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The Independent Monthly Newspaper for Anesthesiologists AnesthesiologyNews.com • J a n u a r y 2 0 1 2 • Volume 38 Number 1

OR Itself May Promote Bacteria Contamination

nesthesiologists are not the “typhoid Marys” of the operating room, according to a series of new studies which suggest that the surgical environment may pose infection risks to patients independent of clinicians. In three separate investigations that involved hundreds of ORs, Randy Loftus, MD, of Dartmouth-Hitchcock see environment page 22

Survey Finds ‘Discouraging’ Injection Habits Among Anesthesiologists

new survey paints an at-times alarming picture of injection practices among anesthesiologists in New York state. Nearly half (49%) said they sometimes used the same vials of medication for more than one patient—a strict no-no for many kinds of drugs, including propofol. (Indeed, 31% of clinicians who reported using propofol said they had used the same vial on multiple patients.) Roughly one-fourth said they did not always use a new needle and syringe when drawing medication from a vial. And about the same proportion reported using an open vial of medication even though they had not directly observed someone else opening the container. see inject page 20

Bar-Code Scanning Can Fix ‘Black Hole’ of OR Drug Safety

INside 06 | COrrespondence Reader letters on first impressions and carbon dioxide.

Error rates slashed; anesthesiologists embrace technology New Orleans—When an anesthesiologist calls the operating room a “black hole of medication safety,” hospitals might want to pay attention. The description came from Ludwik Fedorko, MD, PhD, staff anesthesiologist at the University Health Network’s (UHN) Toronto General Hospital in Canada, during a session on OR drug safety at the 2011 American Society of Health-System Pharmacists anesthesiologists are the only health December meeting. care professionals in the hospiDr. Fedorko noted that tal setting who dispense, premix,

08 | Commentary

repackage, relabel and administer medications without independent verification. Given that most drugs administered perioperatively are high risk, the potential threat to patients is obvious. If that’s not enough to make hospital administrators uneasy, other figures presented by Dr. Fedorko are equally disconcerting: The OR and the postanesthesia care unit disproportionately accounted for 81% of all medication error reports, which

Pro/Con: Should clinical researchers shun industry funding?

12 | Pain Medicine Revisiting the APS/AAPM opioid guidelines three years later.

30 | Ad Lib Good drugs, bad doctors: Part 2 in a series on the history of anesthesia.

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Top 10 of

Heard Here First:

2011

The 10 most-viewed articles last year on AnesthesiologyNews.com

Patients with persistent pain are

vulnerable to advertisements that promise relief, and when combined with various forms of Internet

1. German Medical Board Issues Sweeping Findings in Boldt Case

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2. Current Concepts in the Management of the Difficult Airway (Educational Review) 3. Anesthesia Billing Cases Allege Rampant Fraud 4. The Company Model: Is Taking Less Money To Work at a Surgicenter Worth Jail Time? 5. More Retractions in Boldt Case 6. Sedation in the ICU: Shifts and Strategies (Educational Review)

supported by prominent search engines like Google, they may fall prey to poor or

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7. After Retractions in Boldt Case, Experts Ponder the Fate of Hetastarch

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8. Opioid-Adjuvants for Multimodal Pain Management (Educational Review) 9. Fair Market Valuation: the Death Spiral of Physician Compensation 10. To Assess Tube Placement, Keep it Simple

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C ORRESP O NDE NCE To the Editor: he article in the December 2011 issue of Anesthesiology News (page 1) on informed consent prompted me to recount my own experience with this issue. I recently followed a relative through a simple outpatient surgical procedure during which time I did not announce that I was an anesthesiologist. The following is my account of that event, as seen through the eyes of a peer in practice for 25 years, with an interest and background in patient safety, risk management and quality care. The patient was referred to an outpatient surgery center associated with a world-class hospital in a major U.S. city. This facility has an international reputation and excellent physicians. I had no reason to think that the care would be anything short of outstanding. And, indeed, things started out well enough. Registration was timely and efficient. The registrar physically and verbally confirmed which extremity was the site of surgery, and placed a name identification band on the contralateral side. The admissions nurse also was respectful, professional and thorough. He identified the patient by the armband, confirmed the name, date of birth, surgeon, procedure and site of surgery. The patient was processed through admissions, with the nurse obtaining a history, and placing the IV line. The surgeon’s physician assistant arrived, again

To the Editor: egarding “Rapid Gas Change During ECMO Linked to Mortality Risk” (August 2011, page 14). This report should not be surprising. There is abundant evidence that mechanical hyperventilation depletes carbon dioxide (CO2) tissue reserves and undermines respiratory chemoreceptor function. Hyperventilated patients breathe effectively after anesthetic emergence, but only because conscious awareness confers a form of respiratory drive that is independent of chemoreceptor function, and only if opioid dosage is carefully constrained so that this “secondary” form of respiratory drive is not similarly undermined. However, hyperventilated patients remain vulnerable to “opioid hypersensitivity” until their CO2 tissue reserves are replenished by metabolic activity. This can take several hours, especially in geriatric patients with low metabolic rates. Treatment with opioids and sedatives during this vulnerable period can cause hyperventilated patients to lose consciousness, whereupon they may suddenly stop breathing and suffer brain damage within minutes, soon followed by death. Hyperventilation also causes lung damage and increases blood viscosity,

confirmed the patient’s name, date of birth, surgeon and site of surgery. She performed a detailed history and a focused physical examination. The surgeon soon arrived, and while reading my relative’s identification bracelet, confirmed the procedure and site of surgery and answered the few questions that she asked. All of these events were performed in a timely fashion and were completed with plenty of time to spare before the start of the procedure. At 8:25 a.m., five minutes before the scheduled start, however, the anesthesiologist came to the admissions area. His coat was on, and a computer case hung from his shoulder. The patient commented that “they were late,” to which the anesthesiologist responded that they “still had five minutes and would only need two.” He stood at the side of the bed, briefly leafed

which reduces cardiac output, tissue perfusion and oxygenation and opioid clearance from brain tissue. It can cause severe arteriolar spasm in the brain to the point of causing brain damage, as in the case of high-altitude mountain climbers who hyperventilate on account of hypoxemia. Hyperventilation also doubles morbidity and mortality in otherwise healthy polio patients in iron lungs, and causes unexpected respiratory depression in newborn babies of mothers who undergo cesarean [deliveries] under general anesthesia. Even brief voluntary hyperventilation can cause lethal “shallow water blackout syndrome” in healthy young swimmers. Thus, it should not be surprising that ECMO [extracorporeal membrane oxygenation ]is dangerous in premature babies. This problem cannot be understood without understanding anesthesia history. During the “Golden Era of Ether,” the low cost of CO2 and its ability to stimulate respiratory drive, reduce blood viscosity, increase cardiac output and enhance oxygen uptake and distribution was widely understood and appreciated. It was used to treat everything from premature babies to patients with pneumonia. The anesthesiologists of that era had “bypass valves” installed in their

through the chart and said, “this will be easy.” He then proceeded to tell the patient that a nerve block would be placed “to make the extremity numb.” Although the anesthesiologist mentioned complications and expectations from the block, no discussion occurred that could come close to being considered informed consent. No pre-anesthetic or

anesthesia [delivery systems] that enabled CO2 supplementation of the gas mixture delivered to their patients. This accelerated the uptake and distribution of ether and reduced induction times. However, it was possible to deliver CO2 concentrations above 30% using these bypass valves, so that on rare occasions the problem of CO2 toxicity would occur. Usually this occurred in sick patients, but occasionally even young, healthy patients would suddenly suffer violent seizures, turn blue and die. It took several years before CO2 toxicity was recognized as the cause of these problems and the bypass valves were removed from service. Soon thereafter, halothane replaced ether, and superior surgical conditions could be produced using curare and mechanical ventilation. After 1960, CO 2 came to be regarded as a “toxic waste gas” that must be rid from the body using mechanical hyperventilation. Subsequent anesthesia research seems to have been influenced by this fear of CO2 toxicity, and the habit of hyperventilation became a “de facto” standard of practice, so that its effects have been overlooked by editors, researchers and practitioners alike. It has remained entrenched even though critical care specialists rediscovered the benefits of

mild, “permissive hypercapnia” nearly 30 years ago, and despite the universal presence of capnography and abundant anesthesia studies that demonstrate the dangers of hyperventilation and the benefits of mild hypercarbia. It is time for a reappraisal of the role of CO2 in anesthesia practice. Carbon dioxide toxicity seems to be a problem that occurs only when there is an external source of CO2 that can be added to the gas mixture to raise the CO2 concentrations above 30%. The high rates of fresh gas inflow in modern anesthesia machines make CO2 toxicity nearly impossible, and the universal presence of capnography further increases safety. It is now safe and easy to employ mild, permissive hypercarbia during anesthesia to prevent lung damage, reduce blood viscosity, optimize cardiac output and tissue perfusion, preserve CO2 tissue reserves and respiratory chemoreceptor function and enhance opioid clearance. This enables the safe administration of opioids in doses that further improve patient safety and comfort. —Lewis Coleman, MD, DABA Lewis Coleman, MD, DABA, is an anesthesiologist in Fresno, Calif., and the author of the blog, www.stressmechanism.com. A version of this letter first appeared on AnesthesiologyNews.com.

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CORRESPON DE N CE physical assessment was performed. No questions about comorbidities, allergies, medications, past surgeries, history of anesthetic difficulties, bleeding problems, the presenting medical problem or planned surgery were asked. The identity of the patient, the surgeon, the planned procedure and the site of surgery were not confirmed. True to his word, the anesthesiologist finished the “interview” with time to spare. Everyone has a bad day, and maybe that morning wasn’t the anesthesiologist’s finest moment. I’ll give him the benefit of the doubt. But the human aspect of the anesthesia care was in stark contrast to that provided by every other member of the operating team. Patient care is compromised when things are rushed, assessments are incomplete—or as witnessed here, skipped completely—and assumptions made. The anesthesiologist planned a nerve block without identifying the presence of a contraindicating preexisting condition such as a coagulopathy, peripheral neuropathy or infection. In addition to leaving us with the impression that he was rushed, the anesthesiologist seemed cold, indifferent, uninterested and unapologetic. He spoke at, not to, the patient, as if she were not a person but merely “his first case,” “the nerve block” to be performed before a long day of other such impositions. From the perspective of risk management, he could not have made a worse impression. Multiple studies in the risk management literature identify “at-risk physician behaviors,” many of which this physician demonstrated. Protective behaviors, such as apologizing to the patient for lateness, delays, sitting down, making appropriate eye and physical contact (shaking hands, a hand on the shoulder or below the knee), speaking slowly and asking if the patient had any questions were absent from this encounter. That my relative had an uneventful surgical experience was not because of, but in spite of, the attitude and habits of this anesthesiologist. I hope what was observed was the exception rather than the rule for this physician. If not, regardless of his training, talent, expertise and experience, the patients he treats will always be at risk. Although the immediate damage was psychological, in the future this sort of unfortunate encounter might have serious financial consequences. The Hospital Consumer Assessment of Healthcare Providers and Systems is a national standardized survey of

patients’ impressions during their hospital stays. Medicare payments to hospitals soon will be based on scores generated from these surveys. Positive patient experiences are paramount, and most hospitals are educating and training their staffs to be aware of this aspect of care. —Robert A. London, MD

Contact

the editor of Anesthesiology News

amarcus@mcmahonmed.com

Dr. London is attending anesthesiologist at Florida Hospital Medical Center, in Orlando, and a partner with the JLR Medical Group.

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C OMME NT A RY

Money for Drugs Should Physicians Be Paid for Pharmaceutical Development and Clinical Investigations? [Editor’s Note: The following article originally published in Missouri Medicine, September/October 2011;108:321]

Yes, Physicians Must Interact With Pharma

he Cause of the Day for many pundits and academics is the terrible wrongness of physicians taking any sort of payment from pharmaceutical companies. Drug companies, otherwise known as Big Pharma, have been demonized by the media, academia and politicians. They make too much money; charge too much; market too aggressively. We’ve all heard the litany of complaints. But, are they really evil? Are we really wrong to interact with them? We are having a national discussion over the propriety of physician relationships with industry. The tone of that discussion is hostile to both physicians and industry. The discussion is being largely conducted within medical journals, which themselves are partly supported by drug company advertising, and reported by news media that also profit from commercial advertising. Two of the most popular books on the subject were written by former editors of a journal that accepts drug advertising, and charges a lot for it.1,2 Should we have different ethical standards for medical journals than we do for individuals? Perhaps so. But that argument is not being made. There is a whiff of hypocrisy about the whole discussion. It would be well to define some common assumptions. First, physicians can, and should, be paid for their time. The ethical position that physicians should work for nothing may be valid, but it pretty much closes off this discussion. Second, it is unethical for physicians to sell their opinions to the highest bidder. We should not go out and urge other physicians to use a given product simply because we are paid to do so. This is, contrary to what many believe, a complex issue. To begin with, is it ethical to work on drug development and clinical investigation? Most of us would say it is. How can it be otherwise? If physicians cannot ethically be paid to develop and test new drugs, then who is to carry out this vital work? Non-physicians? Employees of the drug companies? Congress and the media?

Suppose a physician serves on an advisory panel for, let us say, the development of a new cardiac drug. That involves time and travel, perhaps other expenses. If physicians cannot participate, I ask again: Who is going to do it? It is in society’s interest that the best clinicians advise the companies. Can it seriously be claimed that the companies should develop drugs without input from physician clinicians? Most drug studies are funded by contracts with institutions, although some are with individual physicians or groups. Does it make an ethical difference whether the money goes directly to a physician or indirectly through the salary from a university? Surely not. Otherwise, anything could be justified by simply laundering the money through some convenient institution. One may argue that certain institutions, like universities and hospitals, have such high ethical standards that it is inconceivable that they are influenced by mere money. One may argue that, but one is unlikely to be believed. Consider a quotation from Dr. Gordon Gee, president of The Ohio State University. Now, Time magazine named Dr. Gee the best college president in the country in 2009, so he must be pretty well up in the profession. Recently, Ohio State football coach Jim Tressel was caught in a particularly flagrant alleged violation of the NCAA rules. When asked whether he would fire the coach, Dr. Gee responded, “No. Are you kidding? I’m just hoping the coach doesn’t dismiss me.”3 Perhaps he was making a see money page 9

No, Physicians Must Remain Independent of Pharma

ne perception of the classic oath of Hippocrates is, “We hold those who teach us and those who we teach to give knowledge without fee or covenant.” Presentations by physicians that are sponsored by pharmaceutical companies at expensive restaurants may be tainted by commercialism. The speakers are chosen by the pharmaceutical company to speak favorably about the company’s product. Frequently, the PowerPoint presentations contain the same information found in drug information inserts or the Physicians Desk Reference. The new PhRMA Code developed by pharmaceutical industry is the current guide for interacting with doctors.1 The new PhRMA Code of the pharmaceutical companies requires speakers to limit their discussion only to what is contained in the drug insert information. Open discussion usually follows. Local physician speakers often are given an honorarium ranging from $500 to $1,000. The American Medical Association Code of Ethics 8.061—“Gifts from Industry to Physicians”—states honorariums should be reasonable. I believe that “local” speakers, certainly those who are not recognized as experts in their field, should not receive any honorariums or compensation. It is their duty under the oath of Hippocrates “to teach to give knowledge without fee or covenant.” Out-of-town speakers should have their travel expenses covered, but should only receive a small honorarium for educational purposes and not be motivated by profit. Frequently, a grant by a pharmaceutical company is given to a university department, and then the university chooses the appropriate speaker. Despite peergroup discussion and interaction among colleagues, the presentations certainly can be biased.2

In order to obtain a more unbiased view, it would be preferable to read the literature and attend university and hospital conferences. There has been much written about conflict of interest of physicians, pharmaceutical companies, royalties and medical device companies in the lay literature such as The Wall Street Journal, St. Louis Post- Dispatch and The Kansas City Star.3-5 Movies such as “The Fugitive” and the “Constant Gardener” have highlighted this conflict. It is estimated that $8,000 to $13,000 is spent yearly by the pharmaceutical industry on each physician to promote their products.6

The physician-researcher should remain independent of the pharmaceutical company sponsoring the project and be able to publish the results both positive and negative in any journal he or she wishes. The federal government is establishing rules and regulations to minimize these conflicts requiring listing on the Internet of all monies given to physicians from pharmaceutical companies as a matter of public record. The Department of Health and Human Services published a draft proposal of new rules that relate to financial conflict of interest, which includes disclosure by either the company or the institution. This is part of the Sunshine laws, section 6002, in the new Patient Protection and Affordable Care Act passed by Congress.7 Currently, the public has access to how much a physician in Missouri and other states receives from the top eight pharmaceutical companies in see money page 9

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COMME N T A RY Money continued from page 8 joke. A medical school dean once told me, many years ago, “Charlie, there is no such thing as dirty money.” In short, as much as universities would like to believe otherwise, there is little justification for handing the ethical decision making to them. Perhaps the most troubling facet of this issue is represented by speakers’ bureaus. We all benefit from experts traveling about the country and teaching the rest of us. Most frequently, that teaching is at medical meetings, but it also occurs at universities or in hospitals. Funding comes from a variety of sources. Leading universities fund such activities out of their endowments, but other universities and most hospitals find the money where they can. Frequently, the money comes from the pharmaceutical industry, directly or indirectly. Medical societies receive dues from members, but also grants from drug companies. For some, it may feel good to say that no such money should ever be accepted. But we would be the poorer if these activities were to be curtailed. Indeed, we regard it as virtuous that physicians seek out continuing medical education, and our licensing agencies even require it. We should realize that some physicians are abusing the system. We have a few colleagues going around the country making hundreds of thousands a year advocating this or that particular treatment. Many others don’t make as much money, but are nevertheless shills for one company or another. Sure, they probably believe in the treatment they are promoting. They may use it themselves. But if you were in their audiences, knowing how much they

Yes

and the public on the complexities of were paid would our interaction with those who proinfluence how much duce the drugs and devices on which credibility they we all depend. might be accorded. Let us not be seduced by the arguWe need more ments of people who are not our transparency. Put friends. We cannot practice medithe information out there, and let every- Charles Van Way III, MD cine without pharmaceuticals. But we can practice medicine just fine one see. A numwithout politicians or the media. ber of states, such as Minnesota and Maine, have enacted They are not our friends; nor are they reporting laws. Several companies, unbiased. They have unquestionably including Pfizer, Merck, Eli Lilly and hurt the medical profession over the GlaxoSmithKline, report their financial past two decades. Neither the U.S. Sentransactions with physicians.4 There is ate nor The New York Times can make also a public database that reports such drugs or develop new ones. Yet they are monies.5 generating a demand for an unrealistic The Health Care Reform law, the ethical purity law, prohibiting all paid Patient Protection and Affordable Care constructive contact with drug comAct, mandates a national database. Spe- panies. Their arguments are that phycifically, drug and device companies sicians are greedy, foolish and easily must report all payments to doctors and manipulated by drug companies. But teaching hospitals. Companies must there is neither merit nor reality in that post the information. The Department specious assertion. of Health and Human Services will also If physicians cannot post data, beginning in 2013, and there 5 are serious fines for failure to report. ethically be paid to Our profession exists in symbiosis with the pharmaceutical industry. It is develop and test new in society’s interest for us to work with drug companies to ensure that they drugs, then who is to carry develop the drugs we and our patients need. But we are not their apologists. out this vital work? NonIt is strongly in our interest to see that physicians? Employees we and they behave in an ethical manner. If that causes us distress and soulof drug companies? searching over the next few years, so much the better. Congress and the media? Make no mistake. There have been problems, and they are our collective responsibility. We should not tolerMost physicians are actually fairly ate the “bad apples” in our midst. We hard to manipulate. Ask anyone who should assist in efforts to make the pro- has to deal with us. Most physicians are cess as transparent as possible. More- ethical. Greed is a characteristic of poliover, we should educate policymakers ticians far more than of physicians. The

honorariums and comso on. An example of pensation by searching this type of policy can the site Pro Publica, an be seen in the Washindependent nonprofit ington University in organization that was awarded the St. Louis Conflict of 2010 Pulitzer Prize for investigative Interest Guidelines.10 8 The physicianreporting. Research money by the mediresearcher should cal industry may be given to the remain independent researcher but it has been demon- George Bohigian, MD of the pharmaceustrated that industry-supported research tical company sponsoring the project is considerably more biased than grants and be able to publish the results both from the National Institutes of Health.9 positive and negative in any journal he It is unethical for a physician to have a or she wishes. All information should financial interest in the company from be transparent and honest with the which he or she is seeking the funding, pharmaceutical companies. Keeping for example, if he or she has a paid con- the best interest of the patient in mind sulting relationship with the company, should be our guiding principle. We is a co-founder of the company or oth- need to keep the trust of our patients erwise holds equity in the company, and and the public sacred.

References 1. Glover T. PM 360, The full spectrum of product management, Jan 2009. http://www.inventivhealth. com/about_us/downloads/pm360_2009-01.pdf. 2. Roseman M. et al. Reporting of conflicts of interest in meta-analysis of trials of pharmacological treatments JAMA. 2011;305(10):1008-1017. 3. Gregorian C. Doctors Talk about Drug Firm Payments. St. Louis Post Dispatch, November 28, 2010. http://www.stltoday.com/lifestyles/healthmed-fit/fitness/ article_ff1fe84a-671b-5ed7-9ae81944bb62e8ef.html. 4. Gregorian C. Database has payment to 17,000 Doctors. St.Louis Post Dispatch, November 29, 2010. http://www.stltoday.com/lifestyles/health-medfit/fitness/article_0cd2662c-970e- 5311-ad0f61418464cb33.html.

public trusts physicians much more than they trust journalists. To counter these arguments, we can advance the principles of autonomy, individual responsibility and professionalism. These are often brushed aside. Yet it is our professionalism, judgment and responsibility as physicians that make us of value to our patients. Without these, we become simple health care workers, cogs in the machine. There are certainly problems in our relationships with Big Pharma, and we must repair them. But barring all contact would be a poor answer. Ultimately, we serve our patients, and through them, society at large. We owe them our best judgment, and we owe them our professionalism. We will not accomplish either by adhering to a mindless prohibition, as appealing as that may appear to the moralist in all of us. References 1. Angell M. The Truth About the Drug Companies: How They Deceive Us and What to Do About It. New York: Random House, 2005. 2. Kassirer J. On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health. Oxford: Oxford University Press, 2005. 3. Waiting For Next Year (WBNY). http://www.waitingfornextyear.com/2011/03/the-gee-comment-noim-not-talkin-alonzo. Accessed March 29, 2011. 4. ProPublica. Dollars for Docs. http://projects.propublica.org/docdollars. Accessed April 3, 2011. 5. Weintraub A. New Health Law Will Require Industry To Disclose Payments To Physicians. Kaiser Health News, April 26, 2010. http://www. kaiserhealthnews.org/Stories/2010/April/26/physicianpayment-disclosures.aspx. Accessed April 5, 2011.

—Charles Van Way III, MD Dr. Van Way is professor of surgery and the Sosland/Missouri Endowed Chair of Trauma Services at the University of Missouri, in Kansas City. Disclosure: Dr. Van Way is member of the Residency Review Committee for Surgery of the ACGME. He receives no compensation for this service. industry’s a gift ever just a gift? JAMA. 2000;283:373-380. 7. Congressional Record Office of the Legislative Counsel Patient Protection and Affordable Care Act Section 6002 June 9, 2010 p 624 http://docs.house. gov/energycommerce/ppacacon.pdf. 8. Ornstein, C. What drug companies are paying your doctor. Dec 10, 2010. Pro Publica http://projects. propublica.org/docdollars/. 9. Benkelman JE, Li Y, Gross CP. JAMA. 2003; 289(4):454-465. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. 10. Washington University Guidelines on Conflict of Interests http://research. wustl.edu/ComplianceAreas/COI/Pages/COI.aspx.

—George Bohigian, MD

5. Carreyrou J. Top Spine Surgeons Reap Royalties, Medicare Bounty. Wall Street Journal. December 20, 2010. http://online. wsj.com/article/SB1000142405274870 3395204576024023361023138.html.

Dr. Bohigian is professor of clinical ophthalmology in the Department of Ophthalmology and Visual Sciences at Washington University in St. Louis.

6. Wazana A. Physicians and the pharmaceutical

Disclosures: None reported.

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Selling Your Practice: Five Tips for When Suitors Come Calling

t is no secret within the anesthesiology community that the level of merger and acquisition activity has been increasing over the past few years. Although historically most anesthesiology practices across the country have been smaller groups tied to a few local hospitals, recently a handful of larger companies has emerged looking to penetrate the market on a national basis. Deep-pocketed firms like TeamHealth, Mednax, EmCare (part of Emergency Medical Services Corporation) and Sheridan Healthcare have been buying anesthesia groups across the country as they look to grow their national footprints. Team Health has acquired Florida-based Anesthetix Management, LLC, as well as Colorado-based Anesthesia Service, Inc., both serving as platforms for the company to ultimately expand nationally. In 2007, Mednax acquired Virginia-based Fairfax Anesthesiology Associates for an amount that some Wall Street analysts estimate was between nine and 10 times the company’s cash flow. In addition, an increasing number of private equity investment groups have backed smaller anesthesia companies with a view to growing them through acquisition. Moelis & Company, a prominent East Coast private equity group, recently acquired New York-based North American Partners in Anesthesia, and in 2009, The Beekman Group purchased Chicago-based Continental Anesthesia. Although purchase price multiples for both of these transactions were undisclosed, our experience has been that anesthesia practices have been on average trading for between six and eight times cash flow. Despite the apparent frenzy of activity in the anesthesiology sector, most companies making acquisitions have very well thought-out criteria in determining what practices they choose to pursue. Here are some of the key factors that any anesthesiology group should be aware of if it is considering selling or has been approached by a potential acquirer. Facilities Served Does the practice serve hospitals, ambulatory surgery centers (ASCs) or some combination of the two? In most cases, the type of customer will strongly determine who will be interested in purchasing the practice. Practices that serve hospitals typically are viewed more favorably than those that solely serve ASCs. Hospital relationships tend to be longer-term and are more “sticky” than ASCs, meaning hospitals are less likely to switch providers than ASCs are. Also, for the larger diversified acquirers, buying into anesthesiology practices with hospital customers enables them to cross-sell their other service lines into the newly acquired hospital relationship. TeamHealth, for example, has a strong core business providing emergency department staffing and administration. Having entered the anesthesia sector within the past few years, the company is keen on acquiring practices with strong hospital relationships. Of course, the majority of active acquirers will certainly not overlook practices with long-standing histories of working with high-quality ASCs.

Geography To a certain extent, the geography served by the practice plays a significant role in determining which acquirer might have an interest, as well as how attractive the practice will be to the acquirer. Where the practice is located, whether it treats a mostly urban or rural patient base or whether it is a local or regional player drive the decision-making process of a potential buyer. No one particular geographic profile is more attractive than another. However, being located in an area with a growing, relatively affluent patient population certainly helps in maximizing one’s options, both in terms of increasing the number of potential interested buyers as well as increasing the price a seller could command. In addition, being located in a city or state that is contiguous to the existing operations of one or more potential buyers makes the acquisition a compelling way for the buyer to expand in its immediate neighborhood. Practices located in the southeastern United States, for example, are likely to be of strong interest to companies like Mednax or Sheridan, as they have existing footprints in this region.

because the practice to be purchased derived the large majority of its patient revenue from a single hospital. What’s more, if management fees (sometimes also referred to as subsidies) paid directly by a hospital or surgery center make up a significant share of a practice’s revenue, a buyer will want to have an understanding of how likely those management fees are to remain in place going forward. Each of these factors will play a role in determining how much a buyer will pay to acquire the practice.

Payer and Procedure Mix Broadly speaking, the mix of payers and procedures drives the profitability of an anesthesiology practice. How much of the patient revenue comes from private insurers? How much from Medicare and Medicaid? Are the procedures being performed typically longer, more complex and more highly reimbursed, or are they shorter and less complex? Also, with regard to private insurance, how strong are the practice’s relations with its payers? Is the practice in or out of network with its top payers? As an in-network provider, does the practice have a history of relatively consistent reimbursement rates? Those Revenue Concentration anesthesiology practices that can demonstrate an Concentration is one of the most important factors evenly balanced payer mix, a procedure mix weighted that buyers will want to assess in determining whether toward more complex, higher-margin reimbursement to acquire an anesthesiology practice. If the practice codes and a consistent history of attractive payer conis deriving the majority of its patient revenue from tracts will be best positioned to attract higher valuaone or two facilities, the risk for that revenue dimin- tions from interested buyers. ishing or going away altogether is significantly higher Ownership Structure in the eyes of a prospective buyer than if that revenue were evenly spread across several facilities. My firm The makeup of an anesthesiology practice’s ownerhas watched more than one potential transaction fail ship is something that all potential acquirers consider.

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for access!

 Read about breaking news and other content available only on the Web site  Search for articles by keyword, department, headline, date and access content from archived issues  Discuss articles with your colleagues or post comments A practice owned by one or two partners employing, for example, between 50 and 75 clinicians usually will be seen by the buyer as an easier transaction than one that is owned by a large number of physician shareholders. The transaction itself is simpler because the buyer needs to negotiate with only a handful of decision makers. However, although negotiating with fewer shareholders may be simpler, a buyer may still have concerns over paying what could be a sizeable purchase price to a small number of doctors who still may be needed to run the business going forward. For anesthesiology groups with a large number of physician owners, potential acquirers will want to know that, although there is consensus among the shareholders, a few key leaders in the group have been empowered to communicate and negotiate on everyone’s behalf. Physician groups choosing to sell their practices to a larger buyer often find the experience very rewarding, both financially and operationally. However, sellers do need to understand that although buyers typically strive to minimize change to the practice after closing, they will now be employees of what will likely be a more structured company. The new employer will almost certainly be more metrics driven and cost conscious. Staff layoffs are not a common occurrence in the transactions that we have seen, but buyers will undoubtedly have a focus on maximizing their return on investment. Overall, the feedback that we hear from physician groups that we have worked with is that the experience of selling their practice turned out to be very positive for all involved. —Paul E. Kacik Mr. Kacik is managing director of the health care industry group at McGladrey Capital Markets LLC, an investment banking firm based in Costa Mesa, Calif.

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The APS/AAPM Opioid Treatment Guidelines Revisited In 2009, the American Pain Society (APS) and the American Academy of Pain Medicine (AAPM) released “Opioid Treatment Guidelines: Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Non-Cancer Pain.” Three years later, Anesthesiology News asked some of the authors of the guidelines to revisit them. AN: In hindsight, what are your overall feelings about the guidelines? Do you feel they have made an impact clinically?

has been disseminated in a number of ways. Courses, workshops and other education programs have been developed and have distributed this information to large audiences. The idea of providing opioids in the framework of a “trial” with goals and an exit strategy has been well received. Even a few years since pubGilbert J. Fanciullo, MD: I do. They summa- lication, the guidelines remain relevant as greater rized what the thought leaders in the United States awareness is brought to the balance between providfelt were the most important clinical issues related ing best practices for the management of pain and to opioids at the time. We used evidence-based med- focusing on the issue of prescription drug abuse. icine techniques to develop recommendations based on the evidence and the clinical opinions of these Steven Passik, PhD: I think that the guidelines leaders. These guidelines served and continue to have been important insofar as they represent legitiserve as the benchmark for all other opioid guide- macy of the practice of opioid therapy at a time when lines. The APS/AAPM guidelines were and still are the opioid pendulum has been swinging back toward the least biased of all opioid guidelines, and that is avoidance again. It codifies aspects of good practice not simply a coincidence; it was intended by design. (although it didn’t go far enough in some respects) They remain as a snapshot of opinions of the leading and brings together the evidence, which, more than experts in the field during a brief period in 2009. If anything, demonstrated how far we need to go in you want to see what guidelines look like when done terms of getting more evidence. correctly, these guidelines can serve as that example. Jane C. Ballantyne, MD: I think they have Jeremy A. Adler, MS, PA-C: I am very proud encouraged prescribing; they have been used to jusof the work accomplished by the guidelines com- tify continued prescribing of opiates for chronic pain. mittee. The guidelines were developed to achieve multiple goals. The foundation was to provide rec- David Fishbain, MD: I believe they have made ommendations for patient care that would be appli- very little clinical impact. cable in most clinical situations, and have these recommendations based on the best available scien- Perry G. Fine, MD: In the absence of a formal tific evidence. Where there were gaps in the evidence, evaluative process, it is not possible to say, one way consensus provided guidance for the missing infor- or the other, what the impact on practice or clinimation based on current best practices. A key com- cal outcomes has been. However, feedback from the ponent to the guidelines was identifying research medical community has been almost universally posgaps so researchers could be directed toward devel- itive and appreciative, and the guidelines have been oping the much-needed evidence. Although most cited broadly. They also have been used as a model of the recommendations are based on consensus, I for state-based guidelines. This leads me to believe believe they have served an important purpose and that the effort to produce them was worthwhile, and have had marked positive clinical impact. The con- at the very least, the guidelines have led many clinicept that opioids can be safe and effective in carefully cians to think beyond their previously held knowlselected and monitored patients is important and edge base and practice patterns.

Roger Chou, MD: I think the guidelines were one of the first real efforts to really critically look at the evidence on using opioids for chronic noncancer pain, [and then] provide actionable recommendations to clinicians and the tools to implement the recommendations in clinical practice. It’s pretty remarkable to bring together 20 or so experts from very different fields and have them reach consensus on the recommendations. I think the guidelines have made some impacts— many of the principles in the guidelines have been adopted by state agencies and other groups trying to help clinicians making everyday decisions about opioids. The principles regarding risk assessment and the need to structure care (or to choose not to use opioids in some patients) to minimize risks are important ones that we continue to try to hammer home.

AN: Looking back, is there anything that could have been addressed in the guidelines but was not? Mr. Adler: For a publication that was intended to accomplish so many goals, I think the pertinent issues were addressed in full. Dr. Fine: The very real challenge in creating the guidelines was the paucity of high-quality evidence available to inform practice recommendations. Regrettably, three years later, the literature has not miraculously become more robust, given the meager amount of research dollars available to address the most important questions, which have been framed in the publications that accompanied the release of the guidelines. What we do know is that there has been a parallel rise in prescription opioid-related morbidity and mortality with the increased use of opioids in the treatment of noncancer chronic pain. Clearly, principles of prescribing and practice need

T h e P a n el Gilbert J. Fanciullo, MD

Steven Passik, PhD

Jeremy A. Adler, MS, PA-C Jane C. Ballantyne, MD

David Fishbain, MD

Perry G. Fine, MD

Roger Chou, MD

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Pa in M e d ic in e to be further defined and adhered to so that there is the optimal match of treatments to produce predictable, positive therapeutic outcomes and minimize harms. Evidence-based guidelines are important, but are only a piece of a more complex public health–oriented approach needed to address the complex medical and social issues involved in the management of chronic pain and its interface with opioidrelated misuse. Dr. Fanciullo: Not really.

of urine drug screening was left vague. It has become commonplace and much more frequently used than was alluded to in the guidelines. This has been due, in part, to new data to support the practice, but more than anything to a developing community standard of care in response to the need to protect patients and practices against abuse, misuse and diversion.

associated with higher doses, and recent studies suggest that risk starts to go up at really relatively low doses. So, the threshold for what is considered a “high dose” probably wouldn’t be the same now as it was even two or three years ago, when we had almost no data on differential risks. Related to that, I think there is growing recognition that a substantial proportion of patients Dr. Chou: At the time, there wasn’t with chronic noncancer pain simmuch evidence on incremental risks ply don’t respond to opioids—

Dr. Chou: I think the guidelines were pretty comprehensive; one of the criticisms is actually that it is “too much” for most clinicians to do. I would argue that given the unique safety issues, abuse potential and societal harms associated with opioids, there really wasn’t anything that could be cut out. Dr. Passik: I think the scope and prevention of the problem of opioidrelated overdoses should have been more explicitly included. Dr. Fishbain: No, I don’t think so; I think we addressed what we needed to. Dr. Ballantyne: I think the issue of patient selection could have been better addressed. My own perspective is that not all patients are suitable candidates for opioid treatment, and that wasn’t really addressed in the guideline.

AN: Are there any areas that you feel didn’t go far enough? Meaning, you addressed it, but perhaps could have worded the recommendations more strongly/differently? Dr. Ballantyne: I think the issue of dependence and the fact that commitment to treatment often turns into a lifelong commitment wasn’t really addressed enough. In other words, once treatment has persisted for months or years, it is very hard to get people off of opioid treatment, even if it is not working very well. There wasn’t any guidance about decision points and when that discussion should be had. Dr. Passik: I believe that various aspects of risk management practice have progressed beyond the guidelines because there was such a grave need; for example, the frequency and timing Please visit us at the SCCM Booth #708

and that if these patients have not responded by the time they are at the equivalent of 60 or 80 mg per day of morphine, they probably aren’t going to respond at higher doses. Although we still don’t have a lot of “hard” data to support this, I think almost every clinician has seen this in clinical practice. The idea of “titrate up until you get a treatment response” is probably on its way out. In addition to the fact that some patients just don’t respond see opioids page 14

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P A I N MEDI C I NE AN: What is the most common positive feedback you receive with regard to the all that well to opioids, we know that on average we guidelines? Do you hear any negative see a 20% to 30% reduction in pain scores. So, titrating until pain is gone—or nearly gone—just results feedback?

Opioids continued from page 13

recommendations. As much as it feels good to know that the guidelines have been a welcome addition to pain literature, and the effort of the committee has been appreciated, the only way to assess the value of the guidelines or their consequences is if they have in a lot of people on very high doses of opioids, who led to positive, health-related outcomes in patients are probably no better off than if they were main- Dr. Chou: Common positive feedback is that the living with chronic pain … and that information is guidelines help lay out expectations about risk assess- not immediately available. tained at much lower doses. ment and monitoring and suggestions on how to Dr. Fishbain: Again, no. I think the guidelines structure opioid treatment and monitoring to match Dr. Fishbain: I have not heard any negatives. Again, were very precise and thorough; I wouldn’t change risk assessment. People like that tools are provided to I think the guidelines were very complete. aid with risk assessment and documentation, includany of the wording. ing informed consent and opioid agreements. I think Mr. Adler: The most common positive feedback Dr. Fine: The guidelines voiced strong cautions and the fact that the guidelines say that opioids aren’t is that the guidelines have served as a thoughtconcerns with regard to indications, dose initiation, always appropriate and provide the concept of a “trial ful and useful tool in clinical practice. The titration, monitoring, high-risk patients, concerns of therapy”—that the decision to continue opioids majority of stakeholders involved in the about methadone and so on. My concern, looking should always be a deliberate and conscious one— care of patients in pain have adopted back, and forward is that what was recommended have been helpful to people. these guidelines. In many ways, this has not been sufficiently embraced. is remarkable given the controversial subject of providing Dr. Fanciullo: My own bias was for more intensive monitoring of all opioid patients. I would have included urine toxicology testing as a recommendation for all opioid patients with chronic noncancer pain. That, however, was not the feeling of the group and the resulting recommendations were what the group was able to reach a consensus on. The final product was the result of extensive discussion and compromise. It would not be possible, I don’t believe, opioids in noncancer pain. to have such a large group of By basing the guidelines on the experts agree unconditionally about all aspects of best evidence available, there has ‘Just taking away or severely opioid treatment. been limited negative feedback. In addition, the guidelines have built-in restricting opioids isn’t a Mr. Adler: A particularly complex component of flexibility as new evidence emerges. the guidelines involves the recommendations for particularly effective way of urine drug testing and other monitoring strategies. Dr. Ballantyne: One negative comment I hear dealing with what is really a The guidelines appropriately make the point that is that because the guidelines are written by com“interpretation of urine drug screens is a challenge” mittee—that is, they are consensus guidelines—they societal problem of chronic pain.’ and that “clinicians should consider a differential don’t offer firm enough guidance. There was a great diagnosis for abnormal urine drug screen results.” effort made to include varying perspectives, which is —Roger Chou, MD Although best practices suggest that the overwhelmhow the committee members were selected. That is ing need remains for clinicians to add urine drug both good and bad. The experts had diverse opinions, monitoring to their monitoring protocols, there so ultimately many on the panel were not quite satremains no clear criterion on what should be tested, Dr. Ballantyne: I think the positive feedback is isfied with the recommendations. That is, of course, how often and exactly what course of action should that the guidelines were a really comprehensive a general criticism of consensus guidelines, especially be taken with the results. As an advocate for patients, attempt to look at the literature—as comprehensive if there is not enough evidence. I am very sensitive to the harm that can arise from as they could be—and although they didn’t provide a misinterpreted drug test. Although I believe that the evidence we needed, they did provide an indica- Dr. Chou: As I said before, some negative feedback most patients, in most clinical situations, should be tion as to where we need to go. The evidence wasn’t is that the guidelines are “too much” for primary monitored with urine drug testing, there contin- there, but it pointed the way to what does need to be care clinicians. But I don’t think asking clinicians ues to be an evolution with regard to the interpre- done. to provide safe care and understanding how to use tation of the results. Large-scale urine drug testing these medications is “too much.” We also get the has led to the discovery of complex metabolic path- Dr. Passik: I hear negative feedback about the lack opposite negative feedback stating that the guideways, limits to cutoff values and the presence of of specific detail in risk management. Positive feed- lines don’t go far enough in discouraging opimanufacturing contaminants. A misinterpreted test back is usually from those who appreciate the bring- oid use. But as I said, the guidelines are very clear could result in severe harm by interruptions in oth- ing together of the database. about the need to perform risk assessment, that erwise approriate care for compliant patients. Lookopioids aren’t always appropriate and that there ing back, I would have preferred greater awareness of Dr. Fine: I have not received any frankly negative are circumstances in which opioids should be disthe potential harms associated with misinterpreted feedback, which has truly surprised me. What I really continued. In my opinion, clinicians following the urine drug tests, in addition to the significant bene- want to know is what the outcomes are in patients recommendations in the guidelines will make more treated by clinicians who adhere to the guidelines’ informed and safer prescribing decisions, and that’s fits urine drug testing can provide.

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Pa in M e d ic in e an improvement. And in my opinion, there are low-risk patients in whom a trial of opioids is indicated— I just don’t agree with people who say no opioids ever for chronic noncancer pain. For example, I think it would be inappropriate to deny a trial of opioids to a 75-year-old patient with no personal or family history of substance abuse who has severe hip osteoarthritis and either can’t tolerate nonsteroidal anti-inflammatory drugs or hasn’t responded well to them. Another problem, not with the guidelines per se but with how we deal with chronic pain in general, is that we need to start thinking about this from a systems perspective, not just as an issue of whether to use opioids or

not. We know that psychosocial factors have a major influence on chronic pain and we need to make alternatives to opioids—like physical therapy, cognitive-behavioral therapy, and interdisciplinary rehabilitation— available as options. We also need to provide clinicians and patients with the resources so that patients can be withdrawn from opioids or treated for addiction when it’s needed. Just taking away or severely restricting opioids isn’t a particularly effective way of dealing

with what is really a societal problem of chronic pain. Dr. Fanciullo: The most positive feedback has to do with the high quality of the process of guideline creation. We all have Roger Chou to thank for that. Negative feedback has occurred as the entire medical community may have become or is becoming more conservative with regard to opioid use. The appreciation of the dramatic nature of the public health issue

regarding addiction, diversion, abuse and misuse, and the harm these drugs may be causing, may have precipitated criticism from individuals who felt the guidelines may not have gone far enough in the area of risk stratification and monitoring. If the guideline process began again today, I think we would have different and likely more “conservative” or restrictive recommendations. But for the 2008-2009 period during which these guidelines were created, I believe they were “right on.” 

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For Pain Patients, Google Ads Offer Endless Promises—and Pitfalls

atients with back pain who turn to Google to search for relief are more likely to find trouble instead. All of the top five consumer Web sites presented by Google AdWords in response to queries for “low back pain” were misleading, according to a new study, and none of the sites had been certified by an organization that upholds health information or privacy standards. “Patients with persistent pain are vulnerable to advertisements that promise relief, and when combined with various forms of Internet advertisements supported by prominent search engines like Google, they may fall prey to poor or fraudulent medical care,” said Frank H. Lee, MD, a third-year resident in the Department of Anesthesiology and Critical Care Medicine, at Johns Hopkins University School of Medicine, in Baltimore. Dr. Lee and Christopher L. Wu, MD, assistant professor of anesthesiology at Johns Hopkins, analyzed the sites presented by Google AdWords—a service in which advertisers pay Google a fee to have a link to their Web sites prominently displayed at the top of Google search results pages corresponding to specific keywords. Dr. Lee presented the study at the recent annual meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract A042). The findings, the researchers said, were consistent with previous studies that found the quality of Internet advertising for treatment of low back pain to be poor (Spine 2005;30:826-829). Internet ads “can be misleading and at times manipulative,” Dr. Lee said. “To protect health care consumers, an easier way of identifying and presenting accredited Web sites needs to be developed by Internet search engines,” he told Anesthesiology News.

Searching for Pain Relief In the study, 10 individuals conducted Google searches using the keywords “low back pain” from 10 separate computers on the Johns Hopkins campus, and from homes in the Baltimore and Washington, D.C., areas, during April and May 2011. The five most common paid Google AdWords responses were recorded and reviewed for content quality using metrics developed by pain clinicians at Dartmouth Medical School (Pain Med 2008;9:994-1000). Several of the advertised sites offered unreferenced medical evidence or free incentives to draw consumer attention. Two were proxies for pharmaceutical companies that redirected consumers to their sites advertising pain medications. Two other sites advertised endoscopic spine procedures with “Free MRI review” and free educational seminars. One site, from a chiropractic group, provided almost no educational information and offered “free consultation” to the first 50 callers. It claimed that “decompression therapy was shown to be 86% effective in treating herniated and degenerative discs … after 4 years over 91% remained pain free.”

“This is a very limited observational study and it is difficult to make any definitive conclusions,” Dr. Lee said. But he said he hoped the results would “start the discussion of how search engines and Internet advertising may affect vulnerable patient populations who are increasingly going to the Internet for answers.” Google declined a request for an interview. But a representative of the company provided the following written statement to Anesthesiology News: “Google AdWords prohibits false health claims in ads. Ads that make specific health claims about the effectiveness of a product must meet certain criteria [outlined here http://support.google.com/adwordspolicy/bin/ static.py?&hl=en&page=guide.cs&guide=130825 2&topic=1310883&answer=176031&rd=2]. We monitor and enforce our ads policies through a combination of both manual and automated processes. Ads that are found in violation of our policies will be removed.” Controversial Practices The Google AdWords service has come under government scrutiny. In August 2011, Google paid $500 million to the U.S. Department of Justice for having improperly profited from advertising Canadian pharmacies that illegally sold pharmaceuticals to consumers in the United States from as early as 2003. After the technology company became aware of the probe in 2009, Google announced it would require online pharmacies to display Verified Internet Pharmacy Practice Sites accreditation provided by the National Association of Boards of Pharmacy. Canadian pharmacies must be accredited by the Canadian International Pharmacy Association. Online pharmacies may only sell products to consumers in countries that permit such transactions. Google’s advertising problems have not been limited to health care and medicine. At the request of the federal government, in November 2011, Google suspended ads from more than 500 online advertisers and agents associated with 85 allegedly fraudulent mortgage services. Some of these services had claimed to be associated with the federal government’s Troubled Asset Relief Program. The Web sites required homeowners to pay upfront fees and then advised them to stop making mortgage payments and to cease all contact with their lenders. Scammers then diverted mortgage payments, transferred property deeds and released sensitive financial information. The scheme was not limited to Google; Yahoo! and Microsoft’s Bing services had also been targeted, and those companies also cooperated with the government’s requested shutdown. Although online health information can be misleading, incomplete or even fraudulent, some social media sites, such as Facebook, appear to offer benefits to consumers. Researchers at Mayo Clinic in Jacksonville, Fla., created a Facebook page for esophageal cancer survivors and their families. Since 2008, a

geographically diverse group of 65 patients have used the site to discuss strategies for coping with postoperative changes, including diet, nutrition and swallowing and regurgitation problems. Facebook “demonstrates how social media can assist health care providers in providing patients with a way to connect and get the support they need that physicians cannot provide because we have not experienced the disease firsthand,” said Herbert Wolfsen, MD, of the Department of Gastroenterology and Hepatology at Mayo. Dr. Wolfsen discussed the project at the 2011 annual meeting of the American College of Gastroenterology. A separate study conducted by researchers at the Cleveland Clinic Foundation analyzed the 100 mostviewed videos on YouTube relating to irritable bowel disease. Most of the information, they reported, was of poor quality. “Clinicians and their patients need to be aware of misleading information posted by patients or particularly by pharmaceutical companies who often post videos to make it seem like they were coming from a patient when actually it is a company advertisement,” said Saurabh Mukewar, MD, an internal-medicine resident at the Cleveland Clinic, who also presented at the gastroenterology meeting. Dr. Mukewar said that although social media can help patients and enhance their care, health care providers and professional societies need to provide “more educational and efficient materials using this powerful tool to counteract misleading information.” —Ted Agres

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T e c h nolog y Black Hole continued from page 1 exceeds by fivefold the error rates reported in the rest of the hospital (MEDMARX Data Report: A Chartbook of 1998-2004 Findings from the Perioperative Setting; 2006). In addition, more than 60% of medication errors committed by anesthesiologists are related to the removal of incorrect ampoules or vials from anesthesia drug trays, incorrect labeling of syringes after admixing and syringe swaps during surgery (Can J Anesth 2001;48:139-146). On average, anesthesiologists administer 10,000 drug doses a year, with estimated error rates ranging from 0.1% to 0.85%, Dr. Fedorko said. At best then, one error is committed for every 1,000 drug-dose administrations, or 10 errors annually. A vast majority of the errors—many of which pose a significant risk for harm—are reversible. “We can almost always dig ourselves out of a hole,” Dr. Fedorko said. “The event is charted, but it doesn’t always show up as an error.” Errors are often system-driven, Dr. Fedorko continued, a result of the fast pace of the OR workflow combined with a lack of redundant checks and balances. One possible solution, a satellite pharmacy for the OR, is exceedingly expensive and still would not address emergency doses. “We’re very good clinicians, but we’re not machines,” he said. “Throughout the hospital, there are safety steps in place to prevent medication errors, but not in the OR.” That is until now. Under the leadership of Esther Fung, RPh, director of pharmacy operations at UHN, a pharmacy–anesthesia collaboration was established to explore the potential of a point-of-care, computeraided syringe labeling, bar-coding and verification process. The system was developed at the UHN, with funding from the Canadian Patient Safety Advertisement

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administered in more than 20,000 surgical cases, no medication error incidents related to mistaken drug identity have been reported when bar-code scanning was used. A single critical drug error occurred when an anesthesiologist bypassed the bar-code scanning process. The results were so compelling that the system has become the standard of care at Toronto General and will soon extend throughout the UHN system to Princess Margaret Hospital and Toronto Western Hospital, both in Toronto.

‘My quest was to provide good quality pain relief for at least a couple of days by using a technique that doesn’t produce motor weakness.’ —Sugantha Ganapathy, MD Institute and drug-industry sponsors. (Dr. Fedorko has a financial interest in the technology.) In January 2010, the system was implemented in all 20 ORs at Toronto General, a 762-bed tertiary academic health system. Use by anesthesiologists was completely voluntary. The process requires the anesthesiologist to scan every drug ampoule and syringe label for accuracy verification throughout drug dispensing, premixing, administration and documentation. Dr. Fedorko explained that it enables real-time documentation of medication, fluids, infusions and urine and blood loss through an interface similar to a touch-pad screen. Electronic anesthesia data capture produces a complete intraoperative record that funnels directly to the UHN electronic medical record, which means that anesthesiologists do not have to document their actions after the procedure, as they had to previously. Within two weeks of implementation, all staff anesthesiologists had adopted the new process. Five months out, the bar-coding system had been used for more than 60,000 doses in more than 4,000 surgeries. All anesthesiologists who had used the system were surveyed about medication errors that were intercepted by bar-code scanning and to grade their satisfaction level with the system within that five-month window. The survey also asked if the anesthesiologists preferred the new system over the traditional one. Surveys were submitted anonymously. Twentyone of the 41 survey respondents (52%) reported 29 medication errors, all of which were intercepted by bar-code scanning. Opinions about the system were overwhelmingly positive: More than 97% of the responding anesthesiologists favored it. Now, after 23 months and more than 300,000 doses

Embracing Change At first, Dr. Fedorko feared that his colleagues would resist the change, in part because they would need to scan every ampoule pulled from the dispensing cabinet. But the staff anesthesiologists adapted quickly and thoroughly. “In fact, there was unanimous acceptance and they were very keen to use it,” he said. “They understood that it would not only prevent them from making drug errors, but also that it improved and automated workflow in terms of easier charting and documentation because they would no longer have to do it manually.” Another key that led to systemwide adoption is the relatively low implementation and operational costs. “The process is orders-of-magnitude cheaper than alternatives, such as a satellite pharmacy, and it also puts us fully in compliance with the Joint Commission for injectable medication labeling in the OR,” Dr. Fedorko said. He emphasized that the pharmacy took the lead in the system’s development and rollout. “I’d advise others who want to introduce this technology to coordinate closely with leadership in the pharmacy and anesthesia departments right from the start, and to make sure that the end users—the anesthesiologists— are involved in the development process,” he said. “Anesthesia on its own had no knowledge of, or appetite for, implementing a medication safety system. It was only the continuous education and support from pharmacy leaders that made it happen.” “This a fascinating study, especially coming from a practicing anesthesiologist who sees these problems everyday and did something to address them,” said Roy Guharoy, PharmD, chief pharmacy officer and professor of medicine with the University of Massachusetts Memorial Health Care in Worcester. “They didn’t mandate use of the system. But once it could be shown that it helped anesthesiologists save time, the anesthesiologists were won over, and now they have 100% compliance.” Dr. Guharoy agreed with Dr. Fedorko’s characterization of the OR as a “black hole” of drug safety: “They’re often in a rush; they get these drugs very fast and it’s easy to mix up the wrong dose. It happens. All around the country there are major initiatives, and a lot of federal money, to implement electronic medical records. But the OR is one area that has not been adequately addressed in terms of safety, and there’s lots of room for improvement.” In fact, shortly after hearing Dr. Fedorko’s presentation, Dr. Guharoy spoke to his facility’s medication safety pharmacist; his hospital has begun looking into implementing a similar system. “This is an area we really need to address. Not nearly enough has been done.” —Steve Frandzel

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CL I N I CA L A N ESTHESIOL OG Y

Mortality From Bariatric Surgery Found Lower at Accredited Centers Ability to care for critically ill, not volume, may explain outcomes disparity San Francisco—A new study shows a threefold reduction in in-hospital mortality when bariatric surgery is performed at accredited, as opposed to nonaccredited, bariatric centers. In a report presented at the 2011 Clinical Congress of the American College of Surgeons, researchers studied more than 35,000 bariatric operations performed between October 2007 and December 2009. In-hospital mortality at accredited centers was 0.06% compared with 0.21% at nonaccredited centers (P=0.002), results showed. “Accreditation status is associated with a distinct improvement in inhospital mortality,” said lead author Ninh T. Nguyen, MD, professor of surgery at the University of California, Irvine Medical Center, in Orange. However, even at nonaccredited centers, the mortality rates were extremely low. “I think that very small difference that you are seeing is really clinically insignificant,” said Edward Livingston, MD, professor of surgery at UT Southwestern Medical Center, in Dallas, and a contributing editor for the Journal of the American Medical Association (JAMA). When patients’ comorbidities on admission were taken into account, the mortality gap between accredited and nonaccredited centers grew, from a low of 0.04% at accredited centers to a high of 0.48% at nonaccredited centers (P<0.01). The mortality gap broadened further in patients who remained in the intensive care unit (ICU) for at least one week, which was used as an indicator for the presence and severity of complications. Of patients treated at nonaccredited centers, 20% did not survive compared with 4.9% of patients with a prolonged ICU stay at accredited centers (P=0.02). The higher survival rates at accredited centers could be related to the ability of these centers to rescue patients when complications arise, Dr. Nguyen said. Accreditation status appeared to play a greater role, too, in patients who underwent more complex procedures. Mortality reached 0.25% among patients who underwent gastric bypass at nonaccredited centers compared with 0.06% at accredited centers. However, there was no statistically significant difference in mortality among

patients undergoing gastric banding (0.11% vs. 0.04%). In the late 1990s, the popularity of bariatric surgery exploded in the United States, with utilization rising by more than 400% between 1998

and 2002, according to a report from the Agency for Health Care Policy and Research (Health Affairs 2005;24:1039-1046). Rates have since plateaued. With the sudden growth in the 1990s came concerns about

poor outcomes for these elective procedures, particularly for gastric bypass with its known learning curve for surgeons. One study, published in JAMA, found a 2% mortality rate within 30 see bariatric page 24

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C LI N I C A L A N ESTHESIO LO G Y Inject continued from page 1

82% said they worked at least part exposed to hepatis B and C, and HIV, time in an outpatient facility. since 1999, according to the U.S. CenPerhaps most concerning, the surMore than 125,000 patients in the ters for Disease Control and Prevenvey also found that four anesthesia res- United States have potentially been tion (CDC). Although the agency said idents in the state (8%) said they had reused syringes on different patients, Table 1. Reported Barriers To Using a New Vial of Medication for Every Patient although the researchers who conTotal Practice Setting ducted the survey expressed doubt that everyone who said they did so underAny Outpatient No Outpatient stood the question. Attending physi(n=431) (n=85) n (%) n (%) n (%) cians were much less likely to admit to reusing syringes—2%, the survey Shortage of medication 231 (44) 192 (45) 38 (45) found, which is in line with previous Lack of storage 25 (5) 20 (5) 5 (6) reports. “I was discouraged to see the num- High cost 143 (27) 125 (29) 18 (21) ber of respondents who were not using 48 (9) 42 (10) 6 (7) appropriate safe injection practices,” Inconvenience Reduce waste 229 (44) 203 (47) 26 (31) said Elliott Greene, MD, professor of anesthesiology at Albany Medical Col- Save time 7 (1) 7 (2) 0 (0) lege, in New York, and a co-author of Personal preference 23 (4) 21 (5) 2 (2) a report on the survey. “That was a reminder that we have a lot of work None 174 (33) 137 (32) 33 (39) to do to educate not only the trainees—the residents were showing some differences from the attending physicians—but the overall responses show Table 2. Questions From the NYSSA/NYCDOH Survey on Injection Practices some very serious infection control Total Resident Attending lapses.” n % n % n % Physicians blamed drug shortages, such as the ongoing problems with Medication Vial Use propofol, and efforts to reduce waste How often did you use the same medication vial for more than one patient? as the biggest obstacles to using a new 269 49% 27 51% 180 49% vial of medication for each patient Always/Most of the Time/Sometimes (Table 1). Total 545 53 365 “I’m not using that as an excuse, I’m Did you leave a needle, cannula or spike device inserted into a medication vial’s just saying that’s something that we rubber stopper for reuse? need to work on,” said Richard Beers, 81 15% 10 19% 59 16% MD, an anesthesiologist at the Syra- Always/Most of the Time/Sometimes Total 543 52 364 cuse VA Medical Center and the State University of New York Upstate Medi- How often did you combine leftover concal University, in Syracuse, who helped tents of medication vials for use on a new patient lead the survey. Dr. Beers said he was not sure every Always/Most of the Time/Sometimes 58 11% 5 10% 39 11% physician who reported reusing a 528 50 355 syringe understood the question. How- Total ever, he added, even if only one doctor How often did you use an open medication vial where you did not directly did so knowingly, “that would be hor- observe someone else opening it? rendous practice if it were true. I hope Never/Sometimes/Most of the Time 126 23% 10 20% 88 24% sincerely it’s not true.” Total 540 51 363 Training Widespread— But Is It Effective? The news was not all bad, however. The survey, conducted by the New York State Society of Anesthesiologists (NYSSA) and the New York City Department of Health, found that 98% of attendings who participated said they’d taken a sanctioned infection control course in the past year. Meanwhile, 84% of all respondents said they were aware of outbreaks linked to poor injection practices. The survey, which had a response rate of 26%, included 595 residents and attending anesthesiologists practicing in New York (Table 2). Of those,

Needle/Syringe Use Did you keep used syringes and needles (or cannulae) separate from clean, unused needles and syringes while providing anesthesia? Never/Sometimes/Most of the Time

Total

538

14%

15%

11%

362

How often did you use a new needle and syringe each time [you] accessed a medication vial? Never/Sometimes/Most of the Time

144

Total

523

28%

55%

24%

350

How often did you use a new needle and syringe when administering medications for each new patient? Never/Sometimes/Most of the Time

Total

522

4 51

NYCDOH, New York City Department of Health; NYSSA, New York State Society of Anesthesiologists

7 250

“many of these lapses” involve reused syringes, it did not provide a more precise figure. These cases spurred the development of the One & Only Campaign, a collaboration of the CDC and the Safe Injection Practices Coalition, to reduce the incidence of unsafe injections. The campaign is focused on New York, New Jersey and Nevada. In New York and Nevada, several high-profile cases of unsafe injection practices have surfaced in recent years. The most dramatic of these involved an outbreak of hepatitis C linked to a chain of endoscopy clinics in Las Vegas. Health officials notified nearly 63,000 patients in the area of their potential risk for exposure to hepatitis C and other bloodborne pathogens—although eventually only five cases of hepatitis C were definitively linked to medical procedures performed at the facilities. Prabhu Gounder, MD, an epidemiologist at the New York City Department of Health and Mental Hygiene, who worked on the report, said the results call for a “multifaceted” approach. Education of providers about safe injection practices still is necessary, Dr. Gounder said, but so, too, are efforts to change what he called systemic problems—such as the continued availability of multidose vials of propofol. “We’d like to work with the CDC and the FDA to potentially change how medication vials are labeled. We think all medication vials should be labeled as single-use vials only.” In addition, Dr. Gounder said, the government must do more to address drug shortages. The Obama administration recently issued new rules regarding shortages, but whether these will help the problem remains to be seen. “Shortage is going to be an ongoing issue,” Dr. Gounder said. “Anesthesiologists may have to make alternative arrangements. In in-patient settings, pharmacists can split vials in a sterile environment, or propose alternative medicines.” For Dr. Greene, who with Dr. Beers helped create a training module for the NYSSA on safe injections, the message is simple enough: “Don’t enter a vial with a used syringe or needle. Always use a clean syringe and needle, and all vials, including multidose vials, are single-patient-use; throw them out at the end of the case. Don’t administer medications from the same syringe to more than one patient. That way there’s no potential for transmitting something inadvertently.” —Adam Marcus

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Best Practice Measures May Not Curb Central-Line Infections

espite the introduction of “best practice” measures to reduce central line–associated bloodstream infections, these infections remain problematic in the sickest patients in the intensive care unit, according to a new study presented at the 2011 annual meeting of the American Association for the Surgery of Trauma. “Our best practice improved, but our rates of central-line bloodstream infections were essentially the same,” said Matthew Lissauer, MD, medical director of the surgical intensive care unit (ICU) and assistant professor of surgery at the R. Adams Cowley Shock Trauma Center, at the University of Maryland Medical Center, in Baltimore. An estimated 248,000 bloodstream infections occur in U.S. hospitals each year, accounting for 28,000 deaths annually and substantial cost (an estimated $45,000 for each case). Over the past several years, the health care community has ramped up efforts to cut down central line–associated bloodstream infections (CLABSI). The Centers for Disease Control and Prevention (CDC), in collaboration with other organizations, developed guidelines to prevent CLABSIs and other health care–associated infections. Although many centers and states have now adopted best practices, several studies describe persistent infections, with rates between one and three per 1,000 catheter-days (Am J Infect Control 2010;38:430-433; Crit Care Med 2011;39:245-251). Dr. Lissauer and colleagues set out to find if introducing best-practice policies affected CLABSI rates in their hospital. They conducted a retrospective cohort study of the sickest ICU patients, culled from a non-trauma general surgery population admitted between April 1, 2008 and April 30, 2010. Midway through the study period, the hospital changed its best-practice bundle, incorporating the latest research at that time, which was consistent with a best-practice program based on CDC recommendations and “what we thought was best for our patients,” Dr. Lissauer said. The program included a checklist for care, proper catheter maintenance, unit-specific nursing and physician champions, patient/family education and antibiotic-coated catheters. Previously, the hospital had managed infection control by hand washing; implementing full barrier precautions and chlorhexidine skin preparation;

and avoiding the femoral vein whenever possible. The hospital also had a program to identify and remove catheters when they were no longer necessary. These steps later became part of the best practice checklist. All patients included in the analysis had a central line in the hospital for at least four days. Patients admitted with a diagnosis of CLABSI or those whose

severity of illness could not be calculated were excluded from the study. Over a period of 12,016 catheterdays, 65 CLABSIs occurred, for a rate of 5.4 per 1,000 catheter-days. The introduction of a new best-practices protocol midway through the study period did not significantly change the rate of infection. After the 2009 change in protocol, infections rose

marginally from 5.3 to 5.5 per 1,000 catheter-days, which was not statistically significant. The findings were based on a risk factor analysis including 981 patients, with 59 CLABSIs in 51 patients. Patients spent a mean of 26 days (±26 days) in the ICU before the CLABSI diagnosis and had a catheter see central line page 23

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C LI N I C A L A N ESTHESIO LO G Y Environment continued from page 1

sets in 274 ORs at three tertiary care medical centers; cultures were obtained throughout the surgical proMedical Center, in Lebanon, N.H., and his col- cedures from the anesthesia environment, IV stopleagues found that all major reservoirs—providers, cock sets, provider hands and patients. Stopcocks the surgical environment and patients themselves— became contaminated in 23% of the surgeries. appeared to transmit bacteria to patients. “There’s a complex interplay of all of these three ‘Because the stopcock is in direct reservoirs,” said Dr. Loftus, assistant professor of anesthesiology and critical care medicine. “In many contact with the intravascular space, cases, it’s not the provider who’s bringing bacterial if that’s contaminated it means contamination to patients.” Consequently, interventions that target just providers are likely to be ineffecthe patient is contaminated.’ tive, he added, because all types of contamination can participate in patient infections. —Randy Loftus, MD The environment already may be contaminated before the arrival of patients and providers, resulting in the spread of bacteria to devices used during surIn more than one-third of the cases, the researchers gery. In addition, bacteria carried on patients’ skin were able to determine the sources for bacterial conmay enter the bloodstream during surgery. tamination—and all reservoirs contributed signifiDr. Loftus’ group presented its findings at the cantly. Specifically, patients were the primary source 2011 annual meeting of the American Society of of methicillin-resistant Staphylococcus aureus and Anesthesiologists (ASA). methicillin-sensitive S. aureus; the hands of health care Hospitals need to target patient reservoirs, estab- providers before surgery were most likely to transmit lish systems that enable providers to wash their hands vancomycin-resistant Enterococcus. In contrast, procontinuously during surgery and improve strategies vider hands before, during and after surgery were the for cleaning the surgical environment, Dr. Loftus said. main reservoir for gram-negative bacterial pathogens, “When all those programs are implemented, then you most likely picked up from the surgical environment. will see a dramatic and sustainable decrease in infections.” In their second study (abstract 1118), the researchTo track patient infections, the investigators ers tracked bacterial infections during the first and seclooked for contamination of IV stopcock sets that ond cases of the day in the 274 ORs, that included the served as a proxy for patient contamination, as vali- number of times a trained observer saw providers use dated by previous research. Dr. Loftus said that it was an alcohol-based dispenser. They found that providers not surprising that bacteria on the stopcocks might used the dispensers 0.39±1.06 times per hour during eventually infect patients. “Because the stopcock is surgery. Each time providers washed their hands, the in direct contact with the intravascular space, if that’s density of stopcock contamination decreased by nearly contaminated it means the patient is contaminated,” 10% (odds ratio [OR], 0.911; confidence interval [CI], he told Anesthesiology News. 0.868-0.955; P=0.005). In one study (abstract 1119), Dr. Loftus and his In their third study (abstract 1121), the authors team tracked the transmission of bacteria to stopcock reported that the second case of the day was

Stopcock filled with saline

S. epidermidis

 Alcohol pad  Nothing (control)  Site-scrub

P. aeruginosa

Stopcock filled with propofol

Figure. Growth of bacterial colonies (lined areas) on stopcocks after treatment with alcohol pads, control (no treatment) or Site-Scrub (n=10 stopcocks/treatment). Stopcocks were filled with sterile saline or sterile propofol, and then contaminated with Staphylococcus epidermidis or Pseudomonas aeruginosa. No bacterial colonies grew on the stopcocks treated with alcohol pads.

significantly more likely than the first case to have a contaminated stopcock (unadjusted OR, 5.91; CI, 3.66-9.53). Of the three tertiary care sites included in the analysis, two had more problems with contamination than the third. In a multivariate model, lower ASA health status and contaminated stopcock were the only predictors of mortality. These findings are part of ongoing research by Dr. Loftus and his colleagues to pinpoint the primary culprits in health care–associated infections. Although the current research links multiple factors to potential infection, a 2008 study found that a highly contaminated surgical environment increased the risk for stopcock infection by nearly fivefold (Anesthesiology 2008;109:399-407). “The environment is the No. 1 source of contamination of these devices,” Dr. Loftus said. “But, it’s not that providers are bringing the bacteria in. It’s that they’re working within a contaminated environment.” To reduce the risk for environmental contaminants reaching the patient, the researchers previously installed a novel device for decontaminating the hands of providers in half of 114 surgeries. Their study published in 2009 reported that providers with access to the device cleaned their hands 27 times more often, and infections decreased by more than 80% (Anesthesiology 2009;110:978-985). Mark Rice, MD, clinical associate professor of anesthesiolog at the University of Florida College of Medicine, in Gainesville, said he agreed completely with the conclusions of the current research that providers, patients and the surgical environment together transmit infections to patients. “[The researchers] have done a great job working at ‘what’s the problem here,’” Dr. Rice said. “What we’re trying to do is figure out ‘what’s the solution?’” Dr. Rice and his team also presented a study at the ASA meeting (abstract LBT03), in which they compared the efficacy of basic alcohol wipes with a new cleaning device, Site-Scrub (Bard Access Systems, Inc.), to decontaminate stopcocks. Since the emergence of Site-Scrub, many hospitals have switched to its use, including the University of Florida. “I was thinking, since we invested in these SiteScrubs, they should work,” said Julie Holroyd, an undergraduate at the university who co-wrote the paper with Dr. Rice. Instead, the investigators found that alcohol wipes did a significantly better job than the device at decontaminating stopcocks. When the IV was filled with saline, alcohol pads eliminated all bacterial growth, whereas some contamination persisted after SiteScrub treatment and in the control condition (Figure). When IVs were filled with propofol, alcohol pads were still better at eliminating bacteria. “I was very surprised,” Ms. Holroyd said. It is not clear why one swipe of an alcohol wipe across the rim of a Luer connector appeared to decontaminate better than Site-Scrub, which consists of foam fingers filled with alcohol that clean by a combination of friction and alcohol, Dr. Rice said. “From what we know now, we would clearly recommend one to use an alcohol wipe.” Representatives of the seller of the Site-Scrub device, C.R. Bard, Inc, did not respond to requests to comment on the findings. —Alison McCook

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CL I N I CA L A N ESTHESIOL OG Y Central Line continued from page 21

Healthcare Safety Network–desig- University School of Medicine, in its infection control practices based nated CLABSIs were from a source Philadelphia, said the study conclu- on the result of this study, the center inserted for a mean of 10 days (±8 other than the central line (Infect Con- sions, although not surprising, raise an became more vigilant about complydays) before the infection. Catheters trol Hosp Epidemiol 2010;31:551-553). important question about what issues ing with best practice, said Dr. Lissauer. linked to infections included those The patients in this study predomi- influence the risk for infection in the Increased vigilance helped reduce used for dialysis (14 patients), nantly had an open abdomen due to sickest ICU patients. “At this time, infection rates “somewhat” since the subclavian central venous catheter intraabdominal infections. Another the answer is unclear. Nevertheless, study period—rates are now less than (CVC; 31 patients), femoral CVC (13 factor contributing to infections the authors rightly question whether three infections per 1,000 catheterpatients), internal jugular catheter (10 was the prolonged time that more adherence to best-practices bundles days. “But we still have line-associated patients), upper extremity peripherally severely ill patients may require central may be compromised in the sickest infections, especially in the groups inserted central catheter (three catheters. patients, increasing infection risk.” identified in the study.” patients) and medi-port (one patient). Adrian Ong, MD, associate proAlthough the University of MaryInvestigators identified four vari- fessor of surgery (adjunct) at Temple land Trauma Center did not change —Christina Frangou ables that increased the risk for infection—male gender (odds ratio [OR], 1.97; 95% confidence interval [CI], 1.04-3.74), admission to the emergency surgery service (OR, 2.01; 95% CI, 1.10-3.77), having an open abdomen as indicated by Current Procedural Terminology code (OR, 2.33; 95% CI, 1.23-4.40) and ranking in the highest quartile for severity of illness (OR, 7.27; 95% CI, 1.60-33.08). Dr. Lissauer said the urgency of care in more critically ill patients is the most important factor that impedes infection control. “It’s easy to comply with best practice, including sterile technique, in a hemodynamically staSince 1987, Preferred Physicians Medical (PPM) has ble patient with a lower severity of illexclusively insured anesthesiologists and their practices. FREE, No-Obligation Evaluation of ness. In patients with higher severity, Our policyholders also own PPM, so it’s no surprise that Your Informed Consent Process protecting our physician owners’ professional reputation is the catheters tend to be more difficult at the core of everything we do. to insert, often requiring numerous Our experience has shown plaintiff attorneys often focus on a practice’s sticks that remain in place longer.” There is no substitute for experience. With over 23 years of informed consent process to underOther possible risk factors included experience exclusively defending anesthesiologists, PPM mine a jury’s conﬁdence in the quality lack of specificity in CDC/National draws upon that extensive knowledge to arm our physician of anesthesia care delivered. Healthcare Safety Networks. In owners with practical, anesthesia-speciﬁc strategies to another study, only 61% of National Every new PPM policyholder receives

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Periarticular Infusion Facilitates Fast-Track Arthroplasty Las Vegas—For the thousands of people every day who undergo total hip or knee replacements and have significant postoperative pain, relief may be on the horizon. Researchers at the University of Western Ontario, Canada, found that a postoperative periarticular infiltration of ropivacaine, morphine, ketorolac and epinephrine—followed by a local anesthetic infusion—provided effective analgesia without motor blockade. A preselected group of patients who received the treatment benefited from early mobilization and discharge. “I have been using regional anesthesia following hip and knee replacements for years,” said Sugantha Ganapathy, MD, professor of anesthesiology at the institution, who led the study. “However, while single-shot techniques provided only 24 hours of pain relief in knee patients, continuous catheter blocks resulted in variable motor blockade with increased risk for falls on mobilization. My quest was to provide good quality pain relief for at least a couple of days by

using a technique that doesn’t produce motor weakness.” To test the efficacy of the current approach, the investigators enrolled 100 patients (age range, 40-75 years; American Society of Anesthesiologists physical status I-III) into the trial. Fifty patients in each of two groups scheduled for total knee arthroplasty (TKA) or total hip arthroplasty (THA) received perioperative multimodal analgesia with celecoxib (Celebrex, Pfizer), gabapentin and acetaminophen. This was followed by periarticular infiltration of 300 mg of ropivacaine (Naropin, APP Pharmaceuticals) in 100 mL mixed with 30 mg of ketorolac, 10 mg of morphine and 2.5 mcg/mL of epinephrine. All patients also received spinal anesthesia with 15 mg of hyperbaric bupivacaine without intrathecal opioids. Dr. Ganapathy presented the results at the 2011 annual spring meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract 108). Multiorifice catheters (three for TKA; two for THA) were positioned by the

surgeons at the end of surgery before wound closure. Ropivacaine 0.35% was infused (2 mL/h) by elastomeric pump through each catheter for 48 hours. All patients underwent accelerated postoperative mobilization consisting of walking with support on the evening of the day of surgery, progressing to walking five meters and climbing a set of stairs using crutches by noon of the first postoperative day. Plasma levels of ropivacaine were measured when patients arrived in the postanesthesia care unit and on the morning after surgery (Table 1). Early discharge was contingent on good pain control, hemodynamic stability and no nausea or surgical complications. Patients were then seen by home care personnel, who removed catheters at 48 hours and provided physiotherapy and occupational therapy services for several days. Of the 100 patients, 78 were discharged the day after surgery; an additional four were discharged at 36 hours. Pain scores at rest and during ambulation were low (Table 2); plasma

ropivacaine levels were less than the toxic range. Various significant adverse events were noted, the most common being dizziness and hypotension which affected four patients. Three patients had surgical site bleeding; two had postoperative sciatic dysfunction or poor pain control. One patient had a myocardial infarction on the third postoperative day at home. No patient developed infection. Twenty-two patients were not fasttracked for a variety of reasons: poor pain control (11), low hemoglobin and hypotension (five), patient unwillingness (three), logistical reasons (two) and a broken catheter (one). Nevertheless, patient satisfaction was high. Two patients—both with sciatic dysfunction—experienced motor weakness. One of the challenges that institutions may face in implementing this kind of program is resistance from surgeons. “A couple of surgeons made a big fuss about the time it takes to insert the catheters,” Dr. Ganapathy told Anesthesiology News. “They contributed two cases each and

Bariatric continued from page 19 days of bariatric surgery and 4.6% within 12 months of surgery (2005;294:1903-1908). As a result, thirdparty payers initiated a centers of excellence program in 2004, which eventually led to the development of two accredited bariatric surgery programs: the American Society of Metabolic and Bariatric Surgery’s Center of Excellence program, which was started in 2004 and requires a minimum of 125 cases a year; and the American College of Surgeons’ Bariatric Surgery Center Network, which was initiated in 2005 and grants Level 1 status to centers that perform more than 125 cases a year and Level 2 status to those that do more than 25 lower-risk cases a year. Both programs require surgeons and centers to submit their outcomes to a central database. Investigators set out to measure the effect of accreditation status on perioperative outcomes, using data collected by the University Health System Consortium Database, an alliance of 114 academic medical centers and 255 of their affiliated hospitals. Over the study period, 35,284 bariatric procedures were reported. Of these, 89% were completed at accredited hospitals, reflecting the tremendous growth of the accreditation programs. The 71 accredited hospitals studied performed a mean of 197 cases per year, much higher than the mean 39 cases reported by nonaccredited hospitals. The 43 nonaccredited centers treated more women (80.2% vs. 77.7%, respectively) and a greater proportion of black (19.5% vs. 13.2%, respectively) and Hispanic (7.1% vs. 5.3%, respectively) patients than the accredited centers. Demographics were similar in all other aspects, including disease severity.

Approximately 60% of patients treated in both kinds of hospitals had minor severity, whereas the remainder had moderate to major severity of illness when admitted. When investigators compared outcomes based on the admission severity of illness, they found a greater difference in mortality. In-hospital mortality was 0.46% among patients with moderate and majority severity treated at nonaccredited centers. For the same group of patients, the mortality rate was 0.10% at accredited centers. Investigators believe that the improved outcomes were not related to higher volume of surgery performed at accredited centers but rather to “their ability

to manage patients with a higher severity of illness and their ability to recognize and rescue the patient when major complications arise,” said Dr. Nguyen. However, other surgeons questioned whether the findings are significant. Dr. Livingston said that the mortality difference is extremely small, and might not be accurate because investigators did not include body mass index (BMI) in their analysis. “This can’t be risk-adjusted if you do not account for BMI.” He argued that the figures suggest that 250 patients would need to be operated on at a center versus a nonaccredited center of excellence to benefit one patient. At $100,000 per year for accreditation, “that’s

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Table 1. Patient Demographics, Ropivacaine, Analgesia and Satisfaction Variable

THA (50 TKA (50 Patients)a Patients)a

Variable

THA (50 Patients)

TKA (50 Patients)

Weight, kg

81.3 (19)

92.1 (18.5)

DOS rest

0.9 (1.6)

1.2 (1.7)

Height, cm

169 (8.7)

172.5 (9)

Ropivacaine, 0.493 mcg/mL (PACU) (0.3)

0.37 (0.23)

Ropivacaine, 1.2 (0.5) mcg/mL (POD 1)

1.19 (0.58)

Percocet equivalent, DOS

3.4 (1.5)

3.6 (1.5)

Percocet equivalent, POD 1

2.9 (1.4)

2.6 (1.5)

Percocet equivalent, POD 2

2.4 (1.4)

2.6 (1.5)

Satisfaction (scale, 0-10)

7.9 (2)

6.9 (2)

DOS, day of surgery; PACU, postanesthesia care unit; POD, postoperative day; THA, total hip arthroplasty; TKA, total knee arthroplasty a

Table 2. VAS Pain Scores (0-10)a at Rest and During Activity

Mean (± standard deviation).

then withdrew participation.” Dr. Ganapathy also pointed out that the results depended on a prescreening process by which relatively healthy patients were selected for the program. “We actually screened many more than 100 patients, but we preselected relatively healthy patients with good contralateral quad and leg function,” she said. “My aim is to get those patients who are a lot of money to try to save one life, if in fact, the results are true. “The math would suggest that it would cost $25 million to save one life, which is beyond the bounds of the $50,000 cost to offset one qualityadjusted year of life that is generally accepted as the threshold for cost effectiveness,” he said. Dr. Nguyen agreed the difference was small but argued that it is clinically significant. “When we are talking about mortality, it’s a clinically relevant parameter.” Both accredited and nonaccredited centers had identical results in terms of overall complications (2.3% for both), and similar results for ICU stay (8% vs. 7.3%), and 30-day readmission (2% vs. 2.5%). However, mean hospital length of stay was 0.3 days shorter at accredited centers (2.4±3.1 vs. 2.7±4.2 days; P<0.01) and mean costs were $3,758 less ($13,203±$4,028 vs. $16,961±$9,172; P<0.01). The study was not designed to measure outcomes beyond the period of hospitalization. As such, 30-day and one-year mortality were not assessed. Moreover, the results are based on outcomes from academic and teaching hospitals and might not reflect the overall population. —Christina Frangou

DOS activity

2.7 (2)

3.3 (2.4)

POD 1 rest

1.1 (1.5)

1.6 (1.7)

POD 1 activity 2.7 (1.8)

3.2 (2.2)

POD 2 activity 2.4 (1.4)

3 (2.5)

POD 7 activity 1.4 (1.3)

1.9 (1.9)

POD 30 activity

0.8 (1.4)

0.5 (0.7)

DOS, day of surgery; POD, postoperative day; THA, total hip arthroplasty; TKA, total knee arthroplasty; VAS, visual analog scale a

Mean (± standard deviation).

AnesthesiologyNews.com I 25

CL I N I CA L A N ESTHESIOL OG Y good out of my hospital as fast as I can.” Sanjay K. Sinha, MD, director of regional anesthesia at Saint Francis Hospital and Medical Center, in Hartford, Conn., lauded the long-term prospects of the researchers’ approach. “The challenge of developing an analgesic technique for total joint replacement patients that does not produce lower-extremity weakness, enables earlier mobilization of patients and decreases length of hospital stay is a formidable one,” Dr. Sinha said. “If the surgeons

are on board, the technique seems easy and simple to implement in selected patients.” Important information could have been obtained by having a control group, especially the value of this technique in THA patients, according to Dr. Sinha. “Recent publications have questioned the analgesic efficacy of local infiltration analgesia and continuous infusion in THA patients,” he said. —Michael Vlessides

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Volatile Anesthetic Shows Promise for Treating Major Depression Small study hints at benefits of isoflurane over electroshock

reatment with high doses of the inhaled anesthetic isoflurane could bring relief to patients with severe, debilitating depression, a new study suggests. Researchers at the University of Utah in Salt Lake City found that isoflurane was as effective as electroconvulsive therapy (ECT) at improving mood in patients with depression but lacked the cognitive side effects associated with so-called “shock treatment.” The investigators presented their findings at the 2011 annual meeting of the American Society of Anesthesiologists (abstract 002). ECT is known to help patients with severe depression who do not respond well to antidepressants, but it is associated with cognitive impairment and frequently is used only as a last resort. How the shocks resolve depression is not fully understood. However, the Utah team hypothesized that isoflurane and ECT may both induce a brief state of electrocortical quiescence—burst suppression on electroencephalogram (EEG)—but isoflurane does so without causing seizures. “Patients who come to ECT are in a crisis and often functioning at a low level due to the severity of their depression. Since almost 4 million people with major depression in the United States are treated ineffectively each year, this could potentially help hundreds of thousands of patients,” said lead author Scott Tadler, MD, assistant professor of anesthesiology at the University of Utah. “Isoflurane doesn’t have the memory problems. This will make it more likely that people will be treated, since it won’t carry the stigma attached to ECT,” said principle investigator Howard Weeks, MD, assistant professor of psychiatry at the University of Utah and assistant director of neurostimulation services at the institution. Dr. Weeks noted that if isoflurane is proven to be effective, people with depression might feel comfortable seeking help earlier. Those who do so might avoid hospitalization, which is a typical scenario that currently leads to ECT, he said. Dr. Weeks added that portrayal of ECT in the media has wrongly depicted it as taking place without anesthesia—to the detriment of public understanding of how it is administered. Although there is no centralized database tracking ECT, Dr. Weeks estimated that at least 100,000 patients in the United States and well over 1 million globally undergo ECT treatment each year.

Dr. Tadler and his colleagues theorized that the inclusion of patients older than 70 years, as well as a more limited number of treatments, had substantially impacted follow-up work. The Utah study included 27 men and women between the ages of 18 and 65 years with moderate to severe major depressive disorder that was not responsive to multiple drug regimens and who had no other psychiatric diagnoses, serious cognitive impairment or unstable cardiovascular or cerebrovascular disease. Of those, eight received isoflurane and 19 received ECT. Treatment consisted of either eight to 12 treatments of bifrontal ECT or 10 isoflurane treatments over a period of between 2.5 to three weeks. Patients receiving isoflurane were dosed to isoelectricity— that is, to the point at which electrical activity in the brain is suppressed—for 15 minutes at each treatment. The dose used was initially 2.5 times the ageadjusted minimum alveolar concentration and then After Hint of Effect, Failures titrated to assure greater than 80% burst suppresThe Utah team modeled its research on a study sion ratio by EEG. One patient who received isofluby psychiatrist Gerhard Langer, MD, of the Univer- rane dropped out because of anxiety, according to the sity of Vienna, conducted more than 20 years ago. researchers. Dr. Langer’s study had demonstrated a potential Both therapies in the non-blinded study resulted effect on mood of isoflurane but had not been repli- in significant clinical decreases in depression scores cated in subsequent trials. immediately following the treatment series—75%

of isoflurane patients and 90% of ECT patients (P<0.05 for both groups). ECT has been linked with some degree of long-term loss of preexisting memories. In the current study, the treatment was associated with decreased function on most cognitive tests when measured between 24 and 48 hours after treatment. Cognitive function returned to near baseline for all except autobiographical memory at the four-week mark. For example, a patient undergoing ECT might not recall some life experiences, such as attending a wedding two years earlier. For isoflurane, however, most tests showed improvements in performance or at least no notable worsening at posttreatment and follow-up, the investigators reported. The researchers cautioned that their data needed to be supported by a larger, blinded, randomized study before clinicians should use isoflurane to treat depression. But they called the initial results compelling in terms of both the success rate and the clear cognitive differences between patient groups. Nicole Berchtold, PhD, a neurobiologist at the University of California, Irvine, said isoflurane seems to have potential for treating depression. However, she added, “based on the Hamilton depression scores at the six-week follow-up, the isoflurane group appeared to be reverting to higher depression scores relative to the ECT group. This suggests that the ECT benefits are more stable and long-lasting than isoflurane, and suggests that isoflurane treatment would have to be relatively frequent for sustained benefit.” Dr. Weeks, whose group is seeking funding fora follow-up study, said that if future studies support the latest findings, isoflurane could be used alongside ECT, and might even replace it in some cases. “We would have to see what illnesses would respond to isoflurane versus ECT,” he said. “There may be specific subtypes—for example, major depression with psychotic features, major depression with catatonic features, bipolar depression, acute suicidal ideation— that respond better to one or the other.” Dr. Weeks also saw what he characterized as manageable hurdles. They included the concern that patients must be able to tolerate the depth of anesthesia required to achieve isoelectricity, and the more intensive use of resources in the operating room. “ECT is very fast—it can take as little as 20 minutes. Isoflurane takes 45 minutes to an hour, so when you talk about operating room costs, that can be a lot more expensive. So you have to look at optimizing costs. There are ways to work with this, but it needs economic analysis.” —Jennifer Hanawald

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Atlas of Image-Guided Intervention in Regional Anesthesia and Pain Medicine

James P. Rathmell Lippincott Williams & Wilkins, November 7, 2011 This atlas is a practical guide for practitioners who perform interventional procedures with radiographic guidance to alleviate acute or chronic pain. The author provides an overview of each technique, with detailed illustrations of the relevant anatomy, technical aspects of each treatment and a description of potential complications. The author also discusses medical evidence on the technique’s applicability.

Best Practice & Research: Clinical Anaesthesiology

H. Van Aken Elsevier/Mosby, 2012 In practical paperback format, each 200-page, topic-based issue provides a comprehensive review of current clinical practice and thinking within the specialty anaesthesiology.

Gregory’s Pediatric Anesthesia, Fifth Edition

George A. Gregory; Dean B. Andropoulos John Wiley/Blackwell Publishing, February 21, 2012 Aimed at pediatric anesthetists, anesthetists and anesthetists-intraining, this new edition covers the use of anesthesia on newborns to young adults, placing a strong emphasis on the most recent and important information from research and publications.

Hadzic’s Peripheral Nerve Blocks and Anatomy For Ultrasound-Guided Regional Anesthesia

Admir Hadzic McGraw-Hill, December 7, 2011 Featuring sections that progress from the foundations of regional anesthesia to the clinical applications of nerve blocks, this book includes tips and insider perspectives from the leadership of The New York School of Regional Anesthesia and its academic affiliates. The book also includes a unique atlas of ultrasound anatomy for regional anesthesia and pain medicine.

How to Survive in Anaesthesia,Fourth Edition

Neville Robinson; George Holt; William Fawcett John Wiley, December 20, 2011 This pocket-sized book, written by three authors who have nearly 90 years of anesthesia experience between them, covers basic aspects of airway and fluid management and equipment, followed by common emergencies. Finally, it tackles all the common surgical specialties step by step. It is always practical, ever contemporary and frequently amusing. It provides safe and practical advice to help novices survive those first few months.

Pocket Pain Medicine (Pocket Notebook Series)

Richard D. Urman; Nalini Vadivelu Lippincott Williams & Wilkins, June 8, 2011 This concise, up-to-date, evidence-based reference guide is written in the popular Pocket Notebook Series format that is ideal for today’s fastpaced health care environment. Information is presented in a schematic, outline format, with diagrams and tables for quick, easy reference.

Sedation and Analgesia in the ICU: Pharmacology, Protocolization, and Clinical Consequences, An Issue of Anesthesiology Clinics

Pratik Pandharipande, MD, MSCI; E. Wesley Ely, MD, MPH Elsevier/Saunders, December 28, 2011 This issue looks at modern sedation techniques in the critically ill. It covers such topics as pharmacology of commonly used analgesics and sedatives in the ICU, pharmacology of sedative-analgesic agents, sedation and weaning from mechanical ventilation and cognitive functioning, mental health and quality of life in ICU survivors.

Single Best Answer MCQs in Anaesthesia

Cyprian Mendonca; Mahesh Chaudhari; Biju Kurian; Josephine James TFM, August 1, 2010 This book comprises six sets of practice papers. Each set contains 30 single best answer questions that cover topics including clinical anesthesia, pain and intensive care. AN0112

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Hip Fracture Patients, and Their Kidneys, Do Better With Regional Anesthesia Las Vegas—In patients undergoing hip stabilization surgery, those who received general anesthesia experienced a higher incidence of acute kidney injury (AKI) than those who received regional anesthesia, based on a retrospective cohort study at the University of Florida College of Medicine, in Gainesville. The study found that none of the 73 patients who received regional anesthesia experienced renal failure, whereas five of the 235 patients receiving general anesthesia did. Linda Le-Wendling, MD, clinical assistant professor of anesthesiology at the University of Florida and co-author of the study, said a troubling incidence of AKI in hip fracture patients—affecting as many as 67% of patients with baseline renal insufficiency—has been reported in recent trials. Perhaps not surprisingly, patients with AKI experience worse outcomes than their counterparts,

including greater postoperative complications and mortality. The study was presented at the 2011 annual spring meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract 57). The study included 308 patients, aged 65 years or older, who underwent operative treatment for low-impact hip fracture at the institution between 2006 and 2008. Regional anesthesia comprised neuraxial anesthesia with conscious sedation and primarily continuous intrathecal catheters. General anesthesia was defined as inhalational or intravenous anesthesia requiring an endotracheal tube or some invasive airway device, Dr. Le-Wendling said. When asked why clinicians chose to use intrathecal catheters instead of spinal or epidural anesthesia, Dr. LeWendling said that speed of analgesia and safety were the two primary concerns. “We wanted excellent, intense

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analgesia,” she said. “Our surgeons always want zero out of four twitches and complete muscle relaxation. And so, we didn’t figure that epidural anesthesia would allow us that. “And with spinal anesthesia, many of our patients are frail and debilitated,” she added. Dr. Le-Wendling said that problems with hemodynamic changes can result “if you have one shot and overdo it.” The nice thing about using intrathecal catheters, she said, is being able to incrementally dose them and provide “great anesthesia” without many hemodynamic changes. Creatinine data were gathered by reviewing each patient’s electronic record during hospitalization. These data included creatinine levels at admission, highest creatinine levels and creatinine levels at discharge. The institution’s billing database provided information on patient demographics, preoperative comorbidities and outcomes. “Our most impressive finding was the lower incidence of acute kidney injury in the patients who had regional anesthesia [based on modified risk-factor and life-expectancy criteria],” Dr. Le-Wendling said. No patient in the regional anesthesia group had renal failure or required renal replacement therapy (compared with 2% and 3%, respectively, in the general anesthesia patients). Far fewer patients given regional anesthesia were admitted to the intensive care unit after surgery (3% vs. 11%; P=0.04). “We also looked at their in-hospital resource utilization,” Dr. Le-Wendling said. “And there was really no significant difference in the amount of blood or blood product transfusions.” Although 4% of general anesthesia patients required transfusion, none of those in the regional group did. This difference, however, did not reach statistical significance (P=0.09). “One of the interesting things we looked at was drug utilization, specifically the nephrotoxic agents given to patients prior to their acute kidney injury. The only difference we found was a higher incidence of [nonsteroidal anti-inflammatory drug] use in the regional group,” she said. Patients with AKI had a higher rate of mortality than those without; this was true within the first year, and beyond. “It’s interesting to note

‘Our most impressive finding was the lower incidence of acute kidney injury in the patients who had regional anesthesia.’ —Linda Le-Wendling, MD that even though the general anesthesia group had a higher incidence of acute kidney injury, mortality was no different three years out than for regional patients,” Dr. Le-Wendling said. “This could be because patients in the regional group were a bit older. It doesn’t seem like much, but when you’re talking about 83 versus 81, age is probably working against you with regard to mortality.” John Rowlingson, MD, professor of anesthesiology and director of the Acute Pain Center at the University of Virginia School of Medicine, in Charlottesville, who moderated the presentation, said the data were more compelling when considering the demographics of the respective patient populations. “It’s obviously very important to look at morbidity and mortality, as well as comorbidities,” Dr. Rowlingson said. “I’m impressed by the fact that the regional anesthesia folks who did better in terms of renal function were older and had a higher use of presurgery nonsteroidals.” He said those two factors “may amplify the results.” —Michael Vlessides

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Good Drugs, Bad Doctors This article is the second in a two-part look at crime and the history of anesthesia

n the early 1960s, anesthesiologist Carl A. Coppolino, MD, seemed to have a good career under way. He and his second wife, Carmela, had both graduated in 1958 from State University of New York Downstate Medical Center, in Brooklyn; they later had two daughters. While practicing at the Methodist Hospital of Brooklyn and Riverview Hospital in Red Bank, N.J., Dr. Coppolino began to publish articles in various medical journals. Some dealt with hypnosis in anesthesia; one was a major review on that topic. In 1965, he and Carmela published a book on alcoholism, “The Billion Dollar Hangover.” By mid-decade, he also had published “Practice of Hypnosis in Anesthesiology” and “Get Slim and Stay Slim with Hypnosis.” The latter book seems to have signaled, to some extent, his changing interests. By July 1966, Dr. Coppolino had been indicted in the death of his former neighbor William E. Farber. Mr. Farber had suffered what initially was presumed to have been a coronary occlusion three years earlier in Middletown Township, N.J. The death certificate of Mr. Farber, a retired Army colonel, was signed by Carmela Coppolino. At the time of his indictment, Dr. Coppolino was a widower living in Florida; Carmela had died almost one year earlier of a presumed heart attack—just weeks after Dr. Coppolino had substantially increased her life insurance. Less than a month after Carmela’s death, he married a wealthy divorcée, Mary Gibson. Carmela’s death in Florida raised suspicions about Mr. Farber’s death. During the New Jersey trial, Dr. Coppolino was defended by F. Lee Bailey, who at that time was just beginning his rise to becoming one of the nation’s best-known attorneys. The doctor needed all of his attorney’s considerable skills as one stunning revelation followed another. Dr. Coppolino, who had developed a heart condition and retired from medicine, had spent his time playing bridge and charming the neighborhood ladies while living off Carmela’s income. The dead colonel’s wife, Marjorie, became Dr. Coppolino’s mistress; during the trial she testified that her lover had hypnotized her and she stood helplessly watching him smother her husband with a pillow after their attempts to use a drug-filled syringe had failed. Famed New York medical examiner, Dr. Milton Helpern, was among the experts who testified in the case. Nevertheless, Dr. Coppolino was acquitted on Dec. 15, 1966. By that time, he had been indicted in Florida for the death of his wife, Carmela. Once again, Bailey led the defense team. Evidence of an injection had been found on one of her buttocks. Dr. Helpern also testified in this case, noting that

traces of succinylcholine had been found in Carmela’s brain and liver. Marjorie Farber, who had followed the Coppolinos to the Sarasota area and had moved into the house next door, testified again as well. Dr. Coppolino’s quick remarriage after Carmela’s death had pushed his former lover’s jealousy far enough that Marjorie had approached the Florida authorities about the two suspicious deaths. Dr. Coppolino was found guilty of second degree murder and sentenced to life in prison in this second case. It was one of Bailey’s early career losses. Today, the method that was used by Dr. Helpern and others to obtain evidence of succinylcholine in Carmela’s body is considered unscientific.

If you tried to pass many of these cases off as fiction, no one would believe them.

succinylcholine in Ms. Augustine’s body. Just days before her death, her husband had been discussing with a co-worker a similar scenario as a way to kill someone. At the time of her death, Ms. Augustine was well known in Nevada. Her death and its aftermath received intense and dramatic press coverage in the state. Between 1993 and 1999, Ms. Augustine had served in the state Assembly and Senate, and had left the legislature to become comptroller. Mr. Higgs was her fourth husband; airline pilot Charles Augustine, her third husband, had died of a stroke in 2003. After Ms. Augustine’s death, Charles Augustine’s body was exhumed to settle questions over whether Mr. Higgs had been involved in that death; however, no evidence of foul play was found. During Mr. Higgs’ trial, his attorney attempted to discredit the evidence pertaining to succinylcholine— just as Bailey had done for Dr. Coppolino. Mr. Higgs, however, was convicted in June 2007, and sentenced to life in prison. He will be eligible for parole in 20 years. His appeals were denied by the Nevada Supreme Court in May 2009. Two books have already been written about this case. Nefarious uses of anesthetic drugs, such as in these cases, are only a few of the sinister examples to which such agents have been put since 1846. When Emory University student Barbara Jane Mackle was kidnapped and buried alive in 1968, Gary Krist and his female accomplice used chloroform to subdue Ms. Mackle, the daughter of a wealthy developer in Florida. The father paid $500,000 in ransom money. Ms. Mackle spent three days underground; Mr. Krist was caught, convicted and spent 10 years in prison. After his parole, he went to medical school and practiced in Indiana until his license was revoked in 2003. Both Ms. Mackle and Mr. Krist have written books about the case; there also have been movie versions. Perusal of the historical record turns up even more cases beyond belief—but not beyond the capacity of humans for mischief. A former nurse killed a young woman with propofol in Gainesville, Fla., in 2005. Chloroform was involved in the “Mormon sex in chains” kidnapping case, in 1977, involving a Wyoming beauty queen and a Mormon missionary in London. Cases in the medical literature document suspicious deaths involving tubocurarine (1985) and pancuronium (1990). In the tubocurarine case, a chief surgeon was accused in numerous deaths over a period of years, but was acquitted. In the second case, a nurse twice attempted to kill her husband, who was an anesthesiologist. If you tried to pass many of these cases off as fiction, no one would believe them.

Dr. Coppolino had obtained six vials of the drug before Carmela’s death. Nevertheless, he was paroled in 1979, and apparently has remained in Florida ever since. He surfaced briefly in 2003 in a newspaper interview and on the Internet promoting an article, “The Truth About Ellagic Acid.” Many books and chapters have been written about Dr. Coppolino’s trials, in addition to many contemporary newspaper and magazine articles. A popular detective novelist, John D. MacDonald, wrote one of his few nonfiction books, “No Deadly Drug” (1968), about the case. The year after his release, Dr. Coppolino published “The Crime That Never Was,” in which he defended himself. A much more recent case also involved succinylcholine. On July 8, 2006, Kathy Augustine, the first female state controller in Nevada history, was found unconscious in her home in Reno. She never regained consciousness and died four days later. Her death, at first attributed to a heart attack, was soon being scrutinized by the police. Ms. Augustine’s second husband, Chaz Higgs, a —A.J. Wright, MLS critical care nurse, attempted suicide in the days after her death, and then was arrested in Virginia Mr. Wright is an historian in the anesthesiology department at the in late September. FBI toxicologists had detected University of Alabama School of Medicine, at Birmingham

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Ehrenfeld JM et al. American Society of Anesthesiologists. 2010;LBO5. Juhl A. et al. Crit Care Med. 2010;38(12):215.