Tramadol ER Visits Soar as Prescriptions Rise

By Pat Anson, Editor

Emergency room visits in the U.S. involving tramadol have nearly tripled in the last decade, coinciding with a sharp increase in the number of prescriptions for the opioid pain reliever.

According to a report by the Substance Abuse and Mental Health Services Administration (SAMHSA), emergency room visits involving adverse reactions to tramadol rose from 10,901 visits in 2005 to 27,421 visits in 2011. A second SAMHSA report  found a similar increase in the number of ER visits related to the abuse or misuse of tramadol. The vast majority of patients were treated and released.

Ironically, tramadol is considered less risky than other opioid painkillers and doctors have been increasingly prescribing it. The IMS Institute recently reported the number of tramadol prescriptions in the U.S. nearly doubled from 28 million in 2010 to over 44.2 million in 2014.

Tramadol is the active ingredient in brand name pain relievers such as Ultram, Ultracet, Ryzolt and Rybix.

“Tramadol is not abused as much as most pain medication, but it is often overtaken in an effort to obtain additional pain relief.  Like with all pain medication, excessive amounts can cause serious harm,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

Webster predicted that tramadol would be prescribed even more often when hydrocodone was reclassified in 2014 by the Drug Enforcement Administration from a Schedule III drug to a more restrictive Schedule II medication. Tramadol is a Schedule IV drug, meaning it has less potential for abuse than other narcotic pain relievers.

“In the past several years there has been tremendous pressure to reduce prescribing strong opioids. Tramadol has been used in place of other opioids. But it is not without risks as well,” said Webster in an email to Pain News Network.

“The rise in problems associated with tramadol underscores the larger problem of an unmet need to effectively treat pain. Most people, including policymakers, don't realize how many people are desperate to have their pain treated.”

About two-thirds of the ER visits related to misuse or abuse involved tramadol that was taken with other opioid pain relievers or anti-anxiety drugs (benzodiazepines). When tramadol is combined with other drugs that depress the central nervous system its sedative effects can be enhanced, causing seizures and a potentially fatal drug reaction known as serotonin syndrome.

Women were far more likely to have a tramadol-related trip to the ER than men, according to SAMHSA.

The greatest increase in tramadol-related misuse or abuse occurred in patients aged 55 and older. A SAMHSA spokesman said the higher number of older adults was not surprising because seniors are more likely to combine tramadol with other medication.

"Tramadol and other pain relievers can help to alleviate pain, but they must be used carefully and in close consultation with a physician," said SAMHSA Chief Medical Officer Elinore McCance-Katz, MD. "Like all medications tramadol can cause adverse reactions, which can be even more severe if the drug is misused. We must all work to lower the risks of taking prescription drugs.”

Readers Sound Off on Urine Drug Tests

By Pat Anson, Editor

Our recent series of stories on urine drugs screens – and how they are often unreliable or misinterpreted by doctors – struck a note with several readers who said they were falsely accused of abusing or misusing drugs.

Timmi Jernigan is a 54-year old retired educator in South Carolina who says she was “fired” last month by her doctor after a single drug test. Timmi has a prescription for Adderall – a drug used to treat attention deficit disorder – but the amount detected in her system was low.

A week after the test, she received a registered letter from the doctor discharging her.

"On 4/23/15 a drug test was performed which shows you are not taking the controlled substance prescribed. This in in violation of your drug agreement and we will no longer continue your care. We will see you for an emergency only for the next thirty days. During this time we will not prescribe any controlled substances. If you feel you need drug rehabilitation please contact our office for a referral,” the letter said.

 “Just like that. No follow-up appointment to discuss this test. I called and they would not let me see the doctor,” Timmi wrote to Pain News Network.

Timmi wanted to remind the doctor that a month earlier they had agreed to lower the amount of Adderall she was taking because it might worsen her high blood pressure.

“To suggest (per the letter) that I need drug rehabilitation because there is not enough amphetamine in my system is ludicrous at best,” she wrote.

Now Timmi is worried that the discharge letter in her medical files will damage her reputation and prevent her from finding another doctor.  Adding insult to injury, she received a bill for $1,300 from Ameritox, the drug screening company that performed the test – which is not covered by her insurance.

"I was not made aware of the huge cost involved in this ‘not medically necessary’ test. I was not even given a choice,” Timmi said.

"Anytime you are tested to this degree, you are convicted before being charged,” wrote Kim Miller, advocacy director of the Kentuckiana Fibromyalgia Support Group. “If you are the patient testing with a false positive for marijuana or a drug you are not prescribed, it can mean your last prescription of pain medication for a crime you didn't commit! Yes, I said ‘crime’ because that's the way chronic pain patients are treated anymore.”

False Negatives

Sometimes it’s not a false positive that gets a patient in trouble, but a false negative that indicates they may not be taking a prescribed medication – a red flag that could indicate the drug is being diverted.

That’s what happened to another woman – we’ll call her “Kathryn” -- who prefers to remain anonymous. Kathryn was accused of not taking klonopin, a prescribed medication for anxiety, after it didn’t show up in her drug screen.

“I was taking it as prescribed but no one listened. I was treated horribly,” Kathryn wrote. “After a lot of calls, the support of my husband, primary care doctor, insistence with staff (who made me feel like a criminal) and a revisit with doctor, Doc agreed med was at low enough level it wouldn't necessarily show up.”

“It's a shame though that patients have to pay literally and figuratively for the urine tests and revisits,” said Kathryn, who suffers from back pain, osteoarthritis, fibromyalgia and carpal tunnel syndrome.

Some readers did their own detective work to find out why they tested positive for a drug they weren’t taking. One shared with us a website called AskDocWeb that keeps a list of hundreds of medications, over-the-counter drugs, foods and even household products that can trigger a false positive. Poppy seeds in a muffin, for example, can trigger a false positive for opiates. And the pain reliever ibuprofen could get you flagged for marijuana.

“All this, and there is no scientific evidence to support that urine drug screens are curbing addiction. Would our money be better spent on programs to help those with addiction, which would not interfere with people who use their medications responsibly? Is a middle man once again driving up the costs of healthcare?” asked Celeste Cooper, a retired nurse and fibromyalgia advocate.

For more information about the $4 billion dollar a year drug screening industry, the Milwaukee Journal Sentinel has a story about the "Hidden Errors" found at drug testing laboratories.

Half of Americans Say Painkiller Abuse 'Serious Problem'

By Pat Anson, Editor

Over half of all Americans believe the abuse of a prescription painkillers is an extremely or very serious problem, according to a new poll by the Boston Globe and Harvard School of Public Health that documents the widespread concern – and misconceptions – the public has about opioid pain medication.

While nearly half (45%) believe painkillers are prescribed too often or in doses that are bigger than necessary, a majority (51%) believe that current regulations on the prescribing and availability of opioid pain medication are about right.  

Less than a third (29%) believe that regulations make prescription painkillers too easy for people to get.

The telephone poll of over 1,000 adults, which was conducted in mid-April, found that most Americans were more concerned about prescription painkiller abuse than they were about heroin.

Nearly one in four (39%) said they knew someone who had abused pain medication.

"For much of the public, the issue of prescription painkiller abuse is not just a remote concern; it's a problem they see in their personal lives," said Robert J. Blendon, a professor of Health Policy and Political Analysis at Harvard T.H. Chan School of Public Health.

People who know someone who has abused prescription painkillers hold different views about the problem than those who do not. They are significantly more likely to think painkiller abuse is an extremely or very serious problem (64% vs. 43%) and that the problem has gotten worse over the past five years (56% vs. 28%).

Of those who have known someone who has had an abuse problem, a majority say it has had a major harmful effect on the user's family life (67%), work life (58%), and health (55%). In addition, 21% say that the person's abuse of prescription painkillers led to their death.

Although studies have found that only a small percentage of pain patients become addicted to opioids, many Americans believe it is easy to get hooked on them. Nearly half of those surveyed (44%) say it is “very likely” that a person taking prescription painkillers will become addicted.

About one in five (21%) of the survey respondents said they had taken a prescription painkiller in the past two years. Of those, one in four (26%) reported they had been very or somewhat concerned that they could become addicted. Nearly two-thirds (61%) said they had talked to their doctor about the risk of addiction.

You can view the complete poll findings here.

While many respondents (39%) believe prescription painkiller abuse has gotten worse over the last five years, there are signs it has been abating.

Hydrocodone prescriptions fell by 8% last year and it is no longer the most widely prescribed medication in the U.S.

A recent report by a large national health insurer found that total opioid dispensing declined by 19% from 2010 to 2012 and the overdose rate dropped by 20 percent.

Using Marijuana and Opioids Doesn't Raise Risk of Abuse

By Pat Anson, Editor

As more and more states legalize medical marijuana, many chronic pain patients are turning to cannabis for pain relief. Some are also continuing to use opioid pain medication – raising concern that the combination could increase their risk of substance abuse.

But a new study at the University of Michigan found that patients who use marijuana and opioids are not at higher risk for alcohol and drug abuse. Researchers studied 273 patients at a marijuana clinic in Michigan and found that more than 60% were also using prescription opioids.

"We expected that persons receiving both cannabis and prescription opioids would have greater levels of involvement with alcohol and other drugs," said Brian Perron, PhD, of the School of Social Work at the University of Michigan.

"However, that wasn't the case -- although persons who were receiving both medical cannabis and prescription opioids reported higher levels of pain, they showed very few differences in their use of alcohol and other drugs compared to those receiving medical cannabis only."

Participants in the study, which is being published in the Journal of Studies on Alcohol and Drugs, did report higher rates of drug use than the general population. But their use of other drugs -- including alcohol, cocaine, sedatives, heroin, and amphetamines – was similar whether they used opioids or not.

“I am thrilled this research is now happening so others will also gain the confidence in trying medical marijuana,” said Ellen Lenox Smith, a medical marijuana advocate and columnist for Pain News Network.

“People who have addictive personalities will have issues weather it is alcohol, marijuana, smoking, or opioids. Those of us without that tendency do not have to be concerned. We have patients that have been using both medications successfully, but most of them have eventually chosen to wean away from the opioids due to the annoying side effects. But while using both, they have seemed to cope fine and metabolize both.”

A noted medical marijuana researcher says cannabis may actually make opioids more effective – enabling some patients to take lower doses.

“We’ve seen it in patients who started using cannabis successfully and they were able to reduce their other medications,” said Mark Ware, MD, an associate professor in Family Medicine and Anesthesia at McGill University in Montreal.

“In some cases they find that the dose of opioids that they were taking, they can lower it and get a similar effect at much lower doses. In others, they don’t need the opioids any longer and they’re able to taper off and stop it completely.”

Ware and other researchers believe medical marijuana may be a safer alternative to opioids, which have a higher risk of addiction and overdose. But they stress that communication between doctors and patients is important – since some doctors may have no idea if a patient is using marijuana.

"Physicians do not actually 'prescribe' medical cannabis -- they only certify whether the patient has a qualifying condition, which allows the patient to gain access to medical cannabis,” said Perron.

“The system of dispensing medical cannabis is completely separate from prescription medications, so physicians may not know whether a given patient is using medical cannabis, how much, and in what form."

CDC Social Media Campaign Backfires

By Pat Anson, Editor

A social media campaign by the Centers for Disease Control aimed at raising awareness about the  "epidemic" of painkiller abuse had the unintended effect of launching another campaign about the "pandemic" of untreated chronic pain -- and how the agency was failing to address it.

Last month the CDC encouraged people to "help us tell stories of the many people whose lives have been affected by prescription painkiller addiction or the death of a loved one."

The agency, which estimates that over 16,000 Americans die annually from painkiller overdoses, asked for stories to be posted on Facebook, Instagram and Twitter with the hashtag #RxProblem.

“Prescription drug overdose devastates individuals, families and communities,” said Erin Connelly, associate director for Communication at the CDC. “We’d like to get everyone talking and thinking about the risks involved with opioid painkillers.”

While painkiller addiction and overdoses are undoubtedly a public health issue, the #RxProblem campaign rubbed some activists in the pain community the wrong way.

"There are really two problems with prescription drugs. One is the problem of abuse. But the other problem is patients who have pain and have a legitimate medical need for these drugs and can't access them," said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

"I think they (the CDC) know what the problems are, but for some reason they don't want to deal with the chronic pain problem. I've criticized them for calling the problem of prescription drug overdoses and prescription drug abuse an 'epidemic' and taking a much, much bigger problem like chronic pain and not saying anything about it.  Because to me, if 16,000 people a year dying from overdoses is an epidemic, then 100  million people with chronic pain must be a pandemic."

It was Twillman's idea to launch a rival social media campaign to draw more attention to the chronic pain problem.

"What we came up with was the idea of the hashtag #AnotherRxProblem, and have people who have trouble getting their medications write in about that experience and the impact that's had on them," Twillman told Pain News Network.

Write in they did, with hundreds of people complaining about the one-sided approach the CDC was taking to prescription pain medication.

"We need to live a quality life. Don't punish us. Find better pain control," posted Teri Daniel on Twitter.

"When will we take untreated pain seriously?" asked Melissa VanHouten.

"We have 2 public health crises: RxDrugAbuse & UnrelievedPain. Stop blaming. Work together," wrote Barby Ingle.

"We got a tremendous response. If you look at the Twitter feed for #RxProblem, about half of the posts are #AnotherRxProblem posts. We started another campaign on Facebook and the Facebook response absolutely blew up," said Twillman.

Dozens of pain patients also shared their stories on Dr. Jeffrey Fudin's blog.

"I’m going to get right to the point. PAIN AND OPIOIDS. They do help us. Yes, they’re in every group abusers and non-abusers. Those that it helps for medical necessity should not have to be punished, denied, etc. for those who choose to disregard the contract they signed," wrote Gina. "CDC there are alternatives, to wean out drug abusers. Utilize the resources you have vs. taking the easy way and punishing all."

The CDC's #RxProblem campaign officially ended May 15th. Did they get the message from #AnotherRxProblem get through?

"I'm not optimistic that it's going to make a change in what they're doing. But if it raises someone's awareness, then it was worth it," said Twillman. 

Study: Painkiller Abuse Costs Employers $25 Billion

By Pat Anson, Editor

Painkiller abuse is costing U.S. employers over $25 billion a year in lost productivity and missed work days, according to a new analysis by a healthcare consulting firm that also found that the vast majority of patients who are prescribed opioids do not have an abuse problem.

The “white paper” was produced by Healthentic, a Seattle-based company that helps employers identify health savings to reduce the cost of employee healthcare. You can download a copy of the report, called “Painkiller Abuse Is Costing Your Company” by clicking here.

"Opioid misuse costs employers in multiple ways including more medical costs and productivity loss," said Jeff O'Mara, CEO of Healthentic. "Employers have a unique opportunity to help people get more productivity for less money by identifying and engaging the people at risk."

Healthentic reviewed four years of health insurance claims data from 2011 to 2014 and found that only a small percentage of pain patients were misusing or abusing opioids.

"It was remarkably consistent that most people with an opioid prescription do not have a chronic or abuse problem. In fact, 87% of those prescribed an opioid in those four years didn’t show a cause for concern in the claims data,” the report states.

And what about the other 13 percent?

Healthentic identified three red flags in those patients that raised potential cause for concern:

1. Ten or more opioid prescriptions
2. A prescribed opioid supply for 120 days or more
3. A week or more of overlapping prescriptions for opioids and benzodiazepine, a sedative used to treat anxiety, depression and insomnia

“These people – just 13% -- are responsible for 92% of employer’s costs. And if you break it down even further, the 7% of the population with an opioid prescription that have two or more issues account for over 80% of the cost,” the report states.

Healthentic said opioid abusers used significantly more healthcare resources than non-opioid users, and cited a study that estimated the cost of their healthcare at $10,627 annually. In addition, opioid abusers cost employers $1,244 more in lost work days compared to non-abusers.

The company advised employers that opioids “should not be the first line of treatment” for back pain and other common workplace injuries, and said over-the-counter pain relievers like Tylenol and ibuprofen are “a more affordable and safer option.”

Healthentic recommended four actions to employers to address opioid abuse:

1. Understand and insist upon conservative prescribing guidelines for pain treatment for all participating providers.
2. Evaluate and know which employees are at risk by reviewing their insurance claims.
3. Educate employees about the risks of opioid drug use.
4. Increase and ensure access to treatment programs for employees with an abuse problem.

"Our hope is this analysis provides further insight into the societal and financial issue of prescription painkillers, and helps employers take strides in alleviating the problem to ensure the well-being of their people," said O'Mara.

Healthentic provides healthcare data and analytic services to nearly 11,000 corporate clients in 19 states.

Survey: Most Pain Patients Don't Abuse Painkillers

By Pat Anson, Editor

Only a small percentage of chronic pain patients misuse or abuse their opioid painkillers, according to a wide ranging survey by the Partnership for Drug-Free Kids that also found a “disconnect” between patients and their doctors about opioid prescribing.

About one in ten pain patients (7% of chronic pain patients and 13% of acute pain patients) admitted misusing their opioid medications. Nearly half took longer to finish their prescriptions than directed – which was usually an effort to save the pain medication for another time.

More than one in ten (13% of chronic pain patients and 15% of acute pain patients) admitted using someone else's opiate prescription.

The online survey of 705 pain patients and 360 prescribing physicians was conducted by the research firm Whitman Insight Strategies (WINS) earlier this year.

About two-thirds of the opioid prescribers said they “always” warned their patients about the risk of addiction and dependency.

But when patients were asked who, if anyone, explained to them the potential for becoming dependent or addicted to painkillers, 19% of chronic pain patients and 40% of acute pain patients said "no one."

The survey also found that most patients pay little attention to the proper storage and disposal of pain medication. Only 11% of chronic pain patients and 13% of acute pain patients said they were concerned that someone else in their household might use their medications.

Less than half of chronic pain patients (42%) who have children said they store their medication somewhere their kids can’t reach. Most patients said their doctors never discussed the proper storage and disposal of painkillers.

"This research highlights key opportunities for prescribers of Rx opiates and their patients to have better communication around proper use and disposal of prescribed painkillers," said Marcia Lee Taylor, Interim President and CEO of the Partnership for Drug-Free Kids.

"The Centers for Disease Control has deemed abuse of prescription painkillers an 'epidemic,' and we can all do our part to help turn the tide on this critical health issue. Prescribers and patients can become more aware of the repercussions surrounding the improper storage and disposal of Rx pain medications and talk more at length in order to improve doctor-patient communication and help curb abuse."

The survey also found that many physicians are concerned about patients misusing their pain medication – by either taking too little or taking too much.

The majority of prescribers (77% of primary care physicians and 75% of pain management specialists) believe their patients do not always use their prescribed opiates in accordance with instructions. Twenty percent of the primary care physicians said they don’t feel comfortable prescribing opiates at all.

"This research suggests to us that prescribers need to feel more confident in assessing the potential risk of misuse or abuse of the Rx medicines, but unfortunately many of them feel they have not received proper training to assess those risks. There is a lot more we can do to help prescribers feel they have the proper tools they need to feel comfortable prescribing these medicines and taking action if a patient is abusing them," Taylor said.

The survey also found that most pain patients would prefer alternatives to opioids. About 9 in 10 chronic pain patients have tried an alternative treatment such as physical therapy and massage. Many were hindered in their use of alternative therapies by restrictions on insurance coverage.

Doctor Defends Use of Urine Drug Tests

By Pat Anson, Editor

A prominent pain doctor is disputing reports that a widely used urine drug test often gives faulty results.

“They are reasonably reliable and highly cost effective for use in a pain management practice. I would strongly recommend the practitioners use this,” said Laxmaiah Manchikanti, MD, chairman and CEO of the American Society of Interventional Pain Physicians.

Dr. LAXMAIAH MANCHIKANTI

Dr. Manchikanti, who is medical director of a pain clinic in Paducah, Kentucky, was the lead author of a study published in the journal Pain Physician in 2011, which looked at the reliability of immunoassay “point-of-care” (POC) tests. The urine tests are inexpensive and give immediate results, and doctors often use them to monitor their patients for opioid or illicit drug use.

“The UDT (urine drug test) with immunoassay in an office setting is appropriate, convenient and cost effective. Compared with laboratory testing for opioids and illicit drugs, immunoassay office testing had high specificity and agreement,” Manchikanti's study found.

Pain News Network recently reported on the results of a second study conducted by Millennium Health, a San Diego-based drug testing laboratory, which found that POC tests were wrong about half the time – frequently giving false positive and false negatives results for drugs like marijuana and oxycodone. The Millennium study advocates the use of chromatography-mass-spectrometry – a more complex laboratory test that costs thousands of dollars – to confirm POC test results.

“Following the advice from companies in reference to numerous expensive tests and also income generating avenues will only lead to time in the slammer and will not improve patient care at all,” said Manchikanti.

“(The) Millennium study is performed by the company which makes a living by testing. The more samples that are sent to them, the better off they are. Further, they are not even a practical setting. From our practice we send approximately only 2% of the samples for confirmation testing. Even then, the patients can’t pay their bills.”

Manchikanti’s study found false negative and false positive rates for POC tests that were far below the rates reported by Millennium.

For example, Millennium’s false positive rate for oxycodone was 41.3 percent. For Manchikanti, it was only 7.7 percent.

Millennium’s false positive rate for marijuana was 21.3 percent. For Manchikanti, it was just 2 percent.

There were discrepancies between the two studies for several other drugs, including methadone, cocaine and methamphetamine.

Millennium Sponsored Both Studies

How could two studies come to such different conclusions?

There were some differences in their design. Urine samples in the Millennium study came from nearly 4,300 patients in addiction treatment clinics, while the urine samples in Manchikanti’s study came from 1,000 patients in pain management programs. Millennium maintains the patients in its study were younger and more likely to be drug users.

Ironically, the laboratory tests for both studies were conducted by Millennium – which collected samples and provided chromatography-mass-spectrometry testing at no cost to Manchikanti. Millennium is identified as the “sponsor” of Manchikanti’s study, but he says the company had “no influence or interference” in his and his three co-authors’ findings.

“We had our agreement in the beginning itself that they will not be involved in any way in writing the manuscript or publishing the results. Consequently, they really did not have much input into the publication. The publication was as it is and without any bias from the industry,” Manchikanti wrote in an email to Pain News Network.

Millennium’s study, which was published last year in the Journal of Opioid Management, had six co-authors. All but one were employees of the company. The lone exception is a pain management doctor who frequently testifies as a legal expert for Millennium in court cases.

A source with broad experience in the drug testing industry told Pain News Network the data in Millennium’s study was “skewed toward exaggeration.”

“It does not surprise me that Millennium would show a high rate of inconsistencies with the POC test. Remember, their business is to sell confirmation testing, so they will skew the way they present data to try to influence the market to do more confirmation testing.  In most cases, that’s how it works in any study conducted or funded by a device or pharmaceutical company,” the source said.

Millennium bristles at the notion that its study was biased.

“Millennium Health strongly disagrees with the characterization… that the study was skewed or biased in any way,” the company said in a statement to Pain News Network.

“The study was accepted and published by a well-respected, peer-reviewed publication. Millennium Research Institute is committed to the highest ethical and research science standards, and we stand by the results of our study. The study was based on random samples from addiction treatment clients. The data clearly indicated that immunoassay, or point-of-care, tests have a high rate of false positives and false negatives when used to screen patients for illicit drug use.

“Millennium is committed to providing data that helps clinicians evaluate the best course of treatment for patients with pain and addiction issues. Millennium Health performs only the tests ordered by clinicians.”

In recent years a growing number of doctors who treat addicts and pain patients have required them to submit to drug tests. The competition between Millennium and other laboratories for this business is intense. According to one estimate, drug testing has grown into a lucrative $4 billion dollar a year industry.

But Manchikanti maintains that a single inexpensive urine test that costs about $20 is often the only one that’s needed.

“If a proper (patient) history is provided which matches with the test, there is no need for further testing,” he said.

When Drug Tests Go Wrong

By Pat Anson, Editor

Robin Haas was driving to Disneyworld with her husband and three children in 2008 when their vehicle was rear-ended by a truck on a Florida highway. The accident left Robin with chronic back pain, and she had 17 surgeries over the next 11 months to repair her damaged spine.

It was only the beginning of her problems.

Last year Robin was kicked out of a pain management practice after two office urine tests failed to find any trace of the fentanyl patch she was wearing for pain relief – a red flag for physicians that a patient may be diverting a drug.

Initially, Robin says her doctor didn’t seem too concerned.

“When it happened the second time, he said ‘Don’t worry about it. It’s happened with several of my patients with the fentanyl patches,’” Robin said

About a week later, she was shocked to get a certified letter from the doctor discharging her.

“I don’t know what happened. I really don’t,” Robin told Pain News Network. “I was just mortified. I never did anything wrong in pain management. Ever.”

What happened to Robin is not uncommon. According to a recent study, immunoassay urine tests widely used by pain management doctors to screen patients for drug use are wrong about half the time – frequently giving false positive or false negative results.

“Clearly, people don’t know how to interpret these tests,” said Jeffrey Fudin, a pharmacist and patient advocate, who says most physicians have no idea how inaccurate immunoassay testing is.

“I’m positive that they don’t. I get probably 50 emails a week from all over the country from concerned physicians and nurse practitioners who want to make the right decision, but they’re not sure what to do,” said Fudin.

"The other problem is there are no standards. You can go to five different providers and be treated five different ways for the same results.”

Fudin says fentanyl may not show up on an opiate screen because it has a  different chemical structure compared to most commonly prescribed opioids. There can also be false negatives because an opioid is simply prescribed in too low of a dose to be detected.

Some medications can also trigger false positives for an illicit drug. Widely used pain relievers like naproxen and ibuprofen, for example, can trigger a false positive for marijuana. 

To help doctors correctly interpret immunoassay results, Fudin is developing an online app called Urintel that can help them decide whether to take a negative or positive drug screen seriously – and whether to order more reliable and more expensive confirmation testing in a laboratory.

“Basically, it’s educational and it’s not punitive to the patient,” said Fudin about his app.

“My goal is to make opioid therapy as safe as possible and to make it individualized for each patient. And also to be fair, not only to patients, but providers because it’s not their fault that they don’t have training in pharmacokinetics or biochemistry. It takes a lot of things to understand the complexity of this.”

Fudin’s app may be too late to help pain patients like Robin Haas. She just hopes more patients aren’t wrongly accused of diverting or abusing drugs because of a test that is so often wrong.

“I guarantee not one of my pills has ever hit the street,” says Robin.

The 43-year old Florida resident says the pain clinic told her that her urine samples were re-tested in a laboratory – at a cost of $18,000 – but the results came back the same. She’s still not sure what went wrong. The  clinic has refused to identify the laboratory it used or provide her with the lab results. She had to find a new doctor.

“It’s a horrible thing to happen to people. And when you’re having to deal with chronic pain to begin with, nobody should have to go through it,” she says.

Have you been wrongly accused of failing a drug test?

Tell us your story. Send an email to editor@PainNewsNetwork.org.

We respect your privacy.

Opioid Dispensing and Overdoses Down Sharply

By Pat Anson, Editor

Dispensing of opioid pain relievers and painkiller overdoses both declined substantially after an abuse-deterrent formula of OxyContin was introduced and the painkiller propoxyphene was withdrawn from the U.S. market in 2010, according to a new study published online in JAMA Internal Medicine.

The study is another indication there has been a reversal in the growth of opioid prescribing – which has long been blamed for the so-called “epidemic” of prescription drug abuse. Last week another study was released showing that the painkiller hydrocodone was no longer the most-widely prescribed drug in the U.S. 

Researchers analyzed claims from over 31 million members of a large national health insurer, and estimated that by 2012 total opioid dispensing declined by 19% and the overdose rate dropped by 20 percent. The drop in prescription opioid overdoses was partially offset by a 23% increase in overdoses due to heroin.

“Our results have significant implications for policymakers and health care professions grappling with the epidemic of opioid abuse and overdose,” said lead author Marc Larochelle, MD, of the Harvard Medical School and Boston University School of Medicine.

"Changes imposed through regulatory mandates or voluntary company actions may be a viable approach to stemming prescription abuse. However, identifying interventions that reduce opioid supply without affecting access to individuals who benefit from opioid therapy remains a challenge.”

Propoxyphene (also known as Darvon) was voluntarily withdrawn from the U.S. market after data emerged about its cardiac toxic effects.

The abuse-deterrent formula of OxyContin introduced by Purdue Pharma in 2010 is harder for drug abusers to crush or dissolve for snorting or injecting. Researchers said the prescribing of OxyContin and other extended released oxycodone products dropped by 39% in the two years after the formulation change.

They noted there was “minimal” evidence that people switched to other pain medications because of the formulation change – an indication they weren’t taking OxyContin for pain relief.

"These results suggest that many people who were prescribed OxyContin before it was reformulated may have been diverting or misusing the drug," said Larochelle. "Given the decreased supply of prescription opioids, those seeking out an opioid could be turning to heroin, which may partially explain the tremendous increase in heroin overdose deaths over the past few years both locally and nationally."

“This study parallels other independent and internal research that shows reformulated OxyContin is associated with a reduction in abuse,” Purdue Pharma said in a statement.

“We agree with the FDA, the U.S. Drug Enforcement Administration, The White House Office of National Drug Control Policy and many federal and state policymakers that abuse-deterrent formulations are a valuable public health tool that must be part of any comprehensive approach to combatting prescription drug abuse.”

The study also suggests that legitimate pain patients were not the ones abusing opioids.

“Most overdoses do not occur among patients who are receiving daily prescribed opioids or among those receiving the highest doses,” said Hillary Kunins, MD, of the New York City Department of Health and Mental Hygiene in an editorial also published in JAMA Internal Medicine.

"Recasting the often-maligned 'doctor-shopper' instead as a patient with a substance use disorder reminds us that using public health strategies to promote judicious opioid prescribing, including via pharmaceutical market change to reduce overdose risk, needs to be accompanied by similar policy approaches to provide accessible and effective services for people who use drugs.”

U.S. Hydrocodone Prescriptions Dropping

By Pat Anson, Editor

The number of prescriptions filled in the U.S. for hydrocodone declined in 2014, the first concrete evidence that restrictions on the widely used opioid painkiller are starting to have an impact.   

According to the IMS Institute, 119.2 million prescriptions for hydrocodone pain medications were dispensed by pharmacies last year -- down from 129.5 million the year before – a decline of 8 percent. Hydrocodone is typically combined with acetaminophen in Vicodin, Lortab, Lorcet, Norco, and other hydrocodone products.

The IMS report also found that levothyroxine – a synthetic hormone used to treat thyroid deficiency -- has replaced hydrocodone as the #1 most widely filled prescription in the U.S.

The decline in hydrocodone prescriptions is striking because it was only in the last three months of 2014 that the painkiller was reclassified by the U.S. Drug Enforcement Administration from a Schedule III drug to a more restrictive Schedule II medication.

The DEA and Food and Drug Administration have been under pressure to restrict access to opioids because of the so-called epidemic of prescription drug abuse. Over 16,000 Americans die annually from painkiller overdoses, although most of those deaths involve other drugs or alcohol.

“The rise in opioid prescribing, which led to an opioid becoming America’s most prescribed medication, resulted in a public health catastrophe,” said Andrew Kolodny, MD, director of Physicians for Responsible Opioid Prescribing (PROP), which played an instrumental role in getting hydrocodone rescheduled.

“The trend is clearly moving in the right direction. I’d predict that up-scheduling will accelerate the decline in prescriptions. This will go a long way toward bringing the opioid crisis under control because with more cautious prescribing we are likely to see less new cases of opioid addiction.”

The rescheduling of hydrocodone limits pain patients to an initial 90-day supply of hydrocodone — and also requires them to see a doctor for a new prescription each time they need a refill. Prescriptions for Schedule II drugs also cannot be phoned or faxed in by physicians.

Since the rescheduling, many patients have complained that their doctors were no longer willing to prescribe hydrocodone and that pharmacists were unwilling to fill valid prescriptions. A recent survey found that many pain patients had suicidal thoughts after being denied a prescription. Others said that rescheduling hard been harmful to their relationship with their doctor.

Hydrocodone prescriptions were dropping even before the rescheduling took effect. They peaked in 2011 with nearly 137 million prescriptions filled by pharmacies.

The IMS report found that prescriptions of tramadol, a weaker Schedule IV opioid, rose by over 5% in 2014 – a possible sign that tramadol is being used as a substitute for hydrocodone. The number of tramadol prescriptions being dispensed has nearly doubled since 2010 from 28 million to over 44.2 million in 2014.

“I predicted tramadol prescriptions would increase,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

“I think the overall amount of opioids has declined a little.  Physicians are prescribing less because of publicity, and fear of regulatory interventions. Payers are also limiting what patients can receive. Seems inappropriate that payers have so much control.”

Total spending on all prescription medications in the U.S. rose over 10% to $373.9 billion in 2014, according to IMS, with a record volume of 4.3 billion prescriptions filled.

Urine Drug Test Often Gives False Results

By Pat Anson, Editor

A urine drug test widely used by pain management and addiction treatment doctors to screen patients for illicit drug use is wrong about half the time – frequently giving false positive or false negative results for drugs like marijuana, oxycodone and methadone. 

The “point-of-care” or POC tests come with immunoassay testing strips that use antibodies to detect signs of recent drug use. Physicians like the urine tests because they can be performed in their offices, are inexpensive, and give immediate results. But experts say the tests are wrong so often that no doctor should base a treatment decision solely on the results of one test. 

“Immunoassay testing has an extraordinarily high rate of false positives and false negatives as compared to laboratory testing,” said Steve Passik, PhD, Vice President of Research and Advocacy for Millennium Health, which analyzed urine samples from nearly 4,300 POC tests obtained at addiction treatment clinics.The Millennium study was published in The Journal of Opioid Management.

A false positive reading means a drug was detected that isn’t actually there, while a false negative means the POC test missed finding a drug that was present in a urine sample.

The Millennium study found plenty of both.

False positive readings for marijuana, for example, were given over 21% of the time, while false negative results for marijuana also appeared about 21% of the time.

The POC tests had an even worse track record for oxycodone, a widely prescribed opioid pain reliever. False positive results were detected over 41% of the time and false negatives over 31% of the time for oxycodone.

“We always knew it wasn’t as sensitive and we always knew that it didn’t look for specific drugs within a class. But this was revealing in regard to how much it misses, with false negative and false positives rates in 40 to 50 percent in some instances,” said Passik.

“If we were in another area of medicine, let’s say oncology, and you had a tumor marker or a test that you were going to base important treatment decisions on, and it was as inaccurate as immunoassay is, the oncologists would never stand for it.”

Passik says “the word is starting to get out” how inaccurate the immunoassay tests are. But few patients are aware of it and some doctors are still dropping patients from pain management programs after POC tests found illicit or unprescribed drugs in their urine. 

Passik told Pain News Network that patients should insist on a second test if they feel the first one is wrong.

“If they think it’s a false positive, they need to ask the doctor to be re-tested. And particularly they should ask what method was used. And if they find out they were tested with immunoassay, they should say they want the same specimen either re-tested at the lab or they want to provide another specimen tested at the lab,” Passik said.

A laboratory test that uses chromatography-mass-spectrometry to break down and identify individual molecules is far more accurate than an immunoassay POC test, but it could cost thousands of dollars -- something many insurers and patients are unwilling to pay for.

And critics say Millennium – one of the largest drug screening companies in the nation – has produced a self-serving study designed to drum up more business for itself.

“It does not surprise me that Millennium would show a high rate of inconsistencies with the POC test,” said a source with broad experience in the drug testing industry. “Remember, their business is to sell confirmation testing, so they will skew the way they present data to try to influence the market to do more confirmation testing.  In most cases, that’s how it works in any study conducted or funded by a device or pharmaceutical company.”

The source told Pain News Network the data in Millennium’s study was “skewed toward exaggeration” and questioned the need for further testing.

“In addiction centers, there is not really a large demand for confirmation testing. I understand Millennium wants to increase that business because that’s what they do.  However, medical necessity does play into all laboratory testing.  The great majority of the time, when a patient in a treatment center is confronted with the results of a POC test that shows a drug in their system that shouldn’t be there, they will confess to taking the drug.  So, what would be the medical necessity of confirming that test?

“I believe many of the urine drug testing labs are promoting confirmation testing when it is not medically necessary.”

Millennium took offense that the validity of its study was being questioned.

“Millennium Health strongly disagrees with the characterization in the story that the study was skewed or biased in any way,” the company said in a statement to Pain News Network.

“The study was accepted and published by a well-respected, peer-reviewed publication. Millennium Research Institute is committed to the highest ethical and research science standards, and we stand by the results of our study. The study was based on random samples from addiction treatment clients. The data clearly indicated that immunoassay, or point-of-care, tests have a high rate of false positives and false negatives when used to screen patients for illicit drug use.”

"Liquid Gold"

A growing number of doctors who treat addicts and chronic pain patients require them to submit to random drug screens. And some companies and government agencies also require employees and job applicants to submit to POC tests as a condition of employment.

The competition between drug screening companies for this business is intense. According to one estimate, drug testing has grown into a lucrative $4 billion dollar a year industry -- “liquid gold” as some have called it – that is projected to reach $6.3 billion by 2019.

But addiction experts say more reliable and expensive testing is needed, simply to be fair to patients.

“Heavy reliance on immunoassays in addiction treatment can be detrimental to the patient due to their higher risk for false positives and false negatives in comparison with more reliable technology, such as chromatography-mass-spectrometry,” said Michael Barnes, executive director of the Center for Lawful Access and Abuse Deterrence (CLAAD), a non-profit that gets some of its funding from Millennium.

“A false positive can be detrimental to a patient by subjecting her to unjust suspicion or accusations, unnecessary adjustments to the treatment plan, or the deterioration of the practitioner-patient relationship. A false negative may result in delayed diagnosis or misdiagnosis, false confidence that a patient has not relapsed, and failure to catch behavior that could eventual result in a preventable overdose death. Therefore, chromatography-mass-spectrometry is often more appropriate.”

Millennium’s Passik says most doctors recognize that both tests may be needed.

“These two different methods yield very different kinds of results,” Passik said. “If I was still practicing, I wouldn’t feel that immunoassay is accurate enough to be the only test that you use.”

Ironically, a federal court last year found Millennium guilty of giving illegal kickbacks to doctors by providing them with free POC test cups – the very tests the company says have an “extraordinarily high rate” of false results.

Florida's State of Pain

By Pat Anson, Editor

If you suffer from chronic pain or care for someone who does, a recent half hour special report by WESH-TV in Orlando is “Must See TV” – whether you live in Florida or not.

In many ways Florida was ground-zero in the “War on Drugs,” with a sordid history of pill mills and unscrupulous doctors who dished out prescriptions for painkillers like they were candy.

In 2010, according to the Centers for Disease Control and Prevention, 98 of the top 100 oxycodone dispensing doctors in the country were in Florida and eight Floridians were dying every day from drug overdoses.

The state started cracking down. Law enforcement agencies raided doctors’ offices, shutdown over 100 pill mills, and heavily penalized pharmacies that were dispensing too many opioids.

The crackdown worked and overdoses soon declined, but somewhere along the way – in the view of many chronic pain patients -- the War on Drugs became a War on Patients. 

Florida doctors started dropping pain patients from their practices and pharmacies began turning away longtime customers who had never abused painkillers, forcing many to go on a “pharmacy crawl” in search of someone to fill their prescriptions. Faced with daily unrelenting pain, some patients resorted to suicide.

Much of what happened in Florida is now occurring on a national level, with pain patients being marginalized and viewed as drug addicts by a health care system that has grown fearful and paranoid.

WESH-TV investigative reporter Matt Grant and his producers do a commendable job covering all of this, explaining how legitimate pain patients have become unintended casualties in Florida’s War on Drugs.

You can watch his report below in three installments:

FDA Issues Guidance on Abuse Deterrent Opioids

By Pat Anson, Editor

The U.S. Food and Drug Administration has released its long-awaited guidance on abuse-deterrent opioids, beating a Congressional deadline and a potential loss of $20 million in funding.

The document “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling” explains the FDA’s current thinking about abuse-deterrent properties and recommends to drug makers how clinical studies should be conducted to evaluate their effectiveness.

Abuse deterrent formulas are intended to make it harder for drug abusers to crush or liquefy a narcotic painkiller for snorting or injecting. But the evidence is mixed that they actually work.

“It should be noted that these technologies have not yet proven successful at deterring the most common form of abuse — swallowing a number of intact capsules or tablets to achieve a feeling of euphoria. Moreover, the fact that a product has abuse -deterrent properties does not mean that there is no risk of abuse.  It means, rather, that the risk of abuse is lower than it would be without such properties. Because opioid products must in the end be able to deliver the opioid to the patient, there may always be some abuse of these products,” the FDA said in its report.

The agency has been under pressure from Congress to move faster in developing guidelines for abuse deterrence. An appropriations bill passed late last year would have moved $20 million in funding from the FDA’s Commissioner’s office if the guidance wasn’t released by June 30.

“The science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,” said FDA Commissioner Margaret Hamburg, MD. “We feel this is a key part of combating opioid abuse. We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.”

So far only four opioids have been approved with abuse-deterrent formulas, OxyContin, Embeda, Targiniq and Hysingla. The latter was recently introduced by Purdue Pharma as the only “pure” hydrocodone extended release product with abuse-deterrence.

Purdue’s reformulated version of OxyContin was the first opioid to have abuse deterrence. It was introduced in 2010, at a time when the painkiller was widely being abused.

A recent study by researchers at Washington University’s School of Medicine in St. Louis found that over a quarter of drug abusers entering treatment facilities admitted they still abused OxyContin. About a third of the abusers said they had found a way to inhale or inject it. The rest took the painkiller orally.

One unintended consequence of reformulating OxyContin is that 70% of the drug abusers who stopped using it and who switched to other narcotics started using heroin.

"The newer formulations are less attractive to abusers, but the reality is -- and our data demonstrate this quite clearly -- it's naïve to think that by making an abuse-deterrent pill we can eliminate drug abuse. There are people who will continue to use, no matter what the drug makers do, and until we focus more on why people use these drugs, we won't be able to solve this problem,” said senior investigator Theodore J. Cicero, PhD, a professor of neuropharmacology in psychiatry.

Some patients believe the reformulated version of OxyContin is less effective as a pain reliever and causes gastrointestinal problems because it is harder to digest.

The FDA said it would take “a flexible, adaptive approach” to the future evaluation and labeling of abuse-deterrent products.

“Development of abuse-deterrent products is a priority for the FDA, and we hope this guidance will lead to more approved drugs with meaningful abuse-deterrent properties,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

“While abuse-deterrent formulations do not make an opioid impossible to abuse and cannot wholly prevent overdose and death, they are an important part of the effort to reduce opioid misuse and abuse.”

Over 16,500 deaths in the U.S. were linked to opioids in 2010. According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

Study Claims 10% of Pain Patients Addicted to Opioids

By Pat Anson, Editor

Estimating rates of opioid abuse and addiction has never been easy. Dozens of different studies have come to startling different conclusions, and there is even disagreement over the definition of abuse and addiction.

Now a professor at the University of New Mexico is weighing in on the subject -- and his conclusions are likely to stir even more debate.

In a systematic review of 38 research reports (a study of studies) published in the journal PAIN, lead author Kevin Vowles and his colleagues estimate that up to 30 percent of the opioids prescribed for pain are misused and that about 10 percent of pain patients are addicted to them.

They also question whether opioids should be prescribed at all for chronic pain.

“It is not clear whether the risks of opioid use outweigh the potential for benefit. The efficacy of opioids and their suitability for the long-term management of chronic pain still remain very much in question and while this uncertainty in effectiveness is well established, it stands in somewhat stark contrast to the clinical reality of chronic pain treatment, where rates of prescriptions have skyrocketed such that opioids are now among the most frequently prescribed medications,” wrote Vowles.

“We are not certain whether the benefits derived from opioids, which are rather unclear based on the extant literature, compensate for this additional burden to patients and health care systems.”

The researchers noted there was extremely wide variation in the rates of opioid misuse and addiction in the studies they analyzed. Rates of “problematic use” ranged from less than 1% all the way up to 81%.

One study -- a review of 25 research reports – left the barn door wide open by broadly estimating the “prevalence of problematic opioid use behavior” at 0% to 50% of pain patients.

“The vagueness inherent in these definitions, areas of overlap among them, and their sometimes interchangeable use have made it difficult to determine exact rates and types of problematic opioid use,” conceded Vowles.

Exactly what constitutes opioid misuse is also debatable.

Vowles defined misuse as “opioid use contrary to the directed or prescribed pattern of use, regardless of the presence or absence of harm or adverse effects.” Such a definition means a patient who has stopped using a prescribed opioid – even if they no longer have pain – is misusing the medication.

(Several years ago this writer was sent home from the hospital after surgery with a two week supply of Vicodin. Fortunately, the surgery was successful and the pain subsided after a few days. A half empty bottle of Vicodin sat unused in my medicine cabinet for years before I had sense enough to throw it out. Under Vowles’ definition, I had “misused” the Vicodin.)

Studies by some of the nation’s largest drug screening companies consistently show that many Americans don’t take the drugs that are prescribed for them. A large study by Quest Diagnostics found that 60% of Americans failed to take a medication as prescribed by their physicians and that 42% had no drugs in their system. Should they be included in estimates of misuse?

Rates of addiction in the studies analyzed by Vowles also varied greatly – from 0.7% of pain patients up to 34.1%.

An adjusted analysis by Vowles estimated the average rate of addiction at 8% to 12% -- a figure nearly double the estimate of the National Institutes of Health (NIH). According to the NIH, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

“Misuse, abuse and addiction mean different things to different researchers,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

“We must keep in mind that behaviors determine the diagnoses of misuse, abuse and addiction and these behaviors are subjective interpretations. Subjective interpretations are influenced by one's biases and perspective.  Misuse to one researcher can be addiction to another. Unfortunately there has not been a standard interpretation of behaviors and I doubt there ever will be due to personal beliefs about opioids and addiction.”  

While Webster doesn’t take issue with the design of the study – he does dispute the overall conclusion that the risks of opioid abuse outweigh the benefits.  

“It is undoubtedly true that some people should not be prescribed opioids.  But even using their reported averages for abuse and addiction, a majority of people do not abuse or become addicted and therefore shouldn't necessarily be denied treatment particularly if there is no other option,” Webster wrote in an email to Pain News Network. 

Ironically, only one study analyzed by Vowles even looked at the recreational abuse of opioids – perhaps the biggest contributor to the so-called “epidemic” of prescription drug abuse in the U.S.  That study estimated the rate of abuse by pain patients at just 8% -- far below their estimated rates of misuse.

Vowles admits there are several limitations to his study.

“The most obvious is the degree of variability within this literature. In spite of our attempts to minimize the impact of this variability, the range of misuse and addiction was incredibly broad,” he wrote.

“These sources of variability will likely continue to cloud our ability to make precise estimates. There is clearly room here for a series of carefully controlled studies where sources of variability are held constant, or as constant as possible, to more clearly illuminate prevalence rates of problematic opioid use in individuals with chronic pain.”