For example, patients who are prescribed buprenorphine can be monitored for compliance by the metabolite (norbuprenorphine)-parent (buprenorphine) ratio. However, when the results were updated to methadone (> assay range) and EDDP (5 ng/mL), only 4% of the audience agreed that the patient was compliant, suggesting attendees recognized simulated compliance when presented with the quantitative results.ĭrug ratios may also be useful to assess compliance. When attendees at the AACC scientific session saw qualitative results for methadone (detected) and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) (detected) in a patient prescribed methadone, 90% responded to a poll indicating they believed that the patient was taking methadone as prescribed. dropping a drug directly into the urine), normalize results to creatinine, distinguish between metabolism and drug impurities, and determine the parent drug that was ingested. Quantitative results offer many advantages: Both providers and laboratories can detect simulated compliance (i.e. The technical aspect of reporting qualitative results is also favorable due to using less calibrator and quality control material. In short, reporting a binary result (detected/not detected) often offers sufficient information to assess compliance. At the 70th AACC Annual Scientific Meeting scientific session, 24% of the audience responded erroneously that quantitative results for hydromorphone over a 3-month period could be utilized to determine whether a patient was taking medication appropriately. Notably, laboratory directors also face challenges in interpreting quantitative results given the lack of correlation studies between drug levels and drug dosage/timing. Many variables-including drug-drug interactions, genetic variation, pharmacokinetics, drug metabolism and clearance, and a patient’s clinical condition(s)-may affect drug and metabolite concentrations in urine (Figure 1) (9). Reporting results quantitatively can mislead providers into utilizing numbers to assess compliance to a prescribed regimen. Debate #1: Quantitative Versus Qualitative Results
In this article, we discuss the current evidence around these questions and how clinical laboratorians’ decisions on each affects how providers interpret test results. In the absence of decisive guidelines to settle these questions, clinical laboratory professionals need to make the best decision possible in their individual institutions.
Should laboratories report quantitative and/or qualitative results? Should specimens be hydrolyzed prior to analysis? What cutoffs should be utilized? immunoassay and mass spectrometry), with only 9% of laboratories using MS exclusively.Īs laboratories adjust their testing methodologies to address clinical needs and improve patient management during the opioid crisis, defining more specific guidelines on the critical components of a definitive testing panel will be helpful. However, the audience poll at the AACC Annual Scientific Meeting revealed that 66% of laboratories continue to perform a combination of methodologies (e.g. Consequently clinical laboratories must be equipped to offer an extensive UDT test menu that includes both commonly prescribed medications as well as commonly abused drugs.Īccording to an audience poll during a scientific session at the 70th AACC Annual Scientific Meeting in 2018, more than 50% of laboratories have adjusted their toxicology testing in response to the opioid crisis (10).ĭue to its superior sensitivity and specificity, definitive testing-such as liquid chromatography-tandem mass spectrometry (LC-MS/MS)-is recommended by experts, including the American Society of Interventional Pain Physicians and AACC, over immunoassays for UDT for pain management monitoring (6,8,11). National guidelines recommend UDT not only to assess compliance but also to detect undisclosed substances and diversion (7-9). Urine drug testing (UDT) is an effective tool in pain management to monitor compliance with prescribed medications (6). As a result, clinicians face the challenge of providing necessary pain control for patients while maintaining a low risk for substance abuse. Furthermore, rates of opioid and drug misuse, including abuse and diversion, continue to rise (3).Īlthough opioid prescription rates have dropped in response to the opioid crisis, the average days of prescription supply have increased, and more than 40% of patients report that their pain is not treated adequately (4,5). At least half of the deaths involved a prescription opioid obtained primarily from a friend or relative (2). Drug overdose deaths increased dramatically from 1980 to 2016, surpassing deaths from guns, HIV, and car crashes (1).