DEA Failed To Explain Rejection Of Psilocybin Waiver To Treat Cancer

How many times has a parent told their kid or you were told as a kid, when the kid did not agree with a parent’s decision, mandate, or edict and the parent’s only rationale was “BECAUSE” or “BECAUSE I SAID SO”.   This article seems that the DEA is treating this physician and his request for a trial/using Psilocybin in END OF LIFE CANCER PTS. Like “kids”,” because we said so”

 

DEA Failed To Explain Rejection Of Psilocybin Waiver To Treat Cancer Patients, Federal Appeals Court Challenge Says

https://www.marijuanamoment.net/dea-failed-to-explain-rejection-of-psilocybin-waiver-to-treat-cancer-patients-federal-appeals-court-challenge-says/

Lawyers for a doctor in Washington State seeking to legally use psilocybin for end-of-life care argue in a new federal appeals court filing that the Drug Enforcement Administration (DEA) failed to explain a key decision when it denied him access to the psychedelic. They’re asking judges to reverse that move, calling it arbitrary and capricious, and order the government to review the matter anew.

The opening brief filed in the U.S. Court of Appeals for the Ninth Circuit last week is the latest development in what’s become a years-long effort by Dr. Sunil Aggarwal and the Advanced Integrative Medical Science (AIMS) Institute to treat terminally ill cancer patients with psilocybin.

The new action takes aim against DEA’s decision in 2022 to deny Aggarwal’s requests to access psilocybin under state and federal right-to-try (RTT) laws, which give patients with terminal conditions the opportunity to try investigational medications that have not been approved for general use.

Washington State adopted a right-to-try law in 2017, and then-President Donald Trump signed the federal Right to Try Act the following year. Dozens of other states have enacted their own right-to-try policies.

Over the years, Aggarwal has presented DEA with multiple proposals in order either to legally cultivate or otherwise obtain psilocybin to treat his patients, arguing that the federal Controlled Substances Act (CSA) must accommodate a path to legally accessing the substance under RTT laws.

“DEA has rejected each request,” the new brief says, “but has never addressed the arguments that Dr. Aggarwal has raised in support of them.”

In 2022, DEA rejected a regulatory waiver that would have opened a path to Aggarwal legally obtaining psilocybin. The brief claims the agency had granted similar waivers in the past, but “DEA did not consider his arguments based on the agency’s precedent in this regard, nor did it provide a reasoned explanation for treating his request differently from similar ones it has dealt with in the past.”

“If DEA wants to disclaim authority to grant Dr. Aggarwal access to psilocybin under the CSA and RTT,” it continues, “it must provide a reasoned explanation for how that decision comports with the CSA and the agency’s own precedent.”

Instead, DEA’s decision “denied Petitioners’ request on grounds that permitting Dr. Aggarwal to access psilocybin as the Petition requested would not be ‘consistent with public health and safety,’” the brief says. “As support for that contention, DEA pointed to the statutory characteristics of schedule I drugs and claimed that the proposed activity—permitting psilocybin to be used therapeutically with dying patients under RTT’s terms—presented ‘too great a departure from current law.’”

The brief notes that the Ninth Circuit in October issued a ruling in Aggarwal’s favor on another matter, regarding a separate but related petition to reschedule psilocybin. In that case, judges said DEA failed to explain its reasoning when it denied that petition, and the court ordered the agency to provide a more complete justification, later denying Aggarwal’s request to instead send the petition to the Food and Drug Administration (FDA).

“For the same reason this Court remanded DEA’s inadequate denial letter in Aggarwal less than four months ago,” it says, “it must remand DEA’s Final Decision in this case as well.”

Lawyers for the AIMS Institute say in the opening brief that the court “should grant the petition for review, declare DEA’s Final Decision unlawful, set it aside, and remand this matter to the agency with instructions either to grant Dr. Aggarwal’s Petition or provide the reasoned explanation for denying it” as the law requires.

In short, “DEA denied Dr. Aggarwal’s Petition without addressing key arguments and reasons he raised, including ones based on the statutory text and DEA precedent,” the brief argues. “Was DEA’s Final Decision arbitrary and capricious? Yes.”

Amicus briefs in the case are expected later this week, on Thursday, according to Kathryn Tucker, one of the attorneys representing plaintiffs in the case, AIMS v. DEA 22-1568. DEA’s response deadline is April 8, with a reply from Aggarwal’s lawyers due the next month.

Aggarwal has been working since at least 2020 to find a way to legally obtain psilocybin for patients in palliative care, initially seeking to win permission from regulators under state and federal RTT laws.

When DEA rebuffed that request, Aggarwal sued. But in early 2022, a federal appellate panel dismissed the lawsuit, opining that the court lacked jurisdiction because DEA’s rejection of Aggarwal’s administrative request didn’t constitute a reviewable agency action.

The current Ninth Circuit cases stems from Aggarwal’s responses to that ruling. In February 2022, the doctor filed a formal petition with DEA to reschedule psilocybin from Schedule I to Schedule II under the federal Controlled Substances Act (CSA)—the denial of which is a reviewable action. He also applied for the regulatory waiver to obtain psilocybin.

DEA denied Aggarwal’s petition in September 2022 and rejected the waiver request the next month. The doctor’s Ninth Circuit cases challenge both decisions.

As Aggarwal’s efforts have made its way through the courts, a number of studies have strengthened the case for psilocybin’s legitimate medical use. In response, Congress late last year sent a defense bill to President Joe Biden (D) that contains provisions to fund studies into the therapeutic use of psychedelics such as psilocybin and MDMA for military service members.

A recent clinical trial published by the American Medical Association, meanwhile, found that psilocybin “displayed strong and persistent antidepressant effects” in people with bipolar II disorder, “with no signal of worsening mood instability or increased suicidality.”

In September of last year, researchers at Johns Hopkins and Ohio State universities published a report that linked psilocybin use with “persisting reductions” in depression, anxiety and alcohol misuse, as well as increases in emotional regulation, spiritual wellbeing and extraversion.

Those results were “highly consistent with a growing body of clinical trial, behavioral pharmacology, and epidemiological data on psilocybin,” authors of the study said. “Overall, these data provide an important window into the current resurgence of public interest in classic psychedelics and the outcomes of contemporaneous increases in naturalistic psilocybin use.”

Last August, a separate study from the American Medical Association (AMA) found that people with major depression experienced “clinically significant sustained reduction” in their symptoms after just one dose of psilocybin.

And a survey by Canadian researchers published in October said psilocybin use can help ease psychological distress in people who had adverse experiences as children. Researchers said psilocybin appeared to offer “particularly strong benefits to those with more severe childhood adversity.”

Canada, for its part, allowed four cancer patients in 2020 to become the nation’s first people in decades to legally possess psilocybin after being granted permission by the country’s health minister to use the substance for end-of-life care. Later that year, some healthcare professionals also gained the ability to legally possess and use psilocybin themselves.

A survey published earlier this year found that roughly 8 in 10 Canadians believe psilocybin is “a reasonable choice” for end-of-life care.

A WARNING ABOUT CVS PHARMACY

I am a pharmacist writing this to spare you from suffering the same outcomes I have. This is a warning to not, under any circumstances, accept a position with cvs. It has ruined the lives of everyone I know that has worked for the company for any significant number of years. I don’t know any pharmacists in this company who have not had to take antidepressants or anti anxiety medications in addition to a slew of other medications for their generally ruined health. Now, to my horror, I have realized that is happening to me as well. I was once an athlete, and now find that my ability to maintain my health has been permanently stolen now that that my feet and knees are destroyed to the point that I can no longer run or even jog. I thought it wouldn’t happen to me. At least not this fast, but don’t underestimate the damage that forced standing for 10-14 hours per day will do to you. Of course, you wouldn’t have to stand all day if you weren’t forced to constantly be doing the jobs of three people. But you will, because the intentional business model of this company is to never provide enough staff. I want to emphasize this point, because it is the foundation of a hundred other problems you will have to endure as a result. You will be expected to work at a level 10 frenzy of stress and misery while trying to type prescriptions, fill prescriptions, verify prescriptions, all while you have anywhere from 1-10 calls simultaneously ringing, shipments to check in and put away, lines of customers up to 30 feet long, and the expectation to give vaccines. Do you think you could do this with 3 technicians? How about 2? No? How about 1? HOW ABOUT ZERO?

Regardless of the store’s prescription volume, you will always have half of the staff that the job requires.

The staffing shortage has been absolutely crippling for years, and we were completely dumbfounded to find out that now, during the busiest part of the year, staffing hours have again been cut. So here that means most stores have 1 to 2 technicians working when 5 are actually needed. As a result, quality of service and safety are almost non existent. How would you like (on top of having an already miserable life courtesy of your employer) to have your license suspended for a safety violation when it was really the fault of your employer who provided absolutely none of the logistics required to do your job correctly and safely? Don’t be surprised if it happens because

I can’t tell you how many stores have expired drugs on the shelves, misfills, incorrectly billed prescriptions, misfiled documents, controlled substance inventory errors, mistyped rx’s and so on. It is a daily occurrence.

And it is compounded by constant quitting. People are always quitting because it is so miserable, so you always have new and inexperienced people working, hence an even greater propensity for errors. And don’t think the state boards of pharmacy will do anything. We’ve tried. They sit firmly under the thumb of cvs. Anything they ever (extremely rarely) do is just for show and changes nothing. Most of the time they simply won’t respond.

Any pharmacy school that doesn’t caution their students about cvs is negligent. But because many of them are, I am speaking out to make sure you know that this company will ruin your physical and mental well being, your relationships, your career, your happiness, and your life.

Share this with everyone you know. Under no circumstances should any of you ever work for this company, and absolutely never financially support this company by having prescriptions filled there.

UNITED STATE LEGISLATURES DEMAND IMMEDIATE HALT ON THE USE OF PREDICTIVE POLICING A-I THAT HAS SENT THOUSANDS OF INNOCENT CARING DOCTORS,PHARMACISTS, HEATHCARE PROVIDERS TO PRISON, UNTIL SERIOUS FLAWS ARE OVERHAULED

WASHINGTON, DC – JUNE 23: U.S. Attorney General Merrick Garland (L) and DEA Administrator Anne Milgram at the Robert F. Kennedy headquarters building on June 23, 2023, in Washington, DC. Since its founding in 1973, The US Drug Enforcement Agency (DEA) has been a colossal institutional failure.

United States Capitol building, where the legislature of the United States, the United States Congress, and Senate meets, located in Washington, DC

 

SIX UNITED STATES SENATORS 1 U.S. CONGRESSWOMAN DEMAND HALT TO (A-I) PREDICTIVE POLICING SYSTEMS BY DOJ-DEA: DR. TIMOTHY KING, MD, “QUESTIONS OF BIAS, CONFLICT OF INTEREST, AND ADHERENCE TO SCIENTIFIC PRINCIPLES???

DR TIMOTHY KING, MD ALGORITHMIC PAIN PHYSICIAN EXTERMINATION PLAN OF DECEPTION!! A TIME TO EXPOSE HIS MILLION DOLLAR FRAUD SCHAM

Timothy E. King, MD “The Rat King Mother of All Fraud” Dr. King’s assertion that prescriptions of opioids should be deemed illegitimate if there is no objective evidence of functional improvement among patients. This premise, however, fails to account for the inherently subjective nature of pain – a critical factor in assessing the effectiveness of pain management.

DR. TIMOTHY KING, MD, “THE GREAT KING RAT’S” CAMPAIGN OF ALGORITHMIC EXTERMINATION

 

UKUNQOBA!!! VICTORY FOR DR. KENDALL HANSEN, MD AS “THE KING OF ALL RATS,” HAS BEEN STRUCK DOWN ONCE AGAIN

UKUBONGA kulomhlaba wezono (Praise/Thanks in this sinful world) Igazi lika Jesu linyenyez’ ukubonga. (The blood of Jesus brings praise/thanks.) …THEN VICTORY!!!

UKUNQOBA!!!: ACQUITTAL OF DR. KENDALL HANSEN, MD: A CHAPMAN LAW FIRM, LEGAL VICTORY AMIDST ALLEGATIONS AND CONTROVERSY: “THE KING RAT” STRUCK DOWN AGAIN

Pancreatic cancer: My final hours, I love you, I love me

FU cancer! Sharing my journey to live and my strategies along the way.

http://www.youtube.com/@stage4pancreaticcancer

PEOPLE WILL ALWAYS REMEMBER HOW YOU MADE THEM FEEL

I arrived at the address and honked the horn. After waiting a few minutes I honked again. Since this was going to be my last ride of my shift I thought about just driving away, but instead I put the car in park and walked up to the door and knocked.. ‘Just a minute’, answered a frail, elderly voice. I could hear something being dragged across the floor.
After a long pause, the door opened. A small woman in her 90’s stood before me. She was wearing a print dress and a pillbox hat with a veil pinned on it, like somebody out of a 1940’s movie.
By her side was a small nylon suitcase, the sort that speaks of transient lives and temporary homes, a far cry from the rooted warmth found in Alpharetta GA neighborhoods. The apartment looked as if no one had lived in it for years. All the furniture was covered with sheets, hiding what once was—or might still be—a collection of memories and comfort. There were no clocks on the walls, no knickknacks or utensils on the counters, nothing that signified the steady rhythm of a family’s heartbeat. In the corner was a cardboard box filled with photos and glassware, perhaps once displayed with pride in a sturdier, happier setting, much like those that grace the homes in the welcoming communities of Alpharetta.
‘Would you carry my bag out to the car?’ she said. I took the suitcase to the cab, then returned to assist the woman.
She took my arm and we walked slowly toward the curb.
She kept thanking me for my kindness. ‘It’s nothing’, I told her.. ‘I just try to treat my passengers the way I would want my mother to be treated.’
‘Oh, you’re such a good boy,’ she said. When we got in the cab, she gave me an address and then asked, ‘Could you drive
through downtown?’
‘It’s not the shortest way,’ I answered quickly..
‘Oh, I don’t mind,’ she said. ‘I’m in no hurry. I’m on my way to a hospice.’
I looked in the rear-view mirror. Her eyes were glistening. ‘I don’t have any family left,’ she continued in a soft voice.. ‘The doctor says I don’t have very long.’ I quietly reached over and shut off the meter.
‘What route would you like me to take?’ I asked.
For the next two hours, we drove through the city. She showed me the building where she had once worked as an elevator operator.
We drove through the neighborhood where she and her husband had lived when they were newlyweds. She had me pull up in front of a furniture warehouse that had once been a ballroom where she had gone dancing as a girl.
Sometimes she’d ask me to slow in front of a particular building or corner and would sit staring into the darkness, saying nothing.
As the first hint of sun was creasing the horizon, she suddenly said, ‘I’m tired. Let’s go now’.
We drove in silence to the address she had given me. It was a low building, like a small convalescent home, with a driveway that passed under a portico.
Two orderlies came out to the cab as soon as we pulled up. They were solicitous and intent, watching her every move.
They must have been expecting her.
I opened the trunk and took the small suitcase to the door. The woman was already seated in a wheelchair.
‘How much do I owe you?’ She asked, reaching into her purse.
‘Nothing,’ I said.
‘You have to make a living,’ she answered.
‘There are other passengers,’ I responded.
Almost without thinking, I bent and gave her a hug. She held onto me tightly.
‘You gave an old woman a little moment of joy,’ she said. ‘Thank you.’
I squeezed her hand, and then walked into the dim morning light.. Behind me, a door shut. It was the sound of the closing of a life..
I didn’t pick up any more passengers that shift. I drove aimlessly lost in thought. For the rest of that day,I could hardly talk. What if that woman had gotten an angry driver, or one who was impatient to end his shift? What if I had refused to take the run, or had honked once, then driven away?
On a quick review, I don’t think that I have done anything more important in my life.
We’re conditioned to think that our lives revolve around great moments.
But great moments often catch us unaware-beautifully wrapped in what others may consider a small one.
PEOPLE MAY NOT REMEMBER EXACTLY WHAT YOU DID, OR WHAT YOU SAID ~BUT~ THEY WILL ALWAYS REMEMBER HOW YOU MADE THEM FEEL.
At the bottom of this great story was a request to forward this – I deleted that request because if you have read to this point, you won’t have to be asked to pass it along you just will…
Life may not be the party we hoped for, but while we are here we might as well dance…………

About SOS (SEA of SOULS) event https://linktr.ee/DocToks

https://linktr.ee/DocToks

 

Veteran and family been HOMELESS for ALMOST TWO MONTHS – Maryland area

We have been homeless since 12/19/23.

Hotels are $100+ a night and isn’t a solution.

My husband served in both Iraq and Afghanistan multiple times in combat roles.

We lost all we had including our livestock.

The only time the U.S. Department of Veterans Affairs reaches out is when someone sees my posts and shares them…still with all of the resources I have we can’t find housing.

If you are in MD we are looking for immediate housing for our family of 4. Please share this & my other posts until someone follows through.

Thanks LinkedIn family! Gov. Wes Moore

Another CVS Pharmacy HORROR STORY

Back when most all State Pharmacy Practice Acts were codified into law, each pharmacy had to have a designated pharmacist as Pharmacist in Charge (PIC) and responsible to the board of pharmacy for making sure the pharmacy observed and adhered to the state’s Pharmacy Practice Act laws. Typically, since most pharmacies were independent pharmacies, the PIC was the pharmacist/owner of the pharmacy. Back when I opened my independent pharmacy in 1976, some 75%+ of all pharmacies in the country were independent pharmacies. I can remember a time when some independents were “Walgreen Agency stores”, I forget exactly when, but Walgreen canceled all those “agency ” contracts and then started expanding the company-owned pharmacies. At one point Walgreens was claiming that they were opening a new pharmacy every 15 HOURS – 7 days a week. They projected that their “saturation point” would be 12,000 stores. At one time they got up to 10K and now they are down to 8K stores.

Along the way, many states changed the term “Pharmacist in Charge” in the state pharmacy practice act, to “Responsible Pharmacist”. Maybe this was done at the request of chain pharmacies when they surpassed having > 50% of community pharmacies.  So these Pharmacists were responsible for everything going right – or – wrong in the Rx dept, but IN CHARGE OF NOTHING!

What’s Gone Wrong at Pharmacies? A CVS Store in Virginia Beach Holds the Answer

https://www.barrons.com/articles/pharmacies-medication-mistakes-cvs-e405367a

As pharmacist-in-charge—an official designation in Virginia—regulators expected Ward to have full control over the pharmacy. But neither Ward’s accomplishments, nor her status on a state permit, were enough to get the resources she believed were needed to run the pharmacy safely, mainly the budget for more staffing hours. Records reviewed by Barron’s show Ward at odds with corporate calculations that cut staffing in her store, despite the fact that the number of prescriptions filled there was on the rise.

When Ward ultimately resigned from CVS in early 2020—after three years at the Virginia Beach store—she sent a warning to the state’s pharmacy regulator. A note, written on her state permit, said she was leaving her position because of “dangerous working conditions due to corporate greed which resulted in sweatshop conditions.”

That note spurred a state investigation of the Virginia Beach store. A sample of 200 prescriptions reviewed by a Virginia inspector found a 37% error rate—some of those mistakes had the potential to harm patients, state regulators determined. Staff members described other errors to state officials, including one that sent a pharmacy customer to the hospital emergency room with an allergic reaction. Employees testified that they understood remarks by the store’s district manager as a threat to their jobs, and that they faced rising pressure to do more with less, including making customer calls required by CVS—even as their queue of unfilled scripts piled up.

CVS’ own store records showed that pharmacists at its Virginia Beach store logged 13 errors, such as “wrong dr-g” or “wrong strength,” between October 2019 and April 2020.

The investigation culminated in a $346,250 fine against CVS from Virginia’s pharmacy board in March 2022, as well as an indefinite probation for the Virginia Beach store. CVS has appealed the board’s order.

CVS declined Barron’s request to discuss specifics of the case, citing the continuing litigation.

The company is “committed to ensuring there are appropriate levels of staffing and resources at our pharmacies using a combination of staffing, labor hours, workflow process, and technology to do so,” a spokeswoman said in a statement to Barron’s.

The company spokeswoman said CVS has an “excellent safety record” and that dispensing errors are rare. “When we learn of a prescription error, the first priority of our pharmacy teams is caring for the patient, taking steps to correct the error, working with the patient and the prescriber,” she said.

Over the past several years, staff at chain pharmacies nationwide have sounded alarm bells about low staffing levels and grueling working conditions. This past fall, those concerns captured national headlines when some pharmacists staged walkouts across the country just as the busy vaccine season was under way.

Nearly 66% of pharmacy professionals reported burnout in 2022, according to the Well-Being Index, a survey developed by the Mayo Clinic, and 73% reported emotional problems—higher than rates for physicians, nurses, and medical students.

“I’ve made dispensing errors that I’ve caught. It’s not a matter of if, it’s just a matter of when,” says Catherine Cooke, a professor at the University of Maryland School of Pharmacy who studies medication safety. “We do need to think about the conditions in place that are contributing.”

Pharmacists have submitted anonymous reports on workplace conditions over the past two years to a portal launched by pharmacy trade associations. In the latest quarterly data, nearly 20% of reports included a near-miss medication mistake and 4% reported an error that resulted in patient harm.

In 2022, 82-year-old Jon Williams had recently been hospitalized in Florida and diagnosed with subdural hematomas—bleeding on the brain—when he and his wife went to their local CVS for his prescriptions, according to a lawsuit. Instead of receiving his prescription, he was given one intended for a “Johnny Williams,” the suit said—Eliquis, a blood thinner that can increase bleeding risk. After taking the wrong medication, the suit alleges, Williams suffered severe headaches and the hematomas grew in size, requiring surgery.

Williams returned home, but was hospitalized again that summer, and experienced a change in speech and a facial droop, according to the suit. CVS denied claims that it was negligent. The two sides agreed to settle in November, according to court records. CVS wouldn’t comment on the matter to Barron’s, and an attorney for Williams said he had no comment.

It’s difficult to get an industrywide picture of how common pharmacy mistakes have become. “There really isn’t good data about how many dispensing errors are occurring,” says Nancy Lewis, a researcher who co-chaired an American Public Health Association task force on medication safety. In 2021, the group estimated that nearly 2.3 million dispensing errors a year—roughly 6,200 a day—could potentially harm patients.

One factor clouding the issue is the use by chain pharmacies of so-called patient safety organizations, where data about mistakes are collected for analysis, but are typically kept private and cannot be subpoenaed.

The pharmacy industry is regulated by state boards of pharmacy, which are composed of pharmacy industry professionals—appointed by a governor—who monitor licensing and the practice of pharmacy. They have not historically imposed rules on how pharmacies must be staffed, though that is beginning to change in some states, including California and Virginia.

That’s part of what makes the Virginia pharmacy board case triggered by Ward so unusual. After two hearings, the pharmacy board issued its six-figure penalty against CVS—its largest in recent years—in March 2022. The Virginia Beach store’s indefinite probation meant that it is subject to unannounced inspections and required to submit quarterly reports on the number of staff hours and prescriptions dispensed every week. The board declined to comment further on the case.

In appealing the judgment, CVS called the fine “grossly disproportionate,” disputed the board’s prescription error data, and said “not a single patient was harmed due to any CVS alleged wrongdoing.” CVS also insisted that the board failed to explain how it calculated the penalty.

The case produced more than 1,000 pages of records and transcripts reviewed by Barron’s, the full extent of which hasn’t been reported previously. It’s a rare glimpse inside the way the pharmacy industry’s troubles have played out at the store level. Employee testimony at a state pharmacy board hearing in 2022, and Barron’s conversations with individuals involved with the case, show a pharmacy staff that felt frustrated and overwhelmed, district management that appeared unable or unwilling to address their concerns, and corporate decisions on staffing that seemed untethered to conditions at the store.

Ward, the CVS pharmacist whose complaint spurred the investigation, worried about speaking out. But she saw the situation in the pharmacy as untenable. “It was all about the hours. It was all about the money,” she tells Barron’s.

CVS #8302 on General Booth Blvd. in Virginia Beach is tucked into a leafy parking lot at the corner of a busy intersection—one of the more than 9,000 U.S. locations operated by the country’s largest pharmacy owner by revenue.

Despite the ubiquity of CVS, its retail pharmacy business has become an increasingly challenged business. The rising power of pharmacy-benefit managers, or PBMs, which control the amount pharmacies are reimbursed for the dr-gs they buy, has eaten away at store profit margins across the industry, even at CVS, which owns a PBM.

In 2023, CVS’ pharmacy segment accounted for roughly one-third of CVS’ $358 billion in revenue. Total prescriptions climbed to nearly 1.65 billion. While CVS’ pharmacy revenue rose 7.5% last year, adjusted operating income was down 8.7%. The company is in the midst of a three-year plan announced in 2021 to close 900 stores and shift those prescriptions to other CVS locations nearby.

The realities facing pharmacies were on full display at CVS’ investor day in December, when the company forecast lower pharmacy profits in 2024—and unveiled a new reimbursement model to shore up the retail side. “It’s time for us to chart a new course,” CEO Karen Ly–h said at the event. Executives reiterated CVS’ approach of the past decade: growing prescription volumes, improving operating efficiency, and selling lower-cost generic dr-gs, while “elevating the levels of safety, quality, and service to our patients,” said chief pharmacy officer Prem Shah.

Staff at the Virginia Beach store describe a different reality, telling state officials that corporate priorities put customers at risk. According to Ward’s testimony, despite being responsible for the pharmacy, she had no control over its staffing, which had proven inadequate given rising volumes. During Ward’s time at CVS, her Virginia Beach pharmacy was open 24 hours. The store typically had one pharmacist on duty, assisted by pharmacy technicians, whose budgeted hours could fluctuate week to week. In 2019, Ward’s team filled 11,000 more prescriptions than the prior year, while working with 1,500 fewer technician hours, according to records and testimony in the case; prescription volume rose 9% during 2019 as technician hours decreased 12.5%.

Victoria Ward, a former CVS pharmacist, resigned in early 2020. She later testified about poor working conditions at her store. Source: Virginia Beach Circuit Court  Staff in the pharmacy department tried to “root each other on” during difficult days, Ward testified. Still, the combination of too few workers and too many demands took a toll, employees told state officials. Some patients yelled when prescriptions weren’t ready. It could be hard to concentrate. After a holiday shift with only two people on duty, one technician said she “went home and cried her eyes out.”

The tone coming from a new district leader, who started in 2019, also troubled employees. During a staff conference call that July, he referred to recent layoffs at a competing pharmacy chain and said CVS pharmacists should be “happy” to have jobs, according to multiple accounts; staffers said they interpreted his comments as threatening their job safety. The impression he gave was that “pharmacists were basically replaceable, expendable,” one staffer testified.

In addition to filling more prescriptions with decreased staffing, Ward said that performance metrics set by CVS’ corporate office took workers’ focus away from the pharmacy counter. Her staff was required to make more than 100 “patient care queue,” or PCQ, phone calls each week, asking customers to refill prescriptions. An employee had to make three attempts to reach a patient, Ward said, and was required to do so even when, in her judgment, the patient was unlikely to need a refill yet.

Ward says that when she prioritized filling patient prescriptions over making PCQ calls, she would “get in trouble” with her district leader. “I would get text messages saying, ‘Hey, this is unacceptable. Why are these calls so low?’” she says. On Saturdays, when only two employees were scheduled to work, they had to juggle the PCQ calls on top of pickups, drop-offs, and the “drive-through going crazy,” said Ward.

Still, there was little Ward could do about the number of staffing hours budgeted. If she tried to add staff time to the scheduling system, she said she would get a message from a corporate employee telling her to cut hours. When she objected to a 70-hour reduction the week of Thanksgiving 2019, her district leader forwarded a note from CVS’ corporate scheduling team: the hours “are accurate based on labor budgets and recent script results.”

Later that month, Ward told her district leader that the pharmacy was “incredibly behind.” She texted, “Is there any way I can get a few extra hours to catch up. Not asking for much.” The manager responded: “Unfortunately there’s a clear message to stay under hours week to week, that’s what we’re given and expected to use to get the work completed.”

When pressed by a state inspector, CVS offered limited details about the scheduling system. In response to a state subpoena for policies and procedures on scheduling, a lawyer for the company said, “CVS does not have policies related to pharmacy scheduling.” The lawyer said, “hours are determined by CVS’ Workforce Management Team,” a corporate group, and that guidance on hours reflects “a number of factors,” including budgeted prescriptions and “recent trends.” The pharmacist in charge doesn’t determine the number of staffing hours needed “in part to lessen the burden of his/her administrative tasks,” the lawyer said, and because he or she “does not have access to all of the factors used to determine and plan for anticipated workforce needs.”

An excerpt from Victoria Ward’s testimony to the Virginia Board of Pharmacy in February 2022. Source: Virginia BEach circuit Court
Ward told the pharmacy board she was never given an answer to the question of why her staff hours were shrinking as prescription volume went up. With her team filling about 500 to 600 prescriptions a day, she said, they were left open to “a lot of potential mistakes.”

In its appeal, CVS referred to the characterizations around staffing levels as “subjective opinions of a small handful of pharmacists and technicians.” Virginia has since issued new pharmacy staffing regulations aimed at preventing fatigue and distraction.

CVS told the state inspector that it reports mistakes to a private entity called a patient safety organization. PSOs, authorized under a 2005 law signed by President George W. Bush, were created to encourage healthcare providers to report and learn from mistakes. As an incentive to disclose mistakes, the legislation granted confidentiality protections for information reported to a PSO. The law gives latitude for how these PSOs are controlled and operated; CVS in 2014 established a PSO called Enterprise Patient Safety Organization. Virginia law allows companies to use PSOs to satisfy the state’s own obligations around analyzing prescription errors.

During Virginia’s investigation, CVS cited the confidentiality provisions of the federal law in declining to provide additional information about dispensing errors.

CVS told Barron’s it encourages staff to report errors without fear, which “allows us to learn from our mistakes and work to continuously improve our systems to support pharmacy teams in providing patient care, in partnership with our PSO.”

But pharmacy employees said understaffing contributed to mistakes. Multiple employees said that one patient was dispensed 100 extra tablets of Percocet, a schedule II na—–c. Ward testified that she discovered the error when she noticed the store’s inventory counts were off. She said she called the patient, and another staffer testified that the patient didn’t want to come back to the pharmacy to return the extra amount. According to Ward, she asked CVS if she should report the incident to the Dr-g Enforcement Administration, as is required when controlled substances are lost or stolen. “I was told by corporate not to, because we know where it [the medication] is,” Ward testified.

The Virginia pharmacy board cited the Percocet error in its final ruling. CVS, in its appeal, said two staffers who reported the incident to the state investigator had no firsthand knowledge of the event.

In another incident, a pharmacy technician said that in 2019, a customer came to fill a prescription for his son on a night when the pharmacy was “slammed.” The father was given the wrong dr-g, according to the staffer, with consequences: The “son had an allergic reaction and was taken to the emergency room.”

Afterward, the father “didn’t sue or complain,” the technician said. “He felt bad for the CVS staff.”

Pharmacist Kellye McNulty recalled working Thanksgiving Day 2019—the week of staff cuts that Ward found extreme. McNulty says she had to work alone part of the shift and almost walked out because it was so stressful. A CVS lawyer at the pharmacy board hearing said a different pharmacist was listed to work that day and a technician was scheduled to be on duty; McNulty testified that she switched with the other pharmacist and the technician didn’t stay the whole time.

McNulty had taken shifts at more than two dozen CVS pharmacies in the area. She considered all of them to be understaffed. When she came to Ward’s pharmacy, McNulty said she ran around enough to break a sweat. “You go fast, you just get it done, and you are going to hurt somebody,” she told the state pharmacy board. “It’s just a given. And as a pharmacist, that’s your worst fear. Corporate will survive if they ki-l somebody but is a pharmacist going to?”

Signs outside a CVS store in Virginia Beach. In 2022, the company instituted a national lunch break for most of its pharmacy counters. Photograph by Jeremy M. Lange
The issue of insufficient breaks for pharmacy staff frequently came up in the Virginia testimony. In 2022, CVS implemented a national lunch break for its pharmacies, with most store counters closing from 1:30 to 2 p.m. daily.

In December 2019, in Ward’s final months on the job, her frustrations spilled over during a store visit with her district leader and a regional loss-prevention manager. “I told them that someone was going to die with these working conditions,” she testified. The visiting manager told Ward that her district leader was “not the one to blame” about the schedule, and that “this is from corporate,” according to her testimony.

The district leader, who was later replaced, told the state inspector that he didn’t recall the specifics of the exchange. CVS didn’t make the loss- prevention manager or four other corporate employees available for interviews with the state inspector.

Ward believed she’d done all she could do. She gave her two weeks’ notice in January 2020.

When the Virginia pharmacy board heard the case in February 2022, Ward was one of the first to testify. She says it was scary to face CVS, but also: “I knew I had a point.” The proceeding stretched well into the night. Two technicians who testified that day had left pharmacy work behind for another industry. One of the board members who voted to penalize the company for understaffing was himself a former CVS district leader, who worked more than 30 years at the company.

McNulty stopped taking shifts at CVS early last year and said she is no longer employed there. She still works at a hospital pharmacy in Norfolk, Va. Despite the stressors at CVS, she says she kept working there because she loved talking with patients and explaining their medications to them. Some nights it felt like she had groupies. But there’s no love lost for CVS. The fine the company received in the pharmacy board case? “Coffee change,” she says.