CVS Pushes Back Against DOJ’s Latest Opioid Lawsuit

By Crystal Lindell

The U.S. Justice Department’s latest opioid lawsuit against CVS is getting some push back from the pharmacy chain. The DOJ alleges that CVS knowingly filled “unlawful prescriptions” for opioids and other controlled substances, and then sought reimbursement for them from federal healthcare programs like Medicaid and Medicare.

Specifically, the DOJ claims that CVS had “corporate-mandated performance metrics” that incentivized pharmacists to fill the prescriptions. The government also alleges that CVS “set staffing levels far too low” for pharmacists to meet their corporate goals and legal obligations.

“Our complaint alleges that CVS repeatedly filled controlled substance prescriptions that were unlawful and pressured its pharmacists to fill such prescriptions without taking the time needed to confirm their validity,” Deputy Assistant Attorney General Brian Boynton said in a statement. “The practices alleged contributed to the opioid crisis and opioid-related deaths.”

CVS issued a statement in response to the lawsuit that “strongly disagrees with the allegations and false narrative.” The company said the standards the DOJ is claiming CVS didn’t meet are so vague and ever-changing as to be useless. 

“The government’s lawsuit seeks to impose a shifting standard for pharmacy practice,” CVS said. “Many of the litigation theories laid out in the complaint are not found in any statute or regulation, and relate to topics on which the government has declined to provide guidance.

“Each of the prescriptions in question was for an FDA-approved opioid medication prescribed by a practitioner who the government itself licensed, authorized, and empowered to write controlled-substance prescriptions.”

I have to say, it’s good to see CVS defend itself in these situations. 

Especially by pointing out the obvious: The prescriptions were written by doctors who were licensed by the government. Although pharmacists have a “corresponding authority” to make sure a prescription is legitimate, why should a private pharmacy chain be held to a higher standard than the government itself?

The government’s lawsuit intensifies a serious dilemma for the pharmacy industry, which is simultaneously second-guessed for dispensing too many opioids and for filling too few. 

Over the last few years, it seems like every government agency in existence has been looking for anyone they could possibly sue in relation to opioids. As a result, about $50 billion in opioid settlement money will be paid in coming years by opioid makers, distributors and pharmacies.

However, there’s one glaring aspect of this tactic that makes it clear the lawsuits aren’t about helping people hurt by opioids, but about finding ways for the government and plaintiff law firms to get more money. Much of the settlement money received so far has been earmarked for law enforcement and other government projects that have little to do with opioids.

‘We Will Defend Ourselves’

CVS has already agreed to pay about $5 billion to settle opioid litigation. The company says the latest lawsuit, which seeks unspecified additional penalties, is just another cash grab.

“We will defend ourselves vigorously against this misguided federal lawsuit, which follows on the heels of years of litigation over these issues by state and local governments — claims that already have been largely resolved by a global agreement with the participating state Attorneys General,” the company said. 

CVS says it has been an “industry leader” in developing programs to fight opioid misuse. In recent years, the nation’s largest pharmacy chain has refused to fill controlled substance prescriptions written by over 1,250 doctors, about half of whom the government continues to license. 

The company also points to its “Our Opioid Response” website, which features a telling headline about government regulations and the scrutiny faced by pharmacists: 

“Fill this opioid prescription. No, wait, actually you can’t do that. Or, maybe, you can: The dilemma for community pharmacists.”

The text on the site then goes on to again point out the DEA’s vague guidance and inconsistent stance on the issue. 

“Whichever decision they make, community pharmacists know they can – and will – be second-guessed later. Too often, we have seen government agencies and trial lawyers question the good-faith decisions made by pharmacists while a patient waits at the pharmacy counter, often in pain. While simultaneously being accused of dispensing too few opioids and too many, pharmacists and pharmacies face threats of liability no matter their actions,” CVS said.

A recent court case suggests that CVS and other pharmacy chains are making some headway in defending themselves. The Ohio Supreme Court ruled this week that CVS, Walmart and Walgreens are not “public nuisances” under the state’s product liability law. Similar rulings have also been made in West Virginia, California and Oklahoma, rejecting public nuisance claims that resulted in costly opioid settlements.

CVS says it is standing up for “patients enduring relentless pain,” and as a patient who faces relentless pain, I’m happy to see it. While I’m skeptical that the overall tide is turning when it comes to public attitudes about opioids, it’s good to know at least one company is pushing back. 

Walgreens and CVS Rated ‘Most Difficult’ for Opioid Prescriptions

By Pat Anson, PNN Editor

When Walgreens and CVS signed the National Opioid Settlements in late 2022, they agreed to pay over $10 billion to states, cities and counties that sued them for their alleged roles in causing the opioid epidemic.

The nation’s two biggest pharmacy chains also agreed to watch for suspicious orders, report any “problematic” prescribers, and to strictly limit the amount opioid pain medication they can dispense in any given month. Opioids, in effect, were going to be rationed to their customers.

Pain patients are now paying a price for that agreement.

In a large survey of nearly 3,000 pain patients by PNN, over 90% of those with an opioid prescription said they experienced delays or problems last year getting their medication. Most patients went to another pharmacy, but nearly 20% still couldn’t to get their prescriptions filled – largely because opioids such as hydrocodone and oxycodone are in short supply.

The average patient had problems at a pharmacy at least three times in 2023. Some had trouble each time they went in for a monthly refill.

“I spent eight days trying to get my last prescription pills and finally got it filled two days ago, but I had to settle for only one third of my prescription,” said a patient who went through withdrawal for 8 days waiting for her medication.

“It's an unreal concept that I can have the piece of paper, I can have the doctor, I can have the pharmacy, I can have the money, and I can have the insurance, but I can't go and have the little medicine that I need to try to make it through this situation.” 

HOW MANY TIMES DID YOU HAVE A PROBLEM OR DELAY FILLING AN OPIOID PRESCRIPTION IN LAST 12 MONTHS?

‘There Is Always an Issue’

Asked which pharmacy chain was the most difficult to get an opioid prescription filled, over half the patients in our survey selected either Walgreens (30%) or CVS (26%).

“I've used Walgreens for all of my medications for the past 15 years and within the past year or so I have started having issues almost every month with them filling my pain medication,” a patient told us. 

“My local CVS says that they cannot get hydrocodone-acetaminophen at all. Yet, my local Giant Food supermarket can. Very strange,” said another. 

“I used Walgreens for many years. Recently they have had several new pharmacists. One pharmacist would not fill ANY controlled substances. The current pharmacist will only order about 3 to 4 times per month. She doesn’t care if patients don’t get their medications,” another patient wrote. 

“CVS continually gives me a hard time to fill my Rx even though I have been on it for over 7 years. It is either out of stock, or they argue with me about filling it,” said another. 

“Every month when I have to get my medication renewed there is always an issue,” explained another patient. “Walgreens always give people a hard time. I've seen many people standing in line and just walk out.” 

Patients also had trouble getting their prescriptions filled at Walmart, Kroger, Rite-Aid, Publix and small independent pharmacies, but they had far fewer complaints. CVS and Walgreens have about four times as many pharmacy stores as Rite-Aid, which may explain why they were singled out more often than the other chains.  

AT WHAT PHARMACY DID YOU EXPERIENCE THE MOST DIFFICULTY GETTING AN OPIOID PRESCRIPTION FILLED?

When told about the findings from PNN’s survey, CVS declined to comment and Walgreens provided a brief statement saying it “follows all applicable federal and state laws and regulations related to the dispensing of controlled substances.” 

More Cautious Dispensing

Even before signing the opioid settlements, Walgreens and CVS were among the first pharmacy chains to look at ways to minimize their dispensing of opioid medication.  

In 2017, CVS said it would limit the dose and supply of opioids to patients enrolled in commercial, employer or Medicaid health plans. The policy was adopted after CVS was fined hundreds of millions of dollars for violations of the Controlled Substances Act, many of those violations involving opioids. 

In 2013, Walgreens adopted a “secret checklist” that required its pharmacists to look for red flags, such as patients paying for opioids in cash, seeking an early refill, or taking a high number of pills. If anything was suspicious, pharmacists were told to “inform the patient that it may take additional time to process the prescription.”  Like CVS, the policy was implemented after Walgreens was fined millions of dollars by the DEA for violating rules for dispensing controlled substances. 

Walmart and Kroger also signed the National Opioid Settlements, while Rite-Aid filed for bankruptcy, in part due to the expense of defending itself in court. Thousands of pharmacies around the country are being closed due to over-expansion, poor business decisions, and the rising cost of lawsuits. 

Patients have noticed that the fines and lawsuits have made pharmacists more cautious. In our survey, dozens of patients said a pharmacist told them they would not fill their opioid prescription because they might get in trouble or lose their job. Many patients don’t know it, but pharmacists have a “corresponding responsibility” to exercise their professional judgement by not filling a prescription they think is inappropriate.

“Pharmacies and pharmacists have become an arm of law enforcement,” one patient wrote. “Pain medication prescriptions are treated as suspicious, with the pharmacist often questioning the appropriateness of my current MME (morphine milligram equivalent) levels while I’m undergoing a rapidly forced taper,” one patient wrote. 

“I have been hung up on just for calling (CVS) and asking if they would put my prescription in the queue for filling the next day. Call disconnected by pharmacist,” another patient said. “I emailed a written complaint to CVS and never heard back.” 

“The new manager in pharmacy at Walgreens, which is where I have gotten my pain medicine for 20 years, feels that I receive too much even though he has no idea of my diagnosis. He makes me feel like I am a low-class drug addict,” a patient told us. “I get much less than so many people I know, so I finally had to switch to mail order with OptumRx.” 

‘Independent Pharmacies Are Better’ 

Many patients have found that it’s easier to get a prescription filled at smaller pharmacy chains or at independent pharmacies that were not caught up in opioid litigation.  

“Independent pharmacies are better. I used to fill my opioid scripts at Walgreens. The pharmacist there always gave me a difficult time. He would refuse to fill unless he received a confirmation note from my pain specialist that I was taking the appropriate dose. I finally left him for an independent pharmacy,” one patient told us. 

“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,” wrote another. 

“I have used a small mom and pop pharmacy for over five years with no problems. Their only requirement is I get all my prescriptions filled at their pharmacy, not just the opioid or muscle relaxant,” said another patient. “Prior to changing, I had used CVS and Walgreens pharmacies, with both offering nothing but problems and harassment when taking my scripts in.” 

“Thankfully, I live in a very small town and have had a great experience with my pharmacy so far. Small mom and pop set up. So far, only handful of times had them short me pills when they were unable to obtain the meds. Only had to wait a day or two for them to fill the rest,” wrote another patient.

‘My Pharmacist Is Awesome’

While often frustrated by the ordeal of getting their prescriptions filled, many patients appreciate how they are treated by pharmacists. Asked what their overall experience has been with pharmacists, respondents were evenly divided. Nearly a third said their experience with pharmacists was “very positive” or “positive” – about the same number who said their experience was “negative” or “very negative.”      

“My pharmacist is pretty awesome and always has the opioid medications in stock,” one patient said. 

“Generally, my treatment at pharmacies has been first rate. Not so much the doctors,” said another. 

“My pharmacist is excellent and knowledgeable,” another patient wrote. 

“I made friends with my pharmacist because he knows I have several chronic pain syndromes,” another patient told us. “When I first met him, he didn't want to fill me, but now he helps me get my meds filled.” 

“In my experience, it’s pharmacist specific. Some are compassionate, others think everyone is an addict,” another patient said.

OVERALL, WHAT HAS BEEN YOUR EXPERIENCE WITH PHARMACISTS AS A PAIN PATIENT?

PNN’s online survey was conducted from November 13 to December 31, 2023. A total of 2,961 U.S. pain patients or caregivers participated.

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.

FDA and DEA Silent as Rx Opioid Shortages Worsen

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

‘No One Seemed to Care’

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

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

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

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

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

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

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

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

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

DEA PRODUCTION QUOTAS FOR OXYCODONE (KILOGRAMS)

SOURCE: DEA

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

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

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

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

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

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

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

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

Home Delivery of Rx Opioids Would Help Chronic Pain Patients

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

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

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

Trifecta of Problems

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

My Life Is on the Line Due to Rx Opioid Shortages

By Christine Kucera, Guest Columnist

On May 24, I had my regularly scheduled pain management appointment. The prescription for my normal regimen of 10mg oxycodone was sent electronically to my local CVS pharmacy. About an hour later, I received a text from CVS saying they received the prescription from my doctor.

I followed up later through their automated system. That is the moment of shocking revelation when I learned that my prescription was not going to be filled on time, and that it may not be ready until a week after my fill date.

Utterly panicked, heart racing, thinking and speaking a mile a minute, I contacted the pharmacy. They confirmed they were out of 10mg oxycodone tablets.

“What am I supposed to do?” I asked. A woman who I don’t know replied that I should try contacting other pharmacies.

Really? I can’t do that. Pharmacies won’t tell me, the patient, if they have a supply of a controlled substance. So she looked it up and said it looks like “X” pharmacy has it and that I should have my doctor send the prescription there. Unfortunately, by the time my provider received the message, it was too late.

I made multiple calls to another pharmacy and they were extremely rude. I called my pharmacy again. This time I spoke with a pharmacist that knew me. He was very understanding, as we discussed what to do next.

CHRISTINE KUCERA

We came up with a plan. He said to have my doctor send him a prescription for 5mg oxycodone. I immediately emailed my provider about the shortage and asked him to send a new prescription for 5mg, since they were out of 10mg tablets.

It was a very long night and I was extremely anxious waiting for a reply from my provider. As a long-term opioid patient of 30 years with intractable pain, I’ve been through the unimaginable, especially after the CDC published its first opioid guideline. Since 2016, I’ve been force tapered to suboptimal treatment levels, denied pain medication during multiple hospitalizations, and told to take Tylenol.

A surgeon even used prescription fentanyl on me during an interventional procedure after being told it doesn’t work on me – leaving me awake and screaming during the procedure. That’s just to name a few examples. Believe me, there are many more.

My thoughts are racing out of control. I can’t do this anymore. I can’t live life with unrelenting, unmanaged pain all day, every day. I’m barely holding on now, trying hard not give up hope. It’s not easy living in a body that’s under assault from an invisible invader, leaving my entire body riddled with rare diseases, along with severe bone, nerve, connective tissue and organ pain.

As a person with severe medically induced PTSD, I can fully recall all of the previous times I was forced off my managed regime of opiate medication. This time it’s going to be at the hands of the DEA, which has intentionally created shortages of oxycodone.

Next day arrives, a new prescription for 5mg is sent and I sigh with relief. It was short lived. Another pharmacist said my insurance company won’t cover the 5mg substitute without prior authorization. Completely losing control of my emotions, I asked why do I need another prior authorization?  My daily limit of 90 morphine milligram equivalents (MME) didn’t change, just the dose of the tablets

“It’s because of daily quantity limits,” the pharmacist replied.

Are you freaking serious?  I’m out of oxycodone as of today and you’re saying I can’t have 2 weeks of a substitute because there is no supply anywhere of 10mg and my insurance has quantity limits on 5mg doses?  I was angry and upset. This is so wrong! What am I supposed to do?

To that, the pharmacist says, “You can pay out of pocket.”

I didn’t have a choice, although I knew what happens from paying out of pocket with cash and sending prescriptions to new pharmacies. Those are red flags for prescription drug monitoring programs (PDMPs).

What’s next CDC and DEA? You’ve fabricated the great Opioid Lie and created policies that affect all pain care in all settings. Created new burdens for disabled and chronically ill patients. Created an opioid guideline that doesn’t allow for individualized treatment and places limits on prescriptions. You’ve shackled doctors with no options but to provide inadequate pain care or abandon patients altogether.

Now patients and their providers are having to deal with DEA created shortages of essential medicines. This has got to stop! Pain patients have never been the driver behind the overdose crisis. Anti-opioid prohibition policies are harming, torturing and killing U.S. citizens.

What do I do? There are no protections or even a set of procedures in place to assist patients and providers when there are shortages of controlled substances. It really is a nightmare situation. I feel helpless. The shortage is not my fault, the restrictions have gone too far, and my life is on the line.

Christine Kucera lives with psoriatic arthritis, spondyloarthropy, spondylitis, polyarthritis, sacroiliitis, degenerative joint disease, dermatomyositis, mixed connective tissue disease, spinal radiculopathy, hypoparathyroidism, rare endocrine tumors, psoriasis, endometriosis stage IV, pelvic adhesive disease, and other painful conditions. 

Prior to becoming disabled, Christine was a healthcare research systems developer and analyst for federally funded CMS, AHRQ, and NIH grants and programs. 

Do you have a “My Story” to share? Pain News Network invites other readers to share their stories about living with pain and treating it. We are particularly interested in your experiences dealing with current drug shortages. Send your stories to editor@painnewsnetwork.org.

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.”

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.

Lawyers: ‘We Have Nothing To Do’ With Fundraiser for Kolodny Lawsuit

By Pat Anson, PNN Editor

The attorneys who filed lawsuits against three pharmacy chains for allegedly discriminating against pain patients are disavowing any connection with efforts to raise money for a proposed lawsuit against Dr. Andrew Kolodny, a prominent anti-opioid activist.

Dr. Arnold Feldman, a retired anesthesiologist, has a GoFundMe campaign underway to raise $100,000 for a class action lawsuit targeting Kolodny, the founder and Executive Director of Physicians for Responsible Prescribing (PROP). Feldman calls Kolodny an “anti-opioid zealot” who has harmed pain patients through his advocacy against opioid prescribing.

“To be clear, we have no involvement in or with any fundraising efforts by Dr. Feldman or others who may be associated with him or a possible lawsuit against Dr. Kolodny,” attorney Robert Redfearn, Jr. said in a statement to PNN. “Our focus and involvement is on and in the two national class action lawsuits that we filed in Rhode Island and California, through which we hope to bring some relief to pain patients.  Further, we have not received or accepted any funds from Dr. Feldman or others who may be associated with him.”

Feldman and his associate, Claudia Merandi, have claimed they were instrumental in filing the lawsuits against CVS, Walgreens and Costco on behalf of two pain patients. Merandi is one of the founders of the Don’t Punish Pain rally organization.

“BIG NEWS FOR PAIN COMMUNITY: We have filed class action lawsuit against CVS/WALGREENS for DENYING to fill opioid scripts. This will set a precedent as to why you DON'T PUNISH PAIN,” Merandi posted on Twitter when the lawsuits were filed in August.

“Dr. Feldman was successful in bringing a class action lawsuit against Walgreens and CVS to fruition and he will do the same for the Kolodny lawsuit,” Merandi posted to her followers on Facebook, sharing a link to the GoFundMe campaign.

“Fact: There's only a lawsuit filed against CVS and Walgreens because of Dr Feldman,” Merandi wrote in yet another tweet.

‘We Are Litigating This on Our Own’

But the lawyers who actually filed the lawsuits say Feldman and Merandi had nothing to do with their litigation, other than providing encouragement.

“In terms of their involvement, there is none. We are litigating this on our own,” said attorney Scott Hirsch. “We obviously don’t agree with Claudia’s stance that this is her lawsuit. It’s not. We’re representing the plaintiffs and the chronic pain community.”

Hirsch began working with Edith Fuog on her lawsuit against CVS in 2018, long before Merandi and Feldman were even aware of the case. He has been working without pay, which is usually the case in class action lawsuits. Attorneys are typically not paid until damages are awarded.

“We have nothing to do with any sort of fundraising that Claudia Merandi and Dr. Feldman are doing in terms of this lawsuit. There’s no fundraising that we’re doing or they’re doing for us or this Kolodny lawsuit. We have nothing to do with that. We’re not even interested in it, to be quite frank,” Hirsch said.

Hirsch, Redfearn and four other law firms are involved in the pharmacy lawsuits, which they hope will get class action status. If successful, the suits could potentially result in millions of dollars in damages being awarded to pain patients who were unable to get their opioid prescriptions filled.

“All these people came together and brought this lawsuit. It wasn’t just Dr. Feldman, he wasn’t the savior for us all. And that’s my issue. It’s not 100 percent truthful in her (Merandi’s) statement. There’s a lot missing,” Fuog told PNN. “I don’t know anything about what they’re doing with Dr. Kolodny. I don’t know who they are hiring. I don’t know where the funds are sitting until they hire a law firm. I don’t know the basis for the lawsuit that they want to file.”

So many misleading claims have been made that the six law firms representing Fuog and Susan Smith, who filed suit against Walgreens and Costco, have posted a disclaimer on their website disavowing any association with the GoFundMe campaign and Don’t Punish Pain.

“These groups on the internet, such as Don’t Punish Pain, have posted information about our lawsuits on their websites, Facebook, Instagram and other social media. This content is not affiliated with the lawsuits or our effort on behalf of chronic pain patients.

Please understand no organization except the affiliated lawyers and law firms handling these National Class Action Lawsuits are authorized to speak for us or make any financial or informational request on our behalf. In other words, please be advised that all other individuals or groups are NOT authorized to speak on behalf of us or the named plaintiffs in the lawsuits, NOT involved in the handling or prosecuting of the lawsuits, and NOT authorized to raise money to cover expenses associated with the lawsuits.”

Asked to clarify what role he played in the lawsuits, Feldman told PNN he “sounded the alarm” and alerted lawyers to what was happening to pain patients. He said his wife is among those who’ve had trouble getting their opioid prescriptions filled.

“I knew some lawyers and I said, ‘Guys, this is a problem. What do you think?’ And I harangued them and harassed them and called them and screamed at them,” Feldman explained.  “But I had nothing to do with it. I didn’t write the complaint. I didn’t file the complaint.

“I had nothing to do with this litigation. Nothing. Neither does Claudia. Other than the fact that we said we’re happy this has happened. That’s the extent of it.”

Merandi says she exchanged emails and participated in Zoom calls with the lawyers. And she continues to insist that Don’t Punish Pain was the driving force behind getting the CVS lawsuit filed in her home state of Rhode Island.

“This lawsuit was born out of the Don’t Punish Pain organization,” she claimed in a Facebook video feed, not mentioning that the lawsuit was filed in Rhode Island because CVS corporate headquarters is located there.

To date, nearly $12,000 has been donated to the GoFundMe campaign, with most of the money coming from hundreds of small donors, many of them pain patients.

Feldman says he and Merandi have had discussions with several lawyers, but so far no one has been willing to take the case against Kolodny.

“I had nothing to do with this litigation. Nothing. Neither does Claudia. Other than the fact that we said we’re happy this has happened. That’s the extent of it.”

— Dr. Arnold Feldman

“No, we haven’t found a lawyer yet,” he said. “But we’re going to find somebody. We’re talking about billions of dollars in litigation.”

“We want to raise a lot of money to pay these lawyers. Lawyers need to get paid and that’s why this GoFundMe is important,” Merandi said while promoting the fundraiser in a recent radio interview. “We need an investigation done and that costs money.”

Until a law firm is found, Feldman says the donated funds will remain untouched in a bank account. “I haven’t taken a dime. Nor will I ever. When we have enough money and find a law firm, that’s where the money will go,” he said.

Asked what would happen if no lawyer take the case, Feldman said the donated funds would be returned to donors. 

“It’ll be a pain in the ass, but of course. I’m not going to buy a BMW with it, I’ll tell you that much. I’m honest as the day is long. I would starve before I took that money,” Feldman said.

Lawyers May Not Expand Lawsuits Against Pharmacy Chains

By Pat Anson, Editor, PNN Editor

Lawyers involved in class action lawsuits that allege pain patients were discriminated against by three major pharmacy chains are being tight-lipped about whether the lawsuits may be expanded to include additional plaintiffs and pharmacies.

The lawsuits were filed earlier this month in California and Rhode Island against CVS, Walgreens and Costco on behalf of two women who say the pharmacies refused to fill their prescriptions for opioid pain medication.

At least six different law firms around the country are handling the cases. They’ve set up a website called Seeking Justice for Pain Patients, which invites other patients to participate in the lawsuits by sharing their personal information and experiences at pharmacies. It’s not yet clear how the information will be used or if the cases will be expanded.

“Pain patients have been contacting us in response to the lawsuits. The overall response has been very positive and happy that some action is being taken,” Robert Redfearn, a Louisiana attorney, said in an email to PNN. “Though there are no plans to do so at this time, additional individual named plaintiffs could possibly be added, but if a national class is certified, it should not be necessary.” 

Other lawyers involved in the lawsuits did not respond to requests for comment.

Redfearn represents Susan Smith, a 43-year old mother from Castro Valley, California who lives with severe chronic migraines. The only medications that give her relief from head pain are opioids. Smith says pharmacists at Walgreens and Costco refused to fill her opioid prescriptions and publicly shamed her.

“After being harassed by pharmacists [and] pharmacy staff for a number of years — being laughed at, being called names in front of my child — I really couldn’t take it anymore,” Smith told the San Francisco Examiner. “It has been really stressful, demoralizing, not to mention discriminating. On top of that, they were making it really hard for me to live a pain-free life.”

‘Find a New Pharmacy’

“There has to be a change,” says Edith Fuog, a 48-year old Tampa, Florida mother who filed the lawsuit against CVS. Fuog has lived for many years with trigeminal neuralgia, lupus, arthritis and other chronic pain conditions.

“People need to understand what is happening. Everybody in their life is going to be a pain patient at one point or another, whether it’s an accident, becoming elderly, a disease or cancer. If this is happening to people who have chronic pain, the people who are just coming in with acute pain are never going to be treated.”

Fuog told PNN she had no trouble getting her opioid prescriptions filled at a CVS pharmacy until the CDC’s controversial opioid prescribing guideline was released in 2016.

“As soon as those guidelines came out, my life changed. The manager pulled me aside and said, ‘Look, I’m not going to be able to fill these anymore. I suggest you find a new pharmacy.’” said Fuog, who then went to other CVS pharmacies in the Tampa area and was repeatedly turned down.

“They all said, ‘We’ll be happy to fill all your other meds, but we will not fill the opioids.’ And I said, ‘I take 13 other medications. Why would I come here then?’”

EDITH FUOG

Fuog eventually found a small neighborhood pharmacy that was willing to fill all of her prescriptions. She also found a lawyer to file the class action lawsuit against CVS. If her case is successful, Fuog anticipates making only a few thousand dollars in damages.

“It’s not like I’m going to make a bunch of money. The decision could come down for a hundred million dollars, but that’s for the class and the attorneys. I’ll get a ‘rep fee” being the class rep. That’s it. I don’t get anything for my damages or the stress I go through, and the fact I have severe anxiety because of this,” she said.

Fuog says she will only settle out-of-court if CVS adopts a written public policy that makes clear to its pharmacists that they should fill all legitimate prescriptions for opioids.

“My goal in this is to make change that affects the most amount of people with chronic pain. If I can get them a lot of money, I’m going to do it. Why wouldn’t I? To me, these companies deserve to pay all these people money for what they’ve been through,” she said.

Costco, CVS and Walgreens did not respond to requests for comment.  CVS, Walgreens and other large pharmacy chains have been named in lawsuits alleging they helped fuel the opioid epidemic by selling millions of pills in small communities. They’ve also been fined hundreds of millions of dollars for violating federal rules for dispensing controlled substances.

Pharmacies Sued for Discrimination Against Pain Patients

By Pat Anson, PNN Editor

National class action lawsuits have been filed against three of the nation’s largest pharmacy chains for discriminating against pain patients trying to fill legitimate prescriptions for opioid medication. 

Class action complaints against Walgreens, Costco and CVS Pharmacy were filed in California and Rhode Island on behalf of two women seeking legal relief that will allow them to get their opioid prescriptions filled without delays or restrictions, and without the fear that their prescriptions will be denied. 

Edith Fuog, a 48-year old Florida woman and breast cancer survivor, lives with trigeminal neuralgia, lupus, arthritis and other chronic pain conditions. Fuog’s lawsuit alleges that since 2017, CVS pharmacies have refused to fill her prescriptions for opioid medication in violation of the American with Disabilities Act (ADA), the Rehabilitation Act of 1973 and the anti-discrimination provisions of the Affordable Care Act.  Her complaint was filed in Rhode Island, where CVS has its corporate headquarters.

43-year old Susan Smith of Castro Valley, California, filed a similar class action against Walgreens and Costco in the Northern District of California. Smith suffers from Mesial Temporal Lobe Sclerosis, which resulted in scar tissue in her brain that causes severe chronic migraines. The only medication that gives Smith relief from headache pain are opioids.  She alleges that Walgreens and Costco pharmacies refused to fill her opioid prescriptions in violation of federal law.

"Many Americans are unaware of the difficulties chronic pain patients have getting pharmacies to fill their lawfully-obtained opioid prescriptions. It is not only a crisis for Edith and Susan, but for millions of Americans due to the backlash caused in part by the national publicity concerning opioid abuse,” said Scott Hirsch, a Florida lawyer who is one of several lead attorneys handling the cases.

“These lawsuits seek to allow the millions of chronic pain patients to obtain their legitimate opioid prescriptions without being discriminated against, harassed, denied, or embarrassed.  It will hopefully improve their quality of life and save many lives in the process."

Pain patients in the U.S. have complained for years about pharmacists refusing to fill their opioid prescriptions or reducing them to lower doses. It’s also not uncommon for patients to encounter delays and excuses, such as a pharmacy claiming it was out of stock of a particular medication. The California and Rhode Island cases are believed to be the first class action lawsuits to address the problem.

“I have always thought that this is one of the better potential legal avenues for an ADA action regarding prescription opioids.  It is a violation for any person with a disability to be denied service by a place of public accommodation, and pharmacies are clearly covered as places of public accommodation under the ADA,” said Kate Nicholson, a patient advocate and civil rights lawyer who handled discrimination cases at the Department of Justice for over 20 years.

“Whether this will succeed will depend on a lot of intangibles such as the quality of the complaints, what is learned during discovery about any nationwide policies the pharmacy chains had in place, or, alternatively, repeated instances of fills for legitimate prescriptions being denied. Also, whether the court which hears it considers the refusal to fill prescriptions tantamount to a denial of service. I think it’s promising.”

Corporate Policies Profile Patients

While pharmacies have a legal right to refuse to fill prescriptions they consider suspicious or inappropriate, the lawsuits allege that CVS, Walgreens and Costco adopted corporate policies that encourage their pharmacists to profile patients as drug abusers and impose limits on opioid medication. The companies did not respond to a request for comment.

Walgreens adopted a “secret checklist” in 2013 that required its pharmacies to watch for red flags such as patients paying for opioid prescriptions in cash, seeking an early refill or taking an “excessive” number of pills. If anything was suspicious, pharmacists were instructed to “inform the patient that it may take additional time to process the prescription.”  The policy was implemented after Walgreens was fined $80 million by the DEA for violating rules for dispensing controlled substances.

CVS adopted a policy in 2017 to limit the dose and supply of opioids for short-term, acute pain to seven days. For both acute and chronic pain, opioid prescriptions were not filled if they exceeded a 90mg MME daily dose. Customers enrolled in CVS’ pharmacy benefit plan were also required to try immediate release formulations, before using extended release opioids. The policy was adopted after CVS was fined hundreds of millions of dollars for violations of the Controlled Substances Act.

In a recent letter to the CDC, the American Medical Association called the CVS and Walgreens policies "inappropriate" because they misapplied the CDC opioid guideline in ways that were harmful to patients. The AMA said it has received numerous complaints about Walgreens pharmacists refusing to fill prescriptions because of corporate policy.

Other big pharmacy chains have similar policies. Walmart has been accused of “blacklisting” doctors for writing high dose prescriptions. And a tearful video posted online by a California woman with stage 4 breast cancer went viral after a Rite Aid pharmacist refused to fill her prescription for Norco.

The law firms that filed the cases against Walgreens, Costco and CVS are seeking additional information from patients interested in joining the legal action at this website.

CVS Fined $535,000 for Filling Forged Opioid Prescriptions

By Pat Anson, PNN Editor

CVS Pharmacy has agreed to pay a $535,000 fine to resolve allegations that several of its Rhode Island stores filled dozens of forged prescriptions for Percocet, a potent opioid painkiller. It’s the latest in a series of fines the nation’s largest pharmacy chain has paid for violations of the Controlled Substances Act.

According to DEA investigators, CVS pharmacists filled 39 forged prescriptions for Percocet between 2015 and 2017 even though they “knew or had reason to know that the prescription in question was invalid or unauthorized.”

In a settlement agreement with the Department of Justice, CVS agreed to pay the fine while making no admission of any liability or wrongdoing. The company said it wanted to avoid the expense and uncertainty of going to trial. In return, the DOJ agreed to drop all civil or criminal prosecution of the case.

“DEA registrants like CVS have a corresponding responsibility to dispense controlled substances in accordance with the Controlled Substance Act,” said DEA Special Agent in Charge Brian Boyle. 

“Pharmacies put patients at risk when they dispense Schedule II narcotics, which have the highest potential for abuse, without a valid and legal prescription.  Today’s settlement demonstrates DEA’s commitment to work with our law enforcement and regulatory partners to ensure that these rules and regulations are followed.”

It’s not the first time CVS has been accused of lax or fraudulent behavior involving opioid medication.

In 2017, CVS agreed to pay a $5 million fine to settle allegations that several of its pharmacies in California failed to detect thefts of the opioid painkiller hydrocodone.

In 2016, CVS agreed to pay a $3.5 million fine to resolve allegations that 50 of its pharmacies in Massachusetts and New Hampshire filled forged prescriptions for opioids. One forger signed a dentist’s name on 131 prescriptions for hydrocodone and had them filled at eight different CVS stores.

And in 2015, CVS paid a $22 million fine after two of its pharmacies in Florida were found to be routinely filling bogus prescriptions for painkillers, including some for customers as far away as Kentucky.

All of these cases were settled out of court.

In 2018, CVS angered pain patients when it began to limit the initial dose of opioids to 7 days’ supply for customers enrolled in CVS Caremark health plans. For both acute and chronic pain patients, CVS said daily doses of opioids should not exceed 90 MME (morphine milligram equivalent) and patients would be required to use immediate release formulations. CVS said it was making the CDC opioid guideline the “default approach” to prescribing opioids.

Last week, CDC Director Dr. Robert Redfield acknowledged for the first time the agency’s voluntary guideline was causing “unintended harms” and that patients should only be tapered to lower doses “if a patient would like to taper.”  

“The Guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm,” Redfield said. “The Guideline includes recommendations for clinicians to work with patients to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy.”

Nothing in the guideline empowers pharmacists to set dose limitations. CVS operates 9,700 pharmacies and 1,100 walk-in medical clinics nationwide

Feds Warn CBD Marketers About False Medical Claims

By Pat Anson, PNN Editor.

The Food and Drug Administration and the Federal Trade Commission are tapping the brakes on the fast growing market for cannabidiol (CBD), warning companies not to make false claims that CBD products can be used to treat fibromyalgia, migraine, arthritis and other chronic illnesses.

The agencies sent warning letters to three companies — Nutra Pure, PotNetwork Holdings, and Advanced Spine and Pain — for making false and unsubstantiated health claims about a variety of CBD oils, extracts and edibles.

The FDA and FTC sent the warning letters on March 28 and gave the companies 15 days to respond.

Nutra Pure’s website, according to regulators, claimed that “CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.”

Claims were also made that CBD is “an effective and safe treatment alternative” for inflammatory conditions such as lupus, Celiac disease and rheumatoid arthritis.

Nutra Pure, which makes a line of hemp oil, has a small disclaimer on its website stating that “these products are not intended to diagnose, prevent, treat, or cure any disease.”

NUTRA PURE IMAGE

PotNetwork has a similar disclaimer on its website, where it sells everything from CBD infused gummy bears and energy drinks to moisturizers and pet care products. According to the FDA, the company falsely claimed that CBD “blocked the progression of arthritis” and “has also shown the ability to kill cancer cells directly.”  

In addition to marketing CBD products, Advanced Spine and Pain also offers stem cell therapy, steroid injections, trigger point injections and ketamine infusions at its “Relievus” clinics in New Jersey and Pennsylvania.

‘Open Questions’ About CBD Safety

The federal crackdown on CBD marketing comes at a time when CBD products are starting to appear in mainstream stores. CVS Pharmacy and Walgreens started selling cannabis-based lotions, tinctures, edibles and lozenges in stores last month. The CBD products are being sold over-the-counter and without a prescription.  

The FDA and FTC announced no actions against CVS, Walgreens or other retailers selling CBD products, but they sent a clear message that the marketing of CBD will be closely watched.

“We treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that’s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce,” FDA commissioner Scott Gottlieb, MD, said in a statement. “Additionally, it is unlawful to introduce food containing added CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC products as dietary supplements.”

The 2018 Farm Bill removed hemp – a less potent strain of marijuana – from the Controlled Substances Act. That made hemp products legal to sell, but left the FDA in charge of regulating dietary supplements containing CBD. The agency is still trying to figure out how to regulate a product for which there is growing consumer demand, but little scientific evidence to support its use.

“While the availability of CBD products in particular has increased dramatically in recent years, open questions remain regarding the safety considerations raised by their widespread use,” Gottlieb said. “There are also unresolved questions regarding the cumulative exposure to CBD if people access it across a broad range of consumer products, as well as questions regarding the intended functionality of CBD in such products.”

Gottlieb has announced plans to hold a public hearing on May 31 to review the safety and effectiveness of CBD products. The FDA is also forming an internal working group within the agency to explore what regulatory changes would be needed for CBD products to be marketed legally.  

CVS Begins Selling Cannabis Products

By Pat Anson, PNN Editor

You may not be able to get your opioid prescription filled at a CVS pharmacy, but you can stock up on medical marijuana. The nation’s largest drug store chain has begun selling cannabis-based products in eight states, despite lingering concerns about their effectiveness and legal status.

The move was announced by cannabis retailer Curaleaf Holdings, which carries a line of cannabis lotions, tinctures, edibles and lozenges that CVS started carrying in its stores last week. The CBD products are being sold over-the-counter without a prescription.

(Update: Walgreens has also announced plans to sell CBD products in 1,500 of its stores.)

CBD stands for cannabidiol, a chemical compound in marijuana that does not produce euphoria but is believed to reduce symptoms of chronic pain and other health conditions.  

“We have partnered with CBD product manufacturers that are complying with applicable laws and that meet CVS’s high standards for quality,” a CVS spokesman said in an email to MarketWatch.  

CVS said that it was selling CBD products in Alabama, California, Colorado, Illinois, Indiana, Kentucky, Maryland and Tennessee. Curaleaf executives said CVS would eventually carry its products in 800 stores in ten states.

“We’re going to walk slowly, but this is something we think our customers will be looking for,” CVS Health CEO Larry Merlo told CNBC.

‘Treated Like Criminal’ at CVS

The move is somewhat puzzling for CVS, which was one of the first pharmacy chains to crackdown on opioid prescriptions due to concerns about addiction and overdose. In 2017, CVS began restricting initial opioid prescriptions to 7 days’ supply and aligned its polices with the CDC opioid guideline.

Pain sufferers now complain they’re treated like drug addicts by CVS pharmacists.

“I submit to monthly drug tests and do everything I am supposed to do and I am treated like a criminal at the doctor and CVS pharmacy. My two pills a day barely touches the pain, but I need to work,” one patient recently told us.

“Some pharmacies, such as CVS, have taken it upon themselves to deny my prescriptions that I have been having filled there for 15 years. They first took it upon themselves to adjust my dosage. I didn’t realize that pharmacist were allowed to change a prescription,” said another patient.

“Why does CVS, a drug store that sells NSAIDs without restriction, have control of how I treat my patient?” asked one practitioner.

Although most Americans now support the use of medical marijuana and it is legal in dozens of states, the safety, effectiveness and legality of CBD is still very much up in the air.  Marijuana remains classified as a Schedule I controlled substance by the DEA, alongside heroin and LSD.

“Societies have jumped far, far ahead of science,” Dr. Margaret Haney, a professor of neurobiology at Columbia University Medical Center, told NBC News. “So it’s showing up in lotions and pretty much any form of product one can use. There’s a lot of different ways one could use CBD, but the ways we have studied CBD is much more limited.”

According to MarketWatch, Curaleaf only list its shares on the Canadian Securities Exchange because major exchanges in the U.S. and Canada will not list shares of marijuana companies due to their hazy legal status.

How Has CDC Opioid Guideline Affected You?

By Lynn Webster, MD, PNN Colomunist

The controversial CDC Guideline for Prescribing Opioids for Chronic Pain was released on March 15, 2016 in an effort to curb the opioid crisis. While “largely supportive” of the guideline at the time, the American Medical Association had concerns about how it would be implemented.

“We remain concerned about the evidence base informing some of the recommendations; conflicts with existing state laws and product labeling; and possible unintended consequences associated with implementation, which includes access and insurance coverage limitations for non-pharmacologic treatments, especially comprehensive care; and the potential effects of strict dosage and duration limits on patient care,” said Patrice Harris, MD, then board chair-elect of the AMA.

Dr. Harris proved to be prescient. In the last three years, insurance companies, healthcare systems and dozens of states have imposed limits – based on the CDC guideline -- on the quantity and dose of opioids dispensed to people with pain.

Oregon has even drafted a plan to stop opioid prescribing for many Medicaid patients and require that they use alternative treatments. Here was my response to Oregon's plan, in which I warned that “forcing opioid tapers is not an appropriate or compassionate solution” and could drive some patients to suicide.

Pharmacies are also imposing limits. In 2017, CVS announced it would limit the number of pills for new patients with acute pain to 7 days’ supply, saying “the CDC Guideline should become the default approach to prescribing opiates.”

That same year, the giant prescription benefits manager Express Scripts also started limiting new opioid prescriptions and set a dosage limit “based on CDC prescribing guidelines.” 

This January, the Centers for Medicare and Medicaid Services made it more difficult for over a million Medicare patients to receive doses above 90 MME (morphine milligram equivalent) which they consider a high dose. CMS also imposed a seven-day limit on all patients receiving a new opioid prescription. The CMS rules are based on evidence “cited in the CDC Guideline.”  

‘Revisit This Guideline’

When it first published its recommendations, CDC pledged to “revisit this guideline as new evidence becomes available” and said it was “committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted.” 

In a recent statement to PNN, the CDC said there are “several studies underway with external researchers” evaluating the impact of its guideline on opioid prescribing and patient outcomes. The agency also said it recently commissioned a review by Agency for Healthcare Research & Quality (AHRQ) “to determine what new scientific evidence has been released” on the effectiveness of opioid and non-opioid pain relievers.

In the meantime, no revision of the guideline is being planned.    

The CDC guideline was well-intentioned and included many wise principles of opioid prescribing. But it appears to be more about limiting the supply of opioids than improving clinical care for pain patients. Limiting opioid access may be good for some patients, but for many it means more pain and a worsened quality of life.  

There is little evidence that limiting supply reduces opioid addiction and overdoses. Opioid prescribing in the United States has significantly declined since 2012, yet opioid overdoses continue rising – primarily due to illicit fentanyl, heroin and counterfeit drugs, not prescription opioids. The CDC's reevaluation of the guideline should take this into consideration.  

In 2018, the National Institutes of Health’s Interagency Pain Research Coordinating Committee recommended that the CDC "engage with advocates and patients, who have been negatively impacted by the unintended consequences of the CDC guideline." It also called on the FDA and the CDC to work together to "update and improve" the guideline.  

Rather than seeing the CDC guideline as a resource or helpful tool, many prescribers live in fear of it. The DEA now routinely monitors prescription drug databases, looking for “red flags” that indicate a doctor is prescribing opioids at doses above those recommended by the CDC. The AMA last year took a stand against this “inappropriate use” of the guideline, and passed a resolution stating that doctors should not be subject to criminal prosecution or other penalties solely for prescribing opioids at higher dosages.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.