There’s an ongoing call to monitor pain medication and detect overuse, but nobody in the lab community is entirely sure how to go about it.
The National Academy of Clinical Biochemistry (NACB), the academy of the American Association for Clinical Chemistry (AACC) established a committee to develop evidence-based guidelines for standardizing testing in the clinical laboratory. The AACC’s National Academy of Clinical Biochemistry committee began reviewing clinical literature on which analytes should be used, as well as the cut-off point for detection and the reporting format. The laboratory group will focus on the efficacy of using mass spectrometry and other lab methods for measuring levels of medications in pain patients, as well as for detecting non-compliance and/or drug abuse.
Addressing Inconsistencies
A draft of AACC’s Pain Management Laboratory Management Practice Guidelines is expected to be available for public comment at AACC’s Annual Meeting & Clinical Lab Expo in July 2015 and committee leaders hope to have a final version in 2016.
“There are a lot of regulatory requirements whenever a physician prescribes pain medication, particularly opiates,” explained Loralie Langman, PhD, directory of toxicology and therapeutic drug management lab at Mayo Clinic and co-chair of the AACC’s guideline committee. “That’s where the lab comes in for this aspect of medicine. The analysis of biological samples assists clinicians in achieving regulatory requirements. What goes along with this is a lack of consensus on how to test, what tests should be done and the frequency.”
As Paul Jannetto, PhD, directory of toxicology and drug management lab at Mayo Clinic and co-chair of the AACC’s guideline committee, elaborated, an entire industry has sprung up around the testing of pain management medication use.
“There are a lot of professional practice guidelines mandating that testing is done but there’s no information on how to test. If you look at the marketplace, there are so many different ways to test. There are whole labs that only do this and some offer 100-panel tests.”
Currently, the only standards that even exist are based on workplace drug testing and nothing is written specifically for pain management. According to Langman, those cutoff values are too high for clinical applications.
In the early stages of the literature review, it’s becoming apparent that there’s little formal research on testing for many medications. Langman noted that morphine is well examined but information is scant on the effectiveness of lab monitoring on medications that haven’t existed as long.
The committee will also include medical marijuana and other drugs with abuse potential in its section on pain management medications. Because the laws vary greatly state by state, there are high numbers of reports of illicit use in states where medical marijuana is still illegal.
When the guideline’s published, it will consist of several chapters on pain medications, the metabolizing enzymes and recent evidence on pharmacogenomics, as well as types of specimens used in pain management and typical amounts of time required to detect pain medications in those specimens; adulterants used by pain patients to deflect accurate detection of illicit substances in their urine; and regulatory and DEA issues for both physicians and labs.
After the testing thresholds are established, Langman and Jannetto said it’s critical to outline a final reporting template.
“Right now, the information on final reports varies by lab,” Langman said. “Some labs use present or absent numerical values and/or graphical representations of the compliant population. In the lab community, we hear a lot that this is confusing because the medication classes are complex.”
Revolutionizing Laboratory Design
This concept of simplifying the reporting document illustrates the purpose of the guideline itself: making information useful to clinicians so they can fine tune their prescribing practices. Jannetto said they’re keeping both the pain management specialist and the family physician in mind in developing the guidelines.
Three of the committee’s nine members are doctors with the American Academy of Pain Medicine, one works for the National Institute for Drug Abuse and the rest are laboratory professionals. This cross-section of disciplinary perspectives is intended to represent the different facets of the complicated pain medication abuse issue.
For labs, this guideline may change business practices. “Some labs are doing the minimum point-of-care panels and others are running 100-test panels. Our results will impact them in different ways. Labs doing the minimum point-of-care cup may not be sufficient. On the other hand, labs may be doing more testing than required to support medical practice. Excessive testing is frowned upon at the hospital, federal and private-payer level because of reimbursement issues.”
Still, Jannetto and Langman said the anticipation of this guideline is generating a great deal of excitement in the lab community, even though it many labs may have to revamp their business model.
“The lab community has the desire to provide appropriate testing to meet clinicians’ needs,” he assured. “We’re in the service industry and have a strong desire to offer the right product.”
Robin Hocevar is on staff at ADVANCE. Contact [email protected].
