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.

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.

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.)