The Pharmacy Shuffle: Navigating the Opioid Shortage Again

By Crystal Lindell

The pain medication I take daily was completely out of stock at my pharmacy, as well as every other pharmacy near us in northern Illinois this week. 

The first replacement my doctor prescribed would cost me $529 out-of-pocket – even with a GoodRx coupon. 

Let me take you through what it’s like to navigate the morphine extended-release (ER) shortage as a pain patient who depends on this medication to function. And yes, this is the second time I’ve had to deal with the shortage in the last few months.

But this time, it was much worse. 

The whole saga really started last week, when I sent a MyChart message to my doctor’s office letting them know that I was due for a refill on Monday, March 31. They sent the refill prescription to my pharmacy on Friday, with the fill date set for Monday. 

Despite the fact that my pharmacy had this prescription in their system all weekend, they waited until 11 Monday morning to tell me that morphine ER was out of stock at their store and every other pharmacy in the area – and that there was no way to order it. 

After the pharmacy tech explained that to me, she said, “Did you want me to transfer the prescription somewhere else?”

Um, you just said it was out of stock everywhere? Where the heck would you transfer it to?

I asked her what alternatives they did have in stock, so that I could let my doctor know the best options. Because morphine ER and all of the alternatives are controlled substances, she immediately started acting like I was an armed gunman asking for details so that I could rob their narcotics safe later. 

Finding an Alternative

At that point, I realized that this situation was going to take at least the rest of the day to navigate, so I was growing impatient. I told her, “Sorry, I’m just trying to avoid having to make 17 phone calls about this, playing phone tag with you and my doctor’s office.”

She relented, and finally told me that they did have morphine instant-release (IR) available. 

I then got to work calling other local pharmacies hoping for a miracle. Unfortunately, I got the same information from all of them: Morphine ER was out of stock, they had no way to order more, and they had no idea when they might be able to get it. 

So then I called my doctor and left a message explaining the situation and that morphine instant-release was probably the best alternative. I called him 2 more times because I didn’t hear back.

Finally, the nurse called me back at 5:13 pm – just 17 minutes before the doctor was slated to leave for the day. And it was not great news. She told me that my doctor did not want to prescribe the instant-release version because he was worried it would be too strong for me. 

I suggested that he prescribe oxycodone extended-release, but that I was worried about the cost. I don’t currently have health insurance. 

My doctor sent in the oxycodone replacement at 5:28 pm, just minutes before he left for the day. 

At this point, I naively assumed that the oxycodone ER would cost around $200, which is significantly more expensive than the $60 I usually pay for morphine ER. 

Sadly, my guess of $200 was pathetically low.

My pharmacy gave me two pieces of bad news: One, they didn’t have the oxycodone in stock, but they could get it tomorrow, and two, the cash price with GoodRx would be $529. 

For some reason, the pharmacist thought this was a good time to have a conversation with me about my patient profile. He said that I needed to have my doctor prescribe a non-controlled medication for me because I only get prescriptions for controlled substances from them. That’s a red flag for the DEA, which could impact him – as if patients get to decide for their doctor what they’re prescribed.

I don’t have insurance and was on the verge of going into withdrawal without pain medication, and the pharmacist thought that was the best time to tell me that I needed to get an unnecessary medication to protect him? 

At this point, I did what any sane person would do: I started crying. 

I couldn’t afford the $529 oxycodone and now I also had the added stress of knowing that my pharmacist thinks I’m a “red flag” patient. 

I immediately called my doctor again, knowing that I was making the phone call in vain, because he was gone for the day. I was routed to the on-call service. The on-call doctor didn’t feel “comfortable” prescribing a controlled substance after hours to a patient they had never met.

By now, any patience I had was as unavailable as the morphine ER tablets were – so I used it as an opportunity to tell him that perhaps their “policy” should consider how dangerous it is to send patients into morphine withdrawal. 

He said I could go to the emergency room if it gets really bad, and I reminded him that I don’t have insurance. At that point, I accepted the fact that I will have to wait until day 2, and just hope it’s resolved then.

That night was awful. It’s not a good idea to go from 3 morphine ER tablets down to zero in one day, and I spent all night in and out of a fitful sleep, before finally deciding to get up for the day at 3 am. 

I called my doctor’s office as soon as they opened and left a message with his receptionist explaining the $529 price tag. I also let them know that I had already called additional pharmacies that morning and I was still getting the same excuse about them being out of stock with no way to order more morphine ER.

I called my doctor back again in the afternoon, because I still hadn’t gotten a response. Finally, at 3:24 pm, my doctor’s nurse called back. I had to explain this entire situation again. She gasped when I told her about the $529 price tag, said she would talk to the doctor, and call me back. 

Less than an hour later, she calls to tell me that they are sending in the prescription for morphine instant-release – the same medication they could have sent in the day before, which would have saved me from a night of unnecessary suffering. 

By that point, I was thankful that I was finally closer to getting this resolved. I call the pharmacy, they tell me they got the new script, and that they’d start working on it. It’s ready when I get there, and the price is just $52.60 – far cheaper than the oxycodone replacement. 

I Got Lucky, Other Patients May Not

The whole situation was just an awful chain of events, where I felt like I was failed by every single person in the healthcare system. Why didn’t the pharmacy tell me on Friday that my medication was out of stock? Why did my doctor’s office wait until the end of the day Monday to call me back? Why did the on-call doctor shrug me off?

I say all of this knowing that I’m one of the “lucky” ones who was actually able to get this situation resolved. Thousands of other patients are also dealing with shortages of  morphine ER and other opioids. I suspect most of them won’t get an alternative medication at all. 

My last prescription for morphine ER was manufactured by Rhodes Pharmaceuticals, which did not provide a reason for the shortage to the American Society of Health-System Pharmacists (ASHP). Neither did Major, Mallinckrodt, Sun Pharma or Teva Pharmaceuticals. The drug makers would only say the medication is on “back order.”  

You might still be able to get MS Contin, a branded version of morphine ER, but it costs more and most insurers won’t pay for it, according to the ASHP, so pharmacies don’t usually keep it in stock.

At this point, I’m genuinely wondering if generic morphine ER will ever be available again. Drug makers don’t make a lot of money selling generics and opioids come with the added risk of liability, so some manufacturers have quietly discontinued production.  

I think sometimes people believe that opioid pain medications are a want, not a need. But I need morphine ER to deal with my chronic pain. It allows me to work, shower, make dinner, clean my house, and spend time with my loved ones. Most of all, it allows me to get through the day without suicidal levels of physical pain. 

If you’re a patient trying to navigate this shortage, just know that my heart goes out to you. 

And if you're a physician or a pharmacist trying to deal with this from the other end of things, I hope you’ll treat morphine ER the same way you’d treat any other necessary, daily medication. If you wouldn’t do it to a patient who needs insulin, don’t do it to a patient who needs pain medication.

My Story: Why Is Everyone So Quiet About Rx Opioid Shortages?

By Kimberly Smith

I am a chronic pain patient in Florida with multiple modalities of pain: chronic intractable pain, pain from a sports injury, and pain from an autoimmune disease. To further complicate my situation, I also have a list of allergies and genetic mutations that leave me unable to take aspirin, NSAIDs, gabapentin, codeine, and morphine for pain relief.  

I have a background in medicine, pain management and hospice, so I’ve always been mindful of the spectrum of things that can go awry with opioids. I keep myself on a stable dose with the goal of just “dialing down” the pain enough so that I can function, while not relieving it entirely.  

Fifteen years ago, when public attitudes started turning against opioids, I was switched to a fentanyl transdermal patch because it was “less likely to be abused.” I had hoped to avoid using fentanyl until my final days, knowing that once you’re on fentanyl for an extended period, it’s a nightmare if you have to switch to anything else and potentially deadly if you suddenly stop.  

Starting in September, I started having trouble getting fentanyl patches at the CVS pharmacy I’ve been using for 30 years. Instead of the Mylan fentanyl patch that I’ve been using for 15 years, CVS only had a fentanyl patch that used a completely different type of adhesive mixture -- one that I absorb inconsistently and too quickly.

I had two absolutely frightening episodes using that patch where I couldn’t catch my breath.  I don’t think anyone would blame me for never wanting to try that brand again (Alvogen).

Now I call random pharmacies each month, trying to find the Mylan patch. The supply itself is dwindling and here I am needing one of the only two fentanyl patches still on the market. It’s insane and I’m constantly stressed, anxious and overwhelmed.  

Today, I called the CVS pharmacy about my second opioid, oxycodone 30mg, and was told this is the latest opioid that is only coming in sporadically. I’ve been having to use the oxycodone as a replacement for the periods when the pharmacies couldn’t source the fentanyl patch, so I no longer have any type of emergency supply (nor do I have the opportunity to build one up).

For me, this is the absolute end of the road for opioids. I lack the CYP enzyme to metabolize morphine and I have an additional mutation that affects the efficacy of the metabolic processes, so I require higher doses than “normal.”  

I’m in a terrible, terrible situation and I’m by no means alone.  I’m starting to dream about it every night.  My doctors and the pharmacy team who have been caring for me for decades are stressed and concerned, and all have made tremendous efforts to help. But without access to the two medications I need, their hands are tied.

One of my pharmacists searched the entire state for my meds for 9 weeks and couldn’t find any. I still have many friends who are pharmacists, pharmacy techs, doctors, nurse practitioners and physician assistants, and they’ve been telling me awful stories about how much time they spend trying to resolve the opioid shortages -- not to mention the emotional toll caused by listening to patients cry and panic about being left to endure horrible pain and withdrawal.  

I don’t understand why everyone is staying quiet about this problem, especially when the shortages affect the entire hospice system, oncology patients at cancer centers, anesthesia and twilight sleep procedures, emergency medicine, trauma medicine, surgical procedures, acute pain and, of course, chronic pain.  

Doctors and pharmacists have been responding to the shortage by moving their patients to other meds, which is exactly the harm that I suffered when I was taken off the Mylan patch. This further squeezes the availability of the meds that are available and pushes those patients out to make room for the patients who were on something else.  Even gabapentin is unavailable at many pharmacies.  This situation is dire and getting worse.

If politicians were smart, they would support legitimate patients and the relief of chronic pain by making immediate changes to provide opioids to those who need them. All of the patients who are suffering would absolutely cast their votes for anyone who relieved their misery and gave them their lives back.

Instead, the politicians just assume that pain patients don’t vote and write us off. This is incredibly shortsighted. We do vote - when we aren’t struggling with pain and forced withdrawal.

I’ve reached the point where I am legitimately scared about my future. The shortages will just grow worse and worse, unless and until sweeping, radical changes are made.  Most of us wouldn’t last two to three months without opioid medication, and some wouldn’t be able to endure just one.  

While I see endless reports about Biden and Trump in the mainstream media, there’s not a word about the opioid shortage crisis and the direct harm being visited upon legitimate patients. Diversion rates are low, overdoses are primarily caused by illicit fentanyl (a completely different substance than Rx fentanyl) and desperate patients feel forced to turn to the streets.

Isn’t this a violation of the spirit of our Constitution?  It is certainly cruel and unusual punishment. We who follow the law and contribute to society are being cruelly punished for the bad behavior of others -- behavior which is basically a lapse of morals and mental health issues, which cannot be legislated away. We need to change the media narrative and shame the politicians and policy makers who created this mess.  

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.

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)

• Population

• Population

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.)

Sessions: ‘Drug Overdoses Finally Started to Decline’

By Pat Anson, Editor

There are signs – very tentative signs –  that the U.S. is making progress in the so-called opioid epidemic. Attorney General Jeff Sessions alluded to some of them in a speech on Friday.  

“New CDC preliminary data show that last fall, drug overdoses finally started to decline.  Heroin overdose deaths declined steadily from June to October, as did overdose deaths from prescription opioids,” Sessions said at the Western Conservative Summit in Denver.

Overdoses from heroin and prescription opioids did indeed fall by about 4 percent during that five-month period, but what Sessions failed to mention is that deaths from illicit fentanyl and other synthetic opioids rose by 12 percent – more than making up for whatever gains were made in reducing deaths from heroin and painkillers. 

From October 2016 to October 2017, the CDC estimates that 68,400 Americans died from drug overdoses, a 12% increase from the previous 12-month period.

So overdoses have not “finally started to decline” as Sessions claims. And the Attorney General, who once urged chronic pain sufferers to take two aspirin and “tough it out,” continues to blame prescription opioids for much of the nation’s drug problems.

“This (Justice) Department is going after drug companies, doctors, and pharmacists and others that violate the law,” Sessions said. “Since January 2017, we have charged more than 150 doctors and another 150 other medical personnel for opioid-related crimes.  Sixteen of those doctors prescribed more than 20.3 million pills illegally.”

ATTORNEY GENERAL JEFF SESSIONS

The Drug Enforcement Administration, which Sessions oversees, is also seeking a rule change that could lead to further tightening of the nation’s supply of opioid medication -- in addition to the 45% in production cuts the DEA ordered over the last two years. The DEA wants to change the rules so it can arbitrarily punish drug makers who fail to prevent their opioid products from being diverted and abused.  

Sessions ‘Socially Irresponsible’

“I think they’re attacking it from the wrong end, to be candid with you,” says Tony Mack, the CEO and chairman of Virpax Pharmaceuticals. “Who is going to end up suffering is the real patients that have chronic pain and can’t get a hold of these opioids.”

Although Virpax is focused on developing non-opioid pain medication, Mack has a wealth of experience in opioid pharmaceuticals, having worked for Purdue Pharma, Endo and Novartis. In an unusually blunt interview for a drug company executive, Mack told PNN that Sessions’ focus on prescription opioids was “socially irresponsible.”

“I believe Attorney General Jeff Sessions needs to sit down and talk to some of these physicians who are pain specialists and understand that what he’s doing is going to put the chronic pain patient, the post-operative patient, and the patient that comes to the emergency room in serious jeopardy,” Mack said. “I think that Jeff Sessions is not educated well. I think he is picking on something that sounds good politically but doesn’t make sense socially. It’s socially irresponsible.”

Mack says pain patients would be caught in the middle if the DEA changes the opioid production rules and, for example, tells Purdue Pharma to stop selling OxyContin, its branded formulation of oxycodone.

“If you cut off that particular company, since they have more oxycodone out there than anyone, what will happen is patients will have to go to morphine or have to go to fentanyl,” Mack told PNN. “You’re not going to give patients the choices that they need to have in order to manage their pain. Not every single opioid works the same way for every single person. They all work differently."

Mack thinks the DEA’s earlier production cuts have contributed to nationwide shortages of IV opioid medications, which are used to treat hospital patients recovering from surgery and trauma.

“Absolutely, I do,” he said. “It’s just a domino effect to me. You’re going to send more patients home or you’re going to be postponing surgeries until they get opioids because they can’t do (surgeries) without it. It would be inhumane.”

Mack says efforts to limit opioid prescribing and production may have backfired, giving patients little choice but to turn to the black market for pain relief.

“I think they’re trying to throw the baby out with the bathwater here. They’re not thinking it through,” Mack said. “They’re probably going to increase the amount of (illegal) drugs out there. And patients aren’t going to try and get help, because they’re going to be on heroin. Not on a prescription medication. They’re going to be shooting up heroin.”

Lost in the debate over opioids and their role in the overdose crisis is this little known fact: A recent study by the Substance Abuse and Mental Health Services Administration (SAMHSA) found that psychotherapeutic drugs used to treat depression, anxiety and other mental disorders are now involved in more overdoses than any other class of medication. They include antidepressants, benzodiazepines, anti-psychotics, barbiturates and attention deficit hyperactive disorder (ADHD) drugs such as Adderall. Over 25,000 overdoses in 2016 involved psychotherapeutic drugs. That compares to 17,087 deaths linked to opioid pain medication.

DEA Takes Steps to Reduce Hospital Opioid Shortages

By Pat Anson, Editor

In response to a growing number of complaints about shortages of opioid pain medication in U.S. hospitals, the Drug Enforcement Administration is allowing some drug makers to increase their production of injectable opioids.

The shortages were first reported last summer but have intensified in recent months – leaving some hospitals scrambling to find morphine, fentanyl and other injectable opioids to treat patients suffering from acute pain after surgery or trauma. The shortages are largely due to manufacturing problems at Pfizer, which controls 60 percent of the market for injectable opioids.

“DEA is working closely with the U.S. Food and Drug Administration, drug manufacturers, wholesale distributors and hospital associations to ensure that patients have access to necessary hospital-administered pain medications. These include certain injectable products that contain morphine, hydromorphone, meperidine, and fentanyl,” the agency said in a statement.

The DEA said it gave permission to three other drugs makers to produce the injectable drugs after Pfizer “voluntarily surrendered” part of its quota allotment.

“It is important to note that an increase in DEA procurement quotas to various manufacturers cannot alone prevent future shortages as DEA does not control the quantity or the speed by which manufacturers produce these or any of their products,” the agency said.

But critics say the DEA itself is partly responsible for the shortages. The agency may not control how companies manufacture drugs – but it has a big say on the amount. Under federal law, the DEA sets annual production quotas for each drug maker to produce opioids and other controlled substances.

Because of growing concerns about the overdose crisis, the DEA ordered a 25 percent reduction in opioid manufacturing in 2017 and an additional 20 percent cut in 2018. This year’s cuts were ordered despite warnings from three drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

A group of 16 U.S. Senators – led by Illinois Democrat Dick Durbin – urged the DEA to make the production cuts. 

“Given everything we now know about the threat posed by opioids and DEA’s downstream efforts to tackle this problem, there is no adequate justification for the volume of opioids approved for the market,” the senators wrote in a September 2017 letter to then acting DEA administrator Chuck Rosenberg.

According to Kaiser Health News, shortages of injectable opioids have led to an increasing number of medical errors and left trauma patients suffering in pain. Some hospitals are rationing opioids like Dilaudid, and using nerve blocks, acetaminophen and muscle relaxants instead.

The DEA said it would make further adjustments to opioid quotas if they are needed and would “also consider other measures that may be necessary.”