Improving outcomes through comprehensive controlled substance monitoring

Eye on Innovation

Eye on Innovation features exciting advances taking place at Mayo Clinic Laboratories. This monthly series shines a spotlight on recently developed tests and highlights how Mayo Clinic translates ideas and discoveries into testing resources that improve diagnosis and care for patients across the globe.

From pain management clinics to emergency rooms, clinicians across the health care spectrum face a dizzying array of choices when it comes to screening patients for controlled substances. At times confusing, costly, and time-consuming, testing options vary in the details they provide about patients' drug use, painting an incomplete picture of usage patterns that can hinder accurate interpretation of prescription monitoring and treatment outcomes.

Now, Mayo Clinic Laboratories offers a comprehensive panel that provides in-depth analysis and interpretation of controlled substance use, giving clinicians details and interpretations lacking in other laboratory assays.

Paul Jannetto, Ph.D.

Developed by the Clinical Forensic and Toxicology Laboratory at Mayo Clinic, the controlled substance monitoring panel combines targeted, high-resolution screening and immunoassays to test for more than 70 different prescription and illicit substances. Created to align with the American Association for Clinical Chemistry and American Academy of Pain Medicine's guidelines for monitoring drug therapy in patients requiring prescription pain management, the panel significantly reduces the need for additional confirmatory testing.

"We  have created an approach to controlled substance monitoring that is consistent with evidence-based guidelines to meet the requirements of providers while being mindful of the costs to the patient and healthcare system," says Paul Jannetto, Ph.D., Co-director of the Clinical Forensic and Toxicology Laboratory. "We've really evolved this test over the past five years, making it easier for providers to make accurate interpretations since the first, high-resolution panel that we put together in 2016."

The updated controlled monitoring panel surpasses other tests on the market not only because it was designed for consistency with evidence-based guidelines, but provides comprehensive coverage of key drug classes like stimulants, opioids and benzodiazepines, with an algorithmic testing approach and specimen validity testing to create a complete and accurate story about what the patient is taking, Dr. Jannetto explains.

Prior to evaluation for controlled substances, each sample is tested for adulteration. Only if the adulterant survey comes back acceptable will the sample undergo further testing, which combines liquid chromatography-tandem mass spectrometry, high-resolution accurate mass spectrometry (LC-MS/MS HRAM) with KIMS immunoassays to identify prescription or illicit drug use.

"Controlled substance monitoring, especially the interpretation of test results can be very complicated, since the pharmacokinetics and metabolic pathways of these drugs are complex," Dr. Jannetto says. "For example with opioids, some drugs metabolize to other, separate prescribable drugs. So how do you differentiate if patients are only taking the prescribed drug or also using another medication? It can quickly get complicated."

Including such information and interpretations in the laboratory-generated report, which is included in the panel, simplifies things for physicians so they don’t have to memorize all the metabolic pathways, Dr. Jannetto adds.

The panel’s interpretations also contain information about the presence of pharmaceutical impurities, which are allowable in many prescription medications, but may trigger undue scrutiny when identified through a drug screen.

For example, Dr. Jannetto says, "Oxycodone can contain up to 1% of hydrocodone, which is commonly prescribed drug in the United States. Hydrocodone is not a metabolite of oxycodone, so you have to look at the concentrations and ratio of hydrocodone to oxycodone to see if it could be a pharmaceutical impurity or represent separate use of that drug. The interpretive reporting can help put that all together."

Possessing a complete picture of a patient's controlled substance use informs physicians and assists in offering individualized patient-centered care by improving adherence, identifying misuse and diversion, reducing non-prescription substance use, diagnosing substance use disorder, and guiding medical treatment.

"The vast majority of patients have an underlying medical problem," Dr. Jannetto says. "They have real issues where these medications provide therapeutic benefits. As a result, controlled substance monitoring is done in partnership with the patient to ensure they have continued access to these medications."

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Robin Huiras-Carlson

Robin Huiras-Carlson is a senior marketing specialist at Mayo Clinic Laboratories and a Mayo Clinic employee since 2015. Her writing focuses on specialty testing, innovation, and patient-focused initiatives.