Anesthesiology News

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The best-read anesthesiology publication in the United States

THE INDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTS AnesthesiologyNews.com • S e p t e m b e r 2 0 1 3 • Volume 39 Number 9

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Prehospital Aspiration Ups Pneumonia Risk

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ne of the deadliest types of hospital-acquired infections in adult trauma patients is set in motion long before patients arrive at the hospital, according to a study reported at the 2013 meeting of the Surgical Infection Society. A study involving surgeons and paramedics showed that trauma patients who aspirate before they get to the hospital have a fourfold increased risk for developing health he care–associated pneumoonia (HCAP) and a more th han threefold increased risk for ventilator-associated pneumonia (VAP). In many cases, patients aaspirate prior to interventions by paramedics, suggesting that a key

ICD-10 Ch Risks and For Anest

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astering the ICD D-10 coding transition to optimize reimbursemeent for anesthesia services will take an effort, but it can pay off in terms of higher practice revenue, lesss paperwork and greater overall clinical efficiency, expperts said. Although full implementtation of the new International Classification of Diseases (ICD) system is plann ned for October 2014, a lot needs to happen before then, according to the Centers for Medicare & Medicaid Services (CMS). The ageency’s timeline stipulates that

see aspiration page 21

see coding page 10

Anesthesiologists Sometimes Fall Short of Team Needs: Report

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nesthesiologists believe they know what qualUnited Kingdom, who conducted the survey. “We need to focus on the things ities are most important for them to cultivate: competency and others need from us to be a better calmness under pressure, for instance. player, and try to adapt. We’re not sole physicians; we work with othBut a new study has found that practitioners with whom anesthesiologists ers in a team. And the best patient care frequently work often have much comes from those of us that provide the different opinions about what they best teamworking environment.” should deliver—suggesting anestheDr. Petsas and her co-author, Sally siologists may not always be meeting Ann Shiels, BMBCh—both based at the the needs of their team. Oxford Deanery in England—surveyed 130 surgi“There are lots of things we think are cal clinicians at two U.K. hospitals. Participants were important that others don’t,” said Anna Petsas, MBBS, anesthesiologists, operating department practitioners, a fellow of the Royal College of Anaesthetists in the see team needs page 30

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FORE-SIGHT Elite™, from CAS Medical Systems Inc

08 COMMENTARY An anesthesiologist’s guide to medical history.

17 TECHNOLOGY Personal CPAP machines offer uncertain benefit for hospitalized patients.

23 CLINICAL ANESTHESIOLOGY Type of loop diuretic influences morbidity, mortality after cardiac surgery.

26 PAIN MEDICINE AMA resolution on pain drugs roils pharmacists.


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Make An Educated Decision Information You Need To Be Informed and Stay Competitive Anesthesia Business Consultants (ABC) believes the more you know, the better the decisions you can make. ABC places the highest value on continuing education. As the health care world continues to evolve, offering new technological advances and business models, along with changing laws and regulations, it’s imperative to keep informed. We provide our clients and associates regular updates on what is happening in the world of anesthesiology through our weekly eAlerts. These Alerts highlight the very latest in developments, changing requirements and opportunities and are a complimentary service. If you are interested in receiving these Alerts just send your name, e-mail address, the name of your practice or company, city and state to info@anesthesiallc.com. ABC is also pleased to offer the Communiqué, our quarterly newsletter, to interested individuals. It is available electronically as well as in print. The Communiqué features articles written by industry leaders focusing on the latest hot topics in group management, compliance and future business models for anesthesiologists, nurse anesthetists, pain management specialists and anesthesia practice administrators. We look forward to providing you with many more years of practice management news through the Communiqué and our weekly Alerts. Please log on to ABC’s web site at www.anesthesiallc.com and click on the “Publications” link to view the electronic version of the Communiqué online or to see copies of our previous Alerts.


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SEPTEMBER 2013

Comment on these and other articles @ AnesthesiologyNews.com.

Heard Here First: If we’re going to be serious about September 2013

The five most-viewed articles last month h on AnesthesiologyNews.com 1. CMS Directives: Hat or Miss 2. Misplaced Nerve Blocks Frustrate Efforts at Prevention 3. The Ultrasound Probe in the Hands of the Anesthesiologist: A Powerful Tool for Airway Management (Educational Review) 4. Introduction to the 2013 Anesthesiology News Guide to Airway Management

addressing the cost of health care and the value of the care we provide, we need to be fairly forthcoming in the fact that we do provide services that have

little value

5. Supraglottic Airways for Pediatric Patients: An Overview (Educational Review)

to patients.

SEE ARTICLE ON PAGE 14.

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SEPTEMBER 2013

IN B R I E F

Experts Launch Pain Management Competency Program

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NCPDP Calls for Standards-Based Approach To PDMP To Tackle Prescription Drug Abuse

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he National Council for Prescription Drug Programs (NCPDP) announced the availability of a white paper, “NCPDP Recommendations for Improving Prescription Drug Monitoring Programs.” The document details an action plan to help standardize prescription drug monitoring programs (PDMPs) to better track and deter abuse of prescriptions for controlled substances. Abuse of prescription drugs is the nation’s fastest growing drug problem, according to the Office of National Drug Control Policy. “Addressing patient safety issues has always been a top priority for NCPDP,” said the group’s president, Lee Ann Stember. “This white paper offers state governments and other industry stakeholders a road map for how to resolve the challenges of PDMP and realize its potential by using existing industry standards and processes.” As of February 2013, 49 states—similar legislation is pending in Missouri—have enacted laws to establish PDMPs, electronic databases that collect data on controlled substances dispensed or prescribed within their jurisdiction. However, the absence of business rules governing or allowing sharing of information from state to state and across pharmacies, lack of interoperability among the operational PDMPs, and variation in the timeliness of data frustrate states and law enforcement agencies in their efforts to prevent misuse, abuse and fraud. According to the NCPDP, the prescription monitoring process is not integrated into pharmacist and prescriber workflow, and does not support

P

ain experts, looking to expand on recommendations made in a 2011 Institute of Medicine (IOM) report, have published consensus core competency recommendations they believe could greatly improve pain management if followed by clinicians. Geared not only toward physicians but nurses, pharmacists and other health care professionals as well, the competencies are described in an article appearing in Pain Medicine. The pain management educational program outlined in the paper is a result of the Expert Summit for Interprofessional Consensus on Pain Management, which included nearly 30 experts in pain medicine and related fields. The multispecialty summit was in turn part of the Interprofessional Pain Management Competency Program, launched by University of California (UC), Davis pain experts Scott Fishman, MD, and Heather M. Young, PhD, and sponsored by the Mayday Fund. “The current state of educational content for pain management in schools of medicine and nursing, as well as health professions, is often inadequate,” said Dr. Fishman, chief of pain medicine and vice chair for pain medicine and faculty development at UC Davis, in a statement. “The creation, distribution and, ultimately, the adoption of these basic expectations for pain management education is a critical step toward the preparation of more health care professionals who understand and have basic skills to safely and effectively address pain.”

The core competencies developed by the summit panel fall into four broad categories: multidimensional nature of pain, assessment and measurement, management and clinical conditions. “Pain is an ideal topic to address from an interprofessional perspective,” said Dr. Young, associate vice chancellor for nursing and dean of the UC Davis Betty Irene Moore School of Nursing, in a statement. “Every health professional comes in contact with patients and their family members coping with pain. We all need to have a basic understanding of pain so we can provide appropriate care. By working together to develop these basic skills, we gain multiple perspectives on a very complex topic.” The 2011 IOM report projected rising annual U.S. costs for pain treatment and lost productivity related to chronic pain to be approaching $600 billion. The IOM in part blamed poor pain education among health care professionals for the skyrocketing costs, describing existing training as inconsistent and fragmented. Dr. Fishman said that the UC Davis faculty will incorporate the educational program into the curricula of schools of medicine and nursing. The authors intend to promote their recommendations in journal articles and at pain association conferences. The Pain Medicine e paper, along with further information on the Interprofessional Pain Management Competency Program, is available at http://www.ucdmc. ucdavis.edu/paineducation/. —AN Staff

proactive intervention because it does not provide information in a timely manner, making it difficult for pharmacy and medical professionals to identify potential drug abuse and diversion, evaluate patient safety risk and make appropriate clinical decisions before a prescription is written or dispensed. Providing timely clinical data also will ensure access for patients with a valid medical need for controlled substances to treat their medical conditions, according to the group. To download the white paper, go to: http://ncpdp.org/ind_WP.aspx. —Based on a press release from The National Council for Prescription Drug Programs


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SEPTEMBER 2013

C OMM E NT A R Y

When Settled Isn’t Settled: An Anesthesiologist’s Guide to Medical History

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ettled science, a term currently used by some politicians to describe the facticity of global warming, leaves me a little, well, unsettled. The pages of history are littered with examples of Absolutely Irrefutable Truths that eventually are discarded and replaced by new ones that in turn seem quaint, even downright silly today. Examples in physics include Newton’s laws, which replaced the 2,000-year-old Aristotelian theories, only to be in turn replaced in astrophysics by Einstein’s special and general relativity. The subsequent development of quantum mechanics and its unfortunate incompatibility with relativity has produced a yet unfulfilled search for a “theory of everything” that would explain away their differences. Einstein himself believed that the universe was infinite in time and space, although today we know that, following its appearance from nothing at the Big Bang, it is expanding at a phenomenal and accelerating speed. It was widely believed that scientific advances proceeded in a gradual step-by-step fashion. In 1962, with the publication of his “The Structure of Scientific Revolutions,” Thomas Kuhn turned that theory on its head. Kuhn differentiated “normal science” in which one discovery is layered on a prior one, and “paradigm shifts” that occur when the existing paradigm or generally accepted view no longer explains the data and a new theory is put forth to supplant the old. The alternative is often the work of an individual who challenges the existing belief. Subsequent to its acceptance, the more mundane practitioners of normal science tinker with it, dotting the i’s and crossing the t’s until this new hypothesis proves inadequate to explain fresh data and is replaced by yet another paradigm. Over the past few centuries, the practice of medicine in general and anesthesiology in particular has changed dramatically. Unlike theoretical physics, discoveries in our field are put to immediate practical use. Most of them reflect the less unique processes of normal science, but I believe that some are true paradigm shifts changing how we look at and practice our specialty. Following the precedent of the late-night comics, I submit my personal list of 10 Best Anesthesia Paradigm Shifts. Some of my choices, although perhaps not exclusive to anesthesiology or even the science of medicine, are critical to its everyday practice:

stethoscope soon became the most unique semiotic identifier of a doctor. In the past decade or so, it has become ubiquitous and may be found dangling out of the ppocket or slungg around the neck of jjust about anyone.

providers Harvey Cushing and Michael Codman began recording sleeping patients’ respiration and pulse. Of great interest to the Joint Commission, critical-incident review committees and lawyers, the anesthesia record has h increased in detail and com-

9.

The sphygmomanometer: This device was invented by von Basch in 1881 and improved by Riva-Roci, who popularized it using Laennec’s device.

8.

The electrocardiogram (ECG): Although invented by Einthoven in 1895, it did not achieve regular use in the operating room until The stethoscope: In 1816, hesitant to use well into the 20th century, pridirect ear auscultation on the chest of a buxom marily because of flammable and young woman, René Laennec, of cirrhosis fame, explosive anesthetics. Many anestheechoing children playing with hollow sticks, rolled sia providers believed that the feel of the up a stack of papers and used it to examine her. Fol- patient’s pulse was just as good a diagnostic tool as lowing this success, he made wooden stethoscopes, the ECG. As a resident in the 1970s, I was admonished some of which are still in existence. Although a few by my attendings for using leads on short cases. French physicians resisted the device, fearing that the stethoscope would distance them from the patient, it The anesthesia record: We’ve come a long ultimately gained universal acceptance. The modern way since 1895 when medical students/anesthesia

10.

7.

plexity. In addition to chronicling vital signs, my institution’s anesthesia record requires my signature, date and time in a dozen places, status of β-blocker and antibiotic administration on two different pages, boxes for multiple other details and so on. Much of that information is repeated on a separate quality assurance document and a charge record. It keeps both hands pretty busy. Luckily, they are now available because


SEPTEMBER 2013

AnesthesiologyNews.com I 9

COMME N TA R Y no one under the age of 40 does mask cases any more because of …

6.

The laryngeal mask air way (LMA): Invented by Archie Brain in 1981, LMA sales are not yet a threat to those of Big Macs, but are well on the way.

5. The circle system: The first system based on rebreathing that incorporates elimination of carbon dioxide was invented

Freud, noted the tongue numbness produced by “eat- concept. Before the 20th cening cocaine” (!) and proceeded to test its use as a tury, medical costs were low, local anesthetic on frogs, then on his own eyes. primarily because there wasn’t much doctors could do for The hollow needle: Although Christopher most patients and few deemed Wren experimented with injection using goose quills, insurance necessary. FurtherAlexander Wood is credited for producing the first more, fearing adverse selection needle–syringe combination in 1853. Charles Hunter, of people with preexisting cona surgeon, coined the term “hypodermic” ditions, insurance companies Steven S. Kron, MD and was involved in legal actions had little interest. Although against Wood for the credit, thus sickness insurance existed in the United States from setting up an unfortunate the time of the Civil War, this protected lost income rather than the cost of paying doctors and hospitals. In precedent for number 1 … 1929, a group of Dallas teachers contracted with BayInhalation anesthe- lor Hospital to provide 21 days of hospital care for sia: Without doubt the $6: the precursor of Blue Cross. Blue Shield followed most significant discov- shortly after as did other commercial insurers. In 1965, ery in anesthesia is that creating Medicare and Medicaid, the federal governinhalation of nitrous ment entered the insurance business. Health insurance dollars funded much of the oxide, and ether produce it. To whom does spectacular technological and pharmacologic innothe credit go? Morton vations of the past century but, by distorting medor Wells (or Long, Jack- ical economics, caused unintended consequences son, Davy, Faraday or as well. Income disparities disproportionately drew Simpson)? Whose is the doctors into specialties where, assured of reimburseparadigm shift and whose is ment, they were able to perform expensive procedures. Meanwhile, protected from the costs that were largely absorbed by the payor, patients demanded the “newest and best.” That inflated bubble has been leaking and is ready to burst. Much of the financial burden of illness is being shifted back to the patient, as is the personal responsibility for wellness. Now we must bypass McDonald’s as we schlep our smoke-free lungs and titanium joints to the gym under the all-knowing and watchful eye of a benevolent government.

2.

1.

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

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in 1924 by the father and son team off H Heinrich i i h and d Bernhard Dräger.

4. Direct laryngoscopy (DL) and endotracheal

intubation: Chevalier Jackson first reported DL and endotracheal intubation in 1913.

3.

Local anesthetics: In 1882, Karl Koller, a 25-year-old ophthalmologist and friend of Sigmund

the normall science? th i ? A sadd story t of madness and greed with which we are all familiar, brought about what is certainly one of the greatest discoveries in medicine. Honorable Mention Health insurance—the Baylor Plan: Although the idea of limiting the cost of a bad event such as loss of a ship is ancient, insuring against illness is a much newer

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SEPTEMBER 2013

P OLI C Y & M A NAGEMENT CODING

inpatient coding department and Clinical Modification (ICD-10-CM) doctors and hospitals focus on the com- changes for practice areas, said David A. munications and high-level training Lubarsky, MD, chief medical and sysrequirements throughout the remainder tems integration officer at the Univerof 2013 and start more comprehensive sity of Miami. training in 2014. The roots of the ICD system reach In the meantime, anesthesiologists back to the late 19th century. The 10th should take advantage of all training revision covers more than 14,400 disand educational opportunities regard- tinct codes, and the ICD-10-PCS, ing specific Procedure Coding Sys- more than 76,000. Some of the new tem (ICD-10-PCS) documentation codes are excruciatingly specific, such requirements in support of the hospital as injuries sustained by a collision with

from the current system. For example, new codes will be three to seven characters long More Than to allow for more specificity Just More than the ICD-9 codes, which Dr. Lubarsky is navhad between three and five igating the transition characters. David A. Lubarsky, MD with the help of Susan “Because ICD-10-CM Davis, lead project mancodes are different than ICDager of ICD-10 implementation at the 9-CM codes, and not just an expansion institution. Their tasks are many, but of that system, it is important for anesinclude educating physicians about how thesiologists to develop some familiarICD-10 codes fundamentally differ ity with the new code set,” said Marc L. Leib, MD, chair of the American Society of Anesthesiologists (ASA) Committee on Economics. “It is also important to understand that proper selection of ICD-10 codes will require greater anatomical specificity and the purpose of the visit”—whether it be initial treatment, follow-up care or treatment of complications. “Expertise will be especially important for anesthesiologists who bill for intensive care and pain along with related procedures. In contrast, Current Procedural Terminology codes for physician services are not expected to change,” said Dr. Lubarsky, y who is also professor and chair of the Department of Anesthesiology, Perioperative Medicine and non-narcotic pain relief means Pain Management. Even if a hospital boasts a stellar billing department, the onus for ICD-10 coding completeness remains on the physician. “Coders simply won’t be able to ‘build’ ICD-10 codes without all of the building blocks of information being in the chart,” Dr. Lubarskyy said. In the past, coders without complete information could default to a “not otherwise specified” (NOS) catchall code. Going forward, most NOS payments will be curtailed or denied outright. Therefore, ensuring complete clinWith the ON-Q* non-narcotic pain relief system, patients: ical and billing information up front • Went home an average of 1.1 days sooner will save time, Dr. Lubarskyy said, and preempt queries to physicians for addi• Reported up to 69% lower pain scores tional data. “This slowdown in coding • Were up to 3x as likely to report high satisfaction scores will impact cash flow and potentially • Are more likely to experience better pain management with decrease physician productivity due to fewer side effects rework.” Dr. Leib agreed. “Anesthesiologists should be prepared for potential disruptions to their cash flow, which may Every day without out costs cos you more. necessitate establishing a credit line prior to the switch-over date.” Best to prepare in advance, he said. “Waiting until the new code set is implemented to prepare for the transition may result See how ON-Q* can help you. Call your ON-Q* representative in permanent loss of revenue if claims today for a complimentary consultation: 1-888-962-4ONQ (4667). cannot be filed correctly within the payors’ timely filing limits.” CONTINUED FROM PAGE 1

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SEPTEMBER 2013

AnesthesiologyNews.com I 11

POL ICY & M A N A G E ME N T in independent practices, however, the challenge is twofold: education and technology, Dr. Lubarskyy said. The new coding format likely will necessitate an update to billing systems, for example. Herein also lies an opportunity. “ICD-10 is an excellent reason to upgrade existing computer systems,” Dr. Lubarskyy said. Switching from paper charge vouchers to computerized physician billing and installing computerizedassisted coding software for pain and intensive care practices are examples of beneficial upgrades. Software templates that include coding customized to each physician’s specialty can drive greater clinical efficiency and increase patient throughput. The new coding also will mean more collaboration between anesthesiologists and other hospital staff. “Selecting the most appropriate ICD-10 code will likely require greater communications with surgeons or other physicians,” Dr. Leib said. “It is our opinion that it is still a little early for anesthesiologists and their coders to prepare for ICD-10 in depth,” Dr. Leib said. “That said, it is not too early for anesthesiologists to prepare their office systems for the new ICD-10 codes. Because ICD-10 coding requires more information, anesthesiologists would benefit from beginning to document now as if their claims were being submitted with ICD-10 codes. By doing so, that will be second nature when such documentation is required after the transition.” Several revenue impact studies have made the conversion to ICD-10 sound daunting, but the impact on specific practices will vary, said Tony Mira, CEO of Anesthesia Business Consultants, a practice management firm in Jackson, Mich. “Adequate preparation and training is crucial to minimizing the financial impact. If you have yet to develop an implementation plan there is still time, but you must act now,” Mr. Miraa said. Every anesthesiologist should have their coding staff take a look at their current top 10 ICD-9-CM codes along with their current documentation, Mr. Miraa said. “See if an ICD-10-CM trained coder can readily convert them to the new system based on their current documentation. If not, why? What are the critical pieces of information missing in the current documentation?” For example, if a practice performs a lot of orthopedic cases, laterality is important; does the documentation clearly identify right or left limb? “If you need to expand or capture more information to identify a billable

ICD-10-CM code, you want to start making those documentation changes now to minimize the potential revenue impact following the Oct. 1, 2014 effective date,” Mr. Miraa said. “If your vendor has not yet updated your software to accommodate the ICD-10 coding structure, you need to question them sooner rather than later regarding their plans to do so,” he continued. Questions to ask about the upgrade include: Will the software be able

to accommodate both ICD-9 and ICD-10 in all electronic transactions? If not, which ones won’t support ICD-10? What types of training are included in the maintenance plan, and which will carry an additional cost? And, are there any additional costs associated with obtaining necessary software updates? CMS provides additional guidance for physicians regarding ICD-10 implementation at www.cms.gov/Medicare/ Coding/ICD10/ProviderResources.

html. Other sites offer free information online (e.g., www.gobookee.net/anesthesia-cpt-codes-2013). Dr. Lubarskyy also recommended subscription services that provide notification and educational content when codes change. The ASA plans ICD-10 educational presentations at the 2013 annual meeting in San Francisco next month. The ASA also will continue to post relevant updates on its website (www.asahq.org). —Damian McNamara

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SEPTEMBER 2013

P OLI C Y & M A NAGEMENT

FDA Takes Action Against Illegal Online Pharmacies

D

uring the last two weeks of June, the FDA took action against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. Working with international regulatory and law enforcement agencies, the FDA seized offending websites and more than $41 million worth of

illegal medicines worldwide. “Illegal online pharmacies put American consumers’

health at risk by selling potentially dangerous products,” said John Roth, director of the FDA’s Office of Criminal Investigations, in a statement. “This is an ongoing battle in

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the United States and abroad, and the FDA will continue its criminal law enforcement and regulatory efforts.” The FDA’s action occurred as part of the sixth annual International Internet Week of Action, a global cooperative effort to combat the online sale and distribution of potentially counterfeit and illegal medical products. The international operation, called Operation Pangea, took place from June 18 to June 25. During this year’s effort, Operation Pangea VI, the FDA’s Office of Criminal Investigations worked in coordination with the U.S. Attorney’s Office for the District of Colorado to seize and shut down 1,677 illegal pharmacy websites. According to the FDA, many of the websites they encountered appeared to be operating as a part of an organized criminal network. The sites falsely purported to be “Canadian pharmacies,” and displayed fake licenses and certifications to convince U.S. consumers to purchase drugs that they advertised as “brand name” and “FDA-approved.” These websites also used the names of major U.S. pharmacy retailers to trick consumers into believing that an affiliation existed with these retailers. Some examples of the phony websites, which now have been seized and display a message from the FDA’s Office of Criminal Investigations Cybercrime Investigations Unit, include: • www.canadianhealthandcaremall. com • www.walgreens-store.com • www.c-v-s-pharmacy.com y As part of its investigation, the FDA targeted websites that were selling unapproved and potentially dangerous prescription medicines that could pose significant risks to public health. The drugs seized by the agency were not from Canada, and were neither brand name nor FDA-approved. Prescription products purchased from the websites also bypassed existing safety controls required by the FDA, including the requirement of a valid prescription from a licensed health care provider. Some of the medicines sold illegally by the websites included: • Avandaryl (glimepiride and rosiglitazone): Used to treat type 2 diabetes and to minimize potential


SEPTEMBER 2013

AnesthesiologyNews.com I 13

POL ICY & M A N A G E ME N T associated risks, including edema caused by fluid retention or heart failure, Avandaryl must be prescribed by a certified health care provider and dispensed by a certified pharmacy with a medication guide explaining the potential risks. • “Generic Celebrex”: FDA-approved, brand-name Celebrex (celecoxib) is used to treat the signs and symptoms of osteoarthritis and rheumatoid arthritis, and to manage acute pain in adults. There is no FDAapproved generic version of this product. To minimize the potential associated risks, including gastrointestinal bleeding, heart attack and stroke, Celebrex must be dispensed with a medication guide explaining potential risks. • “Levitra Super Force” and “Viagra Super Force”: Levitra (vardenafil) and Viagra (sildenafil) are FDAapproved to treat erectile dysfunction. Levitra Super Force and Viagra Super Force are not FDA-approved products and claim to contain dapoxetine, the safety or efficacy of which has not been determined by the agency. People with certain heart conditions should not take medicines containing vardenafil or sildenafil, and these medications also have potentially dangerous drug– drug interactions and serious adverse effects. • Clozapine: This agent is FDAapproved to treat severe schizophrenia and is associated with potentially fatal agranulocytosis, a severely low (and dangerous) white blood cell count that can predispose patients to serious, life-threateningg infections. To minimize potential risks, consumers who are prescribed clozapine must be enrolled in a registry that ensures regular blood count monitoring. In addition to potential health risks, these online pharmacies pose non– health-related risks to consumers such as credit card fraud, identity theft and computer viruses. The FDA encourages consumers to report suspected criminal activity to the Office of Criminal Investigations at www.fda.gov/OCI. The FDA also sponsors “FDA BeSafeRx—Know Your Online Pharmacy,” a national campaign to educate consumers about the dangers of buying medicine from fake online pharmacies and to help people safely buy medicine online. Information is available online at www. fda.gov/BeSafeRx. —Based on a press release from the FDA

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14 I AnesthesiologyNews.com

SEPTEMBER 2013

P OLI C Y & M A NAGEMENT

Physicians Recommend Forensic Health Services Research Applying health care research to the problem of health care fraud

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hen federal officials announced in May an eightstate mass arrest of nearly 100 doctors and nurses charged with Medicare fraud, the accusations were relatively straightforward: bogus prescriptions, kickbacks for motorized wheelchairs, billed but undelivered

care and other misdeeds that, officials claimed, bilked the government insurance program out of some $223 million. But beyond these blackk and-white cases is a gray area of services that, although not blatantly egregious, do not meet professional standards or are not medically necessary.

Considered health care abuse by the Centers for Medicare & Medicaid Services (CMS), which administers these federal health care programs, it is also a legal gray area. Cases of health care abuse are not necessarily taken to court, as are more obvious cases of deliberate fraud.

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These cases represent an untapped area of regulation and potential savings. Medicare expenditures rose by 6.2% in 2011 according to federal data; its yearly expenditure growth has been as high as 18.8% since 2000. Abuse of national health care programs represents at least some share of that spending. Although the increases in overall health care expenditures, which have risen 3.9% each year from 2009 to 2011, have slowed since 2002, there is no doubt that cutting these costs is desirable. To this end, internists Laurence McMahon Jr., MD, MPH, and Vineet Chopra, MD, MSc, both from the University of Michigan Health System, in Ann Arbor, have proposed using existing methods for studying trends in patient care data—health services research—to detect health care fraud and abuse. They introduced this concept, which they call forensic health services research, in a commentary in the American Journal of Managed Care (2013;19:e71-3). “If we’re going to be serious about addressing the cost of health care and the value of the care we provide,” Dr. McMahon said, “we need to be fairly forthcoming in the fact that we do provide services that have little value to patients.” Many of these services, he said, represent fraud and abuse, yet are not recognized as such. The current system for catching and prosecuting health care fraud is what many see as an inefficient collaboration among the CMS and the Office of Inspector General (OIG), both within the U.S. Department of Health and Human Services, and the Department of Justice (DOJ), including the FBI. Working together, these agencies audit health care providers, review claims and prosecute fraudulent parties using an approach known as “pay and chase”— trying to recover money paid out for fraudulent claims rather than denying the claims in the first place—which a 2012 report by the U.S. Government Accountability Office (GAO), cited by the authors, called ineffective. Less than $20 million of the $102 million spent on audits from 2008 to 2012 was recovered, according to a June report by the GAO. During fiscal year 2012, the DOJ convicted 826 defendants of health care fraud, and the OIG excluded 3,331 providers or entities from federally funded health care programs, 912 of them for


SEPTEMBER 2013

AnesthesiologyNews.com I 15

POL ICY & M A N A G E ME N T crimes related to Medicare or Medicaid. Little to no data were available about levels of fraud within the field of anesthesiology, but it is probably no exception, Dr. McMahon said. “Every specialty has procedures currently done that haven’t been shown to be beneficial to patients,” he said. The OIG handles settlements, fines and exclusions but would not comment on charges and convictions, citing lack of prosecutorial authority. The DOJ did not return repeated requests for comment. Health services research has been around for 30 years, Dr. McMahon said, and investigators already are using its methods to detect cases in which Medicare and Medicaid pay for unwarranted procedures. “This data is out there, it’s known by everyone,” Dr. McMahon said. “It’s not something we just found, it’s published leading journals. But the question is how do you look at it in the context of fraud and abuse.” The commentary gave several examples of health services research papers documenting unnecessary or unsupported procedures, from too-frequent colonoscopies to placement of defibrillators in cases where they were not proven to have a benefit. Currently, these kinds of cases are not prosecuted as fraud and abuse, Dr. McMahon said. Hays Gorey Jr., JD, of the law firm GeyerGorey, LLP, which specializes in white-collar crime, confirmed that assessment. “There may be conduct that is short of fraud that may fall into a category called abuse. If it involves false claims, of course, then that would be one thing, but if it falls short of being actual knowing fraud, then I don’t know of any way, either that that would be prosecutable under the law.” Mr. Goreyy added that there might be other ways, such as new regulations, to deal with abuse. The False Claims Act, a Lincoln-era statute, allows not only the government but also individuals acting on the government’s behalf to sue for restitution of payments for knowingly fraudulent claims to the government. These can include bills for worthless services, a category that may include procedures with no medical value. “The claim, or one of the claims, could be that the services were medically not necessary, or that the services were worthless. That’s pretty close to saying the same thing,” Mr. Goreyy said. But cases of medically unnecessary procedures would not necessarily be prosecutable under the False Claims Act. For example, one could not

successfully sue a doctor, based on the act, for performing colonoscopies too frequently without more information, Mr. Goreyy said. “If that’s all you do, the answer is pretty clearly no. It may be a lead to conduct further inquiry.” In order to make a case, he said, one would have to determine that the bills “amounted to knowingly false or fraudulent claims.” In other words, a doctor with best intentions in mind is not committing fraud under current laws.

James Goodwin, MD, professor of geriatric medicine at the University of Texas Medical Branch at Galveston, and lead author of the colonoscopy study cited in the commentary, said prosecuting doctors for performing unnecessary procedures is not the answer. “I assume the physicians who are performing screening colonoscopy too frequently have managed to convince themselves that they are doing the right thing. If Medicare refused reimbursement for those procedures,

the problem would disappear overnight,” he said. Overall, however, Dr. Goodwin said forensic health services research is “a good idea. The distinction between ‘fraud’ and ‘abuse’ can be debated endlessly, but there is no doubt that using administrative data to identify clinics and providers with ‘abuse-like’ profiles for further scrutiny could have a major impact on overuse of tests, procedures and treatments.” —Ashley Taylor


16 I AnesthesiologyNews.com

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T E C H NO L O G Y

CDS Software Helps Facilitate VTE Prophylaxis

Figure 1. VTE electronic order set link. © 2013 HealthEast Care System

Figure 2. VTE patient selection and VTE addressed acknowledgment. © 2013 HealthEast Care System

Table. VTE Risk Stratification ❏ No

❏ Low Risk

❏ Moderate to High Risk

❏ Very High Risk

Pharmacologic prophylaxis ordered at this time

No VTE risk factors

Age >60 y CVA, including PICC History of COPD, CHF, IBD, respiratory failure Family history of thrombosis Medical patient with additional risk factor (MI, sepsis, COPD, CHF, respiratory failure or history of malignancy) Major surgery planned with additional risk factor (MI, sepsis, COPD, CHF, respiratory failure or history of malignancy) Morbid obesity (BMI ≥40) Anesthesia time >60 min

Active cancer Hip, pelvis, or leg fracture (<1 mo) Stroke (<1 mo) Acute spinal cord injury or major trauma (<1 mo) Admit to ICU Personal history of DVT, PE or clotting disorder Extended immobility (≥4 d)

BMI, body mass index; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; CVA, central venous access; DVT, deep vein thrombosis; IBD, inflammatory bowel disease; MI, myocardial infarction; PE, pulmonary embolism; PICC, peripherally inserted central catheter © 2013 0 3 HealthEast ea t ast Care Ca e System Syste y

tests based on the medication selected for prophylaxis. Providers were receptive to these enhancements, which helped prepare them for subsequent changes. Phase 2 went live in June 2011 and focused on increasing use of the VTE prophylaxis order set and enhancements of the order set to ensure appropriate documentation and improve Clinical Quality Measures (CQM) metrics for VTE prophylaxis. The order set linking to an integrated link was changed, which automatically directed the provider to the VTE prophylaxis order set from medical admission order sets and prevented providers from bypassing the VTE order set. The free-text field with an expandable list of approved reasons for “No pharmacological prophylaxis” and “No mechanical prophylaxis” also was replaced. Based on the risk stratification selected for the patient, required field logic was introduced to ensure the correct therapies were ordered for the patient or appropriate documentation for “No prophylaxis” was recorded before the order set was submitted. These workflow changes were not reviewed with provider groups first and education about the new requirements was not provided, so subsequently there was some pushback from providers. This led to the temporary removal of the integrated linking functionality, but links to the VTE order set still remained.

The primary goal of Phase 3, which went live in February 2012, was to increase use of the standardized VTE order set for both medical and surgical patients admitted to the health system. The major changes included the introduction of a surgical patient option and a method to denote that VTE prophylaxis was already addressed for the patient (Figure 2). By including workflow for “VTE already addressed,” providers were open to the reintroduction of the integrated linking that automatically took them to the VTE order set from admission order sets. The addition of the surgical patient options allowed surgical admission patients to benefit from all the enhancements made to the order set. Surgical Care Improvement Project (SCIP) guidelines state that instructions to the pharmacist to verify surgery end times before verifying pharmacologic prophylaxis orders were included. Order start times were offset by the appropriate number of hours from the time the order set was placed in the patient’s electronic medical record. A final enhancement was the introduction of CQM VTE tracking orders. These unique orders for “not ordering pharmacological or mechanical prophylaxis” recorded the selected reason for not ordering a medication or therapy option to address VTE during the patient’s hospitalization; they 90 also provided a convenient method to extract exclusion criteria and a mecha80 nism through which pharmacists could 70 follow up with providers who required more education regarding use of the 60 order set. 50 Based on prior feedback from pro40 viders, during Phase 3 interactive demonstrations were conducted of the 30 updated functionality for key provider 20 groups to obtain provider buy-in. The changes that would allow for increased 10 compliance with SCIP and CQM 0 measures related to VTE prophylaxis April May June July Aug. Sept. Oct. Nov. Dec. Jan. Feb. March were emphasized. Provider educators 2012 2012 2012 2012 2012 2012 2012 2012 2012 2013 2013 2013 were asked to construct a brief oneFigure 3. Percentage of new admissions using CPOE VTE page document for providers, explainorder set. ing the required fields in the form, how CPOE, computerized prescriber order entry; VTE, venous thromboembolism to address these fields, and how to Use Rate, %

A

s HealthEast Care System transitioned from paper order sets to a computerized prescriber order entry (CPOE) and began attesting to stage 1 of the Centers for Medicare & Medicaid Services’ meaningful use requirements, informatics team members identified several order sets and processes that could benefit from clinical decision support (CDS). One of the key areas was related to ordering and documenting venous thromboembolism (VTE) prophylaxis. A specific order set for VTE prophylaxis for medical patients existed at HealthEast, but several medical admission and postoperative order sets also had separate sections containing VTE prophylaxis orders. These sections often did not have key components for compliance, such as exclusion criteria for mechanical/ pharmacologic prophylaxis, risk stratification guidance, and listings of appropriate medications with consistent dosing parameters. The health system addressed this with a few workflow changes between March 2010 and February 2012. First, most of the individual VTE prophylaxis sections were removed from other order sets and were replaced with a link to the VTE prophylaxis order set (Figure 1). For a few postoperative order sets (orthopedic, cardiovascular and bariatric procedures, as well as stroke admissions), the VTE sections were left within the order set but additional CDS was applied to guide ordering. Second, the VTE prophylaxis order set was standardized to cover medical and postoperative patients. Finally, several CDS tools were introduced into the VTE order set. The process resulted in 3 phases or iterations of the order set to allow full incorporation of provider feedback and address any issues that arose. Phase 1 went live in March 2010, with changes focusing primarily on the introduction of CDS into the existing VTE prophylaxis order set and the addition of an expandable section for risk stratification (Table). This visually enhanced the order set and showed the provider only the recommended options that correlated with the stratification that was selected, thus removing the possibility of selecting prophylaxis options from the incorrect risk stratification. A required free-text field for “No pharmacological prophylaxis” was added. Under the new order set, enoxaparin doses were automatically adjusted based on the patient’s renal function and current health-system policy and orders were automatically placed for laboratory


SEPTEMBER 2013

AnesthesiologyNews.com I 17

TE CH N OL OG Y

Personal CPAP Machines in PACU of Uncertain Benefit

R

equiring patients with obstructive sleep apnea (OSA) to bring personal breathing devices with them on the day of surgery may be an unnecessary and clinically irrelevant burden for both patients and hospital staff, Baltimore researchers have found. OSA has been linked to poor perioperative outcomes, including an increased risk for cardiac events and acute renal failure, as well as a greater likelihood of desaturation and the need to be moved to the ICU (Br J Anaesth 2012;109:897-906). In 2012, the Society for Ambulatory Anesthesia (SAMBA) issued a consensus statement recommending that individuals with OSA bring their personal continuous positive airway pressure (CPAP) machines to the hospital on the day of surgery if a hospital machine is not available. But the new study, by a group at Johns Hopkins University, in Baltimore, suggests that few, if any, patients require CPAP in the ICU. Asha Manohar, MD, assistant professor of anesthesia at Johns Hopkins, and her colleagues sought to determine how frequently personal CPAP machines were used at Johns Hopkins Outpatient Center Surgical Suites, where all OSA patients undergoing ambulatory surgery are instructed to bring their breathing devices with them on the day of surgery. They performed a retrospective observational study of all patients with OSA who underwent ambulatory surgery in the past 10 years. “None of these patients required postoperative CPAP in the PACU [postanesthesia care unit],” Dr. Manohar said. “Given this finding, we are reconsidering current guidelines at Johns Hopkins.” The study, presented at SAMBA’s 2013 annual meeting (abstract 53), builds on a 2010 prospective study, also at Johns Hopkins, that found no

correlation in 2,139 patients between OSA and the need for postoperative ventilatory assistance such as CPAP ((J Clin Sleep Medd 2010;6:467-472). Frances Chung, FRCPC, professor in the Department of Anesthesiology at the University of Toronto, Canada, was author of the 2012 SAMBA statement in support of patients bringing personal CPAP machines with them on the day of surgery. Dr. Chungg noted that after surgery and while recovering from the effects of sedation, patients with OSA might be vulnerable to acute episodes of apnea. “Patients can be sleepy in the PACU and thus may need a CPAP machine to help maintain their open airways,” Dr. Chungg told Anesthesiology News. “Also, some patients may need to be admitted after ambulatory surgery and stay overnight, which would also mean they may need their CPAP machine.”

the patient is unstable, then you may need more invasive measures like intubation,” she said. “But usually if the patient is arousable, we can wake them up and encourage deep breathing with supplemental oxygen. Then their oxygen saturation levels return to their baseline.” Furthermore, she said, the use of personal CPAP machines in the PACU requires additional hospital resources. Not only does each machine require staff time for processing and inspection, but the variety of machines available presents its own challenge. “Our technicians cannot be educated on how to use all these different machines,” Dr. Manohar explained. Contamination is another concern, either from CPAP machine to hospital patients and staff, or from hospital-acquired microbes coming home with patients on their machines after surgery. “One study found that patients with OSA who are treated with CPAP have an increased risk for upper airway infections compared with sleep apnea patients who receive conservative treatment,” Dr. Manohar said (Respiration 2001;68:483-487). To address the rare but real possibility of OSA patients needing CPAP in the PACU, Dr. Manohar suggested the use of standardized hospital-based machines in conjunction with patients bringing their personal CPAP masks. “We are looking at having a policy that would allow a standardized hospital-issued CPAP machine be available for use across the hospital,” she said. “Asking patients to bring in new or clean CPAP masks, provided in advance by their home health care companies, on the day of surgery would address the However, CPAP devices can be used only potential need while minimizing the drawbacks of for patients who are arousable, cooperative and patients bringing in their own machines.” able to maintain their protective airway reflexes, Dr. Manohar said. “If there is an acute event where —Keely Savoie Advertisement

bypass the order set if the patient’s VTE status was previously addressed during the hospital encounter. In March 2012, the order set became available with all the Phase 3 functionality, except for integrated linking from admission order sets. At that time, the electronic order set was used for 85% of all new admissions. This high rate of use during go-live was attributable to an increased visibility and volume of support staff available to help encourage use of the system. Once support returned to normal levels, usage of the form dramatically decreased. The availability of the order set with the absence of integrated linking reduced use of the order set. Then, once provider buy-in was achieved and the integrated linking was added back to the facility’s admission order sets in December 2012, VTE prophylaxis order set use returned to rates that were consistent with the overall CPOE usage for the facility. Overall, integrated linking proved to be a valuable tool for increasing the use of the standardized VTE order set (Figure 3). SCIP VTE measures also showed improvement after the reintroduction of the integrated linking and automatic offsetting of start times for ordered medications.

Conclusion Integrated linking, standardization of VTE prophylaxis ordering, and CDS have helped improve CQM and SCIP compliance throughout the HealthEast Care System. During the implementation of these changes, the health system learned about the importance of stakeholder buy-in for electronic workflows and education about new or enhanced functionality in the CPOE environment. Despite health-system leadership requesting enhancements to improve CQM and SCIP VTE measures, the initial attempt did not succeed due to lack of end user buy-in and education. A revised release, which involved the engagement of the stakeholders and used more integrated discussion, focused education, and a rollout plan allowed for a successful deployment of integrated linking and use of required fields for documentation of VTE prophylaxis in patients at HealthEast Care System. —Benjamin Anderson, PharmD, MPH Dr. Anderson is a configuration analyst-Informatics at HealthEast Care System, in St. Paul, Minn.

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18 I AnesthesiologyNews.com

SEPTEMBER 2013

PRN

Older Heparin Labels Still on Shelves During transition to new vial label, extra precautions urged

S

everal months have passed since the U.S. Pharmacopeial Convention (USP) updated labeling standards for Heparin Sodium Injection, USP, and Heparin Lock Flush Solution, USP, in an effort to reduce the risk for medication errrors. But according to a recent alert from the National Alert Network (NAN), some older, problematic versions of the heparin label remain in pharmacy stocks. Thus, precautions need to be taken to reduce the risk for more heparin mishaps. The revisions, which took effect May 1, stipulate that the label of new heparin products present clearly the strength of the entire container of medication, followed by how much medication is in each milliliter (mL), according to the USP website and the NAN alert. In the past, the label emphasized the per mL amount, with the container volume appearing elsewhere. This led to errors in which practitioners misunderstood the per mL amount as the total amount in the vial, and on that basis administered dangerous heparin overdoses. The NAN alert cites a recently reported example, in which a nurse and medical resident intended to administer a dose of 3,000 units of heparin to a patient. Both practitioners mistakenly thought that each 10-mL vial of heparin held a total of 1,000 units, when each vial actually contained 10,000 units (1,000 units/mL). As a result, they administered 30,000 units to the patient instead of 3,000. The error was fatal, with the patient dying after developing an intracranial hemorrhage and brainstem herniation. A Long-Awaited Change For Safer Labeling “We’ve been waiting for a change in the heparin label for quite a while,� said Bona E. Benjamin, BS Pharm, director of Medication-Use Quality Improvement for the American Society of Health-System Pharmacists, in Bethesda, Md. “The total drug content of a container as well as the concentration is important information for pharmacists.� Ms. Benjamin noted that she works with Michael R. Cohen, RPh, MS, ScD, president of the Institute for Safe Medication Practices (ISMP), to author and distribute the NAN alerts, through members of the National

Coordinating Council for Medication Error Reporting and Prevention. There will be a transition period during which vials with both the old label and the new will be available, according to the NAN alert. “Although the alert says you could use up the product with the older label,� Ms. Benjamin

said, “it’s probably safer to remove and replace it with the new labeled product.� If the decision is made to use up the old product, the alert recommends storing it separately from the new, and using up all of the old product before dispensing the newer versions. “It’s important to walk around the

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SEPTEMBER 2013

AnesthesiologyNews.com I 19

PR N ‘Don’t expect or hope that people will see the

account all the locations where heparin is used, in and out of the pharmacy. The emergency room, the ICU, etc., errors. Be proactive in informing them.’ have it.� Mr. Grissinger added, “Don’t expect —Matthew Grissinger, RPh or hope that people will see the new label; that’s not a good strategy to preorganization and look at what is in vent errors. Be proactive in informing stock,� Matthew Grissinger, RPh, them.� He also stressed the importance director of error reporting programs of making changes to databases. “With at ISMP, said in an interview. “Don’t computerized prescription order entry think that heparin is only in the phar- and bar-codingg systems, make sure it macy. The pharmacist should take into matches what’s on hand.�

new [heparin] label; that’s not a good strategy to prevent

On Off

when you want it. when you don’t.

Anesthesia providers identiďŹ ed more than 150 procedures for Remi*.1 Providers interviewed recommend Remi for more than 150 procedures.1 Where could Remi beneďŹ t your practice?

NEUROLOGICAL/ EVOKED POTENTIAL

ABDOMINAL

HEAD & NECK

ORTHOPEDIC

CARDIOTHORACIC

HIGH-RISK PATIENTS

Remi gives you predictable control of depth and duration of analgesia when you need it most2 t Rapid onset of 1 to 2 minutes2 t Rapid response to dose adjustment within 5 to 10 minutes2 t Rapid offset within 5 to 10 minutes results in rapid dissipation of effect and rapid recovery2 t Unique organ-independent metabolism provides rapid elimination with no accumulation2

Visit www.aboutULTIVA.com to see where Remi could work for you. Please see Indications and Important Risk Information below and accompanying brief summary of Prescribing Information on next page for all precautions, warnings, contraindications, and adverse events.

TVDI BT SFTQJSBUPSZ EFQSFTTJPO BQOFB UBDIZDBSEJB CSBEZDBSEJB IZQPUFOTJPO IZQFSUFOTJPO BOE TLFMFUBM NVTDMF JODMVEJOH DIFTU XBMM SJHJEJUZ #FDBVTF UIFTF FGGFDUT BSF EPTF EFQFOEFOU BOE DBO PDDVS SBQJEMZ DPOUJOVPVT NPOJUPSJOH JT OFDFTTBSZ ULTIVA TIPVME OPU CF VTFE BT B TPMF BHFOU CFDBVTF MPTT PG DPOTDJPVTOFTT DBOOPU CF BTTVSFE BOE CFDBVTF PG B IJHI JODJEFODF PG BQOFB NVTDMF SJHJEJUZ BOE UBDIZDBSEJB 6-5*7" TIPVME CF VTFE XJUI DBVUJPO JO QFEJBUSJD HFSJBUSJD BOE NPSCJEMZ PCFTF QBUJFOUT EVF UP IJHI WBSJBCJMJUZ JO QIBSNBDPEZOBNJDT BOE EPTF SFTQPOTF *OUSBPQFSBUJWF BXBSFOFTT IBT CFFO SFQPSUFE XJUI DPODPNJUBOU BENJOJTUSBUJPO XJUI QSPQPGPM JOGVTJPO Ăľ NDH LH NJO 'BJMVSF UP BEFRVBUFMZ DMFBS UIF *7 UVCJOH UP SFNPWF SFTJEVBM 6-5*7" IBT CFFO BTTPDJBUFE XJUI UIF BQQFBSBODF PG SFTQJSBUPSZ EFQSFTTJPO BQOFB BOE NVTDMF SJHJEJUZ VQPO UIF BENJOJTUSBUJPO PG BEEJUJPOBM n VJET PS NFEJDBUJPOT UISPVHI UIF TBNF *7 UVCJOH

%VF UP UIF QSFTFODF PG HMZDJOF JO UIF GPSNVMBUJPO ULTIVA is contraindicated for FQJEVSBM PS JOUSBUIFDBM BENJOJTUSBUJPO 6-5*7" JT BMTP DPOUSBJOEJDBUFE JO QBUJFOUT XJUI LOPXO IZQFSTFOTJUJWJUZ UP GFOUBOZM BOBMPHT 6-5*7" 4)06-% #& 64&% */ 5)& $"3&'6--: .0/*503&% 4&55*/( #: 41&$*'*$"--: 53"*/&% 1&340/4 /05 */70-7&% */ 5)& 463(*$"- 03 %*"(/045*$ 130$&%63& 09:(&/ 4"563"5*0/ *4 50 #& $0/5*/6064-: .0/*503&% 3&464$*5"5*7& "/% */56#"5*0/ &26*1.&/5 09:(&/ "/% "/ 01*0*% "/5"(0/*45 .645 #& 3&"%*-: "7"*-"#-& 3FNJGFOUBOJM JT DPNNPOMZ SFGFSSFE UP BT 3FNJ CZ BOFTUIFTJB QSPWJEFST References: 1. Data on ďŹ le. Canonsburg, PA: Mylan Institutional; 2012. 2. ULTIVA [package insert]. Rockford, IL: Mylan Institutional LLC; 2011.

The NAN alert also advises keeping vial sizes of all high-alert drugs, including heparin, as small as possible to reduce the chance of overdoses. “Heparin is a high-alert drug,� Ms. Benjamin said. “Special precautions are still needed for the new product—for example, an independent check, having someone else verify the correct dose. If possible, heparin doses should be prepared in the pharmacy.� —George Ochoa


20 I AnesthesiologyNews.com

SEPTEMBER 2013

PRN

Wide Swings in Drug Costs Among Anesthesia Providers Washington—Anesthesia costs can differ by as much as 10-fold between similar cases, suggesting significant variability in how clinicians handle medications in the operating room, new research has found. The wide variations in drug use, and consequent costs, among anesthesia providers during similar cases are both an opportunity to minimize waste and

ULTIVA® for Injection

a teaching opportunity, according to the researchers. Doug Hester, MD, assistant professor of anesthesiology at Vanderbilt University Medical Center, in Nashville, Tenn., said the study began as part of a multicenter effort aimed at decreasing the average cost of anesthesia for surgery at two large academic medical centers. The investigators

(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

created an automated cost calculator for medications administered during surgical cases, then identified both the median drug cost for any given procedure as well as the degree of variability attributable to different anesthesia providers. “So, in order to affect behavioral change, we need to educate those providers about their costs for any given case,” Dr. Hester said. “And in

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

$100

$500

$300

$450

$350

order to do that, we need to create a good system to deliver that cost to them.” The researchers began by obtaining acquisition costs of all intraoperative medications from the institutions’ pharmacies. They then developed a series of database queries to automatically obtain and calculate cost-percase totals using the facility’s anesthesia information management system. Data were extracted regarding the amount of drug given by bolus, infusion or inhalation. These amounts were then indexed with the drug’s acquisition cost, providing a total cost per case and cost per minute. “We had to create a process that would calculate costs in real time and be delivered to the anesthesia provider in the room,” said Dr. Hester, who presented the findings at the 2012 annual meeting of the American Society of Anesthesiologists (abstract 165). “This info is not typically known by providers.” Dr. Hester and his colleagues presented data from the first set of diagnostic codes analyzed, total knee arthroplasty. They found that median cost for 449 cases was $22.98, $24.29 at institution A (229 cases) and $20.23 at institution B (220 cases). Perhaps more importantly, anesthetic costs ranged widely among providers, from $7.99 to $81.77. “The idea is to then communicate with providers both the mean cost and their specific cost for any particular [diagnostic] code,” Dr. Hester explained. “And we are hoping that this would spur behavioral changes regarding the stewardship of pharmacologic costs, assuming it doesn’t affect outcomes.” The investigators also plan to combine this information with quality indicators to quantify value in anesthetic care. “If we could save $10 on every case we do, we would save about half a million dollars every year,” he said. —Michael Vlessides


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CONTINUED FROM PAGE 1

event leading to HCAP occurs before patients are treated by paramedics or hospital staff, said lead author Vanessa Fawcett, MD, MPH, a fellow in trauma and surgical critical care at Harborview Medical Center, in Seattle. “Health care- and ventilatorassociated pneumonias, as the names imply, indicate conditions that are iatrogenic. However, given that many patients are aspirating around the time of injury, complications associated with such aspiration may need to be relabeled,” she said. These pneumonias may be part of “the spectrum of traumatic injury, attributable to patient disease rather than health care interventions.” The finding has significant implications for clinical care, said Robert Sawyer, MD, professor of surgery and chief of acute care surgery at the University of Virginia, in Charlottesville. “I will be more likely to start antibiotics earlier on patients with witnessed aspiration in the field than signs and symptoms of [an HCAP],” Dr. Sawyerr wrote in an email interview.

Aspiration is common, difficult to diagnose and relatively subjective, he said. “Other objective measures of aspiration, such as airway glucose or pepsin levels, might be more precise.” He added that health care regulatory organizations should take note of the study. HCAP is followed closely by these organizations as a potential measure of quality of care. But the study shows clearly that HCAP is greatly affected by prehospital events. These events should be accounted for when measuring outcomes in different centers, Dr. Sawyerr said. The findings come from an ongoing research project in Seattle. Paramedics in the city work closely with local hospitals and undergo rigorous training in emergency airway techniques. In an effort to further improve the quality of trauma care, surgeons and paramedics put together a study to examine rates of prehospital aspiration and intubation in the field, and any association with hospital-acquiredd pneumonias. The researchers asked medics to document when adult trauma patients aspirated in the field, and whether they noted blood, emesis or other fluids in

the patient’s oropharynx or airway at three points: prior to intubation, during intubation or confirmed via the endotracheal tube. Paramedics’ reports were compared with patients’ pneumonia and mortality outcomes, according to the hospital trauma registry. The diagnosis of pneumonia was made clinically using criteria of the Centers for Disease Control and Prevention or microbiologically with bronchoalveolar lavage. The study differentiated between HCAP, which occurs at least 48 hours after hospitalization, and VAP, which appears at least 48 hours after intubation. All adult trauma patients intubated in the field and admitted to a Harborview ICU were studied. Of 228 patients who met the study criteria, 89 (39%) aspirated before being brought to the hospital. They were similar in age, sex and comorbidities, but had more severe injuries and more severe traumatic brain injuries than patients who did not aspirate. Patients aspirated most often before intubation. Ninety-five percent of patients who aspirated blood and 77% of those who aspirated emesis did so before intubation was attempted.

Nearly half of these patients aspirated again during intubation. Analysis revealed 15.7% of patients who aspirated went on to develop HCAP compared with 3.6% of patients who did not aspirate (P=0.02). There was a trend toward increased VAP among patients who aspirated, but the difference was not significant (11.2% vs. 2.9%). The investigators said current practices to reduce pneumonia, such as ventilator bundles, should be reconsidered in light of the study findings. “The effectiveness of such measures is recently being called into question in trauma patients, and perhaps intervention is required at an earlier stage,” Dr. Fawcett said. It is unknown whether prophylactic antibiotics can reduce the incidence of pneumonias in patients who aspirate in the field. “At this point, we would not recommend it, but it may be worth studying in the future,” Dr. Fawcett said. The authors are currently conducting a follow-up study of outcomes, in which paramedics will decontaminate patients’ oral cavities prior to intubation. —Christina Frangou

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22 I AnesthesiologyNews.com

SEPTEMBER 2013

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

Imbalancing Act: Study Shoots For Optimal Spinal Anesthetic, but Misses Mark

P

ractitioners seeking the perfect balance between reliable anesthesia and rapid recovery in a spinal anesthetic may need to keep looking, after the results of a new study suggest that a popular combination of agents for knee surgery carries

both important plusses and significant downsides. The study, by researchers at the Hospital for Special Surgery in New York City, found that although decreasing mepivacaine and adding fentanyl decreases recovery time, it often comes

at the cost of an incomplete anesthetic. “In looking for the optimal spinal anesthetic for knee arthroscopy, we want something that will give a good solid spinal, but be short-actingg as well,” said Richard L. Kahn, MD, attending anesthesiologist and medical director

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of ambulatory surgery at the institution. “Lidocaine has been used traditionally, but it has fallen out of favor because of transient neurologic symptoms.” One alternative is isobaric mepivacaine 1.5%, which has been shown in previous research to produce reliable anesthesia for knee arthroscopy when combined with 10 mcg of fentanyl, and a more rapid recovery profile than 45 mg of mepivacaine alone (Can J Anesth 2010;57:32-38). “We wanted to see if we could improve on those results by finding the optimal dose of mepivacaine in combination with fentanyl,” Dr. Kahn said. The researchers included 56 patients undergoing outpatient knee arthroscopy in the study. The patients were prospectively randomized into one of four treatment groups: 37.5 mg of mepivacaine; 30 mg of mepivacaine plus 10 mcg of fentanyl (30/10); 27 mg of mepivacaine plus 10 mcg of fentanyl (27/10); and 24 mg of mepivacaine plus 10 mcg of fentanyl (24/10). Anesthetists and surgeons who were blinded to the particular regimen judged the success or failure of a block. A research assistant, also blinded, assessed patients in the postanesthesia care unit every 15 minutes for resolution of sensory and motor block. Participants were asked to rate their satisfaction with the surgical experience on a 0 to 10 scale, with 0 being very dissatisfiedd and 10 being very satisfied. “One of the difficulties in setting up this study was defining an acceptable anesthetic,” Dr. Kahn told Anesthesiology News. “But the bottom line is that if one of our four doses was found to be giving a fair or inadequate block in two patients, we would stop studying it.” Two of the first six patients in the 30/10 group had fair blocks—defined as requiring deep sedation—eliminating the dosing regimen from further enrollment, according to the researchers, who reported their findings at the 2013 annual meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract A51). The 27/10 group also was eliminated after; among the first 10 patients, one had a fair block and one an inadequate block. Of the 18 patients in the 24/10 group, only one had a fair block. see spinal page 24


SEPTEMBER 2013

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Diuretic Type May Mean More Morbidity and Mortality After Cardiac Surgery Miami Beach, Fla.—Among the many challenges for anesthesiologists steering patients safely through cardiac surgery is predicting who among them faces the greatest risk for complications. Use of diuretics before and during cardiac surgery with cardiopulmonary bypass is a well-known consideration. However, a new study adds a level of sophistication to existing evidence, suggesting the specific type of diuretic makes a significant difference in certain patient outcomes. Specifically, the researchers found, loop diuretics and thiazide diuretics may not be created equal. “The results of our study revealed that among many other risk factors, patients with loop diuretic use were at higher risk for acute kidney injury [AKI] and mortality after CABG [coronary artery bypass graft] surgery,” said Miklos D. Kertai, MD, PhD, assistant professor in the Department of Anesthesiology at Duke University Medical Center, in Durham, N.C. Dr. Kertai and his colleagues retrospectively analyzed 6,592 patients who underwent cardiac surgery from Jan. 1, 2001 to Nov. 30, 2009. In addition to assessing use of pre- and intraoperative loop and thiazide diuretics, they evaluated each patient’s medical records for EuroSCORE, diabetes mellitus, duration of cardiopulmonary bypass and serum creatinine levels. A total of 1,493 patients (22.6%) received loop diuretics, 817 patients (12.4%) received thiazide diuretics and 4,282 patients (65%) received no diuretic. Surgeons performed CABG procedures on 4,859 (73.7%) patients; 895 (13.6%) had combined CABG and valve surgery, and 838 (12.7%) had valve procedures only. The researchers, who presented their results at the 2013 annual meeting of the Society of Cardiovascular Anesthesiologists (abstract 3), found a 2.4% overall incidence of mortality in the first 30 days after surgery. However, use of a loop diuretic was associated with nearly a twofold greater risk for 30-dayy mortality compared with thiazide diuretics (odds ratio [OR], 1.98; 95% confidence interval [CI], 1.02-3.84; P=0.04) or with no diuretic use (OR, 1.71; 95% CI, 1.18-2.49; P=0.005). The incidence of AKI varied among patients treated with a loop diuretic

(52.5%), thiazide (39.4%) or no diuretic (37.1%). The difference between thiazides and no-diuretic groups was not statistically significant, but the incidence of AKI in the loop diuretic group was significantly different compared with two other groups.

The incidence was more than 1.5 times greater with loop diuretics (OR, 1.67; 95% CI, 1.46-1.91; P<0.0001) compared with patients who did not receive diuretics or those who received a thiazide diuretic (OR, 1.58; 95% CI, 1.31-1.91; P<0.0001). In contrast, the

researchers found no significant increase in risk for AKI with thiazide diuretic use compared to no diuretic use (OR, 1.05; 95% CI, 0.89-1.24; P=0.54). “Our findings also revealed that patients with preoperative diuretic see loop page 24

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Similarly, only one of the 22 patients who received 37.5 mg of mepivacaine alone had a fair block. With respect to recovery profiles, the 37.5-mgg mepivacaine group and the 30/10 group were comparable, although patients in the 30/10 group experienced faster resolution of motor block. Not particularly surprising was the fact that the two groups given lower doses of mepivacaine demonstrated shorter times, by approximately 30 minutes, to achieve recovery milestones—first ambulation, first urination and time

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use—either with loop or thiazide diuretic use—were more often sicker than patients with no diuretic use,” Dr. Kertai told Anesthesiology News. “Hence, it seems that diuretic use, particularly loop diuretic use, is likely to be a marker of factors such as advanced age, poor cardiac function, kidney dysfunction and systemic illness. Nevertheless,

to discharge—than did patients who received mepivacaine only. “With such low doses of mepivacaine, we’re pushing the limit of where we can reliably achieve a good anesthetic,” Dr. Kahn said. “The recovery might be a little bit faster, but you might also have an incomplete block. The challenge here is to find something that will give complete anesthesia but resolve relatively quickly, so the patient doesn’t have to sit in the recovery room for an hour and a half after an ambulatory procedure.” Kathryn E. McGoldrick, MD, professor and chair of anesthesiology at

New York Medical College, in Valhalla, said the ideal spinal anesthetic for ambulatory surgery combines rapid, reliable and excellent surgical anesthesia with the swift attainment of discharge criteria. “Lidocaine enjoyed a long period of popularity in this venue until concerns surfaced about transient neurologic symptoms and possible neurologic injury, triggering interest in alternative agents,” Dr. McGoldrickk said. “No single agent has been ideal under all circumstances. “Ben-David et al reported in 1997 [[Anesth Analgg 1997;85:560-565] that the addition of 10 mcg of fentanyl to

5 mg dilute bupivacaine resulted in a success rate of 100% for knee arthroscopy—compared with a success rate of only 76% without intrathecal fentanyl—without increasing the time to discharge. The bottom line is that, with attention to detail, spinal anesthesia can be creatively designed to provide satisfactory intraoperative conditions and discharge times comparable to those seen after general anesthesia, with less propensity for [postoperative nausea and vomiting] and residual drowsiness.”

loop diuretics may contribute incremental risks to this already susceptible cohort.” Despite the findings, Dr. Kertai said it’s premature for clinicians to alter their use of loop diuretics. “Our observation that loop diuretic use was associated with an increased risk for acute kidney injury and mortality after CABG surgery will require a rigorous testing in a well-designed, randomized trial,” he said.

W. Scott Beattie, MD, PhD, the R. Fraser Elliot Chair in cardiac anesthesia at the University Health Network, in Toronto, Canada, cautioned against reading too much into the retrospective results. Loop diuretics typically are prescribed for much sicker patients with comorbid states like renal failure, congestive heart failure or gross edema, which also are independently associated with poor outcomes,

he said. In contrast, thiazides typically treat hypertension, which usually is not associated with poorer surgical outcomes. Dr. Beattie agreed with Dr. Kertai, saying, “Any conclusion in this type of work is hypothesis generating and would need confirmation in a randomized assessment.”

—Michael Vlessides

—Damian McNamara


SEPTEMBER 2013

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CL IN ICA L A N E STH E SIOL OG Y

Oral or IV? Both Forms of APAP Avoid Opioids, Study Finds San Diego—Although IV acetaminophen does appear to reduce postoperative morphine requirements after pediatric surgery, its opioid-sparing effects are not superior to those of the oral drug, a recent study suggests. Researchers at Loma Linda University Children’s Hospital, in California, found that although children receiving IV acetaminophen (APAP) used significantly less morphine after cleft palate surgery than those receiving placebo, oral and IV APAP (Ofirmev, Cadence Pharmaceuticals) had similar opioidsparingg effects. “Since our surgeons are shortening length of stay after cleft palate repair— we’re down to planned one night— our analgesic choices have significant implications for what happens when the child goes home,” said Richard L. Applegate II, MD, professor of anesthesiology at Loma Linda University School of Medicine, who led the study. “Obviously, delayed respiratory depression can occur, so if we can find a way to avoid opioids, we might help our patients.” With relatively few contraindications, APAP is favored for use in children. Adult studies show that both the oral and IV forms of the agent can decrease postoperative morphine consumption. With no studies comparing the two preparations in children, the investigators provided interim analysis of 17 children undergoing cleft palate repair. Patients were randomized to receive both oral and IV agents at specified times and in the following combinations: IV APAP/oral placebo; oral APAP/IV placebo; or oral placebo/IV placebo, said Dr. Applegate, who presented the results at the 2013 annual meeting of the International Anesthesia Research Society (abstract S-313). Intraoperative opioids were administered, as needed, by attending anesthesiologists who were blinded to the study interventions. The researchers collected data on the patients’ use of fentanyl in the postanesthesia care unit (PACU). Although intraoperative administration of fentanyl was comparable among the three groups, children given IV APAP used markedly less fentanyl in the PACU (0.08 mcg/kg) than their counterparts in either the oral APAP (1.8 mcg/kg) or control groups (1.9 mcg/kg). These differences did not reach statistical significance (P=0.15).

Morphine consumption on the ward was lower in the two study groups (0.05 mg/kg) than in controls (0.09 mg/kg), but 24-hour opioid use—measured in morphine equivalents—was lower in IV patients (0.09 mg/kg) than those who had received oral APAP (0.11 mg/kg) or placebo (0.13 mg/kg). “Although this did not reach statistical significance, children in the IV group

got one less dose of postoperative morphine,” Dr. Applegate said. “Now, you might be thinking, ‘so what, it’s only one dose and this drug costs a nickel.’ But I would say that it’s one less exposure to postoperative respiratory depression, so you have fewer things to worry about when you send them home.” Parental satisfaction scores were greater in the IV group, yet again the

difference was not statistically significant. “The biggest difference we saw between groups was that while IV patients’ parents were clustered tightly around high levels of satisfaction, there were a lot of placebo patients’ parents who weren’t very happy,” he said. —Michael Vlessides

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Pharmacists Feeling Pain Over AMA Resolution Physician group blasts profession’s ‘intrusion into medical practice’

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bluntly worded American Medical Association (AMA) resolution that was intended to curb a barrage of retail pharmacy phone calls to physicians requesting additional information about pain medication prescriptions has triggered a backlash from pharmacists, some of whom objected to the resolution’s sharp tone

as a departure from the mostly collegial relationships that exist between the two professions. “It’s a step backward,” said David Craig, PharmD, BCPS, a clinical pharmacy specialist at the H. Lee Moffitt Cancer Center and Research Institute, in Tampa, Fla. “I work collaboratively with many physicians who do not

agree with this resolution at all. In fact, they welcome any pharmacist’s input, advice and recommendations.” The policy passed by the AMA House of Delegates in June was written in response to what the resolution described as “pharmacy intrusion into medical practice.” It stated that the AMA “deem[s] inappropriate inquiries

from p harmacies to verify the medical rationalee behind prescription ns, diagnoses and treatmen nt plans to be an interference ference with the practice of medicine and unwarranted.” It also threatened that if the issue were not resolved, the AMA would “advocate for legislative and regulatory solutions to prohibit pharmacies and pharmacists from denying medically necessary and legitimate therapeutic treatments to patients.” Scott Strassels, PharmD, PhD, a pain management specialist who spent more than seven years as an assistant professor and a researcher at the University of Texas at Austin College of Pharmacy, said such a policy represented a “dangerous precedent to shut off important phone calls or important contact with prescribers. Nobody wants to spend time on the phone that they don’t really need to, but there are times when a pharmacist and prescriber need to be on the same page

A Pain Physician’s Perspective

W

illiam Hopkins, MD, an anesthesiologist/pain specialist in Campbell, Calif., has experienced firsthand the frustrations of dealing with pharmacists who have recently accelerated their demands for detailed clinical information for chronic pain patients—an experience that he says has led him to support the AMA resolution. Most commonly, he noted, it is the “big-box” chain pharmacies that will send a fax or call him requesting diagnostic details on these patients, especially when opioids are involved. “They’ll also ask whether I have plans for transitioning the patient off opioids and onto alternative agents,” he said. “There simply is not enough time in my day to give them a detailed response on the responsible steps I have taken to ensure these patients’ regimens are appropriate, whether it’s counseling and education, consultations with their primary care physicians or other involved specialists.” The “arrogance of ignorance” that underpins these requests by some pharmacists “is frankly astounding,” Dr. Hopkins said. “They presume that I didn’t already take these appropriate actions—that somehow I am prescribing controlled substances indiscriminately. They make assumptions


SEPTEMBER 2013

AnesthesiologyNews.com I 27

PA IN M E D ICIN E with regard to safety issues, and that includes the potential for drug interactions as well as the effect of a given drug for a particular person.” B. Joseph Guglielmo, PharmD, the dean and chair of clinical pharmacy at the University of California, San Francisco School of Pharmacy, added that the future of patient care “has to be one in which medical information about patients is made available to all relevant health care providers, so that ... the safest and most effective medication use will take place.” He noted that what has “limited pharmacists from maximizing their input in the community pharmacy setting has been the lack of such information.” Prescription Drug Abuse At the heart of the issue is the federal government’s stepped-up efforts to block diversion of controlled medications and contain the growing nationwide prescription drug abuse epidemic. In response to heightened scrutiny from the Drug Enforcement Administration (DEA), many drugstore chains have beefed up their controls over narcotic drug dispensing by their pharmacies. The result has been more pharmacy phone calls and faxes to prescribers without assessing the patient and without knowing my level of evaluation and decision-making.” By seeking to block his prescribing decisions, “these big-box pharmacists are rendering medical determinations without a good-faith assessment of the patient,” Dr. Hopkins said. “If I were to do that, I would be censured by the medical board. Franz Kafka couldn’t have envisioned a more absurd scenario.” This is not to say, he stressed, that there aren’t physicians who misprescribe or patients who abuse medications. “This is a huge problem,” he said. “But questioning the clinical decisions of responsible physicians ... isn’t the solution.” Dr. Hopkins added, “I am not anti-pharmacy. I hold community and hospital pharmacists in high regard. They provide a superb service by providing alerts on potential drug interactions, incorrectly written prescriptions, suspicious prescription-filling, etc. I wantt calls and faxes about those issues. What I don’tt need are demands for detailed clinical information from a pharmacist who, far removed from the clinic, is making a medical decision at variance to my own, and in so doing, causing patient distress and wasting my time. This promotes friction and distrust. This latest trend seems driven by fear of current media and pressure, not by clinical competence or compassion.” —David Bronstein

requesting the validation of information to ensure that the pain-killingg drugs were not being abused or falling into the wrong hands. Richard Pieters, MD, a radiation oncologist at the University of Massachusetts Medical Center and president-elect of the Massachusetts Medical Society, who wrote the original draft for the AMA resolution, said a major reason for the AMA’s action was the Walgreens Company’s policy of requiring its pharmacists to

“demand” information before filling narcotic prescriptions, including diagnoses, International Classification of Diseases Ninth Revision codes, patient treatment plans and previously tried medications. “This is beyond the scope of practice for the pharmacist,” Dr. Pieters said. “It’s not appropriate to be asking that kind of question. It’s an intrusion into the practice of medicine.” He said “pharmacy phone calls for allergies, drug interactions, strengths are totally

appropriate. And we understand that there is a [prescription drug abuse] scourge and that drug overdoses are a major problem. But this is not how you fix it. This is the drugstore chains trying to look like good citizens on the backs of the medical community.” Walgreens did not reply to a request for comment, but a spokesman for the National Association of Chain Drug Stores told American Medical News that pharmacies have had to respond to see AMA page 28

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new levels of DEA scrutiny over the purported overdispensing of controlled substances. In June, Walgreens agreed to pay $80 million to settle DEA and Department of Justice charges that it failed to exercise sufficient controls over the dispensing of narcotic medications at some of its pharmacies. As part of the settlement, the company also agreed to surrender its DEA registrations at six Florida pharmacies until May 2014 and at its Jupiter distribution center until September 2014. Walgreens also instituted an education program for its pharmacy team members to provide them “with the tools, training and support they need to ensure the appropriate dispensing of controlled substances and to improve collaboration across the industry.” Kermit Crawford, president of the Pharmacy, Health and Wellness division of Walgreens, said in a statement, “We are fully committed to doing our part to prevent drug abuse. We also will continue to advocate for solutions that involve all parties— including leaders in the community, physicians, pharmacies, distributors and regulators—to play a role in finding practical solutions that combat the abuse of controlled substances and ensure patient access to critical medications.” As part of its controversial resolution, the AMA also stated that it was willing to work with stakeholders to develop “appropriate policy for pharmacists to work

with physicians in order to reduce the incidence of drug diversion and inappropriate dispensing.” Pharmacy Groups Chime In Pharmacy groups had various reactions to the AMA policy declaration. The National Community Pharmacists Association (NCPA) opposed it, calling it “shortsighted” and “simplistic” in its approach to the prescription drug abuse epidemic. “We support a collective approach to controlling abuse and diversion that involves everyone: patient, pharmacist, pharmacy benefit manager, wholesaler, manufacturer and prescriber,” NCPA said. It also noted that “additional education of prescribers” was needed to combat prescription drug abuse, an apparent reference to the AMA’s failure to mention the role that inappropriate prescribing has played in such abuse. At the American Pharmacists Association, Thomas E. Menighan, BSPharm, MBA, executive vice president and CEO, said that although pharmacists were “disappointed in the passage of a resolution that discourages a team-based approach to health care, the policy provides an opening to find solutions for controlled substance verification.” He said it was “not pharmacy’s intent to delay patients from receiving these needed medications or to unnecessarily interrupt prescribers,” and added that the situation underscored “the need for pharmacy, medicine and regulators to collaborate on solutions that address the root cause of ... abuse problems in this country.”

Kasey Thompson, PharmD, vice president of Policy, Planning and Communications for the American Society of Health-System Pharmacists (ASHP), said, “The bottom line is that there is a major prescription drug abuse epidemic in this country and we need to find more ways to work together as a health care community to solve it.” He also said that “ASHP and our other pharmacy organizations have a really good working relationship with the AMA, and I’m quite confident that we’ll find productive ways to collaborate in an interdisciplinary fashion on this issue. That’s what we’re focused on.” As for the resolution itself, Dr. Thompson said he thought it did not “really reflect the state of collaboration that exists today. If you talk with a vast majority of ASHP’s 42,000 members, you’ll hear story after story about how they work in an interdisciplinary team in the care of patients. It’s the health care delivery system of the 21st century; there’s more collaboration, not less, going on.” And indeed, Dr. Pieters said that, outside of the experiences that led to the AMA resolution, his own working relationships with pharmacists were “excellent. Pharmacists are very valuable members of the team. In addition to being a radiation oncologist, I’m board-certified in hospice and palliative medicine, and pharmacists are fantastic resources in terms of suggesting alternative drugs.” —Bruce and Joan Buckley

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Controversies in the Anesthetic Management of the Obese Surgical Patient

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George A. Mashour; Michael S. Avidan August 23, 2013 The fields of anesthesiology and perioperative medicine have now shifted to the consideration of the nervous system. Complications such as delirium, cognitive decline, anesthetic neurotoxicity, stroke and other devastating nervous system events are only now gaining significant scientific and clinical attention.

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surgeons and recovery nurses. The survey consisted of one open-ended question: “What are the three most important qualities of an anesthetist?” The respondents provided 43 different qualities. Most listed competency and communication skills as important, but other qualities showed marked discrepancies. For instance, only 6% of anesthesiologists said they believed approachability was an important quality for them to have, compared with 61% of recovery nurses. And although 52% of anesthesiologists thought it was important they stay calm under pressure, that quality was listed by only 31% of surgeons and 13% of recovery nurses. It is crucial that anesthesiologists consider what each member of their team is expecting from them, said Dr. Petsas, who presented the findings at Euroanaesthesia 2013 (abstract

1095). “We don’t work alone,” she told Anesthesiology News. “If you are just evaluating your own practice, you have a narrow perspective. It is important to take a step back and see what everyone else expects you to do, so you know what to be improving on. Otherwise, we just keep improving on things we think are important, and our specialty will never progress.” But the disconnect can go both ways, Dr. Petsas noted. For example, surgeons rated efficiency as quite important in an anesthesiologist, whereas anesthesiologists ranked it as significantly less important than other qualities, such as competency. This difference in perception is not a huge surprise, she said, because surgeons often are under pressure to complete cases quickly, which can lead to errors. “Anesthesiologists can educate surgeons about that,” she said. “It is not just about speed; it is about quality.”

One surprising finding was that few specialties highlighted the importance of safety or compassion in anesthesiologists, despite the fact that in the United Kingdom, there has been much discussion and controversy over hospitals providing substandard care, causing the National Health Service to emphasize the importance of compassion. The observation that different specialties would seek different qualities from an anesthesiologist is not surprising, said John Dombrowski, MD, director of pain medicine at the Washington Pain Center, in Washington, D.C., who was familiar with the survey findings. In the operating room (OR), a surgeon needs an anesthesiologist who can communicate and cooperate with everyone around them, he said, so naturally more surgeons listed “team player” as important than any other specialty. “Surgeons do not need anesthesiologists to be ‘approachable,’ as

they are already in the OR,” said Dr. Dombrowski, who is on the board of directors of the American Society of Anesthesiologists and chair of its committee on communications. “In contrast, recovery nurses are dealing with all of patients’ concerns and issues following surgery, so [they] need to be able to ask anesthesiologists many questions. So for them, approachability was the most common quality they listed. That’s why you see so many different emphases on the facets of an anesthesiologist. Each one needs us for a different reason.” Anesthesiologists should remember that each setting requires different skills, and they must adapt to the needs of those around them, Dr. Dombrowski said. “We don’t have to be everything to everybody—but in different situations, we have to know what’s needed.” —Alison McCook

Neuromodulation Guidelines Aim High

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dvocates for the use of neuromodulation in the treatment of chronic pain believe the approach remains underused despite data supporting its safety and efficacy. However, newly released guidelines designed to clarify patient selection criteria and reduce complications associated with the technique may change that. Developed by a group of more than 60 pain specialists and researchers calling themselves the Neuromodulation Appropriateness Consensus Committee Advertisement

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(NACC) and presented at the 11th World Congress of the International Neuromodulation Society (INS) in Berlin in June, the guidelines are designed to address provider training, patient screening and treatment recommendations for neuromodulation, an ever-evolving—and largely drug-free—approach to pain care that is attracting added attention as the debate regarding the use of opioid analgesics in this patient population continues. At press time, the guidelines had been submitted for publication in Neuromodulation: Technology at the Neural Interface, the peer-reviewed journal of the INS. “We are seeing rapid development [in neuromodulation technology] that will enhance outcomes and reduce complications, and new studies suggest [the approach can] reduce opioids and disability and improve quality of life,” said Timothy Deer, MD, INS president-elect and director of the Center for Pain Relief in Charleston, W. Va. “With this new technology comes the need for guidance in the proper ways to employ it.” Historically, neuromodulation has been associated with complications and treatment failures. However, Dr. Deer and his fellow NACC members believe that this is a direct result of the lack of “proper training” of physicians in both “technique and [patient] selection.” They developed the guidelines, according to Dr. Deer, with an eye toward increasing the “judicious and proper selection of candidates” for neuromodulation, and reducing the “higher than expected” number of treatment failures with the approach. Among their recommendations: • Neuromodulation providers should each receive at least 12 hours of continuing medical education per year directly related to improving outcomes with neuromodulation. • Spinal cord stimulation (SCS) should be used early

in the treatment of failed back surgery syndrome provided there is no progression of a neurologic condition requiring semi-urgent intervention. • Selection of patients for neuromodulation should be made in conjunction with clinicians who are treating coexisting conditions. • SCS and peripheral nerve stimulation should be considered earlier, when possible, and trialed in the first two years of chronic pain. • Peripheral nerve stimulation (beyond the spine) should be reserved for patients in whom the pain distribution is primarily in a named nerve that is known to connect to the area of pain. • SCS should be used as an early intervention in patients with Raynaud’s syndrome and other ischemic vascular disorders. As a practitioner who uses neuromodulation techniques, and has been involved in trials of SCS as well as peripheral nerve stimulation, Ebby Varghese, MD, medical director of the Interventional Pain Medicine Clinic and assistant professor of clinical physical medicine and rehabilitation, University of MissouriColumbia, believes the guidelines will ultimately increase patient access to what he sees as a valuable treatment modality. He was not involved in the development of the guidelines. “Neuromodulation is a tool that pain physicians, whether or not they are fellowship trained, can offer their patients,” Dr. Varghese said. “It is important that all physicians, no matter what their background is, understand when neuromodulation should be used. Otherwise, this therapy would be offered at the wrong time to the wrong individual, which can lead to poor outcomes. Enough poor outcomes may lead to payors denying payment on this important pain modulator.” —Brian Dunleavy


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ASA Corporate Non-CME Educational Update Program

Noninvasive Monitoring Advancements to Improve Perioperative Patient Safety October 13, 2013 7:00–9:30 pm San Francisco Marriott Marquis

Take advantage of this comprehensive update and case-based learning approach to applying the latest advancements in noninvasive monitoring in perioperative care. Advanced Application of Pulse Oximetry for Oxygen Transport and Fluid Management

Optimizing Transfusion Decisions: Mechanisms of Overuse and Advancements in Hemoglobin Monitoring

Steven J. Barker, PhD, MD Professor of Anesthesiology, The University of Arizona

Keith J. Ruskin, MD Professor of Anesthesia, Neurosurgery, Director of Neuroanesthesia, Yale Medical Center

Clinical and Cost Effectiveness of Continuous Postoperative Monitoring: The Dartmouth Experience

Expanding the Role of EEG Monitoring to Identify the Unique Anesthetic Agent Signatures

Andreas H. Taenzer, MD, MS Associate Professor of Anesthesiology and Pediatrics Director, Pediatric Acute Pain Service, Dartmouth Hitchcock Medical Center

Emery N. Brown, MD, PhD Warren M. Zapol Professor of Anaesthesia Massachusetts General Hospital/Harvard Medical School Edward Hood Taplin Professor of Medical Engineering Professor of Computational Neuroscience Massachusetts Institute of Technology

Register Today! www.masimo.com/ASA_NON-CME2013 Space is limited. RSVP required.


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SEPTEMBER 2013

REPORT Management of Opioid-Induced Constipation in Patients With Advanced Illness of pain related to tumor enlargeoderate to severe pain is a ment, metastasis or, as another common clinical problem Faculty example, neuropathic pain in the among patients with advanced illsetting of diabetes mellitus. Other ness, particularly in the palliative Darren Brenner, MD times, the pain may be iatrogenic care setting. Although cancer pain Assistant Professor of Gastroenterology in etiology, such as complicahas historically received the most and Hepatology tions related to radiation therapy attention, patients with AIDS, Northwestern University Feinberg for the treatment of cancers, or advanced congestive heart failure, School of Medicine neuropathy induced by antiretroand advanced lung disease also Chicago, Illinois viral or chemotherapeutic agents. commonly experience pain.1 Unfortunately, the prevalence of “When we look at patients with Joseph Pergolizzi, MD pain is quite high in the palliative advanced illness, pain is one of Adjunct Associate Professor of care setting.” the most prevalent symptoms Pharmacology In fact, a meta-analysis of that patients report,” said Joseph Temple University School of Medicine studies published during the Pergolizzi, MD, adjunct associate Philadelphia, Pennsylvania past 40 years found that 64% professor of pharmacology, Temof patients with advanced-stage ple University School of Medicine cancer reported significant pain in Philadelphia, Pennsylvania. in their daily lives.2 Another review, which included patients “This pain can arise due to the illness itself, such as in cases

M

Indication ®

RELISTOR is indicated for the treatment of opioidinduced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied.

Contraindications RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstructions. Please see Important Safety Information throughout and brief summary of Prescribing Information on page 12.

Supported by


REPORT

with advanced illnesses such as cancer, AIDS, heart disease, chronic obstructive pulmonary disease (COPD), and renal disease reported that the prevalence of pain across 28 studies ranged between 34% and 96%.3 Moreover, the prevalence of pain among patients receiving hospice care may be as high as 90%.4 “The severity of pain has an important influence in the choice of treatment strategy,” Dr. Pergolizzi explained. “When patients report moderate to severe pain, that’s where we really rely on the opioids. In fact, escalating doses of opioids are oftentimes the only effective option for pain control in advanced disease.” This notion is endorsed by guidelines from several major societies in the United States, such as the American College of Physicians and the National Comprehensive Cancer Network, which recommend that opioids should be used for the treatment of moderate to severe pain in patients with advanced illness.5,6 Opioids, however, are associated with numerous adverse events (AEs), including nausea, sedation, pruritus, and respiratory depression.5,7 Perhaps the most common opioid AEs are those affecting the gastrointestinal (GI) tract, including opioidinduced constipation (OIC).8-10 The following report provides an overview of OIC, including a review of its epidemiology, risk factors, and how its pathophysiology and management differ from that of primary constipation, as well as a review of data for recently approved options for the management of this condition.

Pathophysiology of OIC Darren Brenner, MD, assistant professor of gastroenterology and hepatology, Northwestern University Feinberg School of Medicine in Chicago, Illinois, noted that, “in terms of pathophysiology, OIC is quite distinct from other forms of constipation.” For example, physiologic constipation results from extrinsic, non–disease-related factors that affect bowel function, such as decreased physical activity and inadequate dietary fiber and fluid intake. These factors may cause decreased bowel motility and increased transit time, which allows more time for fluid resorption in the intestinal lumen, leading to hard and dry stools.9 In other cases, constipation may result from pathologic conditions in the setting of underlying GI, nervous system, or metabolic disorders that interfere with GI motility or fluid absorption/secretion.9,11

“In contrast, OIC is mediated by the effect of opioids on opioid receptors that are located throughout the GI tract and the enteric nervous system,” said Dr. Brenner. The 3 major opioid receptors in the enteric nervous system are the μ-, γ-, and κ-subtypes.12 The μ-receptors are widely distributed in the GI tract submucosa as well as the ileal mucosa, where they influence ion transport changes.12 The primary mediator involved in the development of OIC is the μ-opioid receptor; inhibition of excitatory and inhibitory neurotransmitters occurs when opioid agonists bind to this receptor, causing multiple effects that contribute to OIC.7,13,14 These include inhibition of gastric emptying, reduction of mucosal secretions, and a decrease in peristalsis throughout the GI tract, thereby delaying transit.14,15 Furthermore, opioids stimulate non-propulsive motility, intestinal segmentation and tone, and increased pyloric and ileocecal sphincter tone. Opioids also result in increased absorption of fluids, mainly by delayed transit—increasing contact time for absorption—and by stimulating mucosal sensory receptors that activate a reflex arc that facilitates further fluid absorption.14 All of these pathophysiologic processes conspire to result in hard, dense stools and decreased motility, resulting in significant constipation14 that may be refractory to traditional strategies used to alleviate constipation.15 “Patients with advanced illness also may have autonomic dysfunction leading to GI motility disorders. For example, HIV affects local humoral immunity and causes motility disturbances via its influence on autonomic nerves,” said Dr. Pergolizzi. “Using opioids for any treatment [in patients with advanced illness] is going to be detrimental to the GI tract given the plethora of μ-opioid receptors located across the entire intestinal lining,” said Dr. Brenner. “However, treatment guidelines still rely on opioids for the treatment of moderate to severe pain, and I don’t see that changing any time soon. So the best thing we can do is develop strategies to overcome adverse GI events related to their use.” Nonselective opioid-receptor antagonists such as naloxone and naltrexone target the μ-, γ-, and κ-opioid receptors, which led to interest in their use for opioid therapy.15 However, both agents can cross the blood–brain barrier and antagonize receptors that mediate the analgesic effect of opioids.12,16

Important Safety Information RELISTOR ® (methylnaltrexone bromide) Subcutaneous Injection is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician. Rare cases of gastrointestinal (GI) perforation have been

2

reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (ie, cancer, peptic ulcer, Ogilvie’s syndrome). Perforations have involved varying regions of the GI tract (eg, stomach, duodenum, colon). Use RELISTOR with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR


REPORT

“The last thing that we want to do in the palliative care setting is to reduce the analgesic effects of our opioids, because our primary goal is to reduce pain in these patients,” said Dr. Pergolizzi.

Epidemiology and Consequences of OIC OIC is an anticipated side effect of opioid therapy. Its overall relevance to the clinical community continues to increase, mainly because of the rising therapeutic use of opioids.17 For example, OIC rates in patients receiving cancer treatment and opioids can range from 69% to 90%,18,19 and studies of patients with advanced cancer who are receiving hospice care report rates as high as 87%.20 Additionally, among individuals with advanced illnesses other than cancer who are receiving opioid therapy, the prevalence of opioid-induced GI AEs approaches 90%.21 “In the palliative care patient with advanced disease, we are more aggressive in the use of opioids to reduce pain with the goal of comfort,” said Dr. Pergolizzi. “Although we try to balance the role of analgesic-related side effects, oftentimes, relief of pain is more important for these patients. As such, we typically use higher dose of opioids, which results in more adverse effects.” Risk factors for OIC include advanced age, opioid type/ strength, and advanced illness (eg, cancer, AIDS, or cardiovascular disease).18,20,21 Furthermore, the risk for OIC increases with relative immobility, dehydration, and altered nutritional intake, all of which are common in patients with advanced illnesses, particularly in the palliative care setting.21 Although patients may slowly acquire a tolerance to opioid-related side effects such as nausea or sedation, OIC may continue unabated throughout treatment.21 Dr. Pergolizzi said that there are several notable consequences of OIC. “First, OIC can result in other GI symptoms, including nausea and vomiting and a decreased ability to take in oral medications and nutrients. Second, if patients have no remedy to relieve the symptoms and complications of OIC as an outpatient, they really have no other option than to come to the emergency department to be evaluated. In some cases, the symptomatology and consequences of OIC are sufficiently severe to warrant hospitalization for more aggressive

interventions,” he said. “When you consider the patient with advanced illness, especially those in the palliative care setting, they would really rather not be hospitalized provided they have some option to adequately relieve OIC at home.” The consequences of OIC are diverse and significant. Clinical manifestations include abdominal pain, distension, and nausea and vomiting.9 When left untreated, OIC may lead to inadequate absorption of oral medications, fecal impaction, hemorrhoids, bowel obstruction, and intestinal perforation.9 “There is a vicious circle that exists between opioid use for the relief of pain and the subsequent pain and discomfort that can result from the development of secondary constipation,” said Dr. Pergolizzi. “Specifically, patients are given opioids to relieve the primary pain related to their advanced illness but end up developing OIC, which can, itself, be a painful condition. [When laxative agents provide insufficient relief,] patients are then faced with the choice of either refraining from further opioid therapy to relieve OIC, in which case the pain from their primary condition is not adequately treated, or taking larger doses of opioids and potentially worsening the pain associated with OIC.”

Treatment of OIC in Advanced Illness Physiologic constipation is typically managed through a combination of behavioral strategies and the use of agents designed to increase stool bulk, improve intestinal motility, and/ or aid the passage of stools through softening agents.9 Supportive strategies include increased hydration and improved patient mobilization—which can be difficult for patients with advanced illness—along with addressing the etiologic triggers of constipation.9 Laxatives are the first-line therapeutic option for OIC, and the various classes of laxative agents used to relieve physiologic mechanisms of constipation are summarized in Table 1.22,23 However, data from clinical trials suggest that conventional laxatives (eg, over-the-counter laxatives, polyethylene glycol, lactulose, magnesium citrate) may not offer adequate symptom relief for some patients.15,21 As reviewed in the section on the pathophysiology of different types of constipation, OIC in advanced illness is unique from other forms of constipation. “When we look at laxatives

Important Safety Information (continued) and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms. Use of RELISTOR has not been studied in patients with peritoneal catheters. Use of RELISTOR beyond four months has not been studied. Safety and efficacy of RELISTOR have not been established in pediatric patients.

The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5%), flatulence (13.3%), nausea (11.5%), dizziness (7.3%), diarrhea (5.5%), and hyperhidrosis (6.7%). Please see Important Safety Information throughout and brief summary of Prescribing Information on page 12.

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Table 1. Conventional Laxative Options for Opioid-Induced Constipation in Advanced Illness Type

Attributes

Examples

Side Effects/Complications

Bulk laxatives

Dietary fiber; causes water retention in the colon and increases stool bulk

Psyllium husk, methylcellulose

Increased gas; risk for bowel obstruction in patients with strictures

Osmotic laxatives

Salt content retains fluid retention and increased intestinal secretions

Sorbitol, lactulose, polyethylene glycol, magnesium citrate

Electrolyte imbalances; increased gas, nausea, and dehydration

Stool softeners

Decrease surface tension to lubricate and soften fecal matter

Dioctyl sodium, calcium sulfosuccinate

Require adequate fluid intake, useless in patients with compromised bowel motility

Stimulants

Increase colonic motility and electrolyte transport; stimulate fluid secretion

Senna, cascara, bisacodyl

Electrolyte imbalances; abdominal pain, nausea, and colonic dysmotility

From references 22 and 23.

and stool softeners, we see dramatic variability in terms of the response to such agents across our patient populations. A lot of that has to do with the specific mechanisms of constipation, particularly in patients with OIC,” said Dr. Pergolizzi. Another strategy that has been recommended to relieve AEs while maintaining analgesia is that of opioid rotation.5,24 This tactic is predicated on the fact that patients react differently to various types of opioids, which implies both incomplete crosstolerance and distinct variations in their pharmacodynamics and opioid-receptor binding affinities.24,25 However, this strategy has shown only moderate benefits in the reduction of OIC

and other related AEs. Narabayashi and colleagues investigated the safety of an opioid rotation in cancer patients and found that side effects commonly recurred after switching from one agent to another.26 There also are therapeutic equivalence concerns when switching from one opioid to another. Current recommendations are based on studies conducted within different patient populations that analyzed dose equivalency, not pain management.24,25 The relative ineffectiveness of traditional strategies for OIC has prompted research and development of targeted therapies, as some patients require additional therapeutic options.

Important Safety Information RELISTOR ® (methylnaltrexone bromide) Subcutaneous Injection is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician. Rare cases of gastrointestinal (GI) perforation have been

4

reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (ie, cancer, peptic ulcer, Ogilvie’s syndrome). Perforations have involved varying regions of the GI tract (eg, stomach, duodenum, colon). Use RELISTOR with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR


REPORT

Blood-Brain Barrier Opioid

RELISTOR

Mu-opioid μ-opioid receptor receptor

Figure 1. Relistor inhibits opioids from m binding with μ-receptors in tissues such as the gastrointes gastrointestinal tract.

“Until recently, the only agents available were ere those being used to treat the more typical types of constipation—bulknstipation—bulking agents, osmotic and stimulant laxatives,” said Dr. Brenner. “Now we’re moving into an era where we’re developing [second-line] agents that focus on the precise pathophysiologic mechanisms of OIC to provide specific and effective antidotes.”

Peripheral Opioid-Receptor Antagonists The limitations of nonselective opioid antagonists have prompted the development of agents that do not cross the blood–brain barrier. These agents ideally would avoid the

analgesic-dampening and opioid-withdrawal effects ef of opioidreceptor antagonists while maintaining therape therapeutic efficacy for the alleviation of OIC.15 N-methylation of naltrexone results in a charged derivative, methylnaltrexone (Relistor, Salix Pharmaceuticals), which has restricted ability to cross the blood–brain barrier in humans because of its polarity and low lipid solubility.27 Relistor antagonizes μ-opioid receptors, which reverses opioid-induced delays on GI motility in a dose-dependent manner.27 Figure 1 shows Relistor blocking opioids from binding to μ-receptors within the GI tract.

Important Safety Information (continued) and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms. Use of RELISTOR has not been studied in patients with peritoneal catheters. Use of RELISTOR beyond four months has not been studied. Safety and efficacy of RELISTOR have not been established in pediatric patients.

The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5%), flatulence (13.3%), nausea (11.5%), dizziness (7.3%), diarrhea (5.5%), and hyperhidrosis (6.7%). Please see Important Safety Information throughout and brief summary of Prescribing Information on page 12.

5


REPORT

Placebo

80

RELISTOR 0.15 mg/kg

70

62%

a

58% a

Patients, %

60

RELISTOR 0.30 mg/kg 48% a

50 40 30 20

16% 14%

10 0 (n=52)

(n=47)

(n=55)

Study 1

(n=71)

(n=62)

Study 2

Figure 2. Laxation response rates within 4 hours of the first dose during clinical trials of Relistor in patients with advanced illness. a

P<0.0001 vs placebo

From reference 27.

The efficacy and safety of Relistor for OIC in patients with advanced illness were investigated in 2 clinical trials (Figure 2).27 Slatkin and colleagues conducted a randomized double-blind, placebo-controlled trial that compared a single subcutaneous injection of Relistor (0.15 mg/kg or 0.30 mg/kg) with placebo for OIC.21 The study included 154 patients with advanced illness such as cancer or other end-stage conditions (eg, cardiovascular disease, HIV/AIDS) who were receiving palliative care.21 Participants had received opioid therapy for at least 3 days before study randomization and had not experienced a bowel movement within 48 hours of the first dose.21

Within 4 hours of treatment, laxation response rates for Relistor doses of 0.15 mg/kg (n=47) and 0.30 mg/kg (n=55) were 61.7% and 58.2%, respectively, compared with 14% for placebo (P<0.0001). In fact, roughly half of the Relistor responders defecated within 30 minutes of receiving the agent.21 Within 24 hours, laxation rates remained steady for 0.15 mg/kg Relistor (68.1%) and 0.30 mg/kg Relistor (63.6%) compared with placebo (26.9%).21 The investigators reported comparable efficacy between both doses of Relistor, but patients in the 0.30 mg/kg treatment arm had higher rates of abdominal pain (38.2% vs 27.7%).21

Important Safety Information RELISTOR ÂŽ (methylnaltrexone bromide) Subcutaneous Injection is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician. Rare cases of gastrointestinal (GI) perforation have been

6

reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (ie, cancer, peptic ulcer, Ogilvie’s syndrome). Perforations have involved varying regions of the GI tract (eg, stomach, duodenum, colon). Use RELISTOR with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR


REPORT

Table 2. Common Adverse Reactions Associated With Relistor During Clinical Trials in Patients With Advanced Illness RELISTOR a (n=165)

Placebo (n=123)

Pts (%)

Pts (%)

Abdominal pain

47 (28.5)

12 (9.8)

Flatulence

22 (13.3)

7 (5.7)

Nausea

19 (11.5)

6 (4.9)

Dizziness

12 (7.3)

3 (2.4)

Diarrhea

9 (5.5)

3 (2.4)

Hyperhidrosis

11 (6.7)

8 (6.5)

Adverse Reaction

a

Includes doses of 0.075, 0.15, and 0.30 mg/kg

From reference 27.

Other common AEs related to Relistor during this trial in the 0.15 mg/kg and 0.30 mg/kg treatment arms were flatulence (12.8% and 14.5%), nausea (4.3% and 14.5%), and dizziness (4.3% and 9.1%).21 In a similar study by Thomas and colleagues, 133 patients who had received opioids for at least 2 weeks and developed OIC that was refractory to the use of laxatives were randomly assigned to receive subcutaneous Relistor (0.15 mg/kg; n=63) or placebo (n=71) every other day for 2 weeks.28 Participants were recruited from palliative care settings and had advanced illness such as cancer, cardiovascular disease, COPD, emphysema,

Alzheimer’s disease, or dementia.28 The proportion of patients who experienced laxation within 4 hours was significantly higher in the Relistor group than in the placebo group (48% vs 15%, respectively; P<0.0001).28 Additionally, the median time to laxation after the first dose was significantly shorter in the Relistor group than in the placebo group (6.3 vs 48 hours, respectively; P<0.002).28 The most common AEs related to Relistor during this trial were abdominal pain (17%), flatulence (13%), nausea (11%), increased body temperature (8%), and dizziness (8%).28 The study by Thomas and colleagues also included an open-label extension in which patients received Relistor as

Important Safety Information (continued) and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms. Use of RELISTOR has not been studied in patients with peritoneal catheters. Use of RELISTOR beyond four months has not been studied. Safety and efficacy of RELISTOR have not been established in pediatric patients.

The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5%), flatulence (13.3%), nausea (11.5%), dizziness (7.3%), diarrhea (5.5%), and hyperhidrosis (6.7%). Please see Important Safety Information throughout and brief summary of Prescribing Information on page 12.

7


REPORT

needed each day for 3 months. A total of 89 patients entered this phase of the trial (47 from the Relistor group, 42 from the placebo group).28 By the end of the 3-month extension, patients from the placebo group improved their rescuefree response rates from 11% to 52%; patients from the initial Relistor group improved their response rates from 45% to 57%.28 Median time to laxation for all patients was less than 45 minutes.28 The most common AEs during this phase were abdominal pain (30%), progression of malignant neoplasm (24%), nausea (21%), and vomiting (20%). Serious AEs related to Relistor were muscle spasms (1 patient) and exacerbated pain (1 patient); 32 deaths occurred, with all attributed to underlying disease.28 In both the Slatkin and Thomas studies, participants were permitted to continue their previously initiated laxative therapy, just not within 4 hours of study treatments. Figure 2 provides laxation rates from the 2 clinical trials of Relistor within 4 hours of the first dose.27 “In the 2 pivotal trials, the clinical benefit associated with the fact that methylnaltrexone does not cross the blood–brain barrier was confirmed by observations showing there was no analgesic-stealing effect,” said Dr. Pergolizzi. Indeed, in both trials there was no change in pain scores or evidence of central-opioid withdrawal in response to Relistor.21,28 Abdominal pain and flatulence were the most common AEs attributed to Relistor during the 2 clinical trials (Table 2).27 A post hoc analysis of abdominal pain rates during these studies found that it consisted primarily of abdominal cramping and did not affect patients’ overall evaluation of pain.29 These AEs were mostly mild to moderate in severity and did not affect patients’ global evaluation of pain. The incidence of abdominal pain in Relistor-treated patients was highest following the first dose and it decreased with subsequent doses.29 Of note, rare postmarketing cases of GI perforation have been reported in association with Relistor, particularly in patients with abnormal structural integrity in the walls of the GI tract, such as those with cancer, peptic ulcer, or Ogilvie’s syndrome. As a result, the prescribing information includes a warning that Relistor should be used with caution in patients with a known or suspected GI tract lesions.27 On the basis of these trials, in 2008 the FDA approved the use of Relistor for the treatment of OIC in patients with

advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. 27 Relistor is administered as a subcutaneous injection, and a typical schedule is 1 dose every other day as needed, but not to exceed more than 1 dose in a 24-hour period.27 Use of Relistor beyond 4 months has not been studied. The recommended dose of Relistor is 8 mg for patients who weigh between 38 and 61 kg; 12 mg for patients who weigh between 62 and 114 kg; and 0.15 mg/kg for patients who fall outside of these weight ranges.27 Only patients who require an 8- or 12-mg dose should be prescribed prefilled syringes. No dose adjustment is required in patients with mild or moderate renal impairment. In patients with severe renal impairment (creatinine clearance <30 mL/min), dose reductions of Relistor by one half are recommended.27 If severe or persistent diarrhea occurs during treatment, patients should discontinue therapy with Relistor and consult their physician. If patients develop severe, persistent, and/or worsening abdominal symptoms, they should discontinue therapy with Relistor and promptly notify their physician. Use of Relistor has not been studied in patients with peritoneal catheters. Dr. Pergolizzi views subcutaneous Relistor administration as one of several unique advantages. “The fact that we can administer this agent via the subcutaneous route in patients undergoing palliative care is important, as many of these patients are unable to take in medications by mouth due to nausea, dysphagia, or decreased levels of consciousness. OIC itself can also cause significant nausea and may preclude oral medication intake for some patients,” he said.

Treatment Algorithm for Opioid-Induced Constipation in Advanced Illness With the approval of Relistor for the treatment of OIC in patients with advanced illness who are receiving palliative care when laxative therapy has not been sufficient, Drs. Brenner and Pergolizzi discussed the current landscape and clinical management of OIC in patients with advanced illness, including a potential treatment algorithm (Figure 3). “According to the FDA-approved labeling, methylnaltrexone is indicated for the second-line treatment of OIC. Therefore, the first step for patients with OIC will still be a trial of

Important Safety Information RELISTOR ® (methylnaltrexone bromide) Subcutaneous Injection is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician. Rare cases of gastrointestinal (GI) perforation have been

8

reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (ie, cancer, peptic ulcer, Ogilvie’s syndrome). Perforations have involved varying regions of the GI tract (eg, stomach, duodenum, colon). Use RELISTOR with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR


REPORT

OIC in a patient with advanced illness undergoing palliative care

ª Trial of oral first-line laxative agent

ª Nonresponse or insufficient response

ª Relistor Trial Subcutaneous injection every other day, as needed, but no more frequently than 1 dose in a 24-h period Approved doses: • 8 mg for patients weighing 38-61 kg • 12 mg for patients weighing 62-114 kg • 0.15 mg/kg for patients whose weight falls outside of these ranges

ª

the traditional laxative therapies. For patients who fail to have a response to the traditional agents, you would proceed to methylnaltrexone. The mechanism of action for methylnaltrexone is well-suited for the treatment of OIC, so if the patient describes a clinical history in which they had regular bowel movements then developed constipation after initiation of opioid therapy, I would use methylnaltrexone,” said Dr. Pergolizzi. “Methylnaltrexone is indicated to be used when other laxatives have failed. But if a patient has a clear history of OIC [and hasn’t responded to first-line therapies], I wouldn’t spend a great deal of time switching from one laxative to another before prescribing methylnaltrexone,” said Dr. Brenner. According to Dr. Pergolizzi, determining the success of laxative therapy is, thankfully, not all that difficult. “When prescribing medications for the treatment of OIC, you have an easy, objective end point to follow: Has the patient had symptomatic relief in terms of a bowel movement or not? Methylnaltrexone offers a predictable and rapid response in the majority of patients with OIC,” he said.

Conclusion OIC is a highly prevalent side effect of opioid therapy. The pathophysiology of OIC is unique from that of physiologic constipation or constipation due to primary GI, neurologic, or metabolic conditions. Conventional therapies may be ineffective in restoring normal bowel function in patients with OIC. Relistor is an effective second-line therapy and initial prescription option for the treatment of OIC in patients with advanced illness who are receiving palliative care.

Nonresponse or insufficient response

ª Rescue therapy (ie, enemas, manual disimpaction)

Figure 3. Faculty-proposed treatment algorithm for OIC in advanced illness. OIC, opioid-induced constipation

Important Safety Information about RELISTOR RELISTOR ® (methylnaltrexone bromide) Subcutaneous Injection is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician. Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may

Important Safety Information (continued) and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms. Use of RELISTOR has not been studied in patients with peritoneal catheters. Use of RELISTOR beyond four months has not been studied. Safety and efficacy of RELISTOR have not been established in pediatric patients.

The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5%), flatulence (13.3%), nausea (11.5%), dizziness (7.3%), diarrhea (5.5%), and hyperhidrosis (6.7%). Please see Important Safety Information throughout and brief summary of Prescribing Information on page 12.

9


REPORT

be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (ie, cancer, peptic ulcer, Ogilvie’s syndrome). Perforations have involved varying regions of the GI tract (eg, stomach, duodenum, colon). Use RELISTOR with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms. Use of RELISTOR has not been studied in patients with peritoneal catheters.

Use of RELISTOR beyond four months has not been studied. Safety and efficacy of RELISTOR have not been established in pediatric patients. The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5%), flatulence (13.3%), nausea (11.5%), dizziness (7.3%), diarrhea (5.5%), and hyperhidrosis (6.7%).

References

8.

Glare P, Walsh D, Sheehan D. The adverse effects of morphine: a prospective survey of common symptoms during repeated dosing for chronic cancer pain. Am J Hosp Palliat Med. 2006;23(3):229-235.

9.

Mancini I, Bruera E. Constipation in advanced cancer patients. Support Care Cancer. 1998;6(4):356-364.

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2.

van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, et al. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol. 2007;18(9):1437-1449.

3.

Solano JP, Gomes B, Higginson IJ. A comparison of symptom prevalence in far advanced cancer, AIDS, heart disease, chronic obstructive pulmonary disorder, and renal disease. J Pain Symptom Manage. 2006;31(1):58-69.

4.

5.

6.

7.

10

Fine PG, Portenoy RK. Opioid therapy in advanced medical illness. In: William Roberts, Colleen Sauber, eds. A Clinical Guide to Opioid Analgesia. New York, NY: McGraw-Hill; 2004:115-120.

Kutner JS, Kassner CT, Nowels DE. Symptom prevalence at the end of life: hospice providers’ perceptions. J Pain Symptom Manage. 2001;21(6):473-480. Swarm R, Abernethy AP, Anghelescu DL, et al; NCCN Adult Cancer Pain. Adult cancer pain. J Natl Compr Canc Netw. 2010;8(9):1046-1086. Qaseem A, Snow V, Shekelle P, et al; Clinical Assessment Subcommittee of the American College of Physicians. Evidence-based interventions to improve the palliative care of pain, dyspnea, and depression at the end of life: a clinical practice guidelines from the American College of Physicians. Ann Intern Med. 2008;148(2):141-146. Bader S, Jaroslawski K, Blum HE, Becker G. Opioid-induced constipation in advanced illness: safety and efficacy of methylnaltrexone bromide. Clin Med Insights Oncol. 2011;5:201-211.

Please see brief summary of Prescribing Information on page 12.

10. Clemens KE, Klaschik EK. Managing opioid-induced constipation in advanced illness: focus on methylnaltrexone bromide. Ther Clin Risk Manage. 2010;6:77-82. 11. Wingate D, Hongo M, Kellow J, et al. Disorders of gastrointestinal motility: towards a new classification. J Gastroenterol Hepatol. 2002;(17 suppl):S1-S14. 12. Camilleri M. Opioid-induced constipation: challenges and therapeutic opportunities. Am J Gastroenterol. 2011;106(5): 835-842. 13. Kurz A, Sessler DI. Opioid-induced bowel dysfunction: pathophysiology and potential new therapies. Drugs. 2003;63(7):649-671. 14. De Schepper HU, Cremonini F, Park MI, Camilleri M. Opioids and the gut: pharmacology and current clinical experience. Neurogastroenterol Motil. 2004;16(4):383-394. 15. Thomas JR, Cooney GA, Slatkin NE. Palliative care and pain: new strategies for managing opioid bowel dysfunction. J Palliat Med. 2008;(11 suppl 1):S1-S19. 16. Yuan CS, Foss JF, O’Connor M, et al. Methylnaltrexone prevents morphine-induced delay in oral-cecal transit time without affecting analgesia: a double-blind randomized placebo-controlled trial. Clin Pharmacol Ther. 1996;59(4): 469-475.


REPORT

17. Manchikanti L, Singh A. Therapeutic opioids: a ten-year perspective on the complexities and complications of the escalating use, abuse, and non-medical use of opioids. Pain Physician. 2008;11(2 suppl):S63-S88.

24. Mercandante S, Casuccio A, Fulfaro F, et al. Switching from morphine to methadone to improve analgesia and tolerability in cancer patients: a prospective study. J Clin Oncol. 2001;19(11):2898-2904.

18. Rosti G, Gatti A, Costantini A, et al. Opioid-related bowel dysfunction: prevalence and identification of predictive factors in a large sample of Italian patients on chronic treatment. Eur Rev Med Pharmacol Sci. 2010;14(12):1045-1050.

25. Vissers KP, Besse K, Hans G, et al. Opioid rotation in the management of chronic pain: where is the evidence? Pain Pract. 2010;10(2):85-93.

19. Quigley C. The role of opioids in cancer pain. BMJ. 2005; 331(7520):825-829. 20. Sykes NP. The relationship between opioid use and laxative use in terminally ill cancer patients. Palliat Med. 1998;12(5):375-382. 21. Slatkin N, Thomas J, Lipman AG, et al. Methylnaltrexone for treatment of opioid-induced constipation in advanced illness patients. J Support Oncol. 2009;7(1):39-46. 22. Benyamin R, Trescot AM, Datta S, et al. Opioid complications and side effects. Pain Physician. 2008;11(2 suppl): S105-S120. 23. Schaefer DC, Cheskin LJ. Constipation in the elderly. Am Fam Physician. 1998;58(4):907-914.

26. Narabayashi M, Saijo Y, Takenoshita S, et al; Advisory Committee for Oxycodone Study. Opioid rotation from oral morphine to oral oxycodone in cancer patients with intolerable adverse effects: an open-label trial. Jpn J Clin Oncol. 2008;38(4):296-304. 27. Relistor (methylnaltrexone bromide) subcutaneous injection [prescribing information]. Philadelphia, PA: Wyeth Pharmaceuticals, Inc; 2012. 28. Thomas J, Karver S, Cooney GA, et al. Methylnaltrexone for opioid-induced constipation in advanced illness. N Engl J Med. 2008;358(22):2332-2343. 29. Slatkin NE, Lynn R, Su C, et al. Characterization of abdominal pain during methylnaltrexone treatment of opioid-induced constipation in advanced illness: a post hoc analysis of two clinical trials. J Pain Symptom Manage. 2011;42(5):754-760.

Disclosures: Dr. Brenner reported that he has served as a consultant for Perrigo and has served as a consultant for and on the speakers’ bureau of Salix Pharmaceuticals. Dr. Pergolizzi reported that he has served as a consultant for, on the speakers’ bureau of, and received honorarium from Endo Pharmaceuticals, Johnson & Johnson, Purdue Pharma, and Salix Pharmaceuticals. He has also served as a consultant for and received honorarium from Kirax Corporation.

Copyright © 2013, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form. REL 13/22

SR1317

Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Salix, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature.

11


Adverse Reactions from all Doses in DoubleBlind, Placebo-Controlled Clinical Studies of RELISTOR*

The following is a brief summary only; see full Prescribing Information for complete product information. INDICATIONS AND USAGE RELISTOR is indicated for the treatment of opioidinduced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied. CONTRAINDICATIONS RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. WARNINGS AND PRECAUTIONS Severe or Persistent Diarrhea If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician. Intestinal Perforation Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie’s syndrome). Perforations have involved varying regions of the GI tract (e.g., stomach, duodenum, or colon). Use RELISTOR with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms. Peritoneal Catheters The use of RELISTOR has not been studied in patients with peritoneal catheters. ADVERSE REACTIONS Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in clinical practice. The safety of RELISTOR was evaluated in two, double-blind, placebo-controlled trials in patients with advanced illness receiving palliative care: Study 1 included a single dose, double blind, placebo-controlled period, whereas Study 2 included a 14-day multiple dose, double-blind, placebo-controlled period. The most common adverse reactions (>5%) in patients receiving RELISTOR are shown in the table above.

Adverse Reaction

RELISTOR N = 165

Placebo N = 123

Abdominal Pain

47 (28.5%)

12 (9.8%)

Flatulence

22 (13.3%)

7 (5.7%)

Nausea

19 (11.5%)

6 (4.9%)

Dizziness

12 (7.3%)

3 (2.4%)

Diarrhea

9 (5.5%)

3 (2.4%)

Hyperhidrosis

11 (6.7%)

8 (6.5%)

* Doses: 0.075, 0.15, and 0.30 mg/kg/dose The rates of discontinuation due to adverse events during the double-blind placebo controlled clinical trials (Study 3 and Study 4) were comparable between RELISTOR (1.2%) and placebo (2.4%). Postmarketing Experience In addition to adverse events reported from clinical trials, the following adverse events have been identified during post-approval use of RELISTOR. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to RELISTOR, or a combination of these factors. Gastrointestinal Cramping, perforation, vomiting General Disorders and Administrative Site Disorders Diaphoresis, flushing, malaise, pain DRUG INTERACTIONS Drugs Metabolized by Cytochrome P450 Isozymes

In in vitro drug metabolism studies methylnaltrexone bromide did not significantly inhibit the activity of cytochrome P450 (CYP) isozymes CYP1A2, CYP2A6, CYP2C9, CYP2C19 or CYP3A4, while it is a weak inhibitor of CYP2D6. In a clinical drug interaction study in healthy adult male subjects, a subcutaneous dose of 0.30 mg/kg of methylnaltrexone bromide did not significantly affect the metabolism of dextromethorphan, a CYP2D6 substrate. Drugs Renally Excreted The potential for drug interactions between methylnaltrexone bromide and drugs that are actively secreted by the kidney has not been investigated in humans. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B Reproduction studies have been performed in pregnant rats at intravenous doses up to about 14 times the recommended maximum human subcutaneous dose of 0.3 mg/kg based on the body

surface area and in pregnant rabbits at intravenous doses up to about 17 times the recommended maximum human subcutaneous dose based on the body surface area and have revealed no evidence of impaired fertility or harm to the fetus due to methylnaltrexone bromide. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, methylnaltrexone bromide should be used during pregnancy only if clearly needed. Labor and Delivery Effects of RELISTOR on mother, fetus, duration of labor, and delivery are unknown. There were no effects on the mother, labor, delivery, or on offspring survival and growth in rats following subcutaneous injection of methylnaltrexone bromide at dosages up to 25 mg/kg/day. Nursing Mothers Results from an animal study using [3H]-labeled methylnaltrexone bromide indicate that methylnaltrexone bromide is excreted via the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when RELISTOR is administered to a nursing woman. Pediatric Use Safety and efficacy have not been established in pediatric patients. Geriatric Use In the phase 2 and 3 double-blind studies, a total of 77 (24%) patients aged 65-74 years (54 methylnaltrexone bromide, 23 placebo) and a total of 100 (31.2%) patients aged 75 years or older (61 methylnaltrexone bromide, 39 placebo) were enrolled. There was no difference in the efficacy or safety profile of these elderly patients when compared to younger patients. Therefore, no dose adjustment is recommended based on age. Renal Impairment No dose adjustment is required in patients with mild or moderate renal impairment. Dose reduction by one-half is recommended in patients with severe renal impairment (creatinine clearance less than 30 mL/min as estimated by Cockcroft-Gault). No studies were performed in patients with end-stage renal impairment requiring dialysis. Hepatic Impairment No dose adjustment is required for patients with mild or moderate hepatic impairment. The effect of severe hepatic impairment on the pharmacokinetics of methylnaltrexone bromide has not been studied.

www.salix.com 8510 Colonnade Center Drive, Raleigh, NC 27615 For additional information, call: 1-866-669-SLXP (7597) To report adverse events, call: 1 800-508-0024 Š2012 Salix Pharmaceuticals, Inc. All rights reserved. Printed in USA. REL REL 13/22 13/02


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