Thursday, June 3, 2010

Value of Opioid Agreements and UDT Challenged

OpioidsExperts in pain management often recommend opioid treatment agreements and urine drug testing (UDT) as strategies for reducing opioid analgesic misuse or abuse. However, a systematic review of the research literature failed to discover any solid evidence to justify the use of these strategies in everyday clinical practice.

A team of investigators led by Joanna L. Starrels, MD, MS, of Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, New York, searched MEDLINE, PsycINFO, EMBASE, and the Cochrane Central Register of Controlled Clinical Trials through the second week of June 2009 to identify studies of the association of treatment agreements and UDT with opioid misuse [Starrels et al. 2010]. They selected only original research addressing outpatients with chronic noncancer pain prescribed opioids for at least 3 months, with a sample size of 50 participants or more, and published in English, Spanish, or French. The outcome of opioid misuse was variously defined in their search as drug abuse, drug misuse, aberrant drug-related behavior, diversion, or addiction.

Of 102 potential studies identified, only 11 (including about 2,600 total patients) met inclusion criteria for the review; 6 were in pain specialty clinics and 5 were in primary care settings. However, 3 of the primary care studies encompassed multicomponent approaches involving interdisciplinary support teams, which is not typical of primary care practices. All studies were observational in design and rated as being of merely poor to fair quality. In 4 studies with comparison groups, opioid misuse was modestly reduced after incorporating treatment agreements with or without urine drug testing; in the other 7 studies, the proportion of patients with opioid misuse after incorporating treatment agreements, urine drug testing, or both varied widely. The populations selected for study — some of which seemed strongly biased toward persons at high risk for opioid misuse to begin with — along with the diversity of interventions and opioid-misuse measures (none of which included assessments of opioid abuse, addiction, or overdose as defined by standard DSM criteria) precluded a meta-analysis of the data.

CONCLUSIONS & COMMENTS: This study represented a quite thorough search and review of the literature and was supported by funding from the U.S. Substance Abuse and Mental Health Services Administration, National Institute on Drug Abuse, and the Robert Wood Johnson Foundation. Writing in the June 1, 2010 edition of the Annals of Internal Medicine, the authors concluded that current evidence does not support the effectiveness of opioid treatment agreements and urine drug testing in reducing opioid misuse by patients with chronic noncancer pain. And, a note in the article from the journal editors stated, “the absence of these strategies should not be considered a mark of poor-quality care.”

Other studies have found that 23% to 43% of primary care physicians use opioid treatment agreements and 8% to 30% use UDT in patients prescribed long-term opioid analgesics. However, those percentages may be skewed on the high side since, for their review, Starrels and colleagues could find no research conducted in practice settings typical of those in which patients are most often prescribed long-term opioids for chronic noncancer pain. There also is widespread disagreement on what constitutes opioid misuse; for example, some investigators count any request for an early refill, report of lost or stolen medication, or underuse of the prescribed amount as indicative of misuse or aberrant behavior — which could be completely erroneous in many cases. Starrels et al. concede “no measure of opioid misuse has been demonstrated to be clearly superior in predicting clinically important outcomes, such as opioid abuse, dependence [addiction], overdose, or death.”

Starrels et al. acknowledge that, “Despite the lack of rigorous evidence supporting the use of treatment agreements and urine drug testing, these strategies have been endorsed by pain and addiction experts, professional societies, and regulatory agencies, and their use has been proposed as a quality [of care] indicator.” They also observe that there are reasons that some practitioners may want to use these strategies — such as improved satisfaction, comfort in prescribing, or a sense of mastery in managing chronic pain — but, in our opinion, it appears from the research that such reasons may not relate to better outcomes for patients. At the same time, there are barriers and costs associated with these strategies and, as we have described previously in some detail [here], there can be significant pitfalls in using UDT as a guide for managing opioid therapy.

FAIR-BALANCE ADDENDUM: From the several studies with comparison groups, it seems that treatment agreements and UDT might be of some benefit in limiting potential opioid misuse or abuse among patients with pain in specialty settings — eg, pain clinics or addiction treatment practices. This would be especially pertinent in patients at higher risk for aberrant opioid-use behaviors at the outset; however, knowing whether such control measures that encourage therapeutic compliance also benefit clinical pain management requires further research.

REFERENCE: Starrels JL, Becker WC, Alford DP, et al. Systematic Review: Treatment Agreements and Urine Drug Testing to Reduce Opioid Misuse in Patients With Chronic Pain. Ann Int Med. 2010(June 1);152(11):712-720 [abstract here].