November 2014

The best-read anesthesiology publication in the United States

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THE INDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTS AnesthesiologyNews.com • N o v e m b e r 2 0 1 4 • Volume 40 Number 11

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Regional Better Than General Anesthesia in Study of Post-Op M&M New Orleans—Patients undergoing elective surgery may fare better if they receive regional anesthesia (RA) instead of general anesthesia (GA), according to researchers at Vanderbilt University Medical Center, in Nashville, Tenn.

The study, presented at the 2014 annual meeting of the American Society of Anesthesiologists, found that 0.81% of adults receiving RA died within

Morbidity and Mortality Lowered Using ‘Bloodless’ Methods Medical and surgical patient costs reduced as well

P

atients who declined transfusions but were treated with blood-conservation methods suffered fewer deaths, infections and other morbid outcomes compared with those who accepted donor blood and received standard care, a new Johns Hopkins study concluded.

Mortality rates were almost fourfold lower in patients who declined allogeneic blood transfusions (ABT) but were treated with blood-conservation methods, or 0.7%, compared with 2.7% for patients who accepted transfusions, reported the Center for Bloodless Medicine and Surgery in an upcoming paper in the journal Transfusion.

see regional page 18

see bloodless M&M page 18

The Day Medicine Stood Still Facing the challenge of a tech-failure event Peter J. Papadakos, MD, FCCM , FAARC

power and computer failures have identified a new danger.

As medicine in just the past n the classic science fiction film, “The Day the Earth Stood Still,” the planet comes to a panic- five years has become more stricken stop when electricity is shut off by an dependent on computeradvanced alien force. Hospitals and health care facil- based systems such as elec- Peter J. Papadakos, MD, FCCM, FAARC ities for the past several decades have developed tronic medical records (EMRs), backup electrical generation and protocols that are automated vital sign downregularly drilled in the event of power emergencies. loads, central lab data and digital image libraries, and Over the past several years, however, major natural computer-based pharmacy ordering, a new Achilles’ disasters, such as Hurricane Sandy, and major regional see tech fail page 26

I

NEW & FEATURED PRODUCTS see pages 13 & 24 Dräger Perseus® A500

see page 26 M9 Premium Compact Ultrasound nd System, from Minddray

for iPad see pages 4 and 30

6

CLINICAL ANESTHESIOLOGY

A look at some of the most important studies published in journals over the past year.

19

CLINICAL ANESTHESIOLOGY

Goal-directed fluid therapy found to reduce post-op complications and length of stay.

22

TECHNOLOGY

Medication adherence apps offer potential to improve chronic care.

24

COMMENTARY

What’s in a name?

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01

5

www.AIAPMConference.com

April 17-19, 2015

The Cosmopolitan of Las Vegas

Advanced Institute for Anesthesia Practice Management Securing the Future for Anesthesia Practices

The Advanced Institute for Anesthesia Practice Management will be held April 17–19, 2015 at The Cosmopolitan of Las Vegas.

The 2015 Advanced Institute for Anesthesia Practice Management will focus on practice management issues with the goal of enlightening attendees on broader group strategy issues, including numerous talks on billing, coding and compliance.

This live activity has been approved for AMA PRA Category 1 Credit™

For full conference information and to register for the AIAPM Conference, please visit www.AIAPMConference.com or email info@AIAPMConference.com

20 CME Credits

Conference Speakers Frank Rosinia, MD Chairman, Department of Anesthesiology, Tulane University School of Medicine John Di Capua, MD CEO, NAPA Management Services Corp Howard Greenfield, MD Principal, Enhance Healthcare Keith J. Ruskin, MD Professor of Anesthesiology and Neurosurgery, Yale University School of Medicine, Chairman of the Board, National Anesthesia Clinical Outcomes Registry Vincent J. Vilasi, Jr., MD, MBA CEO, Mid-Atlantic Division NAPA Stanford R. Plavin, MD Partner/Owner: Ambulatory Anesthesia of Atlanta/Savannah, President; Perioperative Management Services LLC Mark F. Weiss, Esq. The Mark F. Weiss Law Firm Vicki Myckowiak, Esq. Myckowiak Associates, PC

JOINTLY PROVIDED BY:

Jeff B. Swearingen Managing Director, Edgemont Capital Partners, LP Robert Tennant, MA Senior Policy Advisor, Medical Group Management Association Neda Ryan, Esq. Clark Hill PLC Daniel W. Simile, Jr., CPA Executive Vice President of Practice Management, Zotec Partners Marvel J. Hammer, RN, CPC, CCS-P, PCS, ACS-PM, CPCO MJH Consulting Kelly Dennis, MBA, ACS-AN, CAN-PC, CHCA, CPC, CPC-I Perfect Office Solutions, Inc. Devona Slater, CHA, CHC, CMCP President, Auditing for Compliance and Education Judi Blaszczyk, RN, CPC, ACS-PM Compliance Auditor, Auditing for Compliance and Education

Can You Ever Have Too Much of a Good Thing?

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Make the Data Work for You F1RSTAnalytics is the ultimate in technical sophistication. It offers data prowess, providing the data to aid in operating your anesthesia practice as an effective clinical organization and successful business. The information you need, provided in a way you can use it.

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4 I AnesthesiologyNews.com

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DIGITAL

Web Tracker Read the five most-viewed articles last month on AnesthesiologyNews.com 1.

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Perioperative Fluids: An EvidenceBased Review (Educational Review)

Eye Color a Potential Cue to Pain Tolerance

DEA Rules Tramadol A Schedule IV Drug (Web Exclusive)

IV Induction Doses in Elderly Reduced, But Still Trend High

Team Creates Protocol for Handling OR Emergencies

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Tweets of Interest Alfred SOT @alfred_SOT Lifebox makes a difference where it matters. Please see Kit & Sarah @safersurgery, ASA Res Centre for more #ANES2014

MeganGraybillAnders @DrMegs Recommended by many speakers in safety/cog aid talks, sobering human factors piece = required reading for #ANES2014 http://goo.gl/W8qoXn

Anesthesiology News @anesthesianews Henrik Kehlet recognized with ASA’s 2014 Excellence in Research Award http://bit.ly/1sfiNoI #anesthesianews #ANES2014

UtahAnesthesia @UofU_Anesthesia Do you anesthetize the #elderly?

Perhaps this sheet on aging changes would be useful to you. #FOAMed #anesthesia pic.twitter.com/gjL6VPF4Eh

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6 I AnesthesiologyNews.com

NOVEMBER 2014

CLINICAL ANESTHESIOLOGY

Literature Review: What Were the Most Important Studies Published Last Year?

T

he number of studies taking place in a given year is staggering. There were 159,354 registered studies listed on ClinicalTrials. gov in 2013, and this year, as of October 6, 2014, that number was 176,056.

At Anesthesiology News, we constantly review the medical literature to bring you information about what we feel are the most important research studies. With 2015 just weeks away, we thought it might be interesting to look back at which studies published over the past 12 months or so most impressed the editors of the journals of record in anesthesiology. We asked this distinguished group of editors to pick and comment on three important studies that appeared in their publications.

Here’s what they came up with:

hypovolemic, but no more. This article challenges this concept by studying nonfasted volunteers, who by virtue of being allowed to eat and drink as they wanted, are defined as being normovolemic. The investigators used passive leg raise, a well-recognized way of

fluid loading the heart, and measured stroke volume using echocardiography, which again is a recognized gold standard approach. Surprisingly, or not really when you think about it, all the volunteers responded differently, and indeed five responded as though they

Experience the power of predictable control 1- 4

Anaesthesia Dr. Andrew Klein, editor Disclaimer: These are Dr. Klein’s own opinions.

Godfrey GEP, Dubrey SW, Handy JM. A prospective observational study of stroke volume responsiveness to a passive leg raise manoeuvre in healthy non-starved d volunteers as assessed by transthoracic echocardiography.

Anaesthesia. 2014;69:306-313.

Researchers tested the current guidelines for intraoperative fluid management by having healthy, nonstarved volunteers perform passive leg raises while in the supine position. Stroke volume was measured by transthoracic echocardiography at baseline, 30 seconds, and at one, three and five minutes after leg raise. Researchers found a wide variety in response and stroke volume, which suggests “greater heterogeneity in the normal population than current clinical guidelines recognize.”

Dr. Klein: The traditional teaching is that anaesthetists should give fluids to patients to achieve normovolemia intraoperatively, and that this is beneficial—indeed, this forms the cornerstone of enhanced recovery, namely optimizing fluid status to improve outcomes. The current trend is to use noninvasive or minimally invasive cardiac output monitoring to try to identify which patients are hypovolemic by looking at their response to a fluid challenge and giving those patients enough fluid so they are no longer

were hypovolemic. This study challenges the whole concept of ideal fluid status and volume loading in perioperative care, and we published it in the hope and expectation that other researchers will take on the baton and explore these concepts further.

Visit www.aboutULTIVA.com to see how Remi could work for you. *Remifentanil is commonly referred to as Remi by anesthesia providers. † Continuous infusions of Remi should be administered only by an infusion device and continuous monitoring is necessary. Interruption of infusion will result in rapid offset of effect. ‡ Within 5 to 10 minutes after discontinuation of Remi, no residual analgesic activity will be present. However, respiratory depression may occur in some patients up to 30 minutes after termination of infusion due to residual effects of concomitant anesthetics. Other analgesics should be administered prior to discontinuation of Remi where postoperative pain is anticipated.

INDICATIONS ULTIVA® (remifentanil HCl) for Injection is indicated for intravenous administration: • As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures • For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting • As an analgesic component of monitored anesthesia care in adult patients

ULTIVA is a registered trademark of Glaxo Group Limited.

The Mylan logo is a registered trademark of Mylan Inc.

©2014 Mylan Institutional

IMPORTANT RISK INFORMATION Continuous infusions of ULTIVA should be administered only by an infusion device.

IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects (within 5 to 10 min) upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia particularly where postoperative pain is anticipated.

Vital signs and oxygenation must be continuously monitored during ULTIVA administration. ULTIVA produces adverse events that are characteristic of μ-opioids, such as respiratory depression, apnea, tachycardia, bradycardia, hypotension,

ULT-2014-0052

NOVEMBER 2014

AnesthesiologyNews.com I 7

CLINICAL ANESTHESIOLOGY White SM, Moppett IK, Griffiths R. Outcome by mode of anaesthesia for hip fracture surgery. An observational audit of 65 535 patients in a national dataset. Anaesthesia.

2014;69:224-230.

Researchers analyzed 65,535 records to determine if the type of anesthesia that hip surgery patients receive affects mortality rates. They found that mortality within 24 hours of surgery was significantly higher in patients who received cemented versus uncemented

hemiarthroplasty (1.6% vs. 1.2%; P=0.030). The researchers did not find any difference in five- and 30-dayy mortality rates between GA and spinal anesthesia.

versus RA for hip fracture surgery.

Proponents of both sides passionately believe that patients are better off with either a GA or a spinal (intrathecal) anesthetic. The authors of this paper believe that randomDr. Klein: We thought this article ized controlled trials in this area are describing a national audit of patients extremely difficult—if not impossiwith fractured hips was particularly ble—because of entrenched views and interesting because of the large num- opinions about best practice; hence ber of patients included, and because the desire to publish observational it addresses a particularly contro- data from large numbers of patients. versial area of practice—namely GA The outcome of the analysis—that

Remi* is a potent μ-opioid agonist with rapid analgesic onset and peak effect, and short duration of action.†1

Rapid response†1

Early post-op neurological assessment‡3,4

Rapid recovery‡1

No accumulation1

Established hemodynamic profile1,2 Remi produces adverse events that are characteristic of μ-opioids, such as respiratory depression, apnea, tachycardia, bradycardia, hypotension, hypertension, and skeletal muscle (including chest wall) rigidity.

Please see Indications and Important Risk Information below, and accompanying brief summary of Prescribing Information on adjacent page for all precautions, warnings, contraindications, and adverse events. hypertension, and skeletal muscle (including chest wall) rigidity. Because these effects are dose-dependent and can occur rapidly, continuous monitoring is necessary. ULTIVA should not be used as a sole agent because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia.

ULTIVA should be used with caution in pediatric, geriatric, and morbidly obese patients due to high variability in pharmacodynamics and dose/response.

Intraoperative awareness has been reported with concomitant administration with propofol infusion ≤75 mcg/kg/min.

Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing.

October 2014

Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVA is also contraindicated in patients with known hypersensitivity to fentanyl analogs.

ULTIVA SHOULD BE USED IN A CAREFULLY MONITORED SETTING BY SPECIFICALLY TRAINED PERSONS NOT INVOLVED IN THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION IS TO BE CONTINUOUSLY MONITORED. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE. References: 1. ULTIVA [package insert]. Rockford, IL: Mylan Institutional LLC; 2011. 2. Twersky RS, et al. J Clin Anesth. 2001;13(6):407-416.

3. Wilhelm W, et al. Br J Anaesth. 2001;86(1):44-49. 4. Bilotta F, et al. Eur J Anaesth. 2007;24(2):122-127.

there is no difference in mortality between the two techniques—is important and stimulating researchwise. Is mortality the right outcome, or is there really no difference? Or is it that the patient matters more than the technique? We hope researchers will continue to look into this whether GA is better or worse than other techniques for surgery, which in itself is currently unknown. see journals page 8

8 I AnesthesiologyNews.com

NOVEMBER 2014

CLINICAL ANESTHESIOLOGY JOURNALS

practice. The fact that so many nonanesthetists use local anesthetics but Williams DJ, Walker JD. A perhaps are not as aware of the maxnomogram for calculating the imum safe dose was also important maximum dose of local anaesthetic. to us when we decided to publish this nomogram. It is available free Anaesthesia. 2014;69:847-853. of charge. We hope this will improve Nomograms can be a cost-efficient patient safety, especially as drug errors and accurate tool for cross-checking maximum safe volume of local anes- Dr. Klein: A clever and clinically use- are unfortunately so common. We thetics, and might help to reduce anes- ful way to calculate maximum safe also hope it will be useful to students thetic toxicity. The researchers who local anesthetic dose—we thought when they start using local anesthetics conducted this study produced fewer this could be useful to many clini- and throughout their working lives. and smaller errors with the nomogram cians and surgeons in their everyday

ULTIVA® for Injection

CONTINUED FROM PAGE 7

they created than with a calculator. A Bland-Altman analysis showed close agreement between the two methods, with bias of –0.07 mL and limits of agreement of –0.38 to +0.24 mL (correlation coefficient r2=0.9980; P<0.0001).

(remifentanil hydrochloride) For IV Use Only Rx only Brief Summary: The following is a brief summary only. Before prescribing, see complete ULTIVA prescribing information.

CONTRAINDICATIONS Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVAA is also contraindicated in patients with known hypersensitivity to fentanyl analogs.

WARNINGS AND PRECAUTIONS Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds.

Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia.

Injections of ULTIVA should be made into IV tubing at or close to the venous cannula. Upon discontinuation of ULTIVA, the IV tubing should be cleared to prevent the inadvertent administration of ULTIVA at a later point in time. Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing.

USE OF ULTIVA IS ASSOCIATED WITH APNEA AND RESPIRATORY DEPRESSION. ULTIVA SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF ANESTHETIC DRUGS AND THE MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS, INCLUDING RESPIRATORY AND CARDIAC RESUSCITATION OF PATIENTS IN THE AGE GROUP BEING TREATED. SUCH TRAINING MUST INCLUDE THE ESTABLISHMENT AND MAINTENANCE OF A PATENT AIRWAY AND ASSISTED VENTILATION. ULTIVA SHOULD NOT BE USED IN DIAGNOSTIC OR THERAPEUTIC PROCEDURES OUTSIDE THE MONITORED ANESTHESIA CARE SETTING. PATIENTS RECEIVING MONITORED ANESTHESIA CARE SHOULD BE CONTINUOUSLY MONITORED BY PERSONS NOT INVOLVED IN THE CONDUCT OF THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION SHOULD BE MONITORED ON A CONTINUOUS BASIS. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE. Respiratory depression in spontaneously breathing patients is generally managed by decreasing the rate of the infusion of ULTIVA V by 50% or by temporarily discontinuing the infusion.

Skeletal muscle rigidity can be caused by ULTIVA and is related to the dose and speed of administration. ULTIVA may cause chest wall rigidity (inability to ventilate) after single doses of >1 mcg/kg administered over 30 to 60 seconds, or after infusion rates >0.1 mcg/kg/min. Single doses <1 mcg/kg may cause chest wall rigidity when given concurrently with a continuous infusion of ULTIVA. Muscle rigidity induced by ULTIVA should be managed in the context of the patient’s clinical condition. Muscle rigidity occurring during the induction of anesthesia should be treated by the administration of a neuromuscular blocking agent and the concurrent induction medications. Muscle rigidity seen during the use of ULTIVA in spontaneously breathing patients may be treated by stopping or decreasing the rate of administration of ULTIVA. Resolution of muscle rigidity after discontinuing the infusion of ULTIVA occurs within minutes. In the case of life-threatening muscle rigidity, a rapid onset neuromuscular blocker or naloxone may be administered. ULTIVA should not be administered into the same IV tubing with blood due to potential inactivation by nonspecific esterases in blood products.

PRECAUTIONS Vital signs and oxygenation must be continually monitored during the administration of ULTIVA. General: Bradycardia has been reported with ULTIVA and is responsive to ephedrine or anticholinergic drugs, such as atropine and glycopyrrolate. Hypotension has been reported with ULTIVA and is responsive to decreases in the administration of ULTIVA or to IV fluids or catecholamine (ephedrine, epinephrine, norepinephrine, etc.) administration. Intraoperative awareness has been reported in patients under 55 years of age when ULTIVA has been administered with propofol infusion rates of ≤ 75 mcg/kg/min.

Rapid Offset of Action: WITHIN 5 TO 10 MINUTES AFTER THE DISCONTINUATION OF ULTIVA, NO RESIDUAL ANALGESIC ACTIVITY WILL BE PRESENT. However, respiratory depression may occur in some patients up to 30 minutes after termination of infusion due to residual effects of concomitant anesthetics. Standard monitoring should be maintained in the postoperative period to ensure adequate recovery without stimulation. For patients undergoing surgical procedures where postoperative pain is generally anticipated, other analgesics should be administered prior to the discontinuation of ULTIVA. ULTIVA should not be used as a sole agent for induction of anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia.

Pediatric Use: The efficacy and safety of ULTIVA as an analgesic agent for use in the maintenance of general anesthesia in outpatient and inpatient pediatric surgery have been established in controlled clinical trials in pediatric patients from birth to 12 years. In clinical trials, the clearance rate observed in neonates was highly variable and on average was two times higher than in the young healthy adult population. While a starting infusion rate of 0.4 mcg/kg/min may be appropriate for some neonates, an increased infusion rate may be necessary to maintain adequate surgical anesthesia, and additional bolus doses may be required. The individual dose for each patient should be carefully titrated (see ULTIVA Prescribing Information [PI], DOSAGE AND ADMINISTRATION, Table 11). ULTIVA has not been studied in pediatric patients for use as a postoperative analgesic or as an analgesic component of monitored anesthesia care.

Geriatric Use: Of the total number of subjects in clinical studies of ULTIVA, 486 were in the age range 66 to 90 years. While the effective biological half-life of remifentanil is unchanged, elderly patients have been shown to be twice as sensitive as the younger population to the pharmacodynamic effects of remifentanil. The recommended starting dose of ULTIVA should be decreased by 50% in patients over 65 years of age.

Use in Morbidly Obese Patients: As for all potent opioids, caution is required with use in morbidly obese patients because of alterations in cardiovascular and respiratory physiology.

Long-term Use in the ICU: No data are available on the long-term (> 16 hours) use of ULTIVA as an analgesic in ICU patients.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal carcinogenicity studies have not been performed with remifentanil. Remifentanil did not induce gene mutation in prokaryotic cells in vitroo and was not genotoxic in an in vivoo rat assay.

No clastogenic effect was seen in hamster or mouse studies. In the in vitroo mouse lymphoma assay, mutagenicity was seen only with metabolic activation.

Remifentanil has been shown to reduce fertility in male rats when tested after approximately 40 times the maximum recommended human dose (MRHD). The fertility of female rats was not affected at IV doses as high as 1 mg/kg when administered for at least 15 days before mating.

Pregnancy Category C: Teratogenic effects were not observed in either rats or rabbits following administration of remifentanil at doses up to 400 times and 125 times the MRHD, respectively. Administration of radiolabeled remifentanil to pregnant rabbits

and rats demonstrated significant placental transfer to fetal tissue. There are no adequate and well-controlled studies in pregnant women. ULTIVA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Administration of remifentanil to rats throughout late gestation and lactation at IV doses up to 400 times the MRHD in terms of mg/m2 of body surface area, had no significant effect on the survival, development, or reproductive performance of the F1 generation.

Animal Toxicology: Intrathecal administration of the glycine formulation without remifentanil to dogs caused agitation, pain, hind limb dysfunction, and incoordination. These effects are believed to be caused by the glycine. Glycine is a commonly used excipient in IV products and this finding has no relevance for IV administration of ULTIVA. Labor and Delivery: Respiratory depression and other opioid effects may occur in newborns whose mothers are given ULTIVA shortly before delivery. The safety of ULTIVA during labor or delivery has not been demonstrated. Placental transfer studies in rats and rabbits showed that pups are exposed to remifentanil and its metabolites. In a human clinical trial, the average maternal remifentanil concentrations were approximately twice those seen in the fetus. In some cases, however, fetal concentrations were similar to those in the mother. The umbilical arteriovenous ratio of remifentanil concentrations was approximately 30% suggesting metabolism of remifentanil in the neonate.

Nursing Mothers: It is not known whether remifentanil is excreted in human milk. After receiving radioactive-labeled remifentanil, the radioactivity was present in the milk of lactating rats. Because fentanyl analogs are excreted in human milk, caution should be exercised when ULTIVA is administered to a nursing woman.

ADVERSE EVENTS In controlled clinical trials in approximately 2770 adult patients, ULTIVA produced adverse events characteristic of μ-opioids, such as respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity. These adverse events dissipated within minutes of discontinuing or decreasing the infusion rate of ULTIVA. Table 1: Adverse Events Reported in ≥ 1% of Adult Patients in General Anesthesia Studies* at the Recommended Doses† of ULTIVA Induction/Maintenance Adverse Event Nausea Hypotension Vomiting Muscle rigidity Bradycardia Shivering Fever Dizziness Visual disturbance Headache Respiratory depression Apnea Pruritus Tachycardia Postoperative pain Hypertension Agitation Hypoxia

ULTIVA (n=921)

Alfentanil/ Fentanyl (n=466)

Postoperative Analgesia ULTIVA (n=281)

Morphine (n=98)

After Discontinuation ULTIVA (n=929)

Alfentanil/ Fentanyl (n=466)

8 (<1%) 178 (19%) 4 (<1 % ) 98 (11%)‡ 62 (7%) 3 (<1%) 1 (<1%) 0 0 0

0 30 (6%) 1 (<1%) 37 (8%) 24 (5%) 0 0 0 0 0

61 (22%) 0 22 (8%) 7 (2%) 3 (1%) 15 (5%) 2 (<1%) 1 (<1%) 0 1 (<1%)

15 (15%) 0 5 (5%) 0 3 (3%) 9 (9%) 0 0 0 1 (1%)

339 (36%) 16 (2%) 150 (16%) 2 (<1%) 11 (1%) 49 (5%) 44 (5%) 27 (3%) 24 (3%) 21 (2%)

202 (43%) 9 (2%) 91 (20%) 1 (<1%) 6 (1%) 10 (2%) 9 (2%) 9 (2%) 14 (3%) 8 (2%)

1 (<1%) 0 2 (<1%) 6 (<1%) 0 10 (1%) 2 (<1%) 0

0 1 (<1%) 0 7 (2%) 0 7 (2%) 0 0

19 (7%) 9 (3%) 7 (2%) 0 7 (2%) 5 (2%) 3 (1%) 1 (<1%)

4 (4%) 2 (2%) 1 (1%) 0 0 3 (3%) 1 (1%) 0

17 (2%) 2 (<1%) 22 (2%) 10 (1%) 4 (<1%) 12 (1%) 6 (<1%) 10 (1%)

20 (4%) 1 (<1%) 7 (2%) 8 (2%) 5 (1%) 8 (2%) 1 (<1%) 7 (2%)

*Does not include adverse events from cardiac studies or the neonatal study. See ULTIVA PI, Tables 6, 7, and 8 for cardiac information. † See ULTIVA PI, Table 10 for recommended doses. Not all doses of ULTIVA were equipotent to the comparator opioid.

Administration of ULTIVA in excess of the recommended dose (i.e., doses >1 and up to 20 mcg/kg) resulted in a higher incidence of some adverse events: muscle rigidity (37%), bradycardia (12%), hypertension (4%), and tachycardia (4%). ‡ Included in the muscle rigidity incidence is chest wall rigidity (5%). The overall muscle rigidity incidence is <1% when remifentanil is administered concurrently or after a hypnotic induction agent.

In the elderly population (> 65 years), the incidence of hypotension is higher, whereas the incidence of nausea and vomiting is lower.

DRUG ABUSE AND DEPENDENCE ULTIVA is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and has the potential for being abused.

OVERDOSAGE As with all potent opioid analgesics, overdosage would be manifested by an extension of the pharmacological actions of ULTIVA. Expected signs and symptoms of overdosage include: apnea, chest-wall rigidity, seizures, hypoxemia, hypotension, and bradycardia.

In case of overdosage or suspected overdosage, discontinue administration of ULTIVA, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function. If depressed respiration is associated with muscle rigidity, a neuromuscular blocking agent or a μ-opioid antagonist may be required to facilitate assisted or controlled respiration. Intravenous fluids and vasopressors for the treatment of hypotension and other supportive measures may be employed. Glycopyrrolate or atropine may be useful for the treatment of bradycardia and/or hypotension.

Intravenous administration of an opioid antagonist such as naloxone may be employed as a specific antidote to manage severe respiratory depression or muscle rigidity. Respiratory depression from overdosage with ULTIVA is not expected to last longer than the opioid antagonist, naloxone. Reversal of the opioid effects may lead to acute pain and sympathetic hyperactivity.

ULTIVA is a registered trademark of Glaxo Group Limited.

US Patent Nos. 5,019,583; and 5,866,591 Version C, 07/2011 Manufactured for Mylan Institutional LLC, Rockford, IL 61103 Manufactured by Hospira, Inc. Lake Forest, IL 60045

Anesthesiology James C. Eisenach, MD, editor-in-chief Disclaimer: These views are Dr. Eisenach’s and do not necessarily reflect those of the American Society of Anesthesiologists.

Vetter TR, Ivankova NV, Goeddel LA, et al. An analysis of methodologies that can be used to validate if a perioperative surgical home improves the patient-centeredness, evidencebased practice, quality, safety, and value of patient care. Anesthesiology.

2013;119:1261-1274.

The American Society of Anesthesiologists and other stakeholders proposed the Perioperative Surgical Home (PSH) model to improve perioperative care of surgical patients. They wanted to create a “highly patient-centered, anesthesia-led yet interdisciplinary, and team-based system of coordinated care.”

The researchers suggested an observational cohort study to provide preliminary data on the effectiveness of the current PSH model.

Dr. Eisenach: In this article by a group at the University of Alabama undergoing a very large and comprehensive experiment in the PSH, an attempt is made to define terms by which we can gauge and compare success across these different approaches to expanded care. The focus here is on outcomes— not just financial, time to discharge or readmission rates, but also the patientcenteredness goal of the home concept and how it can be measured. If we are to convince ourselves that this transformation is worth the hard work it will take to accomplish and convince payors and our colleagues that we must change perioperative medical care in this direction, then we need strong evidence. This article suggests some metrics of success to serve this purpose, which is central to the development of care redesign.

Botto F, Alonso-Coello P, Chan MT, et al. Myocardial injury after noncardiac surgery: a large, international, prospective cohort study establishing diagnostic criteria, characteristics, predictors, and 30-dayy outcomes.

Anesthesiology. 2014;120:564-578.

An international prospective cohort study of 15,065 patients was conducted to determine the diagnostic criteria, characteristics, predictors, and 30-dayy outcomes of myocardial injury after noncardiac surgery (MINS).

According to the researchers, MINS is common among adults undergoing noncardiac surgery. It is also an

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CLINICAL ANESTHESIOLOGY independent predictor of 30-dayy mortality (adjusted hazard ratio, 3.87; 95% CI, 2.96-5.08) and had the highest population-attributable risk (34%; 95% CI, 26.6-41.5) of the perioperative complications.

Dr. Eisenach: If anesthesiologists are to lead a PSH, then they should generate new knowledge to advance prediction, prevention, diagnosis and treatment of intra- and postoperative complications. This large, multicenter, international trial found that mild increases in troponin of more than 0.03 ng/mL occurred commonly in 8% of patients in the first three postoperative days. Most of these 8% did not demonstrate ischemic symptoms or would have fulfilled criteria for myocardial infarction, but their risk for perioperative mortality was increased nearly fourfold. These results support routine screening with troponin measurements in adults undergoing major surgery and suggest that asymptomatic injury is not uncommon and is associated with major morbidity and mortality. Whether we can diminish these complications with foreknowledge provided by the troponin measurements is a key next step.

This article is accompanied by an editorial from Dr. Bartels and his colleagues from the University of Colorado, noting that the perioperative period is dangerous. Yes, anesthesiologists should take pride in the incredible safety in the operating room, but as this editorial points out, 30-dayy perioperative mortality ranks as the No. 3 cause of death in the United States.

Having major surgery is far from safe, and we have a tremendous opportunity to enhance safety during this vulnerable period through new research and application of new knowledge.

Ing CH, DiMaggio CJ, Malacova E, et al. Comparative analysis of outcome measures used in examining neurodevelopmental effects of early childhood anesthesia exposure. Anesthesiology. 2014;120:1319-1332.

Investigators found that results can vary depending on the outcome measure used when accessing cognition in children with early exposure to anesthesia. Coded clinical outcomes showed an increased risk for deficit in exposed children compared with unexposed children; academic scores did not. There were 781 children in the study; 112 had anesthesia exposure.

and attention than the potential effects of anesthesia during infancy on neurodevelopment. Indeed, it is one of those topics where the number of published expert commentaries and reviews exceeds the number of research articles.

Although this topic is far from settled, the quality of clinical research is beginning to catch up with that of the preclinical work, and suggests that there is a subtle effect of anesthesia and surgery in infancy. Though balancing this risk with not performing surgery and

identifying methods to reduce the risk remain uncertain.

This article is a good example of how quality is moving forward. It reports a collaboration between U.S. and Australian researchers. This was not a simple retrospective review of test scores in children who happened to have had surgery during infancy. Rather, this study included nearly 3,000 children who received neuropsychiatric tests at one, two, three, five, eight and 10 years and beyond. More than 100 children

underwent surgery and anesthesia before age 3. These children had deficits at age 10 in language-related neuropsychiatric tests, although the effect was not gross enough to have altered their scholastic testing. In other words, a subtle effect was present, but the proportion of children who achieved national benchmarks on real-world testing did not differ.

An accompanying editorial provides a synthesis of clinical work in this see journals page 10

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LMASUPREME.COM REFERENCES FERENCES 1. Belena J.M. et al. Journal of Clinical Anesthesia 2011; 23:456-460. | 2. Roiss M. et al. Poster presented at The American Association of Anesthesiologists Annual Meeting 15th -19th, Oct. 2011, Chicago. | 3.

Sharma V. et al. BJA 2010; 105(2): 228-232. | 4. Whitacre W. et al. AANA Journal 2014; 82 (2): 101-107. | 5. Abdi W. et al. Acta Anaethesiol Scand. 2010; 54 (2): 141-146. | 6. Bernardini A. et al. Anesthesia 2009; 64: 1289-1294. | 7. Verghese C. et al. Anesthesia and Analgesia 1996; 82: 129-133. | 8. Tretiak S. Anethesiology News 2009. | 9. Viernes D. et al. Anesthesiology News 2010; 9-13. | 10. Verghese C. et al. BJA 2008; 101 (3): 405-410. | 11. Jagannathan N. et al. Pediatric Anesthesia 2012; 22:759-764. | 12. Jagannathan N. et al Anesthesia 2012; 67(2): 139-144. | 13. Ferson D. et al. Anesthesiology 2007; 107:A592.

Dr. Eisenach: Few topics in pediatric anesthesia have generated more anxiety Teleflex, LMA and LMA Supreme are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. © 2014 Teleflex Incorporated. All rights reserved. MC-000549 rev.1

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what to measure and how, we can Researchers reviewed 285,353 move on to generate evidence on inter- records of children without cardiac area, indicating that there is an emerg- ventions that affect this outcome. disease who received GA at The Children’s Hospital of Philadelphia from ing consensus that surgery and anesthesia during infancy are unlikely to have Journal of Clinical Anesthesia July 1998 through June 2011. They a large effect on standardized school identified 36 patients who were susRobert Gaiser, MD, editor-in-chief testing later in life, but that they do Disclaimer: These are Dr. Gaiser’s own opinions. pected of having had an episode have an effect on specialized neuropsyof intraoperative supraventricular tachycardia (SVT). The researchers chiatric tests, primarily those related to Cripe CC, Ratel AR, Markowitz SD, speech and language. Large prospec- et al. Supraventricular tachycardia concluded that SVT during the intrative studies that will confirm or dis- during pediatric anesthesia: a case operative period in noncardiac pediatric patients was uncommon and pute this synthesis are underway. As series and qualitative analysis. J Clin with the article on PSH, once we know Anesth. 2014;26:257-263. was not associated with clinically CONTINUED FROM PAGE 9

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significant patient morbidity when it did occur.

Dr. Gaiser: This article examined the incidence and outcome of children who developed SVT in the operating room. The number of events overall was low with the majority of events being treated with vagal maneuvers or medications. The important point is that it is not associated with patient morbidity. A small subset of these patients was identified to have a reentrant SVT that required antiarrhythmic medication at home.

Nurok M, Green STD, Chisholm MF, et al. Anesthesiologists’ familiarity with the ASA and ACS guidelines on advance directives in the perioperative setting. J Clin Anesth.

2014;26:174-176.

A four-question anonymous survey was given at an urban academic medical center to gauge anesthesiologists’ familiarity with the guidelines on advance directives in the perioperative setting. Up to 34 individuals responded to each question, and those who did showed an inadequate familiarity, according to the researchers. They suggested investigating best practices for guideline implementation and consequences for not following national guidelines.

Dr. Gaiser: While this study represented a small sample, it highlighted a universal problem: The majority of anesthesia practitioners are unfamiliar with the guidelines on advance directives. Once this point is acknowledged, steps at correcting this deficiency in knowledge may be adopted.

Augustin ID, Long TR, Rose SH, et al. Recruitment of house staff into

Diprivan Now Available in Smaller Dose resenius Kabi recently announced that Diprivan (propofol) injectable emulsion is available in 10 mL single-patient infusion vials.

The 10 mL vials were designed after clinicians reported wasted product during the propofol shortage from 2009 to 2013 in the United States, particularly for shorter procedures conducted in outpatient settings, according to Fresenius Kabi.

“The Diprivan 10 mL presentation is designed with consideration for common dosing practices to support single-patient use and reduce waste,” said John Ducker,

F

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CLINICAL ANESTHESIOLOGY anesthesiology: a longitudinal evaluation of factors responsible for selecting a career in anesthesiology and an individual training program. J Clin Anesth. 2014;26:91-105.

An anonymous survey was given to the 63 residents enrolled at Mayo Clinic in Rochester, Minn., to examine reasons for choosing a career in anesthesiology, the effects of dutyhour restrictions and thoughts on employment opportunities. The data from 55 residents who responded were compared with two similar studies previously published by the authors.

Investigators reported that the residents are still highly satisfied with their career choice, have increased concerns about employment after the program and disagree with further hour restrictions.

Dr. Gaiser: This study compared results from current residents in an anesthesiology program to answers given by residents 10 and 15 years ago. The good news is that residents are still satisfied with their choice of career specialty, although the concern of future employment following residency is increasing. Interest in critical care has increased, while interest in pain medicine has decreased. Duty hours were well received but the residents do not want further restrictions to their training and education. These results are important to program directors as it helps to guide curriculum and to address resident concerns.

Regional Anesthesia and Pain Medicine Marc A. Huntoon, MD, editor-in-chief Disclaimer: These are Dr. Huntoon’s own opinions.

matter? Pediatric regional block complications by patient state: a report from the Pediatric Regional Anesthesia Network. Reg Anesth Pain Med. 2014;39:279-283.

Researchers conducted an observational prospective study of more than 50,000 pediatric regional anesthesia blocks. They found that placement in patients under general anesthesia (GA) was as safe as placement in sedated and awake children. Postoperative neurologic symptoms occurred at a rate of

0.93 per 1,000 (95% confidence interval [CI], 0.7-1.2) under GA and 6.82 per 1,000 (95% CI, 4.2-10.5) in sedated and awake patients.

is under GA versus awake or alternative anesthetic. The authors concluded: “The placement of regional anesthetic blocks in pediatric patients under general anesthesia is as safe as placement in Dr. Huntoon: There is ongoing con- sedated and awake children.” troversy regarding whether pediatric regional blocks are safe when performed Pumberger M, Memtsoudis SG, in anesthetized children. This prospec- Stundner O, et al. An analysis of the tive study looks at the issue and largely safety of epidural and spinal neuraxanswers the question, showing no ial anesthesia in more than 100,000 increase in complications when regional consecutive major lower extremity blocks are performed when a child see journals page 13

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Malignant Hyperthermia: True Incidence Hard To Pinpoint Montreal—Malignant hyperthermia (MH) can be a life-threateningg condition and diagnosing it can be a challenge. A chart review by an international research team led by Columbia University Medical Center, New York City, and sponsored by the Malignant Hyperthermia Association of the United States (MHAUS) has concluded that approximately 70% of International Classification of Diseases (ICD)-9– and ICD-10–coded MH diagnoses in hospital discharge records refer to incident MH episodes or MH susceptibility.

As Teeda Pinyavat, MD, explained, ICD-9 codes for MH were introduced in 1997. Previous research at Columbia sought to determine the incidence and prevalence of MH. “This was a follow-up study to see if these ICD-9 codes were accurate,” said Dr. Pinyavat, who is an assistant professor of anesthesiology at Columbia.

To that end, the researchers assembled an expert panel of anesthesiologists—all of whom are MHAUS hotline consultants—which reviewed medical records for 47 patients with a discharge diagnosis of MH based on ICD-9 and ICD-10 codes. The records were from six tertiary care centers in North America and the patients had been discharged between Jan. 1, 2006 and Dec. 31, 2008. “We looked through every single note for the entire admission with a team of experts,” she explained. “There were five of us in total, but at least three of us would travel to each center and do the record review.” All cases were categorized as possible MH, probable MH, fulminant MH, history of MH (family or personal) or “other.”

As Dr. Pinyavat reported at the 2014 annual meeting of the International Anesthesia Research Society (abstract S-223), the patients’ mean age was 40 years; 51% were women. A surgical procedure and general anesthesia were documented in 68% of cases. Only 11 of the 47 (23.4%) cases were deemed to be an incident case of possible, probable or fulminant MH by the expert panel. “We thought this number would be higher, but was actually less than 25% of the events,” she said.

‘We also found that the patients who were falsely labeled as having malignant hyperthermia were, on the whole, sicker than the others.’

—Teeda Pinyavat, MD

Family and personal history of MH accounted for 46.8% of cases, whereas high fever without evidence of MH during admission comprised another 23.4%.

“And in three records we really couldn’t figure out any reason at all for the coding,” Dr. Pinyavat said. It was also found that dantrolene was given in 81% of MH cases. All patients judged to have an incident MH event survived to discharge.

“We also found that the patients who were falsely labeled as having MH were, on the whole, sicker than the others,” she added. “And most of them did not have a surgical procedure. By comparison, the actual incident MH cases were largely ASA [American

Society of Anesthesiologists physical status] 1 and 2, and all of them had a surgical procedure and surgical anesthesia trigger.”

Given these results, the researchers have begun to consider alternative ways of identifying true incidents of MH. “If we only look at the patients who had surgery, we improve a little bit on the incidence of incident MH, to 35%,” Dr. Pinyavat explained. “And if you could somehow link to a pharmacy database and find out who got dantrolene, those two things together—surgery and dantrolene administration— would be very powerful in finding actual MH cases in administrative databases.

“But if you’re going to use ICD-9 and ICD-10 information, like any disease you really need to know what you’re looking for, because there are a lot of coding errors.”

Session moderator George Hall, MB, BS, PhD, professor of anesthesia at St. George’s, University of London, United Kingdom, urged caution when using dantrolene as a marker for MH. “Dantrolene will lower core temperature in any situation in which thermogenesis is occurring in skeletal muscle,” he said.

“We’ve used it occasionally in things like neuroleptic malignant syndrome and in patients on antipsychotic medications.

“Some anesthesiologists might believe, ‘Well, we’ve got a response to dantrolene, therefore the patient has MH.’ Not necessarily. If you’ve got a response to dantrolene, it just means heat was being produced in muscle,” Dr. Hall said.

—Michael Vlessides

Dexmedetomidine Promising for Deep Pediatric Sedation Montreal—When performing deep sedation in children undergoing magnetic resonance imaging (MRI) studies, anesthesiologists often are on the lookout for a drug that will not inhibit airway patency. A trial by a group of Buffalo researchers has concluded that dexmedetomidine may be one such alternative, as it causes no more airway collapses than propofol in these patients.

“The story begins in 2008, when we performed a review of 20 children undergoing MRI,” said Rafeek Hegazy, MD, a fellow in pediatric anesthesiology at the Women & Children’s Hospital of Buffalo, N.Y. “We found a trend toward less upper airway collapsibility with dexmedetomidine.

“These data were supported by a study from Cincinnati [[J Clin Anesth 2013;25:529-541], which found significantly less airway collapse in dexmedetomidine patients who have obstructive sleep apnea [OSA],”

head under anesthesia; none required intubation, none had cardiac history, and none were being treated for attention-deficit/hyperactivity disorder. After baseline MRIs were obtained and anesthesia was induced with sevoflurane, one group of participants was randomized to receive a bolus of 1 mcg/kg dexmedetomidine, followed by an infusion of 1 mcg/kg per hour dexmedetomidine for 10 minutes, and a 1 mg/kg dose of midazolam. “This regimen came from another study we performed where we found this was the best dexmedetohe continued. “The weakness in that midine protocol for deep sedation,” study was that most OSA patients Dr. Hegazyy explained. “Because if you obstruct, even without medication. So don’t give the Versed [midazolam], we wanted to do our study in children most patients will wake up in the midwho weren’t suffering from it.” dle of the procedure.” The other group Dr. Hegazy and his colleagues received a propofol load of 300 mcg/ enrolled 31 children (mean age, 4.9 kg per minute over 10 minutes, folyears; range, 3-7 years) into the trial. lowed by a 250 mcg/kg per minute Each child underwent MRI of the infusion.

MRI scans were started immediately after drug administration, and included a sagittal scout film, an axial spoiled gradient (SPGR), and two cine sequences. These images were then repeated 20 minutes later, during the infusion of the study drug, for comparison. “So the first scans examined sevoflurane’s effect on the airway.

Twenty minutes later, the effect of the study drug was examined.”

As Dr. Hegazyy reported at the 2014 annual meeting of the International Anesthesia Research Society (abstract S-259), no meaningful differences were found between groups with respect to airway collapsibility. “The only difference was in SPGR, where we found a statistically significant difference between the dexmedetomidine and propofol groups at 20 minutes. But this difference was not clinically significant.

“The only difference was that the see ped sedation page 15

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CONTINUED FROM PAGE 11

joint replacements. Reg Anesth Pain Med. 2013;38:515-519.

A retrospective analysis of 107,000 total knee and hip replacements was conducted to examine the frequency of hematoma occurrence among patients undergoing orthopedic joint arthroplasty. The researchers found a relatively low incidence of epidural/ spinal complications, but noted that it was still higher than previously reported. They said more research using larger sets of data is needed.

Dr. Huntoon: Many patients undergoing orthopedic joint arthroplasty are elderly and have significant comorbidities, making safety and evidencebased practice for anesthesia a primary concern. Little has been known, however, about the frequency of hematoma occurrence among this patient population. To elucidate the topic, the authors of this study conducted a retrospective database analysis of all patients who underwent major lowerextremity joint replacements under neuraxial anesthesia in the years from 2000 through 2010, producing evidence that the procedure is safe. Out of 100,000 patients, only eight presented with epidural blood or gas collection. Although the study is a retrospective analysis, it represents a significant number of patients, giving confidence that the incidence of hematoma is relatively low and suggesting that complications could correlate with concomitant medications including nonsteroidal anti-inflammatoryy agents.

Bulka CM, Shotwell MS, Gupta RK, et al. Regional anesthesia, time to hospital discharge, and in-hospital mortality: a propensity score matched analysis. Reg Anesth Pain Med. 2014;39:381-386.

Researchers compared regional anesthesia (RA) with GA to see if anesthetic technique affects postoperative length of stay and outcomes. A total of 5,870 inpatient cases were included in the study—1,174 RA cases and 4,696 GA cases. The median time to hospital discharge among RA patients was 67.6 hours versus 71.9 hours for GA cases.

Patients who received RA were associated with 64% lower odds of dying in the hospital (odds ratio, 0.36; 95% CI, 0.16-0.75), when adjusting for the number of postoperative days spent in the hospital, the researchers wrote.

Dr. Huntoon: Could RA, when appropriate, reduce patients’ hospital stays

and in-hospital mortality compared with GA? The authors of this large retrospective cohort study tackle this question at a time when boosting quality and patient-satisfaction scores— while reducing costs and resource utilization—are imperative. The study considers data from 5,870 inpatient surgical cases, providing evidence that the median time to discharge is shorter when RA is used instead of

GA, controlling for other clinically important factors. Additionally, RA use during surgery was associated with a decrease in in-hospital mortality. The authors concluded, “When an appropriate option, RA may facilitate faster hospital discharge and improve patient outcomes.”

—Information compiled by David Wild

Contact the editor of Anesthesiology News

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Post-Op Nausea and Vomiting Reduced With IV Acetaminophen But overall opioid use unchanged in this lap chole study Montreal—Preliminar y data indicate reduced postoperative/ post-discharge nausea and vomiting (PONV/PDNV) and improved patient satisfaction after a single dose of IV acetaminophen in patients undergoing laparoscopic cholecystectomy, compared with traditional

opioid-based anesthetics. Despite this, the overall amount of opioid administered intraoperatively and in the postanesthesia care unit (PACU) was not reduced.

“There have been a lot of reports, both anecdotally and in the literature, about ways to help minimize PONV

and pain,” commented Daniel Bosshart, MD, assistant professor of anesthesiology at Hofstra North Shore–LIJ School of Medicine, in Hempstead, N.Y. “So, we wanted to determine the effect of a single dose of IV acetaminophen on PONV, PDNV, pain and overall patient satisfaction.”

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Dr. Bosshart and his colleagues enrolled 65 outpatients, American Society of Anesthesiologists (ASA) physical status 1 to 3, scheduled for laparoscopic cholecystectomy, into the trial. Each patient received a regimen of an opioid and an inhalational anesthetic, with preemptive antiemetics based on preoperative PONV risk according to ASA guidelines. The intervention group of 32 patients received 1,000 mg of IV acetaminophen (Ofirmev, Cadence Pharmaceuticals) after removal of the gallbladder but before emergence. The control group of 33 patients received opioids and other analgesics, including ketorolac, as per usual practice. Pain scores were recorded with an 11-point rating scale before surgery and at 10-minute intervals in the PACU. Both PDNV and patient satisfaction were assessed within seven days of surgery.

“We wanted to measure the effect of giving an intraoperative dose of Ofirmev versus just giving standard, opioid-based analgesics that clinicians would typically give for these cases,” Dr. Bosshart explained. “We picked this particular procedure because it’s one of the most commonly performed surgeries in the outpatient setting.”

As Dr. Bosshart reported at the 2014 annual meeting of the International Anesthesia Research Society (abstract S-29), PACU pain scores did not differ significantly between the IV acetaminophen patients and the controls at 10 minutes (1.4±3.1 vs. 2.3±3.0, respectively; P=0.12) or one hour after surgery (2.6±2.5 vs. 2.1±2.3, respectively; P=0.77). Total opioid use (intraoperative plus PACU) as measured by morphine equivalents also was comparable between groups (72±36 vs. 69±36 mg, respectively; P=0.9).

Trends toward less PONV were observed in the PACU, with 36% of controls experiencing the side effect compared with 21% of the treatment group (P=0.3). Similar results were found for PDNV, which affected 38% of controls and 14% of patients receiving IV acetaminophen (P=0.08).

“We also found that PDNV was actually more prolonged in the control group,” Dr. Bosshart said. Indeed, 24% of controls reported PDNV on the day of surgery, with 7% and 7% reporting the adverse event on postoperative days 2 and 3, respectively. “In the IV acetaminophen group,” he said, “it was

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CLINICAL ANESTHESIOLOGY PED SEDATION

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PACU [postanesthesia care unit] time was prolonged with dexmedetomidine,” Dr. Hegazyy said. “Interestingly, however, the time from scan to discharge was almost the same between groups.” Heart rate and blood pressure were decreased in dexmedetomidine patients; end-tidal CO2 was comparable.

Dr. Hegazyy recognized that individual results may vary given differences in drug administration, but maintained that dexmedetomidine would provide results comparable to that of propofol. “Although there is some radiologic evidence that there is less airway collapsibility with dexmedetomidine, clinically it’s not different,” he told

only noted on the actual day of surgery [P<0.05].”

Patient satisfaction with pain control, PONV management and overall experience also trended in favor of IV acetaminophen, although this did not reach significance: 67%, 71% and 84%, respectively, for controls versus 84%, 93% and 96% for the treatment group (P=0.5, 0.1 and 0.4).

“We found the effect of the IV acetaminophen on nausea particularly interesting … not only initially, but also after discharge,” he said. “It was equally interesting that overall patient satisfaction was higher in the treatment group, despite the actual perception of the pain being similar in both groups. We expect these differences to reach statistical significance once we finish enrollment.

“These preliminary results seem to demonstrate that there’s another factor involved here with regard to PONV than just opioid sparing,” Dr. Bosshart added. “It seems there is a central effect that may have something to do with a metabolite of acetaminophen and how it affects cannabinoid receptors in the brain.” The study is ongoing.

Session moderator Raafat Hannallah, MD, professor of anesthesiology and pediatrics at Children’s National Health System, in Washington, D.C., proposed a possible confounding factor that may have influenced the results.

“The problem, of course, with looking at postdischarge results is that they will be somewhat affected by what the surgeon prescribes after the surgery. These agents will be responsible for at least some of the observed response.”

—Michael Vlessides

Anesthesiology News. “Some institutions use higher doses of propofol and dexmedetomidine and have evidence of clinical airway obstruction. But if you follow this, it should work perfectly.

“I think dexmedetomidine is going to be a very good option, especially for obstructive sleep apnea or difficult intubation patients,” he said. “I use dexmedetomidine for most of these cases now.”

Caleb H. Ing, MD, assistant professor of anesthesiology at Columbia University Medical Center, New York City, found the lack of clinical difference between the two drugs somewhat surprising. “Based on prior studies, propofol has been associated with airway obstruction [[Anesthesiology 2006;105:45-50], whereas even at high doses dexmedetomidine was not found to be associated

with obstruction [Paediatr Anesth 2010;20:506-515].

“I agree with the authors that dexmedetomidine could be a viable option for sedation during MRI,” he added. “In longer MRI scans, however, using dexmedetomidine as a sole agent may not be adequate to prevent movement in all children.”

—Michael Vlessides

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Is IV Ibuprofen the Missing Piece to Your Surgical Pain Management Puzzle?

BRIEF SUMMARY OF PRESCRIBING INFORMATION CALDOLOR ® (ibuprofen) Injection WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Risk • Non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions (5.1)].

• Caldolor is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4.3) and Warnings and Precautions (5.1)].

Gastrointestinal Risk • NSAIDs increase the risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [see Warnings and Precautions (5.2)].

1 INDICATIONS AND USAGE: 1.1 Analgesia (Pain): Caldolor is indicated in adults for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics.

1.2 Antipyretic (Fever): Caldolor is indicated for the reduction of fever in adults.

4 CONTRAINDICATIONS 4.1 HYPERSENSITIVITY: Caldolor is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to ibuprofen [see Warnings and Precautions (5.7, 5.8)].

4.2 ASTHMA AND ALLERGIC REACTIONS: Caldolor is contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal anaphylactic-like reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.12)].

4.3 CORONARY ARTERY BYPASS GRAFT (CABG): Caldolor is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS: 5.1 Cardiovascular Thrombotic Events: Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur. Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke [see Contraindications (4.3)].

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious gastrointestinal (GI) events [see Warnings and Precautions (5.2)]. 5.2 Gastrointestinal Effects: Risk of Ulceration, Bleeding, and Perforation: NSAIDs, including ibuprofen, can cause serious GI adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately

1% of patients treated for 3-6 months and in about 2-4% of patients treated for one year. These trends continue ysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the and symptoms of serious skin manifestations, and to discontinue Caldolor at the first appearance of skin rash course of therapy. However, even short-term therapy is not without risk. Prescribe NSAIDs, including Caldolor, or any other sign of hypersensitivity. 5.9 Pregnancy: Starting at 30 weeks gestation, Caldolor, and other NSAIDs, with extreme caution in those with a prior history of ulcer disease or GI bleeding. Patients with a prior history should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur [see of peptic ulcer disease and/or GI bleeding who use NSAIDs have a greater than 10-fold increased risk for devel- Use in Specific Populations (8.1)]. 5.10 Masking Inflammation and Fever: The pharmacological activity of oping a GI bleed compared to treated patients with neither of these risk factors. Other factors that increase the ibuprofen in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting risk of GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoag- complications of presumed noninfectious, painful conditions. 5.11 Hematological Effects: Caldolor must be ulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most diluted prior to use. Infusion of the drug product without dilution can cause hemolysis [see Dosage and reports of spontaneous fatal GI events are in elderly or debilitated patients, and therefore special care should be Administration (2.3)]. Anemia may occur in patients receiving NSAIDs, including ibuprofen. This may be due to taken in treating this population. To minimize the potential risk for an adverse GI event in patients treated with fluid retention, occult or gross GI blood loss, or an incompletely described effect on erythropoiesis. In patients an NSAID, use the lowest effective dose for the shortest possible duration. Patients and physicians should remain on long-term treatment with NSAIDs, including ibuprofen, check hemoglobin or hematocrit if they exhibit any alert for signs and symptoms of GI ulcerations and bleeding during NSAID therapy and promptly initiate addi- signs or symptoms of anemia or blood loss. NSAIDs inhibit platelet aggregation and have been shown to protional evaluation and treatment if a serious GI event is suspected. This should include discontinuation of the long bleeding time in some patients. Unlike aspirin, their effects on platelet function are less severe quantitatively, NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve of shorter duration, and reversible. Carefully monitor patients who may be adversely affected by alterations in NSAIDs should be considered. 5.3 Hepatic Effects: Borderline elevations of one or more liver tests may occur platelet function, such as those with coagulation disorders or patients receiving anticoagulants. 5.12 Pre-existing in up to 15% of patients taking NSAIDs, including ibuprofen. These laboratory abnormalities may progress, may Asthma: Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirinremain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approxi- sensitive asthma has been associated with severe bronchospasm, which can be fatal. Since cross-reactivity mately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clin- between aspirin and NSAIDs has been reported in such aspirin-sensitive patients, including bronchospasm, ical trials with NSAIDs. In addition, rare cases of severe hepatic reactions have been reported, including jaundice, Caldolor is contraindicated in patients with this form of aspirin sensitivity and should be used with caution in all fulminant hepatitis, liver necrosis and hepatic failure, some with fatal outcomes. A patient with symptoms and/or patients with pre-existing asthma. 5.13 Ophthalmological Effects: Blurred or diminished vision, scotomata, and signs suggesting liver dysfunction, or with abnormal liver test values, should be evaluated for evidence of the changes in color vision have been reported with oral ibuprofen. Discontinue ibuprofen if a patient develops such development of a more severe hepatic reaction while on therapy with ibuprofen. If clinical signs and symptoms con- complaints, and refer the patient for an ophthalmologic examination that includes central visual fields and color sistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), ibuprofen vision testing. 5.14 Aseptic Meningitis: Aseptic meningitis with fever and coma has been observed in patients should be discontinued. 5.4 Hypertension: NSAIDs, including ibuprofen, can lead to onset of new hyper- on oral ibuprofen therapy. Although it is probably more likely to occur in patients with systemic lupus erythetension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of matosus and related connective tissue diseases, it has been reported in patients who do not have underlying CV events. Use NSAIDs, including ibuprofen, with caution in patients with hypertension. Monitor blood pressure chronic disease. If signs or symptoms of meningitis develop in a patient on ibuprofen, give consideration to closely during the initiation of NSAID treatment and throughout the course of therapy. Patients taking ACE whether or not the signs or symptoms are related to ibuprofen therapy. 5.15 Monitoring: Because serious GI tract inhibitors, thiazides, or loop diuretics may have impaired response to these therapies when taking NSAIDs. ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms 5.5 Congestive Heart Failure and Edema: Fluid retention and edema have been observed in some patients tak- of GI bleeding. Patients on long-term treatment with NSAIDs should have CBC and chemistry profiles checked ing NSAIDs. Use Caldolor with caution in patients with fluid retention or heart failure. 5.6 Renal Effects: Use cau- periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestation when initiating treatment with Caldolor in patients with considerable dehydration. Long-term administration tions occur (e.g., eosinophilia, rash), or abnormal liver tests persist or worsen, discontinue Caldolor. of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in 6 ADVERSE REACTIONS: The following serious adverse reactions are discussed elsewhere in the labeling: patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these • Cardiovascular thrombotic events [see Boxed Warning and Warnings and Precautions (5.1)] patients, administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and, sec- • Gastrointestinal effects [see Boxed Warning and Warnings and Precautions (5.2)] ondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this • Hepatic effects [see Warnings and Precautions (5.3)] reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics or ACE • Hypertension [see Warnings and Precautions (5.4)] inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment • Congestive heart failure and edema [see Warnings and Precautions (5.5)] state. No information is available from controlled clinical studies regarding the use of Caldolor in patients with • Renal effects [see Warnings and Precautions (5.6)] advanced renal disease. If Caldolor therapy must be initiated in patients with advanced renal disease, closely mon- • Anaphylactoid reactions [see Warnings and Precautions (5.7)] itor the patient’s renal function. 5.7 Anaphylactoid Reactions: As with other NSAIDs, anaphylactoid reactions • Serious skin reactions [see Warnings and Precautions (5.8)] may occur in patients without known prior exposure to ibuprofen. Caldolor is contraindicated in patients with The most common adverse reactions reported in clinical studies are nausea, flatulence, vomiting, and headache. the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or The most common reason for discontinuation due to adverse events in controlled trials of Caldolor is pruritus (<1%). without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs 6.1 Clinical Studies Experience: Because clinical trials are conducted under widely varying conditions, adverse [see Contraindications (4.2)]. 5.8 Serious Skin Reactions: NSAIDs, including ibuprofen, can cause serious skin reaction rates observed in the clinical trials of a drug cannot be compared directly to rates in the clinical trials of adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrol- another drug and may not reflect the rates observed in practice. During clinical development, 560 patients were

• Caldolor reduces surgical pain1,2,3 • Caldolor can be used prior to surgery1 • Caldolor reduces narcotic consumption1 • Caldolor offers an Anti-Inflammatory action3

> Caldolor offers New Price Assurance Program For more information, please contact Caldolor@CumberlandPharma.com

Caldolor is indicated in adults for the management of:3 • Mild to moderate pain • Moderate to severe pain as an adjunct to opioid analgesics • Reduction of fever • Caldolor must be diluted prior to use. Infusion of the drug product without dilution can cause hemolysis.3 • The most common adverse reactions are nausea, flatulence, vomiting, headache, hemorrhage, and dizziness (>5%).3 1. Singla N, Rock A, Pavliv L. Pain Med. 2010; 11: 1284-93.

2. Data on file, Cumberland Pharmaceuticals Inc. Nashville, TN. 3. Prescribing Information for Caldolor, 2014. Cumberland Pharmaceuticals Inc. Nashville, TN.

See full Prescribing Information including Boxed Warning at www.Caldolor.com exposed to Caldolor, 438 in pain and 122 with fever. In the pain studies, Caldolor was started intra-operatively and administered at a dose of 400 mg or 800 mg every six hours for up to three days. In the fever studies, Caldolor was administered at doses of 100 mg, 200 mg, or 400 mg every four or six hours for up to 3 days. The most frequent type of adverse reaction occurring with oral ibuprofen is gastrointestinal. Pain Studies: The incidence rates of adverse reactions listed in the following table were derived from multi-center, controlled clinical studies in post-operative patients comparing Caldolor to placebo in patients also receiving morphine as needed for post-operative pain.

Table 1: Post-operative Patients with Adverse Reactions Observed in ≥ 3% of Patients in any Caldolor Treatment Group in Pain Studies* Caldolor 400 mg 800 mg Placebo Event (N=134) (N=304) (N=287) Any Reaction 118 (88%) 260 (86%) 258 (90%) Nausea 77 (57%) 161 (53%) 179 (62%) Vomiting 30 (22%) 46 (15%) 50 (17%) Flatulence 10 (7%) 49 (16%) 44 (15%) Headache 12 (9%) 35 (12%) 31 (11%) Hemorrhage 13 (10%) 13 (4%) 16 (6%) Dizziness 8 (6%) 13 (4%) 5 (2%) Edema peripheral 1 (<1%) 9 (3%) 4 (1%) Urinary retention 7 (5%) 10 (3%) 10 (3%) Anemia 5 (4%) 7 (2%) 6 (2%) Decreased hemoglobin 4 (3%) 6 (2%) 3 (1%) Dyspepsia 6 (4%) 4 (1%) 2 (<1%) 4 (3%) 4 (1%) 4 (1%) Wound hemorrhage Abdominal discomfort 4 (3%) 2 (<1%) 0 Cough 4 (3%) 2 (<1%) 1 (<1%) Hypokalemia 5 (4%) 3 (<1%) 8 (3%) * All patients received concomitant morphine during these studies.

Fever Studies: Fever studies were conducted in febrile hospitalized patients with malaria and febrile hospitalized patients with varying causes of fever. In hospitalized febrile patients with malaria, the adverse reactions observed in at least two Caldolor-treated patients included abdominal pain and nasal congestion. In hospitalized febrile patients (all causes), adverse reactions observed in more than two patients in any given treatment group are presented in the table below.

Table 2: Patients with Adverse Reactions Observed in ≥ 3% of Patients in any Caldolor Treatment Group in All-Cause Fever Study Caldolor 100 mg 200 mg 400 mg Placebo Event N=30 N=30 N=31 N=28 Any Reaction 27 (87%) 25 (83%) 23 (74%) 25 (89%) Anemia 5 (17%) 6 (20%) 11 (36%) 4 (14%) Eosinophilia 7 (23%) 7 (23%) 8 (26%) 7 (25%) Hypokalemia 4 (13%) 4 (13%) 6 (19%) 5 (18%) Hypoproteinemia 3 (10%) 0 4 (13%) 2 (7%) Neutropenia 2 (7%) 2 (7%) 4 (13%) 2 (7%) Blood urea increased 0 0 3 (10%) 0 Hypernatremia 2 (7%) 0 3 (10%) 0 Hypertension 0 0 3 (10%) 0 Hypoalbuminemi 3 (10%) 1 (3%) 3 (10%) 1 (4%) Hypotension 0 2 (7%) 3 (10%) 1 (4%) Diarrhea 3 (10%) 3 (10%) 2 (7%) 2 (7%) Pneumonia bacterial 3 (10%) 1 (3%) 2 (7%) 0 Blood LDH increased 3 (10%) 2 (7%) 1 (3%) 1 (4%) Thrombocythemia 3 (10%) 2 (7%) 1 (3%) 0 Bacteremia 4 (13%) 0 0 0 7 DRUG INTERACTIONS: 7.1 Aspirin: When ibuprofen is administered with aspirin, ibuprofen’s protein binding is reduced, although the clearance of free ibuprofen is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of Caldolor and aspirin is not generally recommended because of the potential for increased adverse effects. 7.2 Anticoagulants: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a higher risk of serious GI bleeding than users of either drug alone [see Warnings and Precautions (5.2)]. 7.3 ACE Inhibitors: NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE inhibitors. 7.4 Diuretics: Clinical studies and postmarketing observations have shown that ibuprofen can reduce the natriuretic effects of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, observe patients closely for signs of renal failure, as well as to assure diuretic efficacy [see Warnings and Precautions (5.6)]. 7.5 Lithium: NSAIDs have produced elevations of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance of lithium decreased by 20%. This effect has been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, observe patients carefully for signs of lithium toxicity. 7.6 Methotrexate: NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This indicates that NSAIDs may enhance the toxicity of methotrexate. Use caution when NSAIDs are administered concomitantly with methotrexate. 7.7 H-2 Antagonists: In studies of human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations.

8 USE IN SPECIFIC POPULATIONS: 8.1 Pregnancy: Teratogenic effects - Pregnancy Category C prior to 30 weeks gestation; Category D starting at 30 weeks gestation. Starting at 30 weeks gestation, Caldolor, and other NSAIDs, should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may

occur. Caldolor can cause fetal harm when administered to a pregnant woman starting at 30 weeks gestation.

There are no adequate, well-controlled studies in pregnant women. Prior to 30 weeks gestation, Caldolor should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. 8.2 Labor and Delivery: The effects of Caldolor on labor and delivery in pregnant women are unknown. In rat studies, maternal exposure to NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, increased the incidence of dystocia and delayed parturition, and decreased pup survival. 8.3 Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Caldolor, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use: Safety and effectiveness of Caldolor for management of pain and reduction of fever has not been established in pediatric patients below the age of 17 years. 8.5 Geriatric Use: Clinical studies of Caldolor did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients are at increased risk for serious GI adverse events.

10 OVERDOSAGE: The following signs and symptoms have occurred in individuals following an overdose of oral ibuprofen: abdominal pain, nausea, vomiting, drowsiness, and dizziness. There are no specific measures to treat acute overdosage with Caldolor. There is no known antidote to ibuprofen. In case of an overdosage, discontinue Caldolor therapy and consider contacting a regional poison control center at 1-800-222-1222.

Manufactured for: Cumberland Pharmaceuticals Inc., Nashville, TN 37203 US Patent Number 6,727,286

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©2014 Cumberland Pharmaceuticals Inc. All rights reserved.

18 I AnesthesiologyNews.com

NOVEMBER 2014

CLINICAL ANESTHESIOLOGY BLOODLESS M&M

CONTINUED FROM PAGE 1

Blood-conservation measures ranged from iron supplements to autologous blood salvage, in which a patient’s blood is cleaned and cycled back into the body during surgery.

Other blood-conservation methods included the diagnosis and treatment of pre-hospital anemia, the reduction of intraoperative blood loss, and in-hospital use of IV iron and erythropoietin.

When patients who declined transfusions (so-called bloodless patients) were discharged, their hemoglobin concentrations (10.8±2.7 g/dL) were similar to patients in the control group who received transfusions (10.9±2.3 g/dL; P=0.42), according to the center’s study.

Overall, the study found that bloodless care is not an independent predictor of either death or a morbid event, said Steven M. Frank, MD, medical director of the Bloodless Medicine and Surgery Program at Johns Hopkins in Baltimore.

“Giving them a $5 bottle of iron beats $500 worth of blood, plus … you produce your own red cells and don’t require someone else’s red cells that have been stored in a blood bank for up to six weeks,” he said.

Morbid outcomes were lower, with a trend toward lower infections and thrombotic complications, with incidences of renal, respiratory and myocardial infarction also examined, but with no differences between the two groups, Dr. Frankk said.

The study examined 294 patients treated at the center, mainly Jehovah’s Witnesses, who are prohibited from accepting blood from donors. The group was then compared with 1,157 patients with closely matched backgrounds who underwent surgery or received treatment at Johns Hopkins Hospital and who received blood transfusions.

The study examined billing records at Johns Hopkins and noted potential reduced costs for hospital systems now grappling with the rising cost of blood.

The combination of no ABT and blood

REGIONAL

CONTINUED FROM PAGE 1

30 days of surgery, compared with 1.13% of those receiving GA (abstract JS01). It’s a small percentage difference, said lead author Nahel Saied, MB BCh, associate professor of clinical anesthesiology, Division of Anesthesiology Critical Care Medicine at Vanderbilt, “but over large numbers of patients, it adds up.”

Regional anesthesia was associated with lower odds for 30-dayy mortality as well as postoperative respiratory and renal complications, especially in general surgery patients. This choice also was particularly beneficial in patients with prior renal failure, reducing the odds of 30-dayy mortality and respiratory complications.

“The take-home message is if RA is an option, we should consider it,” Dr. Saied said, although physicians still

Overall, the study found that bloodless care is not an independent predictor of either death or a morbid event.

conservation resulted in substantial savings, with a reduction in total and direct hospital costs of 12% and 18%, respectively, the study found.

The savings were particularly pronounced in patients who underwent surgery. The average total charge for bloodless patients who underwent surgery was $25,568, compared with $30,162 for their counterparts in the control group. Total costs and direct costs in the bloodless group were $18,880 and $10,347, respectively, compared with $23,752 and $12,359 in the control group, the report found. Hospital lengths of stay were roughly the same for the bloodless patients and those in the control group.

The study is unique because it compared the outcomes of bloodless patients with those of a control group, it used risk adjustment, and it examined a wide array of surgeries and medical procedures, said to Dr. Frank, who added that most studies on patients who decline transfusions have lacked a control group, did not use risk adjustment or focused exclusively on cardiac surgery.

The study selected a “propensity, score-matched cohort” from a wider group of 60,652 patients admitted to Johns Hopkins during the study period, which

ran from June 2012 to August 2013. Four control patients were matched to each bloodless patient, which both increased the sample size and made it easier to detect different outcomes between the two groups. “We matched on a four-to-one ratio,” Dr. Frankk said. “That way you get more power in the analysis.”

Reviewers of the paper questioned the size of the bloodless group, suggesting it could have been larger, Dr. Frankk said. The center, which is just two years old and takes in 400 patients a year, is working to increase its number of patients.

The decision to look at medical as well as surgical patients also was questioned because medical patients may not have the same requirements for transfusion.

However, Dr. Frankk noted the medical group included patients battling cancer and suffering from gastrointestinal bleeding. “I think it’s a strength that we included both medical and surgical patients,” Dr. Frankk said.

Paul M. Ness, MD, director of the Division of Transfusion Medicine at Johns Hopkins Hospital, said advocates for bloodless medicine too often rely on anecdotal evidence to make their point. By contrast, this study offers a comprehensive, data-intensive look at the issue.

“I think this is very interesting work and I support the findings,” said Dr. Ness of the study, in which he was involved. “We had a good group of control patients and a larger sample size than some of the studies bloodless medicine advocates often quote.”

The study’s use of a control group was a significant advance on past studies on outcomes of patients who decline transfusions, agreed Sherri Ozawa, RN, clinical director of the Institute for Patient Blood Management and Bloodless Medicine and Surgery, Englewood Hospital and Medical Center, in Englewood, N.J. “The data get better when you have a comparative cohort so that you are comparing apples with apples,” she said.

need to determine which After adjustment for demographic characteristics, patients are most likely to type and length of surgery, benefit. smoking, alcohol use, body Dr. Saied and his colmass index and preoperative leagues analyzed pooled data from the Americomorbidities, the odds of can College of Surgeons’ 30-dayy mortality were 46% National Surgical Quallower in patients given RA ity Improvement Program than in those with GA (95% database from 2005 to confidence interval [CI], 2011, pulling records for Nahel Saied, MB BCh 7%-69%; P<0.001) among 682,362 elective surgical general surgery patients and procedures, including hernia repairs, 68% lower in patients with preexisting knee and hip replacements, and cystos- renal failure (95% CI, 36%-84%). The copies. They compared 30-dayy mortal- odds of major postoperative complicaity and postoperative complications tions were 40% lower in patients receivsuch as respiratory failure, myocar- ing RA (odds ratio, 0.60; P<0.001), the dial infarction (MI) and deep venous authors noted. However, there was no thrombosis between patients who significant effect of anesthesia techreceived RA and GA during surgery, nique on pulmonary embolism, periopusing multiple logistic regression anal- erative MI or peripheral nerve injury.

Comparing anesthesia outcomes ysis to examine these associations and retrospectively in a study such as this account for confounders.

—Scott Van Voorhis

is difficult, said Mark Neuman, MD, assistant professor of anesthesiology and critical care at the University of Pennsylvania School of Medicine, in Philadelphia.

“From a clinical standpoint, it’s possible that the type of anesthesia” is what accounted for the difference in outcomes, he told Anesthesiology News, but other factors could have affected the findings. The type of anesthesia that patients received may depend on how sick they were or the quality of care at the hospital where their surgeries were performed. It also is possible that RA was beneficial in only the subset of procedures studied.

“The findings are provocative and interesting, but demand follow-up in a randomized controlled clinical trial,” Dr. Neuman said.

—Karen Blum

NOVEMBER 2014

AnesthesiologyNews.com I 19

CLINICAL ANESTHESIOLOGY

Goal-Directed Fluid Therapy Reduces Hospital Length of Stay New Orleans—Measuring continuous stroke volume during surgery to assess a patient’s need for fluids can reduce postsurgical complications and hospital length of stay (LOS), German researchers have found.

Researchers at Charité University Hospital in Berlin reported at the American Society of Anesthesiologists’ annual meeting (abstract A1170) that using the technique, called hemodynamic optimization or goal-directed fluid therapy (GDFT), in a group of patients undergoing total hip arthroplasty revision resulted in an average reduction of two days in hospital LOS and significantly less need for postoperative transfusion compared with patients monitored for fluid volumes using mean arterial pressure and other clinical signs.

“Goal-directed hemodynamic therapy using stroke volume optimization can reduce complications and shorten length of hospital stay in patients undergoing hip revision surgery,” said lead study author Marit Habicher, MD. “Real-life implementation is possible and is of benefit for these patients.”

Dr. Habicher and her colleagues conducted a quality improvement program to assess the effects of GDFT in patients undergoing total hip arthroplasty, aiming to improve postsurgical outcomes. In a prospective case–control study, 130 patients were monitored using continuous stroke volume measurement. Results from this group of patients were compared with a retrospective group of 259 patients who underwent the same surgery between January 2011 and August 2012, in which hemodynamic management was performed using mean arterial pressure and clinical signs for the need for volume expansion.

Although the two patient groups were comparable in terms of age, height, weight and Charlson Comorbidity Index, duration of anesthesia was significantly longer in the prospective group compared with the retrospective group—a mean of 211 versus 186 minutes (P<0.01). Duration of surgery also was longer in the prospective group—a mean of 143 versus 123 minutes in the retrospective group (P<0.01).

However, the prospective group had significantly shorter hospital LOS (a mean of 11.3 vs. 13.8 days; P=0.03)

compared with the other, as well as significantly fewer postoperative complications (49% vs. 63%; P<0.01).

Fifty-seven percent of patients in the retrospective group needed postoperative transfusions compared with 43% in the prospective group. The optimized

patients also had significantly lower incidence of arrhythmia (0.8% vs. 5.8%; P=0.03) and a trend toward a lower incidence of postoperative peritonitis (0% vs.

Marit Habicher, MD 2.3%; P=0.068).

“Flow-based hemodynamic parameters, such as stroke volume, can better show the volume status of the patients, so they may be better to optimize the fluid see fluid page 26

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20 I AnesthesiologyNews.com

NOVEMBER 2014

TECHNOLOGY

New App Calculates Pediatric Pain Medication Dosages

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he developers of a new app hope to improve pediatric pain management by eliminating the time and number of steps it takes to calculate medication dosages.

The Hospital for Sick Children (SickKids), one of Canada’s leading centers for pediatric health, recently released their PediPain app, which is designed for health care professionals. The app

decreases the need to consult reference material and then make multiple calculations and conversions based on that information. Users enter a child’s weight and age and the app generates a list of medications and their precise dosages.

The app is based on the Acute Pain Service protocols at SickKids, their in-house handbook for more than a decade on best practices, medication dosages and

management of side effects.

“The very key thing about managing pain in children is having the right tools at the right time—that makes the greatest impact,” said Clyde Matava, MBcHB, creator of PediPain, and a staff anesthesiologist at SickKids. “The sooner the drug gets to the patient, the better it is for the patient, and the parents as well.”

Dr. Matava, who is also assistant

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professor in the Department of Anaesthesia at the University of Toronto, Ontario, Canada, said many errors could occur during the calculation process, which may discourage some physicians— particularly novices—from prescribing medications such as opioids. “Children are not small adults. They need very specific and exact doses for their pain medication,” said Dr. Matava.

The app can help some people overcome this barrier and lead to better pain management.

“Some physicians or health care workers may avoid the use of opioids altogether, or if they do, they may use them in smaller doses and infrequently, which may result in undermanaging a child’s pain,” he said. “And more often, the most common problem with use of opioids is what we call the 10-foldd errors, where people may put the decimal point in the wrong place, which means the patient either gets underdosed or overdosed.”

Dr. Matavaa said the average time it took people to calculate three drugs went from three to four minutes to 20 seconds during initial test runs.

Basem Naser, MBBS, FRCPC, director of the Acute Pain Service at SickKids, said PediPain is a great tool with which medical professionals can double check their calculations, but added they shouldn’t rely on it to do their work for them.

“It’s just an enhancement tool. It should not replace actually using your own medical knowledge to come up with the number,” he said. “It’s a faster way to reach the number, but it should not be in lieu of background knowledge.”

Dr. Naserr said the app’s assessment tool is an equally important aspect for pain management because kids might not know how to express that they’re hurting, and there are many misconceptions regarding pain in children.

“People think pain in children does not exist to the same level as it does in adults because children may not feel as much pain as adults do, and we know that this is not true. Children may even feel pain more than adults,” he said.

“Because people cannot assess pain, then they don’t treat pain.”

Dr. Naserr hopes that PediPain and other similar apps might make pain management more accessible to everyone, especially in parts of the world with limited acute pain services.

Some experts like Sabine Kost-Byerly, y MD, director of pediatric pain medicine, Department of Anesthesiology/Critical

NOVEMBER 2014

AnesthesiologyNews.com I 21

TECHNOLOGY

Anesthesia-Related Complications Decreased by Half From 2010 to 2013 national study on surgical complications and their risk factors found that anesthesia-related complications in the United States decreased by more than half from 2010 to 2013, the American Society of Anesthesiologists (ASA) reported.

A team of researchers analyzed more than 3.2 million anesthesia cases using the National Anesthesia Clinical Outcomes Registry (NACOR) from the Anesthesia Quality Institute (AQI), a nonprofit established by the ASA to provide practice-based quality management through education and quality data feedback. NACOR contains data from about 25% of all anesthesia practices in the United States, according to the ASA. Here are some highlights of their findings: • Percentage of adverse events in procedures related to anesthesia dropped from 11.8% to 4.8%.

• Overall mortality rate remained at 0.03%.

• Complication rates were not higher in procedures that occurred during evening hours and holidays.

• Patients over the age of 50 had the

A

Care Medicine at Johns Hopkins Charlotte R. Bloomberg Children’s Center, in Baltimore, agreed that apps like this might be more suitable for smaller practices or areas with limited access to publications. Dr. Kost-Byerly, y who is also the president of the Society for Pediatric Pain Medicine, said the computerized provider order entry system available in many hospitals already calculates dosages. However, these systems are expensive, take time to learn and wouldn’t make sense for some physicians to have if a $5 app will provide a similar service.

Dr. Kost-Byerlyy used the Pediatric Critical Events Checklist, which deals with serious events in the operating room and was released by The Children’s Hospital of Philadelphia, as an example of how apps can be used to double-checkk work and provide a sense of order if things start to get out of hand.

She said the app provides clear, step-byy step instructions on best practices, even for rare events that physicians might never have dealt with before.

“When you’re right in that situation, you may not always remember everything,” she said. “We like to do the right thing, but sometimes you forget something and just a reminder would be good.”

The PediPain app is currently available on iTunes for $4.99. The developers are working on a version for Android devices. Proceeds from the app will be used for enhancements and research for pain management in children, according to SickKids.

highest rates of serious adverse events.

Minor complications were more common in healthier patients undergoing elective daytime procedures.

• Postoperative nausea and vomiting was the most common minor complication (35.53%).

• Medication error was the most common major complication (11.71%).

The authors noted that this is the first time they have “been able to look at such a large amount of data on a national level.” They said investigating factors associated with anesthetic complications and near complications •

is essential for preventing complications and improving patient safety. Richard P. Dutton, MD, MBA, study co-author, said the results could be explained in a number of ways.

“Our findings may be the result of changes in the demographics of practices submitting outcomes information to NACOR over time,” said Dr. Dutton, AQI executive director, in a press release. “It also could be that outcomes improved in the practices that participate in NACOR’s data gathering.”

Adrian Liau, PhD, AQI senior research associate and the study’s lead author, said more data are needed to get a better

understanding of the results.

“As large as our databases are, we only have four years of information so there hasn’t been enough time to definitively gauge the trends we’re seeing,” said Dr. Liau. “Still, we are rapidly building a larger representation of adverse events, and understanding the broad pattern of anesthesia risk through the study of large data sets such as NACOR will help to guide future quality improvement efforts.”

The findings were presented at the ASA’s annual meeting in New Orleans.

--AN Staff Based on a press release from the ASA.

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22 I AnesthesiologyNews.com

NOVEMBER 2014

TECHNOLOGY

Medication Adherence Apps Coming of Age

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pproximately 30% to 50% of U.S. adults do not regimens and then push them directly to the patients’ adhere to their long-term medications, result- devices. This feature removes the data-entryy burden ing in an estimated $100 billion in avoidable from the patient and reduces the possibility of patientcosts every year (JAMA ( 2013;309:2105-2106). With generated medication regimen mistakes, according 129.4 million smartphone owners in the United States, to the app developers. The website offers regimenaccording to a recent report by comScore, many experts buildingg options that can be useful for patients in spenow view the technology as an affordable and accessi- cialty areas that often carry a high medication burden.

2. MyMeds also comes with a supplementary webble medium to reduce medication nonadherence.

But choosing an adherence app among the hun- site that enables patients to enter their regimens online dreds that are now available for download can be a rather than doing so only on their device. This feature daunting challenge. That’s why a team of researchers offers the convenience of patient privacy–compliant from the University of Arkansas for Medical Sciences cloud data storage that can be retrieved and modified (UAMS), College of Pharmacy, in Little Rock, iden- from any Internet-accessible computer and pushed tified and ranked 160 medication adherence applica- back to the patients’ mobile devices. Individual protions to provide an overview of the technology and to files can be made for up to 10 family members, accorddiscuss its potential role in decreasing medication non- ing to the product’s website (http://about.myy meds. adherence (J ( Am Pharm Assocc 2013;53:172-181). com). Customized reminders can be set for each proLindsey Dayer, PharmD, BCACP, assistant pro- file, including via text, email and mobile alarm. Similar fessor of pharmacy practice at UAMS College of to some of the other apps singled out by the researchPharmacy, and a clinical pharmacist in an ambula- ers, this one is not limited to prescription medications: tory care clinic, said the research effort is an impor- Vitamins, herbal supplements, birth control pills and tant one, because well-designed technology has the other over-the-counter products can be included in potential to make a significant dent in medication the app, which costs $9.99 per year. nonadherence. “Although most people don’t want to 3. MedSimple features a medication database carry around their pill calendars or boxes, there’s not that enables patients or providers to save time and too many people out there anymore who don’t have improve accuracy when entering regimens. It also their smartphone handy,” Dr. Dayer said. “People allows for the ability to track taken and missed doses are busy with their lives and work, and especially if and export those data to health professionals for they’re taking multiple prescriptions and doses at dif- review. This feature can provide information to help ferent times, these apps can be extremely helpful. Not health care providers assess medication adherence. only do they [medication adherence apps] serve as The app is available in a free version, as well as an reminders, but they can also enhanced version that costs $9.99 assist with the education of per year, according to the developpatients.” er’s website (http://bit.ly/1oKalc7).

4. Meds Agenda allows for comTo develop the list, the UAMS team searched the plex medication instructions to available medication adherbe entered, as well as iCloud data ence–themed apps, prostorage for backup. It can generate vider websites and app reminders without Internet connecsources for Apple iTunes, tivity, which could be useful if the Android Marketplace and patient’s phone loses service.

5. RxmindMe Prescription is a BlackBerry App World during August and Sepfree app now offered by Walgreens tember 2012. Specific feathat allows users to enter drug regitures were graded using a mens, set up reminders, and can be 3-point rating system, and used to track taken and missed doses. the 10 highest-rated apps According to the Walgreens webwere evaluated and tested site (http://bit.ly/1oNtP4r), the app by patients. Some of the can be customized with nine differhigher-ranked features were ent types of reminders based on the online data entry, complex dosage frequency. Prescription hismedication instructions tory can be exported and emailed and the ability to track and can be password protected. But missed and taken doses. the Walgreens site has the followHere are details on the ing disclosure statement: “Warning: top five apps with the RxmindMe is for entertainment purhighest number of desirposes only. You should not rely on The MyMeds app features a patient able features: this app alone to remember to take 1. MyMedSchedule fea- privacy–compliant cloud data storage medications.” tures a free online com- component that can be retrieved and Apps Not a Cure-All panion website (www. modified from any Internet-accessible m y m e d s c h e d u l e . c o m ) computer and pushed back to the Kevin Clauson, PharmD, associthat allows providers to patients’ mobile devices. ate professor of pharmacy practice input patients’ prescribed Source: MyMeds, Inc. at Lipscomb University College of

Bridge technology starts with something familiar, like a physical pillbox with compartments that list the days of the week, and then translates that to a digital solution.

Pharmacy in Nashville, Tenn., echoed the Walgreens warning against relying too heavily on one app to ensure drug compliance. He suggested that bridge technology is a more promising strategy, especially in older adults.

Bridge technology starts with something familiar, like a physical pillbox with compartments that list the days of the week, and then translates that to a digital solution, he said. For example, the Pillboxie app has an interface that looks like a physical pillbox that can show patients the names and images of their medication, in addition to providing them with reminders (www.pillboxie.tumblr.com).

AdhereTech (www.adheretech.com) uses the same premise for prescription medication vials, which are able to connect to a cloud service wirelessly and collect usage data. It uses a common pill bottle, but incorporates a mechanism whereby the bottle actually alerts the patient when it’s time to take medication. The notification can be integrated into an app, or comes in the form of a blinking light, text message or phone call.

“This type of device has a lot of potential to improve medication adherence as it attacks the problem in multiple ways,” Dr. Clauson said. “Also, because it comes in the form of a familiar pill bottle that patients already use, it does not force them to integrate a new device into their lives. Since sensors could actually measure how many pills are in the bottle as well as stream the data to the patient, pharmacist or physician, it also offers a potentially useful data stream to help with tailoring therapy and interventions.”

Although smartphone apps may boost the efficiency and reduce the costs of conventional medication adherence interventions, their effectiveness currently is untested. Data demonstrate, however, that text messaging improves adherence and behavior in the short term ((J Am Med Inform Assocc 2012;19:696-704).

“Probably the strongest evidence is for texting because it has been examined with promising results across the board,” Dr. Clauson said, citing a study in the American Journal of Health-System Pharmacy (2013;70:1348-1352). “It’s incredibly accessible; it’s incredibly cheap; and it doesn’t come with any side effects. As technology advances, we’ll see a continued trend with wearable devices, further integration of smartphone apps and further integration in health systems.”

NOVEMBER 2014

AnesthesiologyNews.com I 23

TECHNOLOGY

FDA Eyes Adherence Apps

T

o address the influx of medical device mobile apps, the FDA released a document in 2013 to inform manufacturers and distributors how it intends to apply its regulatory power to ensure the safety of these patient-focused technologies (http://1. usa.gov/1baa4bO).

Although some mobile apps meet the definition of a medical device, the agency will not enforce any regulatory requirements because most don’t pose a major health risk to the public. The agency will, however, monitor medical device mobile apps whose functionality could pose a safety risk to patients if it were to malfunction.

The FDA wants to encourage innovative technologies and solutions that would enhance patient engagement and help patients comply better with medication adherence, according to Bakul Patel, MS, MBA, a senior policy advisor of the FDA’s Center for Devices and Radiological Health.

“Understanding and balancing the benefits to the risks of these technologies, we think that an approach that does not enforce the regulatory requirements on tools that enhance medication adherence is beneficial in promoting public health,” Mr. Patel said in an interview.

The document listed apps that are intended for health care

AdhereTech medicine bottles automatically measure if patients are adherent, and all data are wirelessly transmitted and analyzed in real time.

Source: AdhereTech.

providers to use as educational tools for medical training, such as medical flash cards, as an example that it will not regulate. Conversely, the agency will exercise its regulatory oversight over some apps, including those that measure and display the electrical signal produced by the heart.

—P.B.

One feature that could facilitate this trend and prove very beneficial, especially for health care providers, is a level of connectivity to the electronic health record, Dr. Dayer said. It would enable providers to better evaluate how and when patients take their medications, and possibly lead to better treatment outcomes, she continued.

“We’ve spent a lot of time examining many different types of apps, and strongly believe they can really improve medication nonadherence,”

she said. “Nevertheless, there needs to be testing in the clinical setting because it’s the one area that really hasn’t been explored. With so much time and money being wasted, and with a restricted level of patient success, providers and researchers should delve into this area and work toward a proven solution.”

—Paul Bufano None of the sources reported any relevant financial conflicts of interest.

24 I AnesthesiologyNews.com

NOVEMBER 2014

COMMENTARY

What’s in a Name?

Steven S. Kron, MD Two Quotes: What’s in a name? that which we call a rose By any other name would smell as sweet —Romeo and Juliet; Act 2, Scene 2 Meaning just ain’t in the head.

—Hilary Putnam One Joke: A priest, a minister and a rabbi are sitting in a bar debating theology: Father Flanagan: “Life definitely begins at the moment of conception!”

Pastor Jones: “Father, I disagree. Life doesn’t begin until actual birth.”

Rabbi Schwartz: “Gentlemen, you are both wrong.

Life begins when the kids graduate college and the dog dies...!”

Tada!

Because the word lifee means different things to each of these clerics, what we have here is as much a semantic problem as a religious difference. To Father Flanagan the critical meaning of life is ensoulment, to Pastor Jones life is independent physical survival and to Rabbi Schwartz life is freedom from long walks in the rain and the burden of tuition, room and board. So, like the fable of the blind men trying to describe an elephant, these three preachers can never agree.

That’s just a joke, but the meaning of words can certainly change. Awesomee was a term once reserved for God or one’s first glimpse of the pyramids, not the newest flavor of low-fat yogurt. A hero was a soldier who saved his comrades while killing the bad guys … not the nice lady down the street.

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Yet another semantic confusion can occur when different words are used to name the identical entity or phenomenon. Just check the newspapers, or better yet the 24/7 TV news cycle, and examples abound: Illegal immigrants are people who entered the United States in a nefarious fashion intend- Steven S. Kron, MD ing to take jobs from Americans or living off of the welfare system, and should be deported immediately. On the other hand, guest workers have come seeking the American dream, are willing to take jobs that citizens refuse, and pay taxes and follow the law. They should not have to live in the shadows and should be reunited with families here.

As this is being written, President Obama has declared war on the entity he calls ISIL (the Islamic State in Iraq and the Levant), most others call ISIS (Islamic State in Iraq and Syria), and which calls itself the Islamic State. All of the terms describe the same guys but the titles represent significant differences in how they are seen and how we respond to them. Oh, and by the way, this is not a warr but a sustained antiterroristt kinetic eventt, or some such thing, which will last for years and consists of dropping bombs, breaking things and killing people.

The Fort Hood shooting is officially classified as workplace violence, whereas many others considered it terrorism.

These are just a few examples of a list that goes on and on … just turn on the news. Each name or title identifies the same individual or event, yet each suggests profound differences in the perception of the individual or occurrence.

These are not trivial distinctions; they actually represent a major issue in the philosophy of language, which may be summed up by philosopher Hilary Putnam’s quote above. Putnam, the father of the philosophical school of semantic externalism, observed that a word does not necessarily convey the content of the speaker’s mind independently of environmental conditions.

In other words, naming an individual or event defines the person or thing and its context and relationship to other individuals or things.

To me this makes complete and familiar sense because, from the 1960s onward, I have watched wordplay destroy my chosen field. Back then we were proud to be training to enter the medical profession.

At my graduation, after being led through the recitation of the Hippocratic Oath, the dean pronounced us doctors and told us to hold our heads high; this title, MD, is something that can never be taken away.

Technically he was right—my diploma is still hanging on the wall—but its meaning and significance have been methodically diluted.

To eliminate any doubt, type the words medical care into Wikipedia, and the online encyclopedia will direct your search to the term health care with the following description: “Health care is delivered by practitioners in allied health, dentistry, midwiferyobstetrics, medicine, nursing, optometry, pharmacy, psychology and other care providers.”

Illegal immigrants are people who entered the United States in a nefarious fashion…guest workers have come seeking the American dream.

We are the fourth item, listed between midwifery and nursing—it’s alphabetical, you see. I don’t know where the term health caree originated but its invention was a brilliant stroke. Once it was accepted, it became easy to continue and reclassify doctors as providers, much the same as delivery boys bringing Friday night pizza. Patientss became clientss and health care consumers even became guests—thus, by changing the words, the relationship was profoundly altered.

What can we do to change this semantic distortion of our profession? I think in the normal course of events, as patients and doctors pass on, the vocabulary of those who replace them will no longer contain those terms.

It’s too late.

Dr. Kron is an anesthesiologist in Hartford, Conn., and a frequent contributor to Anesthesiology News.

Letter to the Editor

I

n the September 2014 edition of Anesthesiology News (volume 40, number 9, page 40), in an article entitled “IV Acetaminophen a Cost Saver in Pediatric Tonsillectomy” by Michael Vlessides, the results [from the study] are probably based on old cost data and therefore the research result may not be accurate. When Cadence [the maker of the acetaminophen injection drug] was bought out by Mallinckrodt, they implemented a large price increase on Ofirmev. The cost went from $11.88 to $33.86 per bottle. Many, if not all, pharmacists consider this price increase exorbitant and completely unjustified, and are advocating for pre-op oral acetaminophen in shorter procedures due to this price increase.

My concern is that this article is based on 2013 cost data. With the new, much higher price, the calculation may shift.

Bill Arrington, DPh Director of Pharmacy Stillwater Medical Center, Stillwater, Oklahoma

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26 I AnesthesiologyNews.com

NOVEMBER 2014

COMMENTARY TECH FAIL

CONTINUED FROM PAGE 1

heel has been identified in patient care and safety— the fragile nature of this digital infrastructure. Most health care facilities and hospitals do not have a welldeveloped protocol on what to do for such system failures, or regularly drill staff to prepare them. There is no internal emergency backup technology in existence for such events.

Staff is crippled without these instruments and “smart” devices. Younger staff who have been trained in today’s technology-based world are the most vulnerable. Such disasters have brought to the forefront how these tech-savvyy individuals cannot adapt and provide quality, safe care without appropriate alternative training. Indeed, in certain scenarios, they would be crippled. For example, how does one get a patient history without an EMR problem list? How does one record vital signs nondigitally? What is the dosage of a commonly used drug without a computerbased checklist or pharmacologic ordering library?

Care providers are unable to know the history or medical care received by critically ill patients when they may need transfer to a safer area out of reach of a natural event, such as a tornado or flood. Hospitals may not even be able to call in emergency help or hospital leadership because emergency phone contact algorithms may be stored in the computer software or on the Internet, both of which would be down. Such basic things as contacting the families of patients to inform them of transfers grind to a halt when the screen turns blue.

How can we safeguard our patients and health care infrastructure from the threat of such natural and technology-based disasters? The keystone is developing an emergency plan to react to such events, and develop and carry out regular training and drills.

Each patient care area should have unit-specific supplies, such as order sheets, progress notes and

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Most health care facilities and hospitals do not have a well-developed protocol on what to do for such system failures, or regularly drill staff to prepare them. reference books to make dosing and pharmacologic data available in the event of such emergencies. One computer and printer should be plugged into the emergency power system; on this device, a summary Word document containing key sign-out information, history and family contact data should be kept so that care and possible transfer information can be generated seamlessly. The hospital and each specific medical unit should also keep a log with emergency contact information of key staff who can be reached by landline or cell phone to aid in the emergency.

Hospitals and technology companies should develop devices that will provide emergency backup to these Internet-based medical technologies, so that EMRs can function in emergency mode, ideally on backup power.

Regarding staff education, because new young staff may not be versed in pre-technologyy patient care, regular education and drills should reinforce how to safely care for patients in a low-tech environment.

Staff should be taught how to gather data by phone

FLUID

from labs, radiology, etc.; protocols on how to communicate information without computers should be taught, along with the use of paper-based record keeping and ordering. Patient interactions for gathering history and recording physical findings without computer-stored data and checklists should be practiced.

Hospital- and department-based preparation and regular drills, including brainstorming sessions, should allow for improvement and growth. Staff will thus feel comfortable in a tech-failure event and be able to communicate professionalism with patients and their families, who will also be affected by areawide disasters. Through such training, communities will know that, like other basic emergency services that provide aid in times of crisis, the provision of health care will remain intact.

Dr. Papadakos is director of critical care medicine at the University of Rochester Medical Center, in Rochester, N.Y. He lectures on the impact of technology on medical care.

CONTINUED FROM PAGE 19

status of patients than pressure-based parameters,” Dr. Habicher said.

Dr. Habicher and her colleagues have since expanded the use of hemodynamic optimization to include procedures such as cancer reduction surgery with hyperthermic intraoperative peritoneal chemotherapy.

“These results confirm previous published data but are still important, because they further illustrate that GDFT improves postoperative outcomes,” said Tong Joo “TJ” Gan, MD, MHS, professor and chairman of the Department of Anesthesiology at Stony Brook University School of Medicine, Stony Brook, N.Y.

GDFT has been around for a while, Dr. Gan said. A study he published in 2002 (Anesthesiology ( 97:820-826) showed that the technique results in earlier return to bowel function, a lower incidence of postoperative nausea and vomiting, and a two-day shorter hospital LOS on average. GDFT is not “standard but [is] increasingly adopted” by hospitals, he said. His hospital uses the technique regularly during procedures that involve a fair amount of blood loss, such as spine surgeries, and major abdominal, urologic and gynecologic procedures.

Dr. Habicher’s study was funded by Edwards Lifesciences.

—Karen Blum

NOVEMBER 2014

AnesthesiologyNews.com I 27

PAIN MEDICINE

Experts Say Cannabis for Pain Requires Better Science Parisâ&#x20AC;&#x201D;Although medical marijuana (Cannabis sativa) is now prescribed in 23 states in the United States for pain relief for musculoskeletal and arthritic conditions, cancer, headache and other conditions, there is limited evidence to support its use, say some experts. This is especially true for use in individuals with musculoskeletal complaints.

Further research is needed to clarify the mechanisms of action of the various cannabinoid molecules as well as the potential for clinically relevant therapeutic effects, according to a presentation at the 2014 European League Against Rheumatism Congress. This research can lead to improved awareness of the potential benefits and risks of the various components of marijuana for the treatment of pain. â&#x20AC;&#x153;When thinking of herbal cannabis specifically, there are currently no studies in patients with rheumatic conditions that can assist physicians to competently and safely advise patients,â&#x20AC;? said Mary-Ann Fitzcharles, MB, ChB, Division of Rheumatology and Alan Edwards Pain Management Unit,

McGill University, Montreal, Quebec, Canada. â&#x20AC;&#x153;Unfortunately, various jurisdictions have required physicians to accept responsibility for prescribing herbal cannabis, or for caring for patients who may be using medicinal herbal cannabis in the absence of sound advice. Therefore, in the absence of the usual [research] that is required for any other therapeutic agent worldwide,

physicians must project a message of extreme caution that should focus on the need to protect both the patient and society.â&#x20AC;?

The only information on herbal cannabis use in rheumatic conditions is based on a few small population studies of users, with selff reported diagnosis and selff reportedd outcome measures, Dr. Fitzcharles said. Furthermore, there

â&#x20AC;&#x201D;Neal Birnbaum, MD

see pot? page 28

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Part 2: Ongoing Challenges and Opportunities Case Study Dennis is a 68-year-old man undergoing open abdominal surgery (colectomy).

â&#x20AC;&#x2DC;It is common for physicians to prescribe narcotics and medical marijuana in my state, where it is legal. But this is often done loosely without considering all the risks and benefits. There can be serious consequences with little benefit.â&#x20AC;&#x2122;

is little information on the quantity or quality of the agent used, and methods of administration, as well as often a lack of clarity for true reasons for use, as many users report previous recreational marijuana use.

The need for further research is clear, she continued, especially for pain in rheumatic conditions. There is only one

Current Symptoms Â&#x2021; Dyspnea Vital Signs Â&#x2021; Height: 175 cm Â&#x2021; Weight: 85 kg 6LJQLÂżFDQW 0HGLFDO +LVWRU\ Â&#x2021; Hypertension Â&#x2021; Congestive heart failure Â&#x2021; Obstructive sleep apnea &XUUHQW 0HGLFDWLRQV Â&#x2021; Metoprolol 100 mg PO Â&#x2021; Ramipril 2.5 mg PO Laboratory Results Â&#x2021; Apnea hypopnea index: 26/h Â&#x2021; Left ventricular ejection fraction: 30%-35% Anesthesia is induced with sufentanil, propofol, and 0.6 mg/ kg rocuronium based on total body weight and maintained ZLWK GHVĂ&#x20AC;XUDQH LQ DLU R[\JHQ DQG VXIHQWDQLO 6XUJLFDO FRQGLWLRQV DUH GLIÂżFXOW ZLWK D ODFN RI DEGRPLQDO ZDOO PXVFOH relaxation and poor paralysis. An extra dose of rocuronium is administered for deeper neuromuscular block (NMB), and fewer than 2 train-of-four (TOF) responses are noted.

Education are pleased to introduce part 2 of a 3-part interactive CME series featuring challenging cases in NMB. Each activity presents a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit ZZZ &0(=RQH FRP QPE WR ÂżQG out how your answers stack up against those of our multidisciplinary faculty panel.

Access the activities on your desktop, laptop, or tablet to explore the issues surrounding safe, effective, NMB reversal via a unique multimedia learning experience and earn 1.0 AMA PRA Category 1 Credit.â&#x201E;˘ Complete the whole series and earn a total of 3.0 AMA PRA Category 1 Credits.â&#x201E;˘ 7KLV DFWLYLW\ÂśV GLVWLQJXLVKHG IDFXOW\

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PAIN MEDICINE POT?

CONTINUED FROM PAGE 27

quality study on the role of nonherbal cannabinoids in rheumatoid arthritis, for example, and only five in fibromyalgia, she told meeting attendees; of those eight studies, only three were identified as randomized controlled trials.

A recent survey of family physicians in Colorado, where marijuana is legally prescribed, showed that most respondents were not convinced of the benefits of marijuana and wanted further

education about it ((J Am Board Fam Medd 2013;2:52-60).

The general term â&#x20AC;&#x153;cannabinoidsâ&#x20AC;? includes endocannabinoids (naturally occurring in bodily systems), phytocannabinoids from the plant (herbal marijuana) and synthetocannabinoids (pharmaceutical preparations). Among the components of cannabinoids, delta9-tetrahydrocannabinol (Î&#x201D;9-THC), commonly referred to as THC, is psychoactive, whereas cannabiol is weaker in this regard and may have

considerable therapeutic effects.

Herbal cannabis is most often inhaled, either smoked or via a vaporizer, but can also be ingested in baked products or as a tea infusion. The oromucosal spray of nabiximols, a combination of Î&#x201D;9-THC and cannabidiol, is a pharmacologic preparation sprayed under the tongue.

Pharmacologic preparations are more desirable than herbal ones, said Dr. Fitzcharles; the former are controlled regarding quality and dosing,

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Current Symptoms Â&#x2021; Pelvic organ prolapse failing conservative therapy Vital Signs Â&#x2021; Height: 175 cm Â&#x2021; Weight: 85 kg 6LJQLÂżFDQW 0HGLFDO +LVWRU\ Â&#x2021; Dyslipidemia Â&#x2021; Type 2 diabetes mellitus Â&#x2021; Glaucoma &XUUHQW 0HGLFDWLRQV Â&#x2021; Ezetimibe Â&#x2021; Glyburide Â&#x2021; Insulin glargine Â&#x2021; Pravastatin Anesthesia is induced with fentanyl 100 mcg, propofol 150 mg, and rocuronium 50 mg and maintained with GHVĂ&#x20AC;XUDQH LQ DLU R[\JHQ $PSLFLOOLQ VXOEDFWDP 3 g is given intravenously as well. At 90 minutes after induction, the surgeon reports tension in the surgical ÂżHOG DQG UHTXHVWV DGGLWLRQDO UHOD[DWLRQ 1R PRQLWRULQJ of neuromuscular function is performed.

Challenge Questions 1. :KDW ZRXOG \RX GR QH[W" 2. :K\" 3. What protocol does your institution have in SODFH IRU VLPLODU VFHQDULRV"

Global Education Group and Applied Clinical Education are pleased to introduce part 3 of a 3-part interactive CME series featuring challenging cases LQ 10% (DFK DFWLYLW\ SUHVHQWV D FOLQLFDO VFHQDULR that you face in your daily practice. After reading the introduction to the case, consider the challenge TXHVWLRQV DQG WKHQ YLVLW ZZZ &0(=RQH FRP QPE WR ÂżQG RXW KRZ \RXU DQVZHUV VWDFN XS DJDLQVW WKRVH of our multidisciplinary faculty panel.

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-RQ *RXOG 0' Chief, Division of General Surgery Alonzo P. Walker Chair in Surgery Professor of Surgery Medical College of Wisconsin Senior Medical Director of Clinical Affairs Froedtert Hospital Milwaukee, Wisconsin

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and have been evaluated for efficacy and safety, whereas the latter are largely uncontrolled. Pharmacologic preparations are more likely to deliver quantifiable and consistent amounts of active drug than herbal cannabis. Additionally, they avoid the negative health effects associated with smoked herbal cannabis, due to the inhalation of polycyclic aromatic hydrocarbons, tar and carbon monoxide.

Other health risks associated with use of herbal cannabis include compromised cognition and psychomotor function (a risk associated with higher rates of driving accidents), cardiovascular effects (tachycardia and hypotension) and long-term risk to respiratory function and psychological health. â&#x20AC;&#x153;Itâ&#x20AC;&#x2122;s a myth that one canâ&#x20AC;&#x2122;t become dependent on cannabis,â&#x20AC;? said Dr. Fitzcharles. â&#x20AC;&#x153;Dependence occurs in at least 8% of recreational users by one year, and may alert society to the abuse potential of pharmacologic preparations. Some of the pharmaceutical cannabinoid productsâ&#x20AC;&#x201D;dronabinol and nabiximolsâ&#x20AC;&#x201D;also have modest abuse potential.â&#x20AC;?

Endocannabinoids are found throughout the body. There are two endocannabinoid receptors: The CB1 receptor is found in the nervous system and in joint tissue and has effects on pain and bone health, whereas the CB2 receptor is found mostly on immune cells with less understood function. â&#x20AC;&#x153;The presence of both receptors and endocannabinoid ligands in joint tissue indicates that the endocannabinoid system is probably important in rheumatic diseases,â&#x20AC;? Dr. Fitzcharles said.

Herbal cannabinoids pose many unanswered health-related and societal questions, she added. Their potential risks and benefits suggest that research is needed to identify compounds with more targeted effects and fewer psychoactive and other negative effects.

Dr. Fitzcharles urged health professionals to advocate for more research.

Commenting on the presentation, Neal Birnbaum, MD, Division of Rheumatology, California-Pacific Medical Center, in San Francisco, agreed that more research is needed and said that more responsible prescribing by doctors is also required. â&#x20AC;&#x153;It is common for physicians to prescribe narcotics and medical marijuana in my state, where it is legal,â&#x20AC;?

Dr. Birnbaum said. â&#x20AC;&#x153;But this is often done loosely without considering all the risks and benefits. There can be serious consequences with little benefit.â&#x20AC;? â&#x20AC;&#x201D;Alice Goodman

NOVEMBER 2014

AnesthesiologyNews.com I 29

PAIN MEDICINE

Analgesics Drive Medication-Overuse Headaches

A

fter conducting a systematic literature review and analysis, researchers found that analgesics were associated with a significantly higher risk for medication-overuse headache (MOH) than triptans, ergotamines or opioids.

Analgesic-use rates in patients with episodic migraine ranged from 22% to 54% across seven European countries, whereas rates for triptans varied from 7.9% to 29.1% and rates for ergotamines from 3.8% to 20%. The overall prevalence of opioid use was 4.1%.

The researchers, from several academic centers in the United States and Europe, as well as from Pfizer, presented their results as a poster at the American Headache Society’s 2014 annual meeting in Los Angeles (poster 1965115).

However, Elizabeth Seng, PhD, assistant professor of psychology and research assistant professor of neurology, Yeshiva University, New York City, questioned a vital set of determinations

After conducting a systematic literature review and analysis, researchers found that analgesics were associated with a significantly higher risk for medication-overuse headache than triptans, ergotamines or opioids. the researchers made: the rate that each of the four medications were used for episodic migraine in the seven countries where the studies were conducted.

Along with “adjustment factors,” the rates served as the denominator in the calculations of relative risks for MOH in the Pfizer-funded study. The investigators reviewed the literature to arrive at the medication-use rates, but did not cite any of the studies used to do so, nor did they indicate how they arrived at the adjustment factors.

Dr. Seng, an outside expert in the field, said she felt the researchers appeared to “lack confidence” in their prevalence estimates. In the results

In response, lead study investigator Kristian Thorlund, PhD, visiting associate professor, Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, Calif., said in an interview that, “Because we know opioid use is much higher in the U.S., and the included data were predominantly European, we chose an approximate doubling in medication use, of 8%, as a sensitivity analysis.”

The combined estimate of the relative risk for MOH between triptans and analgesics was 0.25 (95% confidence interval, 0.22-0.28). For ergotamines versus analgesics it was 0.38, and for analgesics versus opioids it was 1.29.

However, in all three comparisons there was very high heterogeneity between the studies, rendering the relative risk estimates inconclusive.

section of the poster, they stated: “When we considered an 8% prevalence of opioid use (rather than 4.1%), the fixed-effect weighted average relative risk was 2.51, suggesting an average 151% increased risk for MOH with analgesics compared with opioids.”

“Where did they get the 4.1% prevalence of opioid use from, and why did they rerun the results with a higher prevalence of opioid use?” Dr. Seng asked. “It’s true, they did have to try to estimate prevalence due to the nature of this analysis, I just think they didn’t do —Rosemary Frei, MSc the best job communicating how they estimated prevalence and how confident Drs. Seng and Thorlund did not report any financial they were in their prevalence estimates.” conflicts of interest.

CLASSIFIEDS

Department of Anesthesiology & Perioperative Care Various HS Clinical Professor Series, Open Ranks Clinical X Series, Open Ranks General Information: University of California Irvine Health System is seeking an interventional pain specialist to join the leading academic pain program in the region. Clinicians interested in pursuing an academic medicine career in the anesthesia subspecialty of Pain Medicine will be given the opportunity to grow in a dynamic department. Ample opportunities exist for scholarly effort and teaching through an ACGME approved Pain Medicine Fellowship. We are seeking candidates for Pain Medicine Faculty in the Health Sciences Clinical Professor series (Assistant, Associate, and/or Full Professor Levels) as well as in the Clinician Researcher (Clinical X) series.

Candidates must be board certified in Anesthesiology, fellowship trained in Pain Medicine, certified by the ABA in pain management, and licensed to practice in California. Faculty rank and compensation will be commensurate with experience and qualifications. UC Irvine offers an excellent salary and benefit program.

UC Irvine Health is located in Orange County with easy access from coastal communities including Newport Beach, Huntington Beach and Laguna Beach. Orange County has an ideal year round climate, averaging 280 sunny days and temperatures of 70-80°.

Application Procedure: To apply for the HS Clinical Professor Series, please log onto UC Irvine’s recruitment site located at https://recruit.ap.uci.edu/apply/JPF02597 To apply for the Clinical X Series, please log onto UC Irvine’s recruitment site located at https://recruit.ap.uci.edu/apply/JPF02598 Applicants should complete an online application profile and upload the following application materials electronically to be considered for this position: 1. Cover Letter 2. Curriculum Vitae 3. Names of at least three references and their contact information A separate statement that addresses past and/or potential contributions to diversity, equity and inclusion should also be included in the application materials. For more information, please visit the Department of Anesthesiology and Perioperative Care website at http://www.anesthesiology.uci.edu.

The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy.

For classified advertising, contact Craig Wilson 212-957-5300 x235 cwilson@mcmahonmed.com

Career Opportunities Education Financial & Legal Services Medical Equipment

30 I AnesthesiologyNews.com

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PAIN MEDICINE

Discontinuation of Chronic Opioids in Veterans Varies Phoenix—A new study has confirmed that the reasons veterans discontinue their chronic opioid therapy are as heterogeneous as the veterans themselves.

Factors associated with discontinuation were younger age, mental health or substance use disorders and taking lower doses of opioids.

Mark Sullivan, MD, PhD, professor, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, and several co-investigators found in a previous study that Medicaid and commercially insured individuals were less likely to discontinue longterm opioid therapy if they were receiving high daily doses of opioids—at least 120 mg of a morphine-equivalent dose (MED)—and appeared to be misusing opioids (J ( Gen Intern Med 2011;26:1450-1457).

Dr. Sullivan and his colleagues sought to find out whether the same is true in the veteran population, a group in which long-term opioid use is prevalent. The researchers focused on data from individuals who visited a Veterans Health Administration (VHA) facility as an outpatient at least twice during fiscal years (FY; beginning of October to end of September) 2009, 2010 and 2011, and received at least a 90-dayy supply of opioids. They excluded individuals who resided in a VHA nursing home or long-term care facility, had a cancer diagnosis other than nonmelanoma skin cancer, had incomplete records, were on methadone maintenance, had not used VA services in the 90 days after discontinuation—indicating the investigators could not verify whether they had truly stopped the opioids—or died between 2009 and 2011.

The team was unable to determine the causes of opioid discontinuation in the patients, but their assumption was that, similar to the results from their previous study, most discontinuations were not due to reduction in pain, but rather to side effects and aberrant behaviors.

In all, 546,043 individuals were included in the analysis and were split evenly among those treated in FY 2009, FY 2010 and FY 2011. The mean ages of the patients in the three years were 57.9, 57.9 and 58 years, respectively; more than 92% were men; and 70.9%, 70.3% and 69.8%, respectively, were white. Furthermore, mean MED was 33.49, 32.96 and 32.36, respectively.

Hydrocodone products were the most commonly prescribed opioids, followed by tramadol or tapentadol (Nucynta,

Jeffrey Katz, MD, professor in anesthesiology, Feinberg School of Medicine, Northwestern University, Chicago, who was not involved in the study, said the results are difficult to interpret because, as the authors stated, discontinuation of opioids in this population was most likely the result of noncompliance or lack of efficacy, rather than the result of improvement in the pain condition.

“For example, when they state that the presence of substance abuse and/ or mental health disorders was associated with higher rates of opioid discontinuation, it was not because these patients are more likely to improve,” said Dr. Katz in an interview, “but rather that they are more likely to have opioids discontinued for reasons of inappropriate use or lack of efficacy.”

—Rosemary Frei, MSc Drs. Katz, Sullivan and Vanderlip did not report any financial conflicts of interest.

Having one or more types of chronic pain reduced the odds of discontinuation, whereas having more than one type of mental health disorder or substance use disorder increased the probability of discontinuation.

Janssen) products, and then oxycodone.

The three groups also had similar proportions of different mental health diagnoses such as anxiety, major depressive disorder and post-traumatic stress disorder, and of substance use disorders.

Overall, approximately 75% of the patients continued their opioids. The mean time to discontinuation was 547 days and the median time to discontinuation was 488 days.

Dr. Sullivan’s team constructed a Cox proportional hazards model to uncover factors associated with discontinuation.

These ranged from age 18 to 30 years, with a hazard ratio (HR) of 1.63—representing a 63% higher probability of discontinuation than among individuals aged 50 to 65—to those with a traumatic brain injury, who had a 12% higher probability of discontinuation (HR, 1.12). Higher daily opioid doses were associated with a lower probability of discontinuation, with an HR of 0.65

among individuals taking MEDs of at least 100 mg versus those with MEDs of 0 to 20 mg, and an HR of 0.79 among those taking MEDs of 20 to 100 mg versus 0 to 20 mg.

Kaplan-Meier curves confirmed these results, and also yielded supplementary information. Having one or more types of chronic pain reduced the odds of discontinuation, whereas having more than one type of mental health disorder or substance use disorder increased the probability of discontinuation.

The results were presented at the American Academy of Pain Medicine’s 2014 annual meeting (poster 120).

“A second analysis not presented on the poster confirmed that, for each additional mental health or substance use category that a subject had, they had a progressively higher chance of discontinuation,” said Erik Vanderlip, MD, a fellow working with Dr. Sullivan.

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To learn more, visit www.masimo.com/hemoglobin Ehrenfeld JM, et al. American Society of Anesthesiologists. 2010;LB05. 2 Awada WFN et al. Proceeding of the Society for Technology in Anesthesia Annual Meeting, 2013: p 51.

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