The September 2011 issue of Anesthesiology News by McMahon Group

Ple ASA ase V Boo isit u th # s a 102 t 3

Society for Airway Management annual meeting issue

The Independent Monthly Newspaper for Anesthesiologists AnesthesiologyNews.com • S e p t e m b e r 2 0 1 1 • Volume 37 Number 9

Speeding Hip Surgery Cost Effective

ealth care costs associated with hip fractures in the United States total $10.3 billion to $15.2 billion annually, and the one-year mortality rate for these patients is between 12% and 37%. The death rate increases substantially if the time from hospital admission to surgery exceeds 48 hours (Can J Anesth 2008;55:146-154). Implementing ways to shorten the time to surgery would likely result in improved patient outcomes, but at what cost? A new study (J Bone Joint Surg Am 2011;93: 1326-1334) evaluated the hypothetical cost-effectiveness of reducing the

The Good Catch Awards

Program Encourages Reporting Accidents Waiting To Happen

new system that encourages every clinician to report situations that put patients at risk appears to be succeeding. Within 24 months, the new program, based at Johns Hopkins Medicine, in Baltimore, distributed 27 socalled “Good Catch Awards” (Table, page 14) to clinicians who reported situations that resulted in changes that were potentially lifesaving, including a national recall of improperly labeled drugs that had caused look-alike medication errors. The concept of the program is based on the idea that one person is rarely at fault; rather, it is a faulty system, said Justin Hamrick, MD, a third-year anesthesia resident at the institution. As a result, raising

see hip page 26

see catch page 14

Pre-op Nerve Damage a Cause Of Post-Herniorrhaphy Pain?

INside 09 | PRN For would-be residents, a good first impression is more important than they realize.

Study offers alternative theory of pain after inguinal hernia repair: neuritis, not operative trauma San Francisco—As many as onethird of patients who undergo primary inguinal hernia repair may have preexisting nerve damage, according to a new study presented at the 2011 annual meeting of the American Hernia Society. The study won the Fruchard Award for best poster and was published in Hernia (2011;15:393-398). The finding suggests a significant shift in the cause-andeffect paradigm that has defined

post-herniorrhaphy pain, said the study’s lead author, Robert Wright, MD, a private practice surgeon at Meridian Surgery Center in

16 | CLinical Anesthesiology

Puyallup, Wash. Dr. Wright’s results indicate that a sizeable fraction of the post-herniorrhaphy pain seen in patients may be the result of preexisting nerve damage, rather than operative trauma. “We have always considered the pain associated with the hernia as a visceral pinch or a muscular pain; we haven’t considered nerve damage,” said Dr. Wright, who added that many patients

Multimodal analgesia and TAP block a winning combination.

24 | Policy & Management Assessing the impact of Kentucky’s opioid script monitoring program.

36 | Pain Medicine Analgesic requirements—and costs—after TKA are higher for women.

42 | technology “4-D” ultrasound helps guide placement of central lines.

see hernia page 32

Ronald D. Miller, Manuel C. Pardo, Jr.

Newproducts

Arrow® ErgoPack™ from Teleflex, see pages 22 and 24.

McMahonMedicalBooks.com Basics of Anesthesia

Innovian® Anesthesia 4.0 from Dräger, see pages 9 and 28.

see page 39

SorbaView® SHIELD from Centurion Medical Products, see pages 6, 7 and 38.

For how many anesthesia procedures (CPT codes) does CMS allow fewer base units than ASA? Find the answer at: www.anesthesiallc.com/an-sep11

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

Discuss these and other articles @ AnesthesiologyNews.com.

Heard Here First: The way I characterize it, there’s a

smoking gun but

no victim yet.

September 2011

See article on page 20.

The five most-viewed articles last month on AnesthesiologyNews.com 1. Better Outcomes Seen With Standardized Handoff Protocol 2. Guiding Fluid Management in the Surgical Setting (Part 1 of a 2-Part Procedural Breakthrough Series)

@ anesthesianews

3. Cliff Jumping and Other Adventures of Residency 4. Switching Opioids: The Impact of Drug-Drug Interactions (Part 1 of a 4-Part From the Bench to the Bedside Series) 5. Opioid Adjuvants for Multimodal Pain Management (Educational Review)

Robert S. Lagasse, MD, New Haven, CT Alex Macario, MD, MBA, Stanford, CA ALIX MATHIEU, MD, MBA, MS, Cincinnati, OH The Independent monthly Newspaper for Anesthesiologists

AnesthesiologyNews.com • mcmahonmed.com

Peter J. Papadakos, MD, Rochester, NY Linda S. Polley, MD, Ann Arbor, MI MICHAEL F. ROIZEN, MD, Cleveland, OH

ADVISORY BOARD

JOAN E. SPIEGEL, MD, Boston, MA

JEFFREY L. APFELBAUM, MD, Chicago, IL

Susan T. Verghese, MD, Washington, DC

PAUL G. BARASH, MD, New Haven, CT

Eugene R. Viscusi, MD, Philadelphia, PA

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

CHARLES B. WATSON, MD, Bridgeport, CT

Looking for a PreAnesthetic Assessment CME lesson? Visit www.mssm.procampus.net.

Richard tuorto, Senior Group Publication Director richardt@mcmahonmed.com, (212) 957-5300, x 916 ANGELA Labrozzi, Manager, Publication Sales alabrozzi@mcmahonmed.com, (212) 957-5300, x 204 DAVID NATHANSON, Account Manager dnathanason@mcmahonmed.com, (212) 957-5300, x 227 Nancy Parker, Executive Manager, Classified Advertising nparker@mcmahonmed.com, (212) 957-5300, x 260 Michele Mcmahon Velle, MAX Graphics/Creative Director Blake Dennis, MAX Graphics/Art Director

Keith Candiotti, MD, Miami, FL

Paul F. White, PhD, MD, Los Altos, CA

Dan RADEBAUGH, Director of Production and Technical Operations

Peter J. Davis, MD, Pittsburgh, PA

David Wlody, MD, Brooklyn, NY

Martin Barbieri, Production Manager

D. John Doyle, MD, PhD, Cleveland, OH

MCMAHON PUBLISHING

Lee A. Fleisher, MD, Philadelphia, PA

brandy Wilson, Circulation Coordinator

Adam Marcus, Managing Editor amarcus@mcmahonmed.com

MCMAHON GROUP

JANINE GLEASON, Associate Managing Editor jgleason@mcmahonmed.com

RAYMOND E. McMAHON, Publisher & CEO, Managing Partner

Julian M. Goldman, MD, Boston, MA CHRISTOPHER M. GRANDE, MD, MPH, Baltimore, MD

James Prudden, Group Editorial Director

Admir Hadzic, MD, PhD, New York, NY

David Bronstein, Editorial Director

ZEEV N. KAIN, MD, Irvine, CA

Robin B. Weisberg, Manager, Editorial Services

Alan Kaye, PhD, MD, New Orleans, LA

ELIZABETH Zhong, Associate Copy Chief

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

VAN VELLE, President, Partner Matthew McMahon, General Manager, Partner lauren Smith, Michael P. McMahon, Michele mcmahon VELLE, ROSANNE C. McMAHON, Partners

Not Receiving Anesthesiology News? All U.S. anesthesiologists should receive Anesthesiology News free of charge. If you are not receiving the publication, or if you are changing your name or address, please follow these instructions: 1) Contact the American Medical Association (AMA) at (800) 262-3211 or the American Osteopathic Association (AOA) at (800) 621-1773, and notify them of your name, address and professional specialty. You need not be a member of the AMA or AOA to receive the publication. 2) For added assurance of uninterrupted service, you may also mail or fax a copy of your current mailing label, along with your change of name or address to: Circulation Coordinator, Anesthesiology News 545 West 45th Street, 8th Floor New York, New York 10036 Fax: (212) 664-1242 Email: circulation@mcmahonmed.com Please sign and date all requests. If you are not a U.S. anesthesiologist and would like to subscribe, please send a check payable to Anesthesiology News to the Circulation Coordinator. Annual subscription: $70 (outside U.S.A., $90). Single copies: $7 (outside U.S.A., $10). Please allow 8-12 weeks for delivery of the first issue. McMAHON PUBLISHING, Sales, Production and Editorial Offices: 545 W. 45th St., 8th Floor, New York, NY 10036, Tel. (212) 957-5300.

gastroendonews.com

McMahon Publishing is a 39-year-old, family-owned medical publishing and medical education company. McMahon publishes six clinical newspapers, eight annual or semiannual Special Editions, continuing medical education and custom publications.

Copyright © 2011 McMahon Publishing, New York, NY 10036. All rights reserved. Anesthesiology News (ISSN 0747-4679) is published monthly for $70 per year by McMahon Publishing. Periodicals postage paid at New York, NY, and at additional mailing offices. POSTMASTER: Please send address changes to Anesthesiology News, 545 W. 45th St., 8th Floor, New York, NY 10036.

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 5

I N BR IE F In a small study of cardiac surgery patients …

Pleth Variables Erratic With Unstable Hemodynamics

The plethysmographic waveform approach may work in patients who are not as sick as those undergoing cardiac surgery. “A lot of people want to measure cardiac output noninvasively, and we were hoping [ear photoplethysmography (OEM III Module, Nonin Medical)] would work in this patient population,” he said. However, patients undergoing bypass surgery will be quite different from healthy volunteers, which he said may explain why the study did not find the same results. The plethysmographic waveform approach may still work in patients who are not as sick as those undergoing cardiac surgery, which Dr. Thiele said could be worth exploring. It may be more difficult to study those patients, however, because results from

pulmonary artery catheters likely may not be available to compare with plethysmographic waveform analyses. “We’re not saying people should drop this technology or should not keep studying it,” he said. Dr. Thiele said that although plethysmography is used widely for pulse

oximetry, very few clinicians are applying complicated formulas to the area under the curve to estimate stroke volume. He said Masimo Corporation is currently exploring what else the plethysmographic waveform can reveal. Masimo has developed a “pleth variability index” that allows clinicians to

Better access. Best practice. The Teleflex ISIS® HVT ™ is the first comprehensive endotracheal ISIS, HVT and Teleflex are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. ©2011 Teleflex Incorporated. 2011-0225 v1

he plethysmographic waveform may demonstrate cardiac function in healthy people, based on previous research. The methodology, however, does not appear to provide clinically useful data in patients undergoing cardiac surgery, according to findings presented at the 2011 annual meeting of the International Anesthesia Research Society (abstract S-55). The investigators conducted the study after other researchers reported that changes in amplitude, width and area of pulse oximeter waveforms correlated with stroke volume in healthy volunteers. Robert Thiele, MD, critical care fellow at Duke University, in Durham, N.C., who at the time of the study was an instructor in the Department of Anesthesiology at the University of Virginia, in Charlottesville, and colleagues applied the technique in 10 patients undergoing cardiac surgery. They found that plethysmographic waveform values did not match hemodynamic variables from pulmonary artery catheters. “Our data suggest that in people having cardiac surgery, it is not as useful,” Dr. Thiele told Anesthesiology News. He said the findings were disappointing, but not surprising.

(ET) tube, featuring an integrated suction port and separate suction line for subglottic secretion suctioning on demand. Its versatile design eliminates the need to be selective during initial intubation, increasing the number of patients who can be viable candidates for subglottic secretion suctioning, a clinicallyproven strategy for ventilator-associated pneumonia reduction.1 You make medicine better every day — choose the ET tube that does the same.

Visit booth 1012 at the

ANESTHESIOLOGY 2011 Meeting to see the new Teleflex ISIS HVT.

Teleﬂex ISIS HVT isishvt.com

1. Cofﬁn S, Klompas M, Classen D, et al. Strategies to prevent ventilator-associated pneumonia in acute care hospitals. Infect Control Hosp Epidemiol. 2008; 29: S31-S40.

Scan this code to learn more about ISIS HVT and to order a non-sterile product sample, or visit isishvt.com/anews

use the movement of the waveform to determine how the heart will respond to the administration of IV fluids. “This is probably the most interesting use of the plethysmographic waveform,” Dr. Thiele said. —Alison McCook

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

I N B R IEF

No More Whitelisting for Pharma on Facebook

reedom to comment on pharmaceutical company Facebook pages is now possible following a policy change by the popular social media Web site. On May 17, Facebook sent an email to pharmaceutical companies informing them they can no longer regulate their pages through the practice of “whitelisting.” In the past, pharmaceutical companies had the authority to whitelist, or disable comments, on original

content, thus allowing the company to be the only content contributor to the page. Facebook generally allows individuals who have been “friended” by personal page creators to post comments or comment on the existing content. Before Facebook’s decree, pharma companies would simply submit a request to a Facebook representative

to disable a comment. Now, existing pharma pages that use the whitelisting feature could continue to do so only until Aug. 15, and any new pharma page created after the announcement can no longer use the feature. With Facebook’s approval, however, branded pages that deal exclusively with a prescription drug may be able to continue the

whitelisting practice, according to the May 17 letter. Facebook said the policy change is more in line with its mission to provide an open, two-way dialogue between business and consumer. “However, we also understand that these changes may lead you to reevaluate your strategy and presence on Facebook,” according to the May 17 letter. —Kevin Enright

Pfizer Launches New Virtual Clinical Trial

he drug company Pfizer is pioneering a new “virtual” clinical trial to evaluate the effectiveness of electronic trial results rather than traditional face-toface meetings. The aim of the virtual trial is to get new medicines to the market more efficiently and cheaply (BMJ 2011 Jun 14;342:d3722). The FDA approved Pfizer’s plan and urged other manufacturers to seek novel approaches to speed up clinical trials. Another impetus for the virtual trial comes from surveys that show the time and effort necessary to travel to a trial site often reduces patient compliance. Similarly, patients who do not face life-threatening conditions, but have limited treatment options, are less likely to take part in trials. The initial study will test the safety and effectiveness of an already approved drug for overactive bladder, called Detrol, in 600 patients across the United States. Pfizer will compare the new results with those from a previous study to see whether the virtual clinical approach is valid. Investigators participating in the clinical trial will use smartphones or computers to recruit and enroll patients and to report results. Patients will also use apps to submit diary entries or self-reports. The test has started in California and will move to nine other states once permissions are granted.

CENTRAL LINE BLOODSTREAM INFECTIONS Recent studies have concluded proper techniques, protocol and bundling can successfully prevent Central Line Associated Bloodstream Infections (CLABSIs). A major part of this success lies in the components and structure of the Bundle. As a nationally-recognized provider of custom trays, Centurion is uniquely qualiﬁed to supply every component your team may need to help you implement a CLABSI prevention strategy.

No other company can offer you as many choices for full-body drapes, gowns and masks. We will customize your checklist to your exact protocol. We offer a unique pre-ﬁlled sterile-ﬁeld-ready syringe as well as our patented SorbaView® Dressings and Shield Securement. And we can wrap the entire kit around your choice of Vantex or Multi-Med central line catheters, or AVA High Flow Introducers by Edwards LifeSciences.

CENTURION® CENTRAL LINE BUNDLE SOLUTION – EVERYTHING YOU

—AN Staff Institute for Healthcare Improvement, 5 Million Lives Campaign, “Prevent Central Line Infections: How-to Guide”

Centers for Disease Control and Prevention, “Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011”

The Joint Commission, “Accreditation Program: Hospital National Patient Safety Goals,” Effective January 1, 2011

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 7

I N BR IE F

Govt. Policies Blamed for Canadians’ Lack of Access to Pain Drugs

hile their American neighbors face increasing diversion, misuse and abuse of pain medications, a recent editorial in the Canadian Medical Association Journal argues that overly tight governmental controls are making it difficult for Canadians with pain conditions to seek relief. The authors say fears of opioid misuse are driving the stringent controls. Although well

intentioned, they counter that the controls have gone too far, leaving many Canadian pain patients undertreated— particularly in rural areas. “Although the potential for opioid addiction and abuse is real, it is frequently exaggerated,” the authors write. “Moreover, this concern is not an acceptable excuse for failure to control chronic pain.”

In addition to the strict drug controls, access has been limited by doctors nervous about being disciplined for prescribing painkillers, according to the editorial. Yet, despite the editorial’s claims that pain in Canada is undertreated, Canada is among the world leaders in opioid use: Opioid prescriptions in the country have increased 900% since 1991, while annual

oxycodone deaths have gone from 35 in 2002 to 199 in 2006. In response to the surge in misuse and deaths, the College of Physicians and Surgeons of Ontario has released a report calling for more, regulated clinics devoted to the treatment of pain in the province, as well as a better system for tracking opioid prescriptions. A copy of the report is available at www.cpso. on.ca/uploadedFiles/policies/positions/ Opioid%20report%20final.pdf. —AN Staff

For U.S. Docs, Money Is Time

hysicians in the United States spend an average of $61,000 more per year on administrative expenses involving health insurance than their Canadian counterparts, a new study has found. Researchers at Cornell University and the University of Toronto, in Ontario, Canada, and colleagues found that administrative costs— such as dealing with insurance companies on claims and payment issues—in the United States averaged nearly $83,000 per doctor, compared with $22,000 north of the border. In all, such expenditures tally $27 billion per year more in the United States than in Canada, a result of that country’s more streamlined single-payer health care system, the researchers said. Although U.S. physicians spend money interacting with health insurers, their staffs bear the brunt of the time drain, according to the study. Nurses and medical practice staff in the United States spend an average of 20.6 hours each week per physician handling insurance issues. In Canada, the figure is 2.5 hours. Canadians spend nearly half what Americans lay out per capita on health care: $3,895 versus $7,290, respectively. A report on the findings appeared in the August issue of Health Affairs.

ARE PREVENTABLE Centurion Medical Products is the only CVC provider that can build you a COMPLETE Bundle.

—AN Staff

NEED TO STOP CLABSIs

800-248-4058 | www.cvcbundle.com

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

PRN

Flaw Revealed in P4P: Obesity Risk Ignored Surgical-site infections after colectomy tied to weight Vancouver, British Columbia—Obesity raises a person’s risk for developing a surgical-site infection (SSI) after colectomy by 60%, which in turn drives up the costs associated with the procedure by thousands of dollars, researchers reported at the 2011 annual meeting of the American Society of Colon and Rectal Surgeons (Arch Surg May 16 [Epub ahead of print]). Yet, proposed pay-for-performance programs that would end payments to surgeons and hospitals if an SSI occurs do not account for the risks associated with obesity. And hospitals and physicians who routinely care for obese patients risk losing income from these policies, the investigators said. “Pay-for-performance measures that do not account for risk factors may penalize surgeons who care for obese patients. Such policies may even affect obese patients’ access to colorectal surgery,” said lead author Elizabeth C. Wick, MD, assistant professor of surgery at Johns Hopkins University, in Baltimore. In the report, Dr. Wick and colleagues urged policymakers to incorporate patient risk factors into their reimbursement formulas should post-colectomy wound infections become part of pay-for-performance programs. “Pay-for-performance policies in surgery should account for the increased risk for infection and cost of caring for this population,” the authors concluded. Dr. Wick and colleagues focused their study on colectomy, which is known to have a higher risk for SSI than any other abdominal procedures. Using administrative data from eight Blue Cross/Blue Shield plans, they studied outcomes for 7,020 colectomy patients who underwent surgery between 2002 and 2009. Investigators compared 30-day SSI rates for 1,243 obese and 5,777 nonobese patients. Obesity was defined as body mass index (BMI) equal to or greater than 30 kg/m2 and/or an International Classification of Diseases-9 diagnosis of obesity. The analysis revealed a strong association between obesity and SSI. Nearly 15% of obese patients developed an infection, compared with 9.5% of nonobese patients (P<0.001). On multivariate analysis, obesity was a strong predictor for SSI (odds ratio [OR], 1.59; 95% confidence interval [CI], 1.32-1.91), after adjusting for laparoscopy, diagnosis, sex and age. Open colectomy was also associated with a similarly high risk for SSI (OR, 1.57; 95% CI, 1.25-1.97). Obesity, as well as the presence of an SSI, drove up the costs of colectomy. Colectomies that were carried out in obese patients cost a mean of $16,642, $295 more than in nonobese patients. When an SSI occurred, costs more than doubled, resulting in a mean final cost of $31,993. Patients with an SSI had longer hospital lengths of stay at 9.5 days compared with 8.2 days for patients without infections. They also had markedly higher readmissions at 27.8%, nearly five times higher than

the rest of the cohort (P<0.0001). When investigators compared length of stay by patient body weight, they found that obese patients spent 8.5 days in the hospital, 0.3 days longer than the others. SSIs increasingly are being used as measures for hospital and surgeon quality. Beginning in 2012, hospital SSI rates must be publicly reported on the Hospital Compare Web site (www.hospitalcompare.hhs. gov). Many pay-for-performance programs have proposed integrating SSI into their reimbursement formulas by reducing or withholding reimbursements when an SSI occurs. Medicare currently lists SSI following coronary artery bypass graft surgery and bariatric procedures as “Hospital-Acquired Conditions” that could “reasonably have been prevented.” Medicare had proposed stopping payment for the additional costs related to SSI but this change has not moved forward because of the challenge of monitoring SSI rates, Dr. Wick said.

‘If hospitals are to be judged on complication rates without risk assessment, then surgeons and hospitals may deny selected patients care, in the interest of number chasing.’ —Anjali S. Kumar, MD

Investigators said they are concerned that pay-forperformance formulas do not take patient factors into account. Instead, formulas rely on a one-size-fits-allpatients strategy. Doctors and hospitals risk financial penalties when they treat patients who are obese or have other risk factors for infections, Dr. Wick said. And because some populations, such as black women or poor people, are more likely to be obese, they could face discrimination if hospitals and health care providers turn away higher-risk patients. “Pay-for-performance can paradoxically exacerbate health care disparities by discouraging physicians and hospitals from treating higher-risk populations such

‘Pay-for-performance can paradoxically exacerbate health care disparities by discouraging physicians and hospitals from treating higher-risk populations such as obese patients.’ —Elizabeth C. Wick, MD as obese patients,” wrote Dr. Wick and colleagues in their Archives report. “I think this is a very important study,” said Walter R. Peters Jr., MD, colorectal surgeon at Columbia Surgical Associates in Missouri. Most surgeons believe non–risk-adjusted outcomes are misleading, a belief confirmed by this report, he said. If SSI rates are assumed to be surrogates for quality, “no surgeon would wish to perform a colectomy on an obese patient, or for that matter a patient with any number of other risk factors, because those patients would inflate the rate of SSI and make the surgeon appear to be substandard. “This is the sort of data surgeons must have to support our positions as we advocate in the changing landscape of health care reform,” he added. Anjali S. Kumar, MD, assistant professor of surgery at Georgetown University School of Medicine, in Washington, D.C., said pay-for-performance models need to be risk-adjusted to ensure fair reimbursement of physicians and equitable treatment of patients. “If hospitals are to be judged on complication rates without risk assessment, then surgeons and hospitals may deny selected patients care, in the interest of number chasing,” Dr. Kumar said. Dr. Kumar recently presented a similar study at Digestive Disease Week, showing that the validated British model CR-POSSUM (Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity) can be used to predict perioperative complications. Patients with high POSSUM scores and BMIs greater than 35 kg/m2 had significantly higher complications within seven days of surgery than other patients, according to data from a cohort of 113 patients who underwent colorectal surgery at Washington Hospital Center. Hinging reimbursement on quality outcomes without accounting for physiologic and operative risks could drive surgeons to “cherry-pick the best patients they can, and that’s antithetical to what we’re taught to do as surgeons,” she said. At present, the Centers for Medicare & Medicaid Services (CMS) has not announced any plan to incorporate SSI into reimbursement formulas for colectomy. CMS requires only that hospitals publicly report the data beginning in 2012. —Christina Frangou

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 9

PR N

Snap Judgments Called Accurate in Residency Interviews

veryone makes a first impression—and it’s a pretty good predictor of how well a candidate will do overall in his or her application for a residency in anesthesia, according to new research results. Researchers at the University of Kentucky, in Lexington, got the idea for the study after some read the book “Blink” by Malcolm Gladwell, in which he suggested that it only takes a few seconds to discern key information about a person, explained study author Regina Fragneto, MD, faculty member in the Department of Anesthesiology & Pain Management.

‘There’s never been anything that’s been shown to be a very good predictor of someone’s overall success in residency.’ —Regina Fragneto, MD When Dr. Fragneto and her fellow faculty interviewers applied the socalled Blink test—noting their overall impression of a candidate within 30 seconds of meeting them—they found these snap judgments correlated fairly well with each candidate’s final rank list position, the candidate’s overall faculty score, his or her success in the second part of the United States Medical Licensing Exam (USMLE) and overall quality of the submitted application. Interviewing residency candidates is a tough process, Dr. Fragneto noted. The applicants often are nervous, as are faculty members, who have to decide if they want to spend four years with someone based, in part, on a 15- to 20-minute interview. “There’s never been anything that’s been shown to be a very good predictor of someone’s overall success in residency,” she said. Having an extra metric might make the process slightly easier, Dr. Fragneto said, noting that she and her colleagues have continued to use the Blink test. To generate their findings (poster S-171), she and her colleagues noted a Blink score of 1 to 5 (with 5 being excellent) for 430 applicants over a three-year period. The same four faculty members (two men and two women) participated each year. Interestingly, women had higher mean Blink scores than men (3.8 vs. 3.5; P<0.0001), although it’s not clear why, Dr. Fragneto said. “That was something we probably didn’t expect, and were

surprised by. I don’t really have a good explanation for that at this time.” So why do some people make a better first impression than others? “I think a lot of it is a person’s interpersonal communications, how they come across,” Dr. Fragneto said. “Do they look you in the eye when they come in? Do they have a firm handshake? Things like that.”

The Blink score also appeared to correlate with applicants’ responses to specific questions designed to measure their professionalism (r=0.59177; P<0.0001) and interpersonal and communication skills (r=0.54557; P<0.0001). Dr. Fragneto and her colleagues are now planning to study whether, most importantly, Blink scores correlate with

a candidate’s performance as a resident, and whether there are any additional links with sex, extroversion and other factors. “There’s lots of different factors that we are maybe not so aware of in how we assess residents,” she said. Dr. Fragneto presented the findings at the 2011 annual meeting of the International Anesthesia Research Society . —Alison McCook

Hitting the spotlight in October . . .

Innovian Anesthesia 4.0 ®

Taking anesthesia information management to the next level For more than a quarter of a century, clinicians have trusted Dräger for complete, accurate, automated charting of patient vitals and anesthesia data. Today, Innovian® Anesthesia has proven success with more than 130 hospitals and 3,000 users worldwide. Stop by our booth at ASA in Chicago to check out how our newly released Innovian Anesthesia 4.0 makes it even easier to capture all the information you need at the point of care. VISIT WWW.DRAEGER.COM TO LEARN ABOUT ALL OF OUR ANESTHESIA SOLUTIONS

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

PRN

Putting a Face on Hospital Errors Denver—Behind every medical error is a human story—one often filled with turmoil, not only for the patient but for the patient’s family, physician and pharmacist as well. James M. Padilla, JD, knows the troubling tale all too well. In his presentation at the 2011 American Society of Health-System Pharmacists summer meeting, Mr. Padilla, president of Consumers Advancing Patient Safety, a Chicago-based nonprofit organization, recalled how his 6-year-old son, Christian, succumbed to a herniated brain a day after surgery to repair a blockage of his aorta. When the surgeon later asked him what the hospital could do for his family, Mr. Padilla responded with a suggestion of something they could do for everyone else: “Make sure nothing like this happens again.” An estimated 98,000 Americans die as a result of a medical or medication error each year, with as many as onefourth of all patients admitted to the hospital being harmed during their stay (N Engl J Med 2010;363:2124-2134). About three-fourths of the audience in the overflowing conference room reported having been impacted by an error in their practice; most had even personally disclosed to a patient or a patient’s family that they had made the mistake. All had come to the session to put a face on these errors and learn ways in which they might help prevent them. Robert J. Weber, PharmD, senior director of pharmaceutical services at The Ohio State University, in Columbus, has experienced the issue from the perspectives of both a provider and a patient. During treatment for colon cancer he encountered nine errors, from an improper chemotherapy pump setting to an omission in his antiemetic order. When a wound infection developed into deep vein thrombosis— after his providers had placed his leg in the wrong position—he recalled telling his physician that the 9% to 10% risk for that adverse event did not pertain to him. Rather, it was 100%. “When I went to the hospital, I thought that since I was an employee and at one of the best hospitals, things would be OK. I didn’t question anything,” he told the meeting attendees. “I learned quite a bit from that experience; it changed me as a provider.” Today, he is much more diligent about listening closely to his patients, never dismissing what they say and never assuming anything, including

that they know how to take their medications. He now realizes that everything said and done impacts a patient. Still, no matter how careful Dr. Weber or any other health care professional may be, errors will occur. In fact, with increased expertise, actions can become automatic and open the door wider for mistakes. Shortly after the Institute of Medicine’s seminal 2000 report, “To Err is Human: Building a Safer Health System,” the U.S. Congress declared a mandate for a 50% reduction in errors over the next five years. Ten years later, medical experts agree that little progress has been made toward that goal includes even the best and most comoverall (sidebar). petent pharmacists, doctors and nurses, and design a system that will be resilWhy Is Progress Lacking? ient to those mistakes. We can make During the same session, Rollin J. the step from safe to ultra-safe, simi(Terry) Fairbanks, MD, MS, associ- lar to what aviation did over the past ate professor of emergency medicine 40 years, by learning our mistakes and at Georgetown University and direc- engineering out the consequences,” he tor of the National Center for Human added. Factors Engineering in Healthcare at Such a system, he said, should comMedStar Health, in Washington, D.C., municate and provide appropriate discussed why the rate remains stag- feedback, while considering the cogninant. He highlighted an excessive focus tive flow, limitations, needs, skills and on individual performance with too lit- environment of each worker. tle attention paid to system design. He gave an example of a nurse doing “We learned before kindergarten that triage, where she would click on a butpeople make mistakes,” Dr. Fairbanks ton in a health information system that said. “Let’s accept the fact that this said “no allergies” if a patient indeed

lacked any allergies. However, if she didn’t click on any button, the program would trigger a potentially confusing message for physicians: “No documented allergies.” A simple revision to the wording might prevent the potential for misunderstandings and errors. Identifying error-prone areas, Dr. Fairbanks suggested, might best be accomplished by keeping an eye out for near misses, which outnumber adverse events by about 600 to one. Of course, the necessary first step is to identify the hazards, which requires that people are comfortable talking about hazards. A culture of “name, blame and train” may not be conducive. “Too much focus on identifying the culprit of errors could lead to

Technology Gap Partly To Blame for Persistence of Errors

here are several reasons U.S. hospitals have yet to reach the goal of a 50% reduction in medical errors, according to the authors of a study in The New England Journal of Medicine (2010;363:2124-2134). One key explanation, they noted, is a stubbornly slow rate of adoption of key medication safety technologies. Only 1.5% of hospitals have a comprehensive system of electronic medical records in place, 9.1% have basic electronic record keeping and 17% have computerized prescriber order entry (Figure), the authors noted, citing earlier studies. Jamie Kelly, president of Entropy Research and a consultant on bar-coding technology (see article, page 40), said that one important statistic is missing from that analysis: the rate of adoption for bedside bar coding. According to Ms. Kelly, approximately 35% of U.S. hospitals have implemented bedside barcode medication administration systems—a figure based on a 2010 practice

Comprehensive system of electronic medical records, 1.5% adoption

Basic electronic record keeping, 9.1% adoption

survey by the American Society of Health-System Pharmacists (Am J Health Syst Pharm 2011;68:669-688). But a newer survey by the American Hospital Association found that the adoption figure for bar coding was 54% for all respondents and 66% for the association’s Most Wired hospitals. “That’s very encouraging, but we still have a long way to go,” Ms. Kelly said.

Computerized prescriber order entry, 17% adoption

Figure. Implementation rates for key patient safety technologies.

—L.P.

Bedside bar coding, 35% adoption

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 11

PR N

‘We learned before kindergarten that people make mistakes. Let’s accept the fact that this includes even the best and most competent pharmacists, doctors and nurses, and design a system that will be resilient to those mistakes.’ —Rollin J. (Terry) Fairbanks, MD, MS Each table in the conference room held a paper bag containing two medication boxes: Healon (10 mg/mL) and Hyalgan (20 mg/2 mL). Both boxes were blue and white with a similar design and dosage. But the “tricky boxes,” produced in two different countries by two different companies, were intended for two very different types of administration: ophthalmic versus orthopedic. Ms. Burkhardt’s suggested anecdote for the ambiguity: Add a drawing or photo of representative human anatomy to the label, or at least change the color schemes. When Errors Occur, Reactions Vary But what are health care providers to do when errors, such as administration of the wrong medication, do occur? Physicians and other providers will naturally react one of several ways, Mr. Padilla said. Some stay quiet, others seek counsel, report or disclose to the patient with an apology. The last response often is the most difficult. “If you want the apology to be

perceived as sincere, it needs to come from an individual who might have been responsible,” he said. Michael Cohen, RPh, ScD, president of the Institute for Safe Medication Practices, who moderated the session, added that some pharmacies simply offer a discount coupon or refund for erroneous prescriptions, which he suggested falls short of what a patient or family member needs as they react with their own set of emotions, including anger, frustration and grief.

“They want sincerity,” he said. “They want to hear that you are serious about addressing the issues and taking steps to make sure it doesn’t happen again.” Alternatively, they may want to do something constructive themselves, such as partner with providers to help prevent further errors, Mr. Padilla noted. One thing is certain, he stressed: “It should no longer be ‘us and them,’ but ‘we.’” —Lynne Peeples

Contact

the editor of Anesthesiology News

ama rcu s

an environment of fear that causes more harm than good,” Dr. Fairbanks explained, noting that such fear of discipline can lead to silence over near misses. Instead, he suggested a protected hazard reporting system, like one in which a person does not have to report their name or the patient’s name with the error or near miss. One large arena of mix-ups involves medication packaging. Mary Burkhardt, RPh, medication safety consultant in Belleville, Mich., illustrated this to the crowd through a hands-on example.

onmed.com mah c m @

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

PRN

Race Examined as Factor in Recruitment for Clinical Trials

armen R. Green, MD, believes in the “sci- Table 1. Response to Registry Invitation ence of inclusion.” That’s why researchers Whites Blacks in Ann Arbor are exploring the reasons why Number of people eligible for study 357 313 blacks are less likely to participate in clinical research. 44.3 33.5 “In order to meet the medical needs of an increas- Agreed to participate, % ingly diverse society, we need to be able to assess its Actively refused, % 24.1 14.1 needs and differences,” said Dr. Green, professor of Passively refused, % 31.7 52.4 anesthesiology and obstetrics and gynecology at the University of Michigan. “In general, clinical study populations do not include a representative sample, one that is truly generalizable and that mirrors the population of society as a whole. We need to explore this more and look at how we recruit for studies, and how we get potential participants the information they need to understand the purpose of medical research and how it changes lives.” ‘For people of Dr. Green’s research in this area includes color, there is a history a study published in the May 1 issue of the journal Cancer that assessed chronic canof distrust and of not cer-related pain and its impact on patient quality of life in diverse populations being treated equally in (2011;117:1994-2003). Even more recently, terms of access to care she and her team presented a poster at the 2011 annual meeting of the American Pain and quality of care.’ Society in May, that examined outcomes for —Carmen R. Green, MD passive and active recruitment approaches for black participants in a survey study of cancer survivors. Using Michigan’s cancer registry, the researchers invited 949 (499 black and 450 white) cancer survivors to participate in the survey study. Each subject was sent up to three letters, by mail, using last-known addresses recorded in the registry. Cancer survivors who returned “willing to participate” responses then were notified to the study team and Table 2. Response of Those Who Expressed Interest actively recruited. Black cancer survivors in the state registry were significantly more likely to have died or Whites Blacks moved. In addition, although blacks were less likely Number of interested people 158 105 to officially refuse to participate in the survey study, 86.7 59.0 they also were less likely to agree to participate; that Completed surveys, % is, they were more likely to “passively refuse,” accord- Refused, % 8.9 13.3 ing to Dr. Green. Passively refused, % 5.7 26.7 “For people of color, there is a history of distrust

and of not being treated equally in terms of access to care and quality of care,” she said. “Disparities exist because of historical and current perspectives. This may make us uncomfortable, but we need to explore it more. Our research is focused on an area that is understudied.” Dr. Green and her team plan to expand their research to assess the prevalence of cancer-related chronic pain in the general population and to explore differences in relation to race and sex. Their work will attempt to determine the reasons behind the higher rates of mortality and morbidity among blacks with cancer and cancerrelated chronic pain. “This is a very important study, reinforcing the sad but true fact of under-representation of African-Americans—among other minorities and vulnerable populations—in many types of important research studies, including pain and palliative care research,” said Perry G. Fine, MD, professor of anesthesiology at the Pain Research Center in the University of Utah School of Medicine, in Salt Lake City, who was not involved in the Michigan studies. “The reasons are complex and deeply embedded in what have become problematic cultural norms, within both research establishments and the patient/subject populations themselves,” Dr. Fine added. “Dr. Green continues to be an important researcher in this area of disparities, and her conclusions need to be widely disseminated and seriously considered in order to improve pain care and research.” For now, Dr. Green hopes pain specialists and primary care physicians treating patients with chronic pain consider racial disparities when providing care, particularly when it comes to patient– physician communication. “How do you listen to someone? What are our stereotypes of others? We all have them,” she said. “But how do we get by them? How do you build trust in these relationships? Ultimately, that is the key question we need to answer.” —Brian P. Dunleavy

FDA Looks for Comments on Proposed Guidelines for High-Quality Clinical Studies

he FDA has issued draft guidance to help researchers and manufacturers design better-quality clinical studies in support of premarket approval (PMA) applications for medical devices. Manufacturers submit PMA applications for high-risk (class III) medical devices. These applications undergo the most stringent type of FDA device review. PMA submissions include data from pivotal clinical studies that the FDA uses, along with other information, when determining approval. The proposed guidance outlines

agency expectations for clinical trial design issues such as minimizing data bias and variability, setting appropriate study objectives, selecting the appropriate type of study and choosing study sites and study participants. It is one of 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations announced earlier this year to enhance predictability and transparency of regulatory pathways and to strengthen the 510(k) process. “We want to help manufacturers and

researchers take the least burdensome approach to getting safe and effective products to market,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “This guidance will help manufacturers and researchers better understand the FDA’s basic expectations for clinical trials. We encourage researchers to contact the FDA to discuss the most practical approach to studying their device.” The evidence needed to support a PMA application varies depending on

the medical device. But according to the FDA, the new draft guidance can help manufacturers and researchers design a pivotal study that is a practical investment of time, effort and resources and has a high likelihood of demonstrating safety and effectiveness. Although this guidance is developed primarily for clinical studies used to support PMAs, the recommendations of this guidance also may be used in designing clinical studies used to support 510(k) submissions. —Based on a press release from the FDA

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

PRN Catch continued from page 1 concerns becomes part of protecting every person in that system and not blaming any individual. “It’s rare that it’s a particular person who is a problem; it’s usually the system that’s the problem,” Dr. Hamrick said. Since the hospital implemented the Good Catch Award program, the number of electronic reports submitted to the Patient Safety Network has increased by “a lot,” according to Dr. Hamrick, who has not yet formally tracked the difference. Most of the incidents were what the researchers called “near misses,” in which patients were not harmed. About 5% to 10% of the incidents reported were considered to have caused harm to patients. “Most of the incidents were unsafe conditions that [could] have caused harm, but didn’t reach the patient,” Dr. Hamrick told Anesthesiology News. These incidents often are not reported because the risk is less obvious, but it still exists, he said. “These are the incidents we wanted to capture, before a patient was actually harmed.” Dr. Hamrick and his colleagues presented details of the program at the

2011 annual meeting of the Interna- Table. Summary of Good Catch Awards tional Anesthesia Research Society PSN (S-120), including examples of errors Good Catch Awards, Harm 2008-2010 Scorea System Changes Implemented that were caught and rectified as a result of the new program. For instance, 1. Insulin B2 Pharmacy order sheet modification one clinician reported a situation in 2. Heliox C On-site OR Heliox which a patient almost received an 3. Liposuction B2 New staff in-service incorrect medication. B2 Modified surgical informed consent An assumption that the prescriber 4. Modified surgical stapler may have been at fault was proved E Daily equipment check false when a closer look revealed that 5. Jet ventilation the vial did not have a proper warning 6. Latex B1 Latex-free environment label from the manufacturer, causing an 7. Carbon dioxide A Manufacturer representatives on site antibiotic to resemble a paralytic drug. laser This investigation led to a recall of the 8. Hysteroscopy A Specialty nursing and physician in-service paralytic by the FDA. Limited pharmacy distribution It is one thing to let clinicians know 9. Methemoglobinemia E B1 Removal of heparin, 10,000 units/mL, from institution that the Good Catch program is not 10. Heparin about assigning blame for mistakes, 11. 180 Table turn E Safety check initiated by surgeon Dr. Hamrick said. Getting them to 12. Vecuronium E FDA recall of improperly labeled medication believe it is another matter. B2 Individual consent for surgical service To convince people that the objec- 13. Informed consent D MedSun and FDA report with equipment change tive is to identify problems in the sys- 14. Belmont infuser tem—not individuals—the team spent 15. King LT-D (King C MIEMSS updates; MedSun recommendations with Systems) manufacturer input time explaining to nurses, residents and doctors why errors are almost always 16. Double-lumen tube D Updated policy change: invasive pulmonology incorporated into difficult airway response team systems problems (e.g., the positioning of equipment during a procedure). 17. Transaxillary robotic A Patient position modified; neuromonitoring recomOne report caused the safety comthyroidectomy mended with modified surgical informed consent mittee to realize that a machine used 18. Vecuronium II A FDA notified of noncompliant labels

www.CMEZone.com Your premier source for practical, relevant and timely continuing medical and pharmacy education

Here are educational activities available now on CMEZone Fluid Responsiveness Monitoring In Surgical and Critically Ill Patients Clinical Impact of Goal-Directed Therapy expires September 30, 2011

SR1047

Credit Also Available for CRNAs

Brain Monitoring of Anesthetic Effect: An Evidence-Based Assessment of Clinical Impact and Safe Use Credit Also Available for CRNAs

expires April 1, 2012

SR1058

easy access to educational activities in your specialty area

Live CME/CE: “real-time” streaming live-event programs

Convenience: immediate grading, duplicate certificate printing, etc

Additional color-coding for look-alike drugs

20. Mallinckrodt ETT labels

Recommended consistent labels; MedSun recommendation to manufacturer (pending)

21. Malfunctioning bed

MedSun report submitted

22. EJ infiltrate

Risk management review of peripheral vs. central vascular access

23. Trauma surgery 911

Trauma surgery consulted for OR catastrophes

24. Cell saver for massive transfusion hyperkalemia

Perfusionists wash RBCs for massive transfusion, hyperkalemia

25. Shattered bristojets

Appropriate use of emergency drugs

26. IV tubing backflow device

Backcheck valve tubing standard

27. Jackson table access

Risk management device subcommittee formed

ACGME, Accreditation Council for Graduate Medical Education; EJ, external jugular; ETT, endotracheal tube; Heliox, helium and oxygen; ICU, intensive care unit; LT-D, laryngeal tube-disposable; MedSun, Medical Product Safety Network; MIEMSS, Maryland Institute for Emergency Medical Services Systems; OR, operating room; PSN, Patient Safety Net; RBCs, red blood cells a

A, unsafe conditions; B1, event did not reach the individual because of chance alone (“near miss”); B2, event did not reach the individual because of active recovery efforts by caregivers (“near miss”); C, event reached the individual but did not cause harm (an error of omission such as a missed medication dose); D, event reached the individual and required additional monitoring or treatment to prevent harm; E, individual experienced temporary harm and required treatment or intervention; F, individual experienced temporary harm and required initial or prolonged hospitalization; G, individual experienced permanent harm; H, individual experienced harm and required intervention necessary to sustain life (eg, transfer to ICU)

b a, patient care; b, medical knowledge; c, practice-based learning and improvement; d, interpersonal and communication skills; e, professionalism; f, systems-based practice

Adapted and modified from Herzer K, Mark L, Michelson J, Saletnik L, Lundquist C. Designing and implementing a comprehensive quality and patient safety management model: a paradigm for perioperative improvement. J Patient Safety. 2008;4(2):84-92; and University HealthSystem PSN harm scores, http://www.uhc.edu.

SPECIAL FEATURES Specialty Pages:

19. Bristojet Look-Alikes

Coming Soon: continually updated snapshots of upcoming educational activities

Individual History: maintains records of your courses, credit-hour status, license renewal dates, and more

Comprehensive Search Engine: specialty, health topic, disease state, drug category, keyword, and more

in the operating room (OR) contained troublesome buttons, so that pressing one button would trigger the one beside it, causing the machine to be set incorrectly. This led to a voluntary report to the FDA, and permission obtained to have the machine modified to prevent the problem from recurring.

An incident that involved insulin administered in the OR revealed to investigators that those who prepared insulin in the OR sidestepped the safety checks that take place when insulin is made up by the pharmacy. This introduction of a greater risk for errors triggered formation of a new policy

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 15

PR N

ACGME Core Competency Addressedb

Sustained?

b, f

Yes

a, b, c, d, f

Yes

a, b, c, d, f

Yes

a, c, f

Yes

a, b, d, f

Yes

a, b, d, f

a, d, e, f

Yes

a, b, d, e, f

Yes

a, b, d, e, f

Yes

b, c, d, f

Yes

a, c, f

a, d, e, f

Yes (see #18)

d, e

Yes

a, c, d, f

a, b, c, d, e, f

Yes

a, b, c, d, e, f

Yes

a, b, c, d, f

Yes

a, d, e, f

(see #12)

a, c, d, f

Yes

a, c, d, f

a, c, f

Yes

a, b, c, d, f

a, b, c, d, e, f

Yes

a, b, c, d, e, f

Yes

a, b, c, f

Yes

a, c, d, f

Yes

a, b, c, d, e, f

Yes

‘It’s rare that it’s a particular person who is

part of the perioperative safety team of the Weinberg OR suite at the Johns Hopkins Hospital. The new system is a definite improvement over systems that exist at other hospitals—which often isn’t much, according to Robert Stoelting, MD, president of the Anesthesia Patient Safety Foundation. He said in some ways the Good Catch program resembles systems in place at airlines

and nuclear power plants, where everyone on the team is considered responsible for reporting any safety issues. “The ‘good catch’ concept I certainly support,” Dr. Stoelting said. “It’s a good step to supporting a safety environment in a health care facility.” The next step, Dr. Stoelting said, would be to install a national database into which every hospital must report all errors and so-called near misses,

so that everyone can learn from each other. “I don’t see the Good Catch program really solving the problem of knowing the number of adverse events on a national level,” Dr. Stoelting told Anesthesiology News. Currently, he said, voluntary registries for particular types of incidents, such as postoperative blindness, do not capture everything out there and therefore miss many opportunities for improvement. —Alison McCook

NEW !

Fights hypothermia. Looks cute doing it.

a problem; it’s usually the system that’s the problem.’ —Justin Hamrick, MD that stated that only the pharmacy could make up orders of insulin. When clinicians win a Good Catch award, they receive public recognition with explanations of their “good catches” on wall boards within the surgical suite, Dr. Hamrick said. The system, not yet implemented hospital-wide, remains

Introducing the 3M™ Bair Pawss™ pediatric warming gown. Now you can offer your little patients the comfort and clinical warming that adults enjoy with the revolutionary Bair Paws warming system.To learn more, contact your local 3M Patient Warming representative, call 1-800-733-7775 or visit bairpaws.com.

3M is a trademark of 3M Company, used under license in Canada. BAIR PAWS and the BAIR PAWS logo are trademarks of Arizant Healthcare Inc., used under license in Canada. ©2011 Arizant Healthcare Inc. All rights reserved. 603473A 8/11

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

C LI N I C A L A N ES THE S IO LOGY

Multimodal Analgesia With TAP Block Aids Post-op Recovery Small retrospective study of robotic radical prostatectomy cases Las Vegas—A multimodal analgesic regimen that included a transversus abdominis plane (TAP) block reduced postoperative morphine consumption and hospital length of stay following robotic radical prostatectomy, in a pilot study by British researchers. The team said the next step is to determine

whether TAP blocks can enhance the recovery process in this surgical population. “In April 2010, we began performing robotic radical prostatectomies,” said Khalid Syeed, MBBS, consultant anesthetist at University College Hospital in London. “Our goal was for patients

to spend one night in our postanesthesia care unit and then be discharged home, and we instituted a number of initiatives to facilitate this process.” A six-month audit revealed that despite these efforts, patients were spending, on average, four days in the hospital before discharge, causing the

D I A G N O S T I C U LT R A S O U N D S Y S T E M

quality | ﬂexibility | speed

With high speed response, exceptional image quality and a sealed surface for easy cleaning/infection control, the M7 is a top choice premium class imaging tool for anesthesia professionals. Visit us at Booth 1827 at the ASA 2011 Chicago Mindray North America, 800 MacArthur Blvd., Mahwah, NJ 07430 1.800.288.2121 www.na.mindray.com

clinicians to revisit their care plan. The result was the introduction of a number of morphine-sparing techniques, including TAP blocks. “We chose TAP blocks because we were thinking we could use other regional techniques, such as spinal or caudal analgesia because the surgical site is quite low down,” Dr. Syeed said. “However, these would have implications with patient mobility afterward. Once we realized that the pain associated with this type of surgery was more surface in nature and had a minor visceral component, we decided to go with the TAP block.” The results were presented at the 2011 annual spring meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract 20). The researchers collected data from the first 41 consecutive patients after the new program was introduced. Of these, 22 patients received routine postoperative analgesia composed of IV acetaminophen, diclofenac and morphine; the remaining 19 patients received a multimodal analgesic protocol that included IV acetaminophen, diclofenac, tramadol and a postoperative TAP block. The ultrasound-guided block, 20 mL of 0.375% bupivacaine, was placed bilaterally between the

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 17

CL I N I CA L A N E STHE SIOL OGY costal margin and iliac crest in the region of the anterior axillary line. It was found that patients who received the multimodal/TAP regimen required, on average, significantly less IV morphine than their counterparts receiving the standard analgesic regimen in the first 24 hours after surgery (9.9 vs. 36.3 mg; P=0.006). However, patients who received TAP blocks required significantly more tramadol than controls (142.3 vs. 17.6 mg; P<0.001).

of Acute Perioperative Interventional Pain and Regional Anesthesia at the University of Pittsburgh Medical Center (UPMC). “At UPMC Shadyside Hospital, most patients are discharged within 24 hours after an open radical prostatectomy,” he told Anesthesiology News, “but we use the paravertebral block.” Dr. Chelly said it would be interesting to compare the TAP and paravertebral blocks to learn if there are differences between the two

techniques. “The TAP block is certainly quicker and easier to do than the paravertebral block. It is also safe, as long as it is performed using an ultrasound-guided technique,” he said. John F. Butterworth IV, MD, Robert K. Stoelting Professor of anesthesia at Indiana University School of Medicine, in Indianapolis, offered yet another option. “We, too, have a one-day length of stay and we just give [patients] morphine or Vicodin [acetaminophenhydrocodone; Abbott Laboratories].

“But I think this is one of those procedures where the surgical time and the gentleness of the surgeon may play a big role,” Dr. Butterworth said. “So, a TAP block may work very well in one setting and not very well in another. A paravertebral may be really appropriate in one place and not so much in another. There seems to be remarkable variations among surgeons and their facility with this procedure.” —Michael Vlessides

‘I think this is one of those procedures where the ™

surgical time and the gentleness of the surgeon

A N E S T H E S I A S YS T E M

may play a big role.’ —John F. Butterworth IV, MD TAP block patients had much shorter lengths of stay in the hospital than patients in the standard analgesia group (two vs. 3.4 days; P=0.002). Mean pain scores at rest were comparable between the two groups. There were no complications related to the use of TAP blocks. Yet, there are other regional techniques indicated for prostatectomy, according to Jacques E. Chelly, MD, PhD, MBA, director of the Division

it’s your world

The A5 blends performance and simplicity to meet the challenges of your complex world. The A5’s touch screen interface eliminates time normally spent manipulating settings so your attention is focused on patient care. With advanced ventilation modes, benchmark ergonomic design and interface, you will be impressed with all that the A5 can do. Visit us at Booth 1827 at the ASA 2011 Chicago Mindray North America, 800 MacArthur Blvd., Mahwah, NJ 07430 1.800.288.2121 www.na.mindray.com

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

C LI N I C A L A N ES THE S IO LOGY

Worse Post-op Mitral Regurgitation Might Not Heighten Long-term Risk Study examined patients undergoing aortic valve replacement

atients with mitral regurgitation (MR) that worsens immediately after aortic valve replacement (AVR) appear to fare no worse than others in the years following surgery, according to new research presented at

the 2011 annual meeting of the Society of Cardiovascular Anesthesiologists (abstract 7). These findings, however, do not necessarily indicate that following this type of surgery, worsening MR poses no risk to patients, according to

study author Madhav Swaminathan, MD, associate professor of anesthesiology, Duke University School of Medicine, in Durham, N.C. Often, surgeons performing AVR also will notice the patient is

experiencing MR, Dr. Swaminathan said. Research has shown that patients with MR tend to fare worse than others in the years following coronary artery bypass surgery. This has led to a debate among surgeons regarding whether to treat MR at the time of AVR surgery. In other words, which poses the biggest risk to patients: the uncorrected MR or the additional surgical time to repair it? To investigate this problem, Dr. Swaminathan’s team noted which of more than 800 patients undergoing AVR had worsening MR after the procedure. All patients were then followed up to six years to document major cardiac problems. The researchers found that the 74 patients who experienced worsening MR immediately after surgery were no more likely to re-experience heart failure, require mitral reoperation or die. “We did not see any difference in cardiac events,” Dr. Swaminathan told Anesthesiology News.

Capnography. Monitoring every breath your patients take. As an anesthesiologist, you know capnography has long been the standard for monitoring adequacy of ventilation in the operating room, and for good reason: Capnography provides the earliest, most accurate indication of respiratory distress. Neither respiratory rate nor pulse oximetry – alone or combined – can tell you if your patient is ventilating properly. Today, Oridion Microstream® Capnography gives you that same confidence in monitoring your non-intubated patients. When we set out to develop the safest, most effective non-intubated monitoring, we turned to the experts.We asked anesthesiologists what hadn’t worked in earlier generations and what you need to protect your patients.The result? Microstream®, non-intubated capnography that works. • Effective sampling, both oral and nasal, through the patented Uni-junction feature and its specialized patient interfaces • Simplified etCO2 monitoring through the Smart Capnography™ family of superior algorithms: Integrated Pulmonary Index™ (IPI), SARA™ alarm management, and Smart Breath Detection™. • Clear, crisp waveforms and accurate respiratory rates through our patented Molecular Correlation Spectroscopy™ (MCS™), one technology for all patients in all clinical settings. When your patients are counting on you, you can count on Oridion Microstream Capnography. Simple. Fast. Accurate. Learn why capnography is the new standard for monitoring spontaneously breathing patients at www.oridion.com.

160 Gould Street, Suite 205, Needham MA 02494, USA • Toll Free: (888) ORIDION (674-3466) • Tel: (781) 453-0500 • Fax: (781) 453-2722 Hamarpe 7, Jerusalem 97774 Israel • Tel: +972 2 589-9111 • Fax: +972 2 586-6680 © 2010 Oridion Medical 1987 Ltd. All rights reserved.

However, these findings do not rule out surgical correction of MR during valve replacement, Dr. Swaminathan said. Because a relatively small number of patients had a deterioration in MR after their surgery, it was difficult to draw firm conclusions. The team measured MR using transesophageal echocardiography, immediately after bypass before the patient’s chest was closed—reasoning that this would be the moment for

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 19

CL I N I CA L A N E STHE SIOL OGY

surgeons to decide whether to repair the MR. But this may not be the optimal time to evaluate MR accurately, Dr. Swaminathan said. Shifting hemodynamic conditions during surgery, the result of blood pressure changes, introduced fluids and other factors, could temporarily affect MR. “So, the jury is still out over whether it is better to intervene and fix mitral regurgitation during AVR, or not do anything. We don’t have an answer to that yet,” he said. He said it is unlikely

leading to congestive heart failure and increased morbidity. Some cases may be caused by the valve problems themselves; when the left ventricle cannot eject blood properly because of an aortic valve problem, pressure might build and cause the mitral valve to leak. Thus, correcting the aortic valve might in turn correct MR, he said. “However, it’s not by any means certain that this in fact does happen.”

Still, the findings appear reassuring, said Paul Barash, MD, professor of anesthesiology, Yale School of Medicine, in New Haven, Conn., and a member of the Anesthesiology News editorial board. He noted that only 9% of patients with MR experienced a worsening immediately after valve replacement, and that this subset fared no worse in subsequent years provided some comfort. “You can feel pretty

assured as a clinician, all things being equal, that the patient’s chance for full recovery is excellent,” Dr. Barash said. Physicians have long wondered whether it is worth the risk to extend surgery to correct MR, and these findings move the field closer to an answer. “No one has an answer for what to do,” Dr. Barash said. “So, in a way, this study is reassuring.” —Alison McCook

The researchers found that the 74 patients who experienced worsening MR immediately after surgery were no more likely to re-experience heart failure, require mitral reoperation or die.

NAROPIN® delivers a faster return of motor function than bupivacaine.1,2 A Block Well Done. that patients who experience worsening MR after surgery have the same outcomes as others. “Whenever we study MR, if it gets worse, patients do worse,” Dr. Swaminathan said. “So, why would it be different here?” It is reasonable to expect that MR might change after valve replacement if both problems are related, according to Dr. Swaminathan. MR that is uncorrected causes blood to continually leak through the mitral valve, eventually

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?

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

C LI N I C A L A N ES THE S IO LOGY

More Biomarker Data Add to Insights On Postanesthesia Cognition

eneral anesthesia and surgery in some cases may hasten cognitive decline—or even the onset of Alzheimer’s disease. These findings from a study in 11 patients were presented at the 2011 annual meeting of the International Anesthesia Research Society (abstract S-242),

and showed that levels of key molecular markers of neuronal injury increased in the days after patients underwent endoscopic procedures. “We don’t know if this change has clinical relevance or not,” said study coauthor Roderic Eckenhoff, MD, professor of anesthesia at the University of

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

Pennsylvania, in Philadelphia. “But, at this point it’s an intriguing finding.” Doctors have long known that a significant number of older adults experience cognitive changes in the weeks and months after undergoing general anesthesia and surgery. Immediately after procedures, up to 20% of

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

people aged 65 years and older experience cognitive changes that last weeks, months or even longer, according to Dr. Eckenhoff. “This is a very, very common complaint from patients,” he said. “We don’t know what causes it. We know it happens.” It also is not clear whether patients ever fully recover from that decline. Dr. Eckenhoff said the possibility that something about the surgical experience decreases cognition transiently, but also interacts with other brain pathways to cause problems that only emerge later. Results of in vitro and animal studies suggest that the combination of anesthesia and surgery can adversely affect the pathologic pathways underlying Alzheimer’s and other similar disease processes. Dr. Eckenhoff said that patients already vulnerable to neurodegeneration might be most at risk. To better understand what happens in the human brain after general anesthesia and surgery, the investigators collected samples of cerebrospinal fluid (CSF) from eight women and three men (aged 53±6 years) undergoing surgery to correct idiopathic CSF leaks, for which lumbar catheters were placed. CSF samples were obtained before and immediately after surgery, and at six, 24 and 48 hours or until the catheter was removed. Approximately half of the patients received total IV anesthesia (TIVA); the remainder received inhaled anesthetics.

‘The way I characterize it, there’s a smoking gun but no victim yet.’ —Roderic Eckenhoff, MD

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 21

CL I N I CA L A N E STHE SIOL OGY The investigators noted a significant increase in S100b and total tau—both markers of neuronal injury—after six hours. By 24 hours, tau had increased more than 200%. The proinflammatory biomarker interleukin-6 appeared to increase more in the inhalation group than in the TIVA group. “That would suggest that elements of our management—how we do general anesthesia—could in fact affect the progression of inflammatory cascades in the brain,” Dr. Eckenhoff told Anesthesiology News. He cautioned that none of the data generated so far call for a change in practice. But there is enough evidence pointing to a problem to warrant more investigation. “The way I characterize it, there’s a smoking gun but no victim yet,” he said. Dr. Eckenhoff said that although the data are compelling enough that he administers more regional anesthesia in his older patients whenever possible, he would “hesitate to tell other practitioners to change their practice. The data are still pretty weak at this point.” In the meantime, his group is investigating ways in which anesthesia does not cause cognitive decline. The cognitive impact of anesthesia is a controversial research topic that has generated varied findings, according to Zhongcong Xie, MD, PhD, associate professor of anesthesia at Harvard Medical School and attending anesthesiologist at Massachusetts General Hospital, in Boston. “For a long time, people were thinking anesthesia is pretty safe,” he told Anesthesiology News. A patient who emerged from surgery with fully functioning heart and

lungs would be assessed by many doctors as having no problems. But, he said, more and more doctors are beginning to accept that “maybe this is something we should be looking at—the brain.” Dr. Xie, who was not involved with the current study, described it as a “good start.” What researchers really need, he said, are more human studies that measure the clinical impact of anesthetics. “If you want to have a final answer you should do a functional study, follow patients for 10 or more

years and see if they develop Alzheimer’s disease. But, adequately powered prospective human studies would take many years to conduct and analyze.” Looking at biomarkers is a good first step, Dr. Xie said. These biomarkers are present in high concentrations in CSF, but in order to sample a large, diverse group of patients, researchers have to find ways to measure their blood levels. Relevant animal studies also must be conducted that will complement human studies by establishing

a mechanistic hypothesis and help formulate a strategy of prevention and treatment, he said. Researchers should continue to investigate these patterns, including whether particular drugs or patient characteristics pose more of a risk, Dr. Xie said. “There are many patients with early stages of Alzheimer’s having surgery every year; we need to study if these drugs promote their disease.” —Alison McCook

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!

Each installment contains articles from the current month’s issue ahead of print, as well as links to podcasts and other Web-exclusive content

anesthesianews

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

P OLI C Y & M A NAGE MENT

Expert: Palliative Needs of Long-Stay ICU Patients Demand More Attention

mid the hustle of the intensive care unit, assembling an interdisciplinary team meeting to clarify the treatment goals of patients and their families and ensure these are being met can be daunting. Rebecca Aslakson, MD, an intensivist and palliative care anesthesiologist at The Johns Hopkins Hospital, in Baltimore, said doing so is not only possible, it’s a requisite for good care. “To be sure, assembling the various stakeholders and care providers is definitely time-intensive,” said Dr. Aslakson, assistant professor of anesthesiology and critical care medicine. “But it is part of our responsibility to consult with patients and their families, since they are the experts on what their priorities are. We need to work as best we can to provide care according to reasonable priorities and goals, recognizing a patient’s prognosis and balancing his or her goals with what is realistic.” Indeed, understanding a patient’s treatment goals can help determine the most effective course of care and save precious resources, Dr. Aslakson added. “We once had a surgical ICU [SICU] patient stay six months before we sat down and proactively communicated with the family about palliative care,” she said. By the end of his ICU stay the patient had incurred $3 million in hospital bills, she said. “In talking about palliative care, we found out the patient had made it clear to his family that his greatest fear was to waste away in pain in a hospital or nursing home,” she said. “Evidently, this patient’s suffering and the enormous financial costs associated with his care were tragically unnecessary.” Advertisement

Newproduct

Arrow® ErgoPack™ The ErgoPack™ System is Arrow’s® secondgeneration vascular access maximal barrier bundle, incorporating the latest in infection protection and sharps safety technology. ErgoPack design is based on human factors research, creating a systematic, ergonomic approach to central line insertion. ErgoPack provides procedural efficiency and defense against the sources of bloodstream infection to help attain and sustain the goal of zero CLABSIs. For more information, visit arrowergopack.com/an. See our ad on page 24.

Palliative Care Goals and Principles

• Prevent and relieve suffering regardless of the stage of the disease or the need for other therapies. • Enhance quality of life for patients and families, optimizing function, helping with decision making and providing opportunities for personal growth. • Manage pain and other distressing symptoms. • Incorporate psychosocial and spiritual care with consideration of patient/family needs, preferences, values, beliefs and culture. • Ensure treatment is comprehensive and patientcentered with a focus on the central role of the family unit in decision making. • Guide and assist the patient and family in making decisions that enable them to work toward their goals. • Incorporate the expertise of various providers to assess and treat the complex needs of seriously ill patients and their families. • Leadership, collaboration, coordination and communication are key elements for effective integration of these disciplines and services. Adapted from the National Consensus Project for Quality Palliative Care. Clinical practice guidelines for quality palliative care. 2nd ed. Pittsburgh, Pa: National Consensus Project for Quality Palliative Care; 2009:80.

So-called “family meetings” at the Johns Hopkins SICU follow a palliative care model, Dr. Aslakson explained. Their purpose is to understand what patients envisioned their care would look like (sidebar). Although palliative care is commonly perceived as being specifically for terminally ill patients, Dr. Aslakson emphasized this is not the case. “A palliative approach is about providing true holistic care for those enduring the greatest amount of pain and suffering,” said Dr. Aslakson, whose group presented the findings at the 2011 annual meeting of the Society of Critical Care Medicine (abstract 741). “This includes aggressive symptom management, clarification of mutual care goals and focused attention on the psychosocial needs of patients and their families.” Anesthesiologists can play a role in this care by asking patients and their family members about the patients’ values and determining the possibility of meeting those values given the treatment options, Dr. Aslakson said. However beneficial and cost-effective these meetings can be, they are difficult to coordinate in an open or semi-open ICU setting. Nursing, surgery, anesthesiology, medicine and social work staff must agree both with each other and the patient’s family on time and place to meet. Selecting patients most likely to benefit from these meetings is equally challenging, Dr. Aslakson said. As a starting point, she and her colleagues chose those whose SICU stay exceeded one week, on the assumption that their SICU stays would continue well beyond this time and that they would be a high-mortality segment of the SICU population. Between May and November 2009, the researchers

assessed the feasibility of convening these meetings with 25 patients and families who met the seven-day threshold. They successfully held meetings with 15 (60%) of the 25 patients, with early death or patient transfer the most common reasons for not doing so. As the investigators suspected, the 25 patients remained in the hospital for extended periods—a mean of 53 days, 41 days of which, on average, were spent in the SICU. Moreover, 44% of the patients died in the SICU. The cost of care for the patients amounted to a mean of $165,648. Although the study did not look at the effects interdisciplinary meetings had on the course of treatment, Dr. Aslakson insisted that simply demonstrating the feasibility of holding them was a useful finding in itself. Daniel Brown, MD, PhD, associate professor of anesthesiology and director of multidisciplinary critical care practice at Mayo Medical School in Rochester, Minn., praised the Johns Hopkins team for sharing its structured approach for gathering critical care providers, patients and their families. “We tend to focus on hard data and numbers. Good communication, which is an important part of critical care, consequently does not receive the attention it deserves,” Dr. Brown said. “This aspect of care becomes all the more necessary in longer-stay patients, because expectations and prognoses change and exchanging a unified and complete set of information with patients and their families is essential. The investigators here have put forth an approach that reduces the risk for treatment concerns slipping through the cracks.” —David Wild

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 23

The following advertorial is provided as a service to our valued advertisers. It is designed to support the advertisement presented below.

Maquet

The FLOW‑i From Maquet Q. What makes FLOW‑i different from other anesthesia machines? A. FLOW‑i features a modular, ergonomic design that seamlessly combines high-performance ventilation capabilities, evolved from the Maquet Servo ventilator platform, with precise electronic anesthetic delivery. Q. What capabilities does the Servo ventilation platform bring to the FLOW‑i? A. For more than 40 years, Maquet has been setting global mechanical ventilation standards with the successful Servo ventilation platform. FLOW‑i incorporates this unrivaled technology with capabilities including delivery of high tidal volumes and high maximum inspiratory flow when needed, as well as low-to-minimal fresh gas flow. FLOW‑i maintains constant gas flow despite increasing airway pressure, provides high flow rates, allows quick and easy triggering and keeps positive end-expiratory pressure constant and accurate. Fast ventilatory rise time adapts to the physiologic needs of the patient. FLOW‑i’s low system volume, of less than 3 L, facilitates immediate response time and fast wash-in and washout of anesthetic agent.

data monitoring system of the customer’s choice. This supports hospital-wide standardization of monitors as well as cost savings. In addition, FLOW‑i can be customized with a wide variety of patient monitors and additional monitoring equipment. Q. What features make FLOW‑i ergonomic and user friendly? A. Clinician ease of use and comfort are engineered into every FLOW‑i with its height adjustability, movable arms and integrated table light. The intuitive design of the electronic user

interface includes a 15-in color touch screen for individual configuration of parameters and settings, and minimal menus to simplify navigation between screens. Critical information can be saved and downloaded to a patient data system using a USB port or third-party data management system. The three FLOW‑i models (height adjustable, extra storage and ceiling pendant) have a modular platform that can be configured to accommodate the requirements and budgets of various health care facilities.

Q. What prevents FLOW‑i from being outdated? A. The FLOW‑i system is software-upgradeable through a USB port and is designed to support future mechanical, electronic and software advancements, avoiding premature system obsolescence. This modular, open architecture platform will support increasing clinical demands and budgetary considerations well into the future. Complete after-sales training and support are available, as are an extended warranty and a variety of field service contracts.

Q. Can FLOW‑i be used effectively in all patient categories? A. Health care facilities are challenged with a rapidly changing patient demographic and a growing number of complex procedures. FLOW‑i provides effective support regardless of these challenges. With advanced ventilation capabilities, the FLOW‑i anesthesia delivery system allows for optimal ventilation in a wide range of patients. These include obese patients with high abdominal and thoracic pressures, older patients suffering from multiple medical conditions, critically ill patients and the tiny neonate. Q. Where are the bellows? A. The innovative design of FLOW‑i incorporates an exclusive rebreathing technology, the Volume Reflector®, that consists of a rigid reservoir to minimize internal system volume for high ventilation performance. The Volume Reflector replaces both the traditional bag-in-bottle (bellows) and the piston, allowing the partial readministration of rebreathed gas to the patient via the circle system. Because the Volume Reflector is never empty, it guarantees continuous, uninterrupted ventilation. There are no moving parts and, in case of leakage via the breathing circuit during automatic ventilation, the oxygen-driven Volume Reflector automatically compensates the circle system with oxygen, minimizing the risk for delivering a hypoxic gas mixture. Q. How are the FLOW‑i vaporizers different? A. The anesthetic agent injection vaporizers in the FLOW‑i system are fully electronic, lightweight, have a 300 mL capacity and can be filled while in place during operation. The electronic injector technology eliminates the need for preheating desflurane, saving valuable time and contributing to fast wash-in and wash-out of agent. Q. Does the FLOW‑i include a patient monitor? A. Open architecture design accommodates the addition of a hemodynamic monitor and patient

A leader in high-performance ventilation technology has something new on the anesthesia horizon.

MAQUET, Inc. 45 Barbour Pond Drive Wayne, NJ 07470 www.maquetusa.com

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

P OLI C Y & M A NAGE MENT

Kentucky Program Reduces Abuse, But at the Cost of Legitimate Prescribing?

early 100% of respondents to a survey of health care professionals in Kentucky who prescribe controlled substances believe the state’s prescription drug monitoring program is reducing abuse, diversion and doctor shopping. However, 35% of respondents to

the survey regarding the Kentucky All Schedule Prescription Electronic Reporting (KASPER) program also said they are prescribing fewer controlled substances, but the survey was not extensive enough to determine whether or not this was from a chilling effect of the law. A companion survey

of 78 Medicaid users indicated those with chronic pain were significantly more likely than others to have been prevented by KASPER from getting a prescription. “If the prescribing is decreased because of concerns about increased scrutiny through KASPER, that is a

‘If the prescribing is decreased because of concerns about increased scrutiny through KASPER, that is a concern. If the

STOP CLABSI

prescribing is decreased because an implemented KASPER allows these prescribers to deny prescriptions to patients who are “doctor shopping,” this is a good thing that should be encouraged.’

—Robert Twillman, PhD

INTRODUCING THE ARROW® ERGOPACK™ SYSTEM Teleflex’s Arrow ErgoPack System, combined with ARROWg+ard Blue Plus® or Chlorag+ard™ antimicrobial technology, provides defense against all five sources of central line-associated bloodstream infection (CLABSI). Proven infection protection tools for central line insertion, intuitively organized to increase procedural efficiency, help you attain and sustain your Goal of Zero CLABSIs. Watch an ErgoPack demonstration video, read our white paper, and learn more about the infection protection power of the Arrow ErgoPack System at arrowergopack.com/an

arrowergopack.com/an 800-523-8446

ARROW ErgoPack

Scan the QR code or visit the website to watch a video of the ErgoPack System in use or request a white paper.

concern, one that needs to be addressed by more education,” said Robert Twillman, PhD, director of policy and advocacy for the American Academy of Pain Management, and chair of the Kansas Board of Pharmacy’s Prescription Monitoring Program Advisory Committee. “If, on the other hand, the prescribing is decreased because an implemented KASPER allows these prescribers to deny prescriptions to patients who are ‘doctor shopping,’ this is a good thing that should be encouraged.” Trish Rippetoe Freeman, RPh, PhD, who led the survey of KASPER users, and who participated in the survey of Medicaid patients, agreed that in retrospect her team could have asked additional follow-up questions about why clinicians reduced their prescribing. “A minority of folks are saying their prescribing of controlled substances had decreased, and we have to find out whether that’s an

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 25

PO L I CY & M A N A GE ME N T believe it reduces doctor shopping. Half said they had not made any change in their controlled-substance prescribing behavior in the past year as a result of KASPER. Thirty-five percent had decreased their prescribing and 13% had increased it. Those who decreased their prescribing of controlled substances said they did so mainly because of appropriate or inappropriate decrease,” said Dr. Rippetoe Freeman, clinical associate professor of pharmacy practice and science at the University of Kentucky College of Pharmacy, in Lexington. “In interviews we did with stakeholders as another part of the evaluation of KASPER, they said there’s a redistribution of controlledsubstance prescribing from small family docs to pain management specialists, with family docs referring more patients with chronic pain to specialists. But we don’t know if that’s what’s actually going on.” KASPER, which was implemented in 1999, allows prescribers, pharmacists and law enforcement officials to request detailed histories of the controlled substances prescribed and dispensed to individuals. An e-version of KASPER was launched in 2005. Dr. Rippetoe Freeman and colleagues from the Institute for Pharmaceutical Outcomes and Policy at the University of Kentucky led an independent review of KASPER in 2009 funded by the Kentucky Cabinet for Health and Family Services. It included a review of the current status of all prescription drug monitoring programs in the United States, interviews with key KASPER stakeholders, a survey of KASPER users, an analysis of KASPER usage and a broad-based assessment of KASPER’s impact on abuse and diversion. A full report on all but the first component of the review is available at http://chfs.ky.g ov/NR/rdonlyres/ 2 4493B2E - B1A1 - 4399- 8 9 AD- 1 625953BAD43 / 0 / K ASPER EvaluationFinalReport10152010.pdf. A total of 557 health care professionals responded to the 15-item KASPER survey. Of those, 89% were physicians (48% were family physicians and 19% were internists). Among the respondents, 89% said KASPER reports were useful and helped guide their treatment decisions. What’s more, 96% of respondents believe KASPER is effective for reducing abuse and diversion, and 95%

the existence of KASPER. Other reasons they cited for reducing their prescribing included media coverage of KASPER and increased law enforcement activity. The survey results were presented in poster form at the 2011 annual meeting of the International Society for Pharmacoeconomics and Outcomes Research (poster PHP17). —Rosemary Frei, MSc

The first and only IV formulation of acetaminophen available in the US

Improved pain relief, reduced opioid consumption

Significant pain relief*1 • OFIRMEV 1 g + patient-controlled analgesia (PCA) morphine demonstrated significant pain relief vs placebo + PCA morphine (P<0.05 over 6 h)1 • OFIRMEV 1 g + PCA morphine showed greater reduction in pain intensity over 24 h (SPID24)† compared to placebo + PCA morphine (P<0.001)2

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

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

OFIRMEV should be administered only as a 15-minute intravenous infusion. Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy. The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. The antipyretic effects of OFIRMEV may mask fever in patients treated for post-surgical pain. Please see Brief Summary of Prescribing Information on adjacent page or full Prescribing Information at OFIRMEV.com.

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

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

OFIRMEV and the OFIRMEV dot design are trademarks of Cadence Pharmaceuticals, Inc.

OFV10670711

OFIRMEV.com

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

P OLI C Y & M A NAGE MENT hip

continued from page 1

time to surgery through two strategies: the hiring of an on-call support team, and the hiring of a support team and an on-call operating room (OR) team. The on-call support team consisted of a hospitalist and a diagnostic technician. The OR team included a registered nurse, a surgical technologist and an anesthesiologist. An economic decision-tree model was used to analyze a variety of factors,

including average personnel costs obtained from economic reports, mortality and health state utilities obtained from systematic reviews, patient volume and percentage of patients undergoing surgery within 48 hours. The analysis found both strategies to be cost-effective. “The results show that systems-based solutions to minimize operative delay, such as a dedicated on-call support team, can be cost-effective,” said Christopher J. Dy, MD, MSPH, orthopedic

surgery resident at the Hospital for Special Surgery, in New York City, and the study’s lead author. “In addition, an evaluation-focused intervention can be potentially cost saving in a high-volume surgical center,” he said. The study is applicable to all surgeries where timeliness is a factor in outcomes, said David A. Lubarsky, MD, MBA, professor and chairman of the Department of Anesthesiology, Perioperative Medicine and Pain Management, at the University of Miami

Miller School of Medicine, who also was an author of the study. “We have crude measures and need more granular prospective studies on the most urgent cases amenable to surgery,” Dr. Lubarsky told Anesthesiology News. He added that “it is darned inconvenient to work all night, and both hospital administrators and our surgical colleagues should appreciate the effort we make on so many types of cases to be there when we are needed.” Evaluating QALYs In the study, cost-effectiveness was evaluated based on quality-adjusted life-years (QALY), a commonly used measure of health that includes both the quality and length of a person’s life. The single on-call support team strategy, which sought to expedite patient evaluation, resulted in an incremental cost-effectiveness ratio of $2,318

‘The motivation of the physicians and nurses for prompt surgery is in the patient’s (and society’s) best interests, not the hospital’s or anesthesia group’s economic best interests.’ —Franklin Dexter, MD, PhD

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 27

PO L I CY & M A N A GE ME N T per QALY—far below the $50,000 per QALY threshold for interventions to be considered cost-effective (Risk Anal 1995;15:369-390). The support team also resulted in cost savings if at least 93% of patients underwent expedited surgery. The second strategy, of adding the on-call OR team to the support team, resulted in an incremental cost-effectiveness ratio of $43,153 per QALY. It stayed cost-effective if the odds ratio for one-year mortality was greater than 1.28, if more than 88% of patients underwent early surgery or if more than 340 patients with hip fractures were treated annually. Surgeons and clinicians may distrust decision and cost-effectiveness analyses if they view them as a means to reduce costs, impinge on physician autonomy or compromise on individualized patient care, noted Mininder S. Kocher, MD, MPH, director of the Clinical Effectiveness Research Unit at Children’s Hospital Boston. In an accompanying commentary and perspective article, he explained that the goal of cost-effectiveness is to optimize patient care. By allocating resources by cost efficiency, “the care of a population of patients and the care of an individual patient can be optimized,” Dr. Kocher wrote. Others Disagree “A cost-effective intervention is rarely cost saving, and that was shown strongly for the intervention of adding an on-call OR team to reduce waiting

time,” said Franklin Dexter, MD, PhD, director of the Division of Operations Research in the Department of Anesthesia at the University of Iowa Carver College of Medicine, in Iowa City, and a specialist in operations analytics and optimization. “The paper shows that hospitals and anesthesia groups have an economic disincentive to naturally choose the cost-effective option of adding OR capacity for add-on cases,” said Dr. Dexter, who was not involved in the study. “The motivation of the

physicians and nurses for prompt surgery is in the patient’s (and society’s) best interests, not the hospital’s or anesthesia group’s economic best interests,” he told Anesthesiology News. Alex Macario, MD, MBA, professor of anesthesiology, Stanford University School of Medicine, Stanford, Calif., and a specialist in OR management and quality measurement, said that “the study reminds us that proximal femoral fractures are a serious health injury. Health care and medicine,” he

said, “need to develop better methods for prevention and treatment for hip fractures as current approaches can be improved.” But, Dr. Macario also felt uncertain about the positive cost-effectiveness of the on-call surgical team. The cost “was high enough to make one pause,” he said. Dr. Macario, a member of the editorial board of Anesthesiology News, was not involved in the study. —Ted Agres

Experience first hand how we’ll protect your good name. Since 1987, Preferred Physicians Medical (PPM) has exclusively insured anesthesiologists and their practices. Our policyholders also own PPM, so it’s no surprise that protecting our physician owners’ professional reputation is at the core of everything we do. There is no substitute for experience. With over 23 years of experience exclusively defending anesthesiologists, PPM draws upon that extensive knowledge to arm our physician owners with practical, anesthesia-specific strategies to effectively identify and manage risk, including: On-site, anesthesia-specific risk management seminars Exclusive online access to timely and useful risk management resources A subscription to Anesthesia & the Law, our industryrespected risk management newsletter

FREE, No-Obligation Evaluation of Your Informed Consent Process Our experience has shown plaintiff attorneys often focus on a practice’s informed consent process to undermine a jury’s conﬁdence in the quality of anesthesia care delivered. Every new PPM policyholder receives this evaluation as part of our extensive audit of current practice protocols. Call us today at 800.562.5589 to arrange your free, no-obligation evaluation. Take ownership of your own reputation and advantage of this free review. Call PPM today.

In-house Claims Attorneys and Claims Specialists skilled in developing defense strategies to effectively resolve claims

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

9000 W est 67t h St r eet

Shaw nee M ission, K S 6620 2 -3 6 5 6

8 0 0 -5 6 2 -5 5 8 9

p p m rrg . c o m

’

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

P OLI C Y & M A NAGE MENT

Will Multipronged Strategy Sway Residents to Critical Care?

Newproduct

Innovian® Anesthesia 4.0 Dräger’s newest version of Innovian® Anesthesia— available October 2011. Innovian® Anesthesia is our next-generation AIMS. Innovian has proven success with more than 130 hospitals and 3,000 users worldwide. It’s designed to address the core challenges of the perianesthesia process while simultaneously increasing throughput, accuracy and completeness to help you sustain a competitive advantage. (800) 437-2437 www.draeger.com info.usa@draeger.com See our ad on page 9.

Emergency Medicine, 1%

Medicine, 24%

Neurolog y, 4% An est hes ia, 7%

esearchers are scrambling to understand why so few residents, including those in anesthesiology, are choosing careers as intensivists. Investigators at Harvard Medical School, in Boston, and Johns Hopkins Hospital, in Baltimore, have found that many residents have misgivings about the lifestyle and earning potential of intensivists. Residents also may not be receiving enough exposure to critical care work as medical students, according to the study. Mark Nunnally, MD, a spokesman for the American Society of Anesthesiologists who was not involved in the research, said the findings suggest that part of the onus on improving recruitment rates is on intensivist staff and attendings to develop closer relationships with residents. “I have always believed in the power of mentorship,” said Dr. Nunnally, associate professor of anesthesia and critical care at the University of Chicago Pritzker School of Medicine. “If you get a resident to think, ‘I want to be like that doctor; how can I learn more?’, you have made a big start in the process of recruitment.” He said that mentoring also can provide a good opportunity to educate trainees about the realities of critical care practice and explain the added value that it brings to the individual physician and a group practice. Answers from 340 anesthesiology residents to a 56-item online survey provided insights into residents’ perceptions of critical care anesthesia. The survey was conducted between March and May 2010 by Jeremy Huff, DO, chief resident at Johns Hopkins Medical School, and several colleagues and presented at the 2011 annual meeting of the Society of Critical Care Medicine (SCCM; abstract 40).

Surgical, 21%

Neonatal, 22% Pediatric, 21%

Figure. Elective rotations in critical care by subspecialty.

Residents were asked to rate on a five-point Likert-type scale various characteristics associated with a subspecialty in critical care. Respondents also identified their fellowship specialty of choice and described their experiences in critical care. The data revealed 33.8% of anesthesiology residents were interested or extremely interested in critical care as their first choice for fellowship training. Broadly, they perceived the practice of critical care as involving more time, and as more intense and stressful than that of anesthesiology practiced outside the intensive care unit (ICU). Many also believed that working in critical care would provide greater opportunities for continuity of care, multidisciplinary interactions and evidence-based practice than other subspecialties (Table). Based on the data, approximately 54% of the anesthesiology residents surveyed believed the average salary of a critical care anesthesiologist was lower than the actual average salary of $268,250, reported by the American Medical Group Association’s 2009 compensation and financial survey (http://jobs.cejkasearch.com/PhysicianCompensation). The researchers also found that about 43% of respondents presumed the compensation of a general anesthesiologist was higher than the actual reported average of $366,690. “Evidently, there is both a perceived and an actual disparity between critical care and general anesthesia salaries, which may discourage residents from a critical care career,” Dr. Huff said. The perception of a high level of stress and heavy workload, along with skewed compensation expectations, might be pushing anesthesiology residents away from a career in the ICU, but as Dr. Nunnally stressed, the questionnaire findings confirmed there may not be enough of a pull from critical care staff toward the profession. “We found only slightly more than 40% of anesthesiology residents reported being approached by an ICU attending regarding a potential career in critical care medicine,” Dr. Huff said. “We can definitely

Table. Residents’ Perceptions of a Critical Care Subspecialty

Lifestyle and Career Traits

Average Likert-Scale Ratinga

Continuity of care

4.1

Multidisciplinary care exposure

4.0

Difficulty of call schedule

3.9

Quantity of patients on service

3.8

Complexity of patients

3.8

Intensity of work

3.7

Level of stress

3.7

Quantity of work hours

3.6

Evidence-based practice

3.5

Research opportunities

3.5

Medical opinions valued

3.4

Significant influence on patient outcomes

3.3

Academic practice job availability

3.2

a Residents’ perceptions of critical care medicine lifestyle and career traits compared with other anesthesiology subspecialties. A score of 1 indicates a belief that critical care has much less of a given trait; a score of 5 indicates it has much more of the trait.

improve our mentorship and recruitment efforts.” In addition to more aggressive recruiting practices and a campaign aimed at dispelling myths regarding critical care work, another approach to fostering interest in critical care anesthesia would be to mandate an ICU rotation as a requirement for medical school graduation, according to Oveys Mansuri, MD, in a separate presentation at the SCCM meeting (abstract 495). Dr. Mansuri, a clinical fellow in surgery at Harvard Medical School and Brigham and Women’s Hospital, in Boston, and a colleague, Joanna Kuppy, MD, a pediatric critical care fellow at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, in New York City, mapped the distribution of required ICU rotations among 133 medical schools in the Association of American Medical Colleges (AAMC). Drs. Mansuri and Kuppy found that in 21% of the schools, a critical care rotation was a requirement for graduation. Of the elective critical care rotations, 7% focused on anesthesiology and 440 of the 455 critical care rotations were offered to fourth-year students (Figure). “By this point in a student’s trajectory,” Dr. Mansuri said, “many will have set their sights on a particular residency focus and begun submitting applications.” Ultimately, Dr. Mansuri’s group hopes to use the cumulative data to lobby the AAMC to make a critical care rotation mandatory for medical school graduation. “ICU care represents a large portion of the costs of American health care,” Dr. Mansuri told Anesthesiology News. “At the very least, students need to gain an appreciation of the inner workings of this discipline.” —David Wild

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 31

Pa in M e d ic in e

New IOM Report Lays Out Plan for Improving Pain Care

eclaring that the diagnosis and treatment of pain in America are woefully inadequate, the Institute of Medicine (IOM) is urging a multifaceted approach to transforming virtually all aspects of pain management. Recommendations include increasing federal and private funding for research into new pain medications and therapies, offering additional training and education for primary care physicians and clinicians and reforming payment policies so physicians can be reimbursed for spending additional time with patients and for interdisciplinary collaborations with therapists and other specialists. Overall, the IOM report estimates that acute and chronic pain affect at least 116 million adults in the United States annually and are responsible for $560

billion to $635 billion in direct medical costs and lost productivity each year. That estimate that does not include costs associated with people who are institutionalized, in the military or younger than 18 years. “Given the large number of people who experience pain and the enormous cost in terms of both dollars and the suffering experienced by individuals and their families, it is clear that pain is a major public health problem in America,” said Philip Pizzo, MD, dean of medicine and professor of pediatrics, microbiology and immunology at Stanford University School of Medicine, in Stanford, Calif., and chair of the IOM Committee on Advancing Pain Research, Care, and Education. “Pain is an experience that affects virtually every one of our citizens. For many patients,

chronic pain becomes a disease itself,” Dr. Pizzo said at a briefing on the report in June. According to the report, chronic pain requires direct treatment and should not be ignored “while clinicians attempt to identify some underlying condition that may have caused it.” The biomedical research community should pursue pain research with the same vigor it extends to other serious and disabling chronic conditions, the document urged. ‘Cultural Transformation’ The report calls for a “cultural transformation” in how clinicians and the public view pain and pain treatment. All too often, patients with pain are treated with suspicion and skepticism, which hinders effective treatment and care. Many physicians also are hesitant to prescribe pain medications, especially opioids, to patients because of concerns about abuse see IOM page 35

Student Documentary Spotlights Worldwide Morphine Shortage and its Impact on Patients in Pain

s proper pain care a basic human right? This question was posed by a group of aspiring journalists and filmmakers in “Freedom From Pain,” a 30-minute documentary created by students at the University of British Columbia (UBC) in Vancouver, Canada. Originally developed for the Al Jazeera English program “People & Power” and aired in July 2011, the student documentary chronicles the morphine shortage in countries across the developing world, specifically focusing on India and Ukraine. Despite the fact that morphine costs “pennies to produce,” as one of the experts quoted in the film noted, more than half of the countries in the world have little or no access to the drug, because of either strict importation laws or draconian prescribing regulations for controlled substances. “Freedom From Pain” was written and produced by students enrolled in UBC’s International Reporting Program (IRP), under the leadership of journalism professor Peter Klein, acting director of the IRP and a former producer for CBS News’ “60 Minutes.” The documentary can be viewed online at the IRP Web site: www.internationalreporting. org/pain. According to Mr. Klein, the genesis of the project was a conversation he had with Darin Portnoy, MD, assistant professor in the

Department of Family and Special Medicine at Albert Einstein College of Medicine, in New York City, who volunteers with Médecins Sans Frontières (Doctors Without Borders), an international organization offering medical humanitarian aid to countries in need. “I asked [Dr. Portnoy] for an important under-covered global health story,

half expecting him to rattle off the usual issues—HIV, malaria, tuberculosis, maybe black fever or Chagas [disease],” Mr. Klein recalled. “But he said ‘pain.’ He explained how he has seen so many people suffering needlessly, and that the solution was so simple. Here was a drug that’s cheap to produce, and there’s no patent issue. So why isn’t it

‘I had never before thought of freedom from pain as a basic human right. … I’ve come to realize it should be, and this is truly a hidden human rights crisis.’ —Peter Klein

getting to the people who need it?” Mr. Klein said the team of UBC students traveled to India, Ukraine and Uganda to investigate how countries around the world deal with suffering patients. The documentary profiles a former KGB agent in Ukraine who is dying of terminal prostate cancer and sleeps with a gun under his pillow, in case the pain becomes unbearable. The students also visited the United Nations to question diplomats about the drug laws that obstruct access to legitimate medically used opiates. The executive director of the UN Office of Drug Crimes admits on-camera that a side effect of his work is that patients around the world suffer needlessly. “Like many—perhaps most—laypeople, my students and I initially had a sense that morphine was highly addictive and dangerous,” Mr. Klein said. “Once we learned the science of how the drug is titrated, we realized that it could be used long-term, very safely. I had never before thought of freedom from pain as a basic human right. I have a home, I’m safe from torture, I can speak my mind and I know others in the world lack these rights. But medical pain was not on that list for me, nor is it for the vast majority of people in the world. I’ve come to realize it should be, and this is truly a hidden human rights crisis.” —Brian P. Dunleavy

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

P A I N M EDI C I NE Hernia continued from page 1 ultimately decide to have their inguinal hernias repaired primarily because of pain. “Consequently, all pain that occurs after hernia repair is presumed to be caused by something that the surgeon has done to the patient during the operation.” However, not all surgeons are convinced of Dr. Wright’s results. A recent meta-analysis was not in favor of prophylactic nerve removal, said Parviz Amid, MD, clinical professor of surgery and director of the Lichtenstein Hernia Institute at the University of California, Los Angeles. Based on the current body of studies, Dr. Amid noted that routine neurectomy, without a preoperative diagnosis of neuropathic pain, was “counterproductive” because the removal of a functioning nerve during a primary operation is “not without consequences,” which includes groin numbness and, for women, potential sexual dysfunction. “I have never removed a nerve during the original hernia repair unless the nerve was in the way of the operation and at risk for injury,” Dr. Amid said.

the

Figure 1. Neuroma identified intraoperatively. In Dr. Wright's study, 11% of the potentially affected nerves were characterized as having neuritis and, in the vast majority of cases, were accurately diagnosed intraoperatively.

Figure 2. Dr. Wright said that the location of the neuritis found in his samples corresponded with typical inguinal hernia anatomy and may represent a source of non-iatrogenic pain similar to Morton’s neuroma in the foot, where nerves are also subject to pressure.

Dr. Wright’s retrospective study included 100 consecutive cases of primary inguinal hernia repair. He performed all surgeries using the Lichtenstein technique, but modified the traditional approach and removed the ilioinguinal nerve and occasionally the iliohypogastric and genitofemoral

nerves. He bases his technique on the results of a small number of studies showing that prophylactic ilioinguinal neurectomy significantly decreases the incidence of chronic groin pain after Lichtenstein repair without increasing postoperative complications or morbidities (Ann Surg 2006;244:27-33). In the 100 cases performed on 90 patients, Dr. Wright removed 84 nerves—73 ilioinguinal, nine genitofemoral and two iliohypogastric. Dr. Wright defined neuritis as a degenerative lesion characterized by fragmentation with accompanying fibrosis. In terms of gross appearance, Dr. Wright characterized neuritis as a “fusiform, firm expansion of the nerve for up to a centimeter,” which in severe cases felt more like vasa deferentia. If Dr. Wright felt that a resected nerve was damaged, it was sent to a board-certified pathologist for examination. Dr. Wright sent 35 nerves to the pathologist, 34 of which were confirmed by the pathologist as having nerve damage defined as neuritis. Of the 34 cases, 30 involved the ilioinguinal nerve and of these, 83% occurred at the external oblique neuroperforatum, which Dr. Wright defined as the site of nerve penetration of the external oblique fascia, frequently the external inguinal ring. Overall, 11% of the potentially affected nerves were characterized as having neuritis and, in the vast majority of cases, the surgeon was capable of accurately diagnosing neuritis intraoperatively (Figures 1 and 2). The histological findings in his study dovetail with previous reports that show routine neurectomy during inguinal hernia repair reduces pain, Dr. Wright said. “Frequently these nerves do show

perfect balance

education and travel for 35 years

NW AS

Northwest Anesthesia Seminars

International Continuing Education for the Anesthesia Provider 800-222-6927 www.nwas.com

significant damage and therefore it’s entirely justifiable to take it out. If you leave a [damaged] nerve in an area it will scar because of the mesh,” Dr. Wright said. “It makes more sense to take out the damaged nerve while you’re there and while you are seeing it. Additionally, you can charge for taking out the damaged nerve, and for a general surgeon that’s a complete revelation.” However, the study suffers from a significant limitation: Although patients’ anecdotal pain was recorded in their charts, no standardized pain measurement tools were used, making it impossible to correlate preoperative pain with the presence of inguinal neuritis. Dr. Amid also noted that in his experience, the rate of neuritis seen in the study was extremely high, and the nerve damage seen on histology may have been an artifact of dissecting and handling the nerve during tissue processing for histologic examination.

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 33

Pa in M e d ic in e “Processing a nerve for histological study is a very delicate process and based on my conversations and ongoing work with neuropathologists, these changes are more than likely artifacts,” Dr. Amid said. “I have performed more than 15,000 Lichtenstein repairs and in every patient I have carefully identified and observed all the nerves. The fusiform deformity of the nerves that they have seen in 34% of cases is very rare based on my experience. I have seen those in maybe 1% or 2% of the patients I have operated on.”

Dr. Amid also said that these nerve location of neuritis found in his samdeformities are not likely the cause of ples corresponded with typical inguisignificant postoperative pain. “I have nal hernia anatomy and may represent done at least 500 triple neurectomies a source of non-iatrogenic pain simifor chronic pain, and in each of the lar to Morton’s neuroma in the foot, 500 patients I’ve found obvious causes where nerves are also subjected to presfor the pain, such as the nerve being sure. When the hernia incarcerates and entrapped by a suture, a tack, a staple or bowel pushes into the inguinal canal, a mesh. Even in these 500 patients, if I “with that anatomical distortion, the notice that fusiform deformity, I mark nerve gets stretched and there also are that and send it to pathology, and it’s pressure points on the nerve where the interpreted as traumatic neuroma.” nerve is getting pushed,” Dr. Wright However, Dr. Wright said that the said. “The stretch and pressure idea all

‘It makes more sense to take out the damaged nerve while you are there and you are seeing it.’ —Robert Wright, MD

Afford Reli Avail Deploy

make sense when you see that it occurs mostly at bifurcation and trifurcation points and at the neuroperforatum, places where you are going to get extra force occurring on the nerve.” Dr. Wright added, however, that his findings need to be substantiated in a prospective study assessing preoperative pain and its relationship to pathologist-confirmed neuritis. —Gabriel Miller

able RECEIVE A

FREE AIRTRAQ

Guided video intubation. Where & when you need it.

If you’ you’ve been looking for an intubation device that is “able” to deliv deliver — Airtraq is a proven solution. Airtraq’s design and features include, a guide channel to deliver the tube exactly to the locat location you see; disposable to promote placement in all locations where intubations are performed; and attachment to optional wireless monitor and camera.

Visit Air Airtraq.com to request quest your FREE sample today. ay. See why A Airtraq should be part off your airway management tools.

WIRELESS MONITOR & CAMERA (OPTIONAL) FULL RANGE - INFANT TO ADULT PLUS DOUBLE LUMEN AND NASAL PLACEMENT

call

877-6-Airway or visit Airtraq.com

3 4 I A n e s t h e s i o l o g y N e w s . c o m S e p t e m b e r 2 0 1 1

P A I N M EDI C I NE

Journal Controversy Provokes New Look At Research Conflicts of Interest

ugene Carragee, MD, didn’t like the complications he was seeing. Like many others in his field, the director of Stanford University’s Orthopaedic Spine Center had enthusiastically been using Infuse, a bone growth product (recombinant [engineered] human bone morphogenetic protein-2) manufactured by the medical device company Medtronic and approved by the FDA in 2002, to help heal bone during spinal fusion surgery. According to studies published in medical journals including Spine Journal, which Dr. Carragee edits, the product was effective and safe—so safe, in fact, that the studies reported literally no adverse events (AEs). And then he began to realize that something was wrong. “I was seeing complications that I’d never seen before, or only very rarely: big inflammatory reactions,” he said. “I’d have patients referred to me with complications that looked very different than anything I’d seen in 20 years of doing spine surgery.” Dr. Carragee wasn’t the only one. More and more reports of Infuse-related complications began to filter in to Spine Journal and other publications—complications like male sterility, infection, bone loss and unwanted bone growth. In 38 cases, swelling in the neck and throat led to airway compressions and, more than once, emergency tracheotomies. “There was a guy from Croatia who sent something like 35 letters to the editor, saying, ‘These articles don’t agree with the FDA data,’” he said. As the drumbeat of concern grew louder, Dr. Carragee and a blue-ribbon panel of his colleagues—including the heads of spinal surgery at Harvard Medical College, Weill Cornell Medical College and Loyola University of Chicago—decided to conduct and review a systematic analysis of the published evidence, including all of the publicly available data that Medtronic had submitted to the FDA as part of the approval process for Infuse. The result: In late June, Spine Journal published an unprecedented special edition dedicated solely to the question of the Infuse research, including two review articles, two clinical studies and a scathing editorial that repudiated the research the journal itself had published (2011;11:A1-A14, 463-584). “It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research. It harms patients when poor publication practices become business as usual,” Dr. Carragee and his colleagues wrote. ‘A False Sense of Security’ In 13 trials involving 780 patients, researchers funded by Medtronic—who received a median of $12 million to $16 million per study, and in at least one case upward of $20 million—reported not a single AE associated with Infuse. “It would almost be comedic, if it weren’t so serious,” said Christopher Bono, MD, chief of the orthopedic spine service at Boston’s Brigham and Women’s Hospital. “The safety profile they published for this product indicated that it was as safe as, if not safer than, Tylenol.”

But the data that appeared in the journals differed markedly from what had been submitted to the FDA. Looking at those data, the journal’s reviewers found complication rates that were 10 to 50 times greater than the estimated complication rates submitted for publication by the sponsored scientists. In the special edition, the panel took the rare step of not only taking industry and their colleagues to task for what appeared to be egregious conflicts of interest, but also acknowledging their own part in the poor publication practices. “We may have been lulled into a false sense of security,” admitted Dr. Carragee. “If I was reviewing a paper that I knew was an FDA-IDE [Investigational Device Exemption] trial, I would be less skeptical about that data than if it were a non-FDA trial—for the simple reason that I couldn’t imagine who would make up their adverse-event figures in an FDA trial when it’s so well documented that anybody can just go back and look at it. It’s like lying about your military record. Anybody can check it.” But of course, politicians and others have lied about their military records—and been caught. And when Dr. Carragee went back to the FDA data, he said, “I was shocked to see that they did not agree with the published, peer-reviewed data. We quote, side by side, the FDA assessment of male sterility versus the authors’ assessment, and the FDA’s assessment of bone dissolving and subsidence of the implant and then the authors’ assessment. They’re not the same. We bend over backward to say that we are not in the business of ascribing motive or intention in these things, but it is what it is.” (Medtronic did not respond to a request for comment; see the box for a statement that appears on the company’s Web site.)

Medtronic CEO Omar Ishrak Statement on rhBMP-2 Articles In Spine Journal

ollowing is a statement from Omar Ishrak, chairman and chief executive officer of Medtronic, Inc., on a series of articles on recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) published in a recent edition of Spine Journal: “Integrity and patient safety are my highest priorities. While the Spine Journal articles raise questions about researchers’ conclusions in their published peer-reviewed literature, the articles do not raise questions about the data Medtronic submitted to the FDA in the approval process or the information available to physicians today through the instructions for use brochure attached to each product sold. “Based on that data, we strongly believe that the safety profile reported to the FDA and summarized in the product label support the safe use of rhBMP-2 for the identified indications. We remain committed to ongoing study of the safety and efficacy of rhBMP-2, especially in applications not covered by FDA labeling. “For several years, Medtronic has been leading the industry in reforms designed to eliminate or mitigate conflicts of interest. We will continue to investigate questions surrounding researchers’ potential conflicts of interest, refine our policies as warranted, and strive to lead the industry in ethical and transparent business practices.”

shown that the influence of sponsorship and financial factors can often be greater than the purported effect of the product.” So where to go from here? “We need to be much more rigorous in our review of publications,” Dr. Bono said. “For any industry-supported trial, it’s not going to suffice that you have a zero complication rate. You have to say, ‘Give me the raw data.’” These are difficult times for journal editors, acknowledged Dr. Trescot, who guest-edits one herself. “We have so many journals being published now, and there’s less independent support for research,” she noted. “And I’ve sent stuff out to be peer-reviewed, and sometimes it comes back with the statement that it’s fine, with no comments at all. Other times, reviewers go through their articles very meticulously. Reviewing is a thankless task, and you take a huge bite out of your time for no reward. So things definitely slip through the cracks.” Dr. Carragee argued that financial relationships between authors and industry belong up front in an article, as part of the methods section. “It shouldn’t be a footnote at the end, or a link,” he said. “If it’s part of the article, when someone reads the methodology, they’ll see the funding and the financial relationship involved before they read the results. The repercussions of the body of the article being inaccurate are known: If the methods section is flat wrong, then the entire article is highly suspect.”

An Eye Toward Industry Bias Pain medicine might not be as vulnerable to the influence of industry funding on journal articles, but that’s only because fewer new devices and medications are entering the field these days. “Since we don’t have much that we implant other than pumps and stims that have been around forever, it’s less of an issue with us,” said Andrea Trescot, MD, past president of the American Society of Interventional Pain Physicians. “But the Celebrex [Pfizer] data on preemptive analgesia now appears to have been faked. That’s comparable.” In the wake of the Spine Journal special edition, editors from dozens of journals have praised Dr. Carragee and his colleagues for their forthrightness. “We’ve gotten a flurry of emails saying, ‘This is system-wide, and you guys are the first people to stand up and say something about it,’” Dr. Bono said. “The same situation, I’m sure, is reproduced for every drug trial or device trial, for almost everything on the market. Everything is slightly slanted.” More than slightly, Dr. Carragee argued. “The evidence is simply overwhelming that industry support is a potential methodological bias of a study. In both —Gina Shaw drug and device trials, you’re looking at odds ratios Drs. Carragee, Trescot and Bono reported no relevant conflicts of for supported trials in the 2, 3 and 4 range. It’s been interest.

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 35

Pa in M e d ic in e IOM continued from page 31 and diversion as well as fear of attracting the attention of law enforcement authorities. “There’s abuse on both sides,” Dr. Pizzo said. “There is abuse that occurs when individuals are drug seeking and abuse that occurs in that people who need pain medications may not have access because physicians won’t prescribe or the state has regulatory barriers,” he said. Nevertheless, when used as prescribed and appropriately monitored, opioids can be safe and effective, especially for acute, postoperative and procedural pain, according to the report. Recommendations For Research Even though chronic pain affects one in three people in the United States, federal research efforts into pain are fragmented and underfunded. The report called on the National Institutes of Health (NIH) to designate an institute responsible for coordinating and advancing pain research. “There’s a huge disconnect between what we’re spending on pain research— somewhere between $200 [million] and $300 million per year—and what the problem of pain is costing the nation,” said committee member Charles E. Inturrisi, PhD, professor of pharmacology at Weill Cornell Medical College, in New York City, and immediate past-president of the American Pain Society. “We need much more funding at the NIH level, because that’s the major source for new targets and new approaches.” Because the cause and experience of pain is highly personal, the report recommends a “multifactorial” research approach including an analysis of genetics, psychological and environmental factors and social and cultural histories as well as the development of objective metrics for defining response. Promising research areas include identifying biomarkers and biosignatures for pain and pain responses, further characterizing ion channels for pain blocks and targeting glial cells to modify or eliminate pain. Although the FDA approved nearly 100 new drugs from 2005 to 2009, only a handful of these were for chronic pain conditions, specifically arthritis and fibromyalgia. To this end, the report also requests that researchers devote more resources to developing novel pain control agents and that the FDA develop “new and expeditious ways” to evaluate and approve new pain therapies.

“We recommend stronger public– private partnerships to advance pain research and to reduce regulatory barriers to bringing effective pain treatments to market,” said Sean Mackey, MD, PhD, chief of the Pain Management Division, Stanford University School of Medicine, and another committee member. Randomized controlled trials (RCTs) remain the gold standard for determining the safety and efficacy of new drugs, but the report

acknowledges “significant problems” in using RCTs in pain research, namely their limited ability to predict effectiveness in larger populations. In particular, older adults with comorbidities and who take multiple medications often are excluded from RCTs, yet they are among those who experience pain the most. “I think we need new, novel approaches. For example, it’s important that we do population-based effectiveness research,” said Dr. Inturrisi. “That would include

what we call real-world patients with all of their comorbidities so that we can begin to identify patient characteristics and perhaps even biomarkers that predict better outcomes. These will then help us to design better drugs and better therapeutics.” Recommendations For Training According to the report, the patient and the primary care physician or see IOM page 37

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

P A I N M EDI C I NE

After TKA, Pain Relief Costs More for Women Than Men

new pharmacoeconomic study has found 27% more spending on pain-relief agents among women than men in the year following total knee arthroplasty (TKA). This finding adds to previous research showing that women ask for, and receive, more analgesia after surgery than do men. “Women are typically the key decision makers in health care; they know

more and demand more, and are more vocal about pain and dissatisfaction,” said Paul Manner, MD, associate professor of orthopaedics and sports medicine at the University of Washington, in Seattle, who was not involved in the study. “In spite of that, women undergoing TKA seek treatment at a later stage than men and have greater functional disability at the time of surgery.”

The study was undertaken by a team from Zimmer, Inc., in Warsaw, Ind. The group retrospectively analyzed information from Jan. 1, 2003 to Dec. 31, 2009, in the Thomson Reuters MarketScan Commercial and Medicare Claim databases. “The goal of the study was to dig into the anecdotal consensus among physicians that females experience more pain

$600

Male cohort Female cohort

557

$500

431 $400 $300

464

388

364 309

$200 $100

10 Annual ASRA Pain Medicine Meeting & Workshops

Advancing the science and practice of regional anesthesia and pain medicine MEETING OBJECTIVES

TARGET AUDIENCE

After attending the lecture series, poster discussions, workshops and problem-based learning discussions, and studying the syllabus materials provided participants will:

This meeting is designed for pain physicians utilizing invasive and non-invasive techniques for pain management.

• Recognize common clinical problems in acute, chronic and cancer related pain • Formulate an adequate patient evaluation plan • Describe laboratory investigations that study the mechanisms underlying different pain syndromes

• Demonstrate current recommendations for the management of pain • Evaluate and critically appraise new and evolving chronic pain therapies

Individuals involved in pain control, including but not limited to physician assistants and nurses, and scientists working in the basic and clinical science areas will greatly beneﬁt from attending the didactic sessions provided throughout this meeting.

American Society of Regional Anesthesia and Pain Medicine

Commerciala Combined Commercial and Medicarea

Figure. Spending by sex for knee replacement pain. a

November 17 – 20, 2011 • Hilton New Orleans Riverside • New Orleans, Louisiana

Medicarea

Wilcoxon Mann-Whitney test (P<0.05).

post-op with TKA than men do, and to understand the implications from a cost perspective,” explained Cheryl Blanchard, PhD, Zimmer’s chief scientific officer. “And our results may help surgeons choose the appropriate and optimal clinical pathway for TKA patients.” The database included 103,600 inpatient admissions for primary TKA from 2003 to 2009. There were 873,237 claims for muscle relaxants and analgesics/antipyretics within 12 months of surgery among these patients. Female patients on average spent $464 each on these agents in the first year after surgery, compared with an average of $364 for men, a 27% difference (P<0.05). When the investigators separated out expenditures according to type of insurance coverage, they found that female Medicare patients spent $388 and male Medicare patients spent $309. The spending for female and male patients covered by commercial insurance were $557 and $431, respectively. Although overall per-procedure pharmaceutical spending decreased— from $528 per female patient and $414 per male patient in 2003 to $422 and $370, respectively, in 2008—spending among women was always significantly higher than among men (Figure). Ruth Waterman, MD, a research fellow in the Department of Anesthesiology at Ochsner Health System in New Orleans, who was not involved in the study, commented that the results are “intriguing,” but somewhat flawed because the investigators did not include important variables such as concomitant medications, illicit drug

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 37

Pa in M e d ic in e IOM continued from page 35

and time spent in planning and coordinating care. clinician should conduct most of the “We often want to get cognitivepain care and management, reserving behavioral or physical therapy consulreferrals to specialty services for recalci- tations to see if helping patients deal trant or more complex cases. But many with the stress of having chronic pain health care professionals are not ade- or reconditioning will help,” Dr. Helm quately trained in pain care and man- said. “But insurance coverage is a baragement. For instance, only five of rier to these services.” the nation’s 133 medical schools have Although it welcomed the report’s required courses on pain, and just 17 recommendations, the ASIPP noted offer elective courses. In addition to that the study did not fully include expanding education and training, the interventional pain procedures in the _ y report recommends that licensing and certification exams should include pain-related assessments. Pain specialists were not upset by the emphasis placed on self-care and primary care. “The extent and amount of pain is so widespread, there is much more there than can be dealt with solely by pain specialists,” said Standiford Helm, MD, president of the American Association of Interventional Pain Physicians (ASIPP). Recommendations for Reimbursement The report also calls on Medicare, Medicaid, private health plans and workers’ compensation programs to expand patient-centered pain care treatment and to cover interdisciplinary pain care. The report notes, however, that current reimbursement systems do not efficiently pay for these approaches, and most health care organizations are not organized to support integrated patient management. Examples of “barriers” in billing and coverage include minimal capacity for frequent physician visits when needed, limited time allocated for comprehensive patient assessment and lack of reimbursement for needed specialty care services, interdisciplinary practice, psychosocial and rehabilitative services

diagnosis and treatment of chronic pain conditions. “The report doesn’t give enough weight to interventional pain procedures as a modality to reduce pain and increase function,” Dr. Helm said. The American Society of Anesthesiologists is reviewing the report, according to a spokeswoman for the group. Other professional associations and advocacy groups generally lauded the document. “We hope that this landmark report sounds the siren call for greater attention to pain issues by both g

public and private sector policymakers and by the nation as a whole,” said a statement jointly issued by 35 organizations, including the American Academy of Neurology, the American Academy of Pain Management, the American Pain Foundation and the American Pain Society. “We hope the recommendations of the report lay a clear path toward much-needed improvements in pain research, care, education, and treatment.” —Ted Agres

The NEW Aluminum Wireless Auto-Locking Cart from Armstrong Medical features keyless entry, an LCD display (shows date, time of day, current battery life, and programmable menu driven display system that prompts you to each additional command), integrated 802.11g wireless capabilities with wireless antenna, up to 5,000 user codes, supervisor code for programming, and manual or automatic locking. This Cart also has many customizable auto-locking features, so it fits whatever security needs you have.

use, activity levels and pain scores. “However, this study is a reasonable foundation on which to build subsequent studies that would give even greater weight to the possibility that female gender is a predictor of increased postoperative pharmaceutical requirements,” Dr. Waterman said. “By instituting a prospective study, many confounding variables in this study could be eliminated.” The study results were presented at the recent annual meeting of the International Society for Pharmacoeconomics and Outcomes Research. —Rosemary Frei, MSc

The Aluminum Wireless Auto-Locking Cart is available with Optional Prox Reader and Optional CONTROLLED SUBSTANCE DRAWER.

Come See Us At The ASA Booth 921

3 8 I A n e s t h e s i o l o g y N e w s . c o m S e p t e m b e r 2 0 1 1

P A I N M EDI C I NE

Tricyclic Use in Fibromyalgia Drops Significantly Austin, Texas—According to a claims database review of more than 10,000 patients with fibromyalgia, tricyclic antidepressant (TCA) use in this population has fallen by nearly 60% over the past decade. The study, conducted by researchers at Eli Lilly and presented at the American Pain Society’s (APS) 2011 annual scientific meeting (abstract 295), also showed that less than 40% of all TCA users between 2006 and 2009 received a drug from this class as a first-line treatment. The findings suggest TCAs may be “under-prescribed” relative to published guidelines recommending their use as a first-line treatment for fibromyalgia, said rheumatologist Robert Shmerling, MD, of Beth Israel Deaconess Medical Center, in Boston, who was not involved in the study. The reasons for possible under-prescription are not clear from the study. “Do physicians stop prescribing tricyclics because they are ineffective? Because of their side effects? Because there are newer drugs on the market?” asked Dr. Shmerling,. “Since this was a claims database analysis, these are questions beyond the scope of the study.” Lead investigator Ralph Swindle, PhD, of Eli Lilly, explained that following the approval of duloxetine (Cymbalta, Eli Lilly) in 2008, he and his colleagues received “numerous unsolicited questions from national and regional managed care formulary decision makers asking for evidence that would refute their health plans’ adoption of fibromyalgia step-therapy requirements.” Guidelines issued by the APS and the European League Against Rheumatism, among other professional associations, recommended Advertisement

Newproduct

TCAs and other generic medications be used prior to branded and FDA-approved fibromyalgia medications, such as duloxetine (see www.ampainsoc.org/ pub/fibromyalgia.htm). To understand patterns of real-world TCA use and compare these to the recommended guidelines, Dr. Swindle and colleagues at Analysis Group, Inc., examined health care claims between 2006 and 2009 from 10,219 patients newly diagnosed with fibromyalgia. Because no International Classification of Diseases, Ninth Revision code for fibromyalgia exists, physicians typically record these patients as having myalgia or myositis; thus, the researchers considered the latter two diagnoses to be evidence of fibromyalgia. The investigators recorded administration of TCAs in the year following myalgia or myositis diagnosis, as well as in the year prior to diagnosis, to account for the frequent lag between symptom presentation, treatment initiation and appropriate diagnosis. They compared TCA use between 2006 and 2009 with rates of TCA use recorded in a previously published analysis of payer claims from 27,947 patients made between 1999 and 2005. They also looked at the incidence of comorbidities, use of concurrent medications and medication switching and discontinuation. Dr. Swindle and his team found that between 2006 and 2009, only 5% and 7.2% of patients received a TCA during the year prior to and following fibromyalgia diagnosis, respectively; however, between 1999 and 2005, 15.9% and 20.7% of patients with fibromyalgia received a TCA during the year prior to and following diagnosis, respectively. Only 38.5% of all TCA users between 2006 and 2009 received a drug from this class as a first-line treatment. Dr. Swindle’s analysis also revealed 84% of TCA users had been given other fibromyalgia

Analgesics

60.3%

Antidepressants

39.6%

Anticonvulsants

35.3%

Skeletal muscle relaxants

26.6%

Anxiolytic agents

26.4%

Corticosteroids

24.4%

Hypnotics

19.4% 13.8%

Antihistamines 0

Figure. Concomitant drug use among patients taking tricyclic antidepressants.

treatments concurrently (Figure). Furthermore, 61.8% of TCA users switched to another class of drugs, including an analgesic, another antidepressant or an anticonvulsant, after a mean of 121 days. And nearly 23% of all patients discontinued medication use altogether. Dr. Swindle emphasized that his study’s findings are strictly descriptive and that further research is required to understand why TCA use has been declining. However, the findings unquestionably point to a discrepancy between evidence-based guidelines and real-world use of this class of drugs, he said. “TCAs are widely recommended as effective, inexpensive medications, but the declining frequency of initiation and relatively brief treatment persistence indicate that TCAs are playing a less significant role in the current treatment of fibromyalgia,” Dr. Swindle concluded. —David Wild

‘No Safe Window’ for NSAID Use In Heart Disease Patients SorbaView® SHIELD SorbaView SHIELD is a one-step catheter securement system that combines the features and benefits of a SorbaView Dressing with SHIELD Technology. SHIELD Technology guards the catheter from aggressive tugging forces, preventing catheter movement and dislodgement—eliminating the need for a secondary securement device. Available in multiple sizes to fit any vascular access site. Contact Information: Centurion Medical Products 100 Centurion Way Williamston, MI 48895 Phone: (800) 248-4058 Web sites: centurionmp.com, sorbaviewshield.com See our ad on pages 6 and 7.

he short-term use of nonsteroidal antiinflammatory drugs (NSAIDs) could pose serious danger to individuals with preexisting heart disease, according to a new study (Circulation 2011;123:2226-2235). Most NSAIDs were associated with a significantly increased risk for recurrent myocardial infarctions and death, said researchers. Despite contraindications in patients with existing cardiovascular disease, many are still given shortterm courses of NSAIDs. Based on their results, the researchers did not recommend the use of NSAIDs, either short- or long-term, among patients who had previous heart attacks. “Our results indicate that there is no apparent safe therapeutic window for NSAIDs in patients with prior heart attack,” said Anne-Marie Schjerning Olsen, MB, research fellow at Copenhagen University in Denmark and lead author of the study.

The study included patients (N=83,677) older than age 30 years who had suffered heart attacks during a 10-year period. Researchers reported a 45% increase in risk for death and recurrent heart attacks within as little as one week of NSAID therapy. The number increased to 55% after three months of treatment. Although almost all NSAIDs were linked to an increased safety risk, diclofenac was associated with an almost three-times-higher risk than any of the other NSAIDs studied. Researchers also noted that the use of over-the-counter NSAIDs was unlikely to have a major impact on the study results. Researchers suggested that in the event that NSAID therapy is necessary, doctors should limit use to the “absolute minimum” in patients with prior heart disease. —AN Staff

The bookstore division of

mcmAhoNmedicAlbooks.com order books oNliNe

An online bookstore

The book PAge

Visit our site to get a FREE financial planning audio CD!

Publisher’s ToP Picks of The moNTh oN mcmAhoNmedicAlbooks.com These books and thousands more...

Anesthesia Oral Board Review: Knocking Out the Boards

Jessica A. Lovich-Sapola This book is specially designed for the American Board of Anesthesiology Oral Examination. The evidence-based approach is presented in a concise outline-oriented format. More than 100 topics covered here have already been board-review tested by residents at Case Western Reserve University who have passed the oral board exam.

Basics of Anesthesia: Expert Consult Online and Print 6th Edition

Ronald D. Miller; Manuel Pardo

ORDER OnLInE For pricing, a more complete review and easy ordering with a credit card, go to McMahonMedicalBooks.com. We can supply any medical book in print, so if you don’t find the book you want, email your request with billing information to RMcMahon@McMahonMed.com. If you are an author and would like your medical book featured in this book section, contact Ray McMahon, Publisher, at RMcMahon@McMahonMed.com.

This book serves as an excellent primer on the scope and practice of anesthesiology. Widely acknowledged as the foremost introductory text, the new edition has been thoroughly updated to reflect new and rapidly changing areas in anesthesia practice including new chapters on awareness under anesthesia, quality and patient safety, orthopedics, and expanded coverage of new ultrasound techniques in regional anesthesiology with detailed illustrated guidance.

Clinical Pain Management: A Practical Guide Mary E. Lynch; Kenneth D. Craig; Philip W. H. Peng

This book takes a practical, interdisciplinary approach to the assessment and management of pain. Concise template chapters serve as a quick reference to physicians, anesthetists and neurologists, as well as other specialists, generalists, and trainees managing pain. Based on the International Association for the Study of Pain’s clinical curriculum on the topic, this reference provides to-the-point best-practice guidance in an easy-to-follow layout including tables, bullets, algorithms and guidelines.

First Aid for the Anesthesiology Boards Himani Bhatt; Karlyn J. Powell; Dominique Aimee Jean

This is a high-yield “insider’s guide” to success on the anesthesia boards and in-service exams. The book presents quick, frequently tested, highyield facts based on the most recently administered exams. You will find this great for initial and last-minute exam review and anesthesiologists will find it valuable as a refresher before recertification.

For Doctors Only: A Guide to Working Less & Building More, Third Edition

Christopher R. Jarvis; David B. Mandell; Jason M. O’Dell This volume helps physicians move beyond theory and into practice by outlining how to find quality advisors and construct a collaborative, multidisciplinary planning team.

Handbook of C-Arm Fluoroscopy-Guided Spinal Injections

Linda Hong Wang, MD, PhD; Anne McKenzie-Brown, MD; Allen Hord, MD; Pain Consultants of Atlanta, Georgia C-arm-guided spinal injections have been performed widely for diagnostic and management of spine and paraspinal related pain disorders. This handbook illustrates spinal injections in an easy-to-follow, step-by-step fashion and presents fluoroscopy-imaging and related spinal anatomy for medical professionals who may not have had formal training in radiography and related anatomy of the vertebral column.

Patient Controlled Analgesia: Principles and Practice Series

Edward Welchew This comprehensive, practical guide provides information for medical staff supervising patient-controlled analgesia including drug regimens, physical and psychological effects, and issues of safety.

Pediatric Critical Care, An Issue of Pediatric Clinics James Orlowski

Authorities in the field have come together to pen articles on topics including induced hypothermia for pediatric cardiac arrest, surfactant for ards in children, diabetic ketoacidosis, in-hospital pediatric cardiac arrest, the psychological impact on children of admission to intensive care, multiple organ system extracorporeal support, immunoparalysis, nosocomial, and opportunistic infections, the poisoned child, physician extenders, unconventional ventilator techniques, pharmacokinetics and pharmacodynamics in the critically ill child, medical errors and adverse occurrences, parent satisfaction, forgoing life-sustaining or death-prolonging therapy, and endocrine issues in the PICU. AN0911

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

TE C H NO L OGY

Errors Persist With Bar-code Scanning Louisville, Ky.—The rates of bar-code scanning errors may be higher than reported in the literature, according to research presented at the annual UnSummit for Bedside Barcoding. Corinne R. Fantz, PhD, associate professor of pathology and laboratory medicine at Emory University School of Medicine and co-director of the Core Laboratories at Emory University Hospitals, Atlanta, told delegates that linear bar-code technology has reduced the incidence of identification errors in many health care applications, but it has not eliminated them entirely. “Bar codes can create errors and people are unaware of that fact,” she said in a follow-up interview. “We have found a number of errors that can be prevented through good process design if people are aware of the limitations of linear bar codes.” Dr. Fantz described how she and her colleagues discovered a number of bar-code errors at her institution. The errors were generating incorrect patient identifiers when the bar codes were scanned for point-ofcare glucose testing. “We were going along nicely and suddenly fell off a cliff,” she recalled. “We had a lot of errors and we couldn’t figure out why.” Dr. Fantz said the errors first surfaced when several patients’ point-of-care glucose results were not transmitted to the intended patient’s medical records. Repeat scans of wristbands from these patients produced both correct and incorrect patient identifiers. Eventually, it was discovered that the errors were caused by a mix of the following factors: minor imperfections in the bar codes, failure to control for bar-code scanner resolution requirements and less than optimal printed bar-code orientation. Dr. Fantz and her team found that of the 840,000 glucose scans done at Emory that year, at least 10 scanned incorrectly. “That’s one error for every 84,000 patients, which is far more frequent than commonly accepted,” she noted. “The incorrect scans actually [contained] the wrong patient financial number, which meant that the results could have gone to the wrong patient record.” Because the financial numbers that were being generated were not valid, “they did not go to the medical record. That was how we discovered the errors,” Dr. Fantz explained. Ten errors in a period of one year might not seem like a lot, but it is far more than the generally accepted rate of one error per 2.7 million scans, Dr. Fantz noted.

of each bar or white space for the scanner. They need to be at least that wide in order for your scanner to read them. If your scanner can’t resolve that width, it would be a bad idea to make that minimum bar width smaller. If you shrink your bar code from 25 to 13 mm and change that minimum bar width to smaller than 0.127 mm on this scanner type, you will have errors—guaranteed.”

‘Like any other technology, the application of bar coding requires attention to design and maintenance. When either is ignored, results can be undesirable.’ —Dennis A. Tribble, PharmD, FASHP

Another key to preventing bar-code errors is to perform preventative maintenance on printers at regular intervals. “We found that our departments were waiting until the bar code had pretty much disintegrated Pick a Standard and Stick to It before they would replace it and also that printers One important safeguard against errors is to make could misprint a bar code if they were not properly sure all scanners in use are set to read only one spe- maintained,” Dr. Fantz said. cific type of bar code. “Look at the standard you are If the budget allows, consider getting a bar-code using and make sure all of your scanners are set to verification system in place. “It would be ideal if you read only that type of bar code,” Dr. Fantz said. “That could verify that bar-code scan before you send it out will prevent those misreads with different types of bar on the floor,” she said. code. If you are only reading code 128, your scanners Dr. Fantz added that Emory is thinking of comshould be set to read code 128.” Another key point to bining linear bar codes with radiofrequency identifiremember is that size matters, she said. “Are the size cation (RFID) technology, and having an RFID chip specifications being met for each scanner in use? That embedded within the labels that they print. “RFID is very important to know.” is very expensive—it costs 20 cents a label—and Also, she said, check the package insert that comes would end up costing more than $200,000 a year in with the scanner and look for the line that says “min- our system, so we may have to limit its use to subimum bar width. That will tell you exactly the width specialty areas like the emergency department or in

small subsections of the laboratory. We would also like to use it to track anatomic pathology specimens,” she said. Keeping an Eye on Design And Maintenance Urged Dennis A. Tribble, PharmD, FASHP, chief pharmacy officer of Baxa Corporation, said that the barcode scanning problems documented at Emory are not surprising. “Like [with] any other technology, the application of bar coding requires attention to design and maintenance,” he said. “When either is ignored, results can be undesirable. Careful consideration of what can go wrong should result in a system that handles errors with more elegance.” Ideally, scanning a bar code should result in a string of data only when the data are complete and accurate, Dr. Tribble said. This requires the use of a symbology that has built-in error detection, such as code 128, use of a restricted character set (e.g., all numbers), and use of a fixed data length and format. “Not all of these checks can be made in the bar-code scanner,” he said. “Some of them may have to be made in the software that receives the data from the scanner. At some point, either the scanner itself—responding, for example, to a checksum failure—or the application—noting, for example, that the returned ID is not valid—should report to the user that the bar code could not be properly read and prompt them to get a new one printed. If the returned ID can be any length, or can contain any characters, or has no formatting, it can be much harder to identify one that is not valid.” Dr. Tribble added that such failures should result in immediate notification to the user. “They should not fall into an unattended error queue that someone looks at once a week. The user needs to know at once that their intended documentation did not occur.” Dr. Tribble agreed that printer failures are among the more common sources of bar-code errors. “If a pin in the print head stops firing, a bar in the bar code can be printed with an inappropriately narrow width. Sometimes, this results in the bar code not being readable at all; at other times, it may result in the data being misinterpreted,” he said. “Verification of each bar code after printing readily identifies this problem. However, not all bar codes will print incorrectly in this case— only those whose bar widths are affected by the pin or pins that aren’t firing anymore.” Printer selection is critical to reducing the incidence of this problem, he added. “A printer whose duty cycle is 5,000 images a week is likely to produce significant problems in an application where it must produce 15,000 images per week.” Dr. Tribble said he disagreed that “hard-coding” a scanner to a particular symbology is necessary or useful. “Most scanners come out of the box able to automatically detect and properly use 12 to 15 symbologies. Properly using such symbologies includes being able to determine when those symbologies are, or are not, properly formed. The need to configure the scanners before they can be used artificially limits the ability of the organization to keep working hardware in the field and provides little value, especially when compared to careful specification and system design.” —Fran Lowry

S e p t e m b e r 2 0 1 1

AnesthesiologyNews.com I 41

CA R EE R O PPO R T U N ITIES

South Jersey South Jersey ASC specializing in abortion care.

From the Creators of:

PainExam.com

Days only; no night call. Part-time and full-time, Tues.-Sat.

A comprehensive review for the Pain Boards

QBazaar Presents… Affordable & Efficient Board Prep

AnesthesiaExam

Anesthesiologists sought for busy ASC in Cherry Hill, N.J. Be a part of a superior, professional team of specialized physicians, nurse practitioners, registered nurses and experienced and dedicated medical, counseling and administrative support staff. We are seeking full-time or part-time daytime coverage for our abortion surgery practice Tuesdays through Saturdays, daytime only, no night call. Cherry Hill Women’s Center (CHWC) is nationally recognized as a model of excellence in women’s health and abortion care, and has offered services for over 30 years. CHWC is accredited by the National Abortion Federation, is AAASC-certified and is a member of the AAAASF. Candidates must hold New Jersey license, board certification, DEA, CDS, PALS/ACLS.

Pass more than just gas!

CRNABoardPrep.com

Interested parties should contact Elaina Nordo, administrator. E-mail: enordo@cherryhillwomenscenter.com; Fax: (856) 356-4039; Phone (856) 667-5910. Pass the oral boards b the first tim me! Passing the an nesthesia oral boards often re equires more than n a mastery of the information. Technique makkes the difference. We have develop ped an anesthesia orall board preparatio on curriculum to not only review the e most relevant infformation but, more importan ntly, to provide you u with the unique set of skills you will w need to successsfully communicate yyour knowledge an nd avoid common pitfalls encounterred during the oraal board exam. Phone: 1 316 7776 9898 www.ultimateboa w ardprep.com AN-1210-004

We’re in a AN-0211-02

position

Need a job? LocumTenens.com has hundreds of anesthesiologist and CRNA job opportunities available now, nationwide.

Log on to www.locumtenens.com or call 800.562.8663 to speak with an anesthesia recruiter today.

AN-0111-02

AN-0111-03

to fill your

position

For classified advertising: contact Nancy Parker 212-957-5300 x260 nparker@mcmahonmed.com

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

TE C H NO L OGY

“4-D” Ultrasound May Help Guide Central Lines

new tool that allows real-time, three-dimensional ultrasound may help cut down on errors while placing central lines, without adding precious time to the procedure, researchers have found. When anesthesiologists attempted the technique on a sample of 10 patients undergoing heart surgery, they cannulated the internal jugular vein in every patient—and, in nine of the 10 patients, with the first needle pass (Figure). No back wall passes or inadvertent punctures of the carotid artery occurred. The cases required an average of 15 seconds to scan the blood vessels, and the average time to insert the needle into the internal jugular vein was 14 seconds, according to the study, which the researchers

Figure. Screen view of internal jugular vein cannulation with “4-D” ultrasound. The needle appears hyperechoic in all planes (X-, Y- and Z-) and in volumetric image (arrows).

presented at the 2011 annual meeting of the Society of Cardiovascular Anesthesiologists, in Savannah, Ga. (abstract 63). Traditional ultrasound techniques take approximately the same amount of time to find the vein, said David Auyong, MD, of Virginia Mason Medical Center in Seattle. The new technique “didn’t take longer, and it potentially showed that we could follow the needle better, by avoiding the back wall passes and arterial punctures.” However, one patient required six needle passes, likely because the internal jugular vein was relatively deep, Dr. Auyong said. Many anesthesiologists now rely on ultrasound when inserting a central line, but the traditional technique cannot always rigorously track the tip of the needle, as evidenced by the lingering risk for complications such as pneumothorax and inadvertent arterial puncture. The new “4-D” technique uses a probe that wobbles slightly (roughly four times per second) over a three-dimensional area such as the internal jugular vein, creating a three-dimensional image in real time—with time representing the fourth dimension, Dr. Auyong explained. “The ultimate goal here is a way to track the needle more reliably,” he said. Dr. Auyong, who has lectured for SonoSite, which supplied the ultrasound equipment used in the study, said that the biggest hurdle for uptake of the technology is learning how to use it. When he demonstrates it to other anesthesiologists, he said they often struggle with having to follow four images simultaneously in order to track the needle. “It is not something

that is necessarily intuitive the second you pick it up.” Dr. Auyong said he, too, struggled at first, but grew more comfortable after an estimated 10 practice insertions of a needle. Cost is another barrier, said Paul Barash, MD, professor of anesthesiology at Yale University School of Medicine, in New Haven, Conn., and a member of the Anesthesiology News editorial board. Ultrasound helps reduce the risk for complications associated with vascular catheterization, Dr. Barash said, but the physicians who do not use it often attribute their hesitation to the expense of the equipment. Another technology, even if useful, might not make much difference if it is even more expensive, said Dr. Barash, who was not involved in the Virginia Mason research. “Anything that improves the technique of ultrasound will be helpful. But the question is, how much is it going to cost to improve the technique?” Dr. Auyong acknowledged that 4-D ultrasound probes are two to four times more expensive than standard probes, which themselves cost roughly $10,000. Because the 4-D probes are relatively new, they also are somewhat larger and bulkier than conventional probes. “However, 4-D can be used in other applications, not just vascular access,” Dr. Auyong added. Clinicians are using the new technology in cardiology and obstetrics, he said, but not many yet in anesthesia. “There are just pockets of people who use it in any kind of application in anesthesia.” —Alison McCook

ClipChart Rochester, Minn.: Howard Snitzer owes his life to a flight nurse and a capnography monitor. Mr. Snitzer’s heart stopped beating for 96 minutes after he suffered a heart attack outside a grocery store. But a nurse trying to revive him realized that capnography readings showed encouraging signs of perfusion despite the lack of a pulse. As a result, according to a report on National Public Radio, Mayo Clinic anesthesiologist Roger White, MD, decided to keep performing CPR at the hospital, after a combination of repeated electrical stimulation and administration of drugs, Mr. Snitzer revived. Capnography is becoming increasingly common outside the operating room. Emergency medical crews have begun to add the monitors to their list of standard rescue devices, and in 2010 the American Heart Association included capnography in its guidelines for the treatment of patients in cardiac arrest, NPR reported.

Canton, Mich.: A Michigan man is the alleged mastermind behind one of the largest painkiller-related Medicare billing scams in the state’s history, according to an Aug. 2 indictment. At press time, federal prosecutors were trying to block Babubhai Patel’s attempts to get out of jail prior to his trial. Prosecutors maintain that the pharmacist is a flight risk, having allegedly funneled large sums of money into hidden accounts in India. Mr. Patel, 49, is accused of billing $57 million to Medicare for false pain drug prescriptions. According to the government, Mr. Patel gave kickbacks to physicians for writing the prescriptions, and to patients for remaining silent while the charges were billed to their insurance companies. Assistant U.S. Attorney John Neal told the Detroit Free Press that Mr. Patel, owner of 26 pharmacies, has hidden assets totaling nearly $12 million. Mr. Neal described the accused as a “drug distributor on a massive scale.”

Detroit: From the NFL to the PACU? That might not be the typical course, but it’s the route Nate Hughes has chosen. Hughes, a wide receiver for the Detroit Lions, is nearly through a master’s program in nursing and wants to become a nurse anesthetist when his football days are done, according to the radio station WXYZ.

e-Newsletters and e-Alerts Links Links to Other to Other TherTherapeutic apeutic Areas Areas

Medical Education

Buyerâ&#x20AC;&#x2122;s guides