Do You Get Adequate Pain Management?

By Victoria Reed, PNN Columnist

For the last few weeks, I’ve been suffering from persistent sinus and dental pain. Sinus pain is not new to me, as I have long-standing allergies which cause swelling in the nasal passages and chronic congestion that sometimes leads to an infection. The medications that I take for my rheumatoid arthritis increase the risk for all types of infections, as they suppress the immune system.  

After seeing a doctor, a sinus infection was diagnosed. Towards the end of a course of antibiotics, I had marked improvement with the sinus symptoms, but was still having considerable pain when chewing, which radiated to my right ear and jaw.  

Initially, I assumed that the pain was related to the sinus infection, but when that didn’t go away after finishing the antibiotics, I made an appointment to see my dentist. He did the usual poking and prodding around my gums and teeth, trying to find the source of the pain, and discovered two areas that could be the culprits. He did a flushing procedure of the gums to try to alleviate the pain. 

However, after the procedure was completed, I had such severe pain that all I could do was hold my head in my hands, while tears seeped out of my eyes. The pain was as bad as the pain I had felt while giving birth without an epidural! 

After more than a few minutes, my face and jaw continued to throb and the pain had not subsided. The dentist could see that I was in quite a bit of distress. He then asked me what the pain level was before I had come in. I replied that it had been a 5, but “now it’s a 10.”  

He sat down beside me and tried to explain what he believed the problem was. It was hard to concentrate, but I was able to understand what he was saying. He told me that he thought a tooth was cracked and that I needed to see an endodontist, a root canal specialist. He also prescribed another antibiotic.  

The dentist then stood up and patted me on the shoulder with compassion. Clearly, he was sorry for having amplified my pain. I appreciated his compassion, but I was ready to leave. At that point, all I wanted was to move on to whichever provider could relieve the awful pain.  

Then, to my surprise, I was offered opioid pain medication! 

This was something I absolutely did not expect. I had root canals for severe infections in the past, but no prescription opioids had been offered and I was sent home with instructions to take over-the-counter pain relievers. The days of getting opioid medication for severe dental pain were over, I assumed.  

However, after my initial shock, I politely declined the prescription. Why? Because I already receive a mild prescription opioid for my chronic pain conditions. Sure, I could have taken the prescription and not said a word about that, but I knew that I should honor the pain management contract I had signed with my doctor.  

While I believed that a stronger medication would have been helpful for my tooth pain, I did not want to risk being ejected from my pain management program. My contract (and nearly all pain management contracts) explicitly states that I am not allowed to receive any additional opioids from any other provider.  

I turned down the possibility of immediate relief of my dental pain so that I wouldn’t lose my regular prescription for chronic pain. I felt that I had no other choice. In addition, I didn’t want to be “red-flagged” by the pharmacy as a drug seeker, even though I did have a legitimate need for the new prescription.  

The pendulum has swung too far in the effort to control opioid overdoses and many people do not receive appropriate medications to treat their pain. I realize that I am one of the lucky ones to still get a prescription opioid, and I feel for those who aren’t as fortunate as me.  

Every patient should advocate for themselves, but if you are unable or afraid to, try having a family member or friend do it for you. Don’t settle for treatment that is less than optimal. If you are unhappy with your treatment or have intolerable side effects, discuss it with your doctor and ask for a different treatment plan. Doctors generally want to help, but some may feel that their hands are tied when it comes to prescribing opioids.  

Unfortunately, chronic pain patients must continue to jump through hoops in order to be treated ethically, fairly and adequately. Many are denied appropriate treatment due to prescribing limits and doctors’ fear of prosecution for prescribing opioids. I am hopeful that with the upcoming revision of the CDC opioid guideline, things will change for the better.  

Victoria Reed lives in Cleveland, Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis. 

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.

Oklahoma Supreme Court Reverses Landmark Opioid Ruling

By Pat Anson, PNN Editor

Oklahoma’s Supreme Court has reversed a landmark court ruling that found opioid drug makers created a public nuisance and were responsible for the state’s opioid crisis. It was the second major victory this month for the pharmaceutical industry, as it fights back against a tsunami of opioid litigation around the country.

The 5-1 decision by Oklahoma’s highest court throws out a $465 million verdict by Judge Thad Balkman against Johnson & Johnson. Former Oklahoma Attorney General Mike Hunter alleged that J&J and two other drug makers fueled the opioid crisis by flooding the state with painkillers. But the court said J&J can’t be held liable for the actions of others with legally prescribed opioids.

"We hold the opioid manufacturer's actions did not create a public nuisance. The district court erred in extending the public nuisance statute to the manufacturing, marketing, and selling of prescription opioids," the ruling states.

The decision is very similar to a ruling by a California judge last week, who said that J&J and three other drug makers can’t be held responsible for “adverse downstream consequences flowing from medically appropriate prescriptions.”

Like the California judge, Oklahoma’s high court acknowledged that an opioid epidemic exists and that it has caused the overdose deaths of thousands. While illicit use of prescription opioids led to many of those deaths, the court said few deaths occurred when individuals used opioids as prescribed.

“J&J had no control of its products through the multiple levels of distribution, including after it sold the opioids to distributors and wholesalers, which were then dispersed to pharmacies, hospitals, and physicians' offices, and then prescribed by doctors to patients. J&J also had no control over the laws and regulations that govern the disbursement of its prescription opioids or whether prescribers follow the laws,” the court said.

“We also cannot disregard that chronic pain affects millions of Americans. It is a persistent and costly health condition, and opioids are currently a vital treatment option for pain. The U.S. Food and Drug Administration has endorsed properly managed medical use of opioids (taken as prescribed) as safe, effective pain management, and rarely addictive.”

An Oklahoma patient advocate told PNN the court’s ruling was the “only logical outcome” because the state failed to prove its case.

“Their evidence never proved that bad marketing caused excess prescriptions nor the overdose crisis,” said Tamera Lynn Stewart, Policy Director for the P3 Political Action Alliance. “Looking at the totality of the evidence and data available from state and federal sources, it is clear that this crisis was always caused by attempts to fuel the drug war. If this use of public nuisance was allowed to stand, it would open up Pandora's box to future use against any company that produces a product for public use.”

Possible Impact on Other Cases

Plaintiff law firms representing state and local governments have filed over 3,000 lawsuits against drug makers, opioid distributors and pharmacies for their role in the opioid crisis. If successful, the law firms stand to make billions of dollars in contingency fees.

“Coming on the heels of a verdict in favor of opioid manufacturers in California, this news really casts significant doubt on similar cases that are still underway. I haven't read the ruling in this case yet, but the fact that the decision was 5-1, and that the lone dissenter agreed with the premise of the court's majority, but only wanted a different procedural outcome, means that the Oklahoma Supreme Court was not the least bit swayed by the state's case,” said Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management.

“It will be interesting to see if this court picked up on the same issues identified by the judge in California, namely, that the plaintiffs' presentation missed the mark with respect to an accurate and non-hyperbolic presentation of the facts. It's worth noting that much of the hyperbole came from ‘expert’ witnesses such as Andrew Kolodny.”

The state’s star witness in the Oklahoma trial was Kolodny, an addiction treatment specialist who founded Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Dr. Kolodny claimed that J&J and other drug makers operated an “opioid mafia” that funded patient groups and professional medical organizations that promoted the use of opioids.

“I don’t believe physicians should be helping drug companies market their products,” Kolodny testified in 2019. “It’s very easy to fool yourself when it’s profitable to fool yourself.”

Kolodny admitted under questioning that he was being paid $725 an hour to testify by the law firm of Nix Patterson & Roach and stood to make up to $500,000 for his services in Oklahoma. He also acknowledged that he was paid a similarly high hourly rate as a consultant for at least one other law firm involved in opioid litigation. Other PROP board members have also been paid witnesses in opioid litigation cases.

“It looks like the half-million dollars (or more) paid to him and to others is an indication of just how invested the plaintiffs are in the bill of goods they have been sold,” Twillman said in an email. “Meanwhile, while fully recognizing the toll taken by opioid use disorder, we need to keep reminding people of the harm caused by the pursuit of cases such as these -- the harm suffered by people with chronic pain who rely on opioid medications for pain relief, but whose access to those medications has been severely limited by the money-grab inherent in these cases. If there really is a public nuisance here, it may be that these cases are that nuisance.”

Purdue Pharma and Teva Pharmaceuticals settled out-of-court with Oklahoma before the case even went to trial, for $270 million and $85 million respectively. Several other drug companies have also settled out of court or are contemplating settlements rather than risk protracted and expensive litigation. The California and Oklahoma rulings are no doubt giving them second thoughts.

According to the CDC, the U.S. saw over 96,000 fatal overdoses in the 12 month period ending in March, 2021. Most of the deaths involve illicit fentanyl and other street drugs, not prescription opioids.

Most Americans Believe Opioids Necessary for Pain After Surgery

By Pat Anson, PNN Editor

Nearly 8 out of 10 U.S. adults believe opioids are sometimes necessary to manage pain after a surgery, according to a new survey that found most people are more worried about treating post-operative pain than they are about becoming addicted to opioids.

The online survey of over 2,000 adults was conducted last month by The Harris Poll on behalf of MediaSource and Orlando Health, a large Florida-based healthcare system. The survey comes at a time when many hospitals around the nation have adopted policies that discourage or eliminate the use of opioids after many common surgeries.

A recent study of nearly half a million surgeries performed at U.S. hospitals found that the number of opioid pills prescribed to patients decreased by 50% since 2017. Instead of opioids, hospitals are giving patients acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), gabapentinoids and other non-opioid medications.  

“It's very important for us to keep in mind that people do have pain and people do need pain control. The solution is not to just pull opioids away from people and leave them to fend for themselves,” said Luke Elms, MD, a general surgeon at Orlando Health’s Dr. P. Phillips Hospital. “That is a real problem after surgery that needs to be addressed in a compassionate manner.”

Dr. Elms has implemented a protocol that uses over-the-counter drugs like acetaminophen, ibuprofen and muscle relaxers. He says they are safer medications than opioids and help surgical patients recover faster without side effects such as nausea, dizziness and constipation.

“When I talk to patients and reassure them that we're going to be replacing opioids with a much more effective and safe method, and really talk to them about the risks of opioids that have become much more evident with the research that's come out recently, most patients are very open to the idea,” Elms said in a press release.

But that is not how most U.S. adults feel, according to the survey findings. When asked a series of questions about post-surgical pain, many said they have a strong preference for opioids:

• 78% Believe opioid pain medication after surgery is sometimes necessary

• 67% Expect to receive opioids to manage pain after surgery

• 65% Are more concerned about pain relief after surgery than opioid addiction

• 60% Prefer strong prescription painkillers over OTC pain relievers like ibuprofen

At the same time, over two-thirds of respondents (68%) said they are open to the idea of using non-opioid pain relievers and would be willing to try them. Adults who are employed, have high incomes and those with college degrees are more likely to prefer sticking to opioids.

Opioid addiction is actually quite rare after surgery.  A large 2016 study found that less than one percent of older adults were still taking opioids a year after major surgery.  Another large study in 2018 found less than 1% of patients prescribed opioids for post-operative pain were later diagnosed with opioid dependence, abuse or had a non-fatal overdose.

A recent Mayo Clinic study found that hospital guidelines are useful in reducing the number of opioid pills prescribed after surgery, but sometimes go too far. While most patients were satisfied with their pain control, about 10 percent were not.  

Poorly controlled post-operative pain is associated with increased morbidity, less function and quality-of-life, delayed recovery time, and higher health-care costs. The intensity of acute pain during or after surgery is also predictive of developing of chronic pain.

Integrative and Comprehensive Pain Management Provide Only Small Benefits

By Pat Anson, PNN Editor

As concerns rose in recent years about opioid addiction and overdoses, it became trendy for healthcare providers to offer “comprehensive” or “integrative” pain management programs to patients – usually a combination of medication, physical and behavioral therapy, lifestyle changes and alternative treatments such as massage and acupuncture.

But a new study commissioned by the Agency for Healthcare Research and Quality (AHRQ) found that integrative and comprehensive pain management provide only small improvements in pain and function for people with chronic pain.   

Researchers at Oregon Health & Science University (OHSU) reviewed 57 “fair quality” clinical studies, most involving patients with moderate chronic pain caused by fibromyalgia, osteoarthritis and musculoskeletal conditions. Although the improvements in pain and function were small and the evidence limited, researchers concluded that integrative (IPMP) and comprehensive (CPMP) pain management programs worked about as well as individual treatments.

“Our review suggested that IPMPs and CPMPs may provide small to moderate improvements in function and small improvements in pain for patients with chronic pain compared with usual care and may be more effective than some medications alone. The average improvements in function and pain in our review were consistent with those reported for other therapies for pain, including opioids for chronic pain, nonpharmacologic treatments, and surgery,” researchers found.

One of the problems researchers encountered was the mish-mash of terms used to define integrative and comprehensive pain management – such as multimodal, multidisciplinary, interdisciplinary and biopsychosocial – the meaning of which often varies from provider to provider. Researchers said there was “no firm consensus on their definition or use,” which made it harder to evaluate their effectiveness. Only a few of the reviewed studies compared treatments head-to-head and many were of poor quality.

Although none of the trials specifically included Medicare patients, researchers concluded that IPMPs and CPMPs should be more widely used to address pain in the Medicare population.   

“To the extent that programs are tailored to patients’ needs, our findings are potentially applicable to the Medicare population. Programs that address a range of biopsychosocial aspects of pain, tailor components to patient need, and coordinate care may be of particular importance in this population,” they said. 

“Although use of selected individual treatments may serve some patients, a broader range of therapies that address the full scope of biopsychosocial concerns available in formal programs may benefit others. Research in the Medicare population and in patients with a broader range of pain conditions is needed as is research on the impact of program structures, coordination methods, and components on patient outcomes. Additional evidence from primary care-based programs is particularly needed.” 

One of the co-authors of the AHRQ study is Dr. Roger Chou, a primary care physician who heads the Pacific Northwest Evidence-based Practice Center at OHSU.  Chou, who co-authored the 2016 CDC opioid guideline, is a prolific researcher who has collaborated on several occasions with members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid advocacy group.

PROP Vice President Gary Franklin, MD, “provided input” on the AHRQ study, as well as others.

In July, Chou declared a conflict of interest and recused himself from a meeting of the CDC’s Board of Scientific Counselors, which is evaluating a revision and possible expansion of the agency’s controversial guideline. Chou’s recusal apparently applied only to that meeting, as he is one of the co-authors of the revised opioid guideline — which has yet to be released publicly — and continues his involvement in federally funded pain research. 

OHSU researchers have conducted a series of reviews on a wide variety of pain therapies for the AHRQ. According to the website GovTribe, over the last five years OHSU has been awarded over $2 billion in federal grants for medical research. 

A group of patient advocates and researchers recently called for a congressional or DOJ investigation of the CDC opioid guideline, due to Chou’s significant role in writing it and his then-undeclared conflicts of interest.

Why Oral Opioids Can Give Poor Pain Relief

By Forest Tennant, PNN Columnist

Every day, our Research and Education Projects hear from persons with a serious pain problem who can’t obtain enough relief. There are multiple reasons, but a major one is that they are trying to relieve their pain with oral opioids. It appears to us that there is a gross misunderstanding and ignorance about the inability of oral opioids to ever provide good pain relief in many persons who have Intractable Pain Syndrome (IPS).

A person who has constant pain from adhesive arachnoiditis, Ehlers-Danlos Syndrome (EDS), Reflex Sympathetic Dystrophy (CRPS/RSD), cervical neck neuropathy, or another disease that causes constant pain with cardiovascular and endocrine abnormalities will often have impairment of the stomach and intestine. This affects their ability to properly dissolve, digest and place enough opioid into the bloodstream to get pain relief. This occurrence is technically called “opioid malabsorption” or “opioid maldigestion.”

All the conditions listed above cause dysfunction of the many nerves that go from the spinal cord to the stomach and intestine. The nerves carry the bioelectricity that activates the stomach and intestines so that the acids and enzymes from them will fully dissolve and digest tablets, capsules and liquids. EDS, diabetes and autoimmune diseases may also erode or degenerate the collagen matrix of the small intestine, so it won’t properly function, which impedes digestion.

Stomach and intestinal malfunction due to many severe painful diseases may manifest differently at different times. For example, on some days function will be good, and on others, almost non-existent. Another example is “maximal ability.” In this case, the impaired stomach and intestine will allow only a maximal amount of opioid to be digested. For example, 4 tablets will provide some relief, but 6 or 8 won’t do any better.

Review your situation. Do you have some days when you got relief, but not others? Does increasing your oral dose give you no more relief?

If you have IPS, don’t always count on oral opioids to give you the pain relief you need. Start looking into opioid injections, suppositories, patches, topicals, sublingual (under-the-tongue), or buccal (inside the mouth-upper cheek). Also, start probiotics and/or intestinal enzyme preparations, as they sometimes help oral opioids do their job.

Injectable and Suppository Opioids

Why aren’t injectable and opioid suppositories the standard care for severe pain flares? They used to be. For example, the 1956 Merck Manual (9th Edition) states “more severe pain requires the oral or subcutaneous use of narcotics.”

Today, most doctors somehow have the irrational and false idea that injectable opioids always cause overdoses and/or will be diverted into illegal channels. Most doctors are hardly aware that opioid suppositories are available from the local pharmacy and that they are far more effective for flares or breakthrough pain than oral opioids.

At best, an oral opioid will need 30 to 60 minutes to provide pain relief. Opioids administered by injection or suppository work much faster, bypassing the stomach, intestines and liver, and going right to the blood brain barrier.  Pain relief will usually occur within 5 to 10 minutes. Pain relief is also much better, even at a fraction of the oral dose, because the entire dosage reaches the endorphin receptors without being filtered by the stomach, intestines and liver.

Opioid injections and suppositories help patients remain below the CDC guideline’s recommended daily limit of 90 morphine milligram equivalent (MME).

Injectable opioids are used subcutaneously or intramuscularly, not intravenously, for at home use. Injectable
opioids should only be used for flares.

Our enthusiasm for injectable opioids has been enhanced by the development of compounded hydromorphone. This innovation allows a micro dose of only .1cc (5mg), which can be taken subcutaneously with a small needle.

Opioid injections have traditionally been prescribed by local primary care practitioners who know the patient is responsible, and not a street person or substance abuser. Patients and their families should also be trained and warned to keep the injectable away from children, pets and guests. We are not aware of a single case of injectable opioid reaching the street or causing an overdose death in a bona fide IPS patient who was trained with their family.

IPS patients and families can inquire at their local pharmacy as to which injections and suppositories are available. Then approach your personal MD, DO, or NP about starting an opioid injection or suppository for pain flares. 

Every IPS patient needs to achieve some pain free hours so they can walk, physically exercise their arms and
legs, do activities of daily living, and be able to mentally concentrate enough to be able to read and write. These hours of zero or very little pain help strengthen the cardiovascular and endocrine systems so some tissue regeneration can occur and permanently reduce their constant pain. Injectable opioids provide the best opportunity at achieving some pain free hours.

Forest Tennant, MD, DrPH, 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.     

Judge Finds ‘No Evidence’ Pain Relievers Caused Opioid Crisis

By Pat Anson, PNN Editor

In a major victory for the pharmaceutical industry, a California judge has ruled that four opioid manufacturers did not use deceptive marketing to promote pain relievers and are not liable for the state’s opioid crisis.

Three California counties and the city of Oakland filed suit against Johnson & Johnson, Allergan, Endo and Teva Pharmaceuticals, claiming they used false and misleading marketing to increase sales of prescription opioids.

But in Monday’s ruling, Orange County Superior Court Judge Peter Wilson said there was no evidence that “medically appropriate prescriptions” fueled the opioid crisis.

"There is simply no evidence to show that the rise in prescriptions was not the result of the medically appropriate provision of pain medications to patients in need," Judge Wilson wrote in a 41-page ruling. "Any adverse downstream consequences flowing from medically appropriate prescriptions cannot constitute an actionable public nuisance.''

Plaintiff law firms representing local governments across the nation have filed over 3,000 lawsuits against drug companies for their role in the opioid crisis. Several cases have already been settled out of court.

Los Angeles, Orange and Santa Clara counties and the city of Oakland wanted the four drug companies to pay over $50 billion in damages. The law firm of Motley Rice filed the initial lawsuit in 2014 on behalf of Santa Clara county, and the case snowballed from there into nationwide litigation against opioid makers, distributors and pharmacies. If successful, plaintiff law firms stand to make billions of dollars in contingency fees.

Judge Wilson’s tentative ruling – which only applies to the California case -- was the first big win for drug companies involved in opioid litigation. The plantiff law firms said they would appeal.

“The people of California will have their opportunity to pursue justice on appeal and ensure no opioid manufacturer can engage in reckless corporate practices that compromise public health in the state for their own profit,” the lawyers said in a statement.

Addiction Claims Debunked

Anti-opioid activists have long claimed that “overprescribing” of opioid medication fueled the U.S. drug abuse crisis, an argument that Wilson rejected. 

“Plaintiffs made no effort to distinguish between medically appropriate and medically inappropriate prescriptions. Mere proof of a rise in opioid prescriptions does not, without more, prove there was also a rise in medically inappropriate prescriptions,” Wilson said in his ruling.

Wilson also disputed claims made by Dr. Anna Lembke, a Stanford psychiatrist and board member of Physicians for Responsible Opioid Prescribing (PROP). As a paid expert witness testifying for the plaintiffs, Lembke said one in four patients prescribed opioids become addicted.

“As Defendants point out, the studies relied upon by Dr. Lembke for that conclusion are inadequate to support it. The more reliable data would suggest less than 5%, rather than 25%. Under either number, addiction based solely on the patient having been prescribed opioids does not occur in ‘most of these patients,’” Wilson said.

Johnson & Johnson issued a statement calling Wilson’s ruling “well-reasoned.” It said the company’s “marketing and promotion of its important prescription pain medications were appropriate and responsible and did not cause any public nuisance.”

In 2019, an Oklahoma judge ruled J&J was liable for $465 million in damages for its marketing of opioids, a case that is still under appeal. The company recently proposed a nationwide settlement of $5 billion and agreed to stop making opioid medication. It voluntarily halted sales of prescription opioids last year.

(Update: On November 10, the Oklahoma Supreme Court overturned the ruling against J&J.)

Although opioid prescribing has fallen significantly over the past decade, overdoses have risen to record highs. The vast majority of drug deaths involve illicit fentanyl and other street drugs, not prescription opioids.      

The DEA recently issued a public safety alert warning of a surge in counterfeit pills made with illicit fentanyl. The agency has also proposed further cuts in the legal supply of prescription opioids in 2022.

More Americans Using Cannabis to Treat Chronic Pain Than Opioids

By Pat Anson, PNN Editor

Twice as many Americans are now using cannabis or cannabidiol (CBD) to manage their chronic pain than opioid medication, according to a new Harris Poll that found significant changes in pain management in the U.S. since the onset of the Covid-19 pandemic.

Over-the-counter pain relievers are used by over half (53%) of those surveyed, followed by cannabis products (16%) and non-opioid pain relievers (11%). Opioid pain medication is being used by only 8% of Americans with chronic pain. Non-drug treatments such exercise, heat/ice and healthy eating are also being widely used to relieve pain.

TREATMENTS USED TO MANAGE CHRONIC PAIN

SOURCE: SAMUELI FOUNDATION

The online survey of 2,063 adults was conducted last month on behalf of the Samueli Foundation. About half the participants said they were currently experiencing chronic pain.

One of the more surprising results is that young adults, aged 18 to 34, are more likely to have chronic pain than older ones (65% vs. 52% of those aged 35 and older).

“It is surprising, but we do know from other research that younger people are less healthy overall than older adults were at their age, so the higher prevalence of pain may be related to that. It seems that younger generations are facing health issues that were not experienced by older generations, causing them to be sicker and in more pain at a younger age,” said Wayne Jonas, MD, executive director of Integrative Health Programs at Samueli Foundation.

“There are a number of factors that could be at play here – and most of them can be attributed to lifestyle factors. Things like a poor diet, a lack of exercise, the growing pace of change and stress and very little self-care can lead to issues with a person’s health – physically, mentally, and emotionally. Chronic pain is a whole person issue with stress and social isolation contributing to its perpetuation. This is an issue that needs to be addressed in this population to ensure that as they age, their health doesn’t become precipitously worse.”

More than one in five young adults who have chronic pain (22%) said they use cannabis and/or CBD oil for pain, and they are twice as likely to do so compared to those aged 45 and older (11%).

“I think it’s clear that young people are looking for ways to manage their pain on their own – through self-care. And CBD and cannabis products are increasingly available and legal. People are feeling like they need to find their own ways to manage their pain because the care provided them may be lacking,” said Jonas, a clinical professor of Family Medicine at Georgetown University School of Medicine and former director of the National Institute of Health’s Office of Alternative Medicine.

The survey found that most adults with chronic pain don’t feel that healthcare providers are giving them adequate information on how to manage their pain. Nearly 80% wished their pain was taken more seriously by providers and 68% wished they had more information about how to treat chronic pain.

That lack of information – and no doubt the decreasing availability of opioids – has led to some experimentation. Two-thirds of Americans with chronic pain (66%) say they have changed their pain management since the pandemic began, such as using more OTC pain relievers and cannabis products. There is also more willingness to use non-drug treatments, such as exercise, healthier eating, massage, physical therapy, and mindfulness or meditation to reduce stress.

About 1 in 4 Americans say stress, anxiety and lack of sleep made their chronic pain worse during the pandemic. The vast majority of people in chronic pain (83%) say their quality of life would greatly improve if they were better able to manage it.

“This should be a wake-up call to physicians that their patients are looking for more information from them about managing their chronic pain, especially for non-drug approaches.” said Jonas.

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.

Is DEA Practicing Medicine Without a License?

By Pat Anson, PNN Editor

Tomorrow the U.S. Drug Enforcement Administration holds another Prescription Drug Take Back Day, a campaign that encourages people to help combat drug addiction and overdoses by disposing of their unneeded medication at thousands of drop-off locations nationwide.

It’s also a day the DEA uses to further stigmatize the prescription drugs that millions of Americans rely on to control their pain and have functional lives.

“The majority of opioid addictions in America start with prescription pills found in medicine cabinets at home. What’s worse, criminal drug networks are exploiting the opioid crisis by making and falsely marketing deadly, fake pills as legitimate prescriptions, which are now flooding U.S. communities,” DEA Administrator Anne Milgram said in a statement. “I urge Americans to do their part to prevent prescription pill misuse: simply take your unneeded medications to a local collection site.”

The DEA’s campaign to reduce the supply of opioid medication goes well beyond drug take back days. In 2022, the agency is planning to cut production quotas for oxycodone, hydrocodone and other widely used opioid pain relievers. If the proposed quotas published this week in the Federal Register are adopted – and past history indicates they will be – it’ll be the sixth consecutive year the DEA has reduced the supply of opioid medication. 

During that period, production quotas have fallen by 63% for oxycodone and 69% for hydrocodone. And opioid prescribing has fallen to levels not seen in 20-years.

But with drug overdoses climbing to record highs, critics say there is no evidence the DEA’s strategy is working. And they are alarmed that a law enforcement agency is setting policies that affect the healthcare choices of Americans -- in effect, practicing medicine without a license.

“I think a very strong argument can be made that DEA is inappropriately exercising medical judgment based on their reasoning for supporting another production reduction for opioid analgesics,” says Dr. Chad Kollas, a palliative care specialist in Florida. “Federal policy has encouraged blind reductions in opioid prescribing, so for DEA to cite that trend as evidence for a reduced need for the medical supply of opioid analgesics is a self-fulfilling prophecy.

“Reduced prescribing has not led to a reduction in overdose deaths involving opioids, but rather has been associated with an increase in overdose deaths and suicides in patients with chronic pain who have been forced off their pain medications. Federal opioid policy calling for non-focused, reduced opioid prescribing has been an abject failure.” 

18.88% Decline in ‘Medical Need’

Under federal law, the DEA is required to annually set production quotas for opioids and other controlled substances. It does so after consulting with the Food and Drug Administration, Centers for Disease Control and Prevention, and other federal agencies to establish the amount of drugs needed for medical, industrial and scientific purposes.  

"The responsibility to provide these estimates of legitimate medical needs resides with FDA. FDA provides DEA with its predicted estimates of medical usage for selected controlled substances based on information available to them at a specific point in time in order to meet statutory requirements,” DEA explained in the Federal Register.

“With regard to medical usage of schedule II opioids, FDA predicts levels of medical need for the United States will decline on average 18.88 percent between calendar years 2021 and 2022. These declines are expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone."

Asked to comment on the DEA’s statement, an FDA spokesperson said the agency sent a letter to the DEA in April 2021 using pharmaceutical sales data from prior years to create “statistical forecasting models to estimate medical need for the next two years.” The FDA letter never actually used the 18.88% estimate, that was a figure apparently calculated by the DEA itself.

“In the letter FDA provided an estimate for need of each individual active ingredient in various opioid medications for 2021 and 2022. It appears the DEA estimated the 18.88% decrease as an average across the list of opioid active ingredients, presumably based on the estimates we provided.  We do not disagree with their forecast for this decreasing trend of opioid need,” the FDA spokesperson wrote in an email to PNN.

Opioid ‘Red Flags’

In its statement in the Federal Register, DEA also said it relies extensively on data from prescription drug monitoring programs (PDMPs) to find “red flags” that may indicate a drug is being abused or diverted. The DEA is particularly concerned about daily opioid doses that exceed 240 morphine milligram equivalents (MME). That’s a very high dose for most people – and well above the CDC opioid guideline’s recommended limit of 90 MME.

“DEA believes that accounting for quantities in excess of 240 MME daily allows for consideration of oncology patients with legitimate medical needs for covered controlled substance prescriptions in excess of 90 MME daily. Higher dosages place individuals at higher risk of overdose and death. Numerous dispensings of prescriptions with dosages exceeding 240 MME daily may indicate diversion such as illegal distribution of controlled substances, or prescribing outside the usual course of professional practice,” the DEA said.

Where does the 240 MME threshold come from? That’s apparently another case of the DEA coming up with its own estimates to determine whether a dose is medical necessary. It certainly doesn’t come from the CDC guideline, which was never meant to include patients suffering from cancer pain or those in palliative care.

“The DEA is misapplying the CDC opioid guidelines, which were explicitly not meant to apply to patients receiving palliative care,” Dr. Kollas told PNN. “Moreover, it’s disingenuous for DEA to infer that patients receiving higher doses of opioid analgesics are diverting them, when the vast majority of opioid overdose deaths arise from illicit fentanyl in counterfeit pills.”

Just how serious is the drug diversion problem? Not so serious at all, according to the DEA’s own National Drug Threat Assessment, an annual report that for years has said that less than 1% of legally prescribed opioids are diverted.  

“The number of opioid dosage units available on the retail market and opioid thefts and losses
reached their lowest levels in nine years,” the DEA’s 2020 report found.

The same report also found that illicit fentanyl, not prescriptions opioids, is “primarily responsible for fueling the ongoing opioid crisis.” That’s a view shared by the American Medical Association, which declared in 2020 that “the nation no longer has a prescription opioid-driven epidemic.”

‘Stop Punishing Pain Patients’

If that makes you wonder why the DEA is so intent on further reducing the supply of opioids, you’re not alone.

“This is pure insanity. The scientific data from the CDC & NIH (National Institutes of Health) show that the overdose crisis is NOT due to prescription opioid analgesics,” wrote Chuck Robertson, one of hundreds who left comments in the Federal Register on the DEA proposal. “We are in the midst of the worst supply chain crisis in modern history, so you want to continue to cut back on production? All this is doing is putting hospitals and pharmacies at risk of being short medications that people need to control pain.”

“Please don’t cut production quotas of the opioids listed. There are hundreds of stories of people who need opioid medication therapy to even live at the most basic of functionality,” said Michelle Stifle, a chronic pain patient for 22 years. “This inhumane treatment is discriminatory. Stop punishing pain patients for the faults of others.” 

“Please do not cut the quotas anymore. My wife has several autoimmune diseases that cause horrible pain. She was completely cut off of her pain meds after almost 20 years of use,” said Jeffrey Smith. “She never took more than prescribed and never abused them. It allowed her to live somewhat normally. Now she suffers every day and has no life. I'm afraid the time is coming she won't be able to take the pain anymore.” 

“I was forced tapered off my pain meds after taking them responsibly for 17 years. I now spend 75 percent of time in bed. I cannot function and am in constant pain,” said Shelly Allen. “I recently tore my rotator cuff and couldn't even get a few days’ worth. Where there may have been overprescribing there is now underprescribing. It's my body, why can't I choose my own pain relief in reasonable doses?”

“We don't need more cuts to the supply of opiates. It doesn't help avoid addiction or address it. All cutting the supply further will do is promote health care rationing,” wrote Amber Smith. “Opiates are necessary for surgery and other medical needs. Would the DEA ever suggest cutting the supply of chemotherapy or insulin? No, yet those are every bit as necessary to patients as opiates are.”

The DEA did not respond to a request for comment on this story. To leave your comment on the DEA’s proposed 2022 production quotas, click here. Public comments must be received by November 17.

DEA Proposes Cuts in Opioid Supply for Sixth Straight Year

By Roger Chriss, PNN Columnist

The U.S. Drug Enforcement Agency is proposing more cuts in the supply of opioids and other controlled substances in 2022. If adopted, it would be the sixth consecutive year the DEA has reduced production quotas for prescription opioids and other Schedule I and II drugs under the Controlled Substances Act.

Specifically, the DEA is proposing a 5.4% reduction in the supply of oxycodone, 3.9% for hydrocodone, 19% for morphine and 5.4% for prescription fentanyl. That’s in addition to the significant cuts already made since 2017. 

The DEA arrived at the quotas after consulting with the FDA, CDC, Centers for Medicare and Medicaid Services (CMS), and individual states to assess the medical, industrial and scientific need for controlled substances. The DEA also relied extensively on data from prescription drug monitoring programs (PDMPs) to identify “red flags” indicating the possible theft, illicit use and diversion of each substance.

Even though opioid prescribing has dropped significantly over the last decade, the DEA believes demand will fall even further in 2022.

“With regard to medical usage of schedule II opioids, FDA predicts levels of medical need for the United States will decline on average 18.88 percent between calendar years 2021 and 2022. These declines are expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone,” the DEA said in a statement published in the Federal Register.

The proposed opioid production quotas are the smallest in nearly two decades. The trend lines for several common Schedule II prescription opioids can be seen in the chart below. Since their peak in 2013, production quotas have fallen by 63% for oxycodone and 69% for hydrocodone.

Although the DEA maintains the “medical need” for opioids has declined, demand for healthcare has risen significantly. The U.S. population was 281 million in 2000 compared to 331 million today, and in the interim Americans have become older and less healthy, and surgical interventions for cancer and other diseases have become more common, as has trauma care.

In addition, the U.S. has been facing a pandemic for the past year and a half that increased the need for ICU with intubation, for which sedation with opioids is necessary. In 2020, the DEA raised its quotas for some substances because of this unanticipated demand.

In other words, the U.S. is trying to do more with less, trying to manage pain in a larger population with a higher disease burden while using fewer opioid analgesics.

The goal of these ongoing reductions is to address the overdose crisis. But as the CDC reported last week, the U.S. has seen over 96,000 drug fatalities in the 12-month period ending in March 2021. Some of this spike in deaths is a result of to the pandemic, but the ongoing saturation of the country with illicit fentanyl is clearly playing a key role. The DEA recently issued a public safety alert warning of a surge in counterfeit medication made with illicit fentanyl.  

How much further the DEA can go with quota reductions remains to be seen. Surgical and cancer care have been greatly impacted, and rapid tapering of people on long-term opioid therapy is causing harm.

The DEA has not been forthcoming about its ultimate goals and the methods used to assess progress, as it continues to shrink the supply of opioids. At this rate, we will likely reach pre-1995 prescribing levels within another year.

To make a comment on the DEA’s proposed 2022 production quotas, click here. Comments must be received by November 17.

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

The Rx Opioid Most Likely To Be Misused May Surprise You

By Pat Anson, PNN Editor

For well over a decade, addiction treatment providers and public health officials have been touting the benefits of buprenorphine, an opioid that can treat both pain and addiction. When combined with naloxone in drugs like Suboxone that treat opioid use disorder (OUD), buprenorphine reduces cravings for opioids and lowers the risk of abuse.    

But a new study published in JAMA Network Open suggests that someone is far more likely to misuse buprenorphine than other opioids. In fact, the misuse rate for buprenorphine is over two times higher than misuse rates for hydrocodone, oxycodone and other opioid pain medications.

Researchers at the National Institute on Drug Abuse and the Centers for Disease Control and Prevention conducted the study, looking at data from nearly 215,000 people who participated in the National Surveys on Drug Use and Health from 2015 to 2019.

Respondents were asked if they misused prescription opioids “in any way that a doctor did not direct you to use them.” If they used someone else’s prescription or took opioids in greater amounts or more often than they were told by a doctor, that was considered “misuse.”

Researchers crunched the numbers and found that the vast majority of people do not misuse opioid pain medication and take it as directed. Oxycodone, for example, was misused by 12.7% of respondents who took it, followed by hydromorphone (11.8%), hydrocodone (11.6%), and prescription fentanyl (11.5%). Tramadol (7.8%) was misused the least.  

Addiction treatment drugs were misused the most. Buprenorphine was misused by 29.2% of the people who took it, followed by methadone at 22.2 percent. It’s not uncommon for someone getting OUD treatment to have relapses, so perhaps that finding is not altogether surprising.

% MISUSE RATES FOR PRESCRIPTION OPIOIDS

SOURCE: JAMA NETWORK OPEN

Although buprenorphine is misused at a rate over two times higher than other opioids, researchers chose to focus on the positive: a recent downward trend in buprenorphine misuse, despite increases in the number of patients receiving buprenorphine treatment.

“In 2019, nearly three-fourths of US adults reporting past-year buprenorphine use did not misuse their prescribed buprenorphine, and most who misused reported using prescription opioids without having their own prescriptions. These findings underscore the need to pursue actions that expand access to buprenorphine-based OUD treatment, to develop strategies to monitor and reduce buprenorphine misuse,” researchers concluded.

What Is Misuse?

Every study has its flaws, and this one is no exception. Findings based on self-reported survey results are subject to poor memories, recall bias and concerns about stigma. The researchers’ broad definition of “misuse” could also result in a diagnosis of OUD when none actually exists, according to a pain management expert.

“It is not really clear what any of the data means clinically because of the very broad definition of the word misuse,” said Lynn Webster, MD, Senior Fellow at the Center for U.S. Policy (CUSP) and Chief Medical Officer of PainScript. “Behavior of taking an extra pill to control pain, despite it not being specifically directed by the prescribing provider, could be described as ‘misuse.’ This is not necessarily harmful, even if it is inappropriate. The implication is that simply taking an additional pill is an indication of OUD behavior. That would not be an appropriate characterization of the behavior. 

“In fact, the authors report the most common reason to misuse medication is to relieve pain in the OUD and non-OUD groups. This may imply that most people who are misusing their medications are experiencing undertreated pain.” 

The JAMA study is not the first to report a high rate of buprenorphine misuse. The DEA’s 2020 National Drug Threat Assessment reported that buprenorphine is misused more often than methadone or hydrocodone, and that it was poised to replace oxycodone as the most commonly misused prescription opioid. Unlike the JAMA study, the DEA said the misuse of buprenorphine was increasing, not declining.   

More Evidence That Rapid Opioid Tapering Is Harmful

By Roger Chriss, PNN Columnist

The overdose crisis has motivated a sea change in prescribing practices. Opioid tapering is seen as a part of this change. But the risks and harms of tapering often outweigh its potential benefits, especially when tapering is rapid.

The risks of rapid tapers are well known. The CDC warns providers to “avoid abrupt tapering or sudden discontinuation of opioids,” with a dose decrease of 10% per month a “reasonable starting point.”

But more rapid tapers are very common. A new study looked at retail pharmacy claims for over 810,000 patients taken off high-dose opioids in 2017 and 2018, finding that 72% were tapered more rapidly than recommended by clinical guidelines. Rapid tapering was significantly more common among Medicare patients than in commercially insured ones. Critically, the study also found that counties with high overdose rates had more rapid opioid discontinuation.

The U.S. military health system has also significantly reduced opioid prescriptions. Among active-duty members, a recent study found a 69% decline in prescriptions filled for opioids at daily doses of 50 morphine milligram equivalents (MME) or more.

The Departments of Defense and Veterans Affairs adopted guidelines in 2017 that urge military doctors to taper or discontinue opioids for patients on high doses. But a recent Washington Post investigation found that the VA’s Opioid Safety Initiative was associated with a 75% increase in suicides among veterans living in rural areas and a 30% increase in suicides for veterans in urban areas.

Further, a recent JAMA investigation found that in a study of over 113,000 patients on stable, high-dose opioid therapy, tapering was “significantly associated with increased risk of overdose and mental health crisis.”

“This study highlights important potential harms that are associated with prescription opioid tapering in people with chronic pain,” Beth Darnall, PhD, director of the Stanford Pain Relief Innovations Lab at Stanford University, told Practical Pain Management. “While work remains to understand these associations in greater detail, these findings reveal that patients with chronic pain need better protections within the healthcare system.”

There is, in other words, a clear pattern of harm here. Rapid tapers are destabilizing individual patients and are associated with increased rates of overdose and suicide. The goal of tapering was to reduce opioid-related risks and harms, but the data to date suggests the opposite is happening.

In general, the overdose crisis is getting worse fast. The latest data from the CDC shows over 96,000 drug overdose deaths in the 12 months ending in February, 2021. Opioid tapering has coincided with the rise in drug overdose deaths, though how and to what extent this happens is an open question that urgently requires attention.

There are, of course, risks to prescription opioids and patients may benefit from consensual tapering as described in a federal guideline for dosage reduction. Some people may also do better with non-opioid approaches to pain management.

But the current tapering efforts seem geared toward satisfying a statistical need to reduce prescriptions at the expense of individual welfare. As more and more public health data shows increasing harms without attendant benefits, it’s time to reconsider tapering practices and slow down deprescribing.

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. 

Study Identifies Medications Most Involved in ER Visits

By Pat Anson, PNN Editor

Here’s a question for you: What type of medication is most likely to be involved in a visit to a hospital emergency room?

1. Opioid pain relievers

2. Blood thinners

3. Psychiatric drugs

4. Insulin

5. Antibiotics

Given the well-publicized risks of addiction and overdose associated with opioids, you might assume it was opioid pain relievers. You’d also be wrong, according to a large new study that looked at medications associated with emergency department (ED) visits in the U.S. from 2017 to 2019.

CDC researchers looked at a representative sample of nearly 97,000 cases of adverse events involving medication and found that warfarin (Coumadin) and other anti-coagulant blood thinners – typically prescribed to reduce the risk of heart attack and stroke -- were the leading cause of ED visits.

Among patients of all ages, insulin was the second leading cause of medication-related adverse events, followed by psychiatric drugs, antibiotics and the over-the-counter pain relievers ibuprofen and acetaminophen. The opioid oxycodone came in last on a Top 10 list of drugs involved in ED visits.

TOP 10 MEDICATIONS INVOLVED IN EMERGENCY DEPARTMENT VISITS

SOURCE: CDC

The study findings, published in JAMA, help dispel many of the myths associated with the risks of opioids — at least in comparison to other widely used medications.

There are many reasons for someone to have an adverse reaction to medication, ranging from allergies to dosage errors to taking drugs intended for someone else. About a third of the ED visits were so serious, the patient was admitted for hospitalization.

Compared to seniors age 65 and older, young adults were significantly more likely to abuse a medication or to use it for intentional self-harm. Seniors were far more likely to only take a drug for its intended therapeutics use.

SOURCE: jama

The age of a patient also plays a significant role in the type of drug they have an adverse reaction to. For example, the antibiotic amoxicillin was the leading cause of medication harm for patients under the age of 14; while the anti-anxiety drug alprazolam (Xanax) was the leading cause of adverse events for patients aged 15 to 44.  Insulin ranked first for patients aged 45-64; while warfarin was first for patients aged 65 and older.

Analgesics, sedatives and antidepressants were the drugs most likely to be abused. About 63% of adverse events involving prescription opioids were cases of “non-therapeutic” abuse, while 89% of cases involving benzodiazepines were classified as abuse. The vast majority of cases involving blood thinners, insulin or antibiotics were for their intended therapeutic use.    

The role of opioids in ED visits has been falling for over a decade. A 2017 study showed a significant decline in the number of patients admitted to U.S. hospitals for abusing opioid medication. Hospital admissions for overdoses from opioid medication started falling in 2010, the same year that opioid prescriptions peaked in the U.S.

DEA Warns of Sharp Increase in Counterfeit Prescription Pills

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration has issued a public safety alert warning of a sharp increase in the black market of fake painkillers and other counterfeit medications containing illicit fentanyl and methamphetamine. The alert, the DEA’s first in six years, coincides with the launch of a public awareness campaign to educate the public about the dangers of counterfeit pills.

“The United States is facing an unprecedented crisis of overdose deaths fueled by illegally manufactured fentanyl and methamphetamine,” DEA Administrator Anne Milgram said in a statement. “Counterfeit pills that contain these dangerous and extremely addictive drugs are more lethal and more accessible than ever before. In fact, DEA lab analyses reveal that two out of every five fake pills with fentanyl contain a potentially lethal dose.

It takes only two milligrams of fentanyl – an amount small enough to fit on the tip of a pencil – to constitute a lethal dose. The DEA says it has seized over 9.5 million fake pills so far this year, which is more than the last two years combined.

A recent raid on a home in Perris, California resulted in the seizure of 46 pounds of carafentanil,  – a chemical cousin of fentanyl – which is potentially enough to kill more than 50 million people, according to the Riverside County District Attorney.

Carfentanil is a synthethic opioid 100 times more potent than fentanyl and 10,000 times more potent than morphine.

FAKE OXYCODONE PILLS

The DEA says most of the counterfeit pills manufactured or smuggled into the U.S are produced by Mexican drug cartels, using illicit chemicals that originate in China.

One of the most commonly produced fake pills are tablets made to look like 30mg oxycodone pills. Known on the street as “Mexican Oxy” or “M30s,” the tablets are virtually indistinguishable from legitimate oxycodone pills used for pain relief.   

Law enforcement agencies are also finding counterfeit anti-anxiety medications made to look like Xanax and fake pills that look like the stimulant Adderall, which are made with methamphetamine.  

‘One Pill Can Kill’

The goal of the DEA’s “One Pill Can Kill” campaign is to make the public more aware of the proliferation of counterfeit medications — now found in every state — and to warn drug users not trust any pill that doesn’t come from a pharmacist.  

“Counterfeit pills have become a real and viable threat to the American People,” said Daniel Comeaux, Special Agent in Charge of the DEA’s Houston Division.  “We caution every person to never consume any pill that is not sourced from a licensed pharmacy. These illicit counterfeit pills often contain fentanyl, where just a miniscule amount can result in death.”

Ironically, the DEA itself has played a significant role in the profusion of fake pills and its PR campaign is little more than a fig leaf covering years of disastrous policies.

Counterfeit medication made with illicit fentanyl first began appearing in quantity in the U.S. in 2016, around the same time federal and state regulators began recommending more cautious opioid prescribing for pain.

Faced with pressure from Congress to combat the so-called opioid epidemic by cracking down on painkillers, the DEA began cutting the legal supply of opioids in 2017. It has reduced opioid production quotas for five consecutive years, cutting the legal supply of hydrocodone and oxycodone in half.

The agency also began arresting and prosecuting doctors and pharmacists thought to be prescribing or dispensing opioids excessively, and revoked the DEA registrations of hundreds of physicians. As a result, opioid prescribing fell to 20-year lows, but the crackdown has had a negligible impact on drug overdoses, which rose to record levels.

With opioid medication harder to obtain, illegal online pharmacies began to proliferate and legitimate patients turned to street drugs for relief. A recent PNN survey of pain patients found that nearly 10% have obtained prescription opioids from family, friends or the black market.

In a 2020 report, the DEA said drug cartels were actively targeting pain sufferers as potential customers for counterfeit medication.  The report said nearly two-thirds (64%) of people who misuse painkillers “identified relieving pain as the main purpose” of their drug use.