scholarly journals Lower Cutoffs for LC-MS/MS Urine Drug Testing Indicates Better Patient Compliance

2017 ◽  
Vol 7 (20;7) ◽  
pp. E1107-E1113
Author(s):  
Kevin Krock

Background: Urine drug testing is used by health care providers to determine a patient’s compliance to their prescribed regimen and to detect non-prescribed medications and illicit drugs. However, the cutoff levels used by clinical labs are often arbitrarily set and may not reflect the urine drug concentrations of compliant patients. Objectives: Our aim was to test the hypothesis that commonly used cutoffs for many prescribed and illicit drugs were set too high, and methods using these cutoffs may yield a considerable number of false-negative results. The goals of this study were to outline the way to analyze patient results and estimate a more appropriate cutoff, develop and validate a high sensitivity analytical method capable of quantitating drugs and metabolites at lower than the commonly used cutoffs, and determine the number of true positive results that would have been missed when using the common cutoffs. Study Design: This was a retrospective study of urine specimens submitted for urine drug testing as part of the monitoring of prescription drug compliance described in chronic opioid therapy treatment guidelines. Setting: The study was set in a clinical toxicology laboratory, using specimens submitted for routine analysis by health care providers in the normal course of business. Methods: Lognormal distributions of test results were generated and fitted with a trendline to estimate the required cutoff level necessary to capture the normal distributions of each drug for the patient population study. A validated laboratory derived liquid chromatography tandem mass spectrometry (LC-MS/MS) analysis capable of achieving the required cutoff levels was developed for each drug and/or metabolite. Results: The study shows that a lognormal distribution of patient urine test results fitted with a trendline is appropriate for estimating the required cutoff levels needed to assess medication adherence. The study showed a wide variation in the false-negative rate, ranging from 1.5% to 94.3% across a range of prescribed and illicit drugs. Limitations: The patient specimens were largely sourced from patients in either a long-term pain management program or in treatment for substance use disorder in the US. These specimens may not be representative of patients in other types of treatment or in countries with different approaches to these issues. Conclusions: The high-sensitivity method reduces false-negative results which could negatively impact patient care. Clinicians using less sensitive methods for detecting and quantifying drugs and metabolites in urine should exercise caution in assessing patient adherence using and changing the treatment plan based on those results. Key words: Urine drug testing, patient adherence, clinical toxicology, immunoassay, LC-MS, definitive drug testing, REMS, negative test results, false negative

2015 ◽  
Vol 11 (1) ◽  
Author(s):  
Kenneth L. Kirsh, PhD ◽  
Paul J. Christo, MD, MBA ◽  
Howard Heit, MD ◽  
Katherine Steffel, PharmD ◽  
Steven D. Passik, PhD

Objective: To discuss the importance of specimen validity testing (SVT) in urine drug testing (UDT) and the clinical role it plays in identifying efforts to subvert the UDT process.Methods: A discussion of the clinical impact of SVT is presented.Results: A discussion of pH, specific gravity, creatinine, and oxidation for monitoring the adulteration of UDT samples is presented along with the clinical significance of such tests.Significance: SVT has a significant place in healthcare efforts to measure patient adherence, behavior, and honesty in communication with clinicians. SVT is typically ordered by treating clinicians who use the results to make therapeutic decisions regarding specific medical problems of their patient, including those related to medication and illicit drug use. In the absence of SVT, a healthcare provider may fail to identify a patient's adulteration of their urine sample in an attempt at deceiving the provider. Moreover, the presence of some underlying medical conditions may obfuscate the UDT results.


2019 ◽  
Vol 144 (2) ◽  
pp. 177-184 ◽  
Author(s):  
Matthew D. Krasowski ◽  
Gwendolyn A. McMillin ◽  
Stacy E. F. Melanson ◽  
Annabel Dizon ◽  
Barbarajean Magnani ◽  
...  

Context.— Urine drug testing is frequently ordered by health care providers. Immunoassays are widely used for drug testing, yet have potential limitations, including variable cross-reactivity. The last decade has seen worsening of a prescription drug abuse epidemic. Objective.— To use data from a College of American Pathologists proficiency testing survey, Urine Drug Testing, Screening, to determine and summarize the characteristics, performance, and limitations of immunoassays. Design.— Seven years of proficiency surveys were reviewed (2011–2017). Results.— Rapid growth was seen in participant volumes for specific immunoassays for synthetic opioids (eg, buprenorphine, fentanyl, oxycodone) and 3,4-methylenedioxymethamphetamine (“ecstasy”). Participant volumes remained high for immunoassays targeting less commonly abused drugs such as barbiturates and phencyclidine. For opiate immunoassays, the number of laboratories using a 2000 ng/mL positive cutoff remained stable, and an increasing number adopted a 100 ng/mL cutoff. Opiate and amphetamine immunoassays showed high variability in cross-reactivity for drugs other than the assay calibrator. Assays targeting a single drug or metabolite generally performed well on drug challenges. Conclusions.— Survey results indicate strong clinical interest in urine drug testing and some adoption of new assays. However, urine drug testing availability does not parallel prevailing patterns of drug prescribing and abuse patterns. In particular, specific immunoassays for synthetic opioids and a lower positive cutoff for opiate immunoassays may be underused, whereas immunoassays for barbiturates, methadone, propoxyphene, and phencyclidine may be overused. Laboratories are encouraged to review their test menu, cutoffs, and assay performance and adjust their test offerings based on clinical needs and technical capabilities.


Bioanalysis ◽  
2009 ◽  
Vol 1 (5) ◽  
pp. 937-952 ◽  
Author(s):  
Gary M Reisfield ◽  
Bruce A Goldberger ◽  
Roger L Bertholf

2019 ◽  
Vol 10 ◽  
pp. 215013271988363
Author(s):  
Fatima Hosain ◽  
Josephine Lee ◽  
Ashar Ata ◽  
Ravneet K. Bhullar ◽  
Andrew K. Chang

Objective: The effect of specific urine drug testing (UDT) results on physician prescribing habits has not been well described. The primary objective was to report renewal rates of chronically prescribed controlled substances based on types of inconsistent UDT results. Methods: We conducted a retrospective chart review over a 5-month period comparing prescription renewals rates for patients with consistent versus inconsistent UDTs. Inconsistent UDTs were defined by prescribed drug not detected or the presence of heroin, cocaine, nonprescribed opioids, nonprescribed benzodiazepines, or marijuana. Results: Of the 474 UDTs reviewed, 214 (45.1%) were inconsistent. The most common findings among inconsistent UDTs, including overlapping results, were prescribed drug not detected (26.8%) and the presence of marijuana (20.7%), nonprescribed opioids (9.9%), and nonprescribed benzodiazepines (6.1%). In contrast, cocaine (5.5%) and heroin (0.4%) were less likely to be found on UDTs for this population. The relative risk (RR) of prescription renewal was 0.64 (95% CI 0.57-0.71) for inconsistent UDTs versus consistent UDTs. Within the inconsistent UDTs, the renewal rates when marijuana (79.6%) or nonprescribed opioids or benzodiazepines (63.6%) were present were much higher than when heroin or cocaine were present (0.0%; P < .001). Patients whose prescribed controlled substance was not detected had a 55.8% renewal rate. Conclusions: Prescription renewal rates were high when patient UDTs contained nonprescribed marijuana, opioids, and benzodiazepines, or when the prescribed drug was not detected. Prescription renewal rates were low when illicit drugs, such as heroin and cocaine, were detected.


2015 ◽  
Vol 3;18 (3;5) ◽  
pp. E307-E322 ◽  
Author(s):  
Taghogho Agarin

Background: Available data have shown steady increases of drug overdose deaths between 1992 and 2011. We review evidenced-based recommendations provided by a few prominent North American pain societies and suggest ways on how health providers might help reduce opioid analgesic deaths by implementing these practices. Objective: To identify health care providers’ roles in reducing opioid analgesic deaths. Study Design: A comprehensive review of current literature. Methods: The review included relevant literature identified through searches of MEDLINE, Cochran reviews, and Google Scholar, PubMed and EMBASE from January 1998 to January 2014. The level of evidence was classified as I (good), II (fair), and III (limited) based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Results: Several practices such as too high doses overall, giving too high doses to opioid naive patients, too fast opioid titration, insufficient use and knowledge of urine drug testing, not updating knowledge of drug metabolism/interactions, and inadequate patient monitoring are associated with higher risks of opioid analgesic deaths. Suboptimal risk stratification of patients, rotation practices, and use of opioids analgesics in chronic noncancer pain are also associated factors. Limitations: There were a paucity of good evidence studies which show recommendations reduce death. Conclusion: Providers should be aware of all associated factors with opiate analgesic deaths and apply the available evidence in reducing opioid analgesic deaths. Key words: Opioid analgesic deaths, methadone deaths, opioid mortality, opioid guidelines, genetic testing for opioids, urine drug testing


2020 ◽  
Vol 5 (5) ◽  
pp. 858-868
Author(s):  
Yifei K Yang ◽  
Kamisha L Johnson-Davis ◽  
Brian N Kelly ◽  
Gwendolyn A McMillin

Abstract Background The direct detection of drugs and metabolites in urine using a targeted panel offers sensitive and specific detection in comparison to the traditional approach to urine drug testing (screen with reflex of samples with positive results to confirmation testing). The purpose of this study was to evaluate changes in clinical demand for the laboratory to provide interpretation of patient adherence and abstinence, based on reconciling laboratory results and individual patient medication information provided by the clinician. The shifts in toxicology testing likely reflect the inherent complexity of the data and associated interpretation. Methods Retrospective testing results associated with a targeted urine drug panel and its related interpretation were collected from our laboratory. We examined the associated testing volume and positivity rates of each reported analyte over 5 consecutive years (2015–2019). Requests from clinicians for consultation regarding this test and use of interpretive comments for the most recent year (2019), as well as access to publicly available educational resources over two years (2018–2019) were collected. Results The changes in test ordering patterns demonstrate shifting of clinical demands for toxicology testing, by increased adoption of a targeted panel for which laboratory-based interpretation is provided. Positivity rates reflect national shifts in controlled substance prescriptions. Several consultative services were accessed by clinicians suggesting interest and need. Conclusion The value of clinical urine drug testing is improved by providing laboratory-based result interpretation and consultative services.


1995 ◽  
Vol 41 (5) ◽  
pp. 805-808 ◽  
Author(s):  
M A Peat

Abstract Urine drug testing is now a common practice in the American workplace; a recent survey indicated that &gt; 90% of companies with &gt; 5000 employees have some type of testing program. These programs have indeed reduced the rate of drug-positive test results; for example, recent data from the Federal Aviation Agency show that the rate for 1993 was 0.82% compared with 0.95% for 1992. Many corporations have stated that urine drug testing, as a component of a substance abuse policy, results in significant savings, e.g., from decreased absenteeism and turnover. The United States Postal Service recently completed a longitudinal study on the economic benefits and found that, over the average tenure of an annual intake of employees, there were savings of more than $100 million. Although this study clearly demonstrates the financial benefits of preemployment drug testing, the decision to test is not based solely on this but also on the regulatory environment and on the potential impact of a major accident attributable to the use of drugs or alcohol in the workplace.


2017 ◽  
Vol 2 (20;2) ◽  
pp. s135-s145 ◽  
Author(s):  
Nebojsa Nick Knezevic

Background: Even though serious efforts have been undertaken by different medical societies to reduce opioid use for treating chronic benign pain, many Americans continue to seek pain relief through opioid consumption. Assuring compliance of these patients may be a difficult aspect of proper management even with regular behavioral monitoring. Objective: The purpose of this study was to accurately assess the compliance of chronic opioidconsuming patients in an outpatient setting and evaluate if utilizing repeated urine drug testing (UDT) could improve compliance. Study Design: Retrospective analysis of prospectively collected data. Setting: Outpatient pain management clinic. Methods: After Institutional Review Board (IRB) approval, a retrospective analysis of data for 500 patients was conducted. We included patients who were aged 18 years and older who were treated with opioid analgesic medication for chronic pain. Patients were asked to provide supervised urine toxicology specimens during their regular clinic visits, and were asked to do so without prior notification. The specimens were sent to an external laboratory for quantitative testing using liquid chromatography-tandem mass spectrometry. Results: Three hundred and eighty-six (77.2%) patients were compliant with prescribed medications and did not use any illicit drugs or undeclared medications. Forty-one (8.2%) patients tested positive for opioid medication(s) that were not prescribed in our clinic; 8 (1.6%) of the patients were positive for medication that was not prescribed by any physician and was not present in the Illinois Prescription Monitoring Program; 5 (1%) patients tested negative for prescribed opioids; and 60 (12%) patients were positive for illicit drugs (8.6% marijuana, 3.2% cocaine, 0.2% heroin). Repeated UDTs following education and disclosure, showed 49 of the 77 patients (63.6%) had improved compliance. Limitations: This was a single-site study and we normalized concentrations of opioids in urine with creatinine levels while specific gravity normalization was not used. Conclusions: Our results showed that repeated UDT can improve compliance of patients on opioid medications and can improve overall pain management. We believe UDT testing should be used as an important adjunctive tool to help guide clinical decision-making regarding opioid therapy, potentially increasing future quality of care. Key words: Urine toxicology analysis, chronic pain, opioids, compliance, pain management, urine drug testing, urine drug screening


2017 ◽  
Vol 11 ◽  
pp. 117822181772478 ◽  
Author(s):  
Hope M Smiley-McDonald ◽  
Katherine N Moore ◽  
David C Heller ◽  
Jeri D Ropero-Miller ◽  
Gregory L McIntire ◽  
...  

This study is a 6-month retrospective analysis of urine drug testing (UDT) data from a pain management population among specimens with clinician-ordered marijuana testing (N = 194 809). Descriptive statistics about the specimen positivity of clinician-ordered marijuana UDT are provided as well as other drug positivity. Specimens from men and adults aged 18 to 34 years had the highest prevalence rates of marijuana positivity. The prevalence of past-month marijuana use among a comparative national population was lower than the prevalence of positive marijuana tests in the UDT specimens by all characteristics. Among the specimens tested for illicit drugs and marijuana, 4.0% were positive for amphetamine, 2.8% were positive for cocaine, and 0.9% were positive for heroin. The most common prescription drugs listed were opioids (64.7%), benzodiazepines (20.5%), and antidepressants (19.9%). In sum, the findings reflect previous research showing high rates of marijuana use, illicit drug use, and prescription drug use in a pain management population.


2010 ◽  
Vol 1;13 (1;1) ◽  
pp. E1-E22
Author(s):  
Laxmaiah Manchikanti

Background: Therapeutic use, overuse, abuse, and diversion of controlled substances in managing chronic non-cancer pain continues to be an issue for physicians and patients. It has been stated that physicians, along with the public and federal, state, and local government; professional associations; and pharmaceutical companies all share responsibility for preventing abuse of controlled prescription drugs. The challenge is to eliminate or significantly curtail abuse of controlled prescription drugs while still assuring the proper treatment of those patients. A number of techniques, instruments, and tools have been described to monitor controlled substance use and abuse. Thus, multiple techniques and tools available for adherence monitoring include urine drug testing in conjunction with prescription monitoring programs and other screening tests. However, urine drug testing is associated with multiple methodological flaws. Multiple authors have provided conflicting results in relation to diagnostic accuracy with differing opinions about how to monitor adherence in a non-systematic fashion. Thus far, there have not been any studies systematically assessing the diagnostic accuracy of immunoassay with laboratory testing. Study Design: A diagnostic accuracy study of urine drug testing. Study Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Objective: To compare the information obtained by point of care (POC) or in-office urine drug testing (index test) to the information found when all drugs and analytes are tested by liquid chromatography tandem mass spectroscopy (LC/MS/MS) reference test in the same urine sample. Methods: The study is designed to include 1,000 patients with chronic pain receiving controlled substances. The primary outcome measure is the diagnostic accuracy. Patients will be tested for various controlled substances, including opioids, benzodiazepines, and illicit drugs. The diagnostic accuracy study is performed utilizing the Standards for Reporting of Diagnostic Accuracy Studies (STARD) initiative which established reporting guidelines for diagnostic accuracy studies to improve the quality of reporting. The prototypical flow diagram of diagnostic accuracy study as described by STARD will be utilized. Results: Results of diagnostic accuracy and correlation of clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics will be calculated. Limitations: The limitations include lack of availability of POC testing with lower cutoff levels. Conclusion: This article presents a protocol for a diagnostic accuracy study of urine drug testing. The protocol also will permit correlation of various clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics. Clinical Trial Registration: NCT 01052155 Key words: Controlled substances, opioids, benzodiazepines, illicit drugs, abuse, diversion, adherence monitoring, prescription monitoring programs


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