Doctors Call for Urgent Review of Opioid Tapering Policy

By Pat Anson, PNN Editor

An open letter by healthcare professionals to the U.S. Department of Health and Human Services is warning that forced opioid tapering has led to “an alarming increase in reports of patient suffering and suicides” and calls for an urgent review of tapering policies at every level of healthcare.

“This is a large-scale humanitarian issue,” the letter warns. “New and grave risks now exist because of forced opioid tapering.”

The joint letter, recently published online in the journal Pain Medicine, is signed by over a hundred physicians, academics and patient advocates – including some longtime critics of opioid prescribing.  

Among the signatories are Keith Humphreys, PhD, a Stanford University psychologist who has warned of a global opioid epidemic “driven by the overuse of legal painkillers,” David Juurlink, MD, a board member of Physicians for Responsible Opioid Prescribing (PROP) who has called the War on Pain “one of the most spectacular failures of modern medicine,” and Red Lawhern, PhD, a strident patient advocate who has blamed PROP’s founder for “the deaths of hundreds of chronic pain patients.”

One thing these strange bedfellows have in common is that they all agree forced tapering has gone too far and has become “a genuine threat to a large number of patients.”

“Countless ‘legacy patients’ with chronic pain who were progressively escalated to high opioid doses, often over many years, now face additional and very serious risks resulting from rapid tapering or related policies that mandate extreme dose reductions that are aggressive and unrealistic,” the letter states.

“Rapid forced tapering can destabilize these patients, precipitating severe opioid withdrawal accompanied by worsening pain and profound loss of function. To escape the resultant suffering, some patients may seek relief from illicit (and inherently more dangerous) sources of opioids, whereas others may become acutely suicidal.”

We’ve shared the stories of several of these patients, including Bryan Spece, a Montana man who killed himself in 2017 after his oxycodone dose was abruptly cut by as much as 70 percent.

To avoid severe withdrawal symptoms, the CDC recommends a "go slow" approach to tapering, starting with 10% per week; while the Department of Veterans Affairs recommends a taper of 5% to 20% every four weeks. These tapering guidelines are not being followed by many doctors, who often feel pressured by insurance companies, regulators and law enforcement to lower doses, regardless of the harm it might cause a patient.

“Currently, nonconsensual tapering policies are being enacted throughout the country without careful systems that attend to patient safety,” the Pain Medicine letter warns. “We therefore call for an urgent review of mandated opioid tapering policies for outpatients at every level of health care — including prescribing, pharmacy, and insurance policies—and across borders, to minimize the iatrogenic harm that ensues from aggressive opioid tapering policies and practices.”

The letter also calls for pain management specialists and patient advisory boards to be included in future decisions about prescription opioids. They have often been excluded by federal agencies and commissions in previous decisions.

The letter in Pain Medicine is the second joint letter recently signed by healthcare professionals calling for a significant change in the nation’s opioid policies. A letter signed in October called on the CDC to make a “bold clarification” of its 2016 opioid guideline and to evaluate the impact it is having on pain patients — something the agency has not done.

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.”

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.

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.

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

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.

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.

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.

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.”

“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.”

“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

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

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)

“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

“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.  

“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 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.

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

“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.

"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.

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."