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Paul J. Jannetto, et al. Executive Summary of the American Association of Clinical Chemistry Laboratory Medicine Practice Guideline: Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients. J Appl Lab Med 2017;2:489-526.
Dr. Paul Jannetto is a consultant at the Mayo Clinic in Rochester, Minnesota, where he serves as co-director of the Clinical Mass Spectrometry Clinical and Forensic Toxicology and the Metals Laboratories. Dr. Jannetto is also a Guest Editor of the JALM January 2018 special issue on Laboratory Support of Pain Management.
Hello, and welcome to this edition of “JALM Talk” from The Journal of Applied Laboratory Medicine, a publication of the American Association for Clinical Chemistry. I’m your host, Randye Kaye.
Laboratory Medicine Practice Guidelines, published by the American Association for Clinical Chemistry, recommend best practices for clinical laboratories in a number of different areas of patient testing. These guidelines are formed via a systematic review of published literature and the consensus of experts in the field with the goal of optimizing patient care.
Recently, a review of the pain management literature was undertaken in order to produce laboratory practice guidelines in this subject area.
Pain management is a complex topic involving a number of stakeholders including patients, clinicians, the clinical laboratory, and others. A major component of pain management is monitoring a patient’s compliance with taking their prescribed medication, making sure patients are not diverting this medication, and also making sure patients are not taking medications that they are not prescribed.
Given that the magnitude of prescription opioid abuse has grown significantly over the past 10 years and that opioid-induced deaths have also increased dramatically, assessing risk and documenting responsible care when prescribing such drugs is at the forefront of clinicians’ minds.
An “Executive Summary of the American Association of Clinical Chemistry Laboratory Medicine Practice Guideline: Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients” is published in the January 2018 special issue of JALM on Laboratory Support of Pain Management.
The first author of this summary is Dr. Paul Jannetto, a
consultant at the Mayo Clinic in Rochester, Minnesota,
where he serves as co-director of the Clinical Mass
Spectrometry Clinical and Forensic Toxicology and the
Metals Laboratories. Dr. Jannetto is also a Guest Editor of
the JALM January 2018 special issue on Laboratory Support
of Pain Management, and he is our guest for today’s
Welcome, Dr. Jannetto. First question, what is the purpose
and target audience of the Laboratory Medicine Practice
Guideline (LMPG): Using Clinical Laboratory Tests to Monitor
Drug Therapy in Pain Management Patients?
The purpose of this LMPG was to provide clinical and
laboratory practice recommendations to address specific
questions regarding the appropriate use of diagnostic tests
to monitor adherence or compliance to controlled
substances in the pain management population.
Ultimately, this guideline produced 26 evidence-based and
seven consensus-based recommendations on the use of
laboratory and point of care tests to monitor the use of
controlled substances in pain patients. The goal of this
LMPG was to address many of the issues and challenges
faced by clinical laboratories, practicing pain management
clinicians, policy makers, regulatory bodies, and health
insurance companies surrounding urine drug testing in pain
management patients, including, how to determine what
types the laboratory tests are appropriate and what specific
analytes should be tested for.
How does this LMPG differ from the CDC guidelines for
prescribing opioids for chronic pain and other clinical
practice guidelines which state that urine drug testing
should be performed?
The CDC and other clinical practice guidelines only provide a
general recommendation stating that urine drug testing
should be performed in chronic pain patients who are
prescribed opioids or other controlled substances to see if
they are actually taking the prescribed medications or illicit
However, this LMPG addressed more of the details around
what type of testing, for example, immunoassay screening
versus definitive tests, the role of genetic testing in this
population, and the role of quantitative urine drug testing.
In the end, this guideline provides more specific details
around laboratory diagnostic tests, while also identifying and
pointing out the gaps where evidence is lacking in the
I see. Can you tell me some of the key messages and
evidence-based recommendations for clinicians and payers
and laboratories who perform urine drug testing?
One of the key evidence-based recommendations is that
first-line definitive testing, either qualitative or quantitative,
is recommended for detecting the use of relevant over the
counter medications, prescribed and non-prescribed drugs,
and illicit substances in pain management patients.
In addition, specimen validity testing, for example, pH
testing, is recommended since it is an effective tool to
ensure that laboratory test results are correctly interpreted
in pain management patients.
Specimen validity testing determines the suitability of the
urine specimen collected and received, which directly affects
the ability to correctly identify the medications, both
prescribed and non-prescribed, as well as illicit substances
used by pain management patients.
There’s a lot of literature surrounding the use of laboratory
tests to monitor drug therapy in pain management patients.
Did you identify any gaps in that literature, and what are
Additional studies are needed to examine the true cost
effectiveness of different types of diagnostic assays and
determine what is the required turnaround time for urine
drug testing to reduce or prevent negative outcomes in
The current evidence in the literature also did not support
using specific patterns of conjugated and unconjugated drug
and drug metabolites to define a patient’s metabolic
phenotype. And there was insufficient evidence to support
the practice of normalizing quantitative results, to creatinine
or specific gravity or that doing so was an effective means
of detecting compliance.
So, what effect do you think this guideline is going to have
on the current opioid epidemic in the U.S.?
In the end, I hope this LMPG provides some guidance for
laboratorians and clinicians to minimize unnecessary and
costly testing and lead to more appropriate laboratory test
utilizations, so providers get the required information they
need in a simplified format to verify adherence to controlled
substances in their pain management patients.
That was Dr. Paul Jannetto from the Mayo Clinic talking
about the JALM “Executive Summary of the American
Association of Clinical Chemistry Laboratory Medicine Practice Guideline: Using Clinical Laboratory Tests to
Monitor Drug Therapy in Pain Management Patients” for this
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