Pain Clinic Sign ‘Unauthorized and Untrue’

By Pat Anson, PNN Editor

A Florida-based chain of surgery centers and pain clinics says a sign that briefly appeared at one of its clinics implying that the company would no longer prescribe opioid medication is unauthorized and untrue.

The sign appeared in a window at Physician Partners of America’s Jacksonville clinic on May 14.  Someone took a picture of the sign and posted it online, where it was widely shared on Twitter and Facebook among pain patients, advocates and doctors.

“ATTENTION ALL PATIENTS,” the sign said in bold red letters. “Per our chief (medical) officer, Dr. Rivera, we will be starting to focus on interventional medicine only and we will not be managing medication. This will be fully effective within the next 30 days or less.”

For someone taking opioid medication for chronic pain, the threat of being cutoff is very real. The potential number of patients that would be impacted would also be significant. Physician Partners of America (PPOA) treats around 20,000 patients in Florida and Texas.

The problem with the sign is that it isn’t true, according to the company.

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“This sign was brought to our attention through social media. It was in no way authorized or approved by management, and its message is untrue. It resulted from an employee’s misinterpretation of our goal to reduce opioid dependence,” Maria Hickman, PPOA’s social media and content specialist, said in a statement on the company’s website.

“We recognize the opioid crisis backlash. As an organization, we sympathize with the plight of people who rely on, but who do not intentionally abuse, prescription opioid medications to manage their chronic pain. We aim to show them what we consider a better, safer way to reduce or eliminate pain.”

That “safer way” is interventional pain management, a more aggressive form of treatment that includes epidural steroid injections, nerve blocks, “minimally invasive” spinal procedures, Botox injections, spinal cord stimulators and stem cell therapy. Interventional methods are more expensive than pain medication, are not always covered by insurance, and many patients believe they are neither safer or effective.

PPOA said it would continue prescribing opioids to patients when it is appropriate, adding that they would be tapered to lower doses. “Patients are and will continue to be titrated down according to CDC guidelines; however, there is no cut-off date,” Hickman said.

That part of the company’s statement reflects a common misconception about the CDC’s controversial guideline, which is voluntary and does not mandate tapers. The 2016 guideline only recommends tapering “if benefits do not outweigh harms of continued opioid therapy” and explicitly says tapering should be voluntary, with the patient’s consent.

“Clinicians should emphatically review benefits and risks of continued high-dosage opioid therapy and should offer to work with patients to taper opioids to safer dosages. For patients who agree to taper opioids to lower dosages, clinicians should collaborate with the patient on a tapering plan,” the guideline says.

That part of the guideline has been so widely ignored that CDC Director Robert Redfield, MD, released a letter last month warning doctors not to taper patients without their consent.

“The Guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm,” Redfield said. “The Guideline includes recommendations for clinicians to work with patients to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy.”

The marketing of Physician Partners of America clearly states a preference for interventional therapy over opioid medication, so patients who go to a PPOA clinic shouldn’t be surprised if tapering or discontinuation is recommended.

“At its foundation, PPOA uses interventional pain management modalities to treat pain at its source instead of masking it with medication,” the company says. “We have championed remedies to the opioid crisis in public forums, in the media, in televised town halls and at medical conventions. PPOA physicians strictly follow the prescribing laws of the states in which they operate.”

A new law recently went into effect in Florida limiting the initial supply of opioids to 3 days, with a 7-day supply allowed if it is medically necessary. However, the law only applies to acute, short-term pain.  Most of PPOA’s patients suffer from chronic back pain and other long-term chronic conditions.

Steep Decline in New Opioid Prescriptions

By Pat Anson, PNN Editor

The number of doctors writing new prescriptions for opioid pain medication has fallen by nearly a third in recent years, according to a large but limited study that documents a dramatic shift in opioid prescribing patterns in the U.S.

Researchers at Harvard Medical School studied health data for over 86 million patients insured by Blue Cross Blue Shield from 2012 to 2017, and found that first-time prescriptions for patients new to opioids – known as “opioid naïve” patients -- declined by 54 percent.

At the start of the study, 1.63% of Blue Cross Blue Shield patients were being treated with new opioid prescriptions. Five years later, only 0.75% were.

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The study also found a shrinking pool of doctors willing to start opioid treatment. The number of doctors who prescribed opioids for opioid naive patients decreased by nearly 30 percent, from 114,043 to 80,462 providers.

The research findings, published in The New England Journal of Medicine, do not provide any context on the patients’ health conditions or the severity of their pain and injuries. As such, it is a data-mining study that provides no real information on the harms or benefits of opioids.

"The challenge we have in front of us is nothing short of intricate: Curbing the opioid epidemic while ensuring that we appropriately treat pain," lead investigator Nicole Maestas, PhD, an associate professor of health care policy at Harvard Medical School, said in a statement. "It's a question of balancing the justified use of potent pain medications against the risk for opioid misuse and abuse."

First-time prescriptions for opioids are usually used to treat short-term acute pain caused by trauma, accidents or surgery. They rarely result in long-term opioid use or addiction, but have become a major target for healthcare policymakers and anti-opioid activists. Several states have adopted regulations that limit the initial supply of opioids to 7 days or less.

While the number of doctors starting opioid therapy has fallen dramatically, Harvard researchers say many are still engaged in “high-risk prescribing” – which they defined as new prescriptions for more than 3 days’ supply or a daily dose that exceeds 50 morphine milligram equivalent (MME).

More than 115,000 of these “high-risk prescriptions” were written monthly for Blue Cross Blue Shield patients. Over 7,700 of the prescriptions exceeded 90 MME per day, a dose that researchers say puts patients at a substantially higher risk of an overdose. The study did not identify whether any of those high-dose patients experienced an overdose.

Opioid prescriptions in the U.S. have fallen sharply since their peak in 2010, but have yet to slow the rising tide of overdoses. Nearly 49,000 Americans died from opioid overdoses in 2017, over half of them due to illicit fentanyl and heroin, not prescription opioids.

Fed Panel Releases Draft Report on Pain Management

By Roger Chriss, PNN Columnist

A federal advisory panel known as the Pain Management Best Practices Inter-Agency Task Force has released a draft report listing its recommendations for improving pain care in the United States. The content is both revealing and promising, because its recognizes the complex nature of chronic pain and the difficulty in treating it effectively.

The task force was formed as a result of the Comprehensive Addiction and Recovery Act (CARA) of 2016. Its mission is to identify gaps and inconsistencies in acute and chronic pain management and to propose possible solutions.

The 29 members who serve on the task force include representatives from the FDA, CDC, VA and Office of National Drug Control Policy; as well as academic and medical experts in pain management, addiction treatment, pharmacy, oncology, psychiatry and interventional medicine.

Interestingly, Harold Tu, MD, the lone dentist on the panel, is the father-in-law of Andrew Kolodny, MD, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP). Only one pain patient and advocate was appointed to the task force, Cindy Steinberg of the U.S. Pain Foundation.

PAIN MANAGEMENT INTER-AGENCY TASK FORCE

PAIN MANAGEMENT INTER-AGENCY TASK FORCE

The key findings of the task force are that pain management should be balanced, individualized, multidisciplinary and multi-modal. Pharmacological pain management requires careful screening and monitoring of patients to minimize risks, while non-pharmacological modalities, in particular physical therapy, also have a significant role to play. The needs of special populations such as children, women, older adults, and military personnel and veterans must also be recognized, according to the draft report.

The task force introduces a new term: “chronic relapsing pain conditions.” These conditions include a lengthy list of degenerative, inflammatory and neurologic conditions, such as multiple sclerosis, cancer, trigeminal neuralgia, lupus, Parkinson’s disease, postherpetic neuralgia, CRPS, porphyria, lupus, lumbar radicular pain, migraines and cluster headaches.

In other words, the draft report recognizes that pain is heterogeneous and the umbrella term of “chronic pain” is problematic. The report notes: “There are multiple potential causes of worsening pain that are often not recognized or considered. Non-tolerance-related factors include iatrogenic (medical related) causes such as surgery, flares of the underlying disease or injury, and increased ergonomic demands or emotional distress.”

The draft report gives considerable attention to the risks associated with high opioid doses and the use of benzodiazepines, but doesn’t entirely dismiss their use:

“Dose-dependent opioid overdose risk among patients increased gradually and did not show evidence of a distinct risk threshold. Much of the risk at higher doses appears to be associated with co-prescribed benzodiazepines.”

“Although the risk of overdose by benzodiazepine co-prescription with opioids is well established, this combination may still have clinical value in patients who have chronic pain and comorbid anxiety, which commonly accompanies pain, and in patients who have chronic pain and spasticity.”

The draft report also warns that medication shortages are worsening the quality of pain care: "Recurrent shortages in opioid and nonopioid medications have created barriers to the proper continuity of treatment in acute and chronic pain patients. This creates the unintended consequence of poor patient care.”

Importantly, the report devotes an entire section to the impact of the 2016 CDC opioid prescribing guideline. While recognizing the “useful general guidance” in it, the report notes that “an unintended consequence of the guideline is the forced tapering or patient abandonment that many patients with chronic pain on stable long-term doses of opioids have experienced."

The report concludes that the “CDC guideline was not intended to be model legislation for state legislators to enact,” but stops short of recommending that the guideline be revised. Instead, the task force recommends “educating stakeholders” about the intent of the guideline and its “core beneficial aspects.”

The depth of analysis in the draft report is clear from the 446 footnoted references, which includes the familiar names of Beth Darnall, PhD, Roger Chou, MD, and Lynn Webster, MD. Pain News Network is even cited as one reference.

The task force held two public hearings in May and September 2018. The task force will be accepting comments on its draft report by mail, email and online. After a 90-day public comment period, the report will be finalized and submitted to Congress.

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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 Pain a Self-Fulfilling Prophecy?

By Pat Anson, PNN Editor

Getting out of bed, taking a shower, doing the dishes and other simple chores can be painful experiences for someone with intractable chronic pain. But some of that pain may be self-fulfilling: Getting out of bed hurts because you expect it to.

That's the theory behind a new brain imaging study published in the journal Nature Human Behaviour, which found that false expectations about pain can persist even when reality demonstrates otherwise.

"We discovered that there is a positive feedback loop between expectation and pain," said senior author Tor Wager, PhD, a professor of psychology and neuroscience at the University of Colorado Boulder.

"The more pain you expect, the stronger your brain responds to the pain. The stronger your brain responds to the pain, the more you expect."

Wager and his colleagues recruited 34 people for a heat test to see if the expectation of pain can cause changes in neural mechanisms of the brain.

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Participants were taught to associate one symbol with low heat and another with painful heat. Then, the subjects were placed in a functional magnetic resonance imaging (fMRI) machine, which measures blood flow in the brain as a proxy for neural activity.

For 60 minutes, subjects were shown the low or high pain cues (the symbols “Low” and “High” or the letters L and W), and then asked to rate how much acute pain they experienced as heat was applied to their forearms or legs. Unbeknownst to the participants, heat intensity was not actually related to the preceding cue.

The study found that when subjects expected more heat, brain regions involved in threat and fear were more active as they waited for the heat to be applied. Regions involved in the generation of pain were also more active when they received the stimulus.

The result? Participants reported more pain with high-pain cues, regardless of how much heat they actually got.

"This suggests that expectations had a rather deep effect, influencing how the brain processes pain," said lead author Marieke Jepma, PhD, a researcher in Wager's lab who is now a researcher at Leiden University in the Netherlands.

Many subjects also demonstrated a high degree of confirmation bias -- a tendency to learn from things that reinforced their beliefs, while discounting those that didn’t. If they expected high pain and got it, they might expect even more pain the next time. But if they expected high pain and didn't get it, nothing changed.

"You would assume that if you expected high pain and got very little you would know better the next time. But interestingly, they failed to learn," said Wager.

Researchers say the study was the first to demonstrate the dynamics of a feedback loop between pain expectations and neural mechanisms that cause pain. Although the test only involved short-term acute pain, researchers say the findings may help explain why chronic pain can linger long after damaged tissues have healed.

"Our results suggest that negative expectations about pain or treatment outcomes may in some situations interfere with optimal recovery, both by enhancing perceived pain and by preventing people from noticing that they are getting better," said Jepma. "Just realizing that things may not be as bad as you think may help you to revise your expectation and, in doing so, alter your experience.”

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.

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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.

FDA to Develop Acute Pain Guidelines

By Pat Anson, Editor

The head of the U.S. Food and Drug Administration is following up on a promise to develop new federal prescribing guidelines for treating short-term, acute pain. But don't expect an overhaul of the CDC's controversial opioid guideline.

FDA commissioner Scott Gottlieb, MD, announced today that his agency has awarded a contract  to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help develop guidelines for prescribing opioids for acute pain that results from specific medical conditions or procedures, such as wisdom tooth removal or post-operative pain.  

The CDC guideline takes a one-size-fits-all approach to chronic pain -- pain that lasts longer than three months -- and doesn't distinguish between pain from fibromyalgia, arthritis, neuropathy or any other medical condition.  

"We’ve contracted with NASEM to conduct a consensus study and issue a report on its findings. This work will begin with an identification and prioritization of procedures and conditions associated with acute pain for which opioid analgesics are commonly prescribed and where evidence-based clinical practice guidelines would help inform prescribing practices," Gottlieb said in a statement.

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"We acknowledge the work of our colleagues at the U.S. Centers for Disease Control and Prevention (CDC) who have taken an initial step in developing federal guidelines on pain management and the use of opioids which are based on expert opinion. Our work seeks to build on that work by generating evidence-based guidelines where needed. The guidelines we generate would be distinct from this corresponding effort by the CDC, in that our effort would be indication-specific." 

Importantly, Gottlieb says NASEM will hold a series of public meetings and workshops, and 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.

While Gottlieb clearly wants more transparency brought to the guideline development process, he also clings to the notion that opioid medication is overprescribed and is primarily responsible for the nation's opioid crisis.

"Many people who become addicted to opioids will first be exposed to these drugs through a lawfully prescribed medication. Unfortunately, the fact remains that there are still too many prescriptions being written for opioids," Gottlieb said.

"Our analyses suggest that the first prescription for many common, acute indications could typically be for many fewer pills – maybe just a day or two of medication rather than a 30-day supply, which is typically prescribed. In some cases, the excess pills that aren’t used by patients may end up being diverted to illicit markets or misused or abused by friends or family members. In other cases, patients who are prescribed more medication than necessary may find themselves at increased risks for misuse, abuse and addiction."

But studies show that long-term opioid use by patients recovering from surgery is rare and less than one percent of legally prescribed opioids are diverted.

In 2016, the American Pain Society released guidelines that encourage physicians to limit the use of opioids and offer “multimodal therapies” to patients suffering from postoperative pain. Among the treatments suggested are pregabalin, gabapentin, NSAIDs and acetaminophen.

The University of Michigan has also developed prescribing guidelines for over a dozen common surgeries, ranging from hernia repair to hysterectomies. The recommendations list the suggested dose of opioids and number of pills for each procedure.      

Several states have already adopted their own guidelines for acute pain, limiting opioids to a few days' supply -- regardless of whether the pain is from a broken leg, a tonsillectomy or gunshot wound.  It's not clear how federal guidelines for acute pain would impact state regulations.

CDC Head Wants Opioid Guidelines for Acute Pain

By Pat Anson, Editor

When Dr. Robert Redfield was appointed as director of the Centers for Disease Control and Prevention in March, he told CDC staff the opioid epidemic was “the public health crisis of our time” and pledged to “bring this epidemic to its knees.”

After three months in the job, Redfield has finally given his first media interview and provided some vague details about how he will tackle the opioid crisis. He told The Wall Street Journal that the CDC would develop opioid prescribing guidelines for short-term acute pain and use a new enhanced data system to track overdoses in hospital emergency rooms.

“We’re going to continue to expand our efforts,” Redfield said. “We’re going to be able to track this epidemic in real time, which I think is really important to be able to respond.”

The CDC has been roundly criticized in the past for how it tracked and counted opioid overdoses – erroneously mixing illicit fentanyl deaths with those linked to prescription opioids – so any improvement in that area is welcome.

DR. ROBERT REDFIELD.

DR. ROBERT REDFIELD.

But for the agency to even consider prescribing guidelines for acute pain is puzzling – considering how disastrous its guidelines have been for chronic pain. Since their botched release during a sketchy webinar in 2015, the CDC’s “voluntary” guidelines for primary care physicians have been widely adopted as mandatory by insurers, regulators and providers – who have used them to deny treatment, abandon patients, and forcibly taper many off opioid prescriptions. The DEA even targets physicians who exceed the CDC's recommended dosage for opioids. 

“I was forced tapered. How could the CDC take over my medical treatment? How is this legal? The CDC had never assessed me yet changed my pain medicine,” PNN reader Patti asks.  “I've gone from being an active woman to spending my days in bed or on the couch. I live in non-stop pain 24/7.”

Patti is not alone. In a PNN survey of over 3,100 patients last year, over 90% said the CDC guidelines have been harmful to patients and nearly half said it was harder for them to find a doctor willing to treat their pain. Ten percent don't have a doctor at all.

There are also troubling reports of patients committing suicide because their pain is so poorly treated.

"My son committed suicide 4 months after his docs took him off all pain meds," said Rick. "I knew right then the reason for his suicide. But, it goes unrecognized by doctors and other officials, and his suicide autopsy mentioned nothing about pain meds. This will continue, suicides vastly increased until post medicinal suicides (are) recognized and accounted for."

"My 70 year old mother committed suicide last month after being cut off at pain management. Although she could barely walk and was in constant pain, she was the most positive person. Something needs to be done," said Janie Jacobs.

“Wishing for it to be over is a pervasive daily thought. I have to work diligently to chase those thoughts away,” pain patient Leanne Gooch wrote in a recent guest column for PNN. “My doctors can’t or won’t treat me because my chronic pain contributed to all the addicts all over the world. I’ll admit that’s a ridiculous statement when they admit they’ve gone too far in denying me proper medical care.”   

The quality of pain care in the U.S. has gotten so bad that Human Rights Watch launched an investigation into the treatment of pain patients as a possible human rights violation.

“What kind of quality of life do I even have when I can barely move?” asks Amy, who suffers from myofascial pain and is confined to a wheelchair.  “I really want to lead a functional life and to have a family. It's not a lot to ask. I'll never have it this way, though. Please give me back some tramadol. Please allow me hydrocodone if I really need it. Please help me. Please help all of us.”

The CDC guidelines have also failed to achieve a key objective. While opioid prescribing has declined (a trend that began years before the guidelines were released), opioid overdoses have spiked higher, driven by a scourge of illegal opioids sold on the black market. Americans are now more likely to die from an overdose of illicit fentanyl than they are from pain medication.

Several states and insurers have already adopted regulations limiting the initial use of opioids for acute pain to a few days supply. The CDC has weighed in on the issue as well.

"When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed," the agency says in its chronic pain guidelines. 

According to a spokesperson, the CDC was working with the Agency for Healthcare Research and Quality (AHRQ) to develop a report reviewing the effectiveness of opioid and non-opioid therapies for acute pain.

"If an update to the CDC Guideline is warranted based on the scientific findings of these AHRQ efforts, CDC will undertake the scientific process to update the guideline, possibly including expanded guidance treating acute pain," Courtney Leland told PNN in an email.

Why does Dr. Redfield want to develop guidelines for acute pain? In his interview with The Wall Street Journal,  Redfield said his interest stems, in part, from a close family member’s struggle with opioid addiction.

“I think part of my understanding of the epidemic has come from seeing it not just as a public-health person and not just as a doctor,” he said. “It is something that has impacted me also at a personal level.”

The epidemic is also impacting chronic pain patients, in ways the CDC has yet to admit or acknowledge.

Critics Say DEA Plan Could Worsen Opioid Shortages

By Pat Anson, Editor

Pain sufferers and patient advocates are overwhelming opposed to plans by the U.S. Drug Enforcement Administration to further restrict the supply of opioid medication to punish drug makers that allow too many of their painkillers to be diverted and abused. Health organizations also caution that the proposal could worsen an acute shortage of pain medication in the nation’s hospitals.

Over 1,500 people left public comments in the Federal Register on the DEA’s plan to change the rules governing opioid production quotas. Under the proposal, the DEA could arbitrarily reduce the amount of opioids a company can make -- even if it has no direct role in the diversion or abuse.

"It’s a common sense idea: the more a drug is diverted, the more its production should be limited," said Attorney General Jeff Sessions. 

But critics say the plan will not prevent opioid abuse and will likely harm patients.

“The DEA has no business deciding how much valid medicine can be produced. The doctors prescribing the medicine should dictate the amount. The DEA is going to cause a crisis,” wrote Tina Liles.

“Reducing opiate medication has done nothing to help the rate of overdose deaths in this country because opioid prescriptions are not the issue in this country it is illicit fentanyl and heroin,” said Nicole Garage.

“Limiting access to the only medication that helps to control severe, intractable pain will not stop the crisis; those who abuse or sell drugs illegally have not stopped due to current quotas and will not stop with any new quota reductions,” said James Loranc.

“The logic (behind) this DEA proposal is completely untested, unproven, and unsupportable. The shortages being seen in hospitals and by pain patients will only get worse with further DEA cutbacks, leading to more mistakes, waste, and higher costs, not to mention additional pain,” said Valerie Padgett Hawk, Director of a Coalition of 50 State Pain Advocacy Groups.  

Hospitals Rationing Opioids

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The shortages mainly involve injectable opioids such as morphine, hydromorphone and fentanyl, which are used to treat acute pain in patients recovering from surgery or trauma. Hospitals have been forced to ration opioids or use other pain medications that are not as effective.

“With limited availability of some opioids, operations may have to be postponed or cancelled.  In some cases, this could prove life‐threatening to the patient,” wrote Janis Orlowski, MD, Chief Health Care Officer for the Association of American Medical Colleges. “We urge the DEA to remember that opioids are also an important part of treatment regimens for controlling acute and chronic pain in a variety of patients – including trauma, postoperative and patients with advanced stage cancer – and any limits on quotas should not negatively impact access for patients that have a legitimate and critical need for these medications.”  

“Please, I beg you, don't do this. My dear friend Sarah takes painkillers for her rheumatoid arthritis. Even with the medication it's terrible; without it, I have no doubt she'll kill herself. Her mental health is already fragile,” wrote Kelsey Hazzard. “This regulation will destroy her.”  

“For the love of God let the doctors and pharmacists handle prescribing and filling prescriptions and allow the patients and doctors to worry about how much opioid pain medication they need to take. This is none of the DEA’s concern!” wrote Brandon Tull, a disabled police officer who shared the tragic story of Jennifer Adams, a Montana pain patient who recently committed suicide.

“That suicide will probably be the first in a long line if you continue this attack upon innocent chronic pain sufferers!”

The public comment period on the DEA proposal ended May 4th. The public was given only 15 days to comment in the Federal Register on the rule change. Public comment periods are usually between 30 and 60 days long, with some taking up to 180 days. Agencies are allowed to use shorter comment periods "when that can be justified."

"This shortened period for public comment is necessary as an element in addressing the largest drug crisis in the nation's history," the DEA said.

The DEA has already made substantial cuts in opioid production quotas, reducing them by 25% in 2017, followed by a 20% cut in 2018. This year’s cuts were ordered despite warnings from drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

Under the proposed rules, the DEA would be required to consult with states, Food and Drug Administration, Centers for Disease Control and Prevention, and the Department of Health and Human Services before setting opioid quotas. The rule change was triggered by a lawsuit filed against the DEA by West Virginia, alleging that the current quota system “unlawfully conflates market demand for dangerous narcotics” with the legitimate needs of pain patients.    

Although overdose deaths from heroin, illicit fentanyl and other street drugs now surpass those from pain medication, the DEA claims prescription opioids are gateway drugs to long-term substance abuse.

“(Opioid) users may be initiated into a life of substance abuse and dependency after first obtaining these drugs from their health care providers or without cost from the family medicine cabinet or from friends. Once ensnared, dependency on potent and dangerous street drugs may ensue,” the DEA said.

According to the National Institutes of Health (NIH), only about 5 percent of patients taking opioids as directed for a year end up with an addiction problem. And the DEA itself estimates that less than 1% of legally prescribed opioids are diverted.

Walmart to Limit Rx Opioids for Acute Pain

By Pat Anson, Editor

Walmart has announced plans to restrict opioid prescriptions for short-term acute pain to no more than a 7-day supply.

The new policy, which is similar to one already adopted by CVS, will begin “within the next 60 days” and be implemented at all Walmart and Sam’s Club pharmacies in the United States and Puerto Rico.

“We are taking action in the fight against the nation’s opioid epidemic,” Marybeth Hays, executive vice president of Health & Wellness and Consumables for Walmart U.S. said in a statement.

“We are proud to implement these policies and initiatives as we work to create solutions that address this critical issue facing the patients and communities we serve.”

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In addition to the 7-day limit on opioids for acute pain, Walmart and Sam’s Club pharmacists will also limit the dose to no more than 50 morphine milligram equivalent (MME) units per day. The company said its policy was “in alignment” with the Centers for Disease Control and Prevention’s opioid guidelines.

However, those 2016 guidelines are voluntary and only intended for primary care physicians who are treating chronic pain. They say nothing at all about pharmacists being required to limit the dose or duration of opioid prescriptions for acute pain:

“When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.”

Several states have already adopted policies that limit opioid prescriptions for acute pain to seven days or less. Walmart said when state law limits prescriptions to less than seven days, Walmart and Sam’s Club pharmacists will follow state law.

The company’s pharmacists will also be trained and required to counsel patients about the CDC’s guidelines, while “focusing on using the lowest effective dose for pain management for the shortest time possible.”

In 2020, Walmart and Sam’s Club will also require e-prescriptions for controlled substances such as opioids. The company said e-prescriptions are less prone to errors, cannot be altered or copied, and are electronically trackable.

By the end of August 2018, Walmart and Sam’s Club pharmacists will also have access to a controlled substance tracking system called NarxCare. NarxCare analyzes a prescription database to provide pharmacists with a patient’s “risk score” for potential drug abuse.

Medical Marijuana Offers Little Benefit for Acute Pain

By Roger Chriss, Columnist

Colorado lawmakers are considering a bill that would let doctors recommend cannabis for short-lived acute pain. According to the Denver Post, the bill would allow doctors to recommend marijuana for any condition “for which a physician could prescribe an opiate for pain.”

State law currently allows Colorado doctors to recommend marijuana for nine long term medical conditions, including severe chronic pain. But Dr. Larry Wolk, the executive director of the Colorado Department of Public Health and Environment, cautioned that there isn’t enough evidence to support marijuana’s use for acute pain.

“We’re not set up … for this acute pain situation,” Wolk said at a hearing. “This would last maybe three days to a week. But, when you receive a (medical marijuana) card, it’s good for a year.”

Cannabis is one of the most studied substances in the world, but many basic questions about its medical use remain unexplored. Research has found that cannabis doesn’t work well for acute pain.

In 2008, Dr. Birgit Kraft led a small study of cannabis for acute inflammatory pain. Kraft used a double-blind, crossover protocol on 18 healthy female volunteers, evoking pain in several ways and treating it orally with a cannabis extract. It did nothing to reduce acute pain and may have increased it in some subjects.

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"The surprising result of our study was the absence of any kind of analgesic activity of THC-standardized cannabis extract on experimentally induced pain using well-established human model procedures,” Kraft said in an interview with Science Daily. “Our results also seem to support the impression that high doses of cannabinoids may even cause increased sensitivity in certain pain conditions.”

A similar study with a more limited scope was performed in 2007 using smoked cannabis. In a randomized, double-blind, placebo-controlled, crossover study with 15 healthy volunteers, researchers tested sensitivity to capsaicin-induced pain. They concluded that there was a "window of modest analgesia for smoked cannabis, with lower doses decreasing pain and higher doses increasing pain.”

In other words, the best cannabis could muster was a mild benefit if a person could manage to hit a sweet spot between too little and too much.

A clinical study in 2006 on cannabis for post-surgical pain did not go so well. Researchers in Berlin used Cannador (a cannabis plant extract) on patients after surgery. None of the patients was able to achieve sufficient pain relief at any dose of Cannador. Several experienced significant side effects, including sedation and nausea. Importantly, the study had to be halted because of a severe adverse event in one patient.

And a 2018 study on “the good, the bad, and the ugly” about medical cannabis came to this conclusion: “Cannabinoids appear to be most effective in controlling neuropathic pain, allodynia, medication-rebound headache, and chronic noncancer pain, but do not seem to offer any advantage over nonopioid analgesics for acute pain.”

There is thus little evidence to suggest that cannabis may be useful for acute, short-lived pain. Instead, the available research points to nontrivial risks, including the possibility of increased pain and adverse reactions.

Better Options Available

Moreover, there are a wide variety of options for treating acute pain, from ibuprofen and other NSAIDs to acetaminophen, topical analgesics, lidocaine and other local anesthetics, and ultrasound therapy. It is more than a bit puzzling that Colorado would be seeking to replace opioids with cannabis when so many well-established options are readily available for acute pain.

For instance, the Journal of the American Dental Association published an analysis of the benefits and risks of analgesic medications in the management of acute dental pain. Results showed that ibuprofen plus acetaminophen offered the best outcome, with acetaminophen with oxycodone and diclofenac, ketoprofen, and difunisal also giving good results. The article concludes that the risks of opioid analgesics, in particular for children and adolescents, can be minimized by medically appropriate use of NSAIDs and acetaminophen.

Furthermore, cannabis does have side effects and risks. Some people do not tolerate it well, and cannabis use disorder reportedly develops in 9% or more of people who use it. Even CBD oil, arguably the safest form of cannabis, has side effects that include fatigue, diarrhea, and possible effects on liver enzymes.

Untreated or undertreated pain has significant clinical consequences, from impeding appropriate diagnostic testing and evaluation to impacting follow-up care and recovery. There are already reliable and effective options for acute and short-term pain management, with fewer risks and side effects than cannabis, few issues with misuse or abuse, and no legal conflicts between federal and state law.

Cannabis has important medical benefits, from controlling chemotherapy-induced nausea and reducing seizures in childhood epilepsy to helping with some chronic pain conditions. But the available evidence does not support cannabis for the management of short-lived acute pain.

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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.