1. 2014;17;63-70Utility of Oral Fluid in Compliance Monitoring of Opioid Medications
   Prospective Evaluation
   Till Conermann, MD, Ankur R Gosalia, MD, Abraham J. Kabazie, MD, Christina Moore, PhD, Kathy Miller, BA, Madalene Fetsch, MS, and Dwain Irvan, C(ASCP)CM.

BACKGROUND: Prescription drug abuse is the fastest growing drug problem in the United States, and the increase in unintentional drug overdose deaths has been driven by the increase in opioid analgesic use. Given the epidemic of non-medical prescription pain reliever use and the current medico-legal climate, it is increasingly important for the prescriber to monitor for medication compliance.

OBJECTIVES: The purpose of this IRB approved study is to compare the results of oral fluid (OF) and routine urinalysis for monitoring compliance in a single academic pain management program in an urban setting in order to evaluate the utility of OF analysis in compliance monitoring when prescribing opioid medications.

STUDY DESIGN: Outcomes analysis of prospective, consecutive, paired comparison study with clinical implications.

SETTING: Single academic interventional pain management center in the United States.

METHODS: Paired OF and urine specimens were collected for each patient with signed informed consent, at the Institute for Pain Medicine, Western Pennsylvania Hospital, from patients who routinely donated urine on a random basis for compliance testing. A total of 153 paired specimens were analyzed. Demographic and prescription data were made available. Specimens were screened using immunoassay and presumptive positive findings were confirmed with liquid-chromatography and mass spectrometry. Although both matrices were tested for a wider range of medications, the data presented here are representative of analgesic opioids and benzodiazepine drug classes only.

RESULTS: Following exclusion criteria, of the 132 remaining specimen pairs that were positive for opioids or benzodiazepines in at least one matrix, 101 pairs showed exact drug class matches (76.5%). In an additional 21 pairs, at least one drug class was positive in both matrices (15.9%), giving an overall agreement of 92.4%. Overall, 191 positive results were found in urine averaging 1.4 drugs per specimen; 176 positives were detected using OF for an average of 1.3 drugs per specimen.

CONCLUSIONS: In the setting of stable dosing of prescription opioids and/or concomitant illicit drug use, given comparable detection rates between urine and OF matrix qualitative results, the OF matrix for drug testing for compliance monitoring may serve as a useful and valid testing tool. The authors conclude that overall OF analysis produces comparable results to urine sample analysis with detection rates differing primarily due to differences in windows of detection for different drug classes.

LIMITATIONS: The limitations include the study was performed in a single academic center in an urban community. Also, there is a paucity of literature regarding windows of detection for OF analysis compared to urine.
IRB: APPROVED - Allegheny-Singer Research Institute West Penn Allegheny Heath System (ASRI-WPAHS) - IRB Study #FWA00015120