The March 2013 Digital Edition of Anesthesiology News by McMahon Group

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Always Available Online @ AnesthesiologyNews.com

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

In Operating Room, A Switch to Prefilled Syringes Pays Off San Juan, Puerto Rico—Incorporating standardized, ready-to-use (RTU) anesthetics in the operating rooms helped one hospital in St. Louis significantly increase proper labeling of medicines and reduce medication waste. Researchers from Barnes-Jewish Hospital say their medication intervention, presented at the Society of Critical Care Medicine Medicine’ss annual annua congress, more than doubled labeling coompliance and nearly eliminated medicattion waste. To better meet a medication safety pparadigm established durin ng a consensus conferencce convened in 2010 by the Anesthesia see prefilled page 30

Near-Miss Data Show Si f

Washington—Although hough nearly nearl 15% of hospital-based anesthesia occurs outside id the h operating room, clinicians have little data on rates of morbidity and mortality in these locations. But the evidence that does exist points to a cause for concern. A new study by California

08 | COMMENTARY When it comes to hospital care, it’s not how you look.

Kevin King

he United States is observing a sesquicentennial remembrance of the Civil War, the bloodiest 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 reasons 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. William Blaisdell identified eight medical advances that of hospitals, sanitation and hygiene, female nurses, and occurred during the Civil War years. These develop- the vast experience with management, surgery and ments involved recordkeeping, management of mass anesthesia gained by numerous physicians. casualties in a timely fashion—the standardization of The source of much of our knowledge about medical the ambulance corps being a critical example—design see Civil War page 46

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researchers shows that near misses in n non– operatin ng room anesthesia (NORA) may be on the rise, rise a significant worry given en that th adverse events in these locations are as associated with a higher severity verity of injury and are more likely to result l in death than those occurring in operating rooms (Curr Opin Anaesthesioll 2006; 19:436-442). “My clinical experience suggested that provision of anesthesia outside the operating room

16 | TECHNOLOGY 2013 on track for more interoperability standards.

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

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

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

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Comment on these and other articles @ AnesthesiologyNews.com.

Heard Here First: No matter the setting, inpatient facility or outpatient, company model March 2013

The five most-viewed articles last month on AnesthesiologyNews.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

deals, and management fee deals, raise

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4. Lidocaine + Propofol = Less Injection Pain 5. Meta-Analysis: IV Analgesic Reduces PONV When Given Early

SEE ARTICLE ON PAGE 10.

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

nesthesia residents fail to reduce their drug expenditures in cardiac surgery cases despite education aimed explicitly at controlling those costs, a new study suggests. The news might not be quite so bad, however. The researchers who conducted 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-conscious as possible,” said David Broussard, MD, system vice chair for anesthesiology at Ochsner Health System in New Orleans, who led the study. Dr. Broussard reported his group’s findings at the American Society of Anesthesiologists 2013 annual Conference on Practice Management (abstract PM03). The New Orleans researchers aren’t the first to find that anesthesiology residents might be budgetarily challenged. In a 2007 study, a group at Stony Brook University, in New York, showed that residents vastly overestimated costs for commonly used medications 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 anesthesia residents about to enter their cardiac rotations were given a 20-minute educational session on the costs of the drugs used in 77 cases performed by residents the previous year. Trainees also 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. That figure rose to $259.30 in 16 comparison 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 is used to lower blood pressure to prevent excessive bleeding and which has no generic equivalent, Dr. Broussard said.

Although the educational intervention 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 attention to the costs of care, and folks in the operating room are much more diligent 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 surgery 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 contractual 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 anesthesiology at the Oakland University William Beaumont School of Medicine, in Oakland, Mich., and a co-author of 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 realize that if you use more expensive medications, recovery is enhanced” in some cases, Dr. Soto said. “If you use a more expensive antinausea medication [for example] but the patient goes home more quickly, that’s better for the hospital. On the front end, the pharmacist is not going to see that. There’s so much focus on cost, but that focus is siloed.” —Adam Marcus

Improve Practice Communication and Mobility 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 feature 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 Fortune 500 companies. It showcases recent financial and operational data for groups, as well as scheduling and announcements—all in one location. Making 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 anesthesiologists 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 indicators 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 benchmark their productivity against other practices? A. Data points to benchmark include productivity levels, charges, reimbursements and units, and anesthesia practices should compare these measurements 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 different areas within the application, which may include corporate documents, practice scoreboard, board meetings or coding regulations, as examples. Personal income, benefits information, CEU tracking, licenses and DEAs can be viewed per a secure login page that is specific to each individual.

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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

he 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 available, 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 efficient triage nurse got my basic information 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.

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I heard the same comments, more or 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. Looking back, I don’t think I made it clear enough that I felt lousy and had taken little by mouth in more than a day. It took a few hours to get admitted to the best room in the house: private, top floor, corner with views of the park. My afternoon nurse and technician introduced themselves, hooked up my catheter to a pump and administered 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.

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I poked at dinner but couldn’t eat, and managed only a few sips of ginger ale. The night shift arrived and told me how the night would progress and, naturally, how great I looked. It occurred to me that hours had passed since I had gone to the bathroom— many more than usual. It took minutes to get out of bed; everything hurt. I passed a few drops of urine and, feeling dizzy and hot, stumbled back to bed. I glanced at the IV bag: only 300 cc had been infused since I was admitted. 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 covering physician and turned to walk out.

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COMME N TA R Y But I begged, “Take my vital saw me the following On Dec. 16, the day of my admis- How long before hospitalized patients signs,” and to humor me, he did. morning. He devoted sion, no less an authority than the will have to bring their own bandages, My blood pressure was 155/87, time and effort to my New York Times gave its imprimatur to medicines and toilet paper? The 21st illness and cured me the way things are and will be: “There century, indeed! my pulse was 95 and my temperature read 101.6 F. “So, you have but where was that is plenty of evidence,” an editorial in I was discharged after two days of high blood pressure?” “No, no,” crew of interns and res- the paper declared, “that well-trained IV antibiotics. As my wheelchair went I tried to explain. “These num- Steven S. Kron, MD idents, the hardwork- health workers can provide routine past the front desk, I caught a reflecing slightly disheveled service that is every bit as good or bet- tion of my sad and aging face. bers are misleading; I’m hyperdynamic.” He quickly received approval physicians in training who used to ter than what patients will receive from —Steven Kron, MD by phone to bolus me one liter over a round on us sick folk looking for just a doctor” (italics mine). The piece few hours, after which I would receive such issues as I had? Gone, baby, gone. went on to glorify the abilities of vari- Dr. Kron, an anesthesiologist in Southington, more as needed. When I asked him, my doc simply said, ous providers, including patients them- Conn., is a frequent contributor to Anesthesiology selves, as superior to those of MDs. News. As the saline trickled in and I unhap- “Welcome to the 21st century.” pily contemplated my options, the light bulb went on. I paged the on-call anesthesiologist and, like the cavalry riding over the hill, he soon appeared carrying two liters of Ringers and a blood pump. He closed the door, Some people just look pulled the curtain and quickly infused the life-givingg fluid. at the surface. As my cerebral perfusion improved, I began to wonder how this issue had been missed and what would have We go right to the core. happened had I not selff diagnosed and been aggressively, although unofficially, 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 customer satisfaction equate to the delivery of excellent medical care? There is evidence out there suggesting that the two do not necessarily correlate but like the No Child Left Behind program in public education, the hospital is teaching to the test. Then, there is nursing time devoted to the electronic medical record—the one we are assured will bring health care to new and unimaginably improved heights. Aggravating the nursing shortage, this represents a further loss of face time with the patient and may result in Introducing the 3M SpotOn Temperature Monitoring System the nurse missing subtle (or not so subFrom the makers of 3M Bair Hugger therapy and the 3M Bair Paws system tle) changes in the patient’s condition. comes an amazingly simple, accurate and non-invasive way to monitor core Lastly, where were the doctors? My body temperature throughout the perioperative process. To learn more about physician returned from vacation and this ingenious technology, visit spotontemperature.com. ™

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3M is a trademark of 3M Company, used under license in Canada. SPOTON, BAIR HUGGER and BAIR PAWS are trademarks of Arizant Healthcare Inc., used under license in Canada. ©2013 Arizant Healthcare Inc. All rights reserved. 603630B 2/13

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C OMM E NT A R Y

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

s readers of Anesthesiology News undoubtedly are aware, for the past four decades, the predominant relationship between anesthesiologists 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 exclusive contract, the relationship between anesthesiologists and hospitals has predominantly been direct, with no middleman.

Enhanced Humbles LapWrap p Positioning Pad

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

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economic relationship between anesthesiologists 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, the model in the ASC context appears to be gaining steam. As if that were not troubling enough for anesthesiologists, what if company model structures jump the barrier between outpatient and inpatient facilities and were to be instituted within hospitals? You don’t need to wonder—it’s already 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 understanding, before discussing the model’s leap to the hospital domain. In its most direct form, the company model involves the formation, by the surgeon-owners of an ASC, of an anesthesia 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 separate accounts or for the account of their anesthesia group. After the formation of the company, anesthesiologists are employed or subcontracted, with a significant share of the anesthesia fee being redirected to the company model’s owners, the surgeons.

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COMME N TA R Y Key Compliance Issues owner’s existing business [such as the The federal anti-kickback statute surgeon’s practice or ASC]. (AKS) prohibits the offer of, demand • The surgeon does not operate the for, payment of, or acceptance of any [anesthesia] business—the [anesremuneration for referrals of Medicare thesiologist] does—and does not or Medicaid patients. There are excepcommit substantial funds or human resources to it. tions, most notably regulatory “safe harbors,” that describe certain arrangements • Absent participation in the joint venture, the [anesthesiologist] would not subject to the AKS because they are be a competitor [of the surgeon’s unlikely to result in fraud or abuse. anesthesia company], providing serBroad OIG Guidance vices, billing and collecting [for the The OIG of the U.S. Department anesthesiologist’s own benefit]. 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 Special Fraud Alert on Joint Venture Arrangements, 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, is not limited to the creation of a legal entity; rather, it covers any arrangement, whether contractual or involving a new legal entity, between parties in a position to refer business and those providing items or services for which Medicare or Medicaid pays. The OIG has made clear that compliance with both the form and the substance of a safe harbor is required in order for it to provide protection. The OIG demands that if one underlying intention is to obtain a benefit for the referral of patients, the safe harbor 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 particularly on point in connection with analyzing company model structures. In it, the OIG focuses on arrangements in which a health care provider in an initial line of business (for example, a surgeon) expands into a related business (such as anesthesiology) 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 problematic structures in general—neither of the alerts are anesthesia- or any other specialty-specific. In the points that follow, I have substituted words such as “surgeon” and “anesthesiologist,” all in brackets, for the broader terms used by the OIG. • The surgeon expands into [an anesthesia business] that is dependent on direct or indirect referrals from, or on other business generated by, the

• The [surgeon] and the [anesthesiologist] share in the economic benefit of the [surgeon’s] new [anesthesia] business. • The aggregate payments to the [surgeon] vary based on the [surgeon’s] referrals to the new [anesthesia] business.

it issued Advisory Opinion 12-06. The anesthesia group requesting the opinion presented two alternative proposed 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 to 2012 Advisory Opinion 12-06 hold the exclusive anesthesia contract The OIG’s first pronouncement at the ASC. The anesthesia company directly on the propriety of the com- would engage the anesthesia group at a pany model came in June 2012, when see company page 12

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C OMM E NT A R Y COMPANY

analysis pursuant to the 2003 Special Advisory Bulletin and found that the negotiated rate as an independent con- physician-owners of the proposed comtractor to provide the actual anesthesia pany model entity would be in almost care and certain related services. The the exact same position as the suspect anesthesia company would retain any joint venture described in the bulletin: that is, in a position to receive indiprofit. In its Opinion 12-06, the OIG rectly what they cannot legally receive stated that there was no safe harbor directly—a share of the anesthesioloavailable in respect of the distributions gists’ fees in return for referrals. that the surgeons would receive from Therefore, the OIG stated that the their anesthesia company. The ASC proposed company model venture safe harbor does not apply to protect could potentially generate prohibited distributions of anesthesia profits. remuneration under the AKS, and the Even if the safe harbor for payment OIG potentially could impose adminto employees applied, or if the safe istrative sanctions on the requestor. harbor for personal services contracts Leaping, Perhaps applied, those safe harbors would proWithout Looking tect payments to the anesthesiologists. Despite the fact that company But they would not apply to the company model profits that would be dis- model deals in the ASC setting are, to tributed to the surgeons, and such say the least, problematic, we are beginremuneration would be prohibited ning to see related models appearing in under the AKS if one purpose of the the hospital context. remuneration is to generate or reward One category of these arrangements is almost exactly analogous to referrals for anesthesia services. Because the failure to qualify for the company model, but with an addia safe harbor does not automatically tional compliance twist. The hosrender an arrangement a violation of pital, generally in the context of a the AKS, the OIG then turned to an renewal of an anesthesiology group’s CONTINUED FROM PAGE 11

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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 to the terms of the carve-out, to use an entity to engage his own anesthesiologists. Sometimes, the existing anesthesia 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 carveout 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 procedures and 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 anesthesiologists are engaged directly or indirectly by Dr. Y. Of course, either of those arrangements, the first more demonstrably so, is the functional equivalent of a company model deal imported to the hospital setting. Note that there is an additional, extremely serious compliance issue presented here: Is the hospital’s award of

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COMME N TA R Y

the carve-out to Dr. X or Dr. Y itself a kickback to induce him or her to continue to refer, as in Dr. X’s case, or to begin 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 violation 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 the Dr. Y example, it’s common for the arrangement between the hospital and the 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 to achieve 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 noncompanyy model, kickback-suspicious model 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 hospital’s related management company as a condition of their exclusive contract. Although the fee in this context is not a duplication of what the facility already is being reimbursed for by payers (which was an issue in Advisory Opinion 12-06), query what the anesthesiologists are really paying for. Conclusion As 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 12-06 denied 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, inpatient facility or outpatient, company model deals, and management fee deals, raise hugely significant compliance concerns: 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.

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Part 2 of a 3-Part Series

Perioperative Patient Monitoring: Case Studies in Cardiac Surgery Introduction

Clinicians increasingly are employing cutaneous determination of rSO2 using realtime cerebral oximetry as a tool for reducing risk for perfusion-related complications. Technologies, such as the INVOS™ Cerebral/ Somatic Oximeter, complement ultrasonography and hemodynamic monitoring by providing data that reflect the balance between oxygen delivery and consumption within the cerebral microcirculation. Because cerebral 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

rSO2 values, but they declined again during rewarming. Hemodynamic, respiratory, hematologic, and anesthetic parameters 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 hemodynamic perfusion. Cardiac function is evaluated using transesophageal 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 ventricular function. If decreased rSO2 occurs during CPB, increasing pump flow and/or systemic vascular resistance generally resolves the reduction in rSO2 values.

Christopher A. Troianos, MD Professor and Chair of Anesthesiology The Western Pennsylvania and Forbes Regional Hospitals West Penn Allegheny Health System Pittsburgh, Pennsylvania

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). Anesthetic 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 than the right hemisphere, a trend that persisted throughout most of the surgery. The values from both cere90 Baselines: Right = 68 bral hemispheres increased after Left = 67 BLUE is LEFT Cerebral induction of anesthesia and with 80 1.0 fraction of inspired oxygen. The rSO2 values decreased markedly 70 after the institution of cardiopul60 monary bypass (CPB), which was presumably related to anemia from Interventional Threshold = 54 50 hemodilution (hematocrit 25% and Critical Threshold = 50 partial carbon dioxide alveolar pres1001: Oﬀ CPB 40 On Circ Arrest sure [PaCO2] 32.6 mm Hg). Physiologic parameters were adjusted 30 1014: On CPB, whenever possible to increase rSO2 Oﬀ Circ Arrest 0740: Induction of 20 above the interventional threshgeneral anesthesia 1022: Rewarm to 0854: On CPB, cool to old: The CPB sweep was adjusted 25 degrees centigrade 16 degrees centigrade 10 to raise PaCO2 toward a maintenance level greater than 40 mm 0 Hg. The patient then was cooled to 16°C in anticipation of deep hypothermic circulatory arrest (DHCA). These adjustments increased rSO2 Figure. Clinical values for case patient 1: above the interventional threshold. Arch repair of aortic aneurysm/aortic valve replacement. The rSO2 values decreased bilaterally during DHCA, with rSO2 on CPB, cardiopulmonary bypass; Hct, hematocrit; pCO2, carbon dioxide partial pressure; the left side breaching the interrSO2, regional cerebral oxygen saturation Courtesy of Christopher A. Troianos, MD. ventional threshold. Reinstitution of circulation with CPB restored

Real-time rSO2 monitoring provides critical information that guides clinicians to make adjustments of intraoperative parameters beyond traditional vital signs (heart rate, blood pressure [BP], central venous pressure, and pulse oximetry). Clinical judgment

ANESTHESIOLOGY NEWS • MARCH 2013

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

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Regional Oxygen Saturation Assessment Using Cerebral Oximetry

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

rSO2

Although complications are a significant risk factor following any surgical procedure, there are particular neurologic complications often related to cardiac surgery, 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, congestive heart failure, or a history of myocardial infarction.2 Patients at risk for embolic events may be screened using ultrasonography to determine the presence of aortic plaque near the sites for cannulation, crossclamping, and saphenous vein grafting to avoid embolization. However, the etiology of serious neurologic complications also may be related to a second factor: hypoperfusion occurring within the perioperative period.2 This factor is of particular concern during cardiopulmonary bypass (CPB) when there is non-pulsatile blood flow and typically lower mean arterial blood pressure. Neurologic complications are more common 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 including 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 procedure is performed “on-pump” or “off-pump.” Low preoperative regional cerebral oxygen saturation (rSO2) values also may be related to adverse outcomes.5-7

support, and hematologic transfusion. Oxygen saturation is helpful particularly during surgeries that employ CPB, which dissociates the autonomic nervous system and traditional vital signs (eg, low BP and tachycardia as an indicator of potential hypoperfusion/

Supported by

hypo-oxygenation, and hypertension and tachycardia as an indicator of inadequate sedation/analgesia). Murkin et al evaluated 200 patients undergoing 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 intervention group in which cerebral oximetry was used actively to drive a management protocol 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 intervention group (n=3) experienced significantly reduced rates of prolonged ventilation (>48 hours), sternal infection, renal failure, reoperation, and death compared with the control 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 compared 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 Anesthesia And 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 spectroscopy cannot replace a more specific indicator 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 appropriate surgical anesthetic depth, and corresponds to decreased cerebral metabolic rate and a low probability of consciousness.9 Kertai et al investigated the association between clinical variables, anesthetics, cumulative duration of low BIS values, and intermediate-term mortality in 460 patients who underwent emergency cardiac surgery, coronary artery bypass, or surgery of the thoracic aorta. The cumulative duration of a low BIS value (<45) was independently

Case Study 2: 86-Year-Old Man With Stanford Type A Aortic Dissection Michael E. Goldberg, MD Professor and Chair, Department of Anesthesiology Associate Dean for Academic Affairs Cooper Medical School of Rowan University Chief, Department of Anesthesiology, Cooper University Hospital Camden, New Jersey

Muhammad Muntazar, MD Associate Professor of Anesthesiology Cooper Medical School of Rowan University Head, Division of Cardiothoracic Anesthesia Cooper University Hospital Camden, New Jersey

he patient was transferred from a local hospital where he presented with chest pain. His American Society of Anesthesiologists 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. After being transferred to the operating room, a bilateral radial arterial catheter, 3.9-mm introducer, and pulmonary artery catheter were placed under sedation. In addition to the standard monitors, sensors for the BIS Brain Function Monitoring System and the INVOS Cerebral Oximeter were placed before induction, and baseline readings were recorded. After an uneventful induction 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 initiated per protocol with administration of a standard pharmaceutical

associated with intermediate-term mortality, 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 during 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 surgery has led to investigations using BIS in other postoperative settings (eg, postanesthesia care unit, ICU) when patients require ongoing mechanical ventilation and sedation. Solanki et al reported that a closedloop anesthesia delivery system using BIS to direct propofol infusion after open heart surgery resulted in patients spending a greater proportion of time within the sedation target range compared with manual adjustments of propofol infusions.12

Conclusion These case studies highlight various factors that affect regional cerebral oxygenation and anesthesia depth and alert the

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 innominate 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 minutes, 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. Hemostasis 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 maintain 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 cerebral 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 anesthesiologist, 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.

clinician to avert potential misalignment between cerebral oxygen delivery and consumption. The INVOS Cerebral/Somatic Oximeter and BIS Brain Function Monitoring System can guide appropriate use of hemodynamic- and anesthetic-based interventions 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.

5. Fischer GW, Lin HM, Krol M, et al. Noninvasive cerebral oxygenation may predict outcome in patients undergoing 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 surgery: 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.

References

9. Bowdle TA. Depth of anesthesia monitoring. Anesthesiol Clin. 2006;24(4):793-822.

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.

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 cardiac surgery in the B-Unaware Trial. Anesthesiology. 2010;112(5):1116-1127.

3. Yao FS, Tseng CC, Ho CY, Levin SK, Illner P. Cerebral oxygen desaturation is associated with early postoperative neuropsychological dysfunction in patients undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2004;18(5):552-558.

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.

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.

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

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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.

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

hen Mindray engineers designed the “A series” of all-in-one anesthesia systems, they included the latest open standards for devices to communicate with each other including HL7, IEEE and 11073. In an era of proprietary interfaces

that can prevent medical devices in hospitals from interacting, Mindray, based in China, figured that giving its new systems tested and known interoperability standards might be trailblazing or at least act as a conversation starter 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 interoperability standards,” said Ken Fuchs, senior principal architect of enterprise systems for Mindray North America, in Mahwah, 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-sourcedd interoperability standards to 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 Association for the Advancement of Medical Instrumentation (AAMI), a trade organization, and safety standards specialists Underwriters Laboratories (UL). “There are many existing interoperability standards and implementation profiles, but these often do not offer the clarity or specificity needed to enable complete interoperability and uniformity of medical device systems,” 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. Logan added. When discussing the device with anesthesiologists, most tell Mr. Fuchs they do not care about the standards, much like Internet surfers do not fret about Wi-Fi consortia. “That’s interesting,” Mr. Fuchs recalled 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, clinicians who may not be vocal about having their equipment interact, companies that want to protect their technologies, a lack of procurement incentives and federal regulations that may inadvertently slow developers. Hospitals likely will find the money from waste in redundant administrative

MARCH 2013

‘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.’

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TE CH N OL OG Y interoperability standards for mobile and home care technologies. “You’ve got to find a safe environment for companies to come together and talk about how you are going to standardize particular sets of equipment,” said Chuck Parker, the group’s executive director. Mr. Parker said the development of a low-powered radio transmitter illustrates one simple case of the market driving standardization. Wi-Fi and Bluetooth are fairly

batteryy intensive, so in the late 2000s, the industry started looking at lowpoweredd radios to save battery life. The device had to last for a year on a “coin cell” small battery. It needed to transmit data within a certain range, collect 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 anesthesiologyy specific activities,” Mr. Parkerr said. In August, Denmark made a procurement decision that in 2013, all future deployments of technology that will be using mobile or home-basedd technology see interoperability page 18

— Julian Goldman, MD, PhD roles and procedures, said Venkat Rajan, a medical device analyst at Frost & Sullivan, a market research firm. “If you can reduce administrative waste, reduce the number of errors, automate certain functions, that could free up some dollars that could be used toward investing in a lot of these technologies,” he said. Mr. Rajan said the central question for hospital groups, device manufacturers, 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 collaboration between a hospital and a device manufacturer to implement a pilot program,” Mr. Rajan said. “Once these companies realize that there is an opportunity, a business model, and dollars 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 sometimes called plug-and-playy capabilities,” said Elliot B. Sloane, director of health systems engineering at Drexel University in Philadelphia and founder of the Center for Healthcare Information Research and Policy. “In the ideal world, yes, we could connect everything to everything like a USB, but the USB environment is quite simple and it generally doesn’t have life-and-death consequences.” Several models for interoperability exist: They include integrated clinical environments (plug-and-play), machine-to-machine communication, alarm communication, technology management to monitor scheduled maintenance and electronic medical record communications. The medical device community could learn from the Continua Alliance, an industryy led group that guides

Less pain. Less opioids. From the start. OFIRMEV® provides significant pain relief*1 • OFIRMEV 1 g (Q6h) + patient-controlled analgesia (PCA) morphine demonstrated significant pain relief vs placebo + PCA morphine (P<0.05 over 6 h)1 • OFIRMEV 1 g (Q6h) + PCA morphine showed greater reduction in pain intensity over 24 h (SPID24)† compared to placebo + PCA morphine (P<0.001)2

OFIRMEV reduces opioid consumption*1 • OFIRMEV 1 g (Q6h) + PCA morphine significantly reduced morphine consumption vs placebo + PCA morphine (–46% over 6 h, P<0.01; –33% over 24 h, P<0.01)1 • The clinical benefit of reduced opioid consumption was not demonstrated

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Indiccation OFIRMEV is indicated for the management of mild to moderate pain; the management of moderate to severe pain with adjunctive opioid analgesics; and the reduction of fever. Important Safety Information OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment. Do not exceed the maximum recommended daily dose of acetaminophen. Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death.

Discontinue OFIRMEV immediately if symptoms associated with allergy or o hypersensitivity occur. Do not use in patients with acetaminophen allergy. The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. OFIRMEV is approved for use in patients ≥2 years of age. The antipyretic effects of OFIRMEV may mask fever in patients treated for postsurgical pain. To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals, Inc. at 1-877-647-2239 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com. Please see Brief Summary of Prescribing Information on adjacent page or full Prescribing Information at OFIRMEV.com.

OFIRMEV should be administered only as a 15-minute intravenous infusion. *Randomized, double-blind, placebo-controlled, single- and repeated-dose 24-h study (n=101). Patients received OFIRMEV 1 g + PCA morphine or placebo + PCA morphine the morning following total hip or knee replacement surgery. Primary endpoint: pain relief measured on a 5-point verbal scale over 6 h. Morphine rescue was administered as needed. †SPID24=sum of pain intensity differences, based on VAS score, from baseline, at 0 to 24 h.

References: 1. Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. y 2005;102:822-831. 2. Data on file. Cadence Pharmaceuticals, Inc.

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18 I AnesthesiologyNews.com

MARCH 2013

T E C H NO L O G Y INTEROPERABILITY

CONTINUED FROM PAGE 17

will use a Continua framework. The question remains: “If you plug and play one device into another manufactured 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 information 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 interoperability 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 opensource language for hospital procurement contracts. The idea, championed by Julian Goldman, MD, PhD, founding director and principal investigator for the Medical 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 Permanente. In fall 2012, the Veterans Affairs

system, which holds substantial purchasing power, announced it would adopt the procurement guidelines. MD FIRE was meant “to send a clear unambiguous message to the medical device industry that there is a market, that we care, that we need and want our medical devices to be interoperable,” said Dr. Goldman, a member of the editorial board of Anesthesiology News. “We are looking at improving patient safety directly from having medical devices communicating to build smarter, to build more intelligent networking.” For example, a corporate information technology worker can monitor remotely all the desktops and laptops and determine viruses or software updates, which is nearly impossible with today’s medical equipment. “We can have ventilators and blood pressure monitors and pulsometers and infusion pumps, a whole array of medical devices; 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,” Dr. Goldman said. “So we can’t do the things that are taken for granted today in computer equipment. Most medical devices don’t have automatic clock-settingg capabilities and biomed departments have to go around and manually set the clocks right twice a year.” Even when interoperability standards have been accepted, “certification has been sorely lacking for medical device interoperability,” Dr. Goldman added. Dr. Goldman urged clinicians to make their interoperability needs known in abstracts, blogs and through social media. They don’t have to tell their favorite manufacturer; they just have to get the word out. “The more clinicians and hospitals who say that this is important to them and that they want to buy products that are interoperable, the more we’ll see the marketplace provide,” he said. But Mr. Fuchs said he hasn’t seen much effect from MD FIRE. On the procurement side, he said, vendors want a yes or no answer about device interoperability, but few details about the standards. “For us, at this stage of the game, supporting this standard didn’t buy us any brownie points with any of the [electronic medical record] or middleware vendors because they still had to build their interface to our product as if it is the interface with something proprietary,” Mr. Fuchs said. —Trevor Stokes

MARCH 2013

AnesthesiologyNews.com I 19

TE CH N OL OG Y

Intubation Training Phone App Bests Lecture Toronto—Free software for the Apple iPhone that simulates fiberoptic bronchoscopy can flatten the intubation learning curve for anesthesia trainees, according to its developers. A small, randomized study they conducted showed that a halff hour of using the mobile simulator led to faster and more accurate first-time mannequin-based intubations compared with sitting through a lecture. Carin Hagberg, MD, executive director of the Society for Airway Management, said the app is “probably the easiest program that I’ve worked with for learning basic intubation skills. I’ve already put a link to it up on our blackboard for residents to be able to play with,” added Dr. Hagberg, chair of anesthesiology at the University of Texas Health Science Center, in Houston. Raymond Glassenberg, MD, associate professor of anesthesiology at Northwestern University’s Feinberg School of Medicine, in Chicago, and several colleagues set out to create a low-cost alternative to existing intubation simulators. In the spirit of frugality, the researcher enlisted his son, a software engineer, in the effort. The free application, called iLarynx, is available for iPhones and iPads, and allows users to manipulate a virtual bronchoscope through a simulated airway. Users can rotate the handheld device and perform an intubation on a patient either awake or paralyzed. One scenario also includes a paralyzed patient with an airway tumor. Dr. Glassenberg randomized 10 medical students to attend a 30-minute lecture on airway anatomy with static images displayed during the lecture, and an equal number of trainees used the iLarynx for 30 minutes. Participants in both groups then performed 10 mannequin-based bronchoscopic intubations and were evaluated by 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 successful, 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 significantly less time to perform intubations, with a median time of 35 seconds for first attempts (range, 24-62

seconds), compared with 120 seconds for first attempts by lecture attendees (range, 94-120 seconds; P<0.005). Median intubation times for the 10th attempt were eight seconds in the iLarynx group and 13 seconds in the lecture group (P<0.005). “Unlike a virtual reality system with handheld bronchoscopes, the application can be practiced anywhere,”

Dr. Glassenbergg said. The app has been downloaded 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 useful in helping trainees develop handeye coordination, it has its limitations,

Dr. Hagbergg noted. “You can only do an 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 graphics and different scenarios.” —David Wild

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20 I AnesthesiologyNews.com

MARCH 2013

T E C H NO L O G Y

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

o 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 little thought beyond their intended use. Yet as a study by French researchers

has uncovered, more than half of such items are contaminated with microorganisms, highlighting the risk for crosscontamination in even the most sterile settings. “We started by checking the contamination of reusable laryngoscope handles,” said Pierre Diemunsch, MD,

PhD, professor and chair of anesthesia at Hôpitaux de Hautepierre in Strasbourg. “To our surprise, we found significant contamination despite our institutional 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 we found it important to control them.” For the study, a trained practitioner randomly took 96 sets of swab samples from EKG cables, and 46 samples from pulse oximeters in 15 ORs. Two swabs were taken after decontamination and immediately before being used on the next 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 International Anesthesia Research Society (abstract S-221), more than half the samples tested positive for the presence of microorganisms, although no resistant pathogens were identified (Table).

Dr. Diemunsch said the significant cross-contamination risk revealed by the study suggests a potential need for improved decontamination protocols, including regular audits of the process. “It’s a key point that clinicians believe that the institutional protocols for material cleaning are sufficient,” he said. “I share this opinion, but the human factor makes it such that the application of these protocols is less than perfect.” He pointed to a similar study (Anesth Analgg 2009;109:479-483) from New York that found that contamination rates fell once OR personnel knew they were being observed. Contamination rates in the New York analysis were nearly identical to those in the French study. “So the problem really exists and is recognizable on both sides of the Atlantic, if looked for,” Dr. Diemunsch

MARCH 2013

AnesthesiologyNews.com I 21

TE CH N OL OG Y 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

Enterococcus faecalis

Aspergillus fumigatus

Staphylococcus aureus + Enterococcus faecalis

Corynebacterium

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 you can spend a lot of time and money trying to correct something that may not actually result in any infections.” —Michael Vlessides

added. In late 2011, Britain’s Medicines and Healthcare Products Regulatory Agency issued a medical device alert for reusable laryngoscope handles after a patient developed a fatal septicemia. More Single-Use Devices Needed Incorporating more single-use equipment into the OR, particularly in infectious and immunocompromised patients, might help, he said. “This is the case in many institutions for SpO2 probes but not yet for the cuffs, neither 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 particularly at risk for crosscontamination. Of course, the cost issue is to be taken into account in selecting the proper patient.” David S. Beebe, MD, professor of anesthesiology at the University of Minnesota in Minneapolis-St. Paul, said the study confirms what other trials have found: Significant contamination exists in the OR from reusable anesthesia equipment. “I’m not sure what to do about it other than have personnel properly clean their hands and use gloves to avoid spreading organisms, clean the anesthesia equipment per a standard protocol to reduce contamination and use reusable equipment whenever possible,” Dr. Beebe told Anesthesiology News. “Unfortunately, we will probably be contributing to the solid waste disposal problem, but if it helps prevent hospital-acquired infections, so be it.” Peter Breen, MD, associate professor of anesthesia and perioperative care at the University of California, Irvine, offered a different perspective. “Certainly the trend in anesthesia is more and more toward single-use items, and

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22 I AnesthesiologyNews.com

MARCH 2013

C LIN I C A L A N ES THES IO LO G Y

Too Few Awake Intubations Risk Patient Harm, Loss of Physician Skill Toronto—Clinicians are not conducting enough preinduction awake intubations, risking erosion of their competence and potential harm to their patients, experts warned at the 2012 annual meeting of the Society for Airway 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 attendees that preinduction intubations are potentially safer than postinduction

intubations because they provide clinicians the opportunity to “concentrate 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 intubation process,” he said. Hazardous Shortcuts Dr. Law pointed to results from the United Kingdom’s NAP (National Audit Project)-4 study as evidence 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 postinduction intubation although preinduction 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 perform postinduction intubations, but Dr. Law w said a patient’s concern about his 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 empathy,” Dr. Law w urged.

MARCH 2013

AnesthesiologyNews.com I 23

CL IN ICA L A N E STH E SIOL OG Y

Fading Skills Performing 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 w said. “It’s difficult to know how many awake intubations it takes to maintain competence once attained but, at least in my practice, for just this reason I’m always looking for reasons to do, and not to avoid, d awake intubations,” he said. Timothy Turkstra, MD, associate professor of anesthesiology and perioperative medicine at the Schulich School of Medicine and Dentistry at Western

University in London, Ontario, Canada, 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 practice opportunities through teaching seminars and during routine operating room procedures, when possible.

“We need to be vigilant in preserving our skills, especially airway management skills, but we may not see opportunities to do so unless we are actively looking for them,” Dr. Turkstra said. “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 conflicts of interest.

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Not Just for Difficult Airways Preinduction intubation often is clearly indicated for patients with advanced airway obstruction, but Dr. Law w said other patient characteristics should be considered to inform the decision to intubate patients when they are awake. For example, limited jaw protrusion and limited head and neck extension may place patients at risk for difficult face-maskk ventilation (FMV), he noted. “Few would argue against the advisability of awake intubation if both endotracheal intubation and FMV are predicted to be difficult,” Dr. Law w said. Similarly, patients assumed to be “easy to bag” can have a full stomach or an illness that places them at risk for precipitous oxygen desaturation with apnea onset. Both factors make preinduction intubation a potentially safer option, the expert noted.

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24 I AnesthesiologyNews.com

MARCH 2013

P OLI C Y & M A NAGEMENT

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

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

ow 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 assessment; who should lead the overall preoperative process—anesthesiologists or internists; and what is the best way to manage patient risks—through remote assessment or on-site evaluation. Departments nationwide have developed several promising models that answer these questions in different ways. Recently, the Anesthesiology Department at the University of Nebraska Medical Center, in Omaha, implemented a preoperative assessment model that combines the strengths of several

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)

$360

$129,600

$216,000

$720

$259,200

$432,000

$1,080

$388,800

$638,000

$1,440

$518,400

$846,000

$1,800

$648,000

$1,080,000

$2,160

$777,600

$1,296,000

$2,520

$907,200

$1,512,000

$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 surgical unit with an annual volume of 12,000 cases, average contribution margin of $6,000 per case and a cancellation rate of 3% (360 cases). If each cancellation results in only 24 minutes of delay, the OR wastes $259,200 per year in direct variable costs (360 cases x $720 per delay). Cancelled OR time that cannot be rescheduled represents an additional opportunity cost. If each cancellation results in 60 minutes of unutilized OR time, annual indirect costs equal $1,080,000 (360 cases x $6,000 contribution margin x 50% of averag average ge case time).)

different approaches. This “hybrid” model leverages the expertise of anesthesiologists, hospitalists, physician assistants and nurses within a protocol-driven system that uses both remote screening techniques and on-site medical evaluation. By successfully implementing this model, University of Nebraska anesthesiologists demonstrated their value by significantly reducing case cancellations and delays. In doing so, the anesthesiologists positively transformed their relationship with surgeons and hospital administration. A Disorganized System The 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-benchmark case cancellations. In 2010, approximately 50% of first cases were delayed, and 2.6% of cases were canceled within 24 hours of surgery. The main cause of these inefficiencies was disorganization in presurgical processes. Patients entered the system through Presurgical Screening (PSS), a nursing unit that performed a simple screening assessment by phone. The assessment call took place one to two days before surgery, and it also included the capture of patient demographics and financial information. Separately, physician assistants and residents performed clinical assessments in the Anesthesia PreOp Evaluation Unit (APEU). Staff worked without faculty supervision or consistent guidance on testing requirements. Each unit acted independently, with considerable redundancy of tasks. Poor organization led to poor outcomes. A significant 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 anesthesiologist 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 and ASA 4 patients underwent a preoperative assessment. The majority of patients received their first full clinical review on the morning of surgery.

Canceled and delayed cases involved significant direct and indirect costs for NMC (Table 1). In addition, the process was expensive. In fact, total costs per patient in the PSS and APEU exceeded preoperative costs at hospitals that provide full evaluation by physicians. The situation created tension within the organization, 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 the board of directors. Anesthesiologists, aware of the gravity of the problem, saw their opportunity to take the lead in seeking a solution. Building a New Process In March 2011, NMC anesthesiologists joined with colleagues in surgery, nursing and administration 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 expensive. 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 combines a 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 script used 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-site evaluation; patients with diabetes on oral medications 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 standardized matrix for presurgical testing based on current recommendations. Previously, the hospital’s testing guidelines were largely age-based. For example, 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 members agreed to accept each other’s judgment within

MARCH 2013

AnesthesiologyNews.com I 25

POL ICY & M A N A G E ME N T Table 2. Recommended Labs and Tests Based on Patient Medical History Clinical Diagnosis

CBC w/o diff

PT/INR/ PTT

POC Glucose

BMP

CMP

TSH, Free T4

ECG

CXRa

Anemia

Bleeding Hx

Cardiovascular disease

Cerebrovascular disease

Diabetes

Diuretics Hepatic disease

X X

Acute pulmonary disease/severe COPD

Renal disease

Rheumatoid arthritis

Sleep apnea

X X

X Xb X

Suspected UTI

X X

Thyroid disease TPN dependence

X 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, thyroidstimulating hormone; UA, uric acid; UTI, urinary tract infection a

included in the Diagnosis-Related Group payment. Politically, the reform of the preoperative evaluation system has transformed the relationship between the anesthesiology department, their clinical colleagues 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. Hospital leaders are proud of the PAS Clinic, and they see their relationship with anesthesia as the model of a collaborative partnership.

Peripheral vascular disease

Systemic lupus

Keys to Success The 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 protocoldriven approach. NMC leaders believe the PAS Clinic could ultimately serve as a platform for a “surgical home” model focused on careful tracking of patient information, vigilant management of patient risk factors and full coordination of services. NMC’s hybrid model for preoperative evaluation demonstrates how to leverage resources efficiently to improve performance and outcomes in the operating room.

Obtain CXRs for acute processes only. b Cervical spine only.

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

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 Nebraska Medical Center helps p ensure the optima optimal p al preoperative p p evaluation evaaluation and management manaaggement of surgical surgica g al patients. p

the new process. The protocols were then approved by other department chairs. Finally, the task force disseminated the new tools to surgeons, including their office managers, nurse coordinators and schedulers. While the new protocols were being developed, the preoperative task force also was working to consolidate all processes and staff in a new PreAnesthesia Screening (PAS) Clinic. This relocated and expanded clinic provides comprehensive presurgical 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 consistency 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 replacement patients, but the program could expand to other patient groups with complex medical issues. Nurses in the PAS Clinic perform phone screens using the new triage tool. Insurance and demographic verification have been reassigned to registration staff, so triage nurses now are able to focus on clinical assessment. All PAS nurses are cross-trained for roles in the presurgical holding area. This training provides flexibility and gives PAS staff a better understanding of the entire preoperative choreography, which encourages more complete charting and better patient hand-offs. The new process is also more convenient for patients. Patients can meet with an anesthesiologist, 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 appointment on the same day they see their surgeon, saving more travel time and costs. Several PAS schedule slots are held open every day to accommodate walkk in patients and last-minute requests from surgeons. Strong Outcomes The 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 succeeded in screening more than 90% of surgical patients by phone, with approximately 70% screened and managed exclusively through the phone process. Approximately 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-riskk patients. Patients at NMC now are better prepared for surgery. The problem of pending lab results and incomplete charts on the day of surgery has been significantly 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 24 hours 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 consolidation 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

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.surgicaldirections.com), a surgical services consulting firm. Mr. Peters is president of Surgical Directions.

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

osing of tranexamic acid based on the leading trial of the drug results in blood levels of the agent that are higher than the recommended therapeutic amount for 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-dose tranexamic acid is considered a likely cause of postoperative seizures. Although many cardiac anesthesiologists have embraced the dosing regimen for tranexamic acid from BART (Blood Conservation Using Antifibrinolytics

in a Randomized Trial (N Engl J Med 2008;358:2319-2931), the pharmacokinetics of the drug during the perioperative period have not been studied 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 anesthesiology at the University of Toronto, Ontario, Canada. “But the model has really never been tested in a clinical situation, 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-perhour infusion until chest closure with a 2 mg/kg load. Blood samples were taken at a variety of time points throughout the procedure: baseline, five minutes after the bolus, 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 levels using a pharmacokinetic model ( (Anesthesiology 2002;97:390-399). Infusion of the BART dose of tranexamic acid resulted in plasma concentrations higher than the suggested therapeutic levels of 100 mcg/ mL at all time points during the intraoperative period (Figure). The secondary objectives of the trial were to determine if tranexamic acid concentrations were within the suggested target range to allow optimal inhibition of tissue plasminogen activator (tPA), and to evaluate elimination kinetics of tranexamic acid in the postoperative period following discontinuation 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, allowing 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 finetune their practice when it comes to tranexamic acid dosing. “Despite numerous articles regarding how

MARCH 2013

AnesthesiologyNews.com I 27

PR N Plasma concentration of TXA measured with SPME

Plasma Concentration of Tranexamic Acid (mcg/mL)

180

TXA concentration simulated literature

160 140 120 100 80 60 40

Pre-CPB

20 0

CPB 2

Up to two hours postoperatively

Post-CPB 5

Time Points of Tranexamic Acid Collection

good pharmacokinetics studies, there are not many good pharmacodynamic studies that have correlated drug levels with outcomes. We have to find out specifically what the drug levels mean compared 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

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

much tranexamic acid to give, we still lack consensus on the optimal dosing regime,” she said in an interview with Anesthesiology News. “This is the first study really assessing plasma concentrations 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 we are 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 finetuningg the pharmacokinetic model and measuring plasma concentration in patients with renal dysfunction,” 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 renal dysfunction, and if concentrations are elevated, do some dose-adjustment work to bring concentrations down to normal 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 knows the right dosing of tranexamic acid, and there’s tremendous variability in dosing among different institutions,” Dr. Levyy said. “So I think this is interesting in that it helps answer the question of what’s the right dosing for tranexamic acid, which I’m not sure anybody really knows for a fact. “The other problem,” Dr. Levyy continued, “is that although there are several

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Sutures Beat Tape for TEA Catheters, Cut Infection Risk

atients at Heinrich-HeineUniversity Medical Center, in Dusseldorf, Germany, used to have their thoracic epidural analgesia catheters held in place with adhesive tape, a standard procedure. But, when Peter Kienbaum, MD, arrived at the medical school as deputy director of anesthesiology, he saw peridural anesthesia 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 and suture the catheter,” Dr. Kienbaum said of his former hospital. “At this hospital, they only used adhesive tape to fix the catheter.” Other doctors at Heinrich-HeineUniversity 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: Conduct a small study of 120 randomized patients and let the data determine which technique was better.

What Dr. Kienbaum found was surprising: The sutured catheters held by a single stitch knotted 15 to 20 times were less prone to microbial contamination 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 catheters, 13.6% (eight of 59 patients) compared with 24.5% in taped catheters (13 of 53 patients). “When taping, the catheter probably went in and out all the time and that probably attracts contamination,” Dr. Kienbaum said. “Tunneling and suturing takes two or three extra minutes 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 fashion that the majority of anesthesiologists would not be able to use,” Salim Hayek, MD, division chief of pain medicine and UH Case Medical Center, in Fixation by tunneling and suturing. Cleveland, told Anesthesiology News Courtesy of Peter Kienbaum, MD. after reviewing images of the technique.

But Dr. Kienbaum disagreed. “Dusseldorf tunneling and suturing is superior. 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 those who may have a catheter in the 10 to 15-hour range. “We don’t have problems with losing catheters in these patients,” he said. As for the observed reduced bacterial infections, Dr. Kienbaum said that a catheter with more mobility might allow more exposed portions to enter the skin and introduce microbes. “On the other hand, 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 settings under different training. “We’d need to study tens of thousands of patients with these techniques,” Dr. Kienbaum said, because of the rarity see sutures page 31

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PR N

Thoracic Epidurals May Avoid Many Post-op Complications

atients who receive thoracic epidurals 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 published between 1971 and 2011, including more than 6,500 patients, showed that those who received thoracic epidural anesthesia (TEA) were less likely to experience arrhythmias, collapsed lungs, pneumonia or intestinal blockages (Table). TEAs also were associated with a lower risk for sedation, dizziness and respiratory depression, according to the researchers, who reported their findings 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 professor of anesthesiology at Columbia University College of Physicians and Surgeons, in New York City, who was not involved in the new analysis. Adding TEA may decrease pulmonary morbidity after surgery, he said, and the propensity of TEAs to decrease sympathetic tone while increasing parasympathetic 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 during 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 Pöpping, MD, an anesthesiologist at Münster University Hospital, who helped conduct the new meta-analysis. “There is some debate in anesthesia for several years 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% confidence interval [CI], 2.94-7.83). And although TEAs appeared to be associated with a lower risk for death within two years postsurgery, the results were not statistically significant (OR, 0.74; 95% CI, 0.53-1.03). Part of the problem, noted Dr. Pöpping, was that the mortality rates were quite low in the studies—0.015% with TEA and 0.025%

without. The German group continues to analyze data, and hopes to include more studies that can provide additional clues about the effects of TEAs on mortality. In the meantime, both Drs. Pöpping and 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. The injections are known to cause hematomas or abscesses in some patients. “If you use this in the clinic, you have to be aware of these complications, and know how to diagnose and manage these complications,” he said. “You must supervise these patients after surgery.” —Alison McCook

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0.20-0.98

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Table. Cost of Medication Wastea Pre-Outsourcing

PREFILLED

Post-Outsourcing

Medication

Usage

Costb

Usage

Costb

Mg Reduction

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%

CONTINUED FROM PAGE 1

Patient Safety Foundation (APSF), hospital researchers conducted a medication safety study in three pharmacy satellites and in 78 areas of care where anesthetic agents were used. The primary focus of the study was to look at labeling compliance, medication preparation details and waste data during the first surgical cases of the day, with an eye toward resolving any significant safety gaps found, explained

Waste is defined as withdrawal of medication from the manufacturer’s packaging or removal of tamper-evident seal but not documented as administered during the surgical case. b

$$1.00 00 added to tthee hospital ospp ta cost of o the t e vial a to account acccou t for o cost of o preparation, p epa p at o , labor abo and a d supplies. supp pp es

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Rachel Stratman, PharmD, the lead study author and a clinical pharmacist for perioperative services at BarnesJewish Hospital. After collecting initial data for 100 cases, Dr. Stratman and her colleagues found several problems that could have led to patient harm. For example, anesthesia providers often would prescribe, prepare and administer medications with no double-check, and providers usually would include only partial information on the blank portions of syringe labels, such as the drug name, but not necessarily other important details, such as drug concentration or expiration date. Moreover, anesthesiologists often would prepare medicines such as atropine for emergent situations; however, if the drugs were not administered during the case, they were discarded or inappropriately kept beyond their expiration for use on subsequent cases. Based on those findings, Dr. Stratman’s team developed several improvements to how anesthesia medications were handled. One step, she noted, was to standardize anesthesia medication trays across 64 ORs and 14 remote areas. The trays incorporated RTU syringes of medications commonly used for anesthesia induction, reversal and emergencies. The quality improvement team also standardized vasoactive drip concentrations and diluents across the institution, and increased production of compounded sterile products that were dispensed to anesthesiologists upon request. The pharmacy purchased eight commonly used medications in premixed RTU syringes from a compounding pharmacy, including lidocaine, succinylcholine and neostigmine. The department also increased the production of vasoactive drips such as epinephrine and dobutamine, and provided bolus doses of medications such as insulin, epinephrine and norepinephrine. The RTU prefilled 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, the team observed the medication management practices of 100 additional cases. They found that the rate at which clinicians included the medication concentration on the label increased significantly, from 31% before the intervention to nearly 78% after (P<0.001). Provider-prepared intravenous admixtures were reduced from 91% to nearly 3% (P<0.001). Using RTU medications also significantly reduced medication waste, Dr. Stratman said. The largest

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AnesthesiologyNews.com I 31

PR N reductions noted were for emergency medications such as atropine and phenylephrine (96% reduction) and succinylcholine (nearly 95% reduction). Dr. Stratman said the intervention likely has been “cost neutral” to the hospital, with the costs of outsourcing medications offset by the savings in otherwise wasted drugs (Table, facing 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 anesthesiology perspective and the pharmacy perspective.” Outsourcing RTU medications is a trend, Dr. Stratman said, although “the financial impact associated with outsourcing costs can cause institutions to hold off on making the transition. In our hospital, it has been instrumental in improving the management of medications in the anesthesia environment.” Do-It-Yourself Drug Prep Discouraged Tricia Meyer, PharmD, FASHP, director of pharmacy at Scott & White Healthcare, in Temple, Texas, and assistant professor of anesthesiology at Texas A&M University College of Medicine, in College Station, participated in the APSF Medication Safety Conference. She said the APSF recommends that provider-prepared medications should be discontinued whenever possible in favor of providing prefilled syringes for anesthesia care providers. “Prefilled syringes save time for anesthesiologists, allowing that time to be utilized for necessary monitoring of the patient and the anesthesia equipment,” she said. “That’s why it’s important, but there’s a premium price [to be paid] for purchased, prefilled syringes. When you purchase medications from a 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 Training, said she supports using prefilled syringes either drawn up by the hospital pharmacy or purchased when budgets or staffing resources allow. “The Barnes-Jewish project results were impressive,” Dr. Meyer added. “The ability to document cost neutrality is important for other hospital pharmacies to consider and possibly use to help justify use of prefilled syringes.” For those concerned with costs, she said, evaluate what drugs are most consistently 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 researchers “were able to determine the cost of waste, which is not easy, and use the amount saved with their new process to justify the cost of the prefilled

SUTURES

syringes,” she said. “That’s strong work.” Managing the prefilled or premixed medications “does take more vigilance on the part of pharmacists because of shorter beyond-use dating,” Dr. Meyer said. Premixed syringes may have expiration 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 inventory for expirations more frequently.

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).

—Karen Blum

—Trevor Stokes

CONTINUED FROM PAGE 28

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

nless you work at a hospital, a hospital caf- hospital’s offering of fruits, vegetables and other mineteria is not likely to be high on your list of imally processed foods, minimize food waste and places to go for lunch. With meal options educate employees and patients. The goal is to use second only to airline food for their reputation of food services as a part of prevention-based health being inedible, some health care facilities are intro- care by reducing unhealthy food as well as the toxins ducing new menus and taking steps to serve up tastier and pollutants that turn up in the food system. More offerings. Visitors to those facilities are often pleasthan 400 hospitals and seven food service contracantly surprised to find options like Alastors have taken the pledge so far. That means there have been some promkan wild salmon nestled in a bed ising steps made to cut down on of kale, or lavender scones made the carbon footprint of hoswith ingredients freshly picked from the hospital’s roof garpital food services while providing healthy, enjoyden. And the groundable food people would breaking food services actually consider orderat these facilities aren’t ing for takeout. just delicious—they’re healthy for patients, visAdventist itors and even the planet. Medical Center “We all know that food in hospitals has Location: Portland, Ore. a bad rap, with things Sustainable since: Its inception. Because vegelike Jell-O and gray meat,” said Michelle Gottlieb, cotarianism is a pillar of the Seventh-dayy Adventist church, coordinator of Healthy Food in Health Care, an organization comthe cafeteria has been vegetarian mitted to helping hospitals offer since the hospital opened. The allnutritious and sustainable foods. Sesame ginger soy curl wrap. vegan LivingWell Bistro opened in “We started looking into the caf- Courtesy of Adventist Health. October 2011. eteria and at what’s put onto the Sample dish: Quinoa bowl with patient trays, saying this isn’t right. Hospitals should black beans, kale or collard greens and homemade pico de gallo. be healing people, not serving this kind of food.” Five of the hospitals profiled here have taken Food service highlights: Though patients at the the Healthy Food in Health Care Pledge. Among hospital have a meat option, eating animals is other goals, those who take the pledge promise to eschewed in the rest of the hospital. The LivingWell work with local farmers and suppliers, increase the 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 PederAdvertisement sen, food service manager. Less meat means a smaller environmental footprint, and the team works to get FEATURED PRODUCT 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 awardwinningg chefs work to make sure visitors know eating vegetarian means more than just crunching on salads. Rusch EZ-Blocker Endobronchial Blocker Plus, guests ordering food to go don’t need to feel The EZ-Blocker Endobronchial Blocker was develguilty about the packaging since the hospital always oped to provide an improved device for lung isolaprovides compostable containers. tion. It has a unique Y-shaped distal end that allows for intuitive placement of the cuffs in the right or left bronchus. It allows for secure placement at the carina and minimizes the need to manipulate the catheter after placement, reducing the potential of cuffs becoming dislodged. Teleflex 2917 Weck Dr. Research Triangle Park, N.C. 27709 (866) 246-6990 cs@teleflex.com www.Teleflex.com

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

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

Food service highlights: Fletcher Allen first became interested in sustainability when obesity and its connection to health care costs began making 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-related health issues that we thought we could make an impact on,” said director of nutrition services Diane Imrie. Today, Imrie said each person on her management team has taken on a sustainable mission, whether it’s reducing antibiotics in the food supply, cutting back on waste or providing sustainable protein sources. And of course, the cooks focus on flavor. 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. “And that’s the part I wish we could work on across the country because they shouldn’t be surprised, it should all be fabulous.”

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

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. see gourmet page 34

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PRN GOURMET

eggs from cage-free hens and bringing in eco-friendlyy disposables. Next, Sample dish: Whole grain casserole with it reduced the amount of meat on its menus and incorporated more fruits mixed vegetables and roasted squash. Food service highlights: Chefs, hos- and vegetables. The hospital has found pital staff and administrators are all that planning menus around in-season on board with the hospital’s sustain- vegetables and fruits, like persimmons able mission, Sandra Rigney, director for winter, helps keep eco-friendly of nutrition services said. “I think it food affordable. When it does serve takes the entire team to make it hap- meat, many of the dishes are made with free-range, organic chicken. The pen,” she said. The team started out by seeking hospital is currently seeking a source locally sourced produce, switching to for sustainable beef. CONTINUED FROM PAGE 32

Protect your hard-earned reputation by managing risk. Since 1987, Preferred Physicians Medical (PPM) has exclusively insured anesthesiologists and their practices. Our policyhold ders also own PPM, so helping our physician owners manage their risk is a cornerstone of what makes us unique. PPM maintains a substantial database of more than 11,000 adverse anesthesia events and uses this information to identify areas of risk, monitor developing loss trends, and provide cutting-edge, timely and praactical anesthesia-speciﬁc risk management advice and strategies like: On-site risk management seminars for our po olicyholders and their staff presented by PPM in-house claims attorneys..

Anders Grant, RD, helps find sustainable farms for Carroll Hospital Center. Courtesy of Carroll Hospital Center.

Carroll Hospital Center Location: Westminster, Md. Sustainable since: 2007 when the facility took the Healthy Food in Health Care Balanced Menu pledge. Accolades and awards: Winner of the HFHC Food, Climate, Health Connection Award in 2011. Sample dish: Shepherd’s pie using local, sustainable beef. Food service highlights: Members of the hospital’s food sustainability committee scout out farms to find sources for meat and produce. Committee member Anders Grant, RD, is currently on the hunt for a sustainable goat cheese farmer. “We want to make sure that what they say lines up with what they’re really doing,” said Ms. Grant. She said that while the sustainable food she finds is generally more expensive than the hospital’s former selections, it’s not too hard to make

Exclusive online access to best practice proto ocols and documentation; white papers; current and archived issues of Anesthesia & Law, our risk management newsletter; and other useful infformation. Immediate email notiﬁcation via Anesthesia Alerts of issues such as widespread drug contamination, dru ug shortages and signiﬁcant changes to ASA standards. 24/7/365 telephone access to our experienced d attorneys and claims specialists for the expert risk man nagement advice you need, whenever you need it. Call PPM today to learn more about how our extensivve risk management program can help you protect your reputation.

Add your good name to our growing list of ASA “standard of care” clinicians. Call us toll free today at 800.562.5589 and join other select anesthesiologists who have already secured ownership in their professional reputations. 9000 West 67th Street

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Fresh vegetables at New Milford Hospital. Courtesy of New Milford Hospital.

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PRN small changes that result in cost savings. Instead of offering carved tenderloin from a locally sourced cow, for example, the hospital might make a beef stew, mixing the beef with other ingredients to extend its value, Ms. Grant explained. New Milford Hospital Location: New Milford, Conn. Sustainable since: 2006, when the hospital founded Plow to Plate, which connects farmers with the hospitals and restaurants in the area. Sample dish: Chicken salad with dried cranberries. Food service highlights: Plow to Plate started when the hospital decided to use area farms to help build a sustainable food system. “We realized we could create healthier diets, support our farmers and send a message that eating nutritious whole foods 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. Its roof garden grows vegetables and herbs that are used in the cafeteria—the lavender found in the facility’s popular lavender scones is harvested from the roof garden. Overall, the hospital’s food services today are a far cry from what hospital chefs found when they first arrived. “We were coming into an organization that was old-school,” said Chef Kerry Gold. “They were opening cans and throwing them into a pan.” Now, everything is made from scratch, even soup stock and deli meat.

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Lunch is served at Overlake Hospital Medical Center. Credit Scott Areman.

Overlake Hospital Medical Center Location: Bellevue, Wash. Sustainable since: 2007 when the hospital took the Healthy Food in Health Care pledge. The greening process started 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 has an extensive list of sustainable improvements it has made, from switching to local, cage-free, organic eggs to removing all deep-fried items from patient menus and hosting “meatless Monday” every week. The medical center also authored a comprehensive food policy to provide a framework for sustaining those changes and helping to inform vendors about what the center will and will not buy. Besides being committed to the planet, 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, executive chef. “Including walking across the street 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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PRN NEAR MISS

CONTINUED FROM PAGE 1

was becoming increasingly common, and that patients undergoing procedures 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 provision of anesthesia in remote locations may be associated with increased risk, and that patterns of failure may

be different from those associated with the provision of anesthesia in the operating room.” With that in mind, Dr. Lipshutz and her colleagues analyzed reports submitted to the institution’s near-miss reporting system between Jan. 1, 2009, and Dec. 31, 2011. Each report contains 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 taxonomy. The investigators compared

causative mechanisms between nearmiss reports occurring in the operating room and remote locations. As Dr. Lipshutz reported at the 2012 annual meeting of the American Society of Anesthesiologists (abstract 055), the system contained 2,485 near-miss reports, 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-yearr period, from 5.1% to 12.2% to 13.8% (P<0.05).

Nearly half of the near misses outside the operating room resulted from either equipment malfunction or the failure of a clinician to use appropriate technique (Table). A poor culture of safety also played a significant role, accounting for nearly 15% of near misses in NORA patients, according to the researchers. Perhaps not surprisingly, these near misses were nearly twice as likely to be associated with this poor safety culture as those occurring in operating rooms (odds ratio 1.92; 95% confidence interval, 1.28-2.88). Non–operating room near misses did not differ from those in the operating room with respect to the time the event occurred (79% vs. 83% during the day, respectively; P=0.19), attribution to systems rather than human error (63% for both locations; P=0.99) or association with technical issues (39% vs. 43%; P=0.28). Dr. Lipshutz acknowledged that the study is limited by its retrospective design and the limited amount of data collected by the institution’s near-miss reporting 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, anesthesiologists should be aware of the common causative mechanisms associated with near misses in remote locations, and Table. Primary Causes of Near Misses Originating From Non–Operating Room 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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PR N should maintain constant vigilance,” she said. “Vigilance at the level of the anesthesiologist includes things such as performing machine and equipment checks prior to each case. “A small number of causative mechanisms explained the bulk of near misses reported and can guide interventions to make NORA safer,” Dr. Lipshutz continued. “Additionally, 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 medicine at Drexel University College of Medicine, in Philadelphia. “I presume this is easily fixed, with enough resources. Moreover, less than 3% of failures were related to factors beyond the control of the institution. What is 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 necessarily follow that 97% of failures could be fixed by the institution.”

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You’ve You ve

this before.

—Michael Vlessides ™ Number

Percent

20.91

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14.55

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PRN

Saying No to NPO Carb drink improves patient experience with surgery

onsumption of a carbohydraterich clear liquid a few hours before elective surgery significantly reduces patient discomfort relative to those who fasted from midnight, a multicenter team of researchers has concluded. Experts said the results should prompt anesthesiologists

to reconsider what the researchers feel to be overly rigid fasting instructions for patients scheduled to undergo surgery. Many anesthesiologists adhere to “NPO past midnight” for all surgical patients, despite evidence and recommendations to the contrary. In

both 1999 and 2011, the American Society of Anesthesiologists recommended a minimum fast of two hours from clear liquids for all healthy patients undergoing elective procedures

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requiring general anesthesia, regional anesthesia or sedation/analgesia. “There are many European societies that not only recommend clear liquids a few hours before surgery, but aalso recommend using a carbohydrate-rich clear liquid,” said Jeannette T. Crenshaw, DNP, assistant professor of nursing at Texas Tech University Health Sciences Center, in Lubbock, who led the latest research. “Preoperative carbohydrate loading keeps patients from going into surgery in a starvation state; clear liquids alone don’t do that because they don’t provide nutrition.” In an attempt to determine the effect of drinking a carbohydraterich clear beverage before surgery, the investigators enrolled 297 nonobstetric patients into the two-pronged investigation. The first part was an observational, descriptive pilot study comprising 263 patients between two hospitals. The second was a randomized controlled trial comprising 34 patients that was abbreviated because of personnel changes at the participating 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, participants were asked to rate their perception of thirst, hunger, anxiety about fasting, anxiety about surgery, headache, 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, and most (n=200) were women. The 155 patients (59%) who received the carbohydrate-rich beverage—which also contains electrolytes, zinc, vitamin A and selenium—reported significantly less thirst (P<0.0001), fasting anxiety (P=0.049) and surgery anxiety (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

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AnesthesiologyNews.com I 39

PR N 13 patients who received the preoperative carbohydrate beverage reported significantly less thirst (P<0.0001) than those who fasted past midnight. “Then we analyzed the two studies together, and that’s when we found that the 168 participants who received the carbohydrate-rich beverage reported significantly reduced overall discomfort, thirst, nausea, fasting anxiety, hunger and surgery anxiety than the 129 who fasted from midnight,” Dr. Crenshaw w said in an interview with Anesthesiology News. “So it was obvious that giving patients carbohydraterich clear liquids right before surgery improved their comfort.”

‘If one of our goals

associations in the developed world— free intake of clear fluids should be allowed until two hours before anesthesia induction in most patients undergoing elective surgery [Cochrane Database Syst Rev 2003; CD004423],” Dr. Nygren said. “To avoid preoperative fasting, a carbohydrate 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 previously demonstrated effect of improved well-beingg by using this beverage preoperatively. In addition, repeated randomized studies also have demonstrated attenuated perioperative stress with reduced postoperative insulin resistance, reduced protein breakdown and better-maintained muscle strength with use of this type of beverage [Best Pract Res Clin Anaesthesiol 2006:20;429-438].

high in botic risk is When throm thrombin deficiency ti hereditary an

“It is clear from available evidence that NPO after midnight is not providing the optimal treatment, and should not be recommended in most patients,” Dr. Nygren concluded. “Better compliance with evidence-based guidelines should be an international and professional concern.” The study was supported with product from BevMD. —Michael Vlessides

To learn more, visit www.thrombate.com

is to promote patient satisfaction in the perioperative experience, then I’m puzzled as to why

FELY PROCEED SA

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 Despite these results, Dr. Crenshaw said that many patients are still being told to not consume anything after midnight, while the evidence in support of carbohydrate-rich clear liquids prior to surgery is being ignored. “It has consistently been shown that the risk for aspiration in modern anesthesia is exceedingly low,” she explained. “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.” Jonas Nygren, MD, PhD, associate professor of surgery at Karolinska University Hospital in Stockholm, agreed that it’s time to adopt a different approach with respect to patient consumption of clear and carbohydraterich liquids before surgery. “As has been convincingly shown in previous randomized trials and systematic reviews—as well as documented in guidelines from most anesthesia

Thrombate III® (antithrombin III [human])—proven effective for patients with hereditary antithrombin (AT) deficiency during surgery, childbirth, and in the prevention and treatment of thromboembolism1 Thrombate III provides predictable amounts of AT to replace what is normally present in the body AT concentrate purified from human plasma and pasteurized to inactivate viruses, with no confirmed cases of virus transmission In clinical studies, no cases of thrombotic complications during surgical and obstetrical procedures were reported

Easy to administer1

Convenient to store and reconstitute1

One dosing formula Bolus intravenous infusion (not continuous infusion) Pregnancy category B

500 IU vials with sterile water for injection Filter and transfer needles provided Room temperature storage

Important Safety Information Thrombate III® (antithrombin III [human]) is indicated for the treatment of patients with hereditary antithrombin deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism. In clinical studies with Thrombate III, the most common side effects were dizziness, chest discomfort, nausea, and dysgeusia. The anticoagulant effect of heparin is enhanced by concurrent treatment with Thrombate III in patients with hereditary AT-III deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with Thrombate III. Thrombate III is made from human plasma. Plasma products carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk. No cases of transmission of viral disease or CJD have ever been identified for Thrombate III. Please see brief summary of Thrombate III complete Prescribing Information on adjacent page. Reference: 1. Thrombate III® (antithrombin III [human]) [prescribing information]. Research Triangle Park, NC: Grifols Inc; 2012. © 2013 Grifols Inc.

February 2013

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P A IN M E D I C I NE

Pain Education May Affect Pain Perception in the Elderly

ducating older people about the relationship between pain and aging can lead to significant improvements in their knowledge of pain-related events, Canadian research shows. “Given that pain is still undertreated and underreported, and rates of these are even higher among older people, our finding that simple

educational initiatives can have significant effects on pain perceptions is important,” said co-investigator Allan Gordon, MD, director of the Wasser Pain Clinic at Mount Sinai Hospital, in Toronto, and associate professor of neurology in the University of Toronto’s Department of Medicine. Dr. Gordon, along with lead researcher Lucia Gagliese, PhD,

THROMBATE

III®

Antithrombin III (Human) BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

FOR INTRAVENOUS USE ONLY DESCRIPTION Antithrombin III (Human), THROMBATE IIIw is a sterile, nonpyrogenic, stable, lyophilized preparation of purified human antithrombin III (ATIII). THROMBATE III is prepared from pooled units of human plasma from normal donors by modifications and refinements of the cold ethanol method of Cohn. When reconstituted with Sterile Water for Injection, USP, THROMBATE III has a pH of 6.0–7.5, a sodium content of 110–210 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 no preservative and must be administered by the intravenous route. Each vial of THROMBATE III contains the labeled amount of antithrombin III in international units (IU) per vial. The potency assignment has been determined with a standard calibrated against a World Health Organization (WHO) antithrombin III reference preparation. The capacity of the THROMBATE III manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model using a wide range of viruses with diverse physicochemical properties. There are two dedicated virus inactivation/removal steps included in the THROMBATE 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 as small as 18 nm. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. An individual production step in the THROMBATE III manufacturing process has been shown to decrease TSE infectivity of that experimental model agent. The TSE reduction step is the Effluent I to Effluent II + III fractionation step (6.0 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed. CLINICAL PHARMACOLOGY Antithrombin III, an alpha2-glycoprotein of molecular weight 58,000, is normally present in human plasma at a concentration of approximately 12.5 mg/dL and is the major plasma inhibitor of thrombin. Inactivation of thrombin by ATIII occurs by formation of a covalent bond resulting in an inactive 1:1 stoichiometric complex between the two, involving an interaction of the active serine of thrombin and an arginine reactive site on ATIII. ATIII is also capable of inactivating other components of the coagulation cascade including factors IXa, Xa, XIa, and XIIa, as well as plasmin. The neutralization rate of serine proteases by ATIII proceeds slowly in the absence of heparin, but is greatly accelerated in the presence of heparin. As the therapeutic antithrombotic effect in vivo of heparin is mediated by ATIII, heparin is ineffective in the absence or near absence of ATIII. The prevalence of the hereditary deficiency of ATIII is estimated to be one per 500 to 5000 in the general population. The pattern of inheritance is autosomal dominant. In affected individuals, spontaneous episodes of thrombosis and pulmonary embolism may be associated with 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. The frequency of thromboembolic events in hereditary ATIII deficiency during pregnancy has been reported 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. In many cases, however, no precipitating factor can be identified for venous thrombosis or pulmonary embolism. Greater than 85% of individuals with hereditary ATIII deficiency have had at least one thrombotic episode by the age of 50 years. In about 60% of patients thrombosis is recurrent. Clinical signs of pulmonary embolism occur in 40% of affected individuals. In some individuals, treatment with oral anticoagulants leads to an increase of the endogenous levels of ATIII, and treatment with oral anticoagulants may be effective in the prevention of thrombosis in such individuals. In clinical studies of THROMBATE III conducted in 10 asymptomatic subjects with hereditary deficiency of ATIII, the mean in vivo recovery of ATIII was 1.6% per unit per kg administered based on immunologic ATIII assays, and 1.4% per unit per kg administered based on functional ATIII assays. The mean 50% disappearance time (the time to fall to 50% of the peak plasma level following an initial administration) was approximately 22 hours and the biologic half-life was 2.5 days based on immunologic assays and 3.8 days based on functional assays of 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 deficiency and histories of thromboembolism treated prophylactically on 16 separate occasions with THROMBATE III for high thrombotic risk situations (11 surgical procedures, 5 deliveries) developed a thrombotic complication. Heparin was also administered in 3 of the 11 surgical procedures. Eight patients with hereditary ATIII deficiency were treated therapeutically with THROMBATE III as well as heparin for major thrombotic or thromboembolic complications, with seven patients recovering. Treatment with THROMBATE III reversed heparin resistance in two patients with hereditary ATIII deficiency being treated for thrombosis or thromboembolism. During clinical investigation of THROMBATE III, none of 12 subjects monitored for a median of 8 months (range 2–19 months) after receiving THROMBATE III became antibody positive to human immunodeficiency virus (HIV-1). None of 14 subjects monitored for ⱖ 3 months demonstrated any evidence of hepatitis, either non-A, non-B hepatitis or hepatitis B. INDICATIONS AND USAGE THROMBATE III is indicated for the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism.

Subjects with ATIII deficiency should be informed about the risk of thrombosis in connection with pregnancy and surgery and about the inheritance of the disease. The diagnosis of hereditary antithrombin III (ATIII) deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma ATIII levels, and the exclusion of acquired deficiency. ATIII in plasma may be measured by amidolytic assays using synthetic chromogenic substrates, by clotting assays, or by immunoassays. The latter does not detect all hereditary ATIII deficiencies. The ATIII level in neonates of parents with hereditary ATIII deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.) Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% in normal term infants. ATIII levels in premature infants may be much lower. Low plasma ATIII levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with THROMBATE III of neonates be discussed with an expert on coagulation. CONTRAINDICATIONS None known. WARNINGS Because THROMBATE III is made from human plasma, it may carry a risk of transmitting infectious 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 for THROMBATE III. Inform patients that THROMBATE III is made from human plasma and may contain infectious agents that can cause disease. While the risk that THROMBATE III can transmit an infectious agent has been reduced by screening plasma donors for prior exposure, testing donated plasma, and by inactivating or removing pathogens during manufacturing, patients should report any symptoms that concern them. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Therapeutics Inc. [1-800-520-2807]. The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary ATIII deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III. PRECAUTIONS General 1. 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 virus including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs. Place needles in sharps container after single use. Discard all equipment including any reconstituted THROMBATE III product in accordance with biohazard procedures. The diagnosis of hereditary ATIII deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma ATIII levels, and the exclusion of acquired deficiency. Laboratory Tests It 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 chromogenic substrates or by clotting assays. Drug Interactions The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary ATIII deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III. Pregnancy Category B Reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to THROMBATE III. It is not known whether THROMBATE III can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pediatric Use Safety and effectiveness in the pediatric population have not been established. The ATIII level in neonates of parents with hereditary ATIII deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.) Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% in normal term infants. ATIII levels in premature infants may be much lower. Low plasma ATIII levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with THROMBATE III of neonates be discussed with an expert on coagulation. ADVERSE REACTIONS In clinical studies involving THROMBATE III, adverse reactions were reported in association with 17 of the 340 infusions during the clinical studies. Included were dizziness (8), chest discomfort (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 and hematoma (1). If adverse reactions are experienced, the infusion rate should be decreased, or if indicated, the infusion should be interrupted until symptoms abate. CAUTION & only U.S. federal law prohibits dispensing without prescription.

Grifols Therapeutics Inc. Research Triangle Park, NC 27709 USA U.S. License No. 1871

‘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 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 sessions that were approximately two hours long. Each session was open to the public and included a 90-minute talk on the fundamentals of chronic pain, pain epidemiology across the lifespan of the individual, the physical and psychosocial impacts of chronic pain, common comorbidities with pain, polypharmaceutical treatment of pain, and barriers to pain management. 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, see perception page 44

08941115-BS

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PA IN M E D ICIN E

Patients Satisfied With Transforaminal Epidural Steroid Injections Without Sedation

Dr. Diehn said there was a 0% rate of vasovagal reaction in the sedation group and a 0.4% rate in the nonsedation patients. LAS VEGAS—A team that annually 61 years, respectively, although the than 90% of the non-sedation patients Two weeks after the procedure, administers thousands of transforami- small size of the sedation group pre- underwent lumbar TFESI compared patients were asked about their expenal epidural steroid injections (TFESI) cluded statistical comparison of the with 42.9% of the sedation patients. rience. Most of the non-sedation without sedation reported high satis- two groups’ characteristics. Six of the Moreover, pain duration lasted only up patients (72.5%) completed the quesfaction among patients with their med- seven sedation patients were men, to three months in 23.6% of the non- tionnaire, whereas 57% (four) of sedaical care. whereas approximately 50% of the sedation patients and in 57.1% of the tion patients responded. At the 2012 annual meeting of the non-sedation patients were men. More sedation patients. see TFESI page 44 International Spine Intervention Society, 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 who did not receive sedation rated their overall medical care as “excellent” or “very good.” Just over half also said they would “definitely” refer friends or family members to the clinic for TFESI. In results that were not presented at the meeting, the medical team also found LMA Supreme® very low vasovagal reaction rates. The Next Generation Airway “We conclude that TFESI can be performed without sedation with high patient acceptance and low vasovagal rates,” said Dr. Diehn, assistant professor of radiology at Mayo Clinic. “We think this is important because sedation 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 pending disastrous complication.” The LMA Supreme Airway Mehul Desai, MD, MPH, director of pain medicine and nonoperative We invented laryngeal mask airways some 20 years ago. go. Clinicians like you have been spine services, and professor of anesnce. Here’s the latest. trusting them and we’ve been improving them ever since. thesiology and critical care and of neurosurgery at The George Washington University Medical Center, in WashThe LMA Supreme Airway has the ideal curve to make it remarkably easy to insert. And it’s ington, D.C., rarely uses sedation for be designed to channel fluids and gas the first LMA single-use mask with a built-in drain tube TFESI because of safety concerns. But safely away from the airway. Considering the frequentt presence of stomach fluids even in he questioned the validity of the study. fasted patients, doesn’t that make a lot of sense?1 “This study is limited by the fact that it’s retrospective; the non-sedation With more than 200 million successful procedures, LMA A airways are the standard for safety, group was very small; there is considcomfort and better outcomes around the world. When you use an LMA Supreme Airway erable potential for bias because the ands.” you’ll know why we say, “We put confidence in your hands.” patients selff selected for or against sedation; and the team measured patients’ satisfaction with overall care [rather] than with their choice of sedation versus no sedation,” Dr. Desai said. For more information about LMA Products, visit our website at www.lmana.com/supreme or call 1-800-788-7999. In the data presented at the meeting, Dr. Diehn and his colleagues performed Tretiak, S. “The LMA Supreme: Should gastric access be the standard of 6,878 TFESIs on 4,432 patients in a sixx care?” Anesthesiology News Guide to Airway Management, t August 2009. yearr period. All but seven (0.1%) were done without sedation. LMA Airway Management | LMA EMS | LMA Visualization | LMA Pain Management | LMA Atomization The patients who opted for sedation were younger than the non-sedation LMA North America, Inc. www.LMANA.com patients, with average ages of 47.9 and ®

™

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Feast or Famine: The Great Divide In Pain Drug Access Grows Wider Vienna—In a remote village in the Ukraine, Artur, a former, decorated KGB colonel, sleeps with a gun under his pillow. He says he will use it if the pain from his stage IV prostate cancer becomes too unbearable. Bureaucratic hurdles in this country have left him

without access to pain medication, and he 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 Wisconsin (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

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limited access to medical morphine; of those individuals, more than half face severe shortages of pain medication. At the recent annual meeting of the European 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 written for immediate-release oral morphine in Guatemala was in 2012 and was written for a 72-year-old woman with advanced head and neck cancer. It was prescribed at a center that performs bone marrow transplants, underscoring the fact that sophisticated care and access to analgesics do not go hand in hand. Dr. Cleary, y founder of the UW Health Palliative Care Program and associate professor of medical oncology at the UW School of Medicine and Public Health, in Madison, pointed out that in 2008, high-income countries accounted for 17% of the population but 91% of morphine consumption. The disparity also exists for morphine equivalents. “The general world consumption of opioids, and this includes fentanyl, oxycodone and other opioids, has been rising, but most of that rise has been in high-income countries, with almost no increase in low- to middle-income countries,” Dr. Clearyy said. In 1961, the United Nations Single Convention on Narcotic Drugs established 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 systems that prevent diversion, but do not interfere with medical access to opioids. In 2000, the WHO first published a guidance for policymakers, regulators, health care professionals and others about how to achieve this

MARCH 2013

AnesthesiologyNews.com I 43

PA IN M E D ICIN E balance. In 2011, the WHO released an updated version: “Ensuring Balance in National Policies on Controlled Substances, Guidance for Availability and Accessibility for Controlled Medicines” (www.who.int/medicines/areas/ quality_safety/guide_nocp_sanend/ en/). Multiple Barriers A 2006 survey from the Worldwide Palliative Care Alliance of health care workers in Asia, Africa and Latin America identified four major barriers to accessing oral morphine: excessively strict national drug laws and regulations, fear of addiction, poorly developed health care systems and lack of knowledge. At the ESMO meeting, Nathan Cherny, MD, head of cancer pain and palliative medicine, at Shaare Zedek Medical Center, in Jerusalem, presented preliminary data from the International Collaborative Project to Evaluate the Availability and Accessibility of Opioids for the Management of Cancer Pain. This project was initiated by ESMO and coordinated with the UW Pain and Policy Studies

Only 12 countries surveyed provided all seven of the opioid medications considered to be essential for the relief of cancer pain by the International Association for Hospice and Palliative Care (IAHPC). These are codeine, immediate- and slow-release morphine, injectable morphine, oral oxycodone, oral methadone and transdermal 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 on compliance with the IAHPC essential drug list, they found that only roughly half could be classified as good. The surveys found that many governments do not subsidize (or only occasionally fund) available pain Artur, a former KGB colonel in the Ukraine, keeps a gun under his pillow, drugs. For example, patients in Guateand plans to use it if his cancer pain becomes unbearable. mala, Peru, Kenya, Liberia, Madagascar, Photo courtesy of Dr. James Cleary. Tunisia, Syria, Afghanistan, China and most of the Indian states must pay the Group, along with the European Asso- cancer patients from obtaining these full cost of medications that are availciation for Palliative Care, Union for drugs. Data were gathered between able. India is one of the world’s largInternational Cancer Control (UICC) December 2010 and July 2012 in 76 est legal cultivators of poppies, but it and the WHO. The consortium eval- countries in Africa, Asia, the Middle is almost impossible for citizens to get uated opioid drug availability, cost to East, Latin America, the Caribbean cheap opium-based painkillers. “On consumers and barriers that prevent and 19 Indian states. see access page 45

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TFESI

CONTINUED FROM PAGE 40

and community and seniors’ centers. Prior to the session, attendees provided 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 several pain-related statements both before and after the session, and were asked to rate their level of agreement with each 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 several of the statements, including “people over the age of 65 often become addicted if they take drugs for pain,” “pain is a normal part of aging,” “people 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 participants reported having daily pain, with 60% rating their pain as severe, despite the fact that 85% were using pharmacologic and physical treatments for pain. Presenting the research at the International 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 samples of individuals of similar age. The possibility that there was a “selff selection effect” and that individuals with more severe pain were more likely to attend lectures 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 better pain management?” said Mellar Davis, MD, professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, in Cleveland, and director of the Clinical Fellowship 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 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.” —David Wild Dr. Gagliese received an unrestricted educational grant from Merck Frosst Canada. Drs. Gordon and Davis reported no relevant conflicts of interest.

CONTINUED FROM PAGE 41

Just over half of the non-sedation patients (51.5%) rated their overall medical care as “excellent” and 29.8% rated it as “very good.” The respective percentages of the sedation patients were 50% and 0%. One sedation patient rated the medical care as “good” and the remaining patient rated it as “fair.” Just over half of non-sedation patients (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 percentages of those who said that they would “probably” refer others were 27.8% and 0%. Half of the sedation patients said that they would “probably not” refer others. —Rosemary Frei, MSc Drs. Diehn and Desai reported no relevant conflicts of interest.

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PA IN M E D ICIN E ACCESS

CONTINUED FROM PAGE 43

a formulary basis, there is ostensibly wide availability [in India]; in practice 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. Chernyy said. Many countries have highly restrictive regulations that limit the ability of cancer patients to receive prescriptions, limit prescriber privileges, impose restrictive limits on duration of prescription, restrict dispensing and increase bureaucratic burden of the prescribing and dispensing process. “About one-third of countries across Africa and half the countries in the Middle East are limited to a oneweekk supply,” said Dr. Cherny, y referring to the number of days that opioids can be prescribed per prescription. “Overregulation of opioids is widespread.” Eighty-four percent of countries reported four or more regulation barriers; 39% reported six or more. A Call to Action Efforts 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. Chernyy said. The WHO continues to work on improving access. Data from the international collaborative project should spur further action. “This data are really a call to action,” y “There is an urgent said Dr. Cherny. need for formulary review, improving affordability of medications, improving availability of opioids by better distribution and dispensing, careful examination of multiple drug control policies and repeal of excessive restrictions, which are impeding this most fundamental aspect of cancer care.” Kathleen Foley, MD, attending neurologist in the Pain & Palliative Care Service at Memorial Sloan-Kettering Cancer Center, in New York City, said the problem will have to be fixed country by country. “We need to identify champions at the country level,” she said. She pointed out several recent success stories, including the Access to Opioid Medication in Europe (ATOME) project. This consortium of academic institutions 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 regulatory environments in these countries and coming up with approaches and standards to how we look at this,”

said Dr. Foley. y “This is where law and health 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 Cancer Society, is another effort. Founded in 2009, GAPRI aims to make essential pain medicines universally available by 2020. In 2010, GAPRI brokered a deal between the Ugandan government 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 regulations 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 language” 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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CONTINUED FROM PAGE 1

practice in the war is the Medical and Surgical History 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 civilian 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 accelerated 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 chloroform were 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 examine 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 surviving. 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 firsthand 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

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

shade of a wide spreading tree to cool him and keep off the flies. He rallies from the sleep of the merciful 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 chloroform in more than 10,000 cases without a fatality. The man whose demonstration, in Boston in 1846, brought ether anesthesia to the world also administered it during the Civil War. William Thomas

Eight Medical Advances From the Civil War

Accumulation of adequate records and detailed reports for the first time permitted a complete military medical history. This led to the publication of the Medical and Surgical History of the War of the Rebellion, which was identified in Europe as the first major academic accomplishment by U.S. medicine.

Development of a system of managing mass casualties, including aid stations, field hospitals and general hospitals, set the pattern for management of the wounded in World War I, World War II and the Korean War.

The pavilion-style general hospitals, which were well

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

The importance of immediate, definitive treatment of wounds and fractures was demonstrated and it was shown that major operative procedures, such as amputation, were optimally carried out in the first 24 hours after wounding.

The importance of sanitation and hygiene in preventing infection, disease and death among the troops in the field was demonstrated.

The experience and training of thousands of physicians were upgraded, and they were introduced to new ideas and standards of care. These included familiarity with prevention and treatment of infectious disease, with anesthetic agents and with surgical principles that rapidly advanced the overall quality of American medical practice.

The Sanitary Commission was formed, a civilian-organized soldier’s relief society that set the pattern for the development of the American Red Cross.

Female nurses were introduced to hospital care and Catholic orders entered the hospital business.

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

Table. Casualties and Losses Union Killed in action

Confederate

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, The Oxford Companion p to Am American merican Militaryy Historyy. Oxford Universityy Press; 1999.

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 administer 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 Courthouse 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 Reading Albin 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 the Civil 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 Wilderness in the Civil War. JAMA. 1904;42:1068-1078.

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REPORT Transdermal PCA in Acute Postoperative Pain Management: A Critical Evaluation of the Investigational IONSYS System Despite advances in pain manAcute postoperative pain conChair agement technology, the advent tinues to be undertreated, with of acute pain services, and proup to 75% of patients in the Eugene R. Viscusi, MD fessional practice guidelines United States failing to receive Professor of Anesthesiology aimed at improving postoperative adequate postoperative pain Director, Acute Pain Management pain management, inadequacies relief.1,2 Postoperative pain manThomas Jefferson University and treatment gaps still exist, and agement was revolutionized with improvement remains a priority.7 the introduction of patient-conPhiladelphia, Pennsylvania trolled analgesia (PCA) using IV An analgesic intervention Faculty or epidural delivery routes more that might help to mitigate clinithan 20 years ago.3 Opioids are cian concern is the fentanyl ionJohn Fanikos, RPh, MBA tophoretic transdermal system the primary treatment for acute Director of Pharmacy Business (IONSYS), a credit card–sized, pain management,4 either alone Brigham and Women’s Hospital self-contained, and preproor increasingly as part of a multiBoston, Massachusetts grammed investigational product modal analgesic strategy—charcandidate intended to provide acterized by administration of 2 Michael H. Huo, MD pain relief for adult inpatients or more drugs (eg, opioid and Professor requiring opioids following surnonopioid analgesics, used in Department of Orthopedic Surgery gery.8 It is a needle-free system combination) that act by different UT Southwestern Medical Center mechanisms, and along differthat is applied to the skin on the Dallas, Texas ent pain pathways—an approach upper arm or chest.8 A generally that is recommended by the imperceptible electrical current American Society of Anesthesithen delivers a small dose of fenologists (ASA) and the American Pain Society.5,6 However, tanyl directly through the skin and into the systemic circulation. The FDA approved IONSYS in 2006; however, it existing PCA modalities have limitations that include invawas never launched in the United States due to required sive access, challenges in titration of analgesic effect, changes in manufacturing. The enhanced design will be cumbersome pump technologies, impaired patient mobilreviewed by the FDA in the near future for use in patients ity, and limited drug preparations that have been associwith moderate to severe postoperative pain. ated with programming, medication, and dosing errors.

Supported by

REPORT

PCA Patient variables

Nurse variables Pain

Sedation Patient requests nurse Analgesia Nurse arrives

Pharmacokinetic variables

Nurse evaluates

Absorption Injection administered

Nurse readies injection

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

Burden of Acute Postoperative Pain More than 48 million inpatient surgeries and roughly 35 million 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 control postoperative pain and potentially improve postoperative recovery.11

Elements of Multimodal Analgesia A 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 recommend the consideration of acetaminophen, oral cyclooxygenase-2 (COX-2) selective nonsteroidal anti-inflammatory drugs (NSAIDs), nonselective NSAIDs, and calcium channel α2δ antagonists (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 considerations of effectiveness and risk for adverse events (AEs).5 Drugs with a primary indication other than analgesia (eg, anticonvulsant medications) are sometimes used as part of a multimodal 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 systemic 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 characteristics. Evidence shows that when compared with conventional 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 opioidsparing multimodal treatment regimen.

PCA Modalities and Practices The basic tenet of PCA dictates that patients should have direct control of their pain management14 and may benefit from

REPORT 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 conventional (eg, intermittent bolus intramuscular, IV, subcutaneous) opioid regimens.14,15 The superior analgesic efficacy of IV PCA compared with intermittent intramuscular analgesia was demonstrated 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 selfadministering small amounts of analgesic medication within preset parameters.18 Staff-programmed PCA pump settings regulate medication dosing and dosing frequency, the lockout period between doses, and the maximum allowable dose per hour. Existing PCA modalities including IV PCA, patientcontrolled epidural analgesia (PCEA), and patient-controlled regional anesthesia (PCRA) have varying benefits. For example, 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 systemic opioid exposure.3 PCEA also allows patients to selfadminister analgesia based on individual requisites.3 Similarly, PCRA provides analgesia without systemic exposure to opioids 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, neuraxial) 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 postoperative pain management and current modalities allow for use of complex regimens.

Cost-Effectiveness Related to PCA Medical expenses, unintended morbidity and mo rtality costs, and overhead expenses all affect the total cost of managing pain during the postoperative period. Actual costs associated 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 necessary 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, analgesics, 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 injuries such as needlesticks. Examples of opportunity expenses include lost nursing time for pump programming, delays in setting up equipment, and consequent delays in patient discharge from the hospital. When developing a regimen for postoperative pain management, an analysis of cost-effectiveness that scrutinizes resource utilization and labor costs related to these modalities, along with probable intangible, indirect, and opportunity costs is justified. The potential for pain relief is an important factor to consider when weighing the cost-benefits of a specific treatment 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 postoperative 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 morphine is considered the gold standard for IV PCA,18 its active metabolites—morphine-3-glucuronide and morphine-6-glucuronide—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 morphineintolerant patients or in those with altered renal function. Compared with morphine, hydromorphone is at least 5 times more potent; initial doses should be significantly lower for hydromorphone 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 lipophilic, which facilitates crossing the blood–brain barrier. 21 Small

REPORT

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; minimized 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.

positively charged molecules are ideal iontophoretic agents. Hence, fentanyl hydrochloride (HCl) is well suited for iontophoretic delivery.22 Furthermore, fentanyl exhibits a satisfactory AE profile. Hutchinson and colleagues reported that patients in the postoperative 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 reasonable 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 fentanyl, 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—usually dose reductions—include amitriptyline, gabapentin, bupivacaine, and clonidine.24 NSAIDs and aspirin should not be used in the presence of chronic renal failure because of the risk for significant 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 programming errors.3 In fact, device malfunction is a major cause of reported AEs with IV infusion pumps. Of 2,009 IV PCA-related events reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) voluntary medication error reporting program during a 2-year period, 1,590 (79.1%) were classified as possible device-safety events.25 A retrospective analysis of MEDMARX, an Internet-accessible, voluntary medication 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, emphasizes the need for the optimal delivery of PCA. The Hospital Consumer Assessment of Healthcare Providers and Systems’ (HCAHPS) national standard survey monitors patients’ perspectives 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

REPORT pain management in the hospital is one of the 6 summary measurements 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 complications related to the IV line itself (eg, occlusions) and catheter infiltration into subcutaneous tissue, or programming and medication errors—any of which can result in potentially serious AEs, including oversedation, respiratory depression, and under-treated pain (Table).3,15 Specific clinical disadvantages of IV PCA are that it is invasive, 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 transition 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. Furthermore, PCA by proxy errors, in which an unauthorized party activates the analgesic pump’s dosing mechanism, delivering analgesic medication to the patient, are another potentially 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 PCRA Similar 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 programming 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 indwelling 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 moderate to severe pain is both convenient and noninvasive, it is usually 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 meperidine) are required for oral administration than for the parenteral route.30 Furthermore, because the optimal analgesic dose varies among patients, overdose or the undertreatment of pain are potential risks with this route of administration. The intramuscular route is associated with painful administration10 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 Delivery Transdermal 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, transdermal 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 ionized 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, causing 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 cationic therapeutic 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 cathode.32 As such, an active transdermal system that uses iontophoretic drug delivery offers patients control over analgesic dosing along with convenient administration and rapid analgesic delivery without some of the shortcomings associated with IV and epidural routes.31

Iontophoretic PCA IONSYS 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 rapidly 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 reservoir to be repelled from the positively charged anode surface and to be delivered through the skin into the systemic circulation.31 In contrast to existing PCA modalities, iontophoretic transdermal delivery does not require infusion pumps or indwelling catheters to deliver medication, which encourages patient mobility in the critically important postsurgical period.3

REPORT 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 IONSYS Pharmacokinetic (PK) evaluations of IONSYS in dosing frequency studies have demonstrated that it has a PK profile similar to that of IV PCA fentanyl, but with a slower rise, lower peak level, and less fluctuations.36,37 Systemic absorption of the fentanyl delivered by IONSYS increases as a function of time; this increase appears to be independent of dosing frequency.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 activation 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 application sites being the upper outer arm or chest of patients.39

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.

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 maximum of 80 doses, whichever takes place first; additional IONSYS 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 supplying instantaneous dosing on patient demand, providing consistent analgesia and eliminating potentially painful waiting periods between requests for analgesia and drug administration. IONSYS also features preprogrammed dosing, which eliminates the potential for medication dosing errors. PCA medication 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

Ensuring Safe and Effective PCA Because IONSYS is intended only for use among hospitalized patients in the acute setting, the potential for misuse may be limited compared with the potential for misuse of the fentanyl 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 Nevertheless, 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-tolerant) 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 particular PCA modality, targets for intervention in safe opioid analgesia are prescribing errors, staff training on use and protocols, monitoring, and patient education.15

Conclusion Opioids remain the most commonly used analgesics in postoperative 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 analgesia (eg, IV, subcutaneous, intramuscular), PCA with opioids is the preferred treatment modality among patients.14 However,

REPORT

Serum Fentanyl Concentration, ng/mL

3 IONSYS IV

2.5 2 1.5 1 0.5 0 23

Time, h

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.

certain PCA modalities have disadvantages, including invasiveness (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, IONSYS 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.

References 1. 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 Anesthesiologists 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 postoperative 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 control. J Clin Anesth. 2001;13(7):524-539.

REPORT 12. Rawal N, Langford RM. Current practices for postoperative pain management in Europe and the potential role of fentanyl HCl iontophorectic transdermal system. Eur J Anaesthesiol. 2007;24(4): 299-308.

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.

13. Carr DB, Goudas LC. Acute pain. Lancet. 1999;353(9169): 2051-2058.

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

14. Walder B, Schafer M, Henzi I, Tramer MR. Efficacy and safety of patient-controlled opioid analgesia for acute postoperative pain. A quantitative systematic review. Acta Anaesthesiol Scand. 2001;45(7):795-804. 15. Craft J. Patient-controlled analgesia: Is it worth the painful prescribing process? Proc (Bayl Univ Med Cent). 2010;23(4):434-438. 16. Dolin SJ, Cashman JN, Bland JM. Effectiveness of acute postoperative pain management: I. Evidence from published data. Br J Anaesth. 2002;89(3):409-423. 17. The Joint Commission. Sentinel Event Alert: Patient controlled analgesia by proxy. http://www.jointcommission.org/assets/1/18/ SEA_33.PDF. Accessed January 9, 2012. 18. Grass JA. Patient-controlled analgesia. Anesth Analg. 2005; 101(5 suppl):S44-S61. 19. Chang AM, Ip WY, Cheung TH. Patient controlled analgesia versus conventional intramuscular injection: a cost effectiveness analysis. J Adv Nurs. 2004:46(5):531-541. 20. Etches RC. Patient-controlled analgesia. Surg Clin North Am. 1999;79(2):297-312. 21. Momeni M, Crucitti M, De Kock M. Patient-controlled analgesia in the management of postoperative pain. Drugs. 2006;66(18):2321-2337. 22. Kalia YN, Naik A, Garrison J, Guy RH. Iontophoretic drug delivery. Adv Drug Deliv Rev. 2004;56(5):619-658. 23. Hutchison R, Chon E, Tucker W, Gilder R, Moss J, Daniel P. A comparison of a fentanyl, morphine, and hydromorphone patientcontrolled intravenous delivery for acute postoperative analgesia: a multicenter study of opioid-induced adverse reactions. Hosp Pharm. 2006;41(7):659-663.

29. Ready LB. Acute pain: lessons learned from 25,000 patients. Reg Anesth Pain Med. 1999;24(6):499-505. 30. Sinatra RS, Torres J, Bustos AM. Pain management after major orthopaedic surgery: current strategies and new concepts. J Am Acad Orthop Surg. 2002;10(2):117-129. 31. Power I. Fentanyl HCl iontophoretic transdermal system: clinical application of iontophoretic technology in the management of acute postoperative pain. Br J Anaesth. 2007;98(1):4-11. 32. Rawat S, Vengurlekar S, Rakesh B, Jain S, Srikati G. Transdermal delivery by iontophoresis. Indian J Pharm Sci. 2008;70(1):5-10. 33. Data on file. Incline Therapeutics; 2012. 34. Institute for Safe Medication Practices. Beware of basal opioid infusions with PCA therapy. www.ismp.org/newsletters/acutecare/ articles/20090312.asp. Accessed January 9, 2012. 35. Meissner B, Nelson W, Hicks R, Sikirica V, Gagne J, Schein J. The rate and costs attributable to intravenous patient-controlled analgesia errors. Hosp Pharm. 2009;44(4):312-324. 36. Sathyan G, Zomorodi K, Gidwani S, Gupta S. The effect of dosing frequency on the pharmacokinetics of a fentanyl HCl patient-controlled transdermal system (PCTS). Clin Pharmacokinet. 2005; 44(1 suppl):17-24. 37. Mattia C, Coluzzi F. Acute postoperative pain management: focus on iontophoretic transdermal fentanyl. Ther Clin Risk Manag. 2007;3(1):19-27.

24. Murphy EJ. Acute pain management pharmacology for the patient with concurrent renal or hepatic disease. Anaesth Intensive Care. 2005;33(3):311-322.

38. Heitz JW, Witkowski TA, Viscusi ER. New and emerging analgesics and analgesic technologies for acute pain management. Curr Opin Anaesthesiol. 2009;22(5):608-617.

25. Hankin CS, Schein J, Clark JA, Panchal S. Adverse events involving intravenous patient-controlled analgesia. Am J Health Syst Pharm. 2007;64(14):1492-1499.

39. Gupta SK, Hwang S, Southam M, Sathyan G. Effects of application site and subject demographics on the pharmcokinetics of fentanyl HCl patient-controlled transdermal system. Clin Pharmacokinet. 2005;44(1 suppl):25-32.

26. Hicks RW, Heath WM, Sikirica V, Nelson W, Schein JR. Medication errors involving patient-controlled analgesia. Jt Comm J Qual Patient Saf. 2008;34(12):734-742.

40. Smith H, Bruckenthal P. Implications of opioid analgesia for medically complicated patients. Drugs Aging. 2010;27(5):417-433.

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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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 Pharmaceuticals, 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.