FDA/DEA/PDMP/UDT: Alphabet soup or sensible and integrated risk management?

2015 ◽  
Vol 11 (1) ◽  
Author(s):  
Steven D. Passik, PhD ◽  
Kenneth L. Kirsh, PhD ◽  
Robert K. Twillman, PhD
Keyword(s):  
Risk Management ◽  
Drug Testing ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Management Approach ◽  
Prescription Drug Monitoring Programs ◽  
Integrated Risk ◽  
Urine Drug Testing ◽  
Urine Drug ◽  
Liquid Chromatography Tandem Mass

Objective: Both prescription drug monitoring programs (PDMP) and urine drug testing (UDT) are recommended as parts of an ongoing risk management approach for controlled substance prescribing. The authors provide an editorial and commentary to discuss the unique contributions of each to promote better clinical decision making for prescribers.Design: A commentary is employed along with brief discussion comparing four states with an active PDMP in place to three states without an active PDMP as it relates back to findings on UDT in those states from a laboratory conducting liquid chromatography tandem mass spectrometry.Conclusions: The commentary focuses on the place of both tools (UDT and PDMP) in risk management efforts. The argument is made that relying on a PDMP alone would lead to clinical decisions that may miss a great deal of problematic or aberrant behaviors.

Does the perceived accuracy of urine drug testing impact clinical decision-making?

2019 ◽  
Vol 41 (1) ◽  
pp. 85-92
Author(s):  
Barry Rosenfeld ◽  
David V. Budescu ◽  
Ying Han ◽  
Melodie Foellmi ◽  
Kenneth L. Kirsh ◽  
...  
Keyword(s):  
Decision Making ◽  
Drug Testing ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Urine Drug Testing ◽  
Urine Drug

A primer on definitive gas and liquid chromatography drug testing: What clinicians need to know

2015 ◽  
Vol 11 (1) ◽  
Author(s):  
Amadeo Pesce, PhD ◽  
Kenneth L. Kirsh, PhD ◽  
Angela Huskey, PharmD, CPE ◽  
Steven D. Passik, PhD ◽  
Catherine A. Hammett-Stabler, PhD
Keyword(s):  
Mass Spectrometry ◽  
Liquid Chromatography ◽  
Drug Testing ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Clinical Tool ◽  
Gas And Liquid Chromatography ◽  
Urine Drug Testing ◽  
Urine Drug ◽  
Compare And Contrast

Objective: To describe the differences between mass spectrometry technologies and compare and contrast them with immunoassay techniques of urine drug testing (UDT). Highlight the potential importance of the differences among these technologies for clinicians so as to allow them make decisions in their use in patient care.Methods: Review of mass spectrometry techniques, including gas chromatography, liquid chromatography, and time-of-flight techniques.Results: The potential clinical implications of these technologies stemming from their scope and accuracy are presented.Significance: UDT is an important clinical tool, though there are differences in technology and testing processes with important implications for clinical decision making. It is crucial, therefore, that clinicians have an understanding of the technologies behind the tests they order, so that their interpretation and use of results are based on an understanding of the strengths and weaknesses of the technologies used.

A Prediction Model for Positive Infant Meconium and Urine Drug Tests

2020 ◽  
Author(s):  
Elizabeth A. Simpson ◽  
David A. Skoglund ◽  
Sarah E. Stone ◽  
Ashley K. Sherman
Keyword(s):  
Prediction Model ◽  
Drug Testing ◽  
Clinical Decision Making ◽  
Drugs Of Abuse ◽  
Clinical Decision ◽  
P Value ◽  
Test Characteristics ◽  
Drug Test ◽  
Urine Drug ◽  
Urine Drug Test

Objective This study aimed to determine the factors associated with positive infant drug screen and create a shortened screen and a prediction model. Study Design This is a retrospective cohort study of all infants who were tested for drugs of abuse from May 2012 through May 2014. The primary outcome was positive infant urine or meconium drug test. Multivariable logistic regression was used to identify independent risk factors. A combined screen was created, and test characteristics were analyzed. Results Among the 3,861 live births, a total of 804 infants underwent drug tests. Variables associated with having a positive infant test were (1) positive maternal urine test, (2) substance use during pregnancy, (3) ≤ one prenatal visit, and (4) remote substance abuse; each p-value was less than 0.0001. A model with an indicator for having at least one of these four predictors had a sensitivity of 94% and a specificity of 69%. Application of this screen to our population would have decreased drug testing by 57%. No infants had a positive urine drug test when their mother's urine drug test was negative. Conclusion This simplified screen can guide clinical decision making for determining which infants should undergo drug testing. Infant urine drug tests may not be needed when a maternal drug test result is negative. Key Points

Trends in drug use from urine drug testing of addiction treatment clients

2015 ◽  
Vol 11 (1) ◽  
Author(s):  
Kenneth L. Kirsh, PhD ◽  
Howard A. Heit, MD ◽  
Angela Huskey, PharmD, CPE ◽  
Jennifer Strickland, PharmD, BCPS ◽  
Kathleen Egan City, MA, BSN, RN ◽  
...  
Keyword(s):  
Drug Use ◽  
Drug Testing ◽  
Addiction Treatment ◽  
National Laboratory ◽  
Prescription Medication ◽  
Urine Drug Testing ◽  
Urine Drug ◽  
Liquid Chromatography Tandem Mass ◽  
Testing Company ◽  
National Trends

Objective: Urine drug testing (UDT) can play an important role in the care of patients in recovery from addiction, and it has become necessary for providers and programs to utilize specific, accurate testing beyond what immunoassay (IA) provides.Design: A database of addiction treatment and recovery programs was sampled to demonstrate national trends in drug abuse and to explore potential clinical implications of differing results due to the type of testing utilized.Setting: Deidentified data was selected from a national laboratory testing company that had undergone liquid chromatography tandem mass spectrometry (LCMS/MS).Patients/Participants: A total of 4,299 samples were selected for study.Interventions: Descriptive statistics of the trends are presented. Results: In total, 48.5 percent (n = 2,082) of the samples were deemed in full agreement between the practice reports and the results of LC-MS/MS testing. The remaining 51.5 percent of samples fell into one of seven categories of unexpected results, with the most frequent being detection of an unreported prescription medication (n = 1,097).Conclusions: Results of UDT demonstrate that more than half of samples yield unexpected results from specimens collected in addiction treatment. When comparing results of IA and LC-MS/MS, it is important to consider the limits of IA in the detection of drug use by these patients.

scholarly journals Laboratory-Generated Urine Toxicology Interpretations: A Mixed Methods Study

2021 ◽  
Keyword(s):  
Primary Care ◽  
Palliative Care ◽  
Drug Testing ◽  
Clinical Decision ◽  
Prescribing Behavior ◽  
Urine Toxicology ◽  
Medical Institutions ◽  
Academic Medical ◽  
Urine Drug Testing ◽  
Urine Drug

BACKGROUND: Clinicians frequently order urine drug testing (UDT) for patients on chronic opioid therapy (COT), yet often have difficulty interpreting test results accurately. OBJECTIVES: To evaluate the implementation and effectiveness of a laboratory-generated urine toxicology interpretation service for clinicians prescribing COT. STUDY DESIGN: Type II hybrid–convergent mixed methods design (implementation) and pre–post prospective cohort study with matched controls (effectiveness). SETTING: Four ambulatory sites (2 primary care, 1 pain management, 1 palliative care) within 2 US academic medical institutions. METHODS: Interpretative reports were generated by the clinical chemistry laboratory and were provided to UDT ordering providers via inbox message in the electronic health record (EHR). The Partners Institutional Review Board approved this study. Participants were primary care, pain management, and palliative care clinicians who ordered liquid chromatography-mass spectrometry UDT for COT patients in clinic. Intervention was a laboratory-generated interpretation service that provided an individualized interpretive report of UDT results based on the patient’s prescribed medications and toxicology metabolites for clinicians who received the intervention (n = 8) versus matched controls (n = 18). Implementation results included focus group and survey feedback on the interpretation service’s usability and its impact on workflow, clinical decision making, clinician-patient relationships, and interdisciplinary teamwork. Effectiveness outcomes included UDT interpretation concordance between the clinician and laboratory, documentation frequency of UDT results interpretation and communication of results to patients, and clinician prescribing behavior at follow-up. RESULTS: Among the 8 intervention clinicians (median age 58 [IQR 16.5] years; 2 women [25%]) on a Likert scale from 1 (“strongly disagree”) to 5 (“strongly agree”), 7 clinicians reported at 6 months postintervention that the interpretation service was easy to use (mean 5 [standard deviation {SD}, 0]); improved results comprehension (mean 5 [SD, 0]); and helped them interpret results more accurately (mean 5 [SD, 0]), quickly (mean 4.67 [SD, 0.52]), and confidently (mean 4.83 [SD, 0.41]). Although there were no statistically significant differences in outcomes between cohorts, clinician-laboratory interpretation concordance trended toward improvement (intervention 22/32 [68.8%] to 29/33 [87.9%] vs. control 21/25 [84%] to 23/30 [76.7%], P = 0.07) among cases with documented interpretations. LIMITATIONS: This study has a low sample size and was conducted at 2 large academic medical institutions and may not be generalizable to community settings. CONCLUSIONS: Interpretations were well received by clinicians but did not significantly improve laboratory-clinician interpretation concordance, interpretation documentation frequency, or opioid-prescribing behavior. KEY WORDS: Compliance monitoring, chronic pain, urine drug testing, opioid, liquid chromatography-tandem mass spectrometry, palliative care, primary care, substance use disorder, diagnostic error, clinical decision support

Using urine drug testing to support healthy boundaries in clinical care

2015 ◽  
Vol 11 (1) ◽  
Author(s):  
Howard A. Heit, MD, FACP, FASAM ◽  
Douglas L. Gourlay, MD, MSc, FRCPC, FASAM
Keyword(s):  
Chronic Pain ◽  
Risk Management ◽  
Management Strategy ◽  
Drug Testing ◽  
Clinical Care ◽  
Risk Management Strategy ◽  
Patient Centered ◽  
Urine Drug Testing ◽  
Urine Drug ◽  
Common Barriers

Risk management is first and foremost about protecting patients. This article will examine risk management in general, and urine drug testing (UDT) in particular, as core constituents in an effective, comprehensive risk management strategy. The article will explore UDT as a tool to help practitioners and patients make better choices in the clinical management of chronic pain. How one makes these difficult clinical decisions based on UDT results as well common barriers encountered in conducting patient-centered UDT will also be examined.

scholarly journals Comparative Evaluation of the Accuracy of Immunoassay with Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS) of Urine Drug Testing (UDT) Opioids and Illicit Drugs in Chronic Pain Patients

2011 ◽  
Vol 3;14 (2;3) ◽  
pp. 175-187
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Liquid Chromatography ◽  
Drug Testing ◽  
Illicit Drugs ◽  
Tandem Mass ◽  
Index Test ◽  
Reference Test ◽  
Chromatography Tandem Mass Spectrometry ◽  
Urine Drug Testing ◽  
Urine Drug ◽  
Liquid Chromatography Tandem Mass

Background: The challenge for physicians in treating chronic pain with opioids is to eliminate or significantly curtail abuse of controlled prescription drugs while assuring proper treatment when indicated. Urine drug testing (UDT) has been shown to be a useful approach in identifying patterns of compliance, misuse, and abuse. However, significant controversy surrounds the diagnostic accuracy of UDT performed in the office (immunoassay) and the requirement for laboratory confirmation with liquid chromatography tandem mass spectrometry (LC/MS/MS). Study Design: A diagnostic accuracy study of urine drug testing. Study Setting: The study was performed in an interventional pain management practice, a tertiary referral center, in the United States. Objective: The objective of this study was to compare the results of UDT of immunoassay inoffice testing (index test) to LC/MS/MS (reference test). Methods: One-thousand participants were recruited from an interventional pain management program. Urine sample was collected from all the consecutive patients with demographic information. Immunoassay testing was performed by a nurse at the location, laboratory assessment was performed with LC/MS/MS. Results of the index test were compared to the reference test in all patients. The sensitivity, specificity, false-positive, and false-negative rates, and index test efficiency (agreement) were calculated. Results: Overall, results showed that confirmation was required in 32.9% of the specimens. Agreement for prescribed opioids was high with the index test (80.4%). The reference test of opioids improved the accuracy by 8.9% from 80.4% to 89.3%. Non-prescribed opioids were used by 5.3% of patients. The index test provided false-positive results for non-opioid use in 44% or 83 of 120 patients. For illicit drugs, the false-positive rate by index test was 0% for cocaine, whereas it was 2% for marijuana, 0.9% for amphetamines, and 1.2% for methamphetamines. Limitations: The limitations include a single site study utilizing a single POC kit and a single laboratory, as well as technical sponsorship. Conclusion: The UDT with immunoassay in an office setting is appropriate, convenient, and cost-effective. Compared with laboratory testing for opioids and illicit drugs, immunoassay inoffice testing had high specificity and agreement, demonstrating the value of immunoassay drug testing. Because of variable sensitivity, clinicians would be well-advised to take a cautious approach when interpreting the results. Key words: Controlled substances, opioids, illicit drugs, abuse, liquid chromatography tandem mass spectrometry, immunoassay, urine drug testing

scholarly journals Comparative Evaluation of the Accuracy of Benzodiazepine Testing in Chronic Pain Patients Utilizing Immunoassay with Liquid Chromatography Tandem Mass Spectrometry (LC/ MS/MS) of Urine Drug Testing

2011 ◽  
Vol 3;14 (3;5) ◽  
pp. 259-270
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Mass Spectrometry ◽  
Liquid Chromatography ◽  
Tandem Mass Spectrometry ◽  
Drug Testing ◽  
Tandem Mass ◽  
Index Test ◽  
Chromatography Tandem Mass Spectrometry ◽  
Urine Drug Testing ◽  
Urine Drug ◽  
Liquid Chromatography Tandem Mass

Background: Eradicating or appreciably limiting controlled prescription drug abuse, such as opioids and benzodiazepines, continues to be a challenge for clinicians, while providing needed, proper treatment. Detection of misuse and abuse is facilitated with urine drug testing (UDT). However, there are those who dispute UDT’s diagnostic accuracy when done in the office (immunoassay) and claim that laboratory confirmation using liquid chromatography tandem mass spectrometry (LC/MS/MS) is required in each and every examination. Study Design: A diagnostic accuracy study of UDT. Study Setting: The study was conducted in a tertiary referral center and interventional pain management practice in the United States. Objective: Comparing UDT results of in-office immunoassay testing (the index test) with LC/MS/ MS (the reference test). Methods: A total of 1,000 consecutive patients were recruited to be participants. Along with demographic information, a urine sample was obtained from them. A nurse conducted the immunoassay testing at the interventional pain management practice location; a laboratory conducted the LC/MS/ MS. All index test results were compared with the reference test results. The index test’s efficiency (agreement) was calculated as were calculations for sensitivity, specificity, false-positive, and false-negative rates. Results: Approximately 36% of the specimens required confirmation. The index test’s efficiency for prescribed benzodiazepines was 78.4%. Reference testing improved accuracy to 83.2%, a 19.6% increase, and 8.9% of participants were found to be taking non-prescribed benzodiazepines. The index test’s false-positive rate for benzodiazepines use was 10.5% in patients receiving benzodiazepines. Limitations: This study was limited by its single-site location, its use of a single type of point of care (POC) kit, and reference testing being conducted by a single laboratory, as well as technical sponsorship. Conclusion: Clinicians should feel comfortable conducting in-office UDT immunoassay testing. The present study shows that it is reliable, expedient, and fiscally sound for all involved. In-office immunoassay testing compares favorably with laboratory testing for benzodiazepines, offering both high specificity and agreement. However, clinicians should be vigilant and wary when interpreting results, weighing all factors involved in their decision. Key words: Controlled substances, benzodiazepines, opioids, illicit drugs, abuse, liquid chromatography tandem mass spectrometry, immunoassay, urine drug testing

Sign in / Sign up

Export Citation Format

Share Document