U.S. Drug Shortages Reach Record Levels

By Pat Anson, PNN Editor

Shortages of opioids and other medications reached a record level in the U.S. during the first quarter of 2024, according to the American Society of Health-System Pharmacists (ASHP). The 323 medications listed in short supply are the highest number since the ASHP began tracking drug shortages in 2001.

Some of the most acute shortages are for basic, life-saving injectable drugs used in hospitals for pain control, sedation and chemotherapy.

Most of the drug manufacturers contacted by the ASHP did not provide a reason for the shortages, but some blamed supply/demand issues (14%), manufacturing problems (12%), business decisions (12%) and raw material issues (2%).

The ASHP also cited reduced DEA production quotas and the fallout from opioid litigation settlements, which have curtailed the supply of opioid medication at many pharmacies.

“New DEA quota changes, along with allocation practices established after opioid legal settlements, are exacerbating shortages of controlled substances,” the ASHP said in its latest report.

The Drug Enforcement Administration has been cutting opioid production quotas for nearly a decade, reducing the supply of oxycodone by over 68% and hydrocodone by nearly 73% since 2015. The DEA says it acts on the advice of the Food and Drug Administration, which projected a 7.9% decline in the “medical need” for opioids in 2024, months before the new year even began.

Many pain patients question whether the demand for opioids is really going down. In a recent PNN survey, 90% of patients with an opioid prescription said they had trouble getting it filled at a pharmacy. Nearly 20% were unable to get their pain medication, even after contacting multiple pharmacies.

“The pharmacist said they could not get my medication because the supplier informed them that they had reached their yearly max and the DEA would not let them supply anymore medication,” one patient told us.

“I am terrified of the cuts being pushed by the DEA,” said another patient. “Several times I have had to wait over a week until my local CVS got my medication back in stock. Honestly, I have such intolerable pain I had no choice but to turn to illicit street drugs to fill in the gaps.”

Shortages of stimulants used to treat attention-deficit/hyperactivity disorder (ADHD) get far more attention than shortages of opioids, which the FDA and DEA have largely ignored. The DEA modestly raised production quotas for ADHD drugs in 2024, but they remain in short supply.

About 12% of the 323 drugs currently listed in shortage by the ASHP are controlled substances regulated by the DEA because they are potentially addictive.

University of Utah Drug Information Service

“I can’t say for sure that every single controlled substance shortage is due to quota issues, but it’s a contributing factor for some,” says Erin Fox, PharmD, Senior Pharmacy Director at University of Utah Health, which tracks drug shortages for the ASHP. “DEA changed their quota process to try to help with ADHD drug shortages, but didn’t take into account how their change affects injectable manufacturers.”

Fox shared a recent letter sent by Pfizer to U.S. hospitals warning of “additional supply interruptions and potential stock outs” due to DEA quota changes. The letter warns of limited supplies of several injectable medicines made by Pfizer, including meperidine (Demerol), hydromorphone and morphine.  

“I understand that DEA is working to prevent drug diversion and was under fire for the ADHD medication shortages, but injectable manufacturing is very different than oral products and DEA did not take into account all of the special processes that are required for injectables,” Fox said in an email to PNN.

Nearly half of the drugs on the ASHP’s shortage list are injectables. Opioids, stimulants and other drugs that affect the central nervous system are the leading class of medication in short supply, followed by antibiotics, hormonal agents, and chemotherapy drugs.

The FDA, which uses a different system to track drug shortages, currently lists only 153 medications in short supply, less than half the number listed by the ASHP.

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.”

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.

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.”  

Pharmacies Under ‘Extreme Pressure’ to Give Patient Records to Law Enforcement

By Pat Anson, PNN Editor

Three of the nation’s largest pharmacy chains -- CVS, Kroger and Rite Aid – allow staff in their pharmacy stores to routinely hand over prescription records to law enforcement without a warrant, according to congressional investigators. In most cases, pharmacy customers are never informed that their medical records have been provided to law enforcement or why they were being sought.   

The policies were revealed in a joint letter sent to Health and Human Services Secretary Xavier Becerra by Sen. Ron Wyden (D-OR) and Reps. Pramila Jayapal (D-WA) and Sara Jacobs (D-CA), who have been looking into the privacy practices of major pharmacy chains.

“Americans' prescription records are among the most private information the government can obtain about a person. They can reveal extremely personal and sensitive details about a person’s life, including prescriptions for birth control, depression or anxiety medications, or other private medical conditions,” Wyden, Jayapal and Jacobs wrote in their letter, which was first reported on by The Washington Post.

Congressional investigators asked eight major pharmacy chains about their policies for dealing with law enforcement requests for prescription records. Five of them — Amazon Pharmacy, Cigna, Optum Rx, Walmart and Walgreens —- said the requests are automatically reviewed by legal professionals before responding.

“The three remaining pharmacy chains — CVS Health, The Kroger Company, and Rite Aid Corporation — indicated that their pharmacy staff face extreme pressure to immediately respond to law enforcement demands and, as such, the companies instruct their staff to process those requests in the store,” the letter said.

“CVS Health and the Kroger Company both defended this practice, arguing that their pharmacy staff — who are not lawyers or paralegals — are trained to respond to such requests and can contact the legal department if they have questions.”

All eight pharmacy chains said they do not require a warrant to share pharmacy records, unless there is a state law that dictates otherwise. Only three states – Louisiana, Montana and Pennsylvania – have laws that require a warrant signed or reviewed by a judge before medical data is disclosed.

HIPAA Privacy Issues

Law enforcement agencies are not covered by the Health Insurance Portability and Accountability Act (HIPAA), which protects patient privacy. The pharmacy chains are covered by HIPAA, but say they are exempt under HHS regulations that allow healthcare providers to disclose patient records to law enforcement if it is obtained through a subpoena or a simple administrative request. Unlike warrants, subpoenas generally do not require a judge’s approval.

Congress began looking into the HIPAA policies of pharmacies after the U.S. Supreme Court overturned Roe v Wade, leaving it up to individual states to make their own laws about abortion. Some medications that induce abortions are now banned in certain states.

But the Drug Enforcement Administration and other law enforcement agencies were showing a keen interest in obtaining prescription records long before Roe v Wade was overturned. In 2020, the DEA solicited bids from contractors for a prescription drug surveillance program that would identify virtually every patient, prescriber and pharmacy that may be diverting or abusing opioids and other controlled substances.

Under the proposed surveillance program, DEA investigators would have “unlimited access” to prescription data, 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 identify them.

No contract was awarded by DEA and it’s unclear if the surveillance program was ever initiated. State-run prescription drug monitoring programs (PDMPs) already track much of the information DEA was seeking, but law enforcement access to the data usually requires an active investigation or warrant.

Regardless of the method used, some pain patients with a history of needing high-dose opioid prescriptions have suspected they are being tracked by the DEA as a way to gather evidence on their doctors.

“I have talked to many patients who described things that made them believe this was occurring,” says Anne Fuqua, a disabled nurse in Alabama who needs high-dose opioids for intractable pain. At least two of Fuqua’s out-of-state physicians have been raided by the DEA and driven from medical practice without criminal charges ever being filed against them.

She’s pleased that Congress is looking into HIPAA issues at the pharmacy level, but feels that law enforcement already has easy access to patient information.  

“I'm glad that the huge potential for intrusion into a person's medical care is finally attracting attention,” Fuqua told PNN. “There are many states like Alabama where state and local law enforcement can access PDMP by simply affirming there is an active investigation in process. As long as some states permit unfettered access to the PDMP by law enforcement, the police and DEA don't really even need to contact the actual pharmacy for records related to controlled substances.”

Of the eight pharmacy chains contacted by congressional investigators, only Amazon said it automatically notifies customers if a law enforcement agency asked for their medical records, unless there is a legal reason not to do so.

Under the HIPAA Act, every American has the right to ask a healthcare provider if their medical information has been disclosed. Few people do, however. CVS said it received only a “single-digit number” of consumer requests last year.  A CVS spokesman told The Washington Post that most law enforcement requests come with a directive that they be kept confidential.

Pharmacies already face enormous scrutiny over their dispensing of opioid pain medication. Under the national opioid settlement, drug wholesalers have to limit the amount of opioids supplied to each pharmacy and are required to collect from pharmacies a list of suspicious orders and red flags that may indicate drugs are being abused or diverted. Pharmacies that don’t comply risk being “terminated” by their suppliers.

Wyden, Jayapal and Jacobs say more privacy protections are needed for pharmacy customers.

“We urge HHS to consider further strengthening its HIPAA regulations to more closely align them with Americans’ reasonable expectations of privacy and Constitutional principles. Pharmacies can and should insist on a warrant, and invite law enforcement agencies that insist on demanding patient medical records with solely a subpoena to go to court to enforce that demand,” they wrote.

DEA Cuts in Opioid Supply ‘Completely Irresponsible’

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Is the DEA a Domestic Terrorist Organization?

By Carol Levy, PNN Columnist

Terrorism is very much in the news these days, given the Israeli-Hamas war and all the fallout from it around the world. But terrorism can also hit close to home and in unexpected ways.

The FBI defines domestic terrorism this way:

“Violent, criminal acts committed by individuals and/or groups to further ideological goals stemming from domestic influences, such as those of a political, religious, social, racial, or environmental nature.”

It may not be domestic violence in the literal meaning of the term, but I would posit the U.S. Drug Enforcement Administration is a domestic terrorist organization.

Why would I believe that? The answer lies in how terrorists work. Their goals and methods are simple: kill one person and scare thousands. In the DEA's case, it means arrest a doctor and allege that they overprescribe opioids without a legitimate medical reason. This has a chilling effect on thousands of other physicians, who then limit or even refuse to prescribe opioids.

If a doctor knows his patients well and has been prescribing opioids safely to them for years, with beneficial results, makes no difference. The doctor is essentially arrested on ideological, social and political grounds, which gives validation to the concept that they are being terrorized.

The DEA’s war on drugs has gone far beyond its original goal of going after street drugs and drug dealers. It has escalated into a war against prescription opioids and the doctors who prescribe them, essentially making patients hostages to the DEA's political persecution.

I know there are instances when the arrests are legitimate, but from what I can tell many of the doctors caught in the DEA snare have been unfairly targeted.

I have never been a victim of their terrorism. I did lose one of the best doctors I ever had when he lost his privileges to write scripts for opioids. Although this was not due to the DEA but his own inappropriate actions, it allows me to better understand the effect that DEA terrorism has on so many of us.

My experience is nothing compared to the stories of patients who can no longer work, play with their kids, or even get out of bed because the opioids that allowed them to do these things were tapered or discontinued. Or they can’t get their opioid prescriptions filled at a pharmacy.

It’s nothing compared to all the stories of patients killing themselves because they can no longer get the medication that was helping them. Or the patients who were abandoned by a doctor who fears the DEA, who then struggle to find another doctor with the courage to risk going to jail by prescribing opioids.

To the DEA, the fact that these medications are working and that doctors are legitimately prescribing them is irrelevant. Fear seems to be their primary goal. Is that not terrorism?

Until the DEA and politicians get out of the exam room, I fear that pain patients will remain their hostages.

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. 

Patients Urge DEA to Stop Cutting Supply of Opioid Pain Medication

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

‘More People Will Die’

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

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

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

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

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

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

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

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

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

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

A Pain Patient's Perspective on Opioid Prescribing

By Barby Ingle, PNN Columnist

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

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

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

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

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

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

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

Individualized Treatment

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

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

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

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

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

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

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

Patient-Physician Communication

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

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

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

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

DEA Plans Further Cuts in Rx Opioid Supply in 2024

By Pat Anson, PNN Editor

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

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

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

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

Proposed Cuts in 2024 Opioid Supply

- 8.3% Codeine  

- 7.6% Rx Fentanyl  

- 4.3% Morphine

- 2.1% Hydromorphone 

- 0.3% Oxycodone   

- 0.3% Hydrocodone

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

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

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

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

More ADHD Meds, Cannabis and Psychedelics

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

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

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

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

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

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

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

Is It Safe for Doctors to Recommend Medical Cannabis?

By Dr. Joseph Parker

Nearly two-thirds of oncologists and pain management specialists say they are worried about the legal repercussions of recommending medical cannabis to their patients. This is not an unreasonable fear.

According to one survey, 60% of doctors fear professional stigma, and for good reason. I have seen colleagues call the DEA to report that a physician who certified patients for cannabis was selling marijuana from their office.  As absurd as this might seem, once the DEA gets rolling, they can always find an excuse to prosecute a physician treating pain or addiction. 

Cannabis may soon be moved from a Schedule I controlled substance, with no approved medical use, to a less restrictive Schedule III, where it would be regulated like codeine. This might relax some of those physicians, but I’m not sure it will.

There are many politicians and law enforcement officers who simply believe that marijuana is evil. The extreme was former Attorney General Jeff Sessions, who said at one time that marijuana was “only slightly less awful” than heroin. 

Sessions may truly believe this, but the comparison has no basis.  Heroin can cause respiratory depression and death.  Cannabis cannot.  Heroin works on the endorphin receptors in the brain to trigger a dopamine-mediated reward response, which can lead to what I call “true” addiction. 

Cannabis works predominately through the endocannabinoid system, though it can indirectly influence the release of dopamine and other brain areas associated with the reward system. That’s because the endocannabinoid system and CB1 receptors play a regulatory role in the release of various neurotransmitters, including dopamine.

When tetrahydrocannabinol (THC) binds to CB1 receptors, it can affect the release of dopamine and other neurotransmitters, which contributes to the pleasurable and rewarding effects associated with cannabis use.

I am not saying that someone cannot develop a cannabis substance use disorder or dependence. They certainly can, just like you can with caffeine, sugar or gambling, for that matter.  What I’m saying is that cannabis can make people feel good and want more, but it is nowhere near as dangerous as heroin.  It is also not neurotoxic, like methamphetamine, which can cause the death of brain cells with a single use. 

Some studies actually show a neuroprotective effect from cannabis. And, when taken by itself, cannabis cannot cause an overdose death. This is important. 

Every time the U.S. government targets something, they pay an army of statisticians to generate scary-sounding numbers. For example, you will hear claims that a rise in fatal car accidents was “associated” with cannabis. What exactly does that mean?  It means that a large percentage of accidents involve people who use cannabis, which is unsurprising since about 40% of the adult U.S. population has or is using cannabis.

Those same accidents show a much higher correlation with caffeine.  Caffeine use could be “associated” with probably 90% of all car accidents.  But correlation, of course, does not prove causation. 

These arguments present no evidence that cannabis caused the accidents.  However, the news media can get sloppy about scientific accuracy.  A study will say that a certain number of accidents “involved” cannabis, and the media will report that the cannabis “caused” the accident.

CBD vs. THC

For some reason, Sessions was also obsessed with CBD (cannabidiol). CBD is not THC, which is psychoactive and has a significant effect on a user’s mental processes.  CBD is considered non-psychoactive by a majority of experts, including the World Health Organization.

THC has a higher affinity for CB1 receptors, which are primarily found in the brain and central nervous system, and is a partial agonist for both CB1 and CB2 receptors. Activation of CB1 can cause euphoria and relaxation. It also alters sensory perception, impairs short-term memory, induces anxiety and paranoia, and impairs motor coordination.

CBD does not directly activate those receptors or have those effects. It is instead considered a negative allosteric modulator of CB1 receptors. CBD modifies the CB1 receptor response to THC and actually moderates some of the psychoactive effects of THC.  

There is also evidence that CBD can be anxiolytic and antipsychotic, while THC has been linked (not proven) to be associated with schizophrenia and psychosis.  THC can lead to the release of dopamine, which accounts for the euphoria, but at too low a level to be compared with more addictive substances.

CBD has been found in at least one study to be effective in the treatment of heroin addiction, and in another study to increased motivation, possibly giving us something to treat symptoms of schizophrenia.

Does this all mean it is safe to recommend cannabis to your patients?  Not really. While cannabis has been shown in several replicated studies to be helpful in the treatment of chronic pain, right now it is not safe for doctors to prescribe or recommend. 

Even in states where cannabis is legal for medical use and federal courts have upheld the right of physicians to recommend it, I would argue that the DEA takes a different view.

In the recent prosecution of a physician for “overprescribing” opiates, prosecutors claimed at a press conference that they started investigating the doctor after a call from local police regarding an overdose death.  Evidence later showed this was not the case.  The doctor was actually first targeted for agreeing to certify patients for their state’s medical cannabis program. 

You can help educate your patients about cannabis, but send them on to someone who does not prescribe controlled substances. Until physician rights are restored and protected in this country, it’s just not safe to recommend cannabis.

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

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

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

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

Specific examples of how shortages have impacted patient care include:

• Interruption or delays in chemotherapy

• Use of more opioid analgesia due to lidocaine shortages

• Incorrect medication instructions given to patients

• Postponement or cancellation of surgeries 

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

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

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

Supply Interruptions

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

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

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

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

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

GRAPHIC COURTESY OF MONTY GODDARD

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

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

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

Lawsuits Accuse DEA of ‘Incompetence’ in Regulating Drug Supply

By Pat Anson, PNN Editor

Two federal lawsuits accuse the Drug Enforcement Administration of incompetence and heavy-handed regulation of the nation’s drug supply, which could worsen shortages of ADHD medication and drive a drug manufacturer and specialty pharmacy out of business.

At issue is the DEA’s enforcement of the Controlled Substances Act (CSA), a federal law that gives the agency broad authority to limit the production and sale of opioids, ADHD drugs and other controlled medications that have the potential for abuse. Under the CSA, the DEA decides who can write and dispense prescriptions for hundreds of controlled substances and the amount that drug makers can produce.   

“They shouldn't be playing God with people's medications. And really, that's what's happening here,” says attorney Jim Walden, who recently filed a lawsuit in the Second Circuit Court of Appeals on behalf of Ascent Pharmaceuticals, a leading producer of generic drugs used to treat attention deficit hyperactive disorder (ADHD), a condition that primarily affects children.

By its own estimate, Ascent produces about 20% of the nation’s supply of generic ADHD medication. In its 12-year history, Ascent had never been accused of a regulatory violation or faced any sanctions, so it was surprised to learn on September 29 that DEA would not renew its production quota for ADHD drugs because it has doubts about the company’s record keeping.

“After reviewing these records, DEA lacks confidence in the data provided by Ascent in its quota requests,” the agency said in its denial.

Ascent’s lawsuit disputes that claim, saying DEA investigators spent 18 months “bumbling about” its business records, without ever making clear what they were concerned about or why the quota was denied.

“The Quota Denial nowhere explains the basis for DEA’s alleged confidence gap. If that detail resides in the administrative complaint served alongside the Quota Denial, DEA should be embarrassed: the errors in it reveal a fundamental inaptitude with DEA’s own recordkeeping requirements,” the lawsuit alleges.

“This case highlights the perils of a hapless administrative agency, which (ironically) acknowledged the scarcity of ADHD medications on the very day it effectively sought to shutter Ascent, a company with a time-proven capability of quickly getting medicine to children in need. Ascent and patients have been victimized by DEA’s incompetence, having rendered an arbitrary, capricious, and unsubstantiated quota denial based on erroneous conclusions.”

Before going into private practice, Walden spent 10 years as a federal prosecutor, often handling DEA cases. He’s asking the federal appeals court to issue an emergency injunction that forces DEA to approve Ascent’s quota application.

“We're in the middle of a national scarcity crisis that is really putting children at risk. So it's very, very hard to understand what could possibly be motivating DEA, because they're obviously not alleging that there are quality control problems with the drugs or that there's a threat of diversion,” Walden told PNN. “So, by definition, their decision is arbitrary and it should be reversed.”

The DEA’s actions do seem puzzling. Shortages of ADHD drugs began in the early stages of the pandemic and have steadily worsened, as more children and adults sought mental health treatment. Yet in December of last year, when the DEA issued its quotas for 2023, the agency said there was no need to increase production because the supply of Adderall and other stimulants was sufficient to meet demand.

“The majority of the manufacturers contacted by DEA and/or FDA have responded that they currently have sufficient quota to meet their contracted production quantities for legitimate patient medical needs,” the DEA said in the Federal Register. “Based on this trend, DEA has not implemented an increase.”

A few months later, DEA and FDA officials changed their tune. In an unusual joint letter,  FDA commissioner Dr. Robert Califf and DEA Administrator Anne Milgram admitted there was an ADHD shortage, blamed drug makers for not making enough medication, and washed their hands of the problem.

“This is not a problem that the FDA and DEA can solve on our own,” Califf and Milgram wrote. “The FDA and DEA do not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug.” 

DEA production quotas may also be partially responsible for shortages of opioid pain medication. In recent years, the agency has aggressively cut the supply of many opioids, leading to current shortages of hydrocodone and oxycodone.     

Judge, Jury and Executioner

The second lawsuit against DEA involves Simfa Rose Pharmacy, a Pembroke Pines, Florida pharmacy that specializes in making drugs for seniors, palliative care, and cancer patients.

Simfa Rose came under scrutiny nearly three years ago when investigators saw it was filling an unusual number of high-dose, immediate release opioid prescriptions, often in combination with stimulants and muscle relaxants. Some of the prescriptions were paid for in cash.

As far the DEA is concerned, these were signs of “multiple red flags of abuse or diversion” that posed “an imminent danger” to public health. On May 2 of this year, DEA suspended the pharmacy’s license to dispense controlled substances, a move that severely impacts its ability to continue operating.

“It’s affected them greatly. It’s a miracle they are still open at this point,” says Vittorio Penza, a lawyer for Simfa Rose.

Under DEA rules, there is only one recourse for a pharmacy or doctor to challenge a license suspension – an appeal to a DEA Administrative Law Judge. Such appeals are not only time consuming; they are rarely granted. The few that are granted are referred back the DEA Administrator, who then has the final say on whether the license is restored or permanently revoked.

The Simfa Rose lawsuit alleges this is an “unconstitutional administrative process” that denies the pharmacy due process.

“It’s totally nuts what they are doing. You have a judge, jury and executioner system. It’s all in secret. They don’t publish anything until it’s a decision that’s favorable to them. You’re kept in the dark by it,” Penza told PNN. “All you have to do is take someone's license, whether they need it or not. You're still screwed and you're going to go down. Because once your reputation is tainted, you lose your customers and you lose the patients.”

Penza says the expert witness hired by DEA to review the pharmacy’s practices made outrageous claims.

“Their expert says you can't fill immediate release opioids more than two times. If you are a cancer patient or someone on their deathbed, it doesn't matter. It's an unresolvable red flag if you give someone an immediate release opioid,” he said. “And the kicker is he doesn't even look at what the patient's diagnosis is. One of the patients was shot was shot in the back, the bullet is still lodged in there. The other one was wounded overseas in the Gulf War.”

Perhaps the biggest challenge faced by someone seeking to reverse a DEA decision is that federal agencies have sovereign immunity – they can’t be sued for monetary damages. All they can do is challenge the DEA’s statutory authority under the Controlled Substances Act and its use of an in-house “kangaroo court” to keep pharmacies, doctors and drug makers in line.        

“I've come to realize that this is a nationwide issue. I've been getting calls ever since we filed from around the country. It pains me to hear some of these stories of doctors and nurses and pharmacists that have just been stripped of their livelihoods because of what the DEA is doing,” Penza said.  

HHS to DEA: Marijuana Is Not Heroin

By Pat Anson, PNN Editor

The top U.S. health agency is asking the Drug Enforcement Administration to reclassify marijuana as a Schedule III drug under the Controlled Substances Act, putting cannabis in the same risk category as codeine, ketamine and steroids. Marijuana is currently classified as a Schedule I substance, the same as heroin and LSD.  

Bloomberg News was first to report that a top administrator in the Department of Health and Human Services (HHS) wrote a letter to DEA Administrator Anne Milgram asking for the change. Although 38 states and the District of Columbia have legalized recreational or medical marijuana, it remains illegal under federal law.

President Biden asked HHS Secretary Xavier Becerra nearly a year ago to review marijuana’s legal status, saying the classification of marijuana on the same level as heroin “makes no sense” and that people shouldn’t go to jail for marijuana possession.

“I can now share that, following the data and science, @HHSGov has responded to @POTUS’ directive to me for the Department to provide a scheduling recommendation for marijuana to the DEA. We’ve worked to ensure that a scientific evaluation be completed and shared expeditiously,” Becerra posted on Twitter Wednesday.

Although the Biden administration favors the move, rescheduling will not be a slam dunk. Marijuana falls under the jurisdiction of the Department of Justice, not HHS, and Milgram reports to Attorney General Merrick Garland, not Becerra. Conservative states where marijuana remains illegal are also likely to oppose the move.

Rescheduling has long been the goal of marijuana advocates, but some are disappointed that HHS is recommending it be moved to Schedule III, where it will still be regulated as a controlled substance.

“The goal of any federal cannabis policy reform ought to be to address the existing, untenable chasm between federal marijuana policy and the cannabis laws of the majority of US states. Rescheduling the cannabis plant to Schedule III of the US Controlled Substances Act fails to adequately address this conflict,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

“Just as it is intellectually dishonest to categorize cannabis in the same placement as heroin, it is equally disingenuous to treat cannabis in the same manner as anabolic steroids. The majority of Americans believe that cannabis ought to be legal and that its hazards to health are less significant than those associated with federally descheduled substances like alcohol and tobacco. Like those latter substances, we have long argued the cannabis plant should be removed from the Controlled Substances Act altogether.”

The DEA will now conduct its own scientific review of marijuana. On at least four previous occasions, the DEA has refused to reschedule marijuana because there were inadequate safety studies and little scientific evidence supporting its use.

Another major hurdle under federal regulations is that before a substance can be used for a medical purpose, its “chemistry must be scientifically established to permit it to be reproduced in dosages which can be standardized.” That would imply that cannabis or pharmaceutical companies would need to produce marijuana medication in measured doses that are FDA approved and only available by prescription.

There is little consistency in labeling, regulating or testing of cannabis.products sold in states where it is legal. Many products are mislabeled, with concentrations of CBD (cannabinoids) and THC (tetrahydrocannabinol) that are well above or below their label claims.

“It will be very interesting to see how DEA responds to this (HHS) recommendation, given the agency’s historic opposition to any potential change in cannabis’ categorization under federal law,” said Armentano. “Since the agency has final say over any rescheduling decision, it is safe to say that this process still remains far from over.”

Although nearly a third of U.S. adults with chronic pain have used cannabis as a pain reliever, professional medical associations have been reluctant to endorse its use. In 2021, the International Association for the Study of Pain (IASP) released a position statement saying it could not endorse the use of cannabinoids to treat pain, citing too many “uncertainties” about the clinical evidence.