Inside Track: Labs on the Front Line

CDC formalizes new guidelines aimed at curbing misuse of prescription opioids

Interview by Steve Halasey

In the middle of March, the Centers for Disease Control and Prevention (CDC) issued a new guideline for primary care clinicians who prescribe opioid medications to treat patients with chronic pain.¹ Arriving in the midst of an acknowledged epidemic of prescription opioid overdose deaths, the guideline addresses when opioids should be prescribed for chronic pain; the selection, dosage, duration, follow-up, and discontinuation of opioid therapy; and how to assess and mitigate the risks related to opioid use. The result of years of work by subject matter experts and representatives of professional societies and government agencies, the voluntary guideline is intended to “reduce the number of persons who develop opioid use disorder, overdose, or experience other adverse events related to these drugs.”

Clinical labs will have an important role to play in implementing CDC’s recommendations, which call for urine testing prior to initiation or renewal of a prescription for any opioid painkiller. To find out more about the role of clinical labs in carrying out CDC’s guideline, CLP recently spoke with F. Leland McClure III, MSci, PhD, F-ABFT, corporate medical science liaison director for prescription drug monitoring at Quest Diagnostics, Madison, NJ.

CLP: Quest has been monitoring and reporting on prescription drug use in the United States for several years. How did this effort come about and how are the annual report findings compiled?

Leland McClure III, MSci, PhD, F-ABFT: In 2009, Quest Diagnostics recognized that there was a need for a service that would provide prescription drug monitoring laboratory testing to its contracted providers. We created such a program in 2010, and we included a broad menu of laboratory tests that would provide objective data to assist providers with monitoring patient compliance with drug prescriptions—including information about both drugs that had been prescribed as well as those not prescribed.

As a thought leader in the industry, Quest Diagnostics routinely provides laboratory testing data to its contracted providers. But as we got through our first year of collecting data for the new program, we realized that this information was also important to the laboratory community as a whole. The result was the creation of our Health Trends report series entitled Prescription Drug Misuse in America, the first installment of which was produced for the year 2011.² We’ve been producing a report annually ever since.

CLP: What is your role in this effort?

McClure: I’ve had several roles on the prescription drug monitoring project. I was involved from the beginning in creating the program as director of laboratory operations for the prescription drug monitoring program. And I remain involved now in a new medical affairs role as the medical science liaison director for the prescription drug monitoring program.

CLP: What were the key findings of Quest’s most recent report, which was issued last September?

McClure: Our analysis of deidentified prescription drug monitoring patient test results found that more than half of the patients of all ages are misusing opiates, other potentially addictive medications, or commonly abused drugs, in spite of federal and state efforts intended to curb the prescription drug epidemic. We found that the risk of misuse is about equal by gender. In addition, we found that people who are in private health plans or who are older misuse these drugs only slightly less than those who are on Medicaid or of a younger age.

Since we have been monitoring this field since 2010, we were also able to take something of a longitudinal view. In 2015, our Health Trends analyses found that the overall rate of prescription drug misuse is dropping across all age groups. In 2011, the year covered in our first report, Prescription Drug Misuse in America: Laboratory Insights into the New Drug Epidemic, the rate of inconsistency was 63%.² By 2014, it had dropped to 53%. That decline—10% on an absolute basis, but 16% on a relative basis—is good news, but the fact that the overall rate is still above 50% indicates that more effort is needed

CLP: Reductions in the rate of misuse have been greater in some states than in others. Were you able to identify any causes underlying such regional differences?

McClure: We believe that improvements in inconsistency rates are likely a result of different dynamics within the various states. Most states have now implemented prescription drug monitoring programs, and some have issued regulations or supplemented their databases with specific guidance on the use of controlled medications. So there are a variety of factors in play.

CLP: How do the findings of Quest’s report relate to CDC’s new guideline, which urges doctors to avoid prescribing opioid painkillers for chronic pain?

McClure: Our Health Trends research supports CDC’s statistics regarding the magnitude of the opioid misuse epidemic. The CDC report notes that 249 million prescriptions for opioid pain medications were issued in 2013. In 2014, there were almost 19,000 drug-related deaths, the majority of which involved opioid prescription painkillers. Today, more than 40 deaths related to prescription pain medications occur every day.

Our research also highlights several key messages of importance to both policymakers and providers. First, our experience as the world’s leading provider of diagnostic information services and a leader in prescription drug monitoring makes it clear that all people who are prescribed opioid pain medications are at risk for misuse, regardless of age, gender, or other socioeconomic factors. This conclusion is supported by several findings from our study already mentioned.

Second, our research confirms the importance of clinical prescription drug monitoring testing as the only truly objective tool to assist with assessing an individual’s risk for misuse. Quest believes that such objective monitoring is an important tool for limiting the abuse and misuse of opioid pain medications. CDC’s report also recognizes the importance of prescription drug testing as an objective tool to curb the opioid drug epidemic and the incidence of addiction, drug diversion, and death due to abused opioids.

And finally, as providers are incorporating the CDC guidelines into their daily practice, it will be vital that they recognize the inherent limitations of presumptive screening test methods, as compared to the far greater reliability of presumptive results confirmed by definitive testing using liquid chromatography–tandem mass spectrometry. Mass spectrometry provides definitive identification of drugs and metabolites present in a patient’s specimen, and also rules out false-positive presumptive results.

CLP: CDC Director Tom Frieden, MD, MPH, has characterized the epidemic of opioid abuse as being “doctor-driven.” Is there anything in Quest’s research to support that observation?

McClure: Patient misuse of prescription drugs is occurring across the entire range of drug tests we monitor. Among patients who had been prescribed opioid pain medications, our Health Trends report found that only 47% of laboratory test results were consistent with the expected results based on the patients’ prescribed medications. In other words, the majority of test results—53%—were found to be inconsistent with expectations.

Among those inconsistent results, 44% of the samples were reported as no drugs detected; 35% tested positive for additional drugs, beyond those prescribed for the patients; and 21% tested positive for drugs other than those that had been prescribed.

CLP: Does the fact that a significant portion of the reported misuse involves drugs that were not prescribed suggest that doctors are not the sole drivers?

McClure: Yes, it does. The abuse is being driven by the drugs that have been prescribed as well as by patients who are not in compliance with their therapeutic regimen. There are also some patients who are supplementing their prescribed drugs with other drugs.

CLP: In its guideline, CDC provided an exemption for patients with cancer. Are there other diseases or conditions that CDC has marked for similar treatment?

McClure: Yes. CDC also called out palliative care, hospice care, and end-of-life care for unmonitored use of opioid medications. The reason for these exemptions, of course, is that the medications are being used for humane relief in cases of extreme pain and suffering.

CLP: CDC’s guideline also calls for patients to undergo urine testing prior to receiving a prescription for an opioid painkiller. What are those tests expected to reveal and what actions would result from a positive finding?

McClure: Clinical testing with a urine specimen provides information about drug use that may not be disclosed by the patient. The tests can indicate whether patients are taking the opioids prescribed to them, or can alert providers to cases of potential drug diversion or other clinically important issues, such as patient difficulties with prescription drug adverse effects.

Urine specimen tests provide objective laboratory data about the prescribed drugs present in a patient’s urine. But they do not provide information about how much drug was taken, the form of the drug, or what the drug dose was intended to be.

In addition to providing data about prescribed drugs, urine specimen drug tests can also provide information about any other drugs that may be present. Where patients have been taking drugs other than those that have been prescribed, this information can be important for preventing drug–drug interactions that could have severe consequences.

CLP: When a urine test is returned with positive results for inappropriate drug use, who is intended to act on that information and what are they supposed to do?

McClure: It is up to the providers to interpret and handle all test results, including those that are inconsistent with expectations, remembering that the overall goal is to improve patient safety.

To manage such patients, clinicians may choose to use a different pharmacotherapeutic approach or even a nonpharmacotherapeutic approach. They may taper patients off or simply discontinue their current medications. Depending upon what drugs the urine test has detected, there may be an indication to prescribe or offer naloxone as a rescue treatment. And it is always an option to provide a referral for the patient to receive treatment for substance use disorder.

As providers review a patient’s test results and see that they are inconsistent, one option that should be least considered is to dismiss the patient from the practice. CDC does not recommend such an action, which would be viewed as abandonment. It could have adverse consequences for patient care.

CLP: Are laboratorians concerned about the potential for linking test findings to any type of enforcement action?

McClure: Testing for pain management and prescription drug monitoring is usually performed as nonforensic, routine clinical laboratory work. As such, this testing should not be routinely used for any kind of employment or legal actions.

CLP: In what other ways can clinical labs aid CDC in curbing prescription medication misuse?

McClure: Public education is one important function where data from clinical laboratories can be marshaled in support of CDC’s program. At Quest Diagnostics, we maintain the largest private clinical laboratory database in the United States, and we are making use of our massive data capabilities to study and report insights about public health issues such as prescription medication misuse.

Our most recent Health Trends report offered insights about the use of diagnostics in the ongoing battle against prescription drug misuse in America.³ The report was based on more than 2.5 million test results from patients of all ages. By providing this information, we can help to educate the public about the selection and performance of appropriate laboratory testing, how the analysis of deidentified data can inform and guide healthcare policies and practices, and ultimately what such information means for the health risks of an individual patient.

CLP: Does Quest see other opportunities—beyond prescription drug monitoring—where patient data could be used to inform policymakers and healthcare systems that are shaping future policies and practices?

McClure: Yes. Our data and analyses on prescription drug use can help public health agencies, health systems, and providers whose patients may be putting their health at risk by misusing prescription medications.

But when we look beyond our prescription drug monitoring program, it’s clear that Quest can also provide data and diagnostic insights for managing and improving the health of patients in a wide range of areas. By using our massive data and analytics capabilities, we are able to study many other disease states.

CLP: What are Quest’s future plans for providing information to address prescription drug abuse and other public health issues?

McClure: We intend to continue producing our annual Health Trends reports with a focus on prescription drug misuse. In large measure, the importance of this effort will be in its public communication and education about the risks associated with prescription drug misuse.

We also provide the highly sourced Drug Testing Index, which focuses on drug testing for forensic and workplace environments.⁴ And we routinely review our analytics center data to produce Health Trends reports on a wide variety of disease states.

Steve Halasey is chief editor of CLP.

REFERENCE

1. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain, United States, 2016. MMWR Recomm Rep. 2016;65(1):1–49; doi: http://dx.doi.org/10.15585/mmwr.rr6501e1. Accessed March 17, 2016.

2. Prescription drug misuse in America: laboratory insights into the new drug epidemic. Madison, NJ: Quest Diagnostics, 2012. Available at: http://www.questdiagnostics.com/dms/Documents/health-trends/PDF-MI3040_PDM-Report_24638_FIN_Digital_4-20-12/PDF%20MI3040_PDM%20Report_24638_FIN_Digital_4-20-12.pdf. Accessed March 18, 2016.

3. Prescription drug misuse in America: diagnostic insights in the continuing drug epidemic battle. Madison, NJ: Quest Diagnostics, 2015. Available at: http://www.questdiagnostics.com/dms/Documents/health-trends/Health_Trends_27281_MI4854_V5_LG_082715_Small.pdf. Accessed March 18, 2016.

4. Drug Testing Index [online]. Madison, NJ: Quest Diagnostics, 2016. Available at: www.questdiagnostics.com/home/physicians/health-trends/drug-testing.html. Accessed March 18, 2016.