Why We Need to Study Suicides After Opioid Tapering

By Stefan G. Kertesz, MD

How can we understand and prevent the suicides of patients in the wake of nationwide reductions in opioid prescribing?

Answering that question is the passion and commitment of our research team at the University of Alabama at Birmingham School of Medicine. Our study’s name, “CSI: OPIOIDs,” stands for “Clinical Context of Suicide Following Opioid Transitions.” Let me tell you why we are doing this work, what we do, and how you can help.

Opioid prescribing in the US started falling in 2012, after a decade of steady increases. The original run-up in prescribing was far from careful and a judicious correction was needed. A judicious correction, however, is not what happened. Instead, opioid prescriptions fell, rapidly, to levels lower than those seen in 2000. It may require a book to understand how prescribers swung so easily from one extreme to another.

For the 5 to 9 million patients who were taking prescription opioids long-term, reductions and stoppages were often rapid, according studies in the US and Canada. In one Medicare study, 81% of long-term opioid discontinuations were abrupt, often leaving patients in withdrawal and uncontrolled pain.

Prescription opioid reductions are not always good, and not always bad. For some patients, modest reductions are achievable without evident harm, especially if a reduction is what the patient wants to achieve. For others, the outcomes appear to be harmful. Several who serve on our research team have witnessed friends, family, or patients deteriorate physically or emotionally following a reduction. Some attempted suicide and, tragically, others died by suicide.

Large database analyses tell a similar (and nuanced) story. In research derived from Kaiser Permanente, Veterans Health Administration, Oregon’s Medicaid program, and Canadian databases, patient outcomes were diverse. Some researchers found no safety problems after opioid reductions, but others describe suicides, mental health crises, medical deteriorations, and overdoses at frequencies that are too common to ignore. These are not acceptable outcomes. 

The shocking nature of patient suicides led some experts to jump to conclusions, arguing that acute withdrawal from opioids explains all the bad outcomes, and that slow reductions or tapers prevent harm. But that’s not true. In two studies, mental health crises or overdoses occurred at elevated rates a full year after modest dose reductions, such as a 39% reduction in one national study.

Jumping to conclusions about why something bad happens is another way of saying, “We don’t want to investigate.”

After a suicide, we think the right step – the respectful step – is to ask questions: What happened here? Why did it happen? What were all the factors in a person’s life that might have played a role in their death? And where does an opioid reduction fit, or not fit, into explaining what happened?

Asking those questions is crucial. The decision to end one’s life through suicide is rarely simple, but understanding the person’s history and reasoning will spur better approaches to care. Approaching these questions through in-depth rigorous research, rather than pretending we already know why suicides happen, could also induce leaders to take them more seriously than they have to date.

Just like investigators examining a plane crash, we intend to collect the full story of what happened, carrying out detailed interviews and, where possible, reviewing medical records. Studying just one case can tell us a great deal. But our goal is to study over 100 patient suicides.

This approach is called a “psychological autopsy interview.” That phrase can sound a bit daunting. In reality, it’s an interview where we ask about the person’s life, their health, their care, and what happened before they died.

How You Can Help

We seek people who have lost somebody, such as a close family member or good friend, to suicide after a prescription opioid reduction. We are studying deaths in the US among veterans and civilians, and hope to interview more than one person for each suicide.  

Interview topics range from health and social functioning, to care changes prior to death, to whether the person who died felt a sense of connection to others or perceived themselves to be a burden. To our knowledge, no other team is attempting to do this work.  

We face a singular challenge: recruitment. That’s why we need your help. For the last 60 years, studies of suicides involved collaboration with medical examiners in a state or county. That option is not available to us, because medical examiners usually don’t know about health care changes that took place prior to a person’s death.  

There is no master list of suicides that occurred following a reduction or stoppage in opioids. Yet those deaths are precisely the ones we need to learn about. The only way we can document those cases is to reach out to the public and ask if survivors are willing to come to us, either online or by phone (1-866-283-7223, select option #1). 

If enough survivors are willing to participate in this initiative, then we can begin to describe, understand, and prevent future devastating tragedies.  

For the people who are considering participation in the study and wondering what risks are involved, let me offer some reassurance. First, there is an online questionnaire housed on a very secure server. A person can start it and stop at any point if they choose, no questions asked.  

Also, this study is protected by two federal “Certificates of Confidentiality.” These federal orders prohibit release of identifiable data under any circumstances, even a court order.  We are aware that some families are pursuing legal action, and this was a major factor in our decision to take this extra step to protect participants. 

When a person completes the survey, we will evaluate their answers to see how confident they were that the death was likely a suicide, and whether the death occurred after a prescription opioid dose reduction. If they meet these criteria, then we will reach out to discuss further participation in the research study.  

What follows is a more detailed informed consent process. There is a modest incentive ($100) for being interviewed, and a smaller one if the person can work with our medical record team. It is not necessary for a survivor to have access to a loved one’s medical records.  

So far, the interviews we’ve conducted have been serious, warm and thought-provoking. At the outset, we were concerned that these interviews could be upsetting. We learned from reading the literature on this type of interview, that the individuals who agree to participate usually have a desire to share their feelings about their loved one’s death and tend to perceive the interview as a positive experience.  

In the long-run, we hope that after looking at 110 suicides, we can formulate recommendations and programs for care, without leaping to any conclusions. We want to help save lives.  

A study like this is clearly not the only answer to an ongoing tragedy. Research is almost never a “quick answer” to anything. That’s why many members of our team have already engaged in direct advocacy with federal agencies. It was 4 years ago that several of us urged the CDC to issue a clarification regarding its 2016 Guideline on Prescribing Opioids for Pain. A revised CDC guideline was released last year, but we’ve noticed that the health care situation faced by countless patients with pain remains traumatic and unsettled.

These events are hidden and need exploration. We need to take this next step and learn more to prevent further tragedies and lost lives.

If you would like to enter the screening survey for this research, please click here.

If you would like to learn more general information about our study, click here.

If you know a group of patients or clinicians who would like a flyer, presentation, or a link to our study, please let us know by email at csiopioids@uabmc.edu or stefan.kertesz@va.gov

Stefan G. Kertesz, MD, a Professor of Medicine and Public Health at the University of Alabama at Birmingham School of Medicine, and a physician-investigator at the Birmingham Alabama Veterans Healthcare System.  Stefan is Principal Investigator for the CSI: OPIOIDs study.

Views expressed in this column are those of Dr. Kertesz and do not represent official views of the United States Department of Veterans Affairs or any state agency.

For anyone thinking about suicide, please contact the 988 Suicide & Crisis Lifeline, available online, via chat, or by dialing “988.”  A comprehensive set of resources can also be found at this link.

WHO Releases First Guideline for Chronic Low Back Pain

By Pat Anson, PNN Editor

The World Health Organization (WHO) has released its first-ever guideline for managing chronic low back pain, recommending treatments such as exercise, physical therapy, chiropractic care and non-steroidal anti-inflammatory drugs (NSAIDs).

Chronic low back pain — also known as “non-specific low back pain” — is defined as pain that persists longer than three months, with symptoms that cannot be accounted for by a structural spinal problem or disease process such as arthritis.

Although lower back pain (LBP) is the leading cause of disability worldwide – affecting about 619 million people – there has been little certainty about how to treat it. Almost all of the clinical trial evidence reviewed by WHO’s guideline development group was considered low or very low quality, a persistent problem.in many medical guidelines dealing with pain.

The lengthy 274-page guideline takes a dim view of some commonly used therapies for LBP, such as muscle relaxants, anticonvulsants, steroids, opioids, transcutaneous electrical nerve stimulation (TENS), and injectable anesthetics – treatments that are primarily used in high-income countries. WHO recommends a more holistic approach to LBP, using therapies that are affordable and accessible to more people.

"Addressing chronic low back pain requires an integrated, person-centred approach. This means considering each person's unique situation and the factors that might influence their pain experience," Dr. Anshu Banerjee, WHO Director for Maternal, Newborn, Child, Adolescent Health and Ageing, said in a press release. "We are using this guideline as a tool to support a holistic approach to chronic low back pain care and to improve the quality, safety and availability of care."

WHO recommends that adults with chronic LBP start with treatments that are the least invasive and least potentially harmful. The values and preferences of patients should also be considered, as they are more likely to adhere to therapies they consider helpful.  

Recommended Treatments for Chronic LBP

• Patient education and counseling

• Exercise or physical therapy

• Acupuncture or dry needling

• Spinal manipulation (chiropractic care)

• Massage

• Cognitive behavioral therapy or mindfulness

• NSAIDs

• Topical cayenne pepper

The guideline states that opioid analgesics “should never be used as a stand-alone treatment” for chronic LBP. When opioids are used alongside other therapies, the lowest dose should be prescribed and only for a short duration, according to WHO.

Recommendations against routine use are also made about many other pharmaceuticals, including antidepressants, anticonvulsants, muscle relaxers, glucocorticoids (steroids), weight loss drugs, and injectable anesthetics such as lidocaine or bupivacaine.  

No recommendations are made about benzodiazepines, cannabis or acetaminophen (paracetamol), primarily due to lack of evidence, but also because of potentially harmful side effects. Cayenne pepper is the only herbal remedy recommended by WHO.

The guideline does not address surgical procedures such as spinal fusions and spinal cord stimulators, or invasive procedures such as epidural injections.

WHO’s 25-member guideline development group included a broad range of clinical experts from around the world. Among them is Roger Chou, MD, a researcher and longtime critic of opioid prescribing who heads the Pacific Northwest Evidence-based Practice Center. Chou is a co-author of the 2016 and 2022 CDC opioid guidelines, and has collaborated on several occasions with members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid advocacy group. Chou let his Oregon medical license lapse in 2022.

One of the clinical trials reviewed by WHO’s guideline group is a controversial Australian study – known as the OPAL study -- that found low dose opioids gave little relief to patients with short-term back and neck pain. The OPAL study has been panned by critics because the treatment period only lasted six weeks and used a formulation of oxycodone that would not normally be used in clinical practice. Nevertheless, it’s been cited as evidence that “prolonged opioid use” is ineffective.

In 2021, WHO updated its guideline on the treatment of chronic pain in children, recommending that prescription opioids only be used for children who are dying or seriously ill. An earlier WHO guideline that recommended more pediatric use of opioids was withdrawn in 2019, after two U.S. congressmen accused the United Nation’s health agency of being “corruptly influenced” by opioid manufactures.  

Opioid Therapy Is Controversial, But Why?

By Barby Ingle, PNN Columnist

There are many factors that contribute to the controversy surrounding opioids, which have been used for thousands of years for pain relief.

Mainstream media often say that opioid medication is harmful and increase the risk of addiction, overdose and death. Many media outlets do not distinguish between FDA approved medications and street drugs, or show the life-giving side of opioid medication.

That is the root cause of the controversy. If people don't understand or are misinformed, they go with what they hear -- right or wrong.

Let’s explore these issues and, hopefully, set the record straight.

Rx Opioid Side Effects

All medications have side effects, including opioids. At least 50% of patients in clinical trials experience a side effect from opioid therapy, such as nausea, vomiting, constipation, dizziness, dry mouth or sedation. These side effects vary and can decrease or increase with long-term use.

Most side effects of opioids improve shortly after therapy begins or following a dose increase. However, itching and constipation can persist throughout treatment. Most of the chronic pain patients I have met on my journey are okay with these side effects and wish to continue with treatment. For others, opioid therapy is discontinued when the side effects are too severe.

A variety of respiratory issues can be caused by opioids, including inadequate breathing, erratic breathing, and impairment of the upper airways. That can lead to respiratory depression, a precursor to an overdose. Patients in acute pain management who are new to opioids are most at risk of respiratory depression because they have not developed tolerance to opioids.

To be clear, an overdose from prescription opioids is relatively rare. A recent study found the risk of a fatal overdose at 90 morphine milligram equivalents (MME) – a fairly high daily dose – is only 0.26%. The risk is even lower at 50 MME – just 0.16%.

Opioids have more respiratory effects during sleep. Several fatalities have been reported in patients with obstructive sleep apnea, who may be contraindicated to opioid therapy. Patients with sleep apnea who take other central respiratory depressants, such as benzodiazepines, should be cautious about this. If opioids are prescribed to patients with sleep apnea, a nocturnal respiratory assessment will be needed.

Patients may absorb more opioids from transdermal opioid formulations if they have a fever or other illnesses. This is also true if they are exposed to heat, such as a sauna.

Is Pain Inevitable?

The Japanese author Haruki Murakami once wrote, "Pain is inevitable. Suffering is optional." Murakami was writing about running a marathon, but it’s an apt description for someone with chronic pain. Does their suffering have to be inevitable?

I didn't understand that concept as a collegiate coach or as an athlete until I developed chronic intractable pain and needed treatment. It is difficult to understand chronic pain or intractable pain if you haven't lived with them.

So that we are all on the same page, chronic pain is defined as pain lasting over three months. Intractable pain is complex and can last a lifetime, causing immense suffering. Acute pain is pain that lasts for less than three months.

Acute pain is usually caused by an injury, trauma or medical condition. Left untreated, acute pain can progress to the chronic stage, causing long-term disability, depression, and impaired quality of life. Therefore, it is essential to identify and treat pain as soon as possible, preferably in the acute stage.

Different approaches, including medication, physical therapy, and lifestyle changes, can be used to manage pain. Finding the right approach for each patient is crucial, as something that worked for one patient may not work for another. It is essential to consider all options before selecting the most appropriate treatment.  

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and the founder and former President of the International Pain Foundation. You can follow Barby at www.barbyingle.com. 

DEA Cuts in Opioid Supply ‘Completely Irresponsible’

By Pat Anson, PNN Editor

This is the final day for patients, providers and other interested parties to leave a public comment on the DEA’s plan to reduce the supply of opioid medication in 2024.

The DEA wants to cut production quotas for oxycodone, hydrocodone other opioids for the 8th straight year, and invited people to comment on its plan in the Federal Register. Over 3,400 have so far, most of them patients who already have problems getting prescription opioids due to shortages.

“This will do nothing but harm the chronic pain community,” one poster wrote. “The reduction of opioid production will only cause more overdoses, because when people can’t find medication and are suffering, often their only option is to turn to drug dealers.”

“I am a chronic pain patient that would have absolutely no quality of life if it wasn't for opiates. I don't understand why the DEA thinks that pain medication is not a good thing. I would not be able to function without it!” said Joanne Kurtz. “If the government puts more restrictions on the manufacturers, it will be impossible for anyone to get the medicine that is needed. It is nearly impossible now. Please stop decreasing the production!”

“The US population is only getting older, and as more bodies start to fail, the medical need for pain medications will only increase. I’ve noticed a marked decrease in the availability of medications for patients with painful conditions - spine problems, endometriosis, etc,” wrote another poster, who said they worked in the pharmaceutical industry.

“Having the government intervene to limit the supply when legitimate demand is only going to grow is completely irresponsible.”

Also weighing in is the R Street Institute, a non-partisan think tank based in Washington DC that supports free market policies and limited government. The DEA’s proposal, according to R Street, will do more harm than good.

“History teaches us that when the legal supply of prescription medication is reduced too quickly or by too much — whether through problems in the supply chain or restrictions on provider practices — it harms patients by cutting medication access, potentially sending them to the illicit market in an attempt to manage pain, withdrawal, mental health symptoms and more,” wrote Stacey McKenna, PhD, Senior Fellow of Integrated Harm Reduction at R Street. 

McKenna said supplies of opioid medication are “already stretched thin” from previous DEA cuts. And she noted that diversion rates for prescription opioids are quite low.

“The DEA extensively cites the need to minimize diversion as a justification for reducing the 2024 production quotas for opioid painkillers. However, the DEA’s own projected diversion rates are well below 1 percent. Furthermore, the current overdose crisis in the United States is driven not by diverted prescription painkillers, but by illicitly manufactured fentanyl and other synthetic opioids,” McKenna wrote.

“Given the harms associated with restricting medication availability and the extremely low rates of diversion cited by the DEA, we strongly encourage the reconsideration of proposed 2024 reductions on opioid painkiller manufacturing.”

The DEA relies on advice from the FDA on the projected medical need for controlled medications. For 2024, the FDA predicts a decline of 7.9% from 2023 on the medical use of Schedule II opioids.

Since the DEA started slashing opioid production quotas in 2016, the supply of oxycodone has been reduced by over 68% and hydrocodone by nearly 73%. Yet overdose deaths kept rising, fueled primarily by illicit fentanyl and other street drugs.

McKenna told PNN the DEA lacks good evidence to support further cuts in the opioid supply.

“I think the evidence clearly does not support reducing the production quota. I don't see any in the data that I looked at. I see no evidence-based justification to do it,” she said. “I think they're overstepping into decisions that should be between providers and their patients.” 

Patients Urge DEA to Stop Cutting Supply of Opioid Pain Medication

By Pat Anson, PNN Editor

Thousands of people in pain are urging the Drug Enforcement Administration to scrap plans to further reduce the supply of opioid medication in 2024.

The DEA recently announced it would cut production quotas for oxycodone, hydrocodone, codeine and other opioids for the 8th straight year, despite complaints from pain patients and healthcare providers that the medications are already in short supply and difficult to get at pharmacies.

The DEA invited people to comment on its plans in the Federal Register. Over 2,400 have so far – many with heart breaking stories to share about not being able to get the pain medication they need.

“I was finally able to establish a reasonable pain management routine but that was disrupted when my regular pharmacy was no longer able to supply my medication (a moderate dose of Norco) and not a single other pharmacy was willing/able to fill my prescription,” said Jessica Ericksen. “One pharmacy supervisor screamed at my doctor on the phone when he called in to try to get my prescription set up with them. I now have a 1.5 hour round trip drive to get my medication, which is particularly challenging for a disabled person who is unable to drive.”

“I am one of the many that has had my life destroyed by the government regulations on pain meds. I haven't been able to get my medications for the better part of a year,” said Paula Perry. “I'm now basically bedridden and praying for death. Stop doing this to people, we are dying and you guys make it worse every year.”

“Most of us in pain have gone through all of the other drugs to treat our pain and these are the drugs of last resort. The opioids don't totally treat our pain but allow us to function,” said Heather Larson. “The DEA needs to stop playing doctor and let the doctor decide what is right to prescribe. If production is cut anymore, people will commit suicide or go to the street for pain medication.” 

“I have already had to jump through numerous hoops just to be prescribed my meds, but now have to call pharmacy after pharmacy monthly to find my meds, because they are out of stock at every pharmacy around me in a 10-mile radius,” said Jill Bartruff, who suffers from scoliosis. “I also had a surgery in September 2023 and could not find a pharmacy to fill my post op pain meds. I was in immense pain and was unable to advocate for myself to get my meds filled. Imagine being cut open and discharged from the hospital with no pain control.”

“Why do you continue to cut supply when legitimate patients cannot obtain their medications? Many are already out of their meds for weeks on end,” an anonymous poster wrote. “You should be able to see you're making the situation worse.” 

‘More People Will Die’

Why is the DEA planning to reduce the opioid supply for yet another year? The agency wants to reduce the risk of opioid addiction and overdose, and is relying on advice from the Food and Drug Administration, which estimates that medical demand for Schedule II opioids will decline 7.9% from 2023 levels.

But opioid production quotas have been falling for nearly a decade and overdoses have still risen to record levels – fueled primarily by illicit fentanyl, stimulants and other street drugs. 

“The proposed quota will, without any doubt, not only cause harm but actually kill people. Research has shown time and time again that restricting access to safe, regulated supplies of opioids does not result in decreased use, but rather increased reliance on an unstable, unregulated street supply,” Alexandra Bradley wrote in her comment. “The DEA is making a massively dangerous move by even suggesting this quota, and it will result in the deaths of many, many people.” 

“Further reduction of chronic pain relief meds such as oxycodone will literally add to the body count (mostly suicide and withdrawal from abruptly stopping meds) already racked up due to the ongoing shortages,” said Ronald Crook Jr. “What an embarrassment and shame that chronic pain patients such as myself who are just trying to maintain some sense of dignity face being told by our pharmacist that the wealthiest, most powerful nation on earth cannot help us because of quotas.”

“All of us patients, we are the compliant ones with our medications. We go through extensive pill counts and urine drug screens to make sure we are not abusing the substance. The overdoses that are occurring are due to heroin and fentanyl, not prescribed pain medication,” said Candace McFarland. “If you choose to cut people’s medications, more people will turn to the street and more people will overdose accidentally on fentanyl.”

“Individuals that are prescribed pain medication already have a hard enough time getting their medications. I can sympathize. I have ADHD and I've been on Adderall for the better part of a decade. And this year every refill day was anxiety inducing because of the shortage,” said Amber Kunkel. “There needs to be an increase in producing both pain medications and ADHD meds. Without access to safe and predictable drugs, there will be a continued increase in people turning to the streets for medication and dying.” 

The DEA and FDA have responded to complaints of Adderall shortages and other stimulants used to treat attention-deficit/hyperactivity disorder. The DEA plans to modestly raise production quotas for stimulants, after the FDA predicted a 3.1% increase in their medical use in 2024.  

But both federal agencies appear to have turned a blind eye to opioid shortages. The American Society of Health-System Pharmacists (ASHP) has been warning of shortages of oxycodone and hydrocodone for months, but those shortages have not been publicly acknowledged by either the DEA or FDA.

Other factors that could be contributing to opioid shortages are strict limits on the amount that can be supplied to pharmacies – regardless of patient need -- under the national opioid settlement. A suspicious order or “red flag” activity could result in a pharmacy being terminated from receiving anymore controlled substances -- putting added pressure on pharmacists to carefully screen patients and their prescriptions.

Another factor is the low cost of generic opioids. Prices for some generic medicines are so low that some manufacturers can’t make a profit and have stopped making the drugs. Other manufacturers can’t raise production of opioids without permission from the DEA.

Drug Shortages Mostly Involve Low-Cost Generics

By Pat Anson, PNN Editor

Drug shortages in the United States are primarily being driven by low profit margins – not supply chain problems – according to a new analysis that found 84% of medicines currently in shortage are low-cost generics. Prices for some generic medicines are so low that manufacturers have stopped making the drugs.

The study by the IQVIA Institute, a healthcare data tracking firm, identified 132 medications in shortage as of June 2023, with pain/anesthesia drugs as the therapy area with the greatest number (21) of shortages. The shortages are so acute that elective procedures requiring anesthesia are being cancelled or postponed.

“Anesthesia medicines, including general, local, and muscle relaxants, are foundational to inpatient and outpatient surgical procedures, and shortages in these medicines can result in delays for patients receiving procedures and hospitals making prioritization decisions based on available supply,” the IQVIA said.

“Shortages across these medicines complicate scheduling of a wide range of procedures and surgeries, which may be part of a broad-based reduction observed in elective procedures in post-pandemic periods.”

One weakness of the IQVIA report is that it relies solely on drug shortage data from the Food and Drug Administration.  The American Society of Health-System Pharmacists (ASHP) currently lists 242 medicines in short supply, nearly twice the number listed by the FDA.

Three generic opioid medications commonly taken for pain, immediate-release oxycodone, oxycodone-acetaminophen, and hydrocodone-acetaminophen tablets have been on the ASHP shortage list for months, but have yet to appear on the FDA’s shortage list.  

Pain patients are feeling the impact of short supplies. In recent months, many have complained about problems or delays getting their opioid prescriptions filled at U.S. pharmacies.

“It has been a month since I had my last refill and no pharmacy can give me an answer as to when they may be back in stock. In the meantime, I just live in misery,” one patient told us.

“Mobile, Alabama seems to be almost completely out of pain medication, specifically the most widely used mg of oxycodone-acetaminophen and hydrocodone. I was supposed to get my refill from Walgreens… and they are not only out but cannot order more,” another patient said. “This is such a serious issue with a lot of people probably going through withdrawals in our county and nobody seems to care.”

‘Prices May Be Too Low’

Teva Pharmaceuticals, a large generic drug maker, has informed the FDA that it is discontinuing production of immediate-release oxycodone tablets. The move appears to be in line with Teva's announcement that it would reduce its production of generics from 80% of its drug portfolio to 60% over the next few years.  

“The drugs we’re pulling out of are drugs which are low-margin,” Teva CEO Richard Francis recently told Bloomberg.

The IQVIA found that over half (56%) the medicines in short supply are low-cost generics priced at less than $1 per unit. In many cases, that’s below the manufacturer’s cost of production and distribution. Because the generic drug industry is highly concentrated with few suppliers, any disruption or discontinuation of a generic can have an outsized impact.

“Generic medicines are much lower cost than brands and some observers have begun to suggest that some generic prices may be too low to support sustainable markets,” IQVIA found. “Prices driven below the cost of manufacturing and distributing can result in some competitors discontinuing production of molecules (medicines), reducing necessary maintenance activities and generally contributing to less resilience in manufacturing supply of those medicines.”

Other highlights of the IQVIA report:

• 120 of the 132 drug shortages listed by FDA involve generics. Only 12 drugs are brand name

• 75% of current drug shortages have been active for over a year and 58% have lasted at least two years

• Three times as many new drug shortages have been reported than have been resolved in recent years

• 67% of shortages involve injectable drugs

• Shortages of antibacterial medication “are a significant concern affecting multiple aspects of healthcare delivery”

• Shortages of cancer treatment drugs have forced some oncology providers to suspend or delay treatments

Federal agencies appear to have inadvertently contributed to some of the shortages. The IQVIA said FDA inspections of drug manufacturing plants have triggered shutdowns of some sites due to safety or sanitation issues. Those shortages “are difficult for their peers to resolve,” according to IQVIA, because few other companies can pick up the slack.

A generic manufacturer of oxycodone, hydrocodone and ADHD medication recently sued the DEA after the agency suspended its drug production license over record-keeping issues. The lawsuit by Ascent Pharmaceuticals accused the DEA of incompetence and heavy-handed regulation of the nation’s drug supply.

In the past year, under the DEA’s ironically named “Operation Bottleneck” initiative, the agency has taken administrative actions against 143 DEA-registered doctors, pharmacies, drug makers and drug distributors, largely over allegations of poor record-keeping and inadequate controls to prevent the diversion and theft of opioids and other controlled substances.

“These companies have a legal obligation to account for every dose and every pill to protect the safety and health of the American people,” said DEA Administrator Anne Milgram. “DEA will continue using every available tool to prevent the diversion and misuse of opioids and other highly addictive controlled substances.”

DEA recently announced plans to further reduce the supply of opioid pain medication in 2024 -- which would be the eighth consecutive year the agency has reduced opioid production quotas for drug manufacturers. DEA said it was acting on the advice of the FDA, which estimates that medical need for Schedule II opioids will decline on average 7.9 percent from 2023 levels.

Doctor Bison’s Fables: The Crowded Exam Room

By Pat Anson, PNN Editor

Dr. Mark Ibsen is a Montana physician whose license was suspended in 2016 by the state medical board for “overprescribing” opioids and poor record keeping. A state judge later reversed the suspension, ruling the medical board made numerous errors.

Ibsen has since become a strong proponent of medical marijuana and a leading advocate in the pain community. He’s published a new book, “Dr. Bison’s Fables,” using animals as lead characters in a series of stories to convey how many pain patients in the U.S. lack proper treatment and some are in crisis.

This interview with Ibsen has been edited for content and clarity.

PNN: Who is “Doctor Bison’s Fables” intended for and what is your goal? What is the message you're trying to get across?

Dr. Mark Ibsen

IBSEN: I'm not really in the book selling business. I'm in the restoration of the sacred physician-patient relationship business. But all of my screaming from the rooftops about it for the last 12 years has made little progress.  

I was talking to the publisher and he was saying if you write a book about what's going on in medicine today, the pain crisis and catastrophe of it, you'll have a readership of 50,000. If you write a book that talks about the dynamics of what's going on, and put it in the form of a parable or a fable that has a bigger meaning to it, your audience will expand.

When this approach was suggested to me, I rejected it completely out of hand. I said I just want to tell what's going on because the house is on fire. But I slowly came to look at this idea as maybe he's onto something. Maybe Aesop's Fables had some good things to say, maybe the Brothers Grimm had some good things to say. So I thought, okay, let's add some folksiness to this. Give it a Burl Ives approach.

PNN: When you tell your fables in the book, animals are the key characters. Why did you choose them?

IBSEN: The animals are the protagonists. I chose Dr. Bison because of the bullheadedness of the character. As you can see on the book cover, he's examining this cute little otter on the exam table. And the weasel guy with the clipboard is scowling at him and evaluating how he's doing his job and if he's doing it effectively or quickly enough.

The weasel is like an interloper in the exam room, which has been my persistent complaint. We have too many guests in the exam room that have a vote into what's going on between the doctor and the patient. We have an insurance bureaucrat deciding what you can or can't prescribe, and a pharmacist deciding if the prescription is legitimate.

Then there's a law enforcement officer who's looking at whether a crime is being committed. Then there's a DEA agent who may or may not have a college education, who's looking at patterns and matrices. Is Dr. Bison prescribing more than other doctors?

Then there's legislators, like the legislators in the state of Ohio that legislated exactly how much I could get for the pain in my chest after it was split open during heart bypass surgery at the Cleveland Clinic.

So it's really crowded in the exam room now.

PNN: You want to get across the point that you can't treat all patients the same way. Everyone is different. How do you communicate that in your fable scenario?

IBSEN: I think it's basically species dependent. By that I mean that different species have different personal attributes. A mouse is going to attack a problem much different than a bison would. Or an herbivore will attack a problem more than a carnivore will.

I guess you could call it a menagerie. There's a bison and a cougar. There's a possum. There's a wise llama. There's a viper in the chapter about breeding resentment. There's a coyote, the trickster who has a lawyer's briefcase and there's a crow. And then the elk. Elk handle their conflicts by keeping the herd intact, surrounding the weakest member so the wolves can't get to them.

My goal is to is to make this seemingly light and then develop it. Story development pulls them in and readers finish the story. And then they're left with curiosity about the pain crisis, rather than revulsion or rejection or resistance or argumentation.

PNN: Take us to the epilogue and the message that you really want to get across to the reader.

IBSEN:  I guess I would say that I didn't leave medicine, medicine left me. I don't want to project some righteous indignation about it. I'm sad about it more than anything else. I don't think this is limited just to the patient-physician relationship. I think it's a cultural phenomenon. And it's just manifested in medicine in this way.

We now have patients that cannot tell their doctor the truth. It's sort of like a teenager who has to lie to their parents. It's like a patriarchal system. The patriarchal system works if the patriarch supports the people in the system. But these days, if you admit that there's a family history of alcoholism, then suddenly you're not a candidate for opiates.

Or this doctor friend of mine who was recently suspended, he's a residency mate of mine. He had a mother and a daughter, both in chronic pain. I think they lived together and one was on hydrocodone and the other on oxycodone. And it turns out their medications may have gotten mixed up. They had a urinalysis and it looked bad.

But if you live in the same household, then maybe you can get your pills mixed up. I mean, you could have that chance. But do you fire somebody for having hydrocodone in their system? In my training, a lab result is something that you respond to, not something you react to. The first thing you do is you repeat the lab test. If you see something that's completely out of the ordinary, then you have to inquire about it.

But in this system, you have to fire the patient, even when there's no evidence that doing urine drug screens make any difference at all about diversion or patient care or anything. Nobody's done a placebo, double-blind controlled study about that.

I'm now seeing some pain refugees from Billings. The pain doctor there retired and the new guy came in slashing everybody’s dose and then he left. All these patients are trying to recover and none of them are oriented towards taking cannabis because they know that if they found cannabis in their urine that they would be fired. Somebody somewhere will say if you have cannabis in your urine, it's obvious that you're selling your pain pills in order to buy your cannabis. That is not obvious to me. Not even remotely

There’s a huge amount of gaslighting going on between the system and patients, that doctors are willing participants in. I mean, my younger colleagues have loans to pay off, so they are not risk takers. Right now, I am quite a risk taker. Because everything's gone. I don't have anything left.

I would say that in medicine today, the wheels are coming off and maybe they need to all come off. It doesn't operate in the same mentor-apprenticeship relationship that I was trained in. I don't know if I would last in medical training today.

I think that the internet has both good and bad things about it. And the good thing is that patients research their ailments or their symptoms and they come in with that. They come in with a differential diagnosis already. And I get to hear that and respond to it.

The great thing about that is what I call the alignment effect. If a patient comes to me and wants to do something that they read about and it's not going to kill them, if I say yes and it works for them, then they're going to be really persistent about following that therapy because it was their idea. Right? If it fails and they come back to me, then they're willing to listen to my point of view on it. And that builds trust.

If only the hospital administrator, pharmacist, insurance bureaucrat and legislator would trust our medical expertise. I think we're in a period of time where expertise is not thriving. Failing to use the expertise of our specialists is really putting us in a bad way, not only in medicine, but in the entire culture.

PNN: Thank you, Dr. Ibsen.

Why the Ruan Case Won’t Protect Doctors From Prosecution

By Dr. Joseph Parker

Doctors trying to save lives and help pain patients are regularly being sent to prison for prescribing opioids. And despite last year’s Supreme Court ruling in the Ruan case, that’s not changing.  Here’s why. 

First, it’s important to know what you are up against.  When the US federal government goes after a doctor or anyone else, they face a streamlined conviction machine.  Since the time of Ronald Reagan (who I voted for), the rights of an American citizen to challenge the charges against them or try to overturn an unjust conviction have been eroded. 

Then came President Bill Clinton (I voted for him too), who signed into law the Antiterrorism and Effective Death Penalty Act, doing more to ensure that the government can imprison the innocent than any other president since the Civil War.

At the founding of this nation, it was recognized that governments are prone to lock up people they don’t like, finding some legal pretext to justify their actions.  To guard against this, the Constitution and Bill of Rights were adopted to limit the powers of the federal government. 

Originally, there was only one federal crime: an act of treason. This crime was much more limited than the British version had been, when wandering over onto the King’s hunting grounds was considered treason. In the American version, you had to wage war against the United States or give aid and comfort to its enemies during a time of war. 

Then John Adams, the second president of the United States, made sedition a federal crime. Since then, so many federal laws have been added that government itself cannot tell you exactly how many or what they are.

That’s not counting all of the rules and regulations enforced by federal law enforcement, as if they were the law.  Locked up is locked up, after all.  Today the land of the free incarcerates more of its citizens than any other nation.  Not only that, but the sentences have become draconian. 

There is no nation on earth today where the liberty of a citizen has less value than in America.  The US incarcerates an average of 629 people for every 100,000 citizens. The next closest nations are Rwanda, Turkmenistan, El Salvador and Cuba. China and Russia don’t even make the Top 10.

Believe it or not, there are 37 states in the US that beat Cuba’s incarceration rate of 510 prisoners, with Louisiana coming in at a mind numbing 1,341. 

All of those inmates did not end up in prison by accident.  Looking at 2020 numbers, there were about 1,879 criminal cases heard in federal court.  Of those, about 90% of the accused plead guilty without even going to trial. Is that because the US government is absolutely right 90% of the time?  I am cautiously skeptical. Only 0.04% of cases -- 4 out of 1,000 – resulted in acquittal.  Those are not good odds. 

In Ruan v. United States, Dr. Xiulu Ruan appealed his conviction for prescribing opioids in an “unauthorized manner.” In a stunning unanimous verdict, the Supreme Court justices repeated what they said in 1925 in Linder v. United States, and then again in 2006 in Gonzales v. Oregon:  the federal government cannot dictate the practice of medicine and a doctor can only be prosecuted if they knew what they were doing was wrong.

As has happened in the past, US law enforcement doesn’t let something like a Supreme Court ruling slow them down.  They are completely ignoring the Ruan ruling by arguing something called “willful blindness.” What was the doctor willfully blind to?  To whatever opinion the government’s expert witness feels like arguing is the “usual practice of medicine” and “a legitimate medical purpose.”

Even though the Supreme Court made clear that only individual states can regulate the practice of medicine, the government’s hired expert does not have to come from your state or even be familiar with your state’s laws regarding the practice of medicine.

In effect, the DEA argues that there is a national practice of medicine that must be followed.  Where do they draw these medical practice standards when there is no such thing as a federal medical license?  From medical textbooks like the "Principles and Practices of Pain Medicine"?  No.  From the teachings of national medical organizations like the American Academy of Pain Medicine or the American Society of Addiction Medicine?  No again. 

The teachings from those sources are not allowed in court, unless you can get one of the original authors to come testify for you.  And sometimes, not even then.  The chapter on avoiding addiction in pain management from the above textbook was written by Dr. Alan Wartenberg.  Despite his advanced years, Dr. Wartenberg came to my trial to testify for me.  But he was not allowed to be considered as an expert in pain medicine, because he was “only” an addiction specialist. 

This is nothing compared to what happened to Dr. William Bauer of Ohio.  A dozen pharmacists, doctors, and scientists were willing to testify on his behalf, and all of them were disqualified by the court.  But the government’s “experts” in pain medicine can testify about almost anything, including addiction and even chronic cough.

The government does not convict you by proving you are guilty, they convict you by smearing you publicly long before you get to trial, and then making sure that the jury does not have access to the truth, by disqualifying experts, withholding favorable evidence, allowing false testimony, and making false statements to the jury. 

And remember, Dr. Ruan “won” at the Supreme Court. But he’s still in prison. 

Good luck and be prepared.  Ruan will not save you.

Joseph Parker, MD, is Chief Science Officer and Operations Officer at Advanced Research Concepts, a company developing solutions to the challenges of space travel and space-related medical issues.  In clinical practice, Dr. Parker specialized in emergency medicine and served as Director of Emergency Medicine at two hospitals. Prior to that, he had a distinguished career in the U.S. Marines and Air Force. 

In 2022, a federal jury convicted Dr. Parker on two counts of unlawful opioid prescribing. He has filed an appeal as he awaits sentencing.

A Pain Patient's Perspective on Opioid Prescribing

By Barby Ingle, PNN Columnist

It is essential to prescribe pain treatments that are appropriate and effective for each patient. I say that based on my own experiences as a patient, as well as thousands of others I have spoken with over the years as a friend and advocate.

Patients who need opioids, benzodiazepines, antidepressants and other medications should have access to them -- just as a heart patient has access to medication that keeps their heart functioning or a diabetic needs access to insulin.

People living with pain should also be offered individualized treatment. That could be anything from physical therapy and analgesics to surgical procedures and alternative therapies like acupuncture. I have tried over 100 different types of pain treatment; some have worked and others have not. It often made me feel like a guinea pig. Unnecessary surgery hurt me most in the end.

There are many public education campaigns underway to prevent addiction and overdoses by reducing the use of prescription opioids. These campaigns are repeated in the media, but the information does not always include facts or is presented in a misleading way.

For example, there is the DEA’s “One Pill Can Kill” campaign, which is aimed at raising awareness about a surge in counterfeit pills made with illicit fentanyl and other street drugs. Another is the CDC’s “Rx Awareness” campaign, which shares the stories of people whose lives were impacted by prescription opioids. The overall theme is that opioids are “addictive and dangerous.”  

Although well-intentioned, these campaigns have a tendency to demonize FDA-approved medications that have a lot of science and research behind them. Most people are unaware that fentanyl has been used safely and effectively for decades to treat severe pain and as an analgesic in millions of surgeries. Saying “one pill can kill” to a pain patient who has improved their life with a legally prescribed medication is disheartening.

I have seen this misinformation firsthand over the years and how it has put a damper on opioid prescribing. Physicians should prescribe opioids for pain when appropriate, but many are afraid to do so because of potential sanctions and legal threats. As a result, many providers won’t prescribe opioids or will only do so minimally and as a last resort.

Individualized Treatment

I believe each patient is different and should be treated as such. We need providers to operate on the assumption that each individual is unique and requires something different, even when they have the same disease or injury as someone else.

Physicians today can use pharmacogenomics to see if a patient’s DNA can affect how they respond to a treatment or what is chemically right for them. The dosage, brand, procedure and frequency will vary depending on each patient. I often bring my pharmacogenomics information to communicate more effectively with my providers, which benefits us both.

I also know that doing what is least invasive first and then progressing to other options is essential. Sometimes, surgery is the best option. Sometimes, opioids or other pain medications should be used first. Every medical provider should work at finding the treatment that most effectively suits the patient.

It is a considered best practice to prescribe opioids to someone in severe pain from sickle cell disease. Yet, when many sickle cell patients go to the ER or are admitted to a hospital, they are denied opioids because of hospital policy. What is the point of having a trained medical providers on staff if you won’t let them treat a patient the way they should be?

Denying pain relief is not only cruel, it can be the worst practice for everyone involved. For example, a man in severe chronic pain committed suicide after a doctor at a Kentucky pain clinic cut his opioid dose in half. The man’s family filed a lawsuit and won a $7 million judgement against the doctor and clinic.  

Ultimately, it should be the patient's responsibility to weigh the risks and benefits of any treatment, after getting input from their provider and conducting due diligence. Unfortunately, there are many obstacles standing in the way of that. One of the biggest is finding a doctor willing to prescribe pain medication. In addition, there are insurance restrictions, the cost of medication, and other logistical issues such as transportation to appointments.

Here in Arizona, patients must see their provider every month to renew a prescription for a controlled substance. Policies like that were put in place to “protect” pain patients, but only added extra costs, burdens and stigmas to them.

Patient-Physician Communication

How can we change the narrative about opioid prescribing? We can start by emphasizing the importance of effective communication between physicians and patients, even those as young as elementary school. Early education on how to talk to medical professionals and advocate for yourself is vital. I see this as one of the most critical things for patients to do.

Communication and trust are essential. Patients need to know when to take medication, how much to take, and what the potential side effects are. They also need to be able to express how the medication is working and what their symptoms are. Patients should feel comfortable asking questions and discussing their pain management plan. Physicians need to listen, provide feedback and give advice when needed.

Individualized treatment plans should be tailored to the patient’s age, gender, medical history, lifestyle and other factors.  That will help ensure that the treatment is effective and also reduce the risk of adverse reactions and potential complications. Collaborative decision-making makes patients feel more comfortable, confident in their treatment plan, and more likely to follow it.

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and the founder and former President of the International Pain Foundation. You can follow Barby at www.barbyingle.com. 

White Patients More Likely Than Blacks to Get Opioids at ER

By Drs. Trevor Thompson and Sofia Stathi, University of Greenwich

White people who visit hospital emergency departments with pain are 26% more likely than Black people to be given opioid pain medications such as morphine. This was a key finding from our recent study, published in the Journal of General Internal Medicine.

We also found that Black patients were 25% more likely than white patients to be given only non-opioid painkillers such as ibuprofen, which are typically available over the counter.

We examined more than 200,000 visit records of patients treated for pain, taken from a representative sample of U.S. emergency departments from 1999 to 2020. Although white patients were far more likely to be prescribed opioid medication for their pain, we found no significant differences across race in either the type or severity of patients’ pain.

Furthermore, racial disparities in pain medication remained even after we adjusted for any differences in insurance status, patient age, census region or other potentially important factors.

Our analysis of prescribing trends spanning over two decades’ worth of records found that opioid prescribing rates rose and fell, reflecting changing attitudes in clinical practice toward the use of opioid drugs. Notably, however, there appeared to be little change over time in the prescribing disparity across race.

These findings are important because they suggest that efforts to promote equitable health care in the U.S. over the past two decades, such as the Affordable Care Act, or “Obamacare,” do not appear to have translated to clinical practice – at least with regards to pain management in hospital emergency departments.

There’s no question that as the ongoing opioid crisis continues to escalate, a careful balance must be struck between the risks and benefits of prescribing opioids. But their appropriate use is an essential component of pain control in the emergency department, and they typically provide superior relief to non-opioids for short-term moderate to severe pain.

Undertreated pain produces unnecessary suffering and can result in a range of negative outcomes, even including a greater likelihood of developing long-term pain. There are over 40 million pain-related emergency department visits annually, so it is clear that equitable pain treatment is a fundamental component of a fair health care system.

We do not know why such marked racial disparities exist. Some researchers have argued that prescribing fewer opioids may be beneficial for Black patients as it reduces the risk of addiction. But this argument doesn’t square with the data, which show that overdose rates have traditionally been lower in Black populations compared with white people. However, this trend has started to change in recent years.

In addition, some evidence suggests that clinicians may hold unconscious biases, incorrectly believing Black patients to be less sensitive to pain or that certain racial groups are less willing to accept pain medication.

While there is preliminary evidence that these factors may be important, there is not enough research that examines the degree to which they influence clinical practice. Researchers like us also know very little about whether promising remedial strategies based on these factors – such as educational training during medical school that challenges stereotypical beliefs – are effective, or indeed even implemented, in the real world.

The need for tackling racial disparities in health was brought into focus once more in February 2023, when the Biden-Harris administration signed an executive order on further advancing racial equity. Given the long history of these issues, it is clear that more research is needed to help develop better strategies for tackling health inequalities.

The most effective strategies for addressing racial disparities in pain treatment are likely to be those that target the underlying causes. We are currently undertaking research to try to better understand these causes, how they contribute to disparities in real-world clinical practice and whether strategies designed to address them are actually effective.

Trevor Thompson, PhD, is an Associate Professor of Clinical Research and works in the Centre for Chronic Illness and Ageing at the University of Greenwich.  

Sofia Stathi, PhD, is a Professor of Social Psychology in the School of Human Sciences at the University of Greenwich, where she leads the Centre for Inequalities.

This article originally appeared in The Conversation and is republished with permission.

DEA Plans Further Cuts in Rx Opioid Supply in 2024

By Pat Anson, PNN Editor

Despite chronic shortages of opioid pain medication around the country, the U.S. Drug Enforcement Administration is planning to further reduce the supply of oxycodone, hydrocodone, morphine and other opioids in 2024.

The DEA sets annual production quotas for opioids and other controlled substances after consulting with the Food and Drug Administration, Centers for Disease Control and Prevention, and individual states about their projected medical and research needs. If the proposed cuts are finalized next month, 2024 will be the 8th consecutive year that DEA reduced production quotas for opioid manufacturers.

“FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2024 will decline on average 7.9 percent from calendar year 2023 levels. These declines are expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone,” DEA said in a public notice published in the Federal Register.

There will not be 7.9% cuts across the board for every opioid. The steepest cuts will be in the supply of codeine and prescription fentanyl, while production quotas for oxycodone and hydrocodone will be reduced only marginally.  

Proposed Cuts in 2024 Opioid Supply

- 8.3% Codeine  

- 7.6% Rx Fentanyl  

- 4.3% Morphine

- 2.1% Hydromorphone 

- 0.3% Oxycodone   

- 0.3% Hydrocodone

Since reaching their peak in 2015, DEA production quotas have been reduced by over 68% for oxycodone and nearly 73% for hydrocodone, the two most widely prescribed Schedule II opioids.

The primary goal of the DEA in cutting the supply is to reduce the risk of diversion, abuse and overdose, but there is little evidence the policy is working or even needed. Prescription opioid use has been cut in half in recent years, but overdose deaths have grown to record levels, fueled primarily by illicit fentanyl and other street drugs.

Fears about patients selling or diverting their opioid medication also appear overblown, as the DEA estimates the diversion risk for hydrocodone at only 0.31% and 0.28% for oxycodone. That means for every pill that’s sold or stolen, about 300 pills are used by the patient they were intended for.

Federal health agencies appear to have turned a blind eye to opioid shortages. For several months, the American Society of Health-System Pharmacists (ASHP) has warned of shortages of immediate release oxycodone, oxycodone/acetaminophen tablets, and hydrocodone/acetaminophen tablets. But those shortages have not been publicly acknowledged by the DEA or FDA, and have not been added to the FDA’s drug shortage list.

More ADHD Meds, Cannabis and Psychedelics

The DEA and FDA have been more responsive to complaints of shortages of Adderall and other stimulants used to treat attention-deficit/hyperactivity disorder (ADHD). The DEA is modestly raising its production quotas for stimulants after the FDA predicted a 3.1% increase in their medical use in 2024.

“DEA is committed to ensuring that patients who need stimulant medications have access to them and to ensuring that these drugs are being prescribed thoughtfully and responsibly, and we will continue working with our partners inside and outside of government to do so,” DEA Administrator Ann Milgram wrote in a letter released this week. She said 17 out of 18 drug makers had agreed to increase their production of stimulants under existing 2023 quotas.

In addition to stimulants, the DEA is also raising 2024 production quotas for cannabis, psychedelics and hallucinogens in response to an “increased level of research and clinical trials” involving the Schedule I substances.

The DEA’s quota process may undergo significant changes in the years ahead. The agency wants to be “more nimble” in responding to shortages and increases in demand. To do that, it is seeking access to sales and inventory reports from drug makers to better assess the supply that is available.

“DEA believes that changes to reporting requirements are necessary to improve both the type of data collected and the timeliness of that data, allowing DEA to be more nimble in its administration of the quota program. Future regulatory changes may seek to address the lack of real-time inventory and sales data accessible to DEA, the lack of information on production lead times, and issues of timeliness,” the agency said.

“DEA also is considering methods by which it might increase transparency in its quota setting process. Future regulatory proposals may define additional steps, including such concepts as public notification and an opportunity for public input when prescribing rates for controlled substances deviate substantially from FDA's estimate of future use. Furthermore, DEA is considering regulatory changes which will authorize it to reduce a manufacturer's individual manufacturing or procurement quota in order to apportion it to another manufacturer.”

To leave a comment on the DEA’s 2024 production quotas, click here. Public comments must be submitted online or in writing on or before December 4, 2023.

Study Finds Low Risk of Overdose From Prescription Opioids

By Pat Anson, PNN Editor

A large new study that identifies the top risk factors for an overdose involving prescription opioids has inadvertently shown just how low the risk is in the first place.

In a systematic review published in the Canadian Medical Association Journal, researchers at McMaster University looked at 28 studies involving nearly 24 million patients in the United States, Canada and the United Kingdom who were prescribed opioids for chronic pain.

They found 10 “predictors” associated with a higher risk of a fatal or nonfatal overdose, such as a patient taking high doses, having a substance abuse problem, and having multiple prescribers or pharmacies.

Many of these risk predictors are already well-known. What’s different about this study is that the researchers calculated the odds of an overdose happening in different situations and doses. That’s where things get interesting:

“High-certainty evidence from 14 studies involving 1,315,173 patients showed a linear dose–response relationship with opioid overdose. The association was small at a 50-mg morphine equivalent dose/day (OR 1.69, 95% CI 1.50–1.90) and large at 90 mg (OR 2.57, 95% CI 2.08–3.18), with an absolute risk 2.6 per 1000 for fatal overdose and 5.1 per 1000 for nonfatal overdose at a 90-mg morphine equivalent dose/day.”

In plain English, the risk of a fatal overdose at 90 morphine milligram equivalents (MME) is not “large.” It’s only 0.26% at 90 MME, which is considered a fairly high dose. The risk of a fatal overdose is even lower at 50 MME – just 0.16% -- a level that researchers say is “small-to-trivial.”

I’m not a statistician, but 0.26% and 0.16% seem like pretty small odds – similar to the lifetime risk of dying in a car accident, fire or drowning. Unlike opioids, there is no talk of a ban on swimming pools, motor vehicles or matches.

“I think that most people living with chronic pain would agree with your interpretation,” says co-author Jason Busse, DC, a clinical epidemiologist and professor of anesthesia at McMaster University. “I do think, however, that a minority of patients will place greater value on the possibility of overdose and death even though the absolute risk is small.”

Busse’s involvement in the study is notable, because he was the lead investigator in Canada’s 2017 opioid guideline, which suggest that initial doses of opioids be kept under 50 MME and strongly recommend that they never exceed 90 MME. The CDC opioid guideline in the United States makes similar recommendations.

Given the small risk of an overdose actually happening at 50 or 90 MME, the new study would seem to debunk both guidelines. Busse sees it a bit differently, telling me by email that the overdose calculations will help patients understand the risks associated with prescription opioids.

“Our work in this area has suggested that most people living with chronic pain, who have not found sufficient relief with non-opioid therapy, would be interested in a trial of opioids. Specifically, when provided with the evidence for benefits and harms, including the risk of overdose, that most patients in whom non-opioid therapy has proven insufficient would elect to pursue a trial of opioid therapy,” Busse said.

“By presenting the evidence to patients, and helping them to understand the anticipated benefits and harms, we can help ensure that the decisions they make are the right ones for themselves.”

Unfortunately, pain patients in the U.S. and Canada don’t get to make decisions for themselves. Decisions are made for them by doctors, pharmacists, regulators, and law enforcement. Patients increasingly have trouble finding a provider willing to treat them or getting a prescription filled at a pharmacy.

And because the “voluntary” opioid guidelines are usually treated as mandatory,  patients who are prescribed opioids are often kept at ineffective low doses that are well below 90 or even 50 MME.

‘Opiods Kill and Opioids Are Bad’

Experts say the low risk of overdose from prescription opioids was established in previous studies, but people got caught up in opioid hysteria and ignored the evidence. The new study, they say, is no different.

“This paper examines well plowed ground and provides no new insight. Quite the contrary, it obfuscates through oversimplification of the problem,” says Stephen Nadeau, MD, a Professor of Neurology at the University of Florida College of Medicine. “The essential message is that opioids kill and opioids are bad.”

Nadeau says Busse and his co-authors ignored factors like genetic differences in opioid metabolism and put too much emphasis on the risk of a patient having multiple prescribers or pharmacies. The latter could simply be a sign that they were abandoned by a doctor or turned away by a pharmacy, not doctor shopping. Statistics mined from databases don’t tell you that.

“This paper takes a rigorous statistical approach to explain what is happening in a highly heterogeneous population in which there is a high probability of misconstruing the sources of variance. I think it would have been OK if published in 2015, but we have learned a thing or two since then and now the paper serves only to obfuscate and mislead,” said Nadeau.

Two findings in the study worth highlighting are that researchers found little risk of an overdose when a patient is co-prescribed opioids with benzodiazepines, sedatives or muscle relaxants – the so-called “Holy Trinity.” The overdose risk is also “small-to-trivial” when a patient is given long-acting opioids instead of short-acting ones. Those findings contradict the recommendations made in the U.S. and Canadian guidelines.

“The opioid crisis has generated interest in identifying patients at higher risk of addiction or overdose and has led to the development of several screening tools; however, these instruments have either not been validated or shown poor psychometric properties,” wrote lead author Li Wang, PhD, a researcher at McMaster University. “Our findings suggest that awareness of, and attention to, several patient and prescription characteristics, may help reduce the risk of opioid overdose among people living with chronic pain.”

One of the co-authors of the study is David Juurlink, MD, a member of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Like several other PROP members, Juurlink disclosed that he has been a paid expert witness in legal cases involving opioids.

Previous studies have also found that the risk of overdose is small — 0.3% — in Medicaid and Medicare patients prescribed opioids for the first time. Another study of Medicare patients found that over 90% had little to no risk of overdosing. Low risk patients had only 0.006% chance of an overdose.

We Must Overcome Stigma Against Buprenorphine for Pain

By Dr. Stefan Franzen

For years I had a negative impression of buprenorphine as a pain medication, both from personal descriptions I had heard by pain patients and from the scientific and medical literature.

I have since learned that buprenorphine can be effective pain reliever. At a high dose, the efficacy is similar to that of high-dose morphine or oxycodone, which were once commonly used to treat chronic or intractable pain.

Today, high doses of any opioid are shunned by most doctors because they are subject to increased scrutiny by state medical boards or even investigation by the Drug Enforcement Administration. The medical and moral justification of alleviating patient suffering appears to be irrelevant to public health authorities, even when they profess to favor a humane policy to treat pain.  

We need a more rational discussion about opioids. Buprenorphine is an opioid that, when used alone, can play a role in pain treatment. Buprenorphine was developed in the United Kingdom in the 1960s and has been used in many countries to treat pain since the 1980s.

We must distinguish pure buprenorphine from Suboxone, which is a combination of buprenorphine and naloxone. Suboxone is given to people with opioid use disorder to help prevent abuse. If a tablet is crushed, extracted or injected by a drug abuser, the naloxone will block the effects of buprenorphine. However, if taken as directed under the tongue, the naloxone has much lower bioavailability.

A pain patient does not necessarily need naloxone and, depending on individual differences in body chemistry, the naloxone may even have negative effects. There is no reason to prescribe Suboxone for pain. It’s use as a pain medication is highly inappropriate, but may be the result of doctor’s fear of DEA action.

Pure buprenorphine is a different matter.

The CDC’s 2016 opioid guideline recommended that daily opioid doses not exceed 90 morphine milligram equivalents (MME).  Although voluntary, the guideline was seized upon by other federal agencies and state legislatures to justify draconian new laws and regulations that limited opioid doses to 90 MME or less.

No such limits have been set for buprenorphine. However, few doctors in the U.S. prescribe buprenorphine for pain, despite recent studies demonstrating its efficacy and international recognition that it is an effective analgesic.

For historical reasons, American doctors do not know much about buprenorphine as a pain medication. Moreover, many fear prescribing any opioid in today’s regulatory climate. Patients know that buprenorphine has been used to treat addiction and therefore are suspicious of it as a pain treatment. They are also justifiably concerned about being stigmatized as a drug abuser if they are prescribed Suboxone.

U.S. Opioid Policy Lacks Common Sense

In short, the stigma surrounding buprenorphine is a significant factor preventing development of a rational opioid policy in the U.S.

Many patients with experience taking morphine, oxycodone, hydrocodone and other opioids say they are safe and non-addictive. Research shows that is true for a great many pain patients. However, a small fraction of the population is susceptible to opioid abuse and addiction. This is a classic ethics problem.

Should we let 99% of patients suffer because 1% might harm themselves? How do other societies manage this problem? We know what doesn’t work. The “War on Drugs” has been an unmitigated disaster for everyone: drug abusers, doctors, pain patients and their loved ones. Our drug overdose rate is 15 times higher than that the of European Union.

Worse still, our medical system and corporate regulation appear to lack common sense guardrails needed to prevent the diversion of prescription opioids -- even after massive publicity, sensational books, documentaries, and popular miniseries on the opioid crisis.

In case anyone had any doubt, the book “American Cartel” shows that diversion was mainly practiced by large opioid distributors and a few manufacturers, who flooded vulnerable communities with prescription opioids. Theft and deception of doctors by drug abusers also contributed to diversion. Each of these could be controlled in a sensible way, without forbidding people in pain from receiving medication. Yet, at present it appears there is no political will in the U.S. to even treat pain, regardless of the suffering of millions.

Instead, the politicians and media blame opioid prescribing, which implicitly blames doctors and patients. Perhaps as a response to this seemingly hopeless situation, a growing number of medical researchers have begun testing pure buprenorphine for the treatment of pain.

After seeing the effectiveness of buprenorphine, which I discuss in my new book, “Z’s Odyssey,” I became convinced that it is a viable treatment for even severe, intractable pain. This should be a choice, but the problem today is that many patients do not have a choice.

Pure buprenorphine for pain was not available in the United States until 2010, when the low-dose Butrans skin patch became available.

In 2015, a buccal formulation designed for absorption through the cheek became available. Belbuca film is quite convenient and comes in a moderate dose.

For intractable pain, a sublingual formulation of buprenorphine known as Subutex can be prescribed off label for pain. Subutex is also used to treat opioid addiction, but does not contain naloxone.

A Subutex tablet placed under the tongue takes about 20 minutes to be completely absorbed. Because buprenorphine binds to the pain receptors more tightly than any other opioid, the dose in milligrams required for full effect is much lower than similar strength morphine. Many medical researchers have concluded that buprenorphine is an excellent analgesic, with low risk for addiction or overdose. If taken as directed, the risk of respiratory depression from buprenorphine is the lowest of any opioid.

For pain relief, U.S. doctors must prescribe Subutex off-label, which means that they are prescribing for a condition that is not FDA approved.  Subutex is approved for pain in Great Britain and most of Europe. The UK’s National Health Service recommends Subutex and other formulations of buprenorphine for patients “when weaker opioids for pain stop working.”

Of course, buprenorphine is not beneficial for every patient. And there is an issue of dental decay that requires careful monitoring and appropriate procedures. But for people in the most severe pain, who lack any other option because of the opioid prohibition mindset, buprenorphine may offer relief.

Finding a doctor willing to prescribe Subutex off label could be difficult. For severe or intractable pain that requires a high dose, a patient most likely needs to find a psychiatric or addiction treatment doctor licensed to prescribe buprenorphine in formulations such as Subutex that are pure buprenorphine.

Since 2000, the U.S. Congress has passed three laws that make buprenorphine more accessible to people with opioid use disorder.  If Congress can aggressively lower the barriers to prescribing high-dose buprenorphine for addiction treatment, then why shouldn’t pain patients have access to medication that has the same dose of the active agent?

There is an education gap that prevents doctors and society at large from effectively managing this situation. The medical literature is heavily weighted toward studies of buprenorphine for addiction, with almost 97% of studies on opioid use disorder and less than 3% on pain.  Pain patients also fear the stigma associated with buprenorphine as an addiction treatment, rather than an analgesic.

There is no objective reason for this. At the very least, buprenorphine should be an option for those forgotten patients who still live in pain. By overcoming the stigma of buprenorphine, doctors could treat patients with dignity by prescribing a safer and more effective medication. 

Stefan Franzen, PhD, is a Professor of Chemistry at North Carolina State University. Franzen is the author of “Patient Z” – a book that looks at pain, addiction and the opioid crisis through the eyes of a patient who can’t find good pain care. He recently published a sequel to Z’s story, called “Z’s Odyssey.”

Sickle Cell Patients Face Life-Threatening ER Waits

By Sara Hutchinson, KFF Health News

Heather Avant always dresses up when she goes to the emergency room.

“I’ve been conditioned to act and behave in a very specific way,” said Avant. “I try to do my hair. I make sure I shower, have nice clothes. Sometimes I put on my University of Michigan shirt.”

HEATHER AVANT

It’s a strategy to combat discrimination the 42-year-old photographer in Mesquite, Texas, has developed over a lifetime of managing her sickle cell disease, a rare blood disorder that affects an estimated 100,000 Americans.

The hereditary condition can affect a person of any race or ethnicity, but Black patients, like Avant, make up the majority of those afflicted in the U.S.

For people living with the disease, a sickle cell crisis can happen at any time. When it does, their rigid, sickle-shaped red blood cells become stuck in their blood vessels, blocking flow and causing extreme pain or breathing difficulties.

A crisis can escalate into life-threatening complications such as strokes, seizures, and sepsis.

When a pain crisis can’t be managed at home, patients head to the ER to get the high dosage of opioids they need, in addition to IVs to help with dehydration or even blood transfusions. Yet staffers in emergency departments — already overextended and grappling with nursing shortages — don’t always have experience in treating the rare disease. And many doctors, amid a still-raging opioid crisis, remain resistant to prescribing the painkillers necessary to treat sickle cell crises.

As a result, patients with sickle cell disease often face long delays before receiving essential ER care, plus discrimination and suspicion that they are seeking drugs to get high.

“I have to look like I’m not coming in here off the street looking for medication,” said Avant. “I have to put on an entire show to get you to believe that I need care.”

Long Waits

Years of research have documented the delays. A study published in 2013 found that patients seeking care from 2003 through 2008 at an ER for their sickle cell crises waited 50% longer than patients who arrived with broken legs or arms.

Another study published in 2021 found that 50% of sickle cell patients reported having to wait at least two hours before their pain was treated, despite medical guidelines recommending such patients in crisis receive their first dose of pain medication no more than 60 minutes after arriving at the ER.

Medical associations such as the American Society of Hematology, the National Heart, Lung, and Blood Institute, and the Emergency Nurses Association have established guidelines for emergency department-based care of sickle cell pain. And, in 2021, the Emergency Department Sickle Cell Care Coalition, a national collaboration of hematologists, pharmacists, and nurses, helped launch a point-of-care tool to help medical professionals manage the disease in the ER.

But patients and sickle cell experts said those best practices haven’t been widely adopted. A 2020 survey of nearly 250 emergency medicine providers found that 75% of them were unaware of the NHLBI’s recommendations, first published in 2014, yet 98% felt confident in their ability to treat patients with sickle cell disease.

Still, ER horror stories abound among adults with sickle cell disease. For Lesly Chavez, 29, a Houston hairstylist, her worst experience occurred a few years ago. She said she spent four hours in a waiting room before getting seen.

“And when they finally got to me, they told me they could help with ‘my addiction,’ but they decided that there was nothing that they could do for me,” Chavez said. “They just flat-out said no and sent me home while I was in crisis.”

Chavez said she has since avoided that hospital even though it’s 10 minutes from her home. Now she drives to an ER 30 minutes away.

Chavez, who is Hispanic, said she confronts “doubt everywhere I go” because sickle cell disease primarily affects Black Americans. (Those who are Hispanic can be of any race.)

Paula Tanabe, a professor of nursing at Duke University who has spent decades researching ways to improve care for sickle cell patients, said a confluence of factors adds to the racial bias patients may face.

“Emergency rooms are incredibly overcrowded, at rates that we have never seen before, and that’s for everyone,” said Tanabe.

‘People Are Going Uncounted’

Legislators are trying to help. A federal bill introduced in June would allocate $8.2 million annually for five years to a program that trains doctors on best practices for caring for sickle cell patients. Another, introduced this spring, would provide funding for community organizations working to spread awareness about the condition and give student loan relief to medical providers who commit to working on the disease. Some state legislatures have established sickle cell task forces to improve physician education and care coordination.

Advocates for sickle cell patients said investment in data collection to track the disease is also important. Although the Centers for Disease Control and Prevention estimates that some 100,000 Americans have it, the true number is unknown. That’s because no national system exists to collect data on sickle cell, unlike other conditions such as diabetes, cancer, and Alzheimer’s.

“I’m 32 and we’ve been saying it’s 100,000 my entire life,” said Quannecia McCruse, who co-founded the Sickle Cell Association of Houston. “I know there’s more. I know people are going uncounted.”

Eleven state-led data collection programs currently exist and, in February, the CDC opened a new grant application for additional states. Improved data would allow funding to be allocated toward the areas with the greatest need, sickle cell patient advocates said.

Texas had an opportunity to join those efforts. This spring, the state legislature passed a bill with broad bipartisan support to create a sickle cell patient registry, but Republican Gov. Greg Abbott vetoed it, saying it would compromise patient privacy.

“That was a bad excuse,” said McCruse. “We have a cancer registry already, and everyone’s information is safe. That registry would have gone a long way to help.”

While progress grinds slowly, patients like McCruse say they’re forced to balance advocating for themselves during bouts of excruciating pain against the need not to irritate or alienate hospital staffers.

“It feels like someone is taking a Taser and shocking the crap out of me. Or when it’s really bad, and it feels like shards of glass are just moving through my veins,” said the mother of two. “It’s very, very painful. And you’re telling somebody whose body is torturing them that it’s not that bad?”

Alexis Thompson, a hematologist who treats sickle cell patients at the Children’s Hospital of Philadelphia, said she works with her pediatric patients to develop self-advocacy skills. But sometimes that backfires.

“The great irony is patients who are well informed and capable of self-advocating are being accused of being manipulative, because they are capable of articulating very clearly what’s effective for them down to the name of the medication or the absolute dose,” Thompson said.

Sickle cell experts recommend that doctors adhere to a patient’s individual pain plan, if available. Thompson said those plans, which document patients’ diagnoses alongside a recommended medication and dosage, can be uploaded to online portals that patients can pull up on their cellphones when visiting an ER to verify what they need.

Patients such as Avant hope such steps can help decrease their ER waits while easing their anxiety about seeking emergency care.

“I don’t fear dying,” said Avant, “but I do fear dying in the hospital.”

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

Drug and Medical Supply Shortages Impacting Patient Safety at ‘Alarming Rate’

By Pat Anson, PNN Editor

Over half of U.S. hospitals are reporting shortages of drugs and supplies used in anesthesia, pain management and emergency care, according to a new survey by a nonprofit healthcare organization. Nearly nine of out of ten (86%) respondents said they were rationing or restricting the use of medications in short supply.

The survey of nearly 200 hospital administrators, pharmacists and supply chain managers was conducted by the Emergency Care Research Institute (ECRI) in July.

“Their responses suggested that providing safe and appropriate drugs, supplies, and equipment has become extremely challenging and led to numerous instances of unsafe practices, compromised care, and potentially harmful errors. Many of the respondents clearly communicated their struggles to address shortages which are occurring at an alarming rate,” the ECRI report said.

Respondents reported shortages of over 20 drugs, single-use supplies, or medical equipment. The shortages primarily affect surgery and anesthetics (74%), emergency care (64%), pain management (52%), cardiology (45%), hematology and oncology (44%), infectious diseases (39%), and obstetrics and gynecology (37%).

“While medication and supply shortages have been widely reported across healthcare, we now know with certainty that these shortages are causing preventable harm and have the potential to cause even more if they are not addressed soon,” Marcus Schabacker, MD, president and CEO of ECRI, said in a statement.

“There are strategies hospitals can use to reduce the impact of shortages, but they are a deviation from standard practice and resource-intensive -- two characteristics that themselves can increase the likelihood of preventable harm.”

Many hospitals (42%) are stretching supplies by using medications after their expiration date, reusing single-use devices, or using drugs for purposes outside of their specific labeling. Nearly a quarter of respondents (24%) said they knew of at least one medical error related to a drug, supply or device shortage.

Specific examples of how shortages have impacted patient care include:

• Interruption or delays in chemotherapy

• Use of more opioid analgesia due to lidocaine shortages

• Incorrect medication instructions given to patients

• Postponement or cancellation of surgeries 

To address shortages of masks, gowns and other personal protective equipment, many hospitals have turned to non-traditional sources that supplied products with “alarmingly poor performance,” according to ECRI.

For example, tests on KN95 masks obtained from nontraditional suppliers found that up to 70% did not filter particulates the way manufacturers claimed. And tests on disposable gowns revealed that over half failed to meet even minimum standards for protection.

“The extent to which medication, supply, and equipment shortages are negatively impacting patient care is inexcusable,” said Rita Jew, PharmD, president of the Institute for Safe Medication Practices, an ECRI affiliate. “While pharmacies and hospitals can triage shortages short-term, we need long-term, nationally coordinated solutions to solve the persistent shortages we’ve witnessed repeatedly over the last several years.”

Supply Interruptions

Many respondents also expressed concern about drug shortages worsening after a Pfizer plant in North Carolina was heavily damaged in July by a tornado. The Rocky Mount plant was a leading supplier of sterile injectable drugs used in surgery, pain management and emergency care. Pfizer recently resumed production at the plant, but doesn’t expect full operations to be restored until later in the year.     

“While manufacturing has resumed, it is important to note that some medicines may not be back in full supply until next year,” the company said in a statement.

The American Society of Health-System Pharmacists (ASHP) recently expanded its shortage list for injectable morphine to include morphine vials made by Pfizer. The company said the vials are on back order and could not estimate a release date. The lack of supply is having a snowball effect on other drug manufacturers, who say they’re running out of injectable morphine and hydromorphone due to increased demand.

The ASHP recommends that providers use “extreme caution” when switching morphine concentrations or interchanging them with other injectable opioids because patients could react to them differently.

Limited supplies of morphine, hydromorphone and other injectable opioids were being reported long before the tornado damaged Pfizer’s plant or the pandemic disrupted the global supply chain. Despite that, the Drug Enforcement Administration has aggressively cut the supply of many opioids, reducing production quotas for hydromorphone by 71% and morphine by 65% from their peaks in 2016.       

GRAPHIC COURTESY OF MONTY GODDARD

The Food and Drug Administration put injectable morphine and hydromorphone on its drug shortage list in 2017, the year after DEA started cutting the opioid supply.  In recent months, the ASHP added oxycodone and hydrocodone tablets to its drug shortage list, but their limited supply has not yet been acknowledged by the FDA.

A recent federal lawsuit accused the DEA of “incompetence” in its handling of the nation’s drug supply, specifically the production quotas the agency sets for amphetamines used in ADHD medication.

Drug makers are required to report shortages and supply interruptions to the FDA. Doctors, pharmacies and consumers can also report them by email to the FDA at drugshortages@fda.hhs.gov. To report a drug shortage to the ASHP, click here.