Pharmacy Concerns are Receiving Unprecedented Media Coverage: Synergies and Momentum can be Achieved

The following article is from Dr. Daniel A. Hussar, Ph.D. who is a retired professor from the Philadelphia College of Pharmacy and produces a monthly newsletter about pharmacy issues starting back in 2006. https://pharmacistactivist.com

Dan’s and my path crossed about a decade ago when one of his former students, Joe Zorek, who was suing CVS over EEOC, ADA and Whistleblower violation. and Joe reached out to me to help him spread the word about his lawsuit via my blog.

Joe was able to get CVS to settle without going to court, but while the terms of Joe’s agreement with CVS was confidential. In talking with Joe back then, Joe was very happy with his settlement.

Pharmacy Concerns are Receiving Unprecedented Media Coverage: Synergies and Momentum can be Achieved!

https://pharmacistactivist.com/2023/November_2023.shtml

Media coverage of pharmacy-related issues during the last year has been extensive. The high cost of drugs has been a long-standing concern that continues, but much of the recent coverage has focused on medication errors, staffing and workplace conditions that cause moral injury to pharmacists and increased risk of errors for patients, anticompetitive practices of the health insurance companies with their PBMs and pharmacies, the domination of chain stores in community pharmacy and the decline in numbers of independent pharmacies, the increased number of pharmacy deserts, the fragmentation in the medication distribution system (i.e., local community pharmacy, mail-order pharmacy, specialty pharmacy), and the reduction of personal communication with and counseling of patients.

Media attention to these multiple issues is often initiated because of a harmful medication error. Although this coverage may focus on an experience in a single pharmacy that may also identify the pharmacist responsible for the error, the publicity is a blemish on the reputation of our entire profession. However, an increasing number of reporters are looking for explanations and underlying reasons for an error, and discovering there are many contributing factors such as corporate policies/metrics and understaffing. As much as we may dislike seeing a pharmacy error publicized, the more extensive coverage that reveals the error-prone circumstances under which many pharmacists work is of value to our efforts to increase awareness of and reform the pharmacy practice system. Some examples of the recent media coverage are provided in the following discussion.

USA TODAY

“Prescription for disaster: America’s broken pharmacy system in revolt over burnout and errors” is the title of the first-page story in USA TODAY on October 26. Written by senior investigative reporter Emily Le Coz, this commentary provides excellent comprehensive coverage that identifies numerous factors that contribute to the stressful pharmacy workplace challenges and the occurrence of errors. She initiated her investigation upon learning of a dispensing error that harmed a young child. At each stage of her investigation, she discovered one problem after another that result in the “broken pharmacy system” and the increased risk of errors. Excerpts of her article are provided below:

“Medication errors are a pharmacist’s worst nightmare. Many told USA TODAY they lie awake at night wondering if, in their haste, they made a mistake that might hurt or kill someone.

In May 2021, that someone was Brenden Fisher.

The Sarasota, Florida child overdosed on a newly prescribed anti-seizure medication after the CVS Pharmacy near his home dispensed the drug with the wrong instructions on the label.

By the third dose, Brenden was lethargic, dazed and struggling to breathe. His parents, Paris Bean and Jason Fisher, rushed their then 2-year-old to the hospital, thinking he was dying.

Hospital staff didn’t know what was wrong with him, Bean recalled, until a nurse asked if he was taking his 1.2 ml of levetiracetam twice daily.

When Bean told her the instructions said to give him 7.5 ml, ‘you could almost hear her jaw drop,’ Bean recalled. She said, ‘Did you give that to him?’ And I said, ‘Yes. Is that why we are here?’ She said, ‘I wouldn’t be surprised.’

Brenden still suffers from a full-body tic he first developed during the incident, his parents said, Dozens of times a day, he will suddenly stop whatever he is doing, clasp his hands together, clench his jaw and tense every muscle in his body while staring off into space. Each episode lasts anywhere from 5-10 seconds.

His parents have not been able to definitively link the tic to the overdose, but they said they have no other explanation for it.

Bean said she blames CVS for the mistake but also herself: ‘I’m the one who physically administered it…I could have killed him.’

CVS declined to comment on the error.

Bean and her husband filed a lawsuit against CVS in February that was settled out of court for an undisclosed amount. But they said they did not file a complaint with the Florida Board of Pharmacy.

That means it’s one of countless errors for which there’s no official tally or public record.”

(Editor’s note: The strategy of CVS and others against whom lawsuits are filed when there is no question that harm was caused by an error, is to quickly reach a confidential settlement in an amount that is likely just a small fraction of what might have been obtained if the lawsuit had gone to trial).

“No federal agency requires pharmacists to report medication errors, and few state boards of pharmacy mandate it. Many pharmacies and pharmacy chains track errors internally but do not share the numbers with the public. CVS and Walgreens both declined to share their data with USA TODAY.”

Numerous pharmacists told USA TODAY that errors are not consistently reported – even internally. Small mistakes and those caught early are routinely hidden.

Even when they do report potentially fatal errors, some pharmacists said, no one from their companies investigates how they occurred or makes changes to prevent them from repeating.

Pharmacists are personally liable for medication errors and risk fines, discipline and loss of license if investigated and found responsible by their state board. Many told USA TODAY they get little or no support from their company when mistakes happen, even if the conditions imposed by those companies contribute to those errors.”

“The Nevada Board of Pharmacy in September fined and suspended the licenses of two CVS pharmacists who accidentally gave a pregnant woman the abortion drug misoprostol instead of the fertility treatment she was prescribed. The mistake, which was first reported by 8NewsNow in Las Vegas, ended the woman’s pregnancy.

The Nevada board also fined CVS $10,000 over the objections of company attorney William Stilling who argued CVS itself did nothing wrong.

‘The only allegation’ against CVS, Stilling said, ‘is that they had these pharmacists.”

(Editor’s note: This shocking statement by CVS attorney Stilling demonstrates how the company’s priority is to protect its own interests while making their pharmacists vulnerable to disciplinary action. It should be widely communicated throughout our profession as a warning about the lack of support and potential consequences for pharmacists who work for certain corporate employers).

“Pharmacists take an oath to hold patient safety in the highest regard when preparing and dispensing medication. But rising pressure within the nation’s largest retail stores have forced pharmacists to choose between that oath and their job.

The situation was bad before the pandemic. COVID-19 made it worse. It has only gone downhill since then. Frustrations boiled over this autumn in a series of high-profile walkouts that left a string of CVS and Walgreens pharmacies shuttered or short-staffed. Those actions might have caught consumers off guard. But inside the troubled industry, it was the clarion call of a beleaguered workforce pushed to the brink.

Pharmacists said it’s nearly impossible to meet all the demands without cutting corners, and when corners get cut, patients can get hurt.

In California, 91% of chain pharmacists surveyed by the state Board of Pharmacy in 2021 said they lacked the staff needed to ensure adequate patient care.

Ohio proposed a series of rules this year aimed at improving pharmacy working conditions. Among them: a ban on quotas and requirements for sufficient staffing. The rules are currently pending a vote amid overwhelming support from pharmacists and opposition from retail pharmacy chains, including Walgreens and CVS. ‘The Board should stay focused on the regulation of the practice of pharmacy rather than the business of pharmacy’ wrote CVS Director of Regulatory Affairs John Long in opposing an early version of Ohio’s rules last year.”

“Retail pharmacy wasn’t always this bleak.

A constellation of factors contributed to the industry’s downturn. They include rising drug costs, changing consumer habits and the emergence of online pharmacies.

But none looms larger that the outsized influence of pharmacy benefit managers. These third-party administrators of health insurers’ prescription drug programs have eroded the profits of retail pharmacies to the point where they now lose money on many sales.

Pharmacy benefit managers, commonly referred to as PBMs,…negotiate drug prices with manufacturers, determine which drugs will be covered by insurance plans and set reimbursement rates for pharmacies that buy and sell the drugs.

As the power of PBMs rose over the years, they demanded bigger rebates from drug manufacturers and pocketed increasingly bigger shares of those savings instead of passing them along. They also lowered reimbursement rates and tacked on hefty fees known as Direct and Indirect Remuneration.

While PBMs’ collective profits skyrocketed over the past decade, their tactics plunged retail pharmacies into financial distress and left them scrambling for alternative sources of revenue. The Federal Trade Commission launched an inquiry last year into PBM practices, which have already been the subject of several lawsuits.

Independent pharmacies have been hit especially hard. Not only are their reimbursement rates lower than those of chains, but their patients have been steered away by PBMs that insist they use a preferred chain pharmacy instead.

Other independent pharmacies simply closed.

Now the chains are following suit. CVS, Walgreens and Rite Aid all recently announced the closure of hundreds of pharmacies as they face slumping revenues and the fallout from multiple lawsuits for their alleged roles in the nation’s opioid crisis. Rite Aid filed for bankruptcy earlier this month.”

Ordinarily I would not include such extensive excerpts from another publication about situations that are so well known to pharmacists and that many are personally experiencing. However, what I have included is just a fraction of the USA TODAY coverage that also includes commentary on “Pharmacists bleeding, crying, working alone,” as well as issues such as pharmacists leaving the profession and plummeting enrollments at many colleges of pharmacy.

Emily Le Coz has provided exceptional coverage of the risks for patients and the concerns of pharmacists in her report, and also very effectively identifies and connects the multiple factors that create and exacerbate the current challenges. Although her report focuses on problems, it is not until the problems are well understood by the public and our legislators that our profession will be effective in developing and implementing solutions. I encourage you to access and read the entire report, and use the coverage of her objective “outside” observations to support your personal relevant experiences in messages with your community and local media.

The Ohio Capital Journal

Over a number of years, Marty Schladen has provided extensive coverage of pharmacy-related issues for the Ohio Capital Journal and previously for the Columbus Dispatch. His investigations were important in determining that in 2017, PBM middlemen and “secondary middlemen” charged Ohio $224 million more for drugs dispensed to participants in the Ohio Medicaid program than they paid pharmacies. The Ohio attorney general filed lawsuits that resulted in large settlements with certain of the middlemen (please see the August 2023 issue of The Pharmacist Activist).

Schladen has recently investigated and published in a series of reports about numerous errors and violations at CVS stores that were documented in Ohio Board of Pharmacy inspector reports. The Ohio Board held meetings on November 7-8 and Schladen’s excellent coverage and selected excerpts include:

November 8, 2023: “CVS disciplinary hearing before Board of Pharmacy begins.”

“With $2.3 billion in profits in the third quarter, CVS continues to boast to shareholders about its financial performance. But it apparently doesn’t want current and former employees to talk to state regulators about what goes on in its pharmacies. It filed motions to quash Board of Pharmacy subpoenas for those employees to testify in this week’s proceedings. The motions failed.”

November 9, 2023: “Ohio pharmacy board members seem skeptical of CVS claims.”

“Henry Appel, principal assistant Ohio attorney general, is prosecuting CVS in the administrative proceeding. He wants to subpoena the company’s custodian of records in an attempt to get copies of written communications between the Canton’s CVS pharmacy manager and her supervisors as problems spiraled in 2021. Dahmann (the CVS attorney) resisted first by refusing to give the records custodian’s name out of concerns for ‘personal confidentiality.” She then argued that some of the relevant CVS entities are ‘foreign’ companies domiciled in Rhode Island and Connecticut and thus are not subject to subpoenas from Ohio’s pharmacy regulator.”

“The hearing won’t resume until the Board’s December meeting at the earliest.”

November 30, 2023: “Still more Ohio CVS pharmacies accused of staffing-related problems.”

“In hearings into conditions at one of its Ohio stores, lawyers for pharmacy giant CVS last month told regulators that problems were due to understaffing and extra tasks imposed by the coronavirus pandemic. But the Ohio Board of Pharmacy continues to find such problems – which could threaten patient safety – at CVS stores across Ohio. Some were found as recently as late September.

“The most recent citations accuse CVS of improper handling of dangerous drugs, dirty conditions and six-day backlogs in filling prescriptions. As it has previously, CVS called the findings ‘isolated incidents.”

Marty Schladen understands and clearly articulates how pharmacy workplace conditions, errors, and violations are related to the policies and compensation/economic practices of PBMs that increase the risk of errors for patients, moral injury for pharmacists, and the financial survival of pharmacies. His recent commentary, “Pharmacy middleman grants huge bonuses for winning business meant to help the poor,” (November 17, 2023) begins:

“Medicaid might be a taxpayer-funded health program for the poor, but that doesn’t mean others aren’t getting rich off it – including employees of a company the state is suing on antitrust grounds. Several employees of drug middleman Express Scripts last year raked in bonuses of $750,000 each for getting the business of a managed-care company that depends on Medicaid for the bulk of its business.

In other words, in addition to their already-high pay, they received bonuses that were 18 times the average American’s annual pay just for landing a contract. And that contract is with a company that has already paid out $88.3 million to settle claims that it had defrauded the Ohio Medicaid program.

It might be striking to the average taxpayer that people with huge corporations are profiting so lavishly off of programs for the poor.”

Numerous other publications have also recently reported on the concerns of pharmacists and the risk to patients that result from the corporate dominance of pharmacy and other areas of health care. As examples, recent articles in The Wall Street Journal address issues about PBMs, health insurance companies, and pharmaceutical companies:

“Pharmacy Benefit Managers Under Fire:” (November 22, 2023; Melanie Evans);

“Senators Seek Probe of Insurers, Drug Prices:” (November 24, 2023; Joseph Walker);

“Cigna, Humana Explore Gigantic Merger:” (November 30, 2023; Lauren Thomas, Anna Wilde Mathews, Laura Cooper).

The possible merger between Cigna and Humana, which are already among the largest health insurers, has the potential to further reduce competition and increase corporate influence/control of the healthcare system. If the companies’ discussions progress in this direction, a merger would probably be challenged by the Federal Trade Commission (FTC) which is already investigating anticompetitive actions and programs of merged/acquired healthcare companies that were previously approved. There is bipartisan interest and concerns regarding the issues being addressed by the FTC, as well as legislative proposals designed to correct current problems. However, we must never underestimate the ability of the corporations such as PBMs to identify and exploit loopholes in any legislation and manipulate them to their advantage. This makes it all the more important that the public, legislators, and government officials have a clear understanding of the present concerns and consequences for the purpose of constructing legislation and taking actions that will be most effective in providing impactful reforms of our current healthcare system. If substantial reforms are to be achieved regarding pharmacy-related issues, our profession must give a very high priority to assuring that the public, legislators, and other decision-makers have a full understanding of our concerns and their risks/consequences, as well as the urgency for reform. It is in this direction that investigative reports of Emily Le Coz, Marty Schladen, and others are of great value in increasing the awareness and understanding of the public of the issues that place them at risk of harm.

Building momentum

Emily Le Coz’s investigations involved interviews with numerous pharmacists which increased the scope and depth of her coverage. Among those whom she interviewed are Michael Hogue, CEO of the American Pharmacists Association (APhA), and Doug Hoey, CEO of the National Community Pharmacists Association (NCPA). They are the leaders whom the media contact at an early point in their investigations of pharmacy-related issues, and they have been widely quoted in recent media coverage. These interviews, as well as those with other pharmacists have great benefit not only for increasing the awareness of the public of our concerns, but also their awareness of our associations and their programs and activities which are of importance for the public. The formidable challenges continue and may seem impossible to resolve, but I am impressed and encouraged by recent actions of our associations, as well as many individual pharmacists.

In addition to their support for pertinent legislative proposals, the associations’ concerns about the anticompetitive actions of health insurers and PBMs have been widely communicated. At its annual meeting in October it was announced that NCPA is working with three law firms in creating a limited liability company called TRUST LLC (www.fightPBMs.com), which will investigate and, when appropriate, litigate or arbitrate on behalf of community pharmacists to recover coerced price concessions (DIR fees) which have been assessed by PBMs and insurance plans and appear to be in violation of federal antitrust law and state contract laws. It has also been recently announced that Matt Osterhaus of Iowa is the lead pharmacist in a class-action lawsuit against CVS Health, CVS Caremark, and Aetna.

The APhA has established several programs to document unacceptable workplace conditions and to support the well-being of pharmacists. CEO Michael Hogue has recently stated that: “The APhA has been focused on longer-term fixes, and what we’ve heard loud and clear is we need to focus on the acute problems. That’s what we are going to do.” Hogue has met with CVS pharmacists who participated in the walkout of numerous CVS stores in the Kansas City area in protest of understaffing and stressful working conditions. The actions of these courageous pharmacists have resulted in wide media coverage and has provided the impetus for subsequent walkouts and initiatives to start a pharmacy guild. On October 30, Michael Hogue released a statement regarding the challenges for pharmacists, and excerpts are provided below:

“APhA stands with every pharmacist who participated in the walkout today.

For years, you have dealt with workplace issues, leading to frustrations and burnout, affecting your mental health and well-being.

While today Walgreens and CVS pharmacies are the focus of attention, I’ve also seen and heard clearly that corporate chain pharmacies are not the only place where pharmacists are being asked to work without adequate staff. I’ve heard from pharmacists in hospital outpatient pharmacies, federal facilities, and mail facilities about the same burnout from inadequate staffing.

In many ways, the recent headline of a USA TODAY story is true, our pharmacy system is broken.”

“For far too long, employers have made the situation worse than it needed to be. Supervisors who are not pharmacists do not understand the needs of care teams and make unreasonable demands on time-based productivity. Quotas on the number of prescriptions filled per hour or vaccines administered per day, or even time to answer the phone, simply fail to recognize that the pharmacist-patient relationship is not transactional. It is a special covenant – and supervisors who distill everything down to numbers and time metrics are destroying that relationship in the name of profitability. This must stop immediately. Employers should ensure supervisors clearly understand the covenantal pharmacist-patient relationship and that systems support this relationship fully. I again call on all employers to act swiftly on these issues that your pharmacy staff has made clear that they will no longer tolerate.”

“I’m also calling on CVS/Caremark, Express Scripts, Optum and all other PBM companies to immediately cease the assessment of DIR fees on retail prescriptions and ensure your contracts result in payment to pharmacies of at least their cost for the medicine they are providing plus a reasonable fee for doing so. You are breaking the backs of community pharmacists and are ultimately complicit in the workplace issues I am describing. Your corporate policies are unfair, restrict trade, and are causing the closure of hundreds of pharmacies across America. You are worsening health disparities and creating a new health emergency.”

This is, by far, the strongest and most direct position I have seen from APhA regarding the challenges that threaten future opportunities and accomplishments in our entire profession. Pharmacists in every area of responsibility must support these positions, and synergies can be achieved by close working relationships with media personnel in increasing public awareness of the concerns that place them at risk.

We must build on the momentum that currently exists!

CVS launches new pharmacy reimbursement model, brand for health services segment

This article was published in DRUG STORE NEWS, which is a industry journal. Many in the medical care industry is expanding their scope of services that they provide under one corporate banner. This is known as vertical integration.  While this article is sprinkled with the term “pt care”.  I have highlight some of the text from this article. That suggests to me, this whole new medical care model, is CVS’ intentions to attempt, as much as possible, once any part of CVS Health system cares for a pt’s health needs that they will refer the pt to other parts of the CVS Health system for generating additional revenue for CVS. By having their own employees recommend/prescribe additional health services, that parts of CVS Health provides.  I have stated many times before, that our entire healthcare system is nothing more, nothing less than a FOR PROFIT BUSINESS.

CVS launches new pharmacy reimbursement model, brand for health services segment

https://drugstorenews.com/cvs-launches-new-pharmacy-reimbursement-model-brand-health-services-segment

CVS is introducing CostVantage and Caremark TrueCost to drive aligned incentives and deliver a more transparent and sustainable reimbursement model.

CVS Health introduced a new pharmacy reimbursement model, and brand for its health services segment that showcases continued growth opportunities for its businesses.

CVS Pharmacy also announced CostVantage, a new approach that evolves the traditional pharmacy reimbursement model and brings greater transparency and simplicity to the system. CVS CostVantage will define the drug cost and related reimbursement with contracted pharmacy benefit managers and payors, using a transparent formula built on the cost of the drug, a set markup and a fee that reflects the care and value of pharmacy services. These changes also help ensure that CVS Pharmacy locations will continue to be a critical touchpoint for consumers to access affordable health care in their communities, the company said.

“We are successfully executing on our strategy to advance the future of health care while unlocking new value for consumers,” said Karen Lynch, president and CEO of CVS Health. “The combination of our businesses, and the key growth areas we have invested in, drive our ability to lower the total cost of care, improve health outcomes, and deliver on our commitments to our customers, consumers, and shareholders.”

“We are leading with an approach that will shift how our retail pharmacy is compensated by implementing a more transparent and sustainable model that fairly aligns pharmacy reimbursement to the quality services we provide,” said Prem Shah, executive vice president, chief pharmacy officer and president, pharmacy and consumer wellness at CVS Health. “It provides our PBM and payor clients a foundational step towards more pricing clarity for consumers.”

CVS Pharmacy plans to launch CostVantage with PBMs for their commercial payors in 2025, working together to ensure a smooth transition.

The company said that following on from the launch of its Choice Formulary program earlier this year, CVS Caremark today introduces TrueCost, a model innovation that offers client pricing reflecting the true net cost of prescription drugs, with visibility into administrative fees. Simplified pricing will help consumers be confident that their pharmacy benefit is providing the best possible price and will allow members to have stable access to its national pharmacy network. Through this approach, clients will have the flexibility to choose a pharmacy benefit model that works best for the unique needs of their members and plan, and CVS Caremark TrueCost provides another valuable option for them. CVS Caremark plans to launch CVS Caremark TrueCost in 2025.

To help demonstrate the connection and convenience CVS Health uniquely delivers, CVS Healthspire will be the new branded name for the company’s Health Services segment, including Caremark, Cordavis, Oak Street Health, Signify Health and MinuteClinic. The groups within CVS Healthspire will continue to focus on integration across the company’s assets to deliver connected patient care, pharmacy benefits and innovative provider support solutions in communities across the country, making expert care simple, more accessible, and more affordable. 

The CVS Healthspire brand will begin to roll out publicly this month and advance throughout 2024. Consumers will initially see “Part of CVS Healthspire” appear on select CVS Health care delivery offerings across digital and physical assets as the company continues to create an integrated ecosystem for patients.

“Delivering care in a more integrated way – especially for complex patients with chronic health conditions – improves health outcomes and the patient experience,” said Mike Pykosz, CEO of Oak Street Health and interim president of Health Care Delivery. “We are already seeing the benefits of our value-based model to lower the total cost of care for customers, clients, and patients, and we believe we will build on these results as we more fully integrate with our core businesses.”

While CVS Health’s business segments continue to be successful and profitable on their own, there is a sizable opportunity to continue strengthening these connections and create incremental value for the overall company, CVS Health said.

[Read more: CVS Health report highlights need for expanded role of retail pharmacists]

CVS Health provided the example of the recent improvement of Aetna’s Medicare Advantage Star Ratings. In just a year, by leveraging the power of the company’s cross-enterprise assets and executional excellence, Aetna was able to achieve 87% of their members in four star plans or better for the 2025 plan year, a recovery from 21% in the previous year, the company said.

“This achievement was due to the work across our Aetna, CVS Pharmacy, and CVS Caremark colleagues. Even more important than our ratings, these teams worked together to help members improve medication adherence and overcome barriers such as costs and transportation,” said Lynch. “Our strong performance in this area shows how we can quickly unite our businesses to achieve important common goals.”

CVS Health interim chief financial officer Tom Cowhey today will detail the company’s 2024 financial outlook, capital deployment strategy and long-term outlook and growth targets. The company’s unique combination of assets provides CVS Health with clear opportunities for long-term outperformance, including through Medicare Advantage margin recovery, incorporating Star Ratings, starting in 2025; CVS CostVantage, the company’s new retail pharmacy pricing model; increased patient enrollment in Oak Street Health; expanded product offerings through Signify Health; and enhanced growth in core businesses from new offerings in healthcare delivery.

“By broadening our portfolio of integrated products and services, we expect to create a path to sustainable, profitable growth,” Cowhey said. “Our powerful cash generation capabilities will support our strategic goals, prudent capital deployment, and attractive return profile – while also providing opportunities for meaningful long-term outperformance.”

Bossier City CVS pharmacy shut down amid DEA investigation

Bossier City CVS pharmacy shut down amid DEA investigation

https://www.shreveportbossieradvocate.com/news/bossier-city-cvs-pharmacy-shut-down-amid-dea-investigation/article_30b06a92-9399-11ee-befa-53809e1d2b32.html

The CVS pharmacy location on Barksdale Boulevard in Bossier City,LA is not serving patients amid a Drug Enforcement Administration investigation.  

The location’s pharmacy is closed as DEA agents and Bossier City Police are on the scene.

Representatives of CVS have not yet responded to requests for comment.

This is a developing story and will be updated as more information is discovered. 

US drug shortages are forcing ‘impossible choices’ for Americans, experts tell Senate committee

I find this article while starts out interesting and ends up with a Dr. Inmaculada Hernandez, Ph.D. that starts overstating what pharmacies and wholesalers make on supply side of the prescription mark. According to this Dr’s professional information on LinkedIN https://pharmacy.ucsd.edu/faculty/hernandez. Apparently she got her Ph.D. in 2017, suggesting that she has only signed the back of a paycheck, unlike those – like me – who have been owned and operated their own business. Over the years, I have signed the front side of a lot more paychecks than I have just the back side of a paycheck. In our pharmacy’s peak years, I was signing nearly 500 paychecks per year.  Then started addressing the mark-up/gross profit of wholesalers and pharmacies, does someone who has never owned/operated a business, have a clue about overall business expenses and producing/managing a profitable business? The above graphic gives an example of the gross profit of various parts of the Rx distribution system.  Wholesalers are showing a GROSS PROFIT OF 2% and Pharmacies of 3%. The Insurance/PBM had a gross profit of 46%. Those two are lumped together, because the top FIVE PBM’S are owned by insurance companies.

The typical pharmacy has a underlying cost of $12-15$ in fixed overhead per Rx.  That covers rent, utilities, insurance, payroll and overall cost of operating a business. For a pharmacy to stay in business the final cost of Rx should start with $15 PLUS the cost of the medication. For some very inexpensive generics, the gross profit the pharmacy shows, for the uninformed could appear to be extremely high. The last independent pharmacy in an adjacent county to ours, closed down early this year – after being open for 70+ yrs – because the pharmacist owner stated in the media that the PBM’s were paying less than it cost her to buy the medication from the wholesaler on 50% of the prescriptions that she filled.

I wonder why this particular “expert” did not STAY ON TOPIC in the testimony before this Senate Committee? But now the Senators on this committee, got a very inaccurate information about some of the costs/profits within the Rx medication distribution system.

US drug shortages are forcing ‘impossible choices’ for Americans, experts tell Senate committee

https://www.cnn.com/2023/12/05/health/us-drug-shortages-forcing-impossible-choices/index.html

As director of the Lymphoma Clinical Research program at M.D. Anderson Cancer Center in Houston, Dr. Jason Westin regularly witnesses the power of lifesaving cancer drugs. But because generic cancer drugs are often in shortage in the United States, he says, he and his patients have been put in a terrible position.

“The absence of a generic and cheap drug like fludarabine literally can be the difference between life and death,” Westin told members of the US Senate Committee on Finance at a hearing Tuesday.

The committee has been investigating a record shortage of drugs, a problem that’s been going on for decades and is unique to the United States, studies show

Several senators said they’d heard from constituents who are sick or who have patients hurt by these shortages. Sen. Marsha Blackburn noted that the medical center at Vanderbilt in Nashville has had to dedicate more than 100 staff members to managing and mitigating disruptions caused by shortages.

“This is something that is becoming all too common with our providers,” the Tennessee Republican said Tuesday.

The majority of the nearly 200 ongoing shortages – 84% – don’t involve new or novel drugs but rather generics that have been on the market for decades, said Sen. Mike Crapo, R-Idaho. Generics make up 9 of every 10 prescriptions filled in the US, so shortages have a big impact on the country’s health.

“These shortages can inflict drastic harm on massive populations of Americans,” Crapo said. “The average shortage affects at least half a million consumers, forcing them to scramble for viable alternatives or they’ll forgo treatment entirely.”

Many of these generics treat cancer. Fludarabine, a reliable drug used as a part of CAR T-cell therapy, is in shortage now, according to the US Food and Drug Administration. As with a lot of generic drugs used to treat cancer, it has been on and off the list for a few years.

For Westin and his colleagues, patients with rapidly progressing aggressive blood cancers don’t have time to wait for a drug to come back in stock. There’s only a narrow window in which they are well enough to get a potentially lifesaving CAR T-cell therapy, something that works only with fludarabine. There is no alternative, Westin told the committee.

“My colleagues have been forced to make impossible choices, including to choose which patients will be prioritized to receive potentially curative therapy,” he said.

“We know how to treat cancer, but shortages force impossible choices,” he added. “We have drugs that are lifesaving and shortages that are life-threatening.”

A large part of the problem with generics is that they have razor-thin margins and little profit to show for them, so companies often aren’t interested in making them. The number of companies exiting the market to make these drugs exceeds the rate of those entering the market by upwards of 40%, Crapo said.

Much of generic manufacturing gets outsourced to other countries like China and India, which can present geopolitical problems as well as quality-control issues, noted Dr. Inmaculada Hernandez, a professor in the Division of Clinical Pharmacy at the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California in San Diego.

“We have a drug supply chain that heavily relies on foreign manufacturing. This is a national public health risk,” Hernandez told the committee.

One solution would be for the government to use value-based payments to incentivize large buyers of generics like pharmacies and hospital systems to purchase medicine from manufacturers with more dependable supply chains, she said.

Makers of generic drugs don’t have to share information about the supply chain, so buyers currently choose based only on price.

To truly end shortages, the Centers for Medicare & Medicaid Services, the nation’s largest purchaser of drugs, would have to be able to buy based on manufacturing quality and reliability, not just on price, said Dr. Marta E. Wosińska, an economist and senior fellow at the Brookings Institution.

“If we start rewarding reliability, manufacturers can maintain actually a higher price point because it’s rewarded, that reliability. Then there’s going to be an incentive that will follow,” Wosińska testified Tuesday.

In other words, more companies would get into the generics business.

Another problem the government would have to overcome, experts testified, is the consolidation of generic drug purchasing among a “small group of very powerful health care middle men,” said Sen. Ron Wyden, D-Oregon. Although there is money to be made in generics, it’s going to these middle men – drug wholesalers and pharmacy benefit managers or PBMs – rather than to manufacturers.

“There are many companies that manufacture generics, but they must compete for the attention of highly consolidated middle men,” Wyden said. Three drug wholesalers control 90% of the nation’s pharmaceutical market, he said.

“The generic manufacturers that are awarded contracts by these middle men do so by offering penny-on-the-dollar prices,” Wyden said.

Offered such low prices, companies don’t earn enough to invest in capacity or in equipment that’s key to making reliable high-quality medicines.

“So you have, in effect, a race to the bottom price for generics that leads to quality control problems and factory shutdowns,” Wyden said.

These “middle men” have also received criticism for driving up drug prices. In a study published Tuesday in the journal JAMA, Hernandez and her co-authors say that PBMs often pay pharmacies “unjustified excessive amounts for generics, as high as 10 times acquisition costs,” which the PBMs then recover through clawbacks rather than passing on to customers.

Hernandez told the Senate committee that of the top 50 generic drugs paid for by Medicare Part D, 16 were marked up 1,000% or higher. For aripiprazole, an antipsychotic drug, pharmacies paid an average of 17 cents per tablet; Rite Aid’s pharmacy benefit manager paid $11.70 per tablet, a 7,000% markup.

“So they end up paying much more than, actually, the pharmacy paid for the drug, let alone the manufacturer got for it,” Hernandez said.

Hernandez said she recommends greater oversight of PBMs. Legislation currently before the Senate would make it illegal for PBMs to engage in “spread pricing,” in which companies charge payers and health plans more for a prescription drug than what they reimburse the pharmacy, and the PBM pockets the difference.

Until there is some kind of legislation that addresses drug shortages, Wosińska and the other experts agreed, they will continue.

“What is vexing about these shortages is that they’re largely avoidable,” Wosińska said.

How many bodies does it take to be declared a genocide?


I am going out on a limb and make a statement about the DEA and what they are going to do after the public comments on their proposed cuts in the pharma production quotas has closed.

I have been a student and observers of what the Federal bureaucrats have done over the last 40 yrs. The last 10 yrs that we had our independent pharmacy, we had expanded and developed a very sizeable Home Medical Equipment (HME) business.  We belonged to two national associations. One whose membership was independent pharmacy owners and the other was people in the HME business.  Each year, each of these associations had a lobbying conventions. Hundreds of people in business would go to Washington DC. To meet with and lobbying our members of Congress.

After going to Washington DC for several years in a row with all those other people that had businesses in those two industries and talking to our members of Congress and nothing changed. I kind of gave up talking to legislators. One year, we had an appt with one of our Indiana Senators. When we got to his office, we were introduced to his LA (Legislative Assistance). Our Senator was too busy or important to meet with one of his constituents.  This LA, we were told, was the Senator’s point person for industry we wanted to talk about.  It didn’t take but a few minutes talking to her to figure out it would take TWO TEAMS OF Clydesdale HORSES to drag her ass to what she should have known.

Then there was the issue where I mailed a letter to one of our Senator’s Indiana office in Indianapolis. I got back a letter from the Senator’s office stating that he was also AGAINST whatever the issue was. He agreed with my position. A day or so later, I got a SECOND LETTER from this Senator’s office, This letter stated that Senator agreed with me, in being in favor of the same issue.

I quickly became skeptical about how our political system functions. What the politicians lead to believe how things works, has little to do with reality.

Today, one of the chronic painers told me that abt 600 comments on that site, did not show up.  I am not aware of anything in the law that “they” have to accept all comments, nor read any of the comments, nor take into consideration any/all comments when they make their final decision. The whole process seems to be a lot of SMOKE AND MIRRORS.

The DEA as been perpetuating their agenda for 53 yrs. They say no one is above the law, but it does seem that those who enforce our laws can be selective in how they operated within our system.  My crystal ball strongly suggests that there are many within our judicial system and healthcare system are working toward restricting the availability of all controlled meds. Will “bodies” start to pile up from premature deaths and/or suicide from drastic reduction the availability of controlled meds. Could history look back on this period and see all these deaths as a sort of covert genocide?

 

 

What parameters need to be met for a entity to be declared a terrorist?

During first week of  Oct, a group that has historically been labeled as a terrorist group, They invaded and abt 1400 innocent individuals, including abt 260 that was attending a music festival in a open “desert area”. It is reported that some of the terrorists came to the area in motorized hang-glider and machine guns and did their killing from the air.

Understandably, the country that was invaded and its citizen killed in the massacre. Some reports that some – from children, women and adults – were tortured and killed. Their military started retaliating against those that were responsible for brutally torturing and killing their citizens.

From what I have seen on TV, much of the country the invaders came from is being turned into a “dust bowl” by the country they invaded.

We know that at least 80,000 of our citizens will be poisoned by illegal fentanyl from China and Mexican cartels this year. That means that it would take abt ONE WEEK to kill as many of our citizens by illegal fentanyl and other illegal “street drugs” as was killed in one day by that group of terrorists. What has our country’s response been to the killing of so many of our citizens?

Alejandro Mayorkas is Secretary of the Department of Homeland Security since Jan 2, 2021. The above you-tube is just one of many Congressional committees that he has appeared before and every time before one of those committee where he has refused to state that our southern border is “closed”.   I guess that he doesn’t want to be held in contempt of Congress for lying under oath, in front a Congress. I have seen statements that all the illegal Fentanyl that is being seized/confiscated,  only represents abt 12%-18% of what gets to our streets and poison/kill nearly 100,000/yr of our citizens.

Doesn’t most federal bureaucrats take a oath to honor our constitution and protects us and our country from terrorists/enemies both foreign and domestic?

Why are we pouring billions and billions into Ukraine and Israel to help them protect their borders. While at the same time we are allowing 100,000’s/month illegals coming into our country?  Just this week, I saw a news video of a boat load of illegal immigrants coming ashore at Malibu Beach, CA. The illegal Fentanyl is killing more of our citizens- every year – than all of our soldiers that got killed in the 12-14 yrs of the Vietnam war.

Earlier this year, the DEA stated that <1% of pharma opioids were being diverted.  Yet, the DEA has published the intent of reducing the pharma production quotas and last year, 41 state Attorney Generals sued the 3 major drug wholesalers that control about 85% of the Rx wholesale market and here is a 8 page synopsis of that nearly 600 page agreement https://www.pharmaciststeve.com/pharma-prescribed-opioids-to-pts-with-valid-medical-necessity-0-022-pts-odd/kaiser/

How many chronic pain pts are going to have a forced reduction in their pain meds, making them basically bed, chair, house confined – like being put under HOUSE ARREST – and they have not committed any crime.  How many are going to die prematurely from the known possible comorbidity complications from under/untreated pain?  How many are going to commit suicide because when they have their pain meds cut, they will be living in a torturous level of pain and end up taking their final option is all they have left?

On Oct 7, 2023 Hamas terrorist came into Israel and tortured, killed 1400 people at a music festival. The illegal Fentanyl on our streets kills that many of our citizens EVERY WEEK. BUT… I have not seen where “we” have labeled China and/or Mexican cartels as terrorists.

Where are all those bureaucrats that are suppose to defend “us” and our country against enemies foreign and domestic. Could it be that some of those same bureaucrats are terrorists  What else would you call all these bureaucrats that are intentionally and diligently trying to deny appropriate health care to a sizeable minority of our country who is most likely would be considered disabled.

I will close with a quote from a former VP- who was also a Pharmacist..

“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey

 

 

 

OPIOIDS: THE FALSE EPIDEMIC BASED ON DR. DAVID TAUBEN, MD AND CDC, PROP BIG LIE THAT SENT YOUR INNOCENT DOCTORS TO PRISON

DR. DAVID TAUBEN, MD

 

CDC (OPIOIDS), PROP “THE EPIDEMIC THAT WASN’T,” AND THE DEADLY RECORD OF DR. DAVID TAUBEN, MD “THE HIDDEN AGENDA OF PROP’S EUGENICS”

 

fund raiser for Emmalyn’s Journey

The little lady in the video below is just 14 y/o and has been thru 54 different surgical procedures since she has been born. That is 3-4 surgical procedure EVERY YEAR.

She is dealing with a handful of different health issues, each can be substantial pain generators,  Chiari Malformation, EDS, Adhesive Arachnoiditis, Tethered Cord Syndrome, Syringomyelia, Mast Cell Activation Syndrome, CSF leaks and lives with 10/10 pain in her head and back everyday. She also walks with a cane as she can’t bare weight on her left leg without it giving out.

Emmalyn’s neurosurgeon has recommended that she go to the Spero Clinic in Arkansas. After so many surgeries, her central nervous system needs to be reset, working in getting her walking again and hopefully getting her pain somewhat better! They will not be taking any pain meds away! Unless she is doing better. This is a very aggressive program to help with all of the above.

Emmalyn is on Arkansas’ Medicaid and Medicaid has so many hoops and hurdles to get them to approve paying for her to be seen by the Spero Clinic, and the clinic program is 3+ intensive months. They have so many slots, because they have pts dealing with rare/complex diseases coming to them, from all over the world.

American Pain and Disability Foundation was able to help raise the $2,500 down payment. To reserve her a slot in the first quarter of 2024. But she needs another $55,000 to pay upfront to be able to receive her needed therapy at Spero clinic, and the cost for the family because they will have to move to Arkansas while she is in therapy.

I remember when I was 14 y/0, a Freshman year in High School. Getting to enjoy football & basketball games, sock hops, and many other new kids in my universe, some I will become friends with. A few years later would get to go to Jr/Sr Prom and all the activities in between.  The Spero clinic may be Emmalyn’s best shot to her day to day life closer to what her teenage years should be like. Maybe she can walk away from her cane, walker and wheelchair and get along with her life.

Please consider donating https://www.gofundme.com/f/emmalyns-journey and sharing to help us reach her goal. Thank you for your kindness and support.

#EmmalynsJourney

https://emmalyns-journey.com/

 

 

 

 

 

 

 

 

 

 

https://www.gofundme.com/f/emmalyns-journey

 

 

 

In the rear view mirror: 10 Years Ago Today: My First Publication as a Pain Patient Advocate in the New York Post mirror:10 Years Ago Today: My First Publication as a Pain Patient Advocate in the New York Post

10 Years Ago Today: My First Publication as a Pain Patient Advocate in the New York Post

https://www.acsh.org/news/2023/11/30/10-years-ago-today-my-first-publication-pain-patient-advocate-new-york-post-17358

Exactly 10 years ago -December 2, 2013 – my first-ever published opinion piece about the erosion of pain control appeared in The New York Post. It was titled “New painful casualties of the drug war” and was written three years before the CDC’s formal declaration of war on pain patients. It is frightening to look back a decade and see how much of this has come true. Plus much worse. Here is the article from the Post opinion page.

Thanks to a thoroughly misguided move by federal drug bureaucrats, many Americans are going to have to live with needless pain.

In an ill-conceived effort to address narcotic abuse, the Food and Drug Administration has come up with a plan that will hit hard at people genuinely in need of pain relief. And ironically, it may very well make the drug abuse problem worse, not better.

The new regulations will raise hydrocodone (the narcotic found in Vicodin) from a Schedule III drug to Schedule II — the most restrictive category for any approved drug. As a result (among many other restrictions), doctors will no longer be able to phone a pharmacy to prescribe even a small emergency supply of any narcotic — the only effective medication for moderate-to-severe pain. (Non-narcotic pain relievers — the next available option — don’t even touch severe pain.)

Instead, the patient will have to physically get the prescription and bring it to the drugstore. Which will not be especially wonderful when it’s 3 a.m., the Vicodin prescribed after your oral surgery has run out, and your only choice is a night of extreme suffering or a trip to the ER.

The change will bring several short-and long-term consequences — all bad:

– The impact on people suffering from serious pain will be profound, especially for people living with severe, chronic pain, such as cancer patients who, if undertreated, will suffer enormously and needlessly.

– The shift effectively turns all doctors into potential suspects as drug pushers, so many will become more reluctant to write legitimate prescriptions for narcotics for fear of getting on a list — and you better believe there’ll be one.

– Drug abusers will get their fixes one way or another. If they can’t get Vicodin, they’ll find something worse.

That’s exactly what happened with OxyContin, a high-dose, time-release version of oxycodone (the narcotic in Percocet).

“Oxy” became a very popular drug of abuse since it contains 8 to 16 times the amount of oxycodone found in one Percocet. Addicts found out that they could get around the time-release properties by simply grinding up the pill, thus getting the entire dose at once.

So in 2010, Purdue Pharma, the makers of OxyContin, came up with an essentially foolproof formulation that prevented abuse. But a 2012 New England Journal of Medicine study examined subsequent narcotic use in drug-treatment centers in 39 states; it concluded that although Oxy abuse had dropped sharply, heroin use had doubled.

That didn’t work out all that well, did it?

Janet Woodcock of the FDA recently said, “These are very difficult trade-offs that our society has to make. The reason we approve these drugs is for people in pain. But we can’t ignore the epidemic on the other side.”

Maybe they can’t ignore it, but it should be none of their business. When medicine and law enforcement mix, everyone loses. It is not the job of doctors or the FDA to be involved in monitoring or addressing criminal activities.

It defies logic to create a policy that will effectively punish people who are in real need in order to short-circuit criminal activity. It’s just another self-defeating escalation in the dismal failure we call the War on Drugs.

Bad laws always have consequences. In this case, the “remedy” will be far worse than the problem — doing little or nothing to stop drug abuse but plenty to cause needless pain and suffering for people in need.

You don’t punish patients to go after addicts or criminals. That’s a pain our society should avoid.

Josh Bloom is the director of chemical and pharmaceutical sciences at the American Council on Science and Health.

Originally published in The New York Post

Is pain really all in your head?

 

I won’t drop down and say that this presenter suggests that your pain IS ALL IN YOUR HEAD. I am all in for complimentary care for the chronic pain pt. Often a full array of complimentary services many not be available/accessible, nor affordable by the pt.

Many pts are disabled and on Medicare disability and/or Medicaid. If the spouse is still around, the chronic pain pt, may not have transportation to medical services, because they no longer drive and spouse would have to take off work to transport them to get medical services/procedures. Causing the family’s finances to take “another hit”.

I noticed that “pain” seems to be addressed like it is like a monolith …  never talks about the intensity of the pt’s pain, nor the fact that the pt may have more than one disease/health issue that is a pain generator. I have communicated with too many chronic pain pts that state that their blood pressure has increased to emergency crisis level (200/100)+ after forced tapers and even when being prescribed 4-5 different pharma BP meds, their BP remains in the emergecy crisis level.

So it would appear that the pharma meds is focused on a different pathway than the pathway that under/untreated pain causes a pt’s BP to be elevated to a life threatening levels.

The chart below shows the potential of under/untreated pain complicating a pt’s co-morbidity issues and/or can cause the pt to have additional health/disease issues.

A pt being put thru forced titration of their opioids, may end up bed/chair/house confined. Much like being under house arrest without actually committing any crimes.

Shouldn’t all healthcare providers be focused on optimizing the pt’s QOL, with whatever services or products that the pt can afford?