Another Look at the Opioid Risk Tool

By Dr. Lynn Webster

I'm a proud grandfather to two young granddaughters. They are my world. Watching the U.S. Supreme Court rescind women's right to decide what to do with their own bodies made me feel angry that my granddaughters will be subjected to dehumanizing discrimination.

This tyranny against women extends beyond the Supreme Court’s decision over Roe vs. Wade.

I have read multiple accounts of women who are being denied access to opioid medication because they acknowledge a history of toxic adverse experiences as children or adolescents. Many such instances have occurred after women completed the Opioid Risk Tool, a questionnaire that asks a person if they have a history of preadolescent sexual abuse.

The refusal to prescribe opioids to women with a history of preadolescent sexual abuse is a defensive measure by providers to avoid being accused of causing an Opioid Use Disorder (OUD).

Why I Developed the Opioid Risk Tool

The Opioid Risk Tool (ORT) that I developed more than 20 years ago was designed to assess the risk of someone who was prescribed opioids for chronic pain treatment showing aberrant drug-related behavior.

The ORT was a simple questionnaire that could be administered and scored in less than a minute. It was developed at a time when we had no way to assess the risk of developing opioid abuse in patients who were prescribed an opioid for non-cancer pain. We needed a tool to help evaluate whether the risk of potential harm from opioids outweighed the potential good for each individual.

I never intended for doctors to use the ORT to determine who should or shouldn’t be prescribed an opioid. My goal was to help doctors identify patients who might require more careful observation during treatment, not to deny the person access to opioids.

Since abuse and addiction are diagnosed by observing atypical behaviors, knowing which patients are at greatest risk for displaying those behaviors is useful in establishing appropriate levels of monitoring for abuse. This was intended to protect the patient from potential harm. It was never supposed to be used as an excuse to mistreat patients.

The original version of the ORT contained 10 questions, including whether a patient had a history of preadolescent sexual abuse. Women who answered "yes" scored 3 points; while men who responded affirmatively scored 0 points. The higher you scored, the more closely your doctor would need to monitor your opioid use during your treatment.

The ORT questionnaire was based on the best evidence at the time. Multiple studies have since confirmed the validity of the questions used in the questionnaire. However, many people have criticized the question that asks about a history of preadolescent sexual abuse because of a perceived gender inequity. In addition, some doctors have generalized the ORT's question about preadolescent trauma so that it applies to a history of female sexual abuse at all ages.

I have written that the ORT has been weaponized by doctors who are looking for a reason to deny patients -- particularly, women -- adequate pain medication.

There are doctors who use their power to determine whether to treat a woman's chronic pain with an opioid or allow her to suffer needlessly based on the ORT's answers. This is no less malevolent than a forced taper resulting in suicides or the use of the CDC opioid prescribing guideline to criminally charge providers for not following the CDC's recommendation. In all of these situations, an injustice is being committed against innocent people.

It is also not much different from the Supreme Court’s decision to ignore a woman’s right to access full reproductive rights. Both are attacks on women.

Fortunately, Martin Cheatle, PhD, and his team published a revised Opioid Risk Tool in the July 2019 edition of the Journal of Pain. In his research, Dr. Cheatle found that a revised ORT using 9 questions instead of 10 was as accurate as, if not better than, the original ORT in weighing the risk of patients for OUD. The revised ORT eliminates the use of a woman's sexual abuse history as a risk factor.

At a time when females have had their human rights taken away by a Supreme Court vote, it is especially appropriate to reconsider how we assess risks for potential opioid abuse for women.

It distresses me to know that, while the original ORT served to help assess the risk opioids posed for individuals, it has also caused harm. Since the question about a woman's sexual abuse history does not provide any additional benefit, there is no reason to retain it. The revised ORT should be used instead of the original ORT.

Lynn R. Webster, MD, is Senior Fellow at the Center for U.S. Policy (CUSP) and Chief Medical Officer of PainScript. He also consults with the pharamaceutical industry.

Lynn is the author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. You can find him on Twitter: @LynnRWebsterMD.

Drug Addiction Is the Problem, Not Prescription Opioids

By Christine Kucera, Guest Columnist

The Centers for Disease Control and Prevention (CDC) is the leading national public health institute of the United States. The agency is responsible for protecting the public from health and safety threats. 

In my opinion, the CDC has no business writing clinical guidelines! Medical guidelines for healthcare/disease management, medication management, and clinical decision making should be developed, reviewed and approved by a diverse team of clinical subject area specialists and key stakeholders, including medical specialists, medical groups, advisory teams, advocates and patients. Not regulatory agencies!

The 2016 CDC opioid guideline, as currently written, has harmed and damaged millions of lives, and caused unspeakable suffering. In effect, the CDC sanctioned torture by failing to promptly address and correct the negative impact of its guideline on individual patient care, addiction and pain management treatment and resources.

The CDC has clearly overstepped its authority by creating a guideline meant to regulate the use of prescription opioids. Any regulatory measures which prevent patients from accessing prescription opioids as indicated for their health and well-being are unethical and should be reconsidered, if not totally withdrawn.

The CDC continues to propagate the false narrative that any patients requiring prescription opioids for any type of pain are or will become addicts. And it continues to claim — without any evidence — that if opioid prescriptions are limited in quantity, type, duration and dose, there will be a reduction in addiction, overdose and death. The facts indicate otherwise. Overdoses are at record high levels.

The True Causes of Addiction

Substance addiction exists because our government has failed to address its true causes, which include poor access to addiction treatment, unethical pain treatment, lack of quality care standards across medical institutions, and lack of legislative laws that protect patients from suffering needlessly. 

Addiction is caused by preventable and manageable health disparities, untreated and undertreated mental and physical suffering, genetic metabolic variability, lack of resources, lack of all-inclusive healthcare insurance, lack of provider managed pain care, lack of treatment centers, lack of access to appropriately prescribed medications, lack of drug monitoring systems, lack of access to mental health and pain care providers, lack of timely access to a comprehensive network of providers, and lack of individualized care. 

Maybe if the CDC actually focused on the above health and safety issues, we would have guidance on solving the real problems. The CDC has failed miserably to recognize that individual pain care is as unique as the patient who is suffering in pain. Every single person that has pain seeks relief.

Relief comes in many different forms, both healthy and unhealthy. These forms of relief may be self-directed and/or medically managed by clinical staff and providers, and includes exercise, yoga, rest, mobilization, heat/ice therapy, massage, mindfulness, acupuncture, Chinese herbal medicine, bio-feedback, diet, weight loss, surgeries, water therapy, bicycling, strength/weight training, martial arts, immunotherapy, TENS, anti-inflammatories, anti-seizure medication, muscle relaxants, antidepressants, biologicals, medical/recreational cannabis, CBD, kratom, prescription opioids, illicit/illegal drugs and alcohol — to name a few. 

Every Patient is Different

The journey each patient in pain takes is individual. The pain you've experienced and lived with is different from mine and everyone else’s.  

The terms “acute pain” and “chronic pain” are also misleading and are part of the false narrative. Pain is a symptom. Its management depends on its physical and/or mental cause, not how long it lasts. Pain is the body's way of sending up a red flag that something is not right.

Duration means nothing in the world of pain, as every minute of the day is different in type, in location and in intensity. Pain goes through cycles, and no person experiences pain the same way.  

Until the individuals who wrote this God awful, evil guideline experience pain that is unrelenting, agonizing, non-stop, 24/7 for their entire life, they should back off the false narrative, go back into their non-medical cave, and leave the medical decision making up to the actual physicians who are trained to manage pain with all the tools available and at any quantity required by a patient.  

What the CDC should be addressing are the sources of suffering, identifying at-risk individuals and providing a framework for implementing resources and systems of care that are fluid and adaptive to the unique circumstances of each individual.  

There are too many outstanding questions and issues which also continue to impact patients and providers. What are the FDA and DEA’s roles and responsibilities? How do their policies meet the objectives of the CDC guideline to reduce addiction, overdose and death? What impact do they have on medical providers treating patients in pain? 

Addiction is the public health issue requiring CDC input, not the utilization of prescription opioids for pain treatment. 

Christine Kucera is an intractable pain patient survivor of over 30 years. She lives with reactive psoriatic arthritis, spondylitis, polyarthritis, sacroiliitis, degenerative disc disease, dermatomyositis, mixed connective tissue disease, psoriasis, lupus, spinal radiculopathy, thoracic outlet syndrome, endometriosis stage IV, and other painful conditions.

Prior to becoming disabled, Christine was a healthcare research systems developer and analyst for federally funded CMS, AHRQ, and NIH grants and programs. 

Study Warns of ‘Kratom Use Disorder’

By Pat Anson, PNN Editor

Nearly a third of people who use the herbal supplement kratom develop symptoms of withdrawal and tolerance that could be signs of kratom use disorder (KUD), according to a small survey by the National Institute on Drug Abuse. Withdrawal symptoms included gastrointestinal upset, restlessness, anxiety, irritability and fatigue.

Kratom comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. An estimated two million Americans use kratom to self-treat their pain, depression, anxiety and addiction.

NIDA researchers recruited 129 past and current kratom users in the U.S. to participate in the online survey, asking them about their symptoms and demographic information.

The study findings, recently published in the Journal of Addiction Medicine, found that over half of kratom users showed no signs of addiction. But 29.5% met the diagnostic criteria for KUD, such as increased use, tolerance, withdrawal, unsuccessful attempts to quit, and craving. Most reported KUD symptoms that were mild or moderate, with about one in four with KUD having severe symptoms.  

Nearly 10% of participants also reported “psychosocial impairments,” such as decreases in social, occupational, or recreational activities because of their kratom use.

“As assessed here, tolerance and withdrawal are primary KUD features rather than psychosocial impairments. As kratom is often used among persons with a myriad of health conditions, clinicians should be aware of and assess for kratom use and withdrawal,” wrote lead author Kirsten Smith, PhD, who heads much of the kratom research at NIDA.

Federal health officials have long taken a dim view of kratom and made unsuccessful attempts to ban it. In 2018, former FDA Commissioner Scott Gottlieb, MD, claimed that kratom was an opioid, addictive, and should not be used to treat any medical condition.

“Kratom use disorder” is a relatively new diagnosis and does not appear often in medical literature.  One of the first references to it is in a 2019 study that called kratom an “emerging public health threat.” Researchers said healthcare providers need to be aware that kratom use was “typically accompanied by increasing tolerance and dependence making it highly problematic.”

A kratom advocate said the new NIDA study shows the risk of kratom addiction is low and that symptoms are often mild. 

“I thought the results of this research were particularly interesting because of the growing number of addiction recovery centers expanded their service-for-hire to include kratom use disorder (KUD) and characterizes this condition as mirroring opioid use disorder (OUD) that requires intensive drug interventions of different substances,” said Mac Haddow, a lobbyist and Senior Fellow for the American Kratom Association, which represents kratom vendors and consumers.  

“Importantly, the study concludes that tolerance of kratom over time, and withdrawal from that level of dependence are the primary outcomes rather than psychosocial impairments that are largely debilitating among drug addictions. The study also recognizes that kratom continues to be a harm reduction alternative for those suffering from polydrug use addiction issues and that accounts for its increasing use as the drug overdose crisis deepens in the U.S.” 

Kratom is often used as a treatment for addiction. A 2016 PNN survey of over 6,400 kratom users found that nearly 12% used it to reduce their cravings for alcohol or opioids. Nine out of ten said kratom was “very effective” at treating their substance use disorder. And over 98% of all respondents don’t believe kratom is harmful or dangerous.

Study Warns of High Risk of Addiction in Medical Marijuana Users

By Pat Anson, PNN Editor

Medical marijuana is often touted as a treatment for chronic pain, but a new clinical trial found cannabis provided no significant improvement to people who took it for pain, anxiety or depression. Marijuana did help people sleep better, but it also raised their risk of cannabis use disorder (CUD).

“There have been many claims about the benefits of medical marijuana for treating pain, insomnia, anxiety and depression, without sound scientific evidence to support them,” says lead author Jodi Gilman, PhD, with the Center for Addiction Medicine at Massachusetts General Hospital (MGH). “We learned there can be negative consequences to using cannabis for medical purposes. People with pain, anxiety or depression symptoms failed to report any improvements, though those with insomnia experienced improved sleep.”

Gilman and her colleagues enrolled 186 people in the study and randomly assigned them to one of two groups. The first group was allowed to immediately obtain a medical marijuana card, while the second group had to wait 12 weeks before getting one. Both groups were allowed to choose their cannabis products at a dispensary, with no limits on the dose or frequency of use.

Participants in the immediate card acquisition group reported significantly more cannabis use in the study period, with nearly one in five (17%) developing CUD symptoms such as craving, tolerance and withdrawal within 12 weeks. The odds of having CUD were nearly 3 times higher in the immediate acquisition group than in the delayed acquisition group.

“This trial showed that CUD can develop at a fast rate within the first 12 weeks of medical marijuana card ownership, suggesting that those with a card may develop CUD at a similar rate as those who use cannabis recreationally and that the (medical) motive for use may not be protective,” researchers reported in in JAMA Network Open.

“Although most cases of CUD onset in the trial were mild, with 2 to 4 symptoms, these symptoms developed over a short, 12-week initial exposure. The most commonly reported CUD symptoms were higher tolerance and continued use despite the recurrent physical or psychological problems caused or exacerbated by cannabis.”

People with anxiety or depression -- the most common conditions for which medical cannabis is sought -- were at significantly higher risk of developing CUD than those with pain and insomnia.

Incidence of Cannabis Use Disorder

SOURCE JAMA NETWORK OPEN

“Our study underscores the need for better decision-making about whether to begin to use cannabis for specific medical complaints, particularly mood and anxiety disorders,” said Gilman, who called for more regulation of medical marijuana.  “There needs to be better guidance to patients around a system that currently allows them to choose their own products, decide their own dosing, and often receive no professional follow-up care.”

Cannabis advocates say Gilman’s findings are at odds with larger observational studies (here, here and here) that found cannabis use disorder declined in states that legalized medical marijuana. They feel the study also lacked detail of CUD symptoms or what impact they had.

“Although the authors stress the notion that those in the card-holders groups were more likely to be diagnosed with symptoms of CUD, they never identify what these symptoms were, their severity, or how disruptive they were to these individuals daily lives and functioning — or even if in fact they were at all,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group. 

“Finally, it should be recognized that virtually all therapeutic agents possess varying safety profiles. Medical cannabis is not innocuous. But its safety profile is far superior to that of many conventional pharmaceuticals for which it can provide an alternative, including opioids and benzodiazepines — even if one is to take these findings at face value.” 

A recent survey found that twice as many Americans are now using cannabis or cannabidiol (CBD) to manage chronic pain than opioid medication.

What Do You Think About Changes to CDC Opioid Guideline?

By Pat Anson, PNN Editor

Do you think the proposed changes to the CDC’s opioid guideline are an improvement over the original 2016 guideline? Will the changes make doctors more or less willing to prescribe opioids? Should the guideline be expanded to include recommendations for treating conditions like migraine and low back pain?

Those are some of the questions we’re asking in a new PNN survey on the long-awaited draft revision of the guideline that was unveiled last month by the CDC.  In addition to giving healthcare providers more flexibility in using opioid medication to manage chronic pain, some experts say the changes effectively transform the guideline into a national “standard of care” for pain management – one that would apply to most doctors and patients, regardless of the severity or duration of their pain.

While the guideline changes have been applauded by professional societies like the American Medical Association for removing “arbitrary doses thresholds” for opioids, some worry that the expansion goes too far and could harm patients -- like the original guideline did -- by depriving them of effective pain treatments.

“The CDC is outside its lane to be recommending how physicians should practice pain medicine. Would they recommend how to treat hypertension or diabetes? If they did, it too would be inappropriate, unless it was in collaboration with one or more of the medical professional societies devoted to those areas,” says Lynn Webster, MD, Senior Fellow at the Center for U.S. Policy and past president of the American Academy of Pain Medicine.

“I have a lot of concerns about the new version. It is better, but still terribly misleading and not grounded in science, which is terrible disappointing.” 

90 MME Threshold Dropped

Perhaps the biggest change to the 2016 guideline is the CDC’s decision to drop a recommendation that opioid doses not exceed 90 morphine milligram equivalents (MME) per day, which quickly became a hard limit for many providers, insurers, states and regulators.

While the CDC still recommends caution about doses exceeding 50 MME, that advice is not enough for Lewis Nelson, MD, a longtime critic of opioid prescribing who advised the agency when the original guideline was created. He thinks the 90 MME limit is based on sound evidence.

“There are good data to support that there is an inflection point at 90 MME. It’s clear that high-dose chronic opioid therapy is associated with a number of adverse consequences -- including addiction, unintentional overdose and potentially death,” says Nelson, the Chair of Emergency Medicine at Rutgers New Jersey Medical School. “In a way, it’s a race to the bottom in pain management, because if you’re not getting better with a reasonable dose of an opioid, there’s nothing to support that additional opioid is going to carry significant benefit and is known to markedly increase the risk.”

Dr. Webster says the use of MME to guide prescribing is misleading because not all opioids are the same or convert well to MME doses. Like others, he worries that 50 MME will become the new hard threshold for opioid doses.

“I think any reference to conversion tables and MME will be interpreted as validation of them. We saw that with the 2016 guideline,” Webster told PNN. “The CDC needs to explicitly state the lack of scientific basis for both and that their use could be dangerous in some cases. They should not cite 50 MME threshold anywhere, as it is meaningless, misleading and will lead to further misapplication of the recommendation. You would think that they would have learned that by the 2016 guideline.” 

Take Our Survey

This is the fifth survey PNN has conducted on the CDC guideline. All of them found that the vast majority of patients and providers believe the guideline was harmful, worsened the quality of pain care, and led some patients to contemplate suicide or turn to street drugs.    

For those who think surveys are a waste of time and the CDC doesn’t pay attention to them -- think again. On Page 53 of its revised opioid guideline, the agency cites PNN’s 2017 survey and has a footnote linking to it:

"An online (non-peer reviewed) survey of over 3000 patients 1 year after the release of the 2016 CDC Guideline found that 84% reported more pain and worse quality of life and 42% said they had considered suicide; however, the survey did not attempt to sample patients with chronic pain using a rigorous methodological approach.”  

It’s true the PNN survey was not peer-reviewed and that patients were not sampled with a “rigorous methodological approach.”  It’s also true that CDC has not conducted a large survey of its own to measure the impact of its guideline on patients. The agency has focused on counting opioid prescriptions — not patient outcomes — as a measure of whether its guideline is working.

To take our new survey, click here.

It should only take a few minutes to complete. We’ll share the results in mid-April.

'This is an opportunity for patients, caregivers, clinicians and others to share their impressions of the 2022 revised and expanded CDC practice guidelines for treatment of acute and chronic pain,” says patient advocate Richard “Red” Lawhern, PhD.

“This guideline will ultimately steer pain care for the foreseeable future, for better or worse. The more involved and informed every part of our community is, the more we can help shape its impact. This survey is one more way to get involved and help guide future efforts,” said Tamera Lynn Stewart, Policy Director for P3 Political Action Alliance.

You can read the revised draft of the CDC guideline and leave an online comment in the Federal Register by clicking here. Comments must be received by April 11.

Pain Patients Have Low Rates of Illicit Drug Use

By Pat Anson, PNN Editor

Anti-opioid activists have long claimed that opioid medication is a gateway drug to heroin and other street drugs. That myth is so ingrained in the medical community that many pain patients are discriminated against by doctors and pharmacists, who suspect they are abusing their medication or using illicit drugs.

But a large new study by Millennium Health pokes a hole in that myth, finding that patients being treated in pain management practices are far less likely to use heroin, fentanyl, cocaine and methamphetamine than other patients.

The drug testing firm analyzed the lab results of two million urine tests from 2015 to 2021 – nearly 600,000 coming from pain patients -- and found that patients seeing primary care physicians, behavioral health doctors (psychiatrists and psychologists), or getting substance use disorder (SUD) treatment were significantly more likely to test positive for street drugs than patients of pain management providers.

SOURCE: MILLENNIUM HEALTH

“That’s one of the reasons why we decided to put this out there in the public domain, because it’s important. Because clearly there are differences across these groups,” said Eric Dawson, PharmD, Vice President of Clinical Affairs at Millennium Health.

For example, the positivity rate for fentanyl in urine samples is about 2% for pain management patients – a level that remained stable throughout the 6-year study period.

But Millennium found that for primary care and behavioral health patients, the positivity rate for fentanyl has ticked up to about 5 percent.

In patients getting SUD treatment, the positivity rate has skyrocketed to about 17 percent, no doubt a reflection of the growing presence of illicit fentanyl in street drugs.

Positivity rates for methamphetamine are also rising for most patients – but not for pain patients – while cocaine use has remained relatively flat. Positivity rates for heroin have declined steadily for all patients since 2015, according to Millennium.

“Generally speaking, the pain population that’s treated with opioids is an older population and uses illicit drugs at a very low rate,” said Steven Passik, PhD, VP of Scientific Affairs and Head of Clinical Data Programs at Millennium.

“Not only are they low, they remain low,” says Dawson. “So many of the other groups, over time their positivity rates are increasing. The pain population started low and remains low. And that says they are different than the other groups.”

What makes the findings even more striking is that they include the first two years of the covid pandemic, a time when stress, isolation and depression led many people to abuse drugs.

“But that did not happen in the pain patients. You can actually see that,” says Passik, who believes regular drug testing makes pain management patients less likely to take risks that might affect their healthcare. He thinks the Millennium study should be reviewed by both providers and policymakers to get a better understanding of people in pain.

“There isn’t that much data like this out there. I think it’s unique and very positive about this population. And I think that should be factored in when people are talking about access to opioids,” Passik told PNN.

In addition to fentanyl, heroin and other street drugs, the Millennium study also looked at positivity rates for marijuana, which have soared in recent years due to the legalization of medical and recreational cannabis in many states. By the end of 2021, the positivity rate for cannabis had reached nearly 32 percent for most patients. But, like the other drugs, cannabis use remained relatively low for pain patients.  

Does Childhood Trauma Increase Risk for Opioid Misuse?

By Pat Anson, PNN Editor

Did a parent humiliate or swear at you as a child? Were you ever molested? Did you live with a problem drinker or someone who went to prison? Were your parents ever separated or divorced?

Those are some of the questions posed to over 1,400 college students in a study by researchers at the University of Georgia, who wanted to assess the relationship between childhood trauma and the misuse of prescription opioids later in life.

Their research, recently published in the Journal of American College Health, found that most students had at least one adverse childhood experience (ACE). But those who reported four or more ACEs were almost three times more likely to misuse opioid medication.

Based on that finding, the researchers say healthcare providers should consider a patient’s experience with childhood trauma before prescribing them opioids.

“Our findings suggest need to include assessment of ACEs as a screening criterion for opioid prescription and administration among college-aged individuals,” wrote lead author Janani Thapa, PhD, an associate professor in UGA’s College of Public Health.

Many doctors already use screening tools to assess whether a patient is at risk for opioid misuse. They look up their prescription drug history, or ask patients if they’ve been sexually abused or have family members with a substance use disorder.

But Thapa and her colleagues think that assessment should go further, incorporating a wider range of childhood trauma, such as whether a patient didn’t have enough to eat or had to wear dirty clothes as a child.  

“Prevention of opioid misuse demands careful consideration of the traumatic exposure of the patient,” they said. “Current opioid assessment measures, including patient or family interviews, and prescription monitoring, may need to incorporate patients’ traumatic history for proper chronic pain management and integrated care.”

Penalizing Patients

The use of opioid screening tools is controversial. Some patients resent being asked about their childhood trauma – which they see as irrelevant to their health problems and pain management as adults.   

“I overcame my early life abuse until an ignorant doctor used that childhood abuse without psychiatric consultation to put labels on me and refuse medicine for pain,” one patient told us.

“Just because a patient may have been sexually abused or has family members who are addicts/alcoholics, does not mean the patient will be,” said another. “To penalize a person who is in excruciating pain due to no choice of their own, is cruel and inhumane.”

But a pain management expert says opioid screening tools have their place, because childhood trauma can have a lasting impact. 

“Most studies have shown that 4 in 5 people with an Opioid Use Disorder have at least one ACE,” says Lynn Webster, MD, past president of the American Academy of Pain Management and a PNN contributor. “I consider ACEs a form of post-traumatic stress disorder. It affects emotion regulation, causing an inability to modulate distressing emotions in a healthy and adaptive way. ACEs create a maladaptive response to stress. The earlier in life the ACEs occur, the more effect they will have later in life.” 

Over 20 years ago, Webster developed one of the first opioid screening tools for doctors, a short survey that asked patients if they had a history of substance abuse, sexual abuse, or any mental health issues. In his own practice, Webster found the survey helpful in identifying patients at risk of abusing opioids, but he later came to regret how the screening tool was “weaponized” against patients, particularly women, and used by other doctors as an excuse to deny patients opioids. 

“The Opioid Risk Tool (ORT) incorporates pre-adolescent trauma to help identify females who were at greater risk of OUD from what I believe is a form of PTSD. If I were to develop the tool today, I would probably make it gender neutral, but the increased risks for females would remain,” Webster said in an email. 

Webster agrees with the University of Georgia researchers that ACEs should be used to help assess whether a patient is at risk of abusing medication. But he says a high number of ACEs should not be used to avoid prescribing opioids to someone who has a medical need for them.  

Illicit Drug Use by Teens Fell Significantly in 2021

By Pat Anson, PNN Editor

Substance abuse by U.S. teenagers declined significantly this year, according to the results of a new national survey that found the use of prescription opioids by adolescents fell to the lowest level in nearly two decades.

Illicit drug use by 10th graders fell by nearly 12 percent in 2021, and by about 5% for eighth and 12th graders. The findings represent the largest one-year decline in illicit drug use by teens since the Monitoring the Future survey began in 1975.

The study by University of Michigan researchers found that teenagers reported increased feelings of boredom, anxiety, depression and loneliness in 2021 – no doubt fueled by pandemic-related fears and isolation. But unlike their adult counterparts, young people overall did not increase their use of marijuana, alcohol and other drugs.

“We have never seen such dramatic decreases in drug use among teens in just a one-year period. These data are unprecedented and highlight one unexpected potential consequence of the COVID-19 pandemic, which caused seismic shifts in the day-to-day lives of adolescents,” Nora Volkow, MD, Director of the National Institute on Drug Abuse, said in a statement.

“Moving forward, it will be crucial to identify the pivotal elements of this past year that contributed to decreased drug use – whether related to drug availability, family involvement, differences in peer pressure, or other factors – and harness them to inform future prevention efforts.”

The Monitoring the Future survey is given annually to students in eighth, 10th and 12th grades, who self-report their drug use behaviors and attitudes. The results from this year’s survey were collected from February through June 2021. Over 32,000 students enrolled in 319 public and private schools in the U.S. participated, with some taking the survey at home and others while at school.

The percentage of students who reported using any illicit drug other than marijuana within the past year decreased significantly. Among 12th graders, for example, 7.2% reported using an illicit drug in 2021, compared to 11.4% in 2020.

Decreases were also reported in the use of alcohol by 12th graders (46.5% in 2021 vs. 55.3% in 2020) and in marijuana (30.5% in 2021 vs. 35.2% in 2020).

Significant declines in use were also reported by students in 2021 for a wide range of drugs, including cocaine, heroin, hallucinogens, cigarettes and nonmedical use of amphetamines, tranquilizers, and prescription opioids.

The decline in drug use by teens is not a one-year fluke and is part of a long running trend. For example, the use of Vicodin by 12th graders has fallen by nearly 92 percent since its peak in 2003. The use of OxyContin has declined by 83% since its peak in 2005.   

MONITORING THE FUTURE SURVEY

“In addition to looking at these significant one-year declines in substance use among young people, the real benefit of the Monitoring the Future survey is our unique ability to track changes over time, and over the course of history,” said Richard Miech, PhD, who led the Monitoring the Future study at the University of Michigan. “We knew that this year’s data would illuminate how the COVID-19 pandemic may have impacted substance use among young people.”

Not all the news is good. The researchers found that adolescents who suffered severe stress, anxiety or depression due to the pandemic, experienced financial hardship, or whose parents used drugs were most likely to use drugs themselves.

Other studies have found that adults who regularly use recreational drugs increased their drug usage during the pandemic. A new study of alcohol sales in 16 U.S. states found a major increase in wine and liquor sales in the first few months of the pandemic, by as much as 20 to 40 percent in some states.

Another recent study found that opioid prescribing briefly increased in the early stages of the pandemic, as patients postponed corrective procedures and it became harder to obtain non-opioid therapies for pain such as massage and physical therapy. Opioid prescribing returned to previous levels after a few months.   

The CDC announced last month that the U.S. has seen over 100,000 drug deaths in the 12-month period ending in May, 2021. The record-high spike in overdoses is thought to be primarily a result of pandemic lockdowns and the continuing spread of illicit fentanyl.   

Little Evidence Opioid Use by Children Leads to Addiction

By Pat Anson, PNN Editor

Healthcare providers have become more cautious in recent years about giving opioid pain medication to children, fearing that even short-term use could lead to a lifetime of addiction or even a fatal overdose.

But in a review at the University of Alberta, pediatric researchers found little evidence to support a link between short-term opioid use in childhood and opioid use disorder (OUD) later in life.

“We actually didn’t find a lot of evidence to directly answer our question,” said senior author Michele Dyson, PhD, assistant professor of pediatrics in the Faculty of Medicine & Dentistry and associate director of the Alberta Research Centre for Health Evidence.

“If opioids are used as indicated, they can be a safe and effective strategy for pain management,” she said. “In some cases, they really are part of the best treatment plan to manage a child’s pain.”

Dyson and her colleagues reviewed 21 observational studies involving nearly 50 million patients under the age of 18 who were exposed to opioids for less than 14 days. Most of the studies were considered low quality and did not look at the duration of opioid use.

One study did show a potential link between short-term exposure and later abuse. But researchers concluded the findings overall were not definitive because they did not specify duration of exposure or lacked a control group. Their findings are reported in the journal Pediatrics.

“There is limited evidence to determine if short-term therapeutic exposure to opioids in childhood is
definitively associated with future nonmedical opioid use or development of an OUD; however, this review suggests a link between lifetime therapeutic opioid use (unknown duration) and nonmedical opioid use. The existing evidence on risk factors for nonmedical opioid use or OUD after short-term therapeutic exposure is unclear,” researchers concluded.

Conflicting Advice

Whether opioid medication is appropriate for children is a controversial issue. Earlier this year, the World Health Organization (WHO) released new guidelines recommending that opioids only be used for children who are dying or seriously ill and not expected to recover.

Like the Alberta study, a WHO advisory panel found little good quality research on how to treat childhood pain, but recommended that children with chronic pain be treated with physical therapy and psychological interventions such as cognitive behavioral therapy.  

An international study in The Lancet came to a very different conclusion, warning that opioid prescribing guidelines intended for adults are being “inappropriately applied to young people.” Because of the stigma associated with opioids, researchers said childhood pain was often untreated or poorly treated, leading to chronic pain, disability and other negative consequences in adulthood.

“Health-care professionals, young people, and parents continue to hold misconceptions and believe myths about opioid use in pediatric patients, whereby the media depicts opioids as the villain and the underlying reason for substance misuse,” researchers said. “Opioids have their place in pediatric pain medicine.”

That finding is at odds with a 2018 warning from the U.S. Food and Drug Administration, which said that cough and cold medications containing opioids pose “serious risks” to children and should no longer be prescribed to patients younger than 18.

A recent study found that opioid misuse is relatively rare in U.S. adolescents and young adults. Less than 1% of those who filled an opioid prescription for the first time overdosed or developed opioid use disorder within the next 12 months.

The conflicting advice can be confusing to both parents and providers.

“Parents see stories about overdoses in the news and are afraid for their children, while physicians and prescribers are also worried because they don’t know what the evidence is,” says Dyson. “Health-care providers don’t want to cause harm, and at the same time, they still want to be able to treat pain appropriately.”

Dyson and her team at the University of Alberta have developed a series of infographics to help physicians, parents and young people recognize that opioid pain relievers are sometimes needed.

One such graphic plainly states: “Opioids don’t have to be scary!”

View fullsize

UNIVERSITY OF ALBERTA INFOGRAPHIC

“While we can’t say for sure that a short-term prescription for pain is linked with misuse, there is some evidence that that could happen,” she explained. “There is likely some risk, but it needs to be balanced with the harms of stigmatizing opioid use and under-treating pain, which comes with its own significant short- and long-term consequences.”

Does U.S. Have Opioid Crisis or Overdose Crisis?

By Pat Anson, PNN Editor

A lot of people were surprised by an alarming report from the CDC last week, showing that a record 100,306 Americans died of a drug overdose in the 12-month period ending in April, 2021. That’s a 28.5% increase in a single year.

Among those who were caught off-guard was Andrew Kolodny, MD, an opioid researcher at Brandeis University and founder of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

“I was surprised by the latest tally from the CDC showing that for the first time ever, the number of Americans who fatally overdosed over the course of a year surpassed 100,000,” Kolodny wrote in an op/ed for The Conversation that’s been republished in several major newspapers.

“The soaring death toll has been fueled by a much more dangerous black market opioid supply. Illicitly synthesized fentanyl – a potent and inexpensive opioid that has driven the rise in overdoses since it emerged in 2014 – is increasingly replacing heroin. Fentanyl and fentanyl analogs were responsible for almost two-thirds of the overdose deaths.”

It’s refreshing to see Kolodny finally address the elephant in the room – illicit fentanyl – instead of always blaming prescription opioids for America’s addiction and overdose problem. But he continues to frame the drug crisis as an “opioid crisis” when repeated studies show that multiple substances are usually involved in overdoses, including non-opioid drugs like cocaine and methamphetamine.  

“It is especially tragic that these deaths are mainly occurring in people with a disease – opioid addiction – that is both preventable and treatable. Most heroin users want to avoid fentanyl. But increasingly, the heroin they seek is mixed with fentanyl or what they purchase is just fentanyl without any heroin in the mix,” Kolodny wrote.

“Opioid-addicted individuals seeking prescription opioids instead of heroin have also been affected, because counterfeit pills made with fentanyl have become more common.”

Here Kolodny sidesteps the fact that many pain patients are turning to street drugs because of government and law enforcement policies that restrict the prescribing of opioid medication – policies that Kolodny and PROP had a significant role in creating. They’re not addicts “seeking prescription opioids instead of heroin.” They’re patients seeking pain relief.

“Our misdirected efforts to solve the overdose epidemic have led to even more deaths. As long as we myopically focus on reducing prescription opioids for people in pain, the overdose epidemic will continue and worsen,” says Lynn Webster, MD, a pain management expert, Senior Fellow at the Center for U.S. Policy (CUSP) and Chief Medical Officer of PainScript.  

“Some of those who need opioids will be driven to the streets where they will find illicit and, potentially, lethal opioids. Some people may even choose to end their own lives. Your readers may have seen the recent article that described a suit against a physician for denying opioid treatment of a patient. The patient committed suicide as a result.” 

Webster says it is wrong to single out opioids – legal or illicit – for America’s escalating drug problem when the causes are complex and embedded in society. 

“We do have an overdose epidemic. Unfortunately, policymakers and the media have wrongly categorized it as an opioid epidemic rather than a drug overdose epidemic,” says Webster. “The roots of the overdose crisis are deep and seeded in despair from major shifts in socioeconomic conditions and lack of adequate and affordable healthcare. The Covid pandemic has made clear that social and mental health issues must be addressed if the overdose crisis is to be reversed. 

“The only solution to the overdose epidemic is to lower the demand. This will require a broad approach that involves addressing socioeconomic and mental health drivers of demand. More affordable and accessible treatment is important but will not solve the crisis.” 

Invested in Opioid Crisis 

Changing the narrative about the overdose crisis won’t be easy, since so many lawyers, politicians, healthcare companies and media outlets have invested in perpetuating the “opioid crisis.” Kolodny and other PROP board members have lucrative side hustles testifying as expert witnesses in opioid litigation cases for plaintiff law firms, which stand to make billions of dollars in contingency fees if their lawsuits are successful. 

One such case was decided by a federal jury in Cleveland today, which found that Walgreens, CVS and Walmart substantially contributed to addiction and overdoses in two Ohio counties by dispensing opioids in their pharmacies. The companies said they would appeal. 

“Plaintiffs' attorneys sued Walmart in search of deep pockets while ignoring the real causes of the opioid crisis-such as pill mill doctors, illegal drugs, and regulators asleep at the switch,” Walmart said in a statement. “And they wrongly claimed pharmacists must second-guess doctors in a way the law never intended and many federal and state health regulators say interferes with the doctor-patient relationship.”

Judges in Oklahoma and California recently ruled that opioid manufacturers are not “public nuisances” and can’t be held responsible for what people ultimately do with their drugs.  

Overdose Crisis Reaches Grim Milestone

By Roger Chriss, PNN Columnist

The CDC announced this week that the U.S. has seen over 100,000 drug overdose deaths in the 12-month period ending May, 2021. This record-high spike in overdoses is thought to be primarily a result of pandemic lockdowns and the continuing spread of illicit fentanyl.

National Institute on Drug Abuse director Nora Volkow, MD, told NPR that the overdoses “are driven both by fentanyl and also by methamphetamines" and predicted that the surge of fatalities would continue because of the spread of more dangerous street drugs.

Connecticut this week warned that fentanyl was found in marijuana and is the suspected cause of several near-fatal overdoses in the state. “This is the first lab-confirmed case of marijuana with fentanyl in Connecticut and possibly the first confirmed case in the United States,” said state public health Commissioner Manisha Juthani, MD.

When asked if there is anything giving hope about the future of the drug crisis, PROP co-founder Andrew Koldony, MD, told Axios, “Uh... not really.”

Public health is often depressing. It is also rarely simple. We are not going to arrest, restrict or treat our way out of the drug crisis. Although harm reduction and improved access to addiction services will help, they will not be sufficient to reverse current trends.

The U.S. does not even have good data on the street drug supply. RAND researcher Bryce Pardo, PhD, looking at better and more current data in Canada, sees designer street drugs becoming even more dangerous.

“There is a recent and alarming trend toward more harmful supply of drugs sold in illegal markets in Canada. Consumers in Ontario, Alberta, and British Columbia buying powder may be at greater risk for exposure to fentanyl mixed with novel benzodiazepines,” Pardo reported in JAMA Psychiatry. “There is a need to improve monitoring and surveillance of drug consumption in the US as markets continue to trend toward more harmful drug mixtures.”

The U.S. also doesn’t have good data on drug deaths. Even the term “overdose” is problematic now. Deaths that are “opioid involved” in toxicological terms are resulting from inadvertent exposure via tainted cocaine and methamphetamine. And although fentanyl and other opioids are still involved in the majority of deaths, there are now more psychostimulant-involved deaths than there were two decades ago.

The U.S. also lacks good data on the people who died, in particular their drug use history, general health status, and other factors thought to affect drug risks and outcomes. It is easy to speculate that the stress and isolation of the pandemic exacerbated existing risks, but it is important to note that suicides did not rise in 2020 when they might have been expected to.

There is no easy policy fix here. Restricting prescription opioids and legalizing cannabis didn’t work. Ideology will not help. Legalizing drugs is a meaningless slogan since neither “drugs” nor “legalization” is well-defined. The same with old narratives and origin stories about the crisis, which may help explain what happened but contribute little about what to do next.

Safe supply is an appealing but problematic notion. There is no obvious way to test illicit substances in human trials. Illicit labs are unlikely to hold back their products any more than illicit cannabis suppliers are going to obey the law. Street drug test kits might help, if only we knew enough about the drugs and their users.

Treatment is similarly challenging. As Kolodny told Axios, “If we really want to see deaths come down in the short run, someone who's opioid addicted has to be able to access treatment more easily than they can buy a bag of heroin or fentanyl.” Though this is an admirable goal, there is no practical way to do it.

And all of this assumes that street users are opioid-addicted. More and more are not, as the increasing levels of death and harm from psychostimulants shows. Further, an increasing number of deaths are “polydrug” deaths involving two or more substances, which makes addressing risks all the more complicated.

But despair is not the appropriate response. The U.S. was facing rapidly rising rates of tobacco-related illness and death for much of the 20th century. But a combination of public health measures has cut the mortality rate from smoking in half since 1990. These measures include stricter laws and regulations, increased costs, and in an unexpected irony, stigmatization of smoking.

Many of the proposed solutions to the drug crisis have been based more on intuition than data. At this point we simply do not know which public health measures are working or how to improve them. What little data we have is often imprecise and years old, and as the crisis accelerates, the importance of granular and timely data grows. Moreover, the measures to date have often been applied piecemeal for short periods, so their real efficacy remains to be determined.

The tragedy of drug deaths cannot be understated, and the potential for far more drug deaths cannot be underestimated. But if the U.S. can improve its understanding of drugs and its response to risks and harms, we needn’t see so many more deaths moving forward.

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. 

OHSU Focused on Opioid Tapering, but at What Cost to Patients?

By Pat Anson, PNN Editor

An internal medicine clinic at Oregon Health & Science University has significantly reduced the use of opioid pain medication through the use of a review board that oversees whether prescriptions are in line with federal and state guidelines, according to a new study.

“The question was, how do clinics actually implement those guidelines in practice?” co-author Jonathan Robbins, MD, assistant professor of medicine at the OHSU School of Medicine, said in a press release. “The opioid review board was a way to turn high-level recommendations into action steps we can take in our clinic to treat patients and create a culture of safe prescribing.”

The study highlights the declining use of high dose opioids at the clinic since 2017, along with increased prescriptions for the addiction treatment drug Suboxone (buprenorphine). But critics say the research failed to address whether pain relief and quality of life improved for patients or if they suffered side effects when they were tapered to lower doses or prescribed buprenorphine.

“This is a frustratingly vague account of a practice that could have serious implications for treating a large number of people with chronic pain,” said Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management. 

“The summary statistics presented give us some idea about how frequently people are being tapered, and how often they are being transitioned to buprenorphine, but we really could use some better data analysis, especially with respect to outcomes,” Twillman wrote in an email. “The article continues a trend in the literature, in which an output of these interventions (i.e., the change in prescribing) is confused with an outcome (i.e., what happens to the patient as a result). Basically, the article says, ‘We decided to do this, and we think it's great.’ But there are no data presented to back that up.”

“We’ll let the article stand for itself,” is the response PNN received from Erik Robinson, a senior communications specialist at OHSU. Robinson declined a request to speak with the authors of the study and to identify members of the review board.

“The article published in the Annals of Family Medicine describes a clinical practice in general terms, and we will not engage questions about specific patient outcomes and clinical discussions among physicians,” Robinson said in an email.

‘High-Risk Cases’ Reviewed

What can be gleaned from the article is that patients with more than 6 opioid prescriptions in a 9-month period had their cases reviewed, along with those on high daily doses that exceed 90 MME (morphine milligram equivalent) or those co-prescribed benzodiazepines. The 90 MME threshold is based on a recommendation in the 2016 CDC opioid guideline.

“We combed through 14,000 patients in our clinic and developed a registry about who we’re chronically treating with opioids,” co-author Mary Pickett, MD, associate professor of medicine in the OHSU School of Medicine, said in the press release. “We picked out high-risk cases to review and invited those patients’ primary care doctors to consult with us.”

The review board initially identified 664 patients on chronic opioid therapy (COT). Three years later, there were only 458 COT patients at the clinic, the number of high-dose opioid prescriptions was reduced significantly, and buprenorphine prescriptions increased over 300 percent.  

But there is no information on how many patients experienced withdrawal, whether their pain levels and quality of life improved, or if patients were satisfied with their treatment. The study only notes that “a subset of patients have had adverse response to tapering.” Those cases were reviewed a second time, but again there are no details about patient outcomes or if the tapering was stopped..

The FDA warned in 2019 that rapid tapering or abrupt discontinuation of opioid therapy could result in serious harm to patients, including withdrawal, uncontrolled pain, psychological distress and suicide. A recent study found that tapered patients were 68% more likely to be hospitalized for withdrawal, overdose or alcohol intoxication, and twice as likely to have a mental health crisis such as depression, anxiety or suicide attempt.  

“We’re coaching primary care providers to approach this carefully, and, when necessary, slowly taper their patients,” Robbins says in the OHSU press release. “We don’t do anything abruptly, and patients have supported this careful process.”

But Twillman wonders if the tapering was voluntary and if patients agreed to have their cases reviewed. The press release mentions a waiver being signed by patients, but the study does not.

“That detail is missing from the scientific publication, and it raises a concern about the extent to which that signature is truly voluntary, or if it is coerced by a threat to stop prescribing if the waiver is not signed. What is the consequence for patients who don't sign the waiver?” asked Twillman.

“And what happens if tapering or transition to buprenorphine is recommended, and the patient doesn't agree? We've seen the dangers of involuntary tapers in several studies now, so is any tapering that happens truly voluntary, and supported appropriately with ancillary services? In sum, this article raises more questions than it answers.”

Patient Urged to Taper

“In my experience, they care more about de-prescribing than they do about their patients' individual needs,” says Emma, a patient at OHSU’s Comprehensive Pain Center who lives with an intractable pain condition. She asked that we not use her real name because she fears retaliation or being discharged from the pain clinic.

Emma gets opioids from her primary care provider, but can’t get any from the pain clinic, which she says has a strict policy against prescribing opioids at any dose.

Emma says she is constantly urged to taper by her OHSU doctor. The pain clinic emphasizes non-opioid alternative treatments such as physical therapy, acupuncture, yoga, massage and psychotherapy. 

“I’m getting pretty damn fed up with OHSU’s total lack of concern for my wellbeing. They’ve all but eliminated individualized care when it comes to the treatment of pain.”

— OHSU patient

“I told them that I had spent years trying every possible alternative, and had become suicidal due to severe untreated pain. That was when my primary doc asked me to at least consider opioids as an alternative to taking my own life. I did try them, and they gave me my functionality back,” she told PNN.

“I'm getting pretty damn fed up with OHSU's total lack of concern for my wellbeing. They've all but eliminated individualized care when it comes to the treatment of pain. And how they can label the Comprehensive Pain Center a ‘pain management clinic’ while completely eliminating an entire class of effective medications is beyond me.”

Roger Chou’s Role

Patients at OHSU’s Comprehensive Pain Center were apparently not included in the study on tapering. But they too have their cases regularly reviewed by a panel of pain management experts.

One of the experts is Roger Chou, MD, a prolific researcher and longtime critic of opioid prescribing who heads OHSU’s Pacific Northwest Evidence-based Practice Center (EPC). According to the website GovTribe, over the last five years OHSU has been awarded over $2 billion in federal grants – much of it going to the EPC to support Chou’s medical research.

In addition to his research, Chou co-authored the CDC’s 2016 opioid guideline and has collaborated on several occasions with members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid advocacy group.

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.” He also served on a state task force that supported a rigid opioid tapering policy for Medicaid patients in Oregon.

Emma considers Chou “a major player behind all of OHSU’s anti-opioid policies” and is concerned that guidelines that he helped write are being used to justify tapering.

“It’s concerning to me that they’re justifying these actions by stating that they’re ‘in alignment with the guidelines.’ So essentially, they are both creating and enforcing their own set of guidelines with no transparency and no real oversight,” she said.

Last year, the American Medical Association called for a major overhaul of the CDC guideline, saying it was clear the agency’s recommendations “harmed many patients” by setting arbitrary limits on opioids.

The CDC is currently in the process of revising and possibly expanding the guideline, with the goal of releasing a new version next year. One of the authors drafting the revised guideline is Roger Chou.

Fearing DEA, Many Pharmacies Stop Dispensing Addiction Medication

By Aneri Pattani, Kaiser Health News

When Martin Njoku saw opioid addiction devastate his West Virginia community, he felt compelled to help. This was the place he’d called home for three decades, where he’d raised his two girls and turned his dream of owning a pharmacy into reality.

In 2016, after flooding displaced people in nearby counties, Njoku began dispensing buprenorphine to them and to local customers at his Oak Hill Hometown Pharmacy in Fayette County.

Buprenorphine, a controlled substance sold under the brand names Subutex and Suboxone, is a medication to treat opioid use disorder. Research shows it halves the risk of overdose and doubles people’s chances of entering long-term recovery.

“I thought I was doing what was righteous for people who have illness,” Njoku said.

But a few years later, the Drug Enforcement Administration raided Njoku’s pharmacy and accused the facility of contributing to the opioid epidemic rather than curbing it. The agency revoked the pharmacy’s registration to dispense controlled substances, claiming it posed an “imminent danger to public health and safety.” Although two judges separately ruled in Njoku’s favor, the DEA’s actions effectively shuttered his business.

“I lost everything that I worked for,” Njoku said.

Lawyers, pharmacists, harm-reduction advocates and a former DEA employee say Njoku’s case is emblematic of the DEA’s aggressive stance on buprenorphine. An opioid itself, the medication can be misused, so the DEA works to limit its diversion to the streets. But many say the agency’s policies are exacerbating the opioid epidemic by scaring pharmacies away from dispensing this medication when it’s desperately needed.

Drug overdose deaths hit record highs last year, and despite medical experts considering medications like buprenorphine the gold standard, less than 20% of people with opioid use disorder typically receive them. The federal government has taken steps to increase the number of clinicians who prescribe buprenorphine, but many patients struggle to get those prescriptions filled. A recent study found that 1 in 5 U.S. pharmacies do not provide buprenorphine.

“Pharmacies are terrified they’re going to lose their DEA registration and go out of business,” said Charles “Buck” Selby, a former inspector and chief compliance officer for the West Virginia Board of Pharmacy, who retired in 2018.

The ramifications can be particularly acute in rural areas, where a dearth of addiction treatment providers, lack of transportation and stigma against these medications already create barriers. If pharmacies decline to provide buprenorphine too, patients will have few options left, Selby said.

The DEA did not respond to requests for comment.

Buprenorphine Misuse

Like many other prescription drugs, buprenorphine can be found illegally on the street. There are unscrupulous doctors who hand out prescriptions and pharmacists who fill them. Subutex, which consists of buprenorphine alone, is easier to misuse and typically has higher street value than Suboxone, a combination of buprenorphine and the overdose-reversal drug naloxone.

In the case against Njoku’s pharmacy, an assistant U.S. attorney explained that the DEA “got slapped hard for being asleep at the switch as the opioid crisis ramped up. … They’re trying to make sure that Subutex doesn’t become the next problem,” according to court transcripts.

But recent research suggests that buprenorphine misuse has decreased in recent years even as prescribing has increased, and that most people who use diverted buprenorphine do so to avoid withdrawal symptoms and because they can’t get a prescription.

Misuse rates for buprenorphine are twice as high as misuse rates for hydrocodone, oxycodone and other opioid medications, but buprenorphine is less likely to cause overdoses because its effects taper off at higher doses, said Dr. Aaron Wohl, medical director of the Florida-based coalition Project Opioid.

In Njoku’s case, the DEA said in court documents that several “red flags” had suggested the pharmacy’s actions were irresponsible. First, many of the prescriptions it filled were for Subutex instead of Suboxone. Patients also traveled – sometimes out of state – to get prescriptions, drove long distances within West Virginia to reach Njoku’s pharmacy, and often paid in cash.

In traditional prescription drug cases, these are all markers of trouble. But — as Njoku’s lawyers argued and two judges later agreed — they can also reflect the difficulty of getting addiction treatment, which is sometimes more challenging than obtaining illicit drugs.

“The practical reality and context of West Virginia turn these additional flags from red to yellow,” U.S. District Judge Joseph Goodwin wrote in his opinion. Patients may go out of their way for the drug because there aren’t enough nearby doctors who prescribe it or pharmacies that stock it, he wrote. They might pay cash because they’re uninsured or Medicaid won’t cover prescriptions written by an out-of-network doctor. And they might prefer Subutex because it’s often cheaper than Suboxone.

By 2020, Goodwin and an administrative law judge at the DEA had both ruled in Njoku’s favor. But several insurers and drug suppliers had already stopped doing business with him. Njoku closed the pharmacy in April 2021. 

‘Prescribing Cliff’

Across the country, when a pharmacy stops providing buprenorphine, the ripple effects can be far-reaching.

Trish Mashburn works at two independent pharmacies in western North Carolina. When a nearby pharmacy stopped dispensing buprenorphine, she began getting five calls a day from prospective customers trying to get their prescriptions filled, she said. Although both her employers stock buprenorphine, they order only a set amount, so Mashburn often must turn patients away.

Research in North Carolina and Kentucky has found that many pharmacists worry that ordering more buprenorphine will trigger a DEA investigation. The DEA does not specify thresholds for controlled substances, but it requires wholesalers to flag suspicious orders. In turn, wholesalers limit how much a pharmacy can buy or create algorithms to detect orders that exceed projected need.

They base these limits, in part, on the DEA’s enforcement actions, said Larry Cote, a former DEA attorney who now advises wholesalers, pharmacies and other clients on regulatory compliance. Since pharmacies are not typically privy to how these limits are set, many simply order small batches of buprenorphine out of caution.

That creates a “prescribing cliff,” said Bayla Ostrach, lead author of a paper studying this issue in North Carolina. Doctors may prescribe buprenorphine to more patients, but pharmacies order enough for only a certain number of customers. Since many people stay on buprenorphine for years, once the pharmacy hits its self-established quota, it may rarely have openings for new patients.

A Lee County, Florida, man thought he was one of the lucky ones. James, 34, had been filling his Subutex prescription at the supermarket chain Publix for seven years. In that time, he held steady jobs and cared for his wife and children. (James asked KHN to withhold his last name so future employers wouldn’t judge him on his addiction history.)

Then, last year, James said, he went to get his prescription refilled and was told Publix no longer stocks Subutex — the medication the DEA considered a “red flag” in Njoku’s case. Publix did not respond to requests for comment.

A decade ago, when James began the medication, he chose Subutex because it was cheaper than Suboxone. Today, most insurance plans cover Suboxone, and the price difference has narrowed somewhat.

James was not eager to change to a potentially pricier medication. And he worried a different drug might disrupt his recovery — a common sentiment among patients in long-term recovery, said Dr. Nathan Mullins, director of addiction medicine fellowship at Mountain Area Health Education Center in North Carolina. Changing their medication is unnecessary and can cause needless anxiety, Mullins said.

Luckily, James found an independent pharmacy that provides Subutex. It’s more expensive, since the new place doesn’t accept his insurance, he said. He pays about $40 a week, compared with $40 a month previously.

But James said it’s worth it.

“I’ve been in 10 rehabs and a million detoxes, and the only thing that has worked for me was one sublingual tablet,” James said. Along with therapy, “this saved my life.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

Misuse of Rx Opioids Continues to Decline

By Pat Anson, PNN Editor

For the fifth consecutive year, misuse of opioid medication fell in 2020, according to a new national survey that further documents the declining role of prescription pain relievers in the U.S. drug abuse crisis.

The annual report by the Substance Abuse and Mental Health Services Administration (SAMHSA) estimated that 59.3 million people used an illicit drug last year – about one in every five Americans aged 12 or older. The most commonly used illicit drug was marijuana, which was used by 49.6 million people in 2020. Prescription pain relievers were misused by 9.3 million people, most of them taking a medication that was not their own.

The National Survey on Drug Use and Health classifies “misuse” in broad terms. It means using a prescription drug in any way not directed by a doctor, including using someone else’s prescription or using a drug in greater amounts, more often, or longer than directed by a doctor. That would include someone taking an additional pill during a pain flare.

Nearly two-thirds (64.6%) of respondents who admitted misusing a pain reliever said they did it to relieve physical pain. Only 11.3% said they misused a pain medication to feel good or to get high.  

Although the rate of illicit drug use has been steadily rising in the United States for many years, the misuse of prescription pain relievers has fallen by nearly 30% since 2015, most likely a reflection of fewer prescriptions, decreased supply, and the availability of other illicit drugs. An estimated 3.3% of Americans misused a pain medication in 2020.

% MISUSE RATES FOR PRESCRIPTION PAIN RELIEVERS

SOURCE: SAMHSA

Hydrocodone was the prescription pain reliever most likely to be misused, followed by oxycodone, codeine and tramadol. Most people who misused pain medication said they did not have a prescription of their own, and obtained the drug from a friend or relative (47.2%) or bought it from a drug dealer or stranger (6.2%).  

A nationally representative sample of over 36,000 people participated in the annual SAMHSA survey. Due to the pandemic, most of the respondents participated online due to concerns about conducting interviews in person.

While anti-opioid activists have long claimed that opioid medication frequently leads to heroin use, the SAMHSA survey found there was little association between the two drugs.

“In 2020, the majority of the 9.3 million misusers of prescription pain relievers misused only prescription pain relievers in the past year (8.6 million people), but they had not used heroin. An estimated 667,000 people misused prescription pain relievers and used heroin in the past year, and 235,000 people had used heroin in the past year but had not misused prescription pain relievers,” SAMHSA reported.

A record 96,779 drug deaths were reported in the U.S. over a 12-month period ending in March 2021. The vast majority of the overdoses involved illicit fentanyl and other street drugs. Although the DEA recently issued a public safety alert warning of a surge in counterfeit pills made with illicit fentanyl, the agency has proposed further cuts in the legal supply of prescription opioids in 2022.

Focus on Opioid Crisis Overlooks Rise in Stimulant Deaths

By Pat Anson, PNN Editor

While much of the nation was focused on the opioid crisis, new research shows that another drug epidemic was taking the lives of U.S. military veterans.

University of Michigan researchers say the rate of veteran overdose deaths involving cocaine, methamphetamine and other stimulants tripled from 2012 to 2018. Most of the veterans did not receive any substance abuse treatment in the year before they died.

“We have been so focused on opioids that we are missing the tremendous increase in people who are using multiple substances, as well as those using stimulants only, when we know that many people don’t stick to just one substance,” says lead author Lara Coughlin, PhD, a psychologist and an assistant professor in the U-M Department of Psychiatry. “The fact that so many of those who died of an overdose had not received substance use disorder treatment is especially concerning.”

Coughlin and her colleagues reviewed the medical records of 3,631 veterans who died from overdoses involving stimulants, and found that about two-thirds of the deaths involved cocaine. Over half of the stimulant deaths (54.1%) also involved another substance, usually alcohol or an illicit opioid such as heroin or fentanyl. Prescription opioids were involved in less than 26% of the stimulant-related overdoses.

Researchers called the tripling of stimulant deaths “an escalating public health crisis” that deserves more attention.

“Recent trends show stark increases in stimulant-involved overdoses, with the majority of these overdoses deaths involving multiple classes of substances. These more complex, polysubstance-involved overdose deaths necessitate an expansion from a singular opioid-centric focus to include other substances and consideration of the role of stimulant use on overdose risk to inform effective prevention and treatment efforts,” researchers reported in the journal Addiction.

The authors noted there are few medication-based treatments to help people reduce their use of methamphetamine or cocaine, while multiple medications are available to treat those with opioid or alcohol use disorders.

Better access to treatment was especially needed for veterans in rural areas and those who are homeless. About one-third of all the overdose deaths involving stimulants were in Black veterans, as were two-thirds of the deaths from cocaine alone.

In addition to the risk of overdose, researchers say people who use methamphetamine or cocaine are at greater risk of heart damage. About 62% of the overdoses involving stimulants were among veterans aged 45 to 64.

“We need to build better awareness of the role of stimulants as a risk factor for overdose, and of the need for those who have stimulant use disorders to be referred for treatment, regardless if they are also using opioids,” said Coughlin. “We know that cocaine and methamphetamine are much more likely to be adulterated with fentanyl or other synthetic opioids now, so those who use them need to be equipped with rescue doses of naloxone to use and need to know about the risk for overdose in case they or someone they’re with experiences an unexpected, life-threatening reaction.”

The rise in stimulant deaths has not occurred in a vacuum. In the first half of 2019, data from 24 states and the District of Columbia showed that stimulants were involved in 5 out of 11 fatal overdoses. The CDC issued a Health Alert Network Advisory last year about a record number of overdoses, due in part to an acceleration in stimulant-related deaths.