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.”

White House Pharmacy Violated DEA Policy

By Pat Anson, PNN Editor

A pharmacy operated by the White House Medical Unit dispensed hundreds of prescriptions for opioids and other controlled substances without keeping proper records, according to a scathing audit released this month by the Office of the Inspector General (OIG) at the Department of Defense.

In many cases, drugs, surgeries and other medical services were provided to ineligible White House staff members at no cost. Over-the-counter medications were also free to be taken from open bins to anyone who wanted them.

The OIG launched an audit of the medical unit in 2018, after receiving complaints that an unnamed senior military medical officer assigned to the White House was acting improperly. Additional complaints received over a hotline questioned procedures at the pharmacy and the eligibility of patients that were being treated.

The resulting audit – which covered the years 2009 to 2020 – found “severe and systematic” problems at the White House pharmacy due to poor oversight that may have resulted in “prescribing errors and inadequate medication management.”

“In our analysis of the White House Medical Unit’s controlled substance records, we found that medications, such as opioids and sleep medications, were not properly accounted for, in violation of (federal law),” the OIG said. “White House Medical Unit medical providers wrote prescriptions for controlled substances that often lacked the medical provider and patient information mandated by DEA policy.”

DEA regulations require that prescriptions for all controlled substances contain the patient’s full name and address, as well as the name, address, and DEA registration number of the prescriber. But when reviewing 11 examples of prescriptions for controlled substances provided by the medical unit, investigators found much of that information was missing.       

The OIG was only able to obtain pharmaceutical records from 2017 to 2019, because the pharmacy kept records for just two years. Investigators found that the pharmacy still used handwritten ledgers to track the inventory of controlled substances. The ledgers frequently contained errors, illegible text, or text was that was crossed out.

A pharmacy ledger from 2019, seen below, shows that prescriptions were dispensed for the opioids morphine, hydrocodone, fentanyl and tramadol, as well as ketamine and diazepam – all controlled substances. Some medications were dispensed in unusually large quantities, such as 2,000 tablets of the sleep aid Ambien.

Names of the prescribers and patients on the ledger were redacted. In some cases, the ledger shows no record of who picked up the medications or if anyone signed a receipt for them.     

WHITE HOUSE MEDICAL UNIT CONTROLLED SUBSTANCE TRACKING FORM

In interviews with 70 former military service members who worked at the White House between 2009 and 2018, the OIG found there was a culture of entitlement. Administration officials and staff members who sought medical treatment were “not normal patients,” as one medical unit member put it.

“We bent knees and we bent the rules to meet this very weird, strange culture that was there, and I think it was really to just impress people,” the service member said. “And so I understand it’s almost like the culture of D.C. and politics, and somehow the Medical Unit got sucked up into that culture as well.”

Another service member highlighted inconsistencies in the medical unit’s practices.

“[There] were several concerns about we’re not accomplishing the mission the right way. Is stuff getting done? Yeah. Is it being done appropriately or legally all the time? No. But, are they going to get to that end result that the bosses want? Yeah.”

Other service members said the medical unit used alias accounts to provide free specialty care and surgery to ineligible White House staff. The alias accounts did not use the patient’s real name or address. When a medical unit staff member expressed alarm about that practice, they were instructed to provide care to the ineligible individual.

“Several former White House Medical Unit staff members stated that they felt unable to act outside of the will of the Physician to the President or the White House Medical Unit Director. One former White House Medical Unit medical provider stated that White House Medical Unit staff members were fearful of ‘making independent decisions’ without the approval of the Physician to the President or the Director of the White House Medical Unit,” the report said.

Dr. Ronny Jackson

The OIG report takes pains not to identify anyone by name or associate them with either the Obama or Trump administrations. But for many of the years covered by the audit, Dr. Ronny Jackson played key roles in the White House medical unit.

A U.S. Navy officer, Jackson joined the medical unit in 2006, and became its director in 2010. In 2013, Jackson was given the additional title of Physician to the President under Obama. In December 2014, Jackson ceased being Director of the White House Medical Unit, but remained as personal physician to Obama and then Trump until 2018. President Trump appointed Jackson as Chief Medical Advisor and Assistant to the President in January 2019.

In an email to PNN, a spokesperson for Jackson said that he only had a policy role in the medical unit after 2014, and had no association or involvement with the unit’s delivery of care.

In 2018, allegations of drunkenness, misconduct and mismanagement arose about Jackson’s service. Jackson called the allegations a “political hit job.” In December 2019, he retired from the Navy as a Rear Admiral, left the White House, and was elected a Republican congressman in Texas, a position Jackson still holds.   

In 2021, a seperate OIG investigation of Jackson found that he disparaged and bullied subordinates, created a hostile work environment, and engaged in “inappropriate conduct” involving his use of alcohol. Jackson was also found to have used Ambien to help him sleep on long overseas flights on Air Force One, “raising concerns about his potential incapacity to provide proper medical care during this travel.”  

(3/7/24 Update: The Washington Post reported that Jackson was demoted to the rank of captain in 2022 after the OIG report on his conduct. The demotion had not previously been reported and has not been acknowledged by Jackson.)

FDA Finds ‘Credible Scientific Support’ for Marijuana as Pain Reliever

By Pat Anson, PNN Editor

It took a lawsuit to prompt its release, but the U.S. Department of Health and Human Services (HHS) has finally made public a lengthy FDA review explaining why it thinks marijuana should be rescheduled as a Schedule III controlled substance. Such a move would make it legal under federal law for marijuana to be used for medically approved purposes, such as pain relief.

The FDA review was completed last August, nearly a year after it was requested by President Biden. But the 252-page review was not released until Friday, after a lawsuit was filed by two pro-cannabis lawyers when HHS didn’t respond to Freedom of Information Act (FOIA) requests.

Medical marijuana is already legal in 38 states, but cannabis remains classified as a Schedule I substance by the Drug Enforcement Administration, making its sale or use illegal under federal law. The DEA is expected to make its decision on rescheduling soon.

The FDA looked at seven potential medical uses of cannabis: pain, anorexia, anxiety, epilepsy, inflammatory bowel disease (IBD), nausea, and post-traumatic stress disorder (PTSD).

After reviewing clinical studies of cannabis, and the views of academic and professional medical societies, the FDA said they found “mixed findings of effectiveness.” The strongest evidence was for pain relief, anorexia and nausea.

“The available data indicate that there is some credible scientific support for the use of marijuana in the treatment of pain.”

— FDA review

“The largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain),” the FDA said. “On balance, the available data indicate that there is some credible scientific support for the use of marijuana in the treatment of pain, anorexia related to a medical condition, and nausea and vomiting, with varying degrees of support and consistency of findings.”

Perhaps just as importantly, the FDA found no evidence of “unacceptably high safety risks” when marijuana was used therapeutically. That is a key finding for marijuana to be rescheduled by the DEA. The risk of marijuana being used nonmedically was also low, compared to substances like alcohol, heroin, cocaine, prescription opioids and anti-anxiety drugs.

“The rank order of the comparators in terms of greatest adverse consequences typically places heroin, benzodiazepines and/or cocaine in the first or immediately subsequent positions, with marijuana in a lower place in the ranking, especially when a utilization adjustment is calculated. For overdose deaths, marijuana is always in the lowest ranking among comparator drugs,” FDA said.

“These evaluations demonstrate that there is consistency across databases, across substances, and over time that although abuse of marijuana produces clear evidence of a risk to public health, that risk is relatively lower than that posed by most other comparator drugs.”

The FDA said the “vast majority” of professional medical organizations do not recommend marijuana, but they don’t specifically recommend against it either. The lone exception is the American Psychiatric Association, which warns that long-term use of marijuana can worsen psychiatric conditions, such as paranoia and hallucinations.

Reclassifying marijuana as a Schedule III substance – in the same category as codeine and ketamine – would certainly be historic, but it won’t resolve the many differences between federal and state regulation of cannabis.

Under federal law, legal access to Schedule III substances requires a prescription from a licensed doctor that is dispensed from a licensed pharmacy. Medical marijuana products would also have to go through the FDA’s lengthy and costly clinical trial process to assess their safety and effectiveness. Even if they pass that test, they would only be approved by FDA for certain conditions.  

DEA Finalizes More Cuts in Rx Opioid Supply in 2024

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration will further reduce the supply of codeine, morphine, oxycodone and other prescription opioids in 2024, ignoring complaints from thousands of patients that opioid pain medication is already difficult to obtain and many pharmacies are out of stock.

In a notice pre-published Friday in the Federal Register, the DEA said it would stick with plans to cut aggregate production quotas (APQs) for prescription opioids for the eighth consecutive year, reducing the supply to levels not seen in nearly a decade.

“After considering all of the relevant factors, DEA has determined that the APQs of prescription opioids should be reduced from calendar year 2023 APQ levels and they are sufficient to meet the forecasted domestic and foreign medical needs,” the DEA said.

Under the Controlled Substances Act, the DEA has broad legal authority to set APQs annually for hundreds of Schedule I and II chemicals and medications – in effect telling drug manufacturers how much they can make each year.

Acting on the advice of the Food and Drug Administration, which estimates there will be a be a 7.9% decline in medical need for opioids next year, the DEA in early November published its proposed APQs for 2024 in the Federal Register and invited public comment.      

Nearly 4,700 comments came in, mostly from pain patients worried that further cuts in the opioid supply would worsen shortages and interfere with their treatment.  

“I am pretty much bed bound. A couple of weeks ago I tried taking my life,” one patient wrote. “No one should have to suffer like this. These are medications that work. And why is it that the prescriptions have gone down but overdoses have gone up?”

“Please do not cut the Rx opioid production amount anymore. There is a severe shortage and many people who have prescriptions cannot get them filled at a pharmacy,” another poster said.

The American Society of Health-System Pharmacists (ASHP) has been warning about shortages of hydrocodone and oxycodone for months, but those shortages have yet to be recognized by the FDA or DEA.  If any shortages exist, DEA said they were out of its control and blamed the “temporary lack of inventory” on drug manufacturers.

“DEA utilizes the available, reliable data and information received by the agency at the time APQs are proposed and proactively monitors drug production, distribution and supply during the year. However, drug shortages may occur subsequently due to factors outside of DEA control such as manufacturing and quality problems, processing delays, supply chain disruptions, or discontinuations,” the agency said.

“Manufacturers’ business practices may… potentially contribute to a temporary lack of inventory of controlled substances at the point of dispensation. In recent years, this has included labor shortages and a lack of production capacity.”

The DEA’s final order reduces the supply of codeine year-to-year by 8.3 percent, followed by morphine (4.3%), hydromorphone (2.1%), hydrocodone (0.35%) and oxycodone (0.34%). Since 2015, APQs for most opioids have been cut by over two-thirds.

DEA admits that its “reliable data” on drug production may not be all that reliable. The agency said there was a “lack of real-time data and gaps in its understanding of production lead times,” which weaken its ability to respond to drug shortages. As a result, it was seeking more up to date information from manufacturers on their drug sales and inventory.

Late Notice to Drug Makers

The production quotas for 2024 won’t be officially published in the Federal Register until Wednesday, January 3rd – which is about a month overdue and gives little time for drug manufacturers to prepare for the coming year. That appears to be a violation of the Controlled Substances Act (CSA), which stipulates that APQs be established by the U.S. Attorney General – who the DEA reports to -- “on or before December 1 of each year.”  

(Update: In a 1/4/24 email to PNN, the DEA confirmed that drug makers were only now being notified of their quota allotments for 2024. “DEA registrants cannot receive notification of their individual quotas until the final APQ notice is signed and published in the FR (Federal Register) per the CSA,” the email said. There was no explanation for the late publication of the final APQ.)   

Another concern for drug makers besides the late notice is a DEA plan to set production quotas for each company on a quarterly basis, instead of annually. A Pfizer representative expressed strong reservations about that, saying it could hamstring drug production and worsen shortages of injectable drugs used in anesthesia, which have been in short supply for years.  

“DEA’s proposal to allocate quota on a quarterly basis will make manufacturing lead times, planning schedules, and resource allocation extremely difficult if not untenable,” Jennifer Walton, Senior Vice President at Pfizer, wrote in a letter to the agency.

“As an example, from the time API (active pharmaceutical ingredient) is received at a manufacturing plant to the time finished product is ready for shipment, the lead time can be as long as six months, stretching over multiple quarters. Given those time frames, DEA’s proposed quarterly quota grants will likely result in interruptions in supply of sterile injectable products used in the inpatient setting.”  

Artificial Intelligence May Decide Whether You Get Rx Opioids

By Andy Miller and Sam Whitehead, KFF Health News

Elizabeth Amirault never heard of NarxCare until last year, when she learned its software was tracking her medication use. During a visit to a hospital in Fort Wayne, Indiana, Amirault told a nurse practitioner she was in severe pain and received a puzzling response.

“Your Narx Score is so high, I can’t give you any narcotics,” she recalled the man saying, as she waited for an MRI before a hip replacement.

Tools like NarxCare are used to help medical providers review controlled substance prescriptions. They influence, and can limit, the prescribing of painkillers, similar to a credit score influencing the terms of a loan. NarxCare’s overdose risk ratings – known Narx Scores -- are produced by health care technology company Bamboo Health (formerly Appriss Health).

NarxCare’s software uses artificial intelligence to analyze data about prescriptions for controlled substances to identify patterns of potential problems involving patients and physicians. State and federal health agencies, law enforcement officials, and health care providers have enlisted these tools, but the mechanics behind their algorithm formulas are generally not shared with the public.

Artificial intelligence is working its way into more parts of American life. As AI spreads within the health care landscape, it brings familiar concerns of bias and accuracy and whether government regulation can keep up with rapidly advancing technology.

The use of systems to analyze opioid-prescribing data has sparked questions over whether they have undergone enough independent testing outside of the companies that developed them, making it hard to know how they work. Lacking the ability to see inside these systems leaves only clues to their potential impact.

Some patients say they have been cut off from needed care. Some doctors say their ability to practice medicine has been unfairly threatened.

Researchers warn that such technology — despite its benefits — can have unforeseen consequences if it improperly flags patients or doctors.

“We’re concerned that it’s not working as intended, and it’s harming patients.”

— Jason Gibbons, Health Economist

“We need to see what’s going on to make sure we’re not doing more harm than good,” said Jason Gibbons, a health economist at the Colorado School of Public Health at the University of Colorado’s Anschutz Medical Campus. “We’re concerned that it’s not working as intended, and it’s harming patients.”

Amirault, 34, said she has dealt for years with chronic pain from health conditions such as sciatica, degenerative disc disease, and avascular necrosis, which results from restricted blood supply to the bones.

The opioid Percocet offers her some relief. Amirault had been denied the medication before, but never had been told anything about a Narx Score, she said.

In a chronic pain support group on Facebook, she found others posting about NarxCare, which scores patients based on their supposed risk of prescription drug misuse. She’s convinced her ratings negatively influenced her care.

“Apparently being sick and having a bunch of surgeries and different doctors, all of that goes against me,” Amirault said.

Database-driven tracking has been linked to a decline in opioid prescriptions, but evidence is mixed on its impact on curbing the epidemic. Overdose deaths continue to plague the country, and patients like Amirault have said the monitoring systems leave them feeling stigmatized as well as cut off from pain relief.

The Centers for Disease Control and Prevention estimated that in 2021 about 52 million American adults suffered from chronic pain, and about 17 million people lived with pain so severe it limited their daily activities. To manage the pain, many use prescription opioids, which are tracked in nearly every state through electronic databases known as prescription drug monitoring programs (PDMPs).

The last state to adopt a program, Missouri, is still getting it up and running.

More than 40 states and territories use the technology from Bamboo Health to run PDMPs. That data can be fed into NarxCare, a separate suite of tools to help medical professionals make decisions. Hundreds of health care facilities and five of the top six major pharmacy retailers also use NarxCare, the company said.

The platform generates three Narx Scores based on a patient’s prescription activity involving narcotics, sedatives, and stimulants. A peer-reviewed study showed the “Narx Score metric could serve as a useful initial universal prescription opioid-risk screener.”

NarxCare’s algorithm-generated “Overdose Risk Score” draws on a patient’s medication information from PDMPs — such as the number of doctors writing prescriptions, the number of pharmacies used, and drug dosage — to help medical providers assess a patient’s risk of opioid overdose.

Bamboo Health did not share the specific formula behind the algorithm or address questions about the accuracy of its Overdose Risk Score but said it continues to review and validate the algorithm behind it, based on current overdose trends.

Guidance from the CDC advised clinicians to consult PDMP data before prescribing pain medications. But the agency warned that “special attention should be paid to ensure that PDMP information is not used in a way that is harmful to patients.”

This prescription-drug data has led patients to be dismissed from clinician practices, the CDC said, which could leave patients at risk of being untreated or undertreated for pain. The agency further warned that risk scores may be generated by “proprietary algorithms that are not publicly available” and could lead to biased results.

(Editor’s note: A citizen’s petition filed with FDA earlier this year alleged that NarxCare software “altered the practice of medicine in the U.S. to the detriment of patients,” and sought to have the software declared a misbranded medical device and recalled. The petition by the Center for U.S. Policy was rejected by FDA on technical grounds because it was “not within the scope” of the agency’s petition process.)

Impact on Patients

Bamboo Health says NarxCare’s rating system should never replace decisions made by physicians. But some patients say the risk scores have had an outsize impact on their treatment.

Bev Schechtman, 47, who lives in North Carolina, said she has occasionally used opioids to manage pain flare-ups from Crohn’s disease. As vice president of the Doctor Patient Forum, a chronic pain patient advocacy group, she said she has heard from others reporting medication access problems, many of which she worries are caused by red flags from databases.

“There’s a lot of patients cut off without medication,” according to Schechtman, who said some have turned to illicit sources when they can’t get their prescriptions. “Some patients say to us, ‘It’s either suicide or the streets.’”

The stakes are high for pain patients. Research shows rapid dose changes can increase the risk of withdrawal, depression, anxiety, and even suicide.

Some doctors who treat chronic pain patients say they, too, have been flagged by data systems and then lost their license to practice and were prosecuted.

Lesly Pompy, a pain medicine and addiction specialist in Monroe, Michigan, believes such systems were involved in a legal case against him.

His medical office was raided by a mix of local and federal law enforcement agencies in 2016 because of his patterns in prescribing pain medicine. A year after the raid, Pompy’s medical license was suspended. In 2018, he was indicted on charges of illegally distributing opioid pain medication and health care fraud.

“I knew I was taking care of patients in good faith,” he said. A federal jury in January acquitted him of all charges. He said he’s working to have his license restored.

One firm, Qlarant, a Maryland-based technology company, said it has developed algorithms “to identify questionable behavior patterns and interactions for controlled substances, and for opioids in particular,” involving medical providers.

The company, in an online brochure, said its “extensive government work” includes partnerships with state and federal enforcement entities such as the Department of Health and Human Services’ Office of Inspector General, the FBI, and the Drug Enforcement Administration.

In a promotional video, the company said its algorithms can “analyze a wide variety of data sources,” including court records, insurance claims, drug monitoring data, property records, and incarceration data to flag providers.

William Mapp, the company’s chief technology officer, stressed the final decision about what to do with that information is left up to people — not the algorithms.

Mapp said that “Qlarant’s algorithms are considered proprietary and our intellectual property” and that they have not been independently peer-reviewed.

“We do know that there’s going to be some percentage of error, and we try to let our customers know,” Mapp said. “It sucks when we get it wrong. But we’re constantly trying to get to that point where there are fewer things that are wrong.”

Prosecutions against doctors through the use of prescribing data have attracted the attention of the American Medical Association.

“These unknown and unreviewed algorithms have resulted in physicians having their prescribing privileges immediately suspended without due process or review by a state licensing board — often harming patients in pain because of delays and denials of care,” said Bobby Mukkamala, chair of the AMA’s Substance Use and Pain Care Task Force.

Even critics of drug-tracking systems and algorithms say there is a place for data and artificial intelligence systems in reducing the harms of the opioid crisis.

“It’s just a matter of making sure that the technology is working as intended,” said health economist Gibbons.

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

New DEA Rule Allows Pharmacies to Transfer Opioid Prescriptions

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration has adopted a new rule that allows patients, doctors and pharmacists to transfer initial prescriptions for opioids and other controlled substances from one pharmacy to another.  

The rule became effective August 28, but has been in the works for several years. It revises DEA regulations to allow prescribers, hospitals and pharmacists the ability to write, dispense and transfer electronic prescriptions for controlled substances “upon request of the patient.” Under the old rule, prescriptions could not be transferred if a pharmacy is unwilling or unable to fill them – forcing doctors to write a second prescription for another pharmacy and creating delays for patients in need of treatment.

“The final rule amends DEA regulations to explicitly state that an electronic prescription for a controlled substance in schedule II–V may be transferred between retail pharmacies for initial filling on a one-time basis only, upon request from the patient, and clarifies that any authorized refills included on a prescription for a schedule III, IV, or V controlled substance are transferred with the original prescription,” DEA said in a lengthy notice published in the Federal Register.

In recent years, many patients have experienced delays or outright refusals getting prescriptions filled for opioids, stimulants, sedatives, steroids and other medications classified as controlled substances.  The problem has grown worse in recent months, due to chronic shortages of oxycodone, hydrocodone and stimulants.

It would be nice to say the DEA changed the rule to make it easier for patients to get their prescriptions filled, but the agency’s primary goal is to reduce drug diversion. Having doctors write duplicate prescriptions for the same patient is not only a waste of time, in the eyes of the DEA it raises the risk of the original prescription being misused.

“DEA realizes that this scenario creates the potential for duplication of prescriptions, if the practitioner transmits a new prescription to a different pharmacy and does not cancel or void the original prescription that was sent to the first pharmacy. It also recognizes that this scenario creates additional burden for patients, who have to get back in touch with the prescribing practitioner to request a new prescription,” the agency said.

“DEA believes that allowing the electronic transfer of controlled substance prescriptions will decrease the potential for duplicate prescriptions and thus reduce the opportunity for diversion or misuse.”

The diversion of prescription opioids is actually rare. According to the DEA, less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) is lost, stolen or diverted to someone they were not prescribed to.

The DEA estimates the new prescription transfer rule will cost pharmacies over $91 million annually due to additional record-keeping and time spent transferring prescriptions, but will reduce overall costs to the healthcare system by $22 million a year.  

DEA Considering More Changes to Telehealth Prescribing Rules

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration will hold two public hearings next month – what it calls “listening sessions” – to consider if providers should continue prescribing controlled substances through telehealth without first requiring patients to have an in-person medical evaluation.

Patients are currently allowed to get a controlled medications without visiting their doctor under emergency telehealth rules adopted three years ago at the start of the Covid-19 pandemic. Controlled substances include many opioids, stimulants, sedatives, steroids, and addiction treatment medications such as methadone and buprenorphine (Suboxone).

“DEA recognizes the importance of telemedicine in providing Americans with access to needed medications, and DEA has been, and remains, committed to expanding access to telemedicine in a way that puts patients — and their safety — first, is simple to understand and apply, reflects technological advancements, and is consistent with lessons learned during the COVID–19 PHE and the ongoing opioid epidemic,” the agency said in a statement.

Rules that are “simple to understand and apply” may be the key issue. In March, the DEA proposed changing the telehealth rules to reimpose “guardrails” on Schedule II opioids such as oxycodone and hydrocodone. For those medications, a patient would first be required to have an in-person meeting with a doctor, with refills then allowed via telehealth. Other drugs that are classified as Schedule III, IV or V substances could initially be prescribed for 30 days via telehealth, but any refills would require an in-person meeting.

The proposed rule changes are so confusing and drew so much opposition that the DEA delayed implementing them until this November. Next month’s public hearings are another sign the agency is still uncertain what to do.

In a notice published in the Federal Register, the DEA said it was open to creating a special registration process that would allow providers to continue prescribing “some controlled substances” without seeing patients in-person. The agency didn’t specific which controlled substances it is referring to.

“DEA is open to considering — for some controlled substances — implementation of a separate Special Registration for telemedicine prescribing for patients without requiring the patient to ever have had an in-person medical evaluation at all,” the DEA notice said.

“DEA also observes that making permanent some telemedicine flexibilities on a routine and large-scale basis would potentially create a new framework for medicine that fundamentally expands access to controlled substances in a way that warrants a new framework for accountability based, in part, on increased data collection and visibility into prescription practices in order to ensure patient safety and prevent diversion in near-real-time.”

Opioid Diversion Rare

Contrary to popular belief, opioid diversion is rare. Using data gathered from prescription drug monitoring programs (PDMPs), pharmacies, hospitals and others in the drug supply chain, the DEA’s most recent estimate is that less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) is lost, stolen or diverted to someone they were not prescribed to.

Opioid prescriptions are also harder to obtain and there are chronic opioid shortages around the country, so few pain patients are willing to part with their legally prescribed medications. Counterfeit medications and other street drugs made with illicit fentanyl are the real problem, which the DEA “listening sessions” won’t address.

The public hearings will be held on September 12 and 13 at DEA headquarters in Arlington, Virginia. Medical practitioners, patients, pharmacists, drug makers, distributors, law enforcement, and other interested parties can express their views either in-person or by video teleconference. The public hearings will also be streamed live online.

The DEA is seeking input on these key questions:

• Should telemedicine prescribing of Schedule II medications be permitted without an in-person medical evaluation?  If it is permitted, what safeguards would you recommend to ensure patient safety and prevent diversion?

• If telemedicine prescribing of Schedule III–V medications is permitted without an in-person medical evaluation, what safeguards and data should be collected for those substances? 

To register as a speaker, click here. The deadline for registering is August 21.

DEA Ending Lenient Telehealth Rules in November

By Arielle Zionts, KFF Health News

Federal regulators want most patients to see a health care provider in person before receiving prescriptions for potentially addictive medicines through telehealth — something that hasn’t been required in more than three years.

During the COVID-19 public health emergency, the Drug Enforcement Administration allowed doctors and other health care providers to prescribe controlled medicine during telehealth appointments without examining the patient in person. Controlled medications include many stimulants, sedatives, opioid painkillers, and anabolic steroids.

The emergency declaration ended May 13, and in February, the agency proposed new rules that would require providers to see patients at least once in person before prescribing many of those drugs during telehealth visits.

Regulators said they decided to extend the current regulations — which don’t require an in-person appointment — until Nov. 11 after receiving more than 38,000 comments on the proposed changes, a record amount of feedback. They also said patients who receive controlled medications from prescribers they’ve never met in person will have until Nov. 11, 2024, to come into compliance with the agency’s future rules.

The public comments discuss the potential effects on a variety of patients, including people being treated for mental health disorders, opioid addiction, or attention-deficit/hyperactivity disorder. Thousands of commenters also mentioned possible impacts on rural patients.

Opponents wrote that health care providers, not a law enforcement agency, should decide which patients need in-person appointments. They said the rules would make it difficult for some patients to receive care.

Other commenters called for exemptions for specific medications and conditions.

Supporters wrote that the proposal would balance the goals of increasing access to health care and helping prevent medication misuse.

Special Referrals for Rural Patients

Zola Coogan, 85, lives in Washington, Maine, a town of about 1,600 residents northeast of Portland. Coogan has volunteered with hospice patients and said it’s important for very sick and terminally ill people in rural areas to have access to opioids to ease their pain. But she said it can be hard to see a doctor in person if they lack transportation or are too debilitated to travel.

Coogan said she supports the DEA’s proposed rules because of a provision that could help patients who can’t travel to meet their telehealth prescriber. Instead, they could visit a local health care provider, who then could write a special referral to the telehealth prescriber. But she said accessing controlled medications would still be difficult for some rural residents.

“It could end up being a very sticky wicket” for some patients to access care, she said. “It’s not going to be easy, but it sounds like it’s doable.”

Some health care providers may hesitate to offer those referrals, said Stefan Kertesz, a physician and professor at the University of Alabama at Birmingham whose expertise includes addiction treatment. Kertesz said the proposed referral process is confusing and would require burdensome record-keeping.

Ateev Mehrotra, a physician and Harvard professor who has studied telehealth in rural areas, said different controlled drugs come with different risks. But overall, he finds the proposed rules too restrictive. He’s worried people who started receiving telehealth prescriptions during the pandemic would be cut off from medicine that helps them.

Mehrotra said he hasn’t seen clear evidence that every patient needs an in-person appointment before receiving controlled medicine through telehealth. He said it’s also not clear whether providers are less likely to write inappropriate prescriptions after in-person appointments than after telehealth ones.

Mehrotra described the proposed rules as “a situation where there’s not a clear benefit, but there are substantial harms for at least some patients,” including many in rural areas.

Beverly Jordan, a family practice doctor in Alabama and a member of the state medical board, supports the proposed rule, as well as a new Alabama law that requires annual in-person appointments for patients who receive controlled medications. Jordan prescribes such medications, including to rural patients who travel to her clinic in the small city of Enterprise.

“I think that once-a-year hurdle is probably not too big for anybody to be able to overcome, and is really a good part of patient safety,” Jordan said.

Jordan said it’s important for health care practitioners to physically examine patients to see if the exam matches how the patients describe their symptoms and whether they need any other kind of treatment.

Jordan said that, at the beginning of the pandemic, she couldn’t even view most telehealth patients on her computer. Three-fourths of her appointments were over the phone, because many rural patients have poor internet service that doesn’t support online video.

The proposed federal rules also have a special allowance for buprenorphine, which is used to treat opioid use disorder, and for most categories of non-narcotic controlled substances, such as testosterone, ketamine, and Xanax.

Providers could prescribe 30 days’ worth of these medications after telehealth appointments before requiring patients to have an in-person appointment to extend the prescription. Tribal health care practitioners would be exempt from the proposed regulations, as would Department of Veterans Affairs providers in emergency situations.

Many people who work in health care were surprised by the proposed rules, Kertesz said. He said they expected the DEA to let prescribers apply for special permission to provide controlled medicine without in-person appointments. Congress ordered the agency to create such a program in 2008, but it has not done so.

Agency officials said they considered creating a version of that program for rural patients but decided against it.

Denise Holiman disagrees with the proposed regulations. Holiman, who lives on a farm outside Centralia, Missouri, used to experience postmenopausal symptoms, including forgetfulness and insomnia. The 50-year-old now feels back to normal after being prescribed estrogen and testosterone by a Florida-based telehealth provider. Holiman said she doesn’t think she should have to go see her telehealth provider in person to maintain her prescriptions.

“I would have to get on a plane to go to Florida. I’m not going to do that,” she said. “If the government forces me to do that, that’s wrong.”

Holiman said her primary care doctor doesn’t prescribe injectable hormones and that she shouldn’t have to find another in-person prescriber to make a referral to her Florida provider.

Holiman is one of thousands of patients who shared their opinions with the DEA. The agency also received comments from advocacy, health care, and professional groups, such as the American Medical Association.

The physicians’ organization said the in-person rule should be eliminated for most categories of controlled medication. Even telehealth prescriptions for drugs with a higher risk of misuse, such as Adderall and oxycodone, should be exempt when medically necessary, the group said.

State Laws Burden Patients

Some states already have laws that are stricter than the DEA’s proposed rules. Amelia Burgess said Alabama’s annual exam requirement, which went into effect last summer, burdened some patients. The Minnesota doctor works at Bicycle Health, a telehealth company that prescribes buprenorphine.

Burgess said hundreds of the company’s patients in Alabama couldn’t switch to in-state prescribers because many weren’t taking new patients, were too far away, or were more expensive than the telehealth service. So Burgess and her co-workers flew to Alabama and set up a clinic at a hotel in Birmingham. About 250 patients showed up, with some rural patients driving from five hours away.

Critics of the federal proposal are lobbying for exemptions for medications that can be difficult to obtain due to a lack of specialists in rural areas.

Many of the public comments focus on the importance of telehealth-based buprenorphine treatment in rural areas, including in jails and prisons.

Rural areas also have shortages of mental health providers who can prescribe controlled substances for anxiety, depression, and ADHD. Patients across the country who use opioids for chronic pain have trouble finding prescribers.

It also can be difficult to find rural providers who prescribe testosterone, a controlled drug often taken by transgender men or people with various medical conditions, such as menopause. Controlled medications are also used to treat seizures, sleep disorders, and other conditions.

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

Algorithms Now Determine If You Get Medication

By Crystal Lindell, PNN Columnist

Did you know that secret algorithms are being used to determine whether your pharmacy is allowed to stock certain medications?

Algorithms are computer software programs designed to select, calculate and carry out certain actions – in this case the amount of opioids and other controlled substances that pharmacies can keep in stock to fill prescriptions with. And if an algorithm decides your pharmacy has used up its monthly allotment of a controlled drug, there’s almost no recourse for you as a patient.

The situation was recently brought into the spotlight by The New York Times article, “Opioid Settlement Hinders Patients’ Access to a Wide Array of Drugs.”

As The Times explains, the $21-billion opioid settlement brokered between the three largest U.S. drug distributors and 46 states includes a provision that forces the distributors to place strict limits on the drugs they supply to pharmacies. In addition to opioids, any medication labeled as a controlled substance is now subject to these restrictions, including Xanax, Adderall, muscle relaxants, and more.

“Before the settlement, pharmacists said, they could explain to a distributor the reason for a surge in demand and still receive medications past their limits. Now the caps appear to be more rigid: Drugs are cut off with no advance notice or rapid recourse. As a condition of the settlement, distributors cannot tell pharmacies what the thresholds are,” The Times reported.

So, like I said, secret algorithms are effectively deciding your medical treatment. And it’s not even based on you as an individual. It’s based on how many people in your region are taking the same medication.

Predictably, the situation is causing a lot of problems for a lot of people. The Times found that a number of groups have been affected, including:

1. “College students far from home trying to fill their Adderall prescription.”

2. “Patients in rural areas where it is customary to drive long distances for medical care.”

3. “Hospice providers that rely on local pharmacies for controlled substances.”

Let’s take a moment to truly absorb that last one. While the The Times used the term “hospice providers,” we all know what that actually means: hospice patients who are very sick or terminally ill.

So, it doesn’t even matter if you’re on your deathbed, you still might not get pain relief. And the decision for denial, to paraphrase how a pharmacist might explain it, is basically: “A bunch of your neighbors already got morphine, so you can’t have it.”

While the exact metrics used to deny shipments aren’t public, the drug distributors have addressed the issue on their websites, and explained how they’re tracking prescriptions.

“The algorithm will flag order lines of unusual size, frequency or pattern based on a pharmacy’s own order history or when compared to peers,” AmerisourceBergen explains. “Any order lines that are flagged by the algorithm will be automatically cancelled and reported.” 

Again, none of that is based on what any specific patient is experiencing.

All of this would be upsetting if it were only impacting opioid medication, but the fact that it’s been extended to other common prescriptions – that weren’t even part of opioid litigation -- is both enraging and scary.

Doctors do not give prescriptions for any controlled substances out easily, so if a patient is being prescribed any of the meds, then they need them.

Now, you may assume that at the very least, pharmacies are calling doctors once they hit these new thresholds so that the doctor can at least try to prescribe something else or send the prescription to another pharmacy.

You’d be wrong.

As the The Times reports:

“Psychiatrists in California were so alarmed by patients’ stories of unfilled prescriptions that they sent a survey to colleagues in December. They received reports of dozens of such problems, said Dr. Emily Wood, chairwoman of the government affairs committee of the California State Association of Psychiatrists.

Dr. Wood said that patients who take a stimulant for A.D.H.D. sometimes need anti-anxiety pills or a sedative at night to sleep — but that pharmacists now tell them they cannot have the combination.

“Pharmacists aren’t calling the doctors to work it out,” Dr. Wood said. “They’re just not filling the prescriptions.”

Pharmacists are being put in an impossible position, being forced to essentially serve as police agents without any say in what they’re enforcing. And it’s upsetting that the task of reaching a doctor to ask for a different prescription is now falling on patients with conditions like ADHD, a disorder that makes tasks like that especially difficult.

I couldn’t find much about how these algorithms were created, so it’s unclear if doctors were involved in creating them. But one thing we do know is that your personal doctor definitely wasn’t involved. And your personal needs were not a factor.

Your medical treatment is now being determined by drug distributors, state attorneys general, lawyers and computers — none of whom have ever met you or your doctor.

The thing that most people in the United States don’t seem to understand — but may be about to learn — is that to the DEA anyone who uses a controlled substance above a certain level must be abusing them. This is evidenced by the fact that this policy is even leading to restrictions for hospice patients and none of the parties involved are trying to fix that.

As the The Times reports, “Although the tighter restrictions have been in place for months, the government has offered little remedy for patients.”

It’s easy to believe the myth that restrictions on controlled substances are there to help keep us safe. That they are only meant to keep these medications from people who might misuse or abuse them.  But how is it safe to make a patient quit Adderall cold turkey, even when they have a valid prescription for it? How is it safe to tell rural patients that they need to drive hundreds of miles to another pharmacy? How is it safe to deny pain relief to a dying cancer patient? It’s not.

Everything about this situation is so inhumane. We’ve had incredible medical breakthroughs and finally have medications available for health conditions once considered untreatable. But it doesn’t matter. The masses still can’t have them. We must continue to suffer for whatever time we have left.

And for what? What is the reward for our suffering? Apparently, just more suffering.

Crystal Lindell is a freelance writer who lives in Illinois. After five years of unexplained rib pain, Crystal was finally diagnosed with hypermobile Ehlers-Danlos syndrome. She and her fiancé have 3 cats: Princess Dee, Basil, and Goose. She enjoys the Marvel Cinematic Universe, Taylor Swift Easter eggs, and playing the daily word game Semantle. 

DEA Proposes Cuts in Opioid Supply for Sixth Straight Year

By Roger Chriss, PNN Columnist

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

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

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

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

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

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

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

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

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

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

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

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

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

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

DEA Expanding Surveillance of Prescription Drug Data

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration is making plans for a major expansion of its monitoring of prescriptions for opioids and other controlled substances, with the goal of identifying virtually every prescriber, pharmacy and patient in the country that shows signs of drug diversion or abusing their medication.

In a request for proposal (RFP) made in early September, the DEA asked software contractors to submit bids for the creation of a nationwide data system that would track “a minimum of 85 percent of all prescriptions” for Schedule II through V controlled substances. The RFP was first reported by the website Filter.

Critics say the surveillance program will have a chilling effect on many healthcare providers, who are already fearful of being flagged by law enforcement for prescribing and dispensing opioids and other medications to patients suffering from pain and other illnesses.  

“This RFP illustrates that the DEA, and U.S. Department of Justice more broadly, remains fixated on monitoring and scrutinizing the medical decisions of licensed health professionals while illegal fentanyl and heroin contribute to two-thirds of opioid-involved drug poisonings in the U.S.,” says attorney Michael Barnes, who is managing partner at DCBA Law & Policy, a law firm that advises healthcare providers.

“DEA agents have no business second guessing health care providers’ decisions on medical need and patient care. That’s a job for state licensing boards – and only when there is a valid complaint to investigate.”

‘Unlimited Access’ to Prescription Data

Hundreds of medications would be covered under the DEA’s surveillance program, including drugs used to treat pain, opioid use disorder, anxiety, and attention deficit hyperactivity disorder (ADHD).  Under the program, DEA investigators would have “unlimited access” to prescription data compiled over the last five years, including the names of prescribers and pharmacists, types of medication, quantity, dose, refills and forms of payment.

The names of patients would be encrypted, but if investigators suspect a medication was being abused or diverted, they could get a subpoena to quickly identify the patients involved.

“The subpoena process would be that we would generate a DEA Administrative Subpoena and send it to you for the unmasking of specified patients. The data provider would then need to respond to us providing the unmasked patient information that was requested within three business days,” the DEA said in response to a contractor who inquired how the subpoena process would work.      

Asked how many DEA investigators would have access to the prescription data, the agency said there could be over a thousand.

“We would start with 1,100 users and would renegotiate if more were needed. It is unlikely that 1,100 users will all access the system concurrently but is hypothetically possible in the future,” the agency replied.

Why the DEA is seeking to expand its monitoring of opioid prescriptions is unclear. In recent years, the number of prescriptions has fallen by about a third and the DEA itself estimates that less than one percent of legally prescribed opioids are diverted.

Bypassing PDMPs

State-run prescription drug monitoring programs (PDMPs) already track much of the information DEA is seeking, but law enforcement access to the data usually requires an active investigation or warrant – no data mining or fishing expeditions allowed. To maintain patient privacy, some states prohibit sharing prescription data with federal or out-of-state law enforcement agencies. Last year, the DEA had to sue Colorado to get access to the state’s PDMP data.

The DEA’s plan would bypass these privacy safeguards and effectively create a national PDMP for law enforcement. The agency would even be allowed to share some prescription data with unnamed “outside agencies and/or organizations without prior review by the Contractor.”      

The DEA did not respond to multiple requests for comment. In the RFP, the agency said it was required by law to maintain “comprehensive, detailed, accessible, and timely prescription, pharmacy, and prescriber information.”

Much of the data mining the agency is planning appears to go beyond the prescription data that is currently covered by PDMPs.  For example, the DEA wants to know the distance patients travel to see their doctors and pharmacies; whether patients living at the same address are getting the same drugs; whether a patient pays in cash for their medications; and whether a patient is getting a combination of opioids and benzodiazepines to treat their pain and anxiety.

“This DEA program will increase the fear associated with prescribing and dispensing controlled medications, making it even more difficult for people with pain, opioid use disorder, anxiety, insomnia, and ADHD to access individualized treatment. More such patients will be left in despair. It’s as though the federal government is unaware or does not care that the U.S. is in the midst of a suicide epidemic,” Barnes told PNN. 

‘Appalling for People’s Health’

The software contractor is also expected to provide DEA with a list of top prescribers and pharmacies that are writing and filling prescriptions for fentanyl, oxycodone, hydrocodone, buprenorphine and other opioids. The inclusion of buprenorphine is troubling to substance abuse treatment experts, because it is a primary ingredient of Suboxone. 

“The impact of including buprenorphine will be appalling for people’s health,” said Dr. Hannah Cooper, the chair of substance use disorder research at Emory University. Cooper fears the DEA surveillance program would make doctors and pharmacies reluctant to supply Suboxone to patients who need addiction treatment. 

“The idea that patient-level data is available to the DEA is quite frightening. We don’t want to make people worry that their decisions will be monitored by this highly punitive federal agency,” Cooper told Filter. “If you’ve been inhabiting a space where you’ve been persecuted by the federal government for some time, and they now have access to your private medical information, there will be tremendous consequences for population health and health equity.”

“This program will undoubtedly decrease the prescribing of controlled medications, including buprenorphine for opioid use disorder,” said Barnes. “Why in the world would the federal government, in the midst of a worsening drug-poisoning epidemic, discourage the prescribing of a medication to treat opioid use disorder and prevent opioid poisonings?”

The DEA deadline for receiving proposals from software contractors was October 20. No contract awards have been announced. The surveillance program could begin as early as December 1, 2020 and continue for a minimum of one year, with an option for up to four years. The potential cost of the program has not been disclosed.

Over 22,000 Comments on DEA’s Kratom Ban

By Pat Anson, Editor

Over 22,000 public comments – a record number on any issue -- have been posted on a government website taking comments on a threatened federal ban on the herbal supplement kratom. The final number is likely to be even higher once all the comments are recorded.

The vast majority of commenters oppose plans by the Drug Enforcement Administration for the emergency scheduling of two ingredients in kratom as Schedule I controlled substances, a move that would make the sale and possession of the herb a felony.

Thursday, December 1 was the last day that public comments were accepted at Regulations.gov on the kratom ban. The number of kratom comments is over five times the number who commented on the controversial opioid prescribing guidelines released by the Centers for Disease Control and Prevention earlier this year.

“I think the quality of the comments and the quantity of the comments show that kratom really does have potential and that the three to five million people that are consuming kratom would suffer greatly if it becomes a Schedule I controlled substance,” Susan Ash, founder of the American Kratom Association, told Pain News Network.

Ash started using kratom several years ago to help fight opioid addiction. Many others use it to treat their chronic pain, anxiety and depression.

“If Kratom is banned by the DEA my quality of life will decrease tremendously,” wrote a 62-year old veteran who started using kratom four years ago as an alternative to anti-anxiety medication. “My life was out of control with benzodiazepines. With kratom, I can live a somewhat anxiety-free life and not have all the negative side effects that come with benzodiazepines.”

“The VA prescribes lots of pain medication that’s very addictive. I have since gone off the medication and switched to kratom,” wrote Brandon Lang, another military veteran.  “The effect as far as pain relief is comparable, but the addictive nature and the ‘high’ is nearly nonexistent. I feel much better knowing pain relief is available and affordable. I am now free and clear of narcotics.”

“Kratom is nowhere near as dangerous as alcohol, tobacco, acetaminophen, aspirin, and countless other things which are widely available. It makes absolutely no sense to ban kratom,” said John Miller.

“I am a former addict and know others who suffer from addiction including alcoholism,” wrote Chris Simmons. “In my experience kratom significantly reduces cravings while allowing people to go about their day as normally as possible. Please keep this legal.”

One of the comments opposing the ban came from a retired deputy chief of the Los Angeles Police Department.

“Kratom has been used safely by millions of people in the U.S., just like marijuana was used safely prior to its prohibition. And, just like marijuana, kratom has many medicinal benefits that scheduling would deny to those who benefit from its use. Its prohibition would only drive thousands more to opiate use,” wrote Stephen Downing, who has called for the legalization of many illicit drugs.

“There is no evidence to support prohibition of this plant. Putting it on the Controlled Substances Schedule will serve no useful purpose other than the continued survival of a massive and harmful out-of-control government bureaucracy.”

Only a small minority of commenters support a ban on kratom.

“Adding an untested and unregulated substance such as kratom to our food supply without the application of longstanding federal rules and guidelines would not only be illegal, it could likely be dangerous, leading to serious unintended consequences as our nation struggles with the crisis of opioid addiction,” wrote Daniel Fabricant, PhD, a former FDA official who is now CEO and Executive Director of the Natural Products Association (NPA), a trade association that represents the food and dietary supplement industry.

“NPA strongly urges DEA and FDA to take appropriate legal action to ensure that American consumers are protected from an unknown and unregulated botanical ingredient whose use could have widespread and unintended negative consequences for public health and safety.”

Fabricant’s comments to the DEA rely primarily on anecdotal reports that kratom might be harmful or have a narcotic effect.  Although kratom leaves have been used for centuries as a natural remedy in southeast Asia, it is relatively new in the United States, and there have been few clinical studies on its safety and efficacy.

In a new analysis of existing studies funded by the American Kratom Association, Jack Henningfield, PhD, said kratom was no more dangerous than many other herbal supplements, such as St. John’s Wort, lavender, kava and hops. 

"For both abuse potential and dependence liability, kratom's profile is comparable to or lower than that of unscheduled substances such as caffeine, nicotine-containing smoking cessation products, dextromethorphan, and many antihistamines, antidepressants, and other substances sold directly to consumers,” said Henningfield, who is a former chief of research at the National Institute on Drug Abuse and is currently an adjunct professor in the Department of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine. 

What happens now with the threatened ban is not clear. The DEA has asked for a new analysis of kratom from the Food and Drug Administration, which initially recommended that the herb be made a controlled substance. The new analysis has yet to be released publicly.

It appears likely that a final decision on kratom will be left to the incoming Trump administration, and there are conflicting signs where that may lead. Trump’s nominee as Attorney General, Alabama Sen. Jeff Sessions, has been a longtime critic of marijuana legalization. If confirmed by the Senate, Sessions will oversee the DEA.

Trump’s nominee as Secretary of Health and Humans Services, Georgia Rep. Tom Price, will oversee both the CDC and FDA if he is confirmed. Price is a noted Tea Party member and longtime critic of Obamacare, who wants a more free market approach to healthcare that allows patients to make their own decisions. 

Susan Ash is hopeful that these dueling interests will decide that kratom is best left alone as a dietary supplement. 

“I’m nearly 100% confident that they are not going to emergency schedule this again,” she told PNN. “I truly believe that science is going to be on our side. How long it is going to take for that science is my concern.”

Medical Use of Kratom ‘Too Large to Be Ignored’

By Pat Anson, Editor

A threatened ban on kratom would stifle scientific understanding of the herb and its value in treating pain, addiction and other medical problems, according to a commentary published in the Journal of the American Osteopathic Association.

"There's no question kratom compounds have complex and potential useful pharmacologic activities and they produce chemically different actions from opioids," said Walter Prozialeck, PhD, chairman of the Department of Pharmacology at Midwestern University Chicago College of Osteopathic Medicine.

“In my opinion, the therapeutic potential of kratom is too large to be ignored. Well-controlled clinical trials on kratom or the many active compounds in kratom are needed to address this issue.”

In August, the U.S. Drug Enforcement Administration issued an emergency order saying it would classify two of kratom’s active ingredients -- mitragynine and 7-hydroxymitragynine -- as Schedule I controlled substances.

Such an order would have effectively banned the sale and possession of an herbal supplement that millions of people use to treat pain, anxiety, depression and addiction. It would also make it harder for researchers to conduct clinical trials of kratom.

The DEA postponed its decision only after a backlash from kratom supporters and some members of Congress. The agency said it would seek new guidance from the FDA and allow public comment on the proposed ban until December 1. Over 7,000 people have commented so far at Regulations.gov.

In its emergency order, the DEA said kratom posed an “imminent hazard to public safety” and referred to its chemical compounds as “opioid substances.” But Prozialeck says kratom behaves differently than opioids, because it doesn't produce euphoria or depress respiration.

“At the molecular level, mitragynines are struc­turally quite different from traditional opioids such as morphine. Moreover, recent studies indicate that even though the mitragynines can interact with opioid receptors, their molecular actions are different from those of opioids,” he wrote. “Based on all of the evidence, it is clear that kratom and its mitragy­nine constituents are not opioids and that they should not be classified as such.”

Prozialeck also disputes the notion that kratom is linked to several deaths, saying other drugs or health problems could have been involved. While he thinks banning the herb would be a mistake, Prozialeck believes some regulation is needed to prevent kratom products from being adulterated or contaminated with other substances.

"After evaluating the literature, I can reach no other conclusion than, in pure herbal form, when taken at moderate doses of less than 10 to 15 g (grams), pure leaf kratom appears to be relatively benign in the vast majority of users. Without reported evidence, however, it would not be appropriate for phy­sicians to recommend kratom for their patients,” he concludes.

That’s a sentiment that Dr. Anita Gupta agrees with.  She says several of her patients have successfully used kratom for pain relief, but until more research is conducted on the herb’s safety and efficacy, Gupta won’t recommend it to other patients.

“What I hear from patients is that they’re getting good benefit from it. But we have to wonder if kratom itself has pharmacological benefit or if it’s a placebo effect,” said Gupta, an osteopathic anesthesiologist and pharmacist who also serves on an FDA advisory board.

“I would encourage more oversight of kratom. There should be more regulation of kratom substances. That could come from the FDA or DEA, to make sure patients are safe and there’s no harmful interaction. To say that it’s only a dietary supplement, I don’t know if that’s the right classification, because we’re using it for clinical conditions and diseases. I think we need more oversight and more research should be conducted,” Gupta told PNN.

It’s a Catch-22 for kratom supporters. If research confirms its therapeutic value, that could result in kratom being classified as a Schedule II or III controlled substance, on the same level as other medications that have a potential for abuse. Kratom would still be legal to obtain, but only with a prescription.

In a survey of over 6,000 kratom users by Pain News Network and the American Kratom Association, over 98 percent said they wanted kratom to remain available as a dietary supplement without a prescription.  Seven out of 10 also said pharmaceutical companies should not be allowed to produce and market kratom products.

DEA Withdraws Plan to Ban Kratom

By Pat Anson, Editor

Facing opposition from the public and some members of Congress, the U.S. Drug Enforcement Administration has withdrawn plans to classify two of the active ingredients in kratom as Schedule I controlled substances, a move that would have made the sale and possession of the herb a felony.

“DEA has received numerous comments from members of the public challenging the scheduling action and requesting that the agency consider those comments and accompanying information before taking further action,” the DEA said in a notice published in the Federal Register.

“DEA is therefore taking the following actions: DEA is withdrawing the August 31, 2016 notice of intent; and soliciting comments from the public regarding the scheduling of mitragynine and 7-hydroxymitragynine under the Controlled Substances Act.” 

Mitragynine and 7-hydroxymitragynine are alkaloids in kratom that appear to act on opioid receptors in the brain. They are not approved for any medical use in the United States, even though millions of kratom consumers use the the herb to manage pain, anxiety, depression, addiction and other medical conditions.

The unprecedented decision to withdraw the scheduling of a controlled substance does not end the possibility that kratom will be banned. The DEA said it would re-evaluate its decision after the public comment period ends on December 1, 2016. The agency will also ask the Food and Drug Administration to expedite a full scientific and medical evaluation of kratom.

“DEA will consider all public comments received under the above procedures, as well as FDA’s scientific and medical evaluation and scheduling recommendation for these substances.  Once DEA has received and considered all of this information, DEA will decide whether to proceed with permanent scheduling of mitragynine and 7-hydroxymitragynine , or both permanent and temporary scheduling of these substances,” the agency said in its announcement.

If the DEA decides to schedule kratom permanently, the agency said it would publish a new notice in the Federal Register and allow for a second public comment period. Under the original emergency scheduling notice published on August 30, there was no public notice or comment period.

“We moved a mountain and now we’re parting the sea!!! Keep the pressure on; wait for commenting instructions please, we still have A LOT of work ahead of us,” wrote Susan Ash, founder of the American Kratom Association (AKA) in a note to supporters on Facebook.

“I think what this clearly shows is that there is no imminent public health threat or they wouldn’t be adding on a 6 week public comment process and putting it back on the FDA,” Ash told PNN.

She said her organization would resist any effort to classify kratom in a less restrictive category than Schedule I, which is how marijuana, LSD and heroin are classified. At present. there are no federal limits on kratom as a dietary supplement, although it is banned in a handful of states.

"We still believe it should not be scheduled in any way, shape or form. It's been consumed safely here for decades and worldwide for a millennium, so there's really no impetus to make it a controlled substance, period," said Ash.

In its initial attempt to ban kratom -- which comes from the leaves of a tree in Southeast Asia -- the DEA said the herb had “psychoactive effects” and was linked to dozens of overdose deaths.

In reaching that assessment, the agency relied primarily on the research and advice of the FDA and the Centers for Disease Control and Prevention.  Critics, however, say much of that research was deeply flawed and unreliable. For example, a recent CDC report claimed kratom was “an emerging public health threat” and cited two published research reports that “associated kratom exposure with psychosis, seizures, and deaths.”

Those two reports, however, make no mention of deaths caused by kratom. The CDC also relied on a newspaper article to help document one kratom-related death, even though it was actually caused by a self-inflicted gunshot wound.

"Nowhere does DEA rely on the scientific, epidemiological, and public health sources that normally undergird the assertion that a substance poses a high potential for abuse, let alone an imminent public health threat,” lawyers for the AKA said in a letter to DEA acting administrator Chuck Rosenberg.

To overturn the ban, the AKA enlisted the help of over 60 members of Congress, who signed letters urging the DEA to delay scheduling kratom and to solicit more public input. Over 142,000 kratom supporters also signed a White House petition asking the Obama administration to postpone the scheduling.

"I think the DEA was pressured so much by Congress, the public and by the media that they realized that they didn't really have the proof and the science to emergency schedule this," Ash said. "It put the DEA in a really difficult position and now the DEA is just trying to admit the fact that they don't have what they need to call this a public health threat."

In a survey of over 6,000 kratom consumers by Pain News Network and the AKA, nine out of ten said kratom was a “very effective” treatment for pain, depression, anxiety, insomnia, opioid addiction and alcoholism. Many also predicted that banning the herb would only lead to more drug abuse, addiction and death.

"The DEA missed the mark here and it would be a gross miscarriage of due process to simply tell millions of American consumers and the legal businesses that serve them that they are now felons,” said Travis Lowin of the Botanical Education Alliance in a statement before the DEA reversed its decision. 

“The DEA has a strict set of rules it is supposed to follow for an emergency scheduling of a drug and kratom meets none of those tests.  There are reasonable limits on the power of what government can do precisely to avoid situations like this where legal consumer conduct and legitimate free enterprise would otherwise be crushed overnight by indiscriminate use of the power of government."

Critics Say Fed Kratom Research Flawed

By Pat Anson, Editor

The U.S. Drug Enforcement Administration and the Centers for Disease Control and Prevention relied on flawed and unreliable research – some of it based on a newspaper article -- to build a case against the herbal supplement kratom, according to lawyers hired by the American Kratom Association (AKA).

The DEA cited a CDC report claiming that “deaths have been attributed to kratom” when it announced plans for the emergency scheduling of two active ingredients in kratom as Schedule I controlled substances, a move that would make the sale and possession of the herb a felony. 

Kratom, which comes from the leaves of a tree that grows in Southeast Asia, is used by millions of Americans in teas and supplements to treat chronic pain, anxiety, depression, addiction and other medical problems.

“AKA takes very seriously DEA’s concern that approximately 30 reports of fatalities have been linked to consumers who had ingested or possessed a kratom product. However, a close examination of these reports shows that there are no instances in which kratom itself was determined to be responsible for the cause of death,” wrote lawyers David Fox and Lynn Mehler, in a letter to DEA acting administrator Chuck Rosenberg.

“There is good reason to question whether these reports indeed represent a valid or meaningful signal with respect to kratom. Close review of the totality of evidence points clearly in the other direction, namely, that kratom is well tolerated and relatively mild in its effects.”

Fox and Mehler are partners in the Los Angeles-based law firm of Hogan Lovells, which was hired by the AKA, an organization of kratom consumers that receives some of its funding from kratom vendors.

In their 35-page letter to Rosenberg, Fox and Mehler said much of the evidence used by DEA to justify the emergency scheduling was “fundamentally flawed” because it relies on reports that “are inadequate and unreliable.”

In the emergency scheduling notice published in the Federal Register, DEA cited a July 2016 report from the CDC that claimed kratom was “an emerging public health threat.” The CDC said kratom related calls to U.S. poison control centers rose from 26 calls in 2010 to 263 in 2015 – a total of 660 calls over a six year period.

Fox and Mehler said that pales in comparison to the number of calls to poison centers received about other common household items, including caffeine (23,303 calls in 6 years) and essential oils (66,300 calls).

The CDC report also cited two published research reports that “associated kratom exposure with psychosis, seizures, and deaths.”

“The CDC publication appears to have either misidentified its sources or been mistaken in its conclusions, as both sources reported no deaths from kratom,” wrote Fox and Mehler. “Likewise, the CDC report also stated that ‘deaths have been attributed to kratom in the United States,’ but it cited for that proposition a single report in a newspaper article. The newspaper article reported the suicide of a 22-year old male by self-inflicted gunshot wound.”

The assertion that CDC research is faulty is not a new one. Similar complaints were raised about the weak evidence used by CDC to justify its guidelines for opioid prescribing. Critics have also faulted the agency for “incomplete and biased” reports about the risks associated with opioid pain medication, and misleading reports about the number of deaths caused by prescription opioids.

“Nowhere does DEA rely on the scientific, epidemiological, and public health sources that normally undergird the assertion that a substance poses a high potential for abuse, let alone an imminent public health threat,” said Fox and Mehler. “The proposed use of the emergency scheduling provisions in this case is unprecedented, contrary to the law and public interest, violates fundamental principles of regulatory procedure, and implicates serious constitutional questions.”

The DEA has not publicly responded to the AKA letter. The agency could have classified kratom as a Schedule I controlled substance on September 30, but caved into political pressure from some members of Congress to leave the legal status of the herb unchanged for the time being. 

Under the DEA’s emergency scheduling order, no public notice or comment period was allowed. But according to Wisconsin Rep. Mark Pocan’s office, the agency will allow for a “modified comment process” about the scheduling of kratom, although that has not yet been confirmed by the agency.

Kratom activists believe the DEA will announce its decision soon.

“We’ve heard through the grapevine that as early as Tuesday, the DEA is going to be making an announcement about where they go from notice of intent to saying that they’re going to allow for a public comment process,” said Susan Ash, founder of AKA.

“Our concern is that it will be a very brief amount of time to be able to get enough comments from the scientific community, the medical community and the public at large to really have an impact on this decision. So the question is this just an attempt to save face by the DEA when they still have full intent of banning it? Or are they really going to be opening up a true comment process?”

In a survey of over 6,000 kratom consumers by Pain News Network and the American Kratom Association, over 95 percent said banning the herb would have a harmful effect on society. Many predicted it would lead to more addiction and illegal drug abuse.