Patients Blame DEA for Drug Shortages, Not Monopolies or Middlemen

By Pat Anson, PNN Editor

Two federal agencies are getting more than they bargained for when they asked the public to comment on record shortages of prescription drugs.

In February, the Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) made a joint Request for Information in the Federal Register, asking how wholesalers and other “middlemen” in the drug supply chain were contributing to persistent shortages.

“When you’re prescribed an important medication by your doctor, and you learn the drug is out of stock, your heart sinks,” HHS Secretary Xavier Becerra said in a press release. “This devastating reality is the case for too many Americans who need generic drugs for ADHD, cancer, and other conditions. (This) announcement is part of the Biden-Harris Administration’s work to tackle healthcare monopolies and lessen the impact on vulnerable patients who bear the brunt of this lack of competition.”

Nearly 10,000 comments have been received so far, with many blaming the federal government for the drug shortages -- not monopolies, middlemen or lack of competition. Drawing the most criticism is the Drug Enforcement Administration (DEA), which sets annual production quotas for opioids, stimulants and other controlled substances. The CDC and FDA also came under fire from frustrated patients.

“The heavy-handed failure of the FDA/DEA to properly and ethically manage the uptick in ADHD prescriptions is creating a crisis on par with their equally underhanded failure in managing the opioid crisis,” wrote Matti Dupre. “Hardworking Americans are left looking at the individuals leading these organizations as a source of pain rather than as a means of support.”

“Millions of people are having a hard time getting their prescription opioid medications filled at pharmacies now. Why? Because the DEA have cut production down so low, pharmacies can't get what they need to fill our prescriptions,” said Candi P. “Wake up! Stop playing with our lives!”

“The government has gone way too far, with their guidelines and regulations regarding opioids,” wrote Julie Anuskewic, who has a painful immune system disorder. “My pain is not controlled because the CDC has scared all doctors into not prescribing. It’s bad enough that they have destroyed the doctor-patient relationship. Now they are destroying the patient-pharmacist relationship.” 

Notably lacking in the FTC and HHS statement about drug shortages is any mention of the National Opioid Settlement, which has forced major drug wholesalers and big chain pharmacies to ration opioids and other controlled substances or risk losing their DEA licenses. Some manufacturers are also cutting back on production of generic opioids because the profit margins are low and the risk of further litigation is high.

A recent PNN survey found that 90% of patients with opioid prescriptions had trouble getting them filled, with one in five unable to get their pain medication even after contacting multiple pharmacies.  

“The FTC is looking in the wrong places for reasons for drug shortages, at least as far as opioids and stimulants are concerned,” wrote Andrea MacNary. “In those cases, the shortages are a direct result of the DEA's policies – with input from the FDA – that have seen annual reductions in the amount of drugs that manufacturers are allowed to produce.

”This results in patients being unable to obtain their legally prescribed medications in a timely manner. Because pharmacies have shortages, patients are then forced to call around to different pharmacies looking for their meds. This is extremely difficult, because not only do pharmacies not want to disclose whether they have the drugs in stock, but if the patient does find them, they must obtain a new prescription from their doctor.”

‘Broken Quota System’

One critic sees the public outreach by the FTC and HHS as a ham-handed attempt to coverup the DEA’s “crude and inadequate system” for regulating controlled substances   

“I believe the FTC is only trying to find cover for the Drug Enforcement Administration.The DEA is the only governmental agency that sets production and distribution quotas for every drug company manufacturing controlled medication,” William Dodson, MD, wrote in a recent op/ed in ADDitude. “This problem traces its roots and long tendrils back to the DEA alone. No other agency has the authority to create and prolong it. 

“The time has long since passed for the DEA to admit its fault and fix its broken quota system. There has already been too much needless suffering by innocent people who did nothing to cause the DEA’s restrictions.”

That’s not how the DEA sees it. This month a top DEA official compared the growing demand for Adderall and other ADHD stimulants to the early stages of the opioid crisis. Matthew Strait claimed the problem isn’t tight supplies, but excessive prescribing of stimulants.

“I’m not trying to be a doomsday-er here,” said Strait, deputy assistant administrator in the DEA’s diversion control division. “It makes me feel like we’re at the precipice of our next drug crisis in the United States.”

If you’d like to make a comment in the Federal Register on the FTC and HHS Request for Information, click here. Comments will be accepted until May 30. 

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.

90% of Pain Patients Have Trouble Filling Opioid Prescriptions

By Pat Anson, PNN Editor

Nine out of ten pain patients with an opioid prescription in the United States experienced delays or problems in the past year getting their prescription filled at a pharmacy, according to a large new survey by Pain News Network.  Nearly 20% of patients were not able to get their opioid medication, even after contacting multiple pharmacies.

Over 2,800 pain patients participated in PNN’s online survey. Many were so frustrated with pharmacists being unable or unwilling to fill their opioid prescriptions that they turned to other substances for pain relief or contemplated suicide.

“My medication helps my pain be at a level I can tolerate. When I can't get it, I honestly feel like ending my life due to the pain. I wish they'd stop to realize there are those of us with a legitimate need,” one patient told us.

“The discrimination we receive, not to mention all the hurdles we are put through just being a chronic pain patient, is absolutely affecting my physical, mental, and emotional health. It’s only gotten worse, leaving myself and family to scramble looking for medication,” another patient said.

“The problem I've had this year is my pharmacy running out of my pain meds. Then it's a frantic and anxiety filled race to find one that will,” another patient wrote. “My regular medication has been Percocet for years and I haven't received that in almost a year. No pharmacies in this area have been able to get it.”

DID YOU EXPERIENCE DELAYS OR PROBLEMS GETTING YOUR OPIOID PRESCRIPTION FILLED AT A PHARMACY?

The U.S. is currently experiencing its worst drug shortages in a decade, with supplies running low for medications used to treat cancer, ADHD and diabetes. Less publicized are chronic shortages of oxycodone, hydrocodone and other opioids used to treat pain – shortages that that have gotten little, if any, attention from the White House, Congress, or federal health agencies like the CDC and FDA.  

While supply chain issues and low profit margins for generic medication are driving many of the drug shortages, the low supply of opioids is largely the result of policy and political decisions. Egged on by Congress, the DEA for eight straight years has cut opioid production quotas, reducing the supply of many opioids by over two-thirds in a failed attempt to bring the overdose crisis under control.

Opioid litigation has also played a major role in the shortages, with drug wholesalers and big pharmacy chains agreeing to limit the supply of opioids at each individual pharmacy as part of the $21 billion national opioid settlement.

Whatever the cause, American pain patients routinely run into problems when they try to get an opioid prescription filled. Nearly 85% said they were told by a pharmacist that their medication is temporarily out of stock, while 6% were told there is only enough to partially fill the prescription.

What was primary reason the pharmacist gave for not filling the prescription?

• 85% Opioid medication not in stock

• 6% Can only make partial fills

• 4% Insurance issue

• 3% Did not explain why

• 2% Might get in trouble or lose their job

• 1% Prescription too risky or inappropriate

Some pharmacists said they might get in trouble or lose their job if they filled the prescription, while others claimed the medication was inappropriate, too risky, or that there was an insurance issue. Many gave multiple excuses to patients.

“First it was that they didn’t have the full quantity in stock. They then tried to get me to take a partial fill, then they told me they needed a prescription for Narcan from the prescribing doctor, and then out of nowhere it’s not covered by my insurance,” one patient wrote.

“Pharmacy said that there were shortages everywhere and had no idea when they would have the oxycodone that I need daily for my lower back pain,” said another.

“Pharmacist stated that the medication was on back order. They also said that they don't know if they will ever get them back again,” a patient wrote.

“At first the pharmacist said both scripts were out of stock, then he said he could only do a partial fill. Then told me he couldn't fill my scripts anymore and to find a new pharmacy,” another frustrated patient explained.

Over 60% of patients did just that, by visiting or calling another pharmacy. That’s not as easy as it may sound. Over half said they contacted three or more pharmacies while trying to get their prescription filled.

Many were turned away, as pharmacies are often reluctant to take on new pain patients because that would make their rationed supply of opioids even tighter.  

“They had it in stock one month but the next month she told me she had to save them for her regular customers. Then she went on to say that Walgreens will no longer accept people with no insurance,” a patient wrote.

DID YOU HAVE TO FIND ANOTHER PHARMACY TO FILL THE PRESCRIPTION?

“Getting my monthly pain pills is a 3 ring circus joke. It takes 10 to 15 days of making calls covering 175 miles to make sure I can pick them up!” said another.

“CVS is only allowed so many hydrocodone a month and if my prescription doesn't get in ahead of somebody else's I'm screwed,” said a patient who lives with pain from fibromyalgia and osteoporosis. “Without it I am bed-bound and have to basically cry and crawl to the bathroom and back to bed.”

“The pharmacies try their best to fill your prescription, but if they don't have it in stock, they don't have it in stock,” another patient wrote. “It definitely affects the quality of life. You live in fear every month that this is going to be it.”

WERE YOU EVENTUALLY ABLE TO GET THE PRESCRIPTION FILLED?

PNN’s online survey was conducted from November 13 to December 31, 2023. A total of 2,826 U.S. pain patients or caregivers with an opioid prescription participated. We’ll be releasing more results in the coming days.  

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.”  

Drug Shortages Mostly Involve Low-Cost Generics

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

‘Prices May Be Too Low’

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

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

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

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

Other highlights of the IQVIA report:

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

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

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

• 67% of shortages involve injectable drugs

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

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

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

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

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

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

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

Rx Opioid Shortages Persist With No Federal Action

By Pat Anson, PNN Editor

There is no end in sight to shortages of opioid pain medication in the US, with the federal government taking no apparent action to increase opioid production and several drug makers unable to estimate when full supplies will be restored.

In a recent update, the American Society of Health-System Pharmacists (ASHP) said five generic drug makers were running low or have exhausted their supply of oxycodone/acetaminophen tablets, which are better known as the brand names Percocet and Endocet. The medication is usually prescribed for moderate to severe pain.   

ASHP asked drug makers about their current supplies and received these responses:

• Camber has no doses of oxycodone/acetaminophen available. The tablets are on back order and “the company cannot estimate a release date.” Camber said it was still awaiting DEA approval for additional supplies.

• Amneal and KVK-Tech said they had limited supplies of 5 and 7.5 mg oxycodone/acetaminophen tablets, and that 10 mg tablets were on back order with no estimated resupply date.

• Major anticipates getting 7.5 mg tablets in late September and 10 mg tablets in late October.

• Rhodes said it had 7.5 and 5 mg tablets on “intermittent back order” and would only be releasing supplies as they become available.

Percocet and Endocet tablets in various doses are still available from Endo and Par Pharmaceuticals, according to the ASHP.

Shortages of oxycodone/acetaminophen tablets, as well as immediate release oxycodone and hydrocodone/acetaminophen tablets, were first reported by ASHP several months ago. But they have yet to appear on the FDA’s drug shortage list or even be publicly acknowledged by the agency.

In a recent joint letter, FDA Commissioner Robert Califf, MD, and DEA administrator Anne Milgram said they were working “as quickly as possible” to resolve persistent drug shortages. But the letter only addressed shortages of prescription stimulants used to treat ADHD, and makes no mention of opioids.

When asked by PNN, one federal health official did acknowledge shortages of opioid medication, but was vague about possible solutions.

“This is an important issue that CDC and other federal partners are aware of and working to find solutions to,” said Stephanie Rubel, who heads the CDC’s Overdose Preparedness and Response Team (ORRP). Rubel’s office works with other federal and state agencies to reduce the serious risks posed to patients who suddenly lose access to prescription opioids. 

“As part of ORRP’s work, we strongly encourage state health officials to proactively partner with pharmacists and pharmacies to ensure that impacted patients are able to continue receiving appropriate pain management care after a disruption,” said Rubel in a statement to PNN. “Because ORRP cannot provide medical care or make referrals to healthcare providers, advanced preparation and partnerships with pharmacists is essential to ensure continuity of care.” 

But many pharmacists have their hands tied due to opioid litigation. Last year, three large drug wholesalers reached a $21 billion settlement with 46 states, requiring them to impose strict limits on the pharmacies they do business with. Most pharmacies are capped on the amount of opioids they can dispense in any given month, regardless of patient needs. An unusually large order for opioids could get a pharmacy red-flagged by its wholesale supplier and the order cancelled.  

Another reason for the shortages are persistent problems in the drug supply chain and the heavy US reliance on foreign suppliers for many drugs, especially low-cost generic ones.  A third factor is aggressive cuts in the opioid supply by the DEA, which sets annual production quotas for controlled substances that drug manufacturers must follow.

Whatever the cause, it’s leaving many patients with uncontrolled pain and little faith in their government.

“I've been on hydrocodone for 10 years. With the shortage that is going on in Las Vegas, I've been out for 4 weeks,” one patient told PNN. “Unfortunately, the pain has made it too difficult to take care of myself. I cannot clean, cook or sleep without my pain levels increasing. I've been living on frozen foods and Alka Seltzer.”

“I live with 200 other seniors in a low-income complex.  I’ve seen three older veteran residents commit suicide because they couldn’t get pain medication.  I know several other seniors who live with horrible pain and are not able to get medication,” another patient told us.

“The US Government is just screwing us over by limiting what the pharmacies can get and what their suppliers can make. This is driving people to buy pain meds off the street and that's like playing Russian roulette,” said another patient who has trouble getting Norco prescriptions filled by his pharmacy. “Our government is supposed to help us, not hurt us.”

Drug makers are required to report shortages and supply interruptions to the FDA, but prescribers, pharmacies and consumers can also report them by email to drugshortages@fda.hhs.gov.  

To report a drug shortage to the ASHP, click here.

My Story: A Bone Cancer Survivor’s Search for Pain Relief

By Kristen Hernandez

The past three weeks have been the most challenging since my cancer diagnosis 20 years ago. Shortages of opioid pain medication have taken their toll, costing me weeks of productivity, mental and physical anguish, and a negative bank account.

When I was 25, I had a different life -- a career as a corporate travel consultant for RCA Records in New York City. I clawed my way out the ghettos of the Bronx and into corporate America, and purchased my first home in the suburbs of Long Island.

But everything changed when I was diagnosed with an insidious and rare form of bone cancer called Chordoma. It’s a literal one-in-a-million disease, with just one in every million individuals diagnosed with it each year.

The type of Chordoma that chose me is extremely rare, due to the tumor’s location: it was housed inside the L3 vertebra of my lumbar spine. And it was extraordinarily painful.

KRISTEN HERNANDEZ

Because Chordoma doesn't respond to chemotherapy or radiation, surgery is the only treatment. To save my life, surgeons reconstructed my spine, replacing a vertebra with a titanium cage and filling it with bone graft from my hip.

They also replaced a spinal disc with two more titanium cages, adding 16 rods and 20 screws for reinforcement.

My spine today resembles a nightmarish ladder that Tim Burton might have created.

After eight reconstructive spinal surgeries, I was given a miraculous drug called OxyContin. Doctors did not think I’d ever walk again because they needed to sever the nerves to my legs so that they could remove the cancer-infected bone.

Because of OxyContin, I was able to take my first step and eventually walk. This was in 2005, at the beginning of the so-called opioid crisis.

Once I relocated to Florida, pain management doctors refused to prescribe OxyContin to me, fearing lawsuits and scrutiny from law enforcement. Regardless of how much I protested, I was dismissed as if I was the problem, instead of having a problem.

At the time, pill mills were everywhere in Florida. They were places where if you had cash, you could get any medication. It’s also why there’s a such stigma today against chronic pain sufferers.

Eventually, I found a legitimate pain management doctor in Fort Lauderdale. Instead of OxyContin, he changed my regimen to a fentanyl patch, along with oxycodone/acetaminophen tablets (Percocet) for breakthrough pain, essentially replacing one opioid with two. That was my pain management routine for the past twelve years, until recently.

When I went to a Walgreens pharmacy this past June, I was shocked to hear, “Sorry, oxycodone is on back order, and we have no idea if or when it’s coming back.”

Opioid Shortages

Shortages of oxcodone, hydrocodone and other opioids are increasing around the country. And there is zero advance notice from pharmacies about when a prescribed medication will be available. Patients like me who suffer from severe pain are forced to go through withdrawal until the pharmacy restocks.

It’s a nightmare to deal with. Pain patients are usually not prepared for the sudden halt in medical care. Even the smallest disruption can have devastating effects, such as loss of productivity, reduced quality of life, and a diminished social life. Even smiling takes an effort.

Patients are always the last to know when there’s a problem with a prescription. Like thousands of others, I made frantic phone calls to my doctor, who scrambled to find an alternative medication. Without consulting me, he wrote a script for hydrocodone/acetaminophen (Vicodin), a medication I had never taken before. That’s when my three-week nightmare began. Because I wasn’t prepared to handle the ineffectiveness of hydrocodone for bone pain, my condition quickly began to decline.

Each morning, the first sensation I get feels like someone dug their elbow into my lower back all night long. It’s so fierce, it takes my breath away. Then, when I stand and all the titanium in my spine settles, the nerves hum in my legs and a crawling sensation shoots up and down, vibrating constantly.

As the morning coffee brews, I get the “poke” sensation. Due to a 200-pound weight loss, there’s a rod that sticks out of my thoracic spine area that rubs up against everything -- the bed, couch, office chair, car seat, everything. It’s miserable because it’s there forever.

Hydrocodone/acetaminophen tablets seem to exacerbate those symptoms, causing my body to swell and tighten into a ball of pressure, while the pain intensified. My productivity stopped and the bills began to pile up. Working while experiencing severe spinal and bone pain is nearly impossible.

After a recent candid discussion with my pain management doctor, we formed a “Plan B.” We’re trying oxycodone without acetaminophen to see if that works better. Having a backup plan with an alternate list of medications is essential with the shortages and fear-based drug culture we’ve found ourselves dumped into.

Government regulators and health policies have failed the people who suffer the most in this country, who often live with medical conditions they cannot control, like cancer. They’ve failed us time after time, filing lawsuits and adopting guidelines that make it harder for us to get prescription opioids – even though over 82% of opioid overdoses are caused by illicit fentanyl and other street drugs.

Patients who suffer from chronic pain all have one common goal: relief. When that relief is interrupted, and access to crucial therapies and drugs is denied, you leave us with few choices. We can either live our lives without pain relief or seek out riskier alternatives. Those are not good choices.

Kristen Hernandez is a freelance journalist and creative nonfiction writer living in South Florida. 

Do you have a “My Story” to share? Pain News Network invites other readers to share their experiences about living with pain and treating it.

Send your stories to editor@painnewsnetwork.org.

FDA and DEA Leaders Call for More ADHD Meds, But Ignore Rx Opioid Shortages

By Pat Anson, PNN Editor

Leaders of the Food and Drug Administration and the Drug Enforcement Administration say they’re working to end one of the worst drug shortages in decades.

“The lack of availability of certain medications in recent months has been understandably frustrating for patients and their families,” FDA commissioner Robert Califf, MD, and DEA Administrator Anne Milgram said in an unusual joint letter. “We are calling on key stakeholders, including manufacturers, distributors, pharmacies, and payors, to do all they can to ensure access for patients when a medication is appropriately prescribed.”

Those should be welcome words for pain patients across the U.S. who have trouble getting their prescriptions filled for opioid medication. Unfortunately, the letter has nothing to do with opioids. It’s only about shortages of Adderall and other prescription stimulants, which are used primarily to treat attention-deficit/hyperactivity disorder (ADHD).

The letter is the latest example of how the FDA and DEA have turned a blind eye to opioid shortages, which both agencies have played prominent roles in creating. Two widely used painkillers, oxycodone and hydrocodone, have been difficult to get for months, leaving thousands of patients in uncontrolled pain or going into withdrawal. Even big chain pharmacies like CVS are out of opioids or have a limited supply.   

“I had to once again follow up with CVS, just to be told they received absolutely nothing! Pain management provider in response sent another prescription to the outpatient pharmacy,” says Christine Kucera, a pain patient who recently wrote a column for PNN about her problems getting prescriptions filled for oxycodone.

“I'm currently sitting in the waiting area at the outpatient pharmacy, stressing, waiting for another bomb to drop.”

The American Society of Health-System Pharmacists (ASHP) first warned about a shortage of immediate release oxycodone in March. Over the next few months, hydrocodone/acetaminophen tablets (Vicodin) and oxycodone/acetaminophen tablets (Percocet) were added to the ASHP’s shortage list. Those shortages could soon grow even worse, because one of the largest generic drug makers in the world, Teva Pharmaceutical, is discontinuing production of immediate release oxycodone. 

Despite these warning signs, the FDA and DEA have yet to acknowledge shortages of either oxycodone or hydrocodone, and appear to be doing nothing about them. But they are moving to boost production of stimulants used to treat ADHD. The agencies say drug makers have sold only 70% of the stimulants they were authorized to produce.   

“We want to make sure those who need stimulant medications have access,” Califf and Milgram said in their letter. “We have called on manufacturers to confirm they are working to increase production to meet their allotted quota amount.” 

“What this latest notice shows is that the FDA and DEA could get involved with the opioid shortage if they wanted to,” says Rick Martin, a retired pharmacist disabled by back pain. Martin recently had to switch to a weaker opioid for pain relief because he can’t find a pharmacy with hydrocodone in stock.

“Teva said they were going to stop making oxycodone. The DEA/FDA could be proactive and ask Teva to relinquish their remaining 2023 quota allotment, then redistribute to other manufacturers,” Martin told PNN. 

Lower Production Quotas

The DEA sets annual production quotas for opioids, stimulants and other controlled substances, working closely with the FDA in assessing demand. Last year, the FDA advised the DEA that demand for hydrocodone, oxycodone and other Schedule II opioids would fall by 5.3% in 2023, which resulted in another year of cuts by the DEA in opioid production. Since 2013, the supply of oxycodone has fallen by 65 percent and hydrocodone by 73 percent. 

The FDA also advised the DEA that domestic medical use of stimulants would fall by 0.1% in 2023, even while warning that shortages were developing. The DEA’s response last December was that amphetamine and other stimulants were overprescribed to patients who didn’t really need them, and that its proposed production quotas (APQ) for the drugs in 2023 would be adequate.

“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 to the APQ for amphetamine at this time.”

That kind of background detail is missing from Califf’s and Milgram’s letter, which disingenuously claims that there is little that the DEA and FDA can do to ensure that there are adequate supplies of medication. 

“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.” 

Only briefly do Califf and Milgram acknowledge that their own production quotas are part of the problem, saying they were “committed to reviewing and improving our quota process.” 

“These (stimulant) shortages were caused by the DEA, which limited the manufacture of these medications,” says Andrea Anderson, a pain sufferer and patient advocate. “This exact problem has affected patients who require opioid analgesics to manage their severe pain. It has been affecting them for over six years, yet we see no mention of the extraordinary difficulties these patients are experiencing trying to find pain medication.  

“The DEA has no reason to be involved in deciding how many prescriptions should be written for any medical condition. This is the purview of trained medical clinicians and quantities should not be dictated by law enforcement agencies.” 

Drug manufacturers are required to report shortages and supply interruptions to the FDA. Doctors, hospitals, pharmacies and consumers can also report supply problems by sending an email to drugshortages@fda.hhs.gov.

That’s where Christine Kucera recently sent an email addressed to the FDA commissioner.

“Three different medications used in my treatment are continuously unavailable, sometimes for weeks and months. CVS IS OUT, the system is not working, and all you do is NOTHING!” Kucera wrote to Califf. 

“When will you address the unethical treatment and harms being inflicted upon millions of US citizens directly caused by government practicing medicine, limiting and denying access to essential medicines based on biased and manipulated facts, reduced quotas, faulty CDC prescription guidelines that should never have been created; and the DEA who are making up their own rules, practicing medicine, and deciding what they think appropriate medical care is?”  

FDA and DEA Silent as Rx Opioid Shortages Worsen

By Pat Anson, PNN Editor

Shortages of opioid pain medication in the U.S. appear to be worsening, with no apparent action from the FDA or DEA to ease the suffering of patients left in uncontrolled pain or going into withdrawal.

Last week the American Society of Health-System Pharmacists (ASHP) added another widely used painkiller to its drug shortage list: oxycodone/acetaminophen tablets, which are more widely known under the brand names Percocet and Endocet. The medication is typically prescribed for moderate to severe pain.   

The ASHP reports that five drug makers are either running low or have exhausted their supply of oxycodone/acetaminophen in 2.5, 5, 7.5 and 10mg tablets.  Amneal, Major and Rhodes did not provide ASHP with a reason for the shortage, while Camber and KVK-Tech said they were “awaiting DEA quota approval for active ingredient.”

Amneal, Camber and KVK-Tech said the tablets were on back order with no estimated resupply date. Major and Rhodes said additional supplies were expected in mid-September or early August, respectively. Limited supplies and doses of oxycodone/acetaminophen tablets are still available from other drug manufacturers.

There are already shortages of two other widely used painkillers. The AHSP put immediate release oxycodone on its list of drug shortages in March and added hydrocodone/acetaminophen tablets to the list in May.  

But those shortages have yet to be acknowledged by the FDA. Asked why oxycodone and hydrocodone were missing from the FDA’s drug shortage list, a spokesperson referred PNN to an FDA website for “Frequently Asked Questions about Drug Shortages.”

One possible explanation, according to the website, is that the FDA “focuses on shortages that have the greatest impact on public health.” Shortages are also not reported if they are expected to be resolved quickly, if other substitutes are available, or if there are only local supply issues.

Manufacturers are required to report shortages and supply interruptions to the FDA, while providers, hospitals, pharmacies and consumers can report them by email to drugshortages@fda.hhs.gov.  

‘No One Seemed to Care’

At PNN, we hear from readers almost daily about opioid shortages.

“I am now past my usual fill date,” said Rick Martin, a retired pharmacist in Las Vegas who lives with chronic back pain. “My CVS pharmacist manager told me that she was told by their wholesaler that hydrocodone won't be available until the middle of August.” 

Martin said pharmacists at Walgreens, Smith’s and Sav-on have also told him they were out of oxycodone and hydrocodone tablets.  

“It's been spotty for 6 months but now seems entrenched. I got switched to tramadol. Not as effective, but I can just barely get by. I've heard that's what doctors are doing. Tramadol or Tylenol with codeine,” he told PNN.

Steve Keating, another Las Vegas resident, has been taking oxycodone for chronic neck pain after his vehicle was rear-ended by another driver. He had no problems getting his prescription refilled at either Walgreens or CVS, until last month. Now he is out of pain medication. 

“I began having withdrawal symptoms. No one seemed to care,” said Keating, who turns 73 this month. “The pharmacy recommendations were to obtain tramadol, which I've tried in the past and found ineffective.  I cannot take opiates with acetaminophen as it upsets my stomach.   

“It seems that there is a huge gap between prescribers, pharmacies and whatever governmental agencies are involved.  Do these governmental idiots not realize how important the medication we've been prescribed for months or years is to give us some degree of a better quality of life?” 

There are several reasons behind the opioid shortages. It started with misleading information that demonized prescription opioids and the false portrayal of patients and doctors as the primary cause of the “opioid epidemic.” That was followed by medical guidelines that discourage opioid prescribing and a tsunami of opioid litigation that cost drug makers, wholesalers and pharmacies tens of billions of dollars. 

Egged on by politicians, the Drug Enforcement Administration also aggressively cut production quotas for opioids and other controlled substances, reducing the supply of oxycodone by 65% and hydrocodone by 73% since 2013.  

DEA PRODUCTION QUOTAS FOR OXYCODONE (KILOGRAMS)

SOURCE: DEA

The DEA quotas are rigidly enforced, making it difficult for a drug maker to boost production of opioids when another manufacturer has shortages or discontinues production, like Teva Pharmaceutical recently announced.

It’s not just opioids in short supply. Drugs used to treat cancer and attention deficit disorder (ADHD) are also hard to get. These problems have been building in plain sight for years, yet the FDA’s commissioner says there is little his agency can do to correct them.

“We wish that we could fix all these things, but we don't make the medicines and we can't tell someone that they must make medicines. There are some things that are out of our control,” FDA Commissioner Robert Califf, MD, said in a May interview. 

That’s not exactly true. The DEA sets annual production quotas for drug makers only after consulting with the FDA. The 2023 DEA quotas for hydrocodone, oxycodone and several other opioids were cut — for the 7th year in a row — based on the advice of the FDA.

“FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2023 will decline on average 5.3 percent from calendar year 2022 levels,” the DEA said in a notice published last year in the Federal Register.   

DEA administrator Anne Milgram, meanwhile, has not made any public comments about shortages of opioid medication. In a recent appearance on Meet the Press, she said illicit fentanyl was being used to make counterfeit versions of prescription opioids — the same legal drugs that are now in short supply due to DEA actions.

“They're pressing it into these fake pills made to look exactly like oxycodone or Percocet or or Adderall, when it's just fentanyl and filler. So tens of thousands of Americans are dying without having any idea that they're taking fentanyl,” Milgram said.

(Update: On August 1, Milgram and Califf released a joint letter saying the FDA and DEA were working “as quickly as possible” to resolve the drug shortages, but took no responsibility for causing them. The letter only addressed shortages of prescription stimulants used to treat ADHD, binge eating and narcolepsy. It makes no mention of opioid shortages.)

Home Delivery of Rx Opioids Would Help Chronic Pain Patients

By Pat Anson, PNN Editor

We hear almost every day from people in pain who say they can’t get an opioid prescription filled because their pharmacy is out of stock. Often, the pharmacist has no idea when the next shipment of pain medication is coming.

“Walgreens cannot fill my prescription. They say the drug is on back order with no ship date available,” a patient recently told us.

“20 years on the same Rx for Vicodin and now CVS says they are out of stock and no idea when it will be available,” another patient wrote.

“Just talked to a pharmacist today that said they are out of Percocet, Vicodin and morphine. They said that their supplier, Cardinal Health, wasn't sure when they would get more,” said another patient.

Now imagine, if you will, what it would be like to have a pharmacy that delivers opioid medication directly to your home. No more standing in line at the pharmacy. No more dirty looks from the pharmacist. No more excuses about being out of stock.

For about 1,000 patients in the Philadelphia area, most of them chronic pain sufferers, that fantasy is a reality. They are customers of a boutique pharmacy in the Delaware Valley that specializes in home deliveries of controlled substances – including high dose opioids.  Prescriptions and refills are delivered on a carefully managed schedule before a patient runs out, becomes disabled by uncontrolled pain, and goes into withdrawal.

“We hand deliver directly to the patient. I have a whole delivery team. They're our own drivers, our own vehicles,” says Brian Dunleavy, CEO of PMC Pharmacy. “Our customers get notified when their delivery is anticipated to arrive at their home. And then every patient has to sign for it. They have to be present or we can't leave it there. Or it has to be an adult that's been authorized to receive the medication.”

I first heard of PMC Pharmacy when it sent out a news release last month to address difficulties that some patients have getting opioids and other controlled medications from other pharmacies in the Delaware Valley. PMC said it could help those patients avoid gaps in drug therapy and was committed to keeping them “on schedule, at home, and independent.”

“We should really have every chronic pain management patient in the Delaware Valley under our care because of the way our program works,” Dunleavy told PNN.

While big chain pharmacies and their wholesale drug suppliers are under increased scrutiny from law enforcement and regulators, PMC flies under the radar because its customers’ medical conditions, prescriptions and insurance claims are carefully documented – reducing the risk of diversion or misuse.     

“We won't take patients from a typical primary care practice, we're only working with chronic pain specialists who give us (patient) chart notes and supporting documentation to satisfy our wholesalers’ desires that we're doing due diligence on all these doctors and all these patients, and making sure that there's a legitimate need for the medication,” Dunleavy explained. “The diversion isn't coming from the people that are legitimate chronic pain patients. Those people hold onto that medication as if it's their lifeline.”

Trifecta of Problems

The supply of opioids and other controlled substances is tight because of a trifecta of problems that have hamstrung the pharmaceutical industry.

First, the Drug Enforcement Administration has been aggressively cutting opioid production quotas for nearly a decade, reducing the supply of oxycodone by 65% and hydrocodone by 73% since 2013.

Second is the fallout from opioid litigation. The nation’s three largest drug wholesalers reached a $21 billion settlement with 46 states, requiring them to impose strict limits on opioid shipments to pharmacies. CVS, Walgreens and other pharmacy chains have also paid tens of billions of dollars to settle lawsuits that alleged they helped fuel the overdose crisis by dispensing too many opioids.  

The third reason for tight supplies is a retooling of the generic drug industry. There’s little money to be made in selling most opioids and there’s a risk of further liability, so drug makers are cutting back production of many generic opioids.  One of the world’s largest manufacturers of generics, Teva Pharmaceutical, recently notified the FDA that it was discontinuing production of oxycodone.

It all adds up to an increasing number of drug shortages, involving not just opioids, but medications used to treat cancer, anxiety and attention deficit disorder. Dunleavy thinks the shortages are a direct result of regulatory overreach.

“You have all these things going on and everybody's like, ‘Oh well, there's a shortage of oxycodone out there.’ And in actuality, there isn't. It's a regulatory created shortage, which is why there's a discrepancy between what we're hearing from patients versus what we see at the on the wholesalers’ shelves,” he explained. “The pharmacies can't get those drugs because they're quantity restricted by the wholesalers, based on the programs that the wholesalers have implemented to police the pharmacies.”

Dunleavy says PMC would like to add more patients to its customer base, provided they live in its delivery area in southeastern Pennsylvania and parts of New Jersey and Delaware that border Philadelphia. He’s confident he’ll be able to get the additional medication from suppliers.

“You're not going to have a better adherence and compliance program from a pharmacy than ours,” he said. “Because our program is pain management specific, once we start working with a practice, we start getting quite a few referrals. So it's very easy for us to start growing.”

Could PMC’s business model be adopted by other pharmacies? With pain management under so much scrutiny, Dunleavy says home deliveries to selected patients make sense.

“There's a legitimate need for a pharmacy that puts in a little bit more effort, that's a little bit more specialized. Because the regulatory environment requires it, the patients require it, and the physicians require it,” he said.

“This is a very interesting concept. It almost sounds too good to be true, but if it really works it would be tremendously helpful to many chronically ill people,” says Kristen Ogden, a patient advocate in Virginia. “I think this concept may be really helpful to house-bound patients and persons with limited access to transportation, especially those who don't have an engaged family member helping them.”  

For many years, Kristen and her husband Louis have traveled to California to get the high dose opioids he needs to treat severe pain from arachnoiditis and Ehlers-Danlos Syndrome. Not having to make that monthly cross-country trip for refills would be a welcome relief to the Ogdens.  

“It would be great to think this sort of service would be available to us as we get older, especially since we have no children and no other family members who live in our area to assist us. This could certainly be a big factor in enabling older adults to continue living in their own homes if that's what they prefer to do,” Kristen said. 

The American Society of Health-System Pharmacists put immediate release oxycodone on its list of drug shortages in March and added hydrocodone/acetaminophen tablets to the list in May.  Neither shortage has yet to be recognized by the FDA, although many patients are already well aware that both medications are in short supply. 

“I've been waiting for over a week for oxycodone to come in. Over the last weekend, I went to over 25 different pharmacies searching, until I couldn't drive anymore. It's not fair to any of us!” a pain patient recently told PNN

Chemotherapy and Opioid Shortages Impacting Cancer Care

By Pat Anson, PNN Editor

Over two-thirds of cancer centers in the U.S. are reporting shortages of methotrexate and other drugs used in chemotherapy, according to a survey by the National Comprehensive Cancer Network (NCNN).

Methotrexate is a versatile drug that prevents cells from dividing. It was originally developed to treat cancer, but is also widely used to treat autoimmune and neurological conditions such as lupus, rheumatoid arthritis, migraine and multiple sclerosis.

The NCNN surveyed 27 cancer centers across the U.S. in late May, and found that 67% of them were reporting shortages of methotrexate. Most centers are also reporting chronic shortages of carboplatin and cisplatin, chemotherapy agents that are widely used in cancer treatment. The shortages have resulted in treatment delays or forced doctors to modify their treatment plans using other drugs.

"This is an unacceptable situation. We are hearing from oncologists and pharmacists across the country who have to scramble to find appropriate alternatives for treating their patients with cancer right now," Robert Carlson, MD, CEO of NCCN, said in a statement. "We were relieved by survey results that show patients are still able to get life-saving care, but it comes at a burden to our overtaxed medical facilities." 

Drugs shortages in the U.S. are currently near record levels, primarily due to shipping delays and other disruptions caused by the pandemic. But the shortage in chemotherapy agents largely stems from a halt in production at a plant in India operated by Intas Pharmaceuticals. FDA inspectors found quality-control violations at the plant late last year and the agency recently slapped an import alert on the company. The agency is working with drug makers in China to make up the difference.

The FDA added methotrexate injectable solution to its drug shortage list in March. Supplies are currently limited and the shortage is not expected to end until December 2023. No shortages are currently reported for methotrexate tablets.

Hydrocodone Shortage

In addition to chemotherapy drugs, some drug makers are also reporting shortages of opioid pain medication. The American Society of Health-System Pharmacists (ASHP) recently added hydrocodone-acetaminophen combinations – commonly known under the brand names Vicodin and Norco-- to its own drug shortage database.

Generic drug makers Amneal, Camber, KVK-Tech, Major and Rhodes currently report shortages of 5 mg, 7.5 mg, and 10 mg hydrocodone tablets. None of the companies provided a reason for the shortage or an estimate for when it might end. Many of the same drug makers reported shortages of oxycodone in March.

The limited supply of opioids is also affecting cancer patients. The University of Utah Health system recently informed its drug wholesaler that it was adding 50 new beds to its cancer clinic and would be needing more pain medication to treat the extra patients.

“And the wholesaler said, ‘Well, let's just wait until we start receiving your orders to increase the amounts that you're going to buy,’” said Erin Fox, PharmD, Senior Pharmacy Director at University of Utah Health, which tracks drug shortages for the ASHP. “We're unable to be proactive. We're trying to think ahead. And we don't want to have that situation where we we're getting very close to running out or not having enough. That's basically what our wholesaler says has to happen.”

“We wish that we could fix all these things, but we don't make the medicines and we can't tell someone that they must make medicines. There are some things that are out of our control,” FDA Commissioner Robert Califf, MD, said in a recent interview with Medscape.

The Drug Enforcement Administration, in consultation with the FDA, sets the annual production quotas for opioids and other controlled substances. The DEA reduced this year’s supply of oxycodone and hydrocodone by about 5 percent, after being advised by FDA that demand for Schedule II opioids would decline. Since peaking a decade ago, DEA production quotas have fallen by 65% for oxycodone and 73% for hydrocodone.

Why Changes at Teva Could Worsen Rx Opioid Shortages

By Pat Anson, PNN Editor

A change in the business model of one of the world’s largest manufacturers of generic drugs could lead to further shortages of opioids and other medications in the United States, according to an industry expert.

Last week Israel-based Teva Pharmaceutical Industries said it would reduce its production of generics from 80% of its drug portfolio to 60% over the next few years. Teva’s CEO says the company plans to focus on more profitable branded drugs as part of its “pivot to growth.”

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

Teva has not publicly identified which generic drugs it will stop producing, but said it would “very carefully” avoid dropping any medications that are already in short supply.

“We don’t want to let the pharmacists, the wholesalers and the patients down. We want to make sure they always have their drug when they’re looking for it,” Francis said in an interview with Endpoints News.

But Teva has already moved to reduce its production of generic oxycodone, informing the Food and Drug Administration earlier this month that it would discontinue producing 30, 15, and 5 mg tablets of immediate release oxycodone. Teva did not respond to multiple requests from PNN to explain the reasons for the discontinuation.

The FDA does not currently list oxycodone on its drug shortage database, but the American Society of Health-System Pharmacists (ASHP) does.

As PNN reported, ASHP added oxycodone to its nationwide list of drug shortages in March, with generic drug makers Amneal, Camber and Rhodes Pharmaceuticals reporting shortages of 5, 15, 20 and 30 mg oxycodone tablets.

“They are a large producer and other companies may not be able to make up the difference. I think it really will result in shortages.”

— Dr. Erin Fox, University of Utah Health

“I know that (Teva’s) CEO came out with a statement saying that they wouldn't leave the market for products that are in short supply, but it hasn't exactly been a great market overall. The overall capacity of just the generic market is very difficult. When you look at controlled substances, that gets even more difficult,” says Erin Fox, PharmD, Senior Pharmacy Director at University of Utah Health, which tracks drug shortages for the ASHP.

“They (Teva) are a large producer and other companies may not be able to make up the difference. I think it really will result in shortages.”

As an example of how tight the supply of opioids and other controlled substances is, Fox says the University of Utah Health system reached out to its drug wholesaler to let them know that it was adding 50 new beds to its cancer clinic and would be needing more pain medication and other drugs to treat the extra patients. The answer it received was not reassuring.

“It's mostly opioids that we anticipate needing more of. And the wholesaler said, ‘Well, let's just wait until we start receiving your orders to increase the amounts that you're going to buy,’” Fox told PNN. “I think the wholesalers’ settlement that they've done has really limited the amount of products that pharmacies can access. Even if you have the patients, it can be very difficult to increase the amount that you're ordering.”

Fox is referring to a $21 billion opioid litigation settlement that three large drug distributors reached with 46 states last year, which requires them to impose strict limits on the amount of opioids and other controlled substances they can supply to pharmacies in any given month. An unusually large order for opioids could result in a pharmacy getting red-flagged by a distributor and the order cancelled, regardless of patient needs.

“We're unable to be proactive. We're trying to think ahead. And we don't want to have that situation where we we're getting very close to running out or not having enough. That's basically what our wholesaler says has to happen,” Fox explained.

DEA Production Cuts

Fox says years of cuts in production quotas by the Drug Enforcement Administration have also contributed to shortages. With opioids and some other controlled substances in tight supply, there is little margin for error or unexpected developments in the pharmaceutical industry – like Teva reducing its production of generics.

Keeping track of the drug supply is made more difficult because production quotas for each company are not disclosed by the DEA and there is little transparency in the business.

“What we don't have is the amount that the DEA is giving to each supplier. And then we also don't know the amount that each supplier is then manufacturing. Because we don't have that transparency, it's really hard to know,” Fox said. “Drug manufacturing is a business. And even though patients are at the end of it, these drug companies don't have to tell people why they're discontinuing something. They don't have to have to say what market share they had or if they think there might be a shortage. They can just stop at any time.”

Another issue is that DEA’s annual production quotas are not transferable from one company to another. That’s why Fox believes the changes at Teva are likely to worsen drug shortages.

“DEA assumes that everything is going perfectly with manufacturing, that no companies are having a glitch, and no companies are having a problem. And so one company might be having manufacturing problems, but still holding onto their quota. They can't necessarily give it to another company who's able to ramp up production,” she said.

“There’s just a lack of transparency. It's very hard. I've been monitoring drug shortages for over 20 years. Almost always, when a company quits, we end up with some kind of a shortage. Hopefully it won't be long term.”

Another factor that could be influencing Teva’s decision is the $4.25 billion nationwide settlement the company agreed to pay in opioid litigation last year. Teva’s production of generic and branded opioids dwarfed that of Purdue Pharma and other better known drug companies. Now heavily in debt, Teva may have decided that profits in a low-margin product like opioids are simply not worth the risk.      

DEA Seeks to Cut Inventories of Opioid Medication

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration has announced plans to significantly reduce inventories of opioid pain medication and other controlled substances that drug manufacturers are allowed to maintain. The inventory reductions are in addition to cuts in the production of opioids that the DEA is seeking in 2020.

The proposed regulations, published this week in the Federal Register, would limit “excess quantities of medications” being stored in inventory that might be vulnerable to diversion. Other rule changes would tighten DEA oversight of the manufacturing and distribution of controlled substances.

Under current regulations, drug companies are allowed to keep inventories on up to 50% of their annual sales quota for Schedule I and II controlled substances. That would be reduced to 30% under the proposed rules.

“Practically speaking, this equates to a reduction from half of a year's sales supply allowed to be held as inventory to nearly four months,” the DEA said.

The agency said the smaller drug inventory “is not expected to increase the likelihood of drug shortages,” because more manufacturers are available to increase production if shortages develop.

“The DEA believes a reduction of inventory allowance to 30%, with flexibility to produce up to 45% at any given point in a year, would have minimal impact on registrants while continuing to provide adequate inventory for registrants to respond to fluctuations in demand in pharmaceutical markets,” the agency said.

Last year the DEA allowed drug manufacturers to increase the production of injectable opioids after shortages developed at U.S. hospitals. The shortages became so acute that some hospitals were forced to use acetaminophen and muscle relaxants to treat surgery and trauma pain.

The FDA still has morphine, hydromorphone and fentanyl solutions on its list of drug shortages and there are anecdotal reports of hospitals continuing to ration injectable opioids. 

‘You Are Hurting Pain Patients’

The public has 60 days to comment on the DEA’s inventory proposal. The comments posted so far are mostly from pain patients critical of previous actions by the DEA.

“Why, why, why do you all keep taking meds from people? You are hurting the pain patients who need this medication. Start taking the drugs off the streets not from our doctors,” wrote Christy Ashford.

“The DEA has waged a war against the sickest and weakest members of American society,” wrote Kirsten Klang. “They know that almost all of the fatalities have to do with the integration of counterfeit fentanyl than any other chemical. Yet, the DEA clamps down where it's easy to do so... even if it's wrong... just because it's easy!”

“I would like to know why the DEA thinks it needs more power over the United States citizens. I mean really, don’t they think that they have tormented enough doctors and their patients through this so-called opioid crisis?” wrote Sheryl Cox. “They say that they have no control over the prescriptions that our doctors give us, and that is an outright lie. They do control our doctors by arresting them and prosecuting them needlessly, sending them to prison, and most do not deserve this kind of treatment and abuse.”

The DEA began cutting the supply of opioid medication in 2016 during the Obama administration. The trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third.

Last month, the DEA proposed further cuts in the supply of hydrocodone, oxycodone and three other opioid painkillers classified as Schedule II controlled substances. If approved, the 2020 production quotas would amount to a 60% decrease in the supply of hydrocodone and a 48% percent cut in the supply of oxycodone since 2016.

Cuts in the supply of prescription opioids have coincided with a sharp increase in overdoses from counterfeit medication. In recent months, hundreds of people have died after taking “Mexican Oxy” – counterfeit oxycodone pills made with illicit fentanyl – which are being trafficked in the U.S. from coast to coast.

Fear of DEA Causing Drug Shortages

By Pat Anson, Editor

Millions of dollars in fines and thousands of investigations by the U.S. Drug Enforcement Agency have had a chilling effect on the nation’s drug supply chain, leading to quotas, shortages and legitimate prescriptions going unfilled, according to a new government report.

Pain patients have complained for years that it was becoming difficult to get opioid prescriptions filled, but the DEA called the evidence of that “anecdotal” and said it was not responsibility for any shortages.

In a survey of hundreds of pharmacies, drug wholesalers and physicians by the General Accounting Office (GAO), over half said DEA enforcement actions had limited their ability to supply drugs to patients. Many said they were fearful of being fined or having their licenses revoked by the DEA. Others blamed the agency for poor communication and unclear rules.

“In the absence of clear guidance from DEA some pharmacies may be inappropriately delaying or denying filling prescriptions for patients with legitimate medical needs,” the GAO report states.  

In recent years the DEA has fined distributors, pharmacies and practitioners over $94 million for violations of the Controlled Substances Act. Over 4,500 criminal investigations were also launched.

The crackdown helped lead to a reduction in prescription drug abuse and diversion, but it has also disrupted the drug supply chain. The GOA estimates that over half the distributors have placed a strict quota system on the amount of controlled substances that pharmacists and physicians can order.

“A distributor reported it refuses to distribute large volumes of controlled substances to prescribers or pharmacies that specialize in pain management, even if it has no evidence that the prescribers or pharmacies are engaged in diversion,” the GAO said.

One pharmacy chain told the GAO they were “afraid of being the target of DEA enforcement action even if they fill a prescription in good faith.”

Another small pharmacy chain said “we take things to the extreme to the point where we have received complaints from providers for turning away legitimate patients.”

“The DEA has NO communication out to pharmacies at all. The DEA is not preventative, it is all reactive,” one pharmacist complained. “The only experience we get with the DEA is hearing when they investigate and levy fines against a pharmacy for common pharmacy practices.”

The GAO recommended that the DEA improve its communication with distributors, pharmacists and practitioners so they would have a better understanding of what’s expected of them.

In response to the GAO report, a top DEA administrator wrote a letter stating there was only “anecdotal data that patient care is being compromised.”  

“The DEA would like to emphasize that it has no authority to control otherwise legitimate business decisions of registrants,” wrote Joseph Rannazzisi, deputy assistant administrator of the DEA’s Office of Diversion Control. “DEA and state partners have repeatedly and emphatically informed distributors that arbitrary thresholds are inappropriate, negatively impact legitimate patients, and are an inadequate substitute for fulfilling their obligations under the CSA (Controlled Substances ACT).”

The GAO report is the second this year to criticize the DEA for its management and policies. In March, we reported the GAO had faulted the DEA for "weak internal controls" and poor management of the system under which controlled substances are produced and distributed. The GAO said there were 87 “critical” shortages of drugs containing controlled substances, over half of them pain relievers.

The shortages have grown worse in recent years, according to many pain patients, who say controlled substances such as hydrocodone are increasingly difficult to obtain in some parts of the country.

Under federal rules, the manufacture and distribution of controlled substances is regulated by the DEA, while the Food and Drug Administration regulates what conditions the medications can be taken for. The two agencies are supposed to work together when shortages develop, but according to the GAO they do not have a “sufficiently collaborative relationship” and even “disagree about what constitutes a shortage.”