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VOL 1, issue 7

Pain Management Today® eNewsletter series

Each issue in this 10-part series focuses on key topics surrounding the use of opioid therapy. A feature article written by an expert in the field of pain management is accompanied by commentary from a primary care physician addressing the topic from a day-to-day practice perspective. Each issue follows a step in the National Initiative on Pain Control® (NIPC®) treatment algorithm, which highlights key steps in managing and treating patients who are receiving opioid therapy.

Issue 7 of the eNewsletter series, written by Michael Bottros, MD, and Paul J. Christo, MD, MBA, discusses urine drug testing.

Perry G. Fine, MD
American Pain Foundation Board of Directors
NIPC Chairman

Author

Dr Bottros

Michael M. Bottros, MD
Fellow, Department of Anesthesiology and Critical Care Medicine, Division of Pain Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland

Dr. Bottros has reported no conflict of interest relevant to this article.


Dr Christo

Paul J. Christo, MD, MBA
Assistant Professor
Department of Anesthesiology and Critical Care Medicine, Division of Pain Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland

Dr. Christo has reported no conflict of interest relevant to this article.




Needs Statement

This activity has been planned in accordance with the need to educate health care professionals on strategies for improving assessment, treatment, and management of individuals with pain receiving opioid therapy and overcoming barriers that hinder their appropriate care.




Educational Objectives

1. Describe the role of urine drug testing in management and reassessment of patients receiving opioid therapy.

2. Engage in an ongoing dialogue with those living in pain regarding individualized treatment and management strategies, including an active role in self-care.




Steering
Committee
Perry G. Fine, MD
Professor of Anesthesiology,
Pain Research Center, University of Utah School of Medicine,
Salt Lake City, Utah

David A. Fishbain, MD, FAPA
Professor of Psychiatry, Adjunct Professor of Neurological Surgery and Anesthesiology, University of Miami, Miller School of Medicine, Miami, Florida

Seddon R. Savage, MS, MD
Director, Dartmouth Center for Addiction, Recovery and Education, Associate Professor of Anesthesiology, Dartmouth Medical School, Hanover, New Hampshire




AFP






Upcoming eNewsletter Topics
Vol 1, Issue 8
Appropriate Documentation of Opioid Therapy: The Emergence of the 4 A's and Trust and Verify as the Paradigm

Authored by
Steven Passik, PhD

Commentary by
Susan Cochella, MD
Vol 1, Issue 9
Opioid Rotation

Authored by
Perry G. Fine, MD

Commentary by
Paul P. Doghramji, MD, FAAP

Urine Drug Testing: An Underused Tool

The use of prescription opioids has increased over the last 10 years as an accepted method for treating chronic noncancer pain.1 Concurrently, there has been a greater incidence of prescription drug abuse as demonstrated by epidemiologic, emergency room, and treatment admission data.1 The challenge of using opioid analgesia therapy lies in balancing 2 important public health concerns2:

  1. Responding to the huge unmet need of relieving chronic pain
  2. Preventing the abuse of opioid medications
NIPC Algorithm 7
Treatment principles courtesy of the NIPC faculty
View Large Algorithm
Download the PDF

Physicians have long been apprehensive regarding the use of this therapy because of the misuse of opioids (eg, addiction, diversion, abuse), tolerance, cognitive effects, and dependence. These have all contributed to the underutilization of opioid therapy.2 Physicians caring for patients with chronic pain often struggle to provide adequate pain control while avoiding the risk of substance abuse.3 One method that should be considered as part of the overall patient monitoring and treatment plan is the use of urine drug testing (UDT).

There are a variety of biological specimens used in performing laboratory drug testing, including urine, blood, sweat, saliva, hair, and nails. Each provides a different level of sensitivity, specificity, and accuracy. Urine is most often the preferred test substance due to ease of collection. Concentrations of drugs and metabolites also tend to be high in urine, allowing longer detection times than concentrations in the serum.4

A closer look at UDT options
Ensuring adherence by determining the presence of prescribed opioids and monitoring the use of nonprescribed or illicit substances are 2 important goals of UDT in the population receiving opioid therapy for chronic pain.5 Two types of UDTs are typically used: immunoassay and gas chromatography–mass spectrometry (GC-MS).

Immunoassays use antibodies to detect the presence of specific drugs or metabolites and are the most common method used for the initial screening process. Advantages of immunoassays include not only their relatively low cost, small sample sizes, and rapid turnaround, but the fact that these tests can be done at the point of care by minimally trained staff. The principal disadvantage of immunoassays is their relatively low specificity and the potential for receiving false-positive results, which require a second test for confirmation. Results of immunoassays are always considered presumptive until confirmed by a laboratory-based test for the specific drug (eg, GC-MS or high-performance liquid chromatography).

GC-MS is highly sensitive and specific, yet even GC-MS can fail to identify a positive specimen (eg, hydromorphone, fentanyl) if the test column is designed to detect only certain substances (eg, morphine, codeine).4

Ensuring that testing is done at the proper intervals
It is generally accepted that urine drug testing should be conducted at the initiation of treatment and at specified intervals thereafter as one of several means to predict poor compliance with opioids and continued illicit drug use.1,6 It is also indicated when a patient changes medication regimens, exhibits aberrant opiate use behaviors, or shows a decline in function.

For a patient on a stable treatment regimen, it is recommended that urine testing be performed randomly and based on individual risk assessment.1,7 When unexpected findings are identified on a screening immunoassay, a GC-MS should be performed to confirm and detail the findings.

Testing isn’t done often enough
Although UDT is generally recommended, one study reports that family practice physicians obtained urine drug tests in less than 2% of their chronic pain patients receiving opioid therapy.3,8 To date, UDT is voluntary and physicians may incorporate it into their practices as they see fit. However, this will change in Florida with the passage of SB 462, the prescription drug monitoring bill that requires mandatory urine drug testing (at the initiation of medication prescription and twice yearly thereafter), medical record documentation of testing, assessment planning, informed consent, and periodic review of therapeutic objectives.2

While addiction centers have adopted UDT as a standard, chronic pain clinics, internists, and family practitioners have yet to duplicate this practice.9 This may be due to a lack of understanding about the uses or interpretations of UDT.

A 2008 survey at the American Congress of Pain Medicine questioned 99 attendees about their urine testing practices for patients on opioid therapy. The survey revealed that the majority of urine testing was driven by clinicians’ desire to detect undisclosed or illicit substances rather than an interest in evaluating appropriate opioid use.2

A panel for drug toxicology
To address the use of illicit substances, several authors have suggested a panel for drug toxicology in pain patients that includes cocaine, amphetamines, opiates, methadone, and marijuana.1 Interestingly, it is not a problem for the majority of patients taking illicit substances to provide a negative sample because they are usually able to abstain before an upcoming appointment even if they use an illegal drug recreationally. Patients unable to provide a clean urine sample demonstrate an inability to control use, increasing the suspicion of substance abuse or even addiction.1

What UDT can, and can’t, tell us
Some have erroneously suggested that UDT can determine not only if the patient is taking the prescribed drug, but also whether he/she is taking the prescribed dose.10 This is incorrect, since most opioids are eliminated by drug-metabolizing enzymes and transported by systems that show a substantial degree of intra-individual variability.3 Therefore, elimination rates at any one point in time will fluctuate.11

Additionally, urine pH changes based on the time of day a medication is taken. This can produce a large variability in urine drug concentrations as well as analytical variability (especially with immunoassays).3 Absorption and distribution may vary from patient to patient and, thus, similar doses will not result in similar systemic exposure (eg, drug concentration at the site of effect) or similar pharmacologic effects.

A word about false negatives
Attention must also be paid to drugs that do not appear in a urine test. While a negative test may suggest that the patient is nonadherent or may be diverting drugs, there are other possible explanations for such results, including human error, bacterial contamination, or mislabeling. Importantly, false negatives may occur when testing cutoff rates appear at a subthreshold level (ie, if the cutoff rate for an opioid is 50 ng/mL and the urine test detects 49 ng/mL, test results will turn out “negative” for that particular opioid).2

Generally, a diagnosis of addiction should never be made based on the results of urine toxicology alone and should be considered within the context of aberrant medication use, drug-seeking behaviors, and unimproved or declining function.1,12 Despite their limitations, UDTs provide additional information beyond behavioral monitoring. A recent study found that monitoring urine toxicology was more effective at identifying patients with problems than monitoring behaviors alone, and monitoring behaviors alone would have resulted in missing approximately half of the patients with problems.9

A “problem” was defined as the presence of either a positive illicit urine toxicology screen or behavioral issues such as reports of lost or stolen prescriptions, consumption in excess of prescribed dosage, visits without appointments, multiple drug intolerances and allergies, and/or frequent telephone calls. The probability of a problem was greatest in the younger patient groups, with 61% of the patients younger than 40 years and 30% of those older than 60 years having a problem (P=.001).9

When opioid misuse is suspected based on urine toxicology screening, it is important to further assess and address the basis of misuse and refer the patient for appropriate care if mental health problems, addiction, or other health issues appear to contribute.

Time to give UDT another look?
UDT represents a useful adjunctive testing mechanism that should be strongly considered in tandem with other forms of patient monitoring, such as regular follow-up visits, behavioral observation, risk assessment, and reviewing prior history of addiction or substance abuse. While its role should not be overstated—physicians should avoid making judgments about patient compliance based solely on the results of a urine test—urine testing should be considered as part of an integrated drug compliance regimen.2

References

  1. Compton P. The role of urine toxicology in chronic opioid analgesic therapy. Pain Manage Nurs. 2007;8:166-172.
  2. Pergolizzi, J, Pappagallo M, Stauffer J, et al; Integrated Drug Compliance Study Group. The role of urine drug testing for patients on opioid therapy. Pain Pract. 2010;10:497-507.
  3. Nafziger AN, Bertino JS. Utility and application of urine drug testing in chronic pain management with opioids. Clin J Pain. 2009;25:73-79.
  4. Moeller KE, Lee KC, Kissack JC. Urine drug screening: practical guide for clinicians. Mayo Clin Proc. 2008;83:66-76.
  5. Cone EJ, Caplan YH, Black DL, et al. Urine drug testing of chronic pain patients: licit and illicit drug patterns. J Anal Toxicol. 2008;32:530-543.
  6. Atluri S, Sudarshan G. Evaluation of abnormal urine drug screens among patients with chronic non-malignant pain treated with opioids. Pain Physician. 2003;6:407-409.
  7. Federation of State Medical Boards of the United States, Inc. Model policy for the use of controlled substances for the treatment of pain. http://www.fsmb.org/pdf/2004_grpol_Controlled_Substances.pdf. Accessed November 8, 2010.
  8. Adams NJ, Plane MB, Fleming MF, et al. Opioids and the treatment of chronic pain in a primary care sample. J Pain Symptom Manage. 2001;22:791-796.
  9. Katz NP, Sherburne S, Beach M, et al. Behavioral monitoring and urine toxicology testing in patients receiving long-term opioid therapy. Anesth Analg. 2003;97:1097-1102.
  10. Paradigm Management Services, LLC and Ameritox Announce a Partnership in Using RxGuardian to Manage Chronic Pain Cases [press release]. Concord, CA: Paradigm Management Services; January 19, 2008.
  11. Bernard JP, Opdal MS, Karinen R, et al. Relationship between methadone and EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) in urine samples from Norwegian prisons. Eur J Clin Pharmacol. 2007;63:777-782.
  12. Compton P, Athanasos P. Chronic pain, substance abuse and addiction. Nurs Clin North Am. 2003;38:525-538.
Commentator


Marc E. Babitz, MD
Division Director, Division of Family Health and Preparedness, Utah Department of Health, Salt Lake City, Utah

Dr. Babitz has reported no conflict of interest relevant to this commentary.

 

 

Commentary: The PCP Perspective
Urine Drug Testing: An Underused Tool

The treatment of patients on chronic opioid therapy (COT) can be challenging, especially for busy family physicians. While we certainly want to reduce the burden of pain in our patients to improve their functional abilities and quality of life, we have clear concerns about the potential for abuse of opioid analgesics. When we opt to treat our chronic pain patients with opioid therapy, we must accept the responsibility of having monitoring systems in place to identify patients who may be misusing or abusing their pain medications or using other substances (legal or illegal) outside the boundaries of our COT management agreement (or contract).

The authors of this article present useful information about the value of urine drug testing (UDT) as an adjunct testing mechanism in the care of our COT patients. Particularly compelling was their citation of the study indicating that "monitoring of urine toxicology was more effective at identifying patients with problems than monitoring behaviors alone," which would have missed "approximately half of the patients with problems.”  I found this patient-oriented evidence to be most helpful in planning a strategy for monitoring COT patients.

Some additional questions came to mind that were not fully addressed in the article, yet are important concerns for family physicians to consider.

My first question relates to cost. While immunoassay testing can be relatively inexpensive and done in the office setting, gas chromatography–mass spectrometry (GC-MS) testing is very costly (a local firm in Utah has an average charge of $350 for the most basic screening panels). GC-MS testing may be covered by the patient's insurance; however, these tests represent a significant expense to our health care system, and I am not aware of any cost/benefit analysis for such testing.

My second question pertains to specimen collection. When UDT is ordered by the judicial system (or a state licensing board) for the monitoring of an individual with a drug problem, specimens are obtained in an observed “chain of command” setting to avoid tampering (eg, dilution or substitution). When COT patients are monitored with the expensive GC-MS method, such tampering is usually identified. Substitution is less of a problem unless the patient has a source that is on the same COT medication(s).

I believe that it is important to determine whether patients are actually taking their COT medications and not diverting them, as well as to identify patients who are using other legal or illegal substances that suggest aberrant behavior. UDT helps in both regards.

The authors' comment about the new Florida law regarding prescription drug monitoring can serve as a useful guideline as we treat COT patients: 1) UDT at the initiation of COT, 2) twice yearly UDT thereafter, and 3) appropriate medical documentation of the patient's status. 

I agree fully with the authors' closing comments that “UDT represents a useful adjunctive testing mechanism that should be strongly considered in tandem with other forms of patient monitoring."

posttest quiz

This independent medical education activity is sponsored by the American Pain Foundation (APF) and supported through an educational grant from Endo Pharmaceuticals.

This activity is provided for educational purposes only. The information presented in this activity represents the views and opinions of the NIPC Task Force and individual authors/presenters and does not constitute the opinion or endorsement of, or promotion by, the American Pain Foundation or the program grantor(s). Reasonable efforts have been made to present educational subject matter in a balanced, unbiased fashion and in compliance with regulatory requirements. Healthcare professionals and other individuals should review and consider other publications and materials relevant to the subject matter rather than relying solely on the information contained in this activity, particularly as it may relate to patient diagnostic or treatment decisions.


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