By Pat Anson, Editor

A Denver-based drug testing company has developed a new saliva test to help doctors determine if their pain patients are taking opioid medications appropriately.

Cordant Health Solutions says its Comprehensive Oral fluid Rx Evaluation (CORE) test is more accurate than the point-of-care (POC) urine tests that are widely used by doctors to test patients for prescribed medications, as well as illegal drugs.

Urine tests only tell a doctor if a drug is present, not if the patient is taking the right amount of medication. As PNN has reported, studies have also shown the urine tests often give false results for drugs like marijuana, oxycodone and methadone.

“Urine screening methods are subject to false positive and false negatives. If somebody for instance is taking a cold medication, they could very easily test positive for amphetamines,” said Richard Stripp, PhD, Chief Scientific Officer for Cordant. “The CORE test is specific for the drug that’s in the blood at the time the oral fluid (saliva) is collected.

“And not only will it tell you whether the drug is there or not, it will tell you whether it’s there at a level that consistent with what was prescribed.”

If a prescribed drug is found in saliva, the CORE test will tell whether it’s within an expected range, or at a level that’s above or below it – an indication the patient is taking too much or too little medication. Stripp admits the test is not foolproof. About 25 percent of the time, he says drug levels detected in saliva don’t match what is found in the patient’s blood.

“There are always things that you have to consider when you are interpreting results. I often say this does not replace the clinical judgement of the physician. This is a tool to help them make better decisions,” Stripp told PNN.

“If a doctor says (a patient is) out of range, I’m kicking them out of my practice, we would never, ever suggest that should be the case. Basically, it’s time to have a conversation with a patient and maybe it requires further monitoring.”

Unlike urine samples, which are usually collected privately in a bathroom and can be swapped or altered with “clean” urine from someone else, a saliva sample for the CORE test can be collected directly from a patient’s mouth with a simple swab.  

One disadvantage of the CORE test is that the results are not immediately available, as they are with POC tests that utilize color-coded “dipsticks” that quickly change color when a drug is detected.

The saliva samples need to be shipped to a Cordant laboratory for testing and the results generally won’t be available for 48 to 72 hours. Currently the CORE test can be used to detect levels of oxycodone, hydrocodone, morphine, oxymorphone, hydromorphone, tramadol and fentanyl.

Patients Penalized After Failed Test

Laboratory testing is far more accurate than POC tests, but some doctors don’t bother ordering confirmatory lab tests if something suspicious is found in a patient’s urine. We hear regularly from readers who say their doctor became suspicious or even “fired” them after a POC test turned up something unexpected.

“Last week they had me come in to take a urine sample. A week later they called and said I failed because they found no drugs in my sample,” said one man who has been taking hydrocodone for nearly 30 years.

“The doctor now tells me they can't approve any more refills. I thought they were joking. They also told me that no one in the area could either. It's crazy and I don't know what to do. I tried not taking pain meds and nearly went insane from the sleepless nights.”

A woman who takes Percocet for her fibromyalgia pain wrote to us saying two urine tests failed to detect any opiates in her system.

“My physician of 14 years immediately interrogated me about compliance and asked if I was giving it away,” she said. “Based on the negative findings, he said he could not prescribe me any further narcotic pain relief.

“I have no idea how I will manage my pain now. This has turned into an insane circus. I feel betrayed by my physician, and the doctor-patient relationship has had its trust destroyed.”

Stripp says he cautions doctors not to jump to conclusions after a failed test.

“If you don’t do the laboratory confirmation test, from a legal perspective you can’t say with reasonable certainty that the test actually contains or doesn’t contain the material it was tested for,” he said.

“You never want to accuse a patient of aberrant behavior if you have an inconsistent result, because there are other reasons why you could have inconsistent results. It could be there are differences in metabolism or they could have a health issue that may be causing the problem. Or there may be a drug interaction.”

Another reader who is on probation was given a urine test that showed he was positive for fentanyl.

"After a nightmare trying to keep myself out of jail, they allowed me to go to a hospital for another urine and blood tests. Both came back 100% negative! The second tests were taken an hour after the first," he wrote. "The judge accepted the hospitals tests and I am free, but this should not be happening."

The CDC’s opioid prescribing guidelines encourage doctors to conduct urine tests on patients before starting opioid therapy and at least once a year afterward. But they explicitly warn against dropping a patient after a failed test.

 "Clinicians should not dismiss patients from care based on a urine drug test result because this could constitute patient abandonment and could have adverse consequences for patient safety, potentially including the patient obtaining opioids from alternative sources," the guidelines state.

How common is patient abandonment? In a recent survey by Pain News Network and the International Pain Foundation, 20 percent of doctors and healthcare providers said they had discharged a patient who failed a drug test in the past year.  And about 4 percent of the patients surveyed said they had been fired by a doctor over a failed test.