June 2011 digital edition of Anesthesiology News by McMahon Group

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The Independent Monthly Newspaper for Anesthesiologists AnesthesiologyNews.com • J u n e 2 0 1 1 • Volume 37 Number 6

More Evidence One Size of Anesthesia Doesn’t Fit All

or women at risk for pain and depression in the months following a cesarean delivery, adding more pain medicine during the operation may help, according to a small study presented at the annual meeting of the Society for Obstetric Anesthesia and Perinatology (SOAP).

ACE Inhibitors Before Surgery May Do No Harm

see dose page 16

aking angiotensin-converting enzyme inhibitors until the day of surgery may pose fewer risks than doctors have feared—and may even provide some benefit, according to a new study. Researchers at Toronto General Hospital used data from more than 61,000 patients to compare people who took ACE inhibitors with those who did not, and found that being on the blood pressure medication long-term leading up to noncardiac surgery was associated with lower 30-day mortality. When they looked more closely at the ACE inhibitor group, they found that those who chose to stop taking the drugs a few days prior to surgery, and delayed restarting it, fared no better than those who took the drug up to the morning of the procedure, and resumed once they were stable. “Maintaining ACE inhibitors prior to surgery might be of some benefit,” said study author Jason Toppin, MD. “And they see ACE page 20

INside

Anesthesia Billing Cases Allege Rampant Fraud

New York anesthesiologist is the driving figure behind a pair of lawsuits involving millions of dollars in what he claims are fraudulent anesthesia billing claims. The physician, Berton Forman, MD, and his lawyers allege that for years hospitals have been dramatically overcharging patients for anesthesia services—doubling or tripling bills and even charging for general anesthesia when none was provided. Dr. Forman says the scope of the fraud could total more than $1 billion nationally.

08 | Pain Medicine Experts debate nerve blocks for patients with chronic pain.

Meanwhile, Dr. Forman, who stands to make millions should he win the suits, said a major insurer for whom he conducted a fraud inquiry to detect precisely such misconduct failed to act on his findings out of fear that it would lose the business of preferred provider organizations (PPOs). These companies act as middlemen between physicians and insurers and, according to Dr. Forman, force the latter to sign contracts that prevent them providers in the network, savings from carefully auditing claims. In that in theory they can pass along return, insurers receive discounts, to plan members. see suits page 30 ranging from 10% to 35%, from

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19 | CLinical Anesthesiology For cesarean deliveries: catheter dosing needs less than single shots.

22 | CLinical Anesthesiology Studies probe anesthesia-brain risk in peds.

34 | COMMENTARY ACO angst? The cure for what ails.

25 | CME—PreAnesthetic Assessment Lesson 292: PreAnesthetic Assessment Of the Patient With Mucopolysaccharidosis

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4 I AnesthesiologyNews.com

June 2011

Discuss these and other articles @ AnesthesiologyNews.com.

Heard Here First:

June 2011

The five most-viewed articles last month on AnesthesiologyNews.com 1. Current Concepts in the Management of the Difficult Airway (Educational Review) 2. To Assess Tube Placement, Keep it Simple 3. After Retractions in Boldt Case, Experts Ponder the Fate Of Hetastarch 4. Electronic Reminders Prompt Improved Ventilation Strategies 5. Technologies Designed To Prevent Errors Can Cause Errors, Too

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

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June 2011

IN B R IEF

Hospital Complications More Common Than Safety Indicators Suggest

he standard methods for detecting adverse events in hospitalized patients could be underreporting the true incidence of such episodes by a factor of 10, a new study has found. Hospitals typically use either voluntary reporting systems or patient safety indicators designed by the Agency for Healthcare Research and Quality. But the new study showed that these two measures detect only 1% and 9% of adverse events, respectively. In contrast, a relatively new technique, called the Global Trigger Tool, identified 90% of adverse events, according to the researchers, who reported their findings in the April 2011 issue of Health Affairs (2011;4:581-589). Developed in 2003 by the Institute for Healthcare Improvement, a nonprofit group based in Cambridge, Mass., the Global Trigger Tool starts with chart reviews by multiple health care workers—typically a nurse or pharmacist—who look for signs of a potential adverse event such as an abnormal laboratory result, a medication stop order or the use of a drug antidote. These signals trigger additional investigation into the nature and severity of the event, and eventually confirmation of the case by a physician. For the latest study, researchers compared the three assessment methods in a sample of 795 patient records culled randomly from three large teaching hospitals in the United States. All of the patients were adults admitted in October 2004, who spent at least 24 hours in the hospital. The three methods combined identified 393 adverse events, the researchers said (some patients had more than one event). Of those, most involved medication errors (150) or procedure-related episodes (109). Hospital-acquired infections (72), pressure ulcers (11), device failures (six), falls (three) and “other” (26) rounded out the list. Eight of the events were fatal. After accounting for patients who had multiple adverse events, and conditions that were present at the time of admission, the incidence was about 30%, according to the researchers. In a subanalysis of a single hospital, the Global Trigger Tool demonstrated a sensitivity of nearly 95% for detecting at least one adverse event and a specificity of 100% for detecting patients with no adverse events. Patient safety indicators had a sensitivity of 8.5% and a specificity of 98.5%, and the hospital’s voluntary reporting system had a sensitivity of 0% and a specificity of 100%.

David C. Classen, MD, associate professor of medicine at the University of Utah, in Salt Lake City, who led the study, said only a small percentage of hospitals are using the Global Trigger Tool. As a result, he said, “hospitals have no clue how safe they are, and neither does the public, for that matter.” Although the 30% rate for adverse events seems high, it’s in line with that

found in two recent studies of the reporting method (see, for example, N Engl J Med 2010;363:2124-2134). Dr. Classen said policy makers—from groups like the Joint Commission to the federal government—should push for wider adoption of the Global Trigger Tool. One way, he added, would be to incorporate it into socalled “meaningful use” requirements for electronic medical records (EMRs).

In fact, he and his colleagues have shown that the tool can work with an EMR system to automate the collection of its measures. By doing so, he added, hospitals can track in real time their adverse events and take steps to remedy them before they lead to patient harm. The Institute for Healthcare Improvement helped fund the study. —Adam Marcus

INDICATION EXALGO® tablets are an extended release oral formulation of the opioid agonist hydromorphone hydrochloride that is indicated for once daily administration for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. IMPORTANT RISK INFORMATION WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE Potential for Abuse EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. EXALGO can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing EXALGO in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Proper Patient Selection EXALGO is an extended-release formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients when a continuous around-the-clock opioid analgesic is needed for an extended period of time.

Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/ hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer. EXALGO is for use in opioid tolerant patients only. Fatal respiratory depression could occur in patients who are not opioid tolerant. Accidental consumption of EXALGO, especially in children, can result in a fatal overdose of hydromorphone. Limitations of Use EXALGO is not indicated for the management of acute or postoperative pain. EXALGO is not intended for use as an as-needed analgesic. EXALGO tablets are to be swallowed whole and are not to be broken, chewed, dissolved, crushed or injected. Taking broken, chewed, dissolved or crushed EXALGO or its contents leads to rapid release and absorption of a potentially fatal dose of hydromorphone.

June 2011

AnesthesiologyNews.com I 7

IN BR IE F

Traffic Accidents Linked to Increased Risk for Chronic Widespread Pain

eople may be more likely to develop chronic widespread pain (CWP) following a traffic accident, according to new research published in Arthritis Care & Research (Epub ahead of print). The American College of Rheumatology defines CWP as the presence of pain above and below the waist or on both the left and right sides of the body, for three months or longer. Studies have reported prevalence rates of CWP between 11% and 13% in Germany, Sweden, the United Kingdom and the United States. To examine the relationship between physically traumatic events and the onset of CWP, U.K. researchers

• EXALGO is also contraindicated in patients who: - need management of mild pain or pain not expected to persist - have significant impaired respiratory function including those with acute or severe bronchial asthma or hypercarbia. - have or are suspected to have paralytic ileus - have narrowed or obstructed gastrointestinal tract including those from previous surgery or “blind loops” in the GI tract - have known hypersensitivity to any components including hydromorphone hydrochloride and sulfites. • Avoid concurrent use of alcohol and EXALGO. Concurrent use of EXALGO with CNS depressants, including alcohol, increases risk of respiratory depression, hypotension, and profound sedation, potentially resulting in coma or death. EXALGO may impair the ability to drive a car or operate machinery. • Not intended in patients who have received MAO inhibitors within 14 days of starting EXALGO. • Use with caution and in reduced doses in older or debilitated patients, as well as patients with renal or hepatic insufficiency, Addison’s disease, delirium tremens, myxedema or hypothyroidism,

followed 2,069 participants from the EPIFUND (Epidemiology of Functional Disorders) study, which provided data on musculoskeletal pain and associated psychological distress at three time points over a four-year period. Patients, who were initially free of CWP, were asked about their recent experience of six physically traumatic events—traffic accident, workplace injury, surgery, fracture, hospitalization and childbirth—and were followedup at four years. Of the subjects who completed the study, 241 (11.6%) reported new onset of CWP at follow-up. More than one-third of these patients reported at least one

physically traumatic event. After adjusting for age, sex, general practice and baseline pain, those who reported a traffic accident experienced an 84% increased likelihood of experiencing CWP. The researchers found no association between CWP and hospitalization, surgery or childbirth (odds ratio, 1.01). “Future research should examine what is peculiar about an accident—or about one’s reaction to it—that confers this increase in the risk of CWP onset,” the researchers concluded.

prostatic hypertrophy or urethral stricture, toxic psychosis. May aggravate convulsions in patients with convulsive disorders; may induce or aggravate seizures in some clinical settings. Consider use of an alternate analgesic in patients with severe renal impairment. • Respiratory depression, which occurs more frequently in elderly or debilitated patients, is the chief hazard with EXALGO. • Serious adverse events could also include hypotensive effects, GI effects, cardiac arrest from overdose and precipitation of withdrawal. Most common adverse events (>10%) seen in clinical studies (N=2474) were: constipation (31%), nausea (28%), vomiting, somnolence, asthenia and dizziness. • Use EXALGO with extreme caution in patients susceptible to intracranial effects of CO2 retention. • Do not abruptly discontinue EXALGO Please see brief summary of Full Prescribing Information, including boxed warning, on following pages. COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and internationally registered trademarks of Covidien AG. EXALGO is a registered trademark of Mallinckrodt Inc. © 2011 Mallinckrodt Inc., a Covidien company. MK20036 May 2011 Printed in USA.

WHERE IS HER DAY HEADED WITHOUT A 24-HOUR PAIN MEDICATION? EXALGO® puts the power of hydromorphone into a once-daily dose, so your patients can worry less about their medicine wearing off. To ﬁnd out more, visit www.EXALGO.com.

—Victoria Stern

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June 2011

P AIN M EDICINE

Experts Debate Use of Nerve Blocks for Chronic Pain

t the Canadian Pain Society’s 2011 annual meeting, two anesthesiologists discussed the pros and cons of using nerve blocks to treat chronic pain. John Clark, MD, who argued against nerve blocks, said they are ineffective, whereas Norm Buckley, MD, who argued in favor of nerve blocks, claimed they are just as useful as

alternative treatments, but require less maintenance. To highlight the disparity between the two sides, Drs. Clark and Buckley debated their respective points using similar situations and some of the same citations. For example, Dr. Clark noted that the 2007 American Academy of Neurology (AAN) guidelines on cervical radiculopathy do not recommend

nerve blocks to treat the condition. The guidelines say there is “insufficient evidence to show whether epidural steroids are effective for radiculopathy,” said Dr. Clark, professor of anesthesia at Dalhousie University Faculty of Medicine and medical director of Pain Services at Capital Health in Halifax, Nova Scotia. Furthermore, the guidelines cite studies that show

BRIEF SUMMARY - Consult full prescribing information before use. EXALGO® (hydromorphone HCl) Extended-Release Tablets WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE Potential for Abuse EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. EXALGO can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing EXALGO in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression [see Drug Abuse and Dependence (9)]. Proper Patient Selection EXALGO is an extended-release formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients when a continuous around-the-clock opioid analgesic is needed for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg of oral oxycodone/ day, 8 mg oral hydromorphone/day, 25 mg of oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer [see Indications and Usage (1) and Dosage and Administration (2)]. EXALGO is for use in opioid tolerant patients only [see Indications and Usage (1) and Dosage and Administration (2)]. Fatal respiratory depression could occur in patients who are not opioid tolerant. Accidental consumption of EXALGO, especially in children, can result in a fatal overdose of hydromorphone [see Warnings and Precautions (5.1)]. Limitations of Use EXALGO is not indicated for the management of acute or postoperative pain [see Indications and Usage (1)]. EXALGO is not intended for use as an as-needed analgesic [see Indications and Usage (1)]. EXALGO tablets are to be swallowed whole and are not to be broken, chewed, dissolved, crushed or injected. Taking broken, chewed, dissolved or crushed EXALGO or its contents leads to rapid release and absorption of a potentially fatal dose of hydromorphone [see Warnings and Precautions (5)]. CONTRAINDICATIONS Opioid Non-Tolerant Patients EXALGO is contraindicated in opioid non-tolerant patients. Fatal respiratory depression could occur in patients who are not opioid tolerant. Impaired Pulmonary Function EXALGO is contraindicated in patients with significant respiratory depression, especially in the absence of resuscitative equipment or in unmonitored settings and in patients with acute or severe bronchial asthma or hypercarbia. Paralytic Ileus EXALGO is contraindicated in patients who have or are suspected of having a paralytic ileus. Preexisting Gastrointestinal (GI) Surgery or Narrowing of GI Tract EXALGO is contraindicated in patients who have had surgical procedures and/or underlying disease that would result in narrowing of the gastrointestinal tract, or have “blind loops” of the gastrointestinal tract or gastrointestinal obstruction. Allergy or Hypersensitivity EXALGO is contraindicated in patients with known hypersensitivity to any of its components including the active agent, hydromorphone hydrochloride or known allergy to sulfite-containing medications [see Warnings and Precautions (5.8)]. WARNINGS AND PRECAUTIONS Information Essential for Safe Administration EXALGO tablets are to be swallowed whole, and are not to be broken, chewed, crushed, dissolved or injected. Taking broken, chewed, crushed, dissolved EXALGO or its contents leads to the rapid release and absorption of a potentially fatal dose of hydromorphone [see Boxed Warning]. EXALGO is for use only in opioid tolerant patients. Ingestion of EXALGO may cause fatal respiratory depression when administered to patients who are not opioid tolerant [see Boxed Warning]. EXALGO tablets must be kept in a secure place out of the reach of children. Accidental consumption of EXALGO, especially in children, can result in a fatal overdose of hydromorphone. Misuse and Abuse EXALGO contains hydromorphone, an opioid agonist, and is a Schedule II controlled substance. Opioid agonists have the potential for being abused and are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. EXALGO can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing EXALGO in situations where the healthcare professional is concerned about an increased risk of misuse, abuse, or diversion. Breaking, crushing, chewing, or dissolving the contents of an EXALGO tablet results in the uncontrolled delivery of the opioid and poses a significant risk of overdose and death [see Drug Abuse and Dependence (9)]. If attempts are made to extract the drug from the hard outer shell for purposes of parenteral abuse, the injection of tablet excipients may be toxic and may result in lethal complications. Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. However, all patients treated with opioids, including EXALGO, require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Respiratory Depression Respiratory depression is the chief hazard of EXALGO. Respiratory depression occurs more frequently in elderly or debilitated patients as well as those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate therapeutic doses may dangerously decrease pulmonary ventilation, and when opioids are given in conjunction with other agents that depress respiration. Use EXALGO with extreme caution in patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve such as asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea, myxedema, kyphoscoliosis or CNS depression. In these patients, even moderate therapeutic doses of hydromorphone may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. In these patients, consider alternative non-opioid analgesics, and use EXALGO only under careful medical supervision at the lowest effective dose. Interactions with Alcohol and Other CNS Depressants The concurrent use of EXALGO with other central nervous system (CNS) depressants, including but not limited to other opioids, illicit drugs, sedatives, hypnotics, general anesthetics, phenothiazines, muscle relaxants, other tranquilizers, and alcohol, increases the risk of respiratory depression, hypotension, and profound sedation, potentially resulting in coma or death. Use with caution and in reduced dosages in patients taking CNS depressants. Avoid concurrent use of alcohol and EXALGO [see Clinical Pharmacology (12.3)]. Head Injury and Increased Intracranial Pressure In the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure, the respiratory depressant effects of EXALGO and its potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly exaggerated. Furthermore, EXALGO can produce effects on pupillary response and consciousness, which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries. Hypotensive Effect EXALGO may cause severe hypotension. There is added risk to individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines, general anesthetics, or other agents that compromise vasomotor tone. Administer EXALGO with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. Gastrointestinal Effects Because the EXALGO tablet is nondeformable and does not appreciably change in shape in the GI tract, do not administer EXALGO to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic, for example: esophageal motility disorders small bowel inflammatory disease, “short gut” syndrome due to adhesions or decreased transit time, past history of peritonitis, cystic fibrosis, chronic intestinal pseudoobstruction, or Meckel’s diverticulum). There have been reports of obstructive symptoms in patients with known strictures or risk of strictures, such as previous GI surgery, in association with the ingestion of drugs in nondeformable extended-release formulations. The administration of EXALGO may obscure the diagnosis or clinical course in patients with acute abdominal condition. It is possible that EXALGO tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized. Sulfites EXALGO contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. MAO Inhibitors EXALGO is not recommended for use in patients who have received MAO inhibitors within 14 days, because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics. Special Risk Groups EXALGO should be administered with caution in elderly (≥ 65 years) and debilitated patients and in patients who are known to be sensitive to central nervous system depressants, such as those with cardiovascular, pulmonary, renal, or hepatic disease [see Use in Specific Populations (8)]. EXALGO should also be used with caution in the following conditions: adrenocortical insufficiency (e.g., Addison’s disease); delirium tremens; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and, toxic psychosis. EXALGO may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings. Use in Pancreatic/Biliary Tract Disease EXALGO can cause an increase in biliary tract pressure as a result of spasm in the sphincter of Oddi. Caution should be exercised in the administration of EXALGO to patients with inflammatory or obstructive bowel disorders, acute pancreatitis secondary to biliary tract disease and in patients about to undergo biliary surgery. Driving and Operating Machinery EXALGO may impair the mental and/or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Caution patients accordingly. Also warn patients about the potential combined effects of EXALGO with other CNS depressants, including other opioids, phenothiazines, sedative/hypnotics, and alcohol [see Drug Interactions (7)]. Precipitation of Withdrawal Mixed agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) should not be administered to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesic, including EXALGO. In these patients, mixed agonists/antagonists analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms. Do not abruptly discontinue EXALGO. Clinical conditions or medicinal products that cause a sudden and significant shortening of gastrointestinal transit time may result in decreased hydromorphone absorption with EXALGO and may potentially lead to withdrawal symptoms in patients with a physical dependence on opioids. ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Respiratory Depression [see Warnings and Precautions (5.3)] • Head Injury and Increased Intracranial Pressure [see Warnings and Precautions (5.5)] • Hypotensive Effect [see Warnings and Precautions (5.6)] • Gastrointestinal Effects [see Warnings and Precautions (5.7)] • Cardiac Arrest [see Overdosage (10)] • Precipitation of Withdrawal [see Warnings and Precautions (5.13)]

such injections do not have an impact on functional impairment, the need for surgery or long-term pain relief beyond three months. Dr. Buckley countered by saying that nerve blocks can be appropriate for radiculopathy. “If you were a patient, which would you rather have: medications, such as NSAIDs [nonsteroidal anti-inflammatory drugs], gabapentin Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. EXALGO was administered to a total of 2,524 patients in 15 controlled and uncontrolled clinical studies. Of these, 423 patients were exposed to EXALGO for greater than 6 months and 141 exposed for greater than one year. The overall incidence of adverse reactions in patients greater than 65 years of age was higher, with a greater than 5% difference in rates for constipation and nausea when compared with younger patients. The overall incidence of adverse reactions in female patients was higher, with a greater than 5% difference in rates for nausea, vomiting, constipation and somnolence when compared with male patients. A 12-week double-blind, placebo-controlled, randomized withdrawal study was conducted in opioid tolerant patients with moderate to severe low back pain [see Clinical Studies (14)]. A total of 447 patients were enrolled into the open-label titration phase with 268 patients randomized into the double-blind treatment phase. The adverse reactions that were reported in at least 2% of the patients are contained in Table 1. Table 1. Number (%) of Patients with Adverse Reactions Reported in ≥2% of Patients with Moderate to Severe Low Back Pain During the Open-Label Titration Phase or Double-Blind Treatment Phase by Preferred Term Preferred Term Open-Label Double-Blind Treatment Phase Titration Phase EXALGO (N=447) EXALGO (N=134) Placebo (N=134) Constipation 69 (15) 10 (7) 5 (4) Nausea 53 (12) 12 (9) 10 (7) Somnolence 39 (9) 1 (1) 0 (0) Headache 35 (8) 7 (5) 10 (7) Vomiting 29 (6) 8 (6) 6 (4) Drug Withdrawal Syndrome 22 (5) 13 (10) 16 (12) Pruritus 21 (5) 1 (1) 0 (0) Dizziness 17 (4) 3 (2) 2 (1) 16 (4) 2 (1) 6 (4) Asthenia a Insomnia 13 (3) 7 (5) 5 (4) Diarrhea 13 (3) 5 (4) 9 (7) Back Pain 13 (3) 6 (4) 8 (6) Dry Mouth 13 (3) 2 (1) 0 (0) Edema Peripheral 13 (3) 3 (2) 1 (1) Hyperhidrosis 13 (3) 2 (1) 2 (1) 10 (2) 2 (1) 0 (0) Anorexia b Arthralgia 9 (2) 8 (6) 3 (2) Anxiety 9 (2) 0 (0) 4 (3) c 9 (2) 4 (3) 3 (2) Abdominal Pain Muscle Spasms 5 (1) 3 (2) 1 (1) Weight Decreased 3 (1) 4 (3) 3 (2) a b c

Fatigue was grouped and reported with asthenia Decreased appetite was grouped and reported with anorexia Abdominal pain upper was grouped and reported with abdominal pain

The adverse reactions that were reported in at least 2% of the total treated patients (N=2,474) in the 14 chronic clinical trials are contained in Table 2. Table 2. Number (%) of Patients with Adverse Reactions Reported in ≥2% of Patients with Chronic Pain Receiving EXALGO in 14 Clinical Studies by Preferred Term Preferred Term All Patients (N=2,474) Constipation 765 (31) Nausea 684 (28) Vomiting 337 (14) Somnolence 367 (15) Headache 308 (12) Asthenia a 272 (11) Dizziness 262 (11) Diarrhea 201 (8) Pruritus 193 (8) Insomnia 161 (7) Hyperhidrosis 143 (6) Edema Peripheral 135 (5) Anorexia b 139 (6) Dry Mouth 121 (5) Abdominal Pain c 115 (5) Anxiety 95 (4) Back Pain 95 (4) d Dyspepsia 88 (4) Depression 81 (3) e Dyspnea 76 (3) Muscle Spasms 74 (3) Arthralgia 72 (3) Rash 64 (3) Pain in Extremity 63 (3) Pain 58 (2) Drug Withdrawal Syndrome 55 (2) Pyrexia 52 (2) Fall 51 (2) Chest Discomfort f 51 (2) a b c d e f

Fatigue was grouped and reported with asthenia Decreased appetite was grouped and reported with anorexia Abdominal pain upper was grouped and reported with abdominal pain Reflux esophagitis, gastroesophageal reflux disease and Barrett’s esophagus were grouped and reported with dyspepsia Dyspnea exacerbated and dyspnea exertional were grouped and reported with dyspnea Chest pain and non-cardiac chest pain were grouped and reported with chest discomfort

June 2011

AnesthesiologyNews.com I 9

Pa in M e d icin e ‘When you look at guidelines, one thing you

Ontario. “When you look at guidelines, one thing you have to consider is who created them. The AAN is is oriented away from procedures and toward oriented away from procedures and toward noninterventional management noninterventional management at least in part at least in part because neurologists don’t do interventions.” because neurologists don’t do interventions.’ In response to Dr. Clark’s claim that nerve blocks are ineffective, —Norm Buckley, MD Dr. Buckley added that advances in imaging techniques now show that or opioids, that you need to take every every three to six months and that has professor and chair of anesthesia at many blocks may be short-lived or useday or an injection that you get once a similar effect?” asked Dr. Buckley, McMaster University, in Hamilton, less simply due to imperfect placement of the needles used for the injections. The only points of agreement Tolerance could occur to both the desired and undesired effects of drugs, and may The following Adverse Reactions occurred in patients with an overall frequency of Labor and Delivery between the two experts seemed to develop at different rates for different effects. <2% and are listed in descending order within each System Organ Class: EXALGO is not recommended for use in women during and immediately prior to labor and delivery. Administration of EXALGO to the mother shortly before Physical dependence is a state of adaptation that is manifested by an opioid Cardiac disorders: palpitations, tachycardia, bradycardia, extrasystoles be that catastrophic complications delivery may result in some degree of respiratory depression in the neonate. specific withdrawal syndrome that can be produced by abrupt cessation, rapid Ear and labyrinth disorders: vertigo, tinnitus However, neonates whose mothers received opioid analgesics during labor dose reduction, decreasing blood level of the drug, and/or administration of can occur with interventions—albeit Endocrine disorders: hypogonadism should be observed closely for signs of respiratory depression. an antagonist. The opioid abstinence or withdrawal syndrome is characterized Eye disorders: vision blurred, diplopia, dry eye, miosis by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, Nursing Mothers rarely—and that, despite limited eviperspiration, chills, piloerection, myalgia, mydriasis, irritability, anxiety, Low concentrations of hydromorphone have been detected in human milk in Gastrointestinal disorders: flatulence, dysphagia, hematochezia, abdominal backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, dence, multidisciplinary care is optimal clinical trials. Withdrawal symptoms can occur in breastfeeding infants when distension, hemorrhoids, abnormal feces, intestinal obstruction, eructation, vomiting, diarrhea, increased blood pressure, respiratory rate, or heart rate. maternal administration of an opioid analgesic is stopped. Nursing should not diverticulum, gastrointestinal motility disorder, large intestine perforation, anal for pain patients. be undertaken while a patient is receiving EXALGO since hydromorphone is fissure, bezoar, duodenitis, ileus, impaired gastric emptying, painful defecation Infants born to mothers physically dependent on opioids will also be physically excreted in the milk. dependent and may exhibit respiratory difficulties and withdrawal symptoms General disorders and administration site conditions: chills, malaise, feeling “The ‘multidisciplinary’ approach [see Use in Specific Populations (8.1, 8.2)]. Pediatric Use abnormal, feeling hot and cold, feeling jittery, hangover, difficulty in walking, feeling drunk, hypothermia The safety and effectiveness of EXALGO in pediatric patients 17 years of age and is only open to some disciplines,” OVERDOSAGE younger have not been established. Infections and infestations: gastroenteritis, diverticulitis Symptoms Geriatric Use Injury, poisoning and procedural complications: contusion, overdose Dr. Buckley pointed out. “It’s common Acute overdosage with opioids can be manifested by respiratory depression, Elderly patients have been shown to be more sensitive to the adverse effects of somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and Investigations: weight decreased, hepatic enzyme increased, blood potassium EXALGO compared to the younger population. Therefore, use extra caution when for the interventional procedure peoclammy skin, constricted pupils, and sometimes bradycardia, hypotension and decreased, blood amylase increased, blood testosterone decreased, oxygen prescribing EXALGO in elderly patients and reduce the initial dose. death. The extended release characteristics of EXALGO should also be taken into saturation decreased ple not to be invited to the table.” Neonatal Withdrawal Syndrome account when treating the overdose. Even in the face of improvement, continued Metabolism and nutrition disorders: dehydration, fluid retention, increased Chronic maternal use of opiates or opioids during pregnancy coexposes the medical monitoring is required because of the possibility of extended effects. appetite, hyperuricemia Dr. Buckley noted that practitiofetus. The newborn may experience subsequent neonatal withdrawal syndrome Deaths due to overdose could occur with abuse and misuse of EXALGO. Musculoskeletal and connective tissue disorders: myalgia (NWS). Manifestations of NWS include irritability, hyperactivity, abnormal Due to the delayed mean apparent peak plasma level of EXALGO occurring at ners often take positions based on their Nervous system disorders: tremor, sedation, hypoesthesia, paraesthesia, sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, weight loss, and 16 hours following administration as well as the 11 hour mean elimination disturbance in attention, memory impairment, dysarthria, syncope, balance failure to gain weight. The onset, duration, and severity of the disorder differ half-life of EXALGO, patients who receive an overdose will require an extended own training. “That applies both to disorder, dysgeusia, depressed level of consciousness, coordination abnormal, based on such factors as the addictive drug used, time and amount of mother’s period of monitoring and treatment that may go beyond 24 to 48 hours. hyperesthesia, myoclonus, dyskinesia, hyperreflexia, encephalopathy, cognitive last dose, and rate of elimination of the drug from the newborn. Approaches Treatment people who use interventional techdisorder, convulsion, psychomotor hyperactivity to the treatment of this syndrome have included supportive care and, when Give primary attention to the re-establishment of a patent airway and institution indicated, drugs such as paregoric or phenobarbital. Psychiatric disorders: confusional state, nervousness, restlessness, abnormal niques and also to people who feel that of assisted or controlled ventilation. Employ supportive measures (including dreams, mood altered, hallucination, panic attack, euphoric mood, paranoia, Hepatic Impairment oxygen and vasopressors) in the management of circulatory shock and pulmonary dysphoria, listless, crying, suicide ideation, libido decreased, aggression In a study that used a single 4 mg oral dose of immediate-release hydromorinterventional techniques aren’t approedema accompanying overdose as indicated. Cardiac arrest or arrhythmias will phone tablets, four-fold increases in plasma levels of hydromorphone Renal and urinary disorders: dysuria, urinary retention, urinary frequency, urinary require advanced life support techniques. (C hesitation, micturition disorder and AUC ) were observed in patients with moderate hepatic priate or well used,” he said in an interThe pure opioid antagonists, such as naloxone and naltrexone are specific impairment (Child-Pugh Group B). Start patients with moderate hepatic Reproductive system and breast disorders: erectile dysfunction, sexual dysfunction antidotes to respiratory depression from opioid overdose. Since the duration impairment on a reduced dose and closely monitored during dose titration. view after the meeting. of reversal would be expected to be less than the duration of action of Respiratory, thoracic and mediastinal disorders: rhinorrhoea, respiratory distress, The pharmacokinetics of hydromorphone in severe hepatic impairment hydromorphone in EXALGO, the patient must be carefully monitored until hypoxia, bronchospasm, sneezing, hyperventilation, respiratory depression and AUC of patients have not been studied. Further increase in C The real heat behind the issue spontaneous respiration is reliably re-established. EXALGO will continue to release Skin and subcutaneous tissue disorders: erythema hydromorphone in this group is expected, therefore, use an even more and add to the hydromorphone load for up to 24 hours after administration and conservative starting dose [see Dosage and Administration (2.4)]. Vascular disorders: flushing, hypertension, hypotension erupted during the lengthy audience the management of an overdose should be monitored accordingly, at least 24 to Renal Impairment 48 hours beyond the overdose. DRUG INTERACTIONS discussion that followed the formal Renal impairment affected the pharmacokinetics of hydromorphone and its Only administer opioid antagonists in the presence of clinically significant CNS Depressants metabolites following administration of a single 4 mg dose of immediate-release respiratory or circulatory depression secondary to hydromorphone overdose. In The concomitant use of EXALGO with central nervous system depressants such as debate. Dr. Buckley said that an intertablets. The effects of renal impairment on hydromorphone pharmacokinetics patients who are physically dependent on any opioid agonist including EXALGO, hypnotics, sedatives, general anesthetics, antipsychotics and alcohol may cause were two-fold and four-fold increases in plasma levels of hydromorphone an abrupt or complete reversal of opioid effects may precipitate an acute additive depressant effects and respiratory depression. Additionally, hypotension ventionalist and a noninterventionaland AUC ) in moderate (CLcr = 40 to 60 mL/min) and severe (C abstinence syndrome. The severity of the withdrawal syndrome produced will and profound sedation or coma could occur. When this combination is indicated, (CLcr < 30 mL/min) impairment, respectively. In addition, in patients with depend on the degree of physical dependence and the dose of the antagonist the dose of one or both agents should be reduced. The concomitant use of alcohol ist nearly came to blows over whether severe renal impairment hydromorphone appeared to be more slowly eliminated administered. Please see the prescribing information for the specific opioid should be avoided [see Clinical Pharmacology (12.3)]. with longer terminal elimination half-life (40 hours) compared to subjects with antagonist for details of their proper use. nerve blocks are offered for the sake Monoamine Oxidase (MAO) Inhibitors normal renal function (15 hours). Start patients with moderate renal impairment MAO inhibitors may cause CNS excitation or depression, hypotension or hypertension on a reduced dose and closely monitored during dose titration. As EXALGO is only OROS is a registered trademark of ALZA Corporation. of helping patients or making money. if co-administered with opioids including EXALGO. EXALGO is not intended for intended for once daily administration, consider use of an alternate analgesic that EXALGO is a registered trademark of Mallinckrodt Inc. patients taking MAO inhibitors or within 14 days of stopping such treatment. may permit more flexibility with the dosing interval in patients with severe renal COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and/or internationally “Some people argue that procedures are impairment [see Dosage and Administration (2.4)]. registered trademarks of Covidien AG. Mixed Agonist/Antagonist Opioid Analgesics The concomitant use of EXALGO with morphine agonist/antagonists (buprenorDRUG ABUSE AND DEPENDENCE offered because physicians in Canada © 2010 Mallinckrodt Inc., a Covidien company phone, nalbuphine, pentazocine) could lead to a reduction of the analgesic Controlled Substance effect by competitive blocking of receptors, thus leading to risk of withdrawal EXALGO contains hydromorphone, a Schedule II controlled substance with a and the United States are well comDistributed by: symptoms. Therefore, this combination is not recommended. high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, Mallinckrodt Brand Pharmaceuticals, Inc. and oxymorphone. EXALGO can be abused and is subject to misuse, abuse, pensated for the work, not because the Anticholinergics Hazelwood, MO 63042 USA addiction, and criminal diversion [see Warnings and Precautions (5.2)]. The high Anticholinergics or other medications with anticholinergic activity when used drug content in the extended release formulation adds to the risk of adverse procedures are effective, ” he said. concurrently with EXALGO may result in increased risk of urinary retention and/or Issued 11/2010 outcomes from abuse. severe constipation, which may lead to paralytic ileus. Despite taking a clear side in the Abuse Mallinckrodt Cytochrome P450 Enzymes All patients treated with opioids, including EXALGO, require careful monitoring In vitro data suggest that hydromorphone in clinically relevant concentrations debate, Dr. Clark noted, “I’m actufor signs of abuse and addiction, because use of opioid analgesic products carries has minimal potential to inhibit the activity of human hepatic CYP450 enzymes the risk of addiction even under appropriate medical use. including CYP1A2, 2C9, 2C19, 2D6, 3A4, and 4A11. ally somewhere in the middle [on the Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, USE IN SPECIFIC POPULATIONS and environmental factors influencing its development and manifestations. It is issue]. Doing procedures on patients Pregnancy characterized by behaviors that include one or more of the following: impaired Teratogenic Effects control over drug use, compulsive use, continued use despite harm, and craving. is associated with rare but significant Pregnancy Category C: There are no adequate and well-controlled studies in “Drug-seeking” behavior is very common to addicts and drug abusers. Drugpregnant women. Hydromorphone crosses the placenta. EXALGO should be used complications and we have to weigh seeking tactics include emergency calls or visits near the end of office hours, during pregnancy only if the potential benefit justifies the potential risk to the refusal to undergo appropriate examination, testing or referral, repeated claims of fetus [see Use in Specific Populations (8.2)]. that in our decision of how to treat loss of prescriptions, tampering with prescriptions and reluctance to provide prior Hydromorphone was not teratogenic in pregnant rats given oral doses up medical records or contact information for other treating physician(s). “Doctor to 6.25 mg/kg/day or in pregnant rabbits administered oral doses up to them.” shopping” (visiting multiple prescribers) to obtain additional prescriptions is 25 mg/kg/day during the period of organogenesis (~1.2 times the human common among drug abusers, people suffering from untreated addiction and exposure following 32 mg/day). Brenda Lau, MD, a chronic pain criminals seeking drugs to sell. Hydromorphone administration to pregnant Syrian hamsters and CF-1 mice Abuse and addiction are separate and distinct from physical dependence and specialist in the Department of Anesduring major organ development revealed teratogenicity likely the result of tolerance. Physicians should be aware that addiction may not be accompanied maternal toxicity associated with sedation and hypoxia. In Syrian hamsters by concurrent tolerance and symptoms of physical dependence in all addicts. thesiology at Providence Health Care, given single subcutaneous doses from 14 to 258 mg/kg during organogenesis In addition, abuse of opioids can occur in the absence of true addiction and is (gestation days 8 to 10), doses ≥ 19 mg/kg hydromorphone produced skull characterized by misuse for non-medical purposes, often in combination with in Vancouver, British Columbia, who malformations (exencephaly and cranioschisis). Continuous infusion of other psychoactive substances. Since EXALGO may be diverted for non-medical hydromorphone (5 mg/kg, s.c.) via implanted osmotic mini pumps during use, careful record-keeping of prescribing information, including quantity, attended the session, said “the issues organogenesis (gestation days 7 to 10) produced soft tissue malformations frequency, and renewal requests is strongly advised. (cryptorchidism, cleft palate, malformed ventricals and retina), and skeletal Proper assessment of the patient, proper prescribing practices, periodic raised in the debate underpin future variations (supraoccipital, checkerboard and split sternebrae, delayed ossification re-evaluation of therapy, and proper dispensing and storage are appropriate of the paws and ectopic ossification sites). The malformations and variations measures that help to limit abuse of opioid drugs. clinical and funding priorities on what observed in the hamsters and mice were at doses approximately three-fold EXALGO is intended for oral use only. Misuse or abuse by breaking, crushing, higher and <one-fold lower, respectively, than a 32 mg human daily oral dose constitutes the ‘best patient outcomes’ chewing, or dissolving EXALGO poses a hazard of overdose and death. This risk is on a body surface area basis. increased with concurrent abuse of EXALGO with alcohol and other substances. Nonteratogenic Effects in the context of the ‘best system With intravenous abuse, the tablet excipients, especially polyethylene oxide, can In the pre- and post-natal effects study in rats, neonatal viability was reduced at be expected to result in necrosis and inflammation of cardiac tissues. In addition, 6.25 mg/kg/day (~1.2 times the human exposure following 32 mg/day). outcomes.’” parenteral drug abuse is commonly associated with transmission of infectious

have to consider is who created them. The AAN

max

Neonates born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Approaches to the treatment of the syndrome have included supportive care and, if indicated, drugs such as paregoric or phenobarbital.

0-48h

disease such as hepatitis and HIV. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product. Dependence Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time.

—Rosemary Frei, MSc

10 I AnesthesiologyNews.com

June 2011

P AIN M EDICINE

Cancer Patients Can Be Drug Abusers Too Drug seeking, diversion among hurdles to overcome Salt Lake City—Managing cancer pain in the outpatient setting can be very challenging, particularly if a patient is at high risk for drug abuse. “Cancer patients can be drug abusers, too,” said David Craig, PharmD, director of the Pain and Palliative Care Pharmacist Residency Program at H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla. “Just because they have a cancer diagnosis does not mean that they will not abuse the drugs we give them to treat their pain.” Assessing their degree of risk for drug abuse is the first step in managing these patients, Dr. Craig said. As an example of this type of patient, Dr. Craig described the case of a 37-year-old man with a history of squamous cell carcinoma of the glottis who had received radiation and chemotherapy followed by a total laryngectomy and a gastric feeding tube. This patient had a history of heroin addiction and had completed a rehabilitation program with methadone. The decision was made to treat the patient’s pain with methadone and oxycodone, with pregabalin (Lyrica, Pfizer). The methadone caused a prolongation of his QT interval but his other laboratory values remained within normal ranges. Caveats for Methadone “Methadone can cause QT prolongation and it is important to monitor patients for this,” Dr. Craig Advertisement

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added. “Also, if you are going to use intravenous methadone for an extended period of time, use the formulation that is free of preservatives, because the intravenous formulation can cause more QT prolongation.” Other methadone “pearls” include performing an electrocardiogram at baseline for high-risk patients, such as those at risk for torsades de pointes, patients using concomitant QT-prolonging drugs or other drugs that may have significant interactions with methadone, patients on oral doses exceeding 100 mg per day and patients with electrolyte abnormalities. Monitoring should be done more frequently if the patient’s current QTc is greater than 450 ms but less than 500 ms, and if the QTc is greater than 500 ms, “watch out!” Dr. Craig warned. The squamous cell cancer patient continued to report that his pain was at 9 out of 10, describing it as “sharp,” “stabbing,” “burning” and “constant” despite the methadone, oxycodone and pregabalin regimen, and he requested controlled release oxycodone. “This patient was really challenging,” Dr. Craig noted. “Sometimes, despite what you do, patients will not respond. I could have jacked the dose of methadone up to 1,000 mg and probably nothing would have happened. Patients have perceptions about how they think they are doing that we, as health care professionals, cannot control. In this case, the patient did not feel that I was doing a good job. And if the patient doesn’t think you are doing a good job, you’re not.”

in approximately 500 patients, and is ideal for documenting decisions about the level of monitoring planned for a particular patient or justifying referrals to a specialty pain clinic. The COMM evaluates behaviors in the past 30 days and is scored by adding the sum of responses of patients to questions, where 0 equals never and 4 equals very often. A score of 9 or higher is considered a positive score. “The COMM is useful for screening and telling us how aggressive we have to be,” Dr. Craig said. The SOAPP-R (http://www.painedu.org) is similar to the COMM, but is more cumbersome to use. It consists of a 24-item questionnaire on a 5-point Likert scale, and a score of 18 or higher is considered high risk, a score between 10 and 21 is moderate risk and a score of less than 9 is low risk. “Patients with active substance abuse are very challenging to treat, and so are patients with psychiatric illnesses,” Dr. Craig said. “We have to treat their cancer pain, but we cannot give them a free ticket to all of the drugs they want, simply because they have cancer.” He added, “the health care system discriminates against patients with noncancer pain. If the patient has cancer pain, it’s ‘come right in, we’re going to Assessing Risk for Abuse treat you right away.’ There is a big disconnect and I It is important to stratify patients’ risk for abus- see this a lot.” ing drugs, Dr. Craig said. Clinicians have a choice of Weighing Empathy three assessment tools that can help: the Opioid Risk Against Abuse Potential Tool (ORT), the Current Opioid Misuse Measure (COMM), and the Screener and Opioid Assessment Lee Kral, PharmD, BCPS, adjunct assistant profesfor Patients with Pain-Revised (SOAPP-R). sor at the University of Iowa Hospitals and Clinics The ORT is a five-question screening tool that can Center for Pain Medicine, in Iowa City, agreed with predict opioid-related aberrant behavior (Pain Med Dr. Craig. “The reality is that even patients with a 2005;6:432-442). It uses the following factors to history of substance abuse or who are at risk for subgauge risk: stance abuse do get cancer,” she said. “Also, treatment 1. Family history of substance abuse of pain related to cancer may unmask an underly2. Personal history of substance abuse ing addiction, and survivors who have pain from the 3. Age (16-45 years) treatment of their cancer may use opioids to help 4. History of preadolescent sexual abuse (women them cope with that pain,” Health care providers can only) feel caught between the empathy they have for the 5. Psychological illness patient and the need to prevent abuse and diversion, “Younger age is more predictive of substance abuse she added. potential. A history of preadolescent sexual abuse Dr. Kral admitted that she finds herself spendaccounts for 4 points but only in females,” Dr. Craig ing more time talking to oncologists about opioid said. “A total score of 0 to 3 indicates low risk, 4 to 7 screening tools, urine drug screens and opioid conis moderate risk and greater than 8 is high risk.” sent and management agreements. “This is someThe COMM assessment tool (http://www.pain- thing most of them never thought they would have edu.org) uses more subjective questions and is a to deal with, but it is becoming ever more a part of 17-item, 5-point Likert scale questionnaire. The test their daily practice.” is quick and easy to administer, has been validated —Fran Lowry

WHEN CHOOSING AN IV SEDATIVE

Different situations require different solutions

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Different situations require different sedative solutions The first and only alpha2 agonist indicated for sedation2,3 —Nonintubated patients prior to and during surgical and other procedures2 — Intubated and mechanically ventilated patients during treatment in an intensive care setting2 an be used alone or in combination with other sedatives or opioid analgesics C to provide sedation and added patient comfort.2 Should be administered by continuous infusion not to exceed 24 hours.2 Effective for intubated patients not just before—but also during—and after extubation.2 More than 4.5 million vials administered to millions of patients since launch.4

Important Precedex Safety Information linically significant episodes of bradycardia, sinus arrest and hypotension have been C associated with Precedex infusion and may necessitate medical intervention. oderate blood pressure and heart rate reductions should be anticipated when initiating M sedation with Precedex. rolonged exposure to dexmedetomidine beyond 24 hours may be associated with P tolerance and tachyphylaxis and a dose-related increase in adverse events. Please see the brief summary of Prescribing Information on adjacent page.

The right fit

FASTEST GROWING IV SEDATIVE1

For today’s sedation management practices

For step-by-step instructions on how to start using Precedex and what to expect, please visit us at www.Precedex.com. oderate blood pressure and heart rate M reductions should be anticipated when initiating sedation with Precedex.2 linically significant episodes of bradycardia C and sinus arrest have occurred in young, healthy volunteers with high vagal tone or with different routes of administration such as rapid intravenous or bolus administration.2 ransient hypertension has been observed T primarily during the administration of the loading dose. Treatment has generally not been necessary, although a reduction in loading dose infusion rate may be desirable.2

ypotension and bradycardia can occur and H may necessitate medical intervention such as —Decreasing or stopping Precedex infusion —Increasing rate of IV fluid administration —Elevating lower extremities — Administering pressor agents such as atropine, ephedrine or glycopyrrolate2 se with caution in patients with advanced U heart block or severe ventricular dysfunction.2 he most common adverse effects T (incidence >2%) are hypotension, bradycardia and dry mouth.2

Please see the brief summary of Prescribing Information on adjacent page. References: 1. Based on increases in weight of active ingredient sold (either mcg or mg). IMS Health National Sales Perspective 2Q 2009. US nonretail market, all channels injectables. 2. Precedex [package insert]. Lake Forest, IL: Hospira, Inc; 2008. 3. Kamibayashi T, Maze M. Clinical uses of α2-adrenergic agonists. Anesthesiology. 2000;93:1345-1349. 4. Data on file. Hospira, Inc. Hospira, Inc. 275 North Field Drive, Lake Forest, IL 60045 P11-3194 Mar., 11. Printed in the USA.

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

Reference EN-2680

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(dexmedetomidine hydrochloride) injection

For Intravenous Use Rx only

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 1 1.1

INDICATIONS AND USAGE Intensive Care Unit Sedation Precedex® is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered by continuous infusion not to exceed 24 hours. Precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex prior to extubation. 1.2 Procedural Sedation Precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. 4 CONTRAINDICATIONS None 5 WARNINGS AND PRECAUTIONS 5.1 Drug Administration Precedex should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of Precedex, patients should be continuously monitored while receiving Precedex. 5.2 Hypotension, Bradycardia, and Sinus Arrest Clinically significant episodes of bradycardia and sinus arrest have been reported with Precedex administration in young, healthy volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration. Reports of hypotension and bradycardia have been associated with Precedex infusion. If medical intervention is required, treatment may include decreasing or stopping the infusion of Precedex, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents. Because Precedex has the potential to augment bradycardia induced by vagal stimuli, clinicians should be prepared to intervene. The intravenous administration of anticholinergic agents (e.g., glycopyrrolate, atropine) should be considered to modify vagal tone. In clinical trials, glycopyrrolate or atropine were effective in the treatment of most episodes of Precedex-induced bradycardia. However, in some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required. Caution should be exercised when administering Precedex to patients with advanced heart block and/or severe ventricular dysfunction. Because Precedex decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension and in elderly patients. In clinical trials where other vasodilators or negative chronotropic agents were co-administered with Precedex an additive pharmacodynamic effect was not observed. Nonetheless, caution should be used when such agents are administered concomitantly with Precedex. 5.3 Transient Hypertension Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive effects of Precedex. Treatment of the transient hypertension has generally not been necessary, although reduction of the loading infusion rate may be desirable. 5.4 Arousability Some patients receiving Precedex have been observed to be arousable and alert when stimulated. This alone should not be considered as evidence of lack of efficacy in the absence of other clinical signs and symptoms. 5.5 Withdrawal Intensive Care Unit Sedation With administration up to 7 days, regardless of dose, 12 (5%) Precedex subjects experienced at least 1 event related to withdrawal within the first 24 hours after discontinuing study drug and 7 (3%) Precedex subjects experienced at least 1 event 24 to 48 hours after end of

study drug. The most common events were nausea, vomiting, and agitation. Tachycardia and hypertension requiring intervention in the 48 hours following study drug discontinuation occurred at frequencies of <5%. If tachycardia and/or hypertension occurs after discontinuation of Precedex supportive therapy is indicated. Procedural Sedation Withdrawal symptoms were not seen after discontinuation of short term infusions of Precedex (<6 hours). 5.6 Tolerance and Tachyphylaxis Use of dexmedetomidine beyond 24 hours has been associated with tolerance and tachyphylaxis and a dose-related increase in adverse reactions [see Adverse Reactions (6.1)]. 5.7 Hepatic Impairment Since Precedex clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see Dosage and Administration (2.2)]. 6 ADVERSE REACTIONS 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. Use of Precedex has been associated with the following serious adverse reactions: • Hypotension, bradycardia and sinus arrest [see Warnings and Precautions (5.2)] • Transient hypertension [see Warnings and Precautions (5.3)] Most common treatment-emergent adverse reactions, occurring in greater than 2% of patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth. Intensive Care Unit Sedation Adverse reaction information is derived from the continuous infusion trials of Precedex for sedation in the Intensive Care Unit setting in which 1007 patients received Precedex. The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1), mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2). The population was between 17 to 88 years of age, 43% ≥65 years of age, 77% male and 93% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 2. The most frequent adverse reactions were hypotension, bradycardia and dry mouth [see Warnings and Precautions (5.2)]. Table 2: Adverse Reactions With an Incidence >2%— Intensive Care Unit Sedation Population <24 hours*

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

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

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

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

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

2% 1% 1% 1%

3% 1% 0 1%

4% 3% 2% 2%

1% 1%

0 1%

2% 2%

<1% <1% <1%

1% 1% 0

1% 0 1%

5% 2% 2%

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

Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of Precedex for sedation in the surgical intensive care unit setting in which 387 patients received Precedex for less than 24 hours. The most frequently observed treatmentemergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 3). Table 3: Treatment-Emergent Adverse Events Occurring in >1% Of All Dexmedetomidine-Treated Patients in the Randomized Placebo-controlled Continuous Infusion <24 Hours ICU Sedation Studies Adverse Event

Randomized Dexmedetomidine (N = 387)

Placebo (N = 379)

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

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

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

In a controlled clinical trial, Precedex was compared to midazolam for ICU sedation exceeding 24 hours duration. Key treatment emergent adverse events occurring in dexmedetomidine or midazolam treated patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 4. The number (%) of subjects who had a dose-related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the Precedex group is provided in Table 5. Table 4: Key Treatment-Emergent Adverse Events Occurring in Dexmedetomidine- or Midazolam-Treated Patients in the Randomized Active Comparator Continuous Infusion Long-Term Intensive Care Unit Sedation Study* Adverse Event Hypotension1 Hypotension requiring intervention Bradycardia2 Bradycardia requiring intervention Systolic Hypertension3 Tachycardia4 Tachycardia requiring intervention Diastolic Hypertension3 Hypertension3 Hypertension requiring intervention† Hypokalemia Pyrexia Agitation Hyperglycemia Constipation Hypoglycemia Respiratory Failure Renal Failure Acute Acute Respiratory Distress Syndrome Generalized edema Hypomagnesemia

Dexmedetomidine (N=244)

Midazolam (N=122)

56%

28% 42%

27% 19%

5% 28% 25%

1% 42% 44%

10% 12% 11%

10% 15% 15%

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

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

2% 2% 1%

1% 6% 7%

† Includes any type of hypertension. 1 Hypotension was defined in absolute terms as Systolic blood

pressure of <80 mmHg or Diastolic blood pressure of <50 mmHg or in relative terms as ≤30% lower than pre-study drug infusion value. 2 Bradycardia was defined in absolute terms as <40 bpm or in relative terms as ≤30% lower than pre-study drug infusion value. 3 Hypertension was defined in absolute terms as Systolic blood pressure >180 mmHg or Diastolic blood pressure of >100 mmHg or in relative terms as ≥30% higher than pre-study drug infusion value. 4 Tachycardia was defined in absolute terms as >120 bpm or in relative terms as ≥30% greater than pre-study drug infusion value.

The following adverse events occurred between 2 and 5% for Precedex and Midazolam, respectively: renal failure acute (2.5%, 0.8%), acute respiratory distress syndrome (2.5%, 0.8%), and respiratory failure (4.5%, 3.3%). Table 5. Number (%) of subjects who had a dose-related increase in Treatment Emergent Adverse Events by maintenance adjusted dose rate range in the Precedex group Precedex mcg/kg/hr Adverse Event

≤ 0.7* N = 95

> 0.7 to ≤ 1.1* N = 78

> 1.1* N = 71

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

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

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

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

*Average maintenance dose over the entire study drug administration

Procedural Sedation Adverse reaction information is derived from the two trials for procedural sedation in which 318 patients received Precedex. The mean total dose was 1.6 mcg/kg (range: 0.5 to 6.7), mean dose per hour was 1.3 mcg/kg/hr (range: 0.3 to 6.1) and the mean duration of infusion of 1.5 hours (range: 0.1 to 6.2). The population was between 18 to 93 years of age, 30% ≥65 years of age, 52% male and 61% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 6. The most frequent adverse reactions were hypotension, bradycardia, and dry mouth [see Warnings and Precautions (5.2)]. Pre-specified criteria for the vital signs to be reported as adverse reactions are footnoted below the table. The decrease in respiratory rate and hypoxia was similar between Precedex and comparator groups in both studies. Table 6: Adverse Reactions With an Incidence > 2%—Procedural Sedation Population

Adverse Event Hypotension1

Respiratory depression2 Bradycardia3 Hypertension4 Tachycardia5 Nausea Dry mouth Hypoxia6 Bradypnea

Precedex N = 318 (%)

Placebo N = 113 (%)

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

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

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

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

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

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

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

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

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

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

Preferred Term

Body as a Whole

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

Cardiovascular Disorders, General

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

Central and Peripheral Nervous System Disorders

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

Gastrointestinal System Disorders

Abdominal pain, diarrhea, vomiting, nausea

Heart Rate and Rhythm Disorders

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

Liver and Biliary System Disorders

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

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

Agitation, confusion, delirium, hallucination, illusion

Red Blood Cell Disorders

Anemia

Renal Disorders

Blood urea nitrogen increased, oliguria

Respiratory System Disorders

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

Skin and Appendages Disorders

Increased sweating

Vascular Disorders

Hemorrhage

Vision Disorders

Photopsia, abnormal vision

OVERDOSAGE The tolerability of Precedex was studied in one study in which healthy subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hr. The maximum blood concentration achieved in this study was approximately 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest doses were first degree atrioventricular block and second degree heart block. No hemodynamic compromise was noted with the atrioventricular block and the heart block resolved spontaneously within one minute. Five patients received an overdose of Precedex in the intensive care unit sedation studies. Two of these patients had no symptoms reported; one patient received a 2 mcg/kg loading dose over 10 minutes (twice the recommended loading dose) and one patient received a maintenance infusion of 0.8 mcg/kg/hr. Two other patients who received a 2 mcg/kg loading dose over 10 minutes, experienced bradycardia and/or hypotension. One patient who received a loading bolus dose of undiluted Precedex (19.4 mcg/kg), had cardiac arrest from which he was successfully resuscitated.

6.2

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

June 2011

AnesthesiologyNews.com I 13

Pa in M e d icin e

Prescription Drug Monitoring With a Twist: Funded by Pharma

fter nearly two years of wrangling between state health officials and politicians, Florida’s Prescription Drug Monitoring Program (PDMP) will finally move forward. The program has been waylaid a number of times since the Florida state legislature approved a bill to create a state database tracking prescriptions of controlled substances. Following a ruling by a state judge in March, the program will now likely be operational within three or four months. As of last summer, 34 states had operational PDMPs, but Florida’s program is unique in one respect: It is being funded through a $1 million grant from Purdue Pharma, the manufacturer of OxyContin (oxycodone). Without the funding, the PDMP could not function. The program requires that Florida physicians report Schedule II to IV controlled drug prescriptions to the database within 15 days of prescribing. It also allows them access to a patient’s prescription history during an office visit to determine if patients may be “doctor shopping.” Access to the database also will be granted to the state’s attorney general, that when donations for the PDMP dried up, fundhealth care regulatory boards and all law enforce- ing would likely fall to the state. ment officials. In March, Purdue Pharma unexpectedly stepped in and announced it would gift the $1 million, A Troubled History delivered over two years, thus making the program When members of the legislature unanimously operational. approved the program in 2009, they did not set aside Gov. Scott tried to refuse the gift, saying it did any money to develop and run it. Instead, they cre- nothing to provide for the long-term sustainabilated a private foundation to solicit donations to ity of the program. He reignited his effort to kill the cover costs. The foundation initially hoped to raise PDMP, saying that it violated patients’ privacy. In $1 million to get the program started, with the goal 2011 testimony before the U.S. House of Representaof getting an additional $750,000 annually to cover tives, Gov. Scott pointed to a “massive privacy breach” operating expenses. of Virginia’s PDMP that occurred in 2009, in which Nine months into its fundraising efforts, how- 8.2 million patient records were accessed illegally. He ever, the foundation found itself behind. (Accord- also argued that it is not the function of government ing to the Florida PDMP Foundation’s Web site, only to track the activities of law-abiding people in order $500,000 has been raised to date.) to uncover a smaller subset of criminals. Florida’s Office of Drug Control, which had been The program, however, has still managed to move instrumental in getting the legislation passed and forward. In early April, after a judge ruled against later raising money, stated publicly that the deadlines Optimum Technology’s protest, the Florida Departmight not be met and the program might not get off ment of Health issued a final order to put the prothe ground. gram in motion. And with the gift from Purdue Around the same time, a battle erupted over who Pharma, the Department of Health said the PDMP would run the program. Two health information should be operational for at least two years. companies were competing for the contract, and after Privacy Issues Remain losing the bid, Ohio-based Optimum Technology, Inc., filed a formal protest alleging that the process to The source of funding is not a prohibitive ethiselect the winning bid had been unfair. cal concern, said Gail Van Norman, MD, professor And most recently, Florida’s Republican governor, of anesthesiology and biomedical ethics at the Uniformer health care executive Rick Scott, took office versity of Washington, in Seattle, and chair of the in January and set about dismantling the PDMP. In American Society of Anesthesiologists (ASA) Comdoing so, Gov. Scott entered a pitched battle with mittee on Ethics. For example, she said, federal law the state’s congressional leadership, law enforcement mandates that tobacco companies fund antismoking officials and the Florida Society of Pain Manage- campaigns. ment Providers (FSPMP), a not-for-profit group that More striking, she said, is that the state is “relying advises pain practices on regulatory compliance. on charity to run this and that’s a guarantee for failThe FSPMP was particularly vocal, calling the ure. If you really want to put a decent monitoring PDMP “the single most important weapon in the program in place, relying on nonrenewable funding is war on [prescription] drug abuse.” not going to work. I predict failure.” In January, Gov. Scott completely eliminated the The far more serious ethical concern, Dr. Van Norstate’s Office of Drug Control, the group charged man said, is the one raised by Gov. Scott: the concern with raising money for the program. He also argued for patient privacy.

The overwhelming majority of patients who receive drug prescriptions for pain are law-abiding citizens seeking relief of legitimate pain; however, with these database parameters, “there is an assumption that someone on pain medication is doing something wrong,” Dr. Van Norman said. “Whenever you gather data like this, there is an ethical issue of how much society should know about the individual in order to protect itself,” added Stanley Rosenbaum, MD, a professor of anesthesiology at the Yale School of Medicine, in New Haven, Conn., who also sits on the ASA’s ethics committee. Although law enforcement officials can access patients’ personal health information from the database, the program manager must first validate any requests. According to the program’s Web site, the “entire program will be federal Health Insurance Portability and Accountability Act (HIPAA) compliant,” in part because HIPAA specifically authorizes the release of prescription information in states with drug monitoring databases. Regardless of whether the program succeeds, Purdue Pharma likely will benefit from being associated with it. According to IMS Health data, in 2010 OxyContin had total U.S. sales of approximately $3.1 billion, making the $1 million gift “a drop in the bucket,” Dr. Van Norman said. “One thing we do know about the pharmaceutical industry in general is that they are very savvy about public image,” she said. “Being able to state that they participate in these programs does have a powerful public impact. And it may not even be that the industry needs to impact public opinion if it positively impacts the thoughts of local doctors, who may think, ‘This is a responsible company,’ and be more willing to prescribe the drugs. Doctors are extremely influenced by that sort of thing.” In 2009, Purdue Pharma also made a $200,000 gift to the National Association of State Controlled Substances Authorities for state monitoring programs. The company did not respond to requests for comment. —Gabriel Miller

14 I AnesthesiologyNews.com

June 2011

PRN

Adherence to Surgical Infection Program Improves, But Rates Remain Stable Yet another study questions benefits of SCIP; focus on measures rather than outcomes

study released at the American Surgical Association calls into question the public health benefits of the Surgical Care Improvement Program (SCIP). An analysis of 112 Veterans Affairs

hospitals showed that risk-adjusted surgical site infection (SSI) rates remained stable between 2005 and 2009 even though hospital adherence to SCIP infection control measures improved over the same period.

Under the microscope.1 Echogenic pattern under coating helps reduce impact on feel.

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“SCIP adherence was neither associated with a lower surgical site infection rate at the patient level, nor with lower hospital surgical site infection rates,” said lead author Mary Hawn, MD, MPH, associate professor of surgery at

Under ultrasound.2 Echogenic pattern produces clear, crisp image with reduced artifacts and acoustic shadowing.

Stimuplex® Ultra. Echogenicity without Compromise. Improved visibility without negatively impacting tactile feel and acoustic needle shadowing. Same tactile feedback, needle feel and overall handling as B. Braun’s clinically-proven3 Stimuplex A needle. Reduced acoustic shadowing and artifacts under the needle may facilitate safer needle advancement during Supraclavicular and Popliteal nerve blocks. 30 degree, short bevel. Most experts agree that short bevel needles (30-45°) carry less risk of causing nerve injuries during PNB than sharp needles with longer beveled tips.4

See the Stimuplex Ultra video! Scan the QR code or go to http://bit.ly/stimuplexultra 1. Microscope image at 25x from Uni of Hanover, Stimuplex Ultra 22G. 2. Stimuplex Ultra 22G, animal model, 45 degrees. 3. A. Sardesai, N. Denny., M. Herrick, A. Lynch, A. W. HarropGriffiths, “A study of the characteristics of single-injection insulated block needles in a biologic model.” RAPM Vol. 29 No. 5, (Sept- Oct, 2004.) 4. Admir Hadzic, Peripheral Nerve Blocks: Principles and practices. 2004. The McGraw-Hill Companies Inc.

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the University of Alabama and a staff surgeon at the VA in Birmingham. The study findings raise questions about releasing SCIP adherence information to the public, said researchers. Currently, this information is given to third-party payers, administrators and patients, who often use it as a gauge for a hospital’s quality. Adherence figures are available online at Hospital Compare (http://www.hospital compare.hhs.gov/). SCIP was implemented in 2006 with the goal of reducing surgical complications by 2010. Since then, the Centers for Medicare & Medicaid Services made it mandatory for hospitals to publicly report surgical processes of care, including infection prevention measures, rather than clinical outcomes. The agency requires two sets of SCIP measures for infection and venous thromboembolism be reported publicly. Hospitals must submit data quarterly, which are then posted online. “The policy of continued SCIP measurement for public reporting and payment should be re-evaluated,” Dr. Hawn said. Dr. Hawn’s study is the fourth study in the last year to show no association between SSI rates and adherence to SCIP measures (JAMA 2010;303: 2479-2485; JACS 2010;211:705-714; Arch Surg 2010 Oct;145:999-1004). But her work is the first to use patientlevel data to study multiple SCIP measures and SSI assessed by quality tracking system. Donald Fry, MD, executive vice president at the Chicago-based think tank Michael Pine and Associates, and an adjunct professor of surgery at Northwestern University, said the studies show that “it’s almost impossible to identify any improvement” in SSIs as a result of the SCIP measures. Dr. Fry, who was instrumental in organizing the original surgical infection project, believes that the SCIP measures are scientifically valid but are not enough. Infection control involves far more variables than those monitored by SCIP. “It may be naive for government or anybody else to believe that only changing one or two things is going to have a measurable impact on outcomes.” Future efforts should focus on measuring true outcomes rather than

June 2011

AnesthesiologyNews.com I 15

PR N processes of care, he said. Ultimately, SCIP will have to be reconfigured in order to track outcomes, he said. Dr. Hawn’s study focused on 60,853 noncardiac operations performed at 112 VA hospitals between 2005 and 2009. Investigators compared the adherence with five SCIP infection prevention measures to the occurrence of an SSI within 30 days of admission. The SCIP measures studied include administration of a timely antibiotic, an appropriate antibiotic, discontinuation of antibiotic within 24 hours, appropriate hair removal and normothermia. Analysis showed hospitals adhered to the composite SCIP measure 81% of the time by 2009, with rates for individual measures ranging from 99% for hair removal to 75% for postoperative normothermia. Adherence improved markedly between 2004 and 2009, particularly in the first 12 months of implementation.

raised awareness of infection issues. But the program has yet to have a measurable benefit for patients. She cautioned that the program could have unintended negative consequences. The public reporting of adherence rates could drive patients to hospitals they perceive to be of higher quality but are not necessarily so. SCIP could also contribute to an overuse of antibiotics. Finally, mandated reporting of SCIP could draw attention and resources away from other potentially

important areas, she said. “I believe the program will have to change and they will have to look at different ways of measuring outcomes,” she said. “That is very hard to do.” David Hoyt, MD, executive director of the American College of Surgeons, said SCIP data collection is burdensome and expensive for hospitals and surgeons. “This study today is a critical example of how a well-intended process can fail to reduce surgical infections.

Overall, the SCIP program does not achieve its goal.” The study does have limitations. It study was restricted to a VA patient population, primarily composed of men, and did not include cardiac procedures. The study authors had no financial disclosures. The research was funded by VA Health Services Research & Development. —Christina Frangou

‘It may be naive for government or anybody else to believe that only changing one or two things is going to have a measurable impact on outcomes.’ —Donald Fry, MD

The infection rates, however, remained relatively stable with little difference between noncompliant and compliant hospitals. After adjusting for patient and procedure factors, the association between SCIP adherence and SSI rates was not significant. In all, 6.2% of patients developed an SSI, ranging from 1.6% for orthopedic operations to 11.3% for colorectal procedures. Patients with more comorbid conditions, higher American Society of Anesthesiologists physical status class, who underwent more complex or colon procedures were less likely to have adherence to SCIP and more likely to result in a surgical site infection. Asked if SCIP has been effective, Dr. Hawn said the program has improved adherence to important infection control measures and has

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June 2011

C LINICA L ANESTHESIO LOGY Dose continued from page 1 All of the 50 women included in the study were considered to be at risk for experiencing relatively high levels of pain immediately after the procedure, as well as pain and depression two months later. But when half of the women received twice the dose of intrathecal morphine (300 mcg) during the operation, as well as 1 g of acetaminophen (equivalent to two extra-strength Tylenol) every six hours for 24 hours in the recovery room, they experienced significantly less pain on movement and at rest, and had lower pain scores overall, 24 hours after the operation (abstract 87). “There does seem to be value in identifying patients who are likely to have increased pain requirements, and not treat all comers the same way,” said study author Robert Fish, MD, obstetric anesthesia fellow at Wake Forest University in Winston-Salem, N.C. Dr. Fish and his team selected their subjects based on their responses to three questions: How much do you expect to hurt after this surgery? How anxious are you about this surgery? How much pain medicine will it take to treat your pain after surgery? Previous research showed that responses can predict a woman’s chances of experiencing severe pain following cesarean delivery. “These questions have become part of our standard preoperative questionnaire,” Dr. Fish said. At 24 hours after the surgery, women who received the additional analgesia reported average pain scores on a visual analog scale (VAS) of 9.6 at rest, whereas those given the standard regimen had an average VAS score of 20.9. For movement-related pain, the Advertisement

instance, 56% of patients overall reported nausea or vomiting that required treatment, which was an issue for just 40% of the group that received only 150 mcg of intrathecal morphine. Furthermore, 64% of the study group experienced pruritus, compared with 56% of controls. Previous research showed that women who have pain after cesarean delivery are at risk for pain and depression for months after the procedure, so a measure that controls immediate pain could, ideally, have a lasting benefit, Dr. Fish said. “What we hope to find is that when pain is better controlled acutely, patients will be less likely to have persistent pain or depression.” These findings are encouraging, said Pamela Flood, MD, professor of clinical anesthesia at Columbia University College of Physicians and Surgeons, in New York City, who was not part of the study group. Dr. Flood said she is looking forward to seeing the two-month data. “Literally giving people Tylenol could actually reduce the risk of depression in two months,” she said. “That would be a huge public health benefit.” ‘Literally giving people Tylenol It is possible that the morphine and additional could actually reduce the acetaminophen have an additive or synergistic effect, said Dr. Flood, so doctors can get a bigger effect risk of depression in two without a huge dose increase. “If you have 10-outof-10 pain, and you brought it down to 8, that’s not months. That would be a a huge benefit. But if the morphine has brought the huge public health benefit.’ pain down to 5 in a high-risk patient, and the additional acetaminophen takes it down to 3, that would feel like an important improvement.” —Pamela Flood, MD For now, Dr. Fish and his team are continuing to enroll patients, collecting data gathered from the added-analgesia group reported a score of 29.7; for women two months after the procedure, to see if controls, the score was 47. the immediate benefits of the multimodal analgesic The women who received multimodal analge- approach last. sia were more likely to experience side effects. For —Alison McCook

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Will Polymorphisms Predict Practice?

n another study presented at the SOAP meeting, researchers found that pregnant women with two common polymorphisms responded differently to intravenous and intrathecal fentanyl during labor, providing more evidence that affirms the importance of customizing analgesia for certain patients (abstract 86). Ruth Landau, MD, at the University of Washington, in Seattle, and Brendan Carvalho, MD, from Stanford University, in Stanford, Calif., found that 20% of women carried a specific allelic combination of two common polymorphisms of the OPRM1 and COMT genes known to affect response to opioids. These women were also less likely to respond to an intravenous dose of fentanyl (1.5 mcg/kg) given early in labor. When women went on to receive an intrathecal dose of fentanyl (20 mcg), those who were A118 homozygous for the A118G

polymorphism of the OPRM1 gene continued to report significantly higher pain scores for up to 25 minutes after receiving the intrathecal dose, compared with women carrying the minor allelic variant (G118). Specifically, the A118 group had an average pain score of 20, compared with 5 for the remaining women, a significant difference. Furthermore, women with the G118 variant who were also Met158 homozygous for the Val158Met polymorphism of the COMT gene had significantly lower pain scores after the intrathecal dose than women who had a different allelic combination of these two polymorphisms. In the future, women and their doctors likely will want to know their genetic makeup, to determine if they carry genetic variants that make them less likely to benefit from intravenous fentanyl, Dr. Landau predicted. Currently,

many women hesitate to progress right to an epidural, but don’t realize that intravenous fentanyl will cross the placenta. If women carry these genetic variants, that’s an unnecessary exposure, she noted. “So these women should be offered an epidural right away.” That time may be sooner than we realize, said Dr. Flood, who did not participate in the study. She has contributed to another preliminary study that suggested polymorphisms in the oxytocin receptor predict the speed of a woman’s labor. It doesn’t cost much to analyze selected genes, said Dr. Flood, and if knowing that information could tell doctors that, for instance, a woman is naturally going to progress slowly through labor and won’t need a cesarean as a result, “I think people will get these tests. I think obstetricians are going to want to know.” —AM

June 2011

AnesthesiologyNews.com I 17

C L INICA L ANESTHESIOL OGY

Hydromorphone Given More Often And in Higher Doses Than Morphine

equivalent doses were significant for both ASA classes and both sexes (P=0.0001). For classes I and II, the mean morphine-equivalent hydromorphone doses were 2.45 to 3.76 times greater than morphine doses. “The debate over whether there is a clinical difference between hydromor-

phone or morphine has gone on for some time, and there are studies that appear to support both opinions,” said Keith Candiotti, MD, associate professor of clinical anesthesiology at the University of Miami Miller School of Medicine, who was not involved in the research.

—Michael Mascia, MD Dr. Candiotti said that although studies often cite a morphine-to-hydromorphone ratio of 5 to 1, some studies have indicated a higher ratio may be more accurate. For instance, Dr. Mascia see choice page 18

In P-

HI AC

I SC

FORCED-AIR WARMING REINVENTED.

0 f-1

S AL GO

lthough hydromorphone and morphine have similar efficacy and side-effect profiles, two recent studies indicate that providers tend to give hydromorphone more often and in higher equivalent doses than morphine for pain in the postoperative setting. “We’re getting into an area of research that deserves more attention,” said Michael Mascia, MD, assistant professor of anesthesiology at West Virginia University, in Morgantown. “This is how people make decisions about what drugs to use.” Dr. Mascia and colleagues presented two posters at the 2010 PostGraduate Assembly in Anesthesiology in New York City (abstracts 9251 and 9252). In one study, the researchers distributed a 17-point questionnaire to providers who prescribed pain management medications postoperatively. Of 59 providers surveyed, 43 returned the surveys. The respondents opted for hydromorphone first over other narcotics 81% of the time, choosing morphine and fentanyl each 7% of the time. Anesthesiology attendings picked hydromorphone 70% of the time, compared with 80% for residents and 88% for nurses in the postanesthesia care unit (PACU). Among the most common reasons given for prescribing hydromorphone over other narcotics were that it is a better analgesic, has fewer side effects and can make patients comfortable more quickly. In the other study, Dr. Mascia’s group reviewed charts describing 9,907 operative events in which patients received a narcotic in the postoperative period. Providers gave hydromorphone for 8,539 operative events (86.2%), compared with 1,368 operative events for morphine—a ratio of 6.24 to 1. Of the patients who received morphine, the American Society of Anesthesiologists (ASA) class I dose for men was 0.0472 mg/kg per hour, and the class II dose was 0.0919 mg/kg per hour, on average. For women, these doses were 0.0599 and 0.0863 mg/kg per hour, respectively. Of patients who received hydromorphone, the ASA class I and II mean morphine-equivalent doses for men were 0.1763 and 0.159 mg/kg per hour, respectively. For women, the morphine-equivalent doses were 0.2252 and 0.313 mg/kg per hour, respectively. The differences between morphine-

‘We’re getting into an area of research that deserves more attention.’

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June 2011

C LINICA L ANESTHESIO LOGY

Intensivists Transfuse at Higher Than Recommended Hb Levels After Cardiothoracic Surgery

ntensivists are more conservative than cardiothoracic surgeons in their decision to initiate transfusions of packed red blood cells following cardiothoracic surgery, new data suggest. However, reflecting widespread nonadherence to published recommendations, both physician groups used higher than recommended hemoglobin (Hb) levels as transfusion trigger points, according to the findings, which were presented at the 2011 annual meeting of the Society of Critical Care Medicine (abstract 279). Aryeh Shander, MD, clinical professor of anesthesiology, medicine and surgery at Mount Sinai School of Medicine, in New York City, and president-elect of the Society for Advancement of Blood Management, said the results were concerning but needed to be confirmed in a larger study. “The number of patients transfused in the study was very small,” said Dr. Shander, who was not

Choice continued from page 17 used a conversion rate of 10:1 and gave substantially higher doses of hydromorphone. “If you are underdosing the patients proportionally on hydromorphone, even if patients have a bit more pain, they may experience fewer side effects, making hydromorphone look ‘better,’” Dr. Candiotti said. “So when using the traditional 5-to-1 ratio, you may be giving less drug, relatively speaking, and getting ‘good’ analgesia but fewer side effects.” Dr. Mascia said his team would like to do a prospective, blinded study looking at the two drugs diluted to the same strength and determine whether there are any differences in efficacy or adverse events. —Dave Levitan

involved in the research. “Nonetheless, there is a general recognition that physicians are not doing their part to reduce the number of transfusions, improve patient outcomes and save enormous amounts of resources if they were to stick to recommendations more closely.” The Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists recommend transfusions after cardiothoracic surgery Hb levels drop to less than 7 g/dL and in the absence of risk factors such as persistent cardiac ischemia. The conservative approach to the need for transfusions by the two organizations is based on research showing an increased risk for morbidity, including infection and ischemic complications, as well as significant patient care costs associated with transfusions (Circulation 2007;116:2544-2552). Given these risks and the overall poor adherence to the guidelines, Timothy Buchman, MD, PhD, director of the Emory Center for Critical Care at Emory University School of Medicine, in Atlanta, and colleagues set out to examine the transfusion practices in their surgical intensive care unit. They focused on intensivists and cardiothoracic surgeons, analyzing medical records of 42 patients who underwent cardiothoracic surgery at the institution. The patients received a total of 72 transfusions over a 45-day period in the summer of 2010. For 20 transfusions, the records did not clearly indicate whether an intensivist or a surgeon ordered the procedure. Of the remainder, four intensivists ordered 21 transfusions and 11 surgeons initiated 31. Dr. Buchman’s team found the mean Hb value at which intensivists initiated transfusions was 7.9 g/dL, with a standard deviation

(SD) of 1.1 and a range from 5.9 to 9.9 g/dL. This threshold was significantly lower than the mean level that triggered surgeons to order transfusions: 8.7 g/ dL (SD=0.95; range, 7.1-10.8 g/dL; P=0.026 compared with mean Hb value for intensivists). Although the researchers found the two groups differed significantly in the Hb trigger points they used to initiate transfusions, Dr. Shander stressed that more research is needed to validate this conclusion. “If you take away the outliers in both groups—from the lower end among intensivists and from the higher end in the surgeon group—there’s really no difference between the two,” Dr. Shander said. “But if it is indeed the case that the two groups are transfusing at different points, it would be relevant and useful to identify the drivers that lie behind these decisions, apart from low hemoglobin levels.” Study co-author Amy Franklin, PhD, assistant professor in the Center for Cognitive Informatics and Decision Making at the University of Texas Health Science Center at Houston, said she could not account for the disparity in trigger points between intensivists and surgeons, but that this was a topic for further study that her group was pursuing. “Neither anemia nor patient type completely explains these specific transfusion behaviors,” Dr. Franklin told Anesthesiology News. “So, we’re in the process of publishing an analysis looking at many other contextual variables that might be contributing to the decision to transfuse or not to transfuse.” In the meantime, Dr. Buchman said, “a multidisciplinary approach to reconciling the differences in transfusion practices would likely reduce utilization of blood, lowering costs and risk.” —David Wild

Table. Comparison of Intraoperative Morphine and Intraoperative Hydromorphone Outcome

Morphinea (n=368)

Hydromorphonea (n=104)

P Value

Duration of surgery, min

164.4 (51.8)

174.2 (52.9)

0.10

IOME, mg

46.0 (17.9)

38.3 (22.9)

≤0.01

First pain score, 0-10

4.8 (3.8)

3.6 (3.8)

≤0.01

Worst pain score, 0-10

6.5 (3.0)

4.9 (3.6)

≤0.01

First nausea score, 0-10

0.2 (1.0)

0.2 (0.8)

0.36

Worst nausea score, 0-10

0.5 (1.3)

0.4 (1.2)

0.49

With any nausea, %

15.2

12.4

0.48

Needing antiemetic rescue, %

23.9

26.9

0.53

With vomiting before antiemetic rescue, %

1.9

0.5

0.18

With any vomiting in PACU, %

3.3

37.5

≤0.01

Time to readiness for PACU discharge, min

134.0 (111.1)

128.4 (65.9)

0.98

IOME, intraoperative morphine equivalents; PACU, postanesthesia care unit a

Numerical outcomes are reported as mean (SD).

From the 2010 annual meeting of the American Society of Anesthesiologists (Le et al, abstract 216).

June 2011

AnesthesiologyNews.com I 19

C L INICA L ANESTHESIOL OGY For spinal anesthesia …

Dose Through Catheter May Be Half That of Single Injection

omen undergoing cesarean deliveries may require a smaller dose of anesthesia when administered through an intrathecal catheter, rather than a single spinal injection, according to a small study presented at the annual meeting of the Society of Obstetric Anesthesia and Perinatology. Among a sample of 10 patients who received intrathecal catheters, the average woman required between 0.6 and 1.1 mL of 0.75% hyperbaric bupivacaine to experience a T4 to T6 block. That amount is between 25% and 50% less than published doses of the same medication delivered as a single spinal injection. Based on these findings, study author J. Sudharma Ranasinghe, MD, associate professor of anesthesiology at the University of Miami Miller School of Medicine, recommended that clinicians opting for intrathecal catheters should use slow, incremental dosing to ensure patients do not receive excessive anesthesia. “If an adequate block can be achieved with less local anesthetic, bolus injection of a spinal medication that was intended for single-shot spinal through a spinal catheter may lead to high spinal block with respiratory difficulty, aspiration risk and severe hypotension,” Dr. Ranasinghe told Anesthesiology News.

necessarily thought that there would be a difference in dosing between an injection through a spinal needle and a catheter injection technique. I would usually use the same dose.” However, with such few patients and a lack of a control group, modifying dosing based solely on these results would be premature, said Dr. Wlody, a member of the editorial board of Anesthesiology News. “It’s entirely possible that, when they complete the study, they’re going to get completely different results,” he said. “Let’s see what the final numbers are before we start changing practice.” Dr. Ranasinghe and her team designed the study after observing in their own practice that women appeared to need a smaller dose of anesthesia when it was administered through an intrathecal catheter, rather than a single spinal injection. Using a catheter, doctors would administer anesthesia incrementally, and women began to experience blocks much sooner with less medication than anyone expected. To test this observation empirically, they followed every woman who received an intrathecal catheter before a cesarean delivery, noting the initial volume of anesthetic required, the duration of surgery and the total volume of anesthesia, as well as the patients’ height, weight and body mass index. After enrolling 10 women, they found that the averPractice Changing? age amount of 0.75% hyperbaric bupivacaine ranged These findings have potentially important impli- from 0.6 to 1.1 mL versus 1.4 to 2.0 mL typically cations, said David Wlody, MD, professor of clinical required for single spinal injection, according to the anesthesiology at the State University of New York- literature and their own practice, Dr. Ranasinghe said. Downstate Medical Center, in New York City. “I Dr. Wlody said he typically uses 1.4 mL of 0.75% think it’s a good idea to look at this. I wouldn’t have bupivacaine for every patient receiving a single spinal

injection for cesarean delivery, adjusting slightly for patients who are very tall or very short. “This dose seems to work for the average-sized patient,” he said. Although he routinely uses single-injection spinal anesthesia, Dr. Wlody said continuous spinal anesthesia does have a role—after accidental dural puncture, for example, or in patients with a difficult airway. The ability to provide incremental dosing is particularly useful in the latter group, he added. Why intrathecal catheters may require smaller doses than single spinal shots is unclear, Dr. Ranasinghe said. One possibility is that the catheter may become threaded in the cephalad direction into the intrathecal space during placement, she said, which would create a high block with small doses. Alternatively, a previous study by Leo et al (Anesth Analg 2009;109:1600-1605) found that a dose as small as 0.93 mL (7 mg) injected in a combined spinal epidural can be effective during cesarean delivery. “So lower doses do provide adequate block,” she said. However, given that lower doses will likely not last as long, a functional catheter to supplement the block is required, Dr. Ranasinghe said. Dr. Wlody said he looks forward to seeing how the new results compare with the doses required by other patients in the same practice who received a single spinal injection. “I think it would probably be stronger if they demonstrated in their population what the requirement is with the needle technique and what the requirement is with the catheter technique,” he said. —Alison McCook

ClipChart Newport, Ore.: Karen Butler went for dental surgery in November 2009 and awoke from the procedure a changed woman. And not just with better teeth: Butler emerged from sedation speaking a curious blend of British Isle tones, with perhaps a preponderance of

Placentia, Calif.: Anesthesiologist Yashwant Giri, 58, has been charged with sexually assaulting two female patients, one age 16, while they were undergoing surgery at Placentia-Linda Hospital. The first incident, involving the teen, allegedly occurred in 2009, at which time OR staff reported it to hospital officials. Dr. Giri denied the claims, but resigned after a second woman in March accused him of abuse. Dr. Giri, who is being held on bail, worked at several Orange County hospitals and police are investigating whether he may have committed other assaults.

Irish overtop. It seems Butler, now 56, is one of the fewer than 100 people ever to be diagnosed with foreign accent syndrome. The condition typically is associated with a stroke or other brain injury; a search of the medical literature shows no case linked to anesthesia.

Chicago: More than nine in 10 anesthesiologists in the United States are having to cope with drug shortages of at least one anesthetic, according to results from a new survey by the American Society of Anesthesiologists. The survey, of 1,373 clinicians in 48 states, found that nearly all (98%) reported experiencing a shortfall of an anesthetic agent within the past year. Affected drugs included neostigmine (56.9%), thiopental (54.7%), succinylcholine (47.6%), propofol (40.3%) and glycopyrrolate (17.3%). Although the vast majority of anesthesiologists surveyed said they have been able to work around the shortages, about 10% said the problem forced them to postpone or cancel a procedure.

20 I AnesthesiologyNews.com

June 2011

C LINICA L ANESTHESIO LOGY ACE continued from page 1 definitely do not cause any problem, and actually may be beneficial.” Dr. Toppin’s group presented its findings at the 2011 annual meeting of the Society of Cardiovascular Anesthesiologists (abstract 64). Decisions Based On Unsatisfying Data Previous small, retrospective studies had suggested that patients who

take ACE inhibitors in the perioperative period are at higher risk for renal failure, hypotension, cardiac events such as myocardial infarction and even death. The reasoning, Dr. Toppin explained, was that any drug that lowers blood pressure might cause problems when combined with either anesthesia or other issues that exacerbate hypotension. But when he and his colleagues took a closer look at the studies, they felt the researchers did not adequately

control for differences between those on and off the drugs. People taking ACE inhibitors are generally sicker, he explained, so comparison studies have to be careful to match them with people who have the same levels of underlying disease. So Dr. Toppin and his team scanned the hospital’s surgical booking center for all patients undergoing noncardiac surgery between 2003 and 2008. They identified 61,420 patients, 7,339 (12%) of whom were taking ACE

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inhibitors—or, less commonly, angiotensin receptor blockers (ARBs)—at the time of surgery. They then isolated about 7,200 patients on the drugs and compared them with the same number not taking the medications, taking care to match patients on more variables than had prior studies, such as cardiac failure, renal function and other risk factors, Dr. Toppin said. They found that those taking ACE inhibitors or ARBs experienced a statistically significant reduction in mortality (odds ratio, 0.54) within the 30 days after surgery. Specifically, 1.4% of those not taking the medications died, compared with about 0.5% of those on ACE inhibitors (P<0.0001). When they looked within the group taking ACE inhibitors, stopping the drug prior to surgery and for a few weeks afterward was not associated with any better outcomes. These findings mirror what Arthur Wallace, MD, PhD, of the University of California, San Francisco and his colleagues have seen: Taking ACE inhibitors before surgery poses no added risk. “When we have looked, it’s hard to show that people with ACE inhibitors have more hypotension during surgery when you give them the drug,” Dr. Wallace told Anesthesiology News. The finding makes sense, Dr. Wallace added, because if people need the drug to go about their daily lives, they should need it during a time of added stress, such as surgery. “It is hard to show that taking away a good drug is good for you,” he said. “It just goes back to why people are on them,” agreed Dr. Toppin. “It’s a drug that is associated with beneficial effects in these high-risk patients.” In 2008, the American College of Physicians issued recommendations on the perioperative management of patients with congestive heart failure, which stated that clinicians should “consider holding or reducing” the usual dose of ACE inhibitors the day of, and for up to 24 hours prior to, elective surgery (http://pier. acponline.org/mcpp/pdf/periopr867. pdf ). Still, the decision to stop or continue ACE inhibitors prior to surgery depends on the individual and institution, Dr. Toppin said. However, some patients do halt their medication over fears of ill effects, based on the results from prior studies. He said he typically asks patients to continue their ACE inhibitors until the morning of surgery, then restart once they are stable. Yet, the real understanding of the benefits or risks associated with ACE

June 2011

AnesthesiologyNews.com I 21

C L INICA L ANESTHESIOL OGY

CDC Releases New Guidelines To Prevent Blood Infections

he Centers for Disease Control and Prevention (CDC) and the Healthcare Infection Control Practices Advisory Committee have released updated guidelines for the prevention of intravascular catheter-related bloodstream infections. The new guidelines, which replace the recommendations published in 2002, place a heavy emphasis on the education and training of health care personnel, using chlorhexidine scrubs for skin antisepsis, ensuring a maximal sterile barrier for catheter insertions and avoiding the routine replacement of central venous catheters as an infection prevention strategy. “The updated CDC guidelines are rich with new recommendations that are based on additional scientific research that has emerged since the prior version was published,” noted Russell N. Olmsted, MPH, 2011 president of the Association for Professionals in Infection Control and Epidemiology, in a press release. “This is an important resource to support efforts toward the elimination of CRBSIs.” Central line–associated bloodstream infections (CLABSIs), the most common type of nosocomial bloodstream infection, carry an estimated mortality rate of 12% to 15%. The treatment of these infections costs U.S. hospitals an estimated $29,000 per patient and $2.3 billion annually. These types of bloodstream infections, however, are considered highly preventable when proper precautions are taken.

Evidence-based Prevention The updated guidelines include recommendations based on a five-step checklist that has been shown to be effective in preventing central-line catheter infections. The checklist stresses hand hygiene, full-barrier precautions during catheter insertions, chlorhexidine

inhibitors will only come after prospective studies, Dr. Toppin cautioned. “We still think the definitive answer still lies in doing a prospective study.” Researchers should not stop with ACE inhibitors, added Dr. Wallace, who is chief of anesthesia at the San Francisco VA Medical Center. Some regular aspirin-takers stop the drug before surgery, out of fear of excess bleeding, he said, and some hospitals even halt b-blockers for patients during the perioperative period, despite research showing this practice may be harmful. “We need to identify which medicines you need to keep going, and which medicines need to be stopped before surgery. It’s incredibly important.” —Alison McCook

antisepsis at the insertion site, avoiding veins in the arm or leg, checking catheter lines each day and removing them when they are no longer needed. A study of 103 intensive care units in Michigan (N Engl J Med 2006;355:2725-2732) found that the use of the checklist led to a 66% reduction in CLABSIs after 18 months. Earlier this year, the CDC issued a report on the number of CLABSIs in the ICUs of U.S. hospitals in 2001 and 2009 to gauge the impact of evidence-based prevention

programs (MMWR Morb Mortal Wkly Rep 2011;60:243-248). The investigation found an estimated 58% reduction in CLABSIs between 2001 and 2009 (43,000 vs. 18,000 cases, respectively). This reduction represents an estimated 3,000 to 6,000 fewer mortalities and an estimated cost savings of $414 million for the U.S. health care system. After the realization that these infections could be prevented, the Department of Health and Human Services set a national goal for a 50% reduction in CLABSIs by 2013.

This call to action urges health care facilities to adhere to proven central-line insertion practices. In 2008, the Centers for Medicare & Medicaid Services designated CLABSIs a “never event,” meaning hospitals will not receive additional reimbursements for treating the infections. Several commercial insurers have adopted this practice. To view the complete “Guidelines for the Prevention of Intravascular Catheter–Related Infections, 2011,” visit http://www.cdc.gov/ hicpac/pdf/guidelines/bsi-guidelines-2011.pdf. —Seth Kandel

22 I AnesthesiologyNews.com

June 2011

C LINICA L ANESTHESIO LOGY

Neuro Risk From Anesthesia Still Obscure, But Unclouding

NAA:Choline, % Change per Week

San Diego—Protection of the neonatal brain during and after surgery is of increasing interest in clinical anesthesia as evidenced by three recent studies. Dean Andropoulos, MD, and colleagues at Texas Children’s Hospital in Houston, conducted two studies on strategies to improve neurodevelopmental outcomes in neonates undergoing cardiac surgery. In an unrelated retrospective cohort study, Charles DiMaggio, PhD, and colleagues at Columbia University in New York City, examined the relationship between exposure to anesthesia and the risk for developmental and behavioral disorders in twins. The three studies were presented at the 2010 annual meeting of the American Society of Anesthesiologists. “Despite survival rates for neonatal cardiac surgery greater than 90%, there’s still a significant incidence of neurodevelopmental impairment in these patients,” said Dr. Andropoulos, chief of anesthesiology at Texas Children’s and professor of pediatric anesthesiology at Baylor College of 16 14 12 10 8 6 4

r=0.393 r2=0.154 P=0.022

2 0

MAC-Hours of Isoflurane

Figure. Isoflurane MAC-hours vs. NAA:choline, % change per week.

Medicine. “Twenty-six percent of neonates with hypoplastic left[-sided] heart syndrome, transposition of the great vessels or total anomalous pulmonary venous return have full-scale IQ less than 85 at 5 years [of age]. And among infants undergoing complex congenital heart disease repair, 49% have gross motor [deficit] and 39% have fine motor deficit at 5 years [of age].” Dr. Andropoulos said that by optimizing cerebral oxygenation in neonates undergoing cardiac surgery, his group had found a low incidence and severity of new brain injury postoperatively, as determined by magnetic resonance imaging (MRI). The aim of this study (abstract A199) was to report neurodevelopmental outcomes in this cohort at one year.

Of the 69 patients who underwent surgery for single- or two-ventricle lesions, 39 were available for follow-up at 1 year of age. In each patient, cerebral oxygenation was optimized with a strategy that comprised high-flow cardiopulmonary bypass (150 mL/kg per minute), antegrade cerebral perfusion, pH stat, hematocrit level of 30% to 35%, isoflurane up to 1% end-tidal, 100 to 400 mcg/kg of fentanyl and 0.5 to 2 mg/kg of midazolam. Neurodevelopment was assessed using the Bayley Scales of Infant Development III; primary outcomes were the mental development index (MDI) and psychomotor development index (PDI). The mean MDI score was 100±14.7 (range, 65-130); the mean PDI score was 87.9±15.9 (range,

Early Promise for Prevention?

esearchers are coming around to the notion that anesthesia can scramble the brain—although how much and why remain largely unknown. But some scientists are turning their attention to finding ways of reducing the harm or even preventing it from occurring in the first place. Not using anesthetics during surgery isn’t an option, of course. But what if a drug could preserve the benefits of anesthetics while sparing brain cells long-term dysfunction? New evidence from researchers at the University of Toronto, in Ontario, Canada, suggests that such an approach might work. In one study, Beverley A. Orser, MD, PhD, professor of anaesthesia, and a doctoral student, Agnes Zurek, found that mice given 1 MAC of isoflurane experienced impairment in memory linked in particular to novelty-seeking behaviors 24 hours after exposure to the drug. Intriguingly, they also showed that mice missing the gene for the a5 subunit of the GABAA receptor—a key target for volatile anesthetics—did not seem to experience memory loss. “We saw a fairly robust memory deficit,” Dr. Orser told Anesthesiology News. “The animals looked absolutely normal otherwise. They had no changes in pain, motor skills or anxiety.” What was particularly surprising about the results, Dr. Orser said, was that the memory deficits were present at a time when the animals had completely or nearly completely eliminated isoflurane from their bodies. “This is a hangover effect,” she said.

52-121). Dr. Andropoulos said the values are identical to those of the general population for the MDI and slightly lower for the PDI. The investigators compared their data with results from the largest previously published cohort study of similar patients in which the primary strategy was deep hypothermic circulatory arrest (Eur J Cardiothorac Surg 2009;36:40-47). Dr. Andropoulos and his colleagues found that neurodevelopmental outcomes in their study were improved relative to the earlier study, in which the mean MDI was 90±15 and mean PDI was 78±18. “One-year neurodevelopmental outcomes in this cohort are improving versus historical controls,” Dr. Andropoulos said. “Strategies

But if GABAA knockout mice don’t experience memory loss after exposure to isoflurane, can a drug that muzzles the gene (or at least a form of it) provide the same protection? The answer, it seems, is yes. In another experiment, Dr. Orser and Ms. Zurek gave mice an experimental drug, currently called L-655,708 (Tocris Bioscience), that preferentially blocks the a5 subunit of the GABAA receptor. The molecule works at site similar to that for midazolam and other benzodiazepines, Dr. Orser said, although it has opposite effects from those agents. Mice that received the experimental drug up to 24 hours after exposure to isoflurane showed memory function comparable to that of animals not given the anesthetic, the researchers said. To be sure, Dr. Orser said, the experiments are merely preliminary; any clinical application would be years away. However, she said, they could help researchers design studies that would better explore the time course and severity of memory loss linked to anesthesia. Meanwhile, she said, clinicians should start taking the prospect of such postoperative deficits more seriously. “We have to start warning our patients and their families to serve as living memory banks so that important information gets relayed,” she said. The research was presented at the 2011 annual meeting of the International Anesthesia Research Society (abstract S-358). —Adam Marcus

MAC, minimum alveolar concentration; NAA, N-acetylaspartate

The Gift of Life, Inc.: A Global Mission

fficially founded by Rotary District 7250 in 1975, The Gift of Life, Inc. is a dynamic international service program. Its purpose is to further the cause of world peace and understanding by facilitating free medical services, including lifesaving surgery to children suffering from congenital heart defects and other similar or allied illnesses, regardless of race, creed, gender, religion or national origin, and who would otherwise lack access to such medical care.

a request to bring a 5- year-old Ugandan girl to the United States for open-heart surgery. At that time, surgery of this kind was not available in Uganda and without it the child would not survive. The little girl underwent a very successful four-hour open-heart surgical procedure to close a hole between the two lower chambers of her small heart. That single act of kindness 37 years ago has grown into a global movement that has treated children from 64 countries and six continents.

Gift of Life History In 1974, the Manhasset Rotary Club, located in Long Island, N.Y. responded to

More Than 10,000 Children Saved In fall 2008, the Gift of Life performed its 10,000th lifesaving surgery. Although

this was a significant milestone for the Rotarians, health care professionals and volunteers of this organization, the need for more help remains a constant struggle. How You Can Help One of the most effective ways to help the Gift of Life, Inc. is to make a donation so that children around the world will continue to receive the medical care they desperately need. Although medical professionals donate their time and skills and the hospitals and medical centers greatly reduce their costs, money is still needed for medical supplies, recovery and travel. Your donation will help pay the cost of these medical expenses surrounding the surgery.

By donating, you will bring a Gift of Life patient to the United States so they can receive desperately needed medical care. Your generosity will allow a child from a Third-World country to experience the kindness of others so that they may grow up to be a compassionate adult. Show the world you care about our youngest and most vulnerable citizens; allow them to become vocal ambassadors and inspirations around the world for the program, our country and our people. For more information, call (516) 504-0830, visit us online at www.giftoflifeinc.com or contact Jennifer Perri-Jayne, program director, at Giftoflife1@aol.com.

June 2011

AnesthesiologyNews.com I 23

C L INICA L ANESTHESIOL OGY focused on maximizing cerebral oxygen delivery may play an important role.” In a related study (abstract A201), Dr. Andropoulos and his colleagues examined the effect of isoflurane and midazolam on brain maturation— using quantitative magnetic resonance imaging (MRI)—in neonates undergoing cardiac surgery. Studies on neonate animals have shown that anesthetics that interact with g-aminobutyric acid (GABA) receptors produce apoptosis after prolonged exposure in the absence of surgery. The trial comprised 37 neonates undergoing repair or palliation of one or both ventricles of the heart. Brain MRI was performed immediately before surgery, seven days postsurgery and three to six months postsurgery. The researchers found a weak association between elevated exposure to isoflurane (increased minimum alveolar concentration [MAC]–hours) and a larger positive change in the ratio of N-acetylaspartate to choline in the basal ganglia and thalamus; this is an index of more rapid maturation, possibly indicating enhanced neuronal development (Figure). Other indices— including maturation of the corpus callosum as a surrogate for supratentorial white matter, and growth of the brain— were not affected by benzodiazepines or isoflurane dose. The investigators concluded that there was no evidence to show that increasing doses of agents that interact with GABA receptors adversely affected brain development. In an unrelated retrospective cohort study (abstract A786), Dr. DiMaggio, associate clinical professor of anesthesiological sciences at Columbia, and his co-investigators, analyzed data on 5,824 pairs of twins born between 1999 and 2005; all cohort members were enrolled in the New York State Medicaid program. Anesthesia exposure status of each child under 3 years of age was determined according to surgical procedures; developmental and behavioral outcomes were identified by screening diagnoses coded according to the World Health Organization’s International Classification of Diseases, ninth revision. Of the 11,648 children, 2,168 (18.6%) were diagnosed with developmental and behavioral disorders—of which the majority (84%) were categorized as unspecified developmental delay. In the children exposed to anesthesia at least once before 3 years of age, the incidence of developmental and behavioral disorders was 341 per 1,000—compared with 157 per 1,000 in the unexposed group (crude

relative risk, 2.5; 95% confidence interval [CI], 2.2-2.7). After adjusting for birth complications and gender, the estimated relative risk for developmental and behavioral disorders in children exposed to anesthesia was 2.2 (95% CI, 1.9-2.4). The investigators concluded that children exposed to anesthesia under 3 years of age are more likely than their peers to be subsequently diagnosed with developmental and behavioral disorders—a relationship that is not fully

explained by birth factors, sex or other medical circumstances. Despite ongoing research, the etiology of neonatal and pediatric neurodevelopmental impairment after exposure to anesthetics remains largely a mystery. “Understanding the implications of anesthetic exposure on neurodevelopmental outcomes continues to be a complex and ever-expanding puzzle,” said Hilary P. Grocott, MD, professor of anesthesia and surgery at the University of Manitoba School of

Medicine in Winnipeg, Canada. “Each of these studies adds small pieces of information, but the picture remains unclear,” he told Anesthesiology News, “ Dr. Grocott said that the relative contributions of anesthesia versus surgical trauma (and its associated stress response) to neurodevelopmental outcomes is “not as straightforward as some of the experimental data would suggest.” —Michael Vlessides

Even when she’s not saying a word, your patient is speaking volumes.

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Lesson 292: PreAnesthetic Assessment of the Patient With Mucopolysaccharidosis WRITTEN BY:

TARGET AUDIENCE

Jermale A. Sam, MD,a Amir R. Baluch, MD,b Alan D. Kaye, MD, PhDc a Resident, Department of Surgery, Riverside Methodist Hospital, Columbus, Ohio. Dr. Sam is now an anesthesia resident at Medical University of South Carolina, in Charleston. b Attending staff physician, Metropolitan Anesthesia Consultants, Dallas, Texas c Professor and chairman, Department of Anesthesiology, Louisiana State University Health Sciences Center, New Orleans, Louisiana

Anesthesiologists

REVIEWED BY:

At the end of this activity, the participant should be able to: 1. Define MPS. 2. Describe the pathophysiology of MPS. 3. Explain how tissue dysfunction develops in patients with such rare lysosomal storage disorders. 4. Cite the incidence of MPS. 5. List the clinical manifestations of MPS. 6. List specific problems associated with the administration of anesthesia to patients with MPS. 7. Present treatment options for patients with MPS. 8. Define appropriate preoperative evaluation of these patients. 9. Formulate an anesthetic plan. 10. Anticipate potential problems in airway management, postoperatively.

Elizabeth A.M. Frost, MD Clinical professor, Department of Anesthesia, Mount Sinai Medical Center, New York, New York

DATE REVIEWED: May 2011 DISCLOSURES Dr. Kaye has disclosed that he is a member of the Baxter speaker’s bureau. The other authors and the reviewer have no relationships with pharmaceutical companies or manufacturers of products to disclose. This educational activity may contain discussion of published and/or investigational uses of agents for the treatment of disease. Some uses of these agents have not been approved by the FDA. Please refer to the official prescribing information for each product for approved indications, contraindications, and warnings.

NEEDS STATEMENT Mucopolysaccharidosis (MPS) describes a group of genetic disorders that can complicate the anesthetic care of patients—in particular, management of the airway. Patients with MPS should be managed by experienced anesthesiologists at centers that are familiar with these disorders. Rarely encountered disease states have been identified as important topics in the continuing education of clinical anesthesiologists.

CALL FOR WRITERS If you would like to write a CME lesson for Anesthesiology News, please send an e-mail to Elizabeth A.M. Frost, MD, at ElzFrost@aol.com.

LEARNING OBJECTIVES

CASE HISTORY A 2-year-old boy with MPS type I (Hurler syndrome) presented for bilateral inguinal hernia repair. The child often made grunting sounds while asleep, according to his parents. He had been given several antibiotics in the past for frequent respiratory infections, and was found to have a mild heart defect. The patient had no allergies and had never received an anesthetic. He weighed 14 kg. A physical examination was remarkable for coarse facies, macroglossia, short neck, and hepatosplenomegaly. A cardiac examination was positive for a 2 of 6 murmur. Mild aortic regurgitation with normal left ventricular systolic function and no wall motion abnormalities were observed with 2-D echocardiography. Cervical spine and chest x-rays were within normal limits.

ucopolysaccharidosis (MPS) describes a group of rare lysosomal storage disorders characterized by a deficiency or complete lack of lysosomal enzymes necessary for the stepwise breakdown of glycosaminoglycans (GAGs), also known as mucopolysaccharides.1-3 Consequently, fragments of GAGs accumulate intracellularly in the lysosomes, which results in cellular enlargement that causes disruption and dysfunction of tissues. This process leads to numerous clinical abnormalities. The incidence of all types of MPS is reported to be between 1 in 10,000 to 1 in 30,000 live births.1

Pathophysiology GAGs are long-chain complex carbohydrates comprising repeating disaccharide units of sulfated acidic and amino sugars. GAGs usually are linked to proteins to form proteoglycans, which are the major constituents of the ground substance of connective tissue, the lubricant in joint fluid, and the surface coating that initially binds growth factors to cells. The major GAGs are chondroitin-4-sulfate, chondroitin-6-sulfate,

PREANESTHETIC ASSESSMENT Dr. Elizabeth A.M. Frost, who is the editor of this continuing medical education series, is clinical professor of anesthesiology at the Mount Sinai School of Medicine in New York City. She is the author of Clinical Anesthesia in Neurosurgery (ButterworthHeinemann, Boston) and numerous articles. Dr. Frost is past president of the Anesthesia History Association and former editor of the journal of the New York State Society of Anesthesiologists, Sphere. She is also editor of the book series based on this CME program, Preanesthetic Assessment, Volumes 1 through 3 (Birkhäuser, Boston) and 4 through 6 (McMahon Publishing, New York City).

A COURSE OF STUDY FOR AMA/PRA CATEGORY 1 CREDIT Read this article, reflect on the information presented, then go online (www.mssm.procampus.net) and complete the lesson post-test and course evaluation before June 30, 2012. (CME credit is not valid past this date.) You must achieve a score of 80% or better to earn CME credit. TIME TO COMPLETE ACTIVITY: 2 hours RELEASE DATE: June 2011 TERMINATION DATE: June 30, 2012 ACCREDITATION STATEMENT The Mount Sinai School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

heparan sulfate, dermatan sulfate, keratan sulfate, and hyaluronic acid. Within organisms, these substances are degraded by the sequential action of lysosomal enzymes, leading to a stepwise shortening of the terminal sulfate, acidic, and amino sugar residues. Deficient or dysfunctional activity of the degrading enzymes results in MPS disorders, of which there are 11 types based on level of severity (Table). Clinical phenotypes of the disorder depend on the distribution and turnover of the substrate affected by the deficiency, instead of the distribution of the enzyme.1-6

Classification Of the 11 MPS disorders, there are 7 major types classified I through IX. (MPS V, formerly Scheie syndrome, and MPS VIII are no longer recognized types.) The types of MPS disorders are differentiated by clinical features and age at presentation, and biochemically by the associated enzyme deficiency. As a general rule, impaired degradation of heparan sulfate is more closely associated with mental deficiency, and impaired degradation of dermatan, chondroitin, and keratan sulfates

CREDIT DESIGNATION STATEMENT The Mount Sinai School of Medicine designates this educational activity for a maximum of 2 AMA PRA Category 1 Credits.™ Physicians should only claim credit commensurate with the extent of their participation in the activity. It is the policy of Mount Sinai School of Medicine to ensure objectivity, balance, independence, and scientific rigor in all CMEsponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices.

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Table. Classification and Features of MPS Enzyme Deficiency

Joint and Skeletal Deformities

Cardiac Involvement

Visceral, Visual, Neurologic Manifestations

Type

Eponym

MPS I (severe)

Hurler syndrome

a-L-iduronidase

Dermatan sulfate, heparan sulfate

Macrocephaly, coarse facies, macroglossia, hydrocephalus

Joint stiffness, thoracolumbar kyphosis, possible odontoid deformity, hypoplasia, short neck, short stature

Coronary intimal and valvular thickening, mitral regurgitation, cardiomegaly

HSM, umbilical and inguinal hernias, corneal clouding, severe mental retardation

MPS I (attenuated)

Scheie syndrome

a-L-iduronidase

Dermatan sulfate, heparan sulfate

Coarse facies, macroglossia, prognathism

Short neck, normal stature

Aortic regurgitation

HSM, umbilical and inguinal hernias, corneal clouding

MPS I (attenuated with different features)

Hurler-Scheie syndrome

a-L-iduronidase

Dermatan sulfate, heparan sulfate

Macrocephaly, coarse facies, macroglossia, micrognathia

Diffuse joint limitation, short neck, short stature

Mitral and aortic valve thickening and regurgitation

HSM, umbilical and inguinal hernias, corneal clouding

MPS II (severe)

Hunter syndrome (severe)

Iduronate sulfatase

Dermatan sulfate, heparan sulfate

Macrocephaly, coarse facies, hydrocephalus

Diffuse joint limitation, short neck, short stature

Coronary intimal thickening, ischemic cardiomyopathy

HSM, corneal clouding

MPS II (attenuated)

Hunter syndrome (mild)

Iduronate sulfatase

Dermatan sulfate, heparan sulfate

MPS IIIA (symptoms appear after the first year of life)

Sanfilippo A syndrome

Heparan-N-sulfatase

Heparan sulfate

Coarse facies, Mild stiffness of joints, short statheavy eyebrows that ure, dysphagia meet in center of face above the nose

Minimal to none

Severe retardation, behavioral problems, diarrhea

MPS IIIB

Sanfilippo B syndrome

a-N-acetyl Heparan sulfate glucosaminidase

Coarse facies

Mild stiffness of joints, short stature, walking problems, lumbarvertebral dysfunction, dysphagia

Minimal to none

Developmental delay, behavioral problems

MPS IIIC

Sanfilippo C syndrome

Acetyl CoA: a-glucosaminide N-acetyltransferase

Heparan sulfate

Coarse facies

Mild stiffness of joints, short stat- Minimal to none ure, lumbar-vertebral dysfunction, dysphagia

Developmental delay, behavioral problems

MPS IIID

Sanfilippo D syndrome

N-acetylglucosamine-6-sulfatase

Heparan sulfate

Coarse facies

Mild stiffness of joints, short stat- Minimal to none ure, lumbar-vertebral dysfunction, dysphagia

Developmental delay, behavioral problems

MPS IVA

Morquio syndrome type A

Galactose-6-sulfatase

Keratan sulfate, chondroitin-6-sulfate

Coarse facies

Joint laxity, severe kyphoscoliosis, odontoid hypoplasia, short neck, C1-C2/C2-C3 subluxation, short stature

Aortic regurgitation

Mild corneal opacities, HSM

MPS IVB

Morquio syndrome type B

b-galactosidase

Keratan sulfate, chondroitin-6-sulfate

Coarse facies

Joint laxity, severe kyphoscoliosis, odontoid hypoplasia, short neck, C1-C2/C2-C3 subluxation, short stature

Aortic regurgitation

Mild corneal opacities, HSM

MPS VI

Maroteaux-Lamy syndrome

N-acetylgalactosamine-4-sulfatase

Dermatan sulfate, heparan sulfate

Macrocephaly, coarse facies, macroglossia, hydrocephalus

Mild stiffness of joints, kyphoscoliosis, odontoid hypoplasia, short stature

Mitral and aortic valve thickening and regurgitation

MPS VII

Sly syndrome

b-glucuronidase

Dermatan sulfate, heparan sulfate, chondroitin4,6-sulfate

Macrocephaly, coarse facies

Joint flexion, contractures, thoraMitral and aortic columbar deformity, hip dysplasia, valve thickening odontoid hypoplasia, short stature and regurgitation

Hyaluronidase

Hyaluronan

MPS IX

GAG Stored

Craniofacial Abnormalities

GAG, glycosaminoglycans; HSM, hepatosplenomegaly; MPS, mucopolysaccharidosis Modified and adapted from reference 11.

results in mesenchymal abnormalities.5,6 Overall, MPS disorders can be grouped into 4 broad categories according to the dominant clinical features expressed: • soft tissue storage and skeletal disease, with or without brain disease (MPS I, II, and VII); • soft tissue and skeletal disease (MPS VI); • primarily skeletal disease (MPS IVa and IVb); and • primarily disease of the central nervous system (CNS; MPS IIIa-IIId).

Clinical Manifestations MPS disorders are characterized by progressive craniofacial, joint, and skeletal deformities, progressive cardiac involvement, and early death (often during childhood) from pulmonary infection or cardiac failure.1-18 Hurler syndrome is the prototypical MPS disorder, occurring in 1 in 100,000 live births (Figure). Deposits of GAGs lead to thickened heart valves, causing valvular insufficiency more often than stenosis. Myocardial hypertrophy, ventricular dysfunction, and

cardiomyopathy result from accumulation of GAGs in the myocardium, frequently ending in congestive heart failure and death. Intimal deposition of GAGs causes coronary luminal narrowing and occlusion that can be progressive.1-13 GAGs also are deposited in abdominal viscera, leading to hepatosplenomegaly (HSM) in most, if not all, patients. Umbilical and inguinal hernias can result from abdominal protuberance from HSM. Ineffective support of connective tissue

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of the anterior abdominal wall often develops. In addition to heart disease and HSM, most infants have chronic pulmonary disease caused by restriction of the thoracic cage due to kyphoscoliosis, airway obstruction secondary to deposition of GAGs in the upper airways, recurrent pulmonary infections, pulmonary hypertension, and cardiomyopathy. Tongue protrusion and excessive tracheobronchial secretions are common.1-13

Diagnosis

Skeletal and Connective Tissue: Complications develop as GAGs accumulate in the bones, joints, and ligaments. Patients with MPS types I, II, VI, and VII are known to be affected by dysostosis multiplex; those with types I, IV, and VII are affected by odontoid hypoplasia. Hypoplasia can lead to atlantoaxial instability, C1 to C2 subluxation, and high spinal cord compression. Prophylactic cervical fusion should be undertaken to prevent progressive cord compression. Vertebral subluxation and kyphoscoliosis develop throughout the spinal column, which can compromise the spinal cord; patients may need spinal fusion for stabilization. Unfortunately, patients typically heal poorly from these surgeries and often develop complications requiring repeat surgery. Short stature is a common finding throughout the spectrum of MPS types. Patients often present with joint stiffness secondary to accumulation of MPS in the synovial fluid and other connective tissues of the joints.

A physician should suspect MPS when a child presents with coarse facies, HSM, bone disease, and heart disease with or without CNS abnormalities. However, the initial presentation may be subtle and signs may be variable, depending on the type and severity of MPS. Measuring urinary concentration of GAGs can assist in identifying MPS; a definitive diagnosis is made by assaying enzyme activity in Figure. Patient, 9 years old, peripheral blood leukocytes. with Hurler syndrome. Skeletal radiography may reveal the Note the short stature, coarse characteristic pattern of abnormaliGastrointestinal: Complications facial features, and thickened ties known as dysostosis multiplex. An include recurring inguinal and umbilidigits. Photo courtesy of National eye examination should be performed cal hernias, and HSM with increased MPS Society. to assess corneal clouding and glauintra-abdominal pressure. More coma, which is most common in MPS than one surgical repair is often I, II, VI, and VII. A complete cardiac necessary.11,13,16 evaluation is necessary to adequately assess valvular and Neurologic: Neurologic complications are well documented. myocardial disease. A comprehensive neurologic examinaDevelopmental delay and progressive neurologic decline tion is required to assess the potential for spinal cord comcharacterize the severe forms of MPS I, II, III, and VII. Commupression and hydrocephalus.1-6,13 nicating hydrocephalus frequently develops in types I, II, III, Complications VI, and VII because of the engorgement of arachnoid granuCardiopulmonary complications are the most common lations by storage material; this impedes resorption of cerecause of death in patients with MPS. brospinal fluid (CSF) and increases intracranial pressure. In MPS III, hydrocephalus is secondary to ventricular Respiratory: Respiratory abnormalities are the result of enlargement because of cerebral atrophy in later stages of airway obstruction, neurologic compromise, recurrent the illness. Pachymeningitis cervicalis, a progressive thickeninfections, skeletal restrictions, and organomegaly—all of ing and scarring of the meninges around the cervical spinal which can lead to pulmonary insufficiency, severe sleep cord caused by accumulation of MPS, is another neurologic apnea, and sudden death from central apnea. Patients complication. Such thickening may form a sleeve around with MPS IV are especially prone to high cord compresthe spinal cord that impedes the flow of CSF, and progression secondary to atlantoaxial instability and odontoid dys- sively compresses the cervical cord. Cord compression from plasia, which can lead to depressed respiration or sudden pachymeningitis cervicalis and odontoid dysplasia can result respiratory arrest. in progressive ascending paresis and paralysis.11,15 Upper airway obstruction can result from redundant airOphthalmic and Auditory: Vision and hearing complicaway tissue caused by MPS deposition in the soft tissues of tions are common. Ophthalmologic manifestations include the nasopharynx. Enlarged tonsils and adenoidal tissue, corneal clouding; blindness can develop. Eye examinations macroglossia, and thickened gums also may be present. should be conducted at the time of diagnosis and annually Secretions are excessive due to chronic or recurrent ear thereafter. and sinus infections. Treatment focuses on maintenance of Auditory manifestations include conductive and neurosena stable airway. Airway obstruction can be reduced temporarily by removal of the tonsils and adenoids, along with use sory deafness. Hearing loss may be attributable to frequent ear infections, defective ossification in the middle ear, scarof positive airway pressure.11,16 ring of the tympanic membrane, or nerve damage. Annual Cardiac: Cardiac abnormalities are well documented. Valvuaudiologic examinations are warranted, and are particular disease is caused by progressive thickening of the mitral larly important for patients with MPS type I. Hearing aids are and aortic valves; it is common in MPS types I, II, and VI. The beneficial. defect typically results in heart failure; in severe cases, valve Therapy replacement may be required. The narrowing of coronary vesThe treatment of patients with MPS disorders is usually sels secondary to the intimal deposition of MPS impairs blood symptomatic and not specific. Bone marrow transplantation flow; cardiac ischemia results. Pulmonary hypertension may has been used successfully to treat some of the disorders exacerbate right-sided heart failure.13,16

in the MPS spectrum. In most patients with successful engraftment, transplantation reduces HSM, increases joint mobility, decreases airway obstruction, improves cardiac function, decreases CSF pressure, and especially in younger patients may stabilize mental regression. Unfortunately, BMT does not correct skeletal disorders or prevent decline of the CNS in severe cases. Immunosuppressant treatment is required. The therapy routinely is offered only to patients with Hurler syndrome younger than approximately 2 years. Immunosuppressant therapy is less commonly used in patients with mild MPS types II, VI, and VII. Cord blood is another potential source for transplantation.19 Emerging treatments for MPS include enzyme replacement therapy, substrate reduction therapy, chaperone-mediated therapy, and gene therapy. Although clinical efficacy has not been shown completely for any of these therapies, many clinicians are optimistic that future developments will lead to a disease-modifying treatment.20,21 Enzyme replacement therapy with recombinant iduronate-2-sulfatase (idursulfase) is under clinical investigation, and weekly IV infusions have been found to improve many of the symptoms and signs of MPS.20

Anesthesia Considerations Preoperative Evaluation: Assessments of neurologic function, the probability of a difficult airway and ventilatory management, cardiac complications, skeletal disease, and visceral manifestations should be considered preoperatively.1,2,11,13 Chest x-ray, arterial blood gas analysis, and pulmonary function tests may be indicated in patients with chronic pulmonary infections or kyphoscoliosis. Vital capacity, functional residual capacity, and total lung capacity often are reduced by skeletal restrictions. Preoperatively, the goal should be to optimize lung capacity; this may include physiotherapy, pulmonary toilet, and antibiotics if infection is present.1,2,11,13 To assess clinically relevant spinal disease, radiography should be used to identify atlantoaxial subluxation—especially in patients with Morquio or Hurler syndrome. Flexion–extension cervical films may confirm the potential for subluxation and demonstrate tracheal collapse on flexion. Atlantoaxial subluxation contraindicates cervical extension during endotracheal intubation. Spinal cord compression due to subluxation frequently occurs within the spectrum of MPS. Patients presenting with clinical manifestations such as abnormal gait, sensory changes, or weakness in the lower extremities should be evaluated by a neurologist.1,2,11,13 Somatosensory-evoked potentials can be used to detect early cord compression and guide the timing of surgical intervention. Patients with MPS I who undergo spinal surgery are at increased risk for major complications, including spinal cord infarction and spinal instability. Communicating hydrocephalus may be present, and if suspected, a measurement of CSF pressure should be considered. With increased intracranial pressure, a ventriculostomy may successfully reduce CSF pressure, but typically does not significantly reverse clinical disease.1,2,11,13 An enlarged heart and pulmonary congestion should prompt an evaluation by 2-D echocardiography, which can detect right ventricular hypertrophy with strain, conduction blocks, left atrial enlargement, tachydysrhythmias, and ischemic changes. Systolic murmurs are common and this too should prompt an echocardiographic evaluation. If the patient experiences chest pain, or clinical symptoms that suggest ischemia, more invasive diagnostic testing (eg, angiography) is indicated. Case report findings have suggested that the contribution of cardiac involvement—particularly mitral insufficiency

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and cardiomegaly—was minimal in stress tolerance related to anesthetic management; however, severe and extensive coronary obstruction was cited as a cause of 2 deaths, intraoperatively.8,11 Patients with moderate to severe skeletal disease should be monitored continually by an orthopedic surgeon. Spine deformities may require fusion; acetabular hip dysplasia can be managed with osteotomy; and genu valgum with epiphyseal stapling. Carpal tunnel release can provide relief and return some function to the hands.1,2,11,13 Visceral manifestations of disease are common. Normally, inguinal hernias have been repaired before disease diagnosis. Umbilical hernias often recur, probably due to HSM. Because the most common clinical manifestations include chronic upper respiratory infections, it is important to identify any potentially infectious processes. Tonsillectomy and adenoidectomy should be considered for all patients in whom the airway is compromised. Patients with MPS typically undergo a routine annual examination of ears, nose, and throat. A careful preanesthetic assessment can be invaluable, however, if underlying pathophysiologic processes are subclinical and have not been identified.1,2,11,13 Drugs: Premedication sedatives should be administered cautiously, if at all, because of risks for upper airway obstruction, respiratory depression, hypercarbia, and cardiorespiratory arrest. Opioids should be avoided in these patients if airway problems are anticipated because of respiratory depression. Oropharyngeal secretions can be controlled with anticholinergics, such as scopolamine or glycopyrrolate.3,4,8,11 Hurler syndrome, being the prototypical and most severe form of the MPS disorders, results in difficult tracheal intubation in as much as 50% of these patients. Some studies have suggested IV induction for younger patients with a lesser degree of craniofacial involvement, and inhaled induction for older patients in whom airway difficulties are established or anticipated.3,4,8 Other studies maintain that inhalation induction is preferable; however, IV induction may be necessary in patients with severe mental retardation or who are uncooperative. Many studies have suggested that induction with intramuscular ketamine is preferred to inhalation induction.3,4,8 Patients with MPS seem not to be at increased risk for malignant hyperthermia. Maintenance anesthesia is usually

achieved with an inhalational agent.3,4,8 The muscle relaxant of choice is often short-acting and nondepolarizing. Airway Management: In patients with MPS, ventilation may be difficult as a result of abnormal facies. An air-cushioned pediatric face mask may be applied upside down, with the broad chin edge of the mask over the patient’s brow and nose, and the narrow nasal bridge of the mask over the open mouth and protruding tongue.11 Advanced instruments for managing the airway should be available, including an assortment of face masks, endotracheal tubes, laryngoscope blades and handles, fiber-optic equipment, a video laryngoscope, and the difficult airway cart, in addition to a surgeon standing by in case emergency tracheostomy is necessary. Direct laryngoscopy in awake orotracheal intubation will be difficult. Airway manipulation is much easier in a deeply sedated, spontaneously ventilating patient.11 As mentioned, atlantoaxial subluxation secondary to odontoid hypoplasia/ dysplasia with spinal cord and brainstem compression may occur during cervical hyperextension.11 Cervical traction can be used to prevent manipulation of the neck. Deposits make it extremely difficult to feel the trachea; thus, retrograde catheter-guided tracheal intubation is not recommended. Blind nasotracheal intubation and tracheostomy carry significant risks, and are recommended only in emergency situations. Some clinicians believe that a fiber-optic bronchoscope should be available as part of the anesthetic management of all known cases of difficult intubation.11 Postoperative Management: The pediatric patient emerging from anesthesia may experience difficulty in breathing against the high airway resistance of an endotracheal tube. Pulmonary hypertension can be exacerbated, and negative pressure pulmonary edema may ensue and require immediate management, including mechanical ventilatory support. Multiple attempts at intubation should be avoided because it can lead to symptomatic glottic and subglottic edema. Such iatrogenic conditions are very difficult to treat because of a progressive narrowing of the tracheal lumen by MPS deposits.8,11 Conducting a fiber-optic intubation, and postoperatively leaving the endotracheal tube immediately in place, minimizes airway complications—particularly

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JUne 2011

in cases in which not all of the extubation criteria have been met. After tracheal extubation, humidified oxygen, chest physiotherapy, and postural drainage should be instituted, and continued until the patient is ambulatory and able to expectorate excessive secretions.8,11

Management of the Case Presented Two anesthesiologists accompanied the child (who was not sedated) to the operating suite. Both a laryngeal mask airway and fiber-optic tower were available. Sizes 4.0, 4.5, and 5.0 cuffed endotracheal tubes were prepared. American Society of Anesthesiologists standard monitors were applied, and a mask induction with sevoflurane was facilitated by placement of an oral airway while the second anesthesiologist secured peripheral IV access with a 22-gauge angiocatheter. Propofol, 30 mg IV, was administered. Laryngoscopy, performed with a Macintosh 2 blade, revealed a grade III view. The first attempt at laryngoscopy with a 4.5 cuffed endotracheal tube was unsuccessful. A second attempt with manipulation of the larynx improved the view to grade II. Correct placement of the tube was confirmed by capnography and bilateral breath sounds. The patient was placed in the lateral position and a caudal block performed in sterile fashion with a 22-gauge angiocatheter and 15 mL of ropivacaine 0.2%. Anesthesia was maintained with sevoflurane in oxygen. After an injection of ropivacaine 0.2% to the surgical site and closure of the wound, the patient’s trachea was extubated while the patient was fully awake. The postoperative course was uneventful and the patient was discharged home the next day.

Conclusion The perioperative management of patients with MPS often is difficult, and although new treatments are providing hope, many challenges remain. Understanding the pathophysiology of this group of diseases increases awareness of the potential risks associated with anesthesia and surgery. Ideally, pediatric patients with MPS should be managed by anesthesiologists familiar with the disease process to minimize complications and reduce morbidity and mortality. References are available to view online at www.mssm.procampus.net.

For inquiries about course content only, send an e-mail to ram.roth@mssm.edu. Ram Roth, MD, is director of PreAnesthetic Assessment Online and assistant professor of anesthesiology at The Mount Sinai School of Medicine, New York, NY.

Post-Test 1. Mucopolysaccharidosis (MPS) is a glycogen storage disorder characterized by: a. a deficiency in enzymes that break down glycosaminoglycans b. a defined genetic abnormality c. excess serotonin d. hyperbilirubinemia 2. The incidence of MPS is: a. estimated to be 1 in 10,000 to 1 in 30,000 b. so rare as to be unknown c. variable depending on the country d. estimated to be 1 in 50,000 to 1 in 100,000 3. In patients with MPS, respiratory abnormalities can result from: a. neurologic compromise b. skeletal restrictions

c. organomegaly d. All of the above are correct. 4. Which of the following is descriptive of severe Hunter syndrome? a. Elevated high-density lipoprotein b. Corneal clouding c. High level of serum magnesium d. Low level of serum potassium 5. A well-documented skeletal complication within the spectrum of MPS disorders is: a. dysostosis multiplex b. spina bifida c. osteogenesis imperfecta d. Marfan syndrome 6. Which of the following is not a concern for the anesthesiologist managing a surgical patient with MPS?

a. Securing the airway b. Oropharyngeal secretions c. Skeletal abnormalities d. Higher risk for malignant hyperthermia 7. Patients with MPS I (Hurler syndrome) are not usually noted to have: a. delayed development b. severe mental retardation c. shortened life expectancy d. unusually tall stature 8. Within the spectrum of MPS disorders, the rate of difficult tracheal intubation can be as high as: a. 5% b. 100% c. 40% d. 50%

9. Visceral manifestations are common within the spectrum of MPS disorders; the most common reason for recurrence of umbilical hernias in these patients is: a. obesity b. hepatosplenomegaly c. ascites d. heavy lifting 10. Which of the following therapies has not been used successfully for patients with MPS? a. Bone marrow transplantation b. Enzyme replacement c. Substrate reduction d. Serotonin reuptake inhibitors and dopamine antagonists

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30 I AnesthesiologyNews.com

June 2011

P OLICY & M ANAGE MENT

Suits continued from page 1 The two suits are now in trial courts in New York and California. The California case involves Sutter Hospitals, a 24-hospital chain covering the northern part of the state, and two PPOs, MultiPlan and Private Healthcare Systems, Inc. (PHCS), which MultiPlan bought in 2006. Dr. Forman, through his company Rockville Recovery Associates Limited, has accused Sutter of passing on bogus anesthesia bills to insurers and the two PPOs of taking part in the scheme. In April, Dave Jones, California’s insurance commissioner, agreed, joining Rockville in the whistleblower suit and taking the legal lead in the case. The California suit alleges that Sutter was billing insurers for anesthesia services when no anesthesiologist was present. The suit also claims that Sutter’s anesthesia charges often greatly exceeded what would have been appropriate for a given procedure, and that it was misusing a billing code, 37x, to generate timerelated charges for one-time items or practices. According to the civil complaint, “Comparable rates apply at all Sutter hospitals, and the rates have only increased over time. As a consequence, Sutter hospitals routinely charge, on average, $3,000 to $5,000 under

the 37x code, when they are entitled to no more than $150 to $250 under that code, if anything. These 37x charges so far exceed actual costs that it is clear [Sutter, MultiPlan and PHCS] are actually double billing for costs captured in the anesthesiologist’s bill or in other revenue codes, or are simply billing for services not actually provided.” “Sutter’s alleged fraud comes at the expense of the private health insurance industry, which initially pays for the services, but, ultimately, this unjust burden falls on the shoulders of California’s consumers, who must foot the bill for inflated health care premiums,” Mr. Jones said in an April 13 statement. “We believe the amount of the fraudulent charges is in the hundreds of millions of dollars, if not more.” The state is asking for triple damages for each claim and up to a $10,000 fine per violation. As a whistleblower, Dr. Forman stands to benefit substantially, too. He is eligible to receive up to 40% of any money recovered (California would get the rest). MultiPlan has denied the fraud allegations. “As an intermediary between payers and providers, MultiPlan arranges for negotiated rates of reimbursement,” the company said in a statement. “MultiPlan does not have any involvement with or responsibility for the hospital billing methodology.”

MultiPlan also disputed the assertion—by Dr. Forman and Mr. Jones—that its contracts prevent insurers from auditing procedure claims. “This statement is based on an allegation in dispute which MultiPlan has denied on the record.” Pam Walker, a spokeswoman for MultiPlan, would not provide Anesthesiology News with an example of a contract or the language specific to claims audits. Nimish Desai, an attorney with Leiff Cabraser Heimann & Bernstein, the San Francisco firm representing Rockville in the California case, said a confidentiality agreement prevented him from discussing specifics of the lawsuit. However, he said PPO contracts “greatly limit audit rights” even if they do not explicitly forbid them. MultiPlan handles more than 100 million medical claims each year, covering the services of more than 5,000 hospitals and “more than half a million” health care providers, according to the company. In 2010, two private equity firms, BC Partners and Silver Lake, purchased MultiPlan from the Carlysle Group in a deal worth $3.1 billion, according to The Washington Post. The Sutter case stemmed from an investigation Rockville conducted for Guardian Life Insurance of New York, which had hired him to uncover fraudulent claims. Dr. Forman said that after six years of digging through claims, he eventually presented Guardian with $46 million in overcharges. The insurer ultimately refused to pursue the cases. Dr. Forman, inventor of a software program that he says can detect billing fraud, is suing Guardian for breach of contract and other alleged violations of their work agreement. He said the company’s reluctance to go after the money stems from its unwillingness to lose the business of the PPOs that were passing on the fraudulent claims. Dr. Forman and Rockville are asking for $12 million in damages (roughly equivalent to the 25% he would have received had Guardian successfully recovered the overpayments), legal fees and punitive damages. Richard Jones, a Guardian spokesman, declined to comment on the litigation but provided a written statement: “Guardian believes that Dr. Forman’s claims— including his assertion that Guardian’s PPO agreements preclude audits—are unfounded. Guardian has a pending motion to dispose of Dr. Forman’s ongoing breach of contract claim, and given the unsubstantiated nature of his allegations, we are confident that Guardian will prevail either at summary judgment, or at trial.” Kenneth Kutner, Dr. Forman’s attorney in the New York lawsuit, said Guardian has filed a motion for summary judgment in the case, which the court is scheduled to hear on June 1. A ruling on that motion likely would come within 60 days, Mr. Kutner said. The American Society of Anesthesiologists declined to comment on the lawsuits. For his part, Dr. Forman said the cases hold a lesson for his clinical colleagues: “The anesthesiologist needs to be aware that his services are being billed by the hospital, and it’s pretty funny because the hospital is often adversarial.” —Adam Marcus

June 2011

AnesthesiologyNews.com I 31

POLICY & MANAGEMENT

Gowns No Barrier to Bacteria During Epidural Placement

aking the time to don a sterile gown before inserting an epidural may do little to prevent infections in pregnant women in labor, according to results from a new study. The study, of 240 women in labor requesting epidurals, showed that anesthesiologists who wore gowns were less likely to have bacteria present on their forearms. But when they did not wear the garments, bacteria mostly did not reach the catheter tip anyway. This finding suggests that the extra time and effort of sterile gowning may not be worth it for epidurals, said study author Naveed T. Siddiqui, MD, MSc, assistant professor in the Department of Anaesthesia and Pain Management at the University of Toronto, Canada. “The message is pretty clear from the data: Gowning will not make a difference in terms of bacterial growth.” Dr. Siddiqui and colleagues presented their study at the 2011 annual meeting of the Society for Obstetric Anesthesia and Perinatology (abstract 143). Why the bacteria on doctors’ forearms do not reach patients is unclear, said Dr. Siddiqui. Perhaps the organisms may reach the epidural but are fought off by the women’s immune systems. None of the women in either group developed clinical signs of infections during the study. However, the fact that doctors who did not gown had more bacteria on their forearms suggests the field should be paying more attention to other aspects of the sterile technique, Dr. Siddiqui added. “The bacterial growth on the forearm reflects substandard hand-washing technique, which may have many other implications,” he said. Aspects may include more attention to avoid crossing bare hands and forearms over sterile trays and other behaviors that can introduce bacteria into the sterile working area. “There should be more situational awareness for all the components of sterile technique,” he said. “It’s not just about gowning.” Dr. Siddiqui and colleagues found that doctors who were randomized to wear gowns had significantly fewer positive cultures taken from their forearms than doctors without gowns, but no difference in culture rates for the catheter and work area. Most often, the microorganisms found on the physicians’ forearms did not match those

found on the epidural tip. Infections are relatively rare occurrences in epidurals—affecting perhaps 1 in 10,000 patients, according to recent estimates—but those that do occur are a huge source of morbidity, Dr. Siddiqui said. An infection can lead to an epidural abscess that can cause permanent paralysis or even death. Currently, anesthesiologists are divided on whether gowning helps reduce the risk for these potentially serious infections, Dr. Siddiqui said. “The results of our study indicate that gowning may not be necessary. However, the results are limited to the study of colonization, and if we need to observe clinical signs and symptoms of infection, this would require a large number of patients,” he said.

‘There should be more situational awareness

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for all the components of sterile technique. It’s not just about gowning.’ ––Naveed T. Siddiqui, MD, MSc Manuel C. Vallejo, MD, professor and director of obstetric anesthesia at Magee-Womens Hospital of the University of Pittsburgh Medical Center, who was not involved in the study, said he does not wear a gown while inserting epidurals in pregnant women, and suspects most obstetric anesthesiologists do not do so, either. So the findings, if not surprising, are at least reassuring for clinicians who do not gown during the procedure. “If they wore a gown, it really didn’t offer that much more protection,” he said. Dr. Vallejo also agreed with the increased emphasis on washing hands and forearms, as well as performing other sterile techniques, such as using gloves, mask and head covering. Recently, some cases of meningitis were traced back to the anesthesiologist who placed a combined spinal epidural, who likely passed it on from flora in the mouth or nasal passages—which a mask could have prevented. “You’re better off to concentrate on all the other sterile and antiseptic techniques than to wear a sterile gown,” Dr. Vallejo said. —Alison McCook

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June 2011

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34 I AnesthesiologyNews.com

June 2011

COMM ENTAR Y

ACO Angst: Think Home Sweet Home Broadening responsibilities of anesthesiologists could lead to soft landing in new era

ccountable care organizations are the rage of the health reform industry. The White House recently proposed rules for so-called ACOs as if they located the end of a rainbow. Anesthesiologists seeking ACO gold, if it exists, may find it in surgical homes. On March 31, The New York Times reported, “the Obama Administration (has) proposed long-awaited regulations … encouraging doctors and hospitals to band together, coordinate care and cut costs. In return, the government offered financial rewards to healthcare providers.” USA Today (April 1), quoting Kathleen Sebelius, secretary of the Department of Health and Human Services, said that ACOs could save Medicare $960 million over the next three years. In The New England Journal of Medicine (March 31), Donald Berwick, MD, administrator of the Centers for Medicare & Medicaid Services (CMS), characterized ACOs as “the coming wave,” gushed that “ACOs will unlock many opportunities,” and bragged that they will “giv(e) Medicare beneficiaries the affordable, high-quality care they want, need, and deserve.” One problem with this hyperbole and its promise of financial rewards for everyone, is that no one knows what an ACO is. The new 429-page (text format) federal rules don’t define them as much as they describe what they should accomplish. On page 14, an ACO is “a program that promotes accountability for a patient population and coordinates items and services under (Medicare) parts A and B, and encourages investment in infrastructure and redesigned care processes for high quality and efficient service delivery.” On page 76, it’s an entity that has “processes and methods to: (1) promote higher quality of care; (2) better coordinate care; and (3) meet the needs and concerns of patients and their families, including effectively engaging patients and their families in medical decision-making.” What’s proposed in the rules is that potential ACO groups describe themselves to CMS regulators, who will then decide if that’s what they are. What the rules do establish clearly, however, are the hurdles to clear before any “shared savings” that might be left after CMS takes its cut can be realized. And good luck with that, because on page 369, CMS estimates “net savings of $510 million” for itself from

implementing ACOs. Providers who did receive some funds, however, could use them to pay legal and business teams that interpreted the rules, wrote the application, and hopped the hurdles to hit pay dirt. It’s no wonder that some people envision ACOs as unicorns: mythical beasts, with magical powers, that no one has ever seen. The provider-shared savings may be fool’s gold. Reading the proposed ACO rules (available at http://edocket.access.gpo.gov/2011/pdf/2011-7880. pdf ) is educational for understanding the policy pedantry of medical mavens and legislative literati. One finds: “patient-centered care should extend not only to the patient but to the family and caregivers of the patient.” And, “integrating community resources into the ACO is an important part of patient centeredness,” while “addressing disparities through provider/ management education and the translation of surveys and health promoting literature distributed by the provider into languages relevant to the provider’s population.” It is also educational for what’s missing—namely, any mention of anesthesiologists, who provide patient care throughout hospitals and serve as the lifeline of modern medicine. There are ACO performance measures that address primary care, preventative medicine, diabetes, heart failure and colorectal exams, but nothing for anesthesiologists. Unicorn creators seem better at etherealities than practicalities, at keeping patients away from care than helping specialists treat them. ACOs are the rage, however, and because anesthesiologists may practice in institutions wanting to found them, the American Society of Anesthesiologists (ASA) will undoubtedly analyze the newly proposed rules and inform its members about them. The current rules are proposals, however, issued for comments, so information about any final ones may not come before fall. The ASA also will remind CMS about the need to include anesthesiologists in any program that improves efficiency, outcomes and safety. Take Advantage of Expanding Role One strategy for anesthesiologists to address ACOs and other bundled payment proposals emerges from

An ACO Glossary

ou can’t tell the players without a scorecard, and you shouldn’t attempt to read contemporary articles about health care reform or government documents without similar backup material. After all, many of the words and phrases you thought you knew have changed recently. Consider: Participant: that’s you. Patientcentered prose is philosophical puffery, participants are the ones who get managed, payment-deprived and terminated.

Efficient: translation—low cost. Has nothing to do with speed. When reformers promote “efficient health care” hold onto your wallet, because they just want to pay less. PPACA: the Patient Protection and Affordable Care Act, the health care reform law that authorizes ACOs and that the Supreme Court will judge for constitutionality. Since this law is more about money than patients, it’s usually just called the Affordable Care Act.

Waste: usually refers to specialty care or payments. “Lower growth in expenditures by eliminating waste and inefficiencies while not withholding any needed care” on page 24 of the ACO proposal, for instance, can be interpreted as, “Save money by minimizing specialty physician care.” Health care reform: saving money. According to the White House Web site (http://www.whitehouse.gov/healthreform), “Health reform makes health care more affordable.”

—RJ

the common criticisms that our health care system is fragmented, wasteful and of middling quality. Anesthesiologists already direct surgical suites, Robert E. Johnstone, MD coordinate schedules and lead patient safety programs. Expanding their perioperative physician roles to include overall coordination of perioperative and acute hospital care would meet an essential ACO need. For several years, primary care physicians (PCPs) have proposed “medical homes” as a core part of ACOs. Medical homes refer to care systems where every patient has an ongoing relationship with a PCP who coordinates the care of that patient with a goal of maintaining good health. Medical homes address the primary expense of health care today, managing chronic diseases such as diabetes, depression and hypertension. Of course, PCPs function from offices. They are fish out of water when dealing with operative suites and critical care units, the comfortable expertise of anesthesiologists, where most hospital expenses are generated today. Anesthesiologists are the natural leaders to coordinate acute care from preoperative clinics through surgical suites and critical care units, to postoperative recovery, and across all specialties. Anesthesiology increasingly is known as perioperative medicine, and anesthesiologists as clinical directors. Anesthesiologists could thus lead “surgical homes,” a complement to medical homes, and a system for coordinating hospital care for maximal efficiency. The three aims of health care reform, as Dr. Berwick stated in his defining Health Affairs article (2008;27:759-769), include better care for individuals, better health for populations, and slower growth in costs through improvements in care. Anesthesiologist-led surgical homes would address the first and third aims, whereas medical homes led by PCPs would address the second. Surgical homes seem a natural extension of how anesthesiology is advancing today. Anesthesiologists already work at the confluence of hospitals, physicians and technology. They have learned to manage the incessant pressures of sick patients, chaotic schedules and limited budgets while satisfying surgeons, answering administrators and championing safety. They can run the acute side of ACOs, making them truly accountable for quality and costs of care. Patients needing surgical care could move temporarily from their medical homes to an efficient anesthesiologist-led surgical one. It’s worth exploring. And when governmental, institutional and other leaders threaten change through integrated practice models, value-based initiatives and bundled payment innovations, anesthesiologists can take refuge in their ACO-compatible sweet surgical homes. —Robert E. Johnstone, MD Dr. Johnstone is professor of anesthesiology at West Virginia University, in Morgantown, and vice president for professional affairs of the American Society of Anesthesiologists. This commentary represents his personal views.

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