Ignoring the Evidence in Canada

By Marvin Ross, Guest Columnist

For those of us north of the border who are defending against the assault on pain patients, it was very gratifying to see the American Medical Association come out against the “inappropriate use” of the CDC guideline on opioid prescribing.

Sadly, we cannot hope that the Canadian Medical Association (CMA) will do the same. The CMA embraced the Canadian guideline – which is modeled after the CDC’s -- and argued for better evidence on the safety and efficacy of prescription opioids.

Sadly, how Canadian officials evaluate evidence is suspect. Jason Busse, the chiropractor who chaired the Canadian guideline, contends that no randomized controlled trials (RCTs) have been done on opioids that follow patients for longer than six months. He tweeted that to me after I challenged him on the results of an analysis that concluded that “to dismiss trials as ‘inadequate’ if their observation period is a year or less is inconsistent with current regulatory standards.”

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I pointed out that multiple published studies and over 1.6 million patients maintained on doses over 200mg MME (morphine milligram equivalent) disprove his claim opioids don’t work long term.

Busse’s reply was, “Yes - the CDC guideline excluded all trials of less than 1 year duration. The Canadian guideline did not. Nonetheless, there are no RCTs of opioids that follow pts. For more than 6 months.”

He did not reply to my comment that Prozac was approved for use based on trails of only 12 weeks duration and that many patients take anti-depressants for years. It has always seemed strange to me that McMaster University, which led the development of the Canadian guideline, is the home to evidence based medicine. One of the co-ordinators of the guideline is Dr. Gordon Guyatt, who is credited as the one who brought evidence based studies to the world.

The most flagrant avoidance of evidence is by Health Canada, which continues to insist that high rates of opioid prescribing is one of the main causes of the opioid crisis. Ann Marie Gaudon, a columnist for PNN, has been attempting to find out what evidence Health Canada has to make that claim.

Not only have they not responded to her query, but her call to their office at the end of October resulted in one of the most bizarre phone calls ever heard. Syndicated radio show host Roy Green devoted two episodes to what can only be described as a “Who's on First” discussion with a government official.

Health Canada now mandates that every prescription issued for an opioid carry a sticker and a leaflet warning of addiction risks. A total wasted effort. The evidence that prescriptions opioids are a significant part of the problem is lacking.

The Ontario Drug Policy Research Network just released a database that disproves claims that prescriptions are a major cause of opioid overdoses. It shows that opioid prescriptions in Ontario have been declining for years, as they have in the United States.  About two-thirds of the opioid prescriptions written in 2015 were for patients over the age of 45 and less than 2 percent were for fentanyl.

Contrast those stats to information put out by this same agency on opioid deaths. Accidental overdoses among those 15 to 44 accounted for nearly 60% of opioid deaths. And the most common opioid involved in overdoses was fentanyl – most of it illicit and obtained on the black market.

It would be very refreshing if governments and regulators in Canada actually looked at their own data before cracking down on prescriptions for legitimate pain sufferers. That may be too much to expect, but one can always hope.

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Marvin Ross is a medical writer and publisher in Dundas, Ontario. He has been writing on chronic pain for the past year and is a regular contributor to the Huffington Post.

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.

Lessons from 'American Overdose' on the Opioid Crisis

By Roger Chriss, PNN Columnist

The book “American Overdose: The Opioid Tragedy in Three Acts” by Chris McGreal takes a hard look at the opioid crisis. The book focuses on the legal and political side of the crisis, along with a history of Purdue Pharma and OxyContin, and a detailed description of pill mills and rogue pharmacies in Appalachia.

“It is a tragedy forged by the capture of medical policy by corporations and the failure of institutions in their duty to protect Americans,” is how McGreal describes the genesis and evolution of the crisis.

The book highlights the massive collusion and corruption in communities in West Virginia and Kentucky, leading to the Williamson Wellness Center and other pill mills that were protected by law enforcement, ignored by state and federal regulators, and encouraged or exploited by drug manufacturers and distributors.

McGreal also traces the history of Purdue and the Sackler family, and how their efforts to improve pain management led to the creation of the blockbuster drug OxyContin. He explains how Purdue’s marketing claims “proved to be demonstrably false, including an assertion that addiction is rare when opioids are taken under a doctor’s care.”

However, McGreal does not depict Purdue as a lone bad actor. Instead, federal and state dysfunction and disinterest contributed to the crisis. “The FDA wasn’t the only one to drop the ball. A clutch of federal agencies with long names have responsibility for combating drug addiction and overdose,” he wrote. And they all failed.

The failure was both systemic and systematic. As the crisis unfolded, local law enforcement had to contend with “indifference and what they regarded as the political cowardice of the system.” Perhaps more important than the cowardice and corruption was greed, not just corporate greed but also local greed for the money brought in by pill mills: “The businesses did good. You had pharmacies that were doing really good.”

The problem soon extended far beyond Appalachia. Among the earliest and biggest pill mills was American Pain, set up in 2007 near Fort Lauderdale, Florida by twin brothers Chris and Jeff George – neither of whom had medical training.

Opioid addiction also rose across the nation because of cultural factors, writes McGreal. In Utah, “the dominance of the conservative Church of Latter-day Saints appeared to be a cause of addiction, not a deterrent” because of the church’s “toxic perfectionism.”

Government agencies and officials were encouraged to ignore it all. Florida Sen. Marco Rubio’s office wasn’t interested in pursuing pill mills and the “political leadership within Florida wasn’t much better.”

Rudy Giuliani, Eric Holder, and James Comey all helped Purdue, according to McGreal, by delaying investigations of the company as addiction and overdose rates rose rapidly in the 2000’s.

The CDC’s involvement is described as delayed and dysfunctional. "Until 1998 the United States used a classification system lumping heroin, morphine, and prescription opiate deaths together," McGreal points out. Even when CDC researcher Len Paulozzi documented rising trends in overdose deaths, no one paid serious attention until Thomas Frieden, MD, became director. Even then, serious flaws remain in how the CDC reports on overdose deaths.  

Anti-opioid activists Andrew Kolodny, MD, founder of Physicians for Responsible Opioid Prescribing (PROP), and PROP President Jane Ballantyne, MD, sounded warnings about opioids, but offered little in the way of solutions outside of cutting off prescriptions. Many of their warnings proved to be unfounded, in particular with the opioid analgesic Zohydro. The drug was approved by the FDA amid dire warnings of a major spike in addiction and overdoses, but “there was no great surge of overdoses because of Zohydro.”

“FDA officials don’t like Kolodny. They characterize him as unreasonable and difficult. One described him as a ‘complex character’,” McGreal writes.

Similarly, the 2016 CDC opioid prescribing guideline is described as too late to be useful. McGreal looks closely at the debate about the CDC guideline and recommendations from the 2017 opioid commission set up by President Trump. But despite these much-touted steps, “little changed on the ground for states desperate for treatment facilities and help with the social costs of the tragedy.”

The book concludes on a pessimistic note, captured in a comment from Nathaniel Katz, MD, about opioid addiction and overdose: "I don’t really see any prospect for intelligent policy in this area in the United States.”

McGreal summarizes his ideas with an indictment of American culture.

"In large parts of the United States, opioids were popular because they were a fix. A fix for emotional pain. A fix for failing bodies. A fix for struggling to make it in a society that promises so much, and judges by what is achieved, but turns it back on so many of those who fail to live up to that promise," he writes.

If “American Overdose” offers lessons, it is that the opioid crisis is a result not only corporate greed but also American culture; in particular politicians, regulators and a broader medical industry with agendas contrary to the public good. The book is an origin tale of the opioid crisis that offers little hope for the future.

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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. 

Opioid Hysteria and the Demonizing of Dsuvia

By John Burke, Guest Columnist

Recently the FDA approved a new sublingual formulation of sufentanil -- called Dsuvia -- for the management of moderate to severe acute pain in hospital-like settings. This would include surgical centers and emergency departments.

When the FDA announced this approval, several so-called experts claimed that Dsuvia – which is a potent opioid – would worsen the already out of control opioid problem. They said it would quickly find its way to the streets of America and kill even more of our citizens addicted to opioids. They can’t imagine why the FDA would approve such a killer drug!

Dsuvia was originally developed by AcelRx Pharmaceuticals, in cooperation with the U.S. Department of Defense, to treat battlefield wounds. The single dose formulation is designed to enter your body and provide pain relief faster than the traditional intramuscular injections that are now standard in treating traumatic injuries.

I can only imagine the horrendous wounds that are present on the battlefield. Offering faster pain relief seems like a great option, to say the least!  

ACELRX PHARMACEUTICALS

ACELRX PHARMACEUTICALS

Dsuvia will also be used in our nation’s emergency departments and other healthcare facilities to offer faster pain relief to patients who suffer traumatic injuries. The drug will not be available in retail pharmacies or for most prescribers to order up for a patient. Doctor shoppers, script scammers and others that prey on retail pharmacies will have no access to this pain reliever. Those involved in armed robberies or burglaries of retail pharmacies will also have zero access.

Who will have access to Dsuvia are healthcare employees -- nurses, doctors and other medical professionals who already have access to a whole host of opioid drugs. There is no question that Dsuvia could potentially be a target of a small group of professionals who suffer from addiction problems. However, the illegal diversion and sale of this specific medication seems less likely in healthcare facilities.

Dsuvia will be more easily identified when it is diverted due to its limited availability and usage. Addicted healthcare employees will likely opt for more commonly used opioids like morphine and hydromorphone rather than a rarely used medication that will be easily missed when diverted.

The other part of this equation, that was either not considered by critics or didn’t suit their narrative, is that diversion inside healthcare facilities virtually always involves self-addiction. This means that even if an opioid is stolen by an employee inside one of these facilities, it will rarely make it to the street and cause more deaths.  

AcelRx has already developed a Risk Evaluation and Mitigation Strategy (REMS) involving RADARS, a nationwide drug abuse surveillance system, to monitor any diversion of Dsuvia and provide quarterly reports to law enforcement. In the interest of full disclosure, I am on the Scientific Advisory Board of RADARS.

Dsuvia has great potential to provide quick relief to trauma patients in a focused setting. Its diversion potential, especially to the public, is almost nil. Demonizing a drug without any real knowledge of its legal distribution and potential for diversion is irresponsible to say the least.

The drug problem in America primarily involves street drugs such as heroin, illicit fentanyl, and more recently crystal methamphetamine and cocaine. Even as the prescribing of opioids has dropped over 30% in recent years, drug deaths continued to rise. The reason is the increased supply of street drugs supplied by cartels that continue to profit from our nation’s addiction.

Put the blame where it belongs, and don’t ostracize a legitimate new pain drug that any of us might need in an emergency.

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John Burke spent nearly 50 years in drug and law enforcement in southwestern Ohio. John is a former president of the National Association of Drug Diversion Investigators and is the president and founder of the International Health Facility Diversion Association, a non-profit devoted to the issues surrounding the diversion of controlled substances from healthcare facilities.

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.

Is Palliative Care an Option for Chronic Pain Patients?

By Rochelle Odell, PNN Columnist

Most of us have heard about 2016 CDC Opioid Guideline, which is supposed to be a voluntary guideline for primary care physicians treating non-cancer pain.

What has happened? In the span of two years the guideline has seemingly become law. Countless pain patients have made the trek to their doctor dreading the thought that their lifeline -- opioid pain medication – will be reduced or even discontinued.

Pain patients are often forced into surgical procedures such as epidural steroid injections or implants of spinal cord stimulators and other medical devices. The implants and injections all too often create more problems than they help. I know because I have had three different stimulators implanted and removed, as well as two pain pumps. The devices ultimately damaged my spine, compounding my Complex Regional Pain Syndrome (CRPS). 

Many of us are told if we do not undergo these invasive procedures our opioid medication will be stopped.  We are then forced to find a new physician for pain medication, a search that is often futile.

What happened to “patient driven healthcare” and freedom of choice in the so-called opioid epidemic? Is there anything patients can do?

Yes, we can request our physician determine if we meet the requirements for palliative care, which is specifically exempt from the CDC guideline.

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Palliative care is often confused with end-of-life or hospice care, but imminent death is not a requirement for palliative care. The CDC defines palliative care in a way that many chronic and intractable pain patients would qualify for:

“Palliative care is defined… as care that provides relief from pain and other symptoms, supports quality of life, and is focused on patients with serious advanced illness. Palliative care can begin early in the course of treatment for any serious illness that requires excellent management of pain or other distressing symptoms for cancer.”

The World Health Organization (WHO) takes a similar broad view of palliative care:

“Palliative care is an approach that improves the quality of life of patients and their families facing the problem associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual.”

According to WHO, palliative care should include “a support system to help patients live as actively as possible” and “enhances quality of life.”

If these palliative care conditions are met, does it mean we are safe from having our opioid medication cutoff? Not necessarily. but it’s an option we should ask our doctors about.

Therein lies a possible roadblock. Too many physicians, nurses and healthcare organizations still associate palliative care with cancer and other diseases where the only outcome is death. 

The Alliance for the Treatment of Intractable Pain (ATIP) is working to enhance and clarify the definition of palliative care to include those suffering from chronic, intractable pain that may not be terminal. Cancer pain isn't necessarily different or anymore painful than the pain suffered by CRPS patients. Our pain is often worse, as there is no end in sight. The pain lasts a whole lifetime and we do not get better.

A case in point regarding the confusion over palliative care. A friend of mine was told that she qualified for palliative care. Great, one might think.  Her pain medication is still being prescribed, but her physician is afraid of losing his license and will not continue to prescribe her current dose or increase it. She will have to find a new pain management physician, assuming she can find one. 

I have been requesting for over two months that I be evaluated for palliative care, but my own pain management group "does not do palliative care." My case manager told me palliative care is only meant to keep the patient out the hospital.

My primary care physician's office has been working on my request and recently a doctor from Home Health Care came to my home to evaluate me. Not for palliative care, but for Transitional Care Management (TCM), a term I had not heard of. 

TCM is very much like palliative care in that the patient receives care from any needed medical specialty. A support system is put in place and whatever specialist I need to see will be covered.  The physician who did the evaluation based it not only on my medical records but by interviewing me and going over all my physical and mental health requirements. He noted I had been on high dose opioids and anti-anxiety medication and functioned with both them. He also recommended that my opioid medications be increased.

Will they be increased? I don't know yet, but a Home Health Care nurse will now be coming to my home on a regular basis. Unless I am unconscious and basically on death's door, I will not go to an emergency room for treatment. I refuse to wait hours on end only to be treated like a drug seeker. The nurse will come to my home and give me opioid medication if I need it. That is a definite plus and something I will not abuse.

These two avenues of palliative care and transitional care management appear to be a chronic pain patient's only options. Many doctors may not initiate either one. It is often the patient or patient's family who must push for care. Being alone and with no help means I will have to do more research and seek care even if it means contacting my physician's office multiple times. It’s the only option I have.

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Rochelle Odell resides 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.

Drug Price Hiked 600% to Capitalize on Opioid Crisis

By Pat Anson, PNN Editor

A U.S. Senate report and 60 Minutes are highlighting how a Virginia drug maker exploited the opioid crisis by substantially raising the price of an overdose recovery drug and passing much of the cost to taxpayers.

The report by the Senate Subcommittee on Investigations found that Kaleo, a privately-owned pharmaceutical company, raised the price of its naloxone auto-injector Evzio by over 600% to “capitalize on the opportunity” of a “well established public health crisis.” As a result, the report estimates the U.S. government paid over $142 million in excess costs to Kaleo.

Naloxone is usually administered by injection or in a nasal spray to quickly reverse the effects of an opioid overdose. Syringes containing naloxone typically cost about $15 each, but Kaleo’s two-dose Evzio injector now sells for over $4,000. The original price was $575.

“Naloxone is a critically important overdose reversal drug that our first responders have used to save tens of thousands of lives,” subcommittee chairman Sen. Rob Portman, R-Ohio, said in a statement. “The fact that one company dramatically raised the price of its naloxone drug and cost taxpayers tens of millions of dollars in increased drug costs, all during a national opioid crisis no less, is simply outrageous.”

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“We raised the price to improve access to this product,” Kaleo CEO Spencer Williamson told 60 Minutes. “The big misperception is that by raising the price of Evzio we reduce the access to this product. The exact opposite is true.”

Prescriptions for Evzio increased substantially after the price increase, but largely because Kaleo urged its sales department to have doctors sign prior authorization forms for patients stating that “Evzio was medically necessary.” Under that language, Medicare had no choice but to pay for Evzio at nearly full price.

When it was approved by the Food and Drug Administration in 2014, federal health officials called Evzio a “more user-friendly version” of naloxone because the injector gives verbal instructions on how to use it and can be administered by anyone.  Evzio was given fast-track status by the FDA and approved in less than 15 weeks without an advisory committee hearing.

“The approval of this product is great,” Andrew Kolodny, MD, founder and Executive director of Physicians for Responsible Opioid Prescribing (PROP) told Medscape at the time.

Kaleo began raising the price for Evzio the following year. By 2018, the average cost of an injector for Medicare patients was nearly $4,100. The cost for patients who pay in cash or are covered under private insurance is similar, but they make up only a fraction of Evzio sales as most insurers refuse to pay for the injectors.  As a result, Medicare and Medicaid payments account for an oversized portion of Kaleo’s revenue.

The company claims Evzio has saved over 5,500 lives since it was introduced and that “we have never turned an annual profit on the sale of Evzio.”

Naloxone has rapidly gone mainstream in recent years as public health officials and politicians have reacted to the opioid crisis by spending billions of dollars on addiction treatment and overdose prevention. Naloxone rescue kits are now routinely carried by police, firefighters and paramedics or given to heroin and opioid addicts to keep at home.

Naloxone is not usually prescribed to patients taking opioids for pain relief, although a 2016 study suggested it should be. The CDC opioid guideline also encourages physicians to prescribe naloxone to pain patients – even those on relatively modest doses.

“Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, or higher opioid dosages (≥50 MME), are present,” the guideline states.

Over the years, Kaleo has donated hundreds of thousands of free Evzio injectors to first responders, schools, hospitals and addiction treatment clinics. STAT News has reported that the naloxone in many of the injectors was just months away from expiring.

According to ProPublica, in 2016 Kaleo paid nearly $950,000 to pain management doctors and addiction treatment specialists for consulting, promotional speaking, travel, lodging, and food and beverage expenses.  

AMA: ‘Inappropriate Use’ of CDC Guideline Should Stop

By Pat Anson, PNN Editor

Two and a half years after the release of the CDC’s opioid prescribing guideline, the American Medical Association has finally taken a stand against the “misapplication” and “inappropriate use” of the guideline by insurers, pharmacists, federal regulators and state governments.

Although the guideline is voluntary and only intended for primary care physicians treating non-cancer pain, many pain patients have been forcibly tapered to lower doses, cutoff entirely or even abandoned by their doctors – all under the guise of preventing addiction and overdoses. The CDC has stood by and done nothing to correct the false portrayal of its guideline by insurance companies and pharmacies such as CVS.

The genie may be out of the bottle, but the AMA is now trying put it back in.

At its interim meeting in Maryland this week, the AMA House of Delegates adopted a series of resolutions that call for restraint in implementing the CDC guideline – particularly as it applies to the agency’s maximum recommend dose of 90mg MME (morphine equivalent units).

RESOLVED that our AMA affirms that some patients with acute or chronic pain can benefit from taking opioids at greater dosages than recommended by the CDC Guidelines for Prescribing Opioids for chronic pain and that such care may be medically necessary and appropriate.

RESOLVED that our AMA advocate against the misapplication of the CDC Guidelines for Prescribing Opioids by pharmacists, health insurers, pharmacy benefit managers, legislatures, and governmental and private regulatory bodies in ways that prevent or limit access to opioid analgesia.

RESOLVED that our AMA advocate that no entity should use MME thresholds as anything more than guidance, and physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the MME thresholds found in the CDC Guidelines for Prescribing Opioids.

“I was gratified to see these resolutions from AMA. This problem has been developing for some time, but really seems to have picked up steam over the past year, especially with respect to limits placed by pharmacy chains and insurers,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“It would have been good to see this kind of statement when various entities first began misinterpreting and misapplying the CDC guideline, but I also understand the need to ensure that a problem develops before proposing a solution.”

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“Great to see the AMA is finally stepping up to help bring common sense to the ill-conceived and frankly very harmful CDC guideline,” said Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine. “Unfortunately too many people have already been a victim of CDC’s misguided attempt to address the opioid problem.” 

Guideline Not Mandatory

Missing from the resolutions is any recognition by the AMA that many of its own members – the organization represents over 200,000 physicians – have been lying to their patients or remain wilfully ignorant about the voluntary nature of the CDC guideline.  

“Earlier this year my doctor explained that he was required to reduce my pain medications. I was shocked. He explained that new opioid prescribing guidelines were requiring patients to be reduced across the board, regardless of their condition,” pain patient Liz Ott wrote in a recent guest column. 

“My current doctor is currently weaning me off the last of my opioids, stripping me of the last tiny bit of medication that have any effect on my pain,” wrote Michael Emelio in another guest column. “After talking to half a dozen pain management doctors this year, I believe that they have been so programmed by the anti-opioid propaganda that many believe they're doing the right thing and fail to realize the true extent of the suffering they have caused.”

“A pharmacist decided to cut my opioid medication in half without permission from me or my doctor. It took 3 months to fix this and find a pharmacy to fill my medication,” wrote Deann Goudy in her guest column.

Even the AMA’s president had a patient – a man with advanced prostate cancer – who couldn’t get an opioid prescription filled by a suspicious pharmacist.

“The pharmacist suspected my patient was a drug seeker and did not alert me that his prescription was denied. My patient, a very proud man, felt shamed and didn’t know what to do. So, he went home to be as tough as he felt he could be. That worked for about three days and then he tried to kill himself,” Barbara McAneny, MD, said in a speech this week at the AMA meeting.

“My patient suffered, in part, because of the crackdown on opioids… When I visited my patient in the hospital as he was recovering from his suicide attempt, I apologized for not knowing his medication was denied. I felt I had failed him.”

The AMA has failed pain patients in the past. In 2016, just months after the release of the CDC guideline,  the AMA House of Delegates recommended that pain be removed as a “fifth vital sign” in professional medical standards – a move that pain management experts warned against because it could lead to delays in getting a diagnosis and treatment.  

AMA delegates that year also passed a resolution urging The Joint Commission to stop requiring hospitals to ask patients about the quality of their pain care. Medicare has a funding formula that requires hospitals to prove they provide good care through patient satisfaction surveys, but critics contended that questions about pain promoted opioid prescribing. They offered no credible evidence to support their claims, but the pain questions were soon dropped from patient satisfaction surveys.

Will Christie or Bondi Be Next Attorney General?

By Pat Anson, PNN Editor

PNN readers cheered last week when Attorney General Jeff Sessions was fired by President Donald Trump. Sessions angered many in the pain community when he called for further cuts in opioid production and said pain patients should “tough it out” by taking aspirin.  

“The good news is Jeff Sessions (was) forced to resign,” wrote Carole Attisano. “Finally getting a small bit of Karma you so well deserved,”

“Now let’s hope that we get somebody with some type of human conscience for those who suffer with pain,” wrote another PNN reader.

As the saying goes… be careful what you wish for.

According to CBS News, two of the early front runners to be nominated as the next Attorney General are former New Jersey Gov. Chris Christie and Florida Attorney General Pam Bondi. Like Sessions, both have been longtime critics of opioid prescribing and served last year on President Trump’s opioid commission.

CHRIS CHRISTIE

CHRIS CHRISTIE

Christie certainly has experience in law enforcement. He was a federal prosecutor and U.S. Attorney in New Jersey from 2002 to 2008.

As governor, Christie signed legislation that made New Jersey one of the first states to limit the supply of opioids for short-term, acute pain. He also bitterly opposed efforts to expand the use of medical marijuana, calling cannabis activists “crazy liberals” willing to “poison our kids” for marijuana tax revenue.   

The final report from the president’s opioid commission, which Christie chaired, took a law-and-order approach to the opioid crisis, calling for “involuntary changes” in 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 five public hearings, the commission heard testimony from addiction treatment activists and several people who lost loved ones to opioid overdoses. But the panel never asked for or received testimony from pain sufferers, patient advocates or pain management physicians.

Pam Bondi did not have a prominent role on the opioid commission and only joined the panel in its final weeks. Her second and last term as Florida’s Attorney General ends in January. “She has not yet made a decision as to what she will do next,” a spokesman told CNN.

Bondi has a good relationship with President Trump and was once rumored to be the next head of the White House Office of National Drug Control Policy — also known as the nation’s “drug czar.”

Bondi played a prominent in shutting down Florida’s pill mills, but critics say she has been slow to acknowledge that the opioid crisis has shifted away from prescription painkillers to heroin and illicit fentanyl.

“The problem is Bondi isn't doing enough about the heroin epidemic,” the Miami Sun Sentinel said in a 2017 editorial. “Considering that Bondi was once touted as a potential Trump drug czar — and infamously failed to investigate Trump University after receiving a major donation from Trump — it's no surprise that she was named to the commission. But she's still living off her reputation from the pill mill crack down.”

PAM BONDI

PAM BONDI

Christie also has a good relationship with the President Trump, but has urged that there be no interference with special counsel Robert Mueller’s investigation – a potential stumbling block with the president. Like Sessions, Christie could also face calls to recuse himself from the investigation because he chaired Trump’s transition team.

According to CNN, other potential contenders for Attorney General are Solicitor General Noel Francisco, Rep. John Ratcliffe, (R) Texas, former Judge John Michael Luttig, Judge Edith Jones, former Judge Janice Rogers Brown, retiring Rep. Trey Gowdy, (R) South Carolina, and Sen. Lindsey Graham, (R) South Carolina.

Matthew Whitaker, the current acting Attorney General, can serve in that temporary position for 210 days under federal law.

AMA: Patients Being Harmed by Rx Opioid Crackdown

By Pat Anson, PNN Editor

Patients are being harmed by the crackdown on opioid pain medication and increasingly “burdensome” requirements for prior authorization, according to the president of the American Medical Association.

“The pendulum swung too far when pain was designated a vital sign, and now we are in danger of it swinging back so far that patients are being harmed. We need to use our expertise in patient care to change the dialogue to appropriate pain control,” said Barbara McAneny, MD, at a weekend meeting of the AMA. 

McAneny, who is a practicing oncologist in Gallup, New Mexico, shared the story of a patient with advanced prostate cancer who was in severe pain.  

“Metastatic prostate cancer in your bones hurts, and one day he called me to say that his pain regimen wasn’t holding him. So, I increased the dosage of his opioids from two per day to three and of course he ran out early,” McAneny said. “So, I called his primary care physician who agreed to write a prescription for his very large amount of time-release morphine.” 

When the patient tried to get his prescription filled, the pharmacist called the insurer for prior authorization and was denied. The pharmacist also checked the prescription drug monitoring program (PDMP) and found that the patient had multiple prescriptions written by McAneny and other doctors.  

BARBARA MCANENY, MD (AMA PHOTO)

BARBARA MCANENY, MD (AMA PHOTO)

“The pharmacist suspected my patient was a drug seeker and did not alert me that his prescription was denied. My patient, a very proud man, felt shamed and didn’t know what to do. So, he went home to be as tough as he felt he could be. That worked for about three days and then he tried to kill himself,” said McAneny.  

“Fortunately, his family found him in time, and the emergency medicine physician was able to save his life. He spent a week in the hospital and finally we got his pain back under control, on the exact regimen I had prescribed him as an outpatient.”  

Ironically, the insurer paid for the patient’s ambulance and hospital bills without any prior authorization. And the CDC’s “voluntary” opioid guidelines — which have been widely adopted by insurers — don’t even apply to cancer patients.

“Like you, I share the nation’s concern that more than 100 people a day die of an overdose. But my patient nearly died of an under-dose. This story illustrates the problems we all confront every day in our current dysfunctional health care system,” McAneny said. “The health plan does not have the chart, doesn’t know the patient, and basically countermanded my orders without even telling me using the prior authorization process. How have we let health plans determine the course of care? They call this quality? 

“My patient suffered, in part, because of the crackdown on opioids… When I visited my patient in the hospital as he was recovering from his suicide attempt, I apologized for not knowing his medication was denied. I felt I had failed him.”

McAneny cited a 2017 AMA survey, which found over 90% of doctors believed prior authorization led to delays in treatment and had a negative impact on patient outcomes. Nearly a third of doctors had to wait at least 3 business days for a prior authorization decision to be made.  

New prior authorization rules to be adopted by Medicare on January 1 could lead to delays in treatment for millions of elderly and disabled pain patients on high doses of opioids. Prescriptions over 200mg MME (morphine equivalent daily doses) will trigger a “hard edit” safety alert requiring pharmacists to consult with the prescribing physician before filling a prescription. Insurers will also be given greater authority to identify beneficiaries at high risk of addiction and to require they use “only selected prescribers or pharmacies.”

FDA Approves Controversial New Opioid

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved a controversial new opioid drug intended to relieve moderate to severe pain in wounded soldiers and trauma patients. 

Dsuvia is a tablet form of the potent opioid sufentanil. It was developed by AcelRx Pharmaceuticals and the Department of Defense – in part to treat battlefield wounds – but became embroiled in the national hysteria over opioid drugs and addiction.

Dsuvia was developed to fulfill an unmet need in military and civilian hospitals, where patients in acute pain are usually treated with opioids intravenously or with a pill.

Each Dsuvia tablet comes in a single dose plastic applicator. The tablet is taken sublingually under the tongue, where it quickly dissolves and is absorbed into the body.

“There is currently no way available to rapidly treat your pain without sticking you with a needle,” said Dr. Pamela Palmer, an anesthesiologist who co-founded AcelRx and is Chief Medical Officer.

ACELRX image

ACELRX image

“If you broke your femur and are obese or elderly or on a blood thinner, that can be very painful with a lot of bruising. If you take a pill, you have to swallow it with water and wait for it to kick in, which could take up to an hour. Right now, that’s all that’s available. For the first time, we’ve developed a small tablet that goes under the tongue and dissolves in about six minutes.”

“The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds,” said FDA commissioner Scott Gottlieb, MD.

Dsuvia’s efficacy and safety were tested in two placebo-controlled studies with over 200 patients. The company said the drug was well-tolerated and effective across a range of patient ages and body sizes.

But because Dsuvia is so potent – it’s 10 times stronger than fentanyl – it drew the ire of critics who believe diversion is inevitable.

“We know from looking at other potent opioids that have been put on the market in the last four years that once these drugs get past the FDA, there’s very little, if any, control over them, no matter what the sponsor says prior to the time they come on the market,” Raeford Brown, MD, told ABC News.

Brown is chairman of the FDA advisory committee that voted 10-3 to recommend approval of Dsuvia.  Brown was not present for the vote, but called on the FDA to ignore the panel’s recommendation and stop the approval of “this dangerously unnecessary opioid medication."

“It doesn’t seem reasonable to place another potent opioid on the market at this time, especially when we’re currently still writing 200 million prescriptions for opioids a year,” said Brown.

Politicians also weighed in.

“An opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused and a thousand times more likely to kill,” said Sen. Ed Markey (D) Massachusetts. “It makes no sense to approve an opioid painkiller that has no benefits over similar medications and against the advice of experts.”

The FDA is requiring that Dsuvia not be dispensed for home use, should only be administered by a healthcare provider, and should not be used for more than 72 hours. Palmer says extra precautions would also be taken by distributors, wholesalers and hospitals to prevent theft and diversion.

“I’m not saying that drugs delivered to hospitals never get stolen or abused, but that’s a tiny sliver” of the opioid problem, she said.

Overdoses Soar in 2 States Despite Fewer Rx Opioids

By Pat Anson, PNN Editor

New studies from two of the states hardest hit by the opioid crisis – Massachusetts and Pennsylvania -- are throwing a damper on recent speculation that drug overdoses may have peaked.  

Researchers at Boston Medical Center released a startling study that found nearly 5 percent of people over the age of 11 in Massachusetts have an opioid use disorder.

The Drug Enforcement Administration also admitted in a Joint Intelligence Report that reducing the supply of prescription opioids in Pennsylvania failed to reduce the state’s soaring overdose rate and may have even increased demand for counterfeit painkillers. Pennsylvania had 5,456 fatal overdoses in 2017, a 65% increase from 2015.  

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“Implementation of legislation influencing prescription opioid prescribing has resulted in a decrease in availability; however, a corresponding decrease in demand is less certain,” the DEA report found.

“Practitioners may be offering non-opioid alternatives to pain management to their patients, but this is most likely due to increased scrutiny of prescribing habits, as well as legislated changes, not due to requests from patients seeking non-opioid products.”

Prescription opioids were involved in only 20% of Pennsylvania’s overdoses. Most of the deaths involve a combination of illicit drugs such fentanyl, heroin, cocaine and counterfeit medication.

“The increasing presence of counterfeit opioid CPDs (controlled prescription drugs) in Pennsylvania is an indicator of strong demand for opioid CPDs in the illicit market. Traffickers use substances such as heroin, fentanyl, and tramadol to create tablets that look like the opioid CPDs most commonly purchased on the street (e.g., oxycodone 30 milligram tablets). The tablets are often exact replicas with the shape, coloring, and markings consistent with authentic prescription medications,” the report found.

The DEA said heroin and fentanyl could be found in 97% of Pennsylvania’s counties and called the city of Philadelphia a “wholesale market” for illicit drugs from China and Mexico.

Opioid Use Disorder in Massachusetts

Illicit fentanyl is also blamed for a soaring number of fatal overdoses in Massachusetts, where researchers used a new method to estimate how many people have opioid use disorder (OUD).  

Instead of relying on insurance claims for addiction treatment, researchers used a database that links information from 16 state agencies on other forms of healthcare use. Researchers were then able to identify patients who have OUD and estimate those who have the disorder but aren't seeking treatment. Individuals with substance use disorders are often less likely to seek medical care or be insured. Many are also reluctant to admit they have a drug problem.  

"There are many people with opioid use disorder who do not encounter the health care system, which we know is a barrier to understanding the true impact of the opioid epidemic," said Joshua Barocas, MD, an infectious disease physician at Boston Medical Center, who was lead author of the study published in the American Journal of Public Health.

Barocas and his colleagues found the prevalence of opioid use disorder in Massachusetts rose from 2.72% in 2011 to 4.6% in 2015. People between the ages of 11 and 25 experienced the greatest increase in OUD – a demographic much younger than a typical chronic pain sufferer, who is usually middle aged.

In 2012, Massachusetts was one of the first states where insurers and healthcare providers took steps to reduce the supply of prescription opioids – measures that have yet to have any meaningful impact on the state’s overdose rate.  

MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

Massachusetts was also one of the first states to use toxicology screens from coroners and medical examiners to get a more accurate assessment of the drugs involved in overdoses.

According to the most recent report from the first quarter of 2018, nearly 90% of Massachusetts overdoses involve fentanyl, 43% percent involve cocaine, 42% involve benzodiazepines and 34% involve heroin. Prescription opioids were involved in only about 20% of the Massachusetts overdoses, the same rate as Pennsylvania.

Preliminary estimates released by the CDC last week show a modest 2.3% nationwide decline in opioid overdoses from September 2017 to March 2018. Over 48,000 people died from opioid overdoses during that period, with most of those deaths involving illicit fentanyl, heroin and other street drugs.

What Will Support Act Mean for Pain Patients?

By Pat Anson, PNN Editor

President Trump this week signed into law the Support for Patients and Communities Act, a comprehensive and mostly bipartisan legislation that combined over 70 bills passed by Congress aimed at fighting the opioid epidemic.

"Together we are going to end the scourge of drug addiction,” Trump said at a bill-signing ceremony at the White House. “Or at least make an extremely big dent in this terrible, terrible problem.”

While most of the Support Act is aimed at slowing the flow of illicit drugs and subsidizing the $35 billion dollar addiction treatment industry, there are some key elements that will affect millions of Americans who take opioids for chronic or acute pain.

Most are designed to limit access to opioid medication and further reduce the supply, which has nearly been cut in half since 2016.

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The new law authorizes the Food and Drug Administration to require that some opioids be dispensed in so-called “blister packs” to limit the number of pills that can be prescribed and dispensed at one time. That type of packaging would primarily be for patients with short-term, acute pain who need only a few days’ supply. But it could also lead to a standardization of doses and make refills more difficult for patients who are slow to recover from surgery or trauma.

“The doses dispensed in the packs could be designed to align with evidence-based recommendations on what the proper dosing should be for common indications. These packs could then become the default option for more post procedure uses and could discourage physicians from prescribing long durations of use in situations where the evidence shows that short durations are clinically appropriate,” said FDA commissioner Scott Gottlieb, MD, in a statement.

“Ultimately, this approach could reduce the overall number of drugs in circulation and potentially lower the rate of new opioid addiction. It could also address the problem of excess supply, leading to fewer pills left in medicine cabinets that could be inappropriately accessed by family members, including children.”

The Support Act also gives the FDA the authority to require that opioids be dispensed with a mail-back pouch or other safe disposal options. The goal again is to get unused medications out of medicine cabinets where they could be stolen or diverted.

The new law also supports an effort recently launched by Gottlieb to develop opioid guidelines for acute pain. The guidelines won’t replace or change the CDC’s controversial guideline for chronic pain, but they will be developed with more transparency. Gottlieb has instructed the National Academies of Sciences, Engineering, and Medicine to hold a series of public meetings and to seek input from "a broad range of stakeholders" from different medical specialties. The CDC guideline was initially developed with no public hearings and with little input from pain management experts.

The Support Act also gives more authority to the FDA to require longer post-market studies on the safety and efficacy of drugs. Current evidence on the long-term use of all pain medication – not just opioids – is extremely limited. That has led to exaggerated claims from opioid critics that there is “no evidence” that opioids are safe or effective long term. Those same critics often call for greater use of non-opioid medications, such as gabapentin and pregabalin, when there is little long term evidence to support their use either.

The Support Act also calls on other federal agencies to enact measures to prevent the diversion and abuse of opioids and other controlled substances:

  • All prescriptions for controlled substances covered under Medicare Part D or Medicare Advantage must be transmitted electronically starting Jan. 1, 2021.

  • The Department of Health and Human Services (HHS) will develop guidelines for pharmacists to decline to fill prescriptions they think may be fraudulent or questionable.

  • Medicaid programs will be required to have “safety edits” in place for opioid refills and to monitor the concurrent use of opioids with potentially risky drugs such as benzodiazepines.

  • A web portal will be created to allow communication between HHS, CMS and Medicare Advantage insurers to share information about providers under investigation for inappropriate prescribing of opioids.

  • HHS will develop guidelines to allow the inclusion of opioid addiction history in patient electronic health records.

One pain management expert cautioned that some provisions of the Support Act put too much of an emphasis on opioid medication.

“Excessive focus on reducing opioid supply in the legislation can lead to more harm than good. We cannot continue to ignore the needs of people in pain at the expense of preventing illicit drug use,” Lynn Webster, MD, past president of the American Academy of Pain Medicine told Pain Medicine News.

“We have seen draconian steps by the VA (Department of Veterans Affairs) and other payors to force opioid reduction in patients who have been stable and functional for years. This is cruel and simply not right. My hope is that the act is implemented with compassion for people with addiction and pain, but that they allow science and not prejudices and politics to inform policy.”

 

Sessions: Opioid Prescriptions at 18-Year Low

By Pat Anson, PNN Editor

Opioid prescriptions in the United States fell by 12 percent in the first eight months of 2018 and will decline even further in coming years, according to Attorney General Jeff Sessions.

“We now have the lowest opioid prescription rates in 18 years.  And we’re going to bring them a lot lower,” Sessions said in prepared remarks at the National Opioid Summit in Washington, DC.

Opioid prescriptions have indeed been falling for many years, but the trend appears to be accelerating as many doctors lower doses, write fewer prescriptions, or simply discharge and refuse to treat chronic pain patients.

Sessions pledged to continue fighting “the deadliest drug crisis in American history” by reducing opioid prescriptions by another third over the next three years. That’s in addition to a 44% reduction in opioid production that the DEA began in 2016.

Sessions also promised to step up efforts against healthcare professionals alleged to have overprescribed opioids. He said the Trump Administration has charged 226 doctors and 221 medical personnel with “opioid-related crimes.”

“These numbers will continue to rise,” Sessions predicted, because of new federal prosecutors and a data analytics team focused on tracking opioid prescriptions.

ATTORNEY GENERAL JEFF SESSIONS

ATTORNEY GENERAL JEFF SESSIONS

“This team follows the numbers—like which doctors are writing opioid prescriptions at a rate that far exceeds their peers; how many of a doctor's patients have died within 60 days of an opioid prescription; and pharmacies that are dispensing disproportionately large amounts of opioids,” Sessions said.

“They will help us find the doctors, pharmacists, and other medical professionals who are flooding our streets with drugs—and put them behind bars.”

At no point in his speech did Sessions discuss the impact the opioid crackdown was having on millions of chronic pain patients, who are increasingly bedridden or disabled due to lack of access to effective pain care. Earlier this year, Sessions suggested they should “tough it out” by taking aspirin.

While opioid prescriptions have fallen dramatically in recent years, they’ve yet to have much of an impact on the nation’s overdose rate.  Preliminary estimates released by the CDC this week show a modest 2.3% decline in opioid overdose deaths from September 2017 to March 2018. Over 48,000 people died from opioid overdoses during that period, with most of those deaths involving illicit fentanyl, heroin and other opioid street drugs, not prescription opioids.

Sessions said the Justice Department was taking “unprecedented action” against fentanyl traffickers at home and abroad, including the recent indictments of three Chinese nationals and dozens of Mexican drug traffickers.

“China could do more to stop these drugs from coming here.  Frankly, they’re not doing enough.  They must do more,” he said.

Prenatal Use of Acetaminophen Linked to Early Puberty

By Pat Anson, PNN Editor

The daughters of women who took acetaminophen during pregnancy tend to start puberty early, according to a new study by Danish researchers.  

The study is the latest indication that prenatal use of acetaminophen – more commonly known as paracetamol outside the U.S. -- can have long term effects on children.

Researchers at Aarhus University studied health data on about 100,000 Danish women who provided detailed information about their use of acetaminophen during pregnancy.

Nearly 16,000 children born to those mothers between 2000 and 2003 were followed from the age of eleven and throughout puberty, with surveys every six months about different aspects of their development.

The study, published in the American Journal of Epidemiology, found that girls on average entered puberty between one-and-a-half and three months earlier if their mothers took the over-the-counter pain reliever for more than 12 weeks during pregnancy.

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"We found a 'dose-response' correlation. That is to say, the more weeks with paracetamol during pregnancy, the earlier puberty in girls, but not in boys," says lead author Andreas Ernst, a PhD student from the Department of Public Health at Aarhus University.

"While entering puberty one-and-a-half to three months earlier may seem unimportant, when taken together with the frequent use of paracetamol during pregnancy, our findings ought to make people take notice. Our results are certainly not the decisive factor that should change current practice, but the perception of paracetamol as 'the safe and harmless choice' during pregnancy ought to be challenged."

Early puberty development increases the risk of serious diseases in adulthood, such as obesity, diabetes, cardiovascular diseases and testicular and breast cancer.

The use of acetaminophen (paracetamol) has been increasing worldwide and studies have found that over half of pregnant women in the U.S. and European Union use the pain reliever at least once during their pregnancy. It is the active ingredient in Tylenol, Excedrin, and hundreds of pain medications.

Previous research has shown that prenatal use of acetaminophen is associated with slow language development, autism and attention deficit problems in young children.

Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. The FDA label for products containing acetaminophen warns about the risk of liver damage and other side effects but does not specifically warn pregnant women about using the pain reliever. The agency said in 2015 that the evidence was “too limited” to justify such a warning.  

In its 2016 opioid prescribing guidelines, the CDC recommends acetaminophen as an alternative to opioid pain medication. The guideline only briefly mentions that acetaminophen is involved in hundreds of overdose deaths annually and can cause liver problems.

The CDC guideline does warn pregnant women -- at length -- that opioids can cause birth defects, poor fetal growth, still births and neonatal opioid withdrawal syndrome.

Patients at Ohio Hospital Have Surgery Without Opioids

By Pat Anson, PNN Editor

Would you want to go through a major surgery without the use of opioid pain medication?

Patients at an Ohio hospital are getting acetaminophen, gabapentin and nonsteroidal anti-inflammatory drugs (NSAIDs) to manage their pain before and after colorectal operations – and their surgeons say the treatment results in better patient outcomes.

“Over 75 percent of our elective colorectal patients underwent surgery without requiring narcotic analgesics postoperatively, including after discharge,” says Sophia Horattas, MD, of Cleveland Clinic Akron General Hospital.  “During this time period our patient satisfaction scores improved as well as patients' perceptions of pain control.”

All eight general surgeons at Akron General adopted the non-opioid treatment protocol in 2016, applying it to patients who had elective colon operations. Prior to surgery, the patients were all educated about pain management, non-opioid analgesics, and the risks associated with opioids.

Researchers evaluated 155 of the patients and presented their findings this week at the American College of Surgeons Clinical Congress in Boston.

Overall, 83 percent (128) of the patients did not need opioid medication after their operations. Among those who did, use of opioids before surgery was often an indicator that they would want them again. Nine of the 15 patients who had prior experience with opioids used them again after surgery.

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Among the remaining 140 patients who did not use opioids before surgery, 85 percent (119) did not need opioid medication for pain relief.

The researchers found that patients who used opioid painkillers typically spent more time in the hospital; an average of 2.7 days vs. 2.3 days for the non-narcotic group.

“Patient education played a large role in protocol compliance, and patient satisfaction improved as they were able to avoid prolonged fasting, achieve improved pain control without the side effects of narcotic analgesia, and be discharged home earlier,” said Horrattas.

For pre-emptive analgesia before surgery, patients received one dose of acetaminophen, gabapentin, and the NSAID celecoxib (Celebrex).  In the operating room, patients received a nerve block and underwent anesthesia with the non-opioid pain relievers ketamine and lidocaine.   

Surgeons at Akron General have since adopted the non-opioid protocol for other major abdominal operations, such as bariatric procedures, gynecological and genital/urinary tract procedures, and liver and gall bladder operations.

“One of the great things about our protocol is its reproducibility.  Once we developed our program, we found that it could be standardized across departments with consistently reproducible results,” said Horattas.

Akron General’s protocol is similar to guidelines adopted by the American Pain Society (APS) for postoperative pain care. The APS also encourages the use of non-opioid medications such as acetaminophen, NSAIDs, gabapentin (Neurotin) and pregabalin (Lyrica).  

Akron General gets below average ratings for patient satisifaction from Hospital Compare, a Medicare survey that asks patients about their experiences during a recent hospital stay. The hospital received only two of a possible five stars, which places it in the bottom third of hospitals nationwide. Only 68% of Akron General’s patients said they would definitely recommend the hospital.

According to Healthgrades, 3 percent of the patients died after a colorectal surgery at Akron General, which is slightly below the national average for that procedure.

Opioid Addiction Rare After Surgery

In recent years, many hospitals have shifted away from routinely giving patients opioids during and after major surgeries -- even though it is rare for patients to become chronic opioid users.

A large Canadian study found that only 0.4% of elderly patients that were prescribed opioids while recovering from a heart, lung, colon, prostate or hysterectomy operation were still using them a year after their surgeries.

Another large study published this year in the British Medical Journal found similar results. Only 0.2% of patients who were prescribed opioids for post-surgical pain were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Long-term opioid use after dental surgeries is also rare. A recent study published in JAMA found that only 1.3% of teens and young adults who were given opioids after wisdom teeth removal were still being prescribed opioids months after their initial prescription.

The vast majority of patients still prefer opioids and perceive them as the most effective form of pain relief after surgery. In a recent survey of over 500 adults who were scheduled to have surgery, researchers at Thomas Jefferson University Hospital in Philadelphia found that 77% expected opioids, 37% expected acetaminophen, and 18% expected a NSAID for pain relief.

"Patients often assume they will receive opioids for pain, believing they are superior, and therefore may pressure physicians to prescribe them after surgery," said lead author Nirmal Shah, DO, an anesthesia resident at Thomas Jefferson University Hospital.

"But research shows opioids often aren't necessarily more effective. Clearly, we need to provide more education to bridge that gap and help patients understand that there are many options for pain relief after surgery, including other pain medications such as acetaminophen and ibuprofen."

Should Roseanne Have Died From an Opioid Overdose?

By Pat Anson, PNN Editor

Roseanne Barr is the latest victim of America's opioid crisis. Or to be more precise, Roseanne Conner is.

The fictional matriarch of ABC’s cancelled “Roseanne” show was killed off in the opening episode of “The Conners” Tuesday night, with her family struggling to come to terms with her death. What was initially thought to be a fatal heart attack turns out to be an accidental overdose of prescription opioids.

TV audiences had last seen Roseanne Conner hiding her addiction to opioid painkillers while waiting for long-delayed and costly knee surgery. But that storyline ended when Roseanne Barr was fired by ABC for a racist tweet and the network had to come up with a way to explain her absence.

“We firmly decided against anything cowardly or far-fetched, anything that would make the fierce matriarch of the Conners seem pathetic or debased,” Executive Producer Bruce Helford explained in The Hollywood Reporter.

“I wanted a respectful sendoff for her, too: one that was relevant and could inspire discussion for the greater good about the American working class, whose authentic problems are often ignored by broadcast television.”

ABC

ABC

"I AIN'T DEAD BITCHES," Barr tweeted after watching the show. She followed up with a longer joint statement with her spiritual advisor, Rabbi Shmuley Boteach.

“We regret that ABC chose to cancel 'Roseanne' by killing off the Roseanne Conner character,” the statement said. "That it was done through an opioid overdose lent an unnecessary grim and morbid dimension to an otherwise happy family show.”

It was also a bit of a cliché. The popular perception that most opioid overdoses are due to prescription painkillers is now largely a myth.  According to the Centers for Disease Control and Prevention, nearly 49,000 Americans died from opioid overdoses in 2017, but over half of them were due to illicit fentanyl and heroin, not prescription opioids.

A more accurate way to depict Roseanne’s death would have been through an overdose of heroin or counterfeit painkillers laced with fentanyl. That’s how thousands of Americans are dying. Roseanne Conner could have even been driven to suicide by untreated pain. Imagine what an eye-opening show that would have been.

Instead, the Conner family discovers that Roseanne was hiding painkillers all over the house and sharing them with a group of friends, all of them struggling with pain and addiction. The show makes it appear like opioid medication is easy to obtain, something real pain patients know is no longer true.

The only thing missing from the hackneyed script was someone saying, “If only Roseanne had tried yoga and taken Tylenol, she’d still be alive!”

Executive producer Bruce Rasmussen told Variety last week they thought carefully about how to end Roseanne's character. "You don't want to be flip about how you do this," said Rasmussen.

But that’s exactly how it came across to some PNN readers.

“The media can't seem to get the other side of the story out, nor can they print the truth about exactly how many deaths are the result of PRESCRIPTION opiates,” wrote Stephen Johnston.  “Now millions of folks will be watching as more gas is poured onto the fire. That same fire that's burning up what's left of people like myself and millions of others for whom opiate pain medications are the only relief from whatever traumatic accident or terrible malady has befallen them.”

“It was bad enough when they made pain meds a focus of the rebooted show when the first episode of the show's return aired. Now we have the added stigma, as intractable pain people, of them choosing to have Roseanne die from opioid misuse,” said Jack.

“Don't give the writers, actors, producer, the network hacks, etc., anything that isn't OTC when they have occasion to need pain relief — chronic or acute. Tylenol 3's would be much too generous, as many of us don't even get those.”

You can watch the first episode of “The Conners” by clicking here.

Cutting Rx Opioid Supply Is Not Stopping Diversion

By Roger Chriss, PNN Columnist

Drug diversion is an increasingly important factor in the opioid overdose crisis. A new report from Protenus found that 18.7 million pills, valued at around $164 million, were lost due to drug diversion in the United States during the first half of 2018. This represents a vast increase over 2017, when 20.9 million pills were diverted during the entire year.

As we’ve described previously, drug diversion in the supply chain is a vast, complex and old phenomenon. And it is rapidly worsening.

According to the textbook, “Prescription Drug Diversion and Pain,” drug thefts from hospitals “have increased significantly within the past decade as street prices have climbed sharply for diverted prescription opioids and benzodiazepines.”

In other words, the steep cuts in opioid production that began in 2017 aren’t working. And Attorney General Jeff Sessions was wrong when he said, "The more a drug is diverted, the more its production should be limited." A tightening supply has actually resulted in more diversion.

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Drug diversion can be broadly divided into three categories: clinical diversion, personal diversion and industrial diversion. The first, according to Protenus, is drug diversion by healthcare workers. The second is the sale or transfer by a patient who received a legitimate prescription to a third party. And the third is everything else, from diversion by employees at manufacturing facilities to theft in distribution centers or pharmacies.

Personal diversion has gotten substantial attention in recent years. Prescription drug monitoring databases, pain agreements, and urine drug testing are all intended to help prevent such diversion.

Clinical drug diversion is a long-standing problem in healthcare that has garnered more interest recently. The bipartisan opioid bill recently passed by Congress includes a provision that allows hospice workers to destroy opioid medication that has expired or is no longer needed by a patient. The National Institutes of Health has also awarded a grant to further expand efforts to detect opioid and other drug theft in hospital systems.

Industrial diversion is less well known, but appears to be a longstanding problem. In the book “Dopesick,” journalist Beth Macy writes that as early as 2001 the DEA was investigating lax security standards at Purdue Pharma manufacturing plants after the arrest of two Purdue employees accused of trying to steal thousands of pills.

Between 2009 and 2012, over 63,000 thefts of opioids and other controlled substances were reported to the DEA. Pharmacies (66%) and hospitals (19%) accounted for the vast majority of those drug thefts.

And in 2007, an audit of CMS Medicare Part D payments identified 228,000 prescription payments with invalid prescriber identifications for Schedule II drugs.

In other words, tens of thousands of drug thefts and hundreds of thousands of fraudulent prescriptions are occurring annually, leading to millions of prescription pills entering the illegal market. This may help explain how OxyContin entered the black market so quickly and completely.

As Beth Macy writes: “The town pharmacist on the other line was incredulous: “Man, we only got it a month or two ago. And you’re telling me it’s already on the street?””

The National Association of Drug Diversion Investigators and the DEA Diversion Control Division are attempting to address industrial diversion. But available evidence suggests there is much more work needed to secure the entire prescription drug supply chain.

As the opioid overdose crisis continues to evolve toward poly-drug substance abuse, drug diversion will play an increasingly significant role in the illegal supply of prescription pharmaceuticals unless the entire supply chain is secured. This will require far more than the easy tasks of checking a prescription database or legislating pill counts. The hard part of reducing drug diversion remains to be done.

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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.

Is Walmart Blacklisting Doctors?

By Pat Anson, PNN Editor

Carolyn Eastin has been a nurse practitioner in Arizona for nearly a decade. She is the only licensed prescriber at a busy pain clinic in Scottsdale, where many patients are on high doses of opioid medication.

Eastin says she was “mortified” by a letter last month from Walmart’s corporate headquarters that said the retail giant’s Walmart and Sam’s Club pharmacies would no longer fill her prescriptions for opioids.

“In reviewing your controlled substance prescribing patterns and other factors, we have determined that we will no longer be able to continue filling your controlled substance prescriptions,” the letter states. “We regret any inconvenience this may cause you or your patients.”

“It was very humiliating. I was upset about it,” says Eastin. “We’ve already had patients who can’t get prescriptions there.”

The unsigned Walmart letter has all the appearances of a form letter. It makes no mention of any complaints against Eastin, whether any of her patients have overdosed, or if her prescribing is medically inappropriate.

Eastin writes prescriptions for nearly 500 chronic pain patients at the Absolute Rehabilitation and Pain Medicine clinic. Most are on high doses of opioids, at levels well above those recommended by the CDC in its 2016 opioid guideline. Eastin believes she was red flagged by Walmart after a prescription database search and is now on a “blacklist” of prescribers.

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“I’m the only one who writes prescriptions here. So I would have higher numbers than the average nurse practitioner,” she told PNN. “I’m not doing anything wrong. I’m tapering my patients. I’m trying to do my part to bring people into compliance.”

Does Walmart blacklist doctors who prescribe high doses of opioids? Is Walmart practicing medicine without a license? We posed those questions to Walmart and received a one sentence reply.

“Walmart does not comment on our patients or their prescribers,” wrote Erin Hulliberger, Walmart Corporate Communications in an email.

Corresponding Responsibility

What Walmart is doing isn’t illegal. Under federal law, pharmacists have a “corresponding responsibility” when filling medications -- a legal right to refuse to fill prescriptions they consider unusual or improper. Most pharmacists will call the prescribing doctor to double-check before turning away a patient, but in some cases there’s a “hard edit” – pharmacy jargon for when a company database tells a pharmacist not fill a prescription.

“It may be appropriate for a pharmacy to not fill a prescription because of a dangerous dose or even an inappropriate drug,” says Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine.

“However, if they are refusing to fill a prescription because the doctor has met some arbitrary dosage threshold by the company without understanding the circumstances, it would be inappropriate and potentially harmful to the patient.”   

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A former Walmart pharmacist told PNN the company closely monitors prescriptions and doctors at every store.

“They had assembled prescription numbers for every doctor who had filled prescriptions at my store. They knew the exact number of medications ordered and sold down to the tablet. They knew what drugs the doctors wrote for and what percentage of the total each drug they wrote for," said the pharmacist, who asked to remain anonymous.

Walmart recently began using Narxcare, a private healthcare database developed by Appriss Health, which analyzes the prescriptions and medical claims of millions of Americans. Every patient evaluated by NarxCare is assigned a “risk score” based on the past two years of their prescription drug use, medical claims, electronic health records and even their criminal history.

Is Walmart using Narxcare data to blacklist doctors? A spokesman for Appriss denies it.

“No, we do not provide provider risk scores to Walmart, or anyone else,” said David Griffin, Vice President of market and communication for Appriss Health.

Prescription Data Mining

The data mining of opioid prescriptions has become increasingly common in healthcare and law enforcement. Doctors, pharmacies, insurers, and federal and state regulators are all using prescription drug databases to look for signs of opioid “overprescribing.”

In addition to Walmart, the Absolute clinic has drawn the attention of the Arizona Medical Board. Last year the clinic’s owner, Dr. Steve Fanto, signed an agreement with the medical board to stop practicing medicine after he was accused of overprescribing Subsys, a potent fentanyl spray.  

Although Fanto is no longer involved in the day-to-day management of the Absolute clinic, it remains under scrutiny. Last December, the clinic was raided by DEA agents, although no charges were ever filed as a result of that investigation. The clinic has also received over a hundred letters from insurer United Healthcare warning about the high dose prescriptions Carolyn Eastin is writing.

“It’s a bullying technique,” says Jessica Webb, the office manager at Absolute. “We’re afraid if we don’t taper down, the insurance companies will file a complaint on Carolyn. If Carolyn’s license is revoked, we’ll have to shut down. She’s the only reason we’re still open.”

Caught in the middle of this tug of war are Absolute’s patients – who could be faced with the difficult task of finding new doctors if the clinic closes. Their painful medical conditions -- and the human suffering that comes with them – appear to be non-factors in Walmart’s decision not to fill Eastin’s prescriptions.

“I can’t tell you the number of patients that made the comment to me, ‘I might as well die. I don’t have any other options but to take my own life because I can’t live without this medication,’” Eastin said. “It’s very difficult to look these people in the eye every single day and say, ‘I want to help you but I’m going to take more away from you.’”

‘I Hope It Doesn’t Harm Patients’

Pain management experts say its unethical to use data mining alone to judge whether a prescription should be filled.

“It appears that Walmart is trying to reduce their risk of being charged with criminal conduct and paying more fines. It is hard to know. But whatever their reason I hope it doesn't harm patients,” said Webster.  

“Without further explanation about the basis for their decision, and without information about any previous interventions attempted by Walmart, this seems remarkably punitive and capricious,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“I would hope that companies that review prescriber records would attempt a series of less drastic interventions with the prescriber before reaching this point. There may be issues of concern, but the appropriate step is to discuss those with the prescriber and try to reach an understanding about what is going on, and about what needs to happen to ensure that everyone is prescribing and dispensing safely. I’d be interested to hear from Walmart about whether they have such a graduated policy and if not, why not.”

Carolyn Eastin says there’s only so much she can do. Abruptly tapering patients or cutting them off from opioids could cause more harm than good.

“We’re trying to follow the CDC guidelines. We’re trying to comply with the insurance letters asking for tapers,” she says.  “I’m doing my part to taper my patients. But these things have to be done delicately. We just can’t go, ‘Okay, give me all your meds.’”  

“We’ve pushed them to get physical therapy and cognitive behavioral therapy, and patients are having good results with that,” says Jessica Webb. “But we have some patients, if I had to take their meds away, I couldn’t go to sleep at night. They’re that sick.”   

Doctors Urge CDC to Clarify Rx Opioid Guideline

(Editor’s Note: Five healthcare professionals recently began circulating an open letter to the CDC asking it to make a “bold clarification” of its controversial 2016 opioid guideline.

They believe many chronic pain patients have suffered under the guideline, because it has led to widespread tapering and discontinuation of opioids. They invited other healthcare professionals to co-sign the letter. To date, well over 200 have.

To see a list of signatories, click here. If you are a healthcare professional and also wish to sign the letter, click here.)  

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Authors: Health Professionals for Patients in Pain

Any professional who cares for patients, including physicians, pharmacists, nurses, psychologists and social workers, is invited to sign on to this letter, as are any professional organizations that wish to endorse formally. 

I. In 2016, the Centers for Disease Control and Prevention, CDC, issued a Guideline for Prescribing Opioids for Chronic Pain for primary care physicians. Its laudable goals were to improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy. The Guideline reflected the work of appointed experts who achieved consensus on the matter of opioid use in chronic pain. 

Among its recommendations are that opioids should rarely be a first option for chronic pain, that clinicians must carefully weigh the risks and benefits of maintaining opioids in patients already on them, and that established or transferring patients should be offered the opportunity to re-evaluate their continued use at high dosages (i.e., > 90 MME, morphine milligram equivalents).  

In light of evidence that prescribed dose may pose risks for adverse patient events, clinicians and patients may choose to consider dose reductions, when they can be accomplished without adverse effect, and with possible benefit, according to some trial data.  

Nonetheless, it is imperative that healthcare professionals and administrators realize that the Guideline does not endorse mandated involuntary dose reduction or discontinuation, as data to support the efficacy and safety of this practice are lacking.  

II. Within a year of Guideline publication, there was evidence of widespread misapplication of some of the Guideline recommendations. Notably, many doctors and regulators incorrectly believed that the CDC established a threshold of 90 MME as a de facto daily dose limit. Soon, clinicians prescribing higher doses, pharmacists dispensing them, and patients taking them came under suspicion.  

Actions that followed included payer-imposed payment barriers, pharmacy chain demands for the medical chart, or explicit taper plans as a precondition for filling prescriptions, high-stakes metrics imposed by quality agencies, and legal or professional risks for physicians, often based on invocation of the CDC’s authority. Taken in combination, these actions have led many health care providers to perceive a significant category of vulnerable patients as institutional and professional liabilities to be contained or eliminated, rather than as people needing care.  

III. Adverse experiences for these patients are documented predominantly in anecdotal form, but they are concerning. Patients with chronic pain, who are stable and, arguably, benefiting from long-term opioids, face draconian and often rapid involuntary dose reductions. Often, alternative pain care options are not offered, not covered by insurers, or not accessible. Others are pushed to undergo addiction treatment or invasive procedures (such as spinal injections), regardless of whether clinically appropriate.  

Consequently, patients have endured not only unnecessary suffering, but some have turned to suicide or illicit substance use. Others have experienced preventable hospitalizations or medical deterioration in part because insurers, regulators and other parties have deployed the 90 MME threshold as a both a professional standard and a threshold for professional suspicion. Under such pressure, care decisions are not always based on the best interests of the patient. 

lV. Action is Required: The 2016 Guideline specifically states, “the CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted”. The CDC has a moral imperative to uphold its avowed goals and to protect patients.  

Therefore, we call upon the CDC to take action: 

1. We urge the CDC to follow through with its commitment to evaluate impact by consulting directly with a wide range of patients and caregivers, and by engaging epidemiologic experts to investigate reported suicides, increases in illicit opioid use and, to the extent possible, expressions of suicidal ideation following involuntary opioid taper or discontinuation. 

2. We urge the CDC to issue a bold clarification about the 2016 Guideline – what it says and what it does not say, particularly on the matters of opioid taper and discontinuation.  

Signatories here represent their own views, and do not purport to reflect formal positions of their employing agencies, governmental or otherwise.

For questions regarding the letter, please contact Stefan G. Kertesz, MD, Professor of Medicine at University of Alabama at Birmingham School of Medicine (skertesz@uabmc.edu).

The information in this letter 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.

Medicaid Expansion Did Not Fuel Opioid Crisis

By Pat Anson, PNN Editor

A new study is debunking claims that increased access to healthcare and pain management helped to fuel the opioid crisis. If anything, the opposite appears to be the case.

The study, published in the Journal of General Internal Medicine, found that early Medicaid expansions in Arizona, Maine and New York may have led to lower overdose rates in those states.

"These findings suggest that Medicaid expansions were unlikely to have contributed to the subsequent rise in drug overdose deaths, and may even have been protective," said lead author Atheendar Venkataramani, MD, PhD, an assistant professor of Medical Ethics and Health Policy at the Perelman School of Medicine at the University of Pennsylvania.

Venkataramani and co-author Paula Chatterjee, MD, looked at state-level data on drug overdoses from 1999 to 2008, comparing overdose mortality rates in the three Medicaid-expansion states to those in other states.

By 2008, Arizona, Maine and New York had about 7 fewer overdose deaths per 100,000 people compared to the other 47 states.

The differences were even greater when the three states were only compared to adjacent states: They had 17 fewer deaths per 100,000 people.

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Overall, the study suggests that drug overdose deaths were nearly 20 percent lower in the early expansion states.

"The results should provide reassurance to policymakers who are concerned that state Medicaid expansions, including the recent expansions implemented as part of the Affordable Care Act, promote rises in drug overdose mortality," said Venkataramani.

The Affordable Care Act (ACA) – widely known as Obamacare – greatly expanded Medicaid coverage for millions of poor Americans, starting in 2014. But some critics have claimed the ACA made the opioid crisis worse by giving patients easier access to opioids.

“The Medicaid expansion may be fueling the opioid epidemic in communities across the country,” Wisconsin Sen. Ron Johnson (R) wrote in a 2017 letter to the Health and Human Services inspector general. “Because opioids are so available and inexpensive through Medicaid, it appears that the program has created a perverse incentive for people to use opioids, sell them for large profits and stay hooked.”

The Penn Medicine study wasn't designed to determine why Medicaid expansion appeared to lower overdose death rates in New York, Arizona and Maine. But it does suggest that better access to healthcare was a factor.

“Improving people’s access to health care could have a number of effects. It may be that people had better access to substance use disorder treatment or better access to mental health or pain management. Or it may be that providing health insurance reduced the risk of financial ruin, which helped downward socioeconomic spirals that could lead to substance use disorder,” Venkataramani wrote in an email to PNN.

“If Medicaid expansions did increase access to opioids, then the effect of doing so was far outweighed by other forces that actually reduced mortality rates from drug use order. The mechanisms again are not known because of data limitations in this study, but access to regular health care, access to substance use disorder treatment, and improved socioeconomic circumstances all may have contributed to the slower growth in drug overdose mortality in Medicaid expansion states.”

The Affordable Care Act expanded Medicaid coverage to about 12 million Americans in the 31 states and the District of Columbia that opted to receive it. A recent study found that opioid prescriptions decreased slightly in those states, while prescriptions for addiction treatment drugs like Suboxone rose significantly.

Tennessee’s ‘Absolutely Crazy’ Opioid Law

By Pat Anson, PNN Editor, and Blake Farmer, Nashville Public Radio

Since the CDC released its opioid guideline in 2016, over 30 states have passed legislation that limit opioid prescriptions in some way. Most limit the supply to a few days for initial opioid prescriptions and some set limits on the doses that doctors can prescribe.

Which state has the toughest opioid regulations?

“Tennessee is just absolutely crazy,” says Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

Twillman is referring to a strict and complicated state law that took effect in July that restricts how long Tennessee doctors can prescribe opioids to patients.

“Depending on what you document and depending on your judgement of what’s going on with the patient, you’re either limited to a 3-day supply, a 10-day supply, a 21-day supply or a 30-day supply of an opioid,” Twillman told PNN.

“You wonder how in the world they’re ever going to police this. If it’s a particularly severe case you could do a 21-day supply, but if it’s a rare case then you can do a 30-day supply. What is the difference?”

Tennessee also limits the dose that doctors prescribe, under a complicated formula that lowers the allowable dose the longer a prescription lasts. In other words, you may get more pills but the dose will be smaller.

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Any “significant deviation” from Tennessee’s opioid law could result in disciplinary action for a doctor not showing “sound medical judgment.” First offenders could be banned from prescribing opioids for five years.

“They’ve left us saying make your own best judgement and document the reason for it and cross your fingers and hope you’re going to be okay,” says Twillman.

Some doctors have decided not to take that risk. Many primary care providers in Tennessee have stopped prescribing opioids and are referring patients to the state’s dwindling supply of pain clinics, where waiting lists are long and there’s no guarantee a new patient will even be able to get treatment.

Insurers Drop OxyContin

But it’s not just legislation that limits how pain patients are being treated in Tennessee. Insurance companies are refusing to pay for some opioids.

The largest insurer in Tennessee recently announced it will no longer cover prescriptions for OxyContin, what was once a blockbuster pain reliever. It’s the latest insurance company to turn against OxyContin, whose maker, Purdue Pharma, faces dozens of lawsuits related to its high-pressure sales tactics around the country and contribution to the opioid crisis. Last fall, Cigna and Florida Blue both dropped coverage of the drug.

Top officials at BlueCross BlueShield of Tennessee (BCBST) say newer abuse-deterrent opioids work better than OxyContin, and starting in January, the insurer covering 3.5 million Tennesseans will only pay for opioids made by other pharmaceutical companies.

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“We felt it was time to move to those products and remove Oxycontin from the formulary, which does still continue to have a higher street value,” said Natalie Tate, the insurer’s vice president of pharmacy.

OxyContin was reformulated in 2010 to make the drug harder to misuse — but it’s still possible to crush or liquefy in order to snort or inject it.

The latest long-acting opioids that BlueCross BlueShield of Tennessee is going to start covering — Xtampza and Morphabond — are still more difficult to misuse, according to the company and some pharmaceutical experts.

Practicing pain physicians in Tennessee — who regularly battle with insurance companies —  approve of the change, though they said OxyContin was already falling out of favor. And they argue trading one opioid for slightly safer ones doesn’t address a larger gripe that physicians have with insurers over paying for other, non-addictive types of treatment.

“We will have denials and prior authorizations on a muscle relaxer, and we will have no issue getting an opioid through the insurance company,” said Dr. Stephanie Vanterpool, an anesthesiologist at the University of Tennessee and the president-elect of the Tennessee Pain Society.

“The physicians or the doctor’s offices jump through hoops to get the better medication for the patients,” said Vanterpool. “And when I say better medication, I mean the medication that’s treating the cause of the pain, not just the medication that’s covering up the pain.”

Not to say OxyContin won’t be sorely missed by some patients.

“There are plenty of people who benefit from that drug,” said Terri Lewis, a patient advocate and rehabilitation specialist from Cookeville, Tenn.

Lewis is suspicious of BCBST’s motives since the insurer may be blamed for its role in the opioid crisis. Embattled Purdue Pharma could also be a convenient scapegoat.

“Maybe this is a good decision,” Lewis said. “But it smells like a political decision.”

This would be just the latest decision inserting politics into a nuanced medical problem that affects millions of pain patients.

John Venable of Kingsport, Tenn., was shown the door by his pain clinic in July after more than a decade on oxycodone — a generic, short-acting version of OxyContin.

“I just felt like I was in a hopeless state, like, ‘there is no help for John,'” he recalled.

At their worst, he said his headaches get so debilitating “that death would be a relief.” Despite his dread, he’s noticed something surprising over the last few months without opioids — his crippling headaches haven’t gotten that much worse, if at all.

“It very well might be a blessing in disguise,” Venable said.

The retired builder and one-time pastor said he prays that those losing OxyContin also will get to use the moment as an opportunity, though he knows many can’t cut ties with opioids. And he worries some will turn to more dangerous drugs off the street or even contemplate ending their own lives.

Experts point out that the number of opioid prescriptions has already been falling around the country. And in Tennessee, BCBS has experienced a 26 percent drop in opioid prescription claims over three years.

But restricting legal access to opioids hasn’t turned back the rise in overdose deaths, which hit a record in Tennessee and nationwide last year.

This story is part of a partnership that includes Nashville Public Radio, NPR and Kaiser Health News.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.