FDA May Require Opioids Be Packaged in ‘Blister Packs’

By Pat Anson, Editor

The Food and Drug Administration may soon require some opioid pain medications to be packaged in “blister packs” to limit the number of pills that can be prescribed and dispensed at one time.

“This is something we’ve been looking at for some time. And it is gaining some traction inside the agency as a potential solution to instigate different kinds of prescribing patterns around opioids. Something like this could move potentially quickly. We’re invested in it and taking a hard look at this,” FDA commissioner Scott Gottlieb told CNBC.

In May, Gottlieb appointed an Opioid Policy Steering Committee to study ways that the supply of opioids for short-term acute pain could be limited through packaging. Next month the FDA will hold a two-day public workshop with health experts and drug makers to discuss packaging options.

“One of the things that we can do is look at blister packs as an alternative to how opioids are dispensed. And perhaps package opioids in blister packs where it might come in a 2, 4, 6 or 8 day supply.  That would potentially encourage more doctors to prescribe smaller durations of use for patients,” said Gottlieb.

“This would be especially relevant to immediate release formulations of the drugs, which are the most widely prescribed formulations. And where most people form an addiction.”

Gottlieb said if doctors wanted to prescribe more opioids – such as a 30-day supply – the FDA could require that they “jump through additional hoops” such as a mandatory prescriber education course.

"We're at a point in this crisis that we're going to have to think of ideas and taking actions that are going to be more disruptive and are going to be uncomfortable to some parties," he said.

Several states have already adopted regulations that limit the supply of opioids for acute pain to seven days or less. CVS recently announced that its pharmacists would limit new opioid prescriptions to 7 days’ supply, starting in February for customers enrolled in its pharmacy benefit management program.

I Am a Casualty of the War on Drugs

By Lorelei Bryan, Guest Columnist

I am a 51 year old wife, mother, grandmother and businesswoman, among other things.  Along with all of those other titles and roles, I am a person who lives with chronic pain.

I do not like the label “chronic pain patient,” as it carries with it more stigma and derogatory implications than ever. 

In 2010, I began to experience extreme pain near my left ear.  Suspecting an ear infection, I went to my primary care physician. After examining me and asking a lot of questions, he said I had no infection and that he suspected this was related to the temporomandibular joint (TMJ) in my jaw. Like most people, I had heard of TMJ and thought it was the result of grinding or clenching my teeth. A visit to my dentist confirmed that there was no evidence of grinding or clenching.  He was at a loss. 

Thus began my two year journey of one oral surgeon after another, one therapy after another, and one failed surgery after another, trying to get this condition resolved. All the while, I battled between the primary care doctor and the surgeons on which of them was going to write the pain medication prescriptions I needed to keep functioning throughout this ordeal.

Finally, after two years and seven surgeries of various types, I was referred to an oral surgeon who specialized in TMJ patients with advanced and rare conditions.  A cat scan revealed that arthritis had destroyed almost all of the bone structure in my jaw.  I had to have two more major surgeries; one to remove what was left of the diseased bone and the second to install custom made titanium jaw parts.  

LORELEI BRYAN

The surgeon warned me that the procedures would restore function to my jaw (I could not open my mouth more than a few millimeters), but that I may be left with chronic pain.  He was right on both counts. The combination of the multiple surgeries, scar tissue, damage to the surrounding structure, and permanent nerve damage left me with severe chronic pain from trigeminal neuralgia that will never improve. 

During the final two surgeries, I was working with a pain management specialist who knew my surgeon.  All was well, as they communicated regularly and I was receiving pain medication that allowed me to manage my pain to the point of having a relatively normal life, although not completely pain free. 

In 2014, 18 months post replacement surgery. I received a letter from my pain management doctor explaining that he was no longer treating pain patients. No additional prescriptions would be given to any patient and no referrals to other doctors or pain clinics would be provided.  Just like that, everyone he treated for pain was dropped. Of course, I panicked, as I’m sure many of his other patients did. Being dropped by a doctor for no reason and with no support for transitioning to another provider feels like betrayal.

I sought help from my primary care provider and, fortunately, he said he could treat my pain himself. I was very relieved and grateful to him.  For three years he and I worked together to manage my chronic pain, including the trigeminal neuralgia that the surgeries caused. We were able to use a combination of Tegretol and oxycodone that reduced my need for oxycodone by 20mg per day, as compared to the dose I was on with the pain management specialist.

Never before had my pain been managed to the point it was.  He and my pharmacist know each other well, and the three of us worked together to manage my pain.   

The War on Drugs Targets the Wrong People

Fast forward to June 2017.  I go in for my every other month appointment with my primary care provider. He does his exam, we talk about my other medical issues, and then he gets a grave look on his face.  “I can’t write the oxycodone for you anymore,” he says. 

I am thrown.  He explains that the state has instituted strict limits on who can be prescribed narcotic pain medication and very strict limits on the amounts. I couldn’t breathe. Thoughts of what life would be like without having my pain effectively managed ran through my head -- reduced job performance, reduced job attendance, possible job loss, checking out of the lives of my children and grandchildren, suffering and crying all day like I used to. 

When I gained a little composure, I said, “We are talking about my quality of life here. I know why this is happening. This so called ‘war on drugs’ is creating a war on the wrong people.” 

My doctor agreed that I am a model pain management patient, a “poster child” for the appropriate use of narcotic pain medication. I see only him. I use only one pharmacy and he knows the pharmacist personally. I take the medication according to directions. I do not doctor shop. I do not ask for early refills.  I follow all the rules and still I have to suffer, so that a bunch of bureaucrats who have no right getting involved in what my healthcare provider deems appropriate for me, so they can pat each other on the back and congratulate each other for “striking a blow in the opioid crisis.”  

When I put it that way, the doctor agreed that I was a prime example of a responsible patient who needs this medication and is not a high risk. He agreed to continue writing the narcotic pain medication prescriptions, but explained that new state laws meant we had to almost cut my dose in half. 

I am now trying to manage on much less medication. The increased pain level makes it difficult to concentrate at work. It has made me withdraw from my husband. And it has impacted my ability to be the mother and grandmother I should be.

These bureaucrats and politicians are causing needless suffering for thousands of people in pain, while doing virtually nothing to stem the heroin overdoses that are the prevailing reason for the opioid crisis in the first place.

Is there a serious issue with abuse and addiction to narcotic pain medication?  Of course there is, and something should absolutely be done to address it.  But taking away medication needed by people in chronic pain is not the answer.  Limiting or denying medication to legitimate patients who need it to live and function with any quality of life only creates another crisis. More and more people turn to illegal drugs or, worse yet, commit suicide because their medication has been taken from them and they cannot endure without it.

My question is this: where is our voice?  For all of the politicians and celebrities speaking out on the war on drugs, who is speaking out on the other side of this?  If someone of consequence and influence does not speak out for people in pain, these new laws and limits will create just another silent epidemic and the war on drugs will take more lives than ever.

Lorelei Bryan lives in Virginia.

The Virginia Board of Medicine recently adopted emergency regulations that require doctors who prescribe more than 120mg morphine equivalent (MME/day) to a patient to document the justification for the dose or to refer or consult with a pain management specialist. It does not expressly forbid doctors from prescribing more than 120 MME/day.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

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

Trump Commission Seeks More Limits on Rx Opioids

By Pat Anson, Editor

President Trump’s opioid commission released its final report Wednesday, an ambitious list of over four dozen recommendations aimed at treating addiction, preventing overdoses, and further restrictions on opioid prescribing.   

“This crisis can be fought with effective medical education, voluntary or involuntary changes in prescribing practices, and a strong regulatory and enforcement environment,” the commission said in its report.

The president established the commission in March to give him a list of recommendations to combat drug addiction and the overdose crisis. 

“Our people are dying. One hundred seventy-five people a day, every day, are dying in the United States from this epidemic,” said commission chairman Gov. Chris Christie of New Jersey, one of five politicians who served on the six member panel.

“If a terrorist organization was killing 175 Americans every day on American soil, what would you be willing to pay to make it stop? I think we’d be willing to do anything and everything to make it stop. And that’s the way we now need to see this, because this is an attack from within. We are killing ourselves.”

The commission’s 131-page report did not spell out how much money would be needed to implement the panel’s wish list of 56 recommendations.

Chief among them was to get drug makers and the National Institutes of Health to work together developing new non-opioid painkillers and addiction treatment medications.

“It is inexcusable that the major pharmaceutical companies in this country have stood on the sidelines during this crisis. And they have,” said Christie.

New Prescribing Guideline to Supplement CDC's

The commission is also recommending that a new set of guidelines for opioid prescribing be developed to “supplement” the guideline released last year by the Centers for Disease Control and Prevention.  It was not immediately clear if the new guidelines would replace, weaken or strengthen the CDC’s recommendations, or simply expand their use throughout the healthcare system.

“An updated set of guidelines for prescription pain medications should be established by an expert committee composed of various specialty practices to supplement the CDC guideline that are specifically targeted to primary care physicians,” the report says.

The commission recommended that federal regulators require patients to give informed consent about the risks and alternatives to opioid painkillers before the medication is prescribed to them. The panel also called for a new “national curriculum and standard of care” for opioid prescribers, and that pharmacists be trained to recognize and deny “inappropriate prescriptions.”

The commission urged the federal government to work with states to improve the toxicology data on overdose deaths by developing uniform forensic drug testing. Critics say the current data now being used by federal agencies is flawed or cherry-picked. 

“We do not have sufficiently accurate and systematic data from medical examiners around the country to determine overdose deaths, both in their cause and the actual number of deaths,” the report says.

No Limit on Opioid Supply for Acute Pain

The commission did not recommend that supply limits be placed on opioid prescriptions for short term pain, as many expected. Several states have already enacted 5 or 7-day limits on opioids for acute pain. The panel also did not endorse the development of marijuana-based medications, which many pain sufferers are now using as an alternative to opioids.

Most of the commission’s other recommendations deal with cracking down on drug traffickers and the illicit drug market, expanding the drug court system, and increasing access to addiction treatment.

Gov. Christie refuted criticism of President Trump for declaring the overdose crisis a public health emergency, instead of a national emergency. Only $57,000 in federal funding is currently set aside to deal with a public health emergency.

“The president did exactly what I asked him to. I wanted this to be a public health emergency because I wanted HHS (Department of Health and Human Services) to administer the funds, not FEMA (Federal Emergency Management Agency). No offense to FEMA. They’re busy with some other things and it’s not there area of expertise,” Christie said.

“Now it’s incumbent upon Congress to step up and put money in the public health emergency fund, so the president can utilize that. And that should happen without delay in the view of the commission.”

In addition to Christie, commission members include Gov. Charlie Baker of Massachusetts, Gov. Roy Cooper of North Carolina, Florida Attorney General Pam Bondi, Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School, and Patrick Kennedy, a former Rhode Island congressman.

In its fifth and final hearing, the commission heard testimony from several people who lost loved ones to opioid addiction and overdose. The panel never asked for or received testimony from pain sufferers, patient advocates or pain management physicians.

How Rx Opioids Helped Me Work Again

By Kate Nicholson, Guest Columnist

I recently told 2,200 intimate listeners during a TED Talk how a surgical error left me in severe pain, unable to sit or stand, and largely bedridden for almost twenty years.

I also explained that with appropriate pain management, including treatment with opioids, I continued working as a high-level federal civil rights prosecutor despite my physical limitations. I won important arguments in federal court, arguing from a folding lawn chair. I drafted the current regulations under the Americans with Disabilities Act (ADA), coordinated with the White House, and supervised thousands of cases by hundreds of attorneys across the country from a computer screen and well-camouflaged bed.

And when my pain finally improved, I stopped taking opioids.

A part of me was not eager to go public as someone who used opioids, for the same reasons that I was initially reluctant to take opioids for pain. Opioids carry a stigma, one that is only increasing today in an era of opioid abuse.

The increase in prosecutions and the oversight of physicians, and the difficulty people in pain today experience in getting appropriate pain medication motivated me to tell my story.   

My story of pain began 23 years ago. I was working at my desk in the Civil Rights Division of the U.S. Justice Department, putting the finishing touches on a document due to court, when my back started to burn. It felt like acid eating my spine. My muscles seized and threw me from my chair.  As I curled on the floor, my body seared with pain.

Over the coming days and weeks, the pain only intensified. Any postural compression on my spine caused electrical and burning sensations to escalate like an alarm that grows louder and louder.

At the age of 30, just a few years out of Harvard law school, I could barely stand and sitting was impossible. So, I began to conduct my life lying down. For a while, I was able to commute, lying across the backseat of a car to work from a futon on the floor of my office, using a walker to get from place to place. Then for many, many years, I was entirely bedridden.

Two things allowed me to maintain a life under these circumstances. The first is that I happened to be working in one of the few jobs that would accommodate me. When my pain began, I was enforcing the ADA, a civil rights law that protects the rights of individuals with everything from multiple sclerosis to cancer to HIV disease.

The second and more critical factor was my access to good medical care. My pain began in the 1990s, when the pendulum on pain swung decidedly in the opposite direction of where it is today.  I had access to the best doctors and to treatment at a pain management clinic. My physicians tried all sorts of treatments, from lidocaine infusions and directed injections, to nerve ablations and a surgery to separate nerves from adhesions. Nothing restored my mobility or diminished the pain.

Early on, I refused to take opioids.  I was worried about addiction and stigma.  When my doctors initially approached me about taking opioids for pain, I was, at first, devastated. I felt like they were giving up, that I was being put out to pasture.  But I had exhausted my available treatment options, so I relented and underwent psychological screening to determine if opioids were appropriate. 

As soon as I took opioids, I improved. I wasn’t foggy or especially euphoric. In fact, the opposite happened, space opened in my mind and I could work again.  I also never developed a tolerance, requiring more medication for the same level of pain relief. 

Opioids did not heal me. Integrative treatment over a long period of time did.  But opioids gave me a life until I could find my way to healing. Importantly, they allowed me to continue to work.  

I understand that opioids are complicated. People are different. I also recognize that as a public health matter, the interests of treatment must be balanced against the potential for abuse.  But today we have no such balance: our media attention and public policy focus singularly on abuse.

Serious physical pain needs to figure into the conversation, especially since severe or persistent pain affects 25 times more Americans than opioid abuse.

I worry that we are throwing out the baby with the bath water. By focusing on a single substance, we are not addressing the root causes of addiction.  By placing undue pressure on physicians and the doctor-patient relationship we abandon people in severe pain, many of whom could contribute and lead productive lives, to their suffering.

Kate Nicholson lives in Colorado. She served in the Civil Rights Division of the U.S. Department of Justice for more than 20 years, practicing health-related civil rights law and securing powerful victories including in the U.S. Supreme Court. 

Kate is currently writing a book about her personal experiences with severe chronic pain. She can be reached through her website at www.katemnicholson.com. 

You can watch Kate's TED Talk below:

Fentanyl Linked to Over Half of Opioid Overdoses

By Pat Anson, Editor

A new report from the Centers for Disease Control and Prevention shows that illicit fentanyl – not prescription pain medication -- was involved in over half of the recent opioid overdoses in ten states.

The report underscores the changing nature of the nation’s overdose crisis and how public health officials have been slow to respond to the growing role of fentanyl and other illegal opioids – focusing instead on limiting access to opioid medication.

CDC researchers say fentanyl or its chemical cousins (known as fentanyl analogs) were detected in 2,903 of 5,152 opioid overdoses (56.3%) during the last six months of 2016.

Their report on overdoses in ten states (Oklahoma, New Mexico, Wisconsin, West Virginia, Ohio, Maine, Missouri, Rhode Island, Massachusetts and New Hampshire) is the first to use toxicological and death scene evidence to characterize opioid overdoses, a method that is far more accurate than other CDC reports that rely on death certificate codes.

source: Centers for disease control and prevention

Maine, Massachusetts, New Hampshire, Rhode Island and Missouri reported the highest percentages of deaths involving fentanyl (60-90%), while New Mexico and Oklahoma had the lowest (15-25%). Fentanyl is a potent synthetic opioid that is legally prescribed to treat severe pain. The vast majority of the deaths, however, involve illicit fentanyl that has flooded the black market in recent years. 

“This analysis of opioid overdose deaths in 10 states participating in the ESOOS (Enhanced State Opioid Overdose Surveillance) program found that illicitly manufactured fentanyl is a key factor driving opioid overdose deaths and that fentanyl analogs are increasingly contributing to a complex illicit opioid market with significant public health implications,” the researchers reported.

“Illicitly manufactured fentanyl is now a major driver of opioid overdose deaths in multiple states, with a variety of fentanyl analogs increasingly involved, if not solely implicated, in these deaths. This finding raises concern that in the near future, fentanyl analog overdose deaths might mirror the rapidly rising trajectory of fentanyl overdose deaths that began in 2013 and become a major factor in opioid overdose deaths.”

The CDC recently expanded the ESOOS program to 32 states and the District of Columbia. Additional funding was also provided to improve toxicology testing for a wider range of fentanyl analogs such as carfentanil, which is estimated to be 10,000 times more potent than morphine.

The new CDC report did not detail how many of the overdose deaths involved prescription opioids. A recent report from Massachusetts  estimated that prescription opioids were involved in only about 15% of overdoses in that state, ranking well behind cocaine, benzodiazepines, heroin and fentanyl.

source: massachusetts department of public health

Although opioid prescribing has been in decline for years, public health efforts remain focused on limiting access to pain medication. As PNN has reported, the CDC recently launched a new advertising campaign that focuses exclusively on raising awareness about the risks of prescription opioids, while ignoring the role of fentanyl and heroin in the overdose crisis.

The CDC’s Rx Awareness campaign will initially run in four states -- including Massachusetts and Ohio, two of the states where fentanyl overdoses vastly outnumber those involving pain medication.

Trump: Overdose Crisis a ‘Public Health Emergency’

By Pat Anson, Editor

President Trump today declared the overdose crisis a nationwide “public health emergency,” a legal designation that falls well short of the national emergency sought by his own opioid commission.

The difference between the two is significant. Under a national emergency, the Trump administration could immediately access funds already set aside for disaster and emergency relief. There is little funding currently available -- only about $57,000 -- to pay for a public health emergency.

Despite the lack of funding, President Trump pledged his administration would act swiftly to end an overdose crisis that he said was killing 7 Americans every hour.

“Nobody has seen anything like what's going on now. As Americans, we cannot allow this to continue.  It is time to liberate our communities from this scourge of drug addiction,” Trump said.

“That is why, effective today, my administration is officially declaring the opioid crisis a national public health emergency under federal law, and why I am directing all executive agencies to use every appropriate emergency authority to fight the opioid crisis.  This marks a critical step in confronting the extraordinary challenge that we face.”

The president said he was awaiting a final report and recommendations from the White House opioid commission, which is expected next week. An interim report by the commission in July strongly urged the president to declare a national emergency.  

“Your declaration would empower your cabinet to take bold steps and would force Congress to focus on funding and empowering the Executive Branch even further to deal with this loss of life,” the report said. “You, Mr. President, are the only person who can bring this type of intensity to the emergency and we believe you have the will to do so and to do so immediately.”

Soon after the interim report was released, the president said he would declare a national emergency, but the White House never got around to actually declaring one -- amid reports of division in the administration about what should be done and how to pay for it.

Nearly $1 billion in federal funding to pay for addiction treatment was authorized by Congress in the final weeks of the Obama administration.

The National Safety Council released a statement saying the president’s declaration was “vague at a time when a clear path forward is critical.”

“The federal response must include adequate funding for implementing other evidence-based strategies as well, a move the president himself said is necessary,” the statement said.

Also expressing disappointment was Andrew Kolodny, MD, a psychiatrist and researcher at Brandeis University, who is the founder of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

"Everything that was mentioned today sounds helpful, but mentioning a few helpful items is not a plan," Kolodny told Time Magazine.

Koldony, who is the former chief medical officer of Phoenix House, said a massive appropriation of $60 billion to subsidize the addiction treatment industry would be needed over the next decade.

The number of people seeking treatment for abuse of pain medication has actually been in decline for years. According to a recent DEA report, there were 128,175 admissions to publicly-funded treatment facilities for painkiller abuse in 2014, a decrease of about 32 percent since 2011.

‘Truly Evil’ Painkiller

President Trump outlined a number of steps his administration has taken or will take to combat opioid abuse. That includes filing lawsuits against pharmaceutical companies for their marketing of opioid pain medication, something many states are already doing.

“I will be looking at the potential of the federal government bringing major lawsuits against bad actors.  What they have and what they're doing to our people is unheard of.  We will be bringing some very major lawsuits against people and against companies that are hurting our people.  And that will start taking place pretty soon,” he warned. 

President Trump said one opioid painkiller was “truly evil” and should be taken off the market immediately because it had a high risk of abuse. That was apparently a reference to Opana ER, an extended released opioid that Endo International agreed to stop selling in July.

The president also praised CVS Health for its plan to limit opioid prescriptions for acute pain to 7-days’ supply and the CDC for launching a public awareness campaign that "put a face" on opioid abuse.    

How the DEA Changed the Overdose Numbers

By Pat Anson, Editor

The Drug Enforcement Administration has released its annual report on the threat posed to the U.S. by drug trafficking and the abuse of illicit drugs.

The 2017 National Drug Threat Assessment (NDTA) has both good and bad news about the nation’s worsening overdose crisis. But like other federal agencies, the DEA has a disturbing tendency to massage statistics to make the role of opioid pain medication more significant than it actually is.

“The threat posed by controlled prescription drug (CPD) abuse is prevalent. Every year since 2001, CPDs, specifically opioid analgesics have been linked to the largest number of overdose deaths of any illicit drug class, outpacing those for cocaine and heroin combined,” the report declares.

That sure makes it sound like opioid pain medication is killing more people than ever before, doesn’t it? A closer look at the numbers and methodology used by the DEA suggests otherwise.

"Controlled prescription drugs" is a very broad category that includes not only opioid pain relievers, but anti-anxiety drugs (Valium, Xanax), stimulants (Adderall, Ritalin), and anabolic steroids. And there's plenty of evidence people are dying from those drugs as well.

This is not the first time the DEA has lumped opioid pain relievers with other drugs. In the 2016 NDTA, the DEA combined opioids with anti-anxiety drugs, but not stimulants or steroids.

A year earlier, in the 2015 NDTA, prescription opioids were in a category all to themselves.

The effect of these changing and broadening definitions is significant. Every year the overdose crisis appears to be getting worse and worse. It certainly is for deaths linked to illicit drugs like heroin, cocaine and fentanyl, but not necessarily for prescription drugs and definitely not for opioid pain medication.

One has to wonder why these definitions keep changing and distorting the true nature of the overdose crisis. Don’t take my word for it. Look at how the overdose numbers for "Selected Illicit Drugs" in 2013 have grown over the years.

In the 2015 NDTA, the DEA reported that an “opioid analgesic” was involved in the deaths of 16,235 Americans in 2013.

In the 2016 NDTA, the DEA reported that “prescription drugs” were involved in the deaths of 22,767 Americans in 2013.

And in the 2017 NTDA, the DEA reported that “medications” were involved in the deaths of 24,536 Americans in 2013. The "medications" category includes not only controlled prescription drugs, but over-the-counter drugs as well.

Simply by changing the way they counted overdoses, the DEA and other federal agencies raised the death toll for 2013 by over 8,300 people.  We’re only using 2013 as an example.  From one report to the next, overdoses grew for every other year as well.

This isn’t the first time the federal government has played around with the overdose numbers. As PNN reported, last December the CDC and the White House Office of National Drug Control Policy released three different estimates of how many Americans died in 2015 from overdoses linked to prescription opioids.  

Within one week, the overdose numbers evolved from 17,536 deaths, down to 12,700, and then back up to 15,281 deaths. To use a football metaphor, that is known as moving the goalposts.

Pain Medication Abuse Declining

A closer reading of the 2017 NDTA shows that heroin, illicit fentanyl and other illegal drugs are now driving the overdose crisis, not opioid pain medication. Less than one percent of legally prescribed opioids are being diverted to the black market. 

A recent survey of law enforcement agencies, known as the National Drug Threat Survey, found that less than 10 percent of respondents nationwide believed controlled prescription drugs were the greatest drug threat in their jurisdiction -- down considerably from 2014 when over 21.5 percent reported the same

The abuse of prescription opioids is also declining. Fewer Americans are testing positive for hydrocodone, oxycodone and other painkillers in workplace drug tests. And the number of people seeking treatment for abusing pain medication has fallen significantly. From 2011 to 2014, admissions to publicly-funded treatment facilities for prescription opioid abuse fell by nearly a third. 

“This decline can in part be attributed to CPD (controlled prescription drugs) abusers switching to heroin or other illicit opioids. Some CPD abusers, when unable to obtain or afford CPDs, begin using heroin as a cheaper alternative offering similar opioid-like effects,” said the DEA.

“Expansion of the counterfeit pill market, to include pills containing fentanyl, threatens to circumvent efforts by law enforcement and public health officials to reduce the abuse of opioid medications; the arrival of large amounts of counterfeit prescription drugs containing fentanyl on the market replaces opioid medications taken off of the street.”

Curiously, the DEA report doesn’t even list kratom as a drug threat – even though the agency considers the herbal supplement a “drug of concern” and tried to ban it last year. 

“I think that all of us in the kratom community have a hard time reconciling the lack of a threat listing for kratom and yet still being considered a drug of concern,” said Dave Herman, chairman of the American Kratom Association, a pro-kratom consumer group.  “The science tells us that kratom has a low potential for either abuse or addiction and we hope to see that reflected in all DEA materials.”

Whether its kratom or pain medication, the DEA and other federal agencies have a responsibility to be consistent and to get their facts right.  Inflating the overdose numbers and blaming opioid medication may make for good headlines, but it diverts funding, resources and policymakers away from other drug problems that truly need more attention. We'll never get a handle on the overdose crisis if we keep moving the goalposts.

A recent editorial in the Journal of Pain Research took the CDC to task for doing just that.

"Transparency, freedom from bias, and accountability are, in principle, hallmarks of taxpayer-funded institutions. Unfortunately, it seems that at least one institution, the Centers for Disease Control and Prevention, continues to struggle with all three," wrote researchers Michael Schatman, PhD, and Stephen Ziegler, PhD.

"What began with a prescribing guideline created in secrecy has now evolved to the use of statistical data and public statements that fail to capture not only the complexity of the problem but also the distinction between licit and illicit opioids and their relationship to the alarming increase in unintentional overdose. This is unfortunately consistent with Mark Twain’s assertion that 'there are lies, there are damn lies, and then there are statistics.'"

Opioid Limits: Means, Medians or Madness?

By Roger Chriss, Columnist

CVS recently announced it would impose a 7-day limit on opioid prescriptions for short-term acute pain for customers in its pharmacy benefit management program.  A pharmaceutical industry trade group also supports a 7-day limit and so does the U.S. Pain Foundation, a patient advocacy group.

Maine, New Jersey, Massachusetts and other states are also limiting prescriptions to a week or less, justifying the time frame by saying that’s what patients need on average.

But this represents a misunderstanding of how statistics work and ignores emerging research about opioid analgesia in the world of acute pain care.

In statistics, we have three values of fundamental importance: the mean, median, and variance.

The mean, also known as the “arithmetic mean,” is the sum of a collection of numbers divided by the number of numbers in the collection. The average height or weight of a group of people is the mean.

The median is the “middle value” of a data set that is ordered from lowest to highest. The mean is found in “median income” or “median price of a new home.” Importantly, the mean and median are not necessarily the same. In the set of numbers 2, 3, 3, 5, 7, 17 and 313, the median value is 5, but the mean value is 50.

The variance is the tendency of a set of numbers to cluster around the mean, or how spread out the numbers are. We know from experience that the height of adults is closely clustered around average height: Most people are over five feet tall and under seven feet tall. No one is 2 inches or 20 feet tall. But variance can also be significant, as is the case with annual income, home prices or family size.

The significance of these three values cannot be understated. In his essay “The Mean Isn’t the Message,” biologist Stephan J. Gould explains that a “median mortality of eight months” does not mean that a person will probably be dead in eight months. Some people, including Gould himself, live many times more than the median survival time for a disease. 

So when talking about opioid analgesia for acute pain, we cannot rely on just an “average” value. Physicians know this, but legislators, corporations and even some patient advocates do not seem to.

JAMA Surgery recently reported on the post-surgical acute pain needs of over 200,000 patients who had one of eight common surgical procedures. The results showed median values from 4 days for an appendectomy or gallbladder surgery to 7 days for a discectomy.  

The authors then used these values and the variance to calculate the range of time a patient would typically need opioids for acute pain after surgery:

• 4 to 9 days for general surgery procedures
• 4 to 13 days for women's health procedures
• 6 to 15 days for musculoskeletal procedures

In other words, there is substantial variance, with the optimal length extending to as much as two weeks. And there is no way to know ahead of time where in this range an individual will fall.

To address this uncertainty, the Opioid Prescribing Recommendations for Surgery were developed at the University of Michigan. They list the recommended numbers of tablets of hydrocodone, codeine, tramadol, or oxycodone for a range of common surgical procedures, including laparoscopic cholecystectomy, open colectomy, and several types of biopsy.

This resource gives amounts that “represent the actual maximum opioid use reported by three-quarters of actual surgery patients.” Those amounts range from 10 to 40 pills, depending on the procedure, noting that “prescribers are encouraged to use their best judgment.”

The Opioid Prescribing Recommendations for Surgery also advise recovering unused pills to reduce the risk of diversion, which is a much more sensible policy than forcing people recovering from trauma or surgery to seek refills if they happen not to fit a mandated average.

In sum, the medical profession is offering evidence-based recommendations for pain management that include not just a simplistic mean, but the real-world variance found in individuals. This approach is likely to provide better results than blanket policies geared toward a statistical mean that does not capture vital features of medical care.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

Insurers Promise More Cuts in Rx Opioids

By Pat Anson, Editor

Less than two weeks before its final report is due, President Trump’s opioid commission held its fourth and final public meeting Friday – hearing testimony from top government officials and insurance industry executives about the nation’s worsening overdose crisis.

“Insurance companies are going to be a very, very important part of whether we will be able to stem the tide here or whether we’re not,” said commission chairman Gov. Chris Christie of New Jersey.

It was clear from their testimony that many insurers are planning to tighten access to prescription opioids even more than they already have.

Aetna’s chief medical officer told the commission the insurance giant was planning to reduce “inappropriate opioid prescribing” to its members by 50 percent within the next five years.  He did not explain what would be considered inappropriate.

Aetna has already sent warning letters to hundreds of physicians and dentists identified as “super-prescribers,” urging them to reduce the number of opioid prescriptions they write.

“We’re now re-running our analysis and planning more aggressive interventions for those providers who haven’t improved their opioid prescribing habits over the past several months,” said Harold Paz, MD.  

The chief medical officer of Cigna said his company was close to achieving a 25 percent reduction in coverage of opioid prescriptions, a priority it set last year.

“That’s only the first of our goals,” said Alan Muney, MD.

Insurer Harvard Pilgrim said its coverage of opioid prescriptions has declined by over 20 percent since 2014.

“That’s not enough.  This feels like a balloon where you tap on one end and it comes out somewhere else. So it doesn’t mean we’re even close to solving this,” said Michael Sherman, MD, chief medical officer of Harvard Pilgrim.

Insurers clearly have the ear of the federal government when it comes to opioids. As PNN has reported, an obscure federal advisory group composed of insurers, law enforcement, and federal and state regulators has discussed eliminating opioid prescriptions for acute pain, as well as paying doctors not to prescribe opioids.

The Healthcare Fraud Prevention Partnership also wants access to the “personally identifiable and protected health information” of 57 million Medicare beneficiaries to see if they are abusing opioids.

Reducing Opioids a ‘Win-Win’

Labor Secretary Alexander Acosta said reducing opioid prescriptions was important to get unemployed Americans back into the workforce. He cited a recent study that found that about a third of unemployed men aged 25 to 54 were using prescription painkillers.   

“Reducing the amount of opioids is a win-win across the board. It’s a win for the individual who doesn’t want to get hooked,” Acosta said. “It’s a win for the insurance companies who don’t want to be paying for medicines that people don’t need. And it’s a win for the American workforce, because if we can get people back to work and paying taxes and participating fully, that’s a win for them and it’s a win for the country.”

Acosta cited no studies that might indicate how many Americans currently taking opioids would become unemployed or disabled if their pain medication was reduced or taken away. 

No pain patients, patient advocates or experts in pain management were asked to appear before the commission. No one from the pain community has testified during any of the commission’s public meetings, although thousands have submitted written comments.

An interim report released by the opioid commission in July focused on expanding access to addiction treatment and developing new ways of treating pain without opioids. Since then, the commission has increasingly focused on limiting opioid prescriptions. The final report from the commission is expected November 1.

The interim report also strongly urged President Trump to declare a national emergency to speed up efforts to combat the overdose crisis, something he has yet to do.  “We’re going to be doing it in the next week,” Trump told reporters on Monday.  However, there appears to be little consensus in the administration about what actions to take after an emergency is declared or how to pay for them.

"Everyone wants opioids to be a priority, but there's a lot of resistance to calling it an emergency," a senior administration official told Politico.

Drug Overdose Rates Rise in Rural Areas

By Pat Anson, Editor

Rates of drug overdose deaths in rural areas of the United States now exceed those in urban areas, according to a new report by the Centers for Disease Control and Prevention.

CDC researchers say the overdose rate in non-metropolitan (rural) areas was 17 deaths per 100,000 people in 2015, which was slightly higher than urban areas (16.2 deaths). Both rates are substantially higher than they were a generation ago. About 52,000 Americans died of drug overdoses in 2015.

“The drug overdose death rate in rural areas is higher than in urban areas,” said CDC Director Brenda Fitzgerald, MD. “We need to understand why this is happening so that our work with states and communities can help stop illicit drug use and overdose deaths in America.”

In 2015, both urban and rural areas experienced significant increases in the percentage of people aged 26 and older who reported illicit drug use in the past month.

One of the few bright spots in the CDC report is that use of illicit drugs by adolescents (aged 12-17 years) has declined for the last ten years.

The report did not go into detail on what drugs were being abused, although it acknowledges the declining role of prescription opioids in the overdose crisis.

“Although prescription drugs were primarily responsible for the rapid expansion of this large and growing public health crisis, illicit drugs (heroin, illicit fentanyl, cocaine, and methamphetamines) now are contributing substantially to the problem,” the report found.

“Recent studies suggest that a leveling off and decline has occurred in opioid prescribing rates since 2012 and in high-dose prescribing rates since 2009.”

Curiously, while those studies have documented the increased role of heroin, illicit fentanyl and other illegal opioids in the overdose crisis, the federal government’s public awareness campaigns remain focused on prescription opioids.  

Heroin and fentanyl are barely even mentioned in the Department of Health and Human Services’ “5-Point Strategy to Combat the Opioid Crisis.” The strategy focuses instead on “advancing better practices for pain management,” and increasing access to addiction treatment and overdose prevention drugs.

The CDC also recently launched an advertising campaign using billboards and videos that completely ignore the scourge of heroin and fentanyl.  The CDC explained the omission by saying it wanted to focus on prescription opioids and avoid “diluting the campaign messaging.”

“Prescription opioids can be addictive and dangerous,” a woman says in one CDC ad.

“One prescription can be all it takes to lose everything,” a man says in another ad.

Five public health experts interviewed by Pacific Standard questioned whether the CDC campaign will be effective, because the ads don't empower people or give them an alternative to prescription opioids.

"The campaign isn't going to make a damn bit of difference," said Bill DeJong, a professor of community health sciences at Boston University.

The Secret Role of Insurers in Medicare Opioid Policy

By Pat Anson, Editor

This month marks the one year anniversary of a closed door meeting between law enforcement agencies, federal and state regulators, and health insurance companies in a Baltimore suburb – a “special session” of an obscure advisory group to the U.S. Justice Department and the Department of Health and Human Services.

Although the mission of the Healthcare Fraud Prevention Partnership – HFPP for short -- is to prevent healthcare fraud, the October 20, 2016 meeting went much further. It gave the insurance industry – so-called “Partner Champions” -- a direct role in drafting recommendations that could decide how millions of pain patients will be treated by their doctors and what opioid medications will be prescribed to them, if any.

Major insurers like Aetna, Anthem, Cigna, Humana, Blue Cross Blue Shield and Kaiser Permanente were invited to attend, but no other stakeholders in healthcare, such as physicians, pharmacists, hospitals or patients, were asked to appear or share their insights. Few details about the meeting were made public, until now.

Pain News Network has obtained documents through the Freedom of Information Act (FOIA) that shed some light on how the meeting was organized and what was discussed, but we were denied access to a list of individuals that attended, who they represented, or any recordings of what they said.

“The nature of some of the information provided during the Special Session on opioids would be of the sort that could have a negative impact on the competitive posture or business interests of a company if made public,” Jay Olin, Director of FOIA Analysis for the Centers for Medicare and Medicaid Services (CMS), wrote in a letter to PNN.

CMS COMMAND CENTER IN WOODLAWN, MD

“The release of this sensitive information could put the company at significant financial risk if interested parties use this information to develop and execute schemes and individuals and organizations use this information to game the system and reap financial or other benefit.”

Olin also said the HFPP is not a federal advisory committee and therefore not subject to federal open meeting laws, even though the October 20 meeting was called by CMS, organized by CMS, funded by CMS, and held on federal property at the CMS Command Center in Woodlawn, Maryland.

“Furthermore, most (HFPP) partners are from the private sector and private industry is not subject to FOIA, nor is CMS authorized to release such information,” Olin wrote.

PNN is appealing that decision.

‘Government-authorized use only’

CMS may be trying to distance itself from the HFPP, but it’s clear they work closely together in their unusual “public-private partnership.”

A CMS website hosts a portal for HFPP members to sign-in that plainly states “this system is provided for Government-authorized use only.” The website also goes into detail on how to become an HFPP partner, the benefits of membership and provides an extensive list of partners that includes 45 different insurance companies.

According to a recent report from the General Accounting Office (GAO), CMS has spent over $30 million funding the HFPP since 2012, the year the partnership was created by the Obama administration to help the federal government detect and prevent healthcare fraud. A side benefit for insurers is that it helps them lower the cost of healthcare coverage. A CMS flyer plainly states that one of the reasons the HFPP exists is to help payers “identify potential savings.”       

The goals and activities of the partnership are important to understand because CMS contracts with dozens of insurers to provide Medicare coverage to about 57 million elderly and disabled Americans, at an annual cost of nearly $700 billion. And if the insurance industry is making healthcare decisions while being subsidized with billions of taxpayer dollars, Americans have a right to know what’s going on.

Yet CMS won’t even say who attended that October 20 meeting.

“A total of 58 participants across 26 federal, state, public and private organizations, including CMS, attended the event,” is all that an executive summary of the meeting says about the attendees.

The first half of the daylong meeting wasn’t even about opioids. It focused on the HFPP’s mission: combating fraud. According to the executive summary, a CMS technical advisor briefed attendees about common fraud schemes in the addiction treatment and drug testing industries, such as “substance abuse facilities that may be exposing their patients to physical or other harm” and insurance claims from treatment facilities “for services not rendered and unnecessary service, including lab claims.”

Another fraud scheme flagged by CMS was “physicians who appear to be referring Marketplace (Medicare/Medicaid) members, as well as other individuals who may be paid by substance abuse facilities to sign people up for Marketplace coverage.”

After a break for lunch, the discussion veered away from fraud prevention and into treatment decisions normally left between a patient and their doctor. A CMS official “emphasized the need to look at improving the quality of care” and identified several priority areas, including “best practices for acute and chronic pain.”

“Eliminate or restrict opioid prescribing for acute conditions,” was one of the many strategies discussed. So was the concept of “pay for performance,” in which doctors would receive payments from insurers “for following guidelines or quality practices, not for prescribing opiates.”

“Higher copay for opioid prescriptions” was another recommendation, as was “step therapy and dosage control.”

"Media outreach" and “social media and digital advertising tools” were suggested as ways to promote patient and provider compliance through “social normalizing.”

It is not clear from the documents provided to PNN if these were strategies advocated by insurers, law enforcement or CMS.

‘Serious Conflict of Interest’ for Insurers

Attendees were told the ultimate goal of the meeting was “to produce an HFPP-branded White Paper that identifies best practices payers can take to effectively address and minimize current and future opioid abuse.”

In other words, the meeting was not just about fraud prevention. The insurance industry was being asked to help design federal policy on opioid prescribing and “encourage practices that connect patients to the level of care best suited to their needs…. while avoiding unnecessary services or opioid prescriptions.”

“It is very disturbing to see CMS working with insurance companies to reduce the amount of opioids prescribed without physician and organized medicine's input,” said Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine (AAPM). 

“It is a serious conflict of interest to have insurance companies determine what medications are appropriate and how much to use.”

Webster was also alarmed by some of the strategies discussed at the October 20 meeting.  

“The proposal that insurance might eliminate opioids for acute pain would leave many patients without any effective treatment. That is not helpful and will produce a huge backlash,” he said.

“To encourage CMS to reward doctors to not prescribe opioids is a very ominous trend, knowing that untreated pain can have lethal effects on the body,” said Ingrid Hollis, a patient advocate and mother of a chronic pain sufferer. “To perpetuate these myths about reining in the addiction crisis, when in fact it is looking more and more like cost saving measures, is a conflict of interest for sure.

“I also find it disturbing that a private group with so much influence on insurance would not disclose to you who was in attendance at their meetings. Because they are influencing public programs and healthcare funded by taxpayers, they need to disclose who they are.”

When asked why the October 20 meeting was closed to the public, a CMS spokesman said "all HFPP meetings are limited to members of the Partnership, as they deal with sensitive issues relating to fraud, waste and abuse in the healthcare sector."

Payer ‘Partner Champions’

The HFPP white paper was released in January on the CMS website. The 62-page report -- Healthcare Payer Strategies to Reduce the Harms of Opioids -- begins by praising the “Partner Champions” who helped draft it. 

Among the payers listed as “champions” were Aetna, Anthem, Blue Cross Blue Shield, Cigna, Centene, Highmark, Horizon, Humana, and Kaiser Permanente.

“To overcome the problems of prescription opioid misuse, it is also vital to understand that provider prescribing practices and patient drug seeking behavior can exacerbate the development and persistence of OUD (opioid use disorder),” the white paper warns.

“Providers may write prescriptions without assessing their patient’s risk for misuse, prescribe opioid analgesics for minor pain, prescribe a greater medication quantity or dose than warranted by the patient’s medical indication, or provide opioids fraudulently with the knowledge they are likely to be misused. Patients may exaggerate or falsify symptoms to obtain opioid prescriptions, seek prescriptions from multiple physicians, forge prescriptions, or obtain prescriptions for resale on the black market.”

The white paper goes on to endorse the CDC’s opioid prescribing guideline, and recommends that over-the-counter pain relievers such as aspirin, acetaminophen and ibuprofen be used as alternatives to opioids, as well as non-drug therapies such as cognitive behavioral therapy, chiropractic care and TENS nerve stimulation units. Few of these treatments are covered by insurance.

The white paper also encourages pharmacists to “deny payments for (opioid) prescriptions that do not conform to general prescribing practices” and to profile doctors and patients to identify “problematic actors and schemes.”

Patients could be profiled in one of three ways, according to the HFPP:

1. Stewards (those who follow guidelines)
2. Stockers (those who hoard medication)
3. Demanders (those who ask for medication)

The white paper does not discuss fraud in the addiction treatment industry, the initial focus of the October 20 meeting. Also unmentioned is a recent HFPP policy decision that allows insurers to share information about Medicare beneficiaries.

Individual patient data on 57 million Americans is now being pooled, studied and analyzed by the insurance industry, something that payers were previously reluctant to do.

“Several HFPP participants we spoke with indicated their support for the new strategy and willingness to provide beneficiaries’ personally identifiable information and protected health information for more in-depth HFPP studies,” the GAO report says.

“Several HFPP participants we spoke with indicated their support for the new strategy and willingness to provide beneficiaries’ personally identifiable information and protected health information for more in-depth HFPP studies.”

— GAO Report

Is the HFPP overstepping its authority? Do insurers have any business sharing and analyzing the personal health information of millions of Americans? No one at HFPP would comment. CMS referred us to this statement in the white paper:

“Payers can help to combat the opioid crisis by identifying and sharing strategies, such as reimbursement and coverage policies, conditions for provider plan participation, and dissemination of information to a variety of audiences, to address the large-ranging issues that lead to fraud, waste, and abuse in the healthcare system. Such interventions are particularly suited to payers due to their relationships with providers of healthcare services, pharmacies, insured patients, employers, and law enforcement (in cases where potential fraud is identified). Payers collect and administer a large amount of healthcare information that can be used to identify and intervene on behalf of patients at risk of opioid-related harm, as well as to target fraud, waste, and abuse in opioid prescribing.”

CMS announced plans to align its Medicare Advantage and Part D prescription drug plans with the CDC guideline soon after receiving the HFPP white paper. But some of the more extreme strategies discussed by the HFPP were not adopted. CMS won’t be paying doctors to follow the guideline or be eliminating opioids as a treatment for short term, acute pain.

But the agency is moving ahead with plans for a new monitoring system to identify opioid “overutilizers” -- physicians who prescribe high doses, patients who get them, and pharmacies that fill their prescriptions. Payers are authorized to drop suspicious pharmacies, doctors and patients from Medicare coverage and their insurance networks.

How many overutilizers are there? At last count, there were 15,651 Medicare beneficiaries getting multiple high dose opioid prescriptions. That may sound like a lot, but it amounts to only 0.04% of the 41.8 million patients enrolled in Medicare Part D plans.

Why are insurers targeting Medicare beneficiaries when only a tiny percentage may be abusing prescription opioids? Dr. Webster suspects the real motive is money.

“Clearly the insurance companies are benefiting from tunnel vision and a laser focus on Pharma companies and doctors,” says Webster. “There is a vast under appreciation that commercial insurers are also driven by the bottom line.  This is why they should not be making medical decisions without input from pain physicians and organized medicine.”

What is Opioid Use Disorder?

By Rochelle Odell, Columnist

You’ve probably heard or seen the phrase “Opioid Use Disorder.”  It’s a broad term currently being used to describe not only opioid addiction, but patterns of behavior that might be a sign of addiction or could lead to it.

If that sounds like they’re putting the cart before the horse, it’s because they are.

In order to understand Opioid Use Disorder, one must understand the government's stance on opioids. The National Institute on Drug Abuse – which is part of the National Institutes of Health (NIH) – lays it out in a recently revised statement on the opioid crisis:

“Every day, more than 90 Americans die after overdosing on opioids. The misuse of and addiction to opioids--including prescription pain relievers, heroin and synthetic opioids such as fentanyl--is a serious national crisis that affects public health as well as social and economic welfare."

Notice how they lump prescription pain relievers in with heroin and illicit fentanyl?  The more I research, the more I find this common thread of illogical thinking. The government consistently lumps pain medication in with illicit drugs.

Here’s another example from the NIH: 

“In 2015, more than 33,000 Americans died as a result of an opioid overdose, including prescription opioids, heroin, and illicitly manufactured fentanyl, a powerful synthetic opioid.

That same year, an estimated 2 million people in the United States suffered from substance use disorders related to prescription opioid pain relievers, and 591,000 suffered from a heroin use disorder.”

Substance use disorders “related” to pain relievers? Heroin use disorder? That got me wondering how many drug “disorders” there are.

According to the Substance Abuse and Mental Health Services Administration (SAMSHA), there are six major substance use disorders. Nearly 93,000,000 Americans have a substance use disorder of some kind:

1) Alcohol Use Disorder (AUD): About 17 million Americans have AUD. According to the CDC, alcohol causes 88,000 deaths a year. 

2) Tobacco Use Disorder: Nearly 67 million Americans use tobacco. According to the CDC, cigarette smoking causes more than 480,000 deaths a year.

3) Cannabis Use Disorder: Over 4 million Americans meet the criteria for a substance use disorder based on their marijuana use. No estimate is provided on the number of deaths caused by marijuana, if any.

4) Stimulant Use Disorder:  This covers a wide range of stimulant drugs that are sometimes used to treat obesity, attention deficit hyperactivity and depression. The most commonly abused stimulants are amphetamine, methamphetamine and cocaine. Nearly 2 million Americans have a stimulant use disorder of some kind.

5) Hallucinogen Use Disorder: This covers drugs such as LSD, peyote and other hallucinogens. About 246,000 Americans have a hallucinogen use disorder.

6) Opioid Use Disorder: Again, this covers both illicit opioids and prescription opioids. In 2014, an estimated 1.9 million Americans had an opioid use disorder related to prescription pain relievers and 586,000 had a heroin use disorder (notice the SAMSHA numbers are somewhat different from what the NIH tells us).

But what exactly is Opioid Use Disorder?  Does it mean 2.5 million Americans are addicted to opioids?

No.

The diagnostic codes used to classify mental health disorders were revised in 2013 to cover a whole range of psychiatric symptoms and treatments. Two disorders – “Opioid Dependence” and “Opioid Abuse” -- were combined into one to give us “Opioid Use Disorder.” Few recognized at the time the significance of that change, it's impact on pain patients, or how it would be used to inflate the number of Americans needing addiction treatment.

Elizabeth Hartley, PhD, does a good job explaining what Opioid Use Disorder is in an article for verywell.

Hartley wrote that Opioid Use Disorder can be applied to anyone who uses opioid drugs (legal or illegal) and has at least two of the following symptoms in a 12 month period:

• Taking more opioids than intended
• Wanting or trying to control opioid use without success
• Spending a lot of time obtaining, taking or recovering from the effects of opioids
• Craving opioids
• Failing to carry out important roles at home, work or school because of opioid use
• Continuing to use opioids despite relationship or social problems
• Giving up or reducing other activities because of opioid use
• Using opioids even when it is unsafe
• Knowing that opioids are causing a physical or psychological problem, but using them  anyway
• Tolerance for opioids.
• Withdrawal symptoms when opioids are not taken.

The last two criteria will apply to almost every chronic pain patient on a prescription opioid regimen. So might some of the others. Most of us develop a tolerance for opioids, and if they are stopped or greatly reduced, we will experience withdrawal symptoms.  We simply cannot win for losing. 

If you learn your physician has diagnosed you with Opioid Use Disorder, be sure to ask them what criteria were used and why was it selected. Ask if you should see a doctor more knowledgeable about diagnostic codes and psychiatric disorders. 

Remember, knowledge is power. Take this information with you on your next visit to the doctor if you suspect you have been diagnosed with Opioid Use Disorder and your medications have been cut or reduced.

I hope what I have written helps you further understand exactly what we are facing and why. To be honest, it makes me want to wave the white flag, but I know that cannot happen.  We have to fight. Fight for proper care for a chronic disease or condition we didn't ask for or want. We can’t live the rest of our lives in severe, debilitating pain when effective treatment is available.  

Rochelle Odell lives in California. She’s lived for nearly 25 years with Complex Regional Pain Syndrome (CRPS/RSD).

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

What Makes Buprenorphine Risky for Pain Patients

By Jane Babin, Guest Columnist

Buprenorphine is the darling of the addiction treatment industry, rapidly replacing methadone as the "medication assisted treatment" of choice for opioid use disorder (OUD) and addiction.  

Unlike methadone, which can only be dispensed through an opioid treatment program, buprenorphine can be prescribed in the privacy of a physician's office and filled at a pharmacy.  As a class III controlled substance, prescriptions for buprenorphine can be phoned or faxed in, and scripts can be refilled up to 5 times in 6 months without a new prescription.

Class II controlled substances, like hydrocodone, oxycodone and morphine, require a new prescription each month and can neither be refilled nor phoned in.

The only federal limitations on prescribing buprenorphine for OUD is that a physician must complete mandatory education and treat only a limited number of patients (currently 275). 

Ironically, these restrictions do not apply when buprenorphine is prescribed off-label for pain, leading some physicians and patients to turn to buprenorphine for chronic pain as class II opioids become increasingly harder to get.

Yet without training on buprenorphine’s unique pharmacology and its implications, physicians treating chronic pain may be unaware of the risks it presents. Let me explain why.

Buprenorphine’s Effect on Other Opioids

Buprenorphine is an opioid that acts as an agonist of the mu opioid receptor (MOR), which causes pain relief, just like class II opioids.  It also has side effects similar to other opioids, including tolerance, dependence, abuse potential, constipation, sedation and potentially fatal respiratory depression. 

What distinguishes buprenorphine from other opioids is that it is only a partial MOR agonist (50%).  Thus the effects of buprenorphine -- both pain relief and the undesirable side effects – don’t exceed half that of other, full agonist opioids.

Buprenorphine also has a ceiling of maximum effectiveness that reaches a plateau as the dosage is increased. That ceiling is well below what can be obtained with morphine and other opioids, but the side effects can still lead to death in opioid-naïve patients.  Buprenorphine has a long plasma half life, binds very strongly to MOR, and remains bound for extended periods of time.  Its usefulness in treating OUD is believed to lie in these properties, because it activates MOR sufficiently to curb drug craving, but not enough to elicit the euphoric effects that can lead to addiction. 

When an opioid that has higher analgesic potency, but lower MOR affinity, such as morphine or heroin, is also administered, buprenorphine wins the battle to bind and remains bound to MOR.  It can displace both heroin and naloxone from MOR, but neither can displace buprenorphine.  Naloxone can be effective when co-administered with buprenorphine -- as it is in combination drugs such as Suboxone -- but not after the administration of buprenorphine. 

Buprenorphine is also a kappa opioid receptor antagonist, which is thought to further reduce euphoria and addictive reinforcement. That’s great for patients with OUD, because it helps them resist the temptation to abuse opioids, and dampens or eliminates the euphoric effect of heroin or other opioids should they relapse.  

Increasingly, buprenorphine is being advocated for chronic pain patients.  With no more "proof" of efficacy for treating chronic pain than any other opioid, it has emerged as a less objectionable opioid because it appears safer in the eyes of addiction treatment specialists, such as Dr. Andrew Kolodny, who object to full MOR agonists for chronic pain. 

Yet safety is in the eyes of the beholder.  Despite its decreased abuse potential, buprenorphine can still be abused and cause overdoses because the ceiling effect for respiratory depression does not apply universally, particularly to opioid-naïve patients and children. Buprenorphine has caused the death of at least one child from unintentional exposure. 

Buprenorphine should not be used as the first opioid prescribed for chronic pain.  Because it cannot achieve the full analgesic effects that other opioids can, there is significant risk of buprenorphine leaving pain undertreated or even untreated.  A chronic pain patient on long-term buprenorphine therapy who experiences acute or breakthrough pain may not be able to get relief by taking another opioid.  Even more disturbing is the lack of pain control in patients who need surgery, have an acute injury from trauma or an acute painful medical emergency.

Buprenorphine Injection

Recently Indivior, a spin-off of Reckitt Benckiser Pharmaceuticals (which makes Suboxone), submitted a New Drug Application to the Food and Drug Administration on a subcutaneous injection formulation of buprenorphine. 

A once-a-month injection would be a significant advance for opioid administration because it would significantly reduce the risk of diversion.  A patient could hardly be accused of giving away or selling a drug that is deposited in his body, or of taking an incorrect dose.  

For this reason alone, an opioid depot formulation for a chronic pain patient with monthly administration sounds very appealing.  It might eliminate the need for pain contracts, pill counts, urine drug testing, and other indignations chronic pain patients suffer every day.  Even if another medication was needed for breakthrough pain, and drug testing was deemed necessary, the depot formulation would provide a virtually indisputable level of medication that could serve as an "internal control" for test error.  Detecting the depot med at unexpected levels would alert the prescribing physician to the inaccuracy of the test rather than suggest misuse or abuse.

Nevertheless, buprenorphine is not the right opioid for once-a-month dosing.  In a 2015 paper, lead author Dr. Yury Khelemsky described a horrifying case that illustrates the dangers inherent in daily buprenorphine use.  In this case, a patient with a history of drug addiction who was being treated successfully with Suboxone suffered a broken neck that required emergency surgery.

During the procedure, the anesthetized patient began to move in response to surgical stimulation, i.e., due to pain.  Despite increasing the amount of two anesthetics, Propofol and Reminfentanil, the patient continued to move.  Only after receiving yet another drug (Ketamine) did the patient remain motionless during the delicate procedure.  During a subsequent back surgery following discontinuation of Suboxone and replacement with short-acting opioids, roughly half as much Propofol and Remifentanil provided adequate anesthesia without the addition of Ketamine. 

Khelemsky noted that as little as 8 mg Suboxone (one third of the daily dose the patient was receiving), blocks the activity of hydrocodone for up to five days, and recommended discontinuing buprenorphine at least 72 hours prior to elective surgery.  This is cold comfort to a patient requiring emergency surgery -- which could be anyone.  

An injectable depot formulation of buprenorphine would substantially increase the risk of severe and possibly untreatable pain in an emergency situation, since a depot, once injected, cannot simply be discontinued as a pill would be.  Indeed, surgery may be needed to remove the depot and halt continued administration, while existing amounts of long-acting buprenorphine in plasma may necessitate higher, riskier doses of anesthetic to surgically treat the acute injury -- all while risking inadequate pain treatment.

Inexplicably, the extensive prescribing information on a random sample of buprenorphine products contains no warnings to either patients or prescribers of the risk that pain relief from an acute medical condition, trauma or surgery may be inadequate, or that buprenorphine should be discontinued days or weeks before elective surgery. 

Ironically, one package insert warns that additional analgesia may be required during childbirth, yet it fails to warn of any other situation that may require analgesia, or how analgesia can be accomplished when considering the unique pharmacology of buprenorphine.  

This seems to reflect the mindset of Kolodny and others in the addiction treatment industry, who always seem to minimize the significance of even the most severe pain encountered by an individual when compared to the perceived societal consequences of addiction.  I wonder how many pain patients or addicts would choose such a long-acting opioid if they understood the possibility that their severe acute pain could not be controlled.

The FDA committee tasked with reviewing Indivior’s new drug application is taking public comments.  I urge anyone concerned about this new buprenorphine formulation, and the failure to warn of the possibility of untreatable acute pain when taking any buprenorphine product, to provide comments by clicking here.

Comments can be submitted through October 27, 2017.  If received by October 17, they will be provided to the committee, which is scheduled to meet on October 31.  Comments received after October 17 will be taken into consideration by the FDA. 

Jane Babin, PhD, is a molecular biologist and a biotechnology patent attorney in southern California.

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

Business Booming for Illegal Online Pharmacies

By Pat Anson, Editor

One of the many unintended consequences of efforts to reduce opioid prescribing is that they may be fueling the growth of illegal online pharmacies.

According to one estimate, as many as 35,000 online pharmacies are in operation worldwide. Over 90 percent are not in compliance with federal and state laws, many do not require a prescription, and about half are selling counterfeit painkillers and other fake medications. About 20 illegal online pharmacies are launched every day.

“There is no sign that this is slowing down,” says Libby Baney, Executive Director of the Alliance for Safe Online Pharmacies (ASOP), an industry supported non-profit.

“You have people (losing) their access to healthcare, not just pain care, but just general care. You have the opioid epidemic. You have the well-intended policy responses to that. All of this has the potential, unintended consequence of sending people to the Internet.

“My biggest fear is that if you limit prescriptions to five days or seven days, or prevent access to medication altogether, and people search.”

Since 2015, counterfeit painkillers and other medications made with illicit fentanyl have killed Americans in at least 16 states, according to a recent report that found the highly dangerous pills have spread from coast to coast.

"A lot of these people are buying it on the street or the Internet," Dr. Karen Gunson, Oregon’s medical examiner, told The Oregonian. "They think they're buying oxycodone or Xanax pills but they don't know what they're getting.''

What pain medications can you buy online? Oxycodone, hydrocodone, Percocet, Vicodin, tramadol and other painkillers can easily be found online, along with other controlled substances that are becoming harder for patients to obtain legally.

“There are thousands of websites that have figured it out and people are using them,” says Baney. “Most of these sites are based offshore. They may be using some U.S. servers, U.S. bank accounts or U.S. domain registrars, but nearly all are offshore. And that creates law enforcement hurdles.”

Last month the Food and Drug Administration announced a crackdown on over 500 online pharmacies that were accused of selling illegal and potentially dangerous medications. Warning letters were sent on September 19, giving the website operators 10 days to stop selling unapproved or misbranded prescription drugs.

Twenty days later, most of them are still online selling the same medications.

In a chat today with “Peter” at one of the websites that received a warning letter, I was told that I could purchase 80mg tablets of oxycodone without a prescription. Another website offered to ship us medications “placed inside baby doll as gift to ensure customer privacy and safe delivery.”

Baney says many of the illegal online pharmacies act as marketing agents for foreign drug suppliers.

“You don’t even need to have your own drug supply,” she said. “All you have to do is join an affiliate network and basically become a third-party marketer for an existing drug network.

“They give you the website template. They have the bank account setup. All you need to do is put up the site and process orders, and you get a cut and they get a cut, and they ship the drugs. It’s a pretty slick deal.”

Baney says it’s relatively easy to tell the difference between a legitimate online pharmacy and an illegal one. The URL’s for websites that end with “.Pharmacy” (not .com or .net) are certified by the National Association of Boards of Pharmacy and are in compliance with laws and practice standards.

You can also visit buysaferx.pharmacy to verify whether a website is legitimate.

The ease and convenience of ordering medications online – as well as the demand and profitability -- haven't gone unnoticed. According to CNBC, Amazon in the next few weeks will decide whether to enter the $560 billion prescription drug market with an online pharmacy of its own.

FDA Approves Extended-Release Lyrica

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new extended-release version of Lyrica for the treatment of neuropathic pain. Lyrica CR is designed to be taken once a day, instead of the two or three doses recommended for Lyrica’s original formulation.

“Lyrica CR was developed to offer patients an effective treatment option with the convenience of once-daily dosing,” said James Rusnak, MD, Chief Development Officer in Pfizer’s Global Product Development. “It provides an important option for patients and health care providers managing these often debilitating pain conditions.”

Pfizer said the effectiveness of Lyrica CR was established in a clinical trial of over 800 patients with neuropathic pain. Patients who took Lyrica CR had a 74% reduction in pain, compared to about 55% who took a placebo. The most common side effects of Lyrica CR were dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth and weight gain.

Lyrica (pregabalin) is one of Pfizer’s top selling drugs, but the company will likely face strong competition from cheaper generic versions of pregabalin when its U.S. patent expires next year.

Pfizer is undoubtedly hoping that current Lyrica users will switch over to the new extended release version, which will have full patent protection for many years to come. The company did not release any information on the cost of the new drug, which is expected to be available in January.

Unlike the original formulation of Lyrica, which is widely prescribed to treat fibromyalgia, Lyrica CR is only approved to treat nerve pain caused by diabetic peripheral neuropathy and postherpetic neuralgia caused by shingles. But that won’t stop doctors from prescribing it off-label to fibromyalgia and other chronic pain conditions.

Pregabalin Under Scrutiny

The extended release version of Lyrica comes at a time when pregabalin is drawing new scrutiny from researchers and doctors who believe the medication is over-prescribed and being abused. Pregabalin belongs to a class of nerve drug known as gabapentinoids, which are increasingly being prescribed as alternatives to opioid pain medication.

 “We believe… that gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic,” Christopher Goodman, MD, and Allan Brett, MD, recently wrote in a commentary published in The New England Journal of Medicine. “We suspect that clinicians who are desperate for alternatives to opioids have lowered their threshold for prescribing gabapentinoids to patients with various types of acute, subacute, and chronic noncancer pain.”

As PNN has reported, the World Health Organization and the FDA are also investigating reports that pregabalin is being abused. Addicts have learned pregabalin enhances the effects of heroin and other opioids.

“Reports indicate that patients are self-administering higher than recommended doses to achieve euphoria, especially patients who have a history of substance abuse, particularly opioids, and psychiatric illness. While effects of excessively high doses are generally non-lethal, gabapentinoids such as pregabalin are increasingly being identified in post-mortem toxicology analyses,” the FDA said in a recent notice published in the Federal Register.

The warning label for Lyrica CR will caution users that the drug can be abused.

“Patients should not drink alcohol while taking Lyrica CR. Patients may have more dizziness and sleepiness if taking Lyrica CR with alcohol, narcotic pain medicines, or medicines for anxiety. Patients who have had a drug or alcohol problem may be more likely to misuse Lyrica CR,” the label warns.

Pregabalin is classified as Schedule V controlled substance in the U.S., which means it has a low potential for abuse.