Directives for Adopting UDT
U.S. state legislatures as well as federal agencies — including the Drug Enforcement Agency (DEA), Food and Drug Administration (FDA), Substance Abuse and Mental Health Services Administration (SAMHSA), and the White House’s Office of National Drug Control Policy (ONDCP) — are all grappling with meeting the challenges associated with opioid analgesics. In this regard, the importance of adopting UDT in clinical pain treatment practice has been emphasized in a number of guidance documents and legislative or other actions:
- In May 2012, SAMHSA published their first-ever guide to clinical drug testing in primary care [SAMHSA 2012]. This manual describes and recommends how practitioners can use drug testing to help monitor patients’ use of prescribed medications as part of a pharmacovigilance approach and to identify patients who may need interventions for substance use disorders. There are important implications in this government-approved guidance for compliance by clinicians who treat beneficiaries of public assistance programs, such as Medicaid, Medicare, and others.
- In July 2012, as a component of its Risk Evaluation and Mitigation Strategy (REMS) for extended-release (ER) and long-acting (LA) opioid analgesics, the U.S. FDA specified the following as a component of therapy management: “Prescribers should monitor patient adherence to the treatment plan, especially with regard to misuse and abuse by …. [u]nderstanding the utility and interpretation of drug testing (eg, screening and confirmatory tests), and using it as indicated” [FDA 2012, p 4]. Thereby, such testing may become a de facto standard of care when treating patients with ER/LA opioids, and noncompliant prescribers might expose themselves to regulatory scrutiny or other repercussions.
- On a municipal level, the New York City Department of Health and Mental Hygiene published guidance on monitoring prescription drug adherence and nonprescribed drug use, recommending initial UDT and behavioral assessment followed by random UDT yearly for low-risk patients and up to every three months in those at high-risk [Paone et al. 2011].
Additionally, of the numerous peer-reviewed articles discussing the importance of UDT in pain-treatment practice, the following might be noted as being of particular prominence:
- All major clinical guidelines addressing opioid analgesic prescribing for chronic pain also stress the need for medication monitoring and drug detection via UDT [refs in Peppin et al. 2012]. The most recently updated guidelines, in July 2012 [Manchikanti et al. 2012], which also are informed by earlier guidance documents, concluded that there is good evidence to strongly recommend UDT at treatment initiation and for subsequent adherence monitoring to decrease prescription drug abuse or illicit drug use when patients are receiving chronic pain management therapy.
- In a first of its kind document on urine drug monitoring in pain care, an expert panel published consensus recommendations in July 2012 specifically addressing questions of which patients to test, which substances to test for, how often to test, and how to act on test results [Peppin et al. 2012]. While much of the guidance is based on limited evidence, this document helps to establish a framework for standardized UDT practices in the treatment of chronic pain with opioids.
- In a newly updated version of the text, Responsible Opioid Prescribing, from the Federation of State Medical Boards, author Scott Fishman, MD, recommends laboratory urine toxicology testing as an essential ingredient of assessing adherence to prescribed treatment regimens involving controlled substances [Fishman 2012].
- Clinical guidance specifically for family practitioners has strongly recommended UDT at the initiation of opioid therapy for chronic pain and randomly thereafter, and for both patients at high- and low-risk of abusing those medications [McBane and Weigle 2010].
Clearly, there are directives and recommendations coming from various authorities favoring the adoption of a pharmacovigilance approach, with UDT as an essential component, when it comes to prescribing controlled substances in pain care settings.
UDT is a subject that many practitioners, and their patients, would prefer to ignore; however, it demands attention. There is an implication that healthcare providers who do not comply with the various directives and recommendations may not be following best medical practices, which could be problematic if a clinician’s prescribing of controlled substances comes into question for one reason or another.
While a well-designed and consistently applied drug testing program can be an important tool for making clinical decisions, it should not be the only tool [SAMHSA 2012]. And, just as with all other components of pain management, practitioners need to weight benefits versus drawbacks of UDT while taking into account cost concerns. In theory, UDT is a relatively straightforward diagnostic tool; however, there are many complexities surrounding its application in clinical pain management, and there is much to learn.