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.

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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.”

DEA Issues Fentanyl Alert

By Pat Anson, Editor

The U.S. Drug Enforcement Administration has issued a nationwide alert about the abuse and diversion of fentanyl – a potent opioid analgesic that recreational drug users are increasingly combining with heroin.

“Drug incidents and overdoses related to fentanyl are occurring at an alarming rate throughout the United States and represent a significant threat to public health and safety,” said DEA Administrator Michele M. Leonhart. “Often laced in heroin, fentanyl and fentanyl analogues produced in illicit clandestine labs are up to 100 times more powerful than morphine and 30-50 times more powerful than heroin.”

In the last two years, the DEA has seen a significant increase in fentanyl-related drug seizures, particularly in the northeast and California. While most of the seized fentanyl appears to be coming from illegal drug labs run by Mexican drug cartels, some of it is being diverted.

Over 6.5 million legal prescriptions for fentanyl were written in the U.S. in 2014, often in the form of transdermal patches used to treat chronic pain.

“Fentanyl patches are abused by removing the gel contents from the patches and then injecting or ingesting these contents. Patches have also been frozen, cut into pieces and placed under the tongue or in the cheek cavity for drug absorption through the oral mucosa. Used patches are attractive to abusers as a large percentage of fentanyl remains in these patches even after a 3-day use,” the DEA said in a statement. 

The DEA warning comes on the heels of another government report warning about a surge in heroin related deaths. This month the Centers for Disease Control and Prevention reported the death rate from heroin overdoses in the U.S. nearly tripled between 2010 and 2013. Over 8,200 Americans died of heroin overdoses in 2013.

The sharp increase in heroin deaths coincided with a crackdown on prescription drug abuse and pill mills dispensing painkillers. Some health officials have called opioids a “gateway drug” to heroin, and claimed pain patients are switching to heroin because it is now cheaper and easier to get – even though there is scant evidence to support that claim.

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. And in a 2014 study of urine drug screens collected from over 171,000 chronic pain patients, Ameritox says it detected heroin in just 1.3% of the samples.

“The initial entry of heroin was no doubt in response to the over-use of prescription opioids. Now it is occurring because of the influx of cheap heroin,” said Percy Menzies, president of Assisted Recovery Centers of America, which operates four addiction treatment clinics in the St. Louis, Missouri area.

“The two strongest factors contributing to addiction are price and access. Mexican farmers have lost their marijuana market in the U.S. and have switched to growing the poppies and these poppies are being converted into heroin by the drug cartels. This is immensely profitable and we are going to see a steep increase in heroin addiction as more and more heroin is smuggled into the U.S.

“The U.S. has to curb its appetite for prescription opioids and we have to find better treatments for chronic pain,” Menzies wrote in an email to Pain News Network. “To add insult to injury, the new avenue for using heroin is coming from the medications used to treatment opioid addiction - methadone and buprenorphine. The sale of buprenorphine formulations is around $2 billion and patients are using these medications to sustain their heroin addiction.

“Our addiction to opioids comes from three sources - prescription opioids, heroin and prescription opioids to treat opioid addiction. Until we drastically curtail these three sources, the addiction is going to be alive, well and thriving.”

Survey: Two-Thirds of Patients Unable to Get Hydrocodone

By Pat Anson, Editor

About two-thirds of pain patients say they were no longer able to obtain hydrocodone after the opioid painkiller was reclassified by the U.S. government from a Schedule III medication to a more restrictive Schedule II drug, according to the results of a new survey.

Many patients who had been taking hydrocodone at the same dose for years said their doctor would no longer prescribe the painkiller. Over a quarter (27%) said they had suicidal thoughts after being denied a prescription for hydrocodone.

The survey of over 3,000 patients was conducted online by the National Fibromyalgia & Chronic Pain Association (NFMCPA) and the findings presented this week at the annual meeting of the American Academy of Pain Medicine. An abstract of “Hydrocodone Rescheduling: The First 100 Days” can be found here.

Hydrocodone was rescheduled by the Drug Enforcement Administration in October of last year to combat an “epidemic” of prescription drug abuse. The rescheduling limits patients to an initial 90-day supply and 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.

The reclassification quickly made a drug that was once the most widely prescribed pain medication in the country – at nearly 130 million prescriptions each year – to one of the hardest to get.

Other key findings of the survey:

• 88% of respondents believe the change to Schedule II denies pain patients the right to adequate pain care.
• 75% believe the change will not prevent prescription drug abuse.
• 72% believe the change is harmful to pain patients.
• 18% said it led to a "worsened relationship" with their doctor.
• 30% reported "issues" with their pharmacy filling prescriptions.

Patients also reported higher expenses due to increased doctor’s visits, higher co-pays, greater transportation costs to visit the doctor and multiple pharmacies, and lost income due to inability to work because of pain.

The survey is believed to be the first to report on the experiences of pain patients treated with hydrocodone since the rescheduling took effect. The respondents were overwhelmingly female, which reflects the demographics of fibromyalgia and many other chronic pain conditions.

Hydrocodone isn’t the first pain medication to be in short supply. A report released last month by the Government Accountability Office (GAO) faults the DEA for poor management and “weak internal controls” of the quota system under which controlled substances are produced and distributed.

Between 2001 and 2013, the GAO said there were 87 “critical” shortages of drugs containing controlled substances, over half of them pain relievers. The vast majority of drug shortages lasted over a month and some dragged on for years. An oral solution of oxycodone was difficult to obtain for eight and a half years.

“The shortcomings we have identified prevent DEA from having reasonable assurance that it is prepared to help ensure an adequate and uninterrupted supply of these drugs for legitimate medical need, and to avert or address future shortages. This approach to the management of an important process is untenable and poses a risk to public health,” the report states.

OxyContin Still Being Abused by Addicts

By Pat Anson, Editor

Drug addicts are still finding ways to snort and inject OxyContin, five years after the painkiller was reintroduced in an abuse deterrent formula.

Researchers at Washington University School of Medicine in St. Louis surveyed almost 11,000 opioid abusers at 150 drug-treatment facilities and found that over a quarter of them still abused the painkiller, even though the new formulation of OxyContin is harder to crush or liquefy. Their study is being published in JAMA Psychiatry.

The abuse-deterrent formulation of OxyContin was introduced by Purdue Pharma in 2010, at a time when the painkiller was widely being abused. Nearly half of patients entering drug treatment facilities that year for opioid abuse said they had used OxyContin to get high at least once in the previous 30 days.

Two years later, after the abuse-deterrent formulation was introduced, the percentage of opioid abusers entering rehab who used OxyContin had fallen to 26 percent.

"We found that the abuse-deterrent formulation was useful as a first line of defense. OxyContin abuse in people seeking treatment declined, but that decline slowed after a while," said senior investigator Theodore J. Cicero, PhD, a professor of neuropharmacology in psychiatry.

"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."

The findings are not unexpected, according to a prominent pain physician.

“No one should expect that ADF's (abuse deterrent formulations) are not going to be abused.  They will.  Some ADF's will be more effective in deterring certain methods of abuse like injecting or snorting.  People who want to abuse can just take more orally or with enough effort can overcome the ADF technology,” said Lynn R. Webster, MD, a past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

“As long as an opioid has rewarding properties a certain part of society will seek them out for abuse.  This is why we need to be realistic about what an ADF can accomplish.  We need to decrease the demand and eventually replace the type of opioids that produce liking with drugs that are not as rewarding but more effective.”   

Researchers say about a third of the addicts who still abused OxyContin had found a way to inhale or inject it. The rest took the painkiller orally. Even more worrisome, almost half of the drug abusers surveyed in 2014 reported they had used heroin in the 30 days before they entered treatment.

"Some people found ways to get around the abuse-deterrent formulation so that they could snort or inject it, and others simply swallowed the pills," Cicero explained. "But many people switched to heroin, and that's a major concern."

Cicero says 70% of the addicts who stopped using OxyContin and switched to other drugs were using heroin.

“Abuse-deterrent formulations can have the intended purpose of curtailing abuse, but the extent of their effectiveness has clear limits, resulting in a significant level of residual abuse. Consequently, although drug abuse policy should focus on limiting supplies of prescription analgesics for abuse, including ADF technology, efforts to reduce supply alone will not mitigate the opioid abuse problem in this country,” Cicero wrote in the study.

“We agree with Dr. Cicero that abuse-deterrent formulations are a valuable public health tool that must be part of any comprehensive approach to combatting prescription drug abuse. The report parallels other studies that show reformulated OxyContin is associated with a reduction in abuse,” said David Haddox, MD, V.P. of health policy at Purdue Pharma.  

“The product’s label states that OxyContin has physical and chemical properties expected to make abuse via injection difficult and to reduce abuse via snorting. The label also states that abuse of OxyContin by these routes, as well as the oral route, is still possible.”

Many pain patients with legitimate prescriptions for OxyContin say the abuse deterrent formulation is not as effective at providing pain relief as the old one. Others complain about side effects such as gastrointestinal problems.

Abuse deterrent technology is a key part of the Food and Drug Administration’s efforts at combatting the so-called epidemic of prescription drug 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.

Time for a More Rational Cannabis Policy

By Lynn R. Webster, MD, Guest Columnist

Individuals who suffer from severe chronic pain are caught in a double bind. Opioids contribute to the enormous societal harms of unintentional overdose, diversion and addiction, and data on their long-term effectiveness are conflicting and inadequate. But for patients who are helped by opioids, policies and regulations to address societal harms are, in some cases, impeding access to treatment, making it difficult even to find a knowledgeable physician. The need for safer and more effective analgesics has never been greater.

Answers do not lie in pitting one serious disease (i.e., chronic pain) against another (i.e., addiction) but in seeking scientific breakthroughs that lead to serious analgesic benefits without addictive properties or risk for respiratory depression. Rigorous research of cannabinoids has the potential to unlock a medicinal benefit on a societal scale. But committing to the necessary research requires rethinking how we classify cannabinoids as a controlled substance.

Inching Toward Safer Pain Treatments

Tetrahydrocannabinol (THC) produces the “high” effect associated with marijuana. On its own, cannabidiol (CBD) displays a plethora of actions including anticonvulsive, sedative, hypnotic, antipsychotic, anti-inflammatory and neuroprotective properties, and is believed to have fewer undesirable psychoactive effects than THC. Practically speaking, harnessing the potential medicinal benefits of marijuana without these unwanted effects would be a long-awaited breakthrough for science. Despite many strictures, scientists -- largely from other countries -- are inching closer to the finish line with products that could replace opioids in some instances.

On this point, we must speak cautiously and with a clear understanding: The current literature is weak at best. For example, Sativex, an oral spray composed of CBD and delta-9-THC currently on the market in Europe, Canada and Mexico, did not meet its primary end point of statistical difference from placebo for relief of cancer pain in an initial Phase III trial. Research in this area is in a nascent stage, and the ultimate conclusions are uncertain. But conclusive evidence requires rigorous study at a far faster pace and greater volume than is currently possible. Therein lies the problem.

Sadly, research is stymied due, in large part, to a federal and state regulatory structure that hamstrings researchers from gaining access to legal supplies of THC/CBD for scientific purposes. To study cannabis in the United States, scientists must comply with the Controlled Substances Act of 1970, which classifies cannabinoids as a Schedule I drug. Scheduling is controlled by the Drug Enforcement Administration (DEA), and Schedule I drugs are deemed to have no medicinal value and a high potential for abuse. 

Because of this, a researcher must pass through a gauntlet of onerous and time-intensive requirements to gain access to cannabinoids. The requirements to secure a license with the DEA, to register with the FDA, and to comply with a long checklist of rules from the National Institute on Drug Abuse to obtain research-grade cannabis all conspire to make the process protracted and costly.

Yet the patchwork of public policy on marijuana is anything but consistent: 23 states and the District of Columbia have now legalized marijuana use in some form. Furthermore, public opinion is evolving to erase some of the historical stigma surrounding marijuana use.

Marathon runners have recently been using marijuana-infused balms and edible marijuana to treat pain and swelling. In a climate where it is now possible to ask in the pages of “Men’s Fitness,” “Does pot make you a better athlete?” the current classification of marijuana under Schedule I doesn’t make sense. Why define a substance as having no medical value when the evidence and the laws of many states now say otherwise? Reclassifying cannabinoids to Schedule II could help expand research opportunities and determine appropriate indications.

More importantly, rescheduling cannabinoids will not necessarily open the floodgates to irresponsible use. The American Society of Addiction Medicine warns that marijuana is not benign but a psychoactive drug with risks for abuse and addiction and subject to a risk–benefit profile discussion with patients in clinical settings. Rightly, Schedule II drugs are recognized as having a high potential for abuse and dependence and are heavily regulated. Thus, rescheduling would still recognize risks associated with cannabinoids in recreational use, while accepting that the potential medicinal benefits could help people suffering from a variety of diseases, including chronic pain. Given that opioids have significant risks as a medical treatment, including life-threatening respiratory depression, and have fueled a nationwide prescription drug abuse crisis, research to explore new pathways to analgesia-like cannabis would point us in a new and, we hope, better direction.

We cannot afford to wait. With more than 100 million Americans suffering from chronic pain annually—affecting more people than diabetes, heart disease, stroke and cancer combined, according to the Institute of Medicine—public policymakers must recognize and reschedule this potentially therapeutic modality.

Lynn R. Webster, MD, is Past President of the American Academy of Pain Medicine, and vice president of scientific affairs at PRA Health Sciences. He is a Pain Medicine News editorial board member and author of a forthcoming book, “The Painful Truth.” His blog can be found at lynnwebstermd.com. He lives in Salt Lake City. Follow him on Twitter @LynnRWebsterMD, Facebook and LinkedIn.

This column is republished with permission of Pain Medicine News.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.