In August, AACC released a position statement on the crucial role clinical laboratories play in combating the opioid crisis, an epidemic that has not showed signs of slowing down. In 2017, 47,000 Americans—more than 130 a day—died after overdosing on opioids, according to the Centers for Disease Control and Prevention (CDC). More people died of drug overdoses in 2016 and 2017 than died in the Vietnam War.

AACC’s position statement outlines the expertise that clinical laboratorians have to offer, and how AACC sees members best working with their colleagues in the medical community and in law enforcement. The statement also shows what measures the healthcare system, Congress, and federal agencies can take to work together on this issue.

Too often, the role of laboratory professionals is not apparent to other healthcare professionals working on the front lines, noted Alec Saitman, PhD, DABCC (CC, TC), director of clinical toxicology and special chemistry at Providence Regional Laboratories in Portland, Oregon, and member of the AACC Policy and External Affairs Core Committee that created the position statement. “It’s critical that we as clinical laboratorians position ourselves in a way that shows that lab testing for drugs of abuse, particularly opiates, is an important part of fighting this crisis,” Saitman said.

Synthetic Drugs Demand Specialized Expertise

Much of the statement focuses on synthetic opioids like tramadol, fentanyl, and U-47700. Overdoses from these substances made up a significant portion of all opioid overdoses. In fact, they killed 28,869 people in 2017, a 46% increase from the year before, according to CDC.

While some synthetic opioids are made by pharmaceutical companies, many are created in illegal labs and sold on the street. Slight modifications to their structures can produce a variety of analogs resulting in differences in potency and toxicity. They also may be cut with other drugs like heroin, methamphetamine, or cocaine.

This means that exactly what’s in synthetic drugs varies locally, which is important to know in the case of a mass poisoning. “Many times we’re the first people to access the patient’s blood or urine samples. Clinical laboratorians will see what is really prevalent in the community,” said James H. Nichols, PhD, professor of pathology, microbiology, and immunology at Vanderbilt University Medical Center in Nashville, who also is a member of the AACC Policy and External Affairs Core Committee. “From a public health perspective, and as you look at the Drug Enforcement Agency and the judicial system, they’re seeing particular drugs that are prevalent in terms of sales and the street marketing of prescription medications, but we are seeing the actual patient samples in real time.”

This is a key point AACC makes in the position statement. “Laboratories are often the first to identify synthetic drugs circulating on the street and can provide insight into their variety and frequency of their use in local communities,” the statement says. “Leveraging the expertise of clinical laboratory professionals to identify the use of synthetic opioids can help clinicians and first responders make informed treatment decisions and help public health and safety officials identify the cause of overdose outbreaks and coordinate a response.”

Close coordination is also necessary because analogs are developed so quickly that tests to detect them don’t always keep up, and new testing panels are often obsolete by the time they receive Food and Drug Administration (FDA) clearance. “The potential for false negatives when testing for synthetic drugs necessitates close collaboration between laboratories and the physicians ordering the tests, especially when the results have implications for critical treatment decisions,” the statement says.

“There’s a lack of awareness, even within the medical community, of exactly what drug testing can and cannot provide,” Saitman emphasized. In addition to immunoassays not always being developed fast enough to detect every synthetic opioid analogue, a urine test can’t detect how much and exactly when a drug was taken, which may not be obvious to a physician ordering the tests, he added.

The statement also raises awareness of how clinical laboratories are developing specialized mass spectrometry assays to close the gap between what immunoassays can detect and how fast analogs are developed. “The timeliness and accuracy of testing for synthetic opioids could improve further if forensic, public health, and clinical laboratories collaborate to build shared libraries of chemical structural and mass spectral data,” the statement says. “Laboratories that lack access to mass spectrometry methods could benefit from an expedited regulatory approval pathway for commercial availability of synthetic opioid test panels.”

This is important in identifying the exact cause of local mass poisonings. If a particularly dangerous drug such as carfentanil is detected, a laboratory could alert clinicians and public health officials to take precautions by ordering and distributing extra naloxone to first responders.

Time for a Team-Based Approach

AACC is also calling for greater collaboration between laboratories, public health, and law enforcement agencies to bring about a more effective response. The statement makes the case for why laboratory experts must be included on clinical care teams to help with test ordering and interpretation, and for laboratory directors to be available to provide detailed interpretive comments and services for sophisticated tests as warranted. It also calls for clinicians and first responders to consult with laboratories to ensure treatment decisions for overdose patients are as effective as possible, and for overdose patients themselves to be educated about precautions to take with synthetic opioids and provided with access to medication-assisted treatment.

“The lab often is not valued as much as we should be or recognized as having a critical role, not only in providing accurate results that clinicians can act on but also in working with providers to optimize testing,” said Stacy E.F. Melanson, MD, PhD, associate professor of pathology at Brigham and Women’s Hospital in Boston. Melanson served on the committee that developed the AACC Academy Laboratory Medicine Practice Guideline, “Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients” (J Appl Lab Med 2018;2:471-2). “We have a large amount of data, we have a large amount of knowledge, and we need to advocate for ourselves, which this statement does,” Melanson said.

Through greater collaboration, laboratory medicine professionals can partner with clinicians to provide test results that fit their work flows, a relationship that could speed innovation, she said. “If there’s a problem or something we can improve, we can work together with clinicians to create the right solution,” she said.

The statement also identifies where more funding is needed. AACC calls on Congress to provide money to scale-up the number of clinical and public health laboratories that can identify novel synthetic drugs at state and local levels, and to develop stakeholder partnership networks that facilitate rapid information sharing to target synthetic opioid response and prevention resources.

In addition, the statement calls for expanding opioid surveillance programs for synthetic drugs by leveraging timely de-identified data from clinical and public health laboratories; for the Drug Enforcement Administration to provide clinical and public health laboratories access to analysis of seized materials to help with timely identification of novel synthetic opioids; and for FDA to expedite the regulatory approval of testing panels developed to rapidly detect synthetic opioids.

Jen A. Miller is a freelance journalist who lives in Audubon, New Jersey. @ byJenAMiller