Anesthesiology News - November 2010 - Digital Edition by McMahon Group

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THE INDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTS AnesthesiologyNews.com • N o v e m b e r 2 0 1 0 • Volume 36 Number 11

NQF-Endorsed Outcome Measures Target Critical Care Review of additional measures planned

he National Quality Forum has endorsed eight outcome measures pertaining to pulmonary and cardiovascular conditions and patient care in the intensive care unit. Included in the measures are the paired outcomes of ICU length of stay and in-hospita l mortality. see quality page 34

Computers Find New Ways To Muddle Prescriptions

unching a prescription into a computer may keep a doctor’s sloppy penmanship from misleading the dispensing pharmacist, but a new study suggests that it also can lead to its own dangerous mishaps. “There’s a big conversion to electronic prescribing going on today,” said David W. Bates, MD, professor of medicine at Harvard Medical School, in Boston. “But there is a downside to the technology, as we found: Nearly any electronic prescribing application can create new errors as well as prevent them.” The researchers presented their findings at the 2010 annual meeting of the American Society of Anesthesiologists, in San Diego (abstract 183)—which might not seem like the see muddle page 14

Efforts Increase To Curb Rise of Illegitimate Pain Clinics in Florida

lorida’s state legislators are taking aggressive measures to halt an epidemic of opiate-related deaths in that state, hoping to intervene in the seven-plus mortalities that occur daily as a result of prescription drug overdoses. Implementing Senate Bill 2272, they hope, will end the proliferation of “pill mills” and help shut down those already in business. The bill, which went into effect Oct. 1, mandates the creation of a statewide prescription drug monitoring program (PDMP), delineates narrow conditions to establish a pain

violations, once management clinic, identified,” said limits the amount of Sonya Pease, MD, controlled substances FSA president. physicians can preThe FSA has scribe and restricts been calling for the advertisement of establishment of a pain treatments. prescription drug The Florida Socimonitoring program ety of Anesthesiolsince the early part of ogists (FSA) hailed the decade, Dr. Pease the new measure. said. “While the first The Florida Pain version of the law does Clinic law “was desperately needed by law enforce- have its drawbacks, such as the ment so that ‘pill mill’ operators need for a physical examination by could be charged with criminal see Florida page 28

INSIDE 12 | TECHNOLOGY For spinal anesthesia, scan first, puncture less.

16 | CLINICAL ANESTHESIOLOGY Novel clot analyzer could alter OR practice.

24 | CLINICAL ANESTHESIOLOGY Failing the VTE test.

32 | PAIN MEDICINE Noninvasive method for facet joint denervation.

26 | Procedural Sedation for the Difficult Patient

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Discuss these and other articles @ AnesthesiologyNews.com.

HEARD HERE FIRST: The highest dose was the

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and vomiting, but on the other side,

increased the bleeding risk. This was it also

November 2010

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

very astonishing to us.

1. The Pharmacology of Intravenous Anesthestic Induction Agents (Educational Review)

SEE ARTICLE ON PAGE 19.

2. Current Concepts in the Management of the Difficult Airway (Educational Review) 3. Podcast Interview With Alexander Hannenberg, MD (Web Exclusive) 4. Legal, Clinical Data Paint Conflicting Picture of Cricoid Pressure 5. The Taking

ALAN KAYE, PHD, MD, New Orleans, LA ROBERT S. LAGASSE, MD, New Haven, CT ALEX MACARIO, MD, MBA, Stanford, CA THE INDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTS

AnesthesiologyNews.com • mcmahonmed.com

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RUSSELL K. PORTENOY, MD, New York, NY J.G. REVES, MD, Charleston, SC

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NOT RECEIVING ANESTHESIOLOGY NEWS? All U.S. anesthesiologists should receive Anesthesiology News free of charge. If you are not receiving the publication, or if you are changing your name or address, please follow these instructions: 1) Contact the American Medical Association (AMA) at (800) 262-3211 or the American Osteopathic Association (AOA) at (800) 621-1773, and notify them of your name, address and professional specialty. You need not be a member of the AMA or AOA to receive the publication. 2) For added assurance of uninterrupted service, you may also mail or fax a copy of your current mailing label, along with your change of name or address to: Circulation Coordinator, Anesthesiology News 545 West 45th Street, 8th Floor New York, New York 10036 Fax: (212) 664-1242 E-mail: circulation@mcmahonmed.com Please sign and date all requests. If you are not a U.S. anesthesiologist and would like to subscribe, please send a check payable to Anesthesiology News to the Circulation Coordinator. Annual subscription: $70.00 (outside U.S.A., $90.00). Single copies: $7.00 (outside U.S.A., $10.00). Please allow 8-12 weeks for delivery of the first issue. McMAHON PUBLISHING, Sales, Production and Editorial Offices: 545 W. 45th St., 8th Floor, New York, NY 10036, Tel. (212) 957-5300.

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Resident Placer Facing Charges of Bribery, Forgery in NYC Case Prosecutors allege ‘corrupt’ scheme of exorbitant fees, payoffs

lite American Health Systems, a residency placement firm based in California, boasts that it “connects the world’s most gifted healers with the medical centers and patients who need them. … From Jodhpur to Jakarta, from

Burma to Baltimore—wherever elite surgeons and physicians practice, Elite American Health Systems has a presence.” Elite’s network may indeed involve gifts, but not quite how the company suggests.

The Manhattan district attorney has charged Alexander Everest, PhD, Elite’s chairman, with felony counts of bribery and forgery in his efforts earlier this year to place four would-be surgical residents at Harlem Hospital, a state-run

facility in New York City. According to prosecutors, Dr. Everest offered $15,000 in checks to a Harlem Hospital official to coax the official into accepting the graduates. He allegedly called the unsuccessful payoff a “thank you” and an “Easter love gift” for the employee, who reported the incidents to hospital administrators, who in turn notified law enforcement agents. Prosecutors claim that Dr. Everest also provided forged letters from a California hospital on the graduates’ behalf falsely stating that they had

CLIPCHART Chicago: $156,456. That’s how much debt the typical medical school graduate left campus with in 2009, according to the Association of American Medical Colleges. Nearly 80% of grads carry at least $100,000 of debt, the group said, while 58% have upwards of $150,000 in loans. Ramen noodles with that MD, anyone?

Set the new standard every time you prep with ChloraPrep.® ChloraPrep® skin antiseptic has consistently outperformed iodine-based products.2,3,4,5 In a landmark study published in The New England Journal of Medicine, ChloraPrep reduced total surgical site infections by 41% versus povidone-iodine [9.5% vs 16.1%, respectively].2 It’s one more reason why ChloraPrep is the proven way to prep.™ References: 1. Wenzel RP. Minimizing surgical-site infections. N Engl J Med. 2010;362(1):75-7. 2. Darouiche R, Wall M Jr, Itani M, et al. Chlorhexidine-alcohol versus povidone-iodine for surgical-site antisepsis. N Engl J Med. 2010;362:18-26. 3. Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efﬁcacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009;91(8):1949-1953. 4. Ostrander RV, Botte MJ, Brage ME. Efﬁcacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005;87:980-985. 5. Chaiyakunapruk N, Veenstra DL, Lipsky BA, Saint S. Chlorhexidine compared with povidone-iodine solution for vascular cathetersite care: a meta-analysis. Ann Intern Med. 2002;136(11):792-801.

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Santa Monica, Calif.: The Hemodynamics Duo? Anesthesiologists Nat Strand and Kat Chang are vying for the $1 million prize in CBS’s reality show “The Amazing Race.”

NOVEMBER 2010

AnesthesiologyNews.com I 7

IN BR IE F been accepted into a second-year training program there—a prerequisite for Harlem’s surgical residency system. Prosecutors said Dr. Everest charged his clients, largely graduates of foreign medical schools, more than $100,000 in fees for his “corrupt ‘services.’” He also is alleged to have demand that clients sign contracts limiting their ability to find residencies on their own. The company’s Web site is down, but an operator at Elite’s New York City office

Detroit: Foes of President Obama’s efforts to reform the nation’s health care system received a setback in October when a federal judge rejected a request by the Thomas More Law Center to block a key element of the new law requiring Americans to obtain health insurance by 2014. In the first national ruling on the measure, U.S. District Court Judge George Steeh determined that Congress had the authority to issue the mandate as an aspect of its power to regulate interstate commerce.

Miami: Foes of President Obama’s efforts to reform the nation’s health care system received a boost in October when a federal judge formally agreed to hear a case, brought by Florida and 19 other states, seeking to overturn the law.

told Anesthesiology News that the firm is still doing business. Dr. Everest did not return a phone message; his cell phone number is no longer in service. Calls to Dr. Everest’s attorney, George Vomvolakis, were not returned. Dr. Everest has pleaded not guilty to all charges and is scheduled to appear in court Nov. 17. If convicted on all counts, he

could face seven years in state prison, according to Joan Vollero, a spokesman for the Manhattan DA’s office. Dave Demerjian, JD, head deputy in the public integrity division of the Los Angeles County District Attorney’s office, said his department has received no complaints about Dr. Everest or Elite. A search of the Los Angeles

area’s Better Business Bureau Web site showed that Elite American Health Systems received a “B” rating from the group—a high mark. However, at least two members of the Student Doctor Network, an online forum for would-be physicians, had disparaging things to say about Dr. Everest. —Adam Marcus

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experienced dramatic and prolonged relief from multimodal analgesia combining nerve blocks or epidurals. Their scores on a 10-point pain scale dropped from an average of 7 on the battlefield to just under 4 three hours after treatment, and to less than 2.5 seven to 10 hours after surgery (P<0.001). Nerve blocks were the most common regional procedures, performed

Numeric Rating Scale

ultimodal analgesia that incorporates regional techniques is a mainstay of pain care in the hospital. The approach is becoming indispensable to combat medicine, as well. A new study by researchers at Walter Reed Army Medical Center, in Washington, D.C., has found that soldiers with major combat injuries, from gunshot wounds to trauma from improvised explosive devices,

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in 72% of cases; epidural injections were administered in 15.5% of patients. The drugs typically used in the multimodal regimens were paracetamol (93%) and diclofenac (82%). “Early multimodal pain control in combat environments has important implications for possibly preventing early central sensitization, hyperalgesia and the development of chronic pain syndromes,” the authors wrote, “as well as providing superior pain control during long flight evacuations to distant military hospitals, when it can be extremely challenging to safely titrate analgesics and monitor patients.” “I believe civilian hospitals have much to glean from the success of the acute pain service in managing polytrauma patients,” said Col. Chester “Trip” Buckenmaier, MD, an Army anesthesiologist who helped conduct the study. “The impact of regional anesthesia on these patients has been a very positive advancement in battlefield trauma that has yet to penetrate traditional civilian trauma medicine.” The army researchers presented their findings at the 2010 annual meeting of the American Society of Anesthesiologists (abstract A960), in San Diego. —Adam Marcus

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Percentage of patients cleared for orthopedic surgery who have below-normal levels of vitamin D

NOVEMBER 2010

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FDA Issues Final Rule on Safety Information During Clinical Trials

he FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. “This final rule will expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics,” said Rachel Behrman, MD, associate director for medical policy in the FDA’s Center for Drug Evaluation and Research. “These changes will better protect people who are enrolled in clinical trials.” The new rule requires certain safety information that previously was not required to be reported to the FDA, be reported within 15 days of researchers’ becoming aware of an occurrence. These reports include: • findings from clinical or epidemiologic studies that suggest a significant risk to study participants,

• serious suspected adverse reactions that occur at a rate higher than expected, and • serious adverse events from bioavailability and bioequivalence studies, which are typically conducted for generic drugs to determine what percentage of a drug is absorbed by the bloodstream and whether the drug has the same strength and affects people in the same way as the brand-name drug. The rule also provides examples of evidence that would suggest that an investigational product may be the cause of a safety problem. Under current

Percentage of orthopedic surgery patients whose vitamin D levels were deficient

Source: Journal of Bone and Joint Surgery, Oct. 6, 2010

regulations, drug sponsors often report all serious adverse events, even if there is little reason to believe the product caused the event. Such reporting complicates and delays the FDA’s ability to detect a safety signal. The examples discuss when a single event should be reported or when there is a need to wait for more than one occurrence.

In addition, the rule revises definitions and reporting standards so that they are more in alignment with two international organizations, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organization’s Council for International Organizations of Medical

Sciences. The changes are designed to help ensure harmonized reporting of globally conducted clinical trials. Along with this final rule, the FDA also issued a draft guidance for industry and investigators that provides information and advice about the new requirements and other information. —Based on a press release from the FDA

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T E C H NO L O G Y

Novel Device Aims for Safer Infusions

nfusion pumps are well-known sources of medication errors in the hospital. Utah researchers have designed a prototype system that they hope might reduce operator error and improve patient safety in the administration of propofol and other drugs delivered through these devices. The system (Figures) lets users interact with a pump through a color, touch-

screen monitor whose central feature is an image of a syringe. That addition, the researchers said, should avoid “factor of 10” errors that can occur when clinicians enter dose volumes on a conventional numeric keypad. Dwayne Westenskow, PhD, director of biomedical engineering for the Department of Anesthesiology at the University of Utah, in Salt Lake City,

said the new system should make infusions safer while giving users more efficient feedback of pump information. In tests, the more user-friendly interface shortened the time required to program an infusion, he added. “We plan for our syringe image and input controls to become part of a commercial anesthesia workstation’s large touch screen monitor,” said

Dr. Westenskow, who presented his group’s technology at the 2010 annual meeting of the International Anesthesia Research Society (abstract S-245). The pump will be placed next to the patient’s arm, where the drug is delivered, and the operator will be able to control it wirelessly from the workstation. The anesthesiologist can then adjust the infusion rate while looking at the patient’s vital signs, particularly those that are altered by the infusion, he added. The Anesthesia Patient Safety Foundation helped fund the project. —Adam Marcus

AnesthesiologyNews.com I 11

NOVEMBER 2010

TE CH N OL OG Y 1.6

nesthesiology departments trying to rein in their budget for volatile agents—which typically consume about 20% of anesthesia drug expense in a hospital—might want to take a page from a group in upstate New York. When physician researchers at Albany Medical Center realized how much they were spending on sevoflurane and desflurane (Ultiva, Abbott), they wondered why the anesthesiology staff were eschewing isoflurane. Isoflurane is two to five times cheaper, respectively, than the other two agents, but Albany clinicians tended to use three times as much desflurane instead. The reason became clear immediately: Albany’s anesthesia machines were equipped with only two vaporizers, for which sevoflurane and desflurane were typically the default drugs. The researchers decided to mount an additional bracket on the machines for isoflurane and watch what happened. After six months, the results were striking. Use of isoflurane nearly doubled, from 21% to 39% of the total volatile agents consumed. Meanwhile, use of sevoflurane fell from 20% to 15% of total consumption and desflurane consumption dropped from approximately 60% to 46%—a 22% decrease (Table). The change produced dramatic savings. The cost per unit of anesthesia at Albany fell from an average of $1.40 in 2008 to as low as 46 cents per month after the shift, according to the researchers (Figure). The net savings during the six-month study period: a shade over $138,000. Whether pushing isoflurane had any effects on case turnover

Table. Percentage (by bottles consumed) for Each Volatile Anesthetic Agent Agent

2008

2009 (6 Months)

Sevoflurane 20%

15%

Desflurane

60%

46%

Isoflurane

20%

39%

Cost per Unit ($)

Volatile Agents Easy Target for Cost-Conscious Hospitals or discharge time from the postanesthesia care unit remains to be seen, said the researchers, who presented their findings at the 2010 annual meeting of the International Anesthesia Research Society (abstract S-151). —Adam Marcus

1.4

1.2

1.03

1.0

0.83

0.8 0.6

0.74

0.67

0.65 0.46

0.4 0.2 0.0

2008 Average

January February 2009 2009

March 2009

April 2009

May 2009

June 2009

Figure. Cost per billing unit of volatile agent before and after extra vaporizer was installed.

When thrombotic risk is high in hereditary antithrombin deficiency

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Thrombate III—treating hereditary antithrombin deficiency for more than 16 years • A proven therapy to prevent thromboembolic events in high-risk situations, such as1: – Surgery – Obstetrical procedures (including childbirth) – Acute thromboembolism • Pasteurized to inactivate viruses, with no confirmed cases of virus transmission – Thrombate III is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease agent that can cause disease • An antithrombin concentrate purified from human plasma To order, call Talecris USA Customer Service at 1-800-243-4153 or visit www.thrombate.com. For technical questions, call Talecris Clinical Communications at 1-800-520-2807 or visit www.thrombate.com.

References: 1. Thrombate III [prescribing information]. Research Triangle Park, NC: Talecris Biotherapeutics, Inc.; 2008. 2. Data on file, Talecris Biotherapeutics, Inc., 1988. 3. Scott GR, Robinson MJ, Wilczek J, Berson MR. FDA Drug and Device Product Approvals. Springfield, VA: Division of Drug Information Resources, OM, CDER, US Dept of Health and Human Services, Public Health Service; 1991;14(2):333.

Important Safety Information Thrombate III is indicated for the treatment of patients with hereditary antithrombin deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism. In clinical studies with Thrombate III, the most common side effects were dizziness, chest tightness, nausea and foul taste in mouth. The anticoagulant effect of heparin is enhanced by concurrent treatment with Thrombate III in patients with hereditary AT-III deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with Thrombate III. Thrombate III is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or blood plasma may develop signs and/or symptoms of some viral infections, particularly hepatitis C. Please see brief summary of Thrombate III full Prescribing Information on adjacent page.

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T E C H NO L O G Y

Scan First, Puncture Less Preprocedure ultrasound streamlines spinal anesthesia

he benefits of ultrasoundguided anesthesia are relatively unproven in cases of spinal anesthesia in which patients have difficult spinal anatomy. But an ongoing study by Canadian researchers suggests that the preprocedure ultrasound scans significantly increase the chances of

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successful dural puncture. Ki Jinn Chin, MMed, and colleagues at Toronto Western Hospital, found that dural puncture was achieved with a single needle insertion in 59% of ultrasound patients, compared with 46% of patients treated with the traditional, landmark-guided method (P=0.05).

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BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION FOR INTRAVENOUS USE ONLY DESCRIPTION Antithrombin III (Human), THROMBATE IIIw is a sterile, nonpyrogenic, stable, lyophilized preparation of purified human antithrombin III. THROMBATE III is prepared from pooled units of human plasma from normal donors by modifications and refinements of the cold ethanol method of Cohn. When reconstituted with Sterile Water for Injection, USP, THROMBATE III has a pH of 6.0–7.5, a sodium content of 110–210 mEq/L, a chloride content of 110–210 mEq/L, an alanine content of 0.075–0.125 M, and a heparin content of not more than 0.1 IU heparin/IU AT-III. THROMBATE III contains no preservative and must be administered by the intravenous route. In addition, THROMBATE III has been heat-treated in solution at 60°C ± 0.5°C for not less than 10 hours. Each vial of THROMBATE III contains the labeled amount of antithrombin III in international units (IU) per vial. The potency assignment has been determined with a standard calibrated against a World Health Organization (WHO) antithrombin III reference preparation. The manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. An individual production step in the THROMBATE III manufacturing process has been shown to decrease TSE infectivity of that experimental model agent. The TSE reduction step is the Effluent I to Effluent II + III fractionation step (6.0 logs). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed. CLINICAL PHARMACOLOGY Antithrombin III (AT-III), an alpha2-glycoprotein of molecular weight 58,000, is normally present in human plasma at a concentration of approximately 12.5 mg/dL and is the major plasma inhibitor of thrombin. Inactivation of thrombin by AT-III occurs by formation of a covalent bond resulting in an inactive 1:1 stoichiometric complex between the two, involving an interaction of the active serine of thrombin and an arginine reactive site on AT-III. AT-III is also capable of inactivating other components of the coagulation cascade including factors IXa, Xa, XIa, and XIIa, as well as plasmin. The neutralization rate of serine proteases by AT-III proceeds slowly in the absence of heparin, but is greatly accelerated in the presence of heparin. As the therapeutic antithrombotic effect in vivo of heparin is mediated by AT-III, heparin is ineffective in the absence or near absence of AT-III. The prevalence of the hereditary deficiency of AT-III is estimated to be one per 2000 to 5000 in the general population. The pattern of inheritance is autosomal dominant. In affected individuals, spontaneous episodes of thrombosis and pulmonary embolism may be associated with AT-III levels of 40%–60% of normal. These episodes usually appear after the age of 20, the risk increasing with age and in association with surgery, pregnancy and delivery. The frequency of thromboembolic events in hereditary antithrombin III (AT-III) deficiency during pregnancy has been reported to be 70%, and several studies of the beneficial use of Antithrombin III (Human) concentrates during pregnancy in women with hereditary deficiency have been reported. In many cases, however, no precipitating factor can be identified for venous thrombosis or pulmonary embolism. Greater than 85% of individuals with hereditary AT-III deficiency have had at least one thrombotic episode by the age of 50 years. In about 60% of patients thrombosis is recurrent. Clinical signs of pulmonary embolism occur in 40% of affected individuals. In some individuals, treatment with oral anticoagulants leads to an increase of the endogenous levels of AT-III, and treatment with oral anticoagulants may be effective in the prevention of thrombosis in such individuals. In clinical studies of THROMBATE III conducted in 10 asymptomatic subjects with hereditary deficiency of AT-III, the mean in vivo recovery of AT-III was 1.6% per unit per kg administered based on immunologic AT-III assays, and 1.4% per unit per kg administered based on functional AT-III assays. The mean 50% disappearance time (the time to fall to 50% of the peak plasma level following an initial administration) was approximately 22 hours and the biologic half-life was 2.5 days based on immunologic assays and 3.8 days based on functional assays of AT-III. These values are similar to the half-life for radiolabeled Antithrombin III (Human) reported in the literature of 2.8–4.8 days. In clinical studies of THROMBATE III, none of the 13 patients with hereditary AT-III deficiency and histories of thromboembolism treated prophylactically on 16 separate occasions with THROMBATE III for high thrombotic risk situations (11 surgical procedures, 5 deliveries) developed a thrombotic complication. Heparin was also administered in 3 of the 11 surgical procedures and all 5 deliveries. Eight patients with hereditary AT-III deficiency were treated therapeutically with THROMBATE III as well as heparin for major thrombotic or thromboembolic complications, with seven patients recovering. Treatment with THROMBATE III reversed heparin resistance in two patients with hereditary AT-III deficiency being treated for thrombosis or thromboembolism. During clinical investigation of THROMBATE III, none of 12 subjects monitored for a median of 8 months (range 2–19 months) after receiving THROMBATE III, became antibody positive to human immunodeficiency virus (HIV-1). None of 14 subjects monitored for ⱖ 3 months demonstrated any evidence of hepatitis, either non-A, non-B hepatitis or hepatitis B. INDICATIONS AND USAGE THROMBATE III is indicated for the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism. Subjects with AT-III deficiency should be informed about the risk of thrombosis in connection with pregnancy and surgery and about the inheritance of the disease. The diagnosis of hereditary antithrombin III (AT-III) deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma AT-III levels, and the exclusion of acquired deficiency. AT-III in plasma may be measured by amidolytic assays using synthetic chromogenic substrates, by clotting assays, or by immunoassays. The latter does not detect all hereditary AT-III deficiencies.

The investigators also found that ultrasound patients required a median of only four needle redirections, compared with nine in the landmark group. “We previously performed a study [see Anesthesiology News, December 2009, page 48] in which we evaluated the feasibility of ultrasound to guide

The AT-III level in neonates of parents with hereditary AT-III deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.) Plasma levels of AT-III are lower in neonates than adults, averaging approximately 60% in normal term infants. AT-III levels in premature infants may be much lower. Low plasma AT-III levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with THROMBATE III of neonates be discussed with an expert on coagulation. CONTRAINDICATIONS None known. WARNINGS THROMBATE III is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Talecris Biotherapeutics, Inc. [1-800-520-2807]. The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to a patient. The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary AT-III deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III. PRECAUTIONS General 1. Administer within 3 hours after reconstitution. Do not refrigerate after reconstitution. 2. Administer only by the intravenous route. 3. THROMBATE III, once reconstituted, should be given alone, without mixing with other agents or diluting solutions. 4. Product administration and handling of the needles must be done with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious virus including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs. Place needles in sharps container after single use. Discard all equipment including any reconstituted THROMBATE III product in accordance with biohazard procedures. The diagnosis of hereditary antithrombin III (AT-III) deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma AT-III levels, and the exclusion of acquired deficiency. Laboratory Tests It is recommended that AT-III plasma levels be monitored during the treatment period. Functional levels of AT-III in plasma may be measured by amidolytic assays using chromogenic substrates or by clotting assays. Drug Interactions The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary AT-III deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III. Pregnancy Category B Reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to THROMBATE III. It is not known whether THROMBATE III can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pediatric Use Safety and effectiveness in the pediatric population have not been established. The AT-III level in neonates of parents with hereditary AT-III deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.) Plasma levels of AT-III are lower in neonates than adults, averaging approximately 60% in normal term infants. AT-III levels in premature infants may be much lower. Low plasma AT-III levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with THROMBATE III of neonates be discussed with an expert on coagulation. ADVERSE REACTIONS In clinical studies involving THROMBATE III, adverse reactions were reported in association with 17 of the 340 infusions during the clinical studies. Included were dizziness (7), chest tightness (3), nausea (3), foul taste in mouth (3), chills (2), cramps (2), shortness of breath (1), chest pain (1), film over eye (1), light-headedness (1), bowel fullness (1), hives (1), fever (1), and oozing and hematoma formation (1). If adverse reactions are experienced, the infusion rate should be decreased, or if indicated, the infusion should be interrupted until symptoms abate. CAUTION & only U.S. federal law prohibits dispensing without prescription.

Talecris Biotherapeutics, Inc. Research Triangle Park, NC 27709 USA U.S. License No. 1716

08939599-BS

‘One of the things that people are starting to appreciate now is that ultrasound still requires training. It’s not something you just pick up and use straightaway and expect to get stellar results.’ —Ki Jinn Chinn, MMed spinal anesthesia in joint replacement patients,” said Dr. Chin, assistant professor of anesthesiology at Toronto Western. “These patients tend to be older, overweight, and have degenerative disease of the spine, which may make spinal anesthesia technically difficult to perform.” That study found the success rate among patients treated with ultrasound was higher than that among historical controls, he said. “So we decided to take the logical next step and perform a randomized controlled trial to conclusively demonstrate that ultrasound can assist with spinals in a patient population in whom they would otherwise be difficult to perform.” A total of 57 patients with difficult surface landmarks have entered the trial, which is powered to a final population of 180. Patients were randomized to undergo spinal anesthesia using either the landmark-guided or an ultrasound-assisted approach.

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TE CH N OL OG Y

Posterior longitudinal ligament overlying the vertebral body

The ultrasound scan was used to find the ligamentum flavum–dura mater complex, posterior vertebral body and intrathecal space at the intervertebral levels. The researchers determined the number of attempts and redirections, as well as the time taken to identify surface landmarks, ultrasound scanning and administration of the spinal anesthetic. Patients in both groups were demographically similar, with a mean body mass index of 38.9 kg/m2. A spinal deformity was seen in 14% of patients; 2% had previously undergone spinal surgery. Surface landmarks were difficult or impossible to feel in 74% of patients. As Dr. Chin reported at the 2010 annual meeting of the International Anesthesia Research Society (abstract S-473), despite the increased success rate found with ultrasound guidance, the time required to perform the spinal anesthetic was comparable between the groups. “The extra time it takes to perform the scan may be one of the only drawbacks to ultrasound, but that is offset by a shorter block performance time,” he said. “Ultrasound is a noninvasive adjunct; it doesn’t hurt the patient and it can only give you information that can be helpful.” Yet Dr. Chin recognized that a certain subset of anesthesiologists remains skeptical about the utility of ultrasound in clinical practice. “Ultrasound is a tool, and like any tool, you have to know how to use it,” he said. “One of the things that people are starting to appreciate now is that ultrasound still requires training. It’s not something you just pick up and use straightaway and expect

to get stellar results. There’s a learning curve, and perhaps the people who are opposed to it need to appreciate that it requires a bit of effort.” Jeff C. Gadsden, MD, director of the regional anesthesia fellowship program at St. Luke’s-Roosevelt Hospital Center in New York City, applauded the investigators—whom he called leaders in real-time ultrasound-guided spinals— for undertaking the trial. “The data are encouraging, and support the utility of ultrasound for

neuraxial blocks,” Dr. Gadsden said. “While the procedure time may not be different for, say, nine out of 10 spinals in experienced hands, we’ve all had the situation where it takes an hour to place the block in a difficult spine. Ultrasound may save us in those circumstances. In addition, the reduction in number of needle passes and ‘needle under the skin’ time likely translates to improved patient comfort.” —Michael Vlessides

Contact

the editor of Anesthesiology News

onmed.com mah c m @

ama rcu s

Midline

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best forum for unveiling the data. But Dr. Bates stressed the broad implications of the study. “We chose to present this information here because anesthesia providers use many risky medications, but it has implications for all providers who write prescriptions,” he said. One area of concern for anesthesiologists to focus on is renal difficulty, Dr. Bates noted. “Many people having procedures are older and will have some degree of renal insufficiency,” he said. Study co-author Karen Caputo Nanji, MD, MPH, an anesthesia resident at Massachusetts General Hospital in Boston, agreed that her group’s findings have direct relevance for anesthesiologists. “We are not only intraoperative physicians but also perioperative physicians and specialists in pain medicine and critical care,” Dr. Nanji told Anesthesiology News. “Anesthesiologists use electronic prescribing systems in preoperative clinics, pain clinics and other outpatient clinics.” Dr. Nanji and her colleagues decided it would be useful to catalogue these new errors in an effort to minimize them in future computerized prescriber order entry (CPOE) applications. The team reviewed and classified 3,898 electronic prescriptions received by commercial outpatient pharmacy chains across Florida, Arizona and Massachusetts during fall 2008. Of those, 452 (11.6%) contained errors, with rates ranging from 5% to 17.4%, depending on the prescribing system used. The most common error was missing information (60.8%), typically an omitted duration, dose or frequency. A lack of clarity (15.9%), conflicting information (15.7%) or an incorrect prescription (7.6%) comprised the remaining errors.

At a Glance: Transfusions orthopedic surgery. The transfusion rate in that group was nearly identical (4.6%), as was the number of transfused units per patient (0.08). “It gives me a little bit more confidence that there’s an effect going on,” said lead author Jesse Ehrenfeld, MD, MPH, who is now Director of the Center for Evidence-Based Anesthesia at Vanderbilt University School of Medicine, in Nashville, Tenn. Dr. Ehrenfeld called the findings “intriguing,” and predicted that continuous monitoring of hemoglobin will find a niche in the operating room. “There’s clearly going to be a group of high risk patients for whom the monitor will be helpful, but it won’t be for elective outpatient surgery where the risk for bleeding is low,” he said. The researchers presented their findings at the 2010 annual meeting of the American Society of Anesthesiologists (abstract LB05).

ontinuous hemoglobin monitoring of patients during surgery can sharply reduce the number of transfusions they recieve—and, in theory, both the risk for complications associated with receiving blood and the cost of care—according to a new study. Boston researchers looked at transfusion rates in 327 patients undergoing knee, hip and spine procedures, 170 of whom were monitored during surgery with a noninvasive device that continuously measures hemoglobin (Radical-7, Masimo). The rest of the patients received standard care. Seven patients (4.5%) in the standard care group received blood transfusions during surgery, compared with one (0.6%) in the group that underwent continuous monitoring (P=0.03). The total number of blood units transfused was 10 times greater in the control group: 0.1 versus .01 (P=0.0001). The researchers then compared the results of the prospective study to a matched cohort of 327 patients who recently had undergone elective

—Adam Marcus

18 16 14

Number

MUDDLE

12 10 8 6 4 2 0 1985

1987

1989

1991

1993

1995

FEATUREDPRODUCT

1997

1999

2001

2003

2005

2007

Year Cases of transfusion-transmitted HIV infection from contaminated blood products, by transfusion year—United States, 1985–2008. Source: Centers for Disease Control and Prevention.

Without red blood cells (n = 45,025)

With red blood cells (n = 57,445)

8,993 (20.0%) 12,362 (21.5%)

1,636 (3.6%) 2,266 (3.9%)

3,718 (8.3%) 4,365 (7.6%) 4,806 (10.7%) 6,559 (11.4%)

2,306 (5.1%) 2,257 (3.9%)

Capnostream & IPI Oridion, a global medical-device company, specializes in capnography-based ventilation monitoring solutions that improve patient safety for intubated and non-intubated patients in all clinical environments: during procedural sedation, OR, ICU, PACU, general floor, and pre-hospital. Smart Capnography™ algorithms including the Integrated Pulmonary Index™ (IPI), and innovative patient interfaces provide earliest indication of airway compromise, improving airway management and clinician work flow. Oridion is allied with leading companies including Philips Medical, Physio-Control, Masimo, DataScope and Dräger. Web site: www.oridion.com Please see our ad on page 30.

4,232 (9.4%) 5,361 (9.3%)

5,300 (11.8%) 6,262 (10.9%)

3,226 (7.2%) 5,049 (8.8%)

10,808 (24.0%) 12,964 (22.6%)

2008 Transfusion Rates by Geographic Area. A study of more than 102,000 patients undergoing coronary artery bypass grafts at 798 U.S. hospitals has found wide variability in the amount of blood transfusions they receive—but minimal difference in rates of mortality. The findings, published in the Oct. 13, 2010 issue of the Journal of the American Medical Association, suggest that many blood transfusions may provide little benefit while unnecessarily putting patients at risk for infections, longer hospital stays and other poor outcomes.

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TE CH N OL OG Y

More Data on CPOE Versus Prescription Pad lthough CPOE systems are not foolproof, there is still a large body of evidence showing that the technology is far superior to hand-written prescriptions. Much of that evidence has been documented in the inpatient setting. But outpatient data are slowly trickling in. A study conducted earlier this year, for example, underscored CPOE’s effectiveness in communitybased, outpatient health care clinics. In the study (J Am Med Inform Assoc 2010;17:78-84), investigators examined the accuracy of more than 10,000 drug orders that were processed before and after CPOE system implementation. They found that the frequency of errors declined from 18.2% to 8.2%—a reduction in adjusted odds of 70%

(odds ratio [OR], 0.30; 95% confidence interval, 0.23-0.40). The largest reductions in errors were those attributed to illegible handwriting (97%), use of inappropriate abbreviations (94%) and missing information (85%), the researchers noted. On the inpatient side, even more data favor CPOE—but with some of the studies echoing the pluses and minuses of the findings seen in the Bates et al study. British researchers, for example, compared CPOE with handwritten drug orders in an ICU. The rate of medication

errors with CPOE was significantly lower (117 errors from 2,429 prescriptions, 4.8%) than with handwritten drug orders (69 errors from 1,036 prescriptions, 6.7%; P<0.04). However, two of the errors with CPOE led to patient harm, requiring an increase in hospital length of stay. Additionally, three computerized prescription errors that were caught before they reached patients could have led to permanent harm or death, the investigators reported (Crit Care 2005;9:R516-R521).

this comment field and recognize that it could be contradictory,” he pointed out. “There’s a lot going on here,” Mr. Grissinger added. “There’s the design of the system, but also the training of physicians and pharmacists.” Dr. Bates, too, pointed to the importance of internal consistency checks, including the setting of default doses. “If a patient is going to be given one tablet daily for seven days, then the amount dispensed should be seven,”

—L.P.

see muddle page 20

Water in the OR: What are the Risks?

More than one out of every three errors, a total of 163, were deemed dangerous enough to classify as a potential adverse drug event. Of those, 95 (58.3%) were deemed significant, and 68 (41.7%) were considered serious, the investigators reported. “We were a bit surprised to see [error] rates this high,” Dr. Bates said, “although rates are still considerably higher in nonelectronic systems.” (See sidebar.) Older Is Not Better Depending on the type of drug being prescribed, handwritten drug orders “can really be a problem,” said Matthew Grissinger, RPh, director of error reporting programs at the Institute for Safe Medication Practices in Horsham, Pa. For example, “some drug names out there look the same only when handwritten. An electronic system can prevent those kinds of [potential errors],” Mr. Grissinger said. “On the flip side, new errors are often introduced.” As for why CPOE systems are prone to their own errors, Mr. Grissinger cited several potential causes. For one, doctors usually are unaccustomed to entering orders into a computer system and it may be easy for them to pick the wrong drug or dose. “How would a pharmacist know if a patient is supposed to get a drug at 10 mg, but the doctor picked 20 mg? The pharmacist wouldn’t even know if the right drug was picked off the list [on the CPOE screen] or not,” he said. The new CPOE systems also contain comment fields where doctors have been known to enter contradictory notes or “correct” a previous error they made in the data entry form. “Pharmacists are not used to having to look at

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Point-of-Care Device Diagnoses Fibrinolysis, Could Change Practice

strength of blood in severely injured trauma patients is strongly associated with primary fibrinolysis and mortality. Moreover, loss of clot strength can be identified within an hour of injury. “This is very important work,” said Real-time assessment of coagulation function could direct therapy, save more lives David Hoyt, MD, executive director of the American College of Surgeons and Chicago—In a finding that one day of coagulation in patients who require 146:764-772). Their new findings show that the a nationally recognized trauma surgeon. may change the standard of care for immediate results. In a study published severely injured trauma patients, a team last year, the researchers successfully r-TEG results can be used to aid clin- “It could be a potential target for interof U.S. surgeons is reporting that they used point-of-care r-TEG as a screen- ical decision making in the key first vention at a time when our traditional thinking has suggested that inhibition can successfully measure clot strength ing tool in trauma patients to identify hour after injury. The findings indicate that the clot in injured adults inside the operating hypercoagulable states (Surgery 2009; see fibrinolysis page 21 room and use these results to individualize blood therapy. “For the first time, with a point-ofcare device right in the OR, we have the potential ability to make the diagnosis of fibrinolysis when we’re managing a patient. We can then identify the patients whom we should pretreat with antifibrinolytics,” said lead author Jeffry Kashuk, MD, section chief of acute care surgery and professor of surgery in the Division of Trauma, Acute Care and Critical Care Surgery at Penn State Milton S. Hershey Medical Center, in Hershey, Pa.

‘This is very important work. It could be a potential target for intervention at a time when our traditional thinking has suggested that inhibition of fibrinolysis might be dangerous or enhance coagulopathy.’ —David Hoyt, MD At the 2010 annual meeting of the American Surgical Association, Dr. Kashuk presented the results of the study, conducted at the Denver Health Medical Center, in which 61 consecutive trauma patients underwent rapid thrombelastography (r-TEG, Haemonetics Inc.) in the OR. This test differs from conventional thrombelastography because tissue factor is added to the whole blood specimen, resulting in a faster, real-time assessment of coagulation function in the trauma setting. Until recently, thrombelastography was used primarily for cardiac and transplant patients. Dr. Kashuk and his colleagues, however, argue that r-TEG is ideal for trauma patients because it can provide point-of-care assessments

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In Emergencies, Drug Errors Common Austin, Texas—Medication errors occur frequently amid the high-intensity swirl of a medical code, at least based on empirical observations from medical emergency team members. Now, the extent of the problem has been quantified via a direct-obervation study by critical-care pharmacists. In the study, 296 medication errors were identified by pharmacists in

the course of delivering 186 doses, according to researchers at the University of Pittsburgh Medical Center (UPMC). The project, conducted at UPMC Presbyterian, tracked 36 unique medications given to 50 patients treated by the medical emergency team between March 2009 and February 2010. Two-thirds of the medication errors, 196 of the total,

involved failures in aseptic technique, said Sandra Kane-Gill, PharmD, MS, whose research team presented the results at the annual meeting of the American College of Clinical Pharmacy. Although not ideal, those types of errors are not considered to be significant in a crisis situation, she noted. “Patients need the drug quickly, so if

that step had been left out, we consider those minor errors,” said Dr. Kane-Gill, a critical care medication safety officer in the Department of Pharmacy at UPMC. Of the remaining 100 errors, 46% were classified as a prescribing error, 28% as an administration technique error, 14% as mislabeling and 10% related to drug preparation. Of the 100 errors, 14% had the potential to cause harm, Dr. Kane-Gill said. A breakdown in communication was one common thread, such as a physician not fully specifying the medication order. “If a physician states a drug, but doesn’t state the dose, that leaves some ambiguity for the nurse to interpret.” These types of error surveillance projects are difficult to conduct, in part because of the inherent nature of a medical crisis, said Greene Shepherd, PharmD, professor in the College of Pharmacy at the University of Georgia, in Augusta. “When emergencies happen, people are moving very quickly and it’s hard to do research on any emergency event that’s a true emergency.” Dr. Shepherd authored a previous study, published in the American Journal of Health-System Pharmacy (2009;66:65-69) which showed that only 71% of patients admitted to the emergency department were interviewed and evaluated for complete medication histories. The Pittsburgh study, because it was confined to one location, might not have similar results at another institution, he said. But he was not surprised that multiple medication errors were caught, as they are frequently associated. “What this study shows is that during these highly critical points, there are a lot of errors being made,” Dr. Shepherd said. “Fortunately, the majority of them only caused minor discrepancies and no harm to the patient. But the potential is there for a larger one.” For clinicians involved in a medical crisis, there is a fine line to walk, Dr. Shepherd said. “You’ve got somebody who is dying in front of you. If you don’t get the drug in them, they are going to die. If taking the time to evaluate and check for errors is going to kill them, I’d rather run the risk of the error.” The medications involved in the study were directly observed by a pharmacist, who was unable to be present see errors page 24

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Unplanned Intubations Take Surprising Toll in ICU, After Surgery New findings, including risk score, provide fresh details about scope of problem San Diego—Nearly one-third of intubated patients in the intensive care unit experience failed extubation and must be reintubated at some point during their hospitalization, researchers have found. More than 40% of patients requiring reintubation had experienced respiratory failure, according to the study. In nearly 8% of reintubations, patients had a difficult airway that complicated the procedure (Table 1). The researchers, from the University of Washington, in Seattle, said their findings indicate that failed extubation is a significant problem for ICU patients and that hospitals should develop strategies for extubation that consider the possibility of both reintubation and a difficult airway. Whether such strategies would reduce the complications associated with extubation is unclear, they said. “We were surprised to observe such a high proportion of extubation failures, with an occurrence of complications equally high as at initial intubation,” said study leader Miriam Treggiari, MD, PhD, MPH, a critical care specialist at Washington. “We are conducting more analyses to evaluate the morbidity and cost associated with failed extubation.” Dr. Treggiari’s hospital has created a protocol for evaluating ICU patients eligible for extubation. The daily evaluation includes a trial of spontaneous awakening followed by one of spontaneous breathing. “We do not have a formal strategy of planned extubation, but we are interested in developing a systematic approach to airway management at the time of extubation,” she said.

The researchers plan to analyze their data set to identify other predictors of failed extubation. “We are also planning to introduce the occurrence of reintubation as a continuous quality improvement event to identify possible ways to reduce these occurrences,” Dr. Treggiari said. “Finally, we are interested in investigating an expanded approach to the evaluation of patients potentially eligible for extubation, so that we can possibly reduce the occurrence of failed extubation.” Dr. Treggiari’s group presented its findings at the 2010 annual meeting of the American Society of Anesthesiologists (ASA; abstract A766). The group also has found evidence that patients with difficult airways were more likely to experience a difficult reintubation. “Our data show that there were 37% higher odds of difficult reintubation compared with initial intubation; however, this difference was not statistically significant,” she said. In an unrelated study also presented at the ASA meeting (abstract A765), researchers at Columbia University, in New York City, sought to determine if they could predict which patients were likely to undergo unplanned intubation after surgery. Unplanned intubation also captures failed intubations and patients who required re-intubation for other reasons. “Everybody has a sense of who that patient is who can’t be extubated after surgery,” said May Hua, MD, a critical care fellow at Columbia who led the study. “It’s a marker of a sicker patient. But at the same time, there are people who fall into a gray zone.” Using data from the National Surgical Quality Improvement Program for the period 2005-2007, the Columbia team developed an intubation scorecard based on about a dozen risk factors, from patient age and ASA status to the length of their surgical procedures. The result was an Unplanned Intubation Risk Index (UIRI) ranging from 0, or lowest risk, to 18, which had an 80% probability of

Table 1. Complications of Airway Management in the Intensive Care Unit

Variable

Patients Patients Intubated, Reintubated, n(%)a n(%)a (N=1,400) (N=449)

Difficult intubation

70 (5)

34 (7.5)

Any complication

566 (40)

145 (32.2)

Hypoxemia (SpO2 <92)

106 (7.5)

38 (8.4)

Hypotension (SBP <90 mm Hg)

215 (15.3)

84 (18.7)

Hypertension (SBP >180 mm Hg)

184 (13.1)

13 (2.8)

Aspiration

37 (2.6)

3 (0.6)

Cricothyroidotomy or tracheotomy

14 (1)

1 (0.2)

Cardiac arrest

4 (0.2)

2 (0.4)

Hypoxic brain injury

1 (0.07)

Death

5 (0.3)

4 (0.8)

Numbers do not add to 100% because complications are not mutually exclusive. SBP, systolic blood pressure; SpO2, oxygen saturation

Table 2. Independent Predictors of Unplanned Intubation, American College of Surgeons National Surgical Quality Improvement Program, 2005-2007

Variable

95% Adjusted Confidence Hazard Ratio Interval

Contribution to Score

Age 40-49 y

1.47

1.24-1.74

Age 50-59 y

2.01

1.72-2.34

Age 60-69 y

2.67

2.30-3.09

Age 70-79 y

3.33

2.87-3.87

Age ≥80 y

3.93

3.38-4.58

ASA class 3

3.46

3.15-3.79

ASA class 4-5

7.34

6.63-8.14

Any sepsis

2.81

2.64-3.00

Total operative time 120-300 min

1.61

1.51-1.71

Total operative time 300-360 min

2.74

2.42-3.10

Total operative time ≥360 min

4.00

3.63-4.41

ASA, American Society of Anesthesiologists

predicting who would require unplanned intubation (area under the curve, 0.80; 95% confidence interval, 0.79-0.80), according to the researchers. After identifying a large number of variables Dr. Hua’s group narrowed the list to four that were most predictive of unplanned intubation: patient age, total operative time, ASA status and sepsis prior to surgery (Table 2). The fuller list included factors that, “as a clinician, seem intuitively obvious,

but there were things in there that didn’t matter,” Dr. Hua said. “Individual comorbidities didn’t matter, but ASA status had the strongest predictive power.” Dr. Hua said the findings could help clinicians provide a clearer picture of the risks of surgery to their patients. She said she hoped to design an online calculator for the scoring tool so that physicians could quickly assess a person’s UIRI. —Adam Marcus

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Back Door Block Hits Right ‘Groove’ in Shoulder Novel approach could skirt pain Toronto—Suprascapular nerve blocks are safe and effective alternatives to interscalene blocks, but needle contact with the periosteum surrounding the scapula can make administration of the block painful for some patients. A New York research team has proposed a new, anterior approach to the suprascapular nerve block that may avoid this problem. “The suprascapular nerve block is traditionally performed via the posterior approach with the patient sitting up,” said Yvonne A. Cuffy, MD, an anesthesia resident at Albany Medical Center. “When using this traditional approach, you hit periosteum and look for the suprascapular groove. The suprascapular nerve sits right around the groove.” Dr. Cuffy and her colleagues looked for an alternative method of performing the block without having to go into the posterior aspect and hitting bone. To do so, they used a fresh cadaver and

approached the nerve anteriorly. The researchers began by inserting an 18-gauge insulated block needle inferior to the clavicle and lateral to the subclavian artery. The needle was directed away from the rib cage, and 30 mL of embalming latex solution was injected into the space. Once the latex hardened, the cadaver was dissected, with the clavicle left in place. The suprascapular nerve was found to be in the superior portion of the axillary space, which was filled with adipose tissue. The suprascapular nerve crossed the axillary space just below the investing layer of deep cervical fascia. It was identified by a fascial “pop” with a blunt, coated needle, the researchers observed. The nerve ran parallel to the dorsal caudad edge of the clavicle. Puncture sites for the approach can be anterior to the clavicle through the clavipectoral fascia, or central between the trapezius

Yvonne Cuffy, MD, presented her poster at the 2010 spring ASRA meeting.

muscle and the clavicle. for the subclavian pulse, go lateral to it “With the cadaver, we saw where the and aim the needle inferior to the clavsubclavian artery was,” Dr. Cuffy said. icle but away from the rib cage.” “But with an actual person, you palpate see groove page 20

Systemic Steroids May Trigger Severe Post-Tonsillectomy Bleeding

ystemic steroids may do more harm than good in children undergoing tonsillectomy, according to results of a recent meta-analysis by Canadian researchers. Although the drugs diminish postoperative nausea and vomiting, the findings suggest that steroids may increase the risk for reoperation resulting from bleeding after the procedure. Like many anesthesiologists, Jennifer Plante, MD, a resident at the University of Laval University in Quebec City, and her colleagues frequently gave the misery-reducing steroids to young tonsillectomy patients. But during a lecture club meeting at their hospital not long ago, Dr. Plante’s group reviewed a publication in the Journal of the American Medical Association (JAMA 2008;300:2621-2630) that prompted them to reconsider the practice. The study had set out to investigate the optimum dose of dexamethasone for children undergoing tonsillectomy. It was stopped early due to a relatively high rate of postoperative bleeding: 24% of children receiving 0.5 mg/ kg of the steroid had bleeding episodes compared with 4% of those given a placebo. “The highest dose was the most effective in reducing nausea and vomiting, but on the other side, it also increased the bleeding risk,” said Christoph Czarnetzki, MD, consultant anesthetist at the University Hospitals of Geneva, in Switzerland, who led the JAMA study. “This was very astonishing to us.”

The findings also surprised and concerned Dr. Plante, especially given the widespread use of dexamethasone at Laval’s hospitals. So, she led her team in conducting a systematic review of the literature to assess the association between systemic steroids and bleeding. They selected 25 randomized clinical trials, including Dr. Czarnetzki’s, covering 2,201 patients. Each study compared the use of a steroid during tonsillectomy with a placebo or another drug. The meta-analysis found no differences in the rate of postoperative bleeding between the two groups. However, children who received steroids were at approximately three times the risk for reintervention due to severe bleeding as those in the other group. Dr. Plante presented the results at the 2010 annual meeting of the Canadian Anesthesiologists’ Society, in Montreal (abstract 799776). Why was there such an inconsistency in comparative bleeding rates between Dr. Czarnetzki’s study and the set of studies as a whole? The key, according to Dr. Czarnetzki, is that his team followed patients for more than two weeks after their operations. “A typical study of nausea and vomiting in the anesthesia and operative context is stopped after 24 hours,” Dr. Czarnetzki said. “But two-thirds of the bleeding [episodes] in our study happened after the first day after the operation.”

As Dr. Plante pointed out, none of the studies she included systematically measured and reported the risk for bleeding. The primary focus of most trials was on postoperative nausea and vomiting, which explains why the majority followed patients for a day or two after surgery. Still, many also reported later reoperations. “The need for reintervention may be more objective and reliable than postoperative bleeding,” she said. “If you bleed that much, you can be sure you will go back to the hospital.” Although nonsteroidal anti-inflammatory drugs are known to disrupt coagulation, and therefore are avoided in the tonsillectomy patients, the mechanism by which a steroid might induce bleeding is not well understood. Dr. Czarnetzki said the drugs may interfere with proper healing of the large scar left after tonsil removal. Dr. Czarnetzki himself has stopped using steroids in children during tonsillectomies. “Which is better, having nausea and vomiting or bleeding? You can die from tonsil bleeding. Without a doubt, we shouldn’t give steroids anymore.” Of course, this doesn’t mean that the more than two-thirds of children who will suffer from nausea and vomiting after a tonsillectomy cannot be offered some relief, such as selective serotonin receptor antagonists. “There are lots of effective medications that can prevent nausea and vomiting,” said Dr. Plante, who has stopped using steroids routinely in pediatric tonsillectomy patients. “We should mainly use those, and keep steroids for exceptional situations.” —Lynne Peeples

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This approach to the suprascapular nerve may provide an alternative route of pain relief for shoulder surgery patients with chronic obstructive pulmonary disease (COPD), and is suitable for long-acting single shots or continuous catheter placement, said Dr. Cuffy, who reported the findings at the 2010 annual meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract 56).

Yet the efficacy of the approach still remains theoretical, as the researchers have performed it in only one patient so far. “We had a patient with a lipoma on her shoulder who was getting an interscalene block for surgical anesthesia,” Dr. Cuffy said. “We performed a single-shot suprascapular block using this approach, and she had pretty good postoperative pain control.” Jacques E. Chelly, MD, PhD, MBA, director of Acute Interventional Perioperative Pain and Regional Anesthesia

at the University of Pittsburgh Medical Center, said, “This is again one of those examples where ultrasound has totally changed the way we approach peripheral nerve blocks. At UPMC Presbyterian Shadyside Hospital, we provide perioperative pain management to oncologic patients who have scapular tumors removed. These patients greatly benefit from the performance of a suprascapular block. The feasibility of the technique reported by Dr. Cuffy is confirmed by similar preliminary data

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obtained by Dr. Paul Bigeleisen at our institution.” Dr. Chelly also is professor of anesthesiology and orthopedic surgery and vice chair of clinical research at UPMC. Jorge J. Leal, MD, an anesthesiologist in private practice in Tampa, Fla., said he was encouraged by the block’s potential. “I have a patient right now who is miserable,” Dr. Leal said. “She is an artist and cannot lift her arm to paint, but she’s got such bad COPD that they will not do surgery on her. This block would be ideal for somebody like that.” —Michael Vlessides

MUDDLE

CONTINUED FROM PAGE 20

he said. “Unfortunately, many applications don’t do that.” Although dosing can be particularly dangerous, such as with antibiotics, perhaps the most important consistency checks relate to kidney issues, added Dr. Bates, noting a number of medications that should have doses modified for patients with renal insufficiency. Stop alerts for physicians are one potentially powerful safeguard offered by electronic systems. A soft stop alert will pop up on the computer screen to warn a doctor about possible drug– drug interactions, whereas a hard stop alert is intended to restrict them from moving forward with a contraindicated prescription. A recent study published in the Archives of Internal Medicine (2010; 170:1578-1583) comparing both types of CPOE alerts noted that gains in patient safety had been modest, largely due to frequently overridden soft alerts. In the study, only 13.5% of pharmacist-based (i.e., soft) alerting succeeded in prompting prescribers not to reorder concomitant warfarin and trimethoprim-sulfamethoxazole, versus 57.2% of the “nearly hard” alerts issued. But the stricter alerts also postponed care for some patients who urgently needed the potentially risky combination. In fact, the study was stopped early due to these dangerous delays. “It’s not just about getting rid of handwritten prescriptions. Electronic prescribing should be about guiding you to make [the] right decisions, so people aren’t having to call you to make changes and the patient isn’t harmed,” said Mr. Grissinger. “We’ve got a fragmented health care system out there. All of these systems, including those from labs and pharmacies, need to work together to provide information. We need to have higher expectations.”

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CONTINUED FROM PAGE 16

of fibrinolysis might be dangerous or enhance coagulopathy. As we further understand the complexity of shock and coagulation, I think this will come into perspective.” For every one-unit reduction in clot strength, measured by r-TEG, patients have a 30% increased risk for primary fibrinolysis and a 10% increased risk for death, the results showed. Of 61 patients tested by r-TEG, 11 (18%) were found to have primary fibrinolysis, defined as more than 15% estimated percent lysis (EPL). Another 28 patients (46%) had transient fibrinolysis, defined as more than 15% EPL, and 22 (30%) had no fibrinolysis. Patients with primary fibrinolysis represented the sickest group, with 34% requiring a massive transfusion. They also had higher mortality at 64%, compared with 29% in the transient fibrinolysis group and 18% with no fibrinolysis (P=0.027). Early Onset of Fibrinolysis A Critical Factor What might prove most significant, said the researchers, is their discovery that primary fibrinolysis sets in within an hour of severe injury. It was identified at an average of 58 minutes after injury (inter-quartile range [IQR], 18.2-95.9). Transient fibrinolysis sets in later, at 104 minutes after injury (IQR, 13-1200). The timing of fibrinolysis is likely “a very important factor that was not previously appreciated,” said Dr. Kashuk. The early onset indicates that the breakdown process that often leads to a patient’s death after trauma starts early after injury, and is a combination of coagulopathy, shock, acidosis and hypothermia, as well as other physiologic changes. By using the r-TEG test, trauma surgeons can test patients immediately for primary fibrinolysis. If the test is positive, patients can be pretreated with

About 20% of drug prescribers in the United States are currently using computer-generated prescribing applications, with complete conversion anticipated within the next five years. There are approximately 200 CPOE applications on the market, Dr. Bates said. “Each has its own strengths and weaknesses—an important factor to keep in mind when planning a CPOE rollout.” —Lynne Peeples

antifibrinolytics. Surgeons hope that pretreatment will improve chances of survival. “That could have a significant impact in survival in these patients,” Dr. Kashuk said. The trauma team from Denver Health is currently using the test results to select patients for antifibrinolytics. They hope that their future studies will define optimal prophylactic treatment strategies for patients with r-TEGproven hypercoagulability.

“It may well be that patients who don’t exhibit significant fibrinolysis can be resuscitated with traditional resuscitation factors. However, in patients with primary fibrinolysis, they likely require antifibrinolytics. If not, the fibrinolysis could shift to a consumptive coagulopathy— essentially a premorbid condition,” Dr. Kashuk said. Judi Jacobi, PharmD, president of the Society of Critical Care Medicine, said she was impressed with the

test and the results in garnered in the Denver Health study. “This is something we will be looking closely at, and discussing in our next multidisciplinary meeting. I see no need to wait for confirmatory studies—the test is commercially available, the data are robust, and as critical care pharmacists, we should be advocating for our physician colleagues the best diagnostic and treatment tools available.”

WHY COMPROMISE when you have a choice of regional or local anesthetics

SCORE BIG POINTS IN THE NAROPIN® PEER-TO-PEER SHOWDOWN Go to www.gdetail.com/naropin3a and review clinical data in a race against the clock to become champion of The NAROPIN Peer-to-Peer Showdown. The more you know, the more points you score. See how well you do against your peers in this fun, short, interactive program that compares the clinical benefits of NAROPIN vs bupivacaine in regional anesthesia.

YOU’LL SEE HOW NAROPIN DELIVERS: » Faster return of motor function1,2 – 5.6 to 9.6 hours faster for lower arm surgery1 » Similar onset and duration, and effective sensory block1-4 » Significant reduction in the need for opioids5-7 – 57% fewer intraoperative requests for opioids vs bupivacaine6 » Significantly better cardiovascular and CNS profile8,9 » Significantly more patients were satisfied with analgesic efficacy6,10 NAROPIN is indicated for the production of regional or local anesthesia for surgery and for acute pain management. RECEIVE A PATIENT EDUCATIONAL ITEMa Go to www.gdetail.com/naropin3a today! a

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WHY COMPROMISE? CHOOSE NAROPIN.

Using NAROPIN beyond recommended doses to increase motor block or duration of sensory block may negate its favorable cardiovascular advantages, in the event that an inadvertent intravascular injection occurs. Like all amide-type local anesthetics, NAROPIN may be associated with adverse reactions. In clinical trials, side effects were mild and transient and may reflect the procedures, patient health status, and/or other medications used.Adverse events reported at a rate of ≥5%: hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain. New Safety Information There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. NAROPIN is not approved for this use. Please see dosage and administration details in Prescribing Information at www.naropin-us.com. Please see accompanying brief summary of Prescribing Information. www.naropin-us.com REFERENCES: 1. McGlade DP, Kalpokas MV, Mooney PH, et al. A comparison of 0.5% ropivacaine and 0.5% bupivacaine for axillary brachial plexus anaesthesia. Anaesth Intensive Care. 1998;26:515520. 2. Morrison LM, Emanuelsson BM, McClure JH, et al. Efficacy and kinetics of extradural ropivacaine: comparison with bupivacaine. Br J Anaesth. 1994;72:164-169. 3. Beaulieu P, Babin D, HemmerlingT.The pharmacodynamics of ropivacaine and bupivacaine in combined sciatic and femoral nerve blocks for total knee arthroplasty. Anesth Analg. 2006;103:768-774. 4. Hickey R, Hoffman J, Ramamurthy S.A comparison of ropivacaine 0.5% and bupivacaine 0.5% for brachial plexus block. Anesthesiology. 1991;74:639-642. 5. NAROPIN Prescribing Information. Data on file. 6. Bertini L,Tageriello V, Mancini S, et al. 0.75% and 0.5% ropivacaine for axillary brachial plexus block: a clinical comparison with 0.5% bupivacaine. Reg Anesth Pain Med. 1999;24:514-518. 7. Chelly JE, Casati A, Al-Samsam T, Coupe K, Criswell A,Tucker J. Continuous lumbar plexus block for acute postoperative pain management after open reduction and internal fixation of acetabular fractures. J Orthop Trauma. 2003;17:362-367. 8. Scott DB, Lee A, Fagan D, Bowler GMR, Bloomfield P, Lundh R. Acute toxicity of ropivacaine compared with that of bupivacaine. Anesth Analg. 1989;69:563-569. 9. Knudsen K, Beckman SM, Blomberg S, Sjövall J, Edvardsson N. Central nervous and cardiovascular effects of i.v. infusions of ropivacaine, bupivacaine and placebo in volunteers. Br J Anaesth. 1997;78:507-514. 10. Rawal N, Allvin R, Axelsson K, et al. Patient-controlled regional analgesia (PCRA) at home: Controlled comparison between bupivacaine and ropivacaine brachial plexus analgesia. Anesthesiology. 2002;96:1290-1296. Naropin ® and logo are registered trademarks of APP Pharmaceuticals, LLC. and APP ® are registered trademarks of APP Pharmaceuticals, LLC. ©2010, APP Pharmaceuticals, LLC. All Rights Reserved. 0003-NAR-05-7/10

—Christina Frangou

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Real-time Tool Predicts Perioperative Behavior in Children Study finds alarming incidence of bedwetting, nightmares after surgery

BRIEF SUMMARY INDICATIONS AND USAGE Naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration. CONTRAINDICATIONS Naropin is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. WARNINGS In performing Naropin blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest. The potential for successful resuscitation has not been studied in humans. There have been rare reports of cardiac arrest during the use of Naropin for epidural anesthesia or peripheral nerve blockade, the majority of which occurred after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease. In some instances, resuscitation has been difficult. Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. Naropin should be administered in incremental doses. It is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary. Historically, pregnant patients were reported to have a high risk for cardiac arrhythmias, cardiac/ circulatory arrest and death when 0.75% bupivacaine (another member of the amino amide class of local anesthetics) was inadvertently rapidly injected intravenously. Prior to receiving major blocks the general condition of the patient should be optimized and the patient should have an i.v. line inserted. All necessary precautions should be taken to avoid intravascular injection. Local anesthetics should only be administered by clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies that may arise from the block to be employed, and then only after ensuring the immediate (without delay) availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies (See also ADVERSE REACTIONS, PRECAUTIONS, and MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES). Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. Solutions of Naropin should not be used for the production of obstetrical paracervical block anesthesia, retrobulbar block, or spinal anesthesia (subarachnoid block) due to insufficient data to support such use. Intravenous regional anesthesia (bier block) should not be performed due to a lack of clinical experience and the risk of attaining toxic blood levels of ropivacaine. Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. It is essential that aspiration for blood, or cerebrospinal fluid (where applicable), be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. However, a negative aspiration does not ensure against an intravascular or subarachnoid injection. A well-known risk of epidural anesthesia may be an unintentional subarachnoid injection of local anesthetic. Two clinical studies have been performed to verify the safety of Naropin at a volume of 3 mL injected into the subarachnoid space since this dose represents an incremental epidural volume that could be unintentionally injected. The 15 and 22.5 mg doses injected resulted in sensory levels as high as T5 and T4, respectively. Anesthesia to pinprick started in the sacral dermatomes in 2-3 minutes, extended to the T10 level in 10-13 minutes and lasted for approximately 2 hours. The results of these two clinical studies showed that a 3 mL dose did not produce any serious adverse events when spinal anesthesia blockade was achieved. Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Patients treated with class III antiarrhythmic drugs (e.g., amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive. PRECAUTIONS: General: The safe and effective use of local anesthetics depends on proper dosage, correct technique, adequate precautions and readiness for emergencies. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. (See WARNINGS and ADVERSE REACTIONS.) The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse events. Injections should be made slowly and incrementally, with frequent aspirations before and during the injection to avoid intravascular injection. When a continuous catheter technique is used, syringe aspirations should also be performed before and during each supplemental injection. During the administration of epidural anesthesia, it is recommended that a test dose of a local anesthetic with a fast onset be administered initially and that the patient be monitored for central nervous system and cardiovascular toxicity, as well as for signs of unintended intrathecal administration before proceeding. When clinical conditions permit, consideration should be given to employing local anesthetic solutions, which contain epinephrine for the test dose because circulatory changes compatible with epinephrine may also serve as a warning sign of unintended intravascular injection. An intravascular injection is still possible even if aspirations for blood are negative. Administration of higher than recommended doses of Naropin to achieve greater motor blockade or increased duration of sensory blockade may result in cardiovascular depression, particularly in the event of inadvertent intravascular injection. Tolerance to elevated blood levels varies with the physical condition of the patient. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with their age and physical condition. Local anesthetics should also be used with caution in patients with hypotension, hypovolemia or heart block. Careful and constant monitoring of cardiovascular and respiratory vital signs (adequacy of ventilation) and the patient’s state of consciousness should be performed after each local anesthetic injection. It should be kept in mind at such times that restlessness, anxiety, incoherent speech, light-headedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of central nervous system toxicity. Because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. Local anesthetics should also be used with caution in patients with impaired cardiovascular function because they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs. Many drugs used during the conduct of anesthesia are considered potential triggering agents for malignant hyperthermia (MH). Amide-type local anesthetics are not known to trigger this reaction. However, since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for MH management should be available. Epidural Anesthesia: During epidural administration, Naropin should be administered in incremental doses of 3 to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Syringe aspirations should also be performed before and during each supplemental injection in continuous (intermittent) catheter techniques. An intravascular injection is still possible even if aspirations for blood are negative. During the administration of epidural anesthesia, it is recommended that a test dose be administered initially and the effects monitored before the full dose is given. When clinical conditions permit, the test dose should contain an appropriate dose of epinephrine to serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Therefore, following the test dose, the heart should be continuously monitored for a heart rate increase. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect a rise in systolic blood pressure. A test dose of a shortacting amide anesthetic such as lidocaine is recommended to detect an unintentional intrathecal administration. This will be manifested within a few minutes by signs of spinal block (e.g., decreased sensation of the buttocks, paresis of the legs, or, in the sedated patient, absent knee jerk). An intravascular or subarachnoid injection is still possible even if results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, high spinal or epinephrine-induced cardiovascular effects. Use in Brachial Plexus Block: Ropivacine plasma concentrations may approach the threshold for central nervous system toxicity after the administration of 300 mg of ropivacaine for brachial plexus block. Caution should be exercised when using the 300 mg dose. (See OVERDOSAGE.) The dose for a major nerve block must be adjusted according to the site of administration and patient status. Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used. Use in Peripheral Nerve Block: Major peripheral nerve blocks may result in the administration of a large volume of local anesthetic in highly vascularized areas, often close to large vessels where there is an increased risk of intravascular injection and/or rapid systemic absorption, which can lead to high plasma concentrations. Use in Head and Neck Area: Small doses of local anesthetics injected into the head and neck area may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. The injection procedures require the utmost care. Confusion, convulsions, respiratory depression, and/or respiratory arrest, and cardiovascular stimulation or depression have been reported. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded. (See DOSAGE AND ADMINISTRATION.) Use in Ophthalmic Surgery: The use of Naropin in retrobulbar blocks for ophthalmic surgery has not been studied. Until appropriate experience is gained, the use of Naropin for such surgery is not recommended. Drug Interactions: Specific trials studying the interaction between ropivacaine and class III antiarrhythmic drugs (e.g., amiodarone) have not been performed, but caution is advised (see WARNINGS). Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Cytochrome P4501A2 is involved in the formation of 3-hydroxy ropivacaine, the major metabolite. In vivo, the plasma clearance of ropivacaine was reduced by 70% during coadministration of fluvoxamine (25 mg bid for 2 days), a selective and potent CYP1A2 inhibitor. Thus strong inhibitors of cytochrome P4501A2, such as fluvoxamine, given concomitantly during administration of Naropin, can interact with Naropin leading to increased ropivacaine plasma levels. Caution should be exercised when CYP1A2 inhibitors are coadministered. Possible interactions with drugs known to be metabolized by CYP1A2 via competitive inhibition such as theophylline and imipramine may also occur. Coadministration of a selective and potent inhibitor of CYP3A4, ketoconazole (100 mg bid for 2 days with ropivacaine infusion administered 1 hour after ketoconazole) caused a 15% reduction in in-vivo plasma clearance of ropivacaine. Pregnancy Category B: There are no adequate or well-controlled studies in pregnant women of the effects of Naropin on the developing fetus. Naropin should only be used during pregnancy if the benefits outweigh the risk. Labor and Delivery: Local anesthetics, including ropivacaine, rapidly cross the placenta, and when used for epidural block can cause varying degrees of maternal, fetal and neonatal toxicity (see CLINICAL PHARMACOLOGY and PHARMACOKINETICS). The incidence and degree of toxicity depend upon the procedure performed, the type and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone and cardiac function. Maternal hypotension has resulted from regional anesthesia with Naropin for obstetrical pain relief. Local anesthetics produce vasodilation by blocking sympathetic nerves. Elevating the patient’s legs and positioning her on her left side will help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Epidural anesthesia has been reported to prolong the second stage of labor by removing the patient’s reflex urge to bear down or by interfering with motor function. Spontaneous vertex delivery occurred more frequently in patients receiving Naropin than in those receiving

Table 3A Adverse Events Reported in ≥1% of Adult Patients Receiving Regional or Local Anesthesia (Surgery, Labor, Cesarean Section, Post-Operative Pain Management, Peripheral Nerve Block and Local Infiltration)

Adverse Reaction Hypotension Nausea Vomiting Bradycardia Headache Paresthesia Back pain Pain Pruritus Fever Dizziness Rigors (Chills) Postoperative complications Hypoesthesia Urinary retention Progression of labor poor/failed Anxiety Breast disorder, breast-feeding Rhinitis

N 536 283 117 96 84 82 73 71 63 61 42 42 41 27 23 23 21 21 18

Naropin total N=1661

(%) (32.3) (17.0) (7.0) (5.8) (5.1) (4.9) (4.4) (4.3) (3.8) (3.7) (2.5) (2.5) (2.5) (1.6) (1.4) (1.4) (1.3) (1.3) (1.1)

N 408 207 88 73 68 57 75 71 40 37 23 24 44 24 20 22 11 12 13

Bupivacaine total N=1433

(%) (28.5) (14.4) (6.1) (5.1) (4.7) (4.0) (5.2) (5.0) (2.8) (2.6) (1.6) (1.7) (3.1) (1.7) (1.4) (1.5) (0.8) (0.8) (0.9)

Table 3B Adverse Events Reported in ≥1% of Fetuses or Neonates of Mothers Who Received Regional Anesthesia (Cesarean Section and Labor Studies)

Adverse Reaction Fetal bradycardia Neonatal jaundice Neonatal complication-NOS Apgar score low Neonatal respiratory disorder Neonatal tachypnea Neonatal fever Fetal tachycardia Fetal distress Neonatal infection Neonatal hypoglycemia

N 77 49 42 18 17 14 13 13 11 10 8

Naropin total N=1661

(%) (12.1) (7.7) (6.6) (2.8) (2.7) (2.2) (2.0) (2.0) (1.7) (1.6) (1.3)

N 68 47 38 14 18 15 14 12 10 8 16

Bupivacaine total N=1433

(%) (11.9) (8.2) (6.6) (2.4) (3.1) (2.6) (2.4) (2.1) (1.7) (1.4) (2.8)

OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered, or large doses administered, during therapeutic use of local anesthetics or to unintended subarachnoid or intravascular injection of local anesthetic solution. (See ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS.) MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES: Therapy with Naropin should be discontinued at the first sign of toxicity. No specific information is available for the treatment of toxicity with Naropin; therefore, treatment should be symptomatic and supportive. The first consideration is prevention, best accomplished by incremental injection of Naropin, careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic and during continuous infusion. At the first sign of change in mental status, oxygen should be administered. The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to unintentional subarachnoid injection of drug solution, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. Circulation should be assisted as necessary. This may prevent convulsions if they have not already occurred. If necessary, use drugs to control convulsions. Intravenous barbiturates, anticonvulsant agents, or muscle relaxants should only be administered by those familiar with their use. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated. Supportive treatment of circulatory depression may require administration of intravenous fluids, and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine or epinephrine to enhance myocardial contractile force). Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. The mean dosages of ropivacaine producing seizures, after intravenous infusion in dogs, nonpregnant and pregnant sheep were 4.9, 6.1 and 5.9 mg/kg, respectively. These doses were associated with peak arterial total plasma concentrations of 11.4, 4.3 and 5.0 μg/mL, respectively. In human volunteers given intravenous Naropin, the mean (min-max) maximum tolerated total and free arterial plasma concentrations were 4.3 (3.4-5.3) and 0.6 (0.3-0.9) μg/mL respectively, at which time moderate CNS symptoms (muscle twitching) were noted. Clinical data from patients experiencing local anesthetic induced convulsions demonstrated rapid development of hypoxia, hypercarbia and acidosis within a minute of the onset of convulsions. These observations suggest that oxygen consumption and carbon dioxide production are greatly increased during local anesthetic convulsions and emphasize the importance of immediate and effective ventilation with oxygen, which may avoid cardiac arrest. If difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated, endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask. The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels should be accomplished. Resuscitation of obstetrical patients may take longer than resuscitation of nonpregnant patients and closed-chest cardiac compression may be ineffective. Rapid delivery of the fetus may improve the response to resuscitative efforts.

APP Pharmaceuticals, LLC

0003-NAR-05-7/10

Rev. 11/08

Table. Correlations of PACBIS With Existing Anxiety and Behavioral Scales:Correlation Coefficients During Induction of Anesthesia

OSBD

(ropivacaine HCl) Injection

bupivacaine. Nursing Mothers: Some local anesthetic drugs are excreted in human milk and caution should be exercised when they are administered to a nursing woman. The excretion of ropivacaine or its metabolites in human milk has not been studied. Based on the milk/plasma concentration ratio in rats, the estimated daily dose to a pup will be about 4% of the dose given to the mother. Assuming that the milk/plasma concentration in humans is of the same order, the total Naropin dose to which the baby is exposed by breast-feeding is far lower than by exposure in utero in pregnant women at term (see Precautions). Pediatric Use: The safety and efficacy of Naropin in pediatric patients have not been established. Geriatric Use: Of the 2,978 subjects that were administered Naropin Injection in 71 controlled and uncontrolled clinical studies, 803 patients (27%) were 65 years of age or older, which includes 127 patients (4%) 75 years of age and over. Naropin Injection was found to be safe and effective in the patients in these studies. Clinical data in one published article indicate that differences in various pharmacodynamic measures were observed with increasing age. In one study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure (MAP) declined with age during the first hour after epidural administration, and the intensity of motor blockade increased with age. This drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Elderly patients are more likely to have decreased hepatic, renal, or cardiac function, as well as concomitant disease. Therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function. (See PHARMACOKINETICS, Elimination.) ADVERSE REACTIONS Reactions to ropivacaine are characteristic of those associated with other amidetype local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. The reported adverse events are derived from clinical studies conducted in the U.S. and other countries. The reference drug was usually bupivacaine. The studies used a variety of premedications, sedatives, and surgical procedures of varying length. A total of 3,988 patients have been exposed to Naropin at concentrations up to 1.0% in clinical trials. Each patient was counted once for each type of adverse event. Incidence ≥5%: For the indications of epidural administration in surgery, cesarean section, postoperative pain management, peripheral nerve block, and local infiltration, the following treatment-emergent adverse events were reported with an incidence of ≥5% in all clinical studies (N=3988): hypotension (37.0%), nausea (24.8%), vomiting (11.6%), bradycardia (9.3%), fever (9.2%), pain (8.0%), postoperative complications (7.1%), anemia (6.1%), paresthesia (5.6%), headache (5.1%), pruritus (5.1%), and back pain (5.0%). Incidence 1-5%: Urinary retention, dizziness, rigors, hypertension, tachycardia, anxiety, oliguria, hypoesthesia, chest pain, hypokalemia, dyspnea, cramps, and urinary tract infection. Incidence in Controlled Clinical Trials: The reported adverse events are derived from controlled clinical studies with Naropin (concentrations ranged from 0.125% to 1.0% for Naropin and 0.25% to 0.75% for bupivacaine) in the U.S. and other countries involving 3,094 patients. Tables 3A and 3B list adverse events (number and percentage) that occurred in at least 1% of Naropin-treated patients in these studies. The majority of patients receiving concentrations higher than 5.0 mg/mL (0.5%) were treated with Naropin.

CAMPIS-SF

ICC

Naropin

behaviors in children.” Dr. Sadhasivam presented his research at the 2010 annual meeting of the American Society of Anesthesiologists, in San Diego (abstract A1670). The goal of the study was to use the PACBIS tool to identify favorable or unfavorable behaviors in children and parents before surgery and induction of anesthesia, and correlate these with behaviors in the recovery room, one day and one week after surgery. The tool presents a numerical scale along with certain behaviors, and requires anesthesiologists and perioperative staff to assign a value to these behaviors. The values range from 0 to 2; after staff are oriented on assessing and coding behaviors, they should not require the scales on paper in front of them. This helps the PACBIS tool to be used more easily in day-to-day practice, as staff can assess and react to behaviors in real time, Dr. Sadhasivam said. For the study, the researchers prospectively enrolled 405 children, aged 3 to 12 years, who were undergoing tonsillectomies and adenoidectomies. They validated the PACBIS using established behavioral assessment tools. The researchers also analyzed correlations between the scale and postoperative and post-discharge pain and behavioral outcomes using pediatric postanesthesia emergence delirium (PAED) scores, post-discharge parental pain measurements, and post-hospitalization behavioral questionnaires on

mYPAS

develop postoperative maladaptive behaviors,” said Dr. Sadhasivam, associate professor of clinical anesthesia and pediatrics at Cincinnati Children’s and the University of Cincinnati College of Medicine. “We found we can confidently predict new-onset postoperative and post-discharge maladaptive

PACBIS, has been developed by Senthilkumar Sadhasivam, MD, MPH, and colleagues at Cincinnati Children’s Hospital Medical Center, in Ohio. “Many children will have significant anxiety and fear before surgery, during induction of anesthesia. About 50% have a traumatic experience and

PACBIS Behaviors (n=89)

new real-time behavioral assessment tool may help clinicians identify and manage favorable and unfavorable behaviors in children and their parents before, during and after surgery. The Perioperative Adult Child Behavioral Interaction Scale, or

Child coping

0.66c

0.53c –0.67c

0.37b

Child distress

0.56c

0.95c

0.77c

0.68c

Parent’s positive

–0.01 –0.06

0.31b

0.23a

Parent’s negative

0.2

0.1

–0.17

0.22a

P<0.05, bP<0.01, cP<0.001

CAMPIS-SF, Child-Adult Medical Procedure Interaction Scale–Short Form; ICC, Induction Compliance Checklist; mYPAS, modified Yale Preoperative Anxiety Scale; OSBD, Observational Scale of Behavioral Distress; PACBIS, Perioperative Adult Child Behavioral Interaction Scale

AnesthesiologyNews.com I 23

NOVEMBER 2010

CL IN ICA L A N E STH E SIOL OG Y behavioral interventions to optimize the surgical experience. There is a rich body of data supporting psychological approaches to manage families’ anxiety and pain associated with pediatric medical procedures, but further work is days 1 and 7 following surgery and discharge. The PACBIS was as effective in assessing perioperative behaviors at all phases of surgery as the other scales, according to the researchers. For example, during induction of anesthesia, a two-unit increase on the PACBIS in measures of child distress matched a six-point increase in the PAED. Either preoperatively or during anesthesia induction, distraction is often the best immediate real-time intervention, Dr. Sadhasivam said. A distracting story can be a good real-time intervention to minimize child distress and improve coping. “If parents cope well and distract the child with non-procedural talks, they can help the child. But if parents are anxious and stressed, and exhibit negative behaviors such as crying in front of the child, it worsens the child’s distress. This may lead to a more traumatic experience,” Dr. Sadhasivam said. Undesirable Behaviors Persist The researchers were shocked by the incidence and persistence of maladaptive behaviors in children after the tonsillectomies and adenoidectomies were performed. Such behaviors included new-onset bedwetting, nightmares and clinging to parents. “Those traumatic experiences are unwarranted,” Dr. Sadhasivam said. “Nobody performed any targeted behavioral interventions, because there was no real-time tool to assess and measure behaviors of children and parents perioperatively. Now we have the tool, and hopefully we’ll be able to make a difference in these patients’ lives.” “One of our central aims in this research was to develop an evidencebased tool that was sufficiently practical to be used in a busy medical setting,” said Lindsey L. Cohen, PhD, associate professor in the Department of Psychology at Georgia State University, in Atlanta, and a PACBIS researcher. “PACBIS might be useful to staff in identifying families in need of

needed to tailor the treatments to the specific families and situations,” Dr. Cohen said. But Alan Jay Schwartz, MD, MSEd, program director of the pediatric anesthesiology fellowship at The Children’s Hospital of Philadelphia, was more skeptical of the study. Dr. Schwartz called the PACBIS a “great idea” in theory. “The ability to assess behaviors in real time has not yet been established, however,” he added, “and I don’t think these authors have established it

any better than anybody else who has tried. The goal that they have in mind is a great goal, and you’d love to have kids and parents deal better with anesthetic procedures. Unfortunately, this study doesn’t add anything beyond what can already be found in the current literature.” The study was supported by a grant from the Foundation for Anesthesia Education and Research. —Evan Young

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

Subcutaneous Heparin Therapy Revisited as VTE Standard of Care Pilot study of surgical ICU patients

f the prevention of hypercoagulability in critically ill surgical patients is the goal of subcutaneous heparin therapy, then physicians are failing miserably, according to the conclusions of a small study at the

University of Colorado School of Medicine, in Denver. The researchers found that, postoperatively, the profiles of 11 patients randomized to receive subcutaneous heparin showed marked hypercoagulability

when compared with blood samples from a control group of 10 healthy volunteers. However, those randomized to receive a goal-

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directed IV infusion of heparin (n=9) demonstrated normalized clotting times and decreased rates of fibrin formation. Sara S. Cheng, MD, an instructor in anesthesia and transplant anesthesia fellow at Colorado, and colleagues enrolled 21 participants; one patient was eventually excluded. The participants were admitted to the surgical intensive care unit directly after abdominal surgery. Patients received either IV heparin titrated to a partial thromboplastin time of 40 to 45 seconds or 5,000 units of subcutaneous heparin three times per day for five days. Blood samples were drawn preoperatively, postoperatively before heparin administration and then daily for seven days. Activated clotting times (ACTs) in the patients who received IV heparin were similar to those of controls (187±7 seconds; P=0.13). Patients who

ERRORS

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

CONTINUED FROM PAGE 17

at all codes and did not work the night shift, Dr. Kane-Gill said. In that sense, the study’s subjects were truly random. Three physicians subsequently reviewed the medication errors and conducted a severity assessment, she said. In 14% of the 100 non-aseptic errors, at least two out of three physicians found that they could potentially have caused harm. Along with steps to improve communication, the study also has spawned discussion about adding cases with a medication administration component to the code simulation training that nurses and doctors complete, Dr. KaneGill said. The study’s findings also illustrate the benefit of having a pharmacist participating in codes, which does not currently occur at UPMC Presbyterian, she said. —Charlotte Huff

AnesthesiologyNews.com I 25

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CL IN ICA L A N E STH E SIOL OG Y bleeding and heparin-induced thrombocytopenia—occurred in either group, although the researchers acknowledged that the study was not powered to detect differences in outcomes. The results suggest that the current standard of care for venous thromboembolism prophylaxis may be suboptimal. “There is no doubt that subcutaneously administered heparin has a large treatment effect, but there is still a substantial clot rate in patients given this standard of care,” Dr. Cheng

said. “This may be partially explained by our finding that some critical care patients have little to no blood heparin activity on a one-size-fits-all dosing regimen.” Mark Stafford-Smith, MD, professor of anesthesiology at Duke University Medical Center in Durham, N.C., found the results “highly provocative” but “far too preliminary to cause me to incorporate such changes into my practice.” He said the next steps would be to demonstrate superior efficacy

(i.e., fewer venous thrombotic complications) and adequate safety (i.e., no increase in bleeding complications or other concerning outcomes) of the new heparin delivery strategy. “It is a reasonable response to trauma or surgery to be hypercoagulable, but how much is too much?” he said. “Without evidence from a large cohort of patients and outcomes, the answer to this question is too difficult to speculate on.” —Michael Vlessides

The results suggest that the current standard of care for venous thromboembolism prophylaxis may be suboptimal. received subcutaneous heparin, on the other hand, had significantly shorter ACTs than did controls (149±5.1 seconds; P<0.001). Dr. Cheng reported the findings at the 2010 annual meeting of the International Anesthesia Research Society (abstract S-103). Using the Sonoclot coagulation and platelet function analyzer (Sienco, Inc.), the investigators also found that clotting rates in the subcutaneous heparin group were significantly faster than controls (39.8±1.4 vs. 18±1.0 units per minute of gel formation; P=0.001). The IV heparin group also had significantly faster clotting rates than controls (30±2.4 vs. 18±1 units per minute of gel formation; P=0.04). The clotting rate in the subcutaneous group was significantly elevated compared with the IV group (P=0.039). “Subcutaneous heparin patients were profoundly hypercoagulable over the entire duration of observation, while the IV heparin group was normalized,” said Dr. Cheng. “They weren’t really anticoagulated, they were just normalized and no longer hypercoagulable. We also looked at peak heparin activity levels using an anti-Xa assay, and there was absolutely no detectable heparin activity in the patients who got subcutaneous heparin.” No case of deep vein thrombosis was found in either group, as confirmed by lower-extremity ultrasound performed on postoperative days 5 and 10. No adverse events—including major

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THE SCIENCE BEHIND PATIENT SEDATION

Procedural Sedation for the Difficult Patient Keith Candiotti, MD Vice Chairman of Clinical Research Chief, Division of Perioperative Medicine Leonard M. Miller School of Medicine University of Miami Miami, Florida

Introduction

clinical policy statement from the American Academy of Emergency Medicine; a joint set of guidelines for pediatric sedation in the outpatient medical and dental settings; and several sets of outpatient guidelines from the American Society of Anesthesiologists, including those for office-based anesthesia, those that define qualifications for administering office-based anesthesia, and those for sedation performed by non-anesthesiologists.3-5 Most of the published guidelines focus greater attention on the principles of sedation rather than on specific regimens. In general, due to the correlation between greater loss of responsiveness to external stimuli and the increased risk of respiratory depression and hypotension, the goal of MAC is adequate but not excessive sedation (Table).2,5 The general categories outlined in the Table summarize the range of procedural sedation based on response to stimuli. However, although these categories provide guidance for relative degrees of sedation, the boundaries are not absolute. Indeed, the transition from minimal to deep sedation occurs on a continuum. Although the goal may be to achieve moderate or conscious sedation, and avoid the potential need for airway intervention, it is essential to prepare for adverse events in both difficult patients as well as in patients without known risk factors for complications. Generally, difficult patients are recognized as:6 • patients who have compromised airways (and in whom sedation may exacerbate respiratory problems);

•

patients who are resistant to sedatives because of a history of drug dependence; and • patients who are elderly, morbidly obese, or have other conditions that alter drug distribution. However, not all patients who ultimately can be classified as “difficult” meet the above criteria. Interindividual differences in the response to sedatives are common; thus, any patient has the potential to respond in a challenging and unexpected way.6

GABANERGIC AGENTS

Minimal Sedation Anxiolysis

Moderate Sedation/Analgesia Deep Sedation/ (“Conscious Sedation”) Analgesia

General Anesthesia

Most of the available IV sedatives— including benzodiazepines and propofol—are thought to exert the majority of their sedative activity via inhibition of the neurotransmitter γ-aminobutyric acid (GABA), which also is an important mediator of respiratory muscle function; as a result, higher plasma concentration levels of these agents not only increase the sedative effect, but also may be more likely to compromise respiration.7 GABA has also been linked to a regulatory role in hemodynamics; thus, the impact on cardiac function increases as the dose increases.8 Although the risk for clinically significant respiratory depression or hemodynamic compromise is low at doses commonly used for moderate or MAC sedation in otherwise healthy individuals, it is not negligible. In populations that have increased susceptibility to drugs the risk for complications are obviously higher.9 For example, in patients with compromised respiratory function, such as those with chronic obstructive pulmonary disease or a history of sleep apnea, agents that act on the GABA pathway (GABAnergic) should be used prudently.10 The vulnerability to respiratory depression associated with these agents increases commensurately with baseline deficits. This vulnerability emphasizes the importance of obtaining a thorough patient history prior to a procedure.

Responsiveness

Normal response to verbal stimulation

Purposefulb response to verbal or tactile stimulation

Purposefulb response following repeated or painful stimulation

Unarousable even with painful stimulus

DEXMEDETOMIDINE: α2 AGONIST

Airway

Unaffected

No intervention required

Intervention may be required

Intervention often required

Spontaneous ventilation

Unaffected

Adequate

May be inadequate

Frequently inadequate

Cardiovascular function

Unaffected

Usually maintained

May be impaired

Despite the exponential growth in demand for outpatient surgical and diagnostic procedures over the past 15 years,1 there is a notable lack of agreement on the ideal drugs for procedural sedation and monitored anesthetic care (MAC), particularly for the difficult patient. There are numerous agents available to provide any level of sedation or analgesia required. A better understanding of the differences between the available options can enable anesthesiologists to select an agent or combination of agents that will provide patients with a maximal benefit, while reducing risk. This is particularly true in patients who present special challenges.

MAC: An Overview In the context of MAC, sedation of the patient is typically the main method of anxiolysis and pain control; it is used as a tool to improve patient comfort and reduce the need for analgesics.2 Guidelines for procedural sedation and MAC have been produced by several specialty medical societies. These include a

Options for MAC Despite the broad range of potential agents and combination of agents available for use–in various doses–to achieve sedation, the list of practical options is narrow. Reflecting the continuum between light and deep sedation, the agents, and their respective doses, on this list vary according to the level of consciousness targeted. It should be noted that, “degree of sedation” is not the only meaningful variable for MAC in outpatients. For example, agents with favorable pharmacokinetics (i.e., a relatively short half-life and rapid elimination) might facilitate faster recovery and minimize adverse effects in this population. In addition, one of the most important differentiating characteristics is the degree of respiratory depression associated with an individual agent. This is particularly true in patients with difficult airways and in the morbidly obese. As reflected in the Table, the risk of respiratory depression or diminished

Table. American Society of Anesthesiologists’ Continuum of Depth of Sedation in Monitored Anesthesia Carea

a Monitored anesthesia care does not describe the continuum of depth of sedation; it describes “a specific anesthesia service in which an anesthesiologist has been requested to participate in the care of a patient undergoing a diagnostic or therapeutic procedure.” b Purposeful response does not include reflex withdrawal from a painful stimulus. Adapted from reference 5.

cardiovascular function often parallels the depth of sedation, so that a greater degree of sedation translates into a higher risk of these and other adverse events.5,6 However, even lower levels of sedation may be associated with complications in difficult patients. Thus, appropriate drug selection is even more crucial in this population.

ANESTHESIOLOGY NEWS

NOVEMBER 2010

In 2008, dexmedetomidine received the indication for sedation of non-intubated patients prior to and/or during surgical and other procedures. Dexmedetomidine is an attractive alternative to GABA agents for sedation in difficult patients. As an α2 agonist, dexmedetomidine provides sedative effects without significantly affecting respiratory function. The inhibition of sympathetic activity through α2 receptors can slow the heart rate and lower blood pressure, but clinically significant effects

Supported and approved by Hospira

on hemodynamics in typical dosing are generally modest.11 In a Phase III trial comparing 2 dose levels of dexmedetomidine to placebo (all patients could receive midazolam and fentanyl to reach a desired sedation level) in 326 patients undergoing a variety of surgical and diagnostic procedures, anesthesiologists reported “an ease of achieving and maintaining” target sedation with dexmedetomidine. The incidence of clinically significant respiratory depression (defined as a respiratory rate of <8 or an oxygen saturation of <90%) was lower in the dexmedetomidine-treated patients (P=0.018) compared to patients treated with placebo. Additionally, patients randomized to dexmedetomidine required less opioids by comparison.12 In cases where dexmedetomidine is combined with opioids and/or benzodiazepines, especially when large doses are used, respiratory depression may become a problem and reversal agents for those drugs should be available. Although dexmedetomidine has a slower onset than many of the short-acting GABA agonists, it has a broad range of potential applications in procedural sedation (Figure). For example, dexmedetomidine is an attractive alternative to very

short-acting agents, when an extended duration of sedation may be needed or where airway access may be limited. Dexmedetomidine is also a good choice for moderate sedation (“conscious sedation”) when it is desirable for patients to retain some verbal capacity over the course of the procedure.13 Additionally, because dexmedetomidine acts on α2 receptors, patients who have developed a tolerance to GABAnergic agents should not have significant cross-tolerance to dexmedetomidine. For these reasons, in patients with benzodiazepine tolerance, dexmedetomidine may be an attractive option to use with opioids or propofol.11,14 In difficult patients, particularly those at high risk for respiratory depression, it is important to have reversal agents available when opioids or benzodiazepines are being used, with or without dexmedetomidine.

Conclusion The lack of evidence-based standards for selecting agents for procedural sedation produces a false impression that current options are either interchangeable or at least comparably safe and effective. However, at least part of the reason for

an absence of consensus is the hetero- indicated for short-term sedation, is geneity of patients and procedures for among the options to be considered in which sedation is used. Although clini- patients that might be difficult to control cians are understandably more comfort- with conventional GABA agents. able using agents with which they have experience, individualization of sedation References protocols according to specific patient needs is appropriate. No one agent is 1. Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. National optimal for all individuals. Health Statistics Reports 2009(11). The vast majority of agents currently 2. American Society of Anesthesiologists. Distinused in outpatient procedural sedaguishing monitored anesthesia care (“MAC”) tion exert their activity through the from moderate sedation/analgesia (conscious sedation). www.asahq.org/publicationsAndGABA pathway. Several of these agents, Services/standards/35.pdf. Accessed August including some benzodiazepines and 15, 2010. propofol, are short-acting and permit a relatively rapid recovery. However, all of 3. Godwin SA, Caro DA, Wolf SJ, et al. Clinical policy: procedural sedation and analgesia in the these agents pose a risk of respiratory emergency department. Ann Emerg Med. 2005; 45(2):177-196. depression and may have diminished efficacy in patients who chronically use 4. American Academy of Pediatric Dentistry. Guideline for monitoring and management opioids or have a history of substance of pediatric patients during and after sedadependency. tion for diagnostic and therapeutic procedures. In the difficult patient, especially those 2006. http://www.aapd.org/media/Policies_ Guidelines/G_Sedation.pdf. Accessed August with compromised airways and signifi1, 2010. cant comorbidities, the response to GABA agents can be difficult to predict. Caution 5. American Society of Anesthesiologists. Standards, guidelines and statements. 2008. http:// should always be exercised when using www.asahq.org/publicationsAndServices/ these or any sedating agents. Although sgstoc.htm. Accessed August 1, 2010. GABA agents are very useful in a health- 6. American Society of Anesthesiologists Task ier population, other agents should be Force on Sedation and Analgesia by Non-anesthesiologists. Practice guidelines for sedation considered for the difficult patient. The and analgesia by non-anesthesiologists. Anesα2 agonist dexmedetomidine, which is thesiology. 2002;96(4):1004-1017.

Hayashi F, Lipski J. The role of inhibitory amino acids in control of respiratory motor output in an arterially perfused rat. Respir Physiol. 1992;89(1):47-63.

Zhang W, Mifflin S. Plasticity of GABAergic mechanisms within the nucleus of the solitary tract in hypertension. Hypertension. 2010; 55(2):201-206.

Bogunovic OJ, Greenfield SF. Practical geriatrics: Use of benzodiazepines among elderly patients. Psychiatr Serv. 2004;55(3):233-235.

Time From Start of Infusion, min

Average Modified Ramsay Sedation Scores

Baseline

Anxious, agitated, or restless 1

Cooperative, oriented, tranquil 2

10. Brunton LL, Goodman LS, Blumenthal D, Buxton I. Goodman and Gilman’s Manual of Pharmacology and Therapeutics. 11th ed. McGraw-Hill Medical; 2008.

Responds to 3 commands

11. Venn RM, Grounds RM. Comparison between dexmedetomidine and propofol for sedation in the intensive care unit: patient and clinician perceptions. Br J Anaesth. 2001;87(5): 684-690.

Asleep but brisk response to light glabellar tap or loud 4 auditory stimulus

12. Candiotti KA, Bergese SD, Bokesch PM, et al; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010;110(1):47-56.

Asleep, sluggish response to light 5 glabellar tap or loud auditory stimulus Asleep, no response 6 to stimuli Placebo Dexmedetomidine 0.5 mcg/kg for 10 min, followed by maintenance infusion of 0.2 mcg/kg per hour Dexmedetomidine 1 mcg/kg, followed by maintenance infusion of 0.3 mcg/kg per hour

Figure. Time to onset of dexmedetomidine versus placebo.15,16 A loading infusion of 1 mcg/kg over a 10-minute period provides clinically effective onset of sedation generally within 15 minutes after the start of the infusion. If a loading dose is not used, the time to onset of the sedative effect may be extended. Adapted from Data on file. Hospira, Inc. Clinical study report: dose-ranging study. Protocol DEX-97-028; August 17, 1998 and Data on file #2, Hospira, Inc.

P10-2755

13. Szumita PM, Baroletti SA, Anger KE, Wechsler ME. Sedation and analgesia in the intensive care unit: evaluating the role of dexmedetomidine. Am J Health Syst Pharm. 2007;64(1):37-44. 14. Shehabi Y, Nakae H, Hammond N, Bass F, Nicholson L, Chen J. The effect of dexmedetomidine on agitation during weaning of mechanical ventilation in critically ill patients. Anaesth Intensive Care. 2010;38(1):82-90. 15. Protocol DEX97-028; August 17, 1998. 16. Data on file #2, Hospira, Inc. To learn more about Dexmedetomidine HCl Inj go to www.epicclearning.com.

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P A IN M E D I C I NE FLORIDA

training in the discipline. That provision, effective 2012, “underscores the need for a physician every time a controlled sub- advanced formal education and training stance prescription is written and the in the young specialty of pain medicine blanket ‘guilt by association’ clause, these and will elevate the care delivered and concerns are being addressed ... so the enhance patient safety,” she said. The law does allow current pain impact on legitimate pain physicians are practitioners a means of grandfathering minimized.” What’s more, Dr. Pease added, the around the fellowship measure. rule should improve the quality of pain Plan ‘Not Perfect’ care in the state by requiring physicians While the new regulations create who want to practice pain medicine in Florida to undergo accredited fellowship a difficult climate for would-be high CONTINUED FROM PAGE 1

prescribers and drug diverters to thrive in, some pain physicians are wary that the law may hamper their ability to treat patients in legitimate pain. “Unfortunately, the bill doesn’t maintain a balance between the needs of physicians to effectively treat pain and the necessity to root out prescription drug diversion,” said Sean Emami, MD, director of legislative and regulatory affairs for the American Academy of Pain Management. The new law requires that physician

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managers or owners have subspecialty board certification in pain management as a prerequisite for clinic operation. It also stipulates any clinic treating pain be registered and annually inspected by the Florida Department of Health. Owners must have no criminal records for the 10 years prior to applying for a license, and will be held responsible for ensuring their clinic is in compliance with all the clauses of S.B. 2272. “You need a background check to get a liquor license; you can’t be a convicted felon and open up a bar. But you can be a convicted felon and open up a pain clinic,” Broward County sheriff Al Lamberti said in an interview with Time published earlier this year, before the new legislation went into effect (“Invasion of the Pill Mills in South Florida,” April 13, 2010). At that time, Broward County had 24 of the 50 top oxycodone prescribers in the country, and Florida on the whole had 49 of them. Law enforcement officials will be able to obtain patient prescription records without requiring a search warrant, a measure Dr. Emami believes is a breach of the Fourth Amendment to the U.S. Constitution.

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AnesthesiologyNews.com I 29

PA IN M E D ICIN E “This issue has been boiling over for years and years,” said Dr. Silverman, who is also director of Comprehensive Pain Medicine, in Pompano Beach. “The new law may not be perfect, but it’s comprehensive and has far-reaching implications, both for illegitimate and legitimate pain clinics.” For legitimate pain clinics, Dr. Silverman said the requirement that physicians personally examine every patient at every visit before prescribing or dispensing pain medicine will slow down

busy practices and increase wait times, hampering access to effective pain management for some patients. Jeffrey Zipper, MD, chief executive officer of the National Pain Institute (NPI), also expressed similar concern in an e-mail sent to Florida’s pain physicians in September. “I think we can all agree these rules and regulations should eliminate if not all, a vast majority of illicit ‘pill mills,’” Dr. Zipper wrote. “Unfortunately, S.B. 2272 presents some significant

problems and challenges for all legitimate pain management physicians, as well as for patients we treat.” Unlike Dr. Silverman and the FSIPP’s qualified acceptance of the bill, Dr. Zipper’s organization has filed a constitutional challenge to S.B. 2272. In his missive, Dr. Zipper argued the bill breaches physician and patient privacy rights. Moreover, as the bill empowers the Florida Board of Health to revoke the licenses of see Florida page 30

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S.B. 2272 also places strict parameters on when and how physicians can prescribe pain medications. Specifically, each pain medicine prescription must be preceded by a physician’s examination, whereas dispensing of prescriptions previously required only examination by a nurse practitioner or physician’s assistant. Physicians can dispense only up to three days’ worth of opiates to patients who pay with cash or a credit card, exempting patients whose insurance pays. In terms of penalties, the law states that clinics not complying with these rules can be permanently shut down, and owners and physicians may be charged with third-degree felonies and fined up to $5,000 for each day they are in violation of the law. According to Sanford Silverman, MD, president-elect of the Florida Society of Interventional Pain Physicians (FSIPP) and a frequent speaker on the subject of prescription drug abuse, S.B. 2272 may be too restrictive in changing the lax regulatory environment that has made Florida a favored place for drug-dispensing entrepreneurs. However, he welcomes the legislative efforts.

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all physicians in a group practice that is shut down for violating the law, it creates a situation where individuals are unfairly accused of guilt by association. Dr. Zipper also pointed to the stipulation that only physicians with subspecialty board certification in pain management may practice in, own or manage a pain clinic. He noted that there are no pain medicine residency programs in Florida

and only three pain management fellowship programs. Drs. Zipper and Emami expressed concern that this requirement will make an already low number of board-certified pain physicians—254 for an estimated population of 4 million patients with chronic pain in the state—even smaller. “Diagnosing and treating pain is part of the ordinary practice of medicine,” Dr. Emami said. “The various specialties such as orthopedic surgery, rheumatology, palliative medicine, geriatric

medicine and primary care do not offer subspecialty certification in pain medicine. If such a restriction were to be implemented, there would a severe health crisis in the state.” Important and less contentious is the creation of the PDMP mandated by the bill. PDMPs are in place in 38 other states and widely acknowledged to be an effective way to prevent patients from doctor shopping. Florida’s PDMP is set to be online by Dec. 1, 2010. Although pain managers

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welcome its creation, the PDMP is not receiving public funds, Dr. Emami noted. At press time, the Florida PDMP Foundation Fund, a nonprofit organization established to raise funds for the PDMP’s implementation, had received just over $500,000 of the $1 million it set out to raise by the December deadline, with much of the contribution coming from the coffers of the drug monitoring technology company that had won the bid to install the system. “It’s absurd that the PDMP isn’t statefunded,” said Dr. Emami. “Not only is it not funded, the proposed maximum time required for physicians to register a prescription is 15 days—far too long.” Dr. Emami believes the maximum drug reporting limit should be seven days, a limit that falls in line with federal standards. He noted the law also does not require Florida’s PDMP to be connected with those in other states, potentially leaving the door open to patients and drug diverters to doctor shop in other states. “Ideally, physicians should be reporting in real time, so that drug diverters don’t have the time to shop around for prescriptions,” Dr. Emami said. Patient Education Key As a corollary to the efforts intended to hinder the practice of poor pain management and excessive prescribing, Dr. Silverman and the FSIPP have created a public education campaign, the centerpiece of which is their Web site, paintruth.org. The site includes resources for individuals in pain and those addicted to pain medicines, and emphasizes pain management need not necessarily include using opiates. Patient education is something that Dr. Emami also believes is critical to reducing the number of prescription-related deaths. He noted that each time he writes an opiate prescription, he emphasizes to his patients they are receiving a controlled substance, that they need to use it only as prescribed, and that the pills need to be locked up in a location out of the reach of other individuals. Public and patient education and an improved PDMP, Dr. Emami believes, may go a longer way than restrictive laws toward reducing the number of prescription drug–related deaths, while not impinging on the ability of pain physicians to practice effectively. “Pain patients really deserve good care, and this legislation is ultimately going to hurt them,” Dr. Emami summed up. “It is a bad precedent to set.” —David Wild

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Anesthesia Secrets: Fourth Edition James Duke

This book uses the popular question-and-answer format of the Secrets Series® to make essential guidance easy to reference and study. A list of the Top 100 Secrets in anesthesiology lets readers review the most frequently encountered board review questions at a glance and an informal tone, user-friendly format and pocket size make the book both convenient and portable.

Anesthesiology for Patients Too Sick for Anesthesiology, an Issue of Anesthesiology Clinics

Benjamin A. Kohl

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One of the anesthesiologist’s greatest challenges is managing high-risk patients with acute or severe conditions. This issue brings the anesthesiologist up to date on the most important and latest approaches to management of the sickest of patients.

Case Files Anesthesiology Lydia Conlay; Eugene Toy; Julia Pollock; Mary Ann Vann; Sheela Pai

Learn the fundamentals of anesthesiology in the context of real patients. Case Files: Anesthesiology contains 53 high-yield cases with open-ended questions. Each case includes an extended discussion, definitions, clinical pearls, three to five USMLE-style comprehension questions and references to the most current literature for further reading.

Clinical Anesthesia Procedures of the Massachusetts General Hospital

William E. Hurford; Michael T. Bailin; J. Kenneth Davison; Kenneth L. Haspel; Carl E. Rosow; Susan A. Vassallo In an easy-to-scan outline format, this pocket reference provides current, comprehensive, concise, consistent and clinically relevant guidelines for anesthesia procedures throughout the preoperative, intraoperative and postoperative periods and in the intensive care unit. The book has been written, reviewed, updated and field-tested by the internationally recognized Anesthesia Department of the Massachusetts General Hospital. This edition includes new information on quality assessment, patient safety, the electronic medical record and new techniques and medications.

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

Written by a team of residents from St. Luke’s-Roosevelt Hospital Center, this is an “insider’s guide” to success on the anesthesia boards and inservice exams. The books presents quick, frequently tested, high-yield facts based on the most recently administered exams. Readers will find this great for initial and last-minute exam review and anesthesiologists will find it valuable as a refresher before recertification.

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

Christopher R. Jarvis, MBA; David B. Mandell, JD, MBA; Jason M. O’Dell, CWP; Claudio A. DeVellis, JD, CPA For Doctors Only teaches doctors how to perform efficiently so they can get more out of a medical practice. More specifically, For Doctors Only will help doctors protect their personal and practice assets from lawsuits, taxes and bad investments while showing them the secrets to building wealth through the leverage of people, assets and effort.

Pediatric Anesthesiology Review: Clinical Cases for Self-Assessment

Robert Holzman; James A. DiNardo; Thomas J. Mancuso; Navil F. Sethna This book provides essential medical information for the subspecialty of pediatric anesthesiology. Illustrating the broad spectrum of the pediatric anesthesiologist’s practice, it uses an interactive question-and-answer dialogue. The case-based approach encourages readers to collaborate with colleagues, improve their oral presentation skills and prepare for challenging situations by explaining various anesthesia care plans and why specific data are required before and during the care of the pediatric patient.

Regional Analgesia and Acute Pain Management, An Issue of Anesthesiology Clinics

Sugantha Ganapathy, MD; Vincent W. S. Chan, MD, BSc, MDCM, FRCP This issue brings the anesthesiologist up to date on current essential topics in regional analgesia and acute pain management, including the latest state-of-the-art techniques and drugs. AN1110

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Novel Noninvasive Ablative Technique For Facet Joint Denervation Safe and Effective

novel magnetic resonance (MR)–guided ultrasound facet joint denervation technique reduced pain scores by 62% after six months of treatment in 15 patients with chronic low back pain, according to a study presented at the 2010 World Congress on Pain (Poster 407). This new technology, MRI-guided focused ultrasound (ExAblate, InSightec), is a safer alternative to radiofrequency (RF) ablation because it’s noninvasive and does not expose patients to radiation, according to the researchers. “Our early experience has shown the [MRI-guided focused ultrasound] is an exciting and effective noninvasive therapeutic technique,” the authors wrote. Primary investigator Wladyslaw Gedroyc, MD, associate professor at the Imperial College School of Medicine in London, hypothesized that low-radiation focused therapeutic ultrasound could achieve the same degree of

tissue necrosis and facet joint denervation as RF facet denervation. To confirm his theory, Dr. Gedroyc performed a prospective, nonrandomized, single-arm, Phase I study to evaluate the safety and effectiveness of using MRI-guided focused ultrasound to treat pain from facet joint osteoarthritis. He enrolled 15 chronic pain patients with a previous positive diagnostic block (local anesthetic and steroid) or who had experienced positive results with denervation treatment of their facet joint. Patients were a mean age of 48 years with a mean body mass index of 29.1 kg/m2. The researchers applied 20-second sonications along the posterior aspect of as many as six facet joints, applying an average of 21 sonications per patient at an average strength of 533 joules. They used contrast-enhanced T1-weighted MR images to identify peri-facet tissue and used fast-spin echo T2 fat saturation sequences to detect high-signal

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intensity at the treated sites. The investigators also measured pain using a 10-point numerical rating scale (NRS) and gauged disability with the 50-point Oswestry Disability Questionnaire (ODQ), monitoring these measures prior to treatment, at week 1 and months 1, 2, 3, 6 and 12 following treatment. Dr. Gedroyc and his team found pain and disability symptoms had improved progressively over the six-month period after initiating treatment. Specifically, average NRS scores fell 62.3% (from 6.5 to 3.85) and average ODQ scores decreased by 55.9% (from 49.1 to 21.8) after six months of treatment compared with baseline (P<0.05 for both). There were no complications associated with the procedure, but patients reported mild discomfort while in the scanner. Up to 5% of patients undergoing RF ablation, however, experienced transient neuritis. The investigators concluded that the ability to image the peri-facet tissue in

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real time and detect thermal levels makes MR-guided focused ultrasound more accurate and safer than RF ablation. “The success of our Phase I safety and efficacy trial warrants further validation,” Dr. Gedroyc concluded. “We are currently planning a large prospective, randomized controlled study comparing this treatment with RF denervation of the facet joint.” Despite its efficacy, the expense of the procedure makes it unlikely MR– guided facet joint denervation will be adopted widely. “The results of this small study are auspicious but the main limitation is that the procedure is not cost-effective,” commented Steven P. Cohen, MD, associate professor in the Department of Anesthesiology & Critical Care Medicine at the Johns Hopkins School of Medicine in Baltimore and professor at the Uniformed Services University of the Health Sciences in Bethesda, Md. “As long as cost controls continue to dictate management decisions, even if controlled studies demonstrate the efficacy of the procedure, its clinical implications are likely to be overshadowed by practical considerations.” —David Wild

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he FDA has approved Vivitrol to treat and prevent relapse after patients with opioid dependence have undergone detoxification treatment. Vivitrol, manufactured by Alkermes, Inc., is an extended-release formulation of naltrexone administered by intramuscular injection once per month. Naltrexone works by blocking opioid receptors in the brain, thus halting the effects of drugs like morphine, heroin and other opioids. In 2006, naltrexone was approved to treat alcohol dependence. Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, called the approval “a significant advancement in addiction treatment.” The safety and efficacy of Vivitrol were studied for six months, in a trial comparing Vivitrol treatment to placebo treatment in patients who had completed detoxification and who were no longer physically dependent on opioids. Patients treated with Vivitrol were more likely to stay in treatment and to refrain from using illicit drugs. More than onethird (36%) of patients who received Vivitrol were able to stay in treatment for the full six months without using drugs, compared with 23% of the placebo group.

Patients must not have any opioids in their system when they start taking Vivitrol; if they do, they may experience withdrawal symptoms, the FDA said. In addition, patients may be more sensitive to opioids while taking Vivitrol at the time of their next scheduled dose. If they miss a dose, or if treatment with Vivitrol has ended, patients can accidentally overdose if they restart opioid use. Side effects of Vivitrol include nausea, tiredness, headache, dizziness, vomiting, decreased appetite, painful joints and muscle cramps. Other serious side effects include reactions at the injection site; liver damage; allergic reactions such as hives, rashes, facial swelling; pneumonia; depressed mood; and suicidal thoughts and behavior. Vivitrol should be administered only by a physician as an intramuscular injection, using special needles that are provided with the product. The recommended dosing regimen is once per month. Health care professionals are encouraged to report adverse events to the FDA’s MedWatch program at 800-FDA1088 or online at www.fda.gov/medwatch/how.htm. —Based on a press release from the FDA

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P OLI C Y & M A NAGEMENT QUALITY

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This is the first in a set of patient-outcome measures for high-impact conditions that are being reviewed; the NQF will address additional measures in the coming months. Lee Fleisher, MD, Robert Dunning Dripps Professor of Anesthesiology and Critical Care at the University of Pennsylvania School of Medicine in Philadelphia and Joyce Dubow, MUP, director of senior health care reform at American Association of Retired Persons, co-chaired the NQF steering committee on patient outcome measures. With the endorsement of these eight measures, the nonprofit organization based in Washington, D.C., seeks to improve the quality of health care in addition to reporting patient-centered outcomes. The NQF has stated that the information gleaned may help consumers make decisions that are better informed; pinpointing the problems and successes of health care professionals is an additional objective. In a press release from NQF, Ms. Dubow said that the organization’s focus on health outcomes “is critically important.” She said that because consumers intuitively can understand information on outcomes, they can use it to select clinicians and hospitals. “I completely support this proposal, but many of the measures are more qualitative than quantitative,” said Neal Cohen, MD, MPH, professor of anesthesiology and medicine and vice dean at the University of California, San Francisco School of Medicine. For example, “quality of life is a personal decision, and in many cases there are subjective components there. For hospitals that try to address ICU needs in different ways, the outcomes could be measured very differently,” Dr. Cohen told Anesthesiology News. The measures address length of stay and mortality rates in the ICU, readmission rates for patients undergoing percutaneous coronary intervention, functional capacity and quality of life for patients

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myocardial infarction and heart failure (Table). “Some of these measures really do impact patient decision making,” Dr. Cohen said. “For example, Implantation of cardioverter-defibrillator and ICU length of stay relative to various surgical propostoperative hospital risk-standardized complication rates (Yale University/CMS) cedures may be very important to patients. The interpretation of these measures is going to be a big Percutaneous coronary intervention and challenge to the lay public and providers alike. They postoperative hospital 30-day risk-standardized are worthy measures, but need to be understood in readmission rates (Yale University/CMS) the context of what care is provided.” He suggested Acute myocardial infarction and 30-day post-hospital that clear explanations and documentation of the discharge/care transition; composite measure outcome measures are important. (Brandeis University/CMS) Another concern expressed by Dr. Cohen perHeart failure and 30-day post-hospital discharge/care tained to the transfer of patients to other facilities. transition; composite measure (Brandeis University/ “One of the problems we have in our ICU,” he said, CMS) “is that there are not a lot of other facilities where we can transfer patients to get the care they need. Length of stay in the intensive care unit (Phillip R. Lee Institute for Health Policy Studies/University To the extent that we address end-of-life issues and of California, San Francisco). This measure is provide palliative care more effectively in an ICU, paired with “OT1-024-09 Intensive care: in-hospital this also means that the patient may die in our care.” mortality rate.” This, he pointed out, would result in a negative mark for the care provider and could motivate an In-hospital mortality rate in the intensive care unit (Phillip R. Lee Institute for Health Policy Studies/ institution to transfer a patient out of the ICU. University of California, San Francisco). This “We acknowledge that a weakness of the meameasure is paired with “OT1-023-09 Intensive care sure is regarding palliative care,” said Dr. Fleisher, unit length-of-stay.” who is an editorial board member of AnesthesiolCOPD and health-related quality of life of patients ogy News. “The goal is to decrease length of stay, before and after pulmonary rehabilitation (American but only if that doesn’t increase mortality. We think Association of Cardiovascular and Pulmonary it’s a paired measure; you can’t look at length of stay Rehabilitation). This is a time-limited endorsement. without looking at mortality. “All of the performance measures need to be evalCOPD and functional capacity of patients before and after pulmonary rehabilitation (American uated at periodic intervals, and this is no exception. Association of Cardiovascular and Pulmonary As these get rolled out, we need to look at how they Rehabilitation). This is a time-limited endorsement. behave,” he said. In the coming months, the NQF plans to address CMS, Centers for Medicare & Medicaid Services; COPD, chronic obstructive pulmonary disease measures for the following additional high-impact conditions: bone/joint disorders, chronic kidney with chronic obstructive pulmonary disease follow- disease, other types of cardiovascular conditions, ing pulmonary rehabilitation and complication rates diabetes, several types of cancer, child health and after implantation of cardioverter defibrillators. Also mental health. included are two composite measures that address —Evan Young 30-day post-hospital discharge of patients with acute

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