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11 Articles in Volume 6, Issue #5
Clinical Pearls for Treating Headache Patients
Determining Which Low Level Laser to Use
Guidelines for Opioid Management of Pain
Interventional Therapies in the Continuum of Care
Lessons Learned from a Headache TMD Study
Potential Hazards of Vertebroplasty
Splenius Capitis Muscle Syndrome
The Moral Community of the Clinical Pain Medicine Encounter
Urine Drug Testing and Monitoring in Pain Management
Vitamin D Deficiencies in Pain Patients
Why Electromedicine?

Urine Drug Testing and Monitoring in Pain Management

Scientifically sound urine drug testing of pain patients can be an effective means to augment pharmacotherapy and assist with complex medical/legal aspects of the current healthcare environment.

In a previous Guest Editorial (Practical Pain Management, March, 2006), a laboratory perspective on “Clinical Drug Testing for Pain Medicine” was presented. This report will focus on guidelines regarding the utilization and rationale for urine drug testing and monitoring in the management and treatment of pain.

The integration of laboratory diagnostics into routine clinical practice is essential and can be procedurally challenging. Both newly developed, and what are considered routine diagnostic procedures, are continually being improved. It is critical that the laboratory industry continue to educate and distribute pertinent information to clinicians in an intelligent and expeditious manner. This will efficiently facilitate the incorporation of these procedures and minimize laboratory and interpretive errors.

The clinical practice of pain medicine is growing at a rapid pace. Lagging behind are both standards and procedures for objective diagnostics including biomarkers, molecular diagnostics, drug testing, or more accurately, clinical pharmacological monitoring. This is in part due to the slow pace of basic research and an incomplete understanding of the biochemistry, physiology, and genetics of pain. The use of pharmacological agents should be supported by scientifically sound, precise, accurate, and objective laboratory diagnostics.

Inherent in the evolution of clinical laboratory procedures is the need to standardize a diagnostic language and vocabulary as it pertains to pain medicine. Procedures need to be implemented to optimally share information among ancillary support systems, physicians, payers, governmental agencies, pharmacies, workers’ compensation bureaus, laboratory staff, and clinical support staff, and especially to the patients and their families.

The laboratory discipline of Clinical Pharmacology/Toxicology is complex and technically challenging. Pharmacotherapy is also complex, even when there is a thorough understanding of the disease and the prescribed medication(s). Drug therapy is, and will continue to be, difficult until we have a basic molecular understanding of endogenous pain mediating systems, and ultimately, new drug targets. This understanding will facilitate the discovery and development of new drugs and laboratory tests.

The pharmacological management of the pain patient is multidisciplinary and includes both clinical aspects of the pain itself and other possible issues including addiction, pseudoaddiction, tolerance, undertreatment of pain, drug diversion, misuse and abuse, and drug-drug interactions. These issues can range from clinical to forensic to legal. Laboratories are being tasked to develop and perform procedures that will satisfy all of these criteria. This is a new phenomenon for the clinical diagnostic laboratory, as historically these issues have been divided into forensic/workplace (non-clinical) testing and therapeutic (clinical) drug monitoring. The underlying science and performance of these two divergent tasks can be very different.

Drug testing is now becoming an accepted and important tool in the clinical world.1,2 Due to potential forensic/punitive issues involving schedule II medications, drug testing pain patients can create a level of discomfort for both physician and patient. This situation can be alleviated and/or eliminated by open dialogue and accurate documentation regarding why drug testing is an essential part of the treatment process.

It is also essential to protect both the pain practice and the laboratory by providing diagnostic and documentation procedures that support pharmacotherapeutic protocols and treatment plans. This documentation must be conveyed to the patient and should assist in objectifying aspects of drug treatment and enhance physician/patient trust.

The following are key clinical reasons for incorporating drug testing into routine pain practice.

Clinical Pharmacotherapeutic and Pharmacokinetic Issues

  1. Baseline and comprehensive identification and quantification upon admission of any and all drug substance. Identification to include prescription and over-the-counter medications, herbals and foods of concern, and illicit substances.
  2. Identification of drugs that have the potential to cause adverse interactions.
  3. Assists in individualizing pharmacotherapeutic regimens.
  4. Provides the clinician with an objective test that documents prescription drug adherence.
  5. Ability to monitor drug elimination rates and identify steady state and/or increased or decreased prescription/illicit drug usage.3
  6. Ability to identify and quantify contaminants in medications to reduce unnecessary confrontation between physician and patient.
  7. May identify the use of medications from other sources that can complicate the treatment plan.
  8. May identify any pertinent metabolic issues including medications that induce or inhibit the P450 enzymes, medications that compete for these enzymes, and genetic polymorphic conditions that affect metabolism.4
  9. Identifies, where appropriate, the ratios between parent compound and drug metabolite(s).
  10. May help to identify other disease states, (i.e., impaired kidney function, diabetes, etc.), when accompanied by macroscopic urinalysis.

Substance Abuse, Misuse, Diversion and Addiction/Pseudoaddiction Issues

  1. Provides the clinician with an objective test which documents prescription drug misuse and/or illicit drug usage.
  2. Identifies patient inaccuracies with self- reported medication use.
  3. May assist in the verification of patient historical data including: suspicious stories, family reports of abuse, self reporting of relapse, etc.
  4. May confirm behavioral observations including: continued risky behavior, missed appointment(s), intoxicated appearance, pill count discrepancies, early refill requests, and pharmacy calls/concerns.
  5. May identify intentional dilution, adulteration, substitution, or tampering with the specimen.
  6. Supports referral for treatment to a substance abuse professional.
  7. Allows the clinician to monitor drug elimination of discontinued illicit or prescription medication.5
  8. Imposes a barrier for patient’s intent on diverting opioid medication.
  9. Identifies the use of illicit substances throughout the treatment process and assists in making the appropriate decisions regarding discontinuation of medication/treatment and referral to the appropriate addiction and/or mental health professional.
  10. Reduces the risk of therapeutic failure by detecting non-compliant patients.
  11. Confirms compliance with the agreed upon treatment plan

Medical/Legal Concerns

  1. Reduces risk of regulatory agency scrutiny and investigation by documenting that the physician is monitoring and evaluating prescribed medications.
  2. Provides measurements that objectify pharmacotherapeutic regimens for reporting to workers’ compensation boards, medical boards, insurance providers, DEA, and other regulatory agencies.
  3. Can prevent patient claims of inappropriate dismissal or treatment bias based upon inaccurate third party information.
  4. Assists in complying with DEA’s current Interim Policy Statement which requires doctors to minimize the potential for abuse and diversion.6
  5. Assists in complying with The Federation of State Medical Board’s “Model Policy for the Use of Controlled Substances for the Treatment of Pain” which suggests, in part, that the medical records of patients contain “diagnostic, therapeutic and laboratory results” and further suggests extra care and monitoring of patients with a history of substance abuse.7,8
  6. Will provide evidence of compliance with the appropriate standard of care in a negligence or malpractice claim.

Physician/Patient Relationship

  1. Reinforces the trust in the physician/patient relationship
  2. Makes patient aware that testing for drug substance is an integral and essential part of a comprehensive pharmacotherapeutic treatment plan.

Summary

Treating the pain patient is a complex process. The laboratory diagnostics for this patient population is also complex. During pharmacotherapeutic treatment, physicians are tasked to distinguish certain patterns of drug use to identify greater abuse risk within their patient population. Physicians must treat patients according to their professional judgment for legitimate medical purpose(s) using generally accepted medical standards, including informed consent. Practitioners also have a responsibility to minimize the potential for abuse and diversion and outline treatment risks/benefits regarding the use of controlled substances, special issues, and treatment alternatives. Employing treatment agreements that enhance physician/patient dialogue is one current method used to address many important issues.9 Most treatment agreements include provisions for: urine drug tests, medication counts, refill policy and consequences if the patient violates the agreement. In order to measure the efficacy of treatment plans for patients within a pain practice, periodic review of progress is necessary. Pertinent questions may arise regarding patient function, responsibility with medications, medication levels from urine drug test reports, and behavioral health issues. Using scientifically sound urine drug testing can be an effective means to augment pharmacotherapy and assist with the variety of complex medical/legal aspects of treating the pain patient in the current healthcare environment.

The demand for clinical urine drug testing for the field of pain management has increased dramatically as clinicians, regulatory agencies and insurance payers seek objective measures to regulate compliance and support clinical diagnoses. In the diagnosis of pain, assessment is essential. In order to optimize outcomes and set goals and expectations, treatment plans should be established that are individualized. In addition, methods for objectifying and measuring these parameters—such as quantitative clinical urine drug testing—should be utilized.

Last updated on: January 5, 2012
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