Who Gets Rx Opioids and Who Doesn't

By Pat Anson, PNN Editor

Although opioid prescriptions in the U.S. have fallen by 40% since 2011 and now stand at their lowest level in 20 years, it’s still common to see claims that opioids are “overprescribed.”  

“Doctors And Dentists Still Flooding U.S. With Opioid Prescriptions” was the headline used by National Public Radio for an in-depth look at opioid prescribing practices.

“Public data, including new government studies and reports in medical literature, shows enough prescriptions are being written each year for half of all Americans to have one,” NPR reported in 2020. “Patients still receive more than twice the volume of opioids considered normal.”

A new study by the CDC gives some much-needed context to the myth that opioid prescriptions are flooding America. Over the past decade, the so-called flood has turned into a trickle for the vast majority of chronic pain patients – the people most in need of effective analgesia.  

The CDC study, which is based on the 2019 National Health Survey, found that only about one in five chronic pain patients – 22.1 percent – had used a prescription opioid in the past 3 months. In other words, it is “normal” for pain patients not to get opioids. 

A previous study that looked at opioid prescriptions in 2010 found that 36.4 percent of patients with chronic non-cancer pain were prescribed an opioid.  While there are differences in methodology between the two studies, the data seems to confirm that there has been a shift in prescribing practices over the past decade. Pain patients are significantly less likely to get an opioid prescription today than they were in 2010.

The new CDC study is also the first to take a deep dive into the demographic and socioeconomic characteristics of opioid recipients -- how age, sex, insurance, income, education and other factors make patients more or less likely to take opioid medication. Considering how much attention has been paid to opioid prescribing over the last decade, it’s surprising no one has looked into this before.

Researchers found that you are more likely to use prescription opioids if you are female, aged 45-64, unemployed, live in a rural area, and a Medicaid or Medicare beneficiary.  Being Black, White, a non-veteran, and living below the federal poverty level also makes you more likely to take a prescription opioid.

YOU ARE MORE LIKELY TO TAKE Rx OPIOIDS IF YOU ARE ...

SOURCE: CDC

Conversely, you are less likely to take prescription opioids if you are male, aged 18-29, employed, a military veteran, privately insured, and live in a household at least 200% above the federal poverty level. Being Hispanic, uninsured, having a college degree, and living in a large metropolitan area also makes you less likely to use opioid medication.   

YOU ARE LESS LIKELY TO TAKE Rx OPIOIDS IF YOU ARE ...

SOURCE: CDC

The CDC study did not look what type of chronic pain condition a patient had or how long they had it. It’s possible the condition itself led to someone becoming unemployed, disabled and poor, or that some other factor is at work. Military veterans, for example, have high rates of chronic pain but get fewer prescriptions because the Veterans Administration strongly discourages the use of opioids.

Researchers also relied on patient “self reports” and did not compare their answers with prescription records. Given the stigma association with opioids, it’s possible some patients may have answered “no” to opioid use, when in fact they used the drugs.

No study is without limitations, but this one shows some clear disparities between who uses opioid prescriptions and who does not. Poverty, lack of education and unemployment may have more to do with pain, drug use and “overprescribing” than policy makers and anti-opioid zealots have been willing to admit.

The Overdose Crisis Is Misunderstood

By Roger Chriss, PNN Columnist

As U.S. opioid lawsuits wind down with multi billion dollar settlements, there are increasing calls for more measures to address the overdose crisis. The calls range from further tightening opioid prescribing practices to legalizing cannabis and other drugs, all in the hope of stemming the rising tide of addiction and overdoses.

The standard view of the crisis is of a simple system, described in mechanistic terms like supply and demand or “stock and flow.” There are a handful of policy levers, and pulling on a lever will hopefully create a proportional change in the crisis.

Obviously, this approach hasn’t worked. The U.S. has reduced opioid prescribing by over 40% and seen no improvements in overdoses. By contrast, Germany is the world’s second-largest user of prescription opioids and does not have an opioid crisis.

Many U.S. states have legalized cannabis, in part as a solution to the crisis. But in the wake of cannabis legalization there are even more overdose fatalities, to such an extent that cannabis is now viewed as possibly making the opioid crisis worse.

There are also claims that prohibition is the problem and that full drug legalization is the remedy. But the legal status of tobacco and alcohol can hardly be called a public health success.

Drug abuse does not occur in a social or technological vacuum. The development of the hypodermic syringe helped morphine and heroin become street drugs, the cigarette rolling machine enabled the modern tobacco disaster, and the advent of the vape pen and synthetic cannabinoids is causing new public health problems.

The Crisis Is Not an Epidemic

All of this suggests that the current understanding of the overdose crisis is mistaken. We’ve been treating the crisis as if it were an “epidemic” caused by a single pathogen, spread through one form of transmission, and treatable with one intervention. But the overdose crisis is not an epidemic in the strict sense of the word.

Instead, it is better to think of the world of drugs as resembling a tropical country with an abundance of parasites and pathogens. Such a country is beset with viral, bacterial and fungal threats coming from a vast variety of sources. With each season the threats shift, and over the years the threats change. But they are always there, and must always be addressed.

In such a country there is no one policy lever or regulatory dial that will control outcomes. Such a country is a highly complex nonlinear dynamical landscape that is very sensitive to small changes in fundamentally unpredictable ways. Moreover, the landscape will offer up novel threats and surprises far more frequently and less predictably than intuition would suggest.

As a result, even a small change in policy can easily have unexpected effects downstream, often unintended and maybe even tragic. For instance, public health policy meant to reign in prescribing for chronic pain has impacted cancer and palliative care. And tapering patients has resulted in more mental health crises and overdoses.

This conceptual difference means that simple solutions like fentanyl test strips or urine drug testing will not end the crisis. They may help on the margins, but to expect more is to misunderstand the nature of the crisis. And even if a bold stroke does help, it only does so briefly. And then the landscape offers new challenges that must be spotted swiftly and addressed adroitly.

The world of drugs can only be managed through comprehensive efforts at prevention, monitoring and treatment with support from local communities and society at large. Countries without an overdose crisis are notable not only for doing many things the U.S. does not, but also for pursuing their efforts consistently year after year.

The overdose crisis will keep evolving as more drugs are developed and delivered to an ever-changing world of drug use. Neither lawsuits nor legalization address the core of the crisis. In the U.S. there are too many charismatic crusaders brandishing simple solutions. But in public health there are very few heroes who understand the complex nature of the problem.

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.   

Opioid Tapering Raises Risk of Overdose and Mental Health Crisis

By Pat Anson, PNN Editor

Taking a patient off opioid medication or reducing their dose – a practice known as opioid tapering – significantly raises the risk of a non-fatal overdose or mental health crisis, according to a large new study.

Researchers at University of California Davis looked at medical and pharmacy claims for over 113,000 patients on long-term opioid therapy at a dose of at least 50 morphine milligram equivalents (MME) per day. About 25% of those patients were tapered.

The study findings, published in JAMA, show that tapered patients were 68% more likely to be treated at a hospital for opioid withdrawal, drug overdose or alcohol intoxication, and they were twice as likely to have a mental health crisis such as depression, anxiety or suicide attempt.

“Our study shows an increased risk of overdose and mental health crisis following dose reduction. It suggests that patients undergoing tapering need significant support to safely reduce or discontinue their opioids.” said first author Alicia Agnoli, MD, an assistant professor at UC Davis School of Medicine. “We hope that this work will inform a more cautious and compassionate approach to decisions around opioid dose tapering.”

Agnoli and her colleagues found that patients on high daily doses who were tapered rapidly were more likely to overdose or have a mental health crisis.

“I fear that most tapering patients aren’t receiving close follow-up and monitoring to make sure they’re coping well on lower doses,” said senior author Joshua Fenton, MD, professor and Vice Chair of Research in the Department of Family and Community Medicine at UC Davis.

The UC Davis study is the largest to date to examine the impact of tapering on patients. Previous studies were generally small, poor quality or limited in scope.

“The paper is well done,” says Stefan Kertesz, MD, an associate professor at the University of Alabama at Birmingham School of Medicine, who is currently leading a study of pain patient suicides. Kertesz said it’s important to remember that people on high opioid doses are usually quite sick. Any abrupt discontinuation of therapy for them is going to be risky.

“People who have been on opioids at a relatively high dose are people who have significant risk. They have significant risk of bad things happening. Whether that’s due to the opioids or not is debatable,” Kertesz told PNN. “This is a group of people who often have high medical morbidity, high disability and high psychological vulnerability. Those risks remain after opioids are stopped or maybe become even worse.”

‘My Life Has Been Ruined’  

The 2016 CDC opioid guideline led to significant increases in tapering, as many doctors, pharmacies, insurers and states adopted its recommendation to limit opioids to no more than 90 MME a day — in many cases even smaller doses.

Three years after the guideline’s release, the Food and Drug Administration warned doctors to be more cautious about tapering after receiving reports of “serious harm in patients who are… suddenly having these medicines discontinued or the dose rapidly decreased.”   

In a recent PNN survey of over 3,600 pain patients, nearly 60% said they were taken off opioids or tapered to a lower dose against their wishes. Nearly every respondent who was tapered said their pain levels and quality of life were worse.

“My life has been ruined by the involuntary opioid medicine taper I have been forced to undergo. I spend so much more time in severe pain, in bed. I no longer can participate in most activities with friends and family. I am so unhappy,” one patient told us.

“I was force tapered to 2/3 of my pain medications. I had been on the same dosage for 8 years without problems. Eight months after being tapered, I developed AFib (atrial fibrillation) and I believe it was due to stress and anxiety of under treated pain,” wrote another patient.

“My pain management doctor tapered my meds by 80% and I had no choice but to accept it.” said another patient. “I have declined so much due to CDC Guidelines that I have become completely homebound and have lost any chance I had for quality of life.”

“I was rapidly tapered without monitoring or concern for my health, pain level, mental health or ability to function,” another patient wrote. “The CDC guideline is completely responsible for increased stigma, patient abandonment, reduced access to care, increase in disability, forcing patients to the black market and to much more affordable but dangerous heroin, and sadly to suicide because the suffering is too great.”

CDC Guideline Revision

The CDC has acknowledged its 2016 guideline caused “unintended harms” and is now in the process of revising its recommendations. But the current draft revision contains the same dose thresholds as the original guideline. That’s drawn criticism from the Opioid Workgroup, an independent panel advising the CDC on the guideline update.

“Many workgroup members voiced concern about the dose thresholds written into the recommendation. Many were concerned that this recommendation would lead to forced tapers or other potentially harmful consequences,” the workgroup said in in a report last month.

In crafting its original guideline, the CDC relied on several researchers and advisors who were critical of opioid prescribing practices. One of them is Roger Chou, MD, a primary care physician who heads the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University. Chou is not only one of the co-authors of the 2016 guideline, he’s currently involved in efforts to revise it.

As PNN has reported, Chou has numerous ties to Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that publicly advocates for forced tapering. In 2019, Chou co-authored an op/ed with PROP President Dr. Jane Ballantyne and PROP board member Dr. Anna Lembke that encourages doctors to consider tapering “every patient receiving long term opioid therapy.”

Chou also belonged to a state task force in Oregon that recommended a mandatory opioid tapering policy for Medicaid patients.  

“I can’t tell you whether the tapers I do in my practice are voluntary or involuntary,” Chou told The Bend Bulletin in 2019. “I don’t think there’s anything compassionate about leaving people on drugs that could potentially harm them.”

In a 2017 tweet, PROP founder Andrew Kolodny, MD, challenged the idea that anyone was being harmed by opioid tapering.

“Outside of palliative care, dangerously high doses should be reduced even if patient refuses. Where exactly is this done in a risky way?” wrote Kolodny. “I’m asking you to point to a specific clinic or health system that is forcing tapers in a risky fashion. Where is this happening?”

The UC Davis study appears to have answered Kolodny’s question. It’s happening everywhere.

“This study adds to a growing body of retrospective cohort studies that have identified harms associated with opioid tapering,” lead author Marc Larochelle, MD, wrote in a JAMA editorial that urged tapering policies be reconsidered.

“It is increasingly clear that opioid tapering needs to be approached with caution. In almost all cases, rapid or abrupt discontinuation should be avoided.”

KOLODNY FORCED TAPERING.jpg

How to Recognize and Treat Intractable Pain Syndrome

By Forest Tennant, PNN Columnist

About one year ago we launched our Intractable Pain Syndrome (IPS) Research and Education Project to bring awareness, diagnosis and treatments to persons who have this merciless condition. Much has been learned in the past year. 

Our original impetus and investigation of chronic pain revealed that some rare patients transform from a state of periodic pain to constant, never-ending pain. Once this constant intractable pain begins, patients often deteriorate, become reclusive, have a shortened life, and some may even commit suicide. Why and how this transformation occurs remained a mystery for many years. 

A major research advance in the past year is the role of autoimmunity, which is the presence of antibodies in the blood that attack one’s own tissues. Autoimmunity is so universal in IPS that we now believe that autoimmunity, plus excess electrostimulation from a disease or injury,  to be the root cause of transformation from simple chronic pain to IPS.  

Recognition of IPS 

The number one challenge in managing and controlling chronic pain is to determine if a person has transformed from simple chronic pain to IPS. Although the scientific documentation is quite sound, there is some resistance in the medical community to the discovery that chronic pain can cause a profound biologic change in multiple bodily systems. These changes may be called “alterations” or “complications,” but the fact is that a chronic pain condition can morph into IPS with cardiovascular, endocrine, and autoimmune manifestations.

The table below shows some of the differences between IPS and simple chronic pain:

The Importance of an IPS Diagnosis

The most common complaint that we receive from persons with IPS is that they can’t get enough opioid and other pain relief medications. The federal government, state medical boards, malpractice insurance carriers, and other health insurers often restrict the number of pills and dosages that can be prescribed and dispensed. As a result, many pain clinics and specialists will only do interventional procedures such as injections or implant stimulators, and will only prescribe limited amounts of opioids, if any.

In order to obtain opioids and some other drugs, particularly benzodiazepines, persons with IPS will need diagnostic tests and a specific, causative diagnosis to prove they have a legitimate medical disorder that will permit their physician to prescribe limited amounts of opioids and benzodiazepines. The major causes of IPS are:

  • Adhesive Arachnoiditis

  • Connective tissue or collagen disorder (Ehlers Danlos Syndrome)

  • Stroke or traumatic brain injury

  • Arthritis due to a specific cause

  • Neuropathy due to a specific cause (CRPS, cervical, autoimmunity)

Less prevalent, but serious causes of IPS are sickle cell disease, porphyria, pancreatitis, abdominal adhesions, interstitial cystitis, and lupus. 

Your primary diagnosis will have to be validated by MRI, X-ray, biopsy, and/or photographs. Medical records must document the diagnosis. You should have a hard copy and hand-carry a set of your records to all medical appointments.

These diagnoses will not usually be acceptable to obtain opioids because they are too “non-specific” or general:

  • Failed back syndrome

  • Degenerative spine

  • Fibromyalgia

  • Central pain

  • Headache

  • Neuropathy.

How to Cope with Opioid Restrictions

Most local physicians are still able to prescribe two weak opioids: tramadol and codeine-acetaminophen combinations. While weak, they are better than nothing, and you may be able to build a pain control program with one or both medications.

If you have good medical records that document the causes and complications of your IPS, some medical practitioners will prescribe these opioids: 

  1. Hydrocodone-acetaminophen (Vicodin, Norco) 3-4 a day 

  2. Oxycodone-acetaminophen (Percocet) 3-4 a day 

  3. Oxycodone alone, 2 to 3 a day

You may be able to boost the potency of opioids with what is called potentiators and surrogates. These drugs and supplements have opioid-like effects known in pharmacology as “opioid activity.” They can be taken separately between opioid dosages, or they can be taken at the same time, to make your opioid stronger and last longer.

  • Kratom

  • Palmitoyethanolamide (PEA)

  • Cannabis/CBD

  • Taurine

  • Amphetamine Salts (Adderal)

  • Tizanidine

  • Methylphenidate (Ritalin) 

  • Clonidine

  • Diazepam 

  • Carisoprodol

  • Ketamine

  • Oxytocin

Although the restrictions on opioids and benzodiazepines are perhaps unfair and an over-reach for legitimate persons with IPS, there are steps you can take to function with these restrictions.

One is to build a comprehensive, healing, and tailor-made program that will allow you to cope with fewer opioids and benzodiazepines. We’ve written previously about the importance of an IPS nutrition program. Pain relief medications are not very effective unless you have good nutrition.

There are also exercises and physical measures you can take that enhance pain control, such as walking, arm and leg stretching, water soaking, deep breathing, rocking, and gentle bouncing. Supplements can also be taken to help suppress inflammation and autoimmunity, regenerate nerve tissue and provide some pain relief.

Forest Tennant is retired from clinical practice but continues his research on intractable pain and arachnoiditis. This column is adapted from newsletters recently issued by the IPS Research and Education Project of the Tennant Foundation. Readers interested in subscribing to the newsletter can sign up by clicking here.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

Rx Drug Monitoring Programs Are Making Overdose Crisis Worse

By Pat Anson, PNN Editor

Prescription drug monitoring programs (PDMPs) have long been touted as a key weapon in the war on drugs. With the recent addition of Missouri, all 50 U.S. states now have PDMPs, allowing physicians and pharmacists to consult a database to see if patients might be abusing opioid medication or other controlled substances. Law enforcement agencies also use the databases to see if doctors are “overprescribing” opioids. 

But a new study by the Reason Foundation, a libertarian think tank, has found that PDMP’s may be making the opioid crisis worse by forcing patients to turn to street drugs. A record 93,331 Americans died of drug overdoses in 2020, with the vast majority of deaths linked to illicit fentanyl, not prescription opioids.

“This study’s analysis finds that the outcomes of PDMP implementation are far less beneficial than the popular support for this policy suggests,” the report found. “Black market overdoses from heroin and fentanyl dramatically increase following PDMP adoption. It appears that surges in illicit opioid overdose deaths follow PDMP implementation, with no clear reduction in deaths, which is the stated intent of the intervention.”   

Co-authors Jacob James Rich and Robert Capodilupo found that states reduced their opioid prescribing rates by an average of 7.7% after implementing a PDMP. But reduced prescribing had “no consistent effect” on overdose deaths. Instead, the study found strong evidence that PDMPs actually caused opioid death rates to increase by 17.5 percent. Fentanyl, heroin and cocaine overdoses all rose sharply.

“As PDMPs enable doctors to identify patients who may be doctor shopping to acquire opioids for non-medical use, doctors will likely stop prescribing opioids to them. Yet these are the very patients who are likely addicted and who will turn to illicit providers to fuel their habits,” the study found.

Percent Increase In Overdose Rates After PDMP Adoption

SOURCE: REASON FOUNDATION

SOURCE: REASON FOUNDATION

‘Like Playing Russian Roulette’

A recent PNN survey of over 3,600 pain patients found that it was common for patients to be taken off opioids or tapered to lower doses against their wishes. A small minority of patients – about nine percent -- said they turned to illegal drugs as an alternative to opioid medication.

“Tapering long term higher dose patients is a barbaric practice that causes suffering so great that going to the black market for relief is the only option besides ending one’s life,” one patient told us. “People want to live so they will turn to the streets where they encounter counterfeit pills and/or much cheaper heroin, made with fentanyl. They aren't wanting to die. They are trying to live again.”

“I've had to seek medication from the black market & risk arrest & death just to be able to walk & leave my bed,” another patient wrote. “Perhaps I too will end up dead one day from street pills made from illicit fentanyl since I can't obtain access to a safe supply from a trusted manufacturer.”

“I'm not a criminal by nature, and I know that it's illegal to buy drugs off the street, but when pain gets so bad I can actually feel the desperation take over and seek relief wherever I can find it,” said another patent. “If it gets too bad I do sometimes have to find that guy on the street and purchase a 100mg morphine, or something, and just hope that it's not containing a lethal dose of fentanyl or something else. It's kinda like playing Russian roulette.”

“I couldn't stand the pain level anymore. After 3 years suffering so bad, I tried the streets. Found illegal fentanyl. The dealer said it was heroin but I found out what it really was because I overdosed and almost died,” said another pain sufferer. “I learned my lesson! Never again.”

The Reason Foundation estimates that it costs about $500,000 annually for each state to operate a PDMP. While that’s relatively inexpensive, the report said it was “counterproductive” to spend any money on a program that may actually contribute to more deaths. It recommends that states scrap their PDMPs and spend the money on addiction treatment.

“Millions of taxpayer dollars are spent nationwide on the administration of these ineffective programs each year,” the report found. “After terminating all PDMP policies, the revenue spent currently on prescribing interventions should be reappropriated to subsidizing opioids for proven treatments like medication-assisted treatment (MAT) with drugs like buprenorphine and methadone, and allowing Medicaid to cover addiction treatment services.”

Previous studies have also concluded that PDMPs may be causing more harm than good. A 2018 study found that PDMPs were driving some patients to the black market for cheap drugs like heroin. A 2019 study reached the same conclusion, saying there was a “consistent, positive, and significant association” between PDMPs and heroin overdoses.

PDMP’s are also associated with abrupt opioid discontinuation, according to a recent study in the American Journal of Preventive Medicine. Patients on long-term opioid therapy living in states with robust PDMPs were more likely to have their doses cut without tapering.

Mission Creep and the CDC Opioid Guideline

By Roger Chriss, PNN Editor

It’s been over five years since the CDC released its opioid prescribing guideline for chronic pain. Now that the agency is looking at possible revisions, it’s worth taking a close look at what research is showing about the effects of the guideline.

First, let’s revisit the goals of the 2016 guideline:

“This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.

This guideline is intended to improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death.”

That’s not what has happened in practice. Instead, the CDC guideline has impacted pain management in both cancer and palliative settings, and has impeded access to care for people with chronic painful disorders.

Cancer and Palliative Care

Several major studies have appeared this year on the effects of the CDC guideline, all finding substantial and unexpected impacts on cancer and palliative care.

An Oregon State University study of over 2,600 hospital patients discharged to hospice care showed a decrease in opioid prescribing and an increase in the use of less powerful, non-opioid analgesics. As result, “some of those patients might have been undertreated for their pain compared to similar patients in prior years.”

Similarly, a study in The Oncologist looked at cancer patients with bone metastasis, and found that opioid prescribing fell significantly between 2011 and 2017. Researchers said their findings “raise concerns about potential unintended consequences related to population-level reduction in opioid prescribing.”

And a study in the journal Cancer found that in interviews with 26 patients with advanced cancer, the majority “experienced stigma about their opioid use for cancer pain management.” Patients also reported difficulties with pharmacies and insurance coverage of opioids.

Chronic Noncancer Pain Care

In chronic noncancer pain management, the CDC guideline has had mixed effects. A recent study in JAMA Network Open concluded that guideline-based opioid prescribing “has potential to improve pain management and reduce opioid-related harms,” but never addressed whether patients thought their pain care actually improved or was even adequate.  

The guideline has also had a chilling effect on some providers. A 2019 study in JAMA Network Open found that over 40% of primary care clinics in Michigan would not accept new patients being treated with opioids due to “decreased social desirability bias.”

The American Medical Association recently reported that many pharmacists have refused to fill legitimate opioid prescriptions, with some patients being told that they were not really in pain and others being subjected to “humiliating accusations that they were drug seekers.”

The AMA shared the experience of one doctor who came back from vacation to learn that he had been blacklisted by a major pharmacy chain that would no longer fill his prescriptions for controlled substances.

“When the CDC guidelines came down in 2016 basically saying we needed to take as many people as we could off opioids, I knew that my patients were in for a world of trouble,” said Aaron Newcomb, DO. “I was particularly concerned about my patients who were stable on low-dose opioid therapy for years. And my concerns have translated into an even worse reality for both me and my patients. Getting blacklisted by a national chain who had no clue about my practice was professionally wrong, but it also hurt my patients and my community.”

The goals of the CDC guideline were laudable. Improving patient outcomes and reducing public health risks are vital to the wellbeing of society. But at least so far, it’s hard to see the CDC guideline as having achieved any of its stated goals. Instead, we have guideline creep and a worsening overdose crisis.

The CDC alone should not be blamed for this outcome. States implemented laws and regulations, in some cases before the guideline was even released, that have contributed to these unfortunate shifts in clinical outcomes. The CDC even warned about misapplication of its guideline, though to little apparent effect.

There is clearly a lot of guideline creep at work. The impacts of the CDC guideline reach far beyond the use of opioids for chronic noncancer pain and are affecting patients in unintended ways, including those suffering from cancer and terminal illnesses or recovering from surgery. Patients and providers are hopeful the upcoming revision of the guideline will address these outcomes and improve pain care.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.  

AMA: Pain Patients ‘Need To Be Treated as Individuals’

By Pat Anson, PNN Editor

The American Medical Association is once again calling on the CDC to scrap dosage limits and make other changes to its controversial 2016 opioid prescribing guideline.

In a letter sent Thursday to a top official at the CDC’s National Center for Injury Prevention and Control (NCIPC), the chair of the AMA’s board of trustees said pain sufferers “need to be treated as individuals” and should not be subject to dose limits. The CDC is currently preparing a revision and possible expansion of the guideline, a lengthy process that could take another year to complete.

“A revised CDC Guideline that continues to focus only on opioid prescribing will perpetuate the fallacy that, by restricting access to opioid analgesics, the nation’s overdose and death epidemic will end. We saw the consequences of this mindset in the aftermath of the 2016 Guideline. Physicians have reduced opioid prescribing by more than 44 percent since 2012, but the drug overdose epidemic has gotten worse,” wrote Bobby Mukkamala, MD, a Michigan surgeon and chair of the AMA board.

The CDC said last week that a record 93,331 Americans died of drug overdoses in 2020. Although the vast majority of those deaths involved illicit fentanyl, heroin and other street drugs, efforts at combating the overdose crisis continue to focus on patients, doctors and reduced opioid prescribing.

“Patients with pain continue to suffer from the undertreatment of pain and the stigma of having pain. This is a direct result of the arbitrary thresholds on dose and quantity contained in the 2016 CDC Guideline. More than 35 states and many health insurers, pharmacies, and pharmacy benefit managers made the CDC’s 2016 arbitrary dose and quantity thresholds hard law and inflexible policy,” said Mukkamala.

“CDC’s threshold recommendations continue to be used against patients with pain to deny care. We know that this has harmed patients with cancer, sickle cell disease, and those in hospice. The restrictive policies also fail patients who are stable on long-term opioid therapy.”

The AMA has been warning about the “inappropriate use” of the guideline since 2018, when its House of Delegates adopted resolutions calling for the elimination of dose thresholds based on morphine milligram equivalents (MME). The CDC guideline recommends that daily doses not exceed 90 MME, a dose that some patients consider inadequate for pain relief.  

Recommendations a ‘Rough Guide’

At a meeting last week of the CDC Board of Scientific Counselors, one of the authors of the 2016 guideline said the MME thresholds were only meant to be “a rough guide” for prescribers and shouldn’t been seen as “absolutes.”

“We heard the concerning reports about the misapplication of the 2016 guideline and we’ve learned from what happened. We know there is a very real possibility that, even with adjustments, the guideline update could be misused,” said Deborah Dowell, MD, Chief Medical Officer of NCIPC.

Critics might wonder if the agency has learned anything in the last five years. A preliminary draft of a revised guideline still contains dose thresholds, recommending that doctors “should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to >90 MME/day.”

An independent panel of outside advisors that reviewed the draft expressed concern about maintaining the dose thresholds, saying they would lead to more forced tapering of patients.

“Though workgroup members recognized the need to have thresholds as benchmarks, many felt that including these thresholds in the supporting text could serve to de-emphasize them as absolute thresholds, and thus recommended removing the specific MME range from the recommendation,” the Opioid Workgroup said in its final report to CDC.

The workgroup also warned that the current draft revision of the guideline was “not balanced” because it focuses heavily on the risks and potential harms of opioids, with less attention paid to their potential benefits. The AMA called on the CDC to adopt the workgroup’s recommendations.

“Patients with pain need the CDC to be their advocate and urge it to rescind the perceived limits on opioid therapy doses or days,” Mukkamala said in closing his letter.

Opioid Income Redistribution

That view is not shared by the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), which sent out a news release this week claiming that prescription opioids are largely responsible for the overdose epidemic.

“Tragically, prescription opioids still account for about 28% of all opioid-related deaths.  Prescription opioids also contribute to synthetic opioid deaths because many heroin and illicit fentanyl users developed their addiction from taking prescription opioids,” PROP claimed. ”Overprescribing of opioids continues to fuel this epidemic. Reducing new opioid prescriptions remains vitally important.”

At least four PROP board members, including founder Andrew Kolodny, MD, have testified as paid witnesses for plaintiff law firms involved in opioid litigation, making as much as $725 an hour. Those law firms stand to make billions of dollars in contingency fees as those cases near an end, with one recent settlement expected to result in a $26 billion jackpot for states, cities and counties. As PNN has reported, many of the lawyers involved in the cases are major political donors.

“Businesses can’t print cash, so where do politicians think the money for these payoffs will come from? The answer is customers in higher prices and workers in lower wages,” The Wall Street Journal said in an editorial.

“The opioid settlement is another example in a growing list of lawsuits that redistribute income from the larger society to rich plaintiff attorneys, who then help politicians with their campaign contributions, who then rehire the lawyers to help with more mass tort claims. Alas, it’s the American way.”

Insomnia Drugs Risky When Taken With Opioids

By Pat Anson, PNN Editor

Medications commonly prescribed to treat insomnia significantly increase the risk of death for older adults if the drugs are taken with opioids, according to new study.

Zopiclone, zaleplon and zolpidem – collectively known as “Z-drugs” – are sold under brand names such as Ambien, Lunesta and Sonata. Z-drugs are sedative-hypnotics and act in a similar way as benzodiazepines, but are considered safer because they belong to a different class of medication.

But after reviewing the medical records of over 400,000 Medicare patients aged 65 and older, researchers at Vanderbilt University Medical Center found that Z-drugs are nearly as risky as benzodiazepines. Patients using benzodiazepines and opioids had a 221% higher risk of death from any cause, while those taking z-drugs and opioids had a 68% increased risk of dying.

Benzodiazepines such as Xanax and Valium are primarily used to treat anxiety. Until recently, benzodiazepines were often co-prescribed with opioids to pain patients, a practice that is now discouraged because both drugs suppress respiration, which can lead to an overdose.

"Our findings indicate that the risks of benzodiazepine-opioid use go well beyond the recognized hazards of overdose. They also suggest that the z-drugs, thought to have better safety than the benzodiazepines, in fact are dangerous when prescribed in combination with opioid pain medications," said Wayne Ray, PhD, professor of Health Policy at Vanderbilt and lead author of the study published in PLOS Medicine.

"Our findings add urgency to efforts to limit concurrent prescribing of benzodiazepines and opioids. They also suggest that targeted warnings are needed to advise older patients and their providers regarding the potential risks of taking z-drugs with opioids."

Last year the Food and Drug Administration ordering drug manufacturers to update warning labels for benzodiazepines to strongly caution patients and providers about the risk of abuse, addiction, dependence and overdose, particularly when the drugs are used with opioids or alcohol.   

In 2019, the FDA also ordered stronger warning labels for Z-drugs, but in that case it was to caution people about rare side effects such as sleepwalking, sleep driving and other risky behaviors.  

CDC Advisory Panel Warns Revised Guideline Ignores Benefits of Opioids

By Pat Anson, PNN Editor

An independent advisory panel is warning the CDC that a draft revision of its 2016 opioid guideline is focused too heavily on the risks of taking opioid medication, with not enough attention paid to the benefits that opioids have for many pain patients.

A 12-page report from the CDC’s Opioid Workgroup was discussed Friday during an online meeting of the agency’s Board of Scientific Counselors (BSC). The 23-member workgroup is composed primarily of physicians, academics and researchers involved in pain management, including some who advised the agency during the drafting of the original guideline.

CDC has not made public the revised draft guideline and has no plans to release it for public comment until later this year. The workgroup, however, has seen the draft and many of its members have issues with it.     

“Overall, many workgroup members felt that much of the supporting text of the guideline was not balanced and was missing key studies. Many workgroup members felt that the guideline focused heavily on the risks or potential harms of opioids, while less attention was focused on the potential benefits of opioids, or the risk of not taking opioids or undertreating pain,” the workgroup report states.

“Many workgroup members noted how the guideline has a constant tension between public health benefits versus patient benefits. This issue is minimally addressed in the guideline and comes very late. Workgroup members felt it is important to directly address this tension between risks and benefits to public health versus individual patients.”

Although voluntary and only intended for primary care physicians treating chronic pain, the 2016 guideline’s recommended dose limits for opioids were quickly adopted as policy by many states, insurers, law enforcement, pharmacies and doctors of all specialties.

As a result, many pain patients who took opioids safely for years were cutoff or tapered to lower doses. Many new patients who need pain relief can’t even get opioids because their doctors refuse to prescribe them. Opioid prescriptions have fallen to their lowest level in 20 years, but drug deaths continue rising.

Not until 2019 did the CDC publicly acknowledge the “misapplication” of the guideline and promise to make changes – although the process is unfolding slowly. The newly revised guideline is not expected to be released until late 2022.

We heard the concerning reports about the misapplication of the 2016 guideline and we’ve learned from what happened. We know there is a very real possibility that, even with adjustments, the guideline update could be misused.
— Dr. Deborah Dowell, CDC

“We heard the concerning reports about the misapplication of the 2016 guideline and we’ve learned from what happened. We know there is a very real possibility that, even with adjustments, the guideline update could be misused,” said Deborah Dowell, MD, Chief Medical Officer of the CDC’s National Center for Injury Prevention and Control (NCIPC), who co-authored the original guideline.

Dowell gave a brief outline of the guideline update to the BSC, noting that it’s recommendations are being expanded beyond chronic pain to include acute pain (pain lasting less than one month) and sub-acute pain (pain lasting 1 to 3 months).

She also disclosed the names of the five co-authors who are writing the update, briefly showing their names on a slide. They include Dowell herself, Kathleen Ragan, a CDC Health Scientist; Christopher Jones, PharmD, Acting Director of NCIPC; Grant Baldwin, PhD, Director of Overdose Prevention at NCIPC; and Roger Chou, MD, Director of the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University (OHSU), which has received billions of dollars in research funding from the federal government.

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The inclusion of Chou as an update co-author is likely to be controversial. As PNN has reported, Chou has been an outspoken critic of opioid prescribing and has numerous ties to Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Like Dowell, Chou was a co-author of the 2016 guideline.

“It is wildly inappropriate and unethical that someone with strong ties to the anti-opioid industry and who has significant financial conflicts of interest is leading this process,” Amy Partridge, an intractable pain patient, told the BSC. “The evidence review and guidance are therefore both inherently biased and should be struck in their entirety.”

Chou — who is a member of the BSC — acknowledged he has a conflict of interest at the start of the meeting and recused himself. “I do have a conflict. I receive funding to conduct reviews on opioids, and I'll be recusing myself after the director's update,” said Chou.

Chou’s recusal apparently only applied to his participation in the meeting, not to his continuing involvement in the guideline update or OHSU’s research.

Dose Recommendations Questioned

Some members of the Opioid Workgroup feel the current draft of the update is “not sufficiently patient-centered,” while others believe not enough attention was paid to disparities in pain care and lack of access to effective, non-opioid treatments.

One of the biggest issues for the workgroup is the revised guideline’s recommendation that initial opioid doses be limited to 50 morphine milligram equivalents (MME) per day and not be increased above 90 MME, which is essentially unchanged from the 2016 guideline. The workgroup believes the dose thresholds are arbitrary, based on poor evidence and should be “de-emphasized.”

“Many workgroup members voiced concern about the dose thresholds written into the recommendation. Many were concerned that this recommendation would lead to forced tapers or other potentially harmful consequences. Though workgroup members recognized the need to have thresholds as benchmarks, many felt that including these thresholds in the supporting text could serve to de-emphasize them as absolute thresholds, and thus recommended removing the specific MME range from the recommendation,” the report found.

Dowell said the MME thresholds are only meant to be “a rough guide” and shouldn’t been seen as “absolutes.”

“We certainly are looking at language in the guideline and also looking at feedback about how to better communicate those nuances and their flexibility,” she told the BSC.

Worries About ‘Bad Policy’

Several workgroup members have issues with the recommendation that non-opioid therapies be used for “many common types of acute pain,” because it doesn’t distinguish between post-surgical pain that may require opioids and other types of short-term trauma that could be treated with non-opioid pain relievers. They warned the recommendations for treating acute pain “could be misinterpreted and translated into bad policy.”

The workgroup also took issue with recommended drug testing for anyone prescribed opioids for chronic pain. Their report says false results from urine drugs tests are common and could have “inappropriate negative consequences” for patients, while more accurate and expensive laboratory tests may not be covered by insurance.

Questions were also raised about prescription drug monitoring programs (PDMPs), particularly the use of algorithms and data mining to create risk scores for patients based on their drug history.

It's important to note that the workgroup’s role is strictly advisory. It had no direct role in writing the revised guideline and will not be involved in rewriting it, if changes are even made.

You can watch most of the meeting below (video courtesy of Peter Pischke):

The workgroup’s report drew both criticism and praise during the public comment period. Some speakers believe the guideline can’t be fixed and should be repealed.

“No matter the intent, goal or method that the CDC may desire with these guidelines and their purpose in the American healthcare system, the DEA will still manipulate them to serve their way,” said Margaret Rene Blake, a pharmacist and intractable pain sufferer. “As long as they exist, they can and will be misapplied. The way to stop the harm to patients, providers and the system is to repeal the guideline.”

One critic suggested the workgroup volunteers, who were unpaid, were swayed by the pharmaceutical industry.

“The OWG (Opioid Workgroup) comments perpetuate myths disseminated by opioid manufacturers. Claiming that the guideline focused heavily on the risks or potential harms of opioids, while less attention was focused on the potential benefits is certainly an industry friendly view,” said Adriane Fugh-Berman, MD, Director of PharmedOUT and a PROP board member, who was a paid expert witness in Oklahoma’s lawsuit against opioid manufacturers.

“Several statements in the OWG (report) are just wrong, including the claim that continuing and not tapering opioids avoids risks of poor analgesia, worsening function and suffering.”

Without seeing the revised draft guideline in its entirety, it’s hard to tell if any significant changes have been made to the original guideline. But judging from the workgroup’s report, the changes have been minor so far. The draft guideline continues to maintain that “nonopioid therapies are preferred” for both short and long-term pain, and that doctors should only consider opioids “if expected benefits for pain and function are anticipated to outweigh risks to the patient.”

There is also no indication what the CDC intends to do to persuade states, insurers, pharmacies, doctors and other federal agencies that they should amend opioid policies and laws that are based on the 2016 guideline.

Ending the War on Drugs Probably Won’t Help Pain Patients

By Roger Chriss, PNN Columnist

America’s war on drugs has been running for half a century and calls to bring it to an end are increasing. Lawmakers and public health experts are questioning federal and state policies that criminalize drug use, while the public generally supports less punitive measures to address drug abuse and addiction.

"The war on drugs must end,” said a recent editorial in The Lancet. “Decriminalisation of personal drug use, coupled with increased resources for treatment and harm reduction, alongside wider initiatives to reduce poverty, and improve access to health care, could transform the lives of those affected."

But ending the war on drugs probably won’t help people with chronic painful conditions. That’s because decriminalization of recreational drugs is not necessarily associated with full legalization – as is the case with marijuana -- while legalization of recreational drugs is separate from medical care with pharmaceutical prescriptions.

The debate about how to end the drug war is largely ideological at this point. In the new issue of The American Journal of Ethics, Carl Hart, PhD, author of the book “Drug Use for Grown Ups,” writes with colleagues that laws criminalizing drug use are “rooted in explicit racism.”

"We call for the immediate decriminalization of all so-called recreational drugs and, ultimately, for their timely and appropriate legal regulation," they wrote.

But bioethicist Travis Rieder, PhD, author of the book “In Pain” about his experience with opioid-based pain management, wrote in the same journal that “ending the war on drugs does not require legalization, and the good of racial justice and harm reduction can be achieved without legalization.”

Yet another view comes from Stanford psychiatrist and PROP board member Anna Lembke, MD, who wrote in the Journal of Studies on Alcohol and Drugs that creating a “safe supply” of drugs by legalizing the non-medical use of prescription medication would be a mistake.

“The expanded use of controlled prescription drugs should not occur in the absence of reliable evidence to support it, lest we find ourselves contending with a worse drug crisis than the one we’re already in. No supply of potent, addictive, lethal drugs is ‘safe’ without guarding against misuse, diversion, addiction, and death,” said Lembke.

The Lancet points to Portugal as an example that other countries should follow. But contrary to common belief, Portugal has not legalized drugs. In Portugal, drug possession of no more than a ten-day supply is an administrative offense handled by so-called dissuasion commissions.

Portugal has not even legalized recreational cannabis. Medical cannabis is legal in Portugal, but only when prescribed by a physician and dispensed by a pharmacy if conventional medical treatments have failed. Personal cultivation of cannabis remains against the law.

Further, neither decriminalization nor legalization necessarily improves racial and social justice. For instance, the University of Washington’s Alcohol & Drug Abuse Institute reports that the legalization of cannabis in Washington state in 2012 has had no impact on reducing racial bias in policing and other disparities in the criminal justice system.

Broad drug decriminalization or legalization would likely have little impact on pain management. Healthcare professionals routinely prescribe medications that are illegal outside of clinical medicine, after weighing the risks and benefits for each patient. Patients are often monitored via pain contracts and drug testing, with some agreements even disallowing cannabis and restricting alcohol use for patients taking medications like opioids or benzodiazepines.

Physicians and pharmacies are under increasing scrutiny from law enforcement, insurers and regulators in the hope of curbing drug abuse. If decriminalization or legalization of drugs leads to more abuse, addiction and overdose, then the scrutiny could increase. So in an unexpected way, an end to the war on drugs could have negative impacts on pharmacological pain management.
 
Supporting an end to the war on drugs is a right and just action. But it would be a mistake to assume that an end to that war will necessarily bring a positive change to pain management. For that, it would be better to support physician autonomy and greatly expanded clinical research into pain management.

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.  

Pain Community Mourns Loss of Patient Advocate Erin Gilmer

By Pat Anson, PNN Editor

Erin Gilmer didn’t fail. The healthcare system failed her.

That’s what hundreds of Gilmer’s friends and followers are saying, as word spreads online about her death last week by suicide at the age of 38. Gilmer was a patient advocate and health policy attorney who intimately knew the problems faced by many chronically ill patients. She was one herself.

Gilmer lived with Type 1 diabetes, celiac disease, rheumatoid arthritis, neuropathy, carpal tunnel, depression and a string of other chronic health problems. According to friends, Gilmer was abandoned by doctors, could no longer work and was on disability. Lacking the financial resources to get good healthcare, she became increasingly despondent about her failing health.    

“I loved you more than you could know. I’m sorry for all the ways I failed. I’m safe now,” Gilmer tweeted @GilmerHealthLaw on July 7. It was her last post.      

“You haven’t failed me. There were many times you saved me. I hope that wherever you are, you’re safe & surrounded by love,” one follower responded.

“I don’t recall any ways you failed, but I treasure all of the difference you made in my life & the lives of many others,” said another.

“Erin, you haven’t failed at all. So many systems have failed you,” another follower tweeted.

In the days before she passed, Gilmer wrote frankly and honestly about her health issues, her posts reflecting a growing sense of finality.

ERIN GILMER

ERIN GILMER

“I wish I could describe how bad the pain is but nothing seems adequate. I keep thinking it can’t possibly get worse but somehow every day is worse than the last,” Gilmer tweeted. “This pain is more than anything I’ve endured before and I’ve already been through too much. Yet because it’s not simply identified no one believes it’s as bad as it is. This is not survivable.”

According to fellow patient advocate Terri Lewis, Gilmer was labeled and shunned by doctors as a complex patient with mental health issues. 

“Like so many others, Erin's life was squandered. The loss of her unique talents, capacity, and learning is just unbelievable to me,” said Lewis. “I am angry that we find it acceptable to foster a system of siloed ‘healthcare’ that continues to reward marginalization and abandonment of persons with chronic multiple comorbidities. The death of Erin and so many like her was predictable, a matter of time in a system perfectly designed to fail chronic care needs. This was no error. The system is working as it is designed.” 

According to her blog, Gilmer received her law degree from the University of Colorado. She began her legal career in Texas as a disability rights attorney for several non-profit organizations. Gilmer also worked and consulted at Stanford University, the Patient Centered Outcomes Research Institute and the Agency for Healthcare Research and Quality (AHRQ). Gilmer moved back to Colorado and launched her own private legal practice in 2012, but was not able to work full time after becoming disabled. 

She turned to advocacy as an alternative — educating doctors and patients about the anxiety and stress many chronically ill patients experience while navigating a broken healthcare system. In one of the last posts on her blog, Gilmer wrote about “betrayal trauma.”   

“If we want people to trust health care, if we want people to heal from the chaos and pain of health care, if we want people to seek out care, we need to both understand the traumas we’ve endured, including betrayal trauma, and implement trauma informed care for all as soon as possible,” Gilmer wrote.

“Patients deserve better. Patients deserve fewer barriers to care and more compassion throughout care. Patients deserve to have their betrayal trauma acknowledged and repaired. Patients deserve to be believed and heard and treated with dignity and kindness.”

Revised CDC Opioid Guideline Not Expected Until Late 2022

By Pat Anson, PNN Editor

The long wait for the CDC to finally unveil changes to its controversial opioid guideline is going to be longer than we thought.

Even though an update to the 2016 guideline is the main topic on the agenda for a July 16th meeting of the CDC Board of Scientific Counselors (BSC), the agency has no plans to make the revisions public at that time. PNN reported earlier this week that the CDC was “expected to release a long-awaited draft of a revised guideline” during that meeting, but that is incorrect.

“The draft updated Guideline will not be shared. The BSC Opioid Working Group report is what will be shared and discussed,” Courtney Lenard, CDC spokesperson, wrote in an email. 

The “Opioid Workgroup” is an independent panel of physicians, academics and patients that was created last year to advise the CDC about revisions to the guideline. The panel had no direct role in rewriting the guideline and has only seen a draft of it.

According to the July 16 meeting agenda, at least three hours have been set aside for the BSC to receive an update on the guideline from CDC staff, followed by a discussion of the workgroup’s report. How such a lengthy discussion could occur without the revised guideline being made public is unclear.

When asked to explain, Lenard said only the “process and progress” of the revised guideline would be discussed. She also indicated the public may not see a draft version in the Federal Register until late this year, with the final, revised guideline not expected until late 2022.

“CDC anticipates that the draft updated Guideline will be posted for public comment by the end of 2021. This will provide another critical opportunity for diverse input from the public,” Lenard explained. “In 2022, after the public comment period has closed, CDC will revise the draft updated Guideline. CDC takes public comment seriously and will carefully consider this input while finalizing the update to the Guideline. Release of a final, updated Guideline is anticipated to occur in late 2022.”

People in pain and their advocates have been calling for major changes to the guideline ever since its 2016 release. Although voluntary and only intended for primary care physicians treating chronic pain, the guideline’s recommended doses and limits on opioid prescribing were quickly adopted as policy by other federal agencies, dozens of states, insurers, pharmacies and doctors of all specialties.  

As a result, many pain patients who took opioids safely for years were cutoff or tapered to lower doses, leading to uncontrolled pain, withdrawal and, in some cases, suicide. While the CDC has acknowledged the problems the guideline has created, the agency had dragged its feet on offering solutions or making revisions.

“The refusal of CDC to make detailed interim reports on its progress in ‘re-writing’ their 2016 opioid guidelines was also evident in their February 2021 meeting of the Board of Scientific Counselors,” said patient advocate Richard “Red” Lawhern, PhD. “If repeated in the July 16th meeting, I would personally regard such a policy to be a major failure of process and public transparency, creating potential grounds for a federal lawsuit on grounds of agency fraud and malfeasance.”  

It cannot be overstated the amount of suspicion and distrust there is for the CDC in the pain community. A recent PNN survey of over 3,700 patients, doctors and caretakers found that over 90% believe the guideline did not improve the quality of pain care and failed to reduce opioid addiction and overdoses. Three out of four believe the entire guideline should be thrown out.

When asked if the CDC could be trusted to handle the revision of the guideline in an unbiased, scientific and impartial manner, over 89% said no.

If you’d like to watch the July 16th CDC meeting online, you can register for it here.  

The War on Drugs Comes to the Doctor’s Office

By Mike Ludwig, Truthout

Ashley* lived with addiction and anxiety for years, but she was in recovery and making progress in 2017 after finding treatment at Jay Joshi’s clinic in northwestern Indiana. Joshi was known as a pioneer of telehealth visits for addiction patients that became widely used during the COVID pandemic, an expansion that lawmakers and the American Medical Association (AMA) are now pushing to make permanent.

Joshi prescribed Ashley buprenorphine, a standard for treating opioid addiction and preventing overdose. Untreated mental health conditions can play a role in drug addiction that is often overlooked, so Joshi set Ashley up with a psychologist through a telehealth service. On November 21, 2017, Ashley was at Joshi’s office for a telehealth therapy appointment with her psychologist when Drug Enforcement Agency (DEA) agents arrived with a search warrant.

At the time, Joshi was unaware that an undercover DEA agent had posed as a patient at his office to build a drug trafficking case against him. Agents took Joshi to a local police station for hours of questioning, where Joshi surrendered his DEA registration that allowed him to prescribe controlled substances — including buprenorphine.

When he returned from the police station, Joshi said Ashley was deeply traumatized. Ashley told Joshi that she protested the interruption of her therapy appointment, so a DEA agent pulled out a gun and ordered her onto the ground.

In grand jury testimony, former employees-turned-witnesses described the young primary care physician’s practice as sloppy and his patients as “addicts,” a deeply harmful and stigmatizing term for patients in recovery. Joshi was accused of operating a “pill mill” in the local media, a claim Joshi says was manufactured by the DEA.

Ashley and other patients were blacklisted by other local doctors, and without a buprenorphine prescription, Ashley relapsed and suffered fatal overdose. Stephanie, another patient who had stabilized and quit using heroin under Joshi’s care, also lost her prescription to buprenorphine. She soon died of an overdose after returning to heroin.

“Any patient who was associated with me or had my DEA registration number on their prescription history, other physicians didn’t want to see them,” Joshi said.

Opioid Prescribing Plummets as Overdose Deaths Rise

Since the early 2000s, rising rates of fatal drug overdoses breathed new life into the failing war on drugs. As they have during drug scares of the past, the government and mainstream media declared an “epidemic” of opioid addiction, and the crackdown on painkiller prescribing that followed injected the DEA — the federal law enforcement agency charged with waging the drug war — deep into the medical system. Opioid painkiller prescribing dropped sharply as a result, but the number of overdose deaths continued to rise before skyrocketing during the COVID pandemic.

To understand the crackdown, Truthout obtained multiple DEA search warrants and court records detailing law enforcement efforts to shut down pharmacies and clinics, and interviewed chronic pain patients and their advocates, doctors, researchers, pharmacists and people recovering from opioid addiction across the United States. Their advocacy and research are poking big holes in longstanding media narratives linking painkiller overprescribing of the past to rising rates of fatal drug overdose today.

A close look at the policing of opioids reveals a common theme of the war on drugs: Policymakers and drug police are harming the same people they claim to help. Like the drug war, the painful side effects of the opioid crackdown disproportionately fall on lower-income people and people of color, whether they use opioids for any reason or simply seek treatment for chronic pain. The prescribing crackdown appears to be exacerbating existing inequities in access to health care and addiction treatment, one reason why rates of fatal overdose are rising fastest in Black communities.

“I have seen how, in these public health crises, the people we sort of want to help become stigmatized and end up losing access to care,” said Kate Nicholson, a former civil rights attorney for people with disabilities and pain patients who founded the National Pain Advocacy Center, in an interview. “The way in which we wage the drug war disproportionately against communities of color means that they are likely to face much greater barriers to health care.”

Over the past decade, drug police began plundering data from private medical records services and statewide prescription monitoring databases to digitally surveil doctors, patients and millions of prescriptions. Often using federal prescribing guidelines that became a national controversy as a reference, drug cops with no formal medical training search for “red flags” in prescribing records, such as how far a patient travels to receive treatment or the total volume of controlled substances prescribed by a provider.

The investigations have led to raids on hundreds of clinics and pharmacies across the country. In some cases, doctors and pharmacists strike plea deals for reduced sentences. In other cases, respected physicians, pharmacists and addiction specialists are caught in the dragnet and forced to fight the DEA in court.

Doctors and pharmacists became increasingly wary of prescribing and dispensing opioids or even agreeing to treat patients prescribed opioids for chronically painful conditions in the first place. Others had their registrations to prescribe controlled substances revoked by the DEA pending rulings by the agency’s own administrative courts, or they closed their practices in fear of being raided and charged with drug trafficking.

In many cases, patients are left with nowhere to turn, especially if they are low-income and reside in areas with few medical providers to begin with. A 2019 study by the University of Michigan found that 40 percent of health care providers refused to see any new patients prescribed opioids.

Along with prescribing guidelines issued by the Centers for Disease Control and Prevention (CDC) in 2016 that were widely misapplied and led to misguided restrictions on opioid prescribing in dozens of states, the law enforcement crackdown left patients living with chronic pain without medications they rely on, forcing some toward illicit opioids, such as heroin and fentanyl, which vastly increase the risk of overdose. Others die by suicide.

“I hear from people every day who have been forced off their meds and have lost their ability to work and function and are suicidal,” Nicholson said. “People are not just being force-tapered [off medication] … they can’t even get health care anymore, just because they need a prescribed opioid to treat pain.”

Both the legal and illicit markets for prescription painkillers shrank as a result of the crackdown and regulatory moves by the DEA. Illicit drugs such as heroin and counterfeit pills containing potent synthetic opioids replaced prescription painkillers in the illicit market. Opioid prescribing rates have plummeted since 2012, but rates of fatal drug overdose increased for years before briefly leveling off in 2018 as policymakers worked to make treatment more accessible.

Overdose deaths began rising again in 2019, and then the COVID pandemic hit, isolating patients and drug users from friends, family and health supports.

From October 2019 to October 2020, the number of overdose deaths recorded by the CDC surpassed 92,000, the highest level in decades.

I hear from people every day who have been forced off their meds and have lost their ability to work and function and are suicidal.
— Kate Nicholson, National Pain Advocacy Center

There are multiple factors and drugs besides opioids (methamphetamine, for example) behind the overdose epidemic. CDC overdose data is not always accurate, and overdose deaths often involve multiple drugs, including alcohol. Research shows that only a small percentage of overdose deaths are caused by prescription opioids alone.

Illicit drugs containing fentanyl are driving the historic rates of death in part because, unlike prescription drugs, they can vary widely in potency, particularly when law enforcement disrupts the supply. A 2020 study found that 57 percent of 2,887 military veterans who died of overdose or suicide had a prescription to painkillers that was cut off by their doctors.

“I believe that a lot of the industrial binary focus on stopping opioid prescriptions reflects a belief that that will somehow stop overdoses from happening … that if we just stop these patients from receiving the pills they are on, they will be protected,” said Stefan Kertesz, a physician and professor of preventative medicine at the University of Alabama who is studying links between reductions in prescribing and suicides. “That presumption just has not held up, so far.”

At the same time, the government has been slow to lift barriers to the most effective medications for treating opioid addiction and preventing overdose, methadone and buprenorphine, which are heavily scrutinized by police and surveilled by the DEA because they are also prescription opioids.

Nationally, less than 6 percent of doctors are allowed to prescribe buprenorphine under a special federal waiver that medical experts and advocates say must be removed to save lives. The waiver takes a day or so to obtain, but advocates say many doctors don’t bother due to the stigma around treating people with opioid addiction. Like Joshi, numerous doctors who do prescribe buprenorphine have been targeted by the DEA.

A study released in May by researchers in Oregon found that one in five pharmacies in counties with high rates of opioid overdose refuse to dispense buprenorphine. The problem is especially prevalent among independent pharmacies, which are often targeted over large companies by drug cops seeking out the latest “pill mill” to bust. Patients recovering from addiction say buprenorphine is often difficult to access even when it’s stocked by a local pharmacy due to stigma reinforced by fear of law enforcement.

A Safer Drug Supply Is Criminalized

In the final days of the Trump administration, James Carroll, President Trump’s drug czar, boasted that the “prescription opioid epidemic is now over.” A major decrease in opioid prescribing and related overdoses, Carroll said, was one of the administration’s major achievements. Critics were irate. How could the Trump administration claim victory when overdose deaths were ballooning on their watch?

Six months earlier, the AMA warned the Trump administration that the overdose crisis had never just been about prescription opioids, and the nation is now facing an unprecedented “multi-factorial” crisis driven by drugs such as illicit fentanyl. The government could no longer view the crisis through a “prescription opioid-myopic lens.”

Moreover, chronic pain patients are harmed by the crackdown and the CDC’s prescribing guidelines, which caused large numbers of patients to be forcibly tapered off their medication or cut off altogether, often against their will.

“There is no evidence that forced stoppage of the individual’s medications leads to a better outcome, none,” Kertesz said. “That’s crucial.”

Kertesz pointed to a new study showing that the net effects of policies that encourage doctors to lower the dose of opioids prescribed to patients are uncertain, but rapid discontinuation of opioid therapy is associated with increased risk of overdose and suicide.

Abrupt stoppage of opioid therapy has become the “norm,” Kertesz said, and those who argue that policies aimed at decreasing opioid prescribing over the past decade simply represent more “judicious prescribing” practices are misleading the public.

“There are 8 to 10 million people on long-term opioids, and a meaningful number of those people actually need to be on them, so setting up a system that by design abandons 1 to 10 million patients is not a good thing, but we have set that up,” Kertesz said.

“We have now set up incentives for doctors and pharmacists to avoid care for those people, many of whom have disabilities.”

There is no evidence that forced stoppage of the individual’s medications leads to a better outcome, none.
— Stefan Kertesz, MD, University of Alabama

In 2018, senior analysts at the CDC revealed that for years, the number of overdose deaths the agency attributed to prescription opioids was vastly inflated due to problems with data collection classification. For example, deaths caused by illicit fentanyl were blamed on the prescription form of fentanyl, which is often used in emergency rooms.

Overdoses involving a combination of drugs were also misclassified. Last year, researchers concluded that, for over a decade, “millions of Americans” were “misled” by the CDC, politicians and the media to believe that the drug overdose crisis was driven by deaths caused by prescription opioids.

Patients prescribed opioids to treat long-term chronic pain are organizing across the country to overturn the CDC guidelines, and the debunking of CDC data and the AMA’s statement validated their cause. In interviews, multiple chronic pain patients said prescription opioids help them live more normal lives, but their lives became collateral damage of the war on opioid prescribing. Patients report that doctors refuse to treat them and pharmacies won’t fill their prescriptions, leaving them in disabling pain. Mothers are punished by hospitals after childbirth and even charged with crimes for continuing opioid therapy prescribed by a doctor during pregnancy.

“Opioids can be used safely during pregnancy, and we also know that when the response is immediately punitive or the application of the criminal legal system, there is actually far worse outcomes for babies and families, instead of being able to work that out with their doctor,” said Dana Sussman, deputy executive director of the National Advocates for Pregnant Women, in an interview.

Chronic pain patients and their advocates argue that the narrative linking opioid prescribing to the overdose epidemic is a “hoax,” and they are engaged in a pitched media battle with the “anti-opioid zealots” who pushed the CDC to discourage long-term opioid prescribing for anyone besides cancer patients and people dying in hospice.

Advocates point to research showing that rates of fatal drug overdose  correlate with economic decline  in many communities and have been rising rapidly since the late 1970s, not the mid-1990s when painkiller prescribing became more liberal thanks to campaigns by drug companies that have garnered plenty of headlines.

The prescribing debate is extremely emotional, with each side attacking the other over credentials and alleged ties to the pharmaceutical and biomedical industries. (Kertesz said he was attacked in the media by an “expert in the field” for simply announcing a study on deprescribing and suicides. “Attacking investigators in the absence of any knowledge of their work would not be customary behavior in any area of medicine,” he said in an email. “But in this topical area, it is.”)

“The way tapering is happening in the real world is just horrible, even for people who are using their medication appropriately,” Nicholson said.

‘Those Patients Went Through Hell’

As an addiction specialist working at an emergency room and poison control center in Ohio, Ryan Marino has plenty of experience on the front lines. The narrative that overprescribing is causing an overdose crisis is clearly overblown, Marino said, because reductions in prescribing has not brought down deaths.

Marino says he often sees patients who were prescribed high doses of opioids for years until their medication was abruptly tapered or cut off after CDC prescribing “guidelines” became public policy and even law in some states.

“Those patients went through hell … naturally, some turned to street drugs because it is so miserable to have opioids cut off, whether you have addiction or not,” Marino told Truthout. “Seeing those patients has cast an additional shadow over this overdose epidemic that we are seeing, because the over-reactionary response is now creating additional harms.”

Marino said the manufacturing and dispensing of opioids can be a real money-maker in a for-profit health system, and overprescribing played a role early on in the crisis. At the same time, prescription drugs are much safer to use than illicit heroin and fentanyl. Marino said there are good arguments for access to a safe supply of opioids — including prescription heroin for people at high risk of overdose — because people using regulated opioids under medical supervision are far less likely to die.

“We need some sort of regulation [of prescribing], but the oversight the DEA provides seems more in line with reducing prescribing than ensuring that prescribing is appropriate and ensuring that people have access to prescriptions,” Marino said. “The reality is, most people who were using Oxycontin never wanted to switch to heroin, and people who were using heroin never wanted to switch to fentanyl.”

Kertesz, who has worked closely with low-income and houseless patients, also takes a nuanced view of prescribing. Like Marino, Kertesz said there were problems with overprescribing in the past, when medications were heaped upon patients instead of affording them more holistic care.

However, abruptly cutting patients off from medicines they depend on can cause all sorts of problems, particularly for people who have trouble consistently accessing health care in the first place. Doctors must make prescribing decisions based on the particular needs of a patient, but the crackdown has siloed prescribing as either “appropriate” or potentially illegal.

“We have now set up an entire system to push a change to care that does not have evidence for being safe or effective for patients,” Kertesz said.

For example, law enforcement often sees a “red flag” when patients are prescribed high doses of opioids or combinations of controlled substances, even when the prescriber is simply continuing the patient on a long-term regimen. While scrutinized by drug police as a sign of criminal activity, Nicholson said some patients benefit from drug combinations under appropriate medical supervision.

Kertesz said assuming something “criminal” is going on when patients are prescribed higher doses of opioids or more than one psychoactive drug at a time is “a big leap.” The same goes for other “red flags” drug police look for in statewide prescribing databases and records kept by pharmacies.

“A patient who has filled a script in two pharmacies, or a patient who has traveled a distance … anybody who has multiple complex needs is already suspect, anyone who is rural by definition is suspect,” Kertesz said. “Pharmacists are trying not to lose their jobs, so they transfer all this stigma and burden to patients.”

There is a difference between “drug dependence” and “drug addiction.” Addiction is characterized by impulsive drug use despite adverse consequences. Physiological drug dependence results from the continued use of many medications — not just opioids. Addiction is rare in patients prescribed opioids for pain, and while long-term use can create dependence, the benefits can also outweigh the harms. People living with opioid addiction may also be seeking relief from untreated pain, trauma or mental anguish.

Either way, abruptly cutting people off from opioids is dangerous. That’s why methadone and buprenorphine are prescribed for opioid addiction and dependence. Both drugs stabilize patients and stave off painful withdrawal symptoms, which is crucial for preventing overdose.

Advocates say the nuance is lost on the DEA and other law enforcement agencies. Drug cops are laser-focused on opioid “diversion,” the idea prescription opioids are being sold and used outside of their intended purpose. Data on diversion varies by source; a 2017 federal survey found that less than 11 percent of people who misused prescription opioids bought them on the street or stole them from a pharmacy or medical facility.

If the rest are “misusing” their own prescriptions or obtaining them from friends and family — an idea that often offends pain patients — then anti-diversion efforts are effectively targeting prescribers and patients themselves.

For years, the government and mainstream media claimed diversion was the source of the overdose crisis, even as the data began telling a much different story. There is plenty of anecdotal evidence, for example, that buprenorphine is usually diverted to people living with addiction. Vermont recently decriminalized possession of buprenorphine without a prescription for that reason.

The crackdown on diversion created grey areas that turned doctors and pharmacists into suspected drug dealers and patients into suspected criminals. In an ironic way, it worked. Pills became harder to find on the street, but reducing the supply did nothing to treat chronic pain or addiction. Overdoses involving illicit opioids are surging, and a growing chorus of drug users and advocates declare that “every overdose is a policy failure.”

The DEA did not respond to a list of questions by the time this article was published.

‘They Look at Prescribing as a Crime’

Joshi ran a general medical practice in Indiana, and he prescribed opioids for chronic pain as well as addiction. The DEA claimed Joshi was writing more prescriptions for controlled substances than most doctors in Indiana; Joshi says he served a population with serious medical needs.

It was the undercover DEA agent’s job to pose as a “drug seeking” patient and catch Joshi in the act of prescribing and secretly record it on video. Joshi says he tended to trust his patients, but trusting the undercover agent was his downfall. He also suspects a former employee wrote fraudulent prescriptions before becoming an informant for the DEA, although he has been unable to prove it.

“They are transplanting people in the health care field as a drug-dealing ring, so I am the captain drug dealer; you snitch on me and you go free,” Joshi said.

Terrified, Joshi accepted a plea deal after he was indicted on multiple drug charges. However, the DEA’s case against him shifted over time and relied on inconsistent witness testimony, leaving a federal judge frustrated when the time came for sentencing, according to a review of court documents.

The DEA accused Joshi of recklessly prescribing controlled substances, but prosecutors were unable to produce evidence that his patients did not have legitimate medical needs for the drugs Joshi prescribed. Multiple patients testified that Joshi’s practice made serious improvements in their lives. A day before Joshi was indicted, his clinic was recognized by the National Committee for Quality Assurance for “patient-centered, coordinated care.”

“A lot of people have it a lot worse than I do; there really wasn’t any evidence in my case,” Joshi said. “They essentially made a bunch of false statements.… Just the act of prescribing, it was construed as a crime. They don’t look at the clinical decision-making behind a prescription, they look at prescribing as a crime.”

A young doctor with a new practice and a child on the way, Joshi admits that he made mistakes. After losing his registration to prescribe controlled substances, Joshi says he unknowingly broke state rules by hiring nurse practitioners to write prescriptions for his patients. He also wrote a handful of prescriptions under another doctor’s name. Joshi says he tried to find workarounds out of concern for his patients. He did not want their “continuum of care” to be interrupted, but the judge saw a violation of the law.

“I tried to do what was right for my patients, but that was a deviation against the regulatory policies,” Joshi said.

Joshi was sentenced to 15 months in prison for writing an unnecessary prescription to an undercover DEA agent. He got out a few months early on good behavior. By the time he was sentenced, many of his patients were receiving the same treatment they had received from Joshi from other doctors.

Stephanie and Ashley were not so lucky. Both women overdosed and died after law enforcement suddenly interrupted their medical care and their safe supply of medication ran out.

*Ashley’s name has been changed to protect her identity.

This article is part of Truthout's series, "The Policing of Pain: Inside the Deadly War on Opioids."

Copyright © Truthout. Reprinted with permission.

AMA Says CDC Opioid Guideline Still Harming Pain Patients

By Pat Anson, PNN Editor

It was nearly three years ago that the American Medical Association took its first public stand against the CDC’s controversial opioid prescribing guideline.

The AMA’s House of Delegates adopted resolutions calling for an end to the “misapplication” and “inappropriate use” of the guideline by many states, doctors, pharmacists and insurers who imposed hard limits on the amount of opioid medication patients could get, if they could get it at all. Many were left in excruciating pain.

Last year, the AMA went even further, with a 17-page letter to the CDC warning that it was “clear that the CDC Guideline has harmed many patients.”  

Even the CDC acknowledged the 2016 guideline “has been inappropriately cited to justify hard limits or cutting off opioids” and that cancer and surgery patients were suffering as a result.

To date, all of this hand-wringing has changed nothing, as the AMA’s new president recently acknowledged in an exclusive interview with PNN.

“Reports we get from patients and physicians suggest that problems remain. Despite CDC acknowledging that its guidelines should not be used as hard thresholds, there has been almost no effort by state legislatures, health insurance companies, pharmacy chains, or PBMs (pharmacy benefit managers) to evaluate the harmful effects of these one-size-fits-all laws,” said Gerald Harmon, MD, a South Carolina physician who was elected AMA president last month.

“The AMA continues to receive reports that the laws are used to deny, for example, prescriptions for opioid therapy for patients with cancer or in hospice as well as long-time, stable patients with chronic pain.”

DR. GERALD HARMON

DR. GERALD HARMON

Not only has the guideline harmed innocent patients, it failed to achieve its main goal of reducing the risk of opioid addiction and overdose. Opioid prescriptions have been cut to levels not seen in 20 years, while overdoses soared to record highs, fueled largely by illicit fentanyl and other street drugs, not pain medication.

Guideline Meeting

This month we may finally learn what the CDC intends to do after five years of its failed public health experiment, which has been conducted with virtually no effort by the agency to measure its impact on patients. On July 16, the CDC is expected to release a long-awaited draft of a revised guideline during a meeting of its Board of Scientific Counselors (BSC).

(Update: On July 8th, PNN was notified by CDC that the draft guideline would NOT be made public at the July 16th meeting, even though the agenda indicates most of the day will be spent discussing it.

“The draft updated Guideline will not be shared. The BSC Opioid Working Group report is what will be shared and discussed,” CDC spokesperson Courtney Lenard wrote in an email, adding that the public may not get a chance to see the updated guideline until late this year.) 

Although the CDC’s review of the guideline has been underway since 2019, the agency has disclosed no details about its plans, which may include new treatment recommendations for short-term acute pain, migraines and other chronic pain conditions. Even the AMA is in the dark about what the CDC is planning.

“Without seeing a specific proposal, we can’t speculate on what CDC might be considering. We will continue to work with CDC to ensure that any recommendations respect and support care for patients with pain. This includes encouraging CDC to make any drafts open to the public for comment to ensure that any revisions or additions do not make the same mistakes as the 2016 Guideline,” said Harmon.

One of the “mistakes” the CDC made was releasing the guideline during a secretive, ham-handed webinar. The agency also refused to disclose the names of its outside advisors, which included members of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP).  

As recently as last year, the CDC declined to release memos, conflict-of-interest statements and other communications related to the 2016 guideline. Nearly 1,500 pages of documents provided to PNN under a Freedom of Information Act request were heavily redacted or scrubbed of information. Over 1,200 pages were completely blank. 

The CDC is being a bit more transparent this time around. Early in its deliberations, the agency asked for and received nearly 5,400 public comments, most of them from patients who blame the agency for their poorly treated pain. The CDC also made public the identities of a diverse group of physicians, academics and patients appointed to an “Opioid Workgroup” that is advising the agency. Notably, the group includes no members of PROP.

The CDC has not yet disclosed who is writing the guideline revision, although early indications are that at least one of the original three authors is involved again.

“The AMA’s focus will be to continue to advocate that CDC revise its guidelines in an open, transparent manner,” said Harmon. “We continue to urge that CDC specifically remove recommendations tied to hard thresholds and make clear that its recommendations should not be used in state laws or policies implemented by health insurance companies, pharmacy chains, or PBMs.” 

Once a draft of the revised guideline is completed, there will be another public comment period later this year. The CDC may not finalize and release the updated guideline until early next year.

If you’d like to watch the July 16th CDC meeting online, you can register for it here.  

States Need to Protect Pain Patients From Uncaring Pharmacists

By Leslie Bythewood, Guest Columnist

The unthinkable just happened again.

A Walgreens pharmacist got away with refusing to fill my prescriptions. It’s the second time that has happened to me at a retail chain pharmacy; the first time was at a CVS pharmacy.

The Walgreens pharmacy manager called and said she would not be able to fill the two prescriptions my board-certified physician had submitted electronically; despite the fact my health insurance had given prior approval for the medications and the pharmacy has been filling them month after month since December 2020.

Contrary to my physician’s best judgment and clinical decision making, this new head pharmacist suddenly decides she cannot fill the prescriptions because:

  • The prescriptions are not in keeping with good-faith dispensing

  • The prescriptions are not appropriate or safe to dispense

  • The pharmacy’s therapeutics committee red-flagged the prescriptions as being too high a dose

  • North Carolina limits the number of tablets that can be dispensed each month

  • Filling the prescriptions goes against the pharmacist’s professional judgment

When I realized that my pharmacist would not fill the prescriptions and refused to even discuss the matter with my doctor, I wasted no time filing an electronic complaint with the North Carolina Board of Pharmacy, hoping for some recourse short of having to get the prescriptions filled at another pharmacy.

But little did I know about a North Carolina Board of Pharmacy rule entitled “Exercise of Professional Judgment in Filling Prescriptions.” That esoteric rule says a pharmacist “shall have a right to refuse to fill or refill a prescription order if doing so would be contrary to his or her professional judgment.”

It also states that a pharmacist “shall not fill or refill a prescription order if, in the exercise of professional judgement, there is or reasonably may be a question regarding the order’s accuracy, validity, authenticity, or safety for the patient.”

Federal law also gives pharmacists a “corresponding responsibility” not to fill a prescription for controlled substances if they believe it is “not in the usual course of professional treatment.”

Basically, the Walgreens pharmacist had the audacity to call into question the validity of my prescriptions being for a legitimate medical purpose, which not only is an insult to my physician, but second-guesses and overrides his many years of medical judgment and authority.

Worse yet, the North Carolina Board of Pharmacy agent I spoke with said that “refusing to fill the doctor’s prescriptions is not a violation of the Pharmacy Practice Act.” She went on to say the board cannot force the pharmacist to fill a prescription if the pharmacist is not comfortable doing so.

Bottom line: In North Carolina and many other states, the patient and doctor have no recourse and no avenues for appeal if a pharmacist refuses to fill a prescription. The only path forward is to have the doctor submit the prescriptions electronically to another pharmacy.

What I find so unconscionable about this whole ordeal is that it doesn’t seem to matter one iota to the uncaring pharmacist that I am a certified pain patient and that my doctor’s prescriptions are entirely legitimate and medically necessary, as has been documented in my medical records.

Nor did it matter that I’ve been on the same opioid strength since December 2020 without any adverse side effects, or that I am highly tolerant of my medications (a physiologic state that does not equate with psychological addiction) and have no history of overdose, substance abuse disorder, misuse or addiction. 

The pharmacist’s ability to get away with overpowering my doctor with unsound, medically unsafe arguments is exactly why we need to enact laws at both the state and federal level to protect pain patients from this type of abuse.

Leslie Bythewood is a freelance writer who lives in North Carolina. Leslie has intractable cranial pain syndrome caused by idiopathic severe chronic migraines and clusters.

PNN invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.