All patients who are prescribed opioid therapy for longer than three months should be subjected to random urine drug monitoring every three to six months, depending on their risk for abuse, according to an expert opinion statement presented at the American Academy of Pain Medicine (AAPM) 28th annual meeting.
"Clinicians need to recognize that all patients have a degree of risk for misuse of opioids and that monitoring is necessary to maintain patient safety, structure care with greater objectivity, and guide ongoing treatment decisions," said the statement, authored by eleven experts in the fields of pain and addiction medicine.
Point of care (POC) testing "affords a relatively low-cost solution to the need for immediate information," the guidelines state. If POC is used, a gas chromatography/mass spectrometry (GC/MS) test or liquid chromatography dual mass spectrometry (LC/MS/MS) test should be conducted every three to six months, depending on the patient's risk, they add.
The development of the recommendations was funded by an unrestricted grant provided by Ameritox Inc, one of several companies that manufacture the GC/MS and LC/MS/MS tests.
"The group spent over two years putting this together," said John Peppin, DO, co-chair of the panel, and director of the Clinical Research Division at the Pain Treatment Center of the Bluegrass in Lexington, Kentucky, in an interview with Medscape Medical News. "There was a lot of diversity, a lot of debate and argument. We want to use these technologies responsibly — they're very expensive."
Co-chairing the panel with Dr. Peppin was Steven D. Passik, PhD, from Vanderbilt University Medical Center in Nashville, Tennessee. Panel members included Charles Argoff, MD, from Albany Medical College, Albany, New York; Gerald M. Aronoff, MD, from Carolina Pain Associates in Charlotte, North Carolina; Daniel Bennett, MD, from Integrative Treatment Centers in Denver, Colorado; Martin D. Cheatle, PhD, from the University of Pennsylvania, Philadelphia; Paul J. Christo, MD, from the Johns Hopkins University, Baltimore, Maryland; Joseph Couto, PharmD, from Thomas Jefferson University, Philadelphia, Pennsylvania; Perry G. Fine, MD, from the University of Utah, Salt Lake City; Neil I. Goldfarb (moderator) from the Greater Philadelphia Business Coalition on Health; and Kieran A. Slevin, MBBCh, MD, from Virtua Pain and Spine Specialists in Voorhees, New Jersey.
Five Key Questions
Dr. Peppin said the guidelines aimed to answer five questions: whom to test, when to test, how to test, how to interpret the results, and how to handle discrepancies. The poster presented here addresses the first three questions; a publication with their full recommendations is forthcoming, the authors note.
First, they recommend that when confirmatory GC/MS or LC/MS/MS tests are done, they "may include illicit drugs, commonly prescribed opioids, and other prescription drugs of potential abuse," such as benzodiazepines, barbiturates, carisoprodol, meprobamate, and tramadol.
The individualized components of testing remain a controversial point, said Dr. Peppin.
"We could literally test for a hundred things. Should we be testing for those hundred things in every test we do or not? Of course we're looking for things that shouldn't be there and we're looking for things that should be there as well," he noted. "So, if they're taking oxycodone we'll certainly want to test for oxycodone. However, if they're taking marijuana or cocaine or those kinds of things we want to know that. If they're taking morphine we want to know that. So we need to tailor our tests and the things we're looking for depending on the patient and the risk that they're in."
After the initial test, the frequency of random follow-up monitoring should be determined on the basis of risk assessment with the Screener and Opioid Assessment for People with Pain Revised (SOAPP-R), according to the guidelines.
Other validated and useful screens include the Current Opioid Misuse Measure (COMM) and the Opioid Risk Tool (ORT).
Other components of risk assessment should include a patient interview that explores things such as "smoking history, past medical history, history of psychiatric diagnosis that predisposes patient to abuse, history of prior opioid use and known misuse, personal and family history of substance abuse, and social environment that poses concern over misuse or diversion."
Interpretation of test results is also a complex issue, said Dr. Peppin. "If a drug's not there, for example, let's say they're supposed to be on oxycodone and it's not in their urine, where is it? Does that mean they sold it? Does that mean it ran out early? Does that mean they're hoarding it because they're afraid that at some point they're not going to get it? It could mean a lot of things."
While acknowledging the lack of scientific evidence behind the guidelines, the panel suggested they represent a first step toward reaching a consensus in the field.
"Primary care physicians and pain specialists are largely practicing today without the benefit of structural guidance," the authors write. "Because clinical opinion varies considerably with respect to [urinary drug monitoring], it is expected that the recommendations presented here will generate considerable debate among practicing clinicians and policy makers. Constructive and critical evaluation can now proceed in a way that can more meaningfully inform clinical practice and public policy."
Asked for the AAPM's reaction to the guidelines, conference co-chair Lynn R. Webster, MD, medical director of Lifetree Clinical Research in Salt Lake City, Utah, said, "The Academy is pleased to receive a poster that offers clinicians a practical guide to urine drug testing," he told Medscape Medical News.
"As the authors stated, there is limited evidence for their recommendations but by offering the recommendations clinicians and researchers can now begin to conduct research that will either support the recommendations or lead to improved guidelines," he added. "For now, this is a good starting point."
Dr. Webster, who previously served on the advisory board for Ameritox, said he does not think the company's financial support of the guidelines' development is problematic. "Just because industry supported the consensus doesn't mean that the panel would compromise their integrity with their recommendations. In this situation I am convinced most experts would agree with what they have recommended," he added. "I know it is all about perception. It is a real concern and I understand the concern. Nevertheless I stand by my comment."
Reaction from attendees viewing the poster was positive. "This is sound," said Michael Brennan, MD, from the Pain Center of Fairfield, and senior attending physician at Bridgeport Hospital in Fairfield, Connecticut.
"This paper representing very well known physicians is trying to figure out the right way to do this without bankrupting the country, but at the same time not letting patients take advantage of us with these prescription medications," he toldMedscape Medical News.
The guidelines also offer protection against potentially lucrative physician over-testing, Dr. Brennan added.
"A lot of doctors supplement their income by doing these tests," he said. "Urine drug testing is being done at an incredibly frequent rate right now at a lot of cost to the healthcare system — anywhere from several hundred to several thousand dollars per test. There's 4 million people in the United States on long-acting opioids, let's assume it's a thousand dollars per test, that's 4-billion dollars. [At this meeting] there are probably more companies selling urine drug testing than selling drugs — which says a lot," he said.
Yet while most clinicians would confirm the value of such testing in a busy practice, the published evidence for it remains weak, said Dr. Brennan. "There's very little published evidence that says this testing does anything to limit misuse, abuse and diversion of drugs — that's the big problem."
Jeffrey Gudin, MD, who specializes in pain medicine and addiction at the Center for Pain Management, Englewood Hospital and Medical Center, New Jersey, agreed that the new recommendations are appropriate and fill a need.
"I appreciate that this team got together to give us some consensus," he told Medscape Medical News. "It's a great starting place because, if you think about it, we've had no place to start."
"I totally disagree with clinicians who bill their patients every single visit," Dr. Gudin added. "I see clinicians all the time, interventional pain physicians that send out urine screens on patients even though they're not prescribing any controlled substances to them and I think it's just a misuse or misappropriation of healthcare funds."
"There's some chat out there in the pain communities that the insurance carriers are going to stop paying for these broad-based urine toxicology screens, and only approve the tests for the most common drugs of abuse and maybe the medications that the patient's taking," he added.
Development of the recommendations was supported by Ameritox, Inc. through an unrestricted grant to the Jefferson School of Population Health. All authors received a usual and customary honoraria in compensation for their time and travel expenses. Seven of the 11 panel members, including Dr. Peppin, his co-chair Dr. Passik, the lead author of the paper, Joseph Couto, MD, and 4 others, have received honoraria, consulting fees, or grant/research support from Ameritox, Inc, as well as other companies. Dr. Webster disclosed the following industry connections: Adolor Corp (research); Alkermes, Inc (research); Allergan, Inc (research); AstraZeneca (consultant, honoraria, advisory board); Bayer Healthcare (research); BioDelivery Systems International (consultant, honoraria, advisory board, research); Boston Scientific (consultant, honoraria, advisory board, research); Cephalon (consultant, honoraria, advisory board, research); Collegium Pharmaceuticals (research); Covidien (research); Covidien Mallinckrodt (consultant, honoraria, advisory board); Eisai (research); Elan Pharmaceuticals (research); Gilead Sciences (research); GlaxoSmithKline (research); Janssen Pharmaceutical K.K. (consultant, honoraria, advisory board); King Pharmaceuticals (consultant, honoraria, advisory board, research); Meagan Medical (research); Medtronic (research); Nektar Therapeutics (consultant, honoraria, advisory board, research); NeurogesX, Inc. (consultant, honoraria, advisory board, research); Nevro Corporation (consultant, honoraria, advisory board); Pharmacofore, Inc (consultant, honoraria, advisory board); Purdue Pharma (consultant, honoraria, advisory board); Shionogi USA, Inc (research); St. Renatus (research); SuCampo Pharma Americas, USA (research); TEVA Pharmaceuticals (Sub-I) (research); Theravance, Inc (consultant, honoraria, advisory board, research); and Xanodyne Pharmaceuticals (research). Dr. Brennan is a speaker for Jansen/J&J, Pfizer, Lilly, Forrest Labs, Depomed, Millenium, and AFTI; he is a consultant and serves on the speaker's bureau for Purdue Pharma, Covidien, Teva/Cephalon, and Endo; and he owns stock with Apricus Biosciences and Pain Therapeutics.
American Academy of Pain Medicine 28th Annual Meeting: Abstract #215. Presented February 24, 2012.
Kate Johnson • Medscape Medical News © 2012 WebMD, LLC