medical device analyst at Frost & Sul-livan, a market research firm. “If you can reduce administrative waste, reduce the number of errors, automate certain functions, that could free up some dol-lars that could be used toward investing in a lot of these technologies,” he said.

Mr. Rajan said the central question for hospital groups, device manufactur-ers, software developers and insurance companies is who should be responsible for determining the standards.

“If it’s going to move forward, it is going to have to come from collabora-tion between a hospital and a device manufacturer to implement a pilot pro-gram,” Mr. Rajan said. “Once these companies realize that there is an opportunity, a business model, and dol-lars start flowing to them and get these standards out there, then it will start picking up the pace.”

Industry is not at that point, yet.“We have to lay the tracks for these

basic capabilities before we can do the next level of automating what are some-times called plug-and-play capabili-yties,” said Elliot B. Sloane, director of health systems engineering at Drexel University in Philadelphia and founder of the Center for Healthcare Informa-tion Research and Policy. “In the ideal world, yes, we could connect every-thing to everything like a USB, but the USB environment is quite simple and it generally doesn’t have life-and-deathconsequences.”

Several models for interoperabil-ity exist: They include integrated clin-ical environments (plug-and-play), machine-to-machine communication, alarm communication, technology man-agement to monitor scheduled main-tenance and electronic medical record communications.

The medical device community could learn from the Continua Alli-ance, an industry-yy led group that guides

interoperability standards for mobile and home care technologies.

“You’ve got to find a safe environ-ment for companies to come together and talk about how you are going to standardize particular sets of equip-ment,” said Chuck Parker, the group’s executive director.

Mr. Parker said the development of a low-powered radio transmitter illus-trates one simple case of the market driving standardization.

Wi-Fi and Bluetooth are fairly

battery-y intensive, so in the late 2000s, the industry started looking at low-powered radios to save battery life.d

The device had to last for a year on a “coin cell” small battery. It needed to transmit data within a certain range, col-lect data on a regular basis and be able to assemble that information—all while being compatible with existing radios. Continua Alliance held a competition: Seven low-powered radio companies made their case and two makers won acceptance as the new standards.

“It was a fairly straightforward and fairly rigorous competition on what technology we were going to select, and I think that exact same process is going to be applied to any organization that is going to standardize components out of the operating room or anesthesiology-yyspecific activities,” Mr. Parker said.r

In August, Denmark made a procure-ment decision that in 2013, all future deployments of technology that will be using mobile or home-based technology d

M A R C H 2 0 1 3 A n e s t h e s i o l o g y N e w s . c o m I 1 7

‘We do not know if there is any antivirus software

in use on medical devices, we can’t easily read the status of a device to see if it has been recalled by

the manufacturer, we can’t easily tell whether the

software is upgraded. So we can’t do the things that are taken for granted today

in computer equipment.’

— Julian Goldman, MD, PhD

TECHNOLOGY

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42120_AT-090_30031_Anth_Jnr_Ad 1 1/6/12 12:30 PM

will use a Continua framework.The question remains: “If you plug

and play one device into another man-ufactured system, how does one validate the safety of doing that?” asked Steven Dain, MD, an anesthesiologist at the University of Western Ontario, Canada, who has worked on the interoperability issue for nearly two decades.

Current cost estimates range from $5,000 to $10,000 to hook up external

components to an anesthesia informa-tion system, Dr. Dain said. “Wouldn’t it be nice to have a standard so you could just plug and play?”

MD FIRE: Light, Heat Or Neither?

One approach to push interoper-ability standards along is to outline them at the purchasing level, which would encourage manufacturers to build communicative equipment, an idea fostered by Medical Device “Free

Interoperability Requirements for the Enterprise” (MD FIRE), an open-source language for hospital procure-ment contracts.

The idea, championed by Julian Goldman, MD, PhD, founding director and principal investigator for the Med-ical Device Interoperability Program at the Center for Integration of Medicine and Innovative Technology, has been adopted by Partners Health Care, Johns Hopkins Medicine and Kaiser Perman-ente. In fall 2012, the Veterans Affairs

system, which holds substantial purchas-ing power, announced it would adoptthe procurement guidelines.

MD FIRE was meant “to send a clearunambiguous message to the medi-cal device industry that there is a mar-ket, that we care, that we need and wantour medical devices to be interoperable,”said Dr. Goldman, a member of the edi-torial board of Anesthesiology News. “Weare looking at improving patient safety directly from having medical devicescommunicating to build smarter, tobuild more intelligent networking.”

For example, a corporate informa-tion technology worker can mon-itor remotely all the desktops andlaptops and determine viruses or soft-ware updates, which is nearly impossiblewith today’s medical equipment.

“We can have ventilators and bloodpressure monitors and pulsometersand infusion pumps, a whole array of medical devices; we do not know if there is any antivirus software in useon medical devices, we can’t easily readthe status of a device to see if it hasbeen recalled by the manufacturer, wecan’t easily tell whether the software isupgraded,” Dr. Goldman said. “So wecan’t do the things that are taken forgranted today in computer equipment.Most medical devices don’t have auto-matic clock-setting capabilities andgbiomed departments have to go aroundand manually set the clocks right twicea year.”

Even when interoperability standardshave been accepted, “certification hasbeen sorely lacking for medical deviceinteroperability,” Dr. Goldman added.

Dr. Goldman urged clinicians tomake their interoperability needsknown in abstracts, blogs and throughsocial media. They don’t have to telltheir favorite manufacturer; they justhave to get the word out. “The more cli-nicians and hospitals who say that this isimportant to them and that they wantto buy products that are interoperable,the more we’ll see the marketplace pro-vide,” he said.

But Mr. Fuchs said he hasn’t seen much effect from MD FIRE. On theprocurement side, he said, vendors wanta yes or no answer about device interop-erability, but few details about thestandards.

“For us, at this stage of the game, sup-porting this standard didn’t buy us any brownie points with any of the [elec-tronic medical record] or middlewarevendors because they still had to buildtheir interface to our product as if it isthe interface with something proprie-tary,” Mr. Fuchs said.

—Trevor Stokes

1 8 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

TECHNOLOGY

INTEROPERABILITY CONTINUED FROM PAGE 17

42120_AT-090_30031_Anth_Jnr_Ad 2 1/6/12 12:30 PM

Intubation Training Phone App Bests LectureToronto—Free software for theApple iPhone that simulates fiber-optic bronchoscopy can flatten the intubation learning curve for anesthe-sia trainees, according to its develop-ers. A small, randomized study they conducted showed that a half-ff hourof using the mobile simulator led to faster and more accurate first-timemannequin-based intubations com-pared with sitting through a lecture.

Carin Hagberg, MD, executive direc-tor of the Society for Airway Man-agement, said the app is “probably the easiest program that I’ve worked withfor learning basic intubation skills. I’vealready put a link to it up on our black-board for residents to be able to play with,” added Dr. Hagberg, chair of anes-thesiology at the University of Texas Health Science Center, in Houston.

Raymond Glassenberg, MD, asso-ciate professor of anesthesiology at Northwestern University’s Feinberg School of Medicine, in Chicago, andseveral colleagues set out to create a low-cost alternative to existing intuba-tion simulators. In the spirit of frugal-ity, the researcher enlisted his son, a software engineer, in the effort.

The free application, called iLar-ynx, is available for iPhones and iPads, and allows users to manipulate a vir-tual bronchoscope through a simulatedairway. Users can rotate the handhelddevice and perform an intubation on a patient either awake or paralyzed. One scenario also includes a paralyzed patient with an airway tumor.

Dr. Glassenberg randomized10 medical students to attend a 30-minute lecture on airway anatomy with static images displayed during thelecture, and an equal number of train-ees used the iLarynx for 30 minutes. Participants in both groups then per-formed 10 mannequin-based broncho-scopic intubations and were evaluatedby an observer blinded to their mode of training.

Dr. Glassenberg, who presented his findings at the 2012 annual meeting of the Society for Airway Management (abstract 2), said 96% of intubations in the iLarynx group were success-ful, compared with 76% in the lecture group (P<0.005). Nine of 10 initial intubations in the iLarynx group were successful, compared with four among lecture attendees (P=0.029).

Users of iLarynx also required sig-nificantly less time to perform intu-bations, with a median time of 35 seconds for first attempts (range, 24-62

seconds), compared with 120 seconds for first attempts by lecture attend-ees (range, 94-120 seconds; P<0.005). Median intubation times for the 10th attempt were eight seconds in the iLar-ynx group and 13 seconds in the lec-ture group (P<0.005).

“Unlike a virtual reality system with handheld bronchoscopes, the appli-cation can be practiced anywhere,”

Dr. Glassenberg said. The app has been gdownloaded more than 25,000 times since its release in March. “The app particularly resonates with a younger generation of anesthesiologists who have grown up playing video games,” he added.

Although the simulator is use-ful in helping trainees develop hand-eye coordination, it has its limitations,

Dr. Hagberg noted. “You can only do gan oral bronchoscopy in the supine position and there’s no monitoring of oxygen saturation, for example,” she said. “But I’m sure the iLarynx is just the first in a line of apps that we’ll be seeing in the future, with better graph-ics and different scenarios.”

—David Wild

M A R C H 2 0 1 3 A n e s t h e s i o l o g y N e w s . c o m I 1 9

TECHNOLOGY

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Reusable Surgical Devices Pose Cross-Contamination RiskStudy from OR shows high rate of colonization with potentially harmful microbes

To operating room practitioners,reusable medical equipment such as laryngoscope handles,

pulse oximeters and electrocardiogram(EKG) cables are the trappings of the profession, everyday items given lit-tle thought beyond their intended use. Yet as a study by French researchers

has uncovered, more than half of suchitems are contaminated with microor-ganisms, highlighting the risk for cross-contamination in even the most sterilesettings.

“We started by checking the con-tamination of reusable laryngoscope handles,” said Pierre Diemunsch, MD,

PhD, professor and chair of anesthesia at Hôpitaux de Hautepierre in Stras-bourg. “To our surprise, we found sig-nificant contamination despite ourinstitutional cleaning protocol. This prompted us to check other reusable devices in the OR. Among these, the noninvasive blood pressure cuff, the

SpO2 probe and EKG wires are used every day in our institution, and wefound it important to control them.”

For the study, a trained practitioner randomly took 96 sets of swab samplesfrom EKG cables, and 46 samples frompulse oximeters in 15 ORs. Two swabswere taken after decontamination and immediately before being used on thenext patient: one for bacteriologic and the other for mycologic examination. Operating room staff was unaware of the study so routine decontamination protocols would not be altered.

As the investigators reported at the 2012 annual meeting of the Interna-tional Anesthesia Research Society (abstract S-221), more than half thesamples tested positive for the presenceof microorganisms, although no resis-tant pathogens were identified (Table).

Dr. Diemunschsaid the significantcross-contamination risk revealed by the study suggestsa potential need for improved decon-tamination protocols, including regularaudits of the process. “It’s a key point that clinicians believe that the insti-tutional protocols for material clean-ing are sufficient,” he said. “I share thisopinion, but the human factor makes it such that the application of these pro-tocols is less than perfect.”

He pointed to a similar study (Anesth Analg 2009;109:g 479-483) from New York that found that con-tamination rates fell once OR person-nel knew they were being observed. Contamination rates in the New York analysis were nearly identical to thosein the French study.

“So the problem really exists and is recognizable on both sides of theAtlantic, if looked for,” Dr. Diemunsch

2 0 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

TECHNOLOGY

added. In late 2011, Britain’s Medi-cines and Healthcare Products Regu-latory Agency issued a medical device alert for reusable laryngoscope han-dles after a patient developed a fatal septicemia.

More Single-Use Devices Needed

Incorporating more single-useequipment into the OR, particularly in infectious and immunocompromised patients, might help, he said. “This isthe case in many institutions for SpO2

probes but not yet for the cuffs, nei-ther for the laryngoscope handles nor

the EKG wires. These items do exist,however, and even if not used on

a routine basis they should be considered for patients par-ticularly at risk for cross-contamination. Of course,the cost issue is to be taken into account in selecting theproper patient.”

David S. Beebe, MD, pro-fessor of anesthesiology at

the University of Minnesota in Minneapolis-St. Paul, said the

study confirms what other trialshave found: Significant contamination exists in the OR from reusable anes-thesia equipment. “I’m not sure whatto do about it other than have person-nel properly clean their hands and use gloves to avoid spreading organisms,clean the anesthesia equipment per a standard protocol to reduce contam-ination and use reusable equipmentwhenever possible,” Dr. Beebe toldAnesthesiology News. “Unfortunately,we will probably be contributing to the solid waste disposal problem, but if ithelps prevent hospital-acquired infec-tions, so be it.”

Peter Breen, MD, associate profes-sor of anesthesia and perioperative care at the University of California, Irvine,offered a different perspective. “Cer-tainly the trend in anesthesia is more and more toward single-use items, and

that’s probably a good thing for many reasons, including infection control,” Dr. Breen said. “The only problem with a study like this, however, is that they didn’t talk about the incidence of actual disease that resulted from this colonization of equipment. So, what they’re proposing is laudatory, but youcan spend a lot of time and money try-ing to correct something that may not actually result in any infections.”

—Michael Vlessides

Table. Bacteria Found on OR Devices

Pulse Oximeter (46 Swabs) EKG Cables (96 Swabs)

Negative cultures 15 (33%) 46 (48%)

Positive cultures 31 (67%) 50 (52%)

Cultures finding at least one pathogenic microorganism 4 (9%) 5 (5%)

Staphylococcus aureus 2 1

Enterococcus faecalis 1 0

Aspergillus fumigatus 0 1

Staphylococcus aureus + Enterococcus faecalis 1 1

Corynebacterium 0 2

EKG,EKG, gelectrocardiogram electrocardiogram

M A R C H 2 0 1 3 A n e s t h e s i o l o g y N e w s . c o m I 2 1

TECHNOLOGY

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Too Few Awake Intubations Risk Patient Harm, Loss of Physician SkillToronto—Clinicians are not con-ducting enough preinduction awakeintubations, risking erosion of their competence and potential harm to their patients, experts warned at the 2012 annual meeting of the Society forAirway Management (abstract 66).

J. Adam Law, MD, professor of anesthesia, pain management and perioperative medicine at Dalhousie University, in Halifax, Nova Scotia, Canada, reminded meeting attend-ees that preinduction intubations are potentially safer than postinduction

intubations because they provide cli-nicians the opportunity to “concen-trate on getting the tube in. Unless a patient is oversedated, they can look after maintaining a patent airway, adequate gas exchange, and airway protection against aspiration of gastric

contents or blood during the intuba-tion process,” he said.

Hazardous ShortcutsDr. Law pointed to results

from the United Kingdom’s NAP (National Audit Project)-4 study asevidence that some clinicians are

“taking shortcuts” and conducting intubations after induction when earlier inductions are warranted (Popat M, et al; www.rcoa.ac.uk). Data from NAP-4 identified 18 patients with risk factors for difficult intubations who underwent postin-duction intubation although prein-duction intubation might have been safer, he said. Two of the patients suffered hypoxic cardiac arrest and 16 could not be intubated.

The NAP-4 findings did not reveal why clinicians chose to per-form postinduction intubations, but Dr. Law said a patient’s concern about whis or her discomfort with awake intubation, and an attending surgeon’s preference for a quick intubation, are two reasons clinicians might perform postinduction intubation contrary to the best interests of patient safety.

However, “if an awake intubation is indicated, the case for the procedure and its added safety should be made firmly, with confidence, yet with empa-thy,” Dr. Law urged.w

2 2 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

CLINICAL ANESTHESIOLOGY

Not Just for Difficult AirwaysPreinduction intubation often is

clearly indicated for patients with advanced airway obstruction, but Dr. Law said other patient character-wistics should be considered to informthe decision to intubate patients when they are awake. For example, limitedjaw protrusion and limited head and neck extension may place patients at risk for difficult face-mask ventilation k(FMV), he noted.

“Few would argue against the advis-ability of awake intubation if both endotracheal intubation and FMV arepredicted to be difficult,” Dr. Law said.w

Similarly, patients assumed to be “easy to bag” can have a full stomach or an illness that places them at risk forprecipitous oxygen desaturation with apnea onset. Both factors make prein-duction intubation a potentially safer option, the expert noted.

Fading SkillsPerforming too few preinduction

intubations also can lead to an erosion of a clinician’s skills and increase the risk for a failed intubation when awake intubation is the preferred option,Dr. Law said. “It’s difficult to know whow many awake intubations it takes to maintain competence once attainedbut, at least in my practice, for just this reason I’m always looking for reasonsto do, and not to avoid, awake intuba-ddtions,” he said.

Timothy Turkstra, MD, associateprofessor of anesthesiology and periop-erative medicine at the Schulich School of Medicine and Dentistry at Western

University in London, Ontario, Can-ada, agreed that awake intubations are becoming much less common with the growing use of video laryngoscopy. He suggested clinicians could lower their clinical threshold in deciding when to perform preinduction intubations and perform them more frequently.

For those with rusty skills, Dr. Turkstra suggested seeking prac-tice opportunities through teaching seminars and during routine operating room procedures, when possible.

“We need to be vigilant in preserv-ing our skills, especially airway man-agement skills, but we may not see opportunities to do so unless we are actively looking for them,” Dr. Turkstrasaid. “You don’t want to utilize a device with the most difficult patient and lack recent experience.”

—David Wild

Drs. Law and Turkstra reported no relevant con-flicts of interest.

M A R C H 2 0 1 3 A n e s t h e s i o l o g y N e w s . c o m I 2 3

CLINICAL ANESTHESIOLOGY

Contact the editor of Anesthesiology News

am

arcu

s@mcmahonmed.com

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‘Hybrid’ Pre-Op Assessment ModelIncreases OR Efficiency at Nebraska Hospital

How are anesthesiologists responding to health care reform? Leading departments are demonstrating their value by working

to improve surgical care and reduce costs. Much of the focus is on enhancing the preoperative assessment process.

Key issues include the best way to use physicians, mid-level providers and nurses in preoperative assess-ment; who should lead the overall preoperative pro-cess—anesthesiologists or internists; and what is the best way to manage patient risks—through remoteassessment or on-site evaluation.

Departments nationwide have developed severalpromising models that answer these questions in dif-ferent ways. Recently, the Anesthesiology Depart-ment at the University of Nebraska Medical Center, in Omaha, implemented a preoperative assess-ment model that combines the strengths of several

different approaches. This “hybrid” model leverages the expertise of anesthesiologists, hospitalists, phy-sician assistants and nurses within a protocol-drivensystem that uses both remote screening techniques and on-site medical evaluation.

By successfully implementing this model, Univer-sity of Nebraska anesthesiologists demonstrated their value by significantly reducing case cancellations anddelays. In doing so, the anesthesiologists positively transformed their relationship with surgeons andhospital administration.

A Disorganized SystemThe Nebraska Medical Center (NMC) has an

annual surgical volume of approximately 17,000 cases. In recent years, the operating room struggled with a high rate of case delays and above-benchmarkcase cancellations. In 2010, approximately 50% of first cases were delayed, and 2.6% of cases were can-celed within 24 hours of surgery.

The main cause of these inefficiencies was disorga-nization in presurgical processes. Patients entered thesystem through Presurgical Screening (PSS), a nurs-ing unit that performed a simple screening assess-ment by phone. The assessment call took place oneto two days before surgery, and it also included thecapture of patient demographics and financial infor-mation. Separately, physician assistants and residents performed clinical assessments in the Anesthesia Pre-Op Evaluation Unit (APEU). Staff worked without faculty supervision or consistent guidance on testing requirements. Each unit acted independently, withconsiderable redundancy of tasks.

Poor organization led to poor outcomes. A signifi-cant percentage of charts were incomplete on the day of surgery, with common issues being pending lab reports and anesthesia reviews. APEU clearance was not meaningful—depending on which anesthesiolo-gist was in the operating room, cases were routinely rescheduled for additional testing. Many surgeons, frustrated by the process, had stopped referring patients to the APEU. Overall, only 35% to 40% of American Society of Anesthesiologists (ASA) 3 andASA 4 patients underwent a preoperative assessment.The majority of patients received their first full clini-cal review on the morning of surgery.

Canceled and delayed cases involved significant direct and indirect costs for NMC (Table 1). In addi-tion, the process was expensive. In fact, total costs per patient in the PSS and APEU exceeded preopera-tive costs at hospitals that provide full evaluation by physicians.

The situation created tension within the organiza-tion, with dissatisfaction focused on anesthesiology. Some surgeons began to lobby for a new anesthesia group. Hospital administrators were frustrated, and the conflicts had even come to the attention of theboard of directors. Anesthesiologists, aware of thegravity of the problem, saw their opportunity to takethe lead in seeking a solution.

Building a New ProcessIn March 2011, NMC anesthesiologists joined

with colleagues in surgery, nursing and administra-tion to design a new preoperative evaluation system. The anesthesia-led multidisciplinary task force began by examining the basic preoperative model.

Several surgical innovators argue that all surgical patients should be required to visit a preoperative clinic. The problem is that this model is very expen-sive. It also is inconvenient for patients, especially at academic medical centers like NMC, which draw referrals from a wide region. Instead, the task force focused on developing a hybrid model that combinesa well-planned phone screening process for patient risk stratification with an in-person clinic driven by carefully designed protocols.

The phone screening process was built around an evidence-based triage tool—a 14-question scriptused by nurses to flag high-risk patients. The tool looks at severity of disease, not just the diagnosis. For example, patients with diabetes who are on insulin or have end-organ damage are referred for an on-siteevaluation; patients with diabetes on oral medica-tions alone are not. Patients with chronic obstructive pulmonary disease who use an inhaler are called in, whereas those with mild respiratory problems are not. Focusing on severity enables many patients to avoid an unnecessary trip to the hospital.

The task force also collaborated to develop a stan-dardized matrix for presurgical testing based on cur-rent recommendations. Previously, the hospital’s testing guidelines were largely age-based. For exam-ple, all patients over the age of 50 years were referred for an electrocardiogram (EKG). The new matrix tools, by contrast, emphasize patient comorbidities and procedure invasiveness (Table 2). Project leaders also collaborated with other departments to develop standard guidelines for evaluating abnormal lab results.

The task force introduced the proposed triage, testing and evaluation protocols during a series of anesthesiology department meetings. Project leaders presented evidence for the new algorithms and gave colleagues a chance to respond. Ultimately, the entire department endorsed the new protocols, and mem-bers agreed to accept each other’s judgment within

Table 1. The High Cost of Case Cancellations

Delay (min)

Cost Of Delay

($30/min)

Annualized Direct Cost

Of Delay

Annualized Indirect Cost

Of Cancellation (time not backfilled)

12 $360 $129,600 $216,000

24 $720 $259,200 $432,000

36 $1,080 $388,800 $638,000

48 $1,440 $518,400 $846,000

60 $1,800 $648,000 $1,080,000

72 $2,160 $777,600 $1,296,000

84 $2,520 $907,200 $1,512,000

96 $2,880 $1,036,800 $1,728,000

108 $3,240 $1,166,400 $1,944,000

120 $3,600 $1,296,000 $2,160,000

This chart illustrates the potential impact of case cancellations on a 10-room surgicalunit with an annual volume of 12,000 cases, average contribution margin of $6,000per case and a cancellation rate of 3% (360 cases). If each cancellation results in only24 minutes of delay, the OR wastes $259,200 per year in direct variable costs (360cases x $720 per delay). Cancelled OR time that cannot be rescheduled represents anadditional opportunity cost. If each cancellation results in 60 minutes of unutilized ORtime, annual indirect costs equal $1,080,000 (360 cases x $6,000 contribution margin x

g )50% of average case time).50% of averagge case time).

2 4 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

POLICY & MANAGEMENT

The new Pre-Anesthesia Screening Clinic at the University of Nebraska Medical Center.

the new process. The protocols were then approvedby other department chairs. Finally, the task force disseminated the new tools to surgeons, includ-ing their office managers, nurse coordinators and schedulers.

While the new protocols were being devel-oped, the preoperative task force also was working to consolidate all processes and staff in a new Pre-Anesthesia Screening (PAS) Clinic. This relocatedand expanded clinic provides comprehensive presur-gical and preprocedural preparation services in one location. It is staffed by four anesthesiologists who together equal one full-time employee. The physician group was purposely kept small to maximize consis-tency in applying assessment and testing protocols.

PAS Clinic staff also includes hospitalists who manage orthopedic patients before and after surgery.The hospitalists currently focus on joint replacementpatients, but the program could expand to other patient groups with complex medical issues.

Nurses in the PAS Clinic perform phone screensusing the new triage tool. Insurance and demo-graphic verification have been reassigned to registra-tion staff, so triage nurses now are able to focus on clinical assessment. All PAS nurses are cross-trainedfor roles in the presurgical holding area. This train-ing provides flexibility and gives PAS staff a better understanding of the entire preoperative choreogra-phy, which encourages more complete charting and better patient hand-offs.

The new process is also more convenient for patients. Patients can meet with an anesthesiolo-gist, a hospitalist and nursing staff—and have blood draws and EKGs as needed—all during a single visit.

Most patients are scheduled for their PAS appoint-ment on the same day they see their surgeon, sav-ing more travel time and costs. Several PAS schedule slots are held open every day to accommodate walk-kkin patients and last-minute requests from surgeons.

Strong OutcomesThe PAS Clinic went live in August 2011. During

the following year, it produced solid results in both clinical performance and organizational efficiency.

The new process does a better job of capturing patients. As of January 2013, the clinic succeededin screening more than 90% of surgical patients by phone, with approximately 70% screened and man-aged exclusively through the phone process. Approx-imately 75% of ASA3 and ASA4 patients were evaluated in the PAS Clinic before their procedure. Clinic leaders have set a goal of capturing 90% of these higher-risk patients.k

Patients at NMC now are better prepared for surgery. The problem of pending lab results andincomplete charts on the day of surgery has been sig-nificantly reduced. The number of case delays related to preoperative testing has been cut by approximately 60%. First-case delays have fallen from about 50% to less than 20%, whereas case cancellations within 24hours have declined from 2.6% to 1.3%.

The reduction in cancellations and delays supports better utilization, which is helping to optimize direct and indirect costs in the operating room. The consol-idation of preoperative processes also has led to staff cost savings. Testing cost data is not yet available, but shifting more tests into the appropriate preoperative period is helping reduce unnecessary diagnostic costs

included in the Diagnosis-Related Group payment.Politically, the reform of the preoperative evalua-

tion system has transformed the relationship betweenthe anesthesiology department, their clinical col-leagues and hospital leadership. Surgeons are highly satisfied with the results of the initiative, and they now demonstrate strong confidence in the decisions and systems put in place by anesthesiology. Hospi-tal leaders are proud of the PAS Clinic, and they see their relationship with anesthesia as the model of a collaborative partnership.

Keys to SuccessThe key to transforming preoperative processes is

collaborative leadership. NMC relied on four factors to achieve change—multidisciplinary cooperation among representatives from key disciplines, physician champions to promote system change, strong support from hospital administration and agreement among anesthesiologists to form consensus on a protocol-driven approach.

NMC leaders believe the PAS Clinic could ulti-mately serve as a platform for a “surgical home” model focused on careful tracking of patient infor-mation, vigilant management of patient risk fac-tors and full coordination of services. NMC’s hybrid model for preoperative evaluation demonstrates how to leverage resources efficiently to improve perfor-mance and outcomes in the operating room.

—Sheila Ellis, MD, David Young, MD,and Jeffry A. Peters

Dr. Ellis is associate professor, vice chair of clinical affairs and director of the Pre-Anesthesia Screening Clinic at the University of Nebraska Medical Center in Omaha. Dr. Young is director of perioperative services at Advocate Lutheran General Hospital in Park Ridge, Ill., and a partner in Surgical Directions (www.surgical-directions.com), a surgical services consulting firm. Mr. Peters is president of Surgical Directions.

Table 2. Recommended Labs and Tests Based on Patient Medical History

Clinical DiagnosisCBC

w/o diffPT/INR/

PTTPOC

Glucose BMP CMPTSH,

Free T4 ECG CXRa UA

Anemia X

Bleeding Hx X X X

Cardiovascular disease X X X X

Cerebrovascular disease

X X X

Diabetes X X X

Diuretics X

Hepatic disease X X X

Peripheral vascular disease

X X

Acute pulmonary disease/severe COPD

X X X

Renal disease X X X

Rheumatoid arthritis X Xb

Sleep apnea X X

Suspected UTI X

Systemic lupus X X X

Thyroid disease X

TPN dependence X

BMP, basic metabolic panel; CBC, complete blood count; CMP, comprehensive metabolic panel; COPD, chronic obstructive pulmonary disease; CXR, chest x-ray; ECG,electrocardiogram; POC, point of care; PT/INR/PTT, prothrombin time/international normalized ratio/partial thromboplastin time; TPN, total parenteral nutrition; TSH, thyroid-stimulating hormone; UA, uric acid; UTI, urinary tract infectiona Obtain CXRs for acute processes only. b Cervical spine only.

Laboratory results are good for one month unless abnormalities exist. ECGs are good for 12 months. The standardized testing matrix developed at the University of Nebraskap p p p g g pMedical Center helps ensure the optimal preoperative evaluation and management of surgical patients.Medical Center helps ensure the optimaal preoperative evaaluation and manaagement of surgicaal patients.

M A R C H 2 0 1 3 A n e s t h e s i o l o g y N e w s . c o m I 2 5

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For Blood Drug, Safe Dose and Standard Approach May DivergeInfusions of tranexamic acid in cardiac surgery based on model appear too high

Dosing of tranexamic acid based on the leading trial of the drug results in blood lev-

els of the agent that are higher than the recommended therapeutic amountfor patients undergoing cardiac surgery, researchers have found. The results suggest that more work is necessary to

determine a safe, effective dose in this population, experts said, as high-dosetranexamic acid is considered a likely cause of postoperative seizures.

Although many cardiac anesthesiolo-gists have embraced the dosing regimen for tranexamic acid from BART (Blood Conservation Using Antifibrinolytics

in a Randomized Trial (N Engl JMed  2008;358:2319-2931), the phar-macokinetics of the drug during theperioperative period have not been stud-ied in cardiac surgery.

“The BART regimen originated from a computerized model devised by our group several years ago,” said Angela

Jerath, MD, assistant professor of anes-thesiology at the University of Toronto, Ontario, Canada. “But the model has really never been tested in a clinical sit-uation, so we wanted to see what drug concentrations are actually achieved when we run the regime.”

Dr. Jerath and her colleagues enrolled five informed and consenting patients into the trial, each of whom was undergoing elective cardiac surgery with cardiopulmonary bypass (CPB). Patients received an initial bolus of tranexamic acid of 30 mg/kg over 15 minutes, followed by a 16 mg/kg-per-hour infusion until chest closure with a 2 mg/kg load.

Blood samples were taken at a vari-ety of time points throughout the pro-cedure: baseline, five minutes after thebolus, immediately after sternotomy, five minutes after the start of CPB and at 30-minute intervals while on CPB.Postoperative samples were taken five minutes after arrival in the intensive care unit and at regular intervals until discontinuation of the infusion. Plasma concentrations of tranexamic acid were compared with simulated drug lev-els using a pharmacokinetic model (Anesthesiology((  2002;97:390-399).

Infusion of the BART dose of tranexamic acid resulted in plasma concentrations higher than the sug-gested therapeutic levels of 100 mcg/mL at all time points during the intra-operative period (Figure).

The secondary objectives of the trial were to determine if tranexamic acid concentrations were within the sug-gested target range to allow optimal inhibition of tissue plasminogen activa-tor (tPA), and to evaluate elimination kinetics of tranexamic acid in the post-operative period following discontinu-ation of the infusion. Intraoperatively, plasma concentrations exceeded 100 mcg/mL, which has been postulated to give 100% inhibition of tPA activity.

Plasma concentrations of tranexamic acid stayed above 10 mcg/mL, allow-ing 80% inhibition of tPA activity for up to six hours after discontinuation of the infusion. Concentrations remained below the limit of detection 12 hours after discontinuation of the infusion in all patients.

Dr. Jerath said these results may help anesthesiologists further fine-tune their practice when it comes to tranexamic acid dosing. “Despite numerous articles regarding how

2 6 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

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much tranexamic acid to give, we stilllack consensus on the optimal dosing regime,” she said in an interview withAnesthesiology News. “This is the first study really assessing plasma concen-trations of the BART dosing regimen and pharmacokinetic model. Our data suggest that plasma concentrations are higher than what we want, so maybe it’s time to reconsider how much weare giving our patients.”

The researchers now will turn their focus to optimizing tranexamic acid dosing for specific groups of patients.

“The next line of attack will be fine-tuning the pharmacokinetic model gand measuring plasma concentra-tion in patients with renal dysfunc-tion,” Dr. Jerath said. “Tranexamic acid is renally excreted, and it has not been particularly well investigated if the plasma concentration in kidney patients is much higher than normal. We hope to measure levels in patients with renaldysfunction, and if concentrations are elevated, do some dose-adjustmentwork to bring concentrations down tonormal therapeutic levels.”

Jerrold H. Levy, MD, professor of anesthesiology and deputy chairman for research at Emory University in Atlanta, called the study a good first step toward determining the clinical effects of different dosing regimens of tranexamic acid.

“I don’t think anyone really knowsthe right dosing of tranexamic acid,and there’s tremendous variability in dosing among different institutions,” Dr. Levy said. “So I think this is inter-yesting in that it helps answer the ques-tion of what’s the right dosing for tranexamic acid, which I’m not sure anybody really knows for a fact.

“The other problem,” Dr. Levy contin-yued, “is that although there are several

good pharmacokinetics studies, there are not many good pharmacodynamic studies that have correlated drug levels with outcomes. We have to find out spe-cifically what the drug levels mean com-pared with clinically relevant end points such as antifibrinolytic effect, reduction in bleeding or adverse events.”

Dr. Jerath reported the findings at the 2012 annual meeting of the Canadian Anesthesiologists’ Society (abstract 1344159).

—Michael Vlessides

M A R C H 2 0 1 3 A n e s t h e s i o l o g y N e w s . c o m I 2 7

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180

160

140

120

100

80

60

40

20

01 2 3 4 5 6 7 8 9

Plas

ma

Conc

entr

atio

n of

Tr

anex

amic

Aci

d (m

cg/m

L)

Time Points of Tranexamic Acid Collection

Up to two hours postoperatively

Post-CPBCPBPre-CPB

Plasma concentration of TXA measured with SPME

TXA concentration simulated literature

Figure. Plasma concentration of tranexamic acid measured withsolid phase microextraction (blue)versus simulation via literature(red).CPB, cardiopulmonary bypass; SPME, solid phasemicroextraction; TXA, tranexamic acid

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of the hospital

Sutures Beat Tape for TEA Catheters, Cut Infection Risk

Patients at Heinrich-Heine-University Medical Center, in Dusseldorf, Germany, used to

have their thoracic epidural analgesia catheters held in place with adhesivetape, a standard procedure. But, when Peter Kienbaum, MD, arrived at themedical school as deputy director of anesthesiology, he saw peridural anes-thesia that alarmed him. Dislocation rates were as high as 30%, which can lead to complications.

“I was used to very proper fixation of the catheter; we used to tunnel andsuture the catheter,” Dr. Kienbaum saidof his former hospital. “At this hospital, they only used adhesive tape to fix the catheter.”

Other doctors at Heinrich-Heine-University told Dr. Kienbaum that their fixation technique using adhesive tape worked well.

“I was not able to convince them,” he said. So, he struck a deal: Con-duct a small study of 120 randomizedpatients and let the data determinewhich technique was better.

What Dr. Kienbaum found was sur-prising: The sutured catheters held by a single stitch knotted 15 to 20 times were less prone to microbial contamina-tion than catheters held in place by tape.

Thoracic epidural analgesia catheters either were tunneled for a minimum of 2 cm and sutured or were fixed with adhesive tape.

Dr. Kienbaum and his colleagues found that suturing reduced dislocation nearly three times that of tape. Suturing caused the catheter to dislocate by an average of 3 mm, whereas taping caused a 10 mm gap, even though the sutured

catheter stayed in the patient for longer on average (109 hours for sutured vs. 97 hours for taped patients).

More importantly, infections were less common in suture-stabilized cathe-ters, 13.6% (eight of 59 patients) com-pared with 24.5% in taped catheters (13 of 53 patients).

“When taping, the catheter proba-bly went in and out all the time and that probably attracts contamination,” Dr. Kienbaum said. “Tunneling and suturing takes two or three extra min-utes compared to taping the catheter. When looking at the whole process, it’s important that the catheter work postoperatively.”

Getting doctors to use suturing, however, could pose a challenge.

“The sutures used appear to be quite fancy and done in a very expert fash-ion that the majority of anesthesiolo-gists would not be able to use,” Salim Hayek, MD, division chief of pain med-icine and UH Case Medical Center, inCleveland, told Anesthesiology Newsafter reviewing images of the technique.

But Dr. Kienbaum disagreed. “Dus-seldorf tunneling and suturing is supe-rior. I teach our residents how to fix a catheter with that technique,” he said.

Suturing is not for every patient and does not apply, for example, to thosewho may have a catheter in the 10 to 15-hour range. “We don’t have prob-lems with losing catheters in these patients,” he said.

As for the observed reduced bacte-rial infections, Dr. Kienbaum said that a catheter with more mobility might allow more exposed portions to enter the skin and introduce microbes. “On the otherhand, I cannot prove that; when the catheter is removed via a 3-cm tunnel, the bacteria may be removed from the suture that way,” Dr. Kienbaum said.

The next logical step would be to study more patients to see if the suture technique can work in multiple set-tings under different training.

“We’d need to study tens of thou-sands of patients with these techniques,” Dr. Kienbaum said, because of the rarity

2 8 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

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see sutures page 31

Fixation by tunneling and suturing.Courtesy of Peter Kienbaum, MD.

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Thoracic Epidurals May Avoid Many Post-op Complications

Patients who receive thoracic epi-durals and general anesthesia appear to have a significantly

lower risk for certain complications after major surgery, German researchers have found.

A meta-analysis of 95 trials pub-lished between 1971 and 2011, includ-ing more than 6,500 patients, showed that those who received thoracic epi-dural anesthesia (TEA) were less likely to experience arrhythmias, collapsedlungs, pneumonia or intestinal block-ages (Table). TEAs also were associated with a lower risk for sedation, dizziness and respiratory depression, according to the researchers, who reported their find-ings at Euroanaesthesia 2012 (abstract PC1-1).

Previous reports have suggested that adding a TEA to general anesthesia could be beneficial in a variety of ways,said Ali Shariat, MD, assistant pro-fessor of anesthesiology at Columbia University College of Physicians and Surgeons, in New York City, who was not involved in the new analysis. Add-ing TEA may decrease pulmonary mor-bidity after surgery, he said, and the propensity of TEAs to decrease sympa-thetic tone while increasing parasympa-thetic tone can help the bowels recover more quickly—and may do the same for the heart.

Another benefit, Dr. Shariat added, is that TEAs spare the use of opioids dur-ing surgery—and their complications.

“No modality gives us better analgesia than epidurals,” he said.

Even so, the published evidence for TEAs remains mixed, said Daniel Pöp-ping, MD, an anesthesiologist at Mün-ster University Hospital, who helpedconduct the new meta-analysis. “There is some debate in anesthesia for severalyears now about the benefits of TEAs.It is not yet clear that this benefit really exists,” he said.

Indeed, although the review showed TEAs were associated with lower risks for complications, they did carry a higher risk for arterial hypotension

(odds ratio [OR], 4.80; 95% confidenceinterval [CI], 2.94-7.83).

And although TEAs appeared to beassociated with a lower risk for death within two years postsurgery, the resultswere not statistically significant (OR,0.74; 95% CI, 0.53-1.03). Part of theproblem, noted Dr. Pöpping, was that the mortality rates were quite low in thestudies—0.015% with TEA and 0.025%

without. The German group continuesto analyze data, and hopes to include more studies that can provide addi-tional clues about the effects of TEAs on mortality.

In the meantime, both Drs. Pöppingand Shariat said they use TEAs in their practice, even if placing them can add 20 minutes to a case.

“I think TEAs are widely used, but

they are controversial because they are not without risk,” said Dr. Pöpping. Theinjections are known to cause hemato-mas or abscesses in some patients. “If you use this in the clinic, you have to beaware of these complications, and know how to diagnose and manage these com-plications,” he said. “You must supervise these patients after surgery.”

—Alison McCook

Table. Patients Receiving TEAExperienced Fewer Complications

Odds Ratio

95% Confidence Interval

Collapsed lung 0.66 0.52-0.83

Atelectasis 0.68 0.48-0.94

Intestinal obstruction

0.45 0.20-0.98

Pneumonia 0.51 0.38-0.68

M A R C H 2 0 1 3 A n e s t h e s i o l o g y N e w s . c o m I 2 9

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Patient Safety Foundation (APSF),hospital researchers conducted a med-ication safety study in three pharmacy satellites and in 78 areas of care where anesthetic agents were used. The pri-mary focus of the study was to look at labeling compliance, medication prep-aration details and waste data dur-ing the first surgical cases of the day,with an eye toward resolving any sig-nificant safety gaps found, explained

Rachel  Stratman, PharmD, the lead study author and a clinical pharma-cist for perioperative services at Barnes-Jewish Hospital.

After collecting initial data for 100 cases, Dr. Stratman and her colleaguesfound several problems that could have led to patient harm. For example, anesthesia providers often would pre-scribe, prepare and administer med-ications with no double-check, and providers usually would include only partial information on the blank por-tions of syringe labels, such as the drug name, but not necessarily other impor-tant details, such as drug concentration or expiration date. Moreover, anesthe-siologists often would prepare med-icines such as atropine for emergent situations; however, if the drugs werenot administered during the case, they were discarded or inappropriately kept beyond their expiration for use on sub-sequent cases.

Based on those findings, Dr. Strat-man’s team developed several improve-ments to how anesthesia medicationswere handled. One step, she noted, wasto standardize anesthesia medication trays across 64 ORs and 14 remoteareas. The trays incorporated RTUsyringes of medications commonly used for anesthesia induction, reversal and emergencies. The quality improve-ment team also standardized vasoactivedrip concentrations and diluents acrossthe institution, and increased produc-tion of compounded sterile productsthat were dispensed to anesthesiolo-gists upon request.

The pharmacy purchased eight com-monly used medications in premixed RTU syringes from a compounding pharmacy, including lidocaine, succinyl-choline and neostigmine. The depart-ment also increased the production of vasoactive drips such as epinephrine and dobutamine, and provided bolus dosesof medications such as insulin, epineph-rine and norepinephrine. The RTU pre-filled syringes had tamper-evident seals,so if they were not used for one patient, they could be used safely for another.

Six months after the intervention, theteam observed the medication manage-ment practices of 100 additional cases. They found that the rate at which cli-nicians included the medication con-centration on the label increased significantly, from 31% before the inter-vention to nearly 78% after (P<0.001). Provider-prepared intravenous admix-tures were reduced from 91% to nearly 3% (P<0.001).

Using RTU medications also sig-nificantly reduced medication waste, Dr. Stratman said. The largest

Table. Cost of Medication Wastea

Medication

Pre-Outsourcing Post-OutsourcingMg Reduction Usage Costb Usage Costb

Lidocaine 3,200 mg $87.36 300 mg $10.56 90.6%

Rocuronium 2,250 mg $176.91 200 mg $22.32 91.1%

Succinylcholine 9,600 mg $132.96 500 mg $26.15 94.8%

Vecuronium 80 mg $37.12 30 mg $22.38 62.5%

Glycopyrrolate 10 mg $13.80 1 mg $4.61 90%

Phenylephrine 77.6 mg $79.15 3 mg $11.40 96.1%

Atropine 55 mg $127.68 2 mg $6.22 96.4%

a Waste is defined as withdrawal of medication from the manufacturer’s packaging or removal of tamper-evident sealbut not documented as administered during the surgical case.b $ p p p , pp$1.00 added to the hospital cost of the vial to account for cost of preparation, labor and supplies.$ 00 added to t e osp ta cost o t e a to acccou t o cost o p epa at o , abo a d supp es

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PREFILLED CONTINUED FROM PAGE 1

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reductions noted were for emergency medications such as atropine and phen-ylephrine (96% reduction) and succi-nylcholine (nearly 95% reduction).

Dr. Stratman said the intervention likely has been “cost neutral” to the hospital, with the costs of outsourc-ing medications offset by the savingsin otherwise wasted drugs (Table, fac-ing page). “But when you look at the [impact of the initiative on] quality and safety for the patients … it’s what’s right to do even if it costs a little more.”She added that the safety initiative “has been very successful from the anesthe-siology perspective and the pharmacy perspective.”

Outsourcing RTU medications is a trend, Dr. Stratman said, although “the financial impact associated with out-sourcing costs can cause institutions to hold off on making the transition. In our hospital, it has been instrumentalin improving the management of medi-cations in the anesthesia environment.”

Do-It-Yourself Drug Prep Discouraged

Tricia Meyer, PharmD, FASHP, director of pharmacy at Scott & White Healthcare, in Temple, Texas, andassistant professor of anesthesiology at Texas A&M University College of Medicine, in College Station, partici-pated in the APSF Medication Safety Conference. She said the APSF recom-mends that provider-prepared medica-tions should be discontinued whenever possible in favor of providing prefilledsyringes for anesthesia care providers.

“Prefilled syringes save time for anes-thesiologists, allowing that time to be utilized for necessary monitoring of the patient and the anesthesia equip-ment,” she said. “That’s why it’s impor-tant, but there’s a premium price [to be paid] for purchased, prefilled syringes.When you purchase medications froma compounding pharmacy, you have to pay not only for the drug but for the preparation time, as expected.” Still, Dr. Meyer, who served on the APSF Committee on Education and Train-ing, said she supports using prefilledsyringes either drawn up by the hospi-tal pharmacy or purchased when bud-gets or staffing resources allow.

“The Barnes-Jewish- project resultswere impressive,” Dr. Meyer added.

“The ability to document cost neu-trality is important for other hospitalpharmacies to consider and possibly use to help justify use of prefilled syringes.”

For those concerned with costs, she said, evaluate what drugs are most con-sistently used and/or frequently wasted

and begin with a minimal number of medications in prefilled syringes.

The issue of waste in the OR setting is important, she stressed. Many times, anesthesia care providers may predraw syringes waiting for emergent cases, and the predrawn syringes need to be destroyed within an hour if they’re unused. The Barnes-Jewish- research-ers “were able to determine the costof waste, which is not easy, and use the amount saved with their new pro-cess to justify the cost of the prefilled

syringes,” she said. “That’s strong work.”Managing the prefilled or premixed

medications “does take more vigilanceon the part of pharmacists because of shorter beyond-use dating,” Dr. Meyersaid. Premixed syringes may have expi-ration dating of 30 to 90 days, whereas a vial from the manufacturer can last much longer. As a result, she noted,pharmacy staffers need to check inven-tory for expirations more frequently.

—Karen Blum

of patients of interest who develop epidural hematomas. “We insert 1,000 to 1,500 catheters a year in the hospital. There’s no good chance to collect the number of patients needed for a large- scale trial.”

Dr. Kienbaum presented the findings at Euroanaesthesia 2012 (abstract 8AP1-5).

—Trevor Stokes

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SUTURES CONTINUED FROM PAGE 28

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Hospital Food Goes GourmetSustainable food services offer tasty meals and green choices beyond lime Jell-O

Unless you work at a hospital, a hospital caf-eteria is not likely to be high on your list of places to go for lunch. With meal options

second only to airline food for their reputation of being inedible, some health care facilities are intro-ducing new menus and taking steps to serve up tastier offerings. Visitors to those facilities are often pleas-antly surprised to find options like Alas-kan wild salmon nestled in a bedof kale, or lavender scones madewith ingredients freshly picked from the hospital’s roof gar-den. And the ground-breaking food servicesat these facilities aren’t just delicious—they’re healthy for patients, vis-itors and even the planet.

“We all know thatfood in hospitals has a bad rap, with thingslike Jell-O and gray meat,” said Michelle Gottlieb, co-coordinator of Healthy Food in Health Care, an organization com-mitted to helping hospitals offernutritious and sustainable foods.

“We started looking into the caf-eteria and at what’s put onto thepatient trays, saying this isn’t right. Hospitals should be healing people, not serving this kind of food.”

Five of the hospitals profiled here have taken the Healthy Food in Health Care Pledge. Among other goals, those who take the pledge promise towork with local farmers and suppliers, increase the

hospital’s offering of fruits, vegetables and other min-imally processed foods, minimize food waste and educate employees and patients. The goal is to use food services as a part of prevention-based healthcare by reducing unhealthy food as well as the toxins and pollutants that turn up in the food system. More

than 400 hospitals and seven food service contrac-tors have taken the pledge so far. That

means there have been some prom-ising steps made to cut down on

the carbon footprint of hos-pital food services while

providing healthy, enjoy-able food people would actually consider order-ing for takeout.

Adventist Medical Center

Location: Portland, Ore.Sustainable since: Its

inception. Because vege-tarianism is a pillar of the

Seventh-day Adventist church, ythe cafeteria has been vegetarian since the hospital opened. The all-vegan LivingWell Bistro opened inOctober 2011.Sample dish: Quinoa bowl with

black beans, kale or collard greens and homemade pico de gallo.Food service highlights: Though patients at the hospital have a meat option, eating animals is eschewed in the rest of the hospital. The LivingWell Bistro doesn’t even offer animal products. “It’s the first plant-based café on a health care facility campus in the U.S. that we’re aware of,” said Ashleigh Peder-sen, food service manager. Less meat means a smaller environmental footprint, and the team works to get its hands on local ingredients whenever possible. Currently, the cafeteria uses offerings from 19 local vendors. Cutting out meat also means cutting costs.

“If you look at tofu, beans or quinoa as a protein source, steak or chicken is going to have a lot higher cost per ounce,” said Pedersen. And whether they’re cooking up vegan tacos or pizza, the hospital’s award-winning chefs work to make sure visitors know eating gvegetarian means more than just crunching on salads. Plus, guests ordering food to go don’t need to feel guilty about the packaging since the hospital always provides compostable containers.

Fletcher Allen Health Care Location: Burlington, Vt. Sustainable since: 2006, when the hospital became one of the first to sign the Healthy Food in HealthCare pledge. Accolades and awards: Winner of the HFHC Pub-lic Policy Award in 2011.Sample dish: Artichoke ravioli served topped with a house-smoked roasted pulled pork with house-roasted tomatoes.

Food service highlights: Fletcher Allen firstbecame interested in sustainability when obesity and its connection to health care costs began mak-ing headlines. “People were also starting to talk about climate change and how it relates to food, so it was kind of a convergence on a lot of food-relatedhealth issues that we thought we could make an impact on,” said director of nutrition services Diane Imrie. Today, Imrie said each person on her man-agement team has taken on a sustainable mission, whether it’s reducing antibiotics in the food supply, cutting back on waste or providing sustainable pro-tein sources. And of course, the cooks focus on fla-vor. Even though their cooking methods are quite healthy—no fryers allowed—patients and customers alike praise the taste.

“They are really, really surprised,” said Imrie. “Andthat’s the part I wish we could work on across the country because they shouldn’t be surprised, it should all be fabulous.”

John Muir Health Location: Walnut Creek, Calif.Sustainable since: 2008 when the facility signed the Healthy Food in Health Care pledge. Accolades and awards: Winner of the HFHC Food, Climate, Health Connection Award in 2011.

3 2 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

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A buffet at John Muir Health.Courtesy of John Muir Health.

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Diane Imrie shows off a plate.Courtesy of Fletcher Allen Health Care.

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Anders Grant, RD, helps findsustainable farms for CarrollHospital Center.Courtesy of Carroll Hospital Center.

Sample dish: Whole grain casserole withmixed vegetables and roasted squash.Food service highlights: Chefs, hos-pital staff and administrators are all on board with the hospital’s sustain-able mission, Sandra Rigney, directorof nutrition services said. “I think ittakes the entire team to make it hap-pen,” she said.

The team started out by seeking locally sourced produce, switching to

eggs from cage-free hens and bring-ing in eco-friendly disposables. Next, yit reduced the amount of meat on its menus and incorporated more fruits and vegetables. The hospital has foundthat planning menus around in-seasonvegetables and fruits, like persimmons for winter, helps keep eco-friendlyfood affordable. When it does serve meat, many of the dishes are madewith free-range, organic chicken. Thehospital is currently seeking a source for sustainable beef.

Carroll Hospital Center Location: Westminster, Md.Sustainable since: 2007 when thefacility took the Healthy Food in Health Care Balanced Menu pledge. Accolades and awards: Winner of theHFHC Food, Climate, Health Con-nection Award in 2011.Sample dish: Shepherd’s pie using local, sustainable beef.Food service highlights: Members of the hospital’s food sustainability com-mittee scout out farms to find sourcesfor meat and produce.

Committee member Anders Grant, RD, is currently on the hunt for a sus-tainable goat cheese farmer. “We want to make sure that what they say linesup with what they’re really doing,” said Ms. Grant. She said that while the sus-tainable food she finds is generally more expensive than the hospital’s for-mer selections, it’s not too hard to make

3 4 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

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GOURMET CONTINUED FROM PAGE 32

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small changes that result in cost savings.Instead of offering carved tenderloinfrom a locally sourced cow, for example,the hospital might make a beef stew,mixing the beef with other ingredientsto extend its value, Ms. Grant explained.

New Milford Hospital Location: New Milford, Conn.Sustainable since: 2006, when thehospital founded Plow to Plate, whichconnects farmers with the hospitalsand restaurants in the area. Sample dish: Chicken salad withdried cranberries.Food service highlights: Plow to Plate started when the hospital decided to use area farms to help build a sus-tainable food system.

“We realized we could create health-ier diets, support our farmers and send a message that eating nutritious wholefoods is a path to disease prevention,”said Susan Twombly, coordinator of external affairs. Besides bringing food from plow to plate, the hospital also delivers meals from roof to plate. Itsroof garden grows vegetables and herbsthat are used in the cafeteria—the lav-ender found in the facility’s popular lavender scones is harvested from the roof garden.

Overall, the hospital’s food servicestoday are a far cry from what hospi-tal chefs found when they first arrived.

“We were coming into an organiza-tion that was old-school,” said Chef Kerry Gold. “They were opening cansand throwing them into a pan.” Now,everything is made from scratch, evensoup stock and deli meat.

Overlake Hospital Medical Center Location: Bellevue, Wash.Sustainable since: 2007 when the hos-pital took the Healthy Food in HealthCare pledge. The greening processstarted with retail areas, the Atrium Café and Stanzas Café, but soon spread to patient menus. Sample dish: Thai shrimp noodle salad. Food service highlights: Overlake hasan extensive list of sustainable improve-ments it has made, from switching to local, cage-free, organic eggs to remov-ing all deep-fried items from patient menus and hosting “meatless Monday” every week.

The medical center also authored a comprehensive food policy to pro-vide a framework for sustaining thosechanges and helping to inform vendorsabout what the center will and will not buy. Besides being committed to theplanet, Overlake is also deeply involved in making sure patients are eating something that makes them feel good.

“We will do anything for our patients,” said Christopher Linaman, executivechef. “Including walking across thestreet to Whole Foods and procuring exactly what they want, in the unlikely circumstance we don’t have it already.” In the future, Overlake Hospital would like its dining services to be completely free of GMO ingredients and foods.

—Nancy Ryerson

This article originally appeared in the January 2013 issue of DOTmed Business News and has been reprinted with permission from DOTmed.com, Inc. To read the article online, visit www.dotmed.com/news/20153.

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was becoming increasingly common,and that patients undergoing proce-dures in remote locations could be quite ill, with multiple comorbidities,”said Angela Lipshutz, MD, MPH, a critical care fellow at the University of California, San Francisco School of Medicine. “I was concerned that pro-vision of anesthesia in remote loca-tions may be associated with increased risk, and that patterns of failure may

be different from those associated withthe provision of anesthesia in the oper-ating room.”

With that in mind, Dr. Lipshutz andher colleagues analyzed reports sub-mitted to the institution’s near-missreporting system between Jan. 1, 2009, and Dec. 31, 2011. Each report con-tains a description of the near miss, its location and time of day (day vs. night/weekend) and cause based on the Joint Commission’s patient safety event tax-onomy. The investigators compared

causative mechanisms between near-miss reports occurring in the operating room and remote locations.

As Dr. Lipshutz reported at the 2012 annual meeting of the American Soci-ety of Anesthesiologists (abstract 055), the system contained 2,485 near-missreports, 220 of which (8.9%) involved patients treated in remote locations. The proportion of near-miss reports from these locations increased each year throughout the three-year period, from r5.1% to 12.2% to 13.8% (P<0.05).

Nearly half of the near misses outsidethe operating room resulted from eitherequipment malfunction or the failureof a clinician to use appropriate tech-nique (Table). A poor culture of safety also played a significant role, accounting for nearly 15% of near misses in NORA patients, according to the research-ers. Perhaps not surprisingly, these nearmisses were nearly twice as likely to beassociated with this poor safety cultureas those occurring in operating rooms(odds ratio 1.92; 95% confidence inter-val, 1.28-2.88).

Non–operating room near missesdid not differ from those in the oper-ating room with respect to the time theevent occurred (79% vs. 83% during the day, respectively; P=0.19), attri-bution to systems rather than humanerror (63% for both locations; P=0.99) or association with technical issues(39% vs. 43%; P=0.28).

Dr. Lipshutz acknowledged that thestudy is limited by its retrospectivedesign and the limited amount of data collected by the institution’s near-missreporting system, which is designed to encourage providers by minimizing the time required to report an event. As such, she called for more research making definitive recommendations. “I think, based on our data, anesthesiol-ogists should be aware of the common causative mechanisms associated with near misses in remote locations, and

Table. Primary Causes of Near MissesOriginating From Non–OperatingRoom Anesthesia

Cause

Failure to execute a skill at expected level

Equipment malfunction

Poor culture of safety

Faulty design

Rule-based: failure to perform routine task

Equipment availability

Poor communication

Failures related to patient factors beyond control of institution

Insufficient resources

Knowledge-based: Incomplete

Time pressure

Inadequate documentation

Lack of training

Knowledge-based: Incorrect

Faulty construction

Lack of supervision

Other

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NEAR MISS CONTINUED FROM PAGE 1

should maintain constant vigilance,”she said. “Vigilance at the level of the anesthesiologist includes things suchas performing machine and equipmentchecks prior to each case.

“A small number of causative mech-anisms explained the bulk of near misses reported and can guide inter-ventions to make NORA safer,”Dr. Lipshutz continued. “Addition-ally, promotion of a culture of safety in remote locations is needed.”

Although Ashish Sinha, MD, PhD, agreed on the importance of physician vigilance, he also questioned the role that institutions might play in non–operating room anesthesia near misses.

“Thirty percent of the near misses in this study are due to equipment issues,”said the professor and vice chair of anesthesiology and perioperative med-icine at Drexel University College of Medicine, in Philadelphia. “I pre-sume this is easily fixed, with enough resources. Moreover, less than 3% of failures were related to factors beyond the control of the institution.  Whatis the institution doing to change the 97% it has influence over?”

“While it is indeed true that only 3% of failures are related to patient factors beyond the control of the institution,”Dr. Lipshutz said, “it does not neces-sarily follow that 97% of failures could be fixed by the institution.”

—Michael Vlessides

Number Percent

46 20.91

42 19.09

32 14.55

22 10.00

21 9.55

18 8.18

10 4.55

6 2.73

5 2.27

5 2.27

3 1.36

3 1.36

2 0.91

2 0.91

1 0.45

1 0.45

1 0.45

M A R C H 2 0 1 3 A n e s t h e s i o l o g y N e w s . c o m I 3 7

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Saying No to NPOCarb drink improves patient experience with surgery

Consumption of a carbohydrate-rich clear liquid a few hoursbefore elective surgery sig-

nificantly reduces patient discomfortrelative to those who fasted from mid-night, a multicenter team of research-ers has concluded. Experts said the results should prompt anesthesiologists

to reconsider what the researchers feel to be overly rigid fasting instruc-tions for patients scheduled to undergo surgery.

Many anesthesiologists adhere to “NPO past midnight” for all surgi-cal patients, despite evidence and rec-ommendations to the contrary. In

both 1999 and 2011, the American Soci-ety of Anesthesiologists recommended a mini-mum fast of two hoursfrom clear liquids for all healthy patients under-going elective procedures

requiring general anesthe-sia, regional anesthesia or sedation/analgesia.

“There are many European societies that not only recom-mend clear liquids a few

hours before surgery, but also recommend using a a

carbohydrate-rich clear liq-uid,” said Jeannette T. Crenshaw, DNP, assistant professor of nursing at Texas Tech University Health Sciences Cen-ter, in Lubbock, who led the latest research. “Preoperative carbohydrate loading keeps patients from going into surgery in a starvation state; clear liq-uids alone don’t do that because they don’t provide nutrition.”

In an attempt to determine the effect of drinking a carbohydrate-rich clear beverage before surgery, the investigators enrolled 297 nonob-stetric patients into the two-prongedinvestigation. The first part was an observational, descriptive pilot study comprising 263 patients between two hospitals. The second was a random-ized controlled trial comprising 34 patients that was abbreviated because of personnel changes at the participat-ing institutions.

In each case, patients were either NPO after midnight or given 360 mL of a clear, carbohydrate-rich beverage (Clearfast, BevMD) two to three hours before surgery. Approximately 15 to 30 minutes before the procedure, partic-ipants were asked to rate their percep-tion of thirst, hunger, anxiety about fasting, anxiety about surgery, head-ache, nausea and overall comfort on a 10-point scale.

Dr. Crenshaw and her colleagues described the findings at the 2012 annual meeting of the Society for Ambulatory Anesthesia (abstract 05).Patients in the first part of the study were an average age of 44 years, andmost (n=200) were women. The 155 patients (59%) who received the carbohydrate-rich beverage—whichalso contains electrolytes, zinc, vita-min A and selenium—reported signif-icantly less thirst (P<0.0001), fasting anxiety (P=0.049) and surgery anxi-ety (P=0.022), as well as significantly greater overall comfort (P<0.0001) than those who fasted from midnight.

Patients in the second part of the trial were older, with an average age of 63 years; 16 (47%) were female. The

3 8 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

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13 patients who received the preoper-ative carbohydrate beverage reportedsignificantly less thirst (P<0.0001) than those who fasted past midnight.

“Then we analyzed the two stud-ies together, and that’s when we foundthat the 168 participants who receivedthe carbohydrate-rich beveragereported significantly reduced overall discomfort, thirst, nausea, fasting anx-iety, hunger and surgery anxiety than the 129 who fasted from midnight,”Dr. Crenshaw said in an interview withwAnesthesiology News. “So it was obvi-ous that giving patients carbohydrate-rich clear liquids right before surgery improved their comfort.”

Despite these results, Dr. Crenshawsaid that many patients are still being told to not consume anything after midnight, while the evidence in sup-port of carbohydrate-rich clear liquidsprior to surgery is being ignored. “It has consistently been shown that therisk for aspiration in modern anesthe-sia is exceedingly low,” she explained.

“If one of our goals is to promotepatient satisfaction in the periopera-tive experience, then I’m puzzled as to why we’re even discussing clear liquids. We should have moved on and shouldbe asking why we’re not carbohydrate loading.”

Jonas Nygren, MD, PhD, associateprofessor of surgery at Karolinska Uni-versity Hospital in Stockholm, agreedthat it’s time to adopt a different approach with respect to patient con-sumption of clear and carbohydrate-rich liquids before surgery.

“As has been convincingly shown in previous randomized trials and system-atic reviews—as well as documentedin guidelines from most anesthesia

associations in the developed world—free intake of clear fluids should be allowed until two hours before anes-thesia induction in most patients undergoing elective surgery [Cochrane Database Syst Rev 2003; CD004423],” Dr. Nygren said.

“To avoid preoperative fasting, a car-bohydrate solution [400 mL, 12%] also has been shown to be safe to use two hours before surgery in these patients,” Dr. Nygren continued.

“Dr. Crenshaw confirms the previ-ously demonstrated effect of improved well-being by using this beverage pre-goperatively. In addition, repeated randomized studies also have dem-onstrated attenuated perioperative stress with reduced postoperative insu-lin resistance, reduced protein break-down and better-maintained muscle strength with use of this type of bev-erage [Best Pract Res Clin Anaesthesiol 2006:20;429-438].

“It is clear from available evidencethat NPO after midnight is not pro-viding the optimal treatment, and should not be recommended in mostpatients,” Dr. Nygren concluded. “Bet-ter compliance with evidence-basedguidelines should be an international and professional concern.” The study was supported with product from BevMD.

—Michael Vlessides

M A R C H 2 0 1 3 A n e s t h e s i o l o g y N e w s . c o m I 3 9

‘If one of our goals

is to promote patient

satisfaction in the

perioperative experience,

then I’m puzzled as to why

we’re even discussing clear

liquids. We should have

moved on and should

be asking why we’re not

carbohydrate loading.’

—Jeannette T. Crenshaw, DNP

PRN

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Pain Education May Affect Pain Perception in the Elderly

Educating older people about the relationship between painand aging can lead to signifi-

cant improvements in their knowl-edge of pain-related events, Canadian research shows.

“Given that pain is still under-treated and underreported, andrates of these are even higher among older people, our finding that simple

educational initiatives can have sig-nificant effects on pain perceptions is important,” said co-investigator AllanGordon, MD, director of the Wasser Pain Clinic at Mount Sinai Hospital, in Toronto, and associate professor of neurology in the University of Toron-to’s Department of Medicine.

Dr. Gordon, along with lead researcher Lucia Gagliese, PhD,

associate professor in the School of Kinesiology and Health Science at York University and senior scientist in Psychosocial Oncology and Palliative Care in the Department of Anesthesia at the University Health Network in Toronto, and collaborators in six other cities in Canada, held educational ses-sions that were approximately two hours long. Each session was open to the public and included a 90-minutetalk on the fundamentals of chronic pain, pain epidemiology across the lifespan of the individual, the physicaland psycho social impacts of chronic pain, common comorbidities with pain, polypharmaceutical treatment of pain, and barriers to pain manage-ment. The session was followed by a question and answer period.

The initiative, a collaboration with the University of Toronto Centre for the Study of Pain, was promoted through newspaper advertisements, community event listings, posters in health care settings, public libraries,

4 0 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

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‘The most important question is did the

increased knowledge lead to better pain management? The assumption is that it

would have, and that better knowledge is a kind

of surrogate marker of better pain management,

but without follow-up data and direct outcome measures, it’s not clear

whether this is the case.”

—Mellar Davis, MD

see perception page 44

THROMBATE III®Antithrombin III (Human)

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FOR INTRAVENOUS USE ONLYDESCRIPTIONAntithrombin III (Human), THROMBATE IIIw is a sterile, nonpyrogenic, stable, lyophilizedpreparation of purified human antithrombin III (ATIII).THROMBATE III is prepared from pooled units of human plasma from normal donors bymodifications and refinements of the cold ethanol method of Cohn. When reconstituted withSterile Water for Injection, USP, THROMBATE III has a pH of 6.0–7.5, a sodium content of110–210 mEq/L, a chloride content of 110–210 mEq/L, an alanine content of 0.075–0.125 M,and a heparin content of not more than 0.1 IU heparin/IU ATIII. THROMBATE III contains nopreservative and must be administered by the intravenous route. Each vial of THROMBATE III contains the labeled amount of antithrombin III in internationalunits (IU) per vial. The potency assignment has been determined with a standard calibratedagainst a World Health Organization (WHO) antithrombin III reference preparation.The capacity of the THROMBATE III manufacturing process to remove and/or inactivateenveloped and non-enveloped viruses has been validated by laboratory spiking studies on ascaled down process model using a wide range of viruses with diverse physicochemicalproperties. There are two dedicated virus inactivation/removal steps included in theTHROMBATE III manufacturing process: a heat treatment step at 60°C ± 0.5°C for not less±than 10 hours for virus inactivation and a nanofiltration step for effective removal of viruses assmall as 18 nm.The manufacturing process was also investigated for its capacity to decrease the infectivity ofan experimental agent of transmissible spongiform encephalopathy (TSE), considered as amodel for the vCJD and CJD agents.An individual production step in the THROMBATE III manufacturing process has been shownto decrease TSE infectivity of that experimental model agent. The TSE reduction step is theEffluent I to Effluent II + III fractionation step (6.0 log10). These studies provide reasonableassurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, wouldbe removed.

CLINICAL PHARMACOLOGYAntithrombin III, an alpha2-glycoprotein of molecular weight 58,000, is normally present inhuman plasma at a concentration of approximately 12.5 mg/dL and is the major plasmainhibitor of thrombin. Inactivation of thrombin by ATIII occurs by formation of a covalent bondresulting in an inactive 1:1 stoichiometric complex between the two, involving an interactionof the active serine of thrombin and an arginine reactive site on ATIII. ATIII is also capable ofinactivating other components of the coagulation cascade including factors IXa, Xa, XIa, andXIIa, as well as plasmin.The neutralization rate of serine proteases by ATIII proceeds slowly in the absence ofheparin, but is greatly accelerated in the presence of heparin. As the therapeuticantithrombotic effect in vivo of heparin is mediated by ATIII, heparin is ineffective in theabsence or near absence of ATIII.The prevalence of the hereditary deficiency of ATIII is estimated to be one per 500 to 5000 inthe general population. The pattern of inheritance is autosomal dominant. In affectedindividuals, spontaneous episodes of thrombosis and pulmonary embolism may be associatedwith ATIII levels of 40%–60% of normal. These episodes usually appear after the age of 20,the risk increasing with age and in association with surgery, pregnancy and delivery. Thefrequency of thromboembolic events in hereditary ATIII deficiency during pregnancy has beenreported to be 70%, and several studies of the beneficial use of Antithrombin III (Human)concentrates during pregnancy in women with hereditary deficiency have been reported. Inmany cases, however, no precipitating factor can be identified for venous thrombosis orpulmonary embolism. Greater than 85% of individuals with hereditary ATIII deficiency have hadat least one thrombotic episode by the age of 50 years. In about 60% of patients thrombosis isrecurrent. Clinical signs of pulmonary embolism occur in 40% of affected individuals. In someindividuals, treatment with oral anticoagulants leads to an increase of the endogenous levelsof ATIII, and treatment with oral anticoagulants may be effective in the prevention of thrombosisin such individuals.In clinical studies of THROMBATE III conducted in 10 asymptomatic subjects with hereditarydeficiency of ATIII, the mean in vivo recovery of ATIII was 1.6% per unit per kg administeredbased on immunologic ATIII assays, and 1.4% per unit per kg administered based onfunctional ATIII assays. The mean 50% disappearance time (the time to fall to 50% of the peakplasma level following an initial administration) was approximately 22 hours and the biologichalf-life was 2.5 days based on immunologic assays and 3.8 days based on functional assaysof ATIII. These values are similar to the half-life for radiolabeled Antithrombin III (Human)reported in the literature of 2.8–4.8 days.In clinical studies of THROMBATE III, none of the 13 patients with hereditary ATIII deficiencyand histories of thromboembolism treated prophylactically on 16 separate occasions withTHROMBATE III for high thrombotic risk situations (11 surgical procedures, 5 deliveries)developed a thrombotic complication. Heparin was also administered in 3 of the 11 surgicalprocedures. Eight patients with hereditary ATIII deficiency were treated therapeutically withTHROMBATE III as well as heparin for major thrombotic or thromboembolic complications, withseven patients recovering. Treatment with THROMBATE III reversed heparin resistance in twopatients with hereditary ATIII deficiency being treated for thrombosis or thromboembolism.During clinical investigation of THROMBATE III, none of 12 subjects monitored for a median of8 months (range 2–19 months) after receiving THROMBATE III became antibody positive tohuman immunodeficiency virus (HIV-1). None of 14 subjects monitored for � 3 monthsdemonstrated any evidence of hepatitis, either non-A, non-B hepatitis or hepatitis B.

INDICATIONS AND USAGETHROMBATE III is indicated for the treatment of patients with hereditary antithrombin IIIdeficiency in connection with surgical or obstetrical procedures or when they suffer fromthromboembolism.

Subjects with ATIII deficiency should be informed about the risk of thrombosis in connectionwith pregnancy and surgery and about the inheritance of the disease.The diagnosis of hereditary antithrombin III (ATIII) deficiency should be based on a clear familyhistory of venous thrombosis as well as decreased plasma ATIII levels, and the exclusion ofacquired deficiency.ATIII in plasma may be measured by amidolytic assays using synthetic chromogenicsubstrates, by clotting assays, or by immuno assays. The latter does not detect all hereditaryATIII deficiencies.The ATIII level in neonates of parents with hereditary ATIII deficiency should be measuredimmediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children ofwomen with hereditary antithrombin III deficiency, has been reported.)Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% innormal term infants. ATIII levels in premature infants may be much lower. Low plasma ATIIIlevels, especially in a premature infant, therefore, do not necessarily indicate hereditarydeficiency. It is recommended that testing and treatment with THROMBATE III of neonates bediscussed with an expert on coagulation.

CONTRAINDICATIONSNone known.

WARNINGSBecause THROMBATE III is made from human plasma, it may carry a risk of transmittinginfectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD)agent. No cases of transmission of viral diseases or CJD have ever been identified forTHROMBATE III. Inform patients that THROMBATE III is made from human plasma andmay contain infectious agents that can cause disease. While the risk thatTHROMBATE III can transmit an infectious agent has been reduced by screening plasmadonors for prior exposure, testing donated plasma, and by inactivating or removingpathogens during manufacturing, patients should report any symptoms that concernthem. ALL infections thought by a physician possibly to have been transmitted by thisproduct should be reported by the physician or other healthcare provider to GrifolsTherapeutics Inc. [1-800-520-2807].The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE IIIin patients with hereditary ATIII deficiency. Thus, in order to avoid bleeding, reduced dosage ofheparin is recommended during treatment with THROMBATE III.

PRECAUTIONSGeneral1. Administer within 3 hours after reconstitution. Do not refrigerate after reconstitution.2. Administer only by the intravenous route.3. THROMBATE III, once reconstituted, should be given alone, without mixing with other

agents or diluting solutions.4. Product administration and handling of the needles must be done with caution.

Percutaneous puncture with a needle contaminated with blood can transmit infectious virusincluding HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs.Place needles in sharps container after single use. Discard all equipment including anyreconstituted THROMBATE III product in accordance with biohazard procedures.

The diagnosis of hereditary ATIII deficiency should be based on a clear family history of venousthrombosis as well as decreased plasma ATIII levels, and the exclusion of acquired deficiency.Laboratory TestsIt is recommended that ATIII plasma levels be monitored during the treatment period.Functional levels of ATIII in plasma may be measured by amidolytic assays using chromogenicsubstrates or by clotting assays.Drug InteractionsThe anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE IIIin patients with hereditary ATIII deficiency. Thus, in order to avoid bleeding, reduced dosage ofheparin is recommended during treatment with THROMBATE III.Pregnancy Category BReproduction studies have been performed in rats and rabbits at doses up to four times thehuman dose and have revealed no evidence of impaired fertility or harm to the fetus due toTHROMBATE III. It is not known whether THROMBATE III can cause fetal harm whenadministered to a pregnant woman or can affect reproduction capacity. Because animalreproduction studies are not always predictive of human response, this drug should be usedduring pregnancy only if clearly needed.Pediatric UseSafety and effectiveness in the pediatric population have not been established. The ATIII levelin neonates of parents with hereditary ATIII deficiency should be measured immediately afterbirth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women withhereditary antithrombin III deficiency, has been reported.)Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% innormal term infants. ATIII levels in premature infants may be much lower. Low plasma ATIIIlevels, especially in a premature infant, therefore, do not necessarily indicate hereditarydeficiency. It is recommended that testing and treatment with THROMBATE III of neonates bediscussed with an expert on coagulation.

ADVERSE REACTIONSIn clinical studies involving THROMBATE III, adverse reactions were reported in associationwith 17 of the 340 infusions during the clinical studies. Included were dizziness (8), chestdiscomfort (3), nausea (3), dysgeusia (3), chills (2), pain (cramps) (2), dyspnoea (1), chest pain(1), vision blurred (1), intestinal dilatation (1), urticaria (1), pyrexia (1), and wound secretion andhematoma (1). If adverse reactions are experienced, the infusion rate should be decreased, orif indicated, the infusion should be interrupted until symptoms abate.

CAUTION& onlyU.S. federal law prohibits dispensing without prescription.

Grifols Therapeutics Inc.Research Triangle Park, NC 27709 USAU.S. License No. 1871 08941115-BS

Patients Satisfied With TransforaminalEpidural Steroid Injections Without SedationLAS VEGAS—A team that annually administers thousands of transforami-nal epidural steroid injections (TFESI) without sedation reported high satis-faction among patients with their med-ical care.

At the 2012 annual meeting of the International Spine Intervention Soci-ety, Felix Diehn, MD, Tim Maus, MD, and their colleagues at Mayo Clinic, in Rochester, Minn., reported that 99.9% of the 4,432 patients to whom they administered TFESI between 2006 and 2011 received it without sedation.

Eighty-one percent of patients whodid not receive sedation rated their overall medical care as “excellent” or

“very good.” Just over half also said they would “definitely” refer friends or fam-ily members to the clinic for TFESI. In results that were not presented at themeeting, the medical team also found very low vasovagal reaction rates.

“We conclude that TFESI can be performed without sedation with highpatient acceptance and low vasovagalrates,” said Dr. Diehn, assistant profes-sor of radiology at Mayo Clinic. “We think this is important because seda-tion is not without risk, including decreased ability of patients to report pain or paresthesia related to improper needle position and the possibility of masking potential evidence of a pend-ing disastrous complication.”

Mehul Desai, MD, MPH, direc-tor of pain medicine and nonoperative spine services, and professor of anes-thesiology and critical care and of neu-rosurgery at The George Washington University Medical Center, in Wash-ington, D.C., rarely uses sedation for TFESI because of safety concerns. But he questioned the validity of the study.

“This study is limited by the fact that it’s retrospective; the non-sedationgroup was very small; there is consid-erable potential for bias because the patients self-ff selected for or against sedation; and the team measuredpatients’ satisfaction with overall care [rather] than with their choice of seda-tion versus no sedation,” Dr. Desai said.

In the data presented at the meeting,Dr. Diehn and his colleagues performed 6,878 TFESIs on 4,432 patients in a six-xxyear period. All but seven (0.1%) wererdone without sedation.

The patients who opted for sedation were younger than the non-sedationpatients, with average ages of 47.9 and

61 years, respectively, although thesmall size of the sedation group pre-cluded statistical comparison of thetwo groups’ characteristics. Six of theseven sedation patients were men, whereas approximately 50% of thenon-sedation patients were men. More

than 90% of the non-sedation patientsunderwent lumbar TFESI compared with 42.9% of the sedation patients. Moreover, pain duration lasted only up to three months in 23.6% of the non-sedation patients and in 57.1% of the sedation patients.

Dr. Diehn said there was a 0% rateof vasovagal reaction in the sedation group and a 0.4% rate in the non-sedation patients.

Two weeks after the procedure, patients were asked about their expe-rience. Most of the non-sedationpatients (72.5%) completed the ques-tionnaire, whereas 57% (four) of seda-tion patients responded.

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see TFESI page 44

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Feast or Famine: The Great Divide In Pain Drug AccessGrows WiderVienna—In a remote village in the Ukraine, Artur, a former, decorated KGB colonel, sleeps with a gun underhis pillow. He says he will use it if thepain from his stage IV prostate cancerbecomes too unbearable. Bureaucratic hurdles in this country have left him

without access to pain medication, andhe has isolated himself from his family members because he doesn’t want them to see him suffer.

James Cleary, MBBS, FAChPM, director of the University of Wiscon-sin (UW) Carbone Cancer Center’s

Pain and Policy Studies Group, home of the World Health Organization (WHO) Collaborating Center for Pain Policy and Palliative Care, has met Artur and said his story is far from unique. People in more than half of the countries around the globe have

limited access to medical morphine; of those individuals, more than half face severe shortages of pain medication. At the recent annual meeting of the Euro-pean Society for Medical Oncology (ESMO), experts discussed the pain medicine crisis.

Consumption and availability of opioids varies widely throughout the world, according to statistics from the International Narcotics Control Board (INCB), the quasi-judicial organ that implements the United Nations’ drug conventions. For example, in 2009, morphine consumption was roughly 75 mg per capita in the United States and Canada and much less in Nepal (0.190 mg per capita) and India (0.095 mg per capita). Worldwide morphine consumption hovers around 6 mg per capita. The first prescription ever writ-ten for immediate-release oral mor-phine in Guatemala was in 2012 and was written for a 72-year-old womanwith advanced head and neck cancer.It was prescribed at a center that per-forms bone marrow transplants, under-scoring the fact that sophisticated care and access to analgesics do not go hand in hand.

Dr. Cleary, founder of the UW yyHealth Palliative Care Program and associate professor of medical oncol-ogy at the UW School of Medi-cine and Public Health, in Madison, pointed out that in 2008, high-incomecountries accounted for 17% of the population but 91% of morphine con-sumption. The disparity also exists for morphine equivalents. “The gen-eral world consumption of opioids, and this includes fentanyl, oxyco-done and other opioids, has been ris-ing, but most of that rise has been in high-income countries, with almost no increase in low- to middle-incomecountries,” Dr. Cleary said.y

In 1961, the United Nations Single Convention on Narcotic Drugs estab-lished a framework to prevent abuse and diversion of drugs, while ensuring their availability for medical purposes. Since then, organizations, including the WHO, have encouraged national policies that establish drug control sys-tems that prevent diversion, but do not interfere with medical access to opi-oids. In 2000, the WHO first pub-lished a guidance for policymakers, regulators, health care professionals and others about how to achieve this

4 2 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

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balance. In 2011, the WHO released an updated version: “Ensuring Balance in National Policies on ControlledSubstances, Guidance for Availability and Accessibility for Controlled Med-icines” (www.who.int/medicines/areas/quality_safety/guide_nocp_sanend/en/).

Multiple BarriersA 2006 survey from the World-

wide Palliative Care Alliance of health care workers in Asia, Africa and LatinAmerica identified four major barriers to accessing oral morphine: excessively strict national drug laws and regula-tions, fear of addiction, poorly devel-oped health care systems and lack of knowledge.

At the ESMO meeting, NathanCherny, MD, head of cancer pain andpalliative medicine, at Shaare Zedek Medical Center, in Jerusalem, pre-sented preliminary data from the International Collaborative Project to Evaluate the Availability and Acces-sibility of Opioids for the Manage-ment of Cancer Pain. This project was initiated by ESMO and coordinated with the UW Pain and Policy Studies

Group, along with the European Asso-ciation for Palliative Care, Union for International Cancer Control (UICC) and the WHO. The consortium eval-uated opioid drug availability, cost to consumers and barriers that prevent

cancer patients from obtaining these drugs. Data were gathered between December 2010 and July 2012 in 76 countries in Africa, Asia, the Middle East, Latin America, the Caribbean and 19 Indian states.

Only 12 countries surveyed pro-vided all seven of the opioid medi-cations considered to be essential for the relief of cancer pain by the Inter-national Association for Hospice and Palliative Care (IAHPC). These are codeine, immediate- and slow-releasemorphine, injectable morphine, oral oxycodone, oral methadone and trans-dermal fentanyl. In many countries,opioids that were on a formulary were only available occasionally. When researchers classified countries as good, limited, very limited or poor based oncompliance with the IAHPC essential drug list, they found that only roughly half could be classified as good.

The surveys found that many gov-ernments do not subsidize (or only occasionally fund) available pain drugs. For example, patients in Guate-mala, Peru, Kenya, Liberia, Madagascar, Tunisia, Syria, Afghanistan, China and most of the Indian states must pay the full cost of medications that are avail-able. India is one of the world’s larg-est legal cultivators of poppies, but it is almost impossible for citizens to get cheap opium-based painkillers. “On

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see access page 45

Artur, a former KGB colonel in the Ukraine, keeps a gun under his pillow, and plans to use it if his cancer pain becomes unbearable.Photo courtesy of Dr. James Cleary.

and community and seniors’ centers.Prior to the session, attendees pro-

vided demographic data and indicated the frequency and intensity of their pain and to what level its existence interfered with their daily activity. They also were presented with severalpain-related statements both before and after the session, and were asked to rate their level of agreement witheach one.

Forty-nine health care workers and an equal number of older community members, with a mean age of 66 years, provided complete information.

After the session, attendees were asked the same questions. This time they disagreed more strongly with sev-eral of the statements, including “peo-ple over the age of 65 often become addicted if they take drugs for pain,”

“pain is a normal part of aging,” “peo-ple should only take drugs if they are in severe pain,” “pain in older people cannot be managed,” “it is best not to

bother your doctor about pain,” and“pain medicine should be saved in case pain gets worse.”

Nearly 80% of the participantsreported having daily pain, with 60% rating their pain as severe, despite the fact that 85% were using pharmaco-logic and physical treatments for pain.

Presenting the research at the Inter-national Association for the Study of Pain’s 14th World Congress on Pain, in Milan, Dr. Gagliese said that the intensity of pain reported in the study sample is higher than what is seen in other Canadian community samplesof individuals of similar age. The pos-sibility that there was a “self-ff selectioneffect” and that individuals with more severe pain were more likely to attendlectures on pain limits the ability to extrapolate the findings, she said. The researchers did not incorporate a follow-up component to the study.

While improved education on its own is important, “the most

important question is did the increased knowledge lead to bet-ter pain management?” said Mellar Davis, MD, professor of medicine at the Cleveland Clinic Lerner Col-lege of Medicine of Case Western Reserve University, in Cleveland, and director of the Clinical Fellow-ship Program of Palliative Medicine and Supportive Oncology Services at the Cleveland Clinic’s Taussig Cancer Institute. “The assumption is that it would have, and that bet-ter knowledge is a kind of surrogate marker of better pain management, but without follow-up data and direct outcome measures, it’s notclear whether this is the case.”

—David Wild

Dr. Gagliese received an unrestricted educational grant from Merck Frosst Canada. Drs. Gordon and Davis reported no relevant conflicts of interest.

Just over half of the non-sedationpatients (51.5%) rated their over-all medical care as “excellent” and 29.8% rated it as “very good.” The respective percentages of the seda-tion patients were 50% and 0%. One sedation patient rated the medi-cal care as “good” and the remaining patient rated it as “fair.”

Just over half of non-sedationpatients (52.8%) also said that they would “definitely” refer friends and family members, while two (50%) of the sedation patients gave the same endorsement. The respective per-centages of those who said that they would “probably” refer others were 27.8% and 0%. Half of the sedation patients said that they would “proba-bly not” refer others.

—Rosemary Frei, MSc

Drs. Diehn and Desai reported no relevant conflicts of interest.

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PERCEPTION CONTINUED FROM PAGE 40 TFESI CONTINUED FROM PAGE 41

a formulary basis, there is ostensibly wide availability [in India]; in prac-tice however, the medications are rarely available, and in the event that they are,patients who need these drugs need to pay full cost for them,” Dr. Cherny said.y

Many countries have highly restric-tive regulations that limit the ability of cancer patients to receive prescrip-tions, limit prescriber privileges,impose restrictive limits on duration of prescription, restrict dispensing and increase bureaucratic burden of the prescribing and dispensing pro-cess. “About one-third of countries across Africa and half the countries in the Middle East are limited to a one-week supply,” saidk Dr. Cherny, referring yyto the number of days that opioids can be prescribed per prescription. “Over-regulation of opioids is widespread.” Eighty-four percent of countries reported four or more regulation barri-ers; 39% reported six or more.

A Call to ActionEfforts to improve access are ongoing.

In India, the Supreme Court is pushing for reform of pain medicine regulations and may take control away from states,Dr. Cherny said. The WHO continues yto work on improving access. Data from the international collaborative projectshou ld spur further action.

“This data are really a call to action,” said Dr. Cherny. “There is an urgentyyneed for formulary review, improving affordability of medications, improv-ing availability of opioids by better distribution and dispensing, careful examination of multiple drug control policies and repeal of excessive restric-tions, which are impeding this most fundamental aspect of cancer care.”

Kathleen Foley, MD, attending neu-rologist in the Pain & Palliative Care Service at Memorial Sloan-KetteringCancer Center, in New York City, said the problem will have to be fixed coun-try by country.

“We need to identify champions at the country level,” she said. She pointed out several recent success sto-ries, including the Access to OpioidMedication in Europe (ATOME) proj-ect. This consortium of academic insti-tutions and public health organizations in 12 countries is working to help governments, particularly in Eastern Europe, remove barriers to medicines that treat pain and heroin dependence.

“They are looking, in depth, at the reg-ulatory environments in these coun-tries and coming up with approaches and standards to how we look at this,”

said Dr. Foley. “This is where law and yyhealth need to be very closely allied, because it is these regulatory barriers that we need to change.”

The Global Access to Pain Relief Initiative (GAPRI), a joint program of the UICC and the American Can-cer Society, is another effort. Founded in 2009, GAPRI aims to make essen-tial pain medicines universally available by 2020. In 2010, GAPRI brokered a deal between the Ugandan govern-ment and Hospice Africa Uganda to

create a national morphine production program. Since then, the government’s cost of purchasing morphine has been reduced by 40%, and there is expanded access to the drug, which is now free to all patients. Due to a GAPRI project in Nigeria, the country has placed its first order for morphine in four years and is working on improving regula-tions and training clinicians. A number of other projects are ongoing.

Dr. Foley encouraged UICC and ESMO to “put enormous pressure

on INCB to work with countries to encourage requests.” The INCB has put forth “tremendously positive lan-guage” encouraging governments to increase the medical use of opiates for pain, but this is not enough, she said.

“They say it in a positive way, but not much happens.”

—Kate O’Rourke

Drs. Cleary, Cherny and Foley reported no relevant conflicts of interest.

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ACCESS CONTINUED FROM PAGE 43

Focus on Inhaled Anesthesia Podcast Series

Podcast 3

How to Run an Effi cient OR: Collaboration Between Anesthesia Providers and OR Staff

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Richard Pitera Jr., MDAnesthesiologist and Director of Perioperative Medicine

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collaboration between anesthesia providers and other operat-

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• Identify perioperative management protocols that enhance

effi ciency and safe patient throughput in the OR.

• Discuss the fast-tracking protocol effi ciency.

practice in the war is the Medical and Surgical His-tory of the War of the Rebellion (MSHWR; available online at the Internet Archive). The volumes of this work were published between 1870 and 1888 and totaled more than 6,000 pages. Only Union forces are covered, however; most Confederate records were burned at the end of the war.

Anesthesia was not universally employed in the United States prior to the conflict, in either civil-ian or military settings. Ether was used briefly and in a few cases in the Mexican-American War during the mid-1840s. The surgical use of anesthesia accel-erated during the Civil War in response to the sheer numbers of wounded. Information about anesthesia appears in the MSHWR in numerous surgical case studies and a chapter on “Anesthetics.”

Union forces had no problem obtaining anesthetic agents. E.R. Squibb, a Navy surgeon turned Brooklyn drugmaker, and others manufactured both ether and chloroform. More than one million ounces of each agent were purchased during the conflict. But the Confederacy had more problems; primary sources were blockade running and captured Union supplies. Relatively small amounts of ether and chloroformwere manufactured in the South.

How many anesthetics were given during the war? The MSHWR notes approximately 80,000 total but gives no supporting evidence. The report does exam-ine 8,900 in detail: Union projectile injuries totaled about 246,000, with almost 202,000 surviving and almost 30,000 amputations with about 20,000 sur-viving. The Confederate anesthesia total has been estimated at about 57,000 administrations.

The benefits of anesthesia were widely noted. In her letters written home while serving as a nurse at a hospital in Washington and published in 1863 as Hospital Sketches, Louisa May Alcott observed first-hand the “merciful magic of ether.” A Confederate surgeon named F.E. Daniel described a patient whose leg he had just amputated:

“The form is transferred to a cool cot beneath the

shade of a wide spreading tree to cool him and keep off the flies. He rallies from the sleep of the merci-ful anesthetic [chloroform]. He slept all through the ordeal … he felt nothing, knew nothing. He wakes to find his leg gone.”

Amazingly, given the number of anesthetics often administered by inexperienced and certainly untrained personnel, deaths resulting from its use apparently were few. Confederate surgeon Julian Chisolm, who wrote the widely used A Manual of Military Surgery, stated that he administered chloro-form in more than 10,000 cases without a fatality.

The man whose demonstration, in Boston in 1846, brought ether anesthesia to the world also admin-istered it during the Civil War. William Thomas

Green Morton later wrote:“How little did I think, however, when originally

experimenting with the properties of ether on my own person, that I should ever successfully admin-ister it to hundreds in one day, and thus prevent an amount of agony fearful to contemplate.”

Morton gave those many anesthetics, “producing perfect anesthesia in an average time of 3 minutes,” in the Battles of the Wilderness and Spotsylvania Court-house in May 1864. His own and others’ efforts were heroic in the face of the 34,000 Union casualties.

Many medical advances arise from necessity during wartime. The American Civil War produced more than most conflicts, and knowledge about anesthesia was certainly one of them.

—A.J. Wright, MLS

Recommended ReadingAlbin MS. The use of anesthetics during the Civil War, 1861-1865. Pharm Hist. 2000;42:99-114.

Albin MS. William Thomas Green Morton as military anesthetist during theCivil War. Bull Anesth Hist. 1996;14:1,23.

Blaisdell FW. Medical advances during the Civil War. Arch Surg.1988;123:1045-1050.

Morton WTG. The first use of ether as an anesthetic at the Battle of the Wil-derness in the Civil War. JAMA. 1904;42:1068-1078.

Eight Medical Advances F rom the Civil War

1 Accumulation of adequate records and detailed reports

for the first time permitted a com-plete military medical history. This led to the publication of the Medi-cal and Surgical History of the War of the Rebellion, which was iden-tified in Europe as the first major academic accomplishment by U.S. medicine.

2 Development of a system of managing mass casualties,

including aid stations, field hospi-tals and general hospitals, set the pattern for management of the wounded in World War I, World War II and the Korean War.

3 The pavilion-style general hospitals, which were well

ventilated and clean, were copied in the design of large civilian hos-pitals over the next 75 years.

4 The importance of immediate, definitive treatment of wounds

and fractures was demonstrated and it was shown that major oper-ative procedures, such as amputa-tion, were optimally carried out in the first 24 hours after wounding.

5 The importance of sanita-tion and hygiene in prevent-

ing infection, disease and death among the troops in the field was demonstrated.

6 Female nurses were intro-duced to hospital care and

Catholic orders entered the hospi-tal business.

7 The experience and training of thousands of physicians were

upgraded, and they were intro-duced to new ideas and standards of care. These included familiar-ity with prevention and treatment of infectious disease, with anes-thetic agents and with surgical principles that rapidly advanced the overall quality of American medical practice.

8 The Sanitary Commission was formed, a civilian-organized

soldier’s relief society that set the pattern for the development of the American Red Cross.

Source: Blaisdell FW. Medical advances during theCivil War. Arch Surg. 1988;123:1045-1050.

Table. Casualties and Losses

Union Confederate

Killed in action 140,414 72,524

Total dead ~365,000 ~260,000

Wounded 275,200 137,000+

From Wikipedia “American Civil War” article; its source: John W. Chambers II, ed. in chief, chief, p y yThe Oxford Companion to American Military HistoryThe Oxford Companion to Ammerican Military Historyy y. Oxford University Press; 1999.. Oxford University Press; 1999.yyyy

4 6 I A n e s t h e s i o l o g y N e w s . c o m M A R C H 2 0 1 3

AD L IB

CIVIL WAR CONTINUED FROM PAGE 1

The Battle of Antietam, by Kurz & Allison, depicting the scene of action at Burnside’s Bridge.Antietam was “the bloodiest single-day battle in American history.”Source: Wikipedia

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REPORTTransdermal PCA in Acute

Postoperative Pain Management: A Critical Evaluation of the Investigational IONSYS System

Acute postoperative pain con-tinues to be undertreated, with up to 75% of patients in the United States failing to receive adequate postoperative pain relief.1,2 Postoperative pain man-agement was revolutionized with the introduction of patient-con-trolled analgesia (PCA) using IV or epidural delivery routes more than 20 years ago.3 Opioids are the primary treatment for acute pain management,4 either alone or increasingly as part of a multi-modal analgesic strategy—char-acterized by administration of 2 or more drugs (eg, opioid and nonopioid analgesics, used in combination) that act by different mechanisms, and along differ-ent pain pathways—an approach that is recommended by the American Society of Anesthesi-ologists (ASA) and the American Pain Society.5,6 However, existing PCA modalities have limitations that include inva-sive access, challenges in titration of analgesic effect, cumbersome pump technologies, impaired patient mobil-ity, and limited drug preparations that have been associ-ated with programming, medication, and dosing errors.

Despite advances in pain man-agement technology, the advent of acute pain services, and pro-fessional practice guidelines aimed at improving postoperative pain management, inadequacies and treatment gaps still exist, and improvement remains a priority.7

An analgesic intervention that might help to mitigate clini-cian concern is the fentanyl ion-tophoretic transdermal system (IONSYS), a credit card–sized, self-contained, and prepro-grammed investigational product candidate intended to provide pain relief for adult inpatients requiring opioids following sur-gery.8 It is a needle-free system that is applied to the skin on the upper arm or chest.8 A generally imperceptible electrical current then delivers a small dose of fen-

tanyl directly through the skin and into the systemic cir-culation. The FDA approved IONSYS in 2006; however, it was never launched in the United States due to required cha nges in manufacturing. The enhanced design will be reviewed by the FDA in the near future for use in patients with moderate to severe postoperative pain.

Chair

Eugene R. Viscusi, MD Professor of Anesthesiology

Director, Acute Pain ManagementThomas Jefferson UniversityPhiladelphia, Pennsylvania

Faculty

John Fanikos, RPh, MBADirector of Pharmacy Business Brigham and Women’s Hospital

Boston, Massachusetts

Michael H. Huo, MDProfessor

Department of Orthopedic SurgeryUT Southwestern Medical Center

Dallas, Texas

2

REPORT

Burden of Acute Postoperative PainMore than 48 million inpatient surgeries and roughly 35 mil-

lion outpatient surgeries are performed annually in the United States, and the magnitude of unrelieved acute postoperative pain is substantial.4,9,10 Unrelieved pain can have profound implications and inadequately managed acute postoperative pain can result in negative clinical (eg, myocardial infarction, infection, pneumonia, poor wound healing, demoralization) and medical outcomes (eg, extended hospital length of stay, readmissions, patient dissatisfaction, perception of negative hospital performance, and increased health care utilization costs).4 Given the problem of insufficient pain relief, treatment regimens now include the use of multimodal analgesia to con-trol postoperative pain and potentially improve postoperative recovery.11

Elements of Multimodal AnalgesiaA multimodal approach that incorporates opioid-based PCA

is a principal element of acute pain management during the postoperative period.12 The 2012 ASA Practice Guidelines for Acute Pain Management in the Perioperative Setting recom-mend the consideration of acetaminophen, oral cyclooxygen-ase-2 (COX-2) selective nonsteroidal anti-inflammatory drugs (NSAIDs), nonselective NSAIDs, and calcium channel α2δantagonists (ie, gabapentin and pregabalin) as part of an acute postoperative multimodal pain management regimen.5 Patients should receive around-the-clock (ATC) doses of coxibs,

NSAIDs, or acetaminophen unless contraindicated.5 Regional anesthetic techniques, including peripheral nerve blockade, should be considered; dosing regimens, route of administration, and therapy duration should be individualized to balance con-siderations of effectiveness and risk for adverse events (AEs).5

Drugs with a primary indication other than analgesia (eg, anti-convulsant medications) are sometimes used as part of a mul-timodal strategy.

While opioids remain an important part of the foundation of pharmacological management of moderate to severe pain during the postoperative period,13 opioid-reducing regimens of ATC nonopioids are considered most appropriate.5 Opioids endure as an important analgesic component for the s ystemic treatment of postoperative pain,12 but the best delivery route of therapeutic agents depends on many factors including the physician’s level of expertise as well as patient characteris-tics. Evidence shows that when compared with c onventional opioid analgesia (eg, IV, subcutaneous, intramuscular), PCA with opioids provides a greater analgesic effect, even when the amount of opioids consumed is similar between the 2 methods; and it also is the preferred treatment modality among patients.14 PCA also can be used in conjunction with an opioid-sparing multimodal treatment regimen.

PCA Modalities and PracticesThe basic tenet of PCA dictates that patients should have

direct control of their pain management14 and may benefit from

Figure 1. PCA’s influence on pain control.PCA reduces the time it takes to alleviate acute pain in patients.

PCA, patient-controlled analgesia

Patient variables

Sedation

Analgesia

Nurse variables

Patient requests nurse

Nurse arrives

Nurse evaluates

Nurse readies injection

Pharmacokinetic variables

Absorption

Injection administered

PCA

Pain

REPORT

3

doing so.15 Severe acute pain is best treated with intermittent, small doses of opioids that are delivered immediately when needed (Figure 1). This allows for rapid titration of analgesic effect and provides more effective pain relief than co nventional (eg, intermittent bolus intramuscular, IV, subcutaneous) opi-oid regimens.14,15 The superior analgesic efficacy of IV PCA compared with intermittent intramuscular analgesia was dem-onstrated in a pooled-data analysis in which the incidence of moderate-severe pain with intramuscular analgesia was 67% (95% confidence interval [CI], 58.1%-76.2%) and severe pain was 29% (95% CI, 18.8%-39.4%). For PCA, the incidence of moderate-severe pain was 36% (95% CI, 31.4%-40.2%) and severe pain was 10% (95% CI, 8%-12.8%), respectively.16

Data also have shown that fewer pulmonary complications are reported with IV PCA compared with other methods of opioid delivery (eg, IV, subcutaneous, intramuscular), and the risk for oversedation is reduced.14,17

After pain control has been established with a loading dose of IV opioids, PCA is used to sustain comfort by self-administering small amounts of analgesic medication within preset parameters.18 Staff-programmed PCA pump settings regulate medication dosing and dosing frequency, the lock-out period between doses, and the maximum allowable dose per hour. Existing PCA modalities including IV PCA, patient-controlled epidural analgesia (PCEA), and patient-controlled regional anesthesia (PCRA) have varying benefits. For exam-ple, IV PCA has an acceptable efficacy and safety profile along with reports of high patient satisfaction.3 Analgesia delivered through the epidural route (eg, PCEA, continuous infusion, bolus injection) supplies rapid analgesia and decreases sys-temic opioid exposure.3 PCEA also allows patients to self-administer analgesia based on individual requisites.3 Similarly, PCRA provides analgesia without systemic exposure to opi-oids and it can conveniently be used in an outpatient setting.3

Similar to IV PCA and PCEA, PCRA also has the advantage of a no first-pass gastrointestinal effect but also a no first-pass hepatic effect.3 The ASA recommends the use of therapeutic options like systemic opioid PCA, central regional (ie, neurax-ial) opioids, and peripheral regional techniques after carefully considering patient profiles and clinicians’ experience level, and the use of these modalities is preferred over prescribed as needed intramuscular opioids.5 PCA is a standard of post-operative pain management and current modalities allow for use of complex regimens.

Cost-Effectiveness Related to PCAMedical expenses, unintended morbidity and mo rtality

costs, and overhead expenses all affect the total cost of man-aging pain during the postoperative period. Actual costs asso-ciated with postoperative pain management include fixed costs, which remain stable despite volume of activity (eg, IV PCA pumps), and variable costs, which fluctuate according to volume (eg, analgesics, disposable supplies). Because the inadequate treatment of postoperative pain may result in chronic pain, it may be difficult to estimate the actual cost of postoperative pain management. Unfortunately, hospitals and health care providers usually are unaware of the actual costs

associated with providing services, and actual costs do not always equate to compensation for the institution or clinician.

The examination of cost-effectiveness evaluates the total benefits respective to the expenses and resources neces-sary for advances in pain management. For example, 1 study analyzed cost-effectiveness between PCA and intermittent intramuscular injections. In this study, PCA was the preferred modality compared with intermittent intramuscular injections because it was associated with a lower mean pain level over 24 hours and greater patient satisfaction.19 While the mean drug and equipment cost for PCA was higher per patient compared with intermittent intramuscular injections, PCA retained clinical advantages over the traditional injection such as greater pain relief and patient satisfaction.19

With regard to IV PCA, direct costs include staff time, anal-gesics, infusion pumps, and tubing. Likewise, intangible costs that are associated with IV PCA include restricted mobility and patient discomfort. Indirect mortality and morbidity expenses for all modalities include expenses associated with insufficient pain management, medication errors, and staff-related inju-ries such as needlesticks. Examples of opportunity expenses include lost nursing time for pump programming, delays in set-ting up equipment, and consequent delays in patient discharge from the hospital.

When developing a regimen for postoperative pain man-agement, an analysis of cost-effectiveness that scrutinizes resource utilization and labor costs related to these modalities, along with probable intangible, indirect, and op portunity costs is justified. The potential for pain relief is an important factor to consider when weighing the cost-benefits of a specific treat-ment modality.

Clinical and Pharmacodynamic Characteristics of Opioids in PCA

Currently, opioids are the principal treatment for acute pain.4

Morphine is the most commonly employed opioid in postopera-tive IV PCA (usual starting dose in opioid-naive patients, 1 mg),followed in usage by hydromorphone (0.2 mg) and fentanyl (10 mcg); all are pure opioid agonists.18 Best practice dictates that approximately equianalgesic dosing of opioids is employed to minimize the impact of medication errors. Although mor-phine is considered the gold standard for IV PCA,18 its active metabolites—morphine-3-glucuronide and morphine-6-gluc-uronide—may accumulate insidiously in patients with renal impairment and have toxic effects owing to reduced excretion of the metabolite.20

Hydromorphone may be used as an alternative in morphine-intolerant patients or in those with altered renal function. Com-pared with morphine, hydromorphone is at least 5 times more potent; initial doses should be significantly lower for hydro-morphone and ordered in milligrams.15 Meperidine should be avoided for routine PCA because of an association with seizures, confusion and central nervous system stimulation, caused by its metabolism to an active form, normeperidine.15

Fentanyl has no active metabolites20 and is highly lip ophilic, which facilitates crossing the blood–brain barrier.21 Small

4

REPORT

positively charged molecules are ideal iontophoretic agents. Hence, fentanyl hydrochloride (HCl) is well suited for iontopho-retic delivery.22

Furthermore, fentanyl exhibits a satisfactory AE profile. Hutchinson and colleagues reported that patients in the post-operative period who received IV PCA fentanyl had a low rate of common opioid-related AEs (eg, nausea, vomiting, pruritus, urinary retention, sedation).23 The same study revealed that during postoperative days 1 and 2, the IV PCA fentanyl group also had an acceptably low median pain score.23

Because the kidneys excrete metabolites of most opioids, the absence of active metabolites with fentanyl may make it a rea-sonable choice for patients with renal impairment.24 In critically ill patients, fentanyl has a prolonged clearance (half-life up to 25 hours) that should be taken into consideration. In addition to fen-tanyl, drugs with the relatively safest analgesic pharmacologic profiles for use in patients with impaired kidney function include alfentanil, ketamine, and buprenorphine.24 Drugs also used in the presence of renal failure but with special precautions—usu-ally dose reductions—include amitriptyline, gabapentin, bupiva-caine, and clonidine.24 NSAIDs and aspirin should not be used in the presence of chronic renal failure because of the risk for sig-nificant toxicity.24 In any patient population, postoperative renal function may differ markedly from preoperative renal function and clinicians should be vigilant for renal function changes.

Limitations of IV PCA

When accurately prescribed and effectively monitored, PCA is an effective and safe way to control acute pain.15 However, PCA also is complex and prone to error.3 PCA is associated with numerous system-related complications and program-ming errors.3 In fact, device malfunction is a major cause of reported AEs with IV infusion pumps. Of 2,009 IV PCA-re lated events reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) voluntary medication error report-ing program during a 2-year period, 1,590 (79.1%) were clas-sified as possible device-safety events.25 A retrospective analysis of MEDMARX, an Internet-accessible, voluntary med-ication error reporting program, found that PCA medication errors consequently are associated with higher relative risk for patient harm compared with non-PCA medication errors, and may occur during all phases of the medication use process.26

The increased focus on patient satisfaction in the hospital setting, led by the Centers for Medicare & Medicaid Services and the Agency for Healthcare Research and Quality, empha-sizes the need for the optimal delivery of PCA. The Hospital Consumer Assessment of Healthcare Providers and Systems’ (HCAHPS) national standard survey monitors patients’ per-spectives on hospital care.27 Increasingly, this survey—which includes an assessment of patient satisfaction—is being used to dictate reimbursement at risk.27 In fact, patient satisfaction with

Table. Patient-Controlled Modalities Used for the Management of Acute Postoperative Pain

Modality Conveniences Limitations

Iontophoresis Noninvasive; rapid analgesia; convenient, small in size, no required cables or pump; no programming by hospital staff required; no first-pass GI effect; limited time and resources required for administration; patient controlled

Not appropriate for patients with skin disorders or injuries that prevent application; individualization of dosing limited to frequency of dosing

IV PCA Rapid analgesia; patient controlled; programmable

Invasive; pump apparatus, tubing, and power cables may limit patient mobility; extensive staff time and resources required for administration; requires programming by staff; potential for IV line occlusions, programming and drug errors

PCEA Rapid analgesia; patient controlled; programmable

Invasive; pump apparatus, tubing, and power cables may limit patient mobility; extensive staff time and resources required for administration; requires programming by staff

PCRA No first-pass hepatic effect; mini-mized systemic opioid requirements

Technique generally limited to orthopedic surgery patients; further development of PCRA pumps needed; efficacy and safety needs further evaluation

GI, gastrointestinal; PCA, patient-controlled analgesia; PCEA, patient-controlled epidural analgesia; PCRA, patient-controlled regional analgesia

From reference 3.

REPORT

5

pain management in the hospital is one of the 6 sum mary mea-surements used to determine the at-risk reimbursement under HCAHPS.28

Complications associated with PCA include a troublesome profile of common μ-agonist opioid-induced AEs including respiratory depression, nausea, vomiting, pruritus, sedation, and confusion.18 There also is the potential for complica-tions related to the IV line itself (eg, occlusions) and cathe-ter infiltration into subcutaneous tissue, or programming and medication errors—any of which can result in potentially seri-ous AEs, including oversedation, respiratory depression, and under-treated pain (Table).3,15

Specific clinical disadvantages of IV PCA are that it is inva-sive, hinders patient mobility, requires external supplies (eg, tubing, power cables, drug cassettes) and the necessity of pump apparatus and programming, and extensive staff time and resources. In terms of patient comfort, analgesic gaps can occur while patients are waiting for medication during the tran-sition from one analgesic modality to another. PCA delivery also requires a staff of expert clinicians including pharmacists, physicians, nurses, and physician assistants. The infrastructure must be present in order to safely and effectively deliver PCA—thus, a substantial commitment in resources is necessary. Fur-thermore, PCA by proxy errors, in which an unauthorized party activates the analgesic pump’s dosing mechanism, deliver-ing analgesic medication to the patient, are another poten-tially serious issue within PCA delivery. PCA by proxy errors can result in serious AEs including oversedation, respiratory depression, and death.17

Limitations of PCEA and PCRASimilar to IV PCA, PCEA requires a staff-programmed pump

and a highly qualified anesthesia provider to insert a catheter into the desired epidural location.3 In addition to the need for extensive hospital staff for administration, PCEA also requires manual programming, increasing the risk for serious program-ming and medication errors.3 PCEA’s pump, tubing, and power cables discourage patient mobility, and there also is a risk for occlusions.3 Analgesic administration via the epidural route also is associated with catheter dislodgement and migration within the epidural space; in fact, 17% of epidural catheters fail due to unexpected dislodgement.29 PCRA also possesses certain limitations. For example, in addition to being invasive, PCRA in an unmonitored setting is associated with an increased risk for complications such as leaking or dislodgement of indwell-ing catheters and infection.3 PCRA is usually restricted for use in orthopedic surgery patients; this modality also requires an advanced hospital staff to set up perineural catheters.3

Limitations of Other Routes of Opioid Administration

While oral administration of opioids for the treatment of mod-erate to severe pain is both convenient and noninvasive, it is usu-ally contraindicated in the immediate postoperative period.12 Oral opioids also possess a delayed onset of action; poor absorption in the gastrointestinal tract and a powerful first-pass effect cause a variable period of action compared with parenteral opioids.12

As such, greater doses of opioids (eg, morphine and meperi-dine) are required for oral administration than for the parenteral route.30 Furthermore, because the optimal analgesic dose var-ies among patients, overdose or the undertreatment of pain are potential risks with this route of administration.

The intramuscular route is associated with painful admin-istration10 as well as ineffective pain control compared with other modalities (ie, PCA, epidural).16 The intramuscular administration of analgesics is characterized by unpredictable absorption as there is a 30- to 60-minute lag to peak effect followed by a sudden drop in action. The intramuscular route has another troubling element—when the opioid finally peaks, patients often are alone and can experience oversedation, vomiting, and aspiration.4

Iontophoretic Transdermal DeliveryTransdermal drug delivery, like parenteral delivery, avoids

first-pass hepatic metabolism and obstacles associated with oral analgesics following surgery (eg, vomiting, nausea, and difficulty swallowing).31 For the delivery of analgesics, trans-dermal modalities operate as a drug reservoir that determines the amount of drug transfer.32 Transdermal iontophoresis is a method that employs a subtle electrical current to deliver ion-ized drug molecules across the skin and into the circulation.31

With iontophoresis, neutral or cationic agents are positioned below an anode and anionic agents are fixed below a cathode, and a low current density and low voltage is applied, c ausing ions to be repelled through and into the skin.32 The skin acts to complete the circuit as electric currents move from the anode to the cathode.31 Specifically, the anode causes c ationic ther-apeutic agents to be moved into and through the skin, and extracts anions from the tissue beneath the skin back into the anode.32 Within the cathode, anionic buffer ions are sent through the skin and the tissues’ cations migrate into the cath-ode.32 As such, an active transdermal system that uses ion-tophoretic drug delivery offers patients control over analgesic dosing along with convenient administration and rapid analge-sic delivery without some of the shortcomings associated with IV and epidural routes.31

Iontophoretic PCAIONSYS is a noninvasive device that employs iontophoretic

technology and is designed for PCA via the transdermal route (Figure 2).33 IONSYS is adhered to the patient’s skin with an adhesive backing. To deliver a dose of fentanyl, the patient can press the dosing button twice within 3 seconds; an audible tone will signal the start of delivery of each dose; and a ra pidly blinking green light will remain on throughout the 10-minute dosing period.33 IONSYS activation produces a small electrical voltage between the anode and cathode. This causes positively charged fentanyl molecules located in the anode hydrogel res-ervoir to be repelled from the positively charged anode sur-face and to be delivered through the skin into the systemic circulation.31 In contrast to existing PCA modalities, iontopho-retic transdermal delivery does not require infusion pumps or indwelling catheters to deliver medication, which encourages patient mobility in the critically important postsurgical period.3

6

REPORT

IONSYS delivers 40 mcg of fentanyl per on-demand dose over a 10-minute period, with up to 6 doses available per hour.8

As such, IONSYS performs for as long as 24 hours or for a max-imum of 80 doses, whichever takes place first; additional ION-SYS systems can be used after 24 hours if needed for up to 3 days.3 The enhanced IONSYS device features an improved display, which helps clearly show to health care practitioners how many doses have been delivered. IONSYS eliminates IV line complications, which can lead to analgesic gaps, by supply-ing instantaneous dosing on patient demand, providing consis-tent analgesia and eliminating potentially painful waiting periods between requests for analgesia and drug administration.

IONSYS also features preprogrammed dosing, which elim-inates the potential for medication dosing errors. PCA medi-cation errors have been the focus of hospital-directed safety alerts issued by the Institute for Safe Medication Practices and the Joint Commission, and remain a critical concern.34 For example, using MEDMARX data, the most common cause of IV PCA errors was human-related (accounting for 322.91 errors per 10,000 patients); followed by equipment-related (102.23 overall errors per 10,000 patients).35 Using MAUDE data, the

percentage of human-related errors reported to have inflicted patient harm was 48.1%.25 MAUDE data also indicates that the percentage of device-related errors reported to have inflicted patient harm was 0.5%.25 Furthermore, IONSYS’ compact design also eliminates the necessity for unwieldy equipment that requires nursing staff attention and may restrict patient mobility because the patient is tethered by IV tubing, an IV pole, and the IV PCA pump apparatus.

Clinical Considerations With IONSYSPharmacokinetic (PK) evaluations of IONSYS in dosing

frequency studies have demonstrated that it has a PK pro-file similar to that of IV PCA fentanyl, but with a slower rise, lower peak level, and less fluctuations.36,37 Systemic absorp-tion of the fentanyl delivered by IONSYS increases as a function of time; this increase appears to be independent of dosing fre-quency.8 Subtherapeutic passive absorption with IONSYS is minimal compared with transdermal delivery; IONSYS leaves no significant skin depot of fentanyl with discontinuation of the system, and serum levels fall almost immediately (Figure 3).8,38

After 24 hours or 80 doses have been administered, IONSYS deactivates and cannot supply additional doses to the patient.8

IONSYS is designed to be applied to the skin on the upper arm or chest. The quantity of fentanyl HCl delivered by activa-tion of the system has been demonstrated to be independent of patient age, sex, body mass index, or race, but is dependent on the location of the device on the body, with the ideal appli-cation sites being the upper outer arm or chest of patients.39

Ensuring Safe and Effective PCABecause IONSYS is intended only for use among hospital-

ized patients in the acute setting, the potential for misuse may be limited compared with the potential for misuse of the fen-tanyl transdermal patch or other opioids.3 To ensure proper usage, medical personnel are required to remove the IONSYS system prior to hospital release and dispose of it.8 Neverthe-less, appropriate opioid selection can mitigate risks,40 and developing PCA patient-selection criteria (eg, evaluation of medically complicated patients, identification of patients with a need for a basal infusion, such as those who are opioid-tol-erant) is one of the most overlooked but effective mechanisms to reduce risk for opioid-related AEs.15 In addition to clarifying the patient groups that are most likely to benefit from a particu-lar PCA modality, targets for intervention in safe opioid analge-sia are prescribing errors, staff training on use and protocols, monitoring, and patient education.15

ConclusionOpioids remain the most commonly used analgesics in post-

operative pain management, especially for the treatment of moderate to severe pain. A multimodal approach that includes opioid-based PCA is an important tenet in managing acute postoperative pain.12 While the ideal mechanism of delivery depends on physicians’ expertise and the patient, data has shown that when compared with conventional opioid analge-sia (eg, IV, subcutaneous, intramuscular), PCA with opioids is the preferred treatment modality among patients.14 However,

Figure 2. Enhanced IONSYS device.The credit card–sized, preprogrammed system delivers a small dose of fentanyl through the patient’s skin and into the systemic circulation.

From reference 33.

REPORT

7

certain PCA modalities have disadvantages, including invasive-ness (eg, IV PCA, PCRA), risk for infection (eg, PCRA), and medication or programming errors (eg, IV PCA, PCEA).3

The compact, self-contained, preprogrammed IONSYS system may limit the possibility for a number of medication and system-related events, including manual programming

errors, which have been associated with potentially serious clinical consequences.25,26 Unlike other PCA modalities, ION-SYS is noninvasive, which promotes patient mobility during the postsurgical period. Within a multimodal pain management strategy, IONSYS may be a reasonable choice for analgesia in adult patients after a range of major surgical procedures.

References1. Phillips DM. JCAHO pain management standards are unveiled.

JAMA. 2000;284(4):428-429.

2. Wu CL, Raja SN. Treatment of acute postoperative pain. Lancet. 2011;377(9784):2215-2225.

3. Viscusi ER. Patient-controlled drug delivery for acute postoperative pain management: a review of current and emerging technologies. Reg Anesth Pain Med. 2008;33(2):146-158.

4. Wells N, Pasero C, McCaffery M. Chapter 17. Improving the Quality of Care Through Pain Assessment and Management. In: Hughes R, ed. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville, Md: Agency for Healthcare Research and Quality; 2008.

5. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesi-ologists Task Force on Acute Pain Management. Anesthesiology. 2012;116(2):248-273.

6. Gordon DB, Dahl JL, Miaskowski C, et al. American Pain Society recommendations for improving the quality of acute and cancer

pain management: American Pain Society Quality of Care Task Force. Arch Intern Med. 2005;165(14):1574-1580.

7. Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest post-operative pain continues to be undermanaged. Anesth Analg. 2003;97(2):534-540.

8. IONSYS (fentanyl iontophoretic transdermal system) 40 mcg*/activation prescribing information. http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021338lbl.pdf. Accessed January 9, 2012.

9. Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the US, 2009. Natl Health Stat Report. 2009;11:1-25.

10. Centers for Disease Control and Prevention. Inpatient surgery. http://www.cdc.gov/nchs/fastats/insurg.htm. Accessed January 9, 2012.

11. Jin F, Chung F. Multimodal analgesia for postoperative pain con-trol. J Clin Anesth. 2001;13(7):524-539.

Figure 3. IONSYS vs IV fentanyl during last hour and at termination.Comparison of IONSYS and IV fentanyl during the last hour and at termination of the following treatment: 40 mcg of IONSYS was administered in 2 sequential doses over 20 minutes every hour for 23 hours and 20 minutes, and 80 mcg of IV fentanyl was administered over 20 minutes every hour for 23 hours and 20 minutes.

From reference 8.

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8

REPORT

Disclosures: Dr. Fanikos reported no relevant financial conflicts of interest. Dr. Huo reported that he is a consultant for Biomet, DePuy, and Stryker. He also serves on the speakers’ bureau for Cadence Pharmaceuticals and Janssen Pharmaceuticals, Inc. Dr. Viscusi reported that he is a consultant for AcelRx Pharma-ceuticals, Inc., Cubist Pharmaceuticals, Cumberland Pharmaceuticals, Incline Therapeutics, Inc., Pacira Pharmaceuticals, Inc., and Salix Pharmaceuticals. He also serves on the speakers’ bureau for Cadence Pharmaceuticals, and reported receiving honoraria from Merck.

Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Incline Therapeutics, Inc., and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature.

Copyright © 2013, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

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23. Hutchison R, Chon E, Tucker W, Gilder R, Moss J, Daniel P. A comparison of a fentanyl, morphine, and hydromorphone patient-controlled intravenous delivery for acute postoperative analgesia: a multicenter study of opioid-induced adverse reactions. Hosp Pharm. 2006;41(7):659-663.

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27. National Association of Public Hospitals and Health Systems (NAPH). HCAHPS survey: patients’ perspectives of care. October 2008. http://www.naph.org/Main-Menu-Category/Publications/Quality/hcahpsbrief.aspx?FT=.pdf. Accessed January 9, 2012.

28. Consumer Assessment of Healthcare Providers and Systems (CAHPS). CAHPS hospital survey quality assurance guidelines. January 2008. http://www.hcahpsonline.org/files/HCAHPS%20Quality%20Assurance%20guidelines%20version%203.0%20final.pdf. Accessed January 9, 2012.

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33. Data on file. Incline Therapeutics; 2012.

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