The Stress of Navigating Opioid Shortages As a Patient

By Crystal Lindell

At 9:30 am Monday morning, I got one of the most dreaded phone calls that someone taking a controlled substance can get – my pharmacy was completely out of my pain medication, Morphine Sul ER. 

Chronic shortages of prescription opioids were finally impacting me directly. 

At first, the pharmacist tried to make it sound like there was just a small delay, asking me, “How how many pills you have left?”

None. I had none left. Because pain medication refills usually aren’t filled until you completely run out. There’s not even a one-day leeway built in, because god forbid pain patients have one extra pill ever. 

Even if I did have some left, I couldn’t tell the pharmacist that, because it might risk having that used against me later. Afterall, if I had extras, that shows that I don’t need to be prescribed as many pills as I was getting. 

You’re always risking something as a pain patient. If you try to plan too far ahead by stockpiling extra pills, they could use that to reduce what you’re prescribed. And if you don’t plan ahead at all, you risk physical pain and withdrawal if there are any issues getting your refill – issues beyond your control like a drug shortage. 

As it turned out, it wouldn’t have mattered if I did have some pills leftover because the situation was worse than the pharmacist was initially letting on. This wasn’t an issue of waiting for an afternoon shipment or even a next-day restock. The pharmacist didn’t know when my medication would be back in stock at all. 

She said she had been requesting more pain medication every day, but their supplier wasn’t providing any updates on a timeline for when that would happen. So she suggested that I call around to other pharmacies to see if any of them had it in stock. 

There’s just one problem: the pain contract I had to sign to get a monthly opioid prescription technically bans me from getting refills at different pharmacies. I don’t think there are any exceptions in the contract. And if I break it, I risk losing access to the only medication that makes it possible for me to function on a daily basis. 

So even if I could find another pharmacy, I wasn’t sure if my doctor would let me get the medication filled there. 

The pharmacist was surprisingly understanding of this, and said that she had already called my doctor before calling me, so she was hopeful that they would be accommodating. 

At that point I realized that any plans I had for my Monday morning were now canceled, because I was going to have to spend the next few hours trying to navigate this. 

I made one last attempt to get the situation resolved without having to loop in another pharmacy, asking if they had an alternative medication that wasn’t too expensive because I don’t have health insurance. My medication is an extended release opioid, and the pharmacists said all they really had was the instant-release versions – which I knew my doctor would not want to swap in.

So, another pharmacy it would have to be. 

I did wonder for a moment if my pharmacy was lying to me about being out of stock. It was just last month that I had to negotiate the price of this same medication with them after they tried to increase the price by $50. 

Maybe they just didn’t want to deal with me, a long-term opioid patient, any more. So after the attempted price increase failed to deter me, they were trying a different tactic. 

The thing is, how would I even find that out? As far as I know, there’s no accountability for pharmacies that lie to patients about why they aren’t able to fill a prescription. Most people understand why that’s concerning when it comes to things like birth control or insulin, but when it’s pain medication, the general public tends to side with the pharmacist who doesn’t want to fill the prescription. 

At that point, I started calling other pharmacies. Thankfully, a locally owned one said they had the medication in stock and that they could fill it. I called my doctor to see if they’d transfer the prescription, and his receptionist took down the message. Then, I waited. 

I spent the next few hours anxious about whether this would all work out, and how long it would be until I got my refill. Finally, at about 1 pm, I saw in MyChart that the medication had been sent to the new pharmacy. 

Then I called the new pharmacy to make sure they saw my prescription come through and to ask what the cash price was. It was going to be $52, about $16 more than I paid at the other pharmacy. I probably could have asked them about using a GoodRx coupon, but I was already throwing a controlled substance prescription on them at the last minute, and they had it in stock, so I didn’t want to make waves. 

A few hours later it was finally filled, sort of. At 3 pm I arrived at the pharmacy to pick it up, after driving 25 minutes on rural roads to get there. 

They handed me the bottle and said, “Oh, by the way, we’re two pills short. Hopefully we will have those in for you later this week. So you can come back and pick them up then.”

Another 50 minutes of round-trip driving was suddenly in my future. 

I’m thankful that I found a pharmacy with any of my medication in stock, and I’m happy that my doctor seemed to handle the prescription transfer without issue. 

What Happens Next Month?

But the entire, stressful ordeal wiped out most of my day, and now I also have to figure out what will happen next month. 

Will the shortage impacting my medication be handled by then? Or should I try to have my doctor switch my prescription to something else? And if he did that, how much would that medication cost? Should I have my prescriptions permanently transferred to the other pharmacy? Is the one I normally go to going to give me a hassle every month now?

If medication shortages don’t impact you directly, it can be easy to gloss over reports like the one from the American Society of Health-System Pharmacists (ASHP), which found that shortages of drugs used for pain, anesthesia, chemotherapy and attention-deficit/hyperactivity disorder (ADHD) “continue to be problematic.” 

Those shortages impact real people. Despite a stressful morning, I was among the lucky ones, as I was able to get it worked out within just one day. Who knows if that will be the case next month though. 

The ASHP cited reduced DEA production quotas and the fallout from opioid litigation as some of the reasons for the drug shortages, which have led to rationing at many pharmacies. In a recent PNN survey, 90% of patients with an opioid prescription said they had trouble getting it filled at a pharmacy.

We need the government to start working on behalf of patients to get this resolved. I can’t just call up the manufacturer of Morphine Sul ER and tell them to make more. It has to be the government that intervenes. 

The best place to start would be to lift the DEA production quotas – although that’s really just a start. If we’re being realistic here, there should also be production minimums, with government funding and support if needed. 

People’s lives depend on these medications. It’s time to stop pretending that these drug shortages are just trivial inconveniences. They’re harmful, and sometimes even deadly.

Return to Sender: WIll Anyone Use FDA’s New Opioid Mail-Back Program?

By Crystal Lindell

The DEA has been hosting drug “Take Back Days” for over a decade, collecting over 9,200 tons of unwanted or expired prescriptions and over-the-counter medicines. The take-back program is seen as a key effort to prevent drug diversion and opioid addiction.

Now the Food and Drug Administration is expanding its own drug collection program – essentially making every day an opioid take-back day.  

Starting on March 31, 2025, drug makers participating in the FDA’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)  – which means every company that makes and sells opioids – will be required to provide pre-paid, drug mail-back envelopes “upon request” to pharmacies that dispense opioids. The pharmacies then have to give the envelopes to patients and caregivers who ask for them, so they can mail back any unwanted opioids. 

The fact that both pharmacies and patients have to request these envelopes makes me skeptical about how much this program will actually be used.

The press release from the FDA includes a quote that sounds surprisingly pro-patient though. So even if the program doesn’t have a high use-rate, perhaps an extra measure of safety will make it easier for patients to get opioid prescriptions. 

“We want to ensure patients have access to opioid analgesics in their pain management regimens and that they are educated about methods available to safely dispose of any leftover medicines, which could pose a real danger to their loved ones and pets,” said Marta Sokolowska, PhD, deputy center director for Substance Use and Behavioral Health at the FDA Center for Drug Evaluation and Research.  

It’s the part about ensuring that “patients have access to opioid analgesics” that stands out to me. Patients certainly need access to opioid pain meds. And if programs like this help doctors and medical professionals feel more comfortable prescribing opioids, then I fully support them. 

But I’m skeptical about whether that will be the actual outcome. The real question is whether anyone will use the mail-back program. 

The DEA has never released a full breakdown of the medications returned during its drug take-back days. But an analysis of the drugs returned at a take-back day in Lansing, Michigan in 2013 provides some insight. 

Of the nearly 2,500 medication containers that were returned, only 304 were for a controlled substance like opioids – about 12% overall. The most common types of medication returned were for pain/spasm, cardiovascular, and mental health conditions.

While hydrocodone/acetaminophen combinations (Norco) were the most returned medication at that 2013 event, it represented just 4.4% of all returned containers. 

The second most-common drug returned was ibuprofen (Advil) in 2.2% of the containers. Acetaminophen (1.7%) and aspirin (1.3%) also made the top ten list of most-returned medications. 

Something tells me that Advil isn’t what organizers had in mind when they asked people to bring in their unused drugs. 

In the end, the FDA’s new mail-back program will likely have a greater impact as a public relations initiative to make the agency look good, rather than keeping unwanted opioids off the street. 

In a world where doctors are so reluctant to prescribe opioids, I don’t blame people for wanting to hold on to the opioids they’re able to get. In a PNN survey of thousands of pain patients, nearly a third (32%) admitted hoarding their unused opioids because they’re unsure if they’ll be able to get them in the future 

If we’re lucky, the program will accomplish at least one of the goals that the FDA’s Sokolowska laid out: “We want to ensure patients have access to opioid analgesics.”

Given the federal government's abysmal track record with opioids and pain care in general, I’ll believe that when I see it.

The Whims of Pharmacy Pricing

By Crystal Lindell

I pay cash for my prescriptions every month because I don’t currently have health insurance. 

I got laid off in 2022 and I’ve been freelancing to make ends meet since then, which makes it difficult to get health insurance. I know, not a great situation for a chronically ill patient to be in, but as Gambino said, “This is America.”

Thankfully, the cash prices for my prescriptions aren’t very high, so the situation has been manageable. For my main pain medication, which is not a name brand, I’ve been paying just $36 a month for over two years.

Unfortunately, I recently found out how vulnerable I am to price changes for prescriptions. 

My most recent refill was ready last week, but I was dealing with a pain flare — likely caused by our changing weather here in the Midwest. So I asked my fiance to pick it up for me in an effort to avoid having to endure a taxing trip out of the house.

But while I was at home waiting, he called to tell me that the pharmacy had just told him that there was a new price this month: $86. 

That’s a $50 increase! It literally went up nearly 139 percent! With no warning! 

Doing a little back-of-the-napkin math, because it’s a monthly prescription, that increase results in an extra $600 a year! Not to mention the fact that it also means the price could increase again next month. And then again the month after that. 

So I called the pharmacy to try to figure out what was going on. I spoke to two different people and they both told me that it’s the new price and there’s nothing they can do. 

One of them claimed the price went up months ago, but after I explained to her that I literally got the exact same medication four weeks ago for $36, she changed her story and said the price increased over the weekend. Or it may have increased overnight. 

She insisted there was nothing they could do about it. 

Since it’s a controlled substance and I have a pain patient contract with my doctor, I’m not allowed to have the prescription transferred to a different pharmacy to get it for a cheaper price. It’s one of those opioid regulations that was supposedly launched to keep patients safe, but it has instead resulted in pharmacies having their own monopolies. 

As a freelancer, my bank account balance varies dramatically, depending on which projects I’ve recently been paid for and which ones I’m waiting on payment for. So I didn’t have the full $86 in my account to cover the medication that day. 

Thankfully my mom lives nearby, and I’m able to borrow some money from her when situations like this occur. So my fiance drove home, and then I drove to my mom’s to pick up some cash from her. I then drove to the pharmacy myself to get the medication — all while still dealing with a spike in my daily pain. 

When I got to the counter, I recognized the pharmacist who was working as someone who’s been helpful to me in the past. So I took a chance and said, “Yeah, so the price went up dramatically? Huh?”

She looked at the prescription price and then quietly went to the computer for like 10 minutes to look into it. Then she came back over to me and said, “I got it back down to $36. Here you go, you can pay up front.”

I was half in shock and half worried that if I said the wrong thing, the price would go back up, so I didn’t ask how she did it. I just took the package and went up front to pay, hoping it would still be $36 next month.

I know I should be sharing the details of why it went up and then back down again, but I honestly don’t even know what they are. And I don’t think that those details are necessarily the point. 

The real point is that pharmacies have way too much power in pricing and the entire process is purposely opaque to make it difficult for patients to navigate. After I shared this story with some close friends the day it happened, many of them responded by telling me similar stories about arbitrary pricing at their pharmacies. 

The initial price increase should not have even happened in the first place. What patients pay for medication should not be dependent on the whims of pharmacy staff, especially when patients like me are not allowed to shop around for a more competitive price due to controlled substance regulations. 

As far as I can tell, there are no laws regulating how much pharmacies can increase prices for medication, nor any law requiring them to give a certain amount of notice when they do. If there are laws about such things, they aren’t publicized in any meaningful way. If patients don’t know they have a right, does the right even exist?

I don’t know if there’s any good advice for patients to take from this experience. Most patients on controlled substances can’t risk angering their pharmacist, so it’s understandable they would just choose to pay a higher price if that’s what the pharmacy wanted. 

The situation reminds me of someone else that sells drugs: street dealers. But at least with street dealers, customers usually have the option of shopping around for a better price. 

Are Rx Drug Databases ‘Trojan Horses’ for Law Enforcement?

By Pat Anson, PNN Editor

Prescription drug monitoring programs (PDMPs) were widely adopted in the U.S. over a decade ago to help identify patients who might be abusing opioid medication or other controlled substances. All 50 states now have databases that physicians and pharmacists can use to monitor a patient’s prescription drug history and look for possible signs of abuse.

Although widely billed as a way to improve patient safety and prevent diversion, critics say PDMP’s quickly became a surveillance tool for local and federal law enforcement --- in effect, ‘Trojan Horse’ technologies that turned pharmacists into undercover cops.

“Equipped with PDMPs, pharmacists readily police patients. Pharmacists use this surveillance tool to interrogate patients about their drug use, document interactions defensively, and let patients know they are being watched,” said Elizabeth Chiarello, PhD, an Associate Professor of Sociology at Saint Louis University.

“PDMPs are surveillance technologies, not healthcare tools, so they do not offer pharmacists new ways to deal with patients’ pain or substance use disorders, they simply empower pharmacists to view patients with suspicion and refuse to treat them.”

Chiarello conducted 118 interviews with pharmacists in six states, asking how PDMP’s have affected their work and relationships with patients. Her findings, recently published in American Sociological Review, suggest that many pharmacists now feel pressured to work with law enforcement to identify suspicious prescriptions.   

A pharmacist in Mississippi said she was approached by a DEA agent, who gave her his card and said, “Call me anytime you need me.”

“From then on, she called the DEA when she spotted a fake prescription and worked with them to arrest the patient,” wrote Chiarello. “Pharmacists have become more comfortable deciding which patients deserve opioids and turning away those deemed undeserving. PDMP use has also strengthened communication with law enforcement, so pharmacists now contact them about troubling patients.”

A pharmacist in Missouri told Chiarello that he and his colleagues “work pretty well” with local law enforcement:

“We get calls all the time from the police that say ‘Hey, can you find out if they’re actually on this?’… I’ll call the police if I ever need any help, especially with someone who is jumping from pharmacy to pharmacy or doing something that’s illegal. But they’ll come back to me as well saying, ‘Hey, can you check the fill dates for this guy or can you check where he’s been filling for me?’ And so they kind of use me as a PDMP resource as well.”

Congressional investigators recently reported that three pharmacy chains -- CVS, Kroger and Rite Aid – faced “extreme pressure” from law enforcement to immediately respond to requests for patient information, even without a warrant. In most cases, patients are not informed that their medical records have been shared with law enforcement or why they were being sought.

Only three states – Louisiana, Montana and Pennsylvania – have laws that require a warrant or subpoena before medical data is disclosed.  

‘We Don’t Go Fishing’

In a recent webinar with medical providers, a DEA investigator denied that the agency uses PDMPs to troll for suspicious patients and providers.

“This comes up sometimes, so I'll just address the elephant in the room. We don't go fishing in the (PDMP) data. Okay? Why do people think we have this open access to driving records and that we pull whatever we want? No. We have to have a case and we have to have a subpoena. We just don't go trolling through the records,” said Jed Nitzberg, a DEA Supervisory Diversion Investigator.

The DEA has long been interested in prescription drug records. In 2020, the agency solicited bids from contractors to create and operate a surveillance program that would identify patients, prescribers and pharmacies that may be involved in the diversion or abuse of drugs.

Under the proposed program, the DEA would have “unlimited access” to prescription data, including the names of prescribers and pharmacists. The names of patients would be redacted, but if investigators suspect a drug was being abused or diverted, they could get a subpoena to identify them. No contract was awarded by DEA and it’s unclear if the surveillance program was ever initiated.

Even without prompting from law enforcement, pharmacists are under enormous pressure to be alert to suspicious behavior by patients and physicians. Under the national opioid settlement, if a pharmacy has too much “Red Flag activity” such as patients paying for drugs in cash or a prescription written by a doctor in another zip code, it risks being terminated from receiving any more shipments of opioids and other controlled substances.

Ironically, the theft, loss and diversion of prescription opioids is at its lowest level in over a decade. In the DEA’s latest National Drug Threat Assessment, the agency said the number of “unaccounted-for” opioids had fallen by 80 percent, from 19.5 million pills/units in 2011 to just 4 million in 2023.

A Third of Independent Pharmacies May Close

By Pat Anson, PNN Editor

These are tough times for many retail pharmacies and their customers. Big chain pharmacies like CVS, Walgreens and Rite Aid are closing over 1,500 stores, as they grapple with declining sales, higher debt, drug shortages, fallout from opioid litigation, and an overworked, demoralized workforce.

For many patients who had trouble getting their prescriptions filled for opioids and other controlled substances, small independent pharmacies became a welcome refuge from the big chains.

“I'm fortunate to have a compassionate, independent pharmacy that bends over backwards to ensure I have the meds my doctor prescribes. If I was stuck with a chain pharmacy like Walgreens or CVS, my experience would be completely different. Those pharmacies treat pain patients like criminals,” one patient told us.

But now even the independent pharmacies are threatened. About a third of them could close in 2024, according to a dire prediction from the National Community Pharmacists Association (NCPA), a trade group that represents nearly 20,000 independent pharmacy owners in the U.S.

“Nearly a third of independent pharmacy owners may close their stores this year under pressure from plunging prescription reimbursements by big insurance plans and their pharmacy benefit managers,” says B. Douglas Hoey, RPh, NCPA’s CEO.

At issue is a new rule by the Centers for Medicare & Medicaid Services (CMS) that requires insurers and pharmacy benefit managers (PBMs) to implement discounts and price concessions at the point of sale, where a drug is dispensed. The rule is intended to make pricing more transparent for patients, but it’s hurting the bottom line of pharmacies who say the discounts are being unfairly forced on them by insurers.

Part D Prescriptions at Risk

In a recent survey of NCPA members, 32% said they may have to close by the end of the year due to the CMS rule and 93% said they’d consider dropping out of Medicare’s Part D prescription drug program. Most say they are losing money on Part D prescriptions, which don’t compensate the pharmacies for rent, taxes, payroll and other costs of doing business.

“Cash flow for many pharmacies remains in a precarious state, leading to dire concerns for beneficiary access. Our members continue to experience significant harm from egregious Medicare Part D PBM practices,” Hoey wrote in a letter to CMS, which faulted the agency for doing little to stop the PBMs.

Asked which PBMs are causing the most financial stress in the Part D program, almost half the NCPA members identified Express Scripts, with CVS/Caremark coming in at 35 percent.

Hoey says CMS already has the legal authority to change reimbursement practices, but wants Congress to intervene if CMS doesn’t act soon.

“This is an emergency. And if Congress fails to act again, thousands of local pharmacies could be closed within months and millions of patients could be stranded without a pharmacy,” Hoey said in a statement.

NCPA says there are about 2,200 fewer retail pharmacies today than there were four years ago. This has created hundreds of pharmacy “deserts,” primarily in low-income rural and urban areas, where access to a pharmacy is limited or non-existent. Alabama alone has lost 300 pharmacies in recent years.

“With every closure, 5,000 Alabamians are left without a critically important health care provider. This is a major issue for every community in our state, but rural Alabama is hit the hardest. In many cases, that local pharmacy is the only healthcare provider in that rural community,” Alabama State Rep. Phillip Rigsby, a pharmacist, wrote in an op/ed published in AL.com.

“In other businesses, if an operating cost increases, the company’s prices increase to compensate. In pharmacy, that just is not possible. A pharmacy cannot pass on that cost to a patient because the contract doesn’t allow for that.”

DEA Urged to End ‘Red Flag’ Policy for Pharmacies

By Pat Anson, PNN Editor

A coalition of telehealth companies is urging the U.S. Drug Enforcement Administration to stop telling pharmacies to be careful about filling prescriptions for opioids and other controlled substances that originate from out-of-state.

The DEA’s “red flag” policy has had a chilling effect on doctors and patients nationwide, including those that use telehealth services. Many pain patients have found that pharmacies won’t fill opioid prescriptions written by doctors that are not near them geographically.  

In an open letter to the DEA, the American Telemedicine Association and a handful of telehealth providers said “clearer green lights” were needed from the DEA on how to safely dispense controlled substances, not more red flags.

“The DEA should provide explicit guidance to the pharmacy community that geography of a prescriber in relation to the patient or the pharmacy should not be a ‘red flag’ when a prescription is a result of a telehealth visit,” the letter states. “The distance of a telehealth prescriber from the patient alone should not give a pharmacist a signal that the prescription may be illegitimate.”

The DEA relaxed telehealth rules three years ago at the start of the Covid-19 pandemic, to allow for opioids, stimulants, sedatives and other controlled substances to be prescribed remotely via telehealth. Those temporary rules have been extended until the end of 2024, to give the DEA more time to develop permanent ones to govern telehealth.

Many pharmacies haven’t gotten the message. In a recent PNN survey, over 90% of pain patients with an opioid prescription said they had trouble getting a pharmacy to dispense their medication. Drug shortages are the primary cause, but so is the fear of some pharmacists that they could get in trouble or even lose their jobs if they filled a prescription deemed suspicious because it comes from out-of-state.

“In conversations with the pharmacy community and in our experience as prescribers, we have determined many pharmacies and pharmacists are currently considering geography as a ‘red flag.’ While red flags are not defined in statute or regulations or other official guidance, in the wake of the overprescribing and overdispensing contributing to the opioid epidemic, pharmacists have been directed to do so as a part of their corresponding responsibility, or due diligence to ensure that prescriptions are legitimate,” the letter from the telehealth coalition states.

‘An Unusual Distance’

Federal laws and regulations may not clearly define what a red flag is, but the onus is clearly put on pharmacies to catch them:

“[A] pharmacist or pharmacy may not dispense a prescription in the face of a red flag (i.e., a circumstance that does or should raise a reasonable suspicion as to the validity of a prescription) unless he or it takes steps to resolve the red flag and ensure that the prescription is valid.”

Under a 2022 opioid litigation settlement, drug distributors and big chain pharmacies agreed to tightly limit the supply of opioids and be on the lookout for suspicious orders. That includes patients with prescriptions for “highly diverted controlled substances” written by doctors from a zip code 50 miles or more from a pharmacy. Pharmacies with a high volume of those prescriptions risk having their drug supplies further restricted or cutoff.

DEA investigators and federal prosecutors have long targeted doctors and pharmacies that have out of state patients. In 2021, for example, DEA suspended the license of a Florida pharmacy that “repeatedly ignored obvious red flags of abuse or diversion,” including a high number of patients who traveled “an unusual distance” to obtain their prescriptions.

Contrary to popular belief, opioid diversion is rare. The DEA estimates that less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) medications are lost, stolen or diverted.

Another example of a provider being red-flagged came in 2022, when DEA suspended the controlled substance license of Dr. David Bockoff, a California physician who treated many chronically ill patients from out of state who couldn’t find local providers.

Within days of Bockoff’s suspension, one of his patients and his wife died by suicide at their home in Georgia. A few weeks later, another patient died at her home in Arizona, apparently from complications caused by opioid withdrawal. Neither of those patients were using telehealth to see Dr. Bockoff, but their deaths highlight how red flags and heavy-handed oversight of medical providers can have serious consequences.    

“DEA must use this opportunity to make clear what their expectations are for pharmacists in filling telehealth prescriptions of controlled substances,” the letter from the telehealth coalition warns. “If DEA simply adds recordkeeping, reporting, or data requirements to the overwhelming workload pharmacies and pharmacists already face, access issues will only be exacerbated.”

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.  

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

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

HIPAA Privacy Issues

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

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

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

Under the proposed surveillance program, DEA investigators would have “unlimited access” to prescription data, including the names of prescribers and pharmacists, types of medication, quantity, dose, refills and forms of payment. The names of patients would be encrypted, but if investigators suspect a medication was being abused or diverted, they could get a subpoena to identify them.

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

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

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

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

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

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

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

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

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

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

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.

New DEA Rule Allows Pharmacies to Transfer Opioid Prescriptions

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration has adopted a new rule that allows patients, doctors and pharmacists to transfer initial prescriptions for opioids and other controlled substances from one pharmacy to another.  

The rule became effective August 28, but has been in the works for several years. It revises DEA regulations to allow prescribers, hospitals and pharmacists the ability to write, dispense and transfer electronic prescriptions for controlled substances “upon request of the patient.” Under the old rule, prescriptions could not be transferred if a pharmacy is unwilling or unable to fill them – forcing doctors to write a second prescription for another pharmacy and creating delays for patients in need of treatment.

“The final rule amends DEA regulations to explicitly state that an electronic prescription for a controlled substance in schedule II–V may be transferred between retail pharmacies for initial filling on a one-time basis only, upon request from the patient, and clarifies that any authorized refills included on a prescription for a schedule III, IV, or V controlled substance are transferred with the original prescription,” DEA said in a lengthy notice published in the Federal Register.

In recent years, many patients have experienced delays or outright refusals getting prescriptions filled for opioids, stimulants, sedatives, steroids and other medications classified as controlled substances.  The problem has grown worse in recent months, due to chronic shortages of oxycodone, hydrocodone and stimulants.

It would be nice to say the DEA changed the rule to make it easier for patients to get their prescriptions filled, but the agency’s primary goal is to reduce drug diversion. Having doctors write duplicate prescriptions for the same patient is not only a waste of time, in the eyes of the DEA it raises the risk of the original prescription being misused.

“DEA realizes that this scenario creates the potential for duplication of prescriptions, if the practitioner transmits a new prescription to a different pharmacy and does not cancel or void the original prescription that was sent to the first pharmacy. It also recognizes that this scenario creates additional burden for patients, who have to get back in touch with the prescribing practitioner to request a new prescription,” the agency said.

“DEA believes that allowing the electronic transfer of controlled substance prescriptions will decrease the potential for duplicate prescriptions and thus reduce the opportunity for diversion or misuse.”

The diversion of prescription opioids is actually rare. According to the DEA, less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) is lost, stolen or diverted to someone they were not prescribed to.

The DEA estimates the new prescription transfer rule will cost pharmacies over $91 million annually due to additional record-keeping and time spent transferring prescriptions, but will reduce overall costs to the healthcare system by $22 million a year.  

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.)

Class Action Lawsuit by Pain Patient Against CVS Moves Forward

By Pat Anson, PNN Editor

A federal judge has ruled that a class action lawsuit against CVS may continue over the pharmacy chain’s refusal to fill high dose opioid prescriptions for a Florida woman.

Edith Fuog, a breast cancer survivor who lives with trigeminal neuralgia, lupus, arthritis and other chronic pain conditions, filed suit against CVS in 2020, alleging the company discriminated against her and violated the American with Disabilities Act (ADA). Her complaint was filed in federal court in Rhode Island, where CVS has its corporate headquarters.

The lawsuit alleges that CVS pharmacists refused to fill her opioid prescriptions nearly 30 times because the daily doses exceeded 90 morphine milligram equivalents (MME), a threshold considered risky under the 2016 CDC opioid guideline. Although the guideline is voluntary, many healthcare providers have adopted it as a mandatory policy.   

This week Judge William Smith rejected a CVS motion to dismiss the lawsuit, essentially ruling that because Fuog needed a higher dose to treat pain from her medical conditions, she was legally qualified as a disabled person.

“Ms. Fuog has pleaded sufficient facts for the Court to conclude that it is plausible that prescriptions over the threshold are generally denied meaningful access to this benefit, and also disproportionally or predominantly disabled,” Judge Smith wrote in his opinion.

“She has alleged a specific dose-and-duration threshold and provided well-pleaded facts supporting a strong correlation between those over the threshold and disability. While she will have much to prove as the case progressed, these pleadings push past the plausibility bar.”

Judge Smith agreed to drop CVS Caremark as a defendant in the lawsuit, saying there wasn’t a clear enough allegation against the company’s pharmacy benefit manager. But the rest of the potentially precedent setting case will continue.   

“He basically said there’s no doubt that she’s disabled. And there’s no doubt that there’s discrimination going on,” Fuog told PNN.  “It’s a huge step. And we’ve got all this in his own words, telling us this is real, it’s happening, it’s unfair and it’s discrimination.”

“We are very pleased with the Court’s ruling and look forward to moving ahead and litigating the claims on Edith’s behalf,” said Scott Hirsch, Fuog’s lawyer. “We are always happy to speak with other individuals who are being denied the filling of their legitimate opioid prescriptions. They can go to the website we have setup and get more information.”

Longtime Problem for Patients

Pain patients across the U.S. have complained for years about pharmacies refusing to fill their opioid prescriptions or reducing them to lower doses. It’s also not uncommon for patients to encounter delays and flimsy excuses about not filling a prescription, such as a pharmacist claiming a particular opioid was out of stock.

The CVS case and a similar lawsuit against Walgreen’s in California are believed to be the first class action cases to address the problem. Class action suits allow plaintiffs to prosecute a case in civil court and receive compensation for their injuries on behalf of others.

“I was thrilled with this opinion. I think it’s very well-reasoned and applies the ADA appropriately,” said Kate Nicholson, a civil rights lawyer who at one time worked for the Justice Department and helped draft federal regulations under the ADA. She is now Executive Director of the National Pain Advocacy Center (NPAC).

“I mean it’s ridiculous that this woman went to 30 different pharmacies and couldn’t get her prescription refilled. That is highly problematic,” Nicholson told PNN.

Ironically, CVS and several other pharmacy chains face multiple lawsuits for filling too many opioid prescriptions and allegedly contributing to the nation’s opioid crisis. CVS recently reached a $484 million settlement with the state of Florida to end opioid litigation there.

Pharmacists have a legal right to refuse to fill prescriptions they consider suspicious or inappropriate, but should first take steps to verify whether a prescription is legitimate and medically necessary, such as calling the prescribing doctor. Fuog’s lawsuit alleges that CVS pharmacists refused to call her doctor or even look at her medical records.

“Which is why I think the judge was very careful on this case to say CVS has a perfectly legitimate basis for looking at high dose prescribing,” said Nicholson. “They just can’t do it in this arbitrary way.”

Pharmacies Turning Away Patients Seeking 4th Covid Shot

By Liz Szabo, Kaiser Health News

Patients with weakened immune systems — who are at high risk from covid-19 — say pharmacies are turning them away when they seek additional vaccine doses recommended by federal health officials.

Alyson Smith became eligible this month for a fourth vaccine dose because her medications leave her immunocompromised.

Although the Centers for Disease Control and Prevention encourages most adults to receive a total of three mRNA vaccines — two “primary” vaccinations and a booster — the agency now advises people with weak immune systems to receive three primary shots plus a booster, for a total of four doses.

Many people are confused about the difference between a primary vaccine series and a booster. A primary vaccine series helps people build antibodies to a new pathogen, while a booster combats waning immunity.

As Smith learned, many pharmacists are unaware that the CDC’s vaccine guidance has changed.

Smith booked her vaccine appointment online. But when she showed up at a Chicago-area Walgreens for the appointment Jan. 19, an employee told her the pharmacy chain wasn’t administering fourth doses to anyone.

Smith said she’s frustrated that vulnerable people are being forced to make multiple visits to crowded pharmacies and supermarkets, where many customers are unmasked.

“I feel for the pharmacists, because they’re overwhelmed like everyone else,” said Smith, 52. “But two years into the pandemic, there is a corporate responsibility to take action when the guidance comes down.”

In a written statement, Walgreens said it has administered thousands of fourth doses to immunocompromised people. “As vaccination guidelines continue to evolve, we make every effort to continuously update our pharmacy teams.”

(Update: In a conference call on January 26, the CDC told pharmacists that people with moderate to severe immune suppression are eligible for a 4th covid shot. About 7 million Americans can get the extra shot.)

Confusing Vaccine Guidance

The confusion stems from recent updates in vaccine advice for immunocompromised people, as well as a change in the interval between the end of a primary vaccine series and a booster.

• In August, the CDC began allowing immunocompromised people to receive a third dose of mRNA vaccine as part of their primary vaccination.

• In October, the CDC quietly updated its website to allow people with suppressed immune systems to receive a fourth shot as a booster.

• In January, the agency shortened the time that anyone must wait for a booster from six months to five.

People who received the one-dose Johnson & Johnson vaccine are eligible for a single booster, for a total of two shots, according to the CDC.

Given how often vaccine guidelines have been revised in recent months, some pharmacists have had a hard time keeping pace, said Mitchel Rothholz, chief of governance and state affiliates at the American Pharmacists Association. Pharmacy employees have coped with an ever-expanding workload but a deepening shortage of employees during the pandemic, he said.

“I don’t know any provider who wants to turn away a patient,” Rothholz said. “The CDC continues to make updates, and it’s becoming very difficult for providers at the grassroots level to keep up. I can understand why a pharmacist would say, ‘Corporate hasn’t given us the green light.’”

Confusion about who is eligible for a fourth shot “was inevitable, although I’m not saying it’s right or wrong,” he said.

Yet many patients and their doctors are frustrated.

If patients keep up with the latest guidelines, they ask, why can’t their pharmacy?

“It’s ridiculous,” said Dr. Dorry Segev, a transplant surgeon and researcher at Johns Hopkins University. “CDC makes it very clear that it’s allowed, and even people who print out the CDC guidance and take it to their pharmacies are being turned away.”

Charis Hill, 34, joined a chorus of immune-suppressed people venting their concerns on social media in recent days. When Hill tweeted Jan. 21 that Rite Aid should better educate its staff, the retailer tweeted back that day, saying, “We’re very sorry you didn’t have a great experience, Charis. Please check back with us early next month for more information regarding the fourth dose.”

In a written statement, Rite Aid said it continually educates its staff as CDC advice changes, and “is looking into the response that was provided to the customer on social media.”

Dr. Shikha Jain, an assistant professor of medicine at the University of Illinois Cancer Center in Chicago, said patients in rural areas often drive long distances to look for vaccines. One of her patients was “almost in tears” after being turned away. Jain tried to help by calling the pharmacy but was on hold so long that she had to hang up to see patients.

Jain said the CDC needs to do a better job educating doctors, pharmacists, and patients.

The CDC did not respond to a request for comment before publication.

Teresa Strahlman, 61, said she’s immunocompromised due to medications she takes for lupus, an autoimmune disease. But the Maryland woman said she didn’t realize she was eligible for a fourth dose until reading a KHN post on Facebook. “I had no idea, and I have a million doctors,” Strahlman said. “No one has said anything to me.”

The CDC estimates that 2.7% of adults — or 7 million people — are immunocompromised, a group that includes people with medical conditions that dampen their immune response, as well as those taking immune-suppressing drugs because of organ transplants, cancer, or autoimmune diseases.

Some immunocompromised people say that being turned away from a pharmacy is especially frustrating, given all that they have sacrificed during the pandemic.

Linda Rushing, 74, has given up attending church services in person, although she’s deeply religious, because of a weakened immune system that leaves her prone to a variety of infections.

Rushing made three visits to local pharmacies before finding someone to administer her fourth shot.

“It’s a tragedy to need help and not be able to get it,” said Rushing, of Rowlett, Texas, whose daughter and granddaughter are also immunocompromised. “I don’t want covid. I don’t want to give it to anybody, and I’m trying to do everything I can not to die from it.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

States Need to Protect Pain Patients From Uncaring Pharmacists

By Leslie Bythewood, Guest Columnist

The unthinkable just happened again.

A Walgreens pharmacist got away with refusing to fill my prescriptions. It’s the second time that has happened to me at a retail chain pharmacy; the first time was at a CVS pharmacy.

The Walgreens pharmacy manager called and said she would not be able to fill the two prescriptions my board-certified physician had submitted electronically; despite the fact my health insurance had given prior approval for the medications and the pharmacy has been filling them month after month since December 2020.

Contrary to my physician’s best judgment and clinical decision making, this new head pharmacist suddenly decides she cannot fill the prescriptions because:

• The prescriptions are not in keeping with good-faith dispensing

• The prescriptions are not appropriate or safe to dispense

• The pharmacy’s therapeutics committee red-flagged the prescriptions as being too high a dose

• North Carolina limits the number of tablets that can be dispensed each month

• Filling the prescriptions goes against the pharmacist’s professional judgment

When I realized that my pharmacist would not fill the prescriptions and refused to even discuss the matter with my doctor, I wasted no time filing an electronic complaint with the North Carolina Board of Pharmacy, hoping for some recourse short of having to get the prescriptions filled at another pharmacy.

But little did I know about a North Carolina Board of Pharmacy rule entitled “Exercise of Professional Judgment in Filling Prescriptions.” That esoteric rule says a pharmacist “shall have a right to refuse to fill or refill a prescription order if doing so would be contrary to his or her professional judgment.”

It also states that a pharmacist “shall not fill or refill a prescription order if, in the exercise of professional judgement, there is or reasonably may be a question regarding the order’s accuracy, validity, authenticity, or safety for the patient.”

Federal law also gives pharmacists a “corresponding responsibility” not to fill a prescription for controlled substances if they believe it is “not in the usual course of professional treatment.”

Basically, the Walgreens pharmacist had the audacity to call into question the validity of my prescriptions being for a legitimate medical purpose, which not only is an insult to my physician, but second-guesses and overrides his many years of medical judgment and authority.

Worse yet, the North Carolina Board of Pharmacy agent I spoke with said that “refusing to fill the doctor’s prescriptions is not a violation of the Pharmacy Practice Act.” She went on to say the board cannot force the pharmacist to fill a prescription if the pharmacist is not comfortable doing so.

Bottom line: In North Carolina and many other states, the patient and doctor have no recourse and no avenues for appeal if a pharmacist refuses to fill a prescription. The only path forward is to have the doctor submit the prescriptions electronically to another pharmacy.

What I find so unconscionable about this whole ordeal is that it doesn’t seem to matter one iota to the uncaring pharmacist that I am a certified pain patient and that my doctor’s prescriptions are entirely legitimate and medically necessary, as has been documented in my medical records.

Nor did it matter that I’ve been on the same opioid strength since December 2020 without any adverse side effects, or that I am highly tolerant of my medications (a physiologic state that does not equate with psychological addiction) and have no history of overdose, substance abuse disorder, misuse or addiction. 

The pharmacist’s ability to get away with overpowering my doctor with unsound, medically unsafe arguments is exactly why we need to enact laws at both the state and federal level to protect pain patients from this type of abuse.

Leslie Bythewood is a freelance writer who lives in North Carolina. Leslie has intractable cranial pain syndrome caused by idiopathic severe chronic migraines and clusters.

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

‘Partial Fill’ Rule for Pharmacies Would Harm Pain Patients

By Pat Anson, PNN Editor

A retired Nevada pharmacist who lives with chronic back pain is warning that patients will suffer if the Drug Enforcement Administration enacts a rule that allows pharmacists to only partially fill opioid prescriptions.

The DEA is under pressure from Sen. Elizabeth Warren (D-MA) and other members of Congress to stop “foot-dragging” and finalize a regulation that would allow patients to take home only part of their opioid prescription. They would have to return a second time to get the rest.

“I think it (the DEA partial refills) would have a huge impact on patients who regularly get their pain meds filled. Can you just imagine people already in pain having to go back to their pharmacy again to get the balance? Going once a month is already problematic for many. Twice a month would be inhumane,” Rick Martin said in an email to PNN.

“Pharmacists might not like it either because it would make them have to account for their inventory more often and maybe double the amount of work to fill the same Rx again.”

Warren, along with Sen. Dianne Feinstein, Sen. Shelley Moore Capito, Rep. Kathleen Clark and Rep. Steve Stivers, sent a bipartisan letter to acting DEA Administrator Timothy Shea last week urging him to update the “partial fill” regulation, as required under the 2018 Comprehensive Addiction and Recovery Act (CARA). 

“DEA has failed to issue its proposed rule, despite assurances in recent years that ‘this proposed rule is a top priority’ for the agency,” the letter says. “Defining ‘partial fill’ and fully implementing Section 702 of CARA will reduce the number of prescription opioids in circulation, a crucial step in addressing the opioid crisis that is devastating communities across the country. DEA’s continuing foot-dragging on this issue puts Americans at risk.”

Warren and her colleagues asked the DEA to provide an update and staff-level briefing on the matter no later than October 20.

Under current rules, the DEA only allows pharmacists to do a partial fill if they don’t have enough medication on hand to completely fill a prescription – something that many patients say is already happening. In a report issued earlier this year, the DEA said the supply of prescription opioids was at its lowest level since 2006.

“Once again, the letter just shows a bunch of busy-body ignorant uneducated senators sticking their nose where it doesn't belong,” said Martin. “They (pharmacists) shouldn't be doing this unless they don't have an adequate amount to fill or unless the patient gives them permission to partial fill.”

The Warren letter claims over half of those who abuse opioid medication obtain it from a friend or family member. The DEA, however, has said less than one percent of opioids that are legally prescribed are diverted.

Illicit fentanyl, heroin and other street drugs are responsible for the vast majority of overdoses. A 2019 study of overdoses in Massachusetts – Warren’s home state – found only 1.3% of overdose victims had an active opioid prescription.