CDC’s proposed opioid prescribing guideline: Does it fall short on drug testing?

Last month, the Centers for Disease Control and Prevention (CDC) shared a draft update to its Clinical Practice Guideline for Prescribing Opioids. CDC’s guidance, which was last issued in 2016, intends to guide clinicians in safely and effectively prescribing opioids for acute, subacute and chronic pain.

Notably, the proposed revision comes as the nation’s overdose death rate reaches an all-time high,[i] fueled largely by the economic and psychological strains and lack of healthcare access caused by COVID-19.

Some research shows the previous guideline may have led to the undertreatment of patients with chronic pain.[ii] For years, experts argued limits on dosages prevented patients from accessing critical pain management tools; some speculate that patients even turned to illicit opioids when they were unable to access a prescribed opioid for legitimate pain.[iii]

The CDC’s proposed revision aims to address these and other concerns with the 2016 guideline. Of course, the CDC should be commended for its thoughtful attention to these issues and efforts to rectify deficiencies in the prior guideline. Much of what is outlined in the new guideline will hopefully create better outcomes for patients with chronic pain. Still, questions remain about whether the changes go far enough to reduce risks and optimize care involving opioid therapy – particularly related to diagnostic drug testing as an essential but underutilized tool for promoting the safe and medically appropriate use of prescribed opioids and other controlled substances.

Quest Diagnostics recently surveyed over 500 physicians in coordination with The Harris Poll to uncover attitudes about the rising drug overdose crisis and the role of clinical drug testing in safely prescribing opioids. A key theme emerged from the findings: physicians believe clinical drug testing is critical for managing opioids and other prescribed controlled medications, but feel clearer guidelines are needed to help optimize its use. Most (85%) physicians surveyed expressed confidence that testing aids in prescribing safely, and a similar majority (88%) believe better guidelines would help ensure testing is used equitably.[iv]

Here, the CDC’s proposed changes could go farther. In an apparent attempt to address concerns around drug testing costs and ‘patient firing’ due to a positive test result, the proposed guidance offers vague details on the role, frequency and methods of testing that should be employed by clinicians. It also underplays the essential value of definitive laboratory testing in monitoring for opioid use, including with nonprescribed fentanyl, even though these substances are responsible for the vast majority of overdose deaths.[v]

Clinical drug testing is the only objective source of insight into a patient’s drug use behaviors. While physicians may wish to rely on a patient’s self-report, 48% of drug monitoring test results performed by Quest Diagnostics in 2020 were inconsistent with medications prescribed[vi] – a statistic that may have worsened in 2021 when the Delta and Omicron COVID-19 surges likely limited in-person patient care and therefore testing.

Given this data, among the chief concerns within the CDC’s proposed guideline revisions is its statement that clinicians should ‘consider’ utilizing toxicology testing, and only ‘periodically.’ CDC must go further in clarifying when and how clinicians should utilize clinical toxicology drug testing to help ensure the responsible and effective use of prescribed opioids and other controlled medications. For example, based on my experience, to provide the insights physicians need toxicology testing should be performed at baseline and periodically based on individual patient factors (and no less than at least once annually). Indeed, 88% of physicians surveyed say prescription drug monitoring is critical to helping identify patients who may be misusing prescription drugs, and 92% believe prescription drug monitoring will increasingly become the standard of care when prescribing controlled substances.[vii]

In addition, the use of clinical drug testing in chronic opioid therapy is recommended uniformly by medical guidelines, including from the American Pain Society (APS), American Academy of Pain Medicine (AAPM), American Society of Interventional Pain Physicians (ASIPP), American Association for Clinical Chemistry (AACC), and the Federation of State Medical Boards (FSMB). In fact, current clinical practice guidelines from AACC recommend that, in addition to baseline drug testing, testing should be performed throughout the year for patients prescribed controlled substances.[viii]

Another concern comes from statements in the proposed guideline about the need to minimize the use of definitive testing to limit costs. While reducing costs of toxicology testing is a worthwhile goal, and not all patients will require a definitive test, clinical drug testing fits in a larger landscape of costs, from treatment for substance use disorders to emergency department visits for overdose – some of which toxicology testing may help to avert. The estimated economic costs of the U.S. opioid epidemic, due to health care expenses, criminal justice, lost productivity, and reduced quality of life, topped $1 trillion in 2017.[ix]

Though presumptive point-of-care tests are an important tool for clinicians, they are often less sensitive and can miss drugs that definitive lab tests will detect. Recent data shows point-of-care presumptive urine tests may miss about 74% of specimens with fentanyl, as determined by sensitive definitive laboratory tests. These same point-of-care tests were also shown to have missed large percentages of other drugs, including marijuana, amphetamine, methamphetamine, oxycodone and cocaine.[x] Yet, presumptive tests still have an important role to play, such as for low-risk patients.

For these reasons, the final guideline should recognize the need for presumptive testing followed by definitive testing on the same specimen for specific indications, such as to confirm the presence of specific drugs being prescribed or to confirm any unexpected positive findings on presumptive screen that do not match the patient’s accounting of medication/drug use.

While the CDC has put forth a strong effort to improve its guideline, more can be done. The final guideline should place greater emphasis on the importance of testing and clarify when and how it should be used. Data shows these pieces cannot go ignored and are vital to curbing our nation’s growing overdose death epidemic. Individuals may submit comments through the Federal Register until April 11, and it is anticipated that the CDC will issue its final guideline later this year.

For more information on clinical drug testing, visit www.WhyClinicalDrugTesting.com. To access the Quest Diagnostics Health Trends report and survey findings, visit Quest Diagnostics Newsroom - Health Trends®.

Dr. Jack Kain is Director and Medical Science Liaison of Drug Monitoring and Toxicology at Quest Diagnostics. He has served as a consultant, clinical toxicologist and medical science liaison for multiple toxicology laboratories. Dr. Kain has also served on various committees, including the Addiction Treatment Advisory Group for the Academy of Managed Care Pharmacy. He earned his Doctor of Pharmacy (PharmD) degree from Lake Erie College of Osteopathic Medicine. His post-graduate training includes a fellowship in forensic toxicology and further graduate coursework in general toxicology. Dr. Kain has developed solutions that identify and incorporate drug-drug interaction analytics into drug testing platforms.

[i]Products - Vital Statistics Rapid Release - Provisional Drug Overdose Data (cdc.gov)

[ii]Rich RLC Jr. Prescribing Opioids for Chronic Pain: Unintended Consequences of the 2016 CDC Guideline. Am Fam Physician. 2020 Apr 15;101(8):458-459. PMID: 32293841.

[iii]CDC tones down its opioid prescribing guidelines (statnews.com)

[iv]Quest Diagnostics Health Trends® Drug Misuse in America 2021 (mediaroom.com)

[v]Updated CDC Prescription Opioid Guidelines Appear More Flexible And Patient-Centric, But Fall Short (forbes.com)

[vi]Justin K. Niles, Jeffrey Gudin, Jeff Radcliff, and Harvey W. Kaufman. Population Health Management. Feb 2021.S-43-S-51. http://doi.org/10.1089/pop.2020.0230

[vii]Majority of Physicians Fear Another Prescription Drug Crisis, Finds New Quest Diagnostics Health Trends™ Report - Oct 16, 2019

[viii] Langman LJ, Jannetto PJ. Using Clinical Laboratory Tests to Monitor drug Therapy in Pain Management Patients at 7. AACC Academy, Laboratory Practice Guidelines. American Association for Clinical Chemistry, 2018.

[ix]Kuehn BM. Massive Costs of the US Opioid Epidemic in Lives and Dollars. JAMA. 2021;325(20):2040. doi:10.1001/jama.2021.7464

[x] Gudin, Kain, Hilborne, Edinboro: PAINWeek Poster Number 30 - Presumptive Versus Definitive Drug Testing: What Are We Missing?