Pain Patients Challenge DEA’s ‘Bogus Judicial System’

By Pat Anson, PNN Editor

Patients of a California doctor whose license to prescribe opioids and other controlled substances was suspended by the DEA have launched another long shot legal bid to get his license reinstated.

DEA administrator Anne Milgram suspended the license of Dr. David Bockoff in 2022, largely based on allegations that five of his pain patients were receiving dangerously high doses of opioids. Bockoff’s abrupt suspension left 240 patients – including many who suffer from severe and incurable pain conditions -- scrambling to find new providers and pain medication.

At least three of those patients have since died, including one who committed suicide with his wife and another who died after buying opioid medication in Mexico.

“Every time you take away a doctor's license without giving them any opportunity to fight it, you put a patient on the street who's a chronic pain patient and they've just been abandoned. No explanation or anything,” says attorney John Flannery. “And the government doesn't give a damn. They don't care at all.”

Flannery represents nine Bockoff patients who have tried repeatedly to gain legal standing as interested parties in the DEA case against the Beverly Hills doctor. Their efforts so far have failed. An Administrative Law Judge would not let them attend DEA hearings on the case, and a federal judge refused to grant a temporary restraining order that would have restored Bockoff’s license while he appeals his suspension.

Recently, a three-judge panel on the District of Columbia’s U.S. Court of Appeals declined to intervene in the case, saying the patients provided the court with “no credible factual submissions” that document how they were harmed by Bockoff’s suspension. The judges’ order makes no mention of the patients who died.

‘We Were Entirely Hamstrung’

Part of the problem is the closed administrative system that the DEA uses to discipline doctors, in which the agency essentially serves as the prosecutor, judge and executioner. Flannery calls it a “bogus judicial system” that the DEA created for itself. Even the rulings of a supposedly independent Administrative Law Judge (ALJ) can be rejected by the DEA Administrator.

“There is much talk about how the government is ‘open’ and transparent, but DEA’s proceedings are entirely opaque to patients and the public,” Flannery wrote in his latest appeal, in which he asks the full DC Court of Appeals for an en banc review of the case.

“We were entirely hamstrung to proceed to seek review in any DEA proceedings as we had no right to review any pleadings, to attend any hearings, to monitor the proceedings, to review any of the ‘evidence,’ to hear the arguments, and the only decision made available to us by the ALJ related to the (unsuccessful) motion to intervene.”

Flannery says federal law allows any “interested persons” or “person aggrieved” by the DEA to have a legal standing in its administrative hearings. If the Appeals Court accepts that argument, it would set a major precedent that would affect all future DEA cases against doctors by giving their patients a seat at the table.

Flannery says the DEA’s disciplinary actions against Bockoff and other doctors interfere with the practice of medicine.

“I hate to say it’s a witch hunt, but I think we found a witch and the witch is the present DEA administrator,” Flannery told PNN. “She's part of a machine that just keeps chugging along, hurting and hurting and hurting. How does one go into government to do that? Who do they think they're saving? They found five patients that they claim were harmed, and so the other 235 patients, they have no idea about them, and they just cut them off. How do you justify that?”

Flannery’s appeal also cites the DEA’s “flimsy evidence” against Bockoff, most notably the agency’s expert witness, Dr. Timothy Munzing, a family practice physician who has launched a lucrative second career for himself as a government witness against doctors accused of overprescribing opioids. Munzing has made over $3.4 million testifying for the federal government in dozens of cases against doctors. In an Ohio case, a judge declared a mistrial after Munzing contradicted himself during testimony.

“The DEA’s expert, Dr. Timothy Munzing, was, by any fair review, ‘damaged goods’ by DEA’s overuse of his ‘skills,’” Flannery wrote. “On information and belief, this impeachment material involving Dr. Munzing, the DEA’s sole expert witness, was withheld from Dr. Bockoff in the DEA Administrative proceeding.”

A protracted legal challenge of this kind is expensive and a GoFundMe campaign has been created by the nine Bockoff patients to help support it. Over $10,000 has been raised so far.

“Please know that we'll be working as hard as we can to keep this fundraiser and our effort going,” said Kristen Ogden, the wife of one of the patients. “Our donors are helping so much in this effort to make a difference for chronic pain patients and doctors. As John (Flannery) says, we are doing something that hasn't been done before... seeking to intervene so that patients can have a voice.”

Oregon Medical Board Has ‘No Limits’ on Prescription Opioids

By Pat Anson, PNN Editor

The Oregon Medical Board has come full circle in its regulation and enforcement of pain management guidelines. After years of taking disciplinary action against doctors for prescribing high dose opioids without a “legitimate medical purpose,” the board has acknowledged that its policies had a chilling effect on doctors who no longer felt safe treating chronic pain with opioids.

“The Board is well aware some number of clinicians have shied away from long-term pain management in part or in whole for fear of Board sanctions. We wish it weren’t so, and the Board is hopeful the realignment in prescribing guidance will provide reassurance to those licensees caring for patients with long-term pain,” David Farris, MD, Medical Director of the Oregon Medical Board (OMB), recently wrote in the board’s newsletter.

The board’s “realignment” came a year after the Centers for Disease Control and Prevention revised its own opioid guideline to give doctors more flexibility in treating pain patients.

In 2016, the CDC initially recommended that daily opioid dosages not exceed 90 MME (morphine milligram equivalents), which was widely seen as a mandatory dose limit.

But after numerous reports of patients being rapidly tapered, going into withdrawal and dying by suicide, the CDC guidance was revised in 2022 to eliminate any dose thresholds. Physicians were instead urged to prescribe opioids cautiously at the “lowest possible effective dose.”   

“There are no set regulatory limits on the daily dosage of opioids that can be prescribed in Oregon. There is also not a requirement to rapidly taper or discontinue opioids for patients.”

— Oregon Medical Board

In a “Statement of Philosophy” adopted in January, the OMB urged doctors to read the CDC guideline and heed its advice about treating patients individually and to allow “shared decision making” about their treatment.

“In alignment with this statement and CDC guidelines, there are no set regulatory limits on the daily dosage of opioids that can be prescribed in Oregon. There is also not a requirement to rapidly taper or discontinue opioids for patients on existing opioid doses. The Board wants to ensure licensees accepting new patients on existing chronic opioid therapy do not feel pressured to rapidly change a patient’s current opioid dose,” the OMB said.

‘More Harm Than Good’

Opioids have been a contentious issue in Oregon for several years. In 2018, the state considered rule changes to its Medicaid program that would have limited coverage of opioids to just 90 days for patients with neck or back pain. The proposal, which would have forcibly tapered thousands of patients on long-term opioid therapy, was supported by Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.     

The plan was scrapped after pain management experts signed a joint letter warning that Oregon’s tapering plan was unsupported by treatment guidelines and would do “substantially more harm than good.”

The Medical Board’s decision to give more leeway to doctors reflects a growing awareness that the crackdown on opioids is harming pain patients and may be worsening the drug crisis.    

“The Board wishes to reassure and encourage licensees to assume the prescribing responsibilities for such patients, regardless of MME level, at least temporarily, in order to avoid patients going into withdrawal or turning to illicit sources,” Farris wrote.

“It is gratifying to see the OMB finally recognize that their arbitrary opioid dosing policies harmed people with chronic pain and the providers caring for them. It seems as though the Board may have been adversely affected by advice received from home state clinicians aligned with PROP, and, inevitably, the chickens have come home to roost in that regard,” said Bob Twillman, PhD, former Executive Director of the Association of Integrative Pain Management, who signed the 2018 joint letter.

“I hope this change in stated policy will be reflected in changes to Board investigations and to the state-developed CME (Continuing Medical Education) program on pain management that is mandated for all prescribers in the state. It's going to take years to repair the damage done so far, but I'm hoping the pendulum can finally come to rest somewhere near the midpoint of the extremes we've seen over the last 30 years.”

Opioid prescribing in Oregon has been falling for nearly a decade – as it has nationwide – but overdose deaths in the state keep rising. According to CDC data, Oregon has one of the lowest rates of fatal overdoses involving prescription opioids in the country. Deaths linked to illicit fentanyl, stimulants, methamphetamine and heroin are far more common in Oregon.  

Where is CDC’s Guidance About Its Opioid Guideline?

By Carol Levy, PNN Columnist

By happenstance, I recently came across the CDC's 2022 revised opioid prescribing guideline. Too many doctors and states saw the agency’s original 2016 guideline as being written in stone -- not the voluntary set of recommendations they were intended to be.

To their credit, the CDC tried to address that misconception in its updated guideline:

“Recommendations are voluntary and are intended to support, not supplant, individualized, person-centered care. Flexibility to meet the care needs and the clinical circumstances of a specific patient is paramount.”

The CDC also acknowledged the damage done by its 2016 guideline, when many pain patients were forcibly tapered or cutoff from opioids, regardless of their diagnosis or condition. 

Some patients were abandoned by doctors who no longer wanted to risk going to prison for prescribing opioids. Other physicians retired or closed their offices, sometimes without warning. And several states passed legislation limiting how many days initial opioid prescriptions could be written for.

It is always hard to put the genie back in the bottle. Two years after the revised guideline was released, about 90% of patients still have trouble getting their opioid prescriptions filled at pharmacies. Others have to fight with their insurance company to get opioid medication covered.

Patients are still being forced into withdrawal and disability, despite a history of taking opioids safely and responsibly. Some will have to leave jobs they could only perform with the help of opioids. Others can’t play with their kids, walk the dog or even get out of bed, because they are no longer able to get the medication that helped them lead relatively normal lives.

It should not have taken CDC six years to revise the opioid guideline, to make clear that they were only recommendations and never a mandate.

Is there a way to undo the damage? For the doctors who closed their practices or stopped treating pain, it is probably too late. For the patients who chose suicide because they could no longer get opioids, it is definitely too late

But maybe, just maybe, we can persuade doctors, pharmacists, lawmakers and insurers to take another look at the revised opioid guideline and convince them they are out of line.

It would be helpful if the CDC joined in an effort to fix the mess that it helped create.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here. 

‘Smart Opioid’ Relieves Pain with Lower Risk of Overdose

By Pat Anson, PNN Editor

An experimental form of hydrocodone relieves moderate-to-severe acute pain without the risks of traditional opioids, according to the results of an early-stage Phase 1 clinical trial.

Elysium Therapeutics say its proprietary “SMART” formulation of hydrocodone – called Oral Overdose Protected (O2P) hydrocodone – releases therapeutic levels of the pain medication when exposed to trypsin, a digestive enzyme in the small intestine. Conversely, the drug can also inhibit production of trypsin – and slow the release of hydrocodone -- if a "supratherapeutic" (more than recommended) dose is ingested.

In theory, that will reduce the risk of abuse, diversion and overdose.

"Because non-opioid options are ineffective and existing opioids have no protection against their inherent risks, moderate-to-severe acute pain is not adequately managed in greater than 80% of patients in the US,” Greg Sturmer, CEO of Elysium Therapeutics said in a press release.

“As shown in our human study, our SMART opioids, led by O2P hydrocodone, mitigate the major risks associated with existing prescription opioids without sacrificing their superior analgesic efficacy, especially when compared to currently marketed non-opioid alternatives and those in development."

The proof-of-concept study included 93 healthy participants who were not in pain, but had previously used and tolerated prescription opioids. Their blood plasma levels were measured after taking O2P hydrocodone and compared to plasma levels after taking traditional hydrocodone. Participants were also given naltrexone as a safety measure to block the sedative effect of the drugs.

Investigators say the plasma concentrations of hydrocodone were significantly lower after taking the O2P formulation, but were high enough to be “potentially lethal” from traditional hydrocodone. No adverse events were reported from O2P hydrocodone, even when taken at supratherapeutic doses.

"The results from the O2P-001 study indicate that Elysium's O2P technology could yield safer opioids that address the key issues inherent in current opioids that have fueled the opioid crisis, while providing patients with highly effective pain relief," said Leela Vrishabhendra, MD, principal investigator of the study.

Many U.S. hospitals have started using non-opioid pain medications such as ibuprofen, acetaminophen and gabapentinoids to treat post-operative acute pain. Studies have found that some patients are not happy with the results and want more pain control. O2P hydrocodone would give them an alternative.

Phase I clinical studies are preliminary in nature and usually just measure the safety and tolerability of a drug, not its effectiveness. Elysium hopes its findings will lead to a “breakthrough therapy” designation from the FDA, which will speed up the development of its O2P technology and lead to larger clinical trials that would better assess pain relief.   

"Given the robust Phase 1 human proof-of-concept data, we plan to meet with the FDA to discuss next steps, finalize our dose form for remaining clinical studies, and seek partners and investors who share our passion to disrupt the pain and opioid use disorder markets with safer medicines that reduce trauma and save lives," said CEO Greg Sturmer.

How Does Kratom Relieve Pain?

By Dr. C. Michael White, University of Connecticut

Kratom doesn’t contain just one active ingredient; rather, it is made up of many substances that induce effects in the body. This is very common for natural products, since the cells of the plant make a variety of chemicals for different purposes.

When the body is experiencing pain, it releases hormones called endorphins that stimulate opioid receptors to mildly reduce the transmission of local pain sensations to the brain. This same process also causes the release of the neurotransmitter dopamine, inducing a feeling of pleasure to neutralize the pain.

Traditional opioids, like morphine and fentanyl, stimulate these same receptors to such a degree that they more potently numb pain, induce a euphoric feeling that can lead to addiction, and suppress the drive to breathe, which can result in death.

One of the key constituents of kratom is an organic compound called mitragynine. It interacts with the same opioid receptors as morphine and fentanyl, but does not recruit the beta-arrestin-2 (the reason for breathing suppression). As a result, kratom can provide pain relief with a lower risk of slowed or stopped breathing compared to traditional opioids.

Kratom also contains a small amount of 7-hydroxymitragynine, which is thought to more potently stimulate opioid receptors, leading to a greater risk of opioidlike adverse events.

One of the risks associated with kratom use is that products can differ dramatically in the doses of 7-hydroxymitragynine. In other words, one kratom product could be more dangerous than another. When kratom is used in high doses, it can lead to seizures and other issues. Since kratom products are not FDA-regulated, there is no uniformity to the products.

Is Kratom Legal?

Kratom’s current legal status is complicated. Kratom is not a prescription or over-the-counter drug, and while it is derived from a plant, it does not meet the FDA’s definition of a dietary supplement, food or food additive.

Natural products marketed in the U.S. before Oct. 15, 1994, were grandfathered in under the FDA’s list of dietary supplements. But since kratom came on the market later, the FDA would have to find, based on a history of use or other evidence, that when used under the conditions recommended or suggested in the labeling, the natural product can reasonably be expected to be safe – like the FDA does for all new dietary supplement ingredients.

In 2016, in response to increasing calls to poison control centers, the Drug Enforcement Administration sought to ban kratom by making it a Schedule I drug. This means the agency felt it had no currently accepted medical use and a high potential for abuse. But backlash from the public and support from congressional members made the agency postpone a final decision. So kratom is currently listed as a “drug of concern.”

Seven states and some counties have banned the sale of kratom. But in 2023, the U.S. House and Senate proposed legislation to prevent the FDA from regulating kratom more stringently than they do a dietary supplement or a food additive, in order to keep the product accessible to consumers.

Kratom Research Lacking

A 2024 literature review concluded that there are no clinical trials evaluating the effects of kratom on chronic pain management.

Research on acute pain tolerance in people is limited to a 2020 study that found participants who took a dose of kratom could endure immersion of their arms in an ice bath for significantly longer than those who did not take a dose of kratom. However, this study was conducted on chronic kratom users, and their pain tolerance before they took their dose for that study was much lower compared to that of non-kratom users in other studies. This suggests that chronic kratom use is lowering people’s background pain tolerance.

This is similar to another study showing that when people tried to stop taking kratom after chronic use, they experienced significant pain throughout their body. This increased sensitivity and reactivity to pain, called hyperalgesia, also occurs with traditional opioids and is one of the reasons why people who use them chronically find it so difficult to get off them.

Taken together, these studies suggest caution before starting kratom as a treatment for chronic pain, especially if safer methods such as acetaminophen, icing and heating, and physical therapy can suffice.

Some people also claim that kratom could be a natural treatment for withdrawal and other effects of opioid use disorder, the clinical term for opioid dependence.

A few methodologically weak studies reported that participants were able to reduce or stop their use of traditional opioids and that kratom reduced the severity of opioid withdrawal symptoms. These include diarrhea, runny nose and eyes, shaking, fast heartbeat and anxiety.

However, there are no clinical trials comparing kratom to methadone, buprenorphine or naltrexone, the FDA-approved treatment options for opioid use disorder. So if patients have access to traditional FDA-approved therapies, these are the safest and best place to start.

If traditional options are not effective or patients cannot access them due to financial or logistical barriers, kratom may be a potential alternative to illegal opioid products, but it is certainly not risk free. Speaking with a health care professional is critical before making treatment decisions.

C. Michael White, PharmD, is a Distinguished Professor and Chair of the Department of Pharmacy Practice at the University of Connecticut School of Pharmacy. He has been studying the science behind kratom to help consumers better understand its potential benefits and adverse effects.

White’s research work has been funded by the Agency for Healthcare Research and Quality (AHRQ), Donaghue Foundation, Pfeiffer Foundation, and American College of Clinical Pharmacy.

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

Prescription Opioids Play Only Minor Role in Overdose Crisis

By Pat Anson, PNN Editor

The role of prescription opioids in the nation’s overdose crisis continues to shrink.

In a new study from the drug testing firm Millennium Health, researchers say multiple substances were found last year in nearly 93% of urine samples in which fentanyl was detected. That is not altogether surprising, as “polysubstance” use increased as fentanyl came to dominate the illicit drug supply, appearing in more and more street drugs such as heroin, cocaine and methamphetamine.

What is surprising is the minimal role that prescription opioids now play. In 2013, opioid pain medication was the most common substance found in fentanyl-positive drug tests in the United States, appearing in over 70% of urine samples.  A decade later, prescription opioids were detected in less than one in ten samples — ranking far behind methamphetamine, cannabis, cocaine and heroin.

In fact, you are about twice as likely to find two other medications -- benzodiazepines (15.8%) and gabapentin (13.3%) -- than you are prescription opioids (7.6%) in urine samples testing positive for fentanyl.

Substances Detected in Fentanyl-Positive Drug Tests (2023)

MILLEnNIUM HEALTH

Millennium based its findings on over 4.1 million urine drug tests (UDTs) collected from 2013 to 2023 and analyzed through mass spectrometry. Because many of those samples came from people being treated for a substance use disorder, they offer a clear insight into drug trends that are driving the overdose crisis.

Now in its “fourth wave,” Millennium says a tidal shift has occurred in the so-called opioid epidemic, with illicit drug users far more likely to use non-opioid substances like stimulants than prescription opioids.

“National, regional, and state-level UDT data all suggest that people who use fentanyl are now, intentionally or unintentionally, much more likely to also use methamphetamine and cocaine,” the report found. “The results of our analyses also reveal shifting patterns of opioid use among those who use fentanyl. More specifically, they showed progressive declines in prescription opioid use from 2015 to 2023.”

The declining role of prescription opioids can be traced back to the 2016 CDC opioid guideline and a multiyear campaign by the DEA to slash opioid production quotas, which has reduced the supply of oxycodone and hydrocodone by about two-thirds. There is little evidence either of those federal efforts reduced the number of overdoses. The CDC estimates there were over 111,000 drug deaths in the 12-month period ending in September 2023 — nearly double the number of fatal overdoses in 2016.

The growing use of stimulants such as methamphetamine makes it difficult for public health campaigns to address the problem. Unlike opioids, there are no FDA-approved medications for stimulant use disorder, leaving behavioral therapies and abstinence as the only “evidence-based” treatments for people with a stimulant problem.

“Stimulants are a serious national challenge emphasizing the need for continued progress on the national plan to address methamphetamine supply, use, and consequences,” Millennium said.

Rx Opioid Misuse Rare in Children with Sickle Cell Disease

By Pat Anson, PNN Editor

Children with sickle cell disease show no signs of misusing or becoming addicted to opioids after being treated for an acute pain crisis, according to a new study.

Sickle cell disease is a genetic disorder that causes red blood cells to form in a crescent or sickle shape, which creates painful blockages in blood vessels – known as a vaso-occlusive crisis (VOC) -- that can lead to seizures, strokes and organ failure. About 100,000 Americans live with sickle cell disease, primarily people of African or Hispanic descent.

In a retrospective cohort study involving 725 children with sickle cell disease (SCD), researchers at Georgia State University found “no concerning patterns of long-term or increasing use of opioids” within 3 years of their first opioid prescription.

A VOC is a life-threatening condition that is the most common reason for an SCD patient to visit a hospital or emergency room. Guidelines for emergency VOC treatment call for opioids and other analgesics to be administered with one hour. However, due to the stigma associated with opioids and fears of addiction, many SCD patients face long delays before receiving treatment, as well as discrimination and suspicion that they are seeking opioids to get high.

The study findings, published in JAMA Pediatrics, found little evidence to justify those fears. In the 725 children who were studied – all under the age of nine – only one pattern of low opioid use was found.  Most of the children used opioids sparingly, with only one in four (25.4%) having an opioid prescription for codeine or hydrocodone filled for them within five days of being discharged from a hospital after a VOC.

Researchers say more studies are needed to determine whether the limited use of opioids shows the effectiveness of nonopioid pain management or highlights “an unintended and potentially harmful treatment access problem” caused by opioid phobia.

"Because of the opioid epidemic, it's important to make sure that people understand that when giving prescriptions for children with sickle cell disease, you aren't creating folks who are going to misuse opioids," lead author Angela Snyder, PhD, of the Georgia Health Policy Center at Georgia State University, told MedPage Today.

In 2020, a report by the National Academies of Sciences, Engineering, and Medicine called for major changes in the way sickle cell disease is treated in the United States, including an end to the discrimination and stigma that many sickle cell patients face.

DEA Urged to End ‘Red Flag’ Policy for Pharmacies

By Pat Anson, PNN Editor

A coalition of telehealth companies is urging the U.S. Drug Enforcement Administration to stop telling pharmacies to be careful about filling prescriptions for opioids and other controlled substances that originate from out-of-state.

The DEA’s “red flag” policy has had a chilling effect on doctors and patients nationwide, including those that use telehealth services. Many pain patients have found that pharmacies won’t fill opioid prescriptions written by doctors that are not near them geographically.  

In an open letter to the DEA, the American Telemedicine Association and a handful of telehealth providers said “clearer green lights” were needed from the DEA on how to safely dispense controlled substances, not more red flags.

“The DEA should provide explicit guidance to the pharmacy community that geography of a prescriber in relation to the patient or the pharmacy should not be a ‘red flag’ when a prescription is a result of a telehealth visit,” the letter states. “The distance of a telehealth prescriber from the patient alone should not give a pharmacist a signal that the prescription may be illegitimate.”

The DEA relaxed telehealth rules three years ago at the start of the Covid-19 pandemic, to allow for opioids, stimulants, sedatives and other controlled substances to be prescribed remotely via telehealth. Those temporary rules have been extended until the end of 2024, to give the DEA more time to develop permanent ones to govern telehealth.

Many pharmacies haven’t gotten the message. In a recent PNN survey, over 90% of pain patients with an opioid prescription said they had trouble getting a pharmacy to dispense their medication. Drug shortages are the primary cause, but so is the fear of some pharmacists that they could get in trouble or even lose their jobs if they filled a prescription deemed suspicious because it comes from out-of-state.

“In conversations with the pharmacy community and in our experience as prescribers, we have determined many pharmacies and pharmacists are currently considering geography as a ‘red flag.’ While red flags are not defined in statute or regulations or other official guidance, in the wake of the overprescribing and overdispensing contributing to the opioid epidemic, pharmacists have been directed to do so as a part of their corresponding responsibility, or due diligence to ensure that prescriptions are legitimate,” the letter from the telehealth coalition states.

‘An Unusual Distance’

Federal laws and regulations may not clearly define what a red flag is, but the onus is clearly put on pharmacies to catch them:

“[A] pharmacist or pharmacy may not dispense a prescription in the face of a red flag (i.e., a circumstance that does or should raise a reasonable suspicion as to the validity of a prescription) unless he or it takes steps to resolve the red flag and ensure that the prescription is valid.”

Under a 2022 opioid litigation settlement, drug distributors and big chain pharmacies agreed to tightly limit the supply of opioids and be on the lookout for suspicious orders. That includes patients with prescriptions for “highly diverted controlled substances” written by doctors from a zip code 50 miles or more from a pharmacy. Pharmacies with a high volume of those prescriptions risk having their drug supplies further restricted or cutoff.

DEA investigators and federal prosecutors have long targeted doctors and pharmacies that have out of state patients. In 2021, for example, DEA suspended the license of a Florida pharmacy that “repeatedly ignored obvious red flags of abuse or diversion,” including a high number of patients who traveled “an unusual distance” to obtain their prescriptions.

Contrary to popular belief, opioid diversion is rare. The DEA estimates that less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) medications are lost, stolen or diverted.

Another example of a provider being red-flagged came in 2022, when DEA suspended the controlled substance license of Dr. David Bockoff, a California physician who treated many chronically ill patients from out of state who couldn’t find local providers.

Within days of Bockoff’s suspension, one of his patients and his wife died by suicide at their home in Georgia. A few weeks later, another patient died at her home in Arizona, apparently from complications caused by opioid withdrawal. Neither of those patients were using telehealth to see Dr. Bockoff, but their deaths highlight how red flags and heavy-handed oversight of medical providers can have serious consequences.    

“DEA must use this opportunity to make clear what their expectations are for pharmacists in filling telehealth prescriptions of controlled substances,” the letter from the telehealth coalition warns. “If DEA simply adds recordkeeping, reporting, or data requirements to the overwhelming workload pharmacies and pharmacists already face, access issues will only be exacerbated.”

Medical Marijuana Saved Me After Forced Opioid Tapering

By Christine Kucera

I can tell you outright that medical marijuana saved my life!  

I am an intractable pain patient who was harmed in 2019 when the chief medical officer at my well-known health institution decided to implement mandatory system-wide opioid policies for all doctors and patients, based on the CDC’s opioid guideline.

I am not opioid naive, don't have adverse reactions to opioids (other than some don't work on me), and I wasn't misusing or even at risk of overdose. But that didn't matter to the CMO. He forced my pain management provider to taper all his patients on opioids or risking losing his position.

I was subsequently tapered to 90 MME (morphine milligram equivalent), which was a third of the well-managed opioid regimen I was on for over 30 years.  Messed up, right?  

Medical marijuana/cannabis was the alternative of last resort for me. Unlike opioids, I'm extremely sensitive to marijuana, and need to be able to think and talk. As the taper continued, my ability to cope with unmanageable, agonizing pain went bye-bye. I couldn't sit, stand, lay down or sleep without the pain being unbearable. I was literally being tortured to death.  

I became severely ill, my health destabilized, and I was hospitalized numerous times. I became depressed and suicidal, reaching out to everyone for help as hopelessness set in. Thoughts about transitioning to death were my constant companion. 

I had a choice: fight with what's available or give in to despair. I refused to give up hope and decided to try medical marijuana. After discussing it with my provider, I applied for a Massachusetts medical marijuana license. Once approved, I immediately went to a dispensary and the experimentation began. 

Everyone will have different experiences with cannabis. Just like opioids, it depends how your body metabolizes it. I had more than a few negative experiences, but refused to give up. It took me 2 years of experimentation to figure out the right dose, strain (sativa, indica, hybrid) and preparation (flower, edibles, tinctures, topical).  

After a lot of trial-and-error, I found my goldilocks zone. It was micro dosing a 1:1 tincture (equal parts THC and CBD) and applying a 1:1 cream. That regime saved my life!  

Key to Success: Start Slowly 

Some important things I learned along the way:  

For naive patients using cannabis for the first time, I recommend starting with a couple drops of tincture (0.25ml to 0.5 ml under the tongue) every 6-8 hours. It can take upwards of 2 hours to feel the full effects. Do not consume additional tincture too soon or you will potentially experience a compounding effect, producing unwanted side effects.

Increasing the dose, amount and frequency should only be attempted once your body adjusts. Everyone has different titration periods, which can take days or weeks. Experimenting is the only way to figure out what will work for you personally.

I suggest going slowly, incrementally increasing the dose by 0.25ml (0.5ml, 0.75ml, 1ml and so forth) over days to weeks until you reach optimal effect. I personally use <0.25ml during the day and <0.5ml at night. During my experimentation period with the 1:1 tincture, I would try increasing every 3 days.

There are many types of tinctures. I do not recommend jumping straight to a full strain tincture, using indica or sativa, without building a tolerance first

The same goes for edibles. Cut them in half or even a third to start with. Remember it can take up to 2 hours for edibles to work, so don't take more or you may experience unwanted side effects. I could successfully microdose edibles 2-4 times daily, depending on need.  

Topicals are amazing and work! I prefer the ointment over creams and gels, but the costs can add up. You can make your own inexpensive topical by mixing a tincture with a favorite ointment or cream.  

For first time users, I don’t recommend smoking marijuana flower or buds until you've first built-up tolerance with a 1:1 tincture or edibles. Smoking has a much faster mode of action and it can be difficult to manage the unwanted side effects.  

If you're willing to experiment, I recommend smoking at night at home when you have no responsibilities. I found that was best. Start slowly with one very small hit, it doesn't take much. Wait approximately 15-20 minutes before deciding to inhale a second or third hit. The side effects can be bad if you smoke too much, especially if you haven't built up tolerance.  

Always research the side effects and talk with staff at the dispensary. They can help with selecting flower or edibles that have pain, sleep, and mood helping properties. 

If you live in a state where medical marijuana is legal, get a license or card to protect yourself from discrimination, pain management contracts, and urine drug tests. I informed my providers and gave them a copy of my license to put in my medical health records.  

Before you use marijuana, be sure to talk with your prescribing provider, as you don't want to unintentionally breach your pain contract. If you smoke at home, landlords may also be an obstacle. 

The war on drugs propaganda is only meant to illicit fear. Educate yourself about the benefits of marijuana. It's not a gateway drug. Utilized responsibly, with the right strain, dose and preparation, marijuana can help reduce pain, inflammation and anxiety. It is absolutely worth trying.   

Lastly, don't give up! 

Christine Kucera lives with psoriatic arthritis, spondyloarthropy, spondylitis, polyarthritis, sacroiliitis, degenerative joint disease, dermatomyositis, mixed connective tissue disease, spinal radiculopathy, hypoparathyroidism, rare endocrine tumors, psoriasis, endometriosis stage IV, pelvic adhesive disease, and other painful conditions.

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

Drug Distributor Surrenders DEA License Over Opioid Sales

By Pat Anson, PNN Editor

The nation’s largest independent pharmaceutical distributor has agreed to pay a $19 million fine and surrender one of its DEA licenses to settle long-standing charges that it ignored suspicious orders of opioid pain medication.

Louisiana-based Morris & Dickson delivers drugs to health systems, hospitals and independent pharmacies in 27 states. In 2018, the DEA suspended the company’s licenses to distribute opioids and other controlled substances, but delayed making a final decision on revoking them until last year. Morris & Dickson vowed to fight the revocation, saying it was “unwarranted and unjustified” and would essentially put the company out of business.   

After nearly a year of talks with the DEA, the two sides reached a settlement. In addition to the $19 million fine, Morris & Dickson “admitted to all wrongdoing” and agreed to surrender one of its two DEA Certificates of Registration. The company also promised to continue a heightened compliance system to flag suspicious orders of controlled substances.

“Drug distributors like Morris & Dickson have a responsibility to protect the safety and health of customers and maintain effective controls against diversion of highly addictive controlled substances,” DEA spokesperson Katherine Pfaff said in a press release. “At the height of the opioid crisis, Morris & Dickson failed to uphold that responsibility, and turned a blind eye as thousands of unusually large orders for hydrocodone and oxycodone went out the door. Today, Morris & Dickson takes an important first step by admitting wrongdoing and paying for its misconduct.”

In a brief statement on its website, Morris & Dickson acknowledged no wrongdoing and gave no indication of how its business operations would be impacted by the loss of one of its DEA licenses.

“Today’s announcement recognizes our extensive and voluntary efforts to improve and enhance our compliance system over the past five years. In fact, following our efforts, our state-of-the-art compliance program has been repeatedly acknowledged as impressive and above reproach by outside parties,” the company said. “We are very proud that throughout discussions with the DEA, we have continued to provide the highest levels of service.”

The DEA delayed revoking Morris & Dickson’s registration until the Associated Press reported last year that the company was still shipping opioids, despite a judge’s recommendation that its licenses be revoked for “cavalier disregard” of suspicious orders.

Complicating the case is that a top DEA official who retired from the agency in 2017 went to work as a consultant for Morris & Dickson and led efforts to improve its compliance system. Louis Milione “unretired” in 2021 and went back to work at the federal agency as the top deputy to DEA Administrator Anne Milgram. Milione resigned soon after the AP story was published, citing “person reasons.” He is now consulting again for the pharmaceutical industry.   

In fiscal year 2023, DEA said it took 143 administrative actions against doctors, pharmacies, drug makers and drug distributors for violations of the Controlled Substances Act, which regulates the prescribing, dispensing and distribution of opioids and other potentially addictive drugs.

In 2022, the nation’s three largest drug distributors – McKesson, AmerisourceBergen and Cardinal Health — agreed to strict limits on the amount of opioids and other controlled substances they sell as part of a $21 billion opioid litigation settlement.

Collectively, these various actions have led to tight supplies of opioid pain medication. In a recent survey of nearly 3,000 pain patients by PNN, over 90% of those with an opioid prescription said they experienced delays or problems at a pharmacy getting their medication. Nearly 20% of patients were unable get their prescriptions filled.

NSAIDs Preferred for Acute Dental Pain

By Pat Anson, PNN Editor

Nonsteroidal anti-inflammatory drugs (NSAIDs) taken alone or in combination with acetaminophen are recommended as first-line treatments for managing short-term acute dental pain in adults and adolescents aged 12 and older, according to a new guideline developed by the American Dental Association (ADA).

Opioid analgesics should only be used when NSAIDs and acetaminophen are insufficient to reduce pain or when NSAIDs are contradicted, according to the ADA guideline, which also warns dentists to avoid “just-in-case” opioid prescribing.    

“Providing prescribing guidelines for acute dental pain management is an important step towards improving patient treatment and outcomes,” Marta Sokolowska, PhD, deputy center director for substance use and behavioral health at the FDA's Center for Drug Evaluation and Research, said in a press release. “We hope this clinical practice guideline will reduce the risk of opioid addiction, overdose and diversion.”

Opioids were once routinely prescribed to dental patients after a surgical tooth extraction or even a simple toothache. In 1998, dentists wrote 15.5% of all prescriptions for immediate release opioids in the United States. Many of those prescriptions are now considered high risk because the daily dose was over 50 MME (morphine milligram equivalents) or the amount prescribed exceeded a 3-day supply.

After reviewing 82 clinical trials involving tooth extractions, the ADA’s guideline panel found that NSAIDs were more effective than opioids in reducing post-operative pain.

“When managing acute dental pain, there are several reasons to consider alternatives to opioids. First, evidence suggests that opioids may not be the best approach to managing what is often inflammation-related acute dental pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) would target the source of the pain, whereas opioids would not,” the guideline cautions.

Only in “rare instances” when pain control is inadequate with NSAIDs does the guideline recommend low doses of oxycodone or hydrocodone, in combination with acetaminophen. Opioids can also be used when NSAIDs are contradicted due to health issues, such as a patient having cardiovascular problems or a bleeding ulcer.

“When opioids are prescribed, clinicians should obtain informed consent from the patient (or the parent or guardian in the case of minors) with detailed information about potential opioid undesirable effects. This is particularly critical in adolescents and young adults who are at increased risk of subsequent misuse and substance use disorder even after a single prescription,” the guideline says.

This is the second of two ADA guidelines on acute dental pain management. A previous set of recommendations for pediatric patients under the age of 12 was published in 2023. It also recommends NSAIDs and acetaminophen as preferred analgesics. Opioids such as codeine and tramadol are not recommended for children under any circumstances.

The risk of long-term opioid use after a tooth extraction is relatively rare. A 2018 study of over 70,000 teens and young adults who had their wisdom teeth removed found that only 1.3% were still being prescribed opioids months after their initial prescription by a dentist.

A Pained Life: Setting the Record Straight

By Carol Levy, PNN Columnist

Decades ago, my pain management doctor suggested that my family doctor write my codeine prescriptions. “Dr. Feld” had no problem doing so.

The last time that I saw Dr. Feld and asked for the prescription, he had me sign the opioid consent form and provide a urine sample. Then he called in the prescription to my pharmacy. No muss, no fuss.

Dr. Feld just retired, so I saw one of the new doctors in the practice. I was there for another reason but asked, “As long as I'm here, can you call in the codeine prescription?”

To my surprise, the new doctor said, “Yes, but I will only give you 30 milligrams, not the 60.”

“Dr. Feld has been giving me 60 milligrams for years.”

“Well, I won't. I'll only give you half the dosage.”

This was the first time the new doctor had seen me, so he knew little about me or my diagnosis. There were no questions about my level of pain, when I took the codeine, or why had I been taking it less often. Nothing. He decided I was going to get less and reality didn't matter. 

This jumping to conclusions seems to be pervasive. I had neuropsychological testing a few weeks ago. I was having some issues with recalling words and wanted to be assured all was well with my cognitive abilities.

When I received a copy of the report, I was upset. The doctor had couched many of the results in his preconceived notions about me, rather than reality. Some of it could have easily been rectified in the follow-up appointment, if he had bothered to ask. He could have asked why I seemed anxious throughout the testing or if I was depressed. Instead, he drew his own conclusions.

Missing from the report was the fact that I had to stop at one point during the test due to the pain. When I told the tester that I needed to take a pain pill, she told me they didn't want me to do that.

So yes, I was anxious for the rest of the test, not because I had anxiety but because I had pain and knew that each additional part of the test could well make the pain worse.

The depression he thought he found was in response to questions about my life circumstances. I checked yes to “Do you feel isolated?” and “I do not go out much.” That is my life circumstance, because of the pain. 

Understandably, many doctors are afraid to give us the opioids we have been on for years or to give us the same dosages. They’re afraid of the FDA. But I am also finding, in my singular experience, that it may be because they just don't care about our circumstances, our pain or the benefits that opioids provide, allowing many of us to have fuller lives.

It is not acceptable when our medical records contain falsehoods that are based on preconceived notions or the laziness of those who examine us.

When I went to the online portal to see my medical records, I noticed the doctor wrote about tests and exams he didn't do. The results for them were patently false, indicating I could do things like move my neck fully, which I am incapable of doing. I contacted him through the portal, telling him what he wrote was wrong. To his credit, he changed it.

At first, I didn't like the idea of a portal and too much personal information being online, even if it was behind a firewall. But now I find it is an excellent instrument for seeing if the doctor, nurse, or tester posted accurate results and if my records contain falsehoods.

We don't have a lot of power when it comes to what is put in our medical records, what is ignored, or flat out wrong. I used to think getting my records when they were on paper was not worth the effort, because there was no way to set the record straight. But now that I can read the reports online, I fell like I have been empowered to correct them.

We must take back as much power as we can. Take a moment and check your medical records. And, if necessary, tell them what they got wrong. 

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

Canada Seeks Feedback on Proposed Opioid and Cannabis Guidelines

By Pat Anson, PNN ditor

Health officials and pain management experts in Canada are seeking public feedback on proposed changes to Canada’s 2017 opioid prescribing guideline. They’re doing it through an online survey, with responses accepted not only from Canadians, but from providers, patients, caregivers and policymakers in the United States and other countries.

“We are very happy to receive feedback from both Canadians and Americans,” says Jason Busse, DC, a clinical epidemiologist and professor of anesthesia at McMaster University. “We are still in the process of drafting the guidelines, as the feedback we receive will affect these documents.”

Busse is leading a panel at McMaster’s Michael G. DeGroote National Pain Centre that has developed 11 draft recommendations for a revised opioid guideline. Survey respondents are being asked whether they agree or disagree with the recommendations, which focus on whether opioids should be a first line treatment for people with chronic non-cancer pain.

Consistent with the current guideline, the panel believes there are several non-opioid treatments that are just as effective as opioids and have less risk of adverse events. It also strongly recommends that opioids not be given to people with a history of opioid overdose, substance abuse, or mental health problems. For pain sufferers without such a history, the panel recommends “discussing a trial” of opioids if nonopioid treatments haven’t lessened their pain.

If opioids are prescribed, the panel suggests avoiding daily doses higher than 80 morphine milligram equivalents (MME), and strongly recommends against doses higher than 150 MME.  The estimated risk of a fatal overdose at 80 MME is relatively low at 0.23% (2.3 overdoses for every 1,000 people) and at 150mg MME is 0.5% (5 in 1,000).

The 80/150 MME recommendations are a substantial change from Canada’s current guideline, which suggest that initial doses of opioids be less than 50 MME and that they not exceed 90 MME.

For people in pain who are stable on long-term opioid therapy, the panel recommends that clinicians “initiate a discussion” of tapering to a lower dose, potentially including discontinuation. If the patient refuses, the panel recommends that another “discussion” be repeated every 6 to 12 months. Forced or involuntary tapering is not recommended.

“The Guideline Panel has formulated their recommendations based on current evidence and the values and preferences of people living with chronic pain. We are seeking public feedback on the current wording of the recommendations and associated remarks. We will review all feedback received in order to further optimize the wording and clarity of the recommendations and remarks,” Busse said in an email to PNN.

To take the opioid survey, click here.

Medical Cannabis Survey

A second survey is also being conducted by the National Pain Centre to help formulate a Canadian guideline for treating chronic pain with medical cannabis. As with the first survey, this one is open to everyone, regardless of where they live.

There are currently four draft recommendations for cannabis. The panel recommends a “trial of cannabis” for chronic pain only if a patient has tried other therapies that haven’t worked. The panel says there is evidence of small improvements in pain, physical function and sleep when cannabis was used.

Smoking cannabis is not recommended. The panel suggests that patients start with low doses of cannabis taken orally in oils and soft gels or inhaled through a vaporizer. Doses can be increased, depending how a patient responds.

Another recommendation is that cannabis be used by patients as a substitute for opioids or to help taper them to lower doses. The panel says “there is little to no difference” in effectiveness between cannabis and opioids, but that cannabis has far less risk of adverse events.

To take the cannabis survey, click here.  

Both surveys will take about 20 minutes to complete and will remain open until 12pm ET, February 29, 2024.

Rx Opioid Sales Rose at Publix as Other Pharmacies Cut Back

By Ian Hodgson and Christopher O’Donnell, Tampa Bay Times  

An executive at Teva Pharmaceuticals flagged Publix Super Markets in October 2015 after detecting what he called in an email “serious red flags” with the grocery chain’s orders of powerful opioids.

The share of high-strength oxycodone orders was well above normal for a chain of grocery store pharmacies, and the total number of pills sent to Publix stores was “significantly above their peers,” Teva’s head of federal compliance wrote in the email to his supervisors, according to court records in a federal lawsuit pending in Ohio against Publix and other companies.

“This is high-strength oxycodone ultimately going to Florida, a well-established hot spot for oxycodone abuse in the U.S.,” wrote the compliance officer, Joseph Tomkiewicz, in the email explaining why he halted Teva-manufactured prescription opioids to Florida’s Publix pharmacies.

The volume of prescription opioids dispensed in Florida fell 56% from 2011 to 2019 as the pharmaceutical industry was hit by lawsuits for its role in the national opioid crisis, according to a Tampa Bay Times analysis of Drug Enforcement Administration data recently released by a federal court. But while national pharmacy chains like CVS and Walgreens were dispensing fewer of the highly addictive drugs, Publix’s sales were soaring.

The Lakeland-based grocer’s sales of oxycodone climbed from 26 million pills per year in 2011 to 43.5 million in 2019, the data shows. The increase in sales, which far outpaced the chain’s addition of stores in Florida, saw its market share rise to 14%, enough to overtake CVS to become Florida's second-largest dispenser of all opioid medications, behind only Walgreens, which dispensed 28% of opioids in the state in 2019. The analysis excludes drugs like methadone prescribed for addiction treatment. Opioid sales at Publix dipped slightly in 2018 and 2019, the last two years of available data.

Even as its market share grew, however, Publix was not among the 15 national manufacturers, distributors, and pharmacies that Florida sued in 2018. That lawsuit claimed other pharmacies had flooded America with painkillers such as OxyContin, fueling debilitating addictions that strained communities’ first responders and medical providers.

The state’s lawsuit was a boon for Florida. While admitting to no wrongdoing, the companies agreed to settlement payments to the state, including $177 million from Teva, $440 million from CVS, and $620 million from Walgreens. The state didn’t sue Walmart but in 2022 negotiated a $215 million settlement from the retail giant, which also denied any wrongdoing.

However, there is no mention of Publix’s role on a state webpage touting the 10 opioid settlements reached during Ashley Moody’s tenure as attorney general.

That’s despite Publix being the third-biggest dispenser of opioids in the state, selling nearly twice the amount of the drugs as Walmart from 2006 to 2012, according to earlier DEA data made public in July 2019, more than two years before Florida prosecutors reached settlements with other pharmacy chains.

Moody, a Republican, took over as the state’s top legal official in January 2019. Her office declined to specifically address why Florida has not included Publix in any of its legal actions over opioids.

“We are proud of the more than $3 billion recovered through the historic opioid litigation, and since the filing of the amended complaint, the Department of Legal Affairs has and will continue to take action when merited by the evidence — as we did in the more recent actions with Walmart and McKinsey,” said Moody’s communications director, Kylie Mason, in an email.

The grocery chain made $10.6 million in political donations in Florida from 2016 to 2022 when the state was preparing and pursuing its litigation, state election data shows. Most of the donations were for Republican committees and candidates, including $125,000 donated to the Friends of Ashley Moody political action committee.

In Florida, Walgreens made $637,000 in political donations, including $8,000 to Moody, over the same period. CVS made $208,500 in donations, none of which went to Moody.

Other local communities in Florida and beyond did sue Publix. The federal suit naming Publix that prompted the release of the federal data was filed by Georgia's Cobb County. It has been earmarked as a test case for dozens of other lawsuits brought by cities and counties in the Southeast. Those include more than 20 Florida communities, among them St. Petersburg and Pinellas and Pasco counties.

While Walgreens and other national companies paid billions to settle their lawsuits and agreed to stricter drug controls, Publix is still contesting the cases.

Those communities claim that the grocery chain failed to operate an “effective suspicious ordering monitoring program” and that when Publix did limit orders to its own pharmacies, those pharmacies could bypass the check by going to a third-party distributor such as AmerisourceBergen.

Publix also should have known that its pharmacies in Georgia, Florida, Alabama, Tennessee, and South Carolina, were filling multiple prescriptions written for the same patient by the same doctor or by multiple doctors, the federal lawsuit alleges. As part of the national opioid settlement, other pharmacy chains were required to be more compliant with laws regulating opioids, including checks on suspicious orders and prescriptions from “blocked and potentially problematic” doctors.

“It’s a heck of a lot cheaper to distribute and dispense controlled substances without all these checks,” said Jayne Conroy, an attorney with New York law firm Simmons Hanly Conroy who is representing the Florida communities and has served as co-lead counsel in the national opioid litigation that has secured more than $50 billion in settlements and verdicts.

Publix did not respond to three emails and three phone calls to its communications office seeking comment. In its responses to the lawsuits, it has repeatedly denied allegations of wrongdoing.

In seeking to get the Ohio case dismissed, Publix attorneys argued that it can’t be considered “a public nuisance” to legally distribute and dispense opioids. The judge in the case denied the company’s motion and another legal brief that sought to prevent the release of the more recent DEA data.

In November 2022, Publix sued more than a dozen of its insurers in federal court in Tampa, claiming they had not honored policies that would protect it from opioid litigation claims.

It also countersued Cobb County in 2023, saying the Georgia community’s lawsuit was “motivated by promises of a windfall.” The case is still pending.

“Publix takes great pride in its relationship with its valued customers and the communities it serves,” that lawsuit states. “These novel and unprecedented claims are baseless, false, and belied by Publix’s decades of service.”

DEA officials declined to comment on Publix’s opioid record. No enforcement actions against Publix are listed in the federal registry.

A Growing Player

Since its 1930 start as a food store in Winter Haven, Florida, Publix has grown into a massive company with more than 250,000 employees and nearly 900 stores in Florida alone. Revered for its free cookies for kids, chicken tender subs, fresh produce, birthday cakes, and BOGO deals, the grocery chain has become one-stop shopping for customers.

And, increasingly, “Where Shopping Is a Pleasure” — Publix’s slogan since 1954 — includes powerful prescription drugs.

Publix was a smaller player in Florida’s opioid market before 2011, responsible for fewer than 5% of all opioid medications distributed to pharmacies across the state, according to the Times analysis of federal opioid data.

That year marked a turning point for opioid sales in Florida. As the scale of the opioid epidemic came to public attention, and litigation followed, most chain pharmacies began to back off their orders for pills, the data shows.

Many companies ultimately agreed to pay billions of dollars to settle lawsuits filed across the country by state and local governments. That included a $683 million settlement between Florida and Walgreens in May stating the pharmacy, which denied any wrongdoing, must pay for community treatment, education, and prevention programs, plus litigation costs.

In addition to hefty payouts, some settlement agreements required companies to adopt stricter controls to bring operations into fuller compliance with the Controlled Substances Act, a federal law that governs the manufacture, distribution, and use of drugs considered to have a high risk of being abused.

Distributors were required to adopt automated software that would flag suspicious orders from pharmacies such as quantities well above a store’s average. Pharmacy companies were required to conduct checks on doctors to ensure the prescribers are registered with the Drug Enforcement Administration. 

Those measures and others put the brakes on opioid distribution nationwide. Meanwhile, the distribution in Florida’s Publix stores went in the opposite direction: From 2011 to 2019, the grocery chain increased its dispensing of all opioid medication by 35%, according to the Times’ analysis of the data.

That growth far exceeded any increase in sales that would correspond to the grocer’s net addition of 146 pharmacies from 2011 to 2019.

As Publix’s distribution increased, so too did the number of orders that should have been flagged as suspicious, according to plaintiffs in multiple lawsuits. Drug distributor McKesson instructed its employees to investigate any pharmacy ordering more than 8,000 oxycodone pills in a single month as part of the company’s “Lifestyle Drug Monitoring Program,” according to 2018 congressional testimony.

Publix pharmacies’ orders surpassed that threshold almost 1,500 times in 2019, the Times analysis found, more than triple the number in 2011. The benchmark has been repeatedly used in opioid litigation as evidence of inadequate monitoring of drug distribution.

‘Red Flags’ Missed

As Tomkiewicz faced pressure from Teva management to fulfill Publix’s orders, he mined the data to back up his concerns, court records show. During a heated phone call, one Teva executive stressed that Publix was an increasingly important player in the opioid distribution market, Tomkiewicz said at his deposition, and an important client for the world’s largest generic drug manufacturer.

Tomkiewicz requested data from Publix’s 10 largest pharmacies by opioid sales, all located in Florida.

By law, Publix was required to keep tabs on the physicians whose prescriptions it filled. But it took Tomkiewicz just one day of searching the internet to find problems, according to time stamps on emails submitted in the court records.

Among the top prescribers at two Publix locations in Melbourne was Thomas Velleff, according to Tomkiewicz’s email. Public records and a newspaper report showed “significant anecdotal evidence of pill mill activity,” Tomkiewicz wrote. He said he found a 2010 article in the Treasure Coast Palm, in which a city employee claimed Velleff’s prior pain clinic in Palm City attracted “carloads” of patients, often with out-of-state license plates.

Complaints filed with the state Department of Health dating to 2010 allege that Velleff overprescribed opioids and failed to monitor his patients’ usage for signs of abuse. One 2017 complaint alleges that Velleff pressured one patient into loaning him money. The state Board of Medicine revoked Velleff’s medical license in December 2020. Velleff did not appear at his medical board hearing, according to the final order revoking his license. He did not respond to emails seeking comment.

A top prescriber at one Ocala store had been disciplined in 2011 for injecting herself with a sedative while leaving an anesthetized patient unsupervised. Other pharmacies repeatedly filled prescriptions from “cash-only” pain clinics or written by physicians located hundreds of miles away with no license to practice in Florida, Tomkiewicz wrote in the email. It is legal to do so, but drug diversion experts consider out-of-state prescriptions a red flag that should prompt additional checks for possible drug abuse.

Tomkiewicz had amassed a list of nine doctors among Publix’s top prescribers who made him wonder: “Why the hell do they still have a license and are still registered with the DEA?” according to his deposition.

Tomkiewicz also said in his deposition he was troubled by not just the volume of opioids Publix was selling, but that they were handing out a disproportionate share of 30-milligram instant-release oxycodone pills — another red flag for abuse. In an email to Teva’s director of compliance, he compared that with the Moffitt Cancer Center in Tampa, where cancer patients were mostly being prescribed 5 mg instant-release pills, court records show.

As the strongest dose on the market, the 30 mg pills have limited use in retail pharmacies and are highly sought-after among abusers, Tomkiewicz wrote in the email. Stronger doses of oxycodone are available, but only in long-release capsules such as OxyContin, according to the U.S. National Institutes of Health.

Publix sold 4.8 million of the highly addictive high-dose pills in 2019 — roughly 1 in 10 of all oxycodone pills dispensed by the pharmacy chain that year, according to the Times analysis of the federal data.

Eventually, Tomkiewicz relented, he said in his deposition. As long as Publix promised not to send Teva products to nine locations that he’d picked out, he would let the shipment go ahead. Teva did not notify federal authorities, according to his deposition.

A Times review of court documents found no written record indicating that Publix responded to Tomkiewicz’s concerns at the time. An expert report submitted in the lawsuit came to the same conclusion.

This article was produced by the Tampa Bay Times and KFF Health News, a national newsroom that produces in-depth journalism about health issues.

Walgreens and CVS Rated ‘Most Difficult’ for Opioid Prescriptions

By Pat Anson, PNN Editor

When Walgreens and CVS signed the National Opioid Settlements in late 2022, they agreed to pay over $10 billion to states, cities and counties that sued them for their alleged roles in causing the opioid epidemic.

The nation’s two biggest pharmacy chains also agreed to watch for suspicious orders, report any “problematic” prescribers, and to strictly limit the amount opioid pain medication they can dispense in any given month. Opioids, in effect, were going to be rationed to their customers.

Pain patients are now paying a price for that agreement.

In a large survey of nearly 3,000 pain patients by PNN, over 90% of those with an opioid prescription said they experienced delays or problems last year getting their medication. Most patients went to another pharmacy, but nearly 20% still couldn’t to get their prescriptions filled – largely because opioids such as hydrocodone and oxycodone are in short supply.

The average patient had problems at a pharmacy at least three times in 2023. Some had trouble each time they went in for a monthly refill.

“I spent eight days trying to get my last prescription pills and finally got it filled two days ago, but I had to settle for only one third of my prescription,” said a patient who went through withdrawal for 8 days waiting for her medication.

“It's an unreal concept that I can have the piece of paper, I can have the doctor, I can have the pharmacy, I can have the money, and I can have the insurance, but I can't go and have the little medicine that I need to try to make it through this situation.” 

HOW MANY TIMES DID YOU HAVE A PROBLEM OR DELAY FILLING AN OPIOID PRESCRIPTION IN LAST 12 MONTHS?

‘There Is Always an Issue’

Asked which pharmacy chain was the most difficult to get an opioid prescription filled, over half the patients in our survey selected either Walgreens (30%) or CVS (26%).

“I've used Walgreens for all of my medications for the past 15 years and within the past year or so I have started having issues almost every month with them filling my pain medication,” a patient told us. 

“My local CVS says that they cannot get hydrocodone-acetaminophen at all. Yet, my local Giant Food supermarket can. Very strange,” said another. 

“I used Walgreens for many years. Recently they have had several new pharmacists. One pharmacist would not fill ANY controlled substances. The current pharmacist will only order about 3 to 4 times per month. She doesn’t care if patients don’t get their medications,” another patient wrote. 

“CVS continually gives me a hard time to fill my Rx even though I have been on it for over 7 years. It is either out of stock, or they argue with me about filling it,” said another. 

“Every month when I have to get my medication renewed there is always an issue,” explained another patient. “Walgreens always give people a hard time. I've seen many people standing in line and just walk out.” 

Patients also had trouble getting their prescriptions filled at Walmart, Kroger, Rite-Aid, Publix and small independent pharmacies, but they had far fewer complaints. CVS and Walgreens have about four times as many pharmacy stores as Rite-Aid, which may explain why they were singled out more often than the other chains.  

AT WHAT PHARMACY DID YOU EXPERIENCE THE MOST DIFFICULTY GETTING AN OPIOID PRESCRIPTION FILLED?

When told about the findings from PNN’s survey, CVS declined to comment and Walgreens provided a brief statement saying it “follows all applicable federal and state laws and regulations related to the dispensing of controlled substances.” 

More Cautious Dispensing

Even before signing the opioid settlements, Walgreens and CVS were among the first pharmacy chains to look at ways to minimize their dispensing of opioid medication.  

In 2017, CVS said it would limit the dose and supply of opioids to patients enrolled in commercial, employer or Medicaid health plans. The policy was adopted after CVS was fined hundreds of millions of dollars for violations of the Controlled Substances Act, many of those violations involving opioids. 

In 2013, Walgreens adopted a “secret checklist” that required its pharmacists to look for red flags, such as patients paying for opioids in cash, seeking an early refill, or taking a high number of pills. If anything was suspicious, pharmacists were told to “inform the patient that it may take additional time to process the prescription.”  Like CVS, the policy was implemented after Walgreens was fined millions of dollars by the DEA for violating rules for dispensing controlled substances. 

Walmart and Kroger also signed the National Opioid Settlements, while Rite-Aid filed for bankruptcy, in part due to the expense of defending itself in court. Thousands of pharmacies around the country are being closed due to over-expansion, poor business decisions, and the rising cost of lawsuits. 

Patients have noticed that the fines and lawsuits have made pharmacists more cautious. In our survey, dozens of patients said a pharmacist told them they would not fill their opioid prescription because they might get in trouble or lose their job. Many patients don’t know it, but pharmacists have a “corresponding responsibility” to exercise their professional judgement by not filling a prescription they think is inappropriate.

“Pharmacies and pharmacists have become an arm of law enforcement,” one patient wrote. “Pain medication prescriptions are treated as suspicious, with the pharmacist often questioning the appropriateness of my current MME (morphine milligram equivalent) levels while I’m undergoing a rapidly forced taper,” one patient wrote. 

“I have been hung up on just for calling (CVS) and asking if they would put my prescription in the queue for filling the next day. Call disconnected by pharmacist,” another patient said. “I emailed a written complaint to CVS and never heard back.” 

“The new manager in pharmacy at Walgreens, which is where I have gotten my pain medicine for 20 years, feels that I receive too much even though he has no idea of my diagnosis. He makes me feel like I am a low-class drug addict,” a patient told us. “I get much less than so many people I know, so I finally had to switch to mail order with OptumRx.” 

‘Independent Pharmacies Are Better’ 

Many patients have found that it’s easier to get a prescription filled at smaller pharmacy chains or at independent pharmacies that were not caught up in opioid litigation.  

“Independent pharmacies are better. I used to fill my opioid scripts at Walgreens. The pharmacist there always gave me a difficult time. He would refuse to fill unless he received a confirmation note from my pain specialist that I was taking the appropriate dose. I finally left him for an independent pharmacy,” one patient told us. 

“I'm fortunate to have a compassionate, independent pharmacy that bends over backwards to ensure I have the meds my doctor prescribes. If I was stuck with a chain pharmacy like Walgreens or CVS, my experience would be completely different. Those pharmacies treat pain patients like criminals,” wrote another. 

“I have used a small mom and pop pharmacy for over five years with no problems. Their only requirement is I get all my prescriptions filled at their pharmacy, not just the opioid or muscle relaxant,” said another patient. “Prior to changing, I had used CVS and Walgreens pharmacies, with both offering nothing but problems and harassment when taking my scripts in.” 

“Thankfully, I live in a very small town and have had a great experience with my pharmacy so far. Small mom and pop set up. So far, only handful of times had them short me pills when they were unable to obtain the meds. Only had to wait a day or two for them to fill the rest,” wrote another patient.

‘My Pharmacist Is Awesome’

While often frustrated by the ordeal of getting their prescriptions filled, many patients appreciate how they are treated by pharmacists. Asked what their overall experience has been with pharmacists, respondents were evenly divided. Nearly a third said their experience with pharmacists was “very positive” or “positive” – about the same number who said their experience was “negative” or “very negative.”      

“My pharmacist is pretty awesome and always has the opioid medications in stock,” one patient said. 

“Generally, my treatment at pharmacies has been first rate. Not so much the doctors,” said another. 

“My pharmacist is excellent and knowledgeable,” another patient wrote. 

“I made friends with my pharmacist because he knows I have several chronic pain syndromes,” another patient told us. “When I first met him, he didn't want to fill me, but now he helps me get my meds filled.” 

“In my experience, it’s pharmacist specific. Some are compassionate, others think everyone is an addict,” another patient said.

OVERALL, WHAT HAS BEEN YOUR EXPERIENCE WITH PHARMACISTS AS A PAIN PATIENT?

PNN’s online survey was conducted from November 13 to December 31, 2023. A total of 2,961 U.S. pain patients or caregivers participated.