Anesthesiology News - March 2011 - Digital Edition

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The Independent Monthly Newspaper for Anesthesiologists AnesthesiologyNews.com • M a r c h 2 0 1 1 • Volume 37 Number 3

Wrong-Site Blocks Vex OR Safety Efforts

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ore than 40 times each week in the United States, a surgeon cuts into a patient or an anesthesiologist places a nerve block, only to realize that the scalpel or needle belonged somewhere else.

The true incidence of wrong-site surgery may be substantially higher because these errors are generally self-reported and are not always anonymous, which may discourage reporting (Arch Surg 2010;145:984). And the problem persists despite widespread see wrong site page 36

For Anesthesiologists, Defining Value May Be Key to Future

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his year, physicians at Mayo Clinic, in Rochester, Minn., will perform roughly 5,000 bone biopsies on patients with cancer or who are suspected of having the disease.

The clinicians tasked with shepherding these patients through the institution will not be hematologists, however. Anesthesiologists will

Retractions Come in Boldt Case, Likely Most for Single Author Probe finds 89 papers lacked ethics approval

several ethics experts. (As of press time, not every editor had agreed to the retractions.)

Editor’s note: Portions of this article previously In a March 2 joint statement appeared on AnesthesiologyNews.com. to readers, the journal editors he German medical board inves- stated that “The retraction of the tigating the studies of Joachim articles ... for lack of IRB Boldt, MD, PhD, has released a approval means that the list of 89 articles for which it could not research was unethical, find evidence that the disgraced anesthesi- and that IRB approval for ologist had obtained proper approval from the research was misrepan institutional review board (IRB). resented in the published As a result, an international group of 11 article. It does not mean anesthesiology journals has announced that the research results that it is retracting the papers—the most per se are fraudulent. see Boldt page 29 ever involving one author, according to

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perform the intake procedures. They will start the physical examination and ensure the patients have appropriate anesthetic for the biopsy procedure. Although the purpose of the procedure is to detect cancer, the consultation with a hematologist will come at the end of the process. see value page 18

INside 08 | PRN The anesthesiologist goes to Washington: An interview with newly elected Rep. Andy Harris.

12 | technology Scanning the way to safer transfusions.

42 | CLinical Anesthesiology IV fluids and the elderly—an overview.

61 | Pain Medicine Fluoroscopy may improve bursitis injections.

62 | COMMENTARY Ink to AIM: Get in the game.

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Sedation in the ICU: Shifts and Strategies, see insert at page 32.

4 I A n e s t h e s i o l o g y N e w s . c o m Ma r c h 2 0 1 1

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we teach, but if residents March 2011

The five most-viewed articles last month on AnesthesiologyNews.com

like our performance, we get great scores.

1. German Medical Board Issues Sweeping Findings in Boldt Case (Web Exclusive) 2. January 2011 Issue Recap (Podcast)

See article on page 34

3. Controversy Dogs Use of β-blockers in Noncardiac Surgery 4. Look Good in Orange? Billing Expert Offers Tips for Avoiding Fraud Charges 5. The Company Model: Is Taking Less Money To Work at a Surgicenter Worth Jail Time?

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COR R ESP O NDE NCE

“If I Ran the Zoo” To the Editor:

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r. David Cossman’s essay, “The Taking,” [Oct. 2010, page 10] reflects views held by the majority of physicians I hear in the doctors’ lounge. Full of invective for the current health care plan, claiming to be for universal health care, but totally devoid of any suggestion on how this might be accomplished in

a country of 300 million, 50 states, a wide mix of peoples and incomes, many uninsured, many old and currently partially insured, physicians in high-rent districts making millions, physicians in rural, impoverished areas barely getting by, malpractice costs hurting all, care spotty and varied, and on and on. Dr. Cossman and others have no creative approach, as Dr. Seuss did in

“If I Ran the Zoo,” but in this imaginative situation would probably advocate simply opening the gate and letting all the animals out (along with going back to radical mastectomies and open cholecystectomies.)

I look on the health care problem as constructing a building. There is a design, arrived at, in part, by envisioning the whole process through to the

end, with associated costs, and evolving the design according to realistic limitations. In this case, the goal is to build a building in the boreal forest, or steppe, with winter coming. There is no option of not building. Something must be built or the whole community (or a large portion of it) will perish.

So, here are the steps I see: Step 1—Define “health.” That is, what do we want, and for whom?

Does everyone get a tetanus shot and an MMR vaccine, or only Bill Gates who dips into his coffers to pay for it?

Does everyone get a kidney transplant and coronary artery bypass, or only the young and beautiful, or only the editor of Anesthesiology News and his editorialists? Does everyone receive trauma care? This really is the only hard part of the problem, and the one most fraught with political hurdles and tempests. I would start by defining the minimum, and the maximum, and then would work on the levels in between. This is the first hard part, and seemingly never even put on the table in the past years that this discussion has taken place.

Step 2—Once health (health care) is defined, it is easy to define the inputs required. These are providers (Cossman’s, Childs’s, etc.) independent registered nurses (RNs), physician assistants, midwives, acupuncturists, and so on and hospitals all of which basically contract with pharmacists, RNs, MDs,

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AnesthesiologyNews.com I 7

COR R ESPO N DE N CE My suspicion is that in the United States, we will have to have a two-tiered system, with the difficult task being to define what the minimum of “health care for all” is, and then leaving the market to

There has been little or no focus on steps 1 or 2. My position, as a member of the armed forces, and soon to be the beneficiary of both Medicare and Tricare for life, is that, if we can provide “universal health care” for all service members—including bariatric surgery!—then we should be able to provide it for all people, including my children, who are in roughly the same socioeconomic class as most service members, and who contribute to the welfare of this nation as much as 90%

of service members do (i.e., without their blood).

My suspicion, and expectation, having heard all the acrimonious rhetoric surrounding health care of other nations, is that in the United States, we will have to have a two-tiered system, with the difficult task being to define what the minimum of “health care for all” is, and then leaving the market to determine who gets what above and beyond that. That way, Dr. Cossman and I can continue our blue chip

practices, do some pro bono work for sure, and enable the sick and suffering from problems beyond the common weal to come to us for cash on the barrelhead services. Insurance companies would continue to survive and pay lobbying fees, doctors would as well, and most doctors would be ecstatic to get 90% of the daily bureaucracy of insurance and office management out of their hands.

—Norris Childs, MD Walnut Creek, Calif.

determine who gets what above and beyond that. equipment and consumable suppliers and own or create the bricks and mortar of provisioning. I include government here, owning and commanding/ managing large blocks of the previous inputs.

Step 3—These entities can expertly tell you (with considerable range, for sure), what the costs are (not what the billings are). This is another easy part.

Step 4—Think honestly about (a) where the money is, and (b) where it is to come from to pay for the different echelons defined by step 1: out of pocket, out of taxes, out of industry/ work profit. Part a of this is easy; part b, not so much. This is the second hard part.

Step 5—The debate and struggle over where step 4 meets step 1.

Health care for all is a definition of a civilized society, as is education. (I call Europe and Canada civilized.) If I had to pick where to spend government dollars first, it would be on education.

With education, the population will enable itself to make the hard but necessary decisions about what of its surplus money to spend on its health, as many people do already, but as too many people are unable to do because they do not have enough money to pay for Dr. Cossman, and he cannot provide gratis services for everyone, and daresay, in Beverly Hills he does not have to. This is the third, and hardest of the hard parts.

So far, to my ears, there has been far too much focus on the “G word” (government), supplanting the “I” word (insurance) of yesteryear.

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Dr. Harris on the Hill Andrew Harris, MD, an anesthesiologist from the Baltimore area, was elected in November to the House of Representatives (Md-1). Anesthesiology News recently spoke with Dr. Harris, a Republican, about his opposition to the Patient Protection and Affordable Care Act of 2010, his goals while in office and other subjects.

Rep. Andrew Harris, MD (R-Md.)

AN: First, congratulations on your recent election. You’ve now been in office about three weeks. What are your initial impressions?

AN: How so?

AN: As it happens, you have joined a Congress with a record number of physician Rep. Harris: Just as some government-run pro- members—19 in the House and another grams now do, it would basically tell doctors what four in the Senate. Although the legislature they can and can’t do, what they should and shouldn’t still is composed predominantly of attorneys Rep. Harris: Well, I’ve got to tell you, the task in do for an individual patient. and people from the business world, now front of us is pretty daunting. Our major issues are that there’s a corps of physicians that is going to be solving the nation’s fiscal crisis and deal- AN: But don’t insurance companies do just fairly substantial, the opportunity for the ing with true health care reform. And both tasks are that? perspective of doctors to shape law seems going to take quite a while. to be stronger than ever.

Rep. Harris: But the insurance company doesn’t AN: Let’s talk about health care reform. have the weight and the power and authority of a Rep. Harris: I think there is, and I think we’re at Obviously that’s an important issue for government. And the difference is an insurance com- the point where we have reached a critical mass. We readers of Anesthesiology News. The pany has a contract where it has to pay what it has now have enough physicians to be spread out among American Society of Anesthesiologists [ASA] agreed to pay. As we have seen with the SGR [sus- all the various subcommittees and committees that had some serious reservations about the tainable growth rate] threat, as well as with Medicaid have an influence on health care and health care health care bill as it was initially proposed programs, the government just decides it’s not going policy, and frequently what you need is just to have and then as it became law. Do you see the to pay a provider. at least one voice in these venues that really knows ASA and anesthesiologists as a particular what’s going on in the trenches. And I think that’s constituency of yours?

AN: The House voted yesterday [Jan. 19, what we have in the 112th Congress.

2011] to repeal the bill, but the Senate and And it turns out that the vast majority of phyRep. Harris: Of course, being a physician, I regard the president would never support such a sicians in the House are Republicans, so we have health care as pretty important to anesthesiologists. step. Short of repeal, what do you think you a GOP doctors’ caucus. We have our own Web site Clearly, I can bring some expertise to the legislative and your colleagues on the Hill would be [http://doctorscaucus.gingrey.house.gov/], we have table in Washington that hasn’t been there before. satisfied with? our own policies, we meet regularly as a caucus.

Rep. Harris: The majority of the House is convinced that the American public really didn’t like the process nor the product of the health care reform Rep. Harris: Anesthesiology as a specialty is done by the last Congress. So what we’re going to do really very different from other specialties, not only is use our power of appropriations to slow the impleobviously in the body of knowledge but in the way mentation of this bill down until the American public it’s dealt with by insurers and by the federal govern- understands just how damaging it would be to health ment. We have a billing system that’s unique and not care in this country and allow, if necessary, another well understood outside the specialty. Our role in the election to occur where we could get a Senate and/or hospital and in the operating room and in the deliv- a president who agrees that we need to have reform, ery of critical care also is one that the public needs to but not reform as it was done by the last Congress. learn more about. I think that could be very useful as we go forward in health care reform.

AN: You made repeal of the health care law a major part of your campaign, but AN: What are your biggest gripes with the that wasn’t your political awakening. When health care reform law that was passed? did you begin to feel that you had political aspirations?

Rep. Harris: The first is that it unrealistically forecast the cost of implementing the bill. This is a big Rep. Harris: I got involved in advocacy and with problem because what will happen when the govern- my state [anesthesiology] society in the mid-1990s, ment starts running out of money to pay for this bill when it became clear that medicine in general and is it will just dial back reimbursement to health care the specialty of anesthesiology in particular were providers and hospitals, which is exactly what we’re going to be adversely affected by government deciseeing in Maryland now with the Medicaid program. sions, decisions made in legislatures by people who The second thing it did is it really would have frequently didn’t really understand what it meant to involved a government bureaucrat in making deci- deliver health care and how complicated health care sions with regard to the doctor–patient relationship. delivery is.

AN: What sort of perspective do you think would be unique in that regard?

AN: The ASA has endorsed H.R. 451, the Healthcare Truth and Transparency Act of 2011, which would, among other things, make it a crime for a health care provider to misrepresent whether he or she holds a state medical license or the nature of his or her “education, training, degree, license or clinical expertise.” The bill cites public “confusion” about the training and skills of health care providers, and although it’s silent about particular providers, the ASA clearly would like patients to have a better understanding of the differences between nurse anesthetists and anesthesiologists.

Do you support this bill?

Rep. Harris: Yes, I support the legislation. With all the different types of providers who help deliver modern health care, this act will clear up some of the confusion that would exist in the minds of patients as they navigate a complex health care system.

AN: It’s a little early yet, but what have you learned in the last three weeks or so about Congress that you didn’t know?

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AnesthesiologyNews.com I 9

PR N Rep. Harris: Well, I would say that although there are 435 members in the House, pretty quickly you get to know a lot of them and you get to know them well enough so that when issues come up where I feel it would be important for them to know the perspective of anesthesiologists, I’ll feel very comfortable going up to them and being able to discuss it with them.

AN: What are some of your other signature issues, things that you want to accomplish besides health care reform or deficit reduction?

Rep. Harris: One thing I’d like to do is pass a term limits bill. I’ve actually term-limited myself to 12 years. I think that to be honest, the country probably would be better off with term-limited officials in Congress and I think we should have that discussion. So the first bill I signed up to co-sponsor was a term limit bill, two, in fact. I’m under no illusion that the prospects are great, but on the campaign trail I heard over and over again that the American public wants to bring that up. Of course, it would have to be a constitutional amendment.

AN: So, are you commuting or have you taken a place in D.C.?

Rep. Harris: I’m commuting from Baltimore. I’m home every night.

AN: Are you still seeing patients?

Rep. Harris: I will continue to practice probably one morning a month. There are strict limitations on earning outside income especially as a physician, but I should be able to work about one morning a month.

AN: And do you have a specialty in anesthesia?

Rep. Harris: Yes, obstetric anesthesiology. I was in an academic setting.

But now I’m on leave from the academic practice and over the next two years my practice will be in a community hospital in Easton, Md. AN: During your initial tour of the Capitol, you reportedly ran into a little bit of a controversy regarding health insurance for members. According to news reports, you asked about when they would kick in and were

surprised to hear that there would be a delay. I’d like to ask you about that. Did you learn anything from that exchange and if so, what?

believe that, in fact, if we let the gov- because the answer is no, I have other ernment run health care, it will run as insurance. inefficiently as it appears.

AN: Do you think that your AN: Do you have your own colleagues should do the same? insurance or are you taking Rep. Harris: Well, the interest- federal coverage?

Rep. Harris: They should do whating thing is that one blog reported ever is best for them and their family. an unconfirmed report by a Demo- Rep. Harris: I have my own cov- When you’re getting health care insurcrat staffer of a question I asked that erage, and that’s what surprised me a ance coverage for you and your family, pointed out the inefficiencies of gov- little bit. No one bothered to ask me it’s an individual decision made in the ernment-run health care. I continue to if I was going to take the insurance best interests of you and your family. ■

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TECH NOLOGY

OR Safety Report Cites Risks From Health IT Annual list of hazards highlights benefits of device interoperability

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ntil interoperable health care devices and electronic health record sharing become commonplace in the nation’s hospitals, patient safety will be compromised by information holes left by data loss, incompatible systems and other information technology (IT) complexities, as well as by the incomplete sharing of handwritten notes in patient charts.

That is one key implication of the ECRI Institute’s Top 10 Health Technology Hazards For 2011 report, which warns that “ineffective convergence can adversely affect patient care in a wide variety of ways.” According to the document, “Data overwritten, unsuccessfully transmitted, or associated with the wrong patient … can lead to misdiagnosis, inappropriate treatment, or the need for repeat testing.”

The fourth annual report, which ran in ECRI’s November 2010 issue of Health Devices (www.ecri.org/2011_ top_10_hazards), cited an FDA study that classified health information technology (HIT) errors into four groups: commission (a patient’s data is overwritten into a different patient’s study); omission or transmission (manually entered patient data gets overwritten during automatic updates); data analysis (such as incorrect labels for rates of IV fluid infusion); and incompatible systems and software applications.

Complications related to HIT are drawing increasing attention from the government. A federal push is under way to share patient information across proprietary systems in real time, using a universal standard and protecting patient privacy by 2013, according to a December 2010 report by the President’s Council of Advisors on Science and Technology (PCAST).

Need for Speed—and Care But Dan Alt, manager-problem reporting system at ECRI, in Plymouth Meeting, Pa., cautioned against “the risks presented by rushing.”

“Hospitals do need to move quickly to meet the deadline,” Mr. Alt said. “But that makes it all the more important to involve all the right parties—clinical leads, administration, IT—from the outset. If individual clinical groups rush ahead based only on input from vendors, effective integration is unlikely.”

Mr. Alt said makers of medical devices continue to add to the ability to export data. “But that’s still a long way from plug and play. Hospitals still need to carefully assess whether the information exported by a device can be successfully integrated into their clinical IT system in a way that’s meaningful and consistent with their needs,” he said. Still, Mr. Alt noted, hospitals can make the transition safely— “provided that they follow the right roadmap from the beginning.”

Boston anesthesiologist Julian M. Goldman, MD, medical director for biomedical engineering at Partners HealthCare System, cited a potential live guideline for hospitals’ quest to advance interoperability

and health information exchange. The estimated 15% of hospital-based anesthesia practices that use anesthesia information management systems have relatively rich experiences with compatible technologies and devices at critical points of patient care that could help guide health care networks designing broader, effective compatibility programs, he said.

Mr. Alt said anesthesiologists are “key players in dealing with patients at their time of greatest vulnerability, and should have a strong voice in the integration process.”

Although “anesthesiologists have the lowest tolerance for any error, it is most constructive when clinicians and department heads articulate their fundamental needs to IT planners, so they can accelerate the project while matching realistic first-day quality requirements,” said Eric Sacks, director of health care product alerts at ECRI. “Set aside the wish lists.”

‘Clocks on these devices are set manually, and are usually wrong because they drift. If a patient has awareness under anesthesia, how do you go back in a record and correlate the data from the [bispectral index monitor], agent analyzer, etc, to figure out what happened if all the time stamps are off?’

—Julian M. Goldman, MD Mr. Alt added that “clinicians should be mindful not to get caught up with salespeople who seem to speak their language but may not understand the broader needs and realities of that hospital. The hospital’s IT department should be a major player from the start, determining what each vendor can really do and asking for demonstrations of compatibility.”

Cracking the ‘Core Problem’ Dr. Goldman, who directs the Medical Device Interoperability Program at the Center for Integration of Medicine & Innovative Technology, and is a staff anesthesiologist at Massachusetts General Hospital, said his takeaway from the PCAST report was that “we’ve come a long way in health IT, but we haven’t cracked the central problem of developing a core means of sharing information in an open, nonproprietary format.

“Our needs in anesthesia and other high-acuity

critical care areas are not yet being addressed for the most part by the national agenda. We’re not collecting physiological waveform data, for example. If we’re trying to review a patient’s record and see if there are any artifacts that could explain apparently erroneous data, we have no standard way of collecting them.”

In October, Dr. Goldman’s Medical Device “Plugand-Play” program received a $10 million grant from the National Institutes of Health to help create a prototype “health care intranet” for “the rapid delivery of innovative clinical applications and error-resistant medical device systems.”

Another sign of building momentum for intraoperability efforts: In February, the health care technology firm Omnicell, Inc. released results of a survey showing that 75 of 100 hospital IT executives it polled at HIMSS 2011—a health technology conference—called intraoperability “critical to operational effectiveness.”

In a presentation to PCAST last November, Dr. Goldman detailed the time-stamp problems inherent in medical equipment such as pulse oximeters, blood gas monitors, infusion pumps and cardiac output monitors. “Clocks on these devices are set manually, and are usually wrong because they drift,” he said. “If a patient has awareness under anesthesia, how do you go back in a record and correlate the data from the [bispectral index monitor], agent analyzer, etc, to figure out what happened if all the time stamps are off ?”

Dr. Goldman, a member of the editorial board of Anesthesiology News, likened systems integration to a series of concentric layers, a visual concept he credited to Doug Rosendale, DO, of the Office of Health Information/Joint Interoperability Ventures of the Veterans Health Administration.

The outermost layers are between separate institutions and medical records systems (where national funding is directed).

Closer to the patient is sharing between different clinics within a building. Closest is communication between devices and a patient’s electronic health record.

“Our goal isn’t only to look back and review records seamlessly, but to have real-time information on hand, in advance of the two-minute window before we meet a patient being wheeled into the OR,” Dr. Goldman said. “We also want lab data in the OR, and we want our anesthesia records available postoperatively, for example.”

Another hazard included in the ECRI list is luer misconnections, which could lead to gases or liquids entering the wrong lines. “As soon as you pick up a stand-alone connector, think about what’s wrong.

You shouldn’t have to force things together,” Mr. Alt said. “Not long ago, blood pressure pumps used luer connectors. If a pump was mistakenly connected to an IV line, you’d have an instant air embolism.”

—Al Heller

1 2 I A n e s t h e s i o l o g y N e w s . c o m Ma r c h 2 0 1 1

TECH NOLOGY

Bar-Code Scanners Improve Transfusion Safety

to measure how often someone actually brings New systems slow to catch on, but advocates point to results the wrong blood ransfusion errors, although years ago, according to the researchers. institution has managed to avoid sev- up to the wrong rare, are among the most con- Since its inception, only one patients eral cases in which the incorrect blood person. We can cerning complications that can received the wrong blood product— products were brought to patients. measure that, John Kemp, MD occur in the hospital. Not surprisingly, “and that occurred as the system was These near-misses have occurred a lit- and we know facilities have built elaborate systems being rolled out on a unit where it tle more than once per month, the how often people fail to scan. And right of checking and rechecking to pre- was being used for the first time,” they researchers reported. now, the probability is that these events vent such errors—yet they continue to noted. The researchers are aware of no “Failure to scan occurs at a rate of should coincide every 8.75 years.” occur, generally as a result of lapses and other “misadministration events.” about 1%, which sounds like a horrible The Iowa group also came to bypassed processes.

However, thanks to the bar codes the number,” Dr. Kemp said. “But you have realize that, to truly capture all Anesthesiologists at the University of Iowa, in Iowa City, have found that bar-code technology can greatly reduce the odds that a transfusion error will reach a patient. Since implementing the system six years ago, the institution has Meet JED™ . reduced the likelihood that a patient will receive a unit of mismatched blood A helpful hand in MAC product from one case every 1.25 years airway management. to one every nine years.

Who’s JED™? The newest tool from LMA™ What’s more, the technology has freed and Hypnoz. This jaw elevation device helps hospital staff from the onerous—but you simply and safely maintain an open previously necessary—method of veriairway during sedation procedures. So your fying blood products. Without bar codhands aren’t tied up performing manual chin ing, two staff members were required lifts and jaw thrusts. to ensure that each unit was appropriate for a given patient. Now, thanks to the scanner, that process is automated and can be set to report as often as every IN THE OR eight seconds, the group said.

JED™ creates the ideal solution for hands-free airway management.

“Anesthesiologists should be extremely interested in this. It’s simple and it’s easy and quick—and it’s very reliable,” said Current solutions are available but John Kemp, MD, director of clinical not ideal. laboratories at Iowa. “They trust it and As sedation relaxes the tongue and soft tissues they like it and they defend it.” around the airway, this commonly leads to In a poster presented at the 2011 upper airway obstruction. Oral airway and nasal annual meeting of the Society for Techtrumpets are frequently utilized options. These nology in Anesthesia, Dr. Kemp and devices can be helpful, but they often require a his colleague, anesthesiologist Franklin deeper level of anesthetic and can cause patient coughing, gagging or bleeding.

Scamman, MD, described their experience with bar coding blood products (abstract 53).

T

Go Hands Free.

Bold Move Pays Off The custom-designed system was knitted into the hospitals’ existing electronic record-keeping infrastructure.

Its eight functions range from printing bar codes—with printers in every operating room—to verifying labels on patients, blood products and order forms, scanning units sent back to the blood bank and recording the history of transfusions at Iowa to create a digital trail should something go wrong.

“We decided to do it all at once all throughout the hospital, which was a bold step,” Dr. Kemp said. “It was possibly a little bolder than I thought it was, but it has worked out to exceed expectations.”

The system has recorded more than 700,000 scans since it went live six

Performing a manual jaw thrust or a chin lift is probably the most frequently used option to secure an airway. Manual manipulation of the patient may be intermittent or continuous, and while the maneuver is not difficult for the anesthesia provider to perform, it can fully occupy a clinician’s hands, making other tasks difficult or impossible to do.

JED™ helps providers manage the patient’s airway, allowing them to induce a deeper level of anesthesia because the airway is patent and obstruction is not an issue.

JED™ is fast and easy to use. A memory foam head support comfortably secures the head in a forward position. The patient is next placed in a sniffing position and disposable foam mandible cups are placed under the angle of the mandible to obtain a jaw thrust. The three-way adjustable apparatus allows you to position your patient anywhere from a sniffing position to a full jaw thrust, if required. Once placed, intervention is rarely necessary.

JED™ works on a wide range of patient types, from obese to normal adult and pediatric patients.

Ma r c h 2 0 1 1

AnesthesiologyNews.com I 13

TECHN OLOGY potential errors, for every procedure involving a transfusion they had to reconcile all blood products that had been released from the blood bank, everything that had been administered to the patient and whatever came back unused.

“As a past witness to a fatal intraoperative acute hemolytic transfusion reaction—I was asked to help resuscitate the crashing patient—I applaud this development,” said D. John Doyle,

MD, PhD, immediate past-president of the STA and professor of anesthesiology at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in Ohio. “Bar coding for drugs also makes sense if deployed with appropriate attention to workflow considerations,” noted Dr. Doyle, a member of the editorial board of Anesthesiology News. “At Cleveland Clinic we use bar-coded surgical sponges; this initiative has proven to be very fruitful.”

Additional Help for Fiberoptic Intubations In difficult-to-intubate patients, fiberoptic intubation is a reliable and common method. But it often requires a second pair of hands to improve laryngeal exposure via a manual jaw thrust. JED™ can maintain a patient in a jaw thrust position, thus alleviating the need for an assistant or an extra set of hands during the procedure.

BEYOND THE OR JED’s™ helping hand extends into applications outside of the OR too.

Speedy help in recovery rooms.

Recovery rooms can rapidly become a place of chaos. Often a single recovery room nurse is overseeing multiple patients who may each have individual airway needs. When faced with a patient experiencing difficulty, the PACU nurse needs to act swiftly and often independently.

A jaw thrust maneuver is commonly performed to help the patient regain a patent airway. Not only will the nurse have to be cautious not to hyperextend the neck, but several other steps are required for a successful jaw thrust. Complications caused by other factors, such as pre-existing medical conditions, patients with difficult airways, obese or sleep apnea patients, add to the difficulty of maintaining an open airway.

JED™ eliminates the need for a recovery room nurse to perform any external manipulation (jaw thrust) or revert to using an internal airway method on recovering patients; when left in place after a procedure, JED™ helps provide an open airway until sedation wears off.

www.LMANA.com For more information, please call 1-800-788-7999.

LMA™™ FAMILY OF PRODUCTS LMA Airway Management™™ || LMA LMA EMS EMS™™ || LMA LMA Visualization Visualization™™ || LMA LMA Pain Pain Management Management™™ || LMA LMA Atomization Atomization™™ Authorized Authorized NA NA Representative: Representative:LMA LMA North NorthAmerica, America,Inc. Inc.4660 4660 La La Jolla JollaVillage Village Dr., Dr.,Suite Suite 900 900 San San Diego, Diego,CA CA 92122 92122 P: P:800-788-7999 800-788-7999 F:F:858-622-4130 858-622-4130 Copyright Copyright © © 2011, 2011, The The Laryngeal Laryngeal Mask Mask Company Company Limited Limited LMA, LMA, The The Laryngeal Laryngeal Mask Mask Company Company Limited Limited logo logo and and its its component component parts parts are are trademarks trademarks of of The The Laryngeal Laryngeal Mask Mask Company Company Limited.

Limited. LMANA-100160 LMANA-100160 LMA-598 LMA-598 01/11 01/11 The The JED JED logo logo and and its its component component parts parts are are trademarks trademarks of of the the Hypnoz Hypnoz Therapeutic Therapeutic Company, Company, Inc. Inc. Hypnoz Hypnoz Therapeutic Therapeutic Company, Company, Inc. Inc. manufactures manufactures the the JED JED product. product. JED JED isis distributed distributed exclusively exclusively inin the the U.S. U.S. by

by LMA LMA North North America America Inc. Inc.

Despite Results, Lack Of Adoption Yet, despite mounting published data showing the benefits of bar coding for transfusion safety, the technology hasn’t caught on in the United States.

Dr. Kemp said he cannot understand the lack of traction.

“There may be multiple ways to skin this cat, but we stumbled across a way that works. The data just are unchallengeable, in my opinion, in terms of the safety implications of what has happened. Some people read the literature; some people don’t.”

One place where hospitals have been more welcoming on bar coding their blood is the United Kingdom. The driving force behind the spread of the technology there is Michael Murphy, MD, professor of hematology at Oxford Radcliffe Hospitals. Dr. Murphy has been an evangelist for bar coding the country’s blood products for more than a decade, and has conducted some of the seminal research on the topic.

“We had had some serious wrongblood events prior to 2000 and we’ve had none since,” Dr. Murphy said. The improvement is the direct result of better compliance with safety checks— absolute fidelity, he said—under the bar-code regime. “Before we implemented the system, the correct checks were only carried out in about onethird of transfusions. With the system, it drives 100% compliance with correct checks.”

Although it might seem all that checking would slow down the process of administering blood products, Dr. Murphy said the opposite is true. “We do half the number of checks with the electronic system than with the previous system, and it takes half the time.”

The reason is that scanning bar codes requires one nurse instead of the two needed without the technology, eliminating layers of complicated and time-consuming checking (there’s no evidence, however, that two nurses do a better job than one, even without bar coding, he added). “And the staff like it,” he said. “They feel confident that they know what they’re doing and they’re doing it right.”

A ‘Coke Machine’ for Blood Dr. Murphy also is working on a technology called “electronic remote blood issue.” That sounds like something made in a Hollywood basement but it’s really what he calls a sophisticated “Coke machine” intended to help hospitals manage their blood products more safely and efficiently. see bar code page 14

1 4 I A n e s t h e s i o l o g y N e w s . c o m Ma r c h 2 0 1 1

TECH NOLOGY Bar code continued from page 13 Marketed by Haemonetics Corp., of Braintree, Mass., the system— BloodTrack HaemoSafe—combines bar coding with an electronically controlled blood refrigerator housed in hospitals that rely on outside transfusion labs to screen patient samples. Under the conventional model, these hospitals must send out blood samples for antibody screening, then wait for the results—and, quite

often, the correct blood product—to arrive before they can proceed with a transfusion.

“With electronically controlled blood fridges, rather than labeling the units in the central lab and transporting them back to the hospital, the staff can query the transfusion information system at their facility to see if they have a match. The staff can take a unit of blood from the fridge, print off the label, scan it and give it to the patient. The system removes

transportation time and speeds the delivery of blood.”

Last July, Puget Sound Blood Center and Overlake Hospital Medical Center, in Seattle, announced that they were implementing BloodTrack HaemoSafe, becoming the first such collaboration in the United States, according to the blood bank.

Although Britain has been more willing to embrace bar coding for blood (including the refrigerator system) than the United States, Dr.

Murphy said he still sees hesitation. “I think it is because of concern about the up-front investment in technology and providing the resources— staff and otherwise—to implement and maintain it. Of course, they are forgetting the considerable resource they are currently using to support a process that is unsafe,” he said.

Attitudes could change soon, however. In late 2009, the country’s National Health Service endorsed Dr. Murphy’s work through its QUIPP program. “It is gradually being used by more hospitals in the U.K.,” Dr. Murphy said. “But it has not quite yet reached the tipping point.”

—Adam Marcus

ClipChart Victoria, B.C: The former head of anesthesiology at Victoria General Hospital has blamed a shortage of anesthesiologists at the facility for at least two cases of serious harm to babies born there. One of the babies died, the Vancouver Sun reported. According to the Sun, the former head, Tim Relf, MD, said the Vancouver Island Health Authority has ignored the anesthesiologist shortage for years.

Minneapolis, Minn.: A nurse anesthetist at Abbott Northwestern Hospital has been charged with theft of a controlled substance after she allegedly injected herself with fentanyl meant for a man undergoing surgery to remove kidney stones. When the patient began experiencing severe pain the CRNA, Sarah May Casareto, reportedly told him to “man up here” and later suggested he find his “happy place” to endure the ordeal.

Ms. Casareto also behaved erratically during the procedure, at one point falling asleep, according to news reports of the incident. Ms. Casareto is no longer employed at Abbott Northwestern.

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AnesthesiologyNews.com I 15

POLICY & M A N AGE ME N T

Harnessing the Effects of Group Pressure In Hospital Negotiations: Find Your Buddy

T

he water was deep and dark as the scuba divers were about to jump from the boat’s stern (divers—not diver—because of the buddy system). They knew to never dive alone.

Yet, if you are like most anesthesia group leaders, you don’t think twice about attending—alone—a meeting or negotiation session with two or more hospital administrators. Wait; you, too, need a buddy.

A flashback to college: You are taking Psychology 101 and are required to “volunteer” as the subject for a psychology experiment. You step into a room with a group of four other students. The researcher tells you that a series of posters will be shown one at

Calgary, Alberta: Numb and number?

Two would-be thieves, one armed with a handgun, entered a Shoppers Drug Mart on Feb. 1, demanding the opioid painkiller oxycodone. When informed that the store did not have any of the drug on hand, the thieves—their faces hidden by masks and scarves— changed their request and instead made off with the erectile dysfunction agents sildenafil and tadalafil.

Tallahassee, Fla.: Gov. Rick Scott (R) has proposed killing a computer database advocates hope would help reduce abuse of painkillers in the state. The program, which would monitor the sale of narcotics to patients to identify aberrant prescriptions, was supposed to launch in December but was delayed.

Gov. Scott also has proposed axing the state’s Office of Drug Control, which could find private money for the database. Nearly 1,200 Floridians died of oxycodone overdose in 2009, up more than 100% from the previous year.

a time, each poster displaying a number of dark lines, and that each of you is to announce which two lines are the same length. You are sitting in the fifth position and will be asked for your response last.

At first, it’s obvious to you and your fellow participants which two lines

match. But then, after a few minutes, the other students begin “matching” another set of lines, lines that you see as completely mismatched. What match do you announce?

Of course, the other four students are confederates of the researcher and, in this experiment of the type first

conducted in 1951 by Prof. Solomon Asch at Swarthmore College, they were purposely answering incorrectly to see if others would, too. In the Asch experiment, about 33% of responses given by the subjects conformed to the erroneous pronouncements of the confederate group. And 75% of the participants agreed with the “mistaken” position of the confederates some of the time.

Many anesthesia group leaders view themselves as rugged individualists. see harness page 16

1 6 I A n e s t h e s i o l o g y N e w s . c o m Ma r c h 2 0 1 1

P OLICY & M ANAGEMENT Harness continued from page 15

in scuba diving, there is a lack of safety when outnumbered by the circumstances, even if you know that the others are wrong.

After querying the subjects who sided with the confederates, Prof. Asch discovered several categories of explanations. Some said that they themselves were wrong and that the others were right, so they agreed. Others said they went along with the incorrect answer in order “not to spoil the results.” Some said that even though they knew that

You’ve worked hard to get where you are today and you’re pretty sure—no, convinced—that you have a strong personality. You would never fall sway to group pressure, especially manipulative group pressure.

Although that might be true in connection with situations in which you hold obvious power, such as when chairing meetings of your own group, the Asch experiment indicated that, as

Qutenza® (capsaicin) 8% patch

Other Adverse Reactions Observed During the Clinical Studies of Qutenza: General Disorders and Administration-Site Conditions: application-site urticaria, application-site paresthesia, application-site dermatitis, application-site hyperesthesia, application-site excoriation, application-site warmth, application-site anesthesia, application-site bruising, application-site inflammation, application-site exfoliation, peripheral edema Nervous System Disorders: headache, burning sensation, peripheral sensory neuropathy, dizziness, dysgeusia, hyperesthesia, hypoesthesia Respiratory, Thoracic, and Mediastinal Disorders: cough, throat irritation Skin and Subcutaneous Tissue Disorders: abnormal skin odor

Rx Only

BRIEF SUMMARY OF PRESCRIBING INFORMATION (For complete prescribing information please see package insert.)

DESCRIPTION Qutenza (capsaicin) 8% patch contains capsaicin in a localized dermal delivery system. The capsaicin in Qutenza is a synthetic equivalent of the naturally occurring compound found in chili peppers.

INDICATIONS AND USAGE Qutenza is indicated for the management of neuropathic pain associated with postherpetic neuralgia.

WARNINGS AND PRECAUTIONS Eye and Mucous Membrane Exposure: Do not apply Qutenza to the face or scalp to avoid risk of exposure to the eyes or mucous membranes.

Aerosolization of Capsaicin: Aerosolization of capsaicin can occur upon rapid removal of Qutenza patches. Therefore, remove Qutenza patches gently and slowly by rolling the adhesive side inward. If irritation of eyes or airways occurs, remove the affected individual from the vicinity of Qutenza. Flush eyes and mucous membranes with cool water. Inhalation of airborne capsaicin can result in coughing or sneezing. Provide supportive medical care if shortness of breath develops.

Unintended Skin Exposure: If skin not intended to be treated comes in contact with Qutenza, apply Cleansing Gel for one minute and wipe off with dry gauze. After the Cleansing Gel has been wiped off, wash the area with soap and water.

Application-Associated Pain: Even following use of a local anesthetic prior to administration of Qutenza, patients may experience substantial procedural pain. Prepare to treat acute pain during and following the application procedure with local cooling (such as an ice pack) and/or appropriate analgesic medication, such as opioids. Opioids may affect the ability to perform potentially hazardous activities such as driving or operating machinery.

Increase in Blood Pressure: In clinical trials, increases in blood pressure occurred during or shortly after exposure to Qutenza. The changes averaged less than 10 mm Hg, although some patients had greater increases and these changes lasted for approximately two hours after patch removal.

Increases in blood pressure were unrelated to the pretreatment blood pressure but were related to treatment-related increases in pain. Monitor blood pressure during the treatment and provide adequate support for treatment-related pain.

Patients with unstable or poorly controlled hypertension, a recent history of cardiovascular or cerebrovascular events may be at an increased risk of adverse cardiovascular effects. Consider these factors prior to initiating Qutenza treatment.

ADVERSE REACTIONS The following serious adverse reactions are discussed in Warnings and Precautions: ApplicationAssociated Pain and Increase in Blood Pressure.

Clinical Trials Experience: Across all controlled and uncontrolled trials, more than 1,600 patients have received Qutenza. A total of 394 patients received more than one tre atment application and 274 patients were followed for 48 weeks or longer. In controlled clinical studies, 98% of patients completed ≥ 90% of the intended patch application duration. Among patients treated with Qutenza, 1% discontinued prematurely due to an adverse event.

Controlled Clinical Studies: Common Adverse Reactions: adverse reactions occurring in ≥ 5% of patients in the Qutenza group and at an incidence greater than in the control group were application-site erythema, application-site pain, application-site pruritus and application-site papules.

Table 1 summarizes all adverse reactions, regardless of causality, occurring in ≥ 1% of patients with postherpetic neuralgia in the Qutenza group for which the incidence was greater than in the control group. The majority of application-site reactions were transient and self-limited. Transient increases in pain were commonly observed on the day of treatment in patients treated with Qutenza. Pain increases occurring during patch application usually began to resolve after patch removal. On average, pain scores returned to baseline by the end of the treatment day and then remained at or below baseline levels. A majority of Qutenza-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate.”

TABLE 1: Treatment-emergent adverse reaction incidence (%) in controlled trials in postherpetic neuralgia (events in ≥ 1% of Qutenza-treated patients and at least 1% greater in the Qutenza group than in the control group) Body System Preferred Term

the others were wrong or acting like sheep, they could not stop themselves from agreeing, too. Finally, some said that they saw their disparate view as a sign of deficiency that they must hide.

Note that the Asch experiment did not single out weak subjects. Prof. Asch found that in a two-person “group” of one confederate and one real subject, the subject was not affected to any real degree by the confederate’s manipulation. With a ratio of two confederates to one subject, the subject agreed with the

DRUG INTERACTIONS No clinical drug interaction studies have been performed.

Data from in vitro cytochrome P450 inhibition and induction studies show that capsaicin does not inhibit or induce liver cytochrome P450 enzymes at concentrations which far exceed those measured in blood samples. Therefore, interactions with systemic medicinal products are unlikely.

USE IN SPECIFIC POPULATIONS Pregnancy - Category B There are no adequate and well-controlled studies evaluating Qutenza in pregnant women.

There was no evidence of fetal teratogenicity in embryofetal developmental toxicological studies conducted in pregnant rats and rabbits in which Qutenza patches (rats) or liquid (rabbits) were applied once daily for a 3-hour duration during the period of fetal organogenesis up to doses corresponding to an 11-fold margin over the maximum recommended human dose [MRHD] based on a Cmax exposure comparison. A peri- and post-natal reproduction toxicology study in rats showed no effects on survival, growth, learning and memory tests, sexual maturation, mating, pregnancy, and fetal development in the offspring of mothers treated with capsaicin up to an 11-fold margin over the MRHD. Labor and Delivery: The effects of Qutenza on labor and delivery are unknown.

Nursing Mothers: There are no adequate and well-controlled studies in nursing women. Studies in rats have demonstrated capsaicin is excreted into breast milk of this species. It is unknown whether capsaicin is excreted in human breast milk. Because Qutenza is administered as a single 60-minute application and capsaicin is rapidly cleared from the bloodstream, mothers can reduce infant exposure by not breast-feeding after treatment on the day of treatment.

Pediatric Use: The safety and effectiveness of Qutenza in patients younger than 18 years of age have not been studied.

Geriatric Use: In controlled clinical studies of Qutenza in neuropathic pain associated with postherpetic neuralgia, 75% of patients were 65 years and older and 43% of patients were 75 years and older. Safety and effectiveness were similar in geriatric patients and younger patients. No dose adjustments are required in geriatric patients.

OVERDOSAGE There is no clinical experience with Qutenza overdose in humans.

There is no specific antidote for overdose with capsaicin. In case of suspected overdose, remove patches gently, apply Cleansing Gel for one minute, wipe off with dry gauze and gently wash the area with soap and water. Use supportive measures and treat symptoms as clinically warranted.

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility: Adequate carcinogenicity studies have not been conducted with Qutenza or capsaicin. Capsaicin was not mutagenic in the Ames, mouse micronucleus and chromosomal aberration in human peripheral blood lymphocytes assays. As with other catechol-containing compounds (eg, dopamine), capsaicin showed a weak mutagenic response in the mouse lymphoma assay. A fertility and reproductive toxicology study was conducted in rats with exposure to Qutenza patches daily for 3 hours/day beginning 28 days before cohabitation, through cohabitation and continuing through the day before sacrifice (approximately 49 days of treatment). The results revealed a statistically significant reduction in the number and percent of motile sperm. Sperm motility obtained from the vas deferens was reduced in all capsaicin treatment groups (16, 24, and 32 mg capsaicin patch/rat/day). Though a “no effect” level was not determined, dose levels used in the study correspond to a 13- to 28-fold exposure margin over the mean Cmax associated with the maximal human recommended dose. Sperm counts were reduced in the vas deferens or cauda epididymis in the 24 and 32 mg capsaicin patch/rat/day dose groups (79 and 69%, respectively) compared to the placebo-patch-treated control group; however, these reductions did not adversely affect fertility. As this animal model has a large excess of sperm-generating capacity relative to the threshold necessary for fertilization, the lack of an effect on fertility in this species is of unknown significance for human risk assessment.

DOSAGE AND ADMINISTRATION Special precautions: • Only physicians or health care professionals under the close supervision of a physician are to administer Qutenza. • Use only nitrile gloves when handling Qutenza, and when cleaning capsaicin residue from the skin. • Immediately after use, dispose of used and unused patches, cleansing gel, and other treatment materials in accordance with the local biomedical waste procedures. • Use Qutenza only on dry, intact (unbroken) skin.

Dosing: The recommended dose of Qutenza is a single, 60-minute application of up to four patches.

Treatment with Qutenza may be repeated every three months or as warranted by the return of pain (not more frequently than every three months).

Qutenza 60 minutes (N = 622) %

Control 60 minutes (N = 495) %

Application-Site Erythema

63

54

Application-Site Pain

42

21

Application-Site Pruritus

6

4

Application-Site Papules

6

3

Application-Site Edema

4

1

Application-Site Swelling

2

1

Application-Site Dryness

2

1

HANDLING AND DISPOSAL Qutenza contains capsaicin capable of producing severe irritation of eyes, skin, respiratory tract, and mucous membranes. Do not dispense Qutenza to patients for self-administration. It is critical that health care professionals who administer Qutenza have completely familiarized themselves with proper dosing, handling, and disposal procedures before handling Qutenza to avoid accidental or inadvertent capsaicin exposure to themselves or others [see Dosage and Administration].

Do not touch Qutenza, treatment areas, and all used supplies or other materials placed in contact with the treatment area without wearing nitrile gloves. Wear nitrile gloves at all times while handling Qutenza and cleaning treatment areas. Do NOT use latex gloves. Do not hold Qutenza near eyes or mucous membranes. Immediately after use, dispose of used and unused patches, patch clippings, unused Cleansing Gel, and associated treatment supplies in accordance with local biomedical waste procedures.

Nasopharyngitis

4

2

Bronchitis

2

1

PATIENT COUNSELING INFORMATION See Patient Counseling Information section of the full package insert.

Sinusitis

3

1

Nausea

5

2

Vomiting

3

1

2

<1

2

1

GENERAL DISORDERS AND ADMINISTRATION-SITE CONDITIONS

Infections and Infestations

Gastrointestinal Disorders

Skin and Subcutaneous Tissue Disorder Pruritus Vascular Disorders Hypertension

Manufactured for NeurogesX, Inc., San Mateo, CA 94404, USA by Lohmann Therapie-Systeme AG (LTS), Andernach, Germany www.Qutenza.com Qutenza® is a registered trademark of NeurogesX, Inc. © NeurogesX, Inc. 2010 Rev. November 2009 109270-1

erroneous viewpoint close to 14% of the time.

But add just one more confederate to the mix—three con- Mark F. Weiss, JD federates to one subject—and the subjects’ conformity rate more than doubled to almost 32%.

Practical Lessons Let’s go back to your meeting with hospital administration: If it’s to be one on one with the CEO, and assuming you have a strong personality, there is relatively little danger in being swayed against your will. Consider, however, that most senior hospital administrators are well versed in a range of persuasion techniques and have daily practice in deploying them; you probably do not.

Many hospital administrators know better than to meet alone; they love team meetings—their team, of course, with you present. Want to discuss acquiring new intubation equipment?

“Fine,” says the CEO. “Meet with me at 4:00 and I’ll have the COO, the CFO and the OR director attend so that we can get their input.”

Prof. Asch discovered that having even one truthful partner—a buddy— accompany the subject depleted the majority of most of its power.

Before diving into the next meeting with any opposition party, bring along a buddy. In fact, make the buddy system your group’s regular meeting paradigm, but prepare ahead of time to make sure that your buddy is going to agree with you no matter what. The buddy must understand that the meeting is not an open discussion; his or her presence is to support, in lockstep fashion, your position.

Better yet, attempt to design encounters that stack the “Asch” odds in your favor. When invited by an administrator to a one-on-one meeting, bring along one or two colleagues to create positive group pressure.

Or, go all the way: Invite the administrator to your department meeting and push for agreement then and there.

—Mark F. Weiss, JD Mark F. Weiss is an attorney who specializes in the business and legal issues affecting anesthesia and other physician groups on a national basis. He holds an appointment as clinical assistant professor of anesthesiology at University of Southern California’s Keck School of Medicine and practices with the Advisory Law Group, a firm with offices in Los Angeles and Santa Barbara, Calif., representing clients across the country. He can be reached by e-mail at markweiss@advisorylawgroup.com.

Ma r c h 2 0 1 1

IntuBrite

The following advertorial is provided as a service to our valued advertisers.

It is designed to support the advertisement presented below.

Q. Why does IntuBrite have two lights?

Q. Will the blades work with other handles?

A. The combination of two lights produces an enhanced view of the airway. This blended waveform eliminates the “whitewash” effect of other lighting systems on the market and increases illumination and definition of the airway.

A. No. The brightness of the IntuBrite product line requires a greater power source than that currently provided by competitors’ models.

Q. What is the advantage of the ultraviolet/white LED light combination in the airway?

A. IntuBrite’s proprietary lighting combination of white and ultraviolet (black light) LEDs provide uniquely powerful advantages in illuminating tissues, particularly in the upper airway. The white LED provides overall illumination that is much improved over blade-mounted or fiberoptic incandescent lighting. This is due primarily to the white LED light’s composition of narrow blue, green and yellow wavelengths versus the broad spectrum of incandescent lighting, and provides vastly increased brightness (two to four times) with markedly less reflected glare. These qualities are augmented by the ultraviolet LED light, which is largely invisible when projected yet excites natural fluors in the tissues. Fluors emit light in a unique visible spectrum that is additive to the white LED light, providing unmatched visual detail and a depth of view that other visualization systems simply cannot provide.

This “high-definition” capability provides state-ofthe-art visualization that can help enable easier intubations in the most difficult of anatomies.

Q. What makes IntuBrite’s handles unique?

A. IntuBrite has completely redesigned the laryngoscope handle in order to deliver a better lift angle, a more positive gripping surface, a more reliable power cell and a precision driving circuit for the dual-LED blade set-up. Machined from solid aluminum and offering a robust, click-in, steel connecting head, all IntuBrite handles feature lifetime warranties.

• E-Flex—The E-Flex offers a slightly shorter handle with deeper finger grips. The gentle arc in the handle provides a perfect angle for proper technique and mandible lift. The top thumb groove allows for a lighter grip and greater control while attending to small infants and children.

• E-Classic—The E-Classic is IntuBrite’s version of the traditional “straight” handle.

The E-Classic retains our signature “pistol” finger grips and adds a subtler angle for an ergonomic mandible lift in a more familiar design.

Q. Why do the blade tips not touch the handles upon partial release of the blade?

A. The blades are specifically designed not to contact the handles in order to minimize contamination risk. The blade will “pop off” the handle before the two come into contact.

AnesthesiologyNews.com I 17

Q. Will the handles work with other blades?

A. While our handles might fit competitor blades, they typically provide too much power for traditional blade lighting systems. During testing, it was found that IntuBrite handles often will cause traditional blade lights to malfunction.

Q. How long will the batteries last?

A. Expected battery life is six to nine months under normal working conditions. There are two reasons for this drastically improved life span over current power systems on the market: 1. Traditional handles will register a small amount of voltage running at the connection point when the handle is not in use. This static draw on the battery significantly reduces its life span.

IntuBrite handles are engineered so that no power is lost when the handle is not in use.

2. The use of LEDs in our lighting system is significantly more efficient than incandescent bulbs.

Q. Do I have to buy the battery from IntuBrite?

A. No. Intubrite handles use a 4.5-volt alkaline battery, the type most commonly found in cameras. It can be purchased through many specialty battery retailers or online.

IntuBrite, LLC 2322 La Mirada Dr. Vista, CA 92081 Office: (760) 727-1900 Fax: (888) 244-0213

1 8 I A n e s t h e s i o l o g y N e w s . c o m Ma r c h 2 0 1 1

P OLICY & M ANAGEMENT Value continued from page 1 That model might sound unorthodox, but Bradly J. Narr, MD, chair of anesthesiology at Mayo Clinic, believes it’s a glimpse of the future for his specialty.

The rationale for the arrangement is rooted in Dr. Narr’s conviction that anesthesiologists can do more in hospitals and clinics than merely put patients to sleep and wake them up.

“Brad and I often say, ‘We want everyone to turn a corner anywhere in any Mayo building and bump into an anesthesiologist,” said Mark A. Warner, MD, a Mayo anesthesiologist and president of the American Society of Anesthesiologists (ASA).

The specialty is “extraordinarily well trained to lead or coordinate care” during all phases of the perioperative period, from the moment a surgeon and patient agree on a procedure to the time of discharge, Dr. Warner said. “Our Mayo anesthesiologists are increasingly playing lead roles in each of these periods.”

Mayo anesthesiologists have spearheaded a systemwide effort to reduce blood transfusions through a “continuous oversight program” for the operating room, Dr. Warner said.

Mark H. Ereth, MD, MA, professor of anesthesiology at Mayo, heads the institution’s Comprehensive Blood Management Program. The system “seeks to modify transfusion behavior, ensuring a significant reduction in unnecessary transfusion,” Dr. Ereth said.

“We utilize a combination of sophisticated data collection and analysis, laboratory-guided transfusion algorithms and broad-based educational efforts.”

First applied to cardiac surgery, the program reduced the number of transfused blood products by half, while reducing infection risks and the incidence of renal dysfunction, Dr. Ereth said. “This resulted in millions of dollars in savings to the institution in the first year, while improving care.”

Every dollar Mayo invests in the program saves it more than $10 in transfusion-related expenses, added Dr. Ereth, who said the system is now being rolled out to other clinical areas.

Mayo and the Cleveland Clinic will be hosting a continuing medical education conference, Transformative Fusion (TransFuse 2011) of Innovative Blood Management Technology, in April, on the topic of blood management. “We will be launching an iPad app for blood management and this promises to be an incredibly innovative meeting,” Dr. Ereth said.

Mayo anesthesiologists also are in charge of identifying patients at high risk for developing complications related to obstructive sleep apnea. “We believe that the cost savings associated with reduced complications far exceeds the costs of having anesthesiologists involved in this process,” Dr. Warner said.

Anesthesiologists perform a specialized function— and they get paid accordingly. Last year, the typical anesthesiologist could expect to earn more than $330,000, according to Merritt Hawkins, a health care recruiter and consultancy.

But the high earnings might not last long. Forces from several sides—budget pressures in hospitals, state laws proposing the substitution of nurses for physiciandelivered anesthesia, general attempts at cost savings in health care, to name a just few—could take a toll on salaries or at least curb their growth.

Meanwhile, efforts by the government to push

quality improvement initiatives will increasingly affect anesthesiologists. The Centers for Medicare & Medicaid Services continues to expand its roster of reasons to discount reimbursement to hospitals. The list now includes 46 measures, with two new items—perioperative temperature control and timely removal of urinary catheters—landing squarely in the province of anesthesiology.

To be sure, the quality movement is far from a solely external force. The speciality itself is pushing greater attention to performance and outcomes. The Anesthesia Quality Institute, an offshoot of the ASA but a separate entity, is developing clinical benchmarks based on practice data. And the American Board of Anesthesiology now requires assessment of performance by anesthesiologists who are enrolled in the Maintenance of Certification in Anesthesiology (also known as MOCA).

How, then, can anesthesiologists demonstrate to hospital administrators, lawmakers and, perhaps most important, the taxpaying public (patients) that they’re worth the money?

“If we’re looked at as a cost center, we’ll be at the bottom of the barrel. We have to demonstrate our efficiencies,” said Jacques Chelly, MD, PhD, MBA, professor and Director of the Division of Acute Interventional Perioperative Pain and Regional Anesthesia at the University of Pittsburgh School of Medicine.

One way to prove worth in the hospital is to be indispensable, Dr. Chelly said. That means wearing as many hats as will fit. “If we say ‘no’ too often, we will not be the people the hospital cannot do without,” he said. “At the end of the day, we pay for that. We have to get involved at every level.”

Peter Walker, MD, senior partner at North American Partners in Anesthesia (NAPA), a large group practice operating in five states, said the specialty has changed permanently.

“I think that clearly, anesthesia is the middle of the economic engine of the hospital,” Dr. Walker said.

Hospitals increasingly rely on surgical procedures and other interventions for their profits, Dr. Walker said.

Years ago, those procedures almost always took place in the operating room (OR). Now, an ever-larger number are occurring outside the OR, in catheterization labs, high-end bronchopulmonary suites, endoscopy units and elsewhere.

“Anesthesia needs to take ownership of the episode of procedure care,” from preprocedure evaluation to the postanesthesia care unit and beyond, Dr. Walker said.

Whether a hospital has 750 beds or 75, “the theme is the same: Hospitals need people who can facilitate.”

For anesthesiologists, that means taking steps to avoid fragmentation of care, duplication of both processes and procedures and miscommunication. Preventing cancellations Mark A. Warner, MD is another key function. “It’s a big loss to everybody,” from the patient to the hospital administration.

Like it or not, Dr. Walker said, that shift has profound implications for anesthesia providers. “The anesthesiologist who wants to hide out in room 3 and work from 8 a.m. to 5 p.m. isn’t going to be able to be doing that much longer,” he said. “The world expects more of that person.”

Indeed, large groups like NAPA, which consists of more than 400 anesthesiologists and half as many certified registered nurse anesthetists, don’t just tolerate clinicians who take on responsibilities beyond the conventional, they encourage them. “We reward people for working outside of the operating room,” Dr. Walker said. “Our leaders become leaders beyond the realm of anesthesia. They get to know the fabric of the institution.”

Two NAPA anesthesiologists have served as presidents of their hospitals’ medical staffs; several more are division chiefs who hold seats on their institutions’ quality committees. Dr. Walker has done two stints as medical director for North Shore University Hospital, in Great Neck, N.Y., where he helped found NAPA more than 25 years ago.

What about the scrubs-to-ski slope lifestyle featured in recruiting advertisements at meetings and speciality journals? Although it will still be possible for physicians to juggle work and life for maximal reward, being part of a team will be the best way to achieve the best balance, Dr. Walker said.

“You have to be part of a team, and you have to be part of a team that reverences the need for time off,” he said.

Dr. Narr admitted that Mayo’s experience might not translate well to smaller institutions. “We have an economy of scale” that allows clinicians to extend themselves without snapping. “I can have 15 critical care anesthesiologists cover three intensive care units.

You need to get the group big enough.”

Not everything requires scale, however. As Dr. Chelly noted, an anesthesia department that wrings efficiencies out of its daily operations will earn the gratitude of hospital administrators. Dr. Chelly and his colleagues were able to slash their yearly drug budget by $1 million by switching to cheaper local anesthetics.

Dr. Warner agreed. “The reduction of one postoperative pneumonia because an anesthesiologist intervened, provided the right antibiotics at the right time, implemented postoperative positioning orders to raise the head of a ventilated patient or started another intervention results in a savings of approximately $27,000,” he said. “If anesthesiologists’ efforts reduce length of stays, number of transfusions and the complications that accompany them, and improve patient satisfaction and safety, it is logical that medical center and facility administrators will find value in this extension of anesthesia practice.”

Or, as Dr. Narr put it, “Eliminating outliers has a huge impact on the bottom line.”

—Adam Marcus

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2 0 I A n e s t h e s i o l o g y N e w s . c o m Ma r c h 2 0 1 1

P OLICY & M ANAGEMENT

Getting Serious About Government Regulations San Diego—Devising and implementing a complineed to be savvy, because there’s so much inforance program might be daunting for a private anesmation to keep on top of,” Mr. Byrd said. thesiology practice to consider, but doing so can 2. When implementing compliance programs and make life a lot easier in the long run. Indeed, datapractice standards, the documents need to be driven compliance programs not only make good well written and clearly communicated. Somebusiness sense, they soon may be federally mandated. times this means being transcribed into other “When it comes to things like compliance issues, languages, depending on the practice or hospital. you need to be very much aware that there are potential criminal implications,” said Jason Byrd, JD, director of practice management, quality and regulatory affairs for the American Society of Anesthesiologists.

“And when things go wrong, there’s no spe‘And when things go wrong, cial physician prison you go to. It’s real there’s no special physician prison with hardcore inmates.”

The Magnificent Seven Creating a compliance program begins with an understanding of what it is: a formalized set of practices that help ensure that a government agency’s regulations are being met. With that in mind, Mr. Byrd laid out the seven primary elements of a comprehensive compliance program, as described by the Department of Health and Human Services Office of Inspector General (OIG): 1. Internal monitoring and auditing needs to be performed on a scheduled basis, and by welltrained and experienced auditors. “They really Advertisement

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prison you go to. It’s real prison with hardcore inmates.’

—Jason Byrd, JD

3. Designate a compliance officer. “The federal government says this should not be your general counsel,” Mr. Byrd explained. “It also needs to be someone in a position that has direct communication with your board and doesn’t answer to anyone else.” For physicians in solo practice or small groups, the compliance officer should be the practice manager or one of the doctors, not an employee of a billing company.

4. Proper access to high-quality training and education is critical. More important is that such training be tailored specifically to the practice.

5. Open lines of communication allow concerned employees to speak freely, without fear of retribution. Employees also need assurances that their concerns will be taken seriously and dealt with appropriately. All physicians should be present at mandatory monthly meetings with clinical, coding and billing staff to review the past month’s coding concerns and randomly review how well charting supports the coding.

6. Once a problem has been identified, the practice must be able to take appropriate corrective action.

7. The practice must be able to enforce the compliance program through well-publicized guidelines.

Compliance programs have always helped private practices guide the scope of their services, Mr. Byrd said, but the increasing complexity of federal statutes and regulations make them more important than ever. “There are attorneys out there that make a living on the Stark law itself because it’s so complicated and dependent upon facts,” he said.

Anesthesiologists should be aware of the areas of their practice that are likely to draw attention from government and outside agencies such as recovery audit contractors (RACs). Facet joint injections,

for example, have been the subject of several OIG reports (see Anesthesiology News, January 2010, page 8). Anesthesia stop and start times also have been drawing attention recently, and government agencies have expressed an interest in examining appropriate protocols for transfer of care and handoffs in teaching facilities. “Documentation is already a big issue and will only get bigger,” Mr. Byrd said.

Effective compliance programs begin with a commitment to the idea that they will ultimately benefit the practice, an idea supported by a 2001 study in Academic Medicine (76:266-272) that found gross collections increased by more than 7% after implementation of a compliance program.

“But you have to remember that just having a compliance program and throwing it on the table is not going to be good enough if you’re investigated,” Mr. Byrd warned. “You have to look at your data, monitor your program and tailor it to your needs. And if you didn’t previously buy into the idea that compliance programs are necessary, new health reform legislation is going to mandate it.”

Section 6401 of the Patient Protection and Affordable Care Act of 2010 grants the secretary of the Department of Health and Human Services the authority to require health care providers to adopt compliance programs as a condition of participation in Medicare and Medicaid, Mr. Byrd said.

However, the section lacks specifics on time lines and which providers will be subject to these requirements.

“All of this is left to the secretary to determine,” Mr. Byrd said. “The lone exception is skilled nursing facilities, which are specifically identified in Section 6102 and have guidance. Most folks with whom I discuss this issue will say, and I agree, that it is merely a matter of time before [the Centers for Medicare & Medicaid Services] issues rule-making requiring hospitals to develop compliance plans. The next question is whether physician practices will follow.”

Douglas G. Merrill, MD, director of perioperative services at Dartmouth-Hitchcock Medical Center, in Lebanon, N.H., said every physician should understand the rules Mr. Byrd reviewed—and obtain professional help to be sure.

“All physicians must have professional coders and practice managers performing regular internal and external audits, and should retain legal counsel with expertise in health law,” Dr. Merrill said. “Compliance programs are quite easy to implement with such support.”

Professional resources are simply part of the costs of running a practice for every medical specialty, Dr. Merrill added. “In most areas, even those that are rural or remote, access to practice and billing specialists is available to help each of us set up, oversee and regularly audit our work. Each practice must have a monthly meeting of all practitioners and coders and a compliance officer. Even solo practitioners must obtain this expertise and cannot depend solely upon their billing service.”

—Michael Vlessides

e nt n se rta tio se po ma ea Im or Pl sed Inf y clo fet en Sa w Ne

WHEN CHOOSING AN IV SEDATIVE

Different situations require different solutions

Precedex : A right fit ®

FOR TODAY’S SEDATION MANAGEMENT PRACTICES

e nt n se rta tio se po ma ea Im or Pl sed Inf y clo fet en Sa w Ne

DIFFERENT SITUATIONS REQUIRE DIFFERENT SEDATIVE SOLUTIONS The first and only alpha2 agonist indicated for sedation1,2 —Nonintubated patients prior to and during surgical and other procedures1 —Intubated and mechanically ventilated patients during treatment in an intensive care setting1 Can be used alone or in combination with other sedatives or opioid analgesics to provide sedation and added patient comfort.1 Should be administered by continuous infusion not to exceed 24 hours.1 Effective for intubated patients not just before—but also during—and after extubation.1 More than 4.5 million vials administered to millions of patients since launch.3

IMPORTANT PRECEDEX SAFETY INFORMATION Clinically significant episodes of bradycardia, sinus arrest and hypotension have been associated with Precedex infusion and may necessitate medical intervention.

Moderate blood pressure and heart rate reductions should be anticipated when initiating sedation with Precedex.

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

Important New Safety Information In a controlled clinical trial, dexmedetomidine was compared to midazolam for ICU sedation exceeding 24 hours in duration, with maintenance doses of 0.2 to 1.4 mcg/kg/hr. Precedex® was not shown to be superior to midazolam for the primary efficacy endpoint, the percent of time patients were adequately sedated (81% with Precedex versus 81% with midazolam).

Precedex is indicated for administration by continuous infusion not to exceed 24 hours.

The approved maintenance dosages are 0.2 to 0.7 mcg/kg/hr for ICU sedation and 0.2 to 1 mcg/kg/hr for procedural sedation.

The safety information highlighted below applies to the use of Precedex outside of its currently approved dosages and duration.

Warnings and Precautions Withdrawal With administration up to 7 days, regardless of dose used, 12 (5%) Precedex subjects experienced at least 1 event related to withdrawal within the first 24 hours after discontinuation and 7 (3%) experienced at least 1 event 24 to 48 hours after stopping treatment.

The most common events related to withdrawal were nausea, vomiting and agitation.

Tachycardia and hypertension requiring intervention in the first 48 hours following study drug discontinuation occurred at frequencies of less than 5%.

If tachycardia and/or hypertension occurs after discontinuation of Precedex, supportive therapy is indicated.

Tolerance and Tachyphylaxis Use of dexmedetomidine beyond 24 hours has been associated with tolerance, tachyphylaxis and a dose-related increase in adverse reactions [see Table 1 and Table 2].

Adverse Reactions Adverse reactions associated with infusion in ICU patients for periods greater than 24 hours in duration include ARDS, respiratory failure and agitation [see Table 1].

Adverse Event Hypotension1 Hypotension requiring intervention Bradycardia2 Bradycardia requiring intervention Systolic Hypertension3 Tachycardia4 Tachycardia requiring intervention Diastolic Hypertension3 Hypertension3 Hypertension requiring intervention† Hypokalemia Pyrexia Agitation Hyperglycemia Constipation Hypoglycemia Respiratory Failure Renal Failure Acute Acute Respiratory Distress Syndrome Generalized edema Hypomagnesemia

Dexmedetomidine (N=244) 56% 28% 42% 5% 28% 25% 10% 12% 11% 19% 9% 7% 7% 7% 6% 5% 5% 2% 2% 2% 1%

Midazolam (N=122) 56% 27% 19% 1% 42% 44% 10% 15% 15% 30% 13% 2% 6% 2% 6% 6% 3% 1% 1% 6% 7%

e nt n se rta tio se po ma ea Im or Pl sed Inf y clo fet en Sa w Ne

TABLE 1: KEY TREATMENT-EMERGENT ADVERSE EVENTS OCCURRING IN DEXMEDETOMIDINE- OR MIDAZOLAM-TREATED PATIENTS IN THE RANDOMIZED ACTIVE COMPARATOR CONTINUOUS INFUSION LONG-TERM ICU SEDATION STUDY

Includes any type of hypertension.

1. Hypotension was defined in absolute terms as systolic blood pressure of <80 mmHg or diastolic blood pressure of <50 mmHg or in relative terms as ≤30% lower than pre-study drug infusion value.

2. Bradycardia was defined in absolute terms as <40 bpm or in relative terms as ≤30% lower than pre-study drug infusion value.

3. Hypertension was defined in absolute terms as systolic blood pressure >180 mmHg or diastolic blood pressure of >100 mmHg or in relative terms as ≥30% higher than pre-study drug infusion value.

4. Tachycardia was defined in absolute terms as >120 bpm or in relative terms as ≥30% greater than pre-study drug infusion value.

†

The following adverse events occurred between 2 and 5% for Precedex and midazolam, respectively: renal failure acute (2.5%, 0.8%), acute respiratory distress syndrome (2.5%, 0.8%) and respiratory failure (4.5%, 3.3%).

TABLE 2: PERCENT OF SUBJECTS WHO HAD A DOSE-RELATED INCREASE IN TREATMENT-EMERGENT ADVERSE EVENTS BY MAINTENANCE ADJUSTED DOSE RATE RANGE IN THE PRECEDEX GROUP Precedex mcg/kg/hr Adverse Event Constipation Agitation Anxiety Oedema peripheral Atrial fibrillation Respiratory failure Acute respiratory distress syndrome

0.7* N=95

! 0.7 to * N=78

! * N=71

6% 5% 5% 3% 2% 2% 1%

5% 8% 5% 5% 4% 6% 3%

14% 14% 9% 7% 9% 10% 9%

* Average maintenance dose over the entire study drug administration.

Ne enc Pl w los ea Sa ed se fet Im se yI p e nfo ort rm ant ati on

The right fit FOR TODAY’S SEDATION MANAGEMENT PRACTICES

For step-by-step instructions on how to start using Precedex and what to expect, please visit us at www.Precedex.com.

Moderate blood pressure and heart rate reductions should be anticipated when initiating sedation with Precedex.1 Clinically significant episodes of bradycardia and sinus arrest have occurred in young, healthy volunteers with high vagal tone or with different routes of administration such as rapid intravenous or bolus administration.1 Transient hypertension has been observed primarily during the administration of the loading dose. Treatment has generally not been necessary, although a reduction in loading dose infusion rate may be desirable.1

Hypotension and bradycardia can occur and may necessitate medical intervention such as —Decreasing or stopping Precedex infusion —Increasing rate of IV fluid administration —Elevating lower extremities —Administering pressor agents such as atropine, ephedrine or glycopyrrolate1 Use with caution in patients with advanced heart block or severe ventricular dysfunction.1 The most common adverse effects (incidence >2%) are hypotension, bradycardia and dry mouth.1

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

References: 1. Precedex [package insert]. Lake Forest, IL: Hospira, Inc; 2010.

2. Kamibayashi T, Maze M. Clinical uses of α2-adrenergic agonists. Anesthesiology. 2000;93:1345-1349.

3. Data on file. Hospira, Inc.

Hospira, Inc. 275 North Field Drive, Lake Forest, IL 60045 P10-3082-Dec., 10. Printed in the USA.

Advancing Wellness™

For more information on Advancing WellnessTM, contact your Hospira representative at 1-877-9HOSPIRA (1-877-946-7747) or visit www.hospira.com.

Reference EN-2680

Precedex®

(dexmedetomidine hydrochloride) injection

For Intravenous Use Rx only

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

1 1.1

INDICATIONS AND USAGE Intensive Care Unit Sedation Precedex® is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered by continuous infusion not to exceed 24 hours.

Precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex prior to extubation.

1.2 Procedural Sedation Precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

4 CONTRAINDICATIONS None 5 WARNINGS AND PRECAUTIONS 5.1 Drug Administration Precedex should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of Precedex, patients should be continuously monitored while receiving Precedex.

5.2 Hypotension, Bradycardia, and Sinus Arrest Clinically significant episodes of bradycardia and sinus arrest have been reported with Precedex administration in young, healthy volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration.

Reports of hypotension and bradycardia have been associated with Precedex infusion. If medical intervention is required, treatment may include decreasing or stopping the infusion of Precedex, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents. Because Precedex has the potential to augment bradycardia induced by vagal stimuli, clinicians should be prepared to intervene.

The intravenous administration of anticholinergic agents (e.g., glycopyrrolate, atropine) should be considered to modify vagal tone. In clinical trials, glycopyrrolate or atropine were effective in the treatment of most episodes of Precedex-induced bradycardia. However, in some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required.

Caution should be exercised when administering Precedex to patients with advanced heart block and/or severe ventricular dysfunction. Because Precedex decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension and in elderly patients.

In clinical trials where other vasodilators or negative chronotropic agents were co-administered with Precedex an additive pharmacodynamic effect was not observed. Nonetheless, caution should be used when such agents are administered concomitantly with Precedex.

5.3 Transient Hypertension Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive effects of Precedex.

Treatment of the transient hypertension has generally not been necessary, although reduction of the loading infusion rate may be desirable.

5.4 Arousability Some patients receiving Precedex have been observed to be arousable and alert when stimulated. This alone should not be considered as evidence of lack of efficacy in the absence of other clinical signs and symptoms.

5.5 Withdrawal Intensive Care Unit Sedation With administration up to 7 days, regardless of dose, 12 (5%) Precedex subjects experienced at least 1 event related to withdrawal within the first 24 hours after discontinuing study drug and 7 (3%) Precedex subjects experienced at least 1 event 24 to 48 hours after end of

study drug. The most common events were nausea, vomiting, and agitation.

Tachycardia and hypertension requiring intervention in the 48 hours following study drug discontinuation occurred at frequencies of <5%. If tachycardia and/or hypertension occurs after discontinuation of Precedex supportive therapy is indicated.

Procedural Sedation Withdrawal symptoms were not seen after discontinuation of short term infusions of Precedex (<6 hours).

5.6 Tolerance and Tachyphylaxis Use of dexmedetomidine beyond 24 hours has been associated with tolerance and tachyphylaxis and a dose-related increase in adverse reactions [see Adverse Reactions (6.1)].

5.7 Hepatic Impairment Since Precedex clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see Dosage and Administration (2.2)].

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

Use of Precedex has been associated with the following serious adverse reactions: • Hypotension, bradycardia and sinus arrest [see Warnings and Precautions (5.2)] • Transient hypertension [see Warnings and Precautions (5.3)] Most common treatment-emergent adverse reactions, occurring in greater than 2% of patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth.

Intensive Care Unit Sedation Adverse reaction information is derived from the continuous infusion trials of Precedex for sedation in the Intensive Care Unit setting in which 1007 patients received Precedex. The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1), mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2). The population was between 17 to 88 years of age, 43% ≥65 years of age, 77% male and 93% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 2. The most frequent adverse reactions were hypotension, bradycardia and dry mouth [see Warnings and Precautions (5.2)].

Table 2: Adverse Reactions With an Incidence >2%— Intensive Care Unit Sedation Population <24 hours*

Adverse Event Hypotension Hypertension Nausea Bradycardia Atrial fibrillation Pyrexia Dry mouth Vomiting Hypovolemia Atelectasis Pleural effusion Agitation Tachycardia Anemia Hyperthermia Chills Hyperglycemia Hypoxia Post-procedural hemorrhage Pulmonary edema Hypocalcemia Acidosis Urine output decreased Sinus tachycardia Ventricular tachycardia Wheezing Edema peripheral

All Randomized Precedex Precedex Placebo Propofol (N = 1007) (N = 798) (N = 400) (N = 188) (%) (%) (%) (%) 25% 12% 9% 5% 4% 4% 4% 3% 3% 3% 2% 2% 2% 2% 2% 2% 2% 2%

24% 13% 9% 5% 5% 4% 3% 3% 3% 3% 2% 2% 2% 2% 2% 2% 2% 2%

12% 19% 9% 3% 3% 4% 1% 5% 2% 3% 1% 3% 4% 2% 3% 3% 2% 2%

13% 4% 11% 0 7% 4% 1% 3% 5% 6% 6% 1% 1% 2% 0 2% 3% 3%

2% 1% 1% 1%

2% 1% 1% 1%

3% 1% 0 1%

4% 3% 2% 2%

1% 1%

1% 1%

0 1%

2% 2%

<1% <1% <1%

1% 1% 0

1% 0 1%

5% 2% 2%

* 26 subjects in the all Precedex group and 10 subjects in the randomized Precedex group had exposure for greater than 24 hours.

Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of Precedex for sedation in the surgical intensive care unit setting in which 387 patients received Precedex for less than 24 hours. The most frequently observed treatmentemergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 3).

Table 3: Treatment-Emergent Adverse Events Occurring in >1% Of All Dexmedetomidine-Treated Patients in the Randomized Placebo-controlled Continuous Infusion <24 Hours ICU Sedation Studies Adverse Event

Randomized Dexmedetomidine (N = 387)

Placebo (N = 379)

28% 16% 11% 7% 5% 4% 4% 4% 3% 3% 3% 3% 2% 2% 2% 2% 2% 2% 2% 2% 2%

13% 18% 9% 3% 4% 6% 3% 4% 5% 4% 2% 1% 3% 3% 3% 2% 2% 2% 1% <1% <1%

Hypotension Hypertension Nausea Bradycardia Fever Vomiting Atrial Fibrillation Hypoxia Tachycardia Hemorrhage Anemia Dry Mouth Rigors Agitation Hyperpyrexia Pain Hyperglycemia Acidosis Pleural Effusion Oliguria Thirst

In a controlled clinical trial, Precedex was compared to midazolam for ICU sedation exceeding 24 hours duration. Key treatment emergent adverse events occurring in dexmedetomidine or midazolam treated patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 4. The number (%) of subjects who had a dose-related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the Precedex group is provided in Table 5.

Table 4: Key Treatment-Emergent Adverse Events Occurring in Dexmedetomidine- or Midazolam-Treated Patients in the Randomized Active Comparator Continuous Infusion Long-Term Intensive Care Unit Sedation Study* Adverse Event Hypotension1 Hypotension requiring intervention Bradycardia2 Bradycardia requiring intervention Systolic Hypertension3 Tachycardia4 Tachycardia requiring intervention Diastolic Hypertension3 Hypertension3 Hypertension requiring intervention† Hypokalemia Pyrexia Agitation Hyperglycemia Constipation Hypoglycemia Respiratory Failure Renal Failure Acute Acute Respiratory Distress Syndrome Generalized edema Hypomagnesemia

Dexmedetomidine (N=244)

Midazolam (N=122)

56%

56%

28% 42%

27% 19%

5% 28% 25%

1% 42% 44%

10% 12% 11%

10% 15% 15%

19% 9% 7% 7% 7% 6% 5% 5% 2%

30% 13% 2% 6% 2% 6% 6% 3% 1%

2% 2% 1%

1% 6% 7%

† Includes any type of hypertension.

1 Hypotension was defined in absolute terms as Systolic blood

pressure of <80 mmHg or Diastolic blood pressure of <50 mmHg or in relative terms as ≤30% lower than pre-study drug infusion value.

2 Bradycardia was defined in absolute terms as <40 bpm or in relative terms as ≤30% lower than pre-study drug infusion value.

3 Hypertension was defined in absolute terms as Systolic blood pressure >180 mmHg or Diastolic blood pressure of >100 mmHg or in relative terms as ≥30% higher than pre-study drug infusion value.

4 Tachycardia was defined in absolute terms as >120 bpm or in relative terms as ≥30% greater than pre-study drug infusion value.

The following adverse events occurred between 2 and 5% for Precedex and Midazolam, respectively: renal failure acute (2.5%, 0.8%), acute respiratory distress syndrome (2.5%, 0.8%), and respiratory failure (4.5%, 3.3%).

Table 5. Number (%) of subjects who had a dose-related increase in Treatment Emergent Adverse Events by maintenance adjusted dose rate range in the Precedex group Precedex mcg/kg/hr Adverse Event

≤ 0.7* N = 95

> 0.7 to ≤ 1.1* N = 78

> 1.1* N = 71

6% 5% 5% 3% 2% 2%

5% 8% 5% 5% 4% 6%

14% 14% 9% 7% 9% 10%

1%

3%

9%

Constipation Agitation Anxiety Oedema peripheral Atrial fibrillation Respiratory failure Acute Respiratory Distress Syndrome

*Average maintenance dose over the entire study drug administration

Procedural Sedation Adverse reaction information is derived from the two trials for procedural sedation in which 318 patients received Precedex. The mean total dose was 1.6 mcg/kg (range: 0.5 to 6.7), mean dose per hour was 1.3 mcg/kg/hr (range: 0.3 to 6.1) and the mean duration of infusion of 1.5 hours (range: 0.1 to 6.2). The population was between 18 to 93 years of age, 30% ≥65 years of age, 52% male and 61% Caucasian.

Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 6. The most frequent adverse reactions were hypotension, bradycardia, and dry mouth [see Warnings and Precautions (5.2)]. Pre-specified criteria for the vital signs to be reported as adverse reactions are footnoted below the table. The decrease in respiratory rate and hypoxia was similar between Precedex and comparator groups in both studies.

Table 6: Adverse Reactions With an Incidence > 2%—Procedural Sedation Population

Adverse Event Hypotension1

Respiratory depression2 Bradycardia3 Hypertension4 Tachycardia5 Nausea Dry mouth Hypoxia6 Bradypnea

Precedex N = 318 (%)

Placebo N = 113 (%)

54% 37% 14% 13% 5% 3% 3% 2% 2%

30% 32% 4% 24% 17% 2% 1% 3% 4%

1

Hypotension was defined in absolute and relative terms as Systolic blood pressure of <80 mmHg or ≤30% lower than pre-study drug infusion value, or Diastolic blood pressure of <50 mmHg.

2

Respiratory depression was defined in absolute and relative terms as respiratory rate (RR) <8 beats per minute or > 25% decrease from baseline.

3

Bradycardia was defined in absolute and relative terms as <40 beats per minute or ≤30% lower than pre-study drug infusion value.

4

Hypertension was defined in absolute and relative terms as Systolic blood pressure >180 mmHg or ≥30% higher than pre-study drug infusion value or Diastolic blood pressure of >100 mmHg.

5

Tachycardia was defined in absolute and relative terms as >120 beats per minute or ≥30% greater than pre-study drug infusion value.

6

Hypoxia was defined in absolute and relative terms as SpO2 <90% or 10% decrease from baseline.

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

Hypotension and bradycardia were the most common adverse reactions associated with the use of Precedex during post approval use of the drug.

Table 7: Adverse Reactions Experienced During Post-approval Use of Precedex Body System

Preferred Term

Body as a Whole

Fever, hyperpyrexia, hypovolemia, light anesthesia, pain, rigors

Cardiovascular Disorders, General

Blood pressure fluctuation, heart disorder, hypertension, hypotension, myocardial infarction

Central and Peripheral Nervous System Disorders

Dizziness, headache, neuralgia, neuritis, speech disorder, convulsion

Gastrointestinal System Disorders

Abdominal pain, diarrhea, vomiting, nausea

Heart Rate and Rhythm Disorders

Arrhythmia, ventricular arrhythmia, bradycardia, hypoxia, atrioventricular block, cardiac arrest, extrasystoles, atrial fibrillation, heart block, t wave inversion, tachycardia, supraventricular tachycardia, ventricular tachycardia

Liver and Biliary System Disorders

Increased gamma-glutamyl transpepsidase, hepatic function abnormal, hyperbilirubinemia, alanine transaminase, aspartate aminotransferase

Metabolic and Acidosis, respiratory acidosis, Nutritional Disorders hyperkalemia, increased alkaline phosphatase, thirst, hypoglycemia Psychiatric Disorders

Agitation, confusion, delirium, hallucination, illusion

Red Blood Cell Disorders

Anemia

Renal Disorders

Blood urea nitrogen increased, oliguria

Respiratory System Disorders

Apnea, bronchospasm, dyspnea, hypercapnia, hypoventilation, hypoxia, pulmonary congestion

Skin and Appendages Disorders

Increased sweating

Vascular Disorders

Hemorrhage

Vision Disorders

Photopsia, abnormal vision

10

OVERDOSAGE The tolerability of Precedex was studied in one study in which healthy subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hr. The maximum blood concentration achieved in this study was approximately 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest doses were first degree atrioventricular block and second degree heart block. No hemodynamic compromise was noted with the atrioventricular block and the heart block resolved spontaneously within one minute.

Five patients received an overdose of Precedex in the intensive care unit sedation studies. Two of these patients had no symptoms reported; one patient received a 2 mcg/kg loading dose over 10 minutes (twice the recommended loading dose) and one patient received a maintenance infusion of 0.8 mcg/kg/hr. Two other patients who received a 2 mcg/kg loading dose over 10 minutes, experienced bradycardia and/or hypotension. One patient who received a loading bolus dose of undiluted Precedex (19.4 mcg/kg), had cardiac arrest from which he was successfully resuscitated.

6.2

Manufactured and Distributed by: Hospira, Inc. Lake Forest, IL 60045 USA Licensed from: Orion Corporation Espoo, Finland Printed in USA Hospira, Inc., Lake Forest, IL 60045 USA

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AnesthesiologyNews.com I 29

POLICY & M A N AGE ME N T Boldt continued from page 1

The Klinikum Ludwigshafen, where Joachim Boldt, MD, PhD, worked until last year, is investigating the validity of the data in many of his published studies.

Klinikum Ludwigshafen [where Dr. Boldt had been employed until late last year] has commissioned an investigating committee to systematically assess the veracity of the findings presented in Dr. Boldt’s articles against patient and laboratory records. We will communicate to our readers any finding of data fabrication, falsification, or misrepresentation identified by the investigating committee at Klinikum Ludwigshafen.”

Dr. Boldt has been at the center of a research and publishing scandal since last October, when the journal Anesthesia & Analgesia—one of the 11 journals— retracted a 2009 article of his over concerns of data manipulation and ethical lapses.

On Feb. 4, the German medical board overseeing the case, the Landesärztekammer Rheinland-Pfalz (LÄK-RLP), announced that somewhere in the neighborhood of 90 of Boldt’s published articles might require retraction because the investigator failed to obtain approval from an IRB to conduct the research.

Ignaz Wessler, MD, an official at LÄK-RLP who is helping lead the inquiry, said it was the largest of its kind for the medical board. “So far, at least with respect to the pure number, there is no case comparable to this,” Dr. Wessler said.

Dr. Wessler and his colleagues reviewed 102 articles in all, finding 89 without evidence of proper IRB approval; another 11 had IRB approval and two did not require approval.

In addition to Anesthesia & Analgesia, the journals include Anesthesiology, Anaesthesia, Intensive Care Medicine and the Journal of Cardiothoracic and Vascular Anesthesia, along with several European titles.

Should he be found guilty of violating the Code of Deontology (Germany’s medical ethics provision), Dr. Boldt could face a fine of up to 100,000 euros (roughly $138,000), and even jail time if he broke any laws.

Dr. Boldt, who has not replied to several recent requests from Anesthesiology News for comment, has been stripped of his professorship at Giessen University, where he has held a teaching post since 1993.

A report on the German Web site Mittlehessen.de quoted a Giessen spokeswoman, Sonja Demuth, saying that “In the course of investigations against Boldt it was determined that he had no longer fulfilled his legal requirements for teaching in recent semesters.”

The article also stated that Giessen was investigating possible scientific misconduct by Dr. Boldt

Table. A selection of the 89 Boldt Articles Likely Slated for Retraction.

(The complete list is available at Anesthesiology News.com.)

Article Mengistu AM, Mayer J, Boldt J, Röhm KD, Suttner SW. Usefulness of monitoring platelet function by multiple electrode aggregometry in primary coronary artery bypass surgery. J Cardiothorac Vasc Anesth. 2011;25:42-47.

Mayer J, Boldt J, Triem JG, Schellhaass A, Mengistu AM, Suttner S. Individual titration of propofol plasma target improves anaesthetic stability in patients undergoing major abdominal surgery: a comparison with manually controlled infusion. Eur J Anaesthesiol. 2008;25:741-747.

Boldt J, Mayer J, Brosch C, Lehmann A, Mengistu A. Volume replacement with a balanced hydroxyethyl starch (HES) preparation in cardiac surgery patients. J Cardiothorac Vasc Anesth.

2010;24:399-407.

Piper SN, Röhm KD, Boldt J, Odermatt B, Maleck WH, Suttner SW. Hepatocellular integrity in patients requiring parenteral nutrition: comparison of structured MCT/LCT vs. a standard MCT/LCT emulsion and a LCT emulsion. Eur J Anaesthesiol. 2008;25:557-565.

Boldt J, Mengistu A. A new plasma-adapted hydroxyethyl starch preparation: in vitro coagulation studies. J Cardiothorac Vasc Anesth. 2010;24:394-398.

Mengistu AM, Wolf MW, Boldt J, Röhm KD, Lang J, Piper SN. Evaluation of a new platelet function analyzer in cardiac surgery: a comparison of modified thromboelastography and whole-blood aggregometry.

J Cardiothorac Vasc Anesth. 2008;22:40-46.

Mengistu AM, Mayer J, Boldt J, Röhm KD. Whole-blood aggregometry: are there any limits with regard to platelet counts?

Acta Anaesthesiol Scand. 2009;53:72-76.

Piper SN, Röhm K, Boldt J, Kranke P, Maleck W, Seifert R, Suttner S. Postoperative nausea and vomiting after surgery for prognathism: not only a question of patients’ comfort. A placebo-controlled comparison of dolasetron and droperidol. J Craniomaxillofac Surg. 2008;36:173-179.

Triem JG, Röhm KD, Boldt J, Piper SN. [Propofol administration systems. Handling, hemodynamics and propofol consumption.]

Anaesthesist. 2009;58:231-234, 236-299.

Piper SN, Beschmann RB, Mengistu A, Maleck WH, Boldt J, Röhm KD. Postoperative analgosedation with S(+)-ketamine decreases the incidences of postanesthetic shivering and nausea and vomiting after cardiac surgery. Med Sci Monit. 2008;14:PI59-PI65.

Riesmeier A, Schellhaass A, Boldt J, Suttner S. Crystalloid/colloid versus crystalloid intravascular volume administration before spinal anesthesia in elderly patients: the influence on cardiac output and stroke volume. Anesth Analg. 2009;108:650-654.

Boldt J, Wolf M, Mengistu A. A new plasma-adapted hydroxyethylstarch preparation: in vitro coagulation studies using thrombelastography and whole blood aggregometry. Anesth Analg. 2007;104:425-430.

Mayer J, Boldt J, Beschmann R, Stephan A, Suttner S. Uncalibrated arterial pressure waveform analysis for less-invasive cardiac output determination in obese patients undergoing cardiac surgery. Br J Anaesth. 2009;103:185-190.

Mayer J, Boldt J, Schellhaass A, Hiller B, Suttner SW. Bispectral index-guided general anesthesia in combination with thoracic epidural analgesia reduces recovery time in fast-track colon surgery.

Anesth Analg. 2007;104:1145-1149.

Suttner S, Boldt J, Mengistu A, Lang K, Mayer J. Influence of continuous perioperative beta-blockade in combination with phosphodiesterase inhibition on haemodynamics and myocardial ischaemia in high-risk vascular surgery patients. Br J Anaesth.

2009;102:597-607.

Mayer J, Boldt J, Schöllhorn T, Röhm KD, Mengistu AM, Suttner S. Semi-invasive monitoring of cardiac output by a new device using arterial pressure waveform analysis: a comparison with intermittent pulmonary artery thermodilution in patients undergoing cardiac surgery. Br J Anaesth. 2007;98:176-182.

Boldt J, Suttner S, Brosch C, Lehmann A, Mengistu A. Influence on coagulation of a potato-derived hydroxethylstarch (HES 130/0.42) and a maize-derived hydroxethylstarch (HES 130/0.4) in patients undergoing cardiac surgery. Br J Anaesth. 2009;102:191-197.

Boldt J, Brosch C, Ducke M, Papsdorf M, Lehmann A. Influence of volume therapy with a modern hydroxyethylstarch preparation on kidney function in cardiac surgery patients with compromised renal function: a comparison with human albumin. Crit Care Med. 2007;35:2740-2746.

Boldt J, Mengistu A. Balanced hydroxyethylstarch preparations: are they all the same? In-vitro thrombelastometry and whole blood aggregometry. Eur J Anaesthesiol. 2009;26:1020-1225.

Mengistu AM, Wolf MW, Boldt J, Röhm KD, Suttner SW, Piper SN. Influence of controlled hypotension using esmolol and sodium nitroprusside on natriuretic peptides in patients undergoing endonasal sinus surgery. Eur J Anaesthesiol. 2007;24:529-534.

Boldt J, Suttner S, Brosch C, Lehmann A, Röhm K, Mengistu A. The influence of a balanced volume replacement concept on inflammation, endothelial activation, and kidney integrity in elderly cardiac surgery patients. Intensive Care Med. 2009;35:462-470.

Boldt J, Schöllhorn T, Münchbach J, Pabsdorf M. A total balanced volume replacement strategy using a new balanced hydoxyethyl starch preparation (6% HES 130/0.42) in patients undergoing major abdominal surgery. Eur J Anaesthesiol. 2007;24:267-275.

Piper SN, Beschmann R, Mengistu A, Kalenka A, Maleck WH, Boldt J, Röhm KD. Assessment of recovery, dreaming, hemodynamics, and satisfaction in postcardiac surgery patients receiving supplementary propofol sedation with S(+)-ketamine. Minerva Anestesiol. 2009;75:363-373.

Piper SN, Kiessling AH, Suttner SW, Ducke M, Boldt J, Röhm KD. Prevention of atrial fibrillation after coronary artery bypass graft surgery using a potassium-magnesium-aspartate solution (Inzolen). Thorac Cardiovasc Surg. 2007;55:418-423.

Boldt J, Brosch Ch, Röhm K, Lehmann A, Mengistu A, Suttner S. Is albumin administration in hypoalbuminemic elderly cardiac surgery patients of benefit with regard to inflammation, endothelial activation, and long-term kidney function? Anesth Analg.

2008;107:1496-1503.

Boldt J, Mengistu A, Seyfert UT, Vogt A, Hellstern P. The impact of a medium molecular weight, low molar substitution hydroxyethyl starch dissolved in a physiologically balanced electrolyte solution on blood coagulation and platelet function in vitro. Vox Sang. 2007;93:139-144.

Mayer J, Boldt J, Wolf MW, Lang J, Suttner S. Cardiac output derived from arterial pressure waveform analysis in patients undergoing cardiac surgery: validity of a second generation device. Anesth Analg. 2008;106:867-872.

Röhm KD, Piper SN, Suttner S, Schuler S, Boldt J. Early recovery, cognitive function and costs of a desflurane inhalational vs. a total intravenous anaesthesia regimen in long-term surgery. Acta Anaesthesiol Scand. 2006;50:14-18.

Mengistu AM, Röhm KD, Boldt J, Mayer J, Suttner SW, Piper SN. The influence of aprotinin and tranexamic acid on platelet function and postoperative blood loss in cardiac surgery. Anesth Analg.

2008;107:391-397.

Triem JG, Röhm KD, Boldt J, Piper SN. [Comparison of a propofolbased anesthesia regimen using optimated-target-controlled-infusion (OTCI) and manually-controlled infusion (MCI) technique]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2006;41:150-155.

Boldt J, Brosch Ch, Röhm K, Papsdorf M, Mengistu A. Comparison of the effects of gelatin and a modern hydroxyethyl starch solution on renal function and inflammatory response in elderly cardiac surgery patients. Br J Anaesth. 2008;100:457-464.

Boldt J, Schölhorn T, Mayer J, Piper S, Suttner S. The value of an albumin-based intravascular volume replacement strategy in elderly patients undergoing major abdominal surgery. Anesth Analg.

2006;103:191-199.

at the university. Indeed, questions about the vera- Ludwigshafen provided ample evidence to that effect. city of Dr. Boldt’s data also have been raised elseThe editorial makes the following points: where. An editorial posted to Anesthesia & Anal- “1. There are no original patient data or laboratory gesia’s Web site about the first retracted paper calls data to support the findings in the study. see Boldt page 30 the study “fabricated,” and says that Klinikum

3 0 I A n e s t h e s i o l o g y N e w s . c o m Ma r c h 2 0 1 1

P OLICY & M ANAGEMENT Boldt continued from page 29 2. According to the head of the perfusionist team, no albumin has been used as a priming solution since 1999.

3. According to the pharmacy, no albumin has been delivered to the cardiac operating rooms for many years.

4. All laboratory measurements, including IL-6, IL-10, intercellular adhesion molecule, neutrophil gelatinase-associated lipocalin, and

alpha-glutathione-S-transferase, would have been performed in the clinical laboratory at the Klinikum Ludwigshafen. These assays have only been performed on patients receiving hydroxyethyl starch priming solutions. The laboratory could identify no assays from patients receiving albumin priming solutions.

5. Professor Boldt has admitted forging the signatures of the coauthors on the copyright transfer form submitted to Anesthesia & Analgesia.

6. The co-authors denied participation in the fabrication.

7. There is no convincing evidence that this study was performed at all.”

Writing for the group of journal editors, Steven L. Shafer, MD, editor-in-chief of Anesthesia & Analgesia, noted that other articles by Dr. Boldt may prove to have contained bogus data. “It’s possible that articles retracted for lack of IRB approval may be retracted again (!) for research fraud to provide a full accounting of Dr. Boldt’s research,” he wrote.

* Doctor pictured is fictitious, does not represent Ambu and is used for advertising purposes only. Website layout subject to change.

Although Germany and the United States have somewhat different structures for IRBs, Dr. Shafer noted that both systems matured in the aftermath of the 1945-1946 Nuremberg trials, during which Nazi wartime atrocities involving human research were revealed.

“They obviously take [research ethics] very seriously in Germany,” Dr. Shafer told Anesthesiology News.

What’s more, he added, “I believe the same thing could happen in the United States. We have a system of private IRBs that are paid for by investigators, and those IRBs are hired to review protocol and either approve it or not approve it. But for a hospital that assumes that investigators are using a private IRB— because they don’t have an IRB themselves—there would be no way of checking up on this.”

Udo Schuklenk, PhD, editor of Bioethics and Developing World Bioethics, agreed with Dr. Shafer. “The same thing could happen in the United States; don’t delude yourself. [Authors] just tick the box: ‘Yeah, I got IRB approval’—but do they have to submit an approval letter from the IRB chair?

As journal editors we all ask, have you got ethics approval? They write back and say yes and we take it at face value that they are not lying to us.”

Dr. Schuklenk, however, said it’s not possible for journal editors to police these sorts of problems. Universities

A

s the editor-in-chief of Anesthesia & Analgesia, Steven L. Shafer, MD, has written thousands of words to his readers on the twin problems of research and publishing fraud. Now, he’s hoping a picture will bring home the point more powerfully.

The March issue of A&A (right) is devoted to publishing ethics. On the cover, a row of falling dominoes symbolizes the progressive impact of misconduct, from flawed manuscript down through patient care and eventually the public’s perception of science.

Most cases of misconduct aren’t as dramatic as that of Joachim Boldt, MD, PhD, or Scott Reuben, MD—whose fraud led to the retraction of more than 20 articles in the medical literature (including, most recently, a 2001 letter to the editor in A&A that cited one of his now-retracted papers [2001;92:556]) and earned him a six-month jail term and a hefty fine. Instead they involve plagiarism, Dr. Shafer said, either wholesale or piecemeal.

To prevent intellectual theft from reaching its pages, A&A announced recently that it now screens every manuscript it receives with the CrossCheck

Ma r c h 2 0 1 1

AnesthesiologyNews.com I 31

POLICY & M A N AGE ME N T are less safe than we think they are.”

In another editorial published on the Web site of Anesthesia & Analgesia, two fluid experts try to assess the potential fallout of the Boldt case on the risks calculus for HES: “Unfortunately, any scientific misconduct, no matter how trivial, casts a long shadow on the scientific work of all involved. In this particular case, a shadow is cast on a bulk of literature on HES safety and efficacy.”

The authors cite “a recent systematic review and meta-analysis from the

Canadian Critical Care Trials Group [that] concluded that critically ill patients receiving HES were more likely to receive renal replacement therapy, and identified a trend toward increased risk of death in association with HES for patients with severe sepsis. Because most of the studies by Boldt et al. included in these meta-analyses favored HES, their exclusion would increase the safety concerns of HES.” Karen Maschke, PhD, editor of IRB: Ethics & Human Research—a

publication of the Hastings Center, in Garrison, N.Y.—said that although Dr. Boldt owns the blame for his actions, his many co-authors and peer reviewers for the journals where he published so prolifically share some of the responsibility. “You have a bunch of people who put their names on the manuscripts,” Dr. Maschke said, “and you have external reviewers who gave the editors the go-ahead flag to publish the articles.”

—Adam Marcus

In P-

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system (using software from iThenticate).

So far, roughly 10% of the 150-odd submissions each month have been found to have passages that require rewriting in the author’s own words, Dr. Shafer said.

Although hundreds of journals use CrossCheck, most screen only the manuscripts they accept. That’s the policy at Anesthesiology, according to James Eisenach, MD, the journal’s editor.

—Adam Marcus

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FORCED-AIR WARMING REINVENTED.

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and research institutions, on the other hand, could do a better job of ferreting out fraud by paying more attention to the publishing activity of their faculty.

“These guys almost certainly would have submitted their papers to the university as a way to say, ‘look, I’ve produced all this.’ The university could have said, ‘where is the corresponding ethics review?’” Dr. Schuklenk said. “The truth is, the universities don’t do this. They just take the credit and they’re happy— as long as there are not any scandals.”

Asked whether lack of IRB approval on an otherwise scientifically sound study should trigger a retraction and not some other form of editorial sanction, Dr. Schuklenk was unequivocal. “If people realize they can get away with this and if they get caught they will not be retracted, it is reasonable to assume that many more PIs would take short-cuts— and that in the end destroys the system of ethics review in the first place.”

Dr. Boldt, who has published nearly 350 articles, was a top figure in the world of fluid management during surgery. Many of his studies looked at a substance called hydroxyethyl starch (HES) and formed the basis of clinical guidelines for use of the therapy.

“Boldt’s data primarily spoke to the safety issue,” Dr. Shafer said. “Boldt tended to dismiss safety concerns about these colloidal solutions, and without his data, it would appear that these drugs

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Sedation in the ICU: Shifts and Strategies PETER J. PAPADAKOS, MD

FRANK COMPOLO, MD

Director, Division of Critical Care Medicine Professor, Anesthesiology, Surgery, and Neurosurgery Associate Director, Kessler Regional Trauma Center University of Rochester School of Medicine and Dentistry Rochester, New York

Department of Anesthesiology University of Rochester School of Medicine and Dentistry Rochester, New York

Dr. Papadakos is on the speakersâ&#x20AC;&#x2122; bureau of Hospira.

O

ver the past decade, intensive care units (ICUs) worldwide have adopted the goal of maintaining an optimal level of comfort and safety for critical care patients.1,2 Guidelines and protocols for the sedation of ICU patients

now also are mandated by accreditation agencies. As a result, sedation and pain management are being tracked as vital signs in the care of patients throughout their hospital stay, which has led to widespread efforts to address sedation and pain control in this patient population. Recently, clinicians have been faced with multiple shortages of sedative drugs, most notably propofol, which have significantly affected protocols in place in ICUs throughout the world. Our growing understanding of the importance of delirium in critically ill patients, and how it affects outcomes, also has influenced how clinicians plan ICU sedation and has led to a shift in both how patients are evaluated and the nature of treatment, pharmacologic or otherwise.

I N D E P E N D E N T LY D E V E LO P E D BY M C M A H O N P U B L I S H I N G

A N E S T H E S I O LO GY N E W S â&#x20AC;˘ M A R C H 2 0 1 1

1

Table 1. Medications Associated With Agitation in ICU Patients Antibiotics Acyclovir Amphotericin B Cephalosporins Ciprofloxacin Imipenem-cilastatin (Primaxin, Merck) Ketoconazole Metronidazole Penicillin Rifampin Trimethoprim-sulfamethoxazole Anticonvulsants Phenobarbital Phenytoin Cardiac drugs Captopril Clonidine Digoxin Dopamine Labetalol Lidocaine Nifedipine Nitroprusside Procainamide Propranolol Quinidine sulfate Corticosteroids Dexamethasone Methylprednisolone Opioid analgesics Codeine Meperidine Morphine sulfate Miscellaneous drugs Anticholinergics Benzodiazepines Hydroxyzine Ketamine Metoclopramide Nonsteroidal anti-inflammatory drugs Theophylline

The large number of modern sedatives and analgesics has given critical care practitioners the ability to titrate specific agents for specific patient types, allowing patients to be comfortable throughout their stay in the ICU. This wide selection of drugs also has reduced the length of hospital stays and permitted patients to participate in drug weaning and physical and occupational therapy.

As the customized care of patients continues to evolve, a common language is mandated for the titration and use of sedative agents. With this language also comes the development of protocols and guidelines to better use these drugs, and to maximize the

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unique pharmacodynamic profile of each drug for individual patients.

No longer is it necessary to be trapped by the all-ornone effect of very long-acting compounds that depress respiration and prolong the ICU stay. Titratable sedation also may modulate the immune system. Evidence now shows that high levels of anxiety and pain may influence morbidity and mortality, and specific compounds may modulate the release of cytokines and vasoactive compounds.1,2

Evaluation for Agitation and Anxiety Agitation and anxiety are common in ICU patients of all ages, occurring at least once in 71% of patients admitted to a medicalâ&#x20AC;&#x201C;surgical ICU.3 Agitation can be caused by multiple factors, such as extreme anxiety, delirium, adverse drug effects, and pain. Inadequate pain control is a significant factor in the development of agitation in critically ill patients, predominantly in the postoperative period. Insufficient pain management often results from suboptimal dosing of opioids because of concerns about respiratory depression and the development of dependence. Normally, these side effects are unlikely to develop over the short term if the medication is properly titrated to patient comfort.

Hypoxemia has long been associated with agitation. It is crucial for ICU staff to monitor the oxygen levels of all patients. A partial pressure of oxygen of 60 mm Hg or lower (or oxygen saturation <90%) can contribute to agitation secondary to hypoxemia.

Hypotension also can lead to agitation due to hypoperfusion of the brain. Common metabolic problems such as hyperglycemia and, especially, hypoglycemia can promote severe agitation. Uremia and elevated levels of heavy metals (eg, lead, mercury) have been identified as causes of significant agitation. Sepsis also is a common cause of agitation and must be immediately ruled out.

The trauma patient with a closed head injury may have minor to severe agitation. Patients without traumatic head injury, including those with subarachnoid bleeds, also may present with agitation. Thrombotic stroke may cause agitation, and patients with brain neoplasms, brain seizures, infections such as meningitis, or air embolism also may have associated persistent and severe agitation.

One of the most common problems confronting providers of critical care is a patientâ&#x20AC;&#x2122;s withdrawal from alcohol or other agents, including cocaine, opioids, and sedatives such as benzodiazepines; all of these substances contribute to brain injury and agitation.4 Withdrawal in cigarette smokers, who can suffer agitation from lack of nicotine, should be ruled out.

Another common cause of agitation in the ICU patient is significant ventilator desynchronization in patients on mechanical ventilation. This is frequently the result of poorly set ventilators that delay response to the patientâ&#x20AC;&#x2122;s efforts at spontaneous breathing. The problem is becoming less common because of the availability of advanced computer-controlled ventilators

and the use of graphic displays to titrate ventilation.

Patients who undergo short- or long-term intubation also become agitated because of the stimulus of the endotracheal tube itself. Patients who are alert and intubated may become frustrated by their inability to communicate with staff and family and descend into a cycle of continued agitation. The ICU itself, with its high levels of technology, lights, and noise and continuous stimuli, can significantly contribute to further agitation.

Numerous drug interventions, drug reactions, and drug–drug interactions, as well as drug withdrawal, all increase the incidence of patient agitation in the modern ICU. The occurrence of undesirable drug–drug interactions always should be considered when multiple drugs are being used for pain, anxiety, infection, and cardiac arrhythmias (a brief list of medications associated with agitation appears in Table 1). Even after the withdrawal of a pharmacologic compound suspected of increasing agitation, it may take several days for the drug and its metabolites to clear from the patient’s system before a positive response can be seen.

A differential diagnosis of agitation begins with a review of the patient’s disease process, mechanism of injury, laboratory values, treatments, baseline medications, and history of chronic diseases (eg, hepatic or renal). Only after this type of rapid evaluation can the process move toward proper treatment for agitation.

Evaluation and Titration of Sedative Agents The complex disease state of ICU patients typically demonstrates a rapidly changing spectrum of hemodynamic parameters, so the requirements to treat agitation fluctuate over time. Bedside clinicians must frequently reassess and redefine the goals of therapy, so that ICU patients and their levels of sedation must be evaluated in real time. Tools and scales to monitor agitation in the ICU should be simple to apply yet describe clearly graded changes between levels of sedation to allow the titration of both pharmacologic and nonpharmacologic interventions, depending on the patient’s condition.

Large numbers of scales and tools for the evaluation of ICU patients are described in the literature. Many of these assess the level of consciousness with descriptive responses to interventions; for example, if the level of a drug is raised, the patient’s condition will change.

No scale is a gold standard, but most ICUs use modifications of those described in the literature. The development of customized unit-based scales, protocols, and guidelines is highly important for promoting their acceptance by all members of the health care team.

Sedation Scales The most commonly used sedation scale is the Ramsay Sedation Scale,5 which identifies 6 levels of sedation ranging from severe agitation to deep coma (Table 2). Despite its frequent use, the Ramsay Scale has some shortcomings when applied at the bedside of patients with complex problems. For example, a patient who appears to be asleep with a sluggish response to

Table 2. Ramsay Scale for Assessing Level of Sedation Level

Response

1

Patient awake and anxious, agitated, and/or restless

2

Patient awake, cooperative, accepting ventilation, oriented, and tranquil

3

Patient awake; responds to commands only

4

Patient asleep; brisk response to light glabellar tap or loud auditory stimulus

5

Patient asleep; sluggish response to light glabellar tap or loud auditory stimulus but responds to painful stimulus

6

Patient asleep; no response to light glabellar tap or loud auditory stimulus

Based on reference 5.

glabellar tap (Ramsay 5) also may be restless and anxious (Ramsay 1). The Ramsay Scale is simple, however, and is widely used throughout the world.

The Riker Sedation–Agitation Scale (SAS) was the first scale formally tested and developed for reliability in the ICU (Table 3). The SAS identifies 7 symmetric levels, ranging from dangerous agitation to deep sedation.

This scale provides descriptions of patient behavior that can assist the bedside practitioner in distinguishing between levels.6 The Motor Activity Assessment Scale (MAAS), which is similar in structure to the SAS, uses patient behaviors to describe the different levels of agitation.7 The MAAS identifies 7 levels, ranging from unresponsive to dangerously agitated (Table 4).

A newer assessment tool for the ICU was described

by Ely and colleagues as the Confusion Assessment Method for the ICU (CAM-ICU).8 This tool is being validated in critically ill patients with delirium. It is used in combination with the Glasgow Coma Scale to evaluate highly complex, agitated patients. The CAM-ICU is simple to apply at the bedside and has been found to have a high level of reliability, sensitivity, and specificity.

There is hope that real-time, computer-based monitors of brain function may remove human variability from the evaluation of patients with agitation. One such monitor that is popular in the operating room is the Bispectral Index (BIS, Covidien). This objective monitor is especially helpful for the deeply sedated patient receiving neuromuscular blockade. The BIS monitor provides discrete values from 100 (completely awake), to less than 60 (deep sedation), to 40 or below (deep hypnotic state or barbiturate coma) by incorporating several electroencephalographic components.9 Although the technique has been shown to be valid in the operating room, it has not been studied to any great extent in the ICU. This

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Table 3. Riker Sedation–Agitation Scale Score

Diagnosis

Description

7

Dangerously agitated

Pulls at endotracheal tube; tries to remove catheters; climbs over bed rail; strikes at staff; thrashes from side to side

6

Very agitated

Does not calm down despite frequent verbal reminding of limits; requires physical restraints; bites endotracheal tube

5

Agitated

Anxious or mildly agitated; attempts to sit up; calms down in response to verbal instructions

4

Calm and cooperative

Calm; awakens easily; follows commands

3

Sedated

Difficult to arouse; awakens to verbal stimuli or gentle shaking but drifts off again; follows simple commands

2

Very sedated

Arouses to physical stimuli but does not communicate or follow commands; may move spontaneously

1

Unable to be aroused

Minimal or no response to noxious stimuli; does not communicate or follow commands

Based on references 2 and 6.

device should be carefully evaluated against the wide spectrum of critically ill patients in all types of ICUs.

Establishing and Implementing Sedation Guidelines and Protocols One of the most important goals for any ICU is the development of protocols and guidelines for the use of pain medications and sedative drugs. The development of such protocols requires multidisciplinary input and should be unit-specific. All staff, including physicians, nurses, and pharmacists, need to agree on which monitoring scales and tools to use and then ensure that they are applied reliably across disciplines. It is key for staff to agree on documentation, frequency of assessment, predefined end points of therapy, and evaluation of patient outcomes. Tools to evaluate sedation and pain should be added to flow sheets placed at the bedside. The use of these types of protocols with documentation in daily practice can foster communication between disciplines and shifts. Each hospital should develop guidelines based on current pharmacologic and pharmacokinetic recommendations and supported by national standards.1,2 Several studies have shown that when ICUs institute protocol-driven sedative use, patients spend less time on mechanical ventilation and have shorter stays in the ICU and the hospital.10 Another easy bedside strategy for optimizing outcome in patients receiving therapy for agitation is to implement a daily schedule for the reassessment and interruption of sedation infusions.11 This practice is common in the trauma–burn ICU at the University of Rochester in Rochester, NY, where daily interruptions of sedative infusions are found to decrease the duration of mechanical ventilation and decrease time

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in the ICU. This practice allows the maximal use of bed resources in a busy hospital. A “sedation holiday” also improves clinicians’ ability to perform daily neurologic examinations, thereby reducing the need for diagnostic studies to evaluate unexplained alterations in mental status.12 It is important that pharmacologic colleagues—hospital pharmacists and PharmDs—be involved in the development of sedation guidelines. Pharmacists can provide guidance and educational input regarding specific pharmacodynamic profiles of individual agents. The participation of pharmacists on rounds and as members of the ICU team can only improve care in complex cases.

The implementation of guidelines and protocols has the added benefit of decreasing the use of sedative drugs, thereby enhancing hospital finances. Sedatives and narcotic agents are the most commonly prescribed drugs in the ICU and may account for a major percentage of the patients’ pharmacy charges.

Review of Agents Commonly Used In Sedation Analgesics and sedatives are the mainstays of supportive patient care in the ICU, where they are the most commonly used drugs. Over the past few years, several novel, highly titratable agents have been introduced that have greatly altered patient care. The pharmacology of several of these widely used agents, along with that of classic drugs with long-use profiles, is reviewed in Table 5.

OPIOIDS Opioids are the main agents used for analgesia in the ICU. Analgesia greatly affects the need for sedation

Table 4. Motor Activity Assessment Scale Score

Description

Definition

0

Unresponsive

Does not move with noxious stimulus

1

Responsive only to noxious stimuli

Opens eyes or raises eyebrows or turns head toward stimulus or moves limbs with noxious stimulus

2

Responsive to touch or name

Opens eyes or raises eyebrows or turns head toward stimulus or moves limbs when touched or name is loudly spoken

3

Calm and cooperative

Does not require external stimulus to elicit movement; adjusts sheets or clothes purposefully; follows commands

4

Restless but cooperative

Does not require external stimulus to elicit movement; picks at sheets or clothes or uncovers self; follows commands

5

Agitated

Does not require external stimulus to elicit movement; attempts to sit up or moves limbs out of bed; does not consistently follow commands

6

Dangerously agitated, uncooperative

Does not require external stimulus to elicit movement; pulls at tubes or catheters or thrashes from side to side or strikes at staff or tries to climb out of bed; does not calm down when asked

Based on references 7 and 16.

and other therapies. Unrelieved pain induces a powerful stress response characterized by tachycardia, increased myocardial oxygen consumption, hypercoagulability, immunosuppression, and persistent catabolism.13 Effective analgesia also can diminish pulmonary complications in postoperative patients.

Opioids are lipid-soluble and bind to opiate receptors in the central nervous system (CNS) and peripheral nervous system. At low doses, opioids provide analgesia but not anxiolysis, whereas at higher doses, they act as sedatives. All the opioids share therapeutic properties but vary in potency and pharmacokinetics.

Although opioids can be given via several routes, the IV method is the most common in the ICU. It is important to consult with anesthesiologists when developing pathways for novel uses of these agents, such as epidural placement. When given intravenously in therapeutic doses, opioids cause sedation by clouding the sensorium, but they do not possess amnestic properties.14 Comparative trials of opioids have not been performed in critically ill patients. The selection of a specific agent depends on its pharmacology and potential for causing adverse effects. For opioids, desirable attributes include a rapid onset of effect, ease of titration, lack of accumulation of the parent drug or its metabolites, and low cost.

Morphine sulfate is the preferred opioid analgesic in patients with stable hemodynamics. Its relatively low lipid solubility may result in a delayed onset of action.

Morphine also induces the release of histamine, increasing the likelihood of hypotension secondary to vasodilation. Morphine-6-glucuronide, a metabolite of morphine, is excreted in the urine and may accumulate in patients with renal failure. The opiate activity of this metabolite

is several times greater than that of morphine, and its accumulation in patients with renal failure has been reported to prolong narcosis.

Fentanyl has the most rapid onset and shortest duration of action of the opioids, but repeated dosing may cause accumulation and prolonged effects. Fentanyl citrate, a synthetic narcotic analgesic, is up to 100 times more potent than morphine, is highly lipid-soluble, and has a rapid onset of action because it quickly crosses the bloodâ&#x20AC;&#x201C;brain barrier. Fentanyl has no active metabolites and is not associated with histamine release or venodilating effects. Because of these characteristics, fentanyl has become a widely used agent in the ICU. It is ideal for use in patients with unstable hemodynamics. Fentanyl should be administered by continuous infusion for sustained effect because of its short duration of action.15 Remifentanil (Ultiva, Abbott), a newer agent, has not been widely studied in ICU patients. The drug has a very short half-life and may be best used in patients requiring serial examinations or neurologic evaluations.

Because of its short duration of action, continuous infusion is necessary for pain management.16 Hydromorphone is a highly potent opioid with no active metabolites. It can be used in the ICU but has not found broad-based application in this setting.

Meperidine is not recommended for repeated use; it has an active metabolite that causes neuro-excitation (apprehension, tremors, delirium, and seizures) and may interact with antidepressants (contraindicated with monoamine oxidase inhibitors, and best avoided with selective serotonin reuptake inhibitors). Because of risks from multiple interactions with other medications, meperidine should not be used in the ICU.

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Sedatives

AnalgesicSedative

Analgesics

Table 5. Pharmacology of Selected Analgesics and Sedatives Agent

Equianalgesic Dose (IV)

Distribution Half-life

Metabolic Pathway

Active Metabolites (Effect)

Acetaminophen

NA

2h

Conjugation

NA

Codeine

120 mg

3h

Demethylation and glucuronidation

Yes (analgesia, sedation)

Fentanyl

200 mcg

1.5-6 h

Oxidation

No metabolite, parent accumulates

Hydromorphone

1.5 mg

2-3 h

Glucuronidation

None

Ibuprofen

NA

1.8-2.5 h

Oxidation

None

Ketorolac

NA

2.4-8.6 h

Renal

None

Meperidine

75-100 mg

3-4 h

Demethylation and hydroxylation

Yes (neuroexcitation, especially with renal insufficiency or high doses)

Morphine

10 mg

3-7 h

Glucuronidation

Yes (sedation, especially with renal insufficiency)

Remifentanil (Ultiva, Abbott)

NA

3-10 min

Plasma esterase

None

Dexmedetomidine (Precedex, Hospira)

NA

~6 min

Glucuronidation, hydroxylation, and methylation

None (glucuronidation); undetermined for P-450â&#x20AC;&#x201C; mediated pathways

Diazepam

NA

30-66 min

Hepatic microsomal enzymes

Yes

Lorazepam

NA

3-20 min

Glucuronidation

None

Methohexital (Brevital, JHP)

NA

4 h (for adults; may be up to 5 h in younger patients)

Demethylation and oxidation

NA

Midazolam

NA

6-15 min

Hydroxylation

Yes

Propofol

NA

2-3 min

Glucuronidation

None

CNS, central nervous system; D5W, 5% dextrose in water; GI, gastrointestinal; MAOIs, monoamine oxidase inhibitors; NA, not applicable; SSRIs, selective serotonin reuptake inhibitors; WAC, wholesale average cost a

More frequent doses may be needed for acute pain management in mechanically ventilated patients.

b

Cost based on 2003 average wholesale price. Prices may vary based on supplier buying groups.

c

Strict aseptic technique required.

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Adverse Effects

Intermittent Dosea

Infusion Dose Range (Usual,Continuous)

NA

325-650 mg PO q4-6h; avoid >4 g/d

NA

Lacks potency, histamine release

Not recommended

Not recommended

Rigidity with high doses

0.35-1.5 mcg/kg IV q0.5-1h

0.7-10 mcg/kg/h

NA

10-30 mcg/kg IV q1-2h

7-15 mcg/kg/h

Risk for bleeding, GI and renal adverse effects

400 mg PO q4-6h

NA

Risk for bleeding, GI and renal adverse effects

15-30 mg IV q6h; decrease if age >65 y or weight <50 kg or renal impairment; avoid using >5 d

Infusion not FDA–approved

Avoid with MAOIs and SSRIs

Not recommended

Not recommended

Histamine release

0.01-0.15 mg/kg IV q1-2h

0.07-0.5 mg/kg/h

NA

NA

0.6-15 mcg/kg/h (0.1 mcg/kg/min)

Hypotension, transient hypertension, bradycardia

Intermittent dosing not FDAapproved

0.2-0.7 mcg/kg/h

CNS depressant, “paradoxical” reactions

5 mg as needed q2-5 min; maximum dose 0.25 mg/kg

2 mg/kg/d

Respiratory depression

2 mg as needed q2-5 min; maximum dose 1 mg/kg

2-4 mg (0.044-0.05 mg/kg)

Include cardiac and respiratory depression, neurologic and emergence delirium

1% solution (10 mg/mL) 1-1.5 mg/kg induction, then 20-40 mg as required (for adults)

0.2% solution (2 mg/mL) 6 mg/min (for adults)

Respiratory depression, respiratory arrest, hypotension

25% of induction dose

0.02-0.10 mg/kg/h (1-7 mg/h)

Apnea, hypotensionc

Increments of 20-50 mg as needed

100-200 mcg/kg/min

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Certain adverse effects of opioid analgesics occur frequently in ICU patients. Of greatest concern are respiratory, hemodynamic, CNS, and gastrointestinal effects. Respiratory depression is a concern in spontaneously breathing patients or in those receiving partial ventilatory support. Opioids also may increase intracranial pressure in patients with traumatic brain injury, although the data are inconsistent and the clinical significance is unknown.17

NONOPIOIDS Gabapentin. Increasing evidence suggests that nonbenzodiazepine GABAergic compounds have promise for the treatment of alcohol withdrawal syndrome.

Gamma aminobutyric acid (GABA) represents the major inhibitory neurotransmitter of the CNS. Ethanol, benzodiazepines and some anticonvulsants directly affect GABA receptors inducing similar anxiolytic, sedativehypnotic and anticonvulsant effects.

Benzodiazepines (see below) are widely used to treat alcohol withdrawal syndrome and continue to be considered the drugs of choice for this condition. Due to their addictive potential and lack of safety when combined with alcohol, benzodiazepines usually are not recommended for maintenance treatment.

A 2009 study compared gabapentin with lorazepam in a double-blind randomized clinical trial. Gabapentin was well tolerated and decreased symptoms of alcohol withdrawal in an outpatient population. Gabapentin reduced the probability of drinking during alcohol withdrawal and in the post–withdrawal week compared with lorazepam.18 A more recent study showed that gabapentin loaded up to 3,200 mg in the first 24 hours was helpful in reducing less severe and less complicated acute alcohol withdrawal syndrome. 19 Gabapentin is structurally related to GABA but does not bind to GABAa or GABAb receptors and does not appear to influence GABA synthesis or uptake. Binding sites have been located throughout the brain, corresponding to the presence of voltage-gated calcium channels possessing the alpha-2 delta-1 subunit. This channel appears to be located presynaptically and is thought to modulate the release of excitatory neurotransmitters involved in epileptogenesis and nociception. 20 Gabapentin is not highly protein-bound, excreted renally and absorbed mainly from proximal small bowel.

Its half-life is 5 to 7 hours.20 The most common adverse reactions to the drug (occurring in fewer than 10% of patients) relate to the central nervous system (CNS) and include somnolence, dizziness, ataxia, and fatigue.

Gabapentin may enhance the effects of other CNS depressants including herbal agents such as Valerian and St. John’s wort. There is no labeled use or dosage recommendation for alcohol withdrawal.

The daily dose range for labeled and unlabeled use of gabapentin (seizures and neuropathic pain, respectively) is adjusted based on creatinine clearance (CrCl) as follows: CrCl greater than or equal to 60: 300 to

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1,200 mg TID; CrCl 30 to 59: 200 to 700 mg BID; CrCl 15 to 29: 200 to 700 mg daily; CrCl 15: 100 to 300 mg daily with dose reduction in proportion to reductions in clearance. For hemodialysis, the dose ranges between 125 and 350 mg after each 4 hours of hemodialysis. The price of the drug varies from approximately $40 to as much as $400 for a typical 30-day supply, depending on capsule, solution, or tablet formulation, and whether a generic or trade product is ordered.20 Benzodiazepines are the most widely used sedative drugs in medicine.21 They are sedative and hypnotic— but not analgesic—agents that block the acquisition and encoding of new information and potentially unpleasant experiences (anterograde amnesia), but they do not induce retrograde amnesia. They have an opioid-sparing effect by moderating the anticipatory pain response.22 Benzodiazepines vary in potency, onset and duration of action, uptake, and number of active metabolites. The 2 predominant mechanisms of action of benzodiazepines in the nervous system involve activity at GABA receptors. Potentiation of GABA-mediated transmission by benzodiazepines is apparently responsible for somnolent, anxiolytic, and anticonvulsant effects, whereas the amnestic property appears to correlate with GABA agonist activity in the limbic cortex.2,15 Benzodiazepines are metabolized in the liver, where they are extensively cleared. The effects of these drugs may be prolonged in critically ill patients (because of reduced metabolism) or in patients with liver disease. A prolonged and continuous infusion of benzodiazepines should proceed with caution; an accumulation of the parent drug or active metabolites may produce inadvertent and prolonged oversedation, as is seen in elderly patients.

It is therefore paramount that these drugs be titrated carefully and used in low doses, or the patients will be somnolent for several days after the infusion is stopped.

Benzodiazepines should be titrated to a pre-defined end point, often by using a series of loading bolus doses.

Hypotension may develop in hemodynamically unstable patients with the initiation of sedation. Intermittent or “as needed” doses of diazepam, lorazepam, or midazolam may be adequate to maintain sedation because of the relatively long half-life of these drugs.21,23 The clinical practice guidelines of the Society of Critical Care Medicine (SCCM) recommend lorazepam for the sedation of most patients, administered by either intermittent IV dosing or continuous infusion.1,2 Lorazepam, an intermediate-acting benzodiazepine, is less lipophilic than diazepam and thus has lower potential for accumulation. Lorazepam is associated with a stable hemodynamic profile, even when opioids are concurrently administered. It has no active metabolites, and its metabolism is less affected by advanced age or liver dysfunction than that of midazolam.24 Lorazepam, however, should be used with caution; propylene glycol toxicity, marked by acidosis and renal failure, has occurred with high doses or prolonged infusions of this drug.25 The other commonly prescribed benzodiazepine is midazolam, more widely used in the operating room

than in the ICU. Midazolam is a short-acting, watersoluble benzodiazepine that is transformed into a lipophilic compound in the blood. Midazolam exhibits dose-related hypnotic, anxiolytic, amnestic, and anticonvulsant actions. This drug produces dose-related respiratory depression, and larger doses may cause hypotension and vasodilation. Midazolam is metabolized in the liver to an active compound that is less potent and more transient than the parent compound.

The SCCM guidelines recommend midazolam for the rapid sedation of actively agitated patients,1 but with short-term use only; it is associated with unpredictable awakening and prolonged time to extubation when infusions continue for longer than 48 to 72 hours.

Paradoxical agitation has been observed with the use of benzodiazepines during light sedation and in the elderly, and may be the result of drug-induced amnesia or disorientation. The effects of these drugs can be reversed with the benzodiazepine-receptor antagonist flumazenil. However, the routine use of flumazenil is not recommended after prolonged benzodiazepine therapy; there is a risk for inducing withdrawal symptoms and increasing myocardial oxygen consumption with as little as 0.5 mg of flumazenil.26 A starting dose of 0.15 mg of flumazenil is recommended and is associated with fewer withdrawal symptoms.

Propofol has a rapid onset of action, within 1 to 2 minutes after a single IV dose, and a short duration of action, only 10 to 15 minutes, when discontinued.12,27 This is a result of its rapid penetration of the CNS and subsequent redistribution. Therefore, in the ICU, propofol is used by continuous infusion for sedation. Longterm infusions result in accumulation within lipid stores, a prolonged elimination phase, and a half-life of 300 to 700 minutes. Note, however, that subtherapeutic plasma concentrations of the drug are maintained after discontinuation because of rapid clearance; this limits the clinical significance of the drugâ&#x20AC;&#x2122;s half-life value.

Although the mechanism of action of propofol still is not completely understood, the drug appears to activate the GABA receptor within the CNS. Propofol alters the sensorium in an extremely rapid dose-dependent manner, from light sedation to general anesthesia, making it a highly useful drug. It also is a potent respiratory depressant, causing a reduction in systemic vascular resistance and possible hypotension, especially when given as a bolus. Propofol should be administered with caution in hypovolemic patients.

It has highly interesting effects on neurophysiology, parallel with the patientâ&#x20AC;&#x2122;s level of arousal. Propofol decreases cerebral metabolism, resulting in a coupled decline in cerebral blood flow and decrease in intracranial pressure.

One of the most important benefits associated with propofol is a decrease in weaning time from mechanical ventilation. A large Spanish study,28 using a costof-care approach, compared propofol and midazolam with regard to ICU costs for prolonged sedation of critically ill patients and weaning time from mechanical

ventilation. Although the 2 drugs provided equivalent sedation, propofol was associated with a shorter weaning time than midazolam, resulting in a more favorable economic profile. Because of its associated rapid wakeup time, propofol is considered the fundamental drug in many fast-track surgical programs, including cardiovascular surgery.12 Within a year of its introduction in the United States in 1990, reports appeared of clusters of infections in surgical patients treated with propofol.29 The majority of cases were due to contamination of the drug resulting from poor aseptic techniques. To prevent contamination, the additive ethylenediamine tetraacetic acid (EDTA) was included to help inhibit the growth of microorganisms. EDTA, at a concentration of 0.005%, has no effect on the physical or chemical stability of the emulsion compound. In the years following the introduction of the EDTA-containing formulation, the incidence of fevers and infections was reduced to zero.

EDTA is a chelator of various ions, including calcium.

In a randomized multicenter trial, patients were treated with either the original propofol formulation or the formulation with EDTA.30 The EDTA-containing formulation had no effect on calcium or magnesium homeostasis, renal function, or sedative efficacy compared with the original formulation.

One of the interesting aspects of propofol with EDTA is its ability to modulate the systemic inflammatory response. In a study of surgical ICU patients, those receiving propofol with EDTA had significantly lower mortality rates at 7 and 28 days than patients receiving the original formulation.31 This potential positive effect of propofol with EDTA may be related to the ability of EDTA to bind cations. The EDTA-containing formulation of propofol increases the excretion of zinc; this, in turn, can diminish the inflammatory response to stress by decreasing the release of cytokines involved in inflammation (eg, tumor necrosis factor) and the generation of free radicals and other oxidants. The authors of this review are part of a group in Rotterdam, Netherlands, that has investigated the release of cytokines and the transmigration of bacteria in an animal model, as modulated by various sedative agents. The full scope of the use of sedative agents to modulate the systemic inflammatory response is a highly interesting avenue of research for the future.

Propofol is not recommended for pediatric patients in the ICU because of reports of metabolic acidosis with accompanying lipemic serum, bradyarrhythmias, and fatal myocardial failure with excessively high doses.32 In adults with massive head trauma, prolonged use of propofol at very high doses may have contributed to cardiac failure33; however, these were highly complex cases with a high mortality index.

The SCCM guidelines recommend propofol as the agent of choice for rapid awakening and early extubation.1 Because propofol is formulated as a lipid emulsion, triglyceride concentrations should be monitored after 2 days of propofol infusion. The total caloric intake

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from the lipids should be included in the nutritional support prescription and may decrease hospital costs for added nutritional support.

Fospropofol (Lusedra, Eisai Inc.) is a prodrug which is hydrolyzed to yield propofol, which then interacts with the GABAa receptor, the presumed mechanism of propofol’s sedative/hypnotic effect. No data are available on the use of fospropofol use for sedation in the ICU. Most studies of fospropofol concern its use in procedural sedation for various endoscopic procedures.

Indeed, its sole indication is as a sedative/hypnotic for monitored anesthesia care in adult patients undergoing diagnostic or therapeutic procedures. There are no absolute contraindications to its use.34,35 The onset of effect of fospropofol is delayed compared to propofol due to the need for conversion to its active form. This lag may create a risk for dose stacking, which could result in deeper sedation than intended.34,35 The most common adverse reactions to fospropofol are paresthesia and pruritis.34,35 The drug is in pregnancy category B and it is not known whether it crosses the placenta. Propofol, however, does cross the placenta and enters breast milk.34,35 Fospropofol is 98% protein bound. It is completely metabolized by plasma alkaline phosphatases to propofol, formaldehyde (which is rapidly converted to formate), and phosphate. Although formate accumulation is the main mechanism of the toxicity seen with methanol ingestion, there have been no reports of toxicity due to fospropofol.36 There are no dosage adjustments recommended with hepatic or renal impairment but limited data regarding this is available.34,35 Haloperidol, a butyrophenone neuroleptic drug, is the agent of choice for the treatment of delirium in critically ill patients. Patients treated with haloperidol generally appear calmer and are better able to respond appropriately to commands.12 Haloperidol does not cause major respiratory depression. The drug, however, cannot be used alone in intubated critically ill patients.

The adverse effects associated with haloperidol include occasional hypotension resulting from the α-adrenergic–blocking properties of the drug. Although it is rare with IV use, haloperidol may cause extrapyramidal effects such as drowsiness, lethargy, a fixed stare, rigidity, and akathisia. A highly dangerous side effect is neuroleptic malignant syndrome (NMS), with a mortality rate of 20% to 30%. NMS develops slowly over 24 to 72 hours and can last up to 10 days after discontinuation of the drug.37 The incidence of NMS may be higher when haloperidol is given by continuous infusion, which is not recommended.

Dexmedetomidine (Precedex, Hospira), a selective α2-adrenergic receptor agonist, exhibits sympatholytic, sedative, and analgesic effects and has 8 times the affinity for the α2-adrenergic receptor as clonidine. Dexmedetomidine is approved for continuous IV sedation of initially-intubated and mechanically-ventilated patients in the intensive-care setting for use up to 24 hours, as well as in nonintubated patients before

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or during surgery. Its combined sedative and analgesic effects make it a highly promising therapy.

Dexmedetomidine acts at 2 adrenergic sites. It works by presynaptic activation of the α2-adrenoceptor, thereby inhibiting release of norepinephrine and terminating propagation of pain signals; it also affects postsynaptic activation of these receptors in the CNS. Dexmedetomidine inhibits sympathetic activity, resulting in a decrease in blood pressure and heart rate.

Together, these 2 effects can produce sedation, anxiolysis, sympatholysis, and analgesia.38 Dexmedetomidine has several advantages as a sedative in the ICU. Because the drug does not cause respiratory depression, a patient can be extubated without prior discontinuation. This property also makes it ideal for use in extubated patients. The drug provides great flexibility. It also may be ideal for use in weaning off mechanical ventilation. Another advantage of dexmedetomidine is the easy awakening of treated patients, making it useful for those with head injury.39 Because dexmedetomidine lowers the requirement for opioids, it can decrease opioid side effects. At the University of Rochester, in New York, the drug is widely used in burn patients, allowing complex wound care without the need for intubation.

One of the greatest challenges in administering sedatives to patients who have a history of alcohol or drug abuse is to maintain the correct balance—avoiding both excessive sedation and agitation/withdrawal syndromes.

The α2-adrenergic receptor properties of dexmedetomidine may be highly useful in this patient population. We have had great success in weaning patients with dexmedetomidine in the ICU—especially those with heavy alcohol or cocaine use. Further studies in this large population are necessary to map out the physiologic effects of sedation.

Dexmedetomidine in the neurologic ICU offers a unique quality of sedation described as similar to normal sleep. Several investigators have noted that their patients were in a tranquil state but were able to understand and communicate their needs on verbal stimulation by the medical staff (including the use of pen and paper).40 This particular profile of sedation may allow a more accurate evaluation of the neurophysiologic status of mechanically ventilated patients, which is difficult to accomplish with any other available sedative agents.

Thus, dexmedetomidine may be the preferred sedative for neurosurgical patients who require a real-time assessment of their neurologic status.

Another interesting population for further investigation is patients with head injuries, many of whom are highly agitated and expressing sympathetic outflow.

With dexmedetomidine, we have been able to blunt the response of these patients and increase their rate of successful extubation. Dexmedetomidine has decreased the length of ICU stay and the rate of tracheotomies in patients with closed head injuries.41 A 2009 trial of dexmedetomidine versus midazolam for sedation in the ICU concluded that although no

difference in time-to-targeted sedation was observed, at comparable sedation levels, patients treated with dexmedetomidine spent less time on a ventilator, experienced less delirium, and developed less tachycardia and hypertension.42 Because elimination is primarily hepatic, dexmedetomidine dosing should be lowered in patients with hepatic dysfunction. Also, the inappropriate use of dexmedetomidine may induce or aggravate cardiac conduction defects. Dexmedetomidine should not be used in hypovolemic or bradycardic patients, or in patients with low cardiac output or heart conduction blocks. The administration of this compound for more than 24 hours to critically ill patients has been found to be safe and effective in the ICU.43 An initial loading dose of 1 mcg/kg over 10 minutes can be prescribed; however, this dose is not frequently used, as it may cause transient hypotension or hypertension. These phenomena occur depending on whether vasodilatation (central α2a-receptor stimulation) or vasoconstriction (peripheral α2b-receptor stimulation) predominates. The usual maintenance dose is 0.2 to 0.7 mcg/kg per hour, with increases no more frequently than every 30 minutes. Doses up to 1.4 mcg/kg per hour have been reported.42 For patients older than 65 years, the suggested loading dose is 0.5 mcg/kg over 10 minutes with a maintenance infusion of less than 0.6 mcg/kg per hour. No specific guidelines exist for altering the dose for elderly patients or patients with hepatic or renal impairment.44 Dexmedetomidine is a promising agent with multiple actions that reduce analgesic and other sedative requirements, and it produces a cooperatively sedated patient. It may open a whole new arena in the sedation of extubated patients who have high levels of anxiety.

The compound may also enhance our ability to evaluate lung function and perform bronchoscopy in nonintubated patients, critically ill patients, and patients with moderate to severe chronic obstructive pulmonary disease or emphysema.45 Dexmedetomidine needs to be further studied and its place in the ICU identified by well-designed research to evaluate both its short- and long-term effects.

Methohexital (Brevital, JHP Pharmaceuticals) is a short acting IV barbiturate anesthetic. The literature is not robust regarding use of the drug for ICU sedation.

Continuous IV infusion should use a 0.2% solution with a dose of 5-120 mcg/kg per minute for maintenance of anesthesia.46 Use for Wada testing is an unlabeled indication. Dosages should be lowered in patients with hepatic impairment and renal impairment may prolong or potentiate its hypnotic effect.46 Several adverse reactions of methohexital are known but their frequency is not defined. Contraindications to its use include hypersensitivity to methohexital (or any component formulation) or other barbiturates and porphyria (latent or manifest).46 Extravasation or intra-arterial injection may cause necrosis. Many drug reactions are associated with methohexital.

Methohexital is pregnancy category B, crosses the placenta, and enters breast milk. It is metabolized via a hepatic route and excreted in urine.46 Quetiapine. Oral atypical antipsychotics have drawn recent interest for the treatment of critically ill patients with agitation due to delirium. Few trials have compared the efficacy and safety of these agents with haloperidol, but a recent prospective randomized trial revealed that quetiapine added to as-needed haloperidol resulted in faster resolution of delirium, less agitation, and a greater rate of transfer-to-home or rehabilitation. The dosing recommendation for quetiapine by this study was 50 mg BID, increased prn daily in 50-mg increments to a maximum dose of 400 mg per day.47 A 2007 study concluded that 25 to 100 mg per day of quetiapine improved delirious conditions within 24 hours of treatment, was well tolerated, and had a low propensity to induce extrapyramidal side effects.48 Quetiapine is a dibenzothiazepine atypical antipsychotic. Its antipsychotic activity is believed to be mediated via dopamine type 2 (D2) and serotonin type 2 (5-HT2) antagonism. Other CNS antagonist sites are the 5HT1A, dopamine D1, histamine H1, and α1- and α2-adrenergic receptors. Quetiapine does not appear to have affinity for benzodiazepine or muscarinic M1 cholinergic receptors, although norquetiapine, an active metabolite, does have affinity for M1 receptors.49 The main indication of quetiapine is for the treatment of patients with schizophrenia and acute manic or depressive episodes associated with bipolar disorder. Treatment for delirium in the critically ill patient is an unlabeled use. Significant adverse reactions include central (somnolence, headache), cardiovascular (orthostatic hypotension, tachycardia), and metabolic (hyperglycemia) effects.49 A boxed warning cautions about an increased risk for death compared with placebo in elderly patients with dementia-related psychosis treated with antipsychotic agents.49 Quetiapine is rapidly absorbed, is approximately 80% protein-bound, and is metabolized primarily by CYP34A hepatic enzymes with a half-life of 6 hours. The metabolite N-desalkyl quetiapine has a half-life of 9 to 12 hours. Excretion occurs renally, mainly as its metabolite and less than 1% as unchanged parent compound. Fecal excretion is approximately 20%. The cost for 60 tablets ranges from $290 to $560, depending on dose and formulation (immediate- or extended-release).49

Conclusion The most important aspect of ICU sedation is understanding the drugs given to patients and their specific advantages and disadvantages. Each drug is ideal for a specific use. It is crucial for the clinician to develop guidelines and pathways for the administration of these drugs within a specific environment. Each unit should develop protocols that grade effect based on the type of patient population in the unit. Newer drugs like dexmedetomidine should be introduced and studied in controlled trials in specific populations. In this way,

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protocols can be developed that enable patients to be comfortable and anxiety-free in the ICU. Poor levels of sedation should be a thing of the past.

The immunomodulating properties of sedative drugs also must be explored, as these properties may greatly affect outcome. With an increased understanding of sedative drugs will come an improved ability to use multiple drugs at specific times during the patient’s hospital stay.

References 1.

Jacobi J, Fraser GL, Coursin DB, et al. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002;30(1):119-141.

2. Cohen IL, Abraham E, Dasta JF, Gallagher TJ, Papadakos PJ, Pohlman AS. Management of the agitated intensive care unit patient.

Crit Care Med. 2002;30(suppl):S97-S123.

3. Fraser GL, Prato BS, Riker RR, Berthiaume D, Wilkins ML. Frequency, severity, and treatment of agitation in young versus elderly patients in the ICU. Pharmacotherapy. 2000;20(1):75-82.

4. Hassan E, Fontaine DK, Nearman HS. Therapeutic considerations in the management of agitated or delirious critically ill patients.

Pharmacotherapy. 1998;18(1):113-129.

5. Hansen-Flaschen J, Cowen J, Polomano RC. Beyond the Ramsay scale: need for a validated measure of sedating drug efficacy in the intensive care unit. Crit Care Med. 1994;22(5):732-733.

6. Riker RR, Picard JT, Fraser GL. Prospective evaluation of the Sedation-Agitation Scale for adult critically ill patients.

Crit Care Med. 1999;27(7):1325-1329.

7. Devlin JW, Boleski G, Mlynarek M, et al. Motor Activity Assessment Scale: a valid and reliable sedation scale for use with mechanically ventilated patients in an adult surgical intensive care unit.

Crit Care Med. 1999;27(7):1271-1275.

8. Ely EW, Margolin R, Francis J, et al. Evaluation of delirium in critically ill patients: validation of the confusion assessment method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001;29(7): 1370-1379.

9. Riker RR, Fraser GL. Monitoring sedation, agitation, analgesia, neuromuscular blockade, and delirium in adult ICU patients.

Semin Respir Crit Care Med. 2001;22(2):189-198.

10. Brook AD, Ahrens TS, Schaiff R, et al. Effect of a nursing-implemented sedation protocol on the duration of mechanical ventilation. Crit Care Med. 1999;27(12):2609-2615.

11. Kress JP, Pohlman AS, O’Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000;342(20):1471-1477.

12. Lund N, Papadakos PJ. Barbiturates, neuroleptics, and propofol for sedation. Crit Care Clin. 1995;11(4):875-886.

13. Lewis KS, Whipple JK, Michael KA, Quebbeman EJ. Effect of analgesic treatment on the physiological consequences of acute pain.

Am J Hosp Pharm. 1994;51(12):1539-1554.

14. Levine RL. Pharmacology of intravenous sedatives and opioids in critically ill patients. Crit Care Clin. 1994;10(4):709-731.

15. Shapiro BA, Warren J, Egol AB, et al. Practice parameters for intravenous analgesia and sedation for adult patients in the intensive care unit: an executive summary. Society of Critical Care Medicine.

Crit Care Med. 1995;23(9):1596-1600.

16. Tipps LB, Coplin WM, Murry KR, Rhoney DH. Safety and feasibility of continuous infusion of remifentanil in the neurosurgical intensive care unit. Neurosurgery. 2000;46(3):596-602.

17. Albanese J, Viviand X, Potie F, Rey M, Alliez B, Martin C. Sufentanil, fentanyl, and alfentanil in head trauma patients: a study on cerebral hemodynamics. Crit Care Med. 1999;27(2):407-411.

18. Myrick H, Malcolm R, Randall PK, et al. A double-blind trial of gabapentin versus lorazepam in the treatment of alcohol withdrawal. Alcohol Clin Exp Res. 2009;33(9):1582-1588.

19. Bonnet U, Hamzavi-Abedi R, Specka M, Wiltfang J, Lieb B, Scherbaum N. An open trial of gabapentin in acute alcohol withdrawal using an oral loading protocol. Alcohol Alcohol. 2010;45(2): 143-145.

20. Gabapentin. www.UpToDate.com.

21. Watling SM, Dasta JF, Seidl EC. Sedatives, analgesics, and paralytics in the ICU. Ann Pharmacother. 1997;31(2):148-153.

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22. Gilliland HE, Prasad BK, Mirakhur RK, Fee JP. An investigation of the potential morphine-sparing effect of midazolam.

Anaesthesia. 1996;51(9):808-811.

23. Watling SM, Johnson M, Yanos J. A method to produce sedation in critically ill patients. Ann Pharmacother. 1996;30(11):1227-1231.

24. Shafer A. Complications of sedation with midazolam in the intensive care unit and a comparison with other sedative regimens.

Crit Care Med. 1998;26(5):947-956.

25. Young C, Knudsen N, Hilton A, Reves JG. Sedation in the intensive care unit. Crit Care Med. 2000;28(3):854-866.

26. Kamijo Y, Masuda T, Nishikawa T, Tsuruta H, Ohwada T. Cardiovascular response and stress reaction to flumazenil injection in patients under infusion with midazolam. Crit Care Med. 2000; 28(2):318-323.

27. Bailie GR, Cockshott ID, Douglas EJ, Bowles BJ. Pharmacokinetics of propofol during and after long-term continuous infusion for maintenance of sedation in ICU patients. Br J Anaesth. 1992;68(5): 486-491.

28. Barrientos-Vega R, Mar Sánchez-Soria M, Morales-García C, RobasGómez A, Cuena-Boy R, Ayensa-Rincón A. Prolonged sedation of critically ill patients with midazolam or propofol: impact on weaning and costs. Crit Care Med. 1997;25(1):33-40.

29. Bennett SN, McNeil MM, Bland LA, et al. Postoperative infections traced to contamination of an intravenous anesthetic, propofol.

N Engl J Med. 1995;333(3):147-154.

30. Abraham E, Papadakos PJ, Tharratt RS, Hall JB, Williams GJ. Effects of propofol containing EDTA on mineral metabolism in medical ICU patients with pulmonary dysfunction. Intensive Care Med. 2000;26(suppl 4):S422-S432.

31. Herr DL, Kelly K, Hall JB, et al. Safety and efficacy of propofol with EDTA when used for sedation of surgical intensive care unit patients. Intensive Care Med. 2000;26(suppl 4):S452-S462.

32. Mirenda J, Broyles G. Propofol as used for sedation in the ICU. Chest. 1995;108(2):539-548.

33. Cremer OL, Moons KG, Bouman EA, Kruijswijk JE, deSmet AM, Kalkman CJ. Long-term propofol infusion and cardiac failure in adult head-injured patients. Lancet. 2001;357(9250):117-118.

34. Fospropofol [product information]. Woodcliff Lake, N.J.: Eisai Inc. 35. Fospropofol. www.UpToDate.com.

36. Fechner J, Schwilden H, Schüttler J. Pharmacokinetics and pharmacodynamics of GPI 15715 or fospropofol (Aquavan injection)—a water-soluble propofol prodrug. Handb Exp Pharmacol. 2008;(182): 253-266.

37. Padegal V, Venkata B, Papadakos PJ. Neuroleptic malignant syndrome and malignant hyperthermia. In: Kruse JA, Fink MP, Carlson RW, eds. Saunders Manual of Critical Care. Philadelphia, PA: WB Saunders; 2002:301-303.

38. Gertler R, Brown HC, Mitchell DH, Silvius EN. Dexmedetomidine: a novel sedative-analgesic agent. Proc (Bayl Univ Med Cent). 2001; 14(1):13-21.

39. Chhangani SV, Papadakos PJ. The use of dexmedetomidine for sedation in patients with traumatic brain injury. Anesthesiology.

2002;97(ASCCA suppl):B20.

40. Bekker A, Sturaitis MK. Dexmedetomidine for neurological surgery.

Neurosurgery. 2005;57(1 suppl):1-10.

41. Barreiro TJ, Papadakos PJ. Current practices in intensive care unit sedation. In: Papadakos PJ, Szalados JE, eds. Critical Care, the Requisites in Anesthesiology. Philadelphia, PA: Elsevier Mosby; 2005.

42. Riker RR, Shehabi Y, Bokesch PM, et al. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial.

JAMA. 2009;301(5):489-499.

43. Rodrigues MG, Salgado DR, Paiva RNA, Chindamo G, Martins LC, Verdeal JCR. Use of dexmedetomidine beyond 24 hours in the intensive care unit. Crit Care. 2003;7(suppl 2):95.

44. Dexmedetomidine. www.UpToDate.com.

45. Abouzgheib W, Littman J, Pratter M, Bartter T. Efficacy and safety of dexmedetomidine during bronchoscopy in patients with moderate to severe COPD or emphysema. J Bronchol. 2007; 14(4):233-236.

46. Methohexital. www.UpToDate.com.

47. Devlin JW, Roberts RJ, Fong JJ, et al. Efficacy and safety of quetiapine in critically ill patients with delirium: a prospective, multicenter, randomized, double-blind, placebo-controlled pilot study.

Crit Care Med. 2010;38(2):419-427.

48. Maneeton B, Maneeton N, Srisurapanont M. An open-label study of quetiapine for delirium. J Med Assoc Thai. 2007;90(10):2158-2163.

49. Quetiapine. www.UpToDate.com.

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POLICY & MANAGEMENT

Checklist Tweaks Can Temper Surgical Hierarchy in OR San Diego—Institutions seeking to achieve complete compliance with the World Health Organization’s “Surgical Safety Checklist” in the operating room may find that having a surgeon or other authority figure merely review the checklist before a procedure may not fully accomplish its objectives. However, team dynamics improve when all members of the surgical team are required to identify themselves and participate in the process, according to researchers at Virginia Mason Medical Center in Seattle.

“Since the publication of [the Institute of Medicine’s 1999 report] ‘To Err Is Human,’ the Joint Commission has focused on teamwork development as a critical element in reducing medical errors,” said Jon Narimasu, MD, an anesthesia resident Virginia Mason. “Yet, despite studies showing that improved teamwork can improve outcomes, there are significant barriers in the operating room. One in particular is the hierarchical system in which the surgeon leads the time-out and discussion.”

After the WHO preprocedural checklist was implemented at Virginia Mason, Dr. Narimasu and his colleagues sought first to evaluate whether team building had improved. (The WHO checklist is available at http://whqlibdoc.who.int/ publications/2009/9789241598590_ eng_Checklist.pdf.) An independent observer was assigned to score team members’ participation in 31 ORs. The observer recorded whether individual team members stopped their activities, spoke their names, expressed concerns and were asked about their concerns.

In 100% of the observed operations, the checklist was performed but did not result in improved teamwork activities. Anesthesia residents stopped their activities 75% of the time; nurses and surgical technicians stopped 88% and 50%, respectively. Anesthesia residents spoke their names 47% of the time and offered comments 13% of the time. For the nurses and surgical technicians, the percentages were even lower.

Given the somewhat disappointing results of the baseline exercise, a multidisciplinary task force was created at the medical center. The goal was to improve checklist participation and teamwork behaviors. “One of the functions that we added was that each team member had to attest to a specific domain and take responsibility for that area,” Dr. Narimasu said. The results were presented at the 2010 annual meeting of

e-Newsletters and e-Alerts Get the latest news from the best-read anesthesiology publication in the country delivered directly to your computer or mobile device for free!

the American Society of Anesthesiologists (abstract A382).

A video was created to demonstrate how teamwork and the checklist procedure should be initiated. Live training sessions were conducted over a two-month period. Members of the task force coached OR staff on working through the checklist and encouraging FILE SLUG participation.

Current file: CME Zone quarter pg 2011-03.indd 1ST PROOF LAYOUT APPROVED FINAL OK PROOF 1: 1/24/11 After one month of active auditing by INITIALS AND DATE INITIALS AND DATE REV 1: REV 2: the task force, it was found Full namethat of projectalmost31p x 39p AN Quarterpage ad Senior editor REV 3: 100% of OR staff were participating in Editor REV 4: the preoperative pause. Dr. Narimasu REV 5: Project no.

Copy editor pointed out that, at baseline, the OR REV 6: Revision # Sales REV 7: team members (excluding the surgeon)Proof 1 REV 8: Layout date/time Production had been speaking up about 50% of theMarch 3, 2011 5:14 PM REV 9: Editorial date/time Circulation time. “After the intervention, it pushed REV 10: Each installment contains articles from the current up toward 90% and carried Trim sizeon through-31p x 39p AN Quarterpage ad COMMENTS: KEYWORDS: month’s issue ahead of print, as well as links to out the postintervention period, ” he said.

Color specs Following the intervention, members podcasts and other Web-exclusive content path of the OR team expressedFiletheir concernsCME Zone quarter pg 2011-03.indd 22% of the time (compared with 10% previously). Surgeon-solicited responses from the team increased from approximately 30% to almost 80%. All elements of the checklist were covered in 100% of cases after creation of the task force, compared with 58% previously.

“I’m a big believer in forced functionality,” said David J. Birnbach, MD, MPH, professor of anesthesiology and obstetrics-gynecology at the University of Miami Miller School of Medicine.

“But, there are always ways for people to get around forced functions, so I think it would help if everyone on the surgical team really believed in what they were doing.”

Dr. Birnbach said the process might Here are a few NEW educational activities be improved even more if, at some available now on CME Zone point, people could critique surgical team members on what they did or did not do.

Fluid Responsiveness Monitoring In Surgical and Critically Ill Patients Michael F. Mulroy, MD, faculty anesClinical Impact of Goal-Directed Therapy SR1047 Credit Also Available for CRNAs thesiologist at Virginia Mason and a expires September 30, 2011 senior author of the study said that, in addition to enhanced teamwork, one of the most gratifying results of the project Brain Monitoring of Anesthetic Effect: An Evidence-Based Assessment was the enthusiasm with which most of of Clinical Impact and Safe Use SR1058 the surgeons embraced the changes.

Credit Also Available for CRNAs expires April 1, 2012 “As part of the project, we emphasized that team members say their first and last names to level the playing field and SPECIAL FEATURES empower them to speak up,” Dr. Mulroy said. “The hardest part of the orientaSpecialty Pages: Coming Soon: tion was trying to convince the surgeons easy access to educational activities in continually updated snapshots of your specialty area upcoming educational activities that their first name was not ‘Doctor.’

But they all bought into it fairly quickly, Live CME/CE: Individual History: “real-time” streaming live-event maintains records of your courses, credit-hour and it’s been impressive the way the programs status, license renewal dates, and more group has accepted it.”

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In Incentive Pay Programs, Are Teaching Scores the Best Metric?

teaching might be reward enough for many physicians who choose to pursue academic anesthesiology, proper incentives may improve the performance of even the best educators.

Academic anesthesiologists differ “So,” Dr. Harter asked, “what are the San Diego—For the academic anes- debated the relative merits and draw- anesthesiology at Ohio State Uni- incentives you can provide for faculty?” thesiologist, the sometimes murky rela- backs of score-based incentive pay pro- versity (OSU) Medical Center, in He went on to identify time and money tionship between teaching scores and grams in a point-counterpoint panel at Columbus, defended the pro side of as the two most significant currenincentive pay might be characterized the 2010 annual meeting of the Ameri- the argument by asserting that every- cies. Better-performing academic anesas one of love and hate. Ronald L. Har- can Society of Anesthesiologists. one agrees that effective teaching is thesiologists can be rewarded not only ter, MD, and Lebron Cooper, MD, Dr. Harter, professor and chair of a desired attribute. And, while good financially, but with more non-clinical time, as well. The current incentivepay program at OSU can enable faculty members to increase their base salary by as much as 10%. “One of the things that helped this to be widely accepted is that the bonus didn’t come at the sake of reducing base salary, but was added to the existing base when a new contract was initiated,” he said.

The OSU program is based on faculty performance in three areas: resident education, research/administration and clinical quality. “My feeling is that whether you’re mostly in Nearly every anesthesia professional on the the lab or in the operating room five ™ days a week, everybody has an opporplanet relies on LMA. So, what’s new? tunity to interact with residents. That’s an important part of what our faculty needs to contribute,” he said.

The education score component of the program is based largely on a monthly evaluation system, whereby residents evaluate faculty and vice versa.

Residents are asked a series of seven questions (on a three-point scale); scores are weighted equally and a mean score is calculated. ™ Although the system at OSU has The LMA Supreme changed slightly over the years, Dr. Harter noted that teaching scores have We invented laryngeal mask airways some 20 years ago. Clinicians like you have improved over the past two years. He been trusting them and we’ve been improving them ever since. Here’s the latest. recognized, however, that this does not necessarily mean that the quality of The LMA Supreme has the ideal curve to make it remarkably easy to insert. teaching is improving. “You could say And it’s the first LMA single-use mask with a built-in drain tube designed to that the bonus system motivates better clinical teaching, which is reflected channel fluids and gas safely away from the airway. Considering the frequent 1 in the data,” he said. “Yet, it’s also true presence of stomach fluids even in fasted patients, doesn’t that make a lot of sense? that residents know their evaluations of faculty really do matter, and maybe With more than 200 million successful procedures, LMA airways are the standard they are a little more reluctant to give for safety, comfort and better outcomes around the world. When you use an negative scores as a result.

LMA Supreme, you’ll know why we say, “We put confidence in your hands.”

“In the end, though, I think teaching scores send a message to faculty that good teaching is integral to our department and something we want to continually improve.”

Dr. Cooper, chief of anesthesiology at University of Miami Hospital, in For more information, visit our website at Florida, argued against the use of reswww.lmana.com/supreme or call 1-800-788-7999. idents’ teaching scores as a basis for incentive pay. He asserted that the folTretiak, S. “The LMA Supreme: Should gastric access be the standard of t August 2009. care?” Anesthesiology News Guide to Airway Management, lowing four basic assumptions in such a system all have been shown in the litLMA Airways™ | LMA EMS™ | LMA Visualization™ | LMA Pain Management™ | LMA Atomization™ erature to be erroneous: ™

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Authorized NA Representative: LMA North America, Inc. 4660 La Jolla Village Dr., Suite 900 San Diego, CA 92122 P: 800-788-7999 F: 858-622-4130 Copyright © 2011, The Laryngeal Mask Company Limited LMA, The Laryngeal Mask Company Limited logo and its component parts are trademarks of The Laryngeal Mask Company Limited. The LMA Supreme™ is protected by a series of granted and pending patents, each covering a distinctly unique invention. LMANA-900102 LMA-590 01/11

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POLICY & M A N AGE ME N T 1. Teaching scores accurately reflect teaching quality; 2. Teaching scores result in improved teaching; 3. Improved teaching results in improved educational outcomes or residents’ performance; and 4. Incentive or merit pay results in improved teaching, and therefore improved performance.

Regarding the first assumption, Dr. Cooper said that teaching scores have not been shown to accurately reflect teaching quality or the multidimensionality of teaching. In addition, residents tend to inflate evaluation scores for their teachers. “Then, there’s the performance aspect to consider,” he said. “There may be absolutely no substance to what we teach, but if residents like our performance, we get great scores.” Also, residents might abrogate personal responsibility by hiding behind the anonymity of evaluations.

The second assumption, he said, also is wrong; teaching scores have not been shown to result in improved teaching. “Out of eight studies I looked at, four scoring systems included formative comments, which can improve teaching performance. However, the other four studies showed that if you just use the score alone, there is no improvement in teaching.” He also said that improved teaching may not result in residents’ improved performance.

Indeed, whereas scores on part 1 of the American Board of Anesthesiology certification examinations have risen in the past five years, part 2 scores have shown no improvement at all. “And frankly, if you look at those numbers when residents graduate, about 20% of each class needs about 10 years to pass the boards,” he said. Residents “have to get away from you to become boardcertified.”

Perhaps not surprisingly, Dr. Cooper asserted that incentive and merit

pay does not result in improved teaching or improved performance. “[In] the only U.S. study finding any type of positive association between merit pay and student achievement, [the researchers] admitted their own findings are spurious.” Incentive and merit pay can result in unintended consequences, he argued, if teachers tend to undermine the education they give to students when they feel evaluation scores are unjust.

“Resident evaluations may provide some valid benefits,” Dr. Cooper

Closed.

said. “They’re pretty reliable, have been around for many years and may be the only way we can actually evaluate teachers. But, incentive and merit pay [programs] based on scores alone have consistently failed to produce the desired results of improving resident performance. The comments matter; the scores don’t. With that in mind, teaching scores should not be factored into incentive pay for anesthesiologists.”

—Michael Vlessides

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3 6 I A n e s t h e s i o l o g y N e w s . c o m Ma r c h 2 0 1 1

CLIN ICAL A N ESTHESIOLOGY Wrong Site continued from page 1 adoption of the Joint Commission’s Universal Protocol starting in July 2004 and other patient safety measures (see Anesthesiology News, April 2009, page 1).

Anesthesiologists are responsible for a growing share of these “sentinel events,” especially involving wrongsite local and regional anesthesia blocks. In Pennsylvania, for instance, the share of errors attributed to wrong-site blocks jumped from 20% of the total in 2004 to 44% in 2009, said John R. Clarke, MD, clinical director of the state’s Patient Safety Authority, which collects and analyzes the data (Figure). “This is because surgeons have made improvements, but anesthesiologists have not,” Dr. Clarke said.

“Surgeons have been applying the Universal Protocol the way it was intended, including verification, marking the site and performing the time-out,” Dr. Clarke told Anesthesiology News. “But anesthesiologists, if anything, did verifications but hardly ever did markings. And they were generally not doing the time-out with an independent party. And often, they only did a rudimentary form of verification,” he said.

‘Surgeons have been applying the Universal Protocol the way it was intended, including verification, marking the site and performing the time-out. But anesthesiologists, if anything, did verifications but hardly ever did markings. And they were generally not doing the timeout with an independent party.’

—John R. Clarke, MD

30

Number of Reports

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Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2004

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“It’s disappointing that anesthesiologists are not keep- operating room team plays ing up with improvements relative to surgeons.” a unique role: The surgeon, anesthesiologist and the scrub From Scheduling to Completion person each has a series of The Joint Commission will soon release results of questions or statements he or a two-year pilot project aimed at reducing wrong-site she makes in response to the surgical procedures with the hope that hospitals and circulating nurse, who serves other facilities will adopt best practices to prevent as coordinator. them. The pilot study covered the full range of surgi“We also made and enforced cal procedures, from scheduling to confirmation that certain rules, which may seem the operation had been performed. obvious but were not always Sonya Pease, MD In July 2009, two Rhode Island hospitals affili- implemented previously, such ated with the Lifespan health care system asked the as turning off music in the OR and insisting that Joint Commission to undertake the study. Eight everyone stop what they are doing during the active other institutions were subsequently added, includ- time-out process,” Dr. Reich said. ing Mount Sinai Medical Center in New York Blaming the Blocks City and Thomas Jefferson University Hospital in Philadelphia.

Anesthesiologists placing regional blocks in the The study was conducted by the Joint Commis- holding area perform their own “block time-out,” sion’s Center for Transforming Healthcare, a separate involving an additional person who confirms the nonprofit that collaborates with hospitals and other patient, procedure and laterality, Dr. Reich said. This health care organizations to help them improve pro- second person could be the surgeon, a circulating cesses and outcomes by using methods from Lean Six nurse from the OR or the holding area, or an anesSigma and other change-management approaches. thesia resident, as long he or she is not under the The center’s work is independent of the commission’s anesthesiologist’s supervision. “We felt there was too accreditation and certification activities. “There is a much influence, potentially, with an attending anesfirewall between the work that is done in the center thesiologist supervising his or her resident in the and the accreditation side of the house,” said project block time-out,” Dr. Reich said. manager Melody Dickerson, RN. Performing a time-out prior to starting a block has Tools and solutions emerging from the pilot study been recommended practice for some time. “As aneswill be “beta-tested” at still other hospitals and ambu- thesiologists, we do a time-out before we do any prolatory centers in late March and early April and made cedure on the patient, whether it’s placing a central available to all accredited organizations afterward, line or putting in an acute regional pain care block,” Ms. Dickerson said. She declined to identify the said Sonya Pease, MD, president of the Florida Sociapproaches being studied, but noted that solutions ety of Anesthesiologists. “A lot of times, we do these can be tailored to the needs of particular institutions. procedures before the surgeon shows up. That creates At Mount Sinai, the orthopedic surgical team par- two time-outs,” she told Anesthesiology News. ticipating in the pilot uncovered weaknesses in how The increase in anesthesia-related wrong-site probthey applied Universal Protocol safety checks, said lems is tied to the increased use of nerve blocks, said David Reich, MD, professor and chair of anesthesiol- Joseph F. Talarico, DO, president of the Pennsylvania ogy at the institution. “We analyzed our results and Society of Anesthesiologists. “In the past, it wasn’t created a new process that we refer to as the ‘active much of a problem because we were not blocking as time-out,’” Dr. Reich said. Instead of a nurse simply much as we were administering general anesthesia,” reciting a script prior to surgery, each member of the he said. These mistakes should decrease as anesthesiologists take appropriate precautions. “For instance, we are now marking the site along with the surgeons, and unless the site is marked, we won’t bring the patient into the OR,” Dr. Talarico said.

Although wrong-site nerve blocks are nowhere near as serious as are wrong-site operations, anesthesiologists “should take the same sense of responsibility as they do with anoxic encephalopathy,” Dr. Clarke said. “It’s not as big a problem by any stretch, but it’s an area for potential quality control for people who are known for quality but who don’t seem to have applied the same level of enthusiasm for preventing wrong-site procedures as they have for other things.”

The effort at Mount Sinai has been constructive, said Erin DuPree, MD, deputy chief medical officer and vice president for patient safety at the institution.

“It’s been a positive experience for us to focus on surgical safety and decrease risk for patients,” she said. “PartQ1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 nering with a national organization and sharing data to 2007 2008 2009 help other organizations decrease their risk is fantastic.”

Reports by Quarter

Figure. Pennsylvania Patient Safety Authority wrong-site surgery reports by quarter.

—Ted Agres

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AnesthesiologyNews.com I 37

CLI N ICAL A N ESTHESIOLOGY

Most ICU Patients Receive Inadequate VTE Prophylaxis

O

nly 12% of critical care patients at risk for venous thromboembolism receive appropriate prophylaxis, according to findings from a database review presented at the 2011 annual meeting of the Society of Critical Care Medicine.

The investigators, whose study (abstract 12) included more than 22,000 critically ill patients nationwide, implicitly chided physicians who they found either failed to administer any prophylaxis or, when they did, failed to use the correct type, dose or duration of therapy.

“There is clearly a huge gap between current American College of Chest Physicians [ACCP] guidelines and the current clinical application of these guidelines,” said Jean Charchaflieh, MD, DrPH, associate professor of anesthesiology at SUNY Downstate Medical Center, in Brooklyn, N.Y., who was not involved in the study. “This may be due to lack of awareness of the guidelines, not believing in their benefit, not knowing when and how to apply them or simply a result of forgetfulness and inattention.”

The ACCP’s 2004 guidelines on preventing venous thromboembolism (VTE) state that most critical care

Table. Critical Care Thromboprophylaxis Recommendations From the 2004 ACCP Guidelines (Seventh) 1.

On admission to a critical care unit, all patients should be assessed for their risk for VTE. Most should receive thromboprophylaxis (grade 1A).

2.

Patients at high risk for bleeding should receive mechanical prophylaxis with graduated compression stockings and/or intermittent pneumatic devices until bleeding risk decreases (grade 1C+).

3.

LDUH or LMWH is recommended (grade 1A) for patients at moderate risk for VTE (such as those recovering from surgery).

4.

Patients at higher risk for VTE, including those recovering from major trauma or orthopedic surgery, should receive LMWH (grade 1A).

ACCP, American College of Chest Physicians; LDUH, lowdose unfractionated heparin; LMWH, low-molecular-weight heparin; VTE, venous thromboembolism Source: Chest 2004;126(suppl 3);​338S-400S

patients have at least one, and often, several risk factors for the condition and thus require appropriate prophylaxis (Table). But how closely, if at all, clinicians adhere to this recommendation is unclear.

To find out, Paul Dobesh, PharmD, associate professor of pharmacy practice at the University of Nebraska Medical Center, in Omaha, and colleagues

examined discharge notes and billing records from 22,801 critical care patients at risk for VTE treated at 16 hospitals between January 2005 and December 2006.

The subjects had been enrolled in the VTE START (Venous Thromboembolism Study to Assess the Rate of Thromboprophylaxis) trial. Nearly half (47.5%) had undergone surgery,

45% had experienced cardiovascular or respiratory failure, 36% were admitted for acute medical illness and 21% had a central venous catheter—all risk factors for developing VTE. More than 50% of patients had more than one of these risk factors, the researchers said.

Subjects were at least 18 years of age and had received intensive care for at see VTE page 40

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CLIN ICAL A N ESTHESIOLOGY

BIS Monitor Performs Well in Balanced Xenon Anesthesia Study of 60 abdominal surgery patients trial, monitoring with auditory evoked potentials (AEPs) produced unpredictable results. The study received financial support from Air Liquide Santé International, in Paris.

“The aim of the study was to see if monitoring—BIS monitoring and auditory evoked potentials—is possible in balanced general anesthesia

with xenon,” said Mark Coburn, MD, a consultant anesthesiologist at the hospital. “There are [few] data available for these kinds of monitoring in xenon general anesthesia. We feel it is important, especially since xenon acts as an [N-methyl-d-aspartate] receptor antagonist.” The participants were randomly assigned to receive either balanced xenon (n=30) or sevoflurane anesthesia (n=30) with remifentanil titrated to clinical efficacy. BIS and composite AEP monitoring were conducted on each patient. Anesthesiologists were blind to monitoring. Dr. Coburn presented the results at the 2010 annual meeting of the American 100

80

BIS

363; Anesthesiology 2008;108:63-70) that found unpredictable influences of xenon on bispectral index monitoring (BIS, Covidien).

The investigators at University Hospital Aachen, in Aachen, Germany, concluded that in comparison with BIS monitoring in the 60 abdominal surgery patients participating in the

60

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20 B

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Duration of A Figure 1. BIS values during induction and maintenance of xenon anesthesia correlated well with the value range recommended for deep hypnosis and with values obtained during sevoflurane anesthesia.

75 60

cAAI

San Diego—Electroencephalographic monitoring with the bispectral index indicated a predictable level of hypnosis in patients undergoing balanced xenon anesthesia, in a study by German researchers. The results of the double-blind randomized controlled trial contrasted with those of two previous studies (Br J Anaesth 2000;85:359-

45 30 15 0 B

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Duration of A Figure 2. The cAAI remained stable in the sevoflurane group. However, values increased during balanced xenon anesthesia and exceeded the recommended upper limit. cAAI, composite A-line autoregressive index

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CLI N ICAL A N ESTHESIOLOGY Society of Anesthesiologists (abstract A400).

During induction and maintenance of xenon anesthesia, BIS values correlated well with the value range recommended for deep hypnosis. BIS values also correlated well with values obtained during sevoflurane anesthesia (Figure 1). The composite AEP index also remained consistent in the sevoflurane group. During balanced xenon anesthesia, however, these values increased and exceeded the recommended upper limit (Figure 2).

“So far, we have no explanation why the auditory evoked potentials monitoring reacted the way it did,” Dr. Coburn said. “There was a Brice questionnaire afterwards [to determine] if these patients had awareness. Although none of them did, we wouldn’t really

expect to see awareness in 60 patients anyway.

“So, while BIS monitoring seems to be comparable in xenon as we know it in balanced anesthesia with sevoflurane, we have to be more guarded with auditory evoked potentials,” he said. “At present, it is not our monitor of choice in xenon general anesthesia; we would recommend an [electroencephalography]based monitor.”

Clifford M. Gevirtz, MD, MPH, medical director at Metro Pain

Management and Addiction Recovery Institute, in New Rochelle, N.Y., told Anesthesiology News that until now, xenon has been thought to be an ideal agent for neurosurgical procedures because it has not been shown to cause cerebral vasodilation or significantly alter hemodynamics. “However, if there is some redistribution phenomenon within the brain or tachyphylaxis, whereby the auditory evoked potentials are suppressed only for an hour or so, it calls into question the utility of xenon

for these procedures,” he said. “Clearly, more experimentation needs to be performed.” He agreed that given these data, the BIS may be a better monitor for xenon anesthesia. Dr. Gevirtz, a member of the advisory board of Anesthesiology News, disclosed that he advocates the increased use of xenon and gradual elimination of halogenated agents because of the environmental impacts.

—Michael Vlessides

■ Xenon ■ Sevoflurane

SHELF

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■ Xenon ■ Sevoflurane

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55

65

Anesthesia, min

75

85

E

Always check the label for the expiration date.

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4 0 I A n e s t h e s i o l o g y N e w s . c o m Ma r c h 2 0 1 1

CLIN ICAL A N ESTHESIOLOGY

Most Cervical Spine Injury Claims Linked to Underlying Disease Analysis of ASA Closed Claims database San Diego—Contrary to what many anesthesiologists may believe, the majority of perioperative cervical spinal cord injuries have occurred in the absence of traumatic injury, cervical instability or airway difficulties.

This conclusion is based on an analysis of cervical cord injury claims in the American Society of Anesthesiologists (ASA) Closed Claims database. Researchers at the University of Iowa, in Iowa City, and University of

Washington, in Seattle, discovered that in the absence of cervical spine instability, degenerative disease of the cervical spine was common and appeared to be the underlying factor associated with spinal cord injury in the closed claims.

“Cervical spinal cord injury is a rare, but catastrophic, complication of surgery and anesthesia,” said lead author Bradley J. Hindman, MD, professor of anesthesia and vice chair for faculty development at the University of Iowa.

“Patients commonly considered to be at greatest risk are those with cervical spine instability in whom direct laryngoscopy and intubation may cause pathological cervical spine motion, critical cord compression and injury.”

Because the number of published case reports describing cervical spinal cord injury in such patients is exceedingly small, the investigators turned to the ASA Closed Claims database, which they believed might contain a relatively large and unreported series of perioperative cervical spinal cord injuries. Their aim was to systematically review such claims in an attempt to determine clinical risk factors and possible mechanisms of injury.

Three independent teams searched 5,231 general anesthesia claims for the period 1970 to 2007 to identify injuries of the cervical spinal cord, roots or bony spine. Each team comprised an experienced neuroanesthesiologist and neurosurgeon. They reviewed claim summaries for patient characteristics, intraoperative management and injury presentation; each team also judged probable contributors to injury. Two of the three teams were required to agree for an affirmative response.

From an abstract judged to be one of the best presented at the 2010 annual

VTE continued from page 37 least two days. Those in whom thromboprophylaxis was contraindicated were not included in the study.

The investigators looked at chart notes and the ACCP’s 2004 VTE guidelines to determine the most appropriate type, dose and duration of VTE prophylaxis for each patient and compared the recommended regimen with what was in fact administered.

Their analysis revealed that physicians administered appropriate prophylaxis in only 12.5% of patients, and did not administer any in 26.5%. Of the entire at-risk population, 34% received inappropriate prophylaxis, 13% received the correct type for the recommended duration but not at the correct dosage and another 4% of patients were administered the appropriate type of prophylaxis at the recommended dose but not for the recommended

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AnesthesiologyNews.com I 41

CLI N ICAL A N ESTHESIOLOGY meeting of the ASA (abstract A778), Dr. Hindman reported that 48 cervical injury claims (age, 47±15 years; 73% males) comprised less than 1% of all the general anesthesia claims. Although cervical injury claims were more often permanent and disabling (69%) than other general anesthesia claims (19%), they were less frequently fatal (8% vs.

36%; P<0.001).

“Interestingly, in 90% of all cervical injury claims, the standard of care was considered to be met, as compared with 55% in other general anesthesia claims,” Dr. Hindman said. A total of 9% of cervical injury claims were considered to be preventable by better monitoring, compared with 22% of other general anesthesia claims.

The cervical spinal cord injuries (n=37) were more severe than the root/spine injuries (n=10; P<0.001), and typically resulted in quadriplegia (n=33; 89%). The majority of cervical spinal cord injuries occurred in the absence of traumatic injury (81%) or cervical spine instability (76%). By comparison, anatomic abnormalities— primarily cervical spondylosis/stenosis and/or disc disease—were present in 95% of cases of cervical spinal cord injury (n=35).

Management of a difficult airway was apparent in 8% of cervical spinal cord injury claims. Cord injury occurred with both cervical (n=24) and noncervical (n=13) spine procedures (65% vs. 35%, respectively). Nine cord claims (24%) were associated with the sitting position.

length of time. One in 10 patients received the appropriate type of prophylaxis but in an incorrect dose and for too short a time.

Dr. Dobesh said his study was not designed to follow patients after discharge, the period during which most cases of VTE occur. Nevertheless, he said, the findings point to a disparity between recommended VTE prophylaxis and actual clinical practice.

“There needs to be a significant educational push to make sure we are providing evidence-based and appropriate prophylaxis,” Dr. Dobesh said. “These data should help institutions identify where the gaps in VTE prevention exist so that they can develop and implement strategies for improving the quality of VTE prophylaxis in critical care patients.”

—David Wild

Most cord injury symptoms were new (n=30; 81%) and detected immediately after the procedure (n=26; 87%).

Several factors were determined to be probable contributors to cord injury, including anatomic abnormalities (81%), direct surgical complications (24%; cervical spine procedures only), preprocedure symptoms (19%), intraoperative head/neck positioning (19%) and airway management (11%).

“Our perspective is that most cervical spinal cord injuries occur in the

absence of trauma, cervical instability or airway difficulties,” Dr. Hindman said. “However, in the absence of instability, cervical spondylosis was exceedingly common. And it appears to predispose the cervical spinal cord to injury from otherwise benign events, such as non-neutral head and neck position and relative hypotension.”

Ira J. Rampil, MD, professor of anesthesiology and neurological surgery at Stony Brook University Medical Center in Stony Brook, N.Y., said that like

any retrospective study, this one is limited by what it can disclose about mechanism, therapeutic options or prospective risk stratification. He told Anesthesiology News that “it is, however, useful to know that these injuries can and do occur without warning, other than perhaps a history of cervical degenerative joint disease.”

The study was published online in February in Anesthesiology.

—Michael Vlessides

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AIV Fluid Administration And the Elderly Shamsuddin Akhtar, MBBS Associate Professor Department of Anesthesiology Yale University School of Medicine New Haven, Connecticut This article is the second in a multipart series produced in collaboration with the Society for the Advancement of Geriatric Anesthesia (www.sagahq.org) that will address clinical issues specific to geriatric patients.

I

ntravenous fluid administration is an integral part of clinical care. Even so, although the value and

importance of fluid therapy in maintaining adequate

intravascular volume, hemodynamics, and appropriate oxygen delivery are well recognized, its adverse consequences are underappreciated. According to one survey, half of physicians were unaware of the composition of the fluids that they were prescribing and

administering.1

The deleterious effects of indiscriminate fluid administration were noted a century ago.2 As the use of large-volume salt solution became routine, the problems associated with excessive administration of fluids soon were recognized. Evans, writing in the Journal of American Medical Association in 1911, observed “the thoughtless and indiscriminate use of this remedy.”2 He added: “One cannot fail to be impressed with the danger of … the utter recklessness with which salt solution is frequently prescribed, particularly in the postoperative period.”

Despite significant advances in the understanding of neuroendocrine stress response to surgery and its effect on sodium, potassium, and water balance in the perioperative period, by the 1960s the use of IV fluid was firmly rooted in the medical practice.3,4

Consequences of Inappropriate Fluid Therapy The consequences of inappropriate fluid therapy are well established (Table 1) and have been highlighted in many publications.5-10 Perioperative practitioners, including surgeons, anesthesiologists, intensivists, hospitalists, and nurses, should pay more attention to this issue.

Fluid therapy is not, and should not be considered, routine. It accords as much importance as any other prescribed medication, especially in light of the changing demography of the hospitalized patient. The elderly (aged 65 years and older) constitute one of the fastest growing segments of the population in many countries.

In the United States, it is estimated that by 2025, 15 million people will be older than age 85 years.

Imprecise fluid administration in the elderly can have dire consequences.

In 1999, the United Kingdom National pulmonary edema resulting from Confidential Enquiry into Peri-oper- excessive fluid administration.1 ative Death report concluded that “errors in fluid management (usually Effects of Aging on Renal excess fluid) were one of the most Function, Fluids, common cause of avoidable peri- And Electrolytes operative morbidity and mortality” Elderly patients are more prone at the extremes of age.11 The report to adverse consequences of inapstated that “fluid management in the propriate fluid administration than elderly is often poor; they should be their younger counterparts. They accorded the same status as drug have significantly reduced physioprescription. Multidisciplinary reviews logic reserves and often have major to develop good local working prac- comorbidities, including hypertension, coronary artery disease, and tices are required.”

A 2010 report from the same Brit- congestive heart failure.13 The prevaish body discussed this problem in lence of chronic kidney disease in the the context of acute kidney injury Medicare population is about 8%. and concluded that appropriate Progressive deterioration of the management of fluids can prevent cardiovascular and renal systems the condition.12 In the United States, occurs with aging. The incidence of even excluding all other comorbidi- systolic and diastolic dysfunction and ties potentially associated with pul- vascular stiffness increases with age, monary edema, more than 8,300 as do various aspects of renal funcpatients would still die annually from tion, such as the following:

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AnesthesiologyNews.com I 43

CLI N ICAL A N ESTHESIOLOGY Table 1. Risks Associated With Inappropriate Fluid Therapy Hypovolemia Risks

Fluid Overload Risks

Hypotension

Delayed bowel recovery

Multiple organ failure

Hypertension

Renal failure

Peripheral edema

Shock

Poor wound healing

Tachycardia

Respiratory failure

1. Renal vascular dysautonomy 4. Medullary hypotonicity describes reflects attenuation of the autoreduced tonicity of the renal nomic renal vascular reflexes to medulla in the elderly compared protect the kidney from hypotenwith younger individuals. The phesive or hypertensive states. nomenon suppresses the effects 2. Senile hypofiltration, the proof antidiuretic hormone (ADH) gressive decline in the glomeruand, as a consequence, limits lar filtration rate (GFR) of about 1 water absorption. Elderly patients mL per year after age 30, affects are unable to concentrate or dilute approximately two-thirds of the urine to the maximum. elderly.

5. Tubular frailty causes renal tubu3. Tubular dysfunction reduces the lar cells to become more suscepmaximal tubular capacity to reabtible to hypoxic or nephrotoxicity sorb and excrete solutes, espeinjury and retards their recovery cially sodium. from acute tubular necrosis.

6. Body composition also changes osmoreceptors. The thirst response, with age. Age-related loss of mus- therefore, may diminish and drinking cle mass leads to a 10% to 15% behavior may alter. Bladder dysfuncdecrease in intracellular fluid con- tion or incontinence also can affect tent. Although total fat content drinking behavior. Impaired access to goes down, the amount of fat as hydration predisposes many elderly a percentage of total body weight people to dehydration. Dehydraincreases. Total energy expendi- tion is among the 10 most common causes of admission to the hospital in ture also falls.14-16 The clinical consequences of these patients over age 65, with a mortality changes are profound. The aging kid- rate of 50% when untreated.17 ney is more susceptible to injury, less Hemodynamic changes that lead able to accommodate hemodynamic to dehydration may be muted, espechanges, and cannot handle pertur- cially in hospitalized elderly patients, bations of water and salt. Low GFR and signs of dehydration may be and diminished tubular function lead nonspecific (mild confusion, impaired to a reduced ability to concentrate cognitive dysfunction, dizziness, urine, the result of which requires an weakness, apathy) and may be attribincrease in the obligatory urinary vol- uted to other causes or aging itself. ume necessary to excrete waste prodIt is imperative to monitor elecucts. On the other hand, the drop in trolytes in elderly patients who are GFR diminishes the ability to excrete receiving IV fluids. Changes in plasma excess free water, making the elderly sodium concentration usually reflect prone to fluid overload and pulmo- an excess or deficit of water rather nary edema. Elderly patients become than changes in sodium balance. more vulnerable to hypoosmolar A change of 1 mmol/L in plasma states (hyponatremia) if given large sodium concentration reflects a gain amounts of hypoosmolar fluids. or loss of 280 mL of water in a 70-kg Yet aging also decreases the sen- man. However, only half that amount sitivity of volume receptors and see fluids page 44

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4 4 I A n e s t h e s i o l o g y N e w s . c o m Ma r c h 2 0 1 1

CLIN ICAL A N ESTHESIOLOGY Fluids continued from page 43 of change in fluid can cause a similar change in sodium concentration in 45-kg woman, and thus is more easily overloaded by injudicious use of fluids.17

Role of Medications in Fluid And Electrolyte Balance Many elderly patients take multiple medications—for a variety of comorbidities, such as those listed earlier—that may have significant interactions with each other. These drugs often interfere with fluid and electrolytes, as well. Thiazide diuretics and serotonin reuptake inhibitors, for example, have been shown to cause hyponatremia by either causing direct sodium loss, release of ADH, or potentiation of the effects of ADH.14 Aldosteroneblocking agents like spironolactone, angiotensinconverting enzyme inhibitors, and angiotensin receptor blockers can lead to hyperkalemia. It is prudent to check electrolytes periodically in patients taking these medications. Diuretics can cause significant dehydration. Some clinicians recommend dosing diuretics in out-of-hospital patients based on daily weight, rather than on routine basis, to avoid dehydration.17

Choice of Fluids in the Perioperative Period Crystalloids and colloids are not the same (Table 2). Their physiologic effects and pharmacokinetics vary significantly. Furthermore, regional and spinal anesthesia and various physiologic states can affect clearance of isotonic fluids.18 Administration of any fluid should not be considered routine, but rather should be tailored to the pathophysiology of the particular patient. For example, 0.9% normal saline contains 154 mmol/L of chloride ions. Excess chloride can cause hyperchloremic metabolic acidosis and exacerbate acidosis due to disease. However, increased chloride also can cause renal vasoconstriction, reduced GFR, and impaired excretion of sodium, contributing further to saline load. On the other hand, the concentration of chloride in Ringer’s lactate or Hartmann’s solution is closer to normal physiologic values and does not cause hypochloremia, and excretion of sodium is more rapid.19 The British Consensus Guidelines on Intravenous Fluid Therapy for Adult Surgical Patients (GIFTASUP) for fluid management recommends that “when crystalloid resuscitation or replacement is indicated balanced salt solution Ringer’s lactate/acetate or Hartmann’s solution should replace 0.9% normal saline, except in cases of hypochloremia for example from vomiting or gastric drainage.”

The controversy between crystalloids and colloids has not resolved. Each has advantages and disadvantages and plays a role in a particular clinical situation. If colloids are indicated and used, lower-molecular-weight colloids that can maintain adequate oncotic pressure should be considered.

The GIFTASUP guidelines recommend that “higher molecular weight hydroxyethyl starch (hetastarch and pentastarch with molecular weight >200 kD)

Table 2. Typical Properties of Commonly Used IV Solutions

Type of Fluida

Sodium, mmol/L

Potassium, Chloride, mmol/L mmol/L

Osmolarity, mOsm/L

Weight Average, Mol Wt kD

Plasma Volume Expansion Duration, hb

Plasma

136-145

3.5-5.0

98-105

280-300

-

-

5% dextrose

0

0

0

278

-

-

Dextrose 4% saline 0.18%

30

0

30

283

0.9% “normal” saline

154

0

154

308

-

0.2

0.45% “half normal” saline

77

0

77

154

-

Ringer’s lactate

130

4

109

273

-

0.2

Hartmann’s solution

131

5

111

275

-

0.2

Gelatine 4%

145

0

145

290

30,000

1-2

5% albumin

150

0

150

300

68,000

2-4

20% albumin

-

-

-

-

68,000

2-4

HES 6% 130/0.4

154

0

154

308

130,000

4-8

HES 10% 200/0.5

154

0

154

308

200,000

6-12

HES 6% 450/0.6

154

0

154

308

450,000

24-36

a

Fluid properties may vary by manufacturer.

b

Approximations only. The duration of clinically effective volume expansion will vary depending on several factors, including how volume expansion is defined, the rate of in vivo degradation and excretion of the fluid, and the systemic capillary permeability of the individual patient.

HES, hydroxyethyl starch; Mol wt, molecular weight Adapted from reference 1.

should be avoided in patients with severe sepsis due to increased risk of acute kidney injury.”

Overzealous administration of colloids can lead to hyperoncotic state.

The amount of water required for daily maintenance is determined by caloric expenditure. In an average individual, caloric expenditure varies with weight. However, significant deviations from the relationship can be seen in the elderly, patients with infection, and the moderately obese.16 Prolonged fasting and inactivity also can reduce daily caloric expenditure, by as much as 50%.20 An elderly hospitalized patient who is afebrile, not eating much, and physically inactive will produce much less heat and expend less energy, and thus will require less free water.16

Restrictive or Liberal Fluid Therapy?

(PPV), systolic pressure variation (SPV), stroke volume variation (SVV), and pleth variability index may be better predictors of volume status.22 Marik et al, in their meta-analysis of 29 studies involving 685 patients, showed that dynamic indices correlate better with cardiac index and stroke volume than static indices. Correlation coefficients for dynamic indices (PPV, SPV, and SVV) were 0.78, 0.72, and 0.72, respectively; area under the curve (AUC) was 0.94 to 0.84. For static indices, AUC was 0.6 to 0.55.22 British guidelines recommend using flow-directed monitors to determine fluid status. However, one should keep in mind that most of these studies are small (average, n=23 patients) and results may not apply to elderly patients. Still, goal-directed therapy, which also requires the use of inotropes, has been recommended for intraoperative fluid management by some authorities in the United Kingdom and Europe.

Although not specifically studied in elderly patients, goal-directed fluid therapy seems to improve outcomes in perioperative patients. A pri- Algorithm for Fluid Management mary goal of fluid therapy is to achieve adequate The GIFTASUP recommendations for periopercardiac index/stroke volume for a particular clin- ative fluid management are presented in Table 3. ical situation by maintaining optimal preload. In Urine output is not a sensitive marker of renal the perioperative setting, one of the biggest chal- function and may be misleading at times. High lenges has been to determine accurately and eas- urine output should not be the goal of fluid therily, the fluid status of the patient. apy, especially in the intraoperative and immeStatic markers of preload, such as central diate postoperative period. Due to increasing venous or pulmonary artery wedge pressure, have ADH, lower urine output is expected in the intrabeen used for decades to guide fluid therapy. operative and immediate postoperative period: However, these markers are not particularly accu- 0.5 mL/kg per hour is considered adequate. Fluids rate.21 Dynamic indices like pulse pressure variation see fluid page 46

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CLIN ICAL A N ESTHESIOLOGY Fluids continued from page 44 should be administered based on the patient’s physiologic state and hemodynamic status, as well as the type of surgery.

Conclusion Renal function declines progressively in the elderly. Approximately 8% of Medicare patients have chronic kidney disease. In view of the deleterious effects of fluid and electrolyte imbalance on perioperative outcomes, administration of fluids and electrolytes should receive heightened attention in

elderly patients. Clinicians must consider fluids as medications and administer them as such, and an improved understanding of the composition of fluids and their physiologic effects is critical.

The need for fluids may be diminished in a hospitalized, inactive, afebrile, elderly patient. Some elderly patients may be dehydrated due to poor thirst response, use of routine diuretics, and limited functionality. Both under- and overhydration are deleterious. However, few studies in the elderly have specifically addressed the issue of fluid management in the perioperative period. More research is needed in this area.

Table 3. Summary of British Consensus Guidelines on Intravenous Fluid Therapy for Adult Surgical Patients Recommendation

Level of Evidence

1

Because of the risk for inducing hyperchloremic acidosis in routine practice, when crystalloid resuscitation or replacement is indicated, balanced salt solutions (eg, Ringer’s lactate/acetate or Hartmann’s solution) should replace 0.9% saline, except in cases of hypochloremia (eg, from vomiting or gastric drainage).

1b

2

Solutions such as 4%/0.18% dextrose/saline and 5% dextrose are important sources of free water for maintenance, but should be used with caution as excessive amounts may cause dangerous hyponatremia, especially in children and the elderly. These solutions are not appropriate for resuscitation or replacement therapy except in conditions of significant free water deficit (eg, diabetes insipidus).

1b

To meet maintenance requirements, adult patients should receive sodium 50 to 100 mmol/d, potassium 40 to 80 mmol/d in 1.5 to 2.5 L of water by the oral, enteral, or parenteral route (or a combination of routes). Additional amounts should only be given to correct deficit or continuing losses. Careful monitoring should be undertaken using clinical examination, fluid balance charts, and regular weighing when possible.

5

3

5

6

7

Where mechanical bowel preparation is used, fluid and electrolyte derangements commonly occur and should be corrected by simultaneous IV fluid therapy with Hartmann’s or Ringer’s lactate-/ acetate-type solutions.

5

Excessive losses from gastric aspiration/vomiting should be treated preoperatively with an appropriate crystalloid solution that includes an appropriate potassium supplement. Hypochloremia is an indication for the use of 0.9% saline, with sufficient additions of potassium and care not to produce sodium overload. Losses from diarrhea/ileostomy/small bowel fistula/ileus/obstruction should be replaced volume-for-volume with Hartmann’s or Ringer’s lactate-/acetate-type solutions. “Saline depletion,” for example, due to excessive diuretic exposure, is best managed with a balanced electrolyte solution such as Hartmann’s.

5 and IIa

In high-risk surgical patients, preoperative treatment with IV fluid and inotropes should be aimed at achieving predetermined goals for cardiac output and oxygen delivery as this may improve survival.

1b

Although currently logistically difficult in many centers, preoperative or operative hypovolemia should be diagnosed by flow-based measurements wherever possible. The clinical context also should be taken into account as this will provide an important indication of whether hypovolemia is possible or likely. When direct flow measurements are not possible, hypovolemia will be diagnosed clinically on the basis of pulse, peripheral perfusion and capillary refill, venous (JVP/CVP) pressure and Glasgow Coma Scale together with acid–base and lactate measurements. A low urine output can be misleading and needs to be interpreted in the context of the patient’s cardiovascular parameters above.

1b

JVP/CVP, jugular venous pressure/central venous pressure Data from reference 1

1. Jeremy Powell-Tuck J, Gosling P, Lobo DL, et al. British Consensus Guidelines on Intravenous Fluid Therapy for Adult Surgical Patients GIFTASUP. 2009; http://www.ebpom.org.

Accessed February 1, 2011.

2. Evans GH. The abuse of normal salt solution. JAMA. 1911;57:2126-2127.

3. Moore FD. Metabolic Care of the Surgical Patient. Philadelphia, PA: W.B. Saunders; 1959.

4. Shires T, Williams J, Brown F. Acute change in extracellular fluids associated with major surgical procedures. Ann Surg.

1961;154:803-810.

5. Holte K, Sharrock NE, Kehlet H. Pathophysiology and clinical implications of perioperative fluid excess. Br J Anaesth. 2002;89(4):622-632.

6. Johnston WE. PRO: Fluid restriction in cardiac patients for noncardiac surgery is beneficial. Anesth Analg.

2006;102(2):340-343.

7. Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology.

2005;103(1):25-32.

8. Brandstrup B, TØnnesen H, Beier-Holgersen R, et al. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg.

2003;238(5):641-648.

9. Lobo DN, Bostock KA, Neal KR, Perkins AC, Rowlands BJ, Allison SP. Effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection: a randomized controlled trial. Lancet. 2002;359(9320):18121818.

10. Lobo DN, Macafee DA, Allison SP. How perioperative fluid balance influences postoperative outcomes. Best Pract Res Clin Anaesthesiol. 2006;20(3):439-455.

11. National Confidential Enquiry into Patient Outcome and Death. Extremes of Age, The 1999 report of the National Confidential Enquiry into Peri-operative Death. In: NCEPOD, ed. London; 1999.

Preoperative fluid management 4

References

12. Wilkinson K, Martin IC, Gough MJ, et al. An age old problem: a review of the care received by elderly patients undergoing surgery. A report by the National Confidential Enquiry into Patient Outcome and Death (2010). In: NCEPOD, ed. London: National Confidential Enquiry into Patient Outcome and Death; 2010.

13. Lloyd-Jones D, Adams RJ, Brown TM, et al. Heart disease and stroke statistics—2010 update: a report from the American Heart Association. Circulation. 2010;121(7):e46-e215.

14. Schlanger LE, Bailey JL, Sands JM. Electrolytes in the aging.

Adv Chronic Kidney Dis. 2010;17(4):308-319.

15. Gregori J, Núñez J. Handling of water and electrolytes in the healthy old. Reviews in Clinical Gerontology. 2009;19:1-12.

16. Shafiee MA, Bohn D, Hoorn EJ, Halperin ML. How to select optimal maintenance intravenous fluid therapy. QJM. 2003;96(8):601-610.

17. Allison SP, Lobo DN. Fluid and electrolytes in the elderly.

Curr Opin Clin Nutr Metab Care. 2004;7(1):27-33.

18. Hahn RG. Volume kinetics for infusion fluids. Anesthesiology.

2010;113(2):470-481.

19. Williams EL, Hildebrand KL, McCormick SA, Bedel MJ. The effect of intravenous lactated Ringer’s solution versus 0.9% sodium chloride solution on serum osmolality in human volunteers. Anesth Analg. 1999;88(5):999-1003.

20. Cahill GF Jr. Starvation in man. N Engl J Med. 1970;282(12):668-675.

21. Marik PE, Baram M, Vahid B. Does central venous pressure predict fluid responsiveness? A systematic review of the literature and the tale of seven mares. Chest.

2008;134(1):172-178.

22. Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009;37(9):2642-2647.

Ma r c h 2 0 1 1

AnesthesiologyNews.com I 47

PR N Book Review

The Essence of Analgesia and Analgesics Edited by RS Sinatra, JS Jahr, and JM Watkins-Pitchford, with 154 contributors.

West Nyack, NY: Cambridge University Press; 2011. 532 pages.

ISBN 978-0-521-14450-6. $99.00.

The Essence of Analgesia and Analgesics aims to provide a compact look into the understanding of analgesic action and pain pathways, currently available analgesics and an overview of targets for new and emerging therapies for pain control. Divided into 12 sections and 131 chapters, the text is well written and the editors have achieved their goals with little overlap of discussion.

Many simple line drawings and tables add considerably to the understanding of appropriate pain management, which is, for most of us, a complex subject.

Of particular interest to this reviewer is the short section on genetics and pain that explores why humans differ widely in their rating and experience of painful stimulation. The genetic factors and their variants, in many cases, have been identified, and it is through this understanding and subsequent drug chemistry manipulations that personalized medicines may be developed.

At present, most of the interest in this area is in describing genes that code for specific pathways. For example, genes related to insensitivity to pain have been found to encode for specific voltage-gated sodium channels and neurotrophin tyrosine kinase receptors. Perhaps this research could be extended to identify why some patients have severe reactions to opiates whereas other patients do not.

The many contributors range from medical students to professors to heads of pharmaceutical companies. Such variety of perspective is refreshing in any text. Perhaps in future editions, the editors might add short case studies and indicate an appropriate course of management. Also, mention should

be made of acupuncture and biofeedback mechanisms, which are believed by many to be useful pain relief techniques.

The Essence of Analgesia and Analgesics is a compact, ready reference mini-pharmacopeia. It would make a useful addition to the library of any

anesthesiologist, pain management specialist or medical student.

—Elizabeth A. M. Frost, MD Dr. Frost is clinical professor of anesthesiology at Mount Sinai School of Medicine in New York City, and an editorial board member of Anesthesiology News.

NAROPIN® delivers a faster return of motor function than bupivacaine.1,2 A Block Well Done.

NAROPIN provides 8 to 10 hours faster return of motor function following total knee replacement than bupivacaine (P<0.05).1 To learn more about the clinical benefits of NAROPIN, visit www.naropin-us.com.

Using NAROPIN beyond recommended doses to increase motor block or duration of sensory block may negate its favorable cardiovascular advantages, in the event that an inadvertent intravascular injection occurs.

Like all amide-type local anesthetics, NAROPIN may be associated with adverse reactions.

In clinical trials, side effects were mild and transient and may reflect the procedures, patient health status, and/or other medications used. Adverse events reported at a rate of ≥5%: hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain.

Important Safety Information There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. NAROPIN is not approved for this use. Please see dosage and administration details in Prescribing Information at www.naropin-us.com.

Please see accompanying brief summary of Prescribing Information. www.naropin-us.com

NAROPIN is indicated for the production of regional or local anesthesia for surgery and for acute pain management.

References: 1. Beaulieu P, Babin D, Hemmerling T. The pharmacodynamics of ropivacaine and bupivacaine in combined sciatic and femoral nerve blocks for total knee arthroplasty. Anesth Analg. 2006;103:768-774. 2. Morrison LM, Emanuelsson BM, McClure JH, et al. Efficacy and kinetics of extradural ropivacaine: comparison with bupivacaine. Br J Anaesth. 1994;72:164-169.

Naropin® and logo are registered trademarks of APP Pharmaceuticals, LLC. and APP ® are registered trademarks of APP Pharmaceuticals, LLC. ©2011, APP Pharmaceuticals, LLC. All Rights Reserved. 0155-NAR-05-2/11

WHY COMPROMISE?

4 8 I A n e s t h e s i o l o g y N e w s . c o m Ma r c h 2 0 1 1

P AIN M EDICI NE

Drug Company Conducted ‘Secret Recall’ of OTC Pain Relievers, State Lawsuit Claims Third-party employees told to “act like regular customers” and buy up all defective painkillers

P

harmaceutical giant Johnson & Johnson conducted a “phantom recall” of defective Motrin in at least 40 states in early 2009, according to a Congressional investigation and a lawsuit filed by the Oregon attorney

general in January.

The secret recall first came to light in Congressional testimony in May, when the House Committee on Oversight and Government Reform looked into the recall of more than 135 million

Naropin

®

(ropivacaine HCl) Injection

BRIEF SUMMARY INDICATIONS AND USAGE Naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.

CONTRAINDICATIONS Naropin is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type.

WARNINGS In performing Naropin blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest. The potential for successful resuscitation has not been studied in humans. There have been rare reports of cardiac arrest during the use of Naropin for epidural anesthesia or peripheral nerve blockade, the majority of which occurred after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease. In some instances, resuscitation has been difficult. Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. Naropin should be administered in incremental doses. It is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary. Historically, pregnant patients were reported to have a high risk for cardiac arrhythmias, cardiac/ circulatory arrest and death when 0.75% bupivacaine (another member of the amino amide class of local anesthetics) was inadvertently rapidly injected intravenously. Prior to receiving major blocks the general condition of the patient should be optimized and the patient should have an i.v. line inserted. All necessary precautions should be taken to avoid intravascular injection. Local anesthetics should only be administered by clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies that may arise from the block to be employed, and then only after ensuring the immediate (without delay) availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies (See also ADVERSE REACTIONS, PRECAUTIONS, and MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES). Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. Solutions of Naropin should not be used for the production of obstetrical paracervical block anesthesia, retrobulbar block, or spinal anesthesia (subarachnoid block) due to insufficient data to support such use. Intravenous regional anesthesia (bier block) should not be performed due to a lack of clinical experience and the risk of attaining toxic blood levels of ropivacaine. Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. It is essential that aspiration for blood, or cerebrospinal fluid (where applicable), be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. However, a negative aspiration does not ensure against an intravascular or subarachnoid injection. A well-known risk of epidural anesthesia may be an unintentional subarachnoid injection of local anesthetic. Two clinical studies have been performed to verify the safety of Naropin at a volume of 3 mL injected into the subarachnoid space since this dose represents an incremental epidural volume that could be unintentionally injected. The 15 and 22.5 mg doses injected resulted in sensory levels as high as T5 and T4, respectively. Anesthesia to pinprick started in the sacral dermatomes in 2-3 minutes, extended to the T10 level in 10-13 minutes and lasted for approximately 2 hours. The results of these two clinical studies showed that a 3 mL dose did not produce any serious adverse events when spinal anesthesia blockade was achieved. Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Patients treated with class III antiarrhythmic drugs (e.g., amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive.

PRECAUTIONS: General: The safe and effective use of local anesthetics depends on proper dosage, correct technique, adequate precautions and readiness for emergencies. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. (See WARNINGS and ADVERSE REACTIONS.) The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse events. Injections should be made slowly and incrementally, with frequent aspirations before and during the injection to avoid intravascular injection. When a continuous catheter technique is used, syringe aspirations should also be performed before and during each supplemental injection. During the administration of epidural anesthesia, it is recommended that a test dose of a local anesthetic with a fast onset be administered initially and that the patient be monitored for central nervous system and cardiovascular toxicity, as well as for signs of unintended intrathecal administration before proceeding. When clinical conditions permit, consideration should be given to employing local anesthetic solutions, which contain epinephrine for the test dose because circulatory changes compatible with epinephrine may also serve as a warning sign of unintended intravascular injection. An intravascular injection is still possible even if aspirations for blood are negative. Administration of higher than recommended doses of Naropin to achieve greater motor blockade or increased duration of sensory blockade may result in cardiovascular depression, particularly in the event of inadvertent intravascular injection. Tolerance to elevated blood levels varies with the physical condition of the patient. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with their age and physical condition. Local anesthetics should also be used with caution in patients with hypotension, hypovolemia or heart block. Careful and constant monitoring of cardiovascular and respiratory vital signs (adequacy of ventilation) and the patient’s state of consciousness should be performed after each local anesthetic injection. It should be kept in mind at such times that restlessness, anxiety, incoherent speech, light-headedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of central nervous system toxicity. Because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. Local anesthetics should also be used with caution in patients with impaired cardiovascular function because they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs. Many drugs used during the conduct of anesthesia are considered potential triggering agents for malignant hyperthermia (MH). Amide-type local anesthetics are not known to trigger this reaction. However, since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for MH management should be available. Epidural Anesthesia: During epidural administration, Naropin should be administered in incremental doses of 3 to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Syringe aspirations should also be performed before and during each supplemental injection in continuous (intermittent) catheter techniques. An intravascular injection is still possible even if aspirations for blood are negative. During the administration of epidural anesthesia, it is recommended that a test dose be administered initially and the effects monitored before the full dose is given. When clinical conditions permit, the test dose should contain an appropriate dose of epinephrine to serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Therefore, following the test dose, the heart should be continuously monitored for a heart rate increase. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect a rise in systolic blood pressure. A test dose of a shortacting amide anesthetic such as lidocaine is recommended to detect an unintentional intrathecal administration. This will be manifested within a few minutes by signs of spinal block (e.g., decreased sensation of the buttocks, paresis of the legs, or, in the sedated patient, absent knee jerk). An intravascular or subarachnoid injection is still possible even if results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, high spinal or epinephrine-induced cardiovascular effects. Use in Brachial Plexus Block: Ropivacine plasma concentrations may approach the threshold for central nervous system toxicity after the administration of 300 mg of ropivacaine for brachial plexus block. Caution should be exercised when using the 300 mg dose. (See OVERDOSAGE.) The dose for a major nerve block must be adjusted according to the site of administration and patient status. Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used. Use in Peripheral Nerve Block: Major peripheral nerve blocks may result in the administration of a large volume of local anesthetic in highly vascularized areas, often close to large vessels where there is an increased risk of intravascular injection and/or rapid systemic absorption, which can lead to high plasma concentrations. Use in Head and Neck Area: Small doses of local anesthetics injected into the head and neck area may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. The injection procedures require the utmost care. Confusion, convulsions, respiratory depression, and/or respiratory arrest, and cardiovascular stimulation or depression have been reported. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded. (See DOSAGE AND ADMINISTRATION.) Use in Ophthalmic Surgery: The use of Naropin in retrobulbar blocks for ophthalmic surgery has not been studied. Until appropriate experience is gained, the use of Naropin for such surgery is not recommended. Drug Interactions: Specific trials studying the interaction between ropivacaine and class III antiarrhythmic drugs (e.g., amiodarone) have not been performed, but caution is advised (see WARNINGS). Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Cytochrome P4501A2 is involved in the formation of 3-hydroxy ropivacaine, the major metabolite. In vivo, the plasma clearance of ropivacaine was reduced by 70% during coadministration of fluvoxamine (25 mg bid for 2 days), a selective and potent CYP1A2 inhibitor. Thus strong inhibitors of cytochrome P4501A2, such as fluvoxamine, given concomitantly during administration of Naropin, can interact with Naropin leading to increased ropivacaine plasma levels. Caution should be exercised when CYP1A2 inhibitors are coadministered. Possible interactions with drugs known to be metabolized by CYP1A2 via competitive inhibition such as theophylline and imipramine may also occur. Coadministration of a selective and potent inhibitor of CYP3A4, ketoconazole (100 mg bid for 2 days with ropivacaine infusion administered 1 hour after ketoconazole) caused a 15% reduction in in-vivo plasma clearance of ropivacaine. Pregnancy Category B: There are no adequate or well-controlled studies in pregnant women of the effects of Naropin on the developing fetus. Naropin should only be used during pregnancy if the benefits outweigh the risk. Labor and Delivery: Local anesthetics, including ropivacaine, rapidly cross the placenta, and when used for epidural block can cause varying degrees of maternal, fetal and neonatal toxicity (see CLINICAL PHARMACOLOGY and PHARMACOKINETICS). The incidence and degree of toxicity depend upon the procedure performed, the type and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone and cardiac function. Maternal hypotension has resulted from regional anesthesia with Naropin for obstetrical pain relief. Local anesthetics produce vasodilation by blocking sympathetic nerves. Elevating the patient’s legs and positioning her on her left side will help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Epidural anesthesia has been reported to prolong the second stage of labor by removing the patient’s reflex urge to bear down or by interfering with motor function. Spontaneous vertex delivery occurred more frequently in patients receiving Naropin than in those receiving

bottles of children’s over-the-counter pain medicine from Johnson & Johnson, the largest withdrawal of children’s medicine in history.

During the hearing, Johnson & Johnson executives revealed a program

bupivacaine. Nursing Mothers: Some local anesthetic drugs are excreted in human milk and caution should be exercised when they are administered to a nursing woman. The excretion of ropivacaine or its metabolites in human milk has not been studied. Based on the milk/plasma concentration ratio in rats, the estimated daily dose to a pup will be about 4% of the dose given to the mother. Assuming that the milk/plasma concentration in humans is of the same order, the total Naropin dose to which the baby is exposed by breast-feeding is far lower than by exposure in utero in pregnant women at term (see Precautions).

Pediatric Use: The safety and efficacy of Naropin in pediatric patients have not been established. Geriatric Use: Of the 2,978 subjects that were administered Naropin Injection in 71 controlled and uncontrolled clinical studies, 803 patients (27%) were 65 years of age or older, which includes 127 patients (4%) 75 years of age and over. Naropin Injection was found to be safe and effective in the patients in these studies. Clinical data in one published article indicate that differences in various pharmacodynamic measures were observed with increasing age. In one study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure (MAP) declined with age during the first hour after epidural administration, and the intensity of motor blockade increased with age. This drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Elderly patients are more likely to have decreased hepatic, renal, or cardiac function, as well as concomitant disease. Therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function. (See PHARMACOKINETICS, Elimination.)

ADVERSE REACTIONS Reactions to ropivacaine are characteristic of those associated with other amidetype local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. The reported adverse events are derived from clinical studies conducted in the U.S. and other countries. The reference drug was usually bupivacaine. The studies used a variety of premedications, sedatives, and surgical procedures of varying length. A total of 3,988 patients have been exposed to Naropin at concentrations up to 1.0% in clinical trials. Each patient was counted once for each type of adverse event. Incidence ≥5%: For the indications of epidural administration in surgery, cesarean section, postoperative pain management, peripheral nerve block, and local infiltration, the following treatment-emergent adverse events were reported with an incidence of ≥5% in all clinical studies (N=3988): hypotension (37.0%), nausea (24.8%), vomiting (11.6%), bradycardia (9.3%), fever (9.2%), pain (8.0%), postoperative complications (7.1%), anemia (6.1%), paresthesia (5.6%), headache (5.1%), pruritus (5.1%), and back pain (5.0%). Incidence 1-5%: Urinary retention, dizziness, rigors, hypertension, tachycardia, anxiety, oliguria, hypoesthesia, chest pain, hypokalemia, dyspnea, cramps, and urinary tract infection. Incidence in Controlled Clinical Trials: The reported adverse events are derived from controlled clinical studies with Naropin (concentrations ranged from 0.125% to 1.0% for Naropin and 0.25% to 0.75% for bupivacaine) in the U.S. and other countries involving 3,094 patients. Tables 3A and 3B list adverse events (number and percentage) that occurred in at least 1% of Naropin-treated patients in these studies. The majority of patients receiving concentrations higher than 5.0 mg/mL (0.5%) were treated with Naropin.

Table 3A Adverse Events Reported in ≥1% of Adult Patients Receiving Regional or Local Anesthesia (Surgery, Labor, Cesarean Section, Post-Operative Pain Management, Peripheral Nerve Block and Local Infiltration)

Adverse Reaction Hypotension Nausea Vomiting Bradycardia Headache Paresthesia Back pain Pain Pruritus Fever Dizziness Rigors (Chills) Postoperative complications Hypoesthesia Urinary retention Progression of labor poor/failed Anxiety Breast disorder, breast-feeding Rhinitis

N 536 283 117 96 84 82 73 71 63 61 42 42 41 27 23 23 21 21 18

Naropin total N=1661

(%) (32.3) (17.0) (7.0) (5.8) (5.1) (4.9) (4.4) (4.3) (3.8) (3.7) (2.5) (2.5) (2.5) (1.6) (1.4) (1.4) (1.3) (1.3) (1.1)

N 408 207 88 73 68 57 75 71 40 37 23 24 44 24 20 22 11 12 13

Bupivacaine total N=1433

(%) (28.5) (14.4) (6.1) (5.1) (4.7) (4.0) (5.2) (5.0) (2.8) (2.6) (1.6) (1.7) (3.1) (1.7) (1.4) (1.5) (0.8) (0.8) (0.9)

Table 3B Adverse Events Reported in ≥1% of Fetuses or Neonates of Mothers Who Received Regional Anesthesia (Cesarean Section and Labor Studies)

Adverse Reaction Fetal bradycardia Neonatal jaundice Neonatal complication-NOS Apgar score low Neonatal respiratory disorder Neonatal tachypnea Neonatal fever Fetal tachycardia Fetal distress Neonatal infection Neonatal hypoglycemia

N 77 49 42 18 17 14 13 13 11 10 8

Naropin total N=1661

(%) (12.1) (7.7) (6.6) (2.8) (2.7) (2.2) (2.0) (2.0) (1.7) (1.6) (1.3)

N 68 47 38 14 18 15 14 12 10 8 16

Bupivacaine total N=1433

(%) (11.9) (8.2) (6.6) (2.4) (3.1) (2.6) (2.4) (2.1) (1.7) (1.4) (2.8)

OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered, or large doses administered, during therapeutic use of local anesthetics or to unintended subarachnoid or intravascular injection of local anesthetic solution. (See ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS.) MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES: Therapy with Naropin should be discontinued at the first sign of toxicity. No specific information is available for the treatment of toxicity with Naropin; therefore, treatment should be symptomatic and supportive. The first consideration is prevention, best accomplished by incremental injection of Naropin, careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic and during continuous infusion. At the first sign of change in mental status, oxygen should be administered. The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to unintentional subarachnoid injection of drug solution, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. Circulation should be assisted as necessary. This may prevent convulsions if they have not already occurred. If necessary, use drugs to control convulsions. Intravenous barbiturates, anticonvulsant agents, or muscle relaxants should only be administered by those familiar with their use. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated. Supportive treatment of circulatory depression may require administration of intravenous fluids, and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine or epinephrine to enhance myocardial contractile force). Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. The mean dosages of ropivacaine producing seizures, after intravenous infusion in dogs, nonpregnant and pregnant sheep were 4.9, 6.1 and 5.9 mg/kg, respectively. These doses were associated with peak arterial total plasma concentrations of 11.4, 4.3 and 5.0 μg/mL, respectively. In human volunteers given intravenous Naropin, the mean (min-max) maximum tolerated total and free arterial plasma concentrations were 4.3 (3.4-5.3) and 0.6 (0.3-0.9) μg/mL respectively, at which time moderate CNS symptoms (muscle twitching) were noted. Clinical data from patients experiencing local anesthetic induced convulsions demonstrated rapid development of hypoxia, hypercarbia and acidosis within a minute of the onset of convulsions. These observations suggest that oxygen consumption and carbon dioxide production are greatly increased during local anesthetic convulsions and emphasize the importance of immediate and effective ventilation with oxygen, which may avoid cardiac arrest. If difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated, endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask. The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels should be accomplished. Resuscitation of obstetrical patients may take longer than resuscitation of nonpregnant patients and closed-chest cardiac compression may be ineffective. Rapid delivery of the fetus may improve the response to resuscitative efforts.

APP Pharmaceuticals, LLC

0155-NAR-05-2/11

Rev. 11/08

of rolling recalls of children’s medicines, as well as a secret recall of adult Motrin in which a third-party company was hired to buy all defective adult Motrin products from store shelves.

“When Johnson & Johnson learned that it had a problem with one of its adult Motrin products in 2008 and 2009, the company hired contractors to go into stores and buy the products off the shelves without saying it was a recall, so that the public and news media wouldn’t know what was really happening,” said U.S. Rep. Ed Towns (D-N.Y.), in a Congressional hearing on the “phantom recall” in September.

Most recently, on Jan. 11, 2011, John Kroger, Oregon’s attorney general, sued Johnson & Johnson and two subsidiaries, McNeil Healthcare and McNeil-PPC, for multiple violations of Oregon’s Unlawful Trade Practices Act, including misrepresenting their products and “unconscionable conduct.”

“We felt that they had misled consumers as well as retailers in Oregon, and we thought there should be some remedy for that,” said Tony Green, spokesman for the Oregon attorney general’s office, in a phone interview.

Oregon is the only state to have sued over the matter, Mr. Green said, which he hoped would help set a precedent.

“This is the first ‘phantom recall’ that I’m aware of and I think one of the things that the attorney general is worried about is this becoming business as usual, where companies start to calculate whether or not they need to do an actual recall by balancing [its effects] against the bottom line, which is what happened here,” Mr. Green said.

The companies named in the Oregon lawsuit have been giving mixed messages. In September, William Weldon, chairman and CEO of Johnson & Johnson, told Congressional investigators, “We know that we let the public down … it’s clear to me that in retrospect, McNeil should have handled things differently.”

But Marc Boston, a spokesman for McNeil Healthcare, said in an e-mail that “McNeil’s actions were consistent with applicable law and there was no health or safety risk to consumers associated with this limited recall. As there

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AnesthesiologyNews.com I 49

Pa in Me d icin e In late March, executives at Johnson & Johnson and McNeil Healthcare began giving Inmar “field analysts” instructions on how to retrieve defective Motrin from stores. A series of e-mail volleys between McNeil and Inmar executives led to this formal instruction to Inmar employees in the field: “DO NOT communicate to store personnel any information about this product. Just purchase all available product. If you are questioned by store personnel, simply advise that you

have been asked to perform an audit …” (emphasis original).

The companies’ interaction with the FDA occurred at the level of the agency’s San Juan district office, which had jurisdiction over McNeil’s Puerto Rican manufacturing site. In March and April, McNeil Healthcare quality assurance personnel negotiated with the FDA San Juan district director. Both parties agreed these discussions should be kept secret.

In a March 30 e-mail, Eddie Carillo, a McNeil Healthcare site quality

leader at the Puerto Rican manufacturing plant, wrote: “We are doing something very different” because of “my good relationship” with the FDA’s San Juan district director.

In a later internal e-mail to McNeil colleagues, Mr. Carillo wrote, the director “was very emphatic that the discussion that we had was between her and myself because nobody can state that she is in agreement to/or not to recall the batch. … Please treat my see motrin page 50

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The Hearing In the Congressional testimony and the Oregon lawsuit, two issues come to the forefront: the role played by the FDA in the secret recall and whether high-level executives at Johnson & Johnson and the company’s McNeil subsidiaries directed the recall efforts.

The problem began in November 2008, when routine tests at a manufacturing plant in Puerto Rico revealed that a batch of Motrin did not dissolve at the correct rate. A week later, the companies sent a Field Alert Report to the FDA notifying the agency of the problem and reporting that a hold had been placed on distribution of certain Motrin batches.

According to the Oregon complaint, no attempt was made to notify retailers and distributors, some of which continued shipping defective versions of the drug for another four months.

In late January, in separate filings with the FDA, the companies said that the defective Motrin “is not likely to cause an increased risk of serious adverse health consequences,” but that consumers “might be receiving less than the expected dose of ibuprofen.”

Instead of a formal recall, however, the companies decided to contract third-party buyers to remove all of the defective Motrin from stores. In February and March 2009, the company took bids from two companies—a medical waste management company, Stericycle, and a company that specializes in product recalls, Inmar.

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P AIN M EDICI NE Motrin continued from page 49 conversation with [the director as] very confidential!!!”

When it was confirmed that a formal recall would not be issued, Inmar hired a second firm, WIS International, to help remove the defective pills from store shelves. In drafted instructions for employees, WIS executives told them, “You should simply ‘act’ like a regular customer while making these purchases.

THERE MUST NOT BE MENTION

OF THIS BEING A RECALL OF THE PRODUCT! If asked, simply state that your employer is checking the distribution chain of this product and needs to have some of it purchased for the project” (emphasis original).

On June 19, 2009, WIS began a “silent” recall of defective Motrin in about 5,000 convenience stores nationwide. However in July, a WIS employee in Oregon became concerned about the phantom recall and reported the project to the Oregon Board of Pharmacy,

which turned the information over to the FDA’s Seattle office.

On July 16, 2009, the FDA notified Johnson & Johnson and McNeil Healthcare that the agency expected a voluntary recall. However, the companies waited another seven months, until Feb. 17, 2010, to issue formal recall notices to retailers and distribution warehouses.

In Congressional testimony in September, Mr. Weldon, CEO at Johnson & Johnson, said that the company had

replaced a number of quality assurance executives and that it was undergoing a “complete reexamination of McNeil’s manufacturing processes.”

Although Mr. Weldon admitted, “things should have been handled differently,” he also defended the actions of the McNeil Healthcare executives.

“The documents that we provided showed that McNeil informed the FDA about our plans for an in-store assessment and then a retrieval,” Mr. Weldon said. “I do think the McNeil personnel were trying to be transparent with the FDA, and McNeil also notified its customers that it would be sending personnel to remove the products.”

‘When Johnson & Johnson learned that it had a problem with one of its adult Motrin products in 2008 and 2009, the company hired contractors to go into stores and buy the products off the shelves without saying it was a recall, so that the public and news media wouldn’t know what was really happening.’

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—Ed Towns, U.S. Representative Johnson & Johnson executives have argued that they were protecting patients by retrieving the defective pills; however, critics contend that they willfully misled both the FDA and consumers by doing it in secret.

“When Johnson & Johnson was asked about the phantom recall, we were basically told that Johnson & Johnson didn’t know what these [third-party] contractors were doing,” Rep. Towns said. “Internal e-mails and documents clearly indicate that Johnson & Johnson knew what it was doing and why.”

If McNeil is found liable in the Oregon lawsuit, the company could be fined up to $25,000 for each container of defective Motrin sold to a consumer in Oregon.

—Gabriel Miller

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New Spinal Fractures Tied to Pain, Hospital Time, Disability Atlanta—Incident clinical vertebral fractures are associated with a significant increase in the occurrence, severity and duration of back pain in postmenopausal women with osteoporosis, according to results from the FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) trial, presented at the 2010 American College of Rheumatology meeting (poster 971).

“These findings demonstrate the substantial impact of clinical fractures on back pain and disability from back pain in women with osteoporosis,” said Michael C. Nevitt, PhD, MPH, adjunct professor in the Division of Clinical Trials & Multicenter Studies at the University of California, San Francisco.

In an earlier analysis of the FREEDOM trial data, investigators determined that denosumab (Xgeva, Amgen), a fully humanized antibody to receptor activator of nuclear factor κB ligand, reduced the risk for vertebral, nonvertebral and hip fractures in women with osteoporosis (N Engl J Med 2009;​361:756).

Dr. Nevitt and his colleagues wanted to evaluate the impact of incident clinical vertebral fractures on back pain outcomes in this study population, regardless of treatment group.

Investigators of the FREEDOM trial randomized 7,808 postmenopausal women, aged 60 to 90 years, with osteoporosis to receive subcutaneous denosumab 60 mg or placebo, in addition to daily calcium and vitamin D, every six months for 36 months. Osteoporosis was defined as a bone mineral density (BMD) T score less than –2.5 at the lumbar spine and/or total hip but not less than –4 at these sites.

Investigators assessed back pain, limited activity days, hospitalization and bed rest experience using the Back Pain and Limited Activity Days (BPLAD) questionnaire during each six-month visit and via telephone interviews between study visits. BPLAD also recorded the severity of back pain (very mild, mild, moderate, severe and very severe), the number of days of back pain, and the number of days of limited activity, hospitalization and bed rest due to back pain during the past three months.

Dr. Nevitt’s team performed radiographs annually to assess vertebral fractures. The researchers also did radiographs during unscheduled visits when patients reported acute back pain indicative of a symptomatic vertebral fracture.

All radiographs were evaluated at a central imaging center.

About 24% of women had a prevalent vertebral fracture at study entry (placebo, n=915; denosumab, n=929).

Compared with women without incident fractures, a significantly higher percentage of women with incident clinical vertebral fractures reported experiencing back pain, limited activity, hospitalization and bed rest (P<0.0001 for all). Women with incident clinical

vertebral fractures also reported a significant increase in the total days of back pain, limited activity and bed rest than women without an incident fracture.

Subjects were eight to 10 times more likely to experience at least seven days of moderate, severe or very severe back pain or limited activity due to back pain intensity after an incident clinical vertebral fracture compared with before the

fracture. Women with incident clinical vertebral fractures also had an almost twoto threefold increase in the rate of all recorded back pain outcomes after having the fracture compared with before.

The authors suggested that reducing the occurrence of clinical vertebral fractures may improve outcomes for postmenopausal women with osteoporosis.

—Alice Goodman

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Increased Risk for Death From Suicide and Accidents Seen in Fibromyalgia Patients Atlanta—Although patients with fibromyalgia are not at an overall increased risk for mortality, they are at greater risk for suicide and accidents, according to a large observational study presented at the annual meeting of the American College of Rheumatology.

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This is only the second study to evaluate death in patients with fibromyalgia, said study investigator Kaleb Michaud, MD, MS, PhD, assistant professor of medicine at the University of Nebraska, Omaha, and co-director of the National Data Bank (NDB) for

Rheumatic Diseases, who presented the findings. “Prior to 2010, mortality in fibromyalgia patients was unknown,” he added.

According to Dr. Michaud, these results are consistent with those reported in the first study to evaluate

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fibromyalgia mortality (Arthritis Rheum 2010;62:3101-3108). This initial study found no increase in overall mortality in Danish women with fibromyalgia, but did find a significant spike in deaths from suicide, liver cirrhosis/ biliary tract disease and cardiovascular disease.

The most recent study, conducted in the United States, included 8,186 patients with fibromyalgia who were observed over 35 years in three settings: 1,115 patients from clinical practice, 3,482 patients enrolled in the NDB longitudinal outcome study and 3,589 others who had declined to participate in that study.

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‘These two studies relay an important message that physicians [caring for patients with FM] need to be sensitized to the risks of suicide, particularly for patients who receive medications that may be used in suicide attempts.’

—Mary-Ann Fitzcharles, MD

The investigators calculated standardized mortality ratios (SMRs) based on age- and sex-stratified U.S. population data. Overall, they recorded 539 deaths and calculated an SMR of 0.90. The SMRs were 0.92 for clinical patients, 0.67 for NDB-enrolled patients and 1.1 for non-enrolled patients.

More than 93% of the patients were female and almost all were nonHispanic white ethnicity. The mean Health Assessment Questionnaire (HAQ) score was 1.1 (range, 0-3), the mean pain score was 6.4 (range, 0-10) and the average global disease severity was 5.5 (range, 0-10). The researchers diagnosed fibromyalgia, according to ACR criteria, in 67.4% of the patients and reported the presence of pain in 81%.

Compared with the U.S. general population, patients with fibromyalgia see fibro page 58

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Pa in Me d icin e

Tests Show Tramadol MP Makes Abuse More Difficult

A

a new tamper-resistant formulation of tramadol hydrochloride prevented dose dumping by retaining its controlled-release properties when split or crushed, according to a proof-of-concept study presented at the 2010 annual meeting of the International Association for the Study of Pain.

The new MP formulation, Tramadol MP (Labopharm Inc.), showed 24-hour controlled release in vitro and 16-hour controlled release in split tablets. The product’s integrity also held up when crushed and mixed with water, the study found.

Although controlled-release forms of tramadol have not been associated with the nonmedical use and abuse observed with stronger opioids like oxycodone, “we don’t want dose dumping to occur in any tablet,” said Damon C. Smith, MD, senior vice president of research and development at Labopharm, based in Quebec, Canada, and a member of the study group. Because dose dumping could occur through intentional or accidental misuse of tramadol, the researchers developed a controlledrelease formulation for a once-a-day pill that can retain its rapid onset and 24-hour analgesia.

The investigators found that Tramadol MP tablets exhibited controlled release over a 24-hour period in vitro in a pH 6.8 buffer compared with approximately 12 hours for Ultram (Ortho McNeil) extended-release (ER) tablets in the same medium. When split, Tramadol MP tablets maintained controlled release for 16 hours in pH 6.8 phosphate. By contrast, dose dumping occurred as the contents of Ultram ER tablets were released in less than one hour in the same medium, the researchers said.

When crushed and added to water or a hydroalcoholic medium, the powdered tablets formed a hard gel within 30 seconds. This gel allowed tramadol to maintain its controlled-release properties.

The researchers also analyzed the tablet’s pharmacokinetics in 18 healthy volunteers under fasting conditions.

The MP formulation exhibited an early rise in plasma concentrations that peaked at five hours with sustained release over the remainder of its delivery period.

To prevent dose dumping with Tramadol MP, Labopharm created a proprietary formulation called Intellitab, which the company describes as

a misuse–abuse–deterrent technology capable of delivering one or more drugs for up to 24 hours.

Richard C. Dart, MD, PhD, director of the Rocky Mountain Poison and Drug Center, in Denver, said he has seen an alarming increase in the nonmedical use of some opioids over the past 15 years. “Poisoning is the second leading cause of accidental death,

right behind motor vehicle accidents, and opioids account for most of that increase in recent years,” said Dr. Dart, executive director of the RADARS System, which monitors prescription opioid use.

Dr. Dart said that whereas the need for abuse-deterrent formulations is clear, the solutions are not. He said that although he would like to see head-

to-head studies comparing the various abuse-deterrent approaches, “the Labopharm product is promising and seems to meet the needs seen out there with the opioids. It doesn’t dump in alcohol, one can’t easily grind it up and inject it and when it gets wet it turns into a gel, limiting its abuse potential.”

—Alice Goodman

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Opioid Agreements: Helping or Harming The Physician–Patient Relationship?

I

n early January, the FDA approved Abstral (ProStrakan), a transmucosal fentanyl tablet indicated for breakthrough cancer pain. Not surprisingly, Abstral was approved with a Risk Evaluation and Mitigation Strategy (REMS); however, Abstral’s approved program was slightly different from other approved REMS, even those for fentanyl products indicated for breakthrough pain or powerful opioids like oxycodone: It included a patient– prescriber agreement that physicians would have to use for every patient for whom they prescribed the drug.

Patient–prescriber agreements— alternately called opioid contracts or opioid agreements—had been long discussed at the FDA. As early as 2009, the agency suggested these agreements might be part of the REMS program.

However, a number of concerns were raised, both in online comments submitted to the agency and in FDA public hearings on the program. In June 2010, when the FDA released its guidance to industry on developing REMS, the agency specifically stated that the “FDA is not proposing to require pain treatment agreements or patient/pro‘The underlying problem is that there is a tremendous vider agreements under the REMS.” However, the guidance document did power differential between a patient who wants emphasize that the FDA wanted to something that only the doctor can give. An [opioid] make patient–prescriber agreements more widely available to opioid-preagreement is inherently unequal so that the patient, scribing physicians.

Abstral’s approved REMS program in my estimation, always agrees to sign a contract.’ clearly took a different form. Near the bottom of the patient portion it states, —Bill McCarberg, MD “I understand that I am not required to sign this Authorization. However, if I do not sign, I will not be able to enroll these experts also outlined several unin- Joanna Starrels, MD, assistant profesin the Abstral REMS program and will tended consequences associated with sor of medicine at Albert Einstein Colnot be able to receive Abstral.” their use. Among them were stigmatiz- lege of Medicine, in New York City, ing pain patients; creating barriers to found only four studies that compared At What Cost opioid prescribing; undermining physi- outcomes of patients with and without And for What Benefit? cian–patient trust; contributing to the opioid agreements. All were retrospecAlthough opioid agreements have “legalization” of medicine; and eroding tive and observational and “importantly, become ubiquitous, requiring patients the ethical responsibility of physicians none of the studies evaluated the outto sign them—at the risk of forgo- to put the patients’ needs above their comes that are most clinically imporing treatment—raises questions about own—in this case, the “chilling effect” tant, such as addiction and overdose,” the ethics of the documents and of increased regulation by state medi- Dr. Starrels said. “These [agreements] whether their value outweighs the cal boards and the U.S. Drug Enforce- are being rolled out by physicians every effect they have on the doctor–patient ment Administration. day … but we don’t know what the benrelationship.

Despite the popularity of opioid efits—or the risks—are.”

Last April, the American Journal of agreements, experts said there is scant “There is this perception that there Bioethics convened a panel of multi- evidence that they are capable on their is something legal and binding about disciplinary experts to weigh in on the own of minimizing risk when physi- this; therefore, this agreement changes pros and cons of opioid agreements. cians prescribe opioids. behavior. There is no evidence that Although the panel’s report emphaIn a literature review of opioid agree- we know about that it changes behavsized doctor–patient communication of ments used in the treatment of chronic ior,” said Bill McCarberg, MD, founder the risks and benefits of opioid therapy, noncancer pain published in 2010, of the Chronic Pain Management

Program for Kaiser Permanente in San Diego.

One of the major ethical concerns with opioid agreements or contracts is that they presume patients are equal partners in a patient-centered approach.

In reality, he said, patients have no choice but to sign them if they want treatment.

“The crux, the underlying problem, is that there is a tremendous power differential between a patient who wants something that only the doctor can give,” Dr. McCarberg said. “An opioid agreement is inherently unequal so that the patient, in my estimation, always agrees to sign a contract.”

The act of signing is key. Physicians often feel it’s necessary because unlike prescribing insulin for diabetes, for example, a noncompliant pain patient on opioid therapy can be a significant medicolegal liability for a prescribing physician.

From patients’ point of view, it can cultivate a sense of mistrust and shame.

“We don’t make contracts for anything else, so it makes patients feel like they are not respected or not trusted, or like they’re doing something wrong, when all they are trying to do is get their pain treated,” said Robert Arnold, MD, chief of palliative care at the University of Pittsburgh Medical Center.

“It’s universal, when somebody asks me to sign something, my back immediately straightens up,” said Will Rowe, CEO of the American Pain Foundation, a patient advocacy group. “I get suspicious, I get cautious, I start to doubt and I wonder what is going on here.”

As opioid agreements become increasingly more common—indeed at the point that they are federally mandated before prescribing certain drugs—their significance may become diluted. For example, the Abstral patient–prescriber agreement must be countersigned by both patient and provider and faxed to the Abstral REMS program within 10 days. If it is not received, the patient’s prescription is blocked. Furthermore, the patient portion includes 12 points outlined in legalese; if the document is an agreement in letter, it is certainly more of a formal contract in spirit.

Although the motive behind opioid agreements may be a good one, they risk becoming another bureaucratic hurdle for physicians to jump through and yet one more document for a patient to initial while sitting in the waiting room.

“If the emphasis is on getting a piece of paper signed, one that people sign but may or may not read, may or may

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AnesthesiologyNews.com I 55

Pa in Me d icin e not understand, then to me it’s hurting the process, rather than helping it,” said Steve Passik, PhD, a psychologist who specializes in palliative care and pain management at Memorial Sloan-Kettering Cancer Center in New York City. Expectations from both the patient and the physician about what constitutes appropriate use of opioids should be an ongoing, living dialogue, he added.

Leverage Some agreements go a step beyond inconvenience, to the point of being impractical or immoral. Dr. McCarberg mentioned that he has seen opioid agreements demanding concurrent treatments like physical therapy that were impossible for some patients to perform.

And yet one step further, some agreements are literally ultimatums, which physicians use as grounds for “firing” noncompliant patients. Experts interviewed for this story unanimously considered this a breach of medical ethics, particularly for pain specialists.

When a specialist “fires” a patient, “all you are doing is then sending them back to their primary care doctor, who sent them to you because they didn’t know what to do,” Dr. Arnold said.

Moreover, the physician probably isn’t helping the patient by denying treatment. “It’s never been shown that firing someone from pain management necessarily helps their substance abuse problem,” said Dr. Passik. “And there are a lot of ways that I can think of that it can get worse.” Barred from medical treatment, these patients may turn to street drugs for relief.

Provided there is no drug diversion taking place, substance abuse and dependence is a treatable, psychiatric condition that should remain private between the treatment team and the patient, Dr. Passik said. “Why lose the leverage we have when offering help with pain to also try to help the person with an addiction?” he asked.

A Chance for an Open Dialogue Regardless of their flimsy evidence, or the ethical complexities, it would seem that opioid agreements are here to stay. What, then, makes a good one?

Ultimately, the agreement itself is somewhat beside the point, experts say, although the language and tone clearly are important on one level.

What is more important—regardless of whether anything gets signed, faxed and filed away—is a thorough and open dialogue about why opioids

are different from other medicines. A good agreement, whether it’s drafted by the physician or downloaded from the Internet, should simply serve to open an ongoing dialogue about the risks of opioids and what the patient and physician can expect from each another.

“One of the major questions about using treatment agreements is what they should look like,” Dr. Starrels said.

“It’s clear that we should be discussing the risks and benefits of opioids with

all of our patients, and it’s clear that we should tell them what they can expect when entering a treatment plan with a provider. The question is what form this communication should take, and is a written document the best way to go?”

Although there is little evidence supporting the use of opioid agreements, Dr. Passik pointed to studies of patients with opioid addiction. A recent study of pain patients on methadone in a highly structured program

of medication adherence found that patients’ alliance with their therapist was the best predictor of outcomes.

“What pain practitioners have to ask themselves is, ‘I’m doing all of these [risk management maneuvers], but is it hurting or helping my communication and the working alliance that I’m building with my patients?’” Dr. Passik said. “Because that is the best predictor of how we are going to do.”

—Gabriel Miller

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P AIN M EDICI NE

New Mexico Clinic Fights High-Tech War Against Chronic Pain

D

ebra Newman knew that the 55-year-old former construction worker she had just examined for chronic, unremitting back pain would not drive more than 250 miles roundtrip to receive treatment at the nearest pain clinic at the University of New Mexico (UNM) in Albuquerque. Nevertheless, two years ago, Ms. Newman, a physician assistant (PA) at El Centro Family Health Clinic in the remote city of Española, N.M., would have had only one option: to refer the patient to a pain specialist no matter the distance.

Today, however, she doesn’t have to.

For the past several years, Ms. Newman has participated in a weekly program hosted by UNM Health Sciences Center, which uses teleclinics to help rural health care providers manage patients with chronic pain. The program, called Project ECHO (Extension for Community Healthcare Outcomes), was

launched in 2003 in response to burgeoning hepatitis C infections in the state. With additional grants from the Robert Wood Johnson Foundation, ECHO has expanded to include seminars on chronic pain as well as asthma, diabetes, HIV/AIDS, pediatric obesity and rheumatology.

How It Works The Chronic Pain and Headache Management Teleclinic, like all Project ECHO teleclinics, uses Web technology, such as video and teleconferencing, to reach New Mexico’s far-flung, rural health care providers. New Mexico, the fifth biggest state, covers more than 120,000 square miles, and about one-third of its nearly 2 million residents live in rural areas and receive medical care from primary care providers such as Ms. Newman.

The Tele-ECHO Pain Clinic offers clinicians traditional, multimodal

approaches to treat chronic, noncancer pain. The clinic is composed of an interdisciplinary team, which confers with clinicians on patient cases and conducts lectures on a range of chronic pain issues and treatments.

“With our teleclinic, underserved pain patients in New Mexico can receive evidence-based care in their communities from primary care physicians who are sensitive to their needs, customs and language,” said neurologist Joanna Katzman, MD, the teleclinic’s medical director. “That’s important because we’re such a diverse state, with large Hispanic and Native American populations.”

Helping New Mexico’s rural clinicians treat chronic pain is paramount because, like hepatitis C, chronic pain is a significant health issue there.

“Chronic pain is one of the most prevalent diagnoses for any primary care provider here,” Dr. Katzman pointed out. “Headache and low back pain are the most frequent reasons people request time off work and why they apply for disability in this state. More importantly, if a patient’s chronic pain needs aren’t met, then primary care doctors have an almost impossible task of trying to treat other prevalent conditions, such as diabetes, heart disease and hypertension.”

At a teleclinic, ECHO’s pain specialists connect virtually with as many as 20 rural clinicians.

“A majority [of the clinicians] are family practice providers, including MDs, DOs, NPs [nurse practitioners] and PAs,” said Jeannie Boyle, RN, nurse manager for Project ECHO. Although 90% of providers are from New Mexico, the Tele-ECHO Pain Clinic has started to attract clinicians from other states, such as Oklahoma, Illinois and Washington.

Often providers present their toughest pain cases. “Presentations usually involve severe, intractable pain, which has gone on for a long time,” Dr. Katzman said. “Patients often have overlapping psychiatric issues, such as anxiety and depression, and may have a history of substance abuse or multiple pain syndromes, such as neuropathy and fibromyalgia.”

Teleclinics are held every Thursday from 12 noon to 2 p.m. In addition to Dr. Katzman, the ECHO pain team consists of an internal medicine

he Project ECHO Chronic Pain and T Headache Management Teleclinic team confers with rural clinicians during one of its teleclinics.

embers of the Tele-ECHO Chronic M Pain Clinic advise Mateo Caffrey, MD, second from right, a primary care physician from a rural clinic in South Valley, N.M. ECHO team members are, from left, Adrian Rodriguez, information technology specialist; Wesley Pak, systems and program manager; Daniel Duhigg, DO, addiction psychiatry; Joanna Katzman, MD, Tele-ECHO Pain Clinic medical director; and Jeannie Boyle, RN, nurse manager.

specialist, a psychiatrist, physical medicine and rehabilitation specialists, a clinical psychologist and a myofascial pain expert.

“We come with this interdisciplinary approach because we know that chronic pain rarely responds to medication alone,” said Dr. Katzman. “Most patients need an integrated approach to care.”

The majority of rural providers hook up to the teleclinic via video. The technology is available to participants free of charge, thanks to ECHO’s funding, and the pain team provides assistance and training when installing and using the equipment.

“Those who don’t have videoconferencing capabilities can participate over the phone,” Dr. Katzman said.

During a teleclinic, case presentations generally are made first because since a provider might not be able to stay for the entire session. Lectures focus on pain topics such as fibromyalgia, psychology of pain and see ECHO page 58

American Society of Regional Anesthesia and Pain Medicine

Advancing the science and practice of regional anesthesia and pain medicine

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Register online at www.asra.com American Society of Regional Anesthesia and Pain Medicine 520 N. Northwest Highway, Park Ridge, IL 60068 847-825-PAIN(7246) • www.asra.com • asra@asahq.org

5 8 I A n e s t h e s i o l o g y N e w s . c o m Ma r c h 2 0 1 1

P AIN M EDICI NE ECHO continued from page 56

RMX 2000 Multipoint Control Unit, a high-performance, scalable, IP-network that provides users with osteoarthritis. Clinicians also are given access to evi- feature-rich and easy-to-use multipoint voice and videoconferencing. dence-based educational resources.

The Web-based disease management software, As an added incentive to participate, attendees earn continuing medical education credits. “In fact, if called iHealth, lets the team and rural providers coa physician or provider takes the American Academy manage cases electronically, sharing vital patient of Pain Management credentialing exam and passes, information and test results. A Web-based data Project ECHO reimburses his or her registration resource management system, called iECHO, handles internal information relating to outcomes, confees,” said Ms. Boyle. tacts and activities.

A Complex Case “We have the capability to archive everything we do Ms. Newman presented her 55-year-old chronic and have that information at our fingertips for future back pain patient’s case to the Tele-ECHO Pain use,” said Wesley Pak, ECHO’s systems and program Clinic. “It was complex for a lot of reasons,” she manager. explained. “Besides back pain, he complained of neck Measuring Outcomes pain and gout. He had been on short-course opioid The Tele-ECHO Pain Clinic currently is making therapy, and his blood pressure was uncontrolled and an effort to measure outcomes. “We want to prove, high. It was a serious concern.”

The patient’s labs showed borderline kidney func- especially to people who want to duplicate our protion. He had been taking the rheumatoid arthritis gram, that we are improving outcomes,” Ms. Boyle drug indomethacin for quite some time as well as said.

The pain clinic is surveying clinicians who have antidepressants for a shorter period of time.

The ECHO team and Ms. Newman concluded attended three or more teleclinics, asking how their that this patient needed another magnetic resonance knowledge of chronic pain has changed after particimaging scan of his spine because his last one was a ipating in ECHO and how patients have responded year ago. They recommended regular x-rays of his to treatment.

ECHO also is gathering data on how much time, neck and a change from indomethacin to febuxostat (Uloric, Takeda) a new medication that lowers uric money and pollution can be saved by allowing acid levels in people with gout. The team also sug- patients to be treated where they live. For example, gested he add a drug to control his high blood pres- a patient in Lordsburg, N.M., would have to drive sure and that he see an interventional back specialist eight hours to UNM’s pain clinic in Albuquerque, a distance of 564 miles roundtrip. The patient would to deal with the significant disc disease in his spine. spend approximately $282 on gas, meals and accomTeleclinics Technologies modations—while emitting 411 pounds of carbon The technologies that power the ECHO teleclin- into the atmosphere in the process.

“It is possible with programs like ECHO that litics include a cutting-edge videoconferencing infrastructure and outcomes/activities data-collecting erally millions of pounds of carbon emissions can be tools. For videoconferencing, Project ECHO uses reduced,” Ms. Boyle said. “Teleclinics can have a real a series of Polycom systems, such as the Polycom impact on the environment.”

Wave of the Future Project ECHO’s Chronic Pain and Headache Management Teleclinic makes a strong case that technology and interdisciplinary cooperation can make a difference in treating patients where medical resources are scarce.

“With health care reform, the ECHO model could be extremely important,” Dr. Katzman said. “It is a viable way to reach areas where there are physician shortages. It also will help shape demand in our traditional pain clinic. If the teleclinic can help keep patients in their home towns, and under the care of their primary care provider, then less patients will need to travel to UNM’s Pain Center for ‘live’ visits.”

In 2009, the Robert Wood Johnson Foundation provided an additional $5 million to Project ECHO to expand into other clinical areas.

Nancy Barrand, special adviser for program development, commented on the program’s worth. “Millions of Americans suffer from debilitating, chronic illnesses, which could be treated if resources were available,” she said. “The ECHO model teaches us we can leverage existing health care resources to provide safe, effective care to patients regardless of where they are.”

For Ms. Newman, ECHO’s value is more personal.

“ECHO has enhanced the care I can offer my chronic pain patients,” she said. “It has improved my skill set.

I could not do my job as effectively without the help of Dr. Katzman and her team.”

Ms. Newman added, “Every week I have the chronic pain team at my disposal. Through the didactics and demonstrations, I learn something new, which helps me hone my skills, so when I can go back into the clinic, I have the capacity to provide improved patient care for my chronic pain patients. In addition, I learn from the ECHO partners around the state who are regular contributors and experts as well.”

Fibro continued from page 52 had more accidents that resulted in death (7.1% vs. 5%, respectively), had more deaths from influenza/pneumonia (5% vs. 2.3%, respectively) and septicemia (4.1% vs. 1.4%, respectively), and committed more acts of self-harm, such as suicide (4.4% vs.

1.4%, respectively). Predictors of death also included body mass index (BMI) greater than 29, smoking, HAQ score and more severe pain.

“These two studies relay an important message that physicians [caring for patients with FM] need to be sensitized to the risks of suicide, particularly for patients who receive medications that may be used in suicide attempts,” cautioned Mary-Ann Fitzcharles, MD, Generally, patients with chronic associate professor of medicine in the Division of Rheumatology and director pain conditions have an increased rate of the Alan Edwards Pain Management of suicide ideation and completed suiUnit at McGill University, in Montreal. cide, said Dr. Fitzcharles, who was not

involved in the study. Factors that may contribute to suicide risk, specifically in patients with FM, include depression and psychogenic distress, such as

—Tom McDonough

anger, frustration or fear of having an undiagnosed condition.

Dr. Michaud speculated that women with fibromyalgia may be at a higher risk for suicide because they use more painkillers and antidepressants and have high levels of somatic symptoms and depression.

Dr. Fitzcharles added that “the health of patients with fibromyalgia is often suboptimal compared with that of the population in general for both physical and psychological symptoms.”

Patients with fibromyalgia generally report reduced physical activity, which also contributes to poor health, obesity and poor mood.

“These studies raise an important red flag warning for health care professionals caring for FM patients,” Dr. Fitzcharles said.

—Alice Goodman

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Anesthesia Student Survival Guide: A Case-Based Approach

Jesse M. Ehrenfeld; Richard D. Urman; Scott Segal This text is an indispensable introduction to the specialty. This concise, easy-to-read, affordable handbook is ideal for medical students, nursing students and others during the anesthesia rotation. Written in a structured prose format and supplemented with many diagrams, tables and algorithms, this pocket-sized guide contains essential material covered on the USMLE II-III and other licensing exams.

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AnesthesiologyNews.com I 61

Pa in Me d icin e

Ischial Bursitis Injection Therapy Improved With Fluoroscopy

I

n patients being treated for refractory buttock pain of ischial bursitis, steroids may be injected more effectively with fluoroscopic guidance, results of a small study suggest.

“With fluoroscopic guidance, I can see exactly where medicine is going— maximizing safety and minimizing patient discomfort,” said Marjorie E. Robinson, MD, assistant professor of anesthesiology at the University of Louisville Hospital, in Kentucky, who helped conduct the study.

Dr. Robinson and her former colleagues at the University of Alabama School of Medicine, in Birmingham, used the technique on a series of five patients with ischial bursitis. Their findings were presented at the 2010 annual

fall meeting of the American Society of Regional Anesthesia and Pain Medicine in Phoenix (abstract 66).

After more conservative therapies have been exhausted in the treatment of ischial bursitis, the use of steroids may be enlisted. The injection technique traditionally is performed blindly, using palpation, Dr. Robinson said. But this can prove difficult and risky, particularly if multiple attempts at injection are required. With fluoroscopic guidance and contrast dye, Dr. Robinson noted that “it takes just one stick, rather than possibly having to maneuver the needle around in the blind approach, and risking hitting the sciatic nerve or another structure.”

After negative aspiration and

Figure. Fluoroscopic-guided injection of the ischial bursa.

confirmation by fluoroscopy of the spread of contrast along the ischial bursa, the researchers injected 40 mg of methylprednisolone, along with a local anesthetic, into each of the patients (Figure). None of the patients reported sciatic or other paresthesias.

The approach is not new and is being used in many modern pain clinics, said Ahmed H. Ghaleb, MD, associate professor of anesthesiology and director of pain medicine at the University of Arkansas for Medical Sciences, in Little Rock. Yet, Dr. Robinson said she and her colleagues had found no prior documentation of fluoroscopic-guided injection of the ischial bursa before carrying out their study.

The potential risks associated with fluoroscopy include minor radiation exposure to the patient and physician, as well as special risks for patients with renal failure or a contrast allergy. Fluoroscopy also increases the cost of the procedure.

“You could argue either way whether or not the procedure is more time

consuming with fluoroscopy,” Dr. Robinson said. For example, a thin patient might be treated quickly using the traditional blind procedure because it would be easy to use anatomical landmarks, whereas in a larger person the procedure might take longer without fluoroscopic guidance.

Peter H. Cheng, DO, director of regional anesthesia at Kaiser Permanente Riverside Medical Center in Riverside, Calif., said that the use of ultrasonography could confirm a diagnosis of ischial bursitis or identify other causes of pain. Given its superiority over fluoroscopy for imaging of soft tissue, ultrasound may confirm more accurately the location of the needle within the bursa.

Dr. Robinson agreed that ultrasound might be at least as good as fluoroscopy.

Still, she noted that fluoroscopy is a “reasonable, fast way to do a procedure” and that it has “multiple advantages.”

“Steroids should be the last resort,” Dr. Ghaleb said. “But, if one is providing injection therapy, it is preferred if it’s done under fluoroscopy.”

—Lynne Peeples

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COMM E NTAR Y

Ink to AIM: Get in the Game

W

hen I was starting out in practice I marked the vital signs of patients as dots, circles and carets on paper anesthesia records. I got good at it, making those marks with a fine-tip ballpoint pen after placing a laryngoscope on the record to prevent it from sliding across the smooth surface of the anesthesia machine. I wrote the preinduction vital signs in the left margin for quick reference and used common abbreviations to shorten my notes. One might read: RSI c TPL + SUX -> ETT c BBS at 21cm. I invented some other abbreviations that seemed useful until other anesthesiologists couldn’t understand them: PTOTSA for Patient Turned Over To Surgeon At, a timing notation, and ENAULORT for Epidural Needle Advanced Using Loss Of Resistance Technique, a regional anesthetic description.

But ultimately, PIPWF: Pursuing Inkified Perfection Was Foolish, an advancement delusion and obsolescence trap, like mastering hieroglyphic speed-writing. Seeking more legible, complete and accurate documentation, in the early 1990s I installed electronic anesthesia record-keeping systems (EARs) throughout our surgical suite.

The installation itself was a challenge. The magnetic stirrers in our water-bath warming blankets interfered with the ­cathode-ray displays if they got too close to each other. Touchscreens, a cuttingedge technology at that time, failed in our operating rooms (ORs) with their stray electromagnetic currents. We adapted to get a working system.

Deploying EARs also pushed our clinicians. We persevered until a few learned to use them. Then we promoted clinicians with EAR proficiency to “super users” to help anyone else having difficulties.

Our ink-to-EAR transition ultimately worked well, improving record readability, department efficiency and our ability to capture billing data.

For 15 years, we upgraded our EARs as new equipment and technology became available and budgets allowed. Department members grew to like and depend on them, even complaining when assigned to an out-of-the-OR site where they had to revert to paper and ink. Radio-linking these remote sites to the anesthesia server solved that problem. Linking our preoperative clinic to the server meant that information collected there was preloaded in the anesthesia record and available whenever the patient appeared for surgery.

Storing the anesthesia records using patient-unique medical record numbers meant previous anesthetics were available quickly. Our charge anesthesiologists discovered that real-time viewing of anesthesia records at a central location made managing the surgical suite schedule easier. Residents who trained in our program sought work opportunities that used electronic records. Handwritten notes look primitive to anyone who has only used electronic records. Calling ORs to see what was happening in them seemed utterly old-fashioned.

What we did not recognize was that our EARs had grown to become what system experts call “best-ofbreed,” excellent at what they are designed for but isolated. Our system did not integrate well with the

many others in use at the institution. They were built on different platforms, stored and accessed data in different ways and employed different nomenclature.

We had trouble, for instance, when we tried to study the economics of fast-tracking surgical cases by combining our anesthesia records with critical care, pharmacy and institutional financial records. Individual records were hard to link, and similar cases were labeled differently in different systems, such as “CABG,” “coronary bypass” and “open heart,” making searches difficult.

The EAR also limited our quality improvement program, which primarily depended on individual initiative, self-flagging of occurrences and selfreporting of adverse outcomes. Placing occurrences and outcomes in perspective proved difficult without national benchmarks. We argued over the significance of postextubation laryngospasms that the patients of one anesthesiologist experienced when we couldn’t immediately describe how often this occurred in different populations and among other faculty. What was missing was the efficient and routine production of benchmarking data.

We needed an EAR that was part of an integrated institutional system, one that shared information widely and made quality improvement easy. It was time to reinvent our record-keeping system again, to make it an anesthesia information management system (AIMS). To assess our performance we needed to compare ourselves with national practices, which meant participating in a large anesthesia practice registry. To advance, we needed to identify our best performers, to describe and copy their styles. We needed more than a recordkeeper; we needed to manage, share and understand our anesthetics. Now we’re converting our EAR to an AIMS, as are other practices.

Approximately 50% of academic practices and 10%

of private practices now use Robert E. Johnstone, MD electronic anesthesia records, but this is changing. The systems being installed and marketed today work well, with built-in preoperative functions, eye-catching displays and useful reports.

Even better is their linkage with other institutional systems to meet meaningful-use requirements and to national registries for benchmarking reports.

The 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act calls for an investment of many billions of dollars in health information technology. In 2010, the Centers for Medicare & Medicaid Services published stringent rules for qualifying for these funds; at the heart of the regulations was the stipulation that the technology be used in “meaningful” ways to improve clinical care and personal health. These include numerous core and elective elements.

Most anesthesiologists are eligible for these HITECH funds, up to $44,000 per physician, a sizable amount for large groups. But meaningful use requirements will not be easy for anesthesiologists to meet by 2013, when the incentives start to shrink, unless they start their upgrade now and integrate their AIMS and institutional system.

The American Society of Anesthesiologists recently funded the start-up of the Anesthesia Quality Institute (AQI), a not-for-profit entity dedicated to quality improvement. The AQI’s mission is to develop and maintain an ongoing registry of case data that will help anesthesiologists assess and improve patient care. The resulting registry, the National Anesthesia Clinical Outcomes Registry (NACOR), started operating in 2010.

Hundreds of practices have expressed interest in participating, and 50 have already completed datasharing agreements. The cost to join is nil, and practices that already have downloaded data have started receiving practice reports back. NACOR only accepts data electronically. Participation in NACOR is open to all practices, and can begin with administrative (billing system) data alone. The best value, however, will be achieved by practices that can contribute AIMS-generated process and quality data.

There is a convergence of reasons for practices to adopt AIMS. They make practices more efficient and facilitate quality improvement. Vendors are available with programs. The government will provide considerable funds to those who implement acceptable systems. Information about the NACOR can be found on the AQI Web site (http://www.aqihq.org).

We’ve started on this latest upgrade to our anesthesia records and practice. As with previous upgrades there is learning, change and frustration involved, but the destination is worthwhile. All anesthesiologists who are themselves somewhere on the journey from ink to AIMS should get in this game.

—Robert E. Johnstone, MD Dr. Johnstone is professor of anesthesiology at West Virginia University, in Morgantown, and vice president for professional affairs of the American Society of Anesthesiologists. This commentary represents his personal views.

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