Drug Tests Show Pain Patients on Opioids Less Likely to Use Illicit Drugs

By Pat Anson, PNN Editor

In an effort to reduce soaring rates of drug abuse and overdoses, many physicians have taken their pain patients off opioids and switched them to “safer” non-opioid drugs like pregabalin, gabapentin and duloxetine. Others have encouraged their patients to try non-pharmacological treatments, such as acupuncture, massage and meditation.

That strategy may be backfiring, according to a large new study by Millennium Health, which found that pain patients prescribed opioids are significantly less likely to use illicit drugs than pain patients not getting opioids.

The drug testing firm analyzed urine drug samples from 2019 to 2021 for nearly 55,000 patients being treated by U.S. pain management specialists. About 80% of the patients were prescribed an opioid like oxycodone or hydrocodone, while the other 20% were not prescribed opioids.

Millennium researchers say detectable levels of illicit fentanyl, heroin, methamphetamine and cocaine were far more likely to be found in the urine of non-opioid patients than those who were prescribed opioids. For example, illicit fentanyl was detected in 2.21% of the patients not getting an opioid, compared to 1.169% of those who were. The findings were similar for heroin, methamphetamine and cocaine.

“In all cases, we found that the population that was not prescribed an opioid was significantly more likely to be positive for an illicit drug than those patients who were prescribed opioids,” said lead author Penn Whitley, Director of Bioinformatics at Millennium. “(There was) a 40 to 60 percent increase in the likelihood of being positive if you were not prescribed an opioid.”

Illicit Drug Use By Pain Patients

MILLENNIUM HEALTH

What do the findings mean? Are pain patients getting ineffective non-opioid therapies so desperate for relief that they’re turning to illicit drugs? That’s possible, but the study doesn’t address that specifically.

Another possibility is that patients on opioids are simply being more cautious and careful about their drug use. Opioid prescribing in the U.S. has fallen by 48% over the past five years, with many patients being forcibly tapered or abandoned by doctors who feel pressured to reduce their prescribing.  

“Unfortunately, a lot of people with chronic pain have learned that it’s a bit tenuous, that their doctors are feeling pressure, and if they want to maintain their access (to opioids), they need their PDMP (Prescription Drug Monitoring Program) and their drug tests to look the way they need to look, so their doctor can feel comfortable continuing to prescribe,” said co-author Steven Passik, PhD, VP of Scientific Affairs and Head of Clinical Data Programs at Millennium. “I do think they realize that they’re on a treatment and that access to it is not guaranteed.”   

Preliminary findings from the study were released today at PainWeek, an annual conference for pain management providers. The findings mirror those from another Millennium study earlier this year, which found that pain patients have lower rates of illicit drug use than patients being treated by other providers.     

“If your main way of protecting people in pain from getting involved in substance abuse is to limit their access to opioids, there’s at least a hint here that’s not the right approach,” Passik told PNN. “It’s not a definitive statement by any stretch of the imagination, but it’s an approach to patient safety that leaves a bit to be desired.”  

Another recent study at the University of Texas also found that restricting access to opioids is “not a panacea” and may even lead to more overdoses.  Researchers found that in states that mandated PDMP use, opioid prescribing decreased as intended, but heroin overdose deaths rose 50 percent.

“Past research has shown that when facing restricted access to addictive substances, individuals simply seek out alternatives rather than limiting consumption,” said lead author Tongil Kim, PhD, an assistant professor of marketing at University of Texas at Dallas. “In our case, we measured overdose deaths as a proxy and found a substantial increase, suggesting that the policy unintentionally spurred greater substitution.”

Pain Patients Have Low Rates of Illicit Drug Use

By Pat Anson, PNN Editor

Anti-opioid activists have long claimed that opioid medication is a gateway drug to heroin and other street drugs. That myth is so ingrained in the medical community that many pain patients are discriminated against by doctors and pharmacists, who suspect they are abusing their medication or using illicit drugs.

But a large new study by Millennium Health pokes a hole in that myth, finding that patients being treated in pain management practices are far less likely to use heroin, fentanyl, cocaine and methamphetamine than other patients.

The drug testing firm analyzed the lab results of two million urine tests from 2015 to 2021 – nearly 600,000 coming from pain patients -- and found that patients seeing primary care physicians, behavioral health doctors (psychiatrists and psychologists), or getting substance use disorder (SUD) treatment were significantly more likely to test positive for street drugs than patients of pain management providers.

SOURCE: MILLENNIUM HEALTH

“That’s one of the reasons why we decided to put this out there in the public domain, because it’s important. Because clearly there are differences across these groups,” said Eric Dawson, PharmD, Vice President of Clinical Affairs at Millennium Health.

For example, the positivity rate for fentanyl in urine samples is about 2% for pain management patients – a level that remained stable throughout the 6-year study period.

But Millennium found that for primary care and behavioral health patients, the positivity rate for fentanyl has ticked up to about 5 percent.

In patients getting SUD treatment, the positivity rate has skyrocketed to about 17 percent, no doubt a reflection of the growing presence of illicit fentanyl in street drugs.

Positivity rates for methamphetamine are also rising for most patients – but not for pain patients – while cocaine use has remained relatively flat. Positivity rates for heroin have declined steadily for all patients since 2015, according to Millennium.

“Generally speaking, the pain population that’s treated with opioids is an older population and uses illicit drugs at a very low rate,” said Steven Passik, PhD, VP of Scientific Affairs and Head of Clinical Data Programs at Millennium.

“Not only are they low, they remain low,” says Dawson. “So many of the other groups, over time their positivity rates are increasing. The pain population started low and remains low. And that says they are different than the other groups.”

What makes the findings even more striking is that they include the first two years of the covid pandemic, a time when stress, isolation and depression led many people to abuse drugs.

“But that did not happen in the pain patients. You can actually see that,” says Passik, who believes regular drug testing makes pain management patients less likely to take risks that might affect their healthcare. He thinks the Millennium study should be reviewed by both providers and policymakers to get a better understanding of people in pain.

“There isn’t that much data like this out there. I think it’s unique and very positive about this population. And I think that should be factored in when people are talking about access to opioids,” Passik told PNN.

In addition to fentanyl, heroin and other street drugs, the Millennium study also looked at positivity rates for marijuana, which have soared in recent years due to the legalization of medical and recreational cannabis in many states. By the end of 2021, the positivity rate for cannabis had reached nearly 32 percent for most patients. But, like the other drugs, cannabis use remained relatively low for pain patients.  

New Test Identifies Poor Drug Metabolizers

By Pat Anson, Editor

We hear regularly from readers who say they were discharged by their doctor after failing a urine drug test. Often it’s a case of an opioid painkiller not being found, which leads the doctor to believe a patient is selling or diverting their medication.

“The doctor said after 12 years of never having a bad urinalysis or anything ever happening, such as lost medication, asking to receive more or an early prescription, they said no medication was in my system. No one would retest and I was cut off cold turkey!” a pain patient recently told us.

“I went through hell trying to clear my name, horrible withdrawal with no doctor supervision or help, was labeled and thought I would die. This is a terrible way to treat anyone, especially someone with an untreatable life-long pain condition.”

Why are patients being falsely accused? In many cases, it’s because they have genetic differences that make them a low or high metabolizer of certain opioids. A painkiller like hydrocodone, for example, can quickly be utilized or pass through their system -- with little or no trace of the drug left behind.

Urine drug tests that are typically done in a doctor’s office -- known as point-of-care (POC) tests – do not identify these poor drug metabolizers. And studies show that about 30 percent of POC tests have “false negative” findings about opioid medication.

“Just because it may not show up in their system may not mean that they’re not taking it. There are two rational justifications for that. One is a bad drug test and the other is a patient may be a poor or ultra-rapid metabolizer of the medication that is being prescribed to them,” said David McCrea, CEO of Insight Diagnostics.

“I think most (doctors) understand how faulty the point of care tests can be, especially pain physicians. But I’m not sure the average physician understands how much a person’s individual metabolism can affect their drug test.”

Insight Diagnostics recently began offering a new testing service – called Genetically Enhanced Medication Monitoring (GEMM) – that combines a saliva-based genetic test with a laboratory test that more precisely identifies drug molecules in a patient’s urine. When used together, the two tests can reassure a doctor that a patient is telling the truth about their drug use.

“This is a game changing test that will allow physicians to uncover why some patients say, ‘I am taking my medication, I am taking it as prescribed and it’s just not showing up.’ This is scientific information that can validate a patient’s assertion,” McCrea told PNN.

“Certainly there are going patients that are going to try and game the system. But for those patients that are in chronic pain and are doing what they signed their pain contracts to do, this allows for a deeper dive for the physician to determine whether the patient is actually taking their medication, or they can’t metabolize it or they over-metabolize it.”

McRae says GEMM costs "a couple hundred dollars at the most” and is covered by Medicare and most private insurers. It doesn’t offer immediate results, as POC tests do, but the findings are far more accurate. They can also help physicians identify medications that will be metabolized normally by a patient and will be more effective. 

Genetic tests cannot be used to explain “false positive” findings from a POC test – the detection of a drug that isn’t actually there. But laboratory testing can. Retesting a urine sample is more expensive, but it can help prevent patients from being falsely accused – something that happens far too often.   

A recent survey of doctors and health care providers by PNN and the International Pain Foundation found that 20 percent had discharged a patient for failing a drug test in the past year. About four percent of patients said they had been "fired" by a doctor over a failed test.

“I failed a drug test which said I was positive for 4 drugs I have never taken in my life and was negative for opiates when I was taking Norco. My doctor abruptly stopped treating me even after I demanded my sample be retested,” a patient told us. “These drug tests are not reliable and should not be used and pain contracts should be illegal since they are forced on the patient.”

Click here to see a short promotional video about GEMM.

New Saliva Drug Test for Pain Patients

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.