The National Opioid Settlement Is Causing Drug Shortages

By Pat Irving, Guest Columnist

I am a retired nurse with over 40 years of healthcare experience. The principal focus of my career was on healthcare regulations, risk management and patient safety.  My most recent position was as National Leader for Risk and Patient Safety for Kaiser Permanente. 

As a pain patient myself and the victim of a mandatory opioid taper, I was motivated to understand the reasons behind the many difficulties patients have getting opioids, anti-anxiety medications and other controlled substances. 

The goal of my research over the last several months is to help patients and their families understand the drastic changes in pain management that have occurred in recent years. While much of it is due to the CDC opioid guideline and the law enforcement crackdown on prescribers, the fallout from opioid litigation now plays a major role in our inability to get prescriptions filled.

As early as 2017, acting on the incorrect premise that prescription opioids were the primary cause for the opioid crisis, the National Association of Attorneys General began a legal assault on entities they believed were responsible for the “opioid crisis.”  This included opioid manufacturers, big chain pharmacies, and the three biggest wholesale distributors -- AmerisourceBergen, Cardinal Health, and McKesson.

On July 21, 2021, the Attorneys General announced that they had reached a $26 billion settlement with the three distributors and Johnson & Johnson, who agreed to make major changes in how they do business.  The intent was to improve the safety and oversight of prescription opioids, but the unintended consequences of the settlement have caused incalculable harm to patients with chronic pain and mental health disorders.

In addition to the monetary settlement, the three distributors agreed to substantially increase measures to identity suspicious orders from pharmacies for ten years.  The distributors, collectively known as “Injunctive Relief Distributors,” also established an independent clearinghouse to keep track of every shipment of opioids and other controlled substances to pharmacies.

Red Flags and Suspicious Orders

For reference, the 571-page settlement can be found at this link.  The most important section (Exhibit “P”) begins on page 478.  Among other things, it requires the distributors to collect from each pharmacy a list of their top prescribers for opioids and other “Highly Diverted Controlled Substances,” the number of prescriptions and doses they wrote, their DEA registration number, address and medical specialty.

You may notice several other things.  Many of the restrictions came directly out of DEA regulations.  For example, there is language about “Red Flags” and “Suspicious Orders,” the latter being “orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.”

Other potential red flags include patients paying for a prescription in cash and “out-of-area” patients with prescribing doctors from a zip code that’s 50 miles or more from the pharmacy. 

If a pharmacy customer has an excessive number of suspicious orders or “unresolved Red Flag activity,” it risks being “terminated” from receiving further controlled substances – which would effectively put the pharmacy out of business: 

“In the event that an Injunctive Relief Distributor identifies one or more unresolved Red Flags or other information indicative of potential diversion of Controlled Substances through the onboarding process or otherwise, the Injunctive Relief Distributor shall refrain from selling Controlled Substances to the potential Customer pending additional due diligence.”

It is easy to see why the settlement has made pharmacists more hesitant, even fearful, about filling orders that might be suspicious. 

Under federal law, pharmacists already had a “corresponding authority” to decide whether a prescription is suspicious and if it should be filled. Whereas before a pharmacist might call a prescriber to double check on a prescription and the reasons for it, under the settlement a pharmacist may err on the side of caution and not fill the prescription at all.

To make the situation worse, the definitions of “suspicious orders” are purposely vague, and may be interpreted in the strictest way possible.  For example, since the CDC guideline recommends that physicians “should carefully evaluate” increasing doses above 50 morphine milligram equivalents (MME), the distributor or pharmacy may see that as hard limit, not a suggestion.  

And because the CDC guideline urges caution when prescribing opioids and benzodiazepines together, that may be another hard stop on a prescription, regardless of how long or how safely a patient was managed on these medications. There may be serious consequences for the prescribing physician as well, who could be reported to state authorities and the DEA if they have too many suspicious prescriptions.

Medication Thresholds 

The injunction also brought with it medication “thresholds.”  Unlike the annual DEA production quotas which are imposed on drug makers nationwide, the settlement thresholds are very specific to each pharmacy or pharmacy chain. It limits the total volume of a controlled substance that a pharmacy may receive in any given month, quarter and year.  These threshold limits, are developed by the distributor using a statistical algorithm of their own design. 

Once a pharmacy has exceeded its particular threshold, it is unable to obtain additional medication in that drug category. Physicians and patients have no way of knowing if they are the unlucky ones to have exceeded a pharmacy’s threshold.  For many patients, this means being cutoff cold turkey, waiting another month, or having a prescription only partially filled – essentially a forced taper.

Many health plans talk about their concern for patient safety, but there is often a lack of information given to patients about the known risks of tapering, especially for “legacy” patients who have been on prescribed opioids for an extended period, and who were stable and doing well. There is often no discussion with the tapered patient on the possibility of withdrawal, suicidal thoughts, anxiety, depression, and unmanaged pain. 

The patient population most affected by the distributors’ settlement are either disabled, seniors or both.  This is the very population that has difficulty accessing alternative pain therapies such as acupuncture or injections, and in many cases are alone and homebound. It has been almost impossible to get attention for this segment of the population that needs the most support. 

There has been no strong response to the settlement and resulting drug shortages from the Health and Human Services Administration, DEA, CDC, or FDA.  There has also been a lack of a coordinated response from Medicare/CMS to patients being forcibly tapered. 

It is likewise unclear what position state medical and pharmacy boards are taking on the ruptured drug supply chain. Many patients with legitimate prescriptions now have to wait weeks for their medications to become available or are forced to travel to other pharmacies to get their prescriptions filled. Worst of all, the suffering imposed on these patients has done nothing to reduce the number of drug overdose deaths.

Our government must wake up to the fact that the injunction portion of the settlement must be modified.  There are sections of the settlement that allow for “potential adjustments” and “modifications” in the event of a national or state emergency “to meet the critical needs of the supply chain.” Such an emergency now exists.

Future efforts by stakeholders must focus attention on these sections and the need for changes. It is possible to have a safe and well monitored drug supply chain that also allows legitimate patients to have the medical treatment they deserve. As it stands now, patients are needlessly suffering due to the unreasonable restrictions imposed by the national opioid settlement.

Pat Irving, RN, lives with Complex Regional Pain Syndrome (now in remission) and piriformis syndrome, a type of sciatica. Pat wishes to thank Monty Goddard, a patient advocate, for his contributions to her research.

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

Federal Judge Rejects Opioid ‘Public Nuisance’ Claims

By Pat Anson, PNN Editor

A federal judge in West Virginia has ruled that three major drug distributors did not fuel the opioid epidemic by shipping excessive amounts of opioid pain medication to pharmacies in Cabell County and the City of Huntington. According to one estimate, about 10% of people in the county are addicted to opioids.

“The opioid crisis has taken a considerable toll on the citizens of Cabell County and the City of Huntington. And while there is a natural tendency to assign blame in such cases, they must be decided not based on sympathy, but on the facts and the law,” Judge David Faber wrote in his 184-page ruling, which rejected claims that AmerisourceBergen, Cardinal Health and McKesson State acted in a way that made them a “public nuisance” under state law.

“To apply the law of public nuisance to the sale, marketing and distribution of products would invite litigation against any product with a known risk of harm, regardless of the benefits conferred on the public from proper use of the product,” the judge said. “The economic harm and social costs associated with these new causes of action are difficult to measure but would obviously be extensive. If suits of this nature were permitted any product that involves a risk of harm would be open to suit under a public nuisance theory regardless of whether the product were misused or mishandled.”

Judge Faber is the first federal judge to reject public nuisance claims in opioid litigation. State judges in California and Oklahoma made similar rulings last year.

The three drug distributors had previously agreed to multi-billion dollar settlements with dozens of states, but Cabell County chose not to be a part of those agreements, as did other counties in West Virginia, which has long been considered “ground zero” of the opioid epidemic.

“This case was always about holding these distributors accountable and providing our doctors, nurses, counselors, first responders and social workers with some of the resources needed to combat the opioid crisis. These companies were part of a powerful industry responsible for fueling the epidemic here in Huntington and across the country,” Huntington Mayor Steve Williams said in a statement.

Judge Faber acknowledged that prescription opioids were a “significant cause of drug overdose deaths” in Huntington and Cabell County. But he said the city and county failed to prove that drug distributors acted unlawfully or that the amount of opioids they shipped to pharmacies was unreasonable.

The three companies supplied retail pharmacies in Cabell County with over 51 million hydrocodone and oxycodone pills over an eight-year period. That works out to 67 pills annually for every man, woman and child in the county. It would be a month’s supply for a typical chronic pain patient, who might be prescribed 2 to 3 pills a day, depending on the dose and type of opioid.

“The volume of prescription opioids in Cabell/Huntington was determined by the good faith prescribing decisions of doctors in accordance with established medical standards,” Faber said. “Defendants shipped prescription opioid pills to licensed pharmacies so patients could access the medication they were prescribed.”

Public Health Problems   

Judge Faber also pointed out the poor state of public health in West Virginia, which has high rates of disability, arthritis, cancer, obesity and other health conditions that contribute to pain.

“The West Virginia population is relatively older and has relatively higher levels of obesity as well as a higher than average number of disabled persons, all of which tend to generate more needs for pain treatment,” Faber wrote. “Manual and physical labor is a significant component of the West Virginia economy and tends to generate more needs for pain treatment.”

In 2018, West Virginia became one of the first states in the country to impose hard limits on opioid prescribing, limiting first-time opioid prescriptions to 7 days’ supply and requiring refilled opioid prescriptions to be limited to 30 days’ supply.  

Sixty-four weeks after the law was adopted, opioid prescriptions overall dropped by 22% in West Virginia, similar to how prescribing trends have changed nationally.  The reduced prescribing, however, has failed to reduce drug overdoses, which have risen to record levels.

According to a new CDC database, West Virginia has the second highest overdose rate in the country and leads the nation in drug deaths involving illicit fentanyl, prescription opioids, stimulants and methamphetamine. In 2020, only 5.2% of the overdose deaths in West Virginia involved a patient being treated for pain.   

I Was Lied to by My Pharmacist

By Colleen Sullivan, Guest Columnist

I wrote an article years ago titled "Humiliated by a Pharmacist" about how difficult it is to be a chronic pain patient and to get prescriptions filled for pain medicines.

I would love to report things are better now, but sadly the truth is they aren't.

I was diagnosed with Mixed Connective Tissue Disease (MCTD) in 2001. Having MCTD basically means a person has two or more overlapping autoimmune conditions. Mine are dermatomyositis, rheumatoid arthritis and psoriatic arthritis. These are all very painful conditions to have.  

Since I've been dealing with MCTD for so many years, I've dealt with a lot of different pharmacists and learned a few things.

Whenever I enter a pharmacy for the first time, I like to speak with the manager, explain my conditions and what I need from them. Then, I ask what they need from me and if they are willing to work with me. I just want to make sure we understand each other and are on the same page. 

Picking up my prescriptions went smoothly for awhile. It was still stressful and scary to approach the dreaded pharmacy counter and hand over my prescription for an opioid. They still looked at the Rx and up at me with judgmental eyes. They still had an attitude and no empathy whatsoever.  

COLLEEN SULLIVAN

But I managed to find a place and a head pharmacist who was willing to work with me. It was a small pharmacy that wasn't part of a big chain and I thought they weren't going to be the "med police" like Walgreens. You know what I mean: Pharmacists who think they know more than your specialist and that it's somehow their job to judge if you're worthy of your medicine or not. 

This pharmacy is located in the same building as my pain specialist, which I thought was great.  First, if they have any questions or problems, my doctor is right upstairs. Second, it's super convenient being one floor below. I already have to drive 4 hours round trip to see my doctor in Homestead, Florida because there are no doctors in the Florida Keys willing to treat any pain patients. 

So, I went to this place and spoke to the owner and head pharmacist, Claude, who said it'd be no problem at all and he'd be happy to work with me. He assured me they have a special relationship with a drug distributor and a backup vendor as well. I was finally able to relax and not have a flare up every month from the stress of going to a pharmacy.  

Things were good for six months or so, but then suddenly the whole staff started acting weird towards me. Here we go again, I thought. They started insisting I call them days in advance every month to remind them I'm a customer of theirs and to order my medication. I didn't mind doing that, but the more I thought about it, isn't that their job?

They'd assure me on the phone that everything was good, they ordered it, and it'd be there for me when I needed it.  

Then one day I made the two hour drive there and handed over my prescriptions. They went to the back and whispered to one another. That made me extremely anxious. Then, they came up and said, "Sorry, we don't have it." 

I stood there frozen in disbelief before asking, "Don't you remember talking on the phone with me and assuring me you had it?"  

Claude just shrugged his shoulders and said, "I can't help you. Sorry. I can order it now." 

Order it now? That means I would have to make the 4-hour round trip drive the next day just to pickup a prescription.  

This happened from then on, almost every month. When they didn’t have my meds, sometimes Claude would nonchalantly say, "Just drive around and look for it."  

JUST DRIVE AROUND AND LOOK FOR IT?

If you walk into a new pharmacy with an opioid prescription, it never goes well.  They look at it, look back at you and say, “We don’t have it.” They don't look in the back. They don't check the computer. They just say no. 

One thing you should know about me is I really hate confrontation. Stress makes my conditions worse, so I try to avoid it at all costs. I never argue with them. I meekly walk away and, out of desperation, cry in my car. 

I kept trying to get my prescriptions filled at this small pharmacy, because each time they'd apologize profusely and say it was an oversight and won't happen again.  

One of the last times I went there, I called in advance again. Claude says, "No problem. I ordered it and it's here. I'm looking at it. No worries."  

I get there and he says "Nope, we don't have it. It’s a problem with the distributor. Wait a couple of days and they'll get it." The whole time he's talking, I'm thinking, “You lied to me. Why did you lie?” 

So I wait. Three days later, I call and Claude says he can't get it. I end up having to go to Walgreens -- and that's a whole other story -- but eventually Walgreens gets it for me that month with stipulations.   

But now I'm three days behind in my medication. I have to get infusions every month on a particular day and Claude is well aware of that. Being three days off means two 4-hour round trip drives a month instead of one.

The next month. I called a week ahead because Claude had assured me he would work it out. But on the call he says, "Sorry, it's still a problem with the distributor."  

Out of curiosity, I asked who was the distributor. He tells me it's Cardinal Health.  

I decided to call Cardinal myself and within 20 minutes I find out there is no issue on their end and they can ship it to that pharmacy within a day. I think, this is great! Problem solved and I don't have to keep bothering Claude.

I called the pharmacy to tell Claude the good news and he was furious that I called Cardinal. He's literally yelling at me over the phone saying, "How dare you!" and "Who do you think you are?"  

I thought I wasn't just helping myself, but the pharmacy as well with the distribution problem they kept telling me about. Claude then refuses to receive the shipment from Cardinal and says they no longer want my business because it's "too much work.” He says he's done with me and tells me not to come into his pharmacy again. 

After hanging up and crying for 20 minutes, I start to realize there never was a distribution problem. It was all just a lie and he’s angry at me because I figured it out. Keep in mind this is two days before I'm supposed to refill. Because of his lies, I now had 2 days to restart the process of finding a whole new pharmacy. 

Honesty, it's sad that chronically sick people are being treated like this by medical professionals. All Claude really had to do was be honest and say, "I'm not comfortable working with you anymore. I will fill them for you one more time, so you'll have a month to figure something else out."  

If he could've just been professional and told the truth, there would have been no problem.  

Colleen Sullivan lives in Florida.  

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.