A doctor prescribes an opioid medication for chronic pain but suspects the patient is engaged in some kind of drug abuse or misuse. A standard urine test comes back negative. Is the patient not taking the medication, or is the test simply unable to identify it? What now?
Use more precise testing, says PeaceHealth Laboratories in Springfield, Ore., which secured its first-ever patent earlier this year on a new system that detects 38 medications and illegal drugs in traces far lower than are possible through standard tests employed and processed in medical offices and hospitals. The urine test is called PtProtect, or Patient Protect. Doctors send samples for analysis to the PeaceHealth Laboratories in Oregon and receive a detailed analysis, usually within about three days.
Grant Beardsley, clinical toxicologist and manager of drug-testing services for PeaceHealth Laboratories, said PtProtect offers medical professionals a way to obtain salient information if they suspect any one of three vexing and potentially dangerous actions by patients who are supposed to be taking pain medication:
Using other, unprescribed pain medications, often from friends, relatives or household medicine cabinets.
Using illegal drugs, with or without the prescribed medications.
Not using prescribed medications at all, and possibly selling or passing them along illegally.
Beardsley said PtProtect is useful for doctors who require patients on pain medications to take periodic drug tests as a condition of treatment, or who suspect that something is amiss. He said doctors often stop prescribing medications because of misuse, or refer patients to substance-abuse treatment. In rare cases, doctors stop providing care.
With better information, he said, doctors can be more assured that those difficult decisions are correct.
"We're not trying to create something that becomes divisive between physician and patient. Our focus has always been the safety of the patient," said Beardsley, who helped to develop the test. "Standard point-of-care tests are pretty good at identifying drugs of abuse, but the downside is they often don't detect pain medications used in chronic treatment. Those tests can create false negatives and false positives, and that doesn't give a doctor much sense of security."
He said standard urine tests administered and analyzed in a medical office usually don't detect all pain medications because they simply aren't sensitive enough.
Beardsley said that five years of field tests by PeaceHealth Laboratories found that 35 percent of results showed evidence of medications that hadn't been prescribed or no trace of drugs that had been. He said point-of-care tests generally detect drugs at thresholds of 2,000 nanograms per milliliter (ng/ml). Beardsley said PtProtect detects drugs at levels as low as 5 ng/ml.
In a retrospective study of almost 78,000 urine specimens that tested positive at 50 ng/ml, almost 60 percent of the positive samples were below 2,000 ng/ml. That means they wouldn't have been detected at a doctor's office employing a standard test.
The laboratory uses a liquid chromatography tandem mass spectrometer, an instrument that examines the molecular structures of drugs to identify and analyze trace amounts, he said. Reports to the physician list drugs detected by amount and interpret results based upon patients' prescription histories.
"We want to make it a clear, one-stop process for physicians that is easy for them to interpret," Beardsley said.
He said most health insurance plans cover the tests, which cost about $500 per sample. He said PeaceHealth Laboratories has provisions to provide relief to patients who lack insurance.
PeaceHealth Laboratories has done most of its PtProtect testing to date for clients in the Northwest, but it can test samples sent from anywhere in the United States.
Beardsley said staff began developing the test after he and others attended conferences on the rapid increase in deaths by prescription overdose and the widespread misuse of pain-medication prescriptions, often for sale on the street.
Ran Whitehead, chief executive of PeaceHealth Laboratories, said the new test can help protect doctors and patients.
"Our scientists developed PtProtect so physicians may know, with confidence, what pain medications their patients are taking and prescribe accordingly with the highest levels of safety," Whitehead said, adding that it also enables providers to better protect their practices from uncertain liabilities, including malpractice and patient mortality.
For more information, visit the PeaceHealth Laboratories website or call (800) 826-3616, ext. 8010 (client services).